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 .
Applicant's reply to the previous Office action, dated August 13, 2025, has been received. By way of this reply, Applicant has amended claim 1 and cancelled claim 26.
Claims 1, 5-6, 9, 11-12, 25 and 27 are pending in the application. Claim 11 remains withdrawn from consideration, pursuant to the Restriction Requirement mailed September 22, 2022.
Claims 1, 5-6, 9, 12, 25, and 27 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated March 5, 2025.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5-6, 9, 12, 25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Von Herrath (WO2011091138A1) in view of Deb (PLoS One. 2010 Aug 30;5(8):e 12478).
Applicant argues that the teachings of Von Herrath are hypothetical and provide no data supporting the efficacy of the recited treatment regimen, and provide no reasonable expectation of success. Applicant further argues that Deb does not teach a single dose of an anti-CD8 antibody. Applicant further argues that the claimed method produces unexpectedly superior results; specifically, the claimed method does not cause suppression of overall immunity, but instead suppression of autoimmunity, which is beneficial compared to prior methods of repeated treatment with antibodies.
Applicant's arguments have been considered fully but are not found to be persuasive.
As stated previously, conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367-68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")). MPEP 2143.02.
Applicant has not provided evidence that the method of Von Herrath is inoperable. Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). Examples of statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. MPEP 716.01(c).
The standard to be met in establishing a prima facie case of obviousness is a reasonable expectation. Example 4 of Von Herrath (para. 0229-0223) clearly teaches combinations of an anti-CD20 antibody and an autoantigen for the treatment of multiple sclerosis, with the autoantigen administered two weeks (i.e., 14 days) after the antibody, contrary to Applicant's assertion. Applicant also has not produced evidence of any unexpected criticality of the claimed time frame for administering the autoantigen.
"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). MPEP 2123.
There is nothing in the claims that requires a treatment that avoids suppression of overall immunity in the subject. Additionally, Applicant's specification at page 3, lines 3-15 state that the claimed method depletes B and T cells in the subject, which appears to suggest a suppression of the immune system is a natural occurrence of the claimed method. Applicant has, at best, identified a latent property in the art, which does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). MPEP 2145(II).
With regards to Applicant's arguments concerning the dosage schedule, Applicant's specification at page 34 concedes that dosage regimens can be adjusted to provide the optimum desired response (e.g., tolerizing a subject and/or a therapeutic response), and that a physician or veterinarian having ordinary skill in the art can readily determine and prescribe the effective dose of the pharmaceutical composition required. This is an admission that the dosage schedule is a result effective variable, and the ordinary artisan would be motivated to adjust or optimize the dosage schedule in pursuit of improved results. Additionally, Von Herrath teaches that dosage, combination with other autoimmune agents, timing and frequency of administration is also within the skill of the ordinary practitioner (para. 0150). The claimed dosage schedule could therefore be arrived at through nothing more than routine optimization. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
This rejection is therefore maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ashdown (US20080248022A1) teaches that MOG-derived peptide activates encephalitogenic CD8+ T cells in vivo, and that CD8+ T cells are expanded in active multiple-sclerosis lesions (para. 0006). Ashdown further teaches a method of treating a disease characterized by the production of CD8+ effector cells by treating the patient with an anti-CD8+ antibody (para. 0036-0039). Ashdown further teaches that the disease to be treated is an autoimmune disease (para. 0030-0031), and that the autoimmune disease may be multiple sclerosis (para. 0118). Ashdown further teaches that the above agent may be administered in a single dose (para. 0147).
Smith (US20080089885A1) teaches that anti-CD20 antibodies are useful in treating multiple sclerosis (para. 0011 and claim 18).
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 8:00 to 4:00.
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/PETER JOHANSEN/Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644