DETAILED ACTION
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 Amendments
Applicant's amendments filed 2/12/2026 to claims 1, 4, 6, 7, and 10 have been entered. Claim 9 is canceled. Claims 1-8 and 10 remain pending, of which claims 1-5 and 10 are being considered on their merits. Claims 6-8 remain withdrawn from consideration. References not included with this Office action can be found in a prior action.
The instant amendments to claim 1 have overcome the 35 U.S.C. § 103 rejections of record over Anantharamaiah as the primary reference, which are withdrawn.
Any other rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
Claim Objections
Claims 6-8 are objected to because of the following informalities: these claims recite an incorrect status identifier and so are non-compliant under 37 C.F.R. § 1.121. These claims are withdrawn from consideration, and should also recite the “Withdrawn” identifier in addition to any other identifier reflective of claim amendments. Appropriate correction is required with the next reply.
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.
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.
Claims 1, 3, 4, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Valtueňa et al. (US 2011/0293557).
This rejection addresses both the broader embodiment of an HDL and the narrower embodiment of an HDL mimetic made/reconstituted from murine ApoA1 for claim 1.
Valtueňa teaches administering HDL containing Apo linker P144 fused to murine Apolipoprotein A1 or HDL containing Apo linker P144 fused to murine Apolipoprotein A1 formulated with HDL to subjects (¶0038; i.e. peptide p144 being a TGF β1 inhibitor, see ¶0134, being fused to the murine apolipoprotein A1, i.e., mApoA1, signal peptide, see ¶0167 and ¶0170-0171; claims 28, 43, and 45), reading in-part on claim 1. Valtueňa envisions treating graft versus host disease (¶0113 and ¶0117), reading in-part on claim 1. Valtueňa teaches it is preferred for the therapist to titer the dosage and modify the route of administration as required to obtain the optimal therapeutic effect and that a typical effective dosage is about 0.01 mg/kg to up to 250 mg/kg or more, daily, every 2 days, every 3 days, every 4 days, every 5 days, every 6 days or weekly (¶0138), reading in-part on the effective dosage of claim 1 and on claim 10. Valtueňa teaches intravenous administration (¶0104), reading on claim 3. Valtueňa teaches one or two or more doses administered (¶0109), reading on the repeated dose of claim 4.
Regarding claim 1, it would have been obvious to a person of ordinary skill in the art before the invention was filed to combine the HDL and/or HDL mimetic and the effective dosage taught by Valtueňa into a single embodiment to treat graft versus host disease as envisioned by Valtueňa. A person of ordinary skill in the art would have had a reasonable expectation of success to do so and the skilled artisan would have been motivated to do so because Valtueňa expressly considers the combination, which would then be advantageous to treat graft versus host disease in subjects in need of treatment thereof.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Valtueňa as applied to claim 1 above, and further in view of Anantharamaiah et al. (US 8,557,767) and Badimon et al. (J Clin Invest (1990), 85(4), 1234-1241).
The teachings of Valtueňa are relied upon as set forth above.
Regarding claim 2, Valtueňa does not teach HDL obtained from the blood of a healthy donor.
Badimon teaches administering HDL from healthy (i.e. normal) mammalian subjects reduces atherosclerotic lesions (Abstract; lipoprotein isolation at p1234, subheading “Preparation and isolation of lipoproteins”), reading in-part on claim 2.
Anantharamaiah teaches Apolipoprotein E mimicking peptides (i.e. HDL mimetic) to treat GVHD and atherosclerosis (Col. 58, lines 54-66), reading in-part on claim 2.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the HDL source of Valtueňa with the HDL from healthy (i.e. normal) mammalian subjects in view of Badimon and Anantharamaiah. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Badimon teaches detailed methods of isolating HDL from normal/healthy subjects The skilled artisan would have been motivated to do so because Badimon teaches administering HDL from healthy (i.e. normal) mammalian subjects reduces atherosclerotic lesions and because Anantharamaiah envisions treating both GVHD and Anantharamaiah, thus bridging the teachings of Badimon to the teachings of Valtueňa. The substitution would be particularly advantageous to treat the GVHD subjects of Valtueňa who are further comorbid for atherosclerosis.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Valtueňa as applied to claim 1 above, and further in view of Garnett et al. (Ther Adv Hematol (2013), 4(6), 366-378).
The teachings of Valtueňa are relied upon as set forth above.
Regarding claim 5, Valtueňa does not teach acute graft versus host disease
Garnett reviews the state of the art at that time for treating acute and chronic graft versus host disease (Abstract). Garnett teaches that historically, acute graft versus host disease (aGVHD) was defined as symptoms occurring within 100 days of allogeneic haematopoetic stem cell transplant recipients (1st paragraph of the Introduction on p366). Garnett teaches that grade I a GVHD may respond to topical steroid therapy whereas systemic corticosteroids are the mainstay of first-line treatment of grade II-IV aGVHD (p367, right column, 1st two paragraphs under “First-line management of acute graft-versus-host disease), reading on claim 5. Garnett teaches a starting dosage of prednisolone or methylprednisolone of 1-2 mg/kg/day depending on GVHD severity (paragraph spanning p367-368), reading on claim 5. Garnett teaches that steroids have many well documented side effects, including immunosuppression, hyperglycaemia and osteopenia, meaning that a balance must be drawn between benefit and risk of prolonged courses (paragraph spanning p368-369), reading on claim 5.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to further treat for acute GVHD in the subjects of Valtueňa in view of Garnett. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Valtueňa envisions treating graft versus host disease with HDL, and because Garnett teaches that the disease is known to have an acute phase and a chronic phase. The skilled artisan would have been motivated to do so because Garnett teaches that while steroids are a known first-line treatment for GVHD, steroids have many well documented side effects, including immunosuppression, hyperglycaemia and osteopenia thus making Valtueňa’s methods of treating GVHD advantageous to avoid the known side effects of prolonged steroid treatment for acute GVHD as taught by Garnett.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Response to Arguments
Applicant's arguments on pages 4-8 of the reply have been fully considered, but not found persuasive of error for the reasons given below.
On pages 6-7 of the reply, Applicant alleges that does not teach every element of at least independent claim 1. This not found persuasive of error because Valtueňa sets forth a prima facie case for obviousness by expressly contemplating that their conjugates (e.g. HDL containing Apo linker P144 fused to murine Apolipoprotein A1 or HDL containing Apo linker P144 fused to murine Apolipoprotein A1 formulated with HDL to subjects) to subjects for the treatment of graft-versus-host disease at ¶0113 and 0117 as cited above and so reasonably teaches administering HDL and/or their HDL mimetic for the treatment of graft-versus-host disease absent any showing of nonobviousness to the contrary. The fact that the inventor (may have) recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Conclusion
No claims are allowed. No claims are free of the art.
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 SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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, Sharmila Landau can be reached at 571-272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Sean C. Barron/Primary Examiner, Art Unit 1653
Prosecution Insights