ANTICIPATION IN CHEMICAL PATENTS - Patent law

To help understand the concept of anticipation, let’s consider the following example.A chemist has found that a particular combination of pigments and additives results in a paint with an especially attractive and durable coating. In a U.S. patent application,the chemist claims the composition as follows:
We claim:

  1. A composition consisting of:

    1. pigment A;

    2. pigment B;

    3. additive F;

    4. additive G; and

    5. additive H.

Several prior art references with effective dates before our chemist’s invention are available for examination against the invention described in claim 1 above. The pertinent details of each reference are:
Reference 1. Describes the preparation of pigments A and B and additives G and H and also describes a composition consisting of pigments A and B together with additives G and H.
Reference 2. Describes the preparation of pigment B and additives F, G, and Hand also describes a composition consisting of pigments B and additives F, G,and H.
Reference 3. The reference describes the preparation of pigments A, B, and C and additives F, G, and H. The reference also describes a composition consisting of pigments A, B, and C and additives F, G, and H.
Reference 4. Describes a composition consisting of pigments Aand B and additivesF, G, and H but does not describe or reference the preparation of the pigments or additives.

Do any of these references affect the novelty of the claim in the patent application?

The first step in the analysis of this problem is to engage in a little claim construction.To begin with, the claim preamble is directed toward a “composition,” a generic term that tells us in this case that a material is being claimed and nothing more. If you recognized that the next two words in the claim consisting of is a closed transition and affects the scope of the claim, then congratulations, you have applied your learning well! Since the claim is closed to further ingredients, we know that prior art compositions that describe less and/or more elements than are required by the claim will not anticipate the claim. The claim as now constructed should read as:A composition containing pigments A and B, and additives F, G, and H and those ingredients only. Now that we have constructed the claim, we can proceed to the prior art examples and see how they might affect the novelty of the claimed invention.

ANTICIPATION-IN-CHEMICAL-PATENTS

TABLE : Comparison of Pigments and Additives in the Claimed Composition and in the Prior Art References

Let’s next compare each of the possible prior art references to the claimed composition as shown in Table above.

A quick scan down the table is sufficient to demonstrate that additive F is missing in prior art reference 1, so it does not anticipate the later claimed composition; it does not contain each and every element of the composition our chemist wishes to claim. Prior art reference 2 describes the preparation of pigments B and additives F,G, and H as well as their combination into a composition, but it also fails to disclose a composition that contains all of the claimed elements because it does not disclose pigment A as part of the composition. But what about the fact that prior art reference1 does disclose pigment A, can the combination of pigment A from that reference cure the defect in prior art reference 2? The answer is unequivocally no. Novelty can not be defeated by combining references to provide missing elements. Unlike the first two prior art references, the composition of prior art reference 3 does contain each and every element of the claimed composition, so does it anticipate the claim?Recall the complete definition of anticipation requires that not only must the priorart reference contain each and every element of the later claimed invention but it also must contain each and every limitation. Our claim construction exercise revealed that the claimed composition required the listed elements and those elements only, so the limitation is that no additional ingredients be part of the claimed composition. Priorart reference 3 does contain every element of the claim, but it contains the additional element C so it does not contain every limitation of the claim and, therefore, does not anticipate the later claimed invention.We can see the importance of the transition phrase because if it had been comprising instead of consisting of , the claim would have been anticipated by reference 3.

Prior art reference 4 contains each and every element (and only each and every element) of the claimed composition and so appears to anticipate the later claimed invention. If we’ve read carefully, however, we realize that prior art reference 4 does not describe the preparation of any of the required elements. A prior art reference cannot anticipate that which is not enabled. Is prior art reference 4 enabled? Notice that the question is directed to whether the reference is enabled and not whether the reference is by itself enabled. Even though reference 4 does not enable the preparation of the required pigments and additives, those preparations are within the skill of one of ordinary skill of the art since the prior art itself provides that information. In particular,references 1 and 2 together or reference 3 by itself describe the preparation of all of the pigments and additives. So reference 4 does indeed anticipate the claimed invention. In the example just discussed, the comparisons made were relatively straightforward in that each reference disclosed a composition, so it was just a matter of comparing the prior art compositions to the claim as constructed. Sometimes the prior art is not so accommodating in the sense that prior art references often disclose a lot of information and a single prior art reference may contain each and every element of a later claimed invention, but it may not do so in a way that anticipatesa later claimed invention. For example, consider the following prior art reference in view of the earlier claimed invention.

Prior art reference 5 describes the preparation of numerous pigments (A, B, C,D, and E) and additives (F, G, H, I, and J) as well as their combination into several compositions, though none of the compositions is identical to the claimed composition .Further description in prior art reference 5 explains that additional composition scan be “derived by combining the various possible sub-combinations of the listed pigments with any of the various possible sub-combinations of the listed additives.”

Since the claimed composition is actually a sub-combination of pigments (A and B)together with a sub-combination of additives (F, G, and H), it might be argued that prior art reference 5 anticipates the later claimed invention. However, this argument will fail; prior art reference 5 does not render the claimed invention non novel. Why not? What is missing is the required level of specificity. The anticipating reference not only must contain the requisite elements but must also combine those elements with the requisite level of specificity. It is not sufficient for this prior art reference to list a group of various ingredients, give a few examples and then suggest additional combinations as possibilities. The prior art reference needs to provide both an element-for-element parity and must combine those elements in such a way that there is no question that the prior art is describing the later claimed invention. A composition invention consisting of several ingredients is more than a listing of separate ingredients; the invention is the specific combination of those ingredients. Many inventions are combinations of known ingredients or parts but their novelty depend son the way those known ingredients or parts are combined. In this regard, it is appropriate to think of novel inventions that contain combinations of known ingredients or parts to be similar to a written novel that contains combinations of known words and/or letters, such a novel is still “novel” despite the fact that all of its letters and words are already known.

Since patent novelty is a somewhat abstract concept in the absence of context,it is helpful to consider another example. Gas liquid chromatography instruments can be effective ways for the separation of component mixtures and typically work via vaporization of a sample and injection into a heated column. The sample is then carried through the column by a flow of inert gas functioning as a mobile phase. The column itself typically contains a liquid stationary phase adsorbed onto a solid support located within the column. Molecules are retained by the column according to their particular affinity for the stationary phase and their relative volatility, and different molecules will elute from the column at different time points, depending primarily on these variables. After exiting the column, the sample is processed through a detector and then displayed via readout. An analytical chemist has “invented” the subject of the following claim:
We claim:

  1. A gas chromatograph comprising:

    1. a sample injection port;

    2. an 8-foot column contained within an oven;

    3. a detector; and

    4. a LCD readout.

In the course of examining the patent application, the patent examiner at the USPTO cites three prior art references with reference dates before the chemist’s invention date, and he alleges that each of them anticipate the claimed gas chromatograph.

The key features of the three references that the examiner has cited are explained as follows:
Reference A. Discloses and enables a gas chromatograph, which shows a sample injector port, a column of 8 feet in length contained within an oven, a detector,and a graphical chart readout.
Reference B. Discloses and enables a gas chromatograph, which shows a sample injection port, a column of undisclosed length contained within an oven, a detect or, and an LCD readout.
Reference C. Discloses and enables a gas chromatograph, which shows a sample injection port, one column of 8 foot length, preceded by a separate filtration column of 2 foot length (both columns are located inside an oven), a detector,and a LCD readout.

Can you guess which, if any, of these three prior art references would anticipate the claim to the gas chromatograph given in claim 1?

First, we again engage in some claim construction, the major observation being that the claim transition is open (comprising) and thus the listed parts are the minimal elements necessary to fulfill the claim language.
Starting with reference A, we begin our analysis by looking at each of the required elements in the claim language, and then determine whether each and every element of that claim language has been met. As it turns out, each and every element is not met by the prior art reference A. The reason? The claim requires a LCD readout. If you look carefully, reference A discloses all of the elements except that it does not contain an LCD readout. It contains a graphical readout. Thus reference A does not anticipate the claimed gas chromatograph.

Moving onto reference B, we see that it does not anticipate the claim in question,since it misses one of the limitations. It is important to note that, while reference discloses the inclusion of a column, it does not disclose the column length. The length of the column is a limitation in the claim language. Remember that each and every claim limitation must be met by the prior art document in order for the claim to be anticipated. In this case, one of the limitations has not been met.

As for reference C, it contains all of the elements of the claim, but it also contains some additional elements. In particular, the reference provides an 8-foot column but it also has a 2-foot filtration column. Since the required elements of the claim are preceded by the term comprising, we recognize that the claim is open-ended and thus may include additional elements to those listed. Thus reference C anticipates the claim to the gas chromatograph. What if instead of comprising, the claim to the gas chromatograph had used the term consisting of? In that case, reference C would not have anticipated the claimed gas chromatograph since consisting of is close-ended and thus does not allow for additional, unlisted elements.

What if the patent examiner alleged that references A and B together anticipated the claimed gas chromatograph? For example, the examiner might point out that reference A provides all of the required elements except the limitation of column length. Reference B provides for an 8-foot column length. By combining reference A and reference B, one can match element for element the claimed gas chromatograph.

However, we should know by now that such a rejection is invalid for anticipation since each and every element must be found in a single reference. Although the technical definitions for novelty that we have discussed are important to understand, they don’t necessarily help us in all of our specific novelty inquiries. As a practical matter, it is sometimes difficult to determine whether a priorart disclosure actually anticipates a later claimed invention. One novelty test that has been found to be generally useful is stated as follows: “That which if literally infringes if it comes after, anticipates if it comes before.” To apply this test, one needs to take the allegedly anticipating reference and imagine that instead of being prior art, it occurs after the claimed invention. Then one looks at the pertinent elements
of the reference to see if they would result in a literal infringement of the claim in question. If the prior art disclosure does provide an embodiment that would infringe, then it would anticipate the claim in question. Since literal infringement requires that each and every element and/or limitation of the claim must be met by the infringing item, the patent novelty/infringement test is tautological in its application but useful nevertheless, as we will see in many of the examples and problems to come.

While patent applicants cannot control the prior art, they (together with their agent or attorney) can control the language used in the claiming of the invention. Almost always, an invention can be described in a number of different ways. Dimensionally speaking, these different ways of claiming the invention typically vary in terms of the breadth of the claims. Claims can vary in scope from broad to narrow and each has potential advantages and disadvantages. A broad claim will contain the least limitations and will thus occupy a large amount of intellectual turf. A broad claim has the advantage of providing a wide berth of protection and thus is more likely to keep others far away from the inventor’s staked out turf. However, a broad claim has the disadvantage of being more difficult to support from an enablement perspective.

This is true since a claim needs support in the specification adequate to enable one of ordinary skill in the art to make and use the claimed invention throughout the claim scope. Thus broader claim scope requires greater support in the specification. An additional complication with broader claim scope and particularly relevant to this is that a broad claim, since it occupies more “turf,” is more likely to run afoul of the prior art, and thus it is possible that the something in the prior art will act to render the broad claim not novel.

Conversely, a claim that is narrow in scope will allow others more room to maneuver outside of the narrower claim scope. However, narrower descriptions of the invention are often more readily enabled since they don’t require broad support in the patent specification, and furthermore, the invention is less likely to be anticipated by the prior art since the narrower claim, by occupying less territory, is less likely to overlap with the prior art. So what is an inventor to do? Should the inventors go for broke and claim their invention as broadly as possible but at the same time increase their risk of patent invalidity? Or should they instead take a conservative approach and claim narrowly? Well, as it turns out, the skillful applicant might be able to have her cake and eat it too! A U.S. patent can issue with an unlimited number of claim sand thus a chemical invention can be claimed from broad to narrow, all within the confines of a single patent application.

As a result, when a given piece of prior art is being considered for whether it anticipates a later claimed invention, that piece of prior art must be compared to each of the relevant claims of the later claimed invention. It is very often the case that a piece of prior art can anticipate one or more of the broader claims of a later claimed patent or application, while not anticipating one of the narrower claims.
As an example, consider a chemist at a pharmaceutical company who has synthesized a number of related compounds that are capable of inducing sleep in amammalian species when administered via various routes, including oral and subcutaneous routes. In addition, she believes that the compounds will be effective in the treatment of bacterial infections since the compound inhibits several gram positive and gram-negative bacterial strains. She has not done a thorough search but she believes that the compounds are novel. Her company wishes to get patent protection for
the compounds because they believe that they might be useful as drugs and would like to further pursue their development. For purposes of simplification and illustration,the compound structures are represented as: A, B, C, D, and E. The claims to the invention are as follows:
We claim:

  1. A compound, or pharmaceutically acceptable salt thereof, that is selected from the group consisting of A, B, C, D, and E.

  2. The compound of claim 1, wherein said compound is A.

  3. A compound according to claim 1, wherein said compound is isolated and at least95% pure.

  4. A compound according to claim 1, and at least one pharmaceutically acceptable excipient.

  5. A method of treating bacterial infections in a mammal, comprising the administration of a composition according to claim 4 to a mammal in need thereof.

  6. A method of inducing sleep in a mammal comprising the administration of a composition according to claim 4 to a mammal in need thereof.

  7. The method of either claim 5 or 6, wherein said mammal is a human.

  8. The method of claim 7, wherein said administration is oral.

  9. The method of claim 8, wherein the pharmaceutical composition to be administered comprises:

    1. from 5 to 50% of compound A, B, C, D or E;

    2. from 1 to 10% microcrystalline cellulose; and

    3. from 10 to 50% starch.

In the first office action by the USPTO, the examiner has cited several references:

Reference A. Discloses the identification of compound B as a by-product of an industrial scale chemical synthesis. The compound was unambiguously identified but was not isolated from the mixture it was in. No utility for the compound was discussed.
Reference B.Discloses the preparation of analytically pure compound A. No utility for the compound was discussed.
Reference C. Discloses the dissolution of essentially pure compound C in an aqueous vehicle, and the administration to laboratory rats to determine its effect on the sleep latency time in rats. The compound decreased sleep latency (time to sleep onset) by 22 minutes. A separate reference is cited that shows that compounds like compound C can be readily prepared by synthetic methods common to one of ordinary skill in the art. This reference is cited to show that compound C is enabled.
Now, let’s separately examine each of these references for their effect on the listed claims in regard to anticipation under §102.
Reference A discloses the discovery and identification of an industrial by-product that has the same structure as compound B. Claim 1 encompasses a compound of structure A, B, C, D, or E (or a salt thereof). Claim 1 separately claims each of the listed compounds meaning that an anticipation of any of those compounds means the entire claim is anticipated. Notice that there is no additional limitation on any of the five compounds of claim 1. The claim does not require that the compounds have a specified purity or be present in a minimal amount. Thus the prior art disclosure of compound B contains each and every element of compound B of claim 1, since claim 1 requires only the enabled disclosure of one of its listed compounds and nothing else. However, there might still be a question regarding whether reference A was properly enabled. Would one of ordinary skill in the art be able to prepare the compound B? Although questions of enablement are fact-based inquiries, we should appreciate that the level of enablement required needs to be consistent with what the reference discloses. In this example, the prior art reference can anticipate claim 1without providing a method of isolating the pure material because the claim contains no such limitation. Recall also the prior art reference need not contain a utility. So the examiner will issue a §102 rejection of claim 1.

What about claim 2? Clearly the disclosure of the compound B in reference
1 does not anticipate the separate claim to compound A. This helps explain the advantage of separately claiming A as is done in claim 2. Imagine that out of the five compounds, compound A was specially preferred for some reason. It might be advantageous to claim A separately, that way if one of the “pack” of compounds fell (as happened in claim 1 due to reference A), the most desirable member might still survive since it is claimed separately. Note that claim 2 is a dependent claim in regard to claim 1, which we have just said will be rejected by the examiner. In its present form, claim 2 could issue except for its dependence on a rejected claim. In this scenario, the examiner will “object” to claim 2. The patent applicant can resolve this objection in multiple ways. For example, claim 2 could be made an independent claim. Alternatively, claim1 could be modified so as to longer be rejected by removing compound B.

As you scan through the remaining claims (3–9), take notice of the way the invention is sliced into different embodiments. Various compositions containing the compounds as well as methods of using the compounds of the invention are described.

Although claim 1 may have been anticipated by reference A, the remaining claims are not.
Reference B discloses the preparation of compound A. Notice that the prior art reference B anticipates claim1since it discloses compound A, and it anticipates claim2 as well. Due to the disclosure in the reference that the compound was prepared“analytically pure,” claim 3 is presumably anticipated as well. So claims 1, 2, and 3will all be anticipated and rejected under §102. However, note that claim 4 requires the addition of a pharmaceutically acceptable excipient and that reference B probably does not disclose such a composition, and thus reference B does not anticipate claim4. Likewise, claims 5–9 all include limitations directing the claims to methods of inducing sleep and/or treating bacterial infections and will not be anticipated by reference B.
Reference C discloses compound C, and that disclosure is probably enabled since a separate reference describes the preparation of similar compounds. This assumes that the level of ordinary skill in the art is sufficient to allow one to bridge the gap between what is disclosed in the separate reference and what would be required to prepare compound C. Assuming enablement, claim1is anticipated by reference C. Claim2isnot anticipated because that claim is directed to compound A. Claim3is anticipated if we assume that essentially pure means >95% pure; the ultimate determination would likely require a thorough reading of the specification to determine whether and how the procedures used to isolate the compound might yield such a purified material. Claim4 describes the inclusion of a compound of claim1and a pharmaceutically acceptable excipient. Is water a pharmaceutically acceptable excipient? The answer is probably yes, particularly when one considers that water is used in many pharmaceutical vehicles, including in the prior art reference being cited. However, as we have already learned, the patent applicant can be “his own lexicographer” and so before jumping to any quick conclusions, one would be well advised to carefully read the patent specification to better understand how the applicant might have defined the term.Presumably, reference C would impact upon claim 6 because the compound was used to induce sleep in an a mammal; however, the thoughtful patent drafter further narrowed the claim 6 by dependent claim 7 that limits the type of mammal to a human.So reference C will anticipate claims 1, 3, maybe 4, and 6. The remaining claims may need to be rewritten to be in proper format but they would not be anticipated by reference C.


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