AN OVERVIEW OF THE PATENT PROCESS IN THE UNITED STATES - Patent law

U.S. patent applications are filed with the USPTO, located in Alexandria, Virginia,which is very close to Washington, D.C. It is interesting that the USPTO is one of the few government operations that, at least up until recent years, actually produced more revenue for the government than it used. It is not surprising that such governmental economy could not last for long, and the situation has apparently been corrected such that the USPTO now appears to be approximately revenue neutral in recent years(Figure below). The USPTO is an extraordinarily busy place, with the number of patent applications increasing each and every year without respite (Figure below) Due to the volume of work that it handles, the USPTO is a relatively large operation, employing thousands of patents examiners across a number of specialties. The great majority (if not all) of patent examiners in the chemical, materials, and pharmaceutical science shave bachelor’s degrees and usually advanced degrees in the relevant disciplines.The individual examiner’s work is reviewed and supervised by senior examiners .Depending on the type of decision being made by the examiner, it can be either appealed or petitioned. Appeals go to the Board of Patent Appeals and Interferences(the Board) whose membership is made up of administrative patent judges appointed by the USPTO director. Appeals heard before the Board are typically decided by a three-judge panel.

patent applications increasing each and every year without respite

FIGURE :Revenue and cost figures for the USPTO (2004–2007).

Revenue and cost figures for the USPTO (2004–2007).

FIGURE : Patent applications filed with USPTO by year and type.

Patent applicants may represent them selves (pro se applicants) before the USPTO, though it is more common to have a patent agent or attorney assisting in the process.

To represent clients before the USPTO, the agent or attorney needs to be registered before the USPTO, which usually requires passing an entrance examination, having an accredited degree in an appropriate technical area or enough scientific college or university credits to meet the established criteria, and being able to satisfy certain personal moral fitness criteria. The difference between a patent agent and apartment attorney is that the patent agent is qualified before only the USPTO, where asa patent attorney is qualified before the USPTO as well as before one or more state bars. When matters of representation are limited strictly to patent preparation and prosecution issues only, a patent agent may very well be competent to handle the situation. However, when broader matters are contemplated (e.g., licensing of intellectual property), it is likely one will need a patent attorney.

Normally, the patent applicant or assignee will sign a power of attorney identifying his representative(s), who will then conduct the patent filing and prosecution on the applicant’s behalf. The applicant’s representative will sign off on each item of correspondence with the USPTO and include in each signing his unique USPTO registration number. Ultimately, it is the legal assignee that has the authority in determining how the process should proceed. The assignee may or may not be the inventor(s), depending on whether the inventors have already assigned their rights to another party. Should he desire, the assignee can switch representatives during the process if he is not satisfied with his representation before the USPTO.

The patent application process begins with the filing of a patent application in the USPTO, but it does not end there. From the time of the filing to the grant of a patent and sometimes beyond, a stream of correspondence between the applicant’s representatives and the USPTO will begin. The primary goal of the patent applicant will be to get his invention “allowed” such that one or more patents with claims to the invention will be issued. The process of getting the claims allowed is commonly referred to as patent prosecution. This process is subject to a very large number of rules and formalities, which are outlined in great detail in the Manual of Patent Examining Procedure (MPEP).

Although the patent process begins with the filing of a patent application with the USPTO, the types of patent applications can vary according to whether the applications for a design, plant, or utility patent. As chemists, we probably will be concerned only with the latter of these three choices, and so all references to patents from hereon, unless designated otherwise, will refer to utility patents. Patent applications can be filed directly with the USPTO or may enter the USPTO indirectly through a patent filed internationally under the Patent Cooperation Treaty (PCT). Due to the important differences between these two processes for filing a U.S. patent application, they will each be detailed separately.

The initial filing of a patent application in the United States can be either as a regular (non-provisional) patent application or a provisional patent application. The differences between these two types of patent applications are numerous (and significant), with the largest difference being that a provisional patent application will never be directly examined and it becomes abandoned automatically 12 months after filing. Provisional patent applications are not examined for patent ability, so they do not need to include any claims (although they often do). Given these facts,you might be surprised to learn that a fair percentage of patent applications filed directly in the United States are filed initially as provisional patent applications (Figure below), but once you learn the advantages of filing a provisional patent application,you will come to see why they are so popular.

In addition to decreased filing costs and formalities, a provisional patent application establishes a filing date for the subject matter described in that provisional patent application but does not start the non-provisional patent-life clock ticking. Non-provisional utility patents filed in the United States expire 20 years from their filing date, absent special circumstances;the day the non-provisional patent application is filed is the day the 20-year clock starts counting down. For this reason alone, anything that can delay the filing of the non-provisional patent application without prejudicing the rights or opportunities of the party filing the patent application is very valuable. When a provisional patent application is filed, the effective filing date for the subject matter contained in the provisional patent application is the date it is filed, much in the same way that it is in a regular patent application. Within 12 months of filing the provisional patent application, the applicants have the opportunity to do one of a couple of things.The first and easiest thing that might be done is nothing at all. The applicant may simply decide not to pursue the invention, and after 12 months, the provisional application is automatically abandoned without any affirmative action by the applicant required; it’s as if the patent application never existed at all.12 In this regard, it must be reemphasized that a provisional patent application is not examined for patent ability by the USPTO and, accordingly, will never give birth to an issued patent.

If the option just discussed does not appear particularly productive to you, then you may find the next option to be more to your liking. Under this option, the provisional patent application is filed and then relied on as a priority document by a later-filed, non-provisional patent application. Under this scenario, the non-provisional patent application claims the benefit of (borrows) the filing date of the earlier-filed provisional patent application with respect to the information disclose din the provisional patent application(s) and to the extent that information provides support for what is claimed in the regular application. In a contest for priority,the filing date is particularly critical in the rest of the world (outside the United States) because the filing date establishes who gets awarded priority of invention.In the United States, as we will learn in the next chapter, the priority of invention(within certain limits) is awarded to the first to invent and not the first to file, so the advantages of an earlier filing are not quite as acute but still can be very relevant.

U.S. non-provisional patent applications terms are normally 20 years from the date of their filing. A provisional patent application can establish the filing date of the subject matter disclosed in the application but does not start the 20-year clock ticking. One way of looking at the provisional patent application is that it effectively extends a20-year patent term up to a 21-year patent term. The temporal relationship between a provisional and non-provisional patent application claiming priority to that provisional patent application is illustrated in Figure below. To better appreciate how the provisional patent process works at the USPTO, let’s consider a first hypothetical example (hypothetical 2.1). A synthetic medicinal chemist working at the Wish I Were Here pharmaceutical company has been synthesizing compounds for a neuroscience program targeting schizophrenia. In the course of his work, he makes the following discoveries, and his company takes the following actions. On June 3, 2008, he synthesizes the carbazole-containing structure.A (Figure below shows the structures of the compounds and the respective patent filing sin this example).After establishing that the compound is active in well-established biological models,a provisional patent application (number 61/136,899) is filed on July 15, 2008,describing the synthesis and biological activity of the compound A.

Not content to rest on his laurels, the chemist continues to work on the project by optimizing the properties of his initial lead compound. Every time he makes a new analog with good activity, he writes up his experimental section and heads down to the company’s patent attorney who promptly drafts a new provisional patent application containing information relating only to the new analog in it. On September29, 2008, he synthesizes the molecule with the structure B. After establishing that the compound is active in well-established biological models, a provisional patent application is filed on December 29, 2008, describing the synthesis and biological activity of the compound B.

synthesis and biological activity of the compound B

FIGURE :Timeline showing the effect of provisional filing followed by a regular filing in the United States.

Timeline showing the effect of provisional filing followed by a regular filing in the United States.

FIGURE :Compound structures, filing dates, and application numbers for the filing of compounds A–D.

On April 1, 2009, he synthesizes the molecule with the structure C.After establishing that the compound is active in well-established biological models, a provisional patent application is filed on April 15, 2009, describing the synthesis and biological activity of the compound C.

On July 11, 2009, he synthesizes what is to be the final compound in the series,compound D. The patent attorney, vaguely recalling that somehow there was a limitin terms of how far back a priority application could go back and still have priority claimed from it, decides he should write all the compounds up together (including compound D) and put them into a non-provisional patent application and file it quickly; with considerable alacrity, the application is assembled and filed on July29, 2009 (number 11/997,854). The non-provisional patent application describes the claim to priority under the heading “Cross-Reference to Other Applications,” where it is written, “This application hereby claims priority to U.S. provisional application61/136,899 filed July 15, 2008, U.S. provisional application 63/147,234 filed December29, 2008, and U.S. provisional application 63/257,424 filed April 15, 2009.” What date can be properly claimed as a filing date for compounds A, B, C, and D?Let’s start with the most recently filed patent application and then work backward.For compound D, there was no provisional patent application that was filed containing its structure. Rather, the compound made its first appearance in the non-provisional patent application; therefore, it properly claims priority to a filing date of July 29, 2009. The third (last) provisional application that was filed contained compound Conly, and it was filed on April 15, 2009, so compound C’s effective priority date is April 15, 2009. The second provisional application that was filed contained compoundB only, and it was filed on December 29, 2008, so compound B’s effective priority date is December 29, 2008.

This is n’t too bad, are you getting the hang of it? How about compound A? To properly claim priority to an earlier filed provisional application, that provisional must properly describe the subject matter the later-filed application is attempting to claim .Since the provisional patent application fully describing compound A was filed on July 15, 2008, the correct priority filing date for compound A is July 15, 2008. Right?Actually no, the earliest filing date that can be afforded to compound A is July 29,2009.Why? Because for a regularly filed patent application to properly claimpriority to an earlier-filed provisional application, the provisional must have been filed within1 year of the regularly filed patent application.18 In this case, the 1-year period had already lapsed, and as a result the patent application 61/136,899 containing compound A was abandoned on July 15, 2009, one year after its filing date. So the attempt to claim

AN-OVERVIEW-OF-THE-PATENT-PROCESS-IN-The-United-States

Figure : Timeline for patent applications from hypothetical 2.1.

priority to the application filed on July 15, 2008, will fail. Furthermore, the facts in this hypothetical scenario explained that each provisional case that was filed contained only the molecule described in that case—the first case contained compound Aonly, the second compound B only, etc. As a result, the regular (non-provisional)patent application that described all of the molecules together is the first time that compound A was described in a patent application that was effective; it’s as if the first provisional application had not been filed. A timeline covering the analysis for the three provisional and one non-provisional application is shown in Figure below.

One way to avoid the scenario just outlined for compound A, where effectively a whole year of priority filing for that compound has been lost, is to include the contents of each provisional patent application in the next provisional application. If that had been done in this example, the provisional application containing compoun dB that was filed on December 29, 2008, would also contain the subject matter from the earlier provisional application containing the compound A. This way, if for some reason the 1 year time frame was missed as in the example, the priority date for compound A would be December 29, 2008, rather than pushed all the way forward to July 29, 2009. This may not seem like much, but in a highly competitive area it can sometimes mean a lot.

Can you appreciate the advantage of filing provisional patent applications? They offer ease of filing and reduced costs and thus facilitate the prompt filing of inventions as they occur in the course of a research program. Moreover, they allow for an entire year of effort to develop additional compounds with protection of the inventions as they develop without having to wait for the entire body of work to be finished before filing a single non-provisional patent application. Think of a situation like that described in the hypothetical that we just reviewed, but without taking advantage of the provisional patent application process. The applicants might simply wait until they completed all of their work and then file the non-provisional application on July29, 2009, the same date they filed their non-provisional in the original hypothetical.The risk in this approach is that they do not get the benefit of the earlier filing dates for the compounds that were discovered earlier, such as compound A, B, or C. If somebody else published on or filed a patent application containing the compounds A, B, and/or C between the time that A, B, or C was discovered and the time the non-provisional patent application was filed, this could affect their ability to get a patent in countries outside the United States. Even in the United States, there are advantages to having the earlier filing date; the earlier filing still can act as prior art to another’s earlier invention under some circumstances. Much more will be said about prior art and prior invention in Chapter 3, but for now let’s appreciate that it is often preferable not to delay a patent filing. This is true especially given the low cost burden and flexibility inherent to the provisional patent filing process.

Another alternative to filing a series of provisional patent applications as just discussed would have been to file each of the compounds, as they were invented, into a separate non-provisional patent application. For example, the first patent application could have been filed as a regular patent application containing compound A only.When compound B was discovered, the applicant could have filed another patent application either as a completely separate application or a continuation-in-part. There are many aspects that make this alternative less desirable, including the increased filing costs and complexity of maintaining separate patent prosecution files for each case. More important, the option of filing a non-provisional patent application instead of a provisional patent application would result in a loss of patent term. The reason for this is that the 20-year from patent filing lifetime for a non-provisional patent application is tolled on the day that the patent application is filed. Therefore,if the applicant desired protecting the compounds as soon as they were invented by immediately filing a non-provisional patent application, the applicant would sacrificea longer patent life for immediate protection of the subject material. Filing a provisional patent application allows him to protect the subject material without starting the 20-year clock ticking.

Given the many advantages of filing a provisional patent application, it might be difficult to appreciate that there are circumstances in which it can be advantageous to forgo a provisional patent filing and directly file a regular patent application. In particular, the primary reason for skipping a provisional filing and directly filing a regular patent application is that it gets things moving up to 1 year earlier at the USPTO. Remember that a provisional patent application is not formally examined; it acts more like the foot holding the door open. When moving things forward rapidly in the USPTO is of high importance, one may not want to wait the extra year for the provisional application to fully vest, but rather one may want to try to get the patent application published and issued as soon as possible. This might be of benefit when the applicant’s business plan requires a more mature patent portfolio at an earlier time. In this regard, the sooner the patent publishes and issues, the sooner it can be presented to investors or licensees and/or be available for enforcement against in fingers.

Because we wish to stay with the normal chronology of filing events as much as possible, let’s consider the important third option for how a patent application may be filed in the United States: through the PCT. In this option, a provisional application may still be first filed (if desired) in the United States (or its equivalent elsewhere),and then an international patent application is filed in one of the receiving offices for the PCT. The application, through the initial stages, is processed according to the rules of the PCT.21 In the same way that a regular non-provisional patent application is filed in the United States within 1 year of the provisional patent application from which it claims priority, an applicant may instead opt to file a PCT patent application.

The initial effect of filing a PCT application can be somewhat akin to filing that patent application in every signatory country of the PCT, which is in excess of 140countries and includes the United States, the European Union, China, and Australia.(The most notable nonmembers are Taiwan and Argentina.) Approximately 6 months after filing the PCT application that claims priority to the earlier U.S. provisional patent application (or earlier-filed application of another country), an international search is conducted and a brief opinion of patent ability is presented. The international search and opinion of patent ability will alternatively take place approximately9 months after the filing of the PCT application if no priority application is relied on for an earlier filing date. After approximately 18 months after filing the priority application or the PCT application, if no priority application is claimed, the international patent application is published.

Approximately 18 months after the international application is filed, the applicant will need to make the decision about whether and where among the various PCT participant countries he wishes to pursue his patent application. It is at this stage that the patent prosecution process gets expensive since separate filing and examination fees will have to be paid for many of the individual countries, and translations of the patent application will have to be made for many of the patent offices. The costs of international patent prosecution (foreign patent agents and attorneys will need to be retained and paid) add up very quickly. The convenience and advantages of the PCT filing process include that it allows as ingle application to be filed and it can be filed (and initially examined) in English.

Since it takes approximately 18 months from the time the regular PCT application is filed until applications into the separate countries are required (national stage entry)and the PCT application filing process also allows one to claim priority to a provisional or set of provisional applications filed within 12 months of the PCT application, the total time from the filing of the first provisional application describing the subject matter until entry into the separate countries is approximately 30 months. The process of first filing a provisional patent application followed by a PCT application within1 year of the provisional patent application effectively buys the patent applicant30 months to evaluate and/or develop the invention to better determine if what is described in the patent application is something worth committing significant resources to. In this vein, the PCT-initiated search for prior art and comment on patent ability might help the applicant determine whether the invention is likely to be paten table, all before making the decision whether to enter patent applications in the many different countries where the applicant might eventually wish to enforce the invention.

So what are the disadvantages of filing by the PCT route? First, one needs to appreciate that despite the search and initial examination process, there is no patent that issues from a PCT application. The patents that will eventually issue must come from the separate patent offices, which often means a separate examination of the claimed subject matter will need to be conducted in the many different patent offices.In this regard, one should think of the PCT application primarily as a convenient filing mechanism. Previously, we discussed how the PCT filing buys the applicant precious time, a full 30 months from the time of a provisional filing to the entry into the national stage in the United States and any other national offices of interest.
However, in cases in which a patent applicant desires a more rapid prosecution of the patent application, this extended timeframe can be a disadvantage.

If the convenience of the PCT application process is desired but there is also a concern about the 30-month delay, the applicant also has the option of taking a hybrid approach that blends the convenience of a PCT filing with rapid prosecution at the USPTO. The approach taken in such a situation is to file the PCT application but, at the same time, file a patent application containing the same content in the United States. This allows the prosecution of the application in the United States to begin while the PCT application is waiting. This can shave up to 18 months off the normal PCT timeframe for entry into the United States while still postponing costly translations and fees from multiple foreign filings. In effect, the prosecution in the United States will proceed as if the PCT were not filed but the door will still be left open to the applicant should he decide to pursue prosecution in most of the rest of the world at a later stage.

Now that we’ve reviewed some of the basic types of patent applications that can be filed in the United States (provisional, non-provisional, non-provisional entering through the PCT process) let’s step in farther to see what happens once a non-provisional patent application arrives at the USPTO. Whether an application arrives at the USPTO from the PCT as part of the national stage entry process or whether it arrives directly from an applicant to the USPTO, the first step taken by the office is to take a quick look at the patent application and make sure that it is complete. This initial examination is done by the Office of Initial Patent Examination (OIPE), which will also assign an application number to the case. The next step at the USPTO will be to assign the patent application to an art unit that corresponds to the type of technology that the application deals with. After being assigned to an art unit,the patent application will be assigned to an examiner working in that unit who will proceed to docket the case. The current backlog in the USPTO is such that one should not expect a very quick substantive response on the application. In fact, it would not be uncommon to take more than 2 years from the time a case is assigned to the examiner until the first substantive correspondence from the examiner to the applicant is made; substantive communication from the USPTO by the examiner to the applicantis typically in writing and is referred to as an office action.
Generally, as a parallel consideration, a regular patent application filed with the USPTO will eventually be published and thus made available to the public in much the same manner as that described previously for PCT applications. The timeframe for publication is usually 18 months from the filing of the first application from which priority is claimed (as is the case for a PCT-filed application), except a patent application entering the United States from the PCT will already be 18 months from the non-provisional filing date and up to 30 months from any earlier-filed provisional patent application from which it claims priority (but, of course, such an application will have already been published by the PCT as a WO publication at the 18-monthtime point).

So if an applicant files a provisional patent application on June 1, 2007, and files anon-provisional patent application in the United States on May 28, 2008, that claims priority from the provisional patent application, then, under normal circumstances the patent application will be published around December 1, 2008. The application that is published is the non-provisional patent application and not the provisional application. However, on the day the non-provisional patent application is published,the provisional application together with the patent file history (including the formal correspondence between the applicant and the patent office) become available to the public. There are situations in which an applicant can request that the patent application not be published (non-publication request). Doing this requires that the applicant signs an agreement that the application has not and will not be submitted to another country or multilateral international agreement that requires publication of the application.

Now patent prosecution begins in earnest. One of the first things the USPTO will do with respect to your patent application is prepare for a prior art search. Although we will learn much more about the specifics of patent ability vis-a`-vis the prior art,it’s important to appreciate that the basic patent ability of your invention will be determined in view of what is in the prior art. In the next chapter, we will go into great detail of what qualifies as prior art under U.S. patent law, so for now let’s just consider that prior art as being equal to all of the things in the public domain that could affect the patent ability of the invention that occurred before your patent application was filed (the USPTO will initially assume that the invention occurred on the date it was filed). In the United States, unlike most of the rest of the world, there is a burden on the applicant to provide any material to the patent office that the applicant knows about that may be material to the patent ability of his invention.

This is what is known as the duty of disclosure, and it is a continuing duty up until the patent is issued. The disclosure of references that are material to patentability is submitted in the form of an information disclosure statement (IDS). In addition to noting appropriate references, the applicant is required to provide copies of the references as well as translated copies (if readily available) if the reference is in a language other than English. If a translated version of the foreign language document is not readily available, the applicant will need to provide a concise description or abstract of the document. Of course, a fully translated document can be provided as well, though translation fees can make this very expensive.

Copies of U.S. patents or published U.S. applications are not required to be submitted with the IDS (but you still need to cite them). If additional references come to the attention of the applicant or others associated with the filing during prosecution of the application, a supplemental IDS will need to be submitted to the USPTO disclosing the additional references. As a practical matter, one common way that additional references will come to the attention of the applicant during the patent prosecution is when that same application (or a closely related application)is being prosecuted in different countries where independent searches are also being conducted. In the course of such foreign patent prosecution, one or more of the foreign offices may cite one or more references against the application that the applicant was not aware of up to that point (or was aware of but did not think was material to patent ability). Once the foreign office makes the applicant aware of the reference(s)and if the applicant believes the reference(s) to be material to patent ability, he should submit a copy to the USPTO together with a supplementary IDS.

Despite the duty of disclosure, the applicant does not have a duty to conduct an independent search. The USPTO will conduct its own search of the claimed subject matter in the patent application, but quite often, before conducting the search, the USPTO will issue what is called a restriction requirement. A restriction requirement is an assertion by the patent office examiner that the claimed subject matter represents more than one patent ably independent and distinct invention and that searching the subject matter in one application would be a serious burden. While the applicant has the right to file a petition further arguing against the restriction requirement, in reality most restriction requirements are accepted, unless the restriction requirement is deemed too excessive to continue separate prosecution of each desired group and when the separate prosecution of each independent group is necessary to the applicants. In such a case, a provisional selection still must be made while the petition makes its way through the patent examiner’s chain of command.

In the restriction requirement, the examiner will divide the subject matter up into two or more separate groups and ask the applicant to select the group that he wishes to pursue. The applicant will then select the group he wishes to pursue in that application and cancel the claims to the other groups. These other groups can be electively pursued in one or more separate patent applications, termed divisional applications,that must be filed sometime during the pendency of the parent application (or one of its progeny) and will have the benefit of the filing date of the parent application. To better appreciate how a restriction requirement works, Figure below lists an abbreviated set of claims from an actual patent application (10/346,874) obtained from the USPTO Public PAIR. After the submission of the set of claims shown in Figure below, the USPTO issued the five-way restriction requirement summarized in Figure below.

In the applicant’s response subsequent to the restriction requirement, an amended set of claims were filed where only one of the groups listed above was retained and the claims corresponding to the other groups canceled. The claims to the canceled subject matter were subsequently included in four separate divisional patent applications—the primary patent application eventually issued into US 6,939,578and the four separately filed divisional applications issued into patents as well.fter the applicant has chosen a group to pursue after a restriction requirement (if they received a restriction requirement), the examiner will perform a prior art search.

After reviewing the USPTO prior art search results together with any references that the applicant has submitted in the IDS, the examiner will issue an office action with a decision on whether all, some, or none of the claims is allowed. In some cases, the claims are rejected because the examiner believes that they are non-paten table in view of one or more of the prior art references. Alternatively, the examiner may allege that the claims failed to meet the written description or ennoblement requirement. Or the examiner may not reject the claims outright but may have an objection to the form the claims are in. If there is an objection to form only, the claims can be rewritten according to the examiner’s suggestion and the claims should then be allowed. Rarely are all claims in an application allowed in the first office action, and very often the yare all rejected. If some of the claims are allowed and others rejected, the applicant has the opportunity to cancel the rejected claims and have the allowed claims pass to issue in that application and, if desired, re file the remaining, rejected claims Gina continuation application in which prosecution will be further pursued. In the case where all of the claims are rejected, the applicant can argue the grounds of the rejection, explaining to the examiner why his interpretation of the prior art and/or the law is not correct. Alternatively (or in addition) to the first option, the applicant may choose to amend the claims; often by narrowing them in the hopes of getting around the grounds (prior art, lack of enablement or written description) that were the basis of the rejection.

Figure below shows the overall procedure for handling patent applications at the USPTO.

overall procedure for handling patent applications

FIGURE :Claims pending in application U.S. 10/346,874.

Claims pending in application U.S. 10/346,874.

FIGURE :Restriction requirement by USPTO examiner.

Let’s consider a hypothetical patent prosecution example representative of how applications flow through the patent process in the United States. In this hypothetical example, you will come to better appreciate the way in which an office action rejection by the USPTO is conveyed to the applicant as well as the way an applicant might attempt to amend the claim to overcome that rejection.

A chemist working for the Miracles in a Bottle pharmaceutical company (where the company motto is Discovering yesterday’s drugs, tomorrow. . . maybe) has been working on compounds useful for the treatment of migraine headaches. During the course of his work, he discovers an in dole-containing compound that appears to have a very salubrious effect in pre clinical migraine efficacy models. He writes up a record of invention and submits it to the Miracles in a Bottle patent counsel, who drafts a provisional patent application. Even though provisional patent applications do not require claims, the patent counsel puts two in anyway, or as he says: “Just so I don’t forget to put them in later.

The patent attorney drops off the patent application with the U.S. Postal Service(USPS) using Express Mail to Addressee Service and includes a stamped, self-addressed return postcard to make sure that the patent office gets the application(not that he doesn’t trust the USPS). He deposited the provisional patent application at the post office on January 13, 2005, and later received the postcard confirming that the USPTO had received the provisional application. He dutifully placed the

AN-OVERVIEW-OF-THE-PATENT-PROCESS-IN-The-United-States

Figure : The patent process at the USPTO.

provisional application in the file folder corresponding to the company’s internal docketing numbering system, where he also placed the filing receipt documenting the date he left the application off as well as the postcard. Several weeks later, he received the application number from the USPTO: 01/006,314. About 8 months after the provisional application was filed, the patent counsel got a tickle notice from his docketing system, letting him know that the 1 year time period for filing a regular application that could claim priority back to the first provisional (01/006,314) was4 months away. “I’d better attend to that right away,” he thought, “soon as I get back from lunch, I’ll get right on it.” Three hours later and just back from lunch, the patent attorney called the chemist on the telephone and asked, “Remember the in dole compound you discovered for treating migraines last year? The regular application needs to be filed pretty soon, and I was wondering if you had made any additional analog that you wished to add in the regular filing?”

The chemist replied rather excitedly, “Well actually, I do. You see I had this funny idea to make benzothiophenes instead of in doles, and wouldn’t you know it but one of them was even more active than the in dole; of course, I jazzed it up further a little in the process!”
“I’ll bet your boss is proud of you, eh?” the patent counsel replied.
“Nah, he didn’t seem to happy . . . actually the in dole was his idea, and I think he gets mad when my stuff works better than his,” the chemist averred but then added, once again rather excitedly, “Hey, do you think you can mention that these compounds can prevent cancer, too?”
“Do we have any data to support that assertion?” the patent attorney asked somewhat skeptically.
“Not yet, but trust me . . . I’ve got a good feeling about this one” the chemist replied.
“Well, all that aside, why don’t you send me the experimental results for your new compound, and I will write it up and get a draft back to you and your boss in the next couple of weeks.” “This will be easy,” the patent attorney thought, “I’ll just add the benzothiophene to the old case and file it all together as a regular application and list both guys as inventors.” He also thought “What the heck, let’s go for that cancer indication while we’re at it. They don’t call us Miracles in a Bottle for nothing.” The claims from the first non provisional patent application are shown in Figure below.
The patent attorney executed assignments of the invention from the chemist and his boss as well as signed declarations that they were in fact the inventors of the claimed subject material. In a procedure much like before, the patent attorney went to the post office and used Express Mail to send the patent application and a stamped self-addressed postcard; the date the application was mailed was January 11, 2006.“Geez,” the attorney thought, “I’m getting good at this, I made it with two days to spare!” Arriving back at his office, the patent attorney put his feet up on the desk and clasped his hands behind his head and leaned back in his chair. “Now all we gotta do is wait.”

Approximately 3 months later, the first office action arrived. Seeing the envelope from the USPTO, the patent attorney exclaimed, “Man, I hope that’s the patent!”

AN-OVERVIEW-OF-THE-PATENT-PROCESS-IN-The-United-States

FIGURE :Claims from first non provisional patent application.

Eagerly tearing the envelope’s contents open, he frowns as he sees it’s a notice of a restriction requirement. The restriction requirement dated April 1, 2006, read as follows, in part:
Art Unit: 1672
Application Number 11/786,091
DETAILED ACTION
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claim 1 is drawn to a heteroaryl group of class 548, subclass 490.37
II. Claim 2 is drawn to a heteroaryl group of class 549, subclass 49+.
III. Claim 3 is drawn to methods of treatment/prevention using compounds of class548, subclass 490 and class 549, subclass 49+. The inventions are distinct, each from the other because of the following reasons . . .

“Okay,” our patent attorney thinks, “now instead of one patent we’ll get three patents, and that should really help with my metrics this year.” After conferring with the chemists over the phone, the patent attorney filed a response selecting group II and canceling the other two claims, which he will file independently in two divisional applications. He responds within the 1-month statutory time limit, selecting group II and at the same time files the two separate divisional applications, one containing the original claim1, and the other containing the methods of claim3. The amended claim set in the original application is shown in Figure below, together with the claims from the separate divisional patent applications collectively claiming the canceled subject matter from the first patent application.

Within 3 months (shockingly quick for the USPTO, they apparently have their own metrics), the patent attorney received office actions for all three of the cases on the exact same day (now there is a strange coincidence).“Geez, I feel like a kid opening up his birthday presents, which one do I open first?” he wondered. “I guess I’ll close my eyes, have my administrative assistant hold them in front of me and I’ll just pick one.”
After cajoling his reluctant administrative assistant into holding the office action sup for him, the patent attorney closed his eyes and selected one. Gleefully opening it and then reading it, his face slowly lit up with a big, beaming smile. “Thenceforth patent has been allowed!”“That’s one-for-one so far!” he shrieked, pumping his arm into the air in sort of avictory-type of celebration display.

“Now, let’s try another, I’m on a roll now!” he giddily remarked, nervously jumping up and down in anticipation. He closed his eyes and picked another, all the while his administrative assistant looking at the clock, starting to worry that he wouldn’t begetting too much work done that day.
“Okay, here goes number two,” he blurted out, opening and then reading the contents from the second envelope, “The in dole has been allowed! We got another allowance, that’s two for two . . . that’s close to 100%, right?”
By this time, some of the other workers in the office had started to migrate overtop see what was going on, many of them with worried or puzzled looks on their faces. The patent attorney, aware now that he had begun to attract an admiring crowd decided in his sudden magnanimity to allow his faithful administrative assistant to open the last one.

“No really, it’s your turn . . . I’ve already got to open two, now it’s up to you to make the hat trick,” the patent attorney generously offered. Quickly opening the letter, hoping to get this little ceremony over as quick as possible, the administrative assistant began to read the letter when his expectant boss, the patent attorney snatch edit out of his hands saying, “Darn it, you’re going too slow,” and turned to the apparently admiring crowd now surrounding him while he began to read,
“Claim 1 is pending in this application, claim 1 is . . . rejected,” the let down was huge. Embarrassed to still be in front of the now disbanding crowd, the patent attorney turned to his assistant and said “I knew I shouldn’t have let you open that one, you jinxed it.” Noticing that the attorney was not really smiling when he said this, the

AN-OVERVIEW-OF-THE-PATENT-PROCESS-IN-The-United-States

FIGURE :The first amended claim set in the non provisional patent application and the new claims to the canceled subject matter in two separate divisional application filings.

administrative assistant quickly ducked away, leaving his boss to carry on without him.
“Okay, let’s see where the examiner went wrong,” the attorney said, “but I’d better wait until after lunch, all of this hard work has made me hungry.” Upon returning,the attorney unfolded the office action and began to read:

NON-FINAL REJECTION

The applicant has claimed that the in dole and the benzothiophene can treat migraine and prevent cancer. However, the only data given in the application relate to the use of the compounds for the treatment of migraine headaches. There are no data to support the allegation that these same compounds will prevent cancer. In the absence of such data, the claimed method is simply not credible. For that reason, this claim is rejected for lack of enablement under section 112, paragraph 1.
“Not credible, not credible! Didn’t he see the name of our company—maybe Should call him up and have a little interview just to let him know that he shouldn’tbe misunderestimating us,” the patent attorney mumbled to himself.
Then on further reflection he thought, “Maybe it would be smarter just to amend the claim by removing the cancer aspect. He didn’t seem to have any problem with the migraine stuff; I can leave out the cancer part of the claim and get the rest of the claim issued and just file a continuation and keep after the cancer indication in the continuation application—sooner or later I’ll wear him down. That way, he gets what he wants and I get my patent before the end of the year review period. That’s what Ic all a win–win situation!”“Shoot, it’s already four in the afternoon, I must as well head home now. First thing tomorrow, I’m gonna get right on it,” he thought, heading out the door.Upon arrival the next morning, the patent attorney drafted his amended claim and filed his response on September 1, 2006. The amended claim is shown in Figure below.

AN-OVERVIEW-OF-THE-PATENT-PROCESS-IN-The-United-States

Figure :The amended claim in the rejected divisional method application.

Approximately 4 months after sending in the amended claim, the patent attorney received the letter from the USPTO. He opened the letter and read that his amended claim would be allowed as is. It is surprising that the attorney did not seem at all excited or even very happy about the fact that the claim was now allowed.
His administrative assistant, somewhat puzzled by the patent attorney’s noticeable lack of excitement with this seemingly good news wandered over to the attorney’s office and peeked his head in saying, “Why so glum? I noticed you got the case allowed.”
The attorney responded, “Yes but it’s one week too late, our performance reviews were last week, so this one won’t even count.”
The assistant thought for a minute and then responded, “But it will count for next year, won’t it?”
“Who knows, I think they’re changing the metrics again. And anyway, that’s along time from now,” the attorney grumbled. “Hey, I think it’s about lunchtime, you want to head out and grab a bite to eat?”
In the hypothetical just discussed, the applicant was allowed his claims in two out of the three cases in the first substantive office action. This is a little unusual in that very often at least some if not all of the claims in an application are rejected in the first office action. In this simple example, the applicants were trying to get single claims allowed, and the two cases containing compounds were not drawn to broad genera incorporating large numbers of compounds but, rather, were drawn to single species; perhaps that is the reason for the facile allowances.

Once the first office action is received, the applicant is given a limited amount of time to respond. The amount of time given to respond depends on the nature of the office action. For a restriction requirement, an applicant is normally given 1 month.However, the applicant can extend the response time all the way out to 6 months if he is willing to pay a fee that increases for each additional month that the reply is extended. When the office action is on the merits, the response time is normally3 months, with the possibility of extending the response time out to 6 months, once again by paying an extension fee that increases for each additional month. Failure to respond to an office action in the maximum amount of time will result in the abandonment of the application.

After the first substantive office action is sent back to the USPTO, the examiner will review the arguments and/or amendments and send back what usually is a final office action. This final office action,which takes into account the applicant’s previous amendments and/or arguments, may allow none, some, or all of the pending claims.
In response to a final office action, the applicant’s choices are much more limited.
The applicant can no longer argue or make substantive amendments to the claim that would require additional argument or explanation; the only thing that can be done in response to this final office action is to make any non substantive changes to the claim that the examiner has suggested (if he has made such suggestions) to put the claim sin a condition for allowance.
If there are claims that have been allowed, the applicant can allow those to issue(by, what else, but paying an issue fee!) and file a continuation application to pursue the remaining and/or additional claims if so desired. If no claims are allowed, the applicant can give up and abandon the application (seldom done if the invention is worth pursuing), file a continuation application, or file a request for continued examination (RCE). In cases in which no claims are allowed in the parent application,most applicants choose to file an RCE because it is a simpler procedure. A continuing application is an entire new application that is assigned a new application number and is separately docketed. An RCE, in contrast, keeps the same patent application alive and basically allows the applicant a couple more shots at getting the desired claims issued. However, if one or more claims are allowed in the parent application and the applicant wishes those claims to issue, then he will need to file a continuation application because the application containing the allowed claims that he wishes to issue will have matured into a patent with issued claims; no RCE on that application will be allowed.
Whether the applicant is filing an RCE, a continuation, or a divisional application,an important aspect to keep in mind is that the filing date of the first regular patent application in the chain sets the patent term clock ticking. This means that any of the patents that claim priority (continuations or divisionals) from that original application will have their 20-year lifetime measured from the date on which the parent application was filed (absent special circumstances).
To put a graphical representation on what just transpired in the hypothetical,
a timeline is shown in Figure below. A few extra details (issue dates and patent dates) have been added. Please note a couple of things about the figure. First, the two divisional applications, despite being separate patent application filings, still claim their priority back to their sister application, as a result, the patent life for the divisional applications is still 20 years from the date of the filing of the original application (January 11, 2006). As mentioned before, the same is true for continuation applications and continuation-in-part applications. The filing of the cancer claim has been added to Figure below, it was not included in the narrative but was filed on
January 14, 2007 as a continuation to the divisional application that claimed the

filing of the cancer claim

FIGURE :Graphic patent timeline from the hypothetical example.

cancer and migraine methods together (recall that the claim to the cancer method was canceled so the claim to the migraine could issue). The claim to the cancer would be appropriately pursued in the continuation application. Of course, this does not necessarily mean that the claim will issue because the applicants will still need to convince the examiner that the claim is enabled (which maybe a hard sell based on the facts!).


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