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. Applicant's amendment, filed 08/07/26 is acknowledged.
Claims 1,3,5,7,14,15,28,44,49,53,56,63,65,85-91 are pending.
Claims 1,3,5,7,14,15,28,44,49,53,56,63,65,85-91 read on a method of producing a cell population enriched in NK cells. are under consideration in the instant application.
2. 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.
3. Claims 1,3,5,7,14,15,28,44,49,53,56,63,65,85-91 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20210008109 and US Patent Application 20150225697 in view of US Patent Application 20190330596
US Patent Application’109 teaches a method of producing a population of NK cells from hematopoietic progenitor cells (HPC) comprising a steps wherein a cell population comprising HPC is first incubated in the culture medium comprising FLT3L or TPO and then in the second culture medium comprising IL-7 or SCF or FLT3L ( CD4+/CD8 induction medium as define by instant specification and claims). US Patent Application’109 teaches that the next step in producing NK cells would be incubating in NK induction medium comprising IL-2. US Patent Application’109 also teach that said NK cells can be genetically modified to express CAR cells ( see entire document, paragraphs (0027, 0060, 0061, 0067 and 0068 in particular)
US Patent Application’697 teaches a three -stage method of producing a population of NK cells from hematopoietic progenitor cells (HPC) comprising a steps wherein a cell population comprising HPC is first incubated in the culture medium comprising FLT3L or TPO and then in the second culture medium comprising IL-7, SCF or FLT3L ( CD4+/CD8 induction medium as define by instant specification and claims). US Patent Application’697 teaches that the next step in producing NK cells would be incubating in NK induction medium comprising IL-2. ( see entire document, Abstract, and paragraphs 0007, 0016, 0022-0027 in particular).
US Patent Application’109 and US Patent Application’697 do not explicitly teach the use of p38 inhibitor or SDF-1 inhibitor in CD4/CD8 induction medium.
US Patent Application’596 teaches a method of producing a heterogeneous population of CD4/CD8 cells comprising culturing a population of hematopoietic progenitor cells in a CD4/CD8 induction medium comprising a p38 inhibitor and SDF-1. US Patent Application’596 teaches that said heterogeneous population of CD4/CD8 cells can be used for various purposes including further differentiation into different cells types. ( see entire document Abstract and paragraphs 0018, 0037, 0039).
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 CD4/CD8 induction medium comprising p38 inhibitor and SDF-1 taught by US Patent Application’596 in the method of obtaining NK from hematopoietic progenitor cells taught by US Patent Application’109 and US Patent Application’697 with a reasonable expectation of success because the prior art suggests that CD4/CD8 induction medium comprising a p38 inhibitor and SDF-1 can be used for producing a heterogeneous population of CD4/CD8 cells for various purposes including further differentiation into different cells types.
Claims 7 and 86 is included because said structural properties would be an obvious properties of the recited method because the recited and claimed method of obtaining NK cells would be essentially the same.
See MPEP § 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).” Also, “Products of identical chemical composition can not have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada's polymer latexes for lack of novelty.").”
Claims 53, 56, 87-91 are included because it would be conventional and within the skill of the art to : (i) identify an optimal time of culturing ; (ii) determine the optimum concentration of recited individual compounds in HPC culture media ; CD4/CD8 induction media and NK induction media. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A.
It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious).
From the teachings of the references, it was 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.
4. 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.
5. Claims 1,3,5,7,14,15,28,44,49,53,56,63,65,85-91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No.12/351824.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-16 of U.S. Patent No.12/351824 recited a method of producing a cell population of NK cells from HP cell bulk comprising the same three-steps each comprising the same compounds as instantly claimed.
6. No claim is allowed.
7. 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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