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 .
Information Disclosure Statement
Information Disclosure Statements (IDS), filed on 03/26/2025 and 04/17/2025 have been considered.
Priority
This application claims priority to Japan 2019-146227 with an earliest effective filing date of 08/08/2019.
Status of Claims
Claims 1-12 and 14-15 are cancelled. Claim 13 is currently pending.
Rejections Maintained
The rejection of the claims under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Langermann et al (US 2014/0044738 A1) is maintained.
Rejections Withdrawn
The rejection of the claims on the ground of nonstatutory double patenting as being unpatentable over claim 1, 22, 23, 25, and 37 of U.S. 12,091,461 (Shibayama et al, herein the “reference” patent/claims) in reference to Shah et al (T cell receptor (TCR) signaling in health and disease. Sig Transduct Target Ther 6, 412 (2021). doi.org/10.1038/s41392-021-00823-w) is withdrawn.
Response to Remarks filed 09/11/2025
Applicant’s arguments regarding the 35 USC 102/103 rejections of claims 1-14 have been considered and are not persuasive.
Claims 1-12 and 14 are withdrawn as Applicant has cancelled the claims.
However, the rejection of Claim 13 is maintained. Applicant argues “There is no teaching relating to an antibody capable of binding to PD-1 and CD4 anywhere else in Langermann. Tuberculosis is an infectious disease and not an autoimmune disease. Although Langermann mentions autoimmune diseases among other unrelated diseases (such as cancer, infectious diseases and diseases affecting T cell number or health), Langermann does not teach that autoimmune diseases can be treated by an antibody capable of binding to PD-1 and CD4.”
Applicant further argues “Langermann mentions an antibody capable of binding to PD-1 and CD4 only in the context of treating tuberculosis and does not provide any motivation to use such an antibody "for preventing, suppressing the progression of symptoms of or the recurrence of and/or treating autoimmune disease or graft-versus-host disease" as recited in the present claims with a reasonable expectation of success.”
However, Langermann et al teach a bispecific antibody of PD-1 can include a CD4 arm (Langermann et al, paragraph 0082) and further teaches that antibodies that directly bind PD-1 have utility in treatment of graft v. host and autoimmune disease (Langermann et al, paragraph 00153), which would include the PD-1/CD4 bispecific antibody disclosed earlier in the referenced application.
Applicant argues “With respect to the recitation that "the PD-1/CD4 bispecific antibody or antibody fragment thereof specifically binds to PD-1 and CD4 expressed on T lymphocytes" (previously recited in canceled claim 9 and now incorporated into claim 13), the Examiner asserts that "Langermann et al. teaches the antibody specifically binding to a T cell (Langermann et al, at claim 5)." Office Action, page 4. However, claim 5 of Langermann recites that "said antigen-binding fragment binds to PD-1, and wherein said live cell is a T cell" and does not teach that a bispecific antibody binds to two antigens, PD-1 and CD4, expressed on a T cell.”
However, the ability of a bispecific antibody capable of binding PD-1 and CD4 as disclosed in Langermann to bind PD-1 and CD-4 on T-cells is an inherent property present at the time the instant application was effectively filed. Additionally, the ability for the PD-1/CD4 bispecific antibody to bind CD4+ T-cells is disclosed in Langermann (Langermann et al, paragraph 0082- 0083).
Applicant argues “With respect to the recitation that "the first arm allows an interaction with PD-1 and PD- L1, interaction with PD-1 and PD-L2, or both such interactions" (previously recited in canceled claim 7 and now incorporated into claim 13), the Examiner states that Langermann teaches such limitation. Office Action, page 4. However, this paragraph only discusses signal transduction mediated by B7-H1 and PD-1 and does not mention any antibodies. Thus, Langermann does not disclose this feature.”
However, Langermann et al teach antibodies that can be multispecific that can bind with B7-H1 or PD-1 (Langermann et al, paragraph 0079). It is noted that binding is an interaction. It is also noted that B7-H1 is PD-L1.
For reasons discussed above, the 35 USC 102/103 rejection of claim 13 is maintained.
Applicant’s arguments and amendments regarding the double patenting rejection of claims 1-5, 7, 8, and 11 have been considered and are persuasive. Specifically, filing and approval of a terminal disclaimer remedy the rejection and therefore the rejection is withdrawn.
Previous Rejections Maintained- Nonfinal 03/12/2025
Claim Rejections - 35 USC § 102/103
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.
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.
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.
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.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Langermann et al (US 2014/0044738 A1).
The instant claims are drawn to a composition comprising a PD-1/CD4 bispecific antibody or fragment thereof comprising first and second and specific binding respectively to PD-1 and CD4 (claims 1-9,14), or an isolate (claims 10) or compositions comprising (claims 11,12), or method of administering thereof (claim 13).
Langermann et al ‘738, however, teaches a bispecific antibody of PD-1 can include a CD4 arm (’738 at paragraph [0070]; see instant claims 1 and 10). Regarding claims 2 and 3, Langermann et al teaches the presence of light and heavy chain regions (para. [0061]). Regarding claims 4 and 5, Langermann et al teaches “In some embodiments the Fc region is the native IgG1, IgG2, or IgG4 Fc region” (para. [0095]). Regarding claim 6, Langermann et al teaches modulation of signal transduction (para. [0032], section A). Regarding claim 7, Langermann et al teaches PD-1 is capable of binding both PD-L1 and PD-L2 (para. [0017]). Regarding claim 9, Langermann et al teaches the antibody specifically binding to a T cell (Langermann et al, at claim 5). Regarding claim 11, Langermann et al teaches a pharmaceutical composition and a pharmaceutically acceptable carrier (para. [00150] and [00151]). Regarding claims 12-14, Langermann et al teaches treatment of inflammatory or autoimmune disease and treating patients (para. [00138] and [00146]) Regarding claim 8, Langermann et al teaches “ As discussed above, interactions between PD-1 and B7-H1 inhibit the proliferation of T cells and reduce the production of multiple cytokines (para. [0127]).
The cited reference discloses a composition comprising an antibody which appear to be identical to the presently claimed composition since it describes a PD-1/CD4 bispecific antibody composition, as discussed above, and/or produces such composition effective for autoimmune disease treating. Consequently, the claims appear to be anticipated by the reference.
In the alternative, even if the composition is not identical to the referenced composition, with regard to some unidentified characteristics, the differences between that which is claimed and that which is disclosed, is so slight that the referenced composition is likely to inherently possess the same characteristics of the claimed composition, particularly in view of the similar characteristics which they have been shown to share (as discussed above). Thus, the claimed composition and methods resulting from the administering thereof would have been at least obvious to those of ordinary skill in the art within the meaning of 35 USC § 103(a).
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
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.
No claims are allowed.
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/J.K.D./
Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642