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 7/06/2026 to claims 1, 3, 8, 9, 11, and 13 have been entered. Claims 5, 6, 10, 12, and 14-17 are canceled. Claims 1-4, 7-9, 11, and 13 remain pending and are being considered on their merits. No claims are withdrawn from consideration at this time. 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. § 112(b), 102, and 103 rejections of record. New grounds of rejection are set forth below necessitated by the claim amendments.
Any other rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
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.
Claims 1-4, 7-9, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (STEM CELLS 2017;35:248–255; Reference U) in view of Eichenfield et al. (J Am Acad Dermatol 2014;71:116-32; Reference V).
Kim teaches methods of treating atopic dermatitis with a composition comprising a single dose of human umbilical cord blood-derived mesenchymal stem cells administered subcutaneously (hUCB-MSCs) (Abstract; page 249, subheading “Study Design and Oversight” and “Participants”; Figure 2 and subheading “Response to Treatment” on pages 250-251), reading in-part on the embodiment of atopic dermatitis for claims 1, 7, and 8, the embodiment of human umbilical cord blood-derived mesenchymal stem cells for claim 1 and reading on claim 4, the embodiment of a single dose of stem cells for claims 1 and 11, and implying an aqueous formulation and so reading on the embodiment of water as a carrier for claim 13.
Regarding claim 1, 9 and 11, Kim does not teach any species of calcineurin inhibitor and any particular treatment schedule. Regarding claim 2, Kim does not teach tacrolimus or pimecrolimus. Regarding claim 3, Kim does not teach pimecrolimus.
Eichenfield reviews the prior art at that time for the treatment of atopic dermatitis (Abstract). Eichenfield teaches that topical formulations of calcineurin inhibitors are effective to treat atopic dermatitis, as 0.03% or 0.1% tacrolimus ointment or 1% pimecrolimus cream (page 124, subheading “Efficacy”), reading on the embodiment of tacrolimus and pimecrolimus for claims 1-4. Eichenfield teaches that a twice daily application of tacrolimus ointment and pimecrolimus cream are significantly more effective at decreasing signs of inflammation, affected body surface area, and associated pruritus of lesional areas on the head/neck and non-head/neck locations than vehicle or once-daily application (page 125, subheading “Frequency of Application”), reading on claims 1, 9, and 11.
Regarding the embodiment of tacrolimus and pimecrolimus for claims 1-3, claim 4, and the embodiment of twice-daily dosages of the calcineurin inhibitor for claims 1, 9, and 11, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further treat the subjects suffering from atopic dermatitis of Kim with the topically formulated tacrolimus or pimecrolimus of Eichenfield A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Eichenfield and Kim are directed towards treating subjects suffering from atopic dermatitis. The skilled artisan would have been motivated to do so because Eichenfield teaches that the addition would be predictably advantageous to treat atopic dermatitis by decreasing signs of inflammation, affected body surface area, and associated pruritus of lesional areas on the head/neck and non-head/neck locations in the subjects.
Regarding the order of treatment schedule of claims 1, 9, and 11, optimization within prior art conditions or through routine experimentation will generally not support patentability absent a showing of criticality of the claimed range to the contrary. See M.P.E.P. § 2144.05, particularly subsections II and III. In this case, Kim and Eichenfield respectively teach that a single dose of human umbilical cord blood-derived mesenchymal stem cells and twice-daily topical dosages of either tacrolimus or pimecrolimus are effective to treat symptoms of atopic dermatitis in human subjects/patients. Thus, the burden is shifted back to establish criticality of the claimed order of treatment schedule by objective evidence.
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 5-10 of the reply have been fully considered, but not found persuasive of error. Applicant’s arguments are moot because the new grounds of rejection, necessitated by the instant claim amendments, do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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