PTAB Archives - Page 6 of 13

When U.S. patent examiners cannot find all the components of a claim in a single prior art reference, they usually cite a secondary reference for a missing component. In such cases, examiners often take the position that the missing component is equivalent to one of the components in the primary reference, and that it would have been obvious to replace the component in the primary reference with the equivalent component from the secondary reference.

Sometimes, however, the two components are not actually interchangeable equivalents. This issue is illustrated in the recent Patent Trial and Appeal Board (“Board”) case of Ex parte Fei (Appeal No. 2020-006288).

Independent claim 1 recited:

An anyhydrous dentifrice or toothpaste, comprising:

an orally acceptable vehicle, the orally acceptable vehicle comprising propylene glycol;

a thickening system, the thickening system comprising a polymeric thickener, wherein the polymeric thickener is a copolymer of 2-acrylamidomethylpropanesulphonic acid or a salt thereof; and

a peroxide whitening agent.

The examiner rejected claim 1 as obvious over the combination of two references: Golding and Joiner. Golding described a composition for whitening teeth, comprising propylene glycol, a copolymer of 2-acrylamidomethylpropanesulphonic acid, and a phthalocyanine blue pigment as whitening agent. However, Golding did not describe a peroxide whitening agent.

Joiner described whitening agents such as hydrogen peroxide. The examiner took the position that it would have been obvious to replace the pigment whitening agent in Golding with the peroxide whitening agent in Joiner, since both were “used in the prior art as useful for the same purpose…as a tooth whitening agent.”

The applicant argued that such a replacement would not have been obvious. The applicant explained that in Golding, whitening of teeth was performed “without the use of harsh chemicals or components that effect permanent whitening.” Golding used pigments as temporary whitening agents, applied to teeth to directly alter color. In contrast, Joiner used peroxides as permanent whitening agents, applied to teeth to remove existing stain coloring. The applicant argued that these different mechanisms of action meant that pigments and peroxides were not interchangeable equivalents.

The applicant also argued that if the pigment in Golding were replaced with the peroxide in Joiner, there would be no “need for the copolymer, since peroxide whiteners are not dependent upon being maintained on the teeth throughout the day to achieve their effect.”

The Board agreed with the applicant. The Board found that these whitening components were “not simple substitutes but rather operate in different ways. Golding’s pigment needs to remain on the teeth the entire time that a whitening effect is desired…The peroxide of Joiner, meanwhile, may be removed after it chemically reacts with stains in teeth resulting in whiter teeth.” The Board also found that the examiner provided “no persuasive reason why the other components of claim 1 or Golding, added to result in retention of pigment on teeth, would provide any benefit or improvement on the chemical tooth whitening effect of the peroxide compounds used by Joiner.” Accordingly, the Board reversed the obviousness rejection.

Takeaway: When an examiner takes the position that certain components are interchangeable equivalents, it is worth analyzing whether they really are equivalent. If there is a technical reason why it would not be obvious to substitute the components for each other (such as a difference in the mechanism of action of the components), then this reason can help overcome an obviousness rejection.

Judges: Adams, Fredman, Jenks

Examiners often use U.S. patents in making rejections, and they sometimes cite to the patent’s claims as evidence. In Ex parte Argembeaux the PTAB made it clear that claim scope, in and of itself, could not be used to broaden the overall teachings of a reference.

The claims in Argembeaux were directed to a skin cleansing preparation comprising less than 5% water. The Examiner cited only claim 13 of Franklin, a US patent, as the basis of the rejection – as both anticipating the pending claims and rendering them obvious. Because claim 13 of Franklin did not recite water (but listed all other components of Applicant’s claims) the Examiner found the listed components in Franklin’s claim to be anticipatory, and perhaps hedging his anticipation bet, also rejected the claims as obvious.

The Board reversed both rejections, dismissing the contention that “the absence of any mention of water in Franklin’s claims amounts to an affirmative disclosure that the compositions …. are necessarily water-free” in view of Franklin’s expressly described preference for an aqueous or aqueous-alcoholic carrier and the fact that all of the examples in Franklin used significantly more than 5% water. Based on the totality of Franklin’s disclosure, and finding no explicit disclosure affirmatively stating that water is merely an optional ingredient that may be omitted from the described compositions, the Board held that one of ordinary skill would not immediately envision (anticipation) nor be led to (obviousness) a composition as claimed containing less than 5% water.

The Argembeaux case can thus be useful in rebutting rejections where an Examiner improperly relies on a U.S. patent’s claims as evidence of prior art outside the scope of the specification’s underlying description.

Judges: R. Lebovitz, F. Prats, J. New

In Google LLC v. NavBlazer, LLC, the Patent Trial and Appeal Board (“Board”) declined to institute inter partes review of U.S. Patent No 9,075,136 (“the ’136 patent”). IPR2021-00502, Paper 6 (mailed Aug. 5, 2021).

The ’136 patent is directed to an apparatus that provides a vehicle user with information such as road and traffic conditions. Each of the independent claims of the ’136 patent required an apparatus that “automatically detects a departure of the vehicle from the first travel route, and … identifies a second travel route on which the vehicle can travel to the destination in response to the detected departure of the vehicle from the first travel route.”

The petitioner argued that the claimed dynamic rerouting functionality would have been obvious over the combination of: a primary reference (Behr) that disclosed a base unit that calculated route guidance in response to a query using an up-to-date database located in the base unit and then transmitted the response to a display unit; and a secondary reference (Schreder) that disclosed an automobile equipped with an RF GPS navigation system and RF receivers that monitored updated traffic condition information for dynamic rerouting guidance.

According to the Petitioner, it would have been obvious to include Schreder’s dynamic rerouting functionality within the base unit of Behr so that when the base unit detected a deviation from a specified route, it would identify a new route. The Petitioner further argued that an artisan would have been motivated to make this modification because Behr teaches that guidance systems that are self-contained within a vehicle, such as the system disclosed in Schreder, suffered from many drawbacks, including the need for large data storage capabilities onboard the vehicle.

The Board was not persuaded, stating:

We disagree with Petitioner that reducing vehicle-side processing and data storage justifies modifying Behr’s navigation system to include Schreder’s dynamic rerouting feature. Petitioner’s proffered rationale justifies where a skilled artisan would have located Schreder’s rerouting functionality—in Behr’s central system—but does not address why a skilled artisan would have added that functionality to Behr in the first place. Given this deficiency, we find that Petitioner has not produced the required ‘articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’

Absent an articulated reason for “why” an artisan would have made the modification, the Board found that the Petitioner failed to carry its burden to show a reasonable likelihood of prevailing on any claim, and thus declined to institute inter partes review of the ’136 patent.

Takeaway: In Google v. NavBlazer, the Petitioner arrived at the claimed subject matter but neglected to explain why the modification would have been obvious in the first place. Unlike anticipation, obviousness requires a story, and the most important part of that story is why a skilled artisan would have been motivated to modify the primary reference to arrive at the claimed subject matter. Without “the why” (i.e., a reason), the obviousness rationale collapses into a hindsight-guided combination of elements. Therefore, when challenging the claims of patent for obviousness it is critical to supply the Board with “the why” of the story you are telling.

Judges: K. Turner, G. Baer, A. Moore

Ex parte Ratcliff, is a recent decision of the Patent Trial and Appeal Board (PTAB) addressing whether the requirement that a component of a claimed composition “remains stable in the composition” was indefinite.

In Ex parte Ratcliff, the claim at issue was directed to an oral rinse composition. The relevant claim recited:

An oral rinse composition for enhancing tooth remineralization, comprising:

stabilized chlorine dioxide that remains stable in the composition, the stabilized chlorine dioxide capable of reacting with acidic elements of oral biofilms to produce chlorine dioxide gas;

sodium fluoride; and

a pharmaceutically acceptable buffer effective at establishing an effective pH range of the composition from about 6.0 to about 7.4 for maintaining the stability of the chlorine dioxide in the composition;

wherein the stabilized chlorine dioxide and the sodium fluoride in combination are more effective at enhancing tooth remineralization and reducing tooth demineralization than either of the stabilized chlorine dioxide or the sodium fluoride alone.

In this case, the examiner took issue with the above-emphasized phrase “stabilized chlorine dioxide that remains stable in the composition.” Particularly, the examiner asserted that “… the claim does not provide a discernable boundary on what provides the functional characteristic to the stabilized chlorine dioxide (SCD),” wondering whether stabilized chlorine dioxide is stable in the composition:

… due to the addition of some other structure (such as pH modifiers, stabilizers, etc.), absence of destabilizing agents (such as stannous chloride), other features of the composition (such as specific pH ranges)… due to a sequence of steps by which it is made or by some other means, or a certain combination of these.

Applicant argued that “stability” was adequately defined in the specification as the “ability to maintain levels of the… chlorine dioxide source… within the levels specified by the present invention when the final composition is placed under…” specified storage conditions. However, the PTAB noted that the “levels specified by the present invention” were not defined in the claim or specification (or identified by applicant in its appeal briefing).

The PTAB searched the specification for further guidance and found a general disclosure of amounts of the chlorine dioxide source (0.005% w/w to 0.800% w/w) and disclosure that a reduction in the amount of stabilized chlorine dioxide after storage (0.125% w/w >> 0.04% w/w) indicated that stability was achievable. However, the PTAB found that there was insufficient guidance in the specification regarding “how much stabilized chlorine dioxide must remain in the composition after being stored under the specified conditions, in order to be stable according to the definition of stability provided in [the specification].” Thus, the PTAB affirmed the examiner, finding the claim so ambiguous that it failed to inform a skilled artisan about the scope of the claimed invention with reasonable certainty.

The PTAB reversed the only other rejection on appeal – an obviousness rejection. However, this was a pyrrhic victory. The PTAB stated that “the scope of the claimed subject matter is so uncertain that we cannot meaningfully perform the required comparison between the composition recited in [the claim] and the compositions of the cited prior art.”

Takeaway: It was apparent in this case that the PTAB was looking for a number – how much stabilized chlorine dioxide would need to remain in the composition after storing under specified conditions for the stabilized chlorine dioxide to be deemed “stable in the composition”? For claims as in this case, it can be helpful to consider how the difference between “stable” and “not stable” will be explained to a lay jury. If it will be hard to show a lay jury the line between infringing and not infringing, it may be preferable to claim the composition differently (maybe product-by-process).

In this case, both the examiner and the PTAB relied on their own judgment of how a skilled artisan would have viewed the meaning of stability. While applicant provided experimental evidence to show that certain prior art compositions did not include stabilized chlorine dioxide that remains stable, a succinct statement from a skilled artisan regarding how to determine whether stabilized chlorine dioxide “remains stable in the composition” may have framed the issue of indefiniteness in a more favorable manner.

Judges: Adams, Prats, Townsend

What does “up to at least 150 volts” mean? Does it mean 150 volts is a maximum voltage due to the use of the words “up to” or a minimum voltage due to the use of the words “at least”? This was the problem the Patent Trial and Appeal Board (“Board”) in Ex parte Bagehorn (Appeal 2020-004760) had to solve.

Claim 1 was the sole independent claim on appeal and was directed to a method for the electrolytic polishing of a metallic substrate. The claimed method included a step of “applying a current at a voltage of 270 to 315 volts.”

The Examiner rejected claim 1 as obvious over Clasquin in view of Kodera. Regarding the claimed voltage of “270 to 315 volts,” the Examiner believed Clasquin described an overlapping voltage range based on Clasquin’s disclosure in ¶ 49 that “it has been found that higher voltage up to at least 150 volts can be used.” The Examiner interpreted the phrase “up to at least 150 volts” as teaching a range of “at least 150 volts” and pointed to Clasquin’s disclosure in ¶ 63 that “[c]urrent densities as high as at least 225,000 A/m² can be used at applied voltages of 150 volts or more” for “nickel based alloy 718” as a support.

Appellant argued the Examiner’s interpretation of the phrase indicated that he ignored the preceding words “up to” and failed to read Clasquin’s disclosure in ¶¶ 49 and 63 in the context of Clasquin as a whole. In particular, Appellant argued “up to at least 150 volts” implied a ceiling of 150V, while the words “at least” provided some flexibility to that ceiling so that Clasquin suggested a maximum voltage that is slightly higher than 150V, but not as high as the lower boundary of 270V recited by claim 1. Appellant further argued that the disclosure in ¶ 49 served as an umbrella disclosure and that Clasquin’s specific working examples, including ¶ 63, would be understood by a skilled artisan as falling within that umbrella. In addition, Appellant noted Table 5 of Clasquin, which disclosed more than two dozen examples, used a maximum voltage of 150V.

The Board sided with the Appellant. The Board agreed that the Examiner’s interpretation of the phrase did not adequately account for the words “up to,” which, by their plain meaning, suggested a maximum, not a minimum. The Board noted Clasquin disclosed in ¶ 49 that for certain metals, polishing with voltages above 40V was undesirable because voltages above 40V resulted in loss of luster; however, certain other metals did not demonstrate the same problem and it was for those metals that “higher voltages up to at least 150 volts can be used.” Therefore, the Board held that, in context, the words “at least” did not wholly negate the preceding words “up to” but rather suggested the ceiling indicated by the words “up to” may be somewhat higher than 150V. The Board agreed with the Appellant that this interpretation was supported by the examples disclosed in Table 5 of Clasquin and was consistent with Clasquin’s other disclosures in, for example, ¶¶ 57 and 95.

Regarding Clasquin’s disclosure in ¶ 63, the Board noted “150 volts or more” – in isolation – was consistent with the Examiner’s understanding of Clasquin. However, the Board found that when it was read in view of Clasquin’s other disclosures, a skilled artisan would not have understood ¶ 63 as suggesting that any voltage above 150V could be used even for nickel 718, as evidenced by the dozen nickel 718 based compositions disclosed in Table 5, for which voltages only ranged from 9.7V to 150V.

Therefore, the Board agreed with the Appellant and found Clasquin as a whole as suggesting a voltage ceiling of approximately 150V, with some flexibility. Because 270V, the recited lower boundary of the voltage range, was 80% greater than the 150V suggested by Clasquin and because the Examiner did not establish a person of ordinary skill in the art would have understood Clasquin as teaching or suggesting voltages as high as those of claim 1, the Board reversed the Examiner’s obviousness rejection.

Takeaway: Although the term at issue in Bagehorn is not a claim term but a phrase in a cited reference, the interpretation principle is the same. That is, terms and phrases should be given the interpretation as understood by a person of ordinary skill in the art in light of the disclosure as a whole. Nevertheless, the confusion could have been avoided if a phrase such as “up to around 150 volts” had used instead of “up to at least 150 volts.”

Judges: J. C. Housel, C. C. Kennedy, and J. E. Inglese

In a recent IPR, the PTAB found a chemical formula in the claims not to be fully supported by a provisional application, opening the claims to anticipatory prior art. IPR2020-00349, Paper 53 (PTAB July 15, 2021).

The patented claims related to a battery comprising an additive represented by Chemical Formula 1:

where each of k, l and m is independently an integer of 0 to 20; each of k, l and m are different from each other such that the compound has an asymmetric structure; and n is an integer of 1 to 7.

Chemical Formula 1 itself was identical between the provisional and nonprovisional applications. However, the nonprovisional application added the following statement: “For example, the compound represented by Chemical Formula 1 may be 1,3,6-hexane tricarbonitrile, 1,3,5-hexane tricarbonitrile, or 2,3,6-hexane tricarbonitrile.”

The petitioner argued that a skilled artisan would not have understood the originally disclosed Chemical Formula 1 to encompass the second and third of these exemplary compounds. In particular, 1,3,5-hexane tricarbonitrile does not have a cyano group at position 6 of the hexane backbone. Thus, to map this compound onto Chemical Formula 1 would require a methyl substituent on the main carbon backbone of Chemical Formula 1. Similarly, 2,3,6-hexane tricarbonitrile does not have a cyano group at position 1 of the hexane backbone. To map this compound onto Chemical Formula 1 also would require a methyl substituent on the main carbon backbone of Chemical Formula 1.

The petitioner argued that Chemical Formula 1 is a “bond-line formula” which would be understood in the provisional application to exclude substituents from the backbone -CH₂– moieties. The petitioner argued that the inclusion of 1,3,5-hexane tricarbonitrile and 2,3,6-hexane tricarbonitrile as examples of compounds of Chemical Formula 1 in the nonprovisional application broadened the meaning of Chemical Formula 1 to include substituents on the backbone. Because of this, the petitioner argued that the scope of the patented claims was not fully supported by the provisional application.

The PTAB agreed with the petitioner. The PTAB was not persuaded by the patent owner’s argument that the possibility of substituents was implied in Chemical Formula 1 in the provisional application. The PTAB noted other instances within the provisional application where R groups were used to identify optional substituents, and found that “[w]hen the inventors…intended to disclose a chemical formula that permitted substituents to be optionally added, they knew how to do so.”

Since the priority chain from the patent to the provisional application was broken, the PTAB found the claims to be anticipated by prior art that could not be antedated.

Takeaway: Innovation is dynamic, and often continues between the filing of a priority (e.g. provisional) application and a nonprovisional application. New material that is developed within this time generally can be included in the nonprovisional application. Caution is required, however, since the new material can raise an issue of written description support, breaking the priority chain and opening the application or patent to additional prior art.

Judges: Crumbley, Kokoski, McGee

Ex parte Kiely is a recent decision of the Patent Trial and Appeal Board (PTAB) addressing whether a Markush group stating “selection from the group comprising” was indefinite.

In Ex parte Kiely the Appellant argued that the phrase “selection from the group comprising” was not improper because the Examiner allowed claims in another application with language and alleged that such phrasing was found proper in Multilayer Stretch Cling Film Holdings, Incorporated v. Berry Plastics Corporation, 831 F.3d 1350 (Fed. Cir. 2016). The PTAB disagreed.

First, the PTAB relied on Abbott Labs. v. Baxter Pharm. Products, Inc. for the proposition that “a proper Markush group is limited by the closed language term ‘consisting of.’” 334 F.3d 1274, 1281 (Fed. Cir. 2003). The PTAB also cited MPEP § 2173.05(h), which states “[i]f a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group ‘comprising’ or ‘consisting essentially of’ the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim.”

With respect to Appellant’s reliance on Multilayer Stretch Cling, the PTAB noted that this case did not sanction the phrase “selected from the group comprising.” The claims at issue in Multilayer Stretch Cling did not even use this language. To the contrary, the court in Multilayer Stretch Cling stated:

[I]f a patent claim recites ‘a member selected from the group consisting of A, B, and C,’ the ‘member’ is presumed to be closed to alternative ingredients D, E, and F. By contrast, the alternative transitional term ‘comprising’ creates a presumption that the recited elements are only a part of the device, that the claim does not exclude additional, unrecited elements.

Finally, the PTAB rejected the Appellant’s argument that allowed claims in another application could cure the indefiniteness rejection because “compliance for each case with the statutory requirements is done on a case-by-case basis.” See In re Giolito, 530 F.2d 397, 400 (CCPA 1976)(“We reject appellants’ argument that the instant claims are allowable because similar claims have been allowed in a patent. It is immaterial whether similar claims have been allowed to others.”); see also In re Wertheim, 541 F.2d 257, 264 (CCPA 1976) (holding that “[i]t is immaterial in ex parte prosecution whether the same or similar claims have been allowed to others”).

Accordingly, the PTAB affirmed the Examiner’s indefiniteness rejection.

Takeaway: A Markush group is common when claiming alternative members for a particular purpose. The proper language for a Markush group is “selected from the group consisting of.” The PTAB in Ex parte Kiely was not open to an alternative format that bucked this convention. Thus, when claiming a Markush group it is best to use the standard phrasing. It is also important to remember that a Markush group carries a presumption that it is closed to unrecited alternatives and a presumption, albeit weaker, that it is closed to mixtures/blends of the recited alternatives. This latter presumption was overcome in Multilayer Stretch Cling, because the specification supported blends. Therefore, a Markush group should not be used when there is a clear intent for the claim to remain open to unrecited elements/members.

Judges: T. Owens, M. Colaianni, D. Praiss

Ex parte Hwang, is a recent decision of the Patent Trial and Appeal Board (PTAB) addressing whether a claimed sequence of layers was rendered obvious by a similar sequence of layers in the prior art.

In Ex parte Hwang, the claim at issue was directed to a barrier film used to protect a display device, such as a liquid crystal, electronic ink, or organic light emitting diode (OLED) type device. The relevant claim recited, in part:

A barrier film comprising:

a stacked sheet having a top surface and a bottom surface and comprising:

at least two first layers formed of a semicovalent inorganic material; and

at least one second layer formed of an ionic inorganic material,

wherein:

each second layer is disposed between two first layers with one first layer in contact with a first surface of the second layer and the other first layer in contact with an opposite second surface of the second layer,

each first layer and second layer are alternately disposed, the first layers are disposed to form both the top and bottom surfaces of the stacked sheet…

the difference in binding energy between the semicovalent inorganic material and the ionic inorganic material is in the range of 0.1 eV to 3.9 eV…

Thus, the claim was directed to a film including a stack of alternating layers of a first material and second material, with a layer of the first material at the top of the stack and the bottom of the stack:

1—2—1; or

1—2—1—2—1….

In rejecting the claim, the examiner relied on a prior art reference disclosing a similar sequence of layers in a barrier film. However, in the prior art reference, the alternating layers were joined by “anchor coat” layers for “improving interlayer adhesiveness between two layers.” The prior art reference disclosed, for example:

1—AC—2—AC—1

Applicant argued the first layers could not be “in contact” with the second layers because of the presence of the anchor coat layers.

The PTAB noted that the examiner must give broadest reasonable meaning to “contact” and that such term was not defined in the specification. Interestingly, the PTAB noted that applicant added the requirement of contact to the claim during prosecution, relying for support on the description of sequential deposition of first and second layers in an actual example. Ultimately, the PTAB relied on a dictionary definition as providing the conventional meaning of “contact” as requiring a “union or junction of surfaces.”

The PTAB concluded that the examiner had impermissibly read the requirement of contact out of the claim and relied on impermissible hindsight in making the rejection over the prior art reference.

Takeaway: The number of patents that are directed to new sequences of layers of known materials would probably surprise a non-practitioner. There is always a tension between defining sequences of layers concretely to distinguish over prior art and being permissive of additional, intervening layers to avoid a design-around. Terms that are seemingly clear – “on,” “over,” “in sequence,” “in contact” – can be the source of disputes during examination and thereafter (“indirect contact”? “contact via”?). To avoid uncertainty (if this is desired), terms defining relative location should be defined explicitly in the specification and used consistently in the claims.

Judges: Colaianni, Dennett, McGee

Section 101 specifies four patent eligible categories: process, machine, manufacture, and composition of matter. However, the U.S. Supreme Court has long interpreted § 101 to exclude the so-called “judicial exceptions” as patent eligible subject matter. Specifically, the judicial exceptions are laws of nature, natural phenomena, and abstract ideas (mathematical formulas, certain methods of organizing human activity such as fundamental economic practices, or mental processes). Therefore, a claim determined to be directed to a judicial exception is patent ineligible unless it is found that the claim as a whole includes additional elements “that amount to significantly more than the judicial exception.”

The USPTO published a revised guidance on the application of § 101 in January 2019 followed by an update in October 2019. The Guidance and the Update set forth a step-by-step eligibility analysis, in which Step 2 is the Supreme Court’s Alice/Mayo two-part test to determine whether a claim is patent ineligible because it is directed to a judicial exception. In particular, Step 2A and Step 2B of the Office’s eligibility analysis correspond to the first and second parts of the Alice/Mayo test, respectively.

Step 2A is a two-prong inquiry. Under Step 2A Prong 1, an examiner should look to whether a claim recites any judicial exceptions. If the answer is yes, it does not mean that the claim is “directed to” the judicial exception; instead, the examiner should proceed to Step 2A Prong 2 to look to whether the claim recites additional elements that integrate the judicial exception into a practical application. If so, the claim is not directed to the judicial exception and thus is patent eligible. Only when the claim recites a judicial exception and does not integrate that exception into a practical application does the examiner proceed to Step 2B to consider whether the claim recites additional elements that are significantly more than the judicial exception.

Step 2A Prong 2 is similar to Step 2B in that both analyses involve evaluating a set of the same considerations to determine if the claim is still patent eligible due to the recited additional elements. However, although consideration of whether the additional elements represent well-understood, routine, conventional activity is included under Step 2B, such consideration is specifically excluded under Step 2A Prong 2, because additional elements that represent well-understood, routine, conventional activity may integrate a recited judicial exception into a practical application.

Applying the Office’s eligibility analysis, the Patent Trial and Appeal Board (“Board”) in Ex parte Moritz (Appeal 2020-004626) considered the Examiner’s rejection of Applicant’s claims as being directed to patent-ineligible subject matter.

Claim 1, which was illustrative, was drawn to “[a] multiplexed method to identify proteins to which a test compound binds in a sample containing numerous proteins or for identifying a compound capable of binding to a target protein contained in a sample comprising numerous proteins, including said target protein.” The method included steps (a)-(c), which, according to the Applicant, described a prior art method for determining interaction of a test compound with a single protein. However, the Applicant argued the invention itself was directed to “an improvement which permits multiplexing” of the prior art method and the improvement lied in requiring that the sample comprised numerous proteins and that the step (c) of determining the concentration of multiple proteins was performed by SWATH-MS or SRM-MS.

The Board first analyzed whether the claim recited any judicial exceptions under Step 2A Prong 1. The Board determined that the claim did not recite any method of organizing human activity such as fundamental economic practices or any mathematical concepts. The Board noted that the Applicant did not dispute the Examiner’s contention that the claim recited metal processes and found it was “arguably conceivable that at least the claimed steps of identifying a protein that binds a test compound could be performed in the mind.” The Board thus concluded “the claims recite the judicial exception of mental processes, and, thus, abstract ideas” under the broadest reasonable claim interpretation standard and proceeded to analyze the claim under Step 2A Prong 2.

The Board emphasized that under Step 2A Prong 2, the claim elements must be analyzed both individually and as an ordered combination to determine whether the additional elements integrated the recited abstract idea into a practical application, such as an improvement to technology or to a technical field. To do that, the specification should be evaluated to determine “if the disclosure provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement.” In addition, “the claim must be evaluated to ensure that the claim itself reflects the disclosed improvement.”

Applying to the application at hand, the Board noted that the claimed steps recited a method of identifying and quantifying proteins to which a test compound bound in a sample containing numerous proteins, where the interaction between the test compound and proteins was determined using SWATH-MS or SRM-MS. The Board found that the Specification described the invention as an improvement in the technical field of assays (such as thermal shift assays) that assessed the interaction of a compound with a protein. The Board also found that the Specification specifically explained that the claimed application of SWATH-MS or SRM-MS to prior art thermal shift assays overcame obstacles associated with using such assays on “complex protein samples.” The Examiner recognized the claim included additional elements of the sample preparation and separations steps. However, as held by the Board, the Examiner erred in considering whether the additional elements were “routine and conventional data gathering activity” under Step 2A Prong 2 and also erred in failing to consider the claim as a whole. The Board agreed with the Applicant that when considered as a whole, the claim was directed to “an improvement in determining test compound interaction with proteins” and the additional elements integrated the recited judicial exception into a practical application.

Accordingly, the Board reversed the Examiner’s rejection, finding that the claimed subject matter was patent eligible.

Takeaway: Although analysis under Step 2A Prong 2 is similar to the analysis under Step 2B, a critical difference between the two is that the Step 2A Prong 2 analysis, which determines whether a claim is “directed to” a judicial exception, is performed without considering what is well-understood, routine, conventional activity. Moritz also illustrates that a claim, even if it recites a judicial exception, can be found not to be directed to the judicial exception under Step 2A Prong 2 and thus patent eligible, if the claim elements, when considered as a whole, represent an improvement in a specific technology that is described in sufficient detail in the specification for a skilled artisan to recognize.

Judges: F. C. Prats, T. Chang, and C. M. Hardman

In Ex Parte Mitani, Japan Tobacco took a creative approach in attempting to overcome a non-statutory obviousness-type double patenting rejection before the Patent Trial and Appeal Board: they argued that an improper Markush group rejection during prosecution was tantamount to a restriction requirement, and that it afforded Appellant with “safe harbor” protection under 35 U.S.C.121.

Rather than arguing the merits of the rejection, which was based on an isomeric/close structural similarity relationship between the claimed and the patented compounds, Appellant argued that the Examiner’s improper Markush group rejection, made in the patented case, was a de facto restriction requirement that forced Appellant to prosecute only one of four possible bicyclic substituents. To make them file a terminal disclaimer in a child case in which a different bicyclic structure was being pursued was argued to be unfair.

While sympathetic, the Board found itself constrained by the strict guidance given by the Federal Circuit in Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1382 (Fed. Cir. 2003) that “§ 121 only applies to a restriction requirement that is documented by the PTO in enough clarity and detail to show consonance.” Because Appellant did not cite to any documented restriction requirement in the application under appeal (or any application in the chain of priority) between the subject matter claimed and the patented subject matter, and because Appellant did not identify any authority allowing the Board to substitute an improper Markush group rejection for a documented restriction requirement, the Board affirmed the Examiner.

Takeaway: The safe harbor protection under 35 U.S.C. 121 is contingent on a documented restriction requirement in the application under appeal (or any application in the chain of priority) between the subject matter claimed and the patented subject matter. One issue that did not seem to be fully taken into consideration in this appeal was the issuance of an Election of Species requirement in the abandoned parent application, in which the Examiner stated that “each compound is distinct, having different chemical and physical properties, and is made in a different way. In addition, these species are not obvious variants of each other based on the current record.” Because no prior art was used in the double patenting rejection, this statement of patentable distinctness should still apply.

Judges: E. Grimes, R. Lebovitz, F. Prats

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ODP Safe Harbor Provision, Close but No Cigar…

USPTO Further Delays Non-DOCX Fee Until January 17, 2024

USPTO Further Delays Non-DOCX Fee Until June 30, 2023