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 .
Election/Restrictions
Applicant’s election without traverse of Group II (Claims 17-20; drawn to a method of producing a platelet containing composition) in the reply filed on September 30, 2026, is acknowledged.
DETAILED ACTION
The amended claims filed on September 30, 2021, have been acknowledged. Claims 1-16 were cancelled. Claims 17-20 are new. Claims 17-20 are pending and examined on the merits.
Priority
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d).The applicant claims foreign priority from JP2022-080038 filed on May 16, 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, received November 12, 2024. While a certified copy of the foreign patent application JP2022-080038 is provided with the instant application, a certified English translation of said foreign patent application has not been provided.
Information Disclosure Statement
The information disclosure statements (IDS) filed on November 12, 2024, and July 14, 2026, have been considered.
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 17-20 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.
Claim 17 recites the limitation "the platelet preservation solution" in line 3. There is insufficient antecedent basis for this limitation in the claim. There is no previous recitation of a platelet preservation solution.
Claims 18-20 are also rejected because of their dependency on claim 17.
Claims 19-20 recite the limitation “suspending a platelet in a platelet preservation solution having a volume of 0.1 times or more with respect to the volume of plasma in the platelet.” It is unclear what is meant by the term “volume of plasma in the platelet”. It is unclear whether this is meant to refer to plasma within a platelet itself or if it is meant to refer to the amount of plasma in a platelet solution (such as platelet rich plasma) upon mixing the platelet solution with the platelet preservation solution (as is done in the 20:7 volume ratio of PRP to platelet preservation solution in paragraph 0073 of the instant specification).
Claims 20 is also rejected because of its dependency on claim 19.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 17-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by United States Patent Application No. 20190048365 (Castora).
Regarding claims 17-18, Castora teaches a method for preserving platelets comprising suspending platelets in a Modified Tyrode's Buffer preservation solution comprising sodium chloride and potassium chloride (electrolytes) and EGTA (anticoagulant). The 1.0 ml of suspended platelets is then aliquoted into smaller volumes and stored frozen at -80° C (Example 8).
Regarding claims 19-20, as per the 112b rejection above, it is unclear whether the plasma is meant to refer to what is in the platelet or referring to the volume/volume ratio of a mixed solution of platelet rich plasma (PRP) and a platelet preservation solution. Regarding the teachings of Castora, they teach that as part of their method of preserving platelets, a pure PRP supernatant is carefully transferred to new conical tube and centrifuged at 800xg for 15 minutes to obtain a purified platelet pellet. The supernatant from the above centrifugation is carefully removed and the remaining platelet pellet is resuspended (by gently pipetting up and down) in 1.0 ml of Modified Tyrode's Buffer (Example 8). As the supernatant is removed and the platelets have been pelleted, the addition of the 1.0 mL Modified Tyrode's Buffer to resuspend the platelets would represent well over 100% of the amount of plasma remaining in the pellet.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEENAN A BATES whose telephone number is (571)270-0727. The examiner can normally be reached M-F 7:30-5:00.
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, Doug Schultz can be reached at (571) 272-0763. 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.
/KEENAN A BATES/Examiner, Art Unit 1631
