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
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is the national stage entry of PCT/US2021/058379 filed on November 08, 2021 and claiming the benefit of US Provisional Application No. 62/111,746, filed on November 10, 2020. Claims 1-22 are given an earliest effective filing date of November 10, 2020.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 112(b)
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 and 10 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 allows the “X” regions of the copolymer to be zero amino acids in length, resulting in embodiments consisting only of the peptide epitope. Such embodiments do not constitute an amino acid copolymer and render the claim internally inconsistent and unclear. Claim 1 further recites the limitation of “a peptide epitope that interacts with a major histocompatibility complex.” It is unclear what constitutes an interaction and the instant specification provides no definition or guidance.
Claim 10 recites the copolymer comprising “at least about 30 amino acid residues.” The term “at least about” is a relative term and is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Therefore, claims 1 and 10 are rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 112(a)
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 and 3-22 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 written description requirement. The claim 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.
Claim 1 recites a peptide epitope capable of interacting with MHC class II proteins and T cell receptors, the specification, however, fails to adequately describe the species of epitopes that are encompassed by the claim.
There is no evidence in the specification to support that the inventors had possession of the genus contemplated. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See MPEP 2163. In the instant case, the specification discloses only the sequence AYKAA. The disclosure fails to describe a representative number of species within the genus claimed. Therefore, the specification fails to reasonably convey to one skilled in the relevant art that the inventor, at the time the application was filed, had possession of the claimed genus. Furthermore, claims 3-22 require the copolymer at issue, and are thus also rejected.
Therefore, claims 1 and 3-22 are rejected under 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-22 are rejected under 35 U.S.C. 103 as being unpatentable over Fridkis-Hareli et al (2002) in view of Quandt et al. (2004) and in further view of McGraw and Lublin (2013).
Claims 1-15 and 19 are drawn to an amino acid copolymer comprised of the amino acids Y, F, A, K, and a peptide epitope. Claims 16-18 are drawn to a product consisting of an amino acid copolymer and a therapeutic agent. Claims 20 and 21 are drawn to a method of treating a disease with a copolymer. Claim 22 is drawn to a kit comprising a copolymer.
Regarding claims 1-15 and 19, Fridkis-Hareli et al. teach glatiramer acetate type (henceforth GA-type) random copolymers composed of tyrosine, phenylalanine, alanine, and lysine (YFAK) that bind MHC class II molecules, interact with T-cell receptors (claim 1). These polymers are generated by solid phase method (claim 12), are polymerized in ratios of 0.2:0.8:5:3 and 0.8:0.2:5:3 (claims 3, 4, 5, 7, and 8), and may be 50 amino acids in length (claims 10 and 11). While this reference does not teach the specific molar ratios of claims 6 and 9, the claimed ranges represent routine optimization, as optimization of molar ratios were common in the art at the time, as indicated by the various molar ratios found in the Fridkis-Hareli reference. Furthermore, this reference teaches that when the copolymers are injected into mice via a pharmaceutically acceptable carrier comprising PBS (claim 19), the copolymers inhibit autoantigen-specific T-cell activation and suppress experimental autoimmune encephalomyelitis (the animal model of Multiple Sclerosis) (claims 20 and 21).
However, Fridkis-Hareli does not teach embedding a peptide epitope sequence within the random copolymer, an acetyl or amide modification, modification to inhibit proteolytic degradation, or the addition of a pharmaceutically acceptable carrier.
Quandt et al. teach the incorporation of MHC class II binding motifs or peptide epitopes into random peptide mixtures that are used as immunotherapeutic agents (claim 1). These random peptide mixtures are conceptually similar to the claimed random peptide in that both comprise heterogeneous peptide compositions that modulate immune responses via MHC class II interactions and are similar in nature to glatiramer acetate. Quandt further teaches the inclusion of an acetyl group in the peptide, but although Quandt does not specifically state that it is modified at the N-terminal, such modifications were routine in the art at the time to improve stability, and a person of ordinary skill in the art would have understood such a modification to have occurred at the N-terminal (claim 13). Similarly, Quandt does not teach modification of the C-terminal amino acid with an amide group, however, such modifications were routine in the art to improve stability and resistance to proteolytic degradation (claims 14 and 15).
It would have been obvious to one of ordinary skill in the art to combine these teachings by introducing defined peptide epitopes capable of binding MHC class II proteins and T cell rectors into GA-type copolymers, such as YFAK, in light of the known effects of composition changes on immunomodulatory activity. There would be a reasonable expectation of success given that the mechanisms of action for both the random peptide and peptide epitope were known, and MHC peptide binding motifs were known to retain their function in random peptide mixtures. Finally, the precise selection of a particular peptide epitope, such as AYKAA, would have constituted routine optimization based on known MHC class II binding characteristics (claim 2).
Regarding claims 16-18, McGraw and Lublin disclose a combination therapy for the treatment of Multiple Sclerosis that comprises administration of the cytokine Interferon Beta and glatiramer acetate. Because the claimed copolymer is a GA-type copolymer used for the same immune mediated disorders, and act through the same mechanisms, it would have been obvious to combine the claimed copolymer with a cytokine such as Interferon Beta, with a reasonable expectation of success, because such therapies were known in the art.
Regarding claims 20 and 21, in addition to the reasons above for the rejection of claim 1, Fridkis-Hareli, Quandt, and McGraw teach GA-type immunomodulatory copolymers for treating autoimmune and immune mediated diseases, with particular identification of Multiple Sclerosis.
Regarding claim 22, with respect to the reasons above for the rejection of claim 1, the cited art teaches GA-type copolymers that are formulated for therapeutic administration. It would have been obvious to package such compositions as kits comprising unit dosages for commercial distribution as this was routine and well known in the art.
Therefore, claims 1-22 are rejected under 35 U.S.C. 103.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tirone D Johnson whose telephone number is (571)272-1256. The examiner can normally be reached M-F, 9-5 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.D.J./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675