Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/21/26 has been hereby entered.
2. Claims 1-11,14-16 are pending.
Claims 1-10 and 15,16 are withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 11, and 14 read on the method of treating autoimmune disease in a human subject comprising administering anti-LAG3 antibodies are under consideration in the instant application
3. The following is a quotation of the first paragraph of 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.
4. Claims 11, 14 are rejected under 35 U.S.C. 112, first paragraph, because the specification while been enabling for a method of depleting LAG-3 positive antigen specific CD8 and CD4 T cells comprising administering to the subject an effective amount of anti-LAG-3 antibody comprising CDRs of SEQ ID Nos: 1-3 and 6-8, , does not reasonably provide enablement for the claimed method of treating autoimmune diseases associated with the involvement of pathogenic T cells in the subject comprising administering anti-LAG-3 antibodies, comprising CDRs of SEQ ID Nos: 1-3 and 6-8. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and or use the invention commensurate in scope with this claim for the same reasons set forth in the previous Office Action, mailed on 10/21/26
Applicant’s arguments filed on 01/21/26 have been fully considered but have not been found convincing.
Applicant asserts that the amended claims now recited treating autoimmune diseases and that the Examples of the instant specification support the instantly claimed method of treating autoimmune diseases associated with the involvement of pathogenic T cells in the subject comprising administering anti-LAG-3 antibodies, comprising CDRs of SEQ ID Nos: 1-3 and 6-8. Applicant further assert that Poirier et al., provided evidences that depleting anti-LAG3 antibodies are effective in treating autoimmune disease.
Contrary to Applicant’s assertion as has bend stated previously, the specification does not adequately teach or provide any evidences or data of how to effectively treating autoimmune diseases associated with the involvement of pathogenic T cells in the subject comprising administering anti-LAG-3 antibodies, comprising CDRs of SEQ ID Nos: 1-3 and 6-8.
Moreover, no animals models were used to study the effectively of treating autoimmune diseases associated with the involvement of pathogenic T cells in the subject comprising administering anti-LAG-3 antibodies, comprising CDRs of SEQ ID Nos: 1-3 and 6-8.
Since there is no animal model studies and data in the specification to show the effectively of administering anti-LAG-3 antibodies, it is unpredictable how to correlate in vitro results with in vivo use.
With regards to the Examples of the instant specification.
The Exampless 1-5 only discloses detailed characteristics and binding specificity of the instantly claimed anti-LAG-3 antibodies, comprising CDRs of SEQ ID Nos: 1-3 and 6-8.
Example 6 and 7 only disclosed an in vitro and limited in vivo data confirming the ability of anti-LAG-3 antibodies, comprising CDRs of SEQ ID Nos: 1-3 and 6-8 to deplete LAG3 positive antigen specific CD8 and CD4 T cells.
The Examiner already acknowledge that the instant claims been enabling for a method of depleting LAG-3 positive antigen specific CD8 and CD4 T cells comprising administering to the subject an effective amount of anti-LAG-3 antibody comprising CDRs of SEQ ID Nos: 1-3 and 6-8
However the issue raised by the Examiner was that the specification does not teach how to extrapolate data obtained from in vitro and limited in vivo studies to the development of effective in vivo mammalian including human therapeutic treatment, commensurate in scope with the claimed invention. Therefore, it is not clear that the skilled artisan could predict the efficacy of a claimed method of treating autoimmune diseases associated with the involvement of pathogenic T cells in the subject comprising administering anti-LAG-3 antibodies, comprising CDRs of SEQ ID Nos: 1-3 and 6-8. Moreover, Applicant himself acknowledge that anti-LAG-3 antibodies of the invention may have use in therapy, including cancer treatment ( emphases added, see for example pages 23-24 of the instant Specification). These prophetic examples indicate what the inventors were thinks might happen in the experiments which have not actually been performed. As such, the invention must be considered unpredictable. Thus in the absence of working examples or detailed guidance in the specification, the intended uses of any pharmaceutical composition comprising an antisense nucleic acid are fraught with uncertainties.
With regards to Applicant’s statement that “Poirier et al., provided evidences that depleting anti-LAG3 antibodies are effective in treating autoimmune disease.”
The Examiner disagrees with Applicant’s interpretation of the teaching of Poirier et al.
In particular, Poirier et al explicitly teach that though the use of LAG3 targeting antibody in treating autoimmune disease is promising and might be used in future as potential therapeutic agent it is requires additional studies by using animal and human trials. The use of antibodies that specifically deplete activated T cells in several clinical studies were shown to be complicated and compromised by thromboembolic complications ( see entire document Abstract and Discussion in particular).
US Patent Application 20210371529 and US Patent Application 20210238287 collectively teach that the function of soluble Lag-3 in treating disease including cancer is not known. The use of anti-LAD-3 antibodies for therapy including cancer might hold a great promise and requires further studies using animal and human trials ( see entire documents , Background information in particular).
Perez-Santos ( Expert Opinion on Therapuicic Patents, 2019, v 29 p 1-35) review the current state of the art in the novel therapies use of anti-Lag-3 inhibitors and teaches that there is a continuing development of LAG-3 inhibitors including more than 50 clinical trials including anti- LAG-3 antibodies to show the possible effectivity in treating various diseases where in some showing promising results and other are not effective.
Thus, Applicant has not provided sufficient guidance to enable one skill in the art to use claimed method of treating autoimmune diseases associated with the involvement of pathogenic T cells in the subject comprising administering anti-LAG-3 antibodies, comprising CDRs of SEQ ID Nos: 1-3 and 6-8 in manner reasonably correlated with the scope of the claims.
The scope of the claims must bear a reasonable correlation with the scope of enablement. In re Fisher, 166 USPQ 18(CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute.
If the use disclosed is of such nature that the art is unaware of successful treatments with anti-Lag3 antibody a more complete statement of how to use must be supplied.
"The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements...However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims.” MPEP § 2164.03. Regarding in vivo methods which rely on generally unpredictable mechanisms, "The amount of guidance or direction needed toenable the invention is inversely related to the amount of knowledge in the state of the art aswell as the predictability in the art." In re Fisher, 427 F.2d 833,839, 166 USPQ 18, 24(CCPA 1970). The "amount of guidance or direction" refers to that information in theapplication, as originally filed, that teaches exactly how to make or use the invention. Themore that is known in the prior art about the nature of the invention, how to make, and howto use the invention, and the more predictable the art is, the less information needs to beexplicitly stated in the specification. In contrast, if little is known in the prior art about thenature of the invention and the art is unpredictable, the specification would need more detailas to how to make and use the invention in order to be enabling (MPEP 2164.03)." TheMPEP also states that physiological activity can be considered inherently unpredictable.
"Substantiating evidence may be in the form of animal tests which constitute recognized screening procedures with clear relevance to utility in humans. See Ex parte Krepelka, 231 USPQ 746 (Board of Patent Appeals and Interferences 1986) and cases cited therein." Ex parte Maas, 9 USPQ2d 1746
The scope of the claims must bear a reasonable correlation with the scope of enablement. In re Fisher, 166 USPQ 18(CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute.
In view of the quantity of experimentation necessary, the unpredictability of the art, the lack of sufficient guidance in the specification, the limited working examples, and the limited amount of direction provided given the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
5. 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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.131(c). A registered attorney or agent of record may sign a terminal disclaimer.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit https://www.uspto.gov/patent/patents-forms. The filing date of the application will determine what form 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 https://www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer
6. The claims 11 and 14 stand provisionally rejected on the grounds of nonstatutory double patenting of the claims 1-19 of copending Application US 20230242642. Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-19 of copending Application 20230242642 recited a method of treating a diseases comprising administering anti-LAG-3 antibody.
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 said rejection in abeyance until the allowable subject matter is identified.
7. No claim is allowed.
8. All claims are either identical to or patentably indistinct from claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114.
Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
9. 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
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644
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