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 .
Priority
This application filed 12/14/2023 is a Continuation of PCT/CN23/91021 , filed 04/27/2023 and
claims foreign priority to 202210735384.6, filed 06/27/2022 but no translation has been made of record.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/25/2023 is in compliance with the
provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the
examiner.
Election/Restrictions
Newly submitted claims 3-7 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: In the instant case,
Group I. Claim 1, 2, drawn to a method of preparing an enzymatic hydrolysate classified in A 61P 3/08.
Group II. Claim 3, 4, drawn to a method of promoting CCK secretion classified in A61P 5/02.
Group III. Claim 5, 6, 7, drawn to a method of slowing gastric emptying classified in A61P 5/50.
Inventions I, II and III are directed to related processes. In the instant case, the method of preparing an enzymatic hydrolysate (I) cannot be performed together with the method of promoting CCK secretion in enteroendocrine cells (II); the method of preparing an enzymatic hydrolysate (I) cannot be performed together with the method of slowing gastric emptying (III); and the method of promoting CCK secretion in enteroendocrine cells (II) cannot be performed together with the method of slowing gastric emptying (III). The two processes are mutually exclusive since literature that teaches one need not teach the other. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants as they have different endpoints.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 3-7 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Status of Claims
The amendments and arguments filed on 06/14/2026 are acknowledged and have been fully considered. Claim 1 is amended, claims 2-7 are new. Claims 3-7 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. Claims 1 and 2 are now pending and will be examined on the merits herein.
Objections/Rejections Withdrawn
Objections and/or rejections not reiterated from previous Office Action are hereby withdrawn.
The following rejections and/or objections are either reiterated or newly applied, and constitute the
complete set presently being applied to the instant application.
Claim Objections
Claim 1 is objected to because of the following informalities: Examiner respectfully requests Applicant to italicize the scientific name- ‘Avena sativa L’. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soichiro Nakamura et al., hereinafter Nakamura (JP2009073765A (machine translation); published 2009-04-09).
Regarding claim 1, Nakamura teaches a method comprising powdered buckwheat (Avena sativa; page 3, 1st paragraph, line 5) and defatting step, wherein the defatting treatment is performed on ground oat (see page 2, paragraph 7, lines 1-4) (i.e. extraction). Nakamura teaches treatment of oat protein fraction with pepsin and trypsin (see page 2, paragraph 7, line 7). Specifically, Nakamura teaches that pepsin is added to the protein fraction at an enzyme concentration of 0.1 %. Next, degradation with Trypsin is performed (see page 3, 5th paragraph, lines 1-4). Nakamura teaches the sequence comprising QGDVVALPA (SEQ ID NO: 1 in instant) in Fig 4 is produced when oat globulin is digested after enzymatic digestion (see page 2, 6th paragraph, line 6). Examiner interprets ‘wherein the active peptide….secretion’ (last two lines in claim 1) as intended use. As the teachings in Nakamura meet the limitation of the instant method, and the sequence of the peptide, is 100 % identical to the claimed SEQ ID NO: 1, the claimed peptide would be capable of the same intended use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children's Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (see MPEP §2111. 02 (II)). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical
processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562
F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). (See MPEP § 2112.01 (I)).
Regarding claim 2, Nakamura teaches that after enzymatic treatment, it is preferable to pass through a molecular sieve using ultrafiltration using a membrane (i.e. elution by size exclusion chromatography). Nakamura teaches that it is desirable to select the protein fractionation step according to the purpose and application (see page 3, 6th paragraph).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to elute a fraction containing a peptide consisting of SEQ ID NO: 1. One motivated to do so would have a reasonable expectation of success as Nakamura teaches the method steps of producing an oat protein hydrolysate and teaches the sequence comprising SEQ ID NO: 1 in Fig 4. Thus, one would have recognized that applying the teaching of Nakamura to elute peptides would have yielded predictable results in obtaining the fraction containing the active peptide (See MPEP § 2143 l(A)(D)).
Response to Arguments
Applicant’s arguments with respect to claim 1 has been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-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, Melissa Fisher can be reached at 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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