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. Claims 1-3,7,11,12,14,16,25-28,32-34,38,39,40,42,44 are pending.
2. Applicant’s election without traverse of Group I, claims 25-28,32-34,38,39,40,42,44 in the reply filed on 11/20/25 is acknowledged.
3. Claims 1-3,7,11,12,14,16 are withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 25-28,32-34,38,39,40,42,44 read on a method of improving treatment outcome for human patient having hematological malignancy are under consideration in the instant application.
Prior of setting the art rejection it is noted that the term “optionally” is interpreted as that the claimed method that does not have a second administering of chemotherapy regimen.
3. 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.
4. Claims 25-28,32-34,38,39,40,42,44 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20130095079 and US Patent Application 20110230422
US Patent Application ‘079 teaches a method of treating hematological malignancy in a patient comprising administering to the patient chemotherapy regimen and administering an expanded hematopoietic stem cells ( see entire document, paragraphs 0004, 0017, 0036, 0043, 0060, 0067, 0189 in particular) in particular). US Patent Application ‘079 teaches a step of determining effectivity of the claimed method that is obviously comprising a step of monitoring the status of the patient to determine whether the patient has achieved a remission.
Since US Patent Application ‘079 teaches does not explicitly teach that administered hematopoietic stem cells should be matching for HLA type of the donor, it would be immediately obvious to one skill in the art that US Patent Application ‘079 teaches said expanded hematopoietic stem cells are selected without matching to the HLA type.
US Patent Application ‘422 teaches a method of treating hematological malignancy in a patient comprising administering to the patient chemotherapy regimen and administering an expanded hematopoietic stem cells ( see entire document, paragraphs 0012, 0014, 0017, 0020-0022 in particular). US Patent Application ‘422 teaches a step of determining effectivity of the claimed method that is obviously comprising a step of monitoring the status of the patient to determine whether the patient has achieved a remission.
Since US Patent Application ‘422 teaches does not explicitly teach that administered hematopoietic stem cells should be matching for HLA type of the donor, it would be immediately obvious to one skill in the art that US Patent Application ‘079 teaches said expanded hematopoietic stem cells are selected without matching to the HLA type.
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).
Claims 26-28, 33,34,38,39, 40,42 are included because it would be conventional and within the skill of the art to : (i) identify an optimal timing and dosage of administering stem cells; (ii) type of hematological malignancy to be treated,; (iii) optimal chemotherapy regime; 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 combined teaching of the references, it is 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.
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.
The claims 26-28, 33,34,38,39, 40,42 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Applications No. 16378229; 13/640,298 and 14/801771.
Although the conflicting claims are not identical, they are not patentably distinct from each other because:
- claims of copending Application No. 16378229 teach a method of treating AML comprising administering expanded stem cells and chemotherapy.
- claims of copending Applications Nos. 13/640,298 and 14/801771each teaches a method of treating a patient comprising administering to the patient an chemotherapy regimen and a dose of expanded hematopoietic stem cells.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
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, 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