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
Claims 1-16 are pending.
2. Applicant’s election without traverse of Group II, claims 13-13 in the reply filed on 05/15/26 is acknowledged.
3. Claims 1-12 are withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 13-16 read on a method for treating heterotopic ossification caused by a tendon or ligament disease are under consideration in the instant application.
4. Applicant’s provision of the foreign priority document KR 10-2020-0140504 is acknowledged. However, an English translation has not been provided in accordance with 37 CFR 1.55. See MPEP § 201.15.
5. 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.
6. Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20230330179 and Ji-Hye Yae. Et al, ( Acta Biomateria, 2020, v.114,pages 104-116, IDS) in view of 7745391
US Patent Application ‘179 teaches a method of treating tendon or ligament disease in a subject, comprising administering to the subject umbilical cord-derived mesenchymal stem cells. US Patent Application ‘179 teaches that said umbilical cord-derived mesenchymal stem cells can express zinc finger protein ZKscan8 (( see entire document, paragraphs 0019, 0028, 0029, 0040,0041 in particular )
Ji-Hye Yae et al ., teach a method of treating tendon or ligament disease in a subject, comprising administering to the subject umbilical cord-derived mesenchymal stem cells ( see entire document,abstract and discussion in particular).
Though US Patent Application ‘179 and Ji-Hye Yae et al., do not explicitly teach treating a heterotopic ossification caused by a tendon or ligament disease, it would be immediately obviouse to one skill in the art that the same treatment that can treat tendon and ligament disease in a subject would treat heterotopic ossification caused by a tendon or ligament disease.
US Patent Application ‘179 does not explicitly teach Zkscan8 comprising amino acid sequence of SEQ ID N:2.
US Patent’ 391 teaches a zinc finger protein comprising SEQ ID NO:830185 that is 100% identical to the instantly claim SEQ ID N:2. US Patent’ 391 teaches a zinc finger protein can be used to transduced stem cells ( see entire document, sequence alignment, attached)
All the claimed elements were known in the prior art and one skill in the art could have combine the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to use zinc finger protein taught by US Patent’391 in a method of treating taught by US Patent Application ‘179 with a reasonable expectation of success because the prior art suggests that zinc finger protein can be used to transduced mesenchymal stem cells).
From the combined teaching of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
7. 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 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. 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 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 https://www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
8. The claim 13-16 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application No. 18017884. Although the claims at issue are not identical, they are not patentably distinct from each other because claims of copending Application No. 18017884 recited a method of treating inflammatory disease in a subject comprising administering to the subject umbilical cord-derived mesenchymal stem cell expressing Zkscan8 comprisng SEQ ID N:2.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
9. No claim is allowed.
10. 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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