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 .
Priority
The instant application was filed 03/15/2024 Claims Priority from Provisional Application 63452617, filed 03/16/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/18/2024 is being considered by the examiner.
Drawings
The specification in paragraphs 0084, 0085, 0086, 0087, 0090 of PGPUB teach the figures are in color. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The specification in paragraph 0132 of PGPUB provides an HTTPs. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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.
Claim Objections
Claim 1, 3, 5-6, 11, 15, 20, 27, 29-33, 35, 39, 59, 64, 65-66 objected to because of the following informalities:
Claim 1 is objected to as it recites “Fc” but does not recite the full terminology for the acronym (or abbreviation). Claims are more concise when the first time an acronym (or abbreviation) is presented the full terminology is also presented. Finally an acronym (or abbreviation) may have alternative meanings to an artisan.
Claim 3 is objected to as it recites “IgC” but does not recite the full terminology for the acronym (or abbreviation). Claims are more concise when the first time an acronym (or abbreviation) is presented the full terminology is also presented. Finally an acronym (or abbreviation) may have alternative meanings to an artisan.
Claim 39 is objected to as it recites “TIGIT” but does not recite the full terminology for the acronym (or abbreviation). Claims are more concise when the first time an acronym (or abbreviation) is presented the full terminology is also presented. Finally an acronym (or abbreviation) may have alternative meanings
Appropriate correction is required.
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 1, 3, 5-6, 11, 15, 20, 27, 29-33, 35, 39, 59, 64, 65-66 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As set forth in In re Alonso 88 USPQ2d 1849 (Fed. Cir. 2008), at 1851:
The written description requirement of 35 U.S.C. § 112, ¶ 1, is straightforward: “The specification shall contain a written description of the invention ….” To satisfy this requirement, the specification must describe the invention in sufficient detail so “that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 [41 USPQ2d 1961] (Fed. Cir. 1997); see also LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1345 [76 USPQ2d 1724] (Fed. Cir. 2005); Eiselstein v. Frank, 52 F.3d 1035, 1039 [34 USPQ2d 1467] (Fed. Cir. 1995).
Alonso at 1852:
A genus can be described by disclosing: (1) a representative number of species in that genus; or (2) its “relevant identifying characteristics,” such as “complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.” Enzo, 323 F.3d at 964.
In applying the test as set forth in Alonso, it is noted that applicant is claiming a construct comprising a truncated poliovirus receptor (PVR) and a Fc domain. Thus the claims encompass anything that can be considered a truncated polio receptor from any species and any Fc domain from any species. Dependent claims require at least one of:(a)the construct is soluble;(b) the construct can bind to cognate receptors with similar affinity as compared to a construct comprising a non-truncated PVR;(c) the construct binds to the cognate receptor at low nanomolar affinities, such as, about 0.1 nM to about 10 nM;(d) the construct binds to TIGIT with an affinity of about 2.2 nM;(e) the construct binds to CD96 with an affinity of about 1.7 nM;(f) the construct binds to CD226 with an affinity of about 0.7 nM;(g) the construct suppresses immune responses, wherein the immune response comprises a cytokine response or wherein the immune response comprises proliferation of immune cells;(h) the construct reduces symptoms associated with a inflammatory disease or condition or for treating an inflammatory disease or condition selected from Crohn's disease, ulcerative colitis, multiple sclerosis, asthma, rheumatoid arthritis, or psoriasis; and(i) delays the onset of psoriasis.
Further claims 59, 64-65 encompass nucleic acids comprising at least 80% of SEQ ID NO 9 or SEQ ID NO 10 or fragments thereof.
The specification provides no limiting definition or standard of what is required of a truncated PVR. Thus the specification encompasses any PVR from any species. This is an enormous genus. Further the claims encompass that can be considered a truncated PVR. This is an enormous genus as it appears to comprise the full length sequence minus a single amino acid down to two amino acids from within the PVR sequence. Further this encompasses truncations from N terminus, C-terminus or any interior amino acids. Thus this encompasses an enormous genus of PVR truncations if even limited to the human PVR sequence.
Further the claims encompass any Fc domain from any species.
Benner et al (Trends in Genetics (2001) volume 17, pages 414-418) teaches that, “Here, the ‘homology-implies-equivalency’ assumption is restricted to a subset of homologs that diverged in the most-recent common ancestor of the species sharing the homologs. This strategy is useful, of course. But it is likely to be far less general than is widely thought. Two species living in the same space, almost by axiom, cannot have identical strategies for survival. This, in turn, implies that two orthologous proteins might not contribute to fitness in exactly the same way in two species” (see page 414, 3rd column last full paragraph). Benner specifically describes that although the leptin gene homologs have been found in mice and humans, their affect is different (see page 414, 3rd column last paragraph-3rd column page 415). Benner specifically teaches that the leptin gene in mice plays a major role in obesity, but no such effect has been demonstrated in humans due perhaps to the different evolutionary forces. Benner thus teaches that the activity and function of genes in different species is unpredictable.
Burgin (Journal of Mammalogy, 99(1):1–14, 2018) teaches, “We found 6,495 species of currently recognized mammals.”
Bowers (Virus Research Volume 242, 15 October 2017, Pages 1-6)
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Koike (Proc. Nail. Acad. Sci. USAVol. 88, pp. 4104-4108, May 1991) teaches,
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The specification has not provided a representative number of species to demonstrate possession of the functional outcomes of dependent claims.
Claim Rejections - 35 USC § 112
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 1, 3, 5-6, 11, 15, 20, 27, 29-33, 35, 39, 59, 64, 65-66 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.
Claim 1 is drawn to a construct comprising a truncated poliovirus receptor (PVR) and a Fc domain. Thus the claims encompass anything which can be considered a truncated poliovirus receptor (PVR). The specification does not provide a standard to provide what is required of truncated poliovirus receptor (PVR). Bowers (Virus Research Volume 242, 15 October 2017, Pages 1-6)
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Koike (Proc. Nail. Acad. Sci. USAVol. 88, pp. 4104-4108, May 1991) teaches,
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Thus it is unclear what is inside the scope or outside of the scope of a truncated PVR so the artisan could avoid infringement.
Claim 3 recites, “free of both IgC domains.” The claims do not previously recite, “IgC domains.” Thus it is unclear to which IgC domains the claim is referencing. Thus the metes and bounds are unclear what is required of the claim.
Claim 5 recites, “immunoglobulin-like variable domain.” The recitation of immunoglobulin-like variable domain suggests there is immunoglobulin not like variable domains. The specification and claims do not provide any standard to differentiate immunoglobulin-like variable domain from immunoglobulin not like variable domains. Thus the metes and bounds are unclear.
Claim 39 recites, “the construct can bind to cognate receptors with similar affinity as compared to a construct comprising a non-truncated PVR.” The statement is confusing and unclear. The recitation of “similar affinity” suggests there is non-similar affinity. Further the claim and specification do not define what is required of cognate receptor. Thus the metes and bounds are unclear.
Regarding claim 39 (c), the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 39 (g) recites, “the construct suppresses immune responses, wherein the immune response comprises a cytokine response or wherein the immune response comprises proliferation of immune cells;” The recitation of suppresses suggests there is no suppression. The specification and claims provide no standard to determine what suppression is relative to.
Claim 39 (h) recites, “(h) the construct reduces symptoms associated with a inflammatory disease or condition or for treating an inflammatory disease or condition selected from Crohn's disease, ulcerative colitis, multiple sclerosis, asthma, rheumatoid arthritis, or psoriasis.” The recitation of reduces suggests there is unchanged or increased. The specification and claims provide no standard to indicate what the reduction is relative to.
Claim 39 recites, “(i) delays the onset of psoriasis.” The metes and bounds are unclear what the delay is relative to.
Further claims 59, 64-65 encompass nucleic acids comprising at least 80% of SEQ ID NO 9 or SEQ ID NO 10 or fragments thereof.
Further claims 59, 64-65 encompass nucleic acids comprising at least 80% of SEQ ID NO 9 or SEQ ID NO 10 or fragments thereof.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 5, 39, 66 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tahara-Hanaoka (.International Immunology, Vol. 16, No. 4, pp. 533±538)
Tahara-Hanaoka teaches, “human poliovirus receptor-related (PRR) family
members CD155 [poliovirus receptor (PVR)].”
With regards to claim 1, 5, 66, Tahara-Hanaoka teaches, “CD155±Fc and CD112±Fc fusion proteins were also generated with chimeric cDNAs of the entire extracellular domain of CD155 or CD112 with the human IgG1 Fc.” (534, expression of the Fc fusion proteins)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3, 5-6, 11, 15, 20, 27, 29-33, 39, 59, 64-66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tahara-Hanaoka (.International Immunology, Vol. 16, No. 4, pp. 533±538), Swanson (US 20190175654), Levin (Wo2006124667), Shi (WO202020281), Cherpes (WO2021071979), Anderson (WO2001036637), Swanson (WO2018022946)
Tahara-Hanaoka teaches, “human poliovirus receptor-related (PRR) family
members CD155 [poliovirus receptor (PVR)].”
With regards to claim 1, 5, 66 Tahara-Hanaoka teaches, “CD155-Fc and CD112-Fc fusion proteins were also generated with chimeric cDNAs of the entire extracellular domain of CD155 or CD112 with the human IgG1 Fc.” (534, expression of the Fc fusion proteins)
While, Tahara-Hanaoka teaches CD155-Fc fusion, Tahara-Hanaoka does not teach sequences or specifics of how the construct is made.
However, Swanson (US2019) teaches, “[0005] Provided herein are variant CD155 polypeptides. In some embodiments, the variant CD155 polypeptides comprise an IgV domain or a specific binding fragment thereof, an IgC domain or a specific binding fragment thereof, or both, wherein the variant CD155 polypeptide comprises one or more amino acid modifications in an unmodified CD155 or a specific binding fragment thereof corresponding to position(s) selected from 7, 8, 9, 10, 11, 12, 13, 15, 16, 18, 19, 20, 21, 22, 23, 24, 25, 26, 29, 30, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 64, 65, 67, 68, 69, 70, 72, 73, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 87, 88, 89, 90, 91, 92, 94, 95, 96, 97, 98, 99, 100, 102, 104, 106, 107, 108, 110, 111, 112, 113, 114, 115, or 116 with reference to positions set forth in SEQ ID NO: 47. In some embodiments, the amino acid modifications comprise amino acid substitutions, deletions or insertions. In some embodiments, the unmodified CD155 is a mammalian CD155 or a specific binding fragment thereof. In some embodiments, the unmodified CD155 is a human CD155 or a specific binding fragment thereof.” Swanson teaches, “0017] In some embodiments of any one of the variant CD155 polypeptides, the variant CD155 polypeptide is linked to a moiety that increases biological half-life of the polypeptide. In some embodiments, the variant CD155 polypeptide is linked to an Fc domain or a variant thereof with reduced effector function. In some embodiments, the Fc domain is mammalian, optionally human; or the variant Fc domain comprises one or more amino acid modifications compared to an unmodified Fc domain that is mammalian, optionally human.”
Levin teaches, “[20] An illustrative nucleotide sequence that encodes human CD 155 (also interchangeably known as PVR) is provided by SEQ TD NO: 17; the encoded polypeptide is shown in SEQ ID NO:18. CD155 has been shown to bind to ZB7R1 and thus is a counter-receptor for this B7 family member. Analysis of a human cDNA clone encoding zB7Rl (SEQ ID NO: 17) revealed an open reading frame encoding 417 amino acids (SEQ TD NO: 18) comprising an extracellular domain of approximately 316 amino acid residues (residues 28-343 of SEQ ID NO:18; SEQ TD NO:19), a transmembrane domain of approximately 24 amino acid residues (residues 344-367 of SEQ ID NO: 18), and an intracellular domain of approximately 50 amino acid residues (residues 368-417 of SEQ ID NO: 18). [21] An illustrative nucleotide sequence that encodes a murine CD155 is provided by SEQ TD NO:20; the encoded polypeptide is shown in SEQ TD NO:21. The extracellular domain is shown in SEQ TD NO:22. Analysis of a cDNA clone encoding murine CD155 revealed an open reading frame encoding 408 amino acids (SEQ ID NO:21) comprising an extracellular domain of approximately 319 amino acid residues (residues 29-347 of SEQ DD NO:21; SEQ TD NO:22), a transmembrane domain of approximately 20 amino acid residues (residues 348-367 of SEQ ID NO:21), and an intracellular domain of approximately 40 amino acid residues (residues 368-408of SEQ ID NO:21)” Levin teaches a mouse poliovirus receptor CD155 extracellular domain (SEQ ID NO 22) which copies SEQ ID NO 1. (claims 5-6, 7)
Shi teaches HCDR1 SEQ ID NO 3 (table 3) which comprises SEQ ID NO 3 (111-440) of instant claims.
Cherpes teaches SEQ ID NO 7 (IEGRMDP) a linker for fusion proteins which comprises instant SEQ ID NO 5 and linker of fusion proteins SEQ ID NO 8 (IEGRMD).
Anderson teaches Immunoglobulin (Ig) kappa chain leader peptide SEQ ID NO 16 which consists of instant SEQ ID NO 6. (page 82, example 15)
Swanson (WO2018) teaches SEQ ID NO 1121, example 11 which comprises amino acids 301-371 of SEQ ID NO 7.
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims to use known sequences to construct a soluble CD155-FC fusion. The artisan would be motivated to produce a soluble CD155-FC fusion as Tahara-Hanaoka, Swanson (WO2018), Swanson (US2019) explicitly suggest the production of an CD155-FC fusion for immunomodulation and treatment of disease. The artisan would have a reasonable expectation of success as the artisan is merely using known amino acid sequences with known properties to provide a CD155-FC fusion.
With regards to claim 3, Swanson teaches, “[0095] An Fc (fragment crystallizable) region or domain of an immunoglobulin molecule (also termed an Fc polypeptide) corresponds largely to the constant region of the immunoglobulin heavy chain, and is responsible for various functions, including the antibody's effector function(s).”
With regards to claim 29, Swanson teaches, “In some embodiments, the variant CD155 polypeptide is linked to the multimerization domain or Fc indirectly via a linker, optionally a G4S linker.” (0017)
Claims 59, 64-65 encompass nucleic acids comprising at least 80% of SEQ ID NO 9 or SEQ ID NO 10 or fragments thereof. Thus they are obvious over the cited prior art in view of the fragment thereof.
Summary
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN C POHNERT PhD whose telephone number is (571)272-3803. The examiner can normally be reached Monday- Friday about 6:00 AM-5:00 PM, every second Friday off.
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/Steven Pohnert/ Primary Examiner, Art Unit 1683