Prosecution Insights
Last updated: April 19, 2026
Application No. 18/014,554

COMBINATION THERAPY OF SUBSTANCE-P FOR MOBILIZATION OF HEMATOPOIETIC STEM CELLS

Non-Final OA §103
Filed
Jan 05, 2023
Examiner
BELYAVSKYI, MICHAIL A
Art Unit
1644
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Elphis Cell Therapeutics
OA Round
1 (Non-Final)
64%
Grant Probability
Moderate
1-2
OA Rounds
3y 1m
To Grant
91%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allow Rate
697 granted / 1091 resolved
+3.9% vs TC avg
Strong +27% interview lift
Without
With
+27.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
77 currently pending
Career history
1168
Total Applications
across all art units

Statute-Specific Performance

§101
2.3%
-37.7% vs TC avg
§103
29.0%
-11.0% vs TC avg
§102
9.7%
-30.3% vs TC avg
§112
10.9%
-29.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1091 resolved cases

Office Action

§103
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 Claims 21-26 are withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.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. Applicant’s provision of the foreign priority document KR10-2020-0086108 is acknowledged. However, an English translation has not been provided in accordance with 37 CFR 1.55. See MPEP § 201.15. 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 15-20 are 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 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). 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 Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644
Read full office action

Prosecution Timeline

Jan 05, 2023
Application Filed
Nov 26, 2025
Non-Final Rejection — §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
64%
Grant Probability
91%
With Interview (+27.2%)
3y 1m
Median Time to Grant
Low
PTA Risk
Based on 1091 resolved cases by this examiner. Grant probability derived from career allow rate.

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