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 .
Status of Application, Amendments and/or Claims
1. Claims 1-6 have been amended, claim 7 has been canceled, and new claims 8-12 have been added as requested in the amendment filed November 30, 2021. Following the amendment, claims 1-6 and 8-12 are pending in the present application.
2. Claims 1-6 and 8-12 are under examination in the current office action.
Information Disclosure Statement
3. The information disclosure statements (IDSs) filed 07/19/2021, 03/18/2025, and 04/30/2025 have been considered and the references therein are of record.
Specification
4. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See, in particular, paragraph [0020] at p. 5. 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
5. Claims 1 and 8 are objected to because of the following informalities:
In claim 1, the word “a” is required in line 2 to designate the subject being treated, i.e., “A method for the treatment of a subject…”
In claim 8, the word “and” is required preceding the final CDR component, i.e., “…SEQ ID NO: 9, and a light chain CDR3…”
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.
6. Claims 1-3 and 6 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(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. This is a written description rejection.
Claim 1 and dependent claims thereof are directed to a method for the treatment of a subject having idiopathic pulmonary fibrosis (IPF), comprising administering to the subject an antibody that is determined to be specifically reactive with a citrullinated epitope on the N-terminus of deiminated histone H2A or H4, wherein the citrullinated epitope resides on a peptide comprising SEQ ID NO: 1 or SEQ ID NO: 2. And claim 6 recites that the antibody competes with monoclonal antibody RmmAb 22.101 for binding to SEQ ID NO: 1 or 2. The claims are thus drawn to methods of using a genus of antibodies defined functionally but with no defined structure.
The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117.
The factors to be considered when analyzing claims for compliance with the written description requirement include: actual reduction to practice; disclosure of drawings or structural chemical formulas; sufficient relevant identifying characteristics (e.g., disclosure of complete or partial structure, physical and/or chemical properties, structure/function correlation); method of making the claimed invention; level of skill and knowledge in the art; and predictability in the art. See MPEP §2163.
Moreover, with respect to antibodies, the Federal Circuit has clarified Written Description as it applies to antibodies in the recent decision Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. 112(a) (or pre-AIA first paragraph) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79. The Amgen court expressly stated that the so-called “newly characterized antigen” test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. 112(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the court also stressed that the “newly characterized antigen” test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent. Amgen, 872 F.3d at 1378-79, quoting Ariad, 598 F.3d 1336, 1345 (Fed. Cir. 2010). In view of the Amgen decision, adequate written description of a newly characterized antigen alone is not considered adequate written description of a claimed antibody to that antigen, even when preparation of such an antibody is routine and conventional. Id.
The recitation of an antibody that is specifically reactive with a citrullinated epitope on the N-terminus of deiminated histone H2A or H4, wherein the citrullinated epitope resides within a peptide of SEQ ID NO: 1 or 2, or an antibody that competes for binding to such an epitope with mAb RmmAb 22.101, each represent functional characteristics with no structure. The claims thus encompass the entire genus of antibodies that bind that epitope. While generically the structure of antibodies is known, the structure of the presently claimed antibodies can vary substantially within the above given claimed recitations. Thus, the genus is highly variant because a significant number of structural differences between genus members is permitted.
The instant specification teaches the production of several monoclonal antibodies designated RhmAb2.102, RhmAb2.108, RhmAb2.109, RhmAb2.110, RhmAb2.111, RhmAb2.112, MQ22.101 (i.e., RmmAb 22.101), MQ22.102 and MQ22.101b/d which were all found to react with peptides of SEQ ID NO: 1 or 2 comprising a citrullinated epitope on the N-terminus of deiminated histone H2A or H4 (see [0012]). Thus, the specification provides only a handful of examples of species that fall within the presently claimed genus of antibody molecules.
Apart from the RmmAb 22.101 mAb, there is no guidance or examples regarding the structural requirements for antibodies to be administered according to the presently claimed method, nor does the specification describe a general correlation between the structure of any such antibody and the ability to bind a citrullinated epitope on the N-terminus of deiminated histone H2A or H4, or else to compete with the RmmAb 22.101 antibody for binding to this epitope. Regardless, the relevant art recognizes that diversity of antibodies binding to any particular target antigen or epitope is extremely broad, and therefore there is no way to reasonably predict the structure of the antigen-binding region of an antibody based upon the structure of an antigen or epitope alone (see, for example, Lloyd et al. Protein Eng. Design & Select, 2009, 22(3):159-168; and Edwards et al. J. Mol. Biol. 2003, 334:103-118; both cited on 07/19/2021 IDS). Consequently, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus nor guidance as to which of the myriad of molecules encompassed by the claimed antibodies would meet the limitations of the claims.
Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Abbvie Deutschland GMBH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014, Appeal No. 13-1338 at page 26). Therefore, the full breadth of the claims do not meet the written description provision of 35 U.S.C. 112(a).
7. Claim 5 is rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claim(s) 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.
The claim is drawn to a therapeutic method that comprises administering an antibody comprising a heavy and light chain as contained in monoclonal antibody RmmAb 22.101 produced by the hybridoma cell line deposited as DSMZ ACC 3031. Accordingly, the claim requires the use of the monoclonal antibody RmmAb 22.101, and in order to make such an antibody, a skilled artisan would need to have access to the deposited biological material recited in the claims, that is, the hybridoma cell line ACC 3031. The examiner acknowledges that the specification and claims indicate that the hybridoma has been deposited with the DSMZ, for example at [0044].
If the deposit was made under the terms of the Budapest Treaty, then an affidavit or declaration by Applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
If the deposit was not made under the terms of the Budapest Treaty, then an affidavit or Declaration by Applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, must be provided stating that the deposit has been made at an acceptable depository and that the following criteria have been met:
(a) during the pendency of the application, access to the deposit will be afforded to one determined by the Commissioner to be entitled thereto;
(b) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent;
(c) the deposit will be maintained for a term of at least thirty (30) years and at least five (5) years after the most recent request for the furnishing of a sample of the deposited material;
(d) a viability statement in accordance with the provisions of 37 CFR 1.807; and
(e) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.803-1.809 for additional explanation of these requirements.
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.
8. Claims 8-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raats et al. (WO 2011/070172 A1; cited on 07/19/2021 IDS) in view of Andreakos et al. (Curr Opin Biotech. 2002, 13:615-620).
Raats et al. disclose a therapeutic method for treating inflammatory conditions such as citrulline related diseases comprising administering an antibody directed against citrulline-containing epitopes (see p. 1 lines 4-10). In particular, Raats teaches an antibody that is specifically reactive with a citrullinated epitope on p15 and/or p17, which are defined as human PAD4 and/or PAD2 deiminated human histone 2A and/or histone 4 (see p. 3, line 36 – p. 4 line 6), such as the monoclonal antibody RmmAb 22.101 (DSMZ deposit number ACC 3031) (see p. 13, lines 10-15 and 28-31). Raats discloses that the amino acid sequence of the VH and VL chains of RmmAb 22.101 are encoded by nucleic acid sequences of SEQ ID NO: 44 and 45, respectively; the encoded VH and VL polypeptide sequences comprise the CDR sequences of present claim 8. This monoclonal antibody thus also meets the limitations of instant claim 9 (is specifically reactive with a citrullinated epitope on the N-terminus of deiminated histone H2A or H4), claim 10 (binds to the citrullinated epitope on a peptide comprising SEQ ID NO: 1 or 2), claim 11 (monoclonal antibody), and claim 12 (competes with RmmAb 22.101 for binding to SEQ ID NO: 1 or 2).
Raats teaches that despite the fact that human patients having rheumatoid arthritis (RA) have been found to have autoantibodies against citrullinated epitopes (anti-CCP antibodies), administration of the Rmm Ab22.101 antibody to an animal model of RA was found to abolish the clinical signs of arthritis (see p. 2 line 32—p. 3 line 14; p. 15 line 17—p. 16 line 3). Thus, Raats suggests that the disclosed RmmAb 22.101 antibody can be used in the treatment of an inflammatory disease that affects humans.
However, Raats does not teach a humanized version of the Rmm Ab22.101 mAb, which humanized antibody would comprise the VH and VL CDR sequences of the mAb (SEQ ID NOs: 5-10), as in claim 8.
Andreakos et al. teach that monoclonal antibody (mAb)-based therapeutics are proving to be effective for the treatment of a wide range of immune and inflammatory diseases, including rheumatoid arthritis, Crohn’s disease, spondyloarthropathies, psoriasis and allograft rejection (see abstract). Andreakos teaches that advances in biotechnology mean that mouse-human chimeric, humanized or even fully human monoclonal antibodies of high quality can be produced in abundance, which engineered antibodies have reduced immunogenicity (see p. 615, left column; Table 1 at p. 616). Because of immunogenicity concerns, Anreakos notes that repeated treatments of human patients require humanized mAbs (p. 616, right col, last paragraph).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have humanized the Rmm Ab22.101 antibody of Raats and thereby arrive at the presently claimed invention. The motivation to do so comes from Andreakos, which teaches that several humanized mAbs have already been developed for clinical use and treatment of various immune and inflammatory diseases, and that for repeated administration of mAbs in human patients, it is necessary to use humanized antibodies to reduce immunogenicity and adverse effects. Given that Andreakos also teaches that antibody engineering techniques to produce chimeric and humanized antibodies was well-known and established in the prior art, the artisan would have had a reasonable expectation that making a humanized version of the RmmAb 22.101 antibody would have been predictable and thus successful. The teachings of the prior art references thus render obvious the presently claimed invention of claims 8-12.
Double Patenting
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
9. Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,066,462. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the claims encompass the therapeutic administration of the same antibody (an antibody specifically reactive with a citrullinated epitope on the N-terminus of deiminated histone H2A or H4, wherein the epitope resides on a peptide comprising SEQ ID NO: 1 or SEQ ID NO: 2; as in claims 2-3) to the same patient population (a subject having idiopathic pulmonary fibrosis; as in claim 1). In particular, the patented claims recite an antibody that comprises the same VH and VL CDR sequences (SEQ ID NOs: 5-10) as in instant claim 4, or that the antibody comprises a heavy and light chain as contained in mAb RmmAb 22.101 produced by the hybridoma cell line deposited as DSMZ ACC 3031, which is on point to present claims 5-6.
10. Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. RE46,990 (hereinafter the ‘990 patent) in view of Fischer et al. (Respiratory Med. 2012, 106:1040-1047).
The claims of the ‘990 patent recite an antibody that comprises identical CDRs as the antibody of present claims 4 and 8, and is in fact that same antibody as in present claim 5: RmmAb22.101. The patented claims recite that the antibody specifically binds a citrullinated epitope on human PAD2 deiminated human histone 2A, as in present claims 1 and 9. The patented monoclonal antibody would thus also inherently bind the peptide epitope(s) of instant claims 2 and 10, and compete for binding with itself to the recited peptide epitopes as in claims 6 and 12. The patented claims do not recite a method of administering the antibody, such as for the treatment of IPF.
However, the ‘990 patent discloses that the RmmAb22.101 antibody may be used in therapeutic methods of treating or preventing inflammation and citrulline-related inflammatory diseases, such as rheumatoid arthritis (RA), comprising administering the antibody to a subject in need. The courts have held that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use," which extend to any and all such uses disclosed in the specification of the earlier patent. Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d at 1363 (Fed. Cir. 2008), and Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d at 1385-86 (Fed. Cir. 2003). Indeed, as both cases recognized,
[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, … and then prevent the public from making an beneficial use of such product by securing patents upon each of the uses to which it may be adapted.
Sun Pharmaceuticals Industries, Ltd. v. Eli Lilly and Co., 611 F.3d 1381 (Fed, Cir. 2010), citing Pfizer, 518 F.3d at 1363 n.8 (emphases added); and Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 (CCPA 1931)).
Furthermore, MPEP § 804 (II)(B)(1) states that those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined."
In the instant case, the specification of the ‘990 patent is used merely to define the utility of the patented antibody. However, the ‘990 patent does not teach the treatment of IPF.
Fischer et al. teach that protein citrullination is a process well-known to occur in the lung, and may be a key component in the pathogenesis of RA. In fact, Fischer notes, some investigators speculate that the immune dysregulation of rheumatoid arthritis (RA) originates in the lungs, not the joints (see paragraph spanning pp. 1043-1044). Fischer demonstrates that some patients having interstitial lung disease (ILD), which includes patients having pulmonary fibrosis, but having no evidence of RA or other connective tissue disease (CTD) were found to test positive for the presence of anti-CCP antibodies. Fischer observed that the lung phenotypic characteristics of this cohort of patients resemble those of established RA, and a few of these patients went on to develop articular RA within the short follow-up period (see abstract).
Therefore, it would have been obvious to have administered the RmmAb22.101 antibody of the ‘990 patent in a method of treating a citrulline-related disease, such as IPF, and thereby arrive at the presently claimed invention. This is because the artisan has good reason to pursue the known options within his or her technical grasp to obtain predictable results. Such would amount to the substitution of one known element for another (i.e., the treatment of one known citrulline-related disease for another) to yield a predictable outcome.
11. Claims 8-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-6 of U.S. Patent No. 11,066,462; and
claims 1-2 of U.S. Patent No. RE46,990,
each in view of Andreakos et al. (Curr Opin Biotech. 2002, 13:615-620).
As discussed above, the patented ‘462 and ‘990 claims each contain claims directed to an antibody comprising the same CDR sequences of instant SEQ ID NOs: 5-10, and which explicitly and/or inherently binds the same cirtrullinated epitope on the N-terminus of deiminated histone H2A or H4. Further, the ‘462 claims and the specification of the ‘990 patent make clear that the antibody of the claims is intended for the treatment of human subjects. However, neither the claims of the ‘462 patent nor the ‘990 patent recite that the antibody is humanized.
The teachings of Andreakos et al. are discussed above and provide for the use of humanized antibodies in the treatment of immune-mediated disorders and inflammatory disease in humans.
Therefore, it would have been obvious to have made a humanized version of the RmmAb 22.101 monoclonal antibody for use in clinical applications, because humanized antibodies are recognized in the art to have lower immunogenicity and therefore are safer for use in immunotherapy for human patients. Humanization of antibodies is well-understood and routine in the art, and therefore predictable. Accordingly, the claims of the ‘462 and ‘990 patents in view of the prior art render obvious the invention recited by instant claims 8-12.
Conclusion
12. No claims are allowed.
Advisory Information
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/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675