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 .
DETAILED ACTION
1. Claims 1-6 are pending.
Claims 1-6 read on a method of preparing fibroblast are under consideration in the instant application
2. It is noted that during prosecution of the parent case 16/770495, now Patent 11,959,102 Applicant asserted that the data provided in originally filed specification showing the beneficial properties of carbon monoxide in combination with hypoxia was surprising and unexpected. The prior art references teach that carbon monoxide is a toxic gas to fibroblast. None of the prior art references teach that hypoxia can counter the toxic effects of carbon monoxide. Thus, one skilled in the art would not reasonably expect that carbon monoxide could be combined with hypoxia to culture fibroblast, much less that such combination would in fact enhance the therapeutic properties of the fibroblast.
The broadest reasonable interpretation of instantly claim 1 can read on a method of preparing fibroblast by culturing them either in the presence of hypoxia or carbon monoxide.
3. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
4. Claim 1rejected under 35 U.S.C. 102(a1,2) as anticipated by Spitz et al., ( Methods in Molecular Biology, 2010,v.610, pages 183-199, IDS), Bohrn et al., ( Procedia Engineering, 2010, v.5 pages 17- 20 IDS), Pufe et at., ( J of Pathology, 2003, v.200, pages 130-136 and Saed et al., ( Fertility and Sterility, 2002, v.78 pages 137-143 IDS)
Spitz et al., teach a method of culturing fibroblast to a condition comprising oxidative stress. Spitz et al teach that said condition results in increasing heme oxygenase activity and/or expression ( see entire document, Abstract in particular).
Bohrn et at., teach a method of culturing fibroblast, comprising exposing said fibroblast to carbon monoxide ( see entire document, Abstract in particular).
Pufe et at., teach a method of culturing fibroblast, comprising exposing said fibroblast to hypoxia. Pufe et at., teach that said condition might be beneficial for inducing proliferation of fibroblast. ( see entire document, Abstract in particular).
Saet et at., teach a method of culturing fibroblast, comprising exposing said fibroblast to hypoxia. Saet et at teach that said condition can be beneficial for inducing proliferation and inhibiting apoptosis of fibroblast. ( see entire document, Abstract in particular).
The reference teaching anticipates the claimed invention.
5. 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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.131(c). A registered attorney or agent of record may sign a terminal disclaimer.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit https://www.uspto.gov/patent/patents-forms. The filing date of the application will determine what form 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 [ 1 ].
6. Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No.11959102
Although the claims at issue are not identical, they are not patentably distinct from each other because claims claims 1-17 of U.S. Patent No.11959102 recited a method of generating fibroblast comprising a step of exposing fibroblast to hypoxia and carbon monoxide.
12. The claims 1-6 are provisionally rejected on the grounds of nonstatutory double patenting of the claims 1-44 of copending Application No. 18/570530; claims 1-111 of copending Application 18/561979. claims 1-95 of copending Application 18/042323
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims claims 1-44 of copending Application No. 18/570530; claims 1-111 of copending Application 18/561979. claims 1-95 of copending Application 18/042323 each recited a method of augmenting efficacy of fibroblast comprising a step of exposing fibroblast to hypoxia and carbon monoxide.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
7. No claim is allowed.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch can be reached on 571/ 272-8149
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644
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