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 .
RESPONSE TO APPLICANT’S AMENDMENT
1. Applicants amendment filed on 07/13/26 is acknowledged.
2. Claims 1, 4, 7-19 are pending.
3. Applicant’s submission of Declaration by Dr. Marco Davila on 07/13/26 have obviated the previous rejection of record as being anticipated by US Patent Application 20200108098.
4. 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.
5. Claims 1,4, 7,9,15, 17-19 stand rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by US Patent Application 20180312588 as is evidence by US Patent Application 20170296623 for the same reason set forth in the previous Office Action, mailed on 04/09/26.
Applicant’s arguments filed on 07/31/26 have been fully considered but have not been found convincing.
Applicant asserts that US Patent Application’588 does not disclosed CAR comprising CD83 antigen binding domain. The only appearance of CD83 in US Patent Application’588 occurs within lengthy Markush list of extracellular domain options.
The Examiner disagrees with Applicant’s interpretation of the teaching of US Patent Application’588. As acknowledge by Applicant, US Patent Application’ 588 teaches CARs comprising various antigen-binding domains, including CD83. The fact that US Patent Application’ 588 teaches a Markush list of extracellular antigen binding domains does not means that one skill in the art would not recognized that the claimed CARs would not comprise CD83 antigen binding domain.
Moreover, as is evidence from the teaching of US Patent Application ‘623 the use of T cells expressing CAR having CD83 antigen-binding domain for treating autoimmune diseases was well known ( see entire document, paragraphs 0007, 0040, 0053 in particular).
As has been sated previously, US Patent Application ‘588 teaches a method administering to the subject an effective amount of genetically modified T cells expressing CAR, comprising CD19 antigen binding domain, comprising scFv. US Patent Application ‘588 teaches that CAR comprises CD19 antigen binding domain, transmembrane domain, co-stimulatory signaling domain, comprising CD28, and intracellular signaling domain, comprising CD3zeta. US Patent Application ‘588 further teaches that said cells can also expressed a second CAR comprising CD83 antigen binding domain and having transmembrane domain, co-stimulatory signaling domain and intracellular signaling domain( see entire document, Abstract and paragraphs 0006, 0014, 0046, 0047, 0048, 0049, 0050, 0056, 0069, 0151, 0167 in particular).
It is noted that US Patent Application ‘588 does not explicitly teaches inhibiting of autoreactive lymphocytes in a subject by administering said genetically modified T cells. However said functional properties would be an inherent properties of administered genetically modified T cells expressing CAR, because the referenced cells and instantly claimed are the same.
Thus, although the reference is silent about inhibiting autoreactive lymphocyte in a subject, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories 58 USPQ2d 1508 (CAFC 2001). “{i}t is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable”. In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). The mechanism of action does not have a bearing on the patentability of the invention if the invention was already known or obvious.
Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145.
The reference teaching anticipates the claimed invention.
6. 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.
7. Claims 1, 10-14, stand rejected under 35 U.S.C. 103 as being unpatentable over Patent US Patent Application 20180312588 in view of US Patent 9,562097 for the same reason set forth in the previous Office Action, mailed on 04/09/26.
Applicant’s arguments filed on 07/31/26 have been fully considered but have not been found convincing.
Applicant asserts that since US Patent Application 20180312588 does not teach CAR comprising CD83 antigen- binding domain it can not be used for the rejection under 35 U.S.C. 103.
Contrary to Applicant’s assertion as has been stated above, it is the Examiner’s position that US Patent Application 20180312588 does teach CAR comprising CD83 antigen- binding domain and thus can be used for the rejection under 35 U.S.C. 103
The teaching of US Patent Application 20180312588 have been discussed supra.
US Patent Application 20180312588 do not explicitly teaches that anti-CD83 antigen binding domain comprising VH of SEQ ID NO: 19 and VL of SEQ ID N:20 and anti-CD83 antigen binding domain comprising VH CDRs of SEQ ID N:1-3 and VL CDRs of SEQ ID Nos:4-6.
US Patent’ 097 teaches an anti-CD83 antibody comprising anti-CD83 antigen binding domain comprising VH of SEQ ID :30 and VL of SEQ ID: Nos: 36 and comprising anti-CD83 antigen binding domain comprising VH CDRs and VL CDRs that are 100% identical to the instantly claimed VH of SEQ ID NO: 19 and VL of SEQ ID N:20 ( see sequence alignment, attached).
US Patent’ 097 teaches that said anti-CD83 antibody can be used for treating autoimmune diseases.
All the claimed elements were known in the prior art and one skill in the art could have combine the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute anti-CD83 antigen binding domain of CAR taught by US Patent Application 20180312588 with an anti-CD83 antibody comprising anti-CD83 antigen binding domain taught by US Patent’097 with a reasonable expectation of success because the prior art suggests that both anti-CD83 antigen binding domain can be used for treating autoimmune diseases.
From the combined teaching of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
8. 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. The claims 1-15 17-19 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application No. 18/719814, 18/547,748, 16/717,537, 18,478247 each in view of US Patent 9,562097 and US Patent Application 20230183313.
Claims of copending Application No. 18/719814, 18/547,748, 16/717,537, 18,478247 each recited a method comprising administering to the patient CAR-T cells , wherein CAR comprising a CD83 antigen binding domain, transmembrane domain an intracellular domain and a costimulatory domain.
US Patent’ 097 teaches an anti-CD83 antibody comprising anti-CD83 antigen binding domain comprising VH of SEQ ID :30 and VL of SEQ ID: Nos: 36 and comprising anti-CD83 antigen binding domain comprising VH CDRs and VL CDRs that are 100% identical to the instantly claimed VH of SEQ ID NO: 19 and VL of SEQ ID N:20 ( see sequence alignment, attached).
US Patent’ 097 teaches that said anti-CD83 antibody can be used for treating autoimmune diseases.
US Patent Application’313 teaches a method of treating autoimmune diseases, comprising administering to the patient CAR-T cells , wherein CAR comprises CD19 antigen binding domain, a transmembrane domain, an intracellular domain and costimulatory domain ( see entire document, paragraphs 0006, 0058, in particular).
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute anti-CD83 antigen binding domain of CAR taught by Patent Application 20200108098 or US Patent Application 20180312588 with an anti-CD83 antibody comprising anti-CD83 antigen binding domain taught by US Patent’097 with a reasonable expectation of success because the prior art suggests that both anti-CD83 antigen binding domain can be used for treating autoimmune diseases.
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to combine CAR comprising CD83 antigen binding domain with CAR comprising CD19 antigen binding domain in the method of treating autoimmune disease with a reasonable expectation of success because the prior art suggests CAT-T cells comprising each of said CARs have been used for treating autoimmune disease.
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. . . [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06).
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
It is noted that Applicant requested to hold that provisional double patenting rejection in abeyance until allowable subject matter is identified.
10. Claim 16 stand objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
11. THIS ACTION IS MADE FINAL. See MPEP § 609(B)(2)(i). 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 mailing date of this final action.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch can be reached on 571/ 272-8149
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644
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