Prosecution Insights
Last updated: July 17, 2026
Application No. 18/283,330

BLOOD SEPARATION COMPOSITION, BLOOD SAMPLING CONTAINER, AND METHOD FOR SEPARATING LEUKOCYTES

Non-Final OA §102§103§112
Filed
Sep 21, 2023
Priority
Mar 24, 2021 — JP 2021-049602 +1 more
Examiner
SMITH, PETER DANIEL
Art Unit
1634
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Sekisui Chemical Co., Ltd.
OA Round
1 (Non-Final)
51%
Grant Probability
Moderate
1-2
OA Rounds
6m
Est. Remaining
97%
With Interview

Examiner Intelligence

Grants 51% of resolved cases
51%
Career Allowance Rate
36 granted / 70 resolved
-8.6% vs TC avg
Strong +46% interview lift
Without
With
+46.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
31 currently pending
Career history
105
Total Applications
across all art units

Statute-Specific Performance

§103
94.7%
+54.7% vs TC avg
§102
2.2%
-37.8% vs TC avg
§112
0.8%
-39.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 70 resolved cases

Office Action

§102 §103 §112
DETAILED ACTION 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 . Claim Status Applicant’s response to the Restriction Requirement issued January 27th, 2026 in the reply filed on March 26th, 2026 is acknowledged and addressed below. Claims 1-12 are currently pending. Claims 8-12 have been withdrawn as pertaining to non-elected claim Groups II and III. Claims 1-7 are currently under consideration. Election/Restrictions Applicant's election with traverse of the Restriction Requirement issued January 27th, 2026 in the reply filed on March 26th, 2026 is acknowledged. The traversal is on the ground(s) that Okamoto is not seen to anticipated the special technical feature of a silica that has a hydrophobicity of 60% or more as measured by a methanol wettability method as applicant’s specification states in ¶0167 determines R812 to have a hydrophobicity of 50% as measured by a methanol wettability method and the applicant’s specification states that R812 does not correspond to hydrophobic silica (X). This is not found persuasive because the claim limitations do not specifically state the requirement of hydrophobic silica (x) and simply require a hydrophobic silica meeting the requirement of 60% or more as measure by a methanol wettability test. While the applicant has stated that the R812 according to their methanol wettability measurement exhibits a 50% hydrophobicity, R812 is shown to exhibit a 60% hydrophobicity as measured by a methanol wettability test as evidenced by the disclosure of Eng et al. (WIPO Publication 2011/076518) on Page 9 line 15 stating that AEROSIL R812 exhibits an approximate methanol wettability of 60 as determined by the procedure utilized by Eng. As evidenced by Eng, the disclosure of Okamoto et al. is seen to anticipate the 60% hydrophobicity as this hydrophobicity is an inherent feature of the AEROSIL R812. As the claim limitations do not require the hydrophobicity to be greater than 60% according to the applicant’s specific method of measuring methanol wettability, the fact that the applicant has presented a different value for the methanol wettability of AEROSIL R812 is seen to be a moot argument as it is not currently claimed. As such these arguments are not found to be persuasive and the restriction requirement presented on January 27th, 2026 is still deemed proper and is therefore made FINAL. Claim Rejections - 35 USC § 112 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. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 2 and 3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 2 and 3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph as being indefinite as the term “specific gravity” does not particularly point out and distinctly claim the subject matter in that the claim language does not define what structure has the claimed specific gravity. The term specific gravity relates a density of an element/structure to a reference standard. While it is well known in the art for the reference standard for calculation of specific gravity to be that of pure water, the claim still fails to describe what element of the invention the specific gravity is related to and as such it is unclear with the current claim language as to what element is required to have the claimed specific gravity. For the purpose of examination, the specific gravity is being interpreted to be a specific gravity of the composition itself rather than its individual components. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claim(s) 1-2 and 4-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okamoto et al. (WIPO Publication 2019/131613) as evidenced by Eng et al. (WIPO Publication 2011/076518). Regarding claim 1-2 and 4-7, Okamoto discloses a blood separation composition comprising: An organic component having fluidity at 25°C (Claim 1) containing a resin wherein the resin (Claim 4) is a (meth)acrylic resin (Claim 5) (see annotation 3/annotation 4 of attached annotated translation of Okamoto), and fine powder silica (see annotation 4 of Okamoto translation, finely powdered silica), the fine powder silica including hydrophobic silica (see annotation 5 of Okamoto translation, hydrophobic silica) having a hydrophobicity of 60% as measured by a methanol wettability method (Claim 1) (see annotated translation of Okamoto annotation 6 use of R812, R812 60% hydrophobicity evidenced by disclosure of Eng et al. (WIPO Publication 2011/076518) on Page 9 line 15 stating that AEROSIL R812 exhibits an approximate methanol wettability of 60 as determined by the procedure utilized by Eng), wherein the fine powder silica included hydrophilic silica (Claim 6) (see annotation 5 of Okamoto translation, hydrophilic silica) and wherein the specific gravity of the composition at 25°C is 1.038 or more and 1.095 or less (Claim 2) (¶0019; see annotated attached translation annotation 1); and comprises silicone oil (Claim 7) (see annotation 4 silicone oil). Claim Rejections - 35 USC § 103 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. Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okamoto et al. (WIPO Publication 2019/131613) as evidenced by Eng et al. (WIPO Publication 2011/076518). Regarding claim 3, Okamoto discloses the blood separation composition according to claim 1. Okamoto further discloses the specific gravity of the blood separation composition at 25°C being 1.060 or more and 1.095 or less (¶0021, see annotated translation of WIPO 2019/131613 annotation 2). While Okamoto does not expressly disclose 1.090 or less, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the range of specific gravity of Okamoto, from 1.095 or less to 1.090 or less as applicant appears to have placed no criticality on the claimed range (¶0123 may be 1.095 or less, 1.090 or less, 1.085 or less…etc.) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Okamoto would not operate differently with the claimed range and since the claimed ranged falls within the range disclosed by Okamoto it is found to be obvious. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Inoue et al. (U.S. Patent No. 8,642,343) discloses (meth)acrylic resin based blood separating agents. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /PETER DANIEL SMITH/Examiner, Art Unit 3781 /PHILIP R WIEST/Primary Examiner, Art Unit 3781
Read full office action

Prosecution Timeline

Sep 21, 2023
Application Filed
Jun 01, 2026
Non-Final Rejection mailed — §102, §103, §112 (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
51%
Grant Probability
97%
With Interview (+46.0%)
3y 4m (~6m remaining)
Median Time to Grant
Low
PTA Risk
Based on 70 resolved cases by this examiner. Grant probability derived from career allowance rate.

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