DOCTRINE OF INHERENCY
Disclosure of a prior art reference, whether express, implicit or inherent, may be relied upon to reject claims for lacking novelty under 35 USC section 102 or PCT Article 33(2) or for being obvious or lacking an inventive step 35 USC section 103 or PCT Article 33(3)
InherencyDisclosure of a prior art reference, whether express, implicit or inherent, may be relied upon to reject claims for lacking novelty under 35 USC section 102 or PCT Article 33(2) or for being obvious or lacking an inventive step 35 USC section 103 or PCT Article 33(3). Determination of lack of novelty is simple when the prior art reference expressly and unambiguously discloses exactly the same thing that an inventor claims to have allegedly invented. A claimed invention is anticipated by a prior art reference, only when a single reference discloses each and every element of the claimed invention. The anticipation analysis becomes considerably less clear when the prior art does not expressly disclose all of the elements of the invention. If there is some difference between the claimed invention and the single reference, then the invention is novel, but it may lack an inventive step if the difference is insignificant or would have been obvious to a person having ordinary skill in the art (PHOSITA)[iii]. The United States courts have developed a "doctrine of inherency (DOI) for considering such cases. Section 2112 of the USPTO's Manual of Patent Examining Procedure (MPEP) sets out the guidelines provided to US patent examiners for applying the DOI when assessing novelty. DOI states that anticipation can be inferred despite a missing element in a prior art reference if the missing element is either necessarily present in or a natural result of the product or process and a PHOSITA would know it, wherein the inherency is predicated on an idea that anticipation should not be avoided merely because a claimed feature is undisclosed or unrecognized in the prior art reference. Accordingly, DOI precludes patenting an existing invention by merely defining it by an inherent element. At the same time, DOI allows the later patentability of a substance that was inadvertently created but not recognized or appreciated
AnticipationOnly when a single prior art reference discloses, expressly or under principles of inherency, each and every element of the claimed invention[iv]. Newly discovered results of known processes directed to the same purpose are not patentable if such results are inherent[v]. There is no requirement that a PHOSITA would have recognized or understood the inherent disclosure at the time of invention, as long as the subject matter is in fact inherent in the prior art reference. In other words, inherent anticipation does not require recognition by a PHOSITA before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency[vi]. A characteristic necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention[vii]. Because 'sufficient aeration' was inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of the invention. An inherent structure, composition, or function is not necessarily known[viii]. If a product that is offered for sale inherently possesses each of the limitations of the claims, the invention is on sale, whether or not the parties to the transaction recognize that the product possesses the claimed characteristics[ix]. A prior art patent to an anhydrous form of a compound "inherently" anticipated the claimed hemihydrate form of the compound because practicing the process in the prior art to manufacture the anhydrous compound "inherently results in at least trace amounts of" the claimed hemihydrate even if the prior art did not discuss or recognize the hemihydrate[x]. However, the fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic. In other words, inherency cannot be based on what would result due to optimization of conditions, not what was necessarily present in the prior art[xi]. The mere fact that a certain thing may result from a given set of circumstances is not sufficient. Thus, inherency may not be established by probabilities or possibilities. To establish inherency, the extrinsic evidence 'must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill. When claims were drawn to a disposable diaper having three fastening elements, the reference disclosed two fastening elements that could perform the same function as the three fastening elements in the claims; it is interpreted that the claims required three separate elements and the reference did not disclose a separate third fastening element, either expressly or inherently[xii]. It should be noted that an invitation is not an inherent disclosure where a prior art reference discloses no more than a broad genus of potential applications of its discoveries[xiii]. A prior art reference that discloses a genus still does not inherently disclose all species within that broad category, but must be examined to see if a disclosure of the claimed species has been made or whether the prior art reference merely invites further experimentation to find the species. In relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art[xiv],[xv]. The extrinsic evidence[xvi] must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by a PHOSITA. The Patent Office[xvii] always bears the initial burden of developing reasons supporting a reliance on inherency. To satisfy this burden, the Office must identify some basis in fact or articulate some reasoning at least tending to show that allegedly inherent subject matter flows from cited art. The fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic[xviii]. To establish inherency, the extrinsic evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill. Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient[xix]. In relying upon the DOI, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art[xx]. Products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable[xxi]. A composition in terms of a function, property or characteristic is same as the composition of the prior art wherein the composition is same as that of the claim but the function is not explicitly disclosed by the reference[xxii]. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established[xxiii]. The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using[xxiv]. However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated[xxv]. Under the DOI, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device[xxvi]. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process[xxvii]. In addition, in considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom[xxviii]. Further, Official notice without documentary evidence to support an examiner's conclusion is permissible, although these circumstances should be rare when an application is under final rejection or action under 37 CFR 1.113. Official notice unsupported by documentary evidence should only be taken by the examiner where the facts asserted to be well-known, or to be common knowledge in the art are capable of instant and unquestionable demonstration as being well-known[xxix]. Inherent anticipation, an admittedly difficult concept, and the DOI's fundamental purpose have been questioned by the Federal Circuit, thereby undermining the predictability of the patent system and casting uncertainty over patent law[xxx]. Therefore, the examiners at the USPTO are confused and scared to use the DOI for the fear of failing to meet the initial burden of showing the basis in fact or technical reasoning supporting a determination. An examiner relying on the DOI must provide a basis in fact and/or technical reasoning supporting a determination that an allegedly inherent characteristic necessarily would be present if the teachings of the prior art were followed, even if the inherent feature would not have been recognized at the time it disclosed in the prior art. When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not[xxxi]. An examiner, relying on the doctrine of inherency to reject a claim as being anticipated, must provide a basis in fact or technical reasoning supporting an allegedly inherent characteristic present in the teachings of the prior art, even if the inherent feature would not have been recognized. An exception to this inherency doctrine is found in the US, wherein a hitherto unknown, novel and non-obvious use of a known matter is patentable, e.g., Viagra[xxxii], wherein an inventor indentified that a known vasodilator could be used to treat erectile dysfunction. In this exception, even though the vasodilator inherently dilates the blood vessels in the entire body including the vessels in the penis, thereby causing an erection along with the dilation of the entire vasculature in the body of the subject. Identifying a new use for an old product is difficult and requires a lot of innovation and research. However, there is an easy way to avoid "anticipation" which is to simply reciting certain properties or characteristics (even if they are inherent to the compound) of an old method or product, e.g., see WO 2015/035361 A2/3[xxxiii], the USPTO provided obviousness argument instead of anticipation and identified the invention to be novel, while it is inherently anticipated by Schmidt, under DOI. In this case, the applicant has used covalent bond, first portion, second portion, mar resistance etc to define an old known process of coating a synthetic polymer. Alkyl silanol of Schmidt inherently has a covalent bond between the first portion of SiO and the second portion of alkyl group providing coating which inherently has mar resistance (scratch resistance). Now, the applicant can overcome the rejection by submitting an affidavit under 37CFR 1.132 showing 'secondary considerations' as indicia of objective evidence of nonobviousness[xxxiv] such as evidence of criticality or unexpected results, commercial success, long-felt but unsolved needs, failure of others, skepticism of experts, etc.
ObviousnessDisclosures of a prior art reference, express, implicit or inherent, may be relied upon in the rejection of claims under 35 USC section 103[xxxv] or PCT Article 33(3)[xxxvi]. However, it is simple and easier to the inherency doctrine for anticipation than for obviousness. Nevertheless, inherency is an important factor that should not be ignored in determining obviousness of a claim over a prior art that inherently discloses relevant elements. It was held that the inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness[xxxvii], affirming obviousness rejection based in part on inherent disclosure in one of the references. The Federal Circuit set forth a test for the application of inherent obviousness: A party must, therefore, meet a high standard in order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis - the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art[xxxviii]. The patent statute makes it clear that subject matter that would have been obvious to one of ordinary skill in the art as of the effective filing date of a patent application is not patentable[xxxix]. The obviousness considerations have been set [xl]: (1) The scope and content of the prior art; (2) The level of ordinary skill in the art; (3) The differences between the claimed subject matter and the prior art; and (4) Secondary considerations of non-obviousness. The Court[xli] envisioned a hypothetical "person having ordinary skill in an art (PHOSITA)" having access to the entire relevant prior art available to public anywhere in the world, at the time the invention was made, then the court would step into the shoes of the PHOSITA to find the alleged invention obvious or not. However, disputes have arisen as to what the relevant scope of the art should be and what motivation if any would be required for the PHOSITA to combine the art to come up with the claimed invention without the hindsight. The Supreme Court[xlii] attempted to clarify the proper analysis for an obviousness determination. The KSR decision reinforced earlier decisions that validated a more flexible approach to providing reasons for obviousness. However, the Supreme Court's pronouncement in KSR overruled cases such as In re Lee[xliii], insofar as those cases require record evidence of an express reason to modify the prior art. In KSR, the Supreme Court particularly emphasized "the need for caution in granting a patent based on the combination of elements found in the prior art,[xliv]" and discussed circumstances in which a patent might be determined to be obvious. The Supreme Court reaffirmed principles based on its precedent that "[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results[xlv]." The Supreme Court stated that there are three cases decided after Graham that illustrate this doctrine[xlvi]. Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result[xlvii], i.e., it should be more than two pre-existing elements would in separate, sequential operation[xlviii]. When a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious[xlix]. The principles underlining these cases are instructive when the question is whether a patent application claiming the combination of elements of prior art would have been obvious[l]. The Supreme Court further stated that when a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, ? 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill[li]. When considering obviousness of a combination of known elements, the operative question is thus whether the improvement is more than the predictable use of prior art elements according to their established functions[lii]. As reiterated by the Supreme Court in KSR, the framework for the objective analysis for determining obviousness under 35 U.S.C. 103 is stated in Graham[liii]. Obviousness is a question of law based on underlying factual inquiries. The factual inquiries enunciated by the Court are as follows: (A) Determining the scope and content of the prior art; and (B) Ascertaining the differences between the claimed invention and the prior art; and (C) Resolving the level of ordinary skill in the pertinent art. Objective evidence relevant to the issue of obviousness must be evaluated by Office personnel[liv]. Such evidence, sometimes referred to as "secondary considerations," may include evidence of commercial success, long-felt but unsolved needs, failure of others, and unexpected results. The evidence may be included in the specification as filed, accompany the application on filing, or be provided in a timely manner at some other point during the prosecution. The weight to be given any objective evidence is made on a case-by-case basis. The mere fact that an applicant has presented evidence does not mean that the evidence is dispositive of the issue of obviousness. While each case is different and must be decided on its own facts, the Graham factors, including secondary considerations when present, are the controlling inquiries in any obviousness analysis. The Graham factors were reaffirmed and relied upon by the Supreme Court in its consideration and determination of obviousness in the fact situation presented in KSR[lv]. The Supreme Court has utilized the Graham factors in each of its obviousness decisions since Graham[lvi]. While the sequence of these questions might be reordered in any particular case, the Graham factors continue to define the inquiry that controls[lvii]." Federal Circuit[lviii] has explained that the use of common sense does not require a specific hint or suggestion in a particular reference, only a reasoned explanation that avoids conclusory generalizations. However, when the examiner and the Board have found motivation for substituting one type of memory for another with a reasoned explanation, but without providing a citation of any relevant, identifiable source of information justifying such substitution; such reasoned explanation was considered conclusory, and was held inadequate to support a finding of motivation, which is a factual question that cannot be resolved on subjective belief and unknown authority[lix]. Apparently, in 1991, a PHOSITA needed a reference to understand Content Addressable Memory (CAM), bitmap memory or bitmapped CAM. This requirement throws out an inherent property of a known material. The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness[lx]. The Federal Circuit[lxi] held that to establish obviousness based upon an inherent property in the prior art, that inherent property would have to be obvious to the PHOSITA at the time of the invention. An inherent element may be not necessarily known[lxii]. Obviousness cannot be predicated on what is unknown. "Hindsight of inherency" is not a substitute for some teaching or suggestion supporting obviousness. On the contrary, there is no such limitation for the application of hindsight of inherency for anticipation under 35 USC 102, and accordingly, there is no requirement that the inherent quality of the prior art was understood by a PHOSITA to support an argument of inherent anticipation, because the inherent property in the prior art inevitably would result in the invention. Inherency is predicated on the idea that anticipation should not be avoided merely because a claimed feature is undisclosed or unrecognized in the prior art reference. Further, if the claimed element is inherent in the prior art then the prior art cannot be practiced without infringing the claimed invention. Therefore, logic requires that it should be anticipated by the prior art. Thus, according to the DOI, anticipation can be inferred despite a missing element in a prior art reference if the missing element is either necessarily present in or a natural result of the product or process. For example, if a medication for headache is available in the market without the knowledge of its mechanism of action, a claim to such hitherto unknown mechanism of action identified by the inventor cannot be sustained because of it is an inherent property of the matter, whether it is known or unknown at the time of the discovery of the mechanism. Therefore, such discovery of an inherent property of matter is not patentable, because the matter was known already. Thus, the quality of the US patents is in jeopardy. As explained above, it is much more simple and easy to apply the DOI for anticipation that for obviousness; and yet the USPTO examiners are hesitant to use DOI for anticipation for the fear of being overturned by courts that have thrown the DOI into an unreliable and useless doctrine. As a result, it is even more difficult to apply the DOI for obviousness. The status DOI in the patent system is further complicated by the "inventor as lexicographer," who can define a well known invention in applicant's own terms. Sometimes, inventor lexicographers define articles against the basic concepts of underlying science and therefore there could not be any prior art to be found using the same terminology. As a result, the USPTO examiners do not use DOI for anticipation or obviousness; despite the requirement that during patent examination, the pending claims must be given their broadest reasonable interpretation consistent with the specification, and that the USPTO employs use the broadest reasonable interpretation standard: giving claims their broadest reasonable construction in light of the specification[lxiii]. Overall result is that the patents granted in the US may be old products defined by synonymous and bombastic language not used by the prior art to define the same thing that is in the public domain, thereby reducing the overall quality of patents granted in the US and increased troll activity costing real innovators and raising cost of discoveries, including the new pharmaceuticals.