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 15-26 are pending.
2. Applicant’s election without traverse of Group I, claims 15-20 in the reply filed on 10/02/25 is acknowledged.
Claims 21-26 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 15-20 read on a method for mobilizing hematopoietic stem cells in blood are under consideration in the instant application.
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 15-20 stand rejected under 35 U.S.C. 103 as being unpatentable over Kim Suna ( In situ tissue regeneration, 2016, pp 73-85) and US Patent Application 20090028834 in view of US Patent Application 20200188483 and US Patent Application 20190322633 for the same reasons set forth in the previous Office Action, mailed on 01/02/26.
Applicant’s arguments filed on 04/17/26 have been fully considered but have not been found convincing.
Applicant asserts that the results of combination of substance -P and AMD 3100 in a method of mobilizing hematopoietic stem cells are surprising , unexpected and can not be obvious over the recited prior art.
As initial matter it is noted that the arguments of counsel cannot take the place of evidence in the record. In re Schulze , 145 USPQ 716, 718 (CCPA 1965). See MPEP 716.01© Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long - felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant.
Moreover, it is noted that Applicant relies on unexpected results based on the Data shown on Fig. 3 of the instant specification. However, the data on Fig. 3 only compare combination of G-CSF and AMD3100 with combination of SP and AMD3100. The is no comparison between the effects of AMD3100 and SP alone and their combination, thus the Examiner can not conclude that the claimed combination is really have unexpected and surprising results over the teaching of prior art.
Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. MPEP §716.02 (emphasis added).
The unexpected property or result must actually be unexpected and of significant, practical advantage. MPEP §716.02(a) (emphasis added). Also Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd.Pat. App. & Inter. 1991). For example, synergism is merely a property like any other property – it may be expected or unexpected depending on the particular art.
Evidence of unexpected results must be weight against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2D 1082 197 USPQ 601 (CCPA 1978). When the unexpected properties of the claimed invention are not shown to have a significance equal to or greater than the expected properties, the evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness. In re Nolan, 553 F.2D 1261,1267,193,USPQ 641,645 (CCPA, 1977) ( see MPEP 716.02( c )
As has been stated previously, Suna et al., teach the use of substance -P for hematopoietic stem cells mobilizing in blood ( see entire document, Abstract in particular).
US Patent Application’834 teaches the use of substance -P for mobilizing hematopoietic stem cells in blood ( see entire document, paragraphs 0016, 0055, 0057 and 0155 in particular).
Suna et al., and US Patent Application’834 do not explicitly teaches the use of AMD 3100 for mobilizing hematopoietic stem cells in blood.
US Patent Application’483 teaches the use of AMD-3100 for mobilizing hematopoietic stem cells in blood ( see entire document, paragraph 0003, in particular).
US Patent Application’633 teaches the use of AMD - 3100 for mobilizing hematopoietic stem cells in blood ( see entire document, paragraph 0039, 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 both substance-P and AMD 3100 with a reasonable expectation of success because the prior art teach that each of said compounds can be used for mobilizing hematopoietic stem cells in blood.
“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).
Claims 17-20 are included because it would be conventional and within the skill of the art to : (i) determine an optimal schedule, means of administering and dosage of each of compounds 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.
As dosing and modes of administration are known to the ordinary artisan, it would have been obvious to optimize both the dosing regimens and mode of administration to meet the needs of the patient at the time the invention was made.
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).
5. No claim is allowed.
6. THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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, however, event will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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