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 .
Status of the Claims
Claims 1-5 as filed 3/24/2025 are pending and under current examination.
Withdrawn Objections and Rejections and Response to Arguments and Declaration
Applicant’s arguments filed 3/24/2026 (hereafter, “Remarks”) have been fully considered and are addressed as follows.
All objections to claims 1-3 are withdrawn in view of Applicant’s amendments to the claims. Applicant’s argument to this effect is persuasive.
Regarding the previously issued rejections of claims 1-5 under 35 U.S.C. 112(b), some of the reasons for rejections are withdrawn in view of the claim amendments filed 3/24/2026. As to the unclear claim language “at least 253 peptides as listed in the specification”, Applicant argues that a Korean application provides similar disclosure and that the actual issue is one of written description (antecedent basis) and not lack of clarity. In reply, Applicant’s position has been considered but is not persuasive because the claim has not been rejected for a lack of antecedent basis or for lack of written description. The language is unclear because it is not apparent what peptides are included and/or excluded from the structure of claim 1, and limitations are not imported from the specification as filed.
As to the concentration range recited in claim 1 additional claim language previously indicated unclear, Applicant’s arguments are persuasive, and the rejections below have been modified accordingly.
Applicant provides evidence in the form of a declaration of inventor Nai-Hua Ye as filed 3/24/2026 in the file wrapper wherein said inventor concludes that a POSITA would know what the concentration range claimed means. In reply, the rejection stating this recitation is unclear is withdrawn. For the purpose of interpreting the claim, the part and whole of the claimed concentration in ppm units will be interpreted as the concentration of any of whatever at least 253 peptides in total are included per total KP solution. The concentration is not interpreted to mean any piecemeal representation of any total 253 peptides but rather represents a sum of any at least 253 peptide component in total solution.
Regarding the previously issued double patenting rejections, Applicant argues that terminal disclaimers have been provided. However, it is noted that only one terminal disclaimer has been provided, submitted 3/24/26 and approved 4/7/2026 in the file wrapper. In reply, the obviousness double patenting rejection corresponding to the approved terminal disclaimer has been withdrawn. All other obviousness double patenting rejections are maintained.
Applicant’s responses to “near art” are noted. It appears Applicant is arguing that the cited references have nothing to do with the present invention and are absolutely irrelevant. In reply, it is clarified that these references have been cited as the nearest art and have not been applied in rejections of record.
Maintained Grounds of Rejection, Modified as Necessitated by Amendments of 3/24/2026
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 1-5 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 1 recites the limitation "at least 253 peptides as listed in the specification" in line 8. There is insufficient antecedent basis for this limitation, specifically “as listed in the specification”, in the claim. Limitations are not imported from the specification into the claim.
Appropriate clarification is required. Claims depending from a rejected base claim are also rejected here.
Maintained Rejections
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.
Claims 1-5 provisionally are rejected on the ground of nonstatutory double patenting as being unpatentable over claims (“B” in Table below) as listed in the table below in copending Application Numbers (“A” in Table below) as listed in the table below(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims pertain to a method of using a keratin hydrolysis peptide (KHP) solution by preparing a solution from mixing feathers and water in a sealed container, hydrolyzing said mixture according to specific time, pressure, and duration parameters, and using a mass spectrometer to confirm peptide content, and administering the solution to soil and/or to leaf surfaces of specified plants (“C” in Table below).
The instant claims differ from the copending claims in that (1) both claim sets have slightly different but still qualitatively similar numerical amounts with regard to mass of feathers, water content percentage, and hydrolysis temperature, pressure, and duration terms and (2) the instantly claimed method applies the solution to soil around cucumber plants at early growth stage or to their leaf surface, whereas the copending claims are drawn to methods of applying the solution to the soil and/or leaves of the plants, specified particularly in the table below.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to adjust the hydrolysis conditions as part of routine optimization procedure as is customary in the art, with a reasonable expectation of success. One would have been motivated to do so to achieve the desired degree of hydrolysis reaction efficacy in a method of preparing a peptide solution from feathers in aqueous solution based on the copending claims’ suggestions of hydrolysis reactions for preparing keratin hydrolysis peptide solutions for enhancing crop yields and quality. Further, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to substitute one for the other, the cucumber crop instantly claimed for and/or in place of the crops of the copending claims as detailed in the Table above, with a reasonable expectation of success. One would have been motivated to apply the prepared solution to soil and/or leaves of alternate food or cash crops to achieve similar end results of enhanced production yield and quality of said food or cash crops.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion, Maintained
No claim is allowed at this time.
Following is near-art which may be applicable upon resolution of issues detailed above:
KR20060053360A teaches mass spectrometry characterization of peptide products from hydrolyzed feathers;
DE60015807T2 discloses the state of the art of peptides derived from keratin. The peptides are disclosed to be useful in wound healing applications and include peptides having a molecular weight around 850 Daltons; and
JP2006124341 teaches hydrolysis of horse keratin from overlapping ranges of hydrolysis parameters including 3-12 bar pressure; 4-25 minutes process duration; and 160 to 205 degrees Celsius temperature range to produce a peptide of 500 Daltons.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
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/AUDREA B CONIGLIO/ Primary Examiner, Art Unit 1617
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