DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment, filed on 9/29/2023, is acknowledged.
Claims 1-20 are currently pending.
Claim 1 is an independent claim.
Election/Restrictions
Applicants’ election without traverse of Group I, claims 1-8 and 13-17, directed to a GUCY2C binding polypeptide, and the antibody CDR sequences of the Clone D08 (A10) species, filed on 3/26/2026, is acknowledged.
As stated in the Restriction Requirement mailed on 3/26/2026, Groups I (claims 1-8 and 13-17) and IV (claims 18 and 19 in part) have unity of invention.
Claims 9-12 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and/or species.
Claims 1-8 and 13-19 are under examination as reading on a GUCY2C binding polypeptide with the antibody CDR sequences of the Clone D08 (A10).
Priority
Applicant’s claim for the benefit of a prior-filed Korean Patent Application No. 10-2021-0045510 filed on April 7, 2021, is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9/29/2023, 6/14/2024, 10/07/2024, and 11/27/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner in their entireties.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Specifically, an embedded hyperlink is disclosed on pg. 9. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the terms:
Nunc™ (pg. 65);
MaxiSorp (pg. 65);
Lipofectamine™ (pg. 70); and
Lenti-X™ (pg. 71);
which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1-8 and 13-17 are objected to because the claims recite the acronym “GUCY2C”. This is not a readily recognized acronym in the art, such as “DNA” for 5’-deoxyribonucleic acid. Please define the acronym “GUCY2C” when it is first used in the claims.
Claims 16 and 17 are objected to because the claims recite, in part, and unelected invention. For example, claim 16 recites: “…a polynucleotide encoding the GUCY2C binding polypeptide…”
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
Breadth of claims and nature of invention:
Claims 16 and 17 encompass pharmaceutical compositions for the prevention and treatment of cancer (claim 16) or GUCY2C expressing cancer (claim 17) comprising a broad genus of binding polypeptides with a partial structure at best and the function “GUCY2C binding polypeptide”.
Claims 18 and 19 encompass methods of treating or preventing cancer (claim 18) or GUCY2C expressing cancer (claim 19) comprising administration a broad genus of binding polypeptides with a partial structure at best and the function “GUCY2C binding polypeptide”.
The specification discloses screening of antibody clones to identify antibody scFv structures that that specifically bind to GUCY2C (pg. 43-44): “[a] recombinant antigen was prepared by conjugating human GUCY2C (R&D Systems, Cat no. 2157-GC; SEQ ID NO: 112)) with CD4 (SEQ ID NO: 115), and clones secreting a scFv specific to the antigen were screened, to secure 18 scFvs specifically binding to GCUCY2C.”
Amount of direction and existence of working examples:
The instant specification discloses identification of the following clones from a screen to identify GUCY2C binders: A01, A02, A03, A04, A05, A06, A07, A08, A10, A12, B01, B07, B08, B10, B11, B12, C01, C02, and C07 (Tables 1-3). Each of these clones are specific antibody structures, defined by their amino acid sequences especially in the CDR regions critical for antigen binding, that give rise to the function “GUCY2C binding polypeptide”.
The specification further discloses that the binding polypeptide scFv structures can be incorporated into CARs and expressed by NK cells, and these CAR-NK cells can be used to target and kill GUCY2C expressing cells in vitro (Example 4.6) and in vivo (Example 4.7).
Level of predictability, state of prior art, and quantity of experimentation needed:
Claims 16 and 17 recite pharmaceutical compositions for the prevention or treatment of any and all cancers, regardless of GUCY2C status (claim 16), and GUCY2C expressing cancers, comprising the elected invention of GUCY2C binding polypeptides, or chimeric antigen receptors comprising the binding polypeptides, with a partial structure at best.
Claims 18 and 19 encompass methods of treating or preventing cancer (claim 18) or GUCY2C expressing cancer (claim 19) comprising administration a broad genus of anti-GUCY2C binding polypeptides, or chimeric antigen receptors comprising the binding polypeptides with a partial structure at best.
However, the instant specification only discloses working examples of NK cells expressing anti-GUCY2C eliminating GUCY2C expressing tumor cells in vivo (Example 4.7). Neither the instant specification nor the prior art disclose sufficient guidance to one with ordinary skill in the art to make pharmaceutical compositions for the prevention or treatment of any cancer (claim 16), or any GUCY1C expressing cancer (claim 17) comprising the claimed GUCY2C binders, or CARs comprising the claimed binders. Neither does the instant specification nor the prior art disclose sufficient guidance to enable one with ordinary skill in the art to use a method of treating cancer (claim 18), or GUCY2C expressing cancer (claim 19) comprising administration of a GUCY2C binding polypeptide, or CARs comprising binding polypeptides. For example, neither the instant specification nor the prior art provide sufficient guidance to enable one with ordinary skill in the art to treat GUCY2C expressing cancer comprising administration of anti-GUCY2C CARs that are not expressing on T-cells or NK cells.
Additionally, the burden of enabling the prevention of a disease (i.e. the need for additional testing) would be greater than that of enabling a treatment due to the need to screen those mammals susceptible to such diseases and the difficulty of proof that the administration of the drug was the agent that acted to prevent the condition. Further, the specification does not provide guidance as to how one skilled in the art would go about screening those patients susceptible to cancer (claims 16 and 18) or GUCY2C expressing cancer (claims 17 and 19) within the scope of the presently claimed invention. Nor is sufficient guidance provided as to a specific protocol to be utilized in order to prove the efficacy of the presently claimed GUCY2C binding polypeptides in preventing cancer. For example, the specification discloses that the experimental mice were first injected with GUCY2C expressing tumor cells, and then later injected with NK cells engineered to express anti-GUCY2C CARs (Example 4.7). The specification does not show that GUCY2C binding polypeptides, or CARs comprising the binding polypeptides being injected prior to tumor cell administration.
Undue experimentation would be required to make the invention as currently claimed. Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
Claims 1, 2, 4, 5, 7, 8, and 13-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for binding polypeptides comprising the CDR sequences of the antibody clones A01-A08, A10, A12, B01, B07, B08, B10-B12, C01, C02, and C07 with the function of “GUCY2C binding polypeptide”, and compositions for diagnosing GUCY2C expressing cancer comprising the GUCY2C binding polypeptide clones; does not reasonably provide enablement for a broad genus of binding polypeptides with a partial structure at best and the function of “GUCY2C binding polypeptide” (claims 1, 2, 4, 5, 7, 8, and 13-19), or compositions for diagnosing any cancer regardless of GUCY2C expression status (claim 14). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
Breadth of claims and nature of invention:
Claims 1, 2, 4, 5, 7, and 13-19 encompass a broad genus of binding polypeptides with the HCDR1-3 sequences recited in instant claim 1, the LCDR1-3 sequences recited in instant claim 1, or both, all with the function of “GUCY2C binding polypeptide”. For example, claim 1 encompasses a subgenus of binding polypeptides with all 6 CDR sequences defined, encompassing any combination of the HCDR1-3 and LCDR1-3 sequences, which is (8*9*12)*(13*10*17) = 1.9x106 binding polypeptide structure with the function of “GUCY2C binding polypeptide”. The claims also encompass structures where either the HCDR1-3 or the LCDR1-3 are the only defined structures.
The specification discloses screening of antibody clones to identify antibody scFv structures that that specifically bind to GUCY2C (pg. 43-44): “[a] recombinant antigen was prepared by conjugating human GUCY2C (R&D Systems, Cat no. 2157-GC; SEQ ID NO: 112)) with CD4 (SEQ ID NO: 115), and clones secreting a scFv specific to the antigen were screened, to secure 18 scFvs specifically binding to GCUCY2C.”
Amount of direction and existence of working examples:
The instant specification discloses identification of the following clones from a screen to identify GUCY2C binders: A01, A02, A03, A04, A05, A06, A07, A08, A10, A12, B01, B07, B08, B10, B11, B12, C01, C02, and C07 (Tables 1-3). Each of these clones are specific antibody structures, defined by their amino acid sequences especially in the CDR regions critical for antigen binding, that give rise to the function “GUCY2C binding polypeptide”.
Level of predictability, state of prior art, and quantity of experimentation needed:
The claims are directed to binding polypeptides with a partial structure at best with the function of “GUCY2C binding polypeptide”, which includes broad genera of millions to billions of different structures, including antibodies and other polypeptide structures, with the recited function.
However, the specification did not give the skilled in the art enough information to choose candidate antigen binding structures from the vast number of options of millions of candidates, and therefore required scientists to engage in a great deal of experimentation and failure. “That is not enablement”—it is a “hunting license.”
The specification discloses 19 different anti-GUCY2C antibody structures with the function of “GUCY2C binding polypeptide”.
In Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Supreme Court held that claims drawn to a genus of monoclonal antibodies, which were functionally claimed by their ability to bind to a specific protein, PCSK9, were invalid due to lack of enablement. The claims at issue were functional, in that they defined the genus by its function (the ability to bind to specific residues of PCSK9) as opposed to reciting a specific structure (the amino acid sequence of the antibodies in the genus). The Supreme Court concluded that the patents at issue failed to adequately enable the full scope of the genus of antibodies that performed the function of binding to specific amino acid residues on PCSK9 and blocking the binding of PCSK9 to a particular cholesterol receptor, LDLR. This decision reaffirmed the prior decision made by the Federal District Court in Amgen Inc. v. Sanofi, Aventisub LLC., 987 F.3d 1080 (Fed. Cir. 2021).
The Court clarified that the specification does not always need to "describe with particularity how to make and use every single embodiment within a claimed class." Id. at 610-11. However, "[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class….The more one claims, the more one must enable." Id.
The specification may require a reasonable amount of experimentation to make and use the invention and what is reasonable will depend on the nature of the invention and the underlying art. For example, "it may suffice to give an example (or a few examples) if the specification also discloses some general quality … running through the class that gives it a peculiar fitness for the particular purpose" and "disclosing that general quality may reliably enable a person skilled in the art to make and use all of what is claimed, not merely a subset." Id. at 611 (internal quotations omitted). However, the Supreme Court found that Amgen failed to enable all that it claimed, even if allowing for a reasonable degree of experimentation. Id. at 613; see also Baxalta Inc. v Genentech, Inc., 81 F.4th 1362, 1367, 2023 USPQ2d 1103 (Fed. Cir. 2023) ("[t]he facts of this case are more analogous to—and are, in fact, indistinguishable from—those in Amgen. We do not interpret Amgen to have disturbed our prior enablement case law, including Wands and its factors."). Moreover, "[w]e see no meaningful difference between Wands' ‘undue experimentation’ and Amgen's ‘[un]reasonable experimentation’ standards. Id. at footnote 4. See also Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024), which explains that regardless of the technology the Wands factors should be used when assessing enablement.
However, while the specification in Amgen identified 26 exemplary antibodies that performed the claimed function by their amino acid sequences, the claims at issue were directed to a class which included "a ‘vast’ number of additional antibodies" that Amgen had not described by their amino acid sequences. Id. at 613. The Court found that Amgen sought to monopolize an entire class by their function, even though that class was much broader than the 26 exemplary antibodies disclosed by their amino acid structure. Id. at 613.
In Amgen Inc. v. Sanofi, Aventisub LLC, 987 F.3d 1080 (Fed. Cir. 2021), which the Supreme Court affirmed, the Federal Circuit explicitly applied the Wands factors to assess whether the specification of Amgen’s patent provided sufficient enablement, for purposes of 35 U.S.C. 112(a), to make and use the full scope of the claimed invention. The court relied on evidence showing that the scope of the claims encompassed millions of antibodies and that it was necessary to screen each candidate antibody in order to determine whether it met the functional limitations of the claim. Id. at 1088. Consequently, the Federal Circuit concluded that there was a lack of enablement. See also the following cases across various technology areas: McRO, Inc. v. Bandai Namco Games Am. Inc., 959 F.3d 1091, 2020 USPQ2d 10550 (Fed. Cir. 2020); Wyeth & Cordis Corp. v. Abbott Laboratories, 720 F.3d 1380, 107 USPQ2d 1273 (Fed. Cir. 2013); Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., 928 F.3d 1340 (Fed. Cir. 2019); and Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., 941 F.3d 1149, 2019 USPQ2d 415844 (Fed. Cir. 2019).
Amgen attempted to claim an entire class of compounds by their function, namely antibodies that bind to the “sweet spot” of PCSK9 thereby inhibiting it from binding to LDL, while only describing 26 amino acid sequences in its specification. The two processes, the “roadmap” and “conservative substitution” did not save Amgen. According to the Court, these amounted to “little more than two research assignments” which forced scientists to conduct “painstaking experimentation” to see what worked. (citing Incandescent Lamp). The Court therefore held that Amgen’s specification did not enable the claims.
This case is akin to the issue in Amgen Inc. v. Sanofi, Aventisub LLC, in which the court relied on evidence showing that the scope of the claims encompassed millions of antibodies and that it was necessary to screen each candidate antibody in order to determine whether it met the functional limitations of the claim. Sanofi-Aventisub at 1088. Consequently, the Federal Circuit concluded that there was a lack of enablement. While the specification in Amgen identified 26 exemplary antibodies that performed the claimed function by their amino acid sequences, the claims at issue were directed to a class that included “a ‘vast' number of additional antibodies” that Amgen had not described by their amino acid sequences. Id. at 1256. The Supreme Court found that Amgen sought to monopolize an entire class of antibodies by their function, which was much broader than the 26 exemplary antibodies disclosed by their amino acid structure.
In the instant case, the claims are directed to a broad class of binding polypeptides, which includes antibodies, all with the function of “GUCY2C binding polypeptide”, while the instant specification only discloses 19 different antibody structures with this function.
The instant claims are directed to classes of polypeptides that include “a ‘vast’ number” of additional structures (i.e., amino acid sequences of all of the CDR regions that are necessary for antigen binding in the case of antibodies) in which the instant specification fails to describe. It would be necessary to first generate and then screen each candidate binding polypeptide to determine whether or not it met the function limitations of “GUCY2C binding polypeptide”. The Federal Circuit concluded that there was a lack of enablement, which was affirmed by the Supreme Court in Amgen.
The instant specification does not disclose any common structural feature delineating which other polypeptide structures would have the function of “GUCY2C binding polypeptide”. The only structure-function relationship guidance the specification provides is to disclose individual examples of anti-GUCY2C antibody structures with this function.
The instant claims simply direct skilled artisans to engage in the same iterative, trial-and-error process the inventors followed to discover the antibody structures they elected to disclose and that “[u]nder Amgen, such random trial-and-error discovery, without more, constitutes unreasonable experimentation that falls outside the bounds required by § 112(a).” Id. at *8, *10.
Additionally, the specification discloses the following GUCY2C binders: A01, A02, A03, A04, A05, A06, A07, A08, A10, A12, B01, B07, B08, B10, B11, B12, C01, C02, and C07, which were not random combinations of VH and VL i.e., they had specific VH domains paired with specific VL domains, which were disclosed as scFv sequences (SEQ ID NO: 1-18, Table 3). No other VH/VL domain was provided that mix, for example, the CDRH1 of SEQ ID NO: 38-44, CRRH2 of SEQ ID NO: 45-53, and CDRH3 of SEQ ID NO: 54-65, or CDRL1 of SEQ ID NO: 66-78, CDRL2 of SEQ ID NO: 79-88, and CDRL3 of SEQ ID NO: 89-106.
Neither the specification, nor the prior art provides any examples to support the premise of mixing and matching a HCDR or LCDR of the VH/VL of different antibodies would result in antigen binding. The prior art does not support a definition of an antibody structure by mixing and matching the HCDR1-3 sequence of a VH and/or LCDR of sequence of a VL and result in functional anti-GUCY2C antibodies. The specification fails to show that all HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, LCDR3 of the anti-GUCY2C antibodies A01, A02, A03, A04, A05, A06, A07, A08, A10, A12, B01, B07, B08, B10, B11, B12, C01, C02, and C07, are equivalent. The specification fails to establish that, for example, by replacing at least one different CDR of the antibody clone A10 with another CDR from the antibody clones A01, A02, A03, A04, A05, A06, A07, A08, A12, B01, B07, B08, B10, B11, B12, C01, C02, or C07 maintains specific GUCY2C binding. Mixing and matching different CDRs from different anti-GUCY2C antibodies has not been shown to lead to specific GUCY2C binding. Such teachings were not made part of the specification at the time the invention was made.
Applicant is relying upon certain biological activities such as inhibitory antibodies or specific GUCY2C binding polypeptides and a limited number of species with defined structures (e.g. amino acid sequences) to support an entire genus of diverse and structurally unrelated inhibitory polypeptide structures. Yet the instant specification does not provide sufficient guidance and directions as to the structural features of the polypeptide structures and the correlation between the structure and the desired antigen binding and inhibitory function.
The Supreme Court’s 2023 decision in Amgen v. Sanofi, which mainly involves the enablement requirement, states that “where a patentee purports to invent an entire genus, it must enable the entire genus”; “disclosing how to produce some antibodies that perform a specified function is not equivalent to disclosing how to produce all such antibodies – and it is the latter that petitioners claim as their invention”; S. Ct.
Additionally, in its recent decision in Baxalta Inc. v. Genentech, Inc., No. 2022-1461, 2023 WL 6135930 (Fed. Cir. Sept. 20, 2023) the Federal Circuit found the facts of this case to be "materially indistinguishable from those in Amgen." Baxalta, 2023 WL 6135930, at *4. According to the Federal Circuit, claim 1 covers "millions of potential candidate antibodies" (id.) that bind to Factor IX/IXa and increase the procoagulant activity of Factor IXa. The court, however, noted that the specification discloses the amino acid sequence of just 11 of those antibodies. And like the roadmap in the patents at issue in Amgen, "the '590 patent's roadmap simply directs skilled artisans to engage in the same iterative, trial-and-error process the inventors followed to discover the [11] antibodies they elected to disclose." (Id.) Missing from the specification, according to the Federal Circuit, was "'a quality common to every functional embodiment' ... that would allow a skilled artisan to predict which antibodies will perform the claimed functions" (id.; quoting Amgen Inc. v. Sanofi., 598 U.S. 594, 614 (2023)), such as a common structural or other feature that would allow the antibodies to perform the claimed functions, or an explanation as to why the 11 antibodies do so and others do not. (Baxalta, 2023 WL 6135930, at *4). And the Federal Circuit was not persuaded by Baxalta's argument that its disclosed hybridoma-and screening process "predictably and reliably generates new claimed antibodies every time it is performed" (id.), because "it is undisputed that to practice the full scope of the claimed invention, skilled artisans must make candidate antibodies and screen them to determine which ones perform the claimed functions." (Id.).
Additionally, regarding claim 14, the instant specification discloses that the anti-GUCY2C binding scFv structures will specifically bind to GUCY2C on tumor cells (Example 4.6), enabling one with ordinary skill in the art to make compositions for the diagnosis of GUCY2C expressing cancer comprising the anti-GUCY2C antibody clones that are disclosed, however neither the instant specification nor the prior art provides sufficient guidance to allow one with ordinary skill in the art to make compositions for the diagnosis of cancer the does not express GUCY2C using the anti-GUCY2C antibody structures(i.e., the invention encompassed by claim 14).
The specification does not reasonably provide enablement to make and use the invention of instant claims 1, 2, 4, 5, 7, and 13-17. The specification does enable one with ordinary skill to make the antibody clone discussed supra.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
To resolve this issue, it is recommended to amend instant claim 1 to recite the antibody structure of the anti-GUCY2C antibody clones A01, A02, A03, A04, A05, A06, A07, A08, A10, A12, B01, B07, B08, B10, B11, B12, C01, C02, and C07 structures.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 6, and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “represented by” in claim 3, line 1; claim 6, line 2; and claim 8, line 2, implies any member of a genus that is “represented by” the respective SEQ ID NO: 1 to 18. Such language fails to establish the metes and bounds of amino acid sequences encompassed by the instant claim language; therefore the claims are indefinite.
Conclusion
No claim is allowed.
An anti-GUCY2C binding polypeptide comprising the HCDR1-3 sequences of SEQ ID NO: 44, 52, and 59, respectively and the LCDR1-3 sequences of SEQ ID NO: 73, 85, and 97, with the scFv sequence of SEQ ID NO: 9 (i.e., the elected anti-GUCY2C binding polypeptide species) is free of the prior art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Magee et al. (Cancer Immunol Res. 2018 May;6(5):509-516. doi: 10.1158/2326-6066.CIR-16-0362) teaches the anti-GUCY2C scFv 5F9 can be incorporated into a CAR to generate anti-GUCY2C CAR-T cells that reduce colon cancer progression (entire document). However, Magee et al. does not teach anti-GUCY2C CARs comprising the instantly elected antibody clone CDRs.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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