DETAILED ACTION
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 .
Priority
Acknowledgement is made of Applicants’ claim for benefit under 35 USC 120 as a continuation of prior-filed US application No. 15/998529 (filed 8/16/2018, now USP 11583557), which claims benefit under 35 USC 120 as a continuation of prior-filed US application No 14/912066 (now USP 10058572), which is a national stage entry of PCT/US14/051155, filed 8/14/2014), which claims benefit of prior-filed US Provisional applications 61/982804 (filed 4/22/2014) and 61/866524 (filed 8/15/2013).
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.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 16-20 of U.S. Patent No. 11583557.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate and/or render obvious the instant claims as follows:
Regarding claim 1: Patented claim 1 is directed to a method of treating, inter alia, myelomeningocele (MMC) in a subject in need thereof. The steps of patented claim 1 are identical to the steps of the current claim. MMC is a form of spina bifida. As such, patented claim 1 anticipates instant claim 1.
Regarding claims 3-16: Patented claims 2-10 and 16-20 teach the limitations of claims 3-16, respectively.
Regarding claim 2: The patented claims do not specify treatment of a human, however application of a therapeutic method to a human would have been prima facie obvious. There is implicit motivation to treat human diseases.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 16-20 of U.S. Patent No. 11583557.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate and/or render obvious the instant claims as follows:
Regarding claims 1, 5-11: Patented claim 1 teaches treatment of spina bifida in a subject in need thereof, comprising administering to the subject an effective amount of isolated pre-term placenta-derived multipotent stem cell or cells (PMSCs) or a conditioned culture media therefrom. Patented claim 2 teaches the PMSCs comprise C-mpSCs.
The patented claims are broader than the instant claims, as the patented claims recite administration of an isolated population of pre-term PMSCs that comprise C-mpSCs, whereas the instant claims require administration of an isolated population of pre-term C-mpSCs. However, given that the patented claims identify the C-mpSCs as the active cell type (i.e. in claim 2), it would have been prima facie obvious to have delivered an isolated population of pre-term C-mpSCs.
The properties of the C-mpSCs (recited in current claims 1, 5-11) are inherent to C-mpSCs.
Regarding claim 2: The patented claims do not specify treatment of a human, however application of a therapeutic method to a human would have been prima facie obvious. There is implicit motivation to treat human diseases.
Regarding claim 3: Patented claim 3 teaches the cells are administered in a pharmaceutically acceptable carrier or a biocompatible matrix.
Regarding claim 4: Patented claim 4 teaches the cells are administered to a fetus in utero.
Regarding claim 12: The patented claims differ from current claim 12 in that they do not specify the age of the PMSCs or C-mpSCs beyond ‘pre-term’. However, the current claim limitation is considered an obvious variant of the patented claims. Specifically, it is noted that the patent specification exemplifies isolation of pre-term C-mpSCs from 10-14 week and 17 week gestational age placentas (See Experiment 1 and Experiment 3); thus the patent claims cover within their scope pre-term C-mpSCs isolated during the first and second trimester of pregnancy. Those portions of a patent specification which provide support for the reference claims can be considered to determine whether an application defines an obvious variation of an invention claimed in a reference patent (See MPEP 804(II)(B)(2)(a)). As the patent claims cover within their scope use of pre-term PMSCs isolated from 10-14 and 17 week gestational age placentas, instant claim 12 is considered an obvious variant of the patented claim.
Regarding claims 13-16: The patent claims differ from instant claims 13-16 in that they do not specify the manner by which the pre-term PMSCs are isolated. However the current claims are considered obvious variants of the patented claims. There is evidence in the specification that C-mpSCs obtained via explant culture (as in current claims 13 and 15-16) and enzymatic digestion (current claim 14) have different phenotypes, however the patent claim covers both types of cells. The patent specification exemplifies isolation of C-mpSCs using both explant culture and enzymatic digestion (See Experiment 1) for use in their therapeutic methods. As the patent claims cover within the scope pre-term C-mpSCs isolated via ether of the explant or enzymatic digestion method, both of instant claims 13-16 are considered obvious variants of the patented claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON M FOX whose telephone number is (571)272-2936. The examiner can normally be reached M-F 10-6 EST.
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, Christopher Babic can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALLISON M FOX/Primary Examiner, Art Unit 1633
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