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 .
Response to Amendment
Applicant’s amendment filed 05/11/2026 is acknowledged. Claim 16 is marked as “Previously Presented”, but is amended so it should be marked as “Currently Amended”. Claims 8, 10 and 16 are amended and claims 11-14 are newly canceled.
Claims 8, 10, 15, 16 and 18-21 are under examination.
Objections/Rejections Withdrawn
Any previous rejections over claims 11-14 are hereby withdrawn in response to Applicant’s cancelation of those claims.
Specification
The objection to the disclosure for informalities is withdrawn in response to Applicant’s amendment to the abstract of the disclosure to remove legal phraseology from the claims.
Claim Objections
The objection to claim 16 for minor informalities is withdrawn in response to Applicant’s amendment amending the claim as suggested to address grammatical errors.
Claim Rejections - 35 USC § 112(b)
The rejection of claim 10 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in response to Applicant’s amendment of the claim to recite “wherein the pharmaceutical composition is selected from the compositions
Claim Rejections - 35 USC § 112(a) – Scope of Enablement
The rejection of claims 8, 15, 16 and 18-21 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for scope of enablement is withdrawn in response to Applicant’s amendment of the claims to limit the treating graft versus host disease (GVHD), skin transplant, kidney transplant, liver transplant, systemic lupus erythematosus (SLE), lupus nephritis, type I diabetes mellitus, inflammatory bowel disease (IBD), Crohn's disease or hemolytic disease of the fetus and newborn comprising administering a pharmaceutical composition, wherein said pharmaceutical composition comprises an anti-CCL24 (eotaxin-2) antibody and a CXCL5 (ENA-78) protein.
Claim Rejections - 35 USC § 102
The following rejections under 35 U.S.C. 102(a)(1) are withdrawn in response to Applicant’s amendment of the claims to require the composition comprise an antibody and an MSC derived protein.
Claims 8, 12, 15 and 16 as being anticipated by George (WO2010/086854—on IDS filed 11/03/2022).
Claims 8, 12, 15 and 16 under 35 U.S.C. 102(a)(1) as being anticipated by Lillard (US Patent 8,541,564).
Claim Rejections - 35 USC § 103
The rejection of claims 8, 12, 15, 16 and 18 under 35 U.S.C. 103 as being unpatentable over George (WO2010/086854—on IDS filed 11/03/2022) is withdrawn in response to Applicant’s amendment of the claims to require the composition comprise an antibody and an MSC derived protein.
New Objection/Rejections
Claim Objections
Claims 19-21 are 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.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. This rejection was necessitated by amendment.
Claims 10 recites various combinations of antibodies and mesenchymal stromal cell-derived proteins. There is insufficient antecedent basis for this limitation in the claims because claim 8, from which claim 10 depends, has been amended to be limited to an antibody targeting CCL24 (Eotaxin-2) and the mesenchymal stromal cell-derived protein, CXCL5 (ENA-78).
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 8, from which claim 10 depends, has been amended to be limited to an antibody targeting CCL24 (Eotaxin-2) and the mesenchymal stromal cell-derived protein, CXCL5 (ENA-78). Claims 10, however, recites various combinations oof antibodies and mesenchymal stromal cell-derived proteins, and therefore, is broader in scope than claim 8. Applicant may cancel the claim, amend the claim to place it in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Rejections Maintained
Claim Rejections - 35 USC § 112(a) – Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 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.
The rejection of claim 10 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph for scope of enablement is maintained. Applicant’s amendment limiting the patient population to graft versus host disease (GVHD), skin transplant, kidney transplant, liver transplant, systemic lupus erythematosus (SLE), lupus nephritis, type I diabetes mellitus, inflammatory bowel disease (IBD), Crohn's disease or hemolytic disease of the fetus and newborn comprising is acknowledged. However, claim 10 still reads upon administering pharmaceutical compositions comprising agents other than an anti-CCL24 (eotaxin-2) antibody and a CXCL5 (ENA-78) protein.
Response to Arguments
Applicant argues at p. 8 of the Remarks filed 05/11/2026 that the amendment limiting claim 8 to pharmaceutical composition comprising anti-CCL24 (eotaxin-2) antibody and a CXCL5 (ENA-78) protein overcomes the rejection.
This argument has been fully considered, but is not found persuasive. Claim 10 still encompasses administering various pharmaceutical compositions comprising agents other than an anti-CCL24 (eotaxin-2) antibody and/or a CXCL5 (ENA-78) protein, and therefore, the issues raised at pages 6-8 of the Office action mailed 03/16/2026 are still relevant.
Claim Rejections - 35 USC § 102
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.
The rejection of claim 10 under 35 U.S.C. 102(a)(1) as being anticipated by George (WO2010/086854—on IDS filed 11/03/2022) is maintained for reasons of record and the following. Claim 10 recites composition C25a, which comprises an anti-CCL24. Note that because claim 10 does not properly limit claim 8, it is treated as an independent claim for the sake of prior art (see rejection above under 35 USC 112(d)).
The rejection of claim 10 under 35 U.S.C. 102(a)(1) as being anticipated by Lillard (US Patent 8,541,564) is maintained for reasons of record and the following. Claim 10 recites composition C27a, which comprises CXCL5. Note that because claim 10 does not properly limit claim 8, it is treated as an independent claim for the sake of prior art (see rejection above under 35 USC 112(d)).
Response to Arguments
Applicant argues at p. 9 of the Remarks filed 05/11/2026 that the amendment limiting claim 8 to pharmaceutical composition comprising anti-CCL24 (eotaxin-2) antibody and a CXCL5 (ENA-78) protein overcomes the rejection.
This argument has been fully considered, but is not found persuasive. As noted above, claim 10 is treated as an independent claim and therefore is anticipated by the prior art of George, which teaches administering an anti-CCL24 to treat type I diabetes mellitus, Crohn’s disease and systemic lupus erythematosus (see p. 4, lines 3-6; p. 13, lines 9-20) and Lillard, which teaches administering a CXCL5 to treat inflammatory bowel disease, systemic lupus erythematosus, Crohn’s disease and rheumatoid arthritis (column 29, lines 55-62 and column 30, line 19). Thus, the prior art still anticipates the limitations of claim 10.
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.
The rejection of claim 10 is maintained for reasons of record and the following. Claim 10 recites composition C27a, which comprises CXCL5. Note that because claim 10 does not properly limit claim 8, it is treated as an independent claim for the sake of prior art (see rejection above under 35 USC 112(d)).
Response to Arguments
Applicant argues at p. 9 of the Remarks filed 05/11/2026 that the amendment limiting claim 8 to pharmaceutical composition comprising anti-CCL24 (eotaxin-2) antibody and a CXCL5 (ENA-78) protein overcomes the rejection.
This argument has been fully considered, but is not found persuasive. As noted above, claim 10 is treated as an independent claim and therefore is rendered obvious by the prior art of George, which teaches administering an anti-CCL24 to treat type I diabetes mellitus, Crohn’s disease and systemic lupus erythematosus (see p. 4, lines 3-6; p. 13, lines 9-20)
Double Patenting
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.
The rejection of claims 8, 10, 15, 16 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,246,910 in view of George (WO2010/086854—cited above) is maintained for reasons of record and the following.
Response to Arguments
Applicant argues at pages 9 and 10 that the instant specification provides evidence of unexpected results because paragraphs [0124]-[0126] teach that in severe GVHD, treatment with the combination of anti-CCL24 and CXCL5 resulted in a synergistic improvement in survival.
This argument has been fully considered, but is not found persuasive. While synergism of effect may be evidence of lack of obviousness, the MPEP 716.02(d) instructs that “‘objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.’ In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)”. The specification passage cited by Applicant also teaches that each of the compositions, anti-CCL24 and CXCL5, when administered alone to treat mild to moderate GVHD, results in comparable effects to administration of the combination of the two compositions. The instant claims are not limited to treatment of severe GVHD, thus the rejection is maintained.
Conclusion
Claims 8, 10, 15, 16 and 18 are rejected. Claims 19-21 are objected to.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 5712720911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675
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