RESPONSE TO APPLICANT’S AMENDMENT
1. Applicant's amendment, filed 06/16/2026, is acknowledged.
2. Claims 1, 6-9 and 10-19 are pending.
3. Claim 19 is objected to for the recitation “eg Grave’s)” because “e.g.,” means “such as” and it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
4. The following new ground of rejection is necessitated by the amendment submitted 06/16/2026.
5. The following is a quotation of 35 U.S.C. 112(a) (Pre-AIA 35 U.S.C. 112, first paragraph):
(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.
6. Claims 1, 6-9 and 10-19 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 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims recite “a H/LCDRY of SEQ ID NO: X” using open language and “a” to refer
to sequences identified by SEQ ID Nos.
The claims use open language “comprising” and “a H/LCDRY of SEQ ID NO: X”, the phrase results in an antigen binding domain comprising the claimed CDRs or any portion of the claimed “SEQ ID NO: X”. The claim terminology “ a H/LCDR of SEQ ID NO: X” does not place size limits on the VH/VL/CDRs, but rather reads on any portion of the claimed VH/ VL/ CDRs of SEQ ID NO. The VH/VL/CDRs are generic with respect to size, encompassing anything from dimers on up to the full size of the claimed SEQ ID NOs.. The claims encompass a genus of CDR fragments incorporated into any larger amino acid sequence, VH and VL. The claims encompass fragments that, in addition to the tetra-, penta-, hexa-, hepta-, octa-, nona-, deca- and undeca-peptide recited in SEQ ID NO: X, also have flanking VH and VL of considerable size up to 120 amino acids in length. However, every member of that genus does not include a common structural feature of the sequence recited in SEQ ID NOs. There are no drawings or structural formulas disclosed of CDR polypeptide fragment that binds to CD79b. There are no teachings in the specification regarding which amino acid of VH and VL CDR polypeptide fragment that can be deleted while retaining the ability of the fragment to bind to CD79b. Further, there is no art-recognized correlation between any structure of the CDR polypeptide fragment and the activity of binding to CD79b based on which those of ordinary skill in the art could predict which amino acids can be deleted from a CDR sequence without losing the binding to CD79b. Consequently, there is no information about which amino acids can deleted from any CDR sequence in the claimed genus of antigen binding domain and still retain the ability to bind CD79b.
Replacing the article “a” with “the” would overcome this rejection.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the written description inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116.). Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 USPQ2d 1398.
Applicant is invited to point to clear support or specific examples of the claimed invention in the specification as-filed.
7. Claims 18-19 stand rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as containing 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 for the same reasons set forth in the previous Office Action, mailed 03/16/2026.
The specification does not reasonably provide enablement for methods of administering to a therapeutically effective amount of the isolated protein that binds to CD79b to a subject has an autoimmune; wherein the autoimmune disease is Systemic lupus erythematosus (SLE), Sjogren's syndrome (SjS), Rheumatoid arthritis, Autoimmune myopathies, Type I diabetes, Addison disease, Pernicious anemia, Autoimmune hepatitis, Primary biliary cholangitis (PBC), Autoimmune pancreatitis, Celiac disease, Focal segmental glomerulosclerosis, Primary membranous nephropathy, Ovarian insufficiency, Autoimmune orchitis, Dry eye disease, Idiopathic interstitial pneumonias, Thyroid disease (eg Grave's), Systemic sclerosis (Scleroderma), Myasthenic syndromes, Autoimmune encephalitis, Bullous skin diseases, TTP, ITP, AIHA, Anca vasculitis, Myocarditis/dilatory CM, NMOSD, Maternal-fetal alloimmunity, Maternal-fetal autoimmunity, Anti- cardiolipin/antiphospholipid syndrome, Hypergammaglobulinemia, Transplant-associated ID, Multifocal motor neuropathy. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The claims are directed to the treatment of a broad genus of diseases including each and every autoimmune disease with the claimed anti-CD79b antibodies.
To determine the broadest reasonable of intentional purpose of methods comprising administering anti-CD79b antibodies to subject having an autoimmune disease in claim 18, the specification is consulted. The “correct inquiry in giving a claim term its broadest reasonable interpretation in light of the specification is . . . an interpretation that corresponds with what and how the inventor describes his invention in the specification, i.e., and interpretation that is “consistent with the specification.” In re Smith Int’l Inc., 871 F.3d 1375, 1375-1383 (Fed. Cir. 2017). The specification on page 92 under Methods of Treatment and Uses, discloses that the antigen binding domain that binds CD79b of the disclosure may be administered to a subject in
need thereof to manage, treat, prevent, or ameliorate an autoimmune disease or disorder or one or more symptoms thereof. The disclosure also provides methods comprising administering a therapeutically effective amount of the antigen binding domain that binds CD79b of the disclosure to a subject having an autoimmune disease. The specification at the paragraph spanning pages 98-99 discloses methods of inhibiting aberrant B cell activation in a subject comprising administering a therapeutically effective amount of a composition comprising an antigen binding domain that binds CD79b of the disclosure to the subject in need thereof for a time sufficient to inhibit aberrant B cell activation. "Therapeutically effective amount" or "effective amount" as used interchangeably herein, refers to an amount effective, at dosages and for periods of time necessary, to achieve a desired therapeutic result (see page 20).
Accordingly, “the subject has an autoimmune disease” is an essential part of the claimed invention and therefore necessarily limiting. see Boehringer Ingelheim Vetmedica, Inc. V. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Thus, there are required functionalities for the claimed anti-CD79b antibodies administered to the subject “has autoimmune disease” such as the one recited in claim 19 in achieving a desired therapeutic result.
The instant claims are directed to a genus of autoimmune methods of treatments using claimed anti-CD79b antibodies. However, the specification does nto enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Applicant’s arguments, filed 03/16/2026, have been fully considered, but have not been found convincing.
Applicant submits that it is well-settled that an Applicant need not have actually reduced the invention to practice prior to filing. MPEP §2164.02 (citing Gould v. Quigg, 822 F.2d 1074 (Fed. Cir. 1987)). Indeed, the invention need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908 (C.C.P.A. 1970). The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. MPEP §2164.01 (citing In re Angstadt, 537 F.2d 498, 504 (C.C.P.A. 1976)). The fact that experimentation may be complex does not necessarily make it undue if the art typically engages in such experimentation. Id. Further, the specification need not disclose what is well-known to those skilled in the art and preferably omits that which is well-known to those skilled and already available to the public. MPEP §2164.05(a) (citing In re Buchner, 929 F.2d 660, 661 (Fed. Cir. 1991)). Therefore, under current law, enablement does not require a working example and experimentation is allowed so long as it is not undue.
Furthermore, there is no requirement under the current law of enablement that each
embodiment be reduced to practice. Amgen Inc. v. Chugai Pharm. Co., 18 USPQ2d 1016, 1027 (Fed. Cir. 1991) made clear that enablement does not require working examples for each species encompassed by a claim. Accord In re Robbins, 166 USPQ 552 (CCPA 1970).
Applicant submits that a skilled artisan would have readily understood, based on the
teachings of the Specification and the state of the art, how to formulate, prepare, and administer the claimed anti-CD79b antibodies or antigen-binding fragments thereof without undue experimentation.
This is not found persuasive because the specification does not provide empirical data to show the efficacy of the claimed anti CD79b antibodies on any disease. No working empirical data demonstrating that the anti-CD79b antibody would treat autoimmune diseases including Systemic lupus erythematosus (SLE), Sjogren's syndrome (SjS), Rheumatoid arthritis, Autoimmune myopathies, Type I diabetes, Addison disease, Pernicious anemia, Autoimmune hepatitis, Primary biliary cholangitis (PBC), Autoimmune pancreatitis, Celiac disease, Focal segmental glomerulosclerosis, Primary membranous nephropathy, Ovarian insufficiency, Autoimmune orchitis, Dry eye disease, Idiopathic interstitial pneumonias, Thyroid disease (eg Grave's), Systemic sclerosis (Scleroderma), Myasthenic syndromes, Autoimmune Preliminary Amendment encephalitis, Bullous skin diseases, TTP, ITP, AIHA, Anca vasculitis, Myocarditis/dilatory CM, NMOSD, Maternal-fetal alloimmunity, Maternal-fetal autoimmunity, Anti- cardiolipin/antiphospholipid syndrome, Hypergammaglobulinemia, Transplant-associated ID, Multifocal motor neuropathy.
The specification does not provide exemplification or animal model to treat a subject with anti-CD79b antibodies. There is no correlation on this record between the claimed anti-CD79b antibodies and a practical method of in vivo use in currently available form for subject suffering from autoimmune diseases. It is not enough to rely on scientific theories where a person having ordinary skill in the art has no basis for perceiving those studies as constituting recognized screening procedures with clear relevance to methods of in vivo use in humans or animals. There must be a rigorous correlation of pharmacological activity between the disclosed in vitro use and an in vivo or ex vivo use to establish practical methods of in vivo use. The influence of a scientific theory should depend on its empirical and demonstrable aspects and not its underlying logic. Yet such empirical and demonstrable aspects of the claimed methods with the anti-CD79b antibodies are lacked in the instant specification. It is not clear that the skilled artisan could predict the efficacy of the anti-CD79 antibodies, encompassed by the claims. The specification fails to provide empirical data to show that the claimed method would work in vivo.
No autoimmune disease data ( in vitro or in vivo ) are presented in the specification. There are no working examples in the specification and therefore the "correlation" to autoimmune disease treatment is absent.
8. No claim is allowed.
9. The claimed antigen binding domain that binds CD79b comprises claimed SEQ ID NOs is free from prior art.
10. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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July 21, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644
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