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. Applicant’s amendment filed on 02/19/26 is acknowledged.
2. Claims 1-9, 11,12, 15-26 are pending.
3. Claims 1-8 and 16-25 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 9, 11, 12, 15 and 26 are drawn to a method for producing and expanding CD34+CD7+CD41a- lymphoid progenitor cells are under consideration in the instant application.
4. 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.
5. Claims 9, 11,12, 15, 26 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20130011376, US Patent Application 20180155688 and US Patent Application 20200323923 US Patent Application 20140286955 , US Patent Application 20230193200 , in view of US Patent Application 20220017873 and US Patent Application 20220090009 for the same reasons set forth in the previous Office Action, mailed on 08/19/25.
Applicant’s arguments filed on 02/19/26 have been fully considered but have not been found convincing.
Applicant asserts that none of the prior art references recognized the superior degree to which inclusion of UM171 amplifies the expansion/increase in the number of lymphoid progenitor cells.
Contrary to Applicants assertion, the issue raised in the previous Office Action was not about superior degree to which inclusion of UM171 amplifies the expansion/increase in the number of lymphoid progenitor cells but rather it would be obvious to one skill in the art to add UM171 to the culture medium comprising CD34+ hematopoietic progenitor cells.
As acknowledged to Applicant , the prior art teaches the inclusion of UM171 in the culture medium results in expanding and increasing the number of lymphoid progenitor cells ( see Applicant’s response filed on -2/19/26 pages 9 in particular).
It is the Examiner’s position that it would be obvious and within the skill in the art to add UM171 in the culture medium for expansion culture medium in the plates coated with DLL4-Fc with a reasonable expectation of success because the prior art suggests that said compounds and plates can be used for culturing and expanding CD34+ hematopoietic progenitor cells.
Moreover, it is notice that the instant claims do not even recited the “the superior degree to which inclusion of UM171 amplifies the expansion/increase in the number of lymphoid progenitor cells” and Applicant provided no evidences or declaration of why it would not be obvious to one skilled in the art to add to the culture medium for expansion/increase in the number of lymphoid progenitor cells.
As has been stated previously, US Patent Application ‘376 teaches a method of culturing CD34+ hematopoietic progenitor cells in the expansion differentiation medium comprising IL-7, FLT-3 and SCF ( see entire document, paragraphs 0011, 0063, 0126 in particular.
US Patent Application ‘688 teaches a method of culturing CD34+ hematopoietic progenitor cells in the expansion differentiation medium comprising Notch ligand DLL-4, SCF and Flt-3 ( see entire document, abstract and paragraphs 0051, 0052 0102, and claims in particular.)
US Patent Application ‘923 teaches a method of culturing CD34+ hematopoietic progenitor cells in the expansion differentiation medium comprising SCF, Flt-3 ,Notch ligand and pyrimidol indole derivative UM 171. US Patent Application ‘923 teaches that the presence of UM171 in the culture medium expand and increase the number of CD34+CD43+ lymphoid progenitor cells ( see entire document, paragraphs 0105, 0106, 0375 and 0376 in particular.)
US Patent Application’200 teaches a method of culturing and expanding CD34+ hematopoietic progenitor cells in the culture medium comprising IL-7, FLT-3, SCF, NOTCH ligands DLL4 or DLL1 ( see entire document, paragraphs 0078, 0157,0085, 0245, 0378 in particular).
US Patent Application’955 teaches the advantage of culturing and expansion CD34+ progenitor cells in the culture plates coated with DLL4-Fc ( see entire document, paragraph 0116, 0158)
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 ordinary skill in the art before the effective filing date of the claimed invention to add Notch ligand DLL4 and/or DLL1 and UM171 to the expansion culture medium in the plates coated with DLL4-Fc with a reasonable expectation of success because the prior art suggests that said compounds and plates can be used for culturing and expanding CD34+ hematopoietic progenitor cells
“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).
Although US Patent Application 20130011376, US Patent Application 20180155688 and US Patent Application 20200323923 , US Patent Application 20140286955 , US Patent Application 20230193200 do not explicitly teach that culturing and expanding CD34+ hematopoietic progenitor cells in expansion differentiation medium comprising SCF, Flt-3 ,Notch ligand , UM 171 and IL-7 will result in producing and expanding CD34+CD7+CD41a lymphoid progenitor 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. Thus it is clear that both the prior art and applicant use same expansion medium to achieve the same results. When the prior art method is the same as a method described in the specification, it can be assumed the method will obviously perform the claimed process absent a showing of unobvious property. 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.
US Patent Application 20130011376, US Patent Application 20180155688 and US Patent Application 20200323923 do not explicitly teach culturing hematopoietic progenitor cells under xenogeny-free and serum albumin-free conditions.
US Patent Application’009 teaches a method of culturing and expanded pluripotent stem cells in chemically defined expansion medium under xenogeny-free condition ( see entire document, Abstract and paragraph 0004, 0019 in particular)
US Patent Application’873 teaches a method of culturing and expanded pluripotent stem cells in chemically defined expansion medium under serum albumin-free condition ( see entire document, 0026, 0027, 0033, 0050 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 to one of ordinary skill in the art before the effective filing date of the claimed invention to use chemically defined expansion medium under xenogeny-free and serum-free condition in a method of producing CD34+CD7+CD41- cells taught by US Patent Application 20130011376, US Patent Application 20180155688 and US Patent Application 20200323923 with a reasonable expectation of success because the prior art suggests that said condition can be used for useful and beneficial for expanding progenitor cells.
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.
6. 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.
7. The claims 9, 11-13, 15, 26 are provisionally rejected on the grounds of nonstatutory double patenting of the claim of copending Application No. US 20240191189 A1 in view of US Patent Application 20220017873 and US Patent Application 20220090009.
Claims of copending Application No. US 20240191189 A1 recited a method of producing CD34+ lymphoid progenitor cells, comprising culturing CD34+ hematopoietic progenitor cells in the culture medium comprising Notch ligand, IL-7, FLT-3 and SCF.
US Patent Application’009 teaches a method of culturing and expanded pluripotent stem cells in chemically defined expansion medium under xenogeny-free condition ( see entire document, Abstract and paragraph 0004, 0019 in particular)
US Patent Application’873 teaches a method of culturing and expanded pluripotent stem cells in chemically defined expansion medium under serum albumin-free condition ( see entire document, 0026, 0027, 0033, 0050 in particular)
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to use chemically defined expansion medium under xenogeny-free and serum-free condition in a method recited in claims of copending Application No. US 20240191189 in with a reasonable expectation of success because the prior art suggests that said condition can be used for useful and beneficial for expanding progenitor cells.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
8. It is noted that Applicant requested to hold that double patenting rejection in abeyance until allowable subject matter is identified.
9. No claim is allowed.
10. 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. 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