DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-30 are currently pending.
Election/Restrictions
3. Applicant's election with traverse of Group II, claims 16-30, and chronic inflammation (claim 27) for the species in the reply filed on November 11, 2025 is acknowledged. The traversal is on the ground(s) that the election of species is improper because the restriction requirement does not show burden. This is not found persuasive because it is not required to establish burden for an election of species requirement in a 371 application because restriction in a 371 application is based on lack of unity requirements set forth in MPEP 1850 section rather than MPEP section 803.02 as asserted by applicant. Applicant also argues that the restriction between groups I and II is improper because a technical relationship exists between the two groups because they are drawn to a product and a process for using the product. However, MPEP section 1850 states that linked invention must have the same inventive concept as represented by a special technical feature. If the linking technical feature is not a special technical feature, then the groups of invention lack unity because the linking feature is not an inventive concept because it is a known concept. “Lack of unity of invention may be directly evident "a priori," i.e., before considering the claims in relation to any prior art, or may only become apparent "a posteriori," i.e., after taking the prior art into consideration. For example, independent claims to A + X, A + Y, X + Y can be said to lack unity a priori as there is no subject matter common to all claims. In the case of independent claims to A + X and A + Y, unity of invention is present a priori as A is common to both claims. However, if it can be established that A is known, there is lack of unity a posteriori, since A (be it a single feature or a group of features) is not a technical feature that defines a contribution over the prior art…”. Applicant also argues that the restriction is improper because burden has not been established. However, as discussed above, it is not required to establish burden in restrictions based on lack of unity.
The requirement is still deemed proper and is therefore made FINAL.
4. Claims 1-15, 21-26, 28, and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
5. Claims 16-20, 27, and 30 are examined on the merits.
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 16-20, 27, and 30 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.
6. Claims 16-20 and 30 are indefinite because the metes and bounds of “quality of life” are unclear. It is unclear what parameters are used to determine “quality of life” and what would be considered an improvement in “quality of life.” Claim 16 states that the composition is administered to a human; however, it is unclear how to select the particular subject for administration because “quality of life” is indefinite.
7. Claim 27 is indefinite because it states that “improves quality of life based on chronic inflammation.” It is unclear what is meant by “based on chronic inflammation.” It appears that the claim intends to treat chronic inflammation or reduce chronic inflammation. However, clarification of the intended scope of the claim is needed.
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.
8. Claim(s) 16-20, 27, and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Higashi (WO 2019/009437 – English translation).
Higashi teaches a fermented plant product that is the same as the product claimed by applicant as defined by applicant in paragraphs 6 and 9 of the specification. The reference teaches that the product is administered in a dosage of 0.1 g or more to reduce the incidence of spontaneous cancers. The reference teaches that chronic inflammation causes spontaneous cancers (see pages 2, 3, and 5 of the translation). Thus, the reference teaches administering the same composition as claimed to a subject with chronic inflammation. The reference does not specifically teach that the administration improves the “quality of life” of the subject. However, applicant’s claim 27 and the specification states the improvement in chronic inflammation and reduction in the incidence of spontaneous cancer improves the “quality of life” (see paragraphs 9 and 13). Thus, the reference method should inherently result in the improvement in “quality of life” because the reference method is structurally the same as the claimed method, i.e. the same composition is administered to the same subject. Therefore, applicant’s claimed invention is considered to be anticipated by the prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
9. Claims 16-20 and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/484,738 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application are drawn to administering the same composition as claimed to suppress immune checkpoints. Applicant’s specification states that the suppression of immune checkpoints improves a subject’s quality of life (see paragraph 9). Thus, the claims of the reference applicant inherently anticipate the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
10. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Coe Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelvey can be reached at 571-272-0775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655