DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's preliminary amendment filed on 04/19/2024 is acknowledged.
Claims 1, 4-6, 8, 15, 17-18, 20, 22-25, 28, 31-32, 51, 57-59 and 67 are pending.
3. 35 U.S.C. § 101 reads as follows:
"Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title".
4. Claims 1, 4-5, 24-25, 28 and 31-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon (including a product of nature), or an abstract idea) without significantly more.
Claim 28 recites a chimeric autoantibody receptor (CAAR), wherein the CAAR comprises an extracellular domain comprising a phospholipase A2 receptor (PLA2R) autoantigen or fragment thereof, and optionally, a transmembrane domain, an intracellular domain of a costimulatory molecule, and/or a signaling domain.
Claim 1 recites a polynucleotide encoding the same polypeptide.
Claim 28 reads on naturally occurring phospholipase A2 receptor, i.e. a product of nature, which comprises an extracellular domain, a transmembrane domain and a signaling domain. A polynucleotide encoding naturally occurring phospholipase A2 receptor (e.g. human PLA2R1 gene) is itself a product of nature.
Claims 4, 5, 31 and 32 are included in the rejection, because naturally occurring phospholipase A2 receptor comprises the recited domains.
Claim 24 is included, because a chromosome comprising PLA2R1 gene is a vector. Claim 25 is included, because naturally occurring mRNA molecules encoding PLA2R are RNA vectors.
5. 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.
6. Claims 1, 4-6, 8, 15, 17-18, 20, 22-25, 28, 31-32, 51, 57-59 and 67 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claims 1, 28, 58 and 59 are indefinite in the recitation of phospholipase A2 receptor (PLA2R) “autoantigen,” because the scope of the genus of PLA2R autoantigens is not defined. While the specification describes three PLA2R epitopes often recognized by autoimmune antibodies of patients suffering from primary membranous nephropathy, and examples of such epitopes are known in the art, the claim encompasses antibodies in any organism specific to any and all possible PLA2R epitopes in the same organism in any disease or condition. Therefore, a person of ordinary skill in the art would not be reasonably apprised of the scope of the claims.
(ii) Claims 1, 28, 58 and 59 are further indefinite in the recitation of a “signaling domain,” because it is unclear whether the scope of the genus is limited to a certain type or class of signaling domains, such as e.g. intracellular signaling domains of various activatory receptors of T cell , as suggested by the context of the claims, or encompasses any and all signaling molecules, such as hormones and neuropeptides.
(iii) Claims 4 and 31 are indefinite in use of the conjunction “and” between subclauses (f) and (g), which requires that all of the configurations (a) through (g) be present within the same chimeric receptor.
(iv) Claim 15 is indefinite in the recitation of an “intracellular domain of a costimulatory molecule” which “comprises 4-1BB.” A person of ordinary skill in the art would be aware that 4-1BB comprises an extracellular domain, a transmembrane domain, and an intracellular domain, and therefore it is unclear how 4-1BB can itself be comprised within the intracellular domain of the claimed chimeric receptor.
(v) Claim 17 is indefinite, because the recitation of “the 4-1BB intracellular domain” lacks proper antecedent basis in base claim 15 which does not recite an intracellular domain of 4-1BB.
(vi) Claims 4-6, 8, 15, 17-18, 20, 22-25, 31-32, 51, 57 and 67 are indefinite, because they encompass the indefinite limitations of the claim(s) on which they depend.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
7. The following is a quotation 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.
8. Claims 58-59 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contain(s) 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.
The specification does not provide a sufficient enabling description of a method for treating a generically recited autoantibody-mediated kidney disease, or a method for preventing or reducing glomerulus damage in a subject at risk of or suffering from a generically recited autoantibody-mediated kidney disease.
The specification discloses that the proposed therapeutic effect of the claimed method is theorized to be achieved through recognition and killing of B cells expressing anti-PLA2R B cell receptors (e.g. [0179] of US 20240383965). A person of ordinary skill in the art would readily understand that any therapeutic effect of the method would be limited to conditions mediated by anti-PLA2R antibodies. Therefore, experimentation aimed at treating generically recited autoantibody-mediated kidney disease will almost certainly be unsuccessful, and as such unnecessarily, and improperly, extensive and undue.
9. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
10. Claims 1, 6, 8, 15, 17-18, 20, 24-25, 28, 51 and 57 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by June et al. (US 20170283775).
Claim interpretation: claims 1 and 28 recite a phospholipase A2 receptor (PLA2R) autoantigen or “fragment thereof,” without placing any limitations on the properties or size of the fragment. Accordingly, fragments of any size, including as short as one amino acid in length, are within the scope of the claims.
June teaches chimeric receptors comprising extracellular antigen-binding domain, CD8 transmembrane domain, 4-1BB intracellular costimulatory domain, and CD3 zeta intracellular signaling domain (e.g. claims 1, 4 and 5). Extracellular antigen-binding domain comprises at least one amino acid, and as such is within the scope of instantly recited PLA2R “fragment.”
Claims 8, 17 and 20 are included in the rejection, because the recited amino acid sequences are inherent in the teachings of the respective domains.
11. Claims 1, 4-5, 24-25, 28, 31-32, 51 and 57 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Bernard et al. (US 20140155470, cited on IDS).
Bernard teaches methods of treatment comprising administering to a patient a composition comprising a polynucleotide encoding the human PLA2R1 polypeptide (e.g. claim 1).
Human PLA2R1 polypeptide comprises an extracellular domain comprising a PLA2R autoantigen, a transmembrane domain, and an intracellular signaling domain, and as such is within the scope of instant claims 1 and 28.
12. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
13. Claims 1, 4-6, 8, 15, 17-18, 20, 22-25, 28, 31-32, 51 and 57-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11884716.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of US ‘716, which are directed to the same subject matter as instant claims.
Specifically, the polynucleotides of instant claims 1, 4-6, 8, 15, 17-18, 20 and 22-25 are recited in US ‘716 claims 1-6,
the receptors and modified cells of instant claims 28, 31-32, 51, 57 are recited in US ‘716 claims 7-14, and
the methods of instant claims 58-59 are recited in US ‘716 claims 15-18.
14. Claims 1, 4-6, 8, 15, 17-18, 20, 23-25, 28, 31-32, 51 and 57-59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 18293921, published as US 20250073265.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of USSN ‘921.
Specifically, the polynucleotides of instant claims 1, 4-6, 8, 15, 17-18, 20 and 23-25 are recited in USSN ‘921 claims 1-12 and 15-23,
the receptors and modified cells of instant claims 28, 31-32, 51, 57 are recited in USSN ‘921 claims 24, 44 and 48-49, and
the methods of instant claims 58-59 are recited in USSN ‘921 claims 50 and 71.
USSN ‘921 recites CAARs of SEQ ID NOS: 16 and 18, which are 99.5% identical to instant SEQ ID NOS: 36 and 34, respectively (see SCORE), but neither discloses nor recites amino acid sequences 100% identical to any of the sequences recited in instant claim 22.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
15. Conclusion: no claim is allowed.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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