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. Applicants amendment filed 08/04/25 is acknowledged.
1.Claims 7,8,10-20 are pending.
Claims 7,8, 10-20 read on a comprising population of CIK NKT cells and a cell culture mixture comprising said cells and IL-7,ALT-803, FLT3 and Gal-Cer 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 7, 8, 10-20 stand rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20130059379, US Patent Application 20170029777,US Patent Application 20200199532, US Patent Application 20080254037 for the same reasons set forth in the previous Office Action, mailed on 05/16/25.
Applicant’s arguments filed on 08/04/25 have been fully considered but have not been found convincing.
Applicant asserts that : (i) the none of the cited references teach or suggest the very specific combination of IL-7,ALT-803, FLT3 and Gal-Cer in the culture medium. One skilled in the art could not have simply select this exact combination without prior knowledge of the Applicant’s disclosure. ; (ii) none of the prior art references teach or suggest the claimed feature of the claimed CIK NKT cells, i.e. expressing express CD56 and CD3 and less than 10% of which express Va24 .
As initial matter it is noted that it has been recently stated that KSR forecloses the argument that a specific teaching, suggestion, or motivation are required to support a finding of obviousness See Board decision ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
All the prior art references teach that the use of IL-7,ALT-803, FLT3 and Gal-Cer in the culture medium for CIK NKT was well know and routinely used. Thus it is the Examiner’s position that it would be conventional and within the skill of the art to determine the optimum combination of well known and routinely used compounds for culturing CIK NKT. 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).
With regards to Applicant statement that “none of the prior art references teach or suggest the claimed feature of the claimed CIK NKT cells, i.e. expressing express CD56 and CD3 and less than 10% of which express Va24”
As has been stated in the previous Office Action, it is the Examiner’s position that said structural properties would be would be an inherent/obvious properties of the referenced cells since the referenced cells would be obtained by the same method as instantly claimed. 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.
It is noted that Applicant provided no evidences, data or Declaration that the recited CIK NKT obtained by similar method of culturing are structurally/functionally different from the instantly claimed.
As has been stated previously, US Patent Application’ 379 teaches a population of CIK NKT cells wherein said cells were isolated from mononuclear cells and cultured in the culture medium comprising IL-7, IL-15 and FLT3 ligand. US Patent Application’ 379 teaches that IL-7 is present in a concentration from about 4 to 400 ng/ml, and FLT ligand at concentration of about 4 to 400 ng/ml. US Patent Application’379 teaches that CIK NKT were expanded in the presence of anti-CD3 and IL-2 ( see entire document, paragraphs 001,007, 0012, 0014 and 0018, 0065, and claims in particular)
US Patent Application’ 777 teaches a population of CIK NKT cells wherein said cells were isolated from mononuclear cells and cultured in the culture medium comprising IL-7, IL-15, a-Gal-Cer and FLT3 ligand. US Patent Application’ 379 teaches that IL-7 is present in a concentration from about 4 to 400 ng/ml, and FLT ligand at concentration of about 4 to 400 ng/ml. US Patent Application’379 teaches that CIK NKT are expanded in the presence of anti-CD3 and IL-2 ( see entire document, paragraphs 0025, 0033, 0047, 0057,0077, 0080 in particular)
US Patent Application ‘532 teaches a population of CIK NKT cells wherein said cells were expanded in the culture medium comprising ALT-803, IL-15, IL-2 and IL-15. US Patent Application ‘532 teaches that ALT-803 is present at concentration of 100 ng/ml(see entire document, paragraphs 0016, 0019, 0045, 0123, 0157)
US Patent Application ‘037 teaches a population of CIK NKT cells wherein said cells were expanded in the culture medium comprising in the culture medium comprising a-Gal-Cer, anti-CD3 and anti-CD28 antibody (see entire document, paragraphs 0079 in particular)
US Patent Application ‘857 teaches a population of CIK NKT cells wherein said cells were expanded in the culture medium comprising a-Gal-Cer, (see entire document, paragraphs 0021, 0176, 0181, in particular).
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 obvious to one of the ordinary skill in the art at the time the invention was made to obtain CIK NKT cells by incubation mononuclear cells in the culture medium comprising IL-7,ALT-803,IL-15, FLT3 ligand Gal-Cer with a reasonable expectation of success because the prior art suggests combination of all of said compound was used for successful culturing, expanding and generation of CIK NKT.
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. . . [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06).
It is noted that thought the prior art references do not explicitly teaches that in obtained CIK NKT cells greater than 90% of cells express CD56 and CD3 and less than 10% of which express Va24, said structural characteristics would be an inherent properties of the referenced cells since the referenced cells were obtained by the same method as instantly claimed. 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.
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.").”
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 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 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/process/file/efs/guidance/eTD-info-I.jsp.
5. Claims 7, 8, 10-20 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-24 of U.S. Patent No.11,351,196. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 16-24 of U.S. Patent No.11,351,196 recite a population of CIK NTK and a composition comprising said cells and IL-7, ALT-803, IL-15, FLT ligand and Gal-Cer.
6. The claims 7, 8, 10-20 stand provisionally rejected on the grounds of nonstatutory double patenting of the claims 1-21 of co-pending application US 20210205367
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims 10-27 of copending Application No17/151,085; and claims 10-22 of copending Application 17/260,544 each recite a method of obtaining CIK NTK comprising contacting isolated mononuclear cells with IL-7, ALT-803, IL-15,FLT ligand and Gal-Cer.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
It is noted that Applicant requested that said rejection be held in abeyance until the allowable claims are found.
The following new ground of rejection is necessitated by the amendment filed on 08/04/25.
7. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
8. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
9. Claim 7 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor.
In claim 7 it is improper to recite “wherein greater than 50% of the CIK NKT ….” There is insufficient antecedent basis for this limitation in the claim since claim 7 is drawn to a kit comprising IL-7, ALT-803 or IL-15 FLT3 and Gal-Cer, not CIK NKT .
10. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609(B)(2)(i). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
11. No claims is allowed.
12. 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