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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/25/2025 has been entered.
Response to Amendments
Applicant's amendments filed 9/25/2025 to claim 27 have been entered. Claims 1-26 and 29 canceled. Claims 27, 28, and 30-33 remain pending, and are being considered on their merits. References not included with this Office action can be found in a prior action. Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.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 27, 28, and 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (US 2013/0202553; provided in the IDS dated 3/02/2022) in view of Garcia-Bosch et al. (Aliment Pharmacol Ther 2010; 32: 939–952) and Thin et al. (Inflamm Bowel Dis 2013;19:1490–1498)
Zheng teaches methods of mobilizing stem cells in a subject in-preparation for downstream stem cell transplantation, the method comprising administering an effective dosage of AMD3100 (Example 3 or 9; [0383]-[0385] for dosages), reading in-part on claim 27 and inherently reading on the functional property of claim 28, and reading in-part on claims 30 and 31. Zheng teaches that the dosing regimen would be expected to vary according to the dosage form, mode of administration, the condition being treated and particulars of the patient being treated. ([0383]), reading in-part on claims 30 and 31. Zheng teaches intravenous or subcutaneous administration ([0038]), reading on those embodiments of claim 32 and on claim 33.
Regarding claim 27, Zheng does not teach treating inflammatory bowel disease. Regarding claim 27, Zheng does not teach administering an effective dosage of 0.005 mg/kg of Tacrolimus.
Garcia-Bosch teaches that it was known to persons of ordinary skill in the art to treating inflammatory bowel disease by administering stem cells (Abstract).
Thin teaches methods of administering Tacrolimus to treat inflammatory bowel disease at a dosage of 0.1 mg/kg per day (Abstract), reading on claim 27. Thin teaches that inflammatory bowel diseases are lifelong conditions. (paragraph starting “The inflammatory bowel diseases…” on p1490), reading in-part on claim 27.
Regarding claim 27, it would have been obvious to a person of ordinary skill in the art before the invention was filed to add the Tacrolimus of Thin to the methods of Zheng in view of Garcia-Bosch. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Garcia-Bosch conceptually bridges the stem cell therapy methods of Zheng with the methods of treating inflammatory bowel syndrome of Thin, and because Thin teaches an effective dosage of Tacrolimus such as to treat symptoms of inflammatory bowel syndrome in subjects. The skilled artisan would have been motivated to do so because combining separate steps taught as useful in a method into a singular method must be held as prima facie obvious, as each step is taught separately useful for the same purpose. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980); in this case, the stem cell transplantation method of Zheng in view of Garcia-Bosch and the Tacrolimus administration methods of Thin are taught as useful for the same purpose of treating inflammatory bowel disease in subjects and so their combination must be held prima facie obvious absent a showing of nonobviousness to the contrary.
Regarding the dosage range of claim 27 and the timing of dosages of claims 30 and 31, 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, Thin teaches a known dose of Tacrolimus which is results-effective to treat inflammatory bowel disease and Zheng teaches that the dosing regimen would be expected to vary according to the dosage form, mode of administration, the condition being treated and particulars of the patient being treated and so any timing of dosages must be held as prima facie obvious over the routine optimization of Thin and Zheng absent any showing to the contrary.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
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.
Claim 27 and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. US 10,420,751.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘751 patent is the narrower embodiment of instant claims 27 and 28, thus “anticipating” those claims with respect to double patenting.
Claim 27 and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4 of U.S. Patent No. US 11,291,657.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘657 patent is the narrower embodiment of instant claims 27 and 28, thus “anticipating” those claims with respect to double patenting.
Claim 27 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, and 6 of copending Application No. 18/768,644 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because while the copending ‘644 Application does not teach every element of instant claim 27 in a single claim, combining separate steps or elements taught as useful in a method into a singular method must be held as prima facie obvious, as each step is taught separately useful for the same purpose. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments on pages 3-4 of the reply have been fully considered, but not found persuasive of error for the reasons given below. This is not found persuasive of error and directly contradicted by the factual teachings of Thin as cited above. Absent any showing of criticality of the dosage range to the contrary, that the prior teaches away in any material respect, or a showing that the claimed dosage is disclosed in a very broad range in the prior art, said dosage must be held prima facie obvious, see M.P.E.P. § 2144.05 (III).
Applicants arguments on page 4 of the reply have been fully considered, but the double patenting rejections will not be held in abeyance. The guidance given in M.P.E.P. § 804 subsection I, A & B, is clear that double patenting rejections should continue to be made by the examiner in the instant application as long as there are conflicting claims with an issued patent, unless the double patenting rejections are the only rejections remaining of record. Applicant may overcome the nonstatutory double patenting rejection in one of three ways: 1) Amending the claims in question so the claimed invention in the instant application and the conflicting patent are no long obvious variants of each other as set forth above, 2) file a terminal disclaimer, or 3) persuasively argue why the instantly claimed invention is not obvious over the issued patent.
Conclusion
No claims are allowed. No claims are free of the art.
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).
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/Sean C. Barron/Primary Examiner, Art Unit 1653