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 .
Claims 5, 7, 15, 19, 24, 54, 56, 60-63, 68 and 70-74 are pending in this application and were examined on their merits.
The rejection of Claim(s) 5, 60 and 68 under 35 U.S.C. § 103 as being
unpatentable over Peak et al. (04/09/2018), as evidenced by Thoma (2015), both of
record, has been withdrawn due to the Applicant’s amendments to the claims filed 04/15/2026.
The rejection of Claim(s) 5, 54, 56, 60 and 68 under 35 U.S.C. § 103 as being
unpatentable over Peak et al. (04/09/2018), as evidenced by Thoma (2015), has been withdrawn due to the Applicant’s amendments to the claims filed 04/15/2026.
The rejection of Claim(s) 5, 7, 60, 68 and 70 under 35 U.S.C. § 103 as being
unpatentable over Peak et al. (04/09/2018), as evidenced by Thoma (2015), and further in view of Lang et al. (2017) and Shi et al. (2013), all of record, has been withdrawn due to the Applicant’s amendments to the claims filed 04/15/2026.
The rejection of Claim(s) 5, 7, 15, 19, 20, 41, 46, 60, 61, 62, 63, 68 and 70 under 35 U.S.C. § 103 as being unpatentable over Peak et al. (04/09/2018), as evidenced by
Thoma (2015), in view of Lang et al. (2017, and further in view of Bader et al. (US 2014/0378528 A1) and Kao et al. (2014), all of record, has been withdrawn due to the Applicant’s amendments to the claims filed 04/15/2026.
Claim Interpretation
Consistent with the Specification as filed at [0129] which states:
“The term “extracellular vesicles”, as used herein, refers to all cell-derived vesicles secreted from a cell including but not limited to exosomes and microvesicles”,
the term “extracellular vesicles” is interpreted as equivalent to the term “exosomes”.
Claim Objections
Claims 5, 7, 15, 68 and 73 are newly objected to because of the following informalities: the “vesicle” in the claims should be changed to “vesicles”. Appropriate correction is required.
Claim 61 and 70 are newly objected to because of the following informalities” “MSC” should be changed to “CH-MSC”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5, 7, 15, 19, 24, 54, 56, 60-63, 68 and 70-74 are newly rejected under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, as necessitated by Applicant’s amendment to the claims filed 04/15/2026. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. § 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 5, 68 and 73 now recite: “selecting a subject suffering from a PD-L1 high cancer, wherein a PD-L1 high cancer expresses PD-L1 above a predetermined threshold”. There is insufficient support in the originally filed disclosure for this new limitation. The Specification as filed, at best, only refers to “PD-L1 positive” cancers, see Paragraphs [040], [041] and [095] and embodiments wherein a patient or immune cell “highly expresses” PD-L1, see [096].
The disclosure however provides no teaching of predetermining a threshold value for assessing the “high” expression status of a PD-L1 cancer and does not provide any teaching or definition of what expression value or range constitutes a “high” PD-L1 cancer. Applicant is required to indicate with specificity where support for the new limitation may be found or delete the NEW MATTER. Claims 7, 15, 19, 24, 54, 56, 60-63, 70-72 and 74 are rejected as being dependent upon rejected Claims 5, 68 and 73.
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 5, 7, 15, 19, 24, 54, 56, 60-63, 68 and 70-74 are newly 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, as necessitated by Applicant’s amendment to the claims filed 04/15/2026. Claims 5, 68 and 73 now recite; “PD-L1 positive cancer” and “PD-L1 high cancer”. It is unclear if a PD-L1 “positive” cancer is the same as a PD-L1 “high” cancer as one denotes the presence of PD-L1 and the other denotes the magnitude of the PD-L1. Thus, the metes and bounds of the claims cannot be readily determined.
Claim 5 recites the limitation "said chorionic placenta mesenchymal stem cells". There is insufficient antecedent basis for this limitation in the claim.
The term “high” in claims 5, 68 and 73 is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the claims also recite, “wherein a PD-L1 cancer expresses PD-L1 above a predetermined threshold”, the method for determining said threshold or what values above or below the unspecified threshold meet the limitation are taught in the disclosure such that the metes and bounds of the claims cannot be readily determined. Claims 7, 15, 19, 24, 54, 56, 60-63, 70-72 and 74 are rejected as being dependent upon rejected Claims 5, 68 and 73 and do not themselves rectify the indefiniteness.
Claim 56 now recites, “and wherein said”. It is unclear what is being referred to by the limitation which could refer to an anticancer treatment or to a subject.
Response to Arguments
Applicant’s arguments, see Remarks, filed 04/15/2026, with respect to the rejection(s) of claim(s) 5, 7, 15, 19, 20, 24, 41, 46, 54, 56, 60-63, 68 and 70 under 35 U.S.C § 103 have been fully considered and are persuasive.
Therefore, the rejections have been withdrawn. However, new ground(s) of rejection are made as set forth above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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