RESPONSE TO APPLICANT’S AMENDMENT
1. Applicant's amendment, filed 02/20/2026, is acknowledged.
2. Claims 113-127 are pending.
3. Claims 113-116, and 121-127 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
4. Claims 117-120 are under examination as they read on the species of (ii) a ratio of Tscm:Tn that is ≥ 50:50.
5. Applicant’s IDS, filed 02/20/2026, is acknowledged.
6. In view of the amendment filed on 02/20/2026, only the following rejections are remained.
7. 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.
8. Claims 117-120 stand rejected under 35 U.S.C. 103 as being unpatentable over US Pat. 9434785(IDS #119) for the same reasons set forth in the previous Office Action mailed 11/20/2025.
Applicant’s arguments, filed 02/20/2026, have been fully considered, but have not been found convincing.
Applicant submits that as the Office concedes, the '785 patent does not teach or disclose selecting patients with dermatitis having a ratio of Tscm:Tn that is equal to or greater than 50:50 (recited in independent claim 117) or a ratio of Tscm:Tn that is equal to or greater than 55:45, 60:40, 65:35, 70:30, 75:25, 80:20, 85:15, 90:10, or 95:5 (recited in dependent claim 118). The Federal Circuit in Ortho-McNeil emphasized that:
[e]vidence of obviousness . . . is insufficient unless it indicates that the possible options skilled artisans would have encountered were "finite,""small," or "easily traversed," and that skilled artisans would have had a reason to select the route that produced the claimed invention.
Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008) (emphasis added).
The Office has failed to establish why a person of skill in the art would have selected dermatitis among the numerous diseases/conditions listed in the '785 patent. Indeed, dermatitis is only mentioned twice in the '785 patent among a laundry list of over eighty diseases/conditions. See '785 patent, paragraphs [0096]-[0184]. Thus, it would not have been obvious to a person of skill in the art to select a patient with dermatitis having the claimed Tscm:Tn ratios and to administer an anti-OX40L antibody or an antigen-binding fragment thereof to reduce the proportion of Tscm cells compared to Tn cells in those patients based on the disclosure of the '785 patent.
This is not found persuasive because Applicant’s specification does not go beyond '785 patent, teachings regarding selecting patients with dermatitis having a ratio of Tscm:Tn that is equal to or greater than 50:50, if prior art teachings are enabled, so is the specification. If prior teachings are not enabled neither is specification. The specification does not go beyond what was already known in the art. It appears that Applicant’s specification suffers the same deficiency as the prior art. The instant specification mentions dermatitis only three times within a laundry list of hundreds of diseases/conditions (see pages 21-25). Applicant’s amendment to the claims filed 12/27/2023 fails to provide support for selecting a patient with dermatitis having a ratio of Tscm:Tn that is equal to or greater than 50:50 among the numerous diseases /conditions listed in the instant specification. Applicant cannot represent to the public that their claimed dermatitis patient can be selected based on a ratio of Tscm:Tn that is equal to or greater than 50:50 from among a laundry list of hundreds of diseases/conditions, while at the same time discounting the relevance of that very same selection method to the obviousness of their claims. Applicant’s specification does not go beyond the teachings of the prior art and elaborated upon what was known in the prior art with respect to claimed dermatitis selection, yet argues that
it would not have been obvious to a person of skill in the art to select a patient with dermatitis having the claimed Tscm:Tn ratios and to administer an anti-OX40L antibody or an antigen-binding fragment thereof to reduce the proportion of Tscm cells compared to Tn cells in those patients based on the disclosure of the '785 patent. The teachings of the instant application do not go beyond the teachings of the prior art regarding the dermatitis patient population selection. The specification fails to show different dermatitis populations comprising different Tscm:Tn ratios.
9. Claims 117-120 stand rejected under 35 U.S.C. 103 as being unpatentable over US Pat. 9139653 (IDS # 115) in view of US Pat. 9434785 (IDS #119) for the same reasons set forth in the previous Office Action mailed 11/20/2025.
Applicant’s arguments, filed 02/20/2026, have been fully considered, but have not been found convincing.
Applicant submits that the '653 patent fails to cure the deficiencies of the '785 patent As discussed above and incorporated herein, the Office has failed to establish why a person of skill in the art would have selected dermatitis among the numerous diseases/conditions listed in the '785 patent. Indeed, dermatitis is only mentioned twice in the '785 patent among a laundry list of over eighty diseases/conditions. See '785 patent, paragraphs [0096]-[0184]. Thus, it would not have been obvious to a person of skill in the art to select a patient with dermatitis having the claimed Tscm:Tn ratios and to administer an anti-OX40L antibody or an antigen-binding fragment thereof to reduce the proportion of Tscm cells compared to Tn cells in those patients based on the disclosure of the '785 patent.
It remains the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine the Tscm:Tn ratio of dermatitis subject as taught by the `785 patent and target dermatitis subject having Tscm:Tn ration ≥50:50 with 02D10 anti-OX40L antibody taught by the `653 patent because these Tscm:Tn ratios identify patients in need for anti-OX40L antibody treatment which would result in reducing the proportion of Tscm cells compared to Tn cells in those patients.
The `785 patent explicitly teaches methods of treating or reducing the risk of a Tscm-mediated disease or condition in a subject comprising administering to said subject a therapeutically effective amount of an agent (e.g. an anti-OX40 or an anti-OX40L antibody or fragment thereof) which reduces the proportion of Tscm cells (e.g. which depletes or decreases the level of said Tscm cells), and whereby the proportion of CD45RA+CCR7+CD95+ OX40+ Tscm cells is reduced (e.g. whereby the level of said Tscm cells is decreased or depleted), wherein the Tscm-mediated disease or condition is thereby treated or the risk of said Tscm-mediated disease or condition is reduced, when the ratio of Tscm:Tn cells in the sample is determined in the assay to be greater than 50:50. (col. 40-41, under Concepts 11, 16, 21, 26), wherein the Tscm-dediated disease or condition is autoimmune disease such as dermatitis (see col., 52, under concept 75 and col. 11, line 24). The `653 patent teaches that the autoimmune diseases/conditions include dermatitis (see col., 10-11, bridging ¶). Also, the `653 patent teaches the use of anti-human OX40L (hOX40L) antibodies and fragments and novel medical applications for treating or preventing hOX40L-mediated diseases or conditions in humans (col., 2, lines 55+) including a systemic inflammatory disease (col., 24, lines 25+, col., 13, lines 28+)) such as dermatitis (col., 24, line 27), wherein the antibody is 02D10 (comprising identical SEQ ID NOs: 36/42, 38/44, 40/46, 50/56, AAS/58 , 54/60 and 34/48) (col., 3, lines 8+).
Applicant argues that contrary to the Office's assertion, the claimed Tscm:Tn ratios are not inherent to a patient with dermatitis, and the Office has failed to provide any evidence that the claimed Tscm:Tn ratios are necessarily present in a patient with dermatitis. See Office Action, p. 5. "In relying upon the theory of inherency, the Examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art." See MPEP § 2112 (quoting Ex parte Levy, 17 USPQ2d 1461, 1464 (Bd. Pat. App. & Inter. 1990)) (emphasis in original). The fact that some dermatitis patients may have the claimed Tscm:Tn ratios is not sufficient to establish inherency. See MPEP§ 2112; see also Continental Can Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264, 1269 (Fed. Cir. 1991) (quoting In re Oelrich, 666 F.2d 578, 581 (C.C.P.A. 1981) ("Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.") (emphasis added). Applicant submits that the Office's unsupported statement that the claimed Tscm:Tn ratios are inherent in a patient with dermatitis does not "provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art." MPEP § 2112.
This is not found persuasive because neither the instant specification nor the Applicant present experimental data showing the claimed Tscm:Tn ratios do not always occur in a patient with dermatitis. Applicant fails to show that inherent feature does not always exist in the prior art method.
10. No claim is allowed.
11. 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 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 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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March 18, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644