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 .
RESPONSE TO APPLICANT’S AMENDMENT
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/23/26 has been hereby entered.
2 Claim 13 is pending.
Claims 13 read on a composition comprising NK cells isolated from peripheral blood and expanded I vitro are under consideration in the instant application.
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 13 is rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by US Patent Application 20180015123 , US Patent 11066643 and newly cited Prakash et al ( Blood, 2004, 104, 11, Abstract).
Applicant arguments filed on 08/08/25 have been fully considered but have not been found convincing.
Applicant asserts that : (i) US Patent Application’123 disclosed NK phenotype lacking expression of CD16 ( Fig.2c of USPatent Application ‘123); (ii) US Patent’643 used a method of obtaining NK that is different from the instantly claimed.
With regards to Applicatin statement that US Patent Application’123 disclosed NK phenotype lacking expression of CD16 ( Fig.2c of US Patent Application ‘123).
The Examiner disagrees with Applicant interpretation of the whole teaching of US Patent Application’123.
In particular, US Patent Application’123 explicitly stated that expression of CD13 is a characteristic phenotype of NK cells that is used for identification of said cells ( emphases added, see paragraph 0004 in particular). The data on Fig. 2c compare the phenotypes of fresh and cryopreserved NK cells. US Patent Application’123 explicitly stated the phenotypes and characteristics of these two types of NK cells are essentially the same ( emphases added, see paragraph 0217).
With regards to Applicants statement that US Patent’643 used a method of obtaining NK that is different from the instantly claimed.
It is noted that the instant claims are drawn to the product, i.e. NK cells, and the patentability of the product does not depend on its method of production. In re Thrope,227 USPQ 964,966 (Fed. Cir. 1985). See MPEP 2113.
Applicant provided no evidence that the instantly claimed and recited NK cells are structurally/functionally different.
Newly cited Prakash et al., teaches NK cells that were isolated from peripheral blood, expanded in vitro , cryopreserved and thawing. Prakash et al., teach teaches that said NK cells are CD16+ NK cells that can be used for various purposes including intravenously infusion ( see entire document).
As has been stated previously, US Patent Application ‘123 teaches NK cells that were isolated from peripheral blood, expanded in vitro , cryopreserved and thawing. US Patent Application ‘123 teaches that said NK cells are CD3-CD56+ NK cells that can be used for various purposes including intravenously infusion ( see entire document, Abstract and 0007, 0015, , 0090, 0108 , 0109 paragraphs).
US Patent ‘643 teaches NK cells that were isolated from peripheral blood, expanded in vitro , cryopreserved and thawing. US Patent ‘643 teaches that said NK cells can be used for various purposes including intravenously infusion ( see entire document, Abstract and claims in particular).
US Patent Application 20180015123 , US Patent’ 643 and Prakash et al., do not explicitly teach reducing blood plasma level of inflammatory cytokines, said functional properties would be an inherent properties of referenced NK cells, because the prior art references and the instant Application recited the same NK cells. It does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories 58 USPQ2d 1508 (CAFC 2001). “{i}t is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable”. In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). The mechanism of action does not have a bearing on the patentability of the invention if the invention was already known or obvious.
Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145.
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. 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.
6. Claim 13 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,066643. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-8 of U.S. Patent No. 11066643 recited an isolated population of NK cells that was thawed following cryopreservation and expanded in vitro.
It is noted that Applicant requested to hold that provisional double patenting rejection in abeyance until allowable subject matter is identified.
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, Daniel Kolker can be reached on 571/ 272-3181
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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