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 .
Claim Status
Claims 9-12 are pending under examination. Claims 1-8 have been cancelled. Claims 9-11 are amended.
Priority
Applicants have claimed the effective filing date of 7/13/21 based on the CN202110791272.8 but no translation has been made of record.
Response to Arguments
Applicant’s arguments, filed 12/3/2025 with respect to the rejection(s) of claim(s) 9-12 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of amendment.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
See [0007] and [0009] where the sequence of SEQ ID NO: 1 is listed without its SEQ ID NO.
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.
Claim 11 is 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 11 recites the limitation "the obesity complications" in line 2-3. There is insufficient antecedent basis for this limitation in the claim as there is no prior recitation of “obesity complications”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 recites the method according to claim 9 wherein the polypeptide derivative is prepared as drugs or a health care product. Because claim 9 recites a method of treating obesity, a type of disease or disorder, it is inherent that a method of treating would involve administration of drugs; moreover, drugs are a type of health care product. Therefore, claim 10 does not further limit parent claim 9.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Dal et al. (The Protective Effect of Antioxidants Consumption on Diabetes and Vascular Complications. Diseases. 2016 Jul 11;4(3):24.) in view of Gupta (Gupta et al., Identification of antioxidant peptides in cheddar cheese made with adjunct culture lactobacillus casei ssp. casei 300, 2010, Milchwissenschaft, vol. 65, no. 4, 396-399; Abstract only) and Xie et al. (WO 2016123493 A1, published 8/4/2016).
Dal teaches that obesity and diabetes are accompanied by a chronic state of oxidative stress, disequilibrium in the redox balance, and is implicated in the development and progression of complications such as micro- and macro-angiopathies (Abstract). Many studies have shown that diabetes patients undergo chronic oxidative stress, particularly due to hyperglycemia (Pg 2, first paragraph). Additionally, O2.− , produced by chronic oxidative stress, decreases nitric oxide (NO), which is associated with hypercholesterolemia (hyperlipidemia; Pg 12, “3.4.1. Free radicals, NO and NO Synthases”, first paragraph).
Dal further teaches that antioxidants can be used to treat reactive oxygen species and come from a variety of sources; thus, by extension, antioxidants can treat hyperglycemia and hyperlipidemia (Pg 14, “4. Nutritional Prevention: Antioxidants against Diabesity and Complications”; Tables 1-7).
Dal does not teach a method utilizing any of the instant SEQ ID NO: 2-5.
Gupta teaches the peptide VKEAMAPK, derived from β-casein, exhibits antioxidant properties comparable to commercial chemical antioxidants (Abstract).
Xie teaches a method for treating obesity complications such as hyperglycemia and dyslipidemia by administering a polypeptide antagonist conjugated to a cell penetrating peptide such as GRKKRRQRRRPPQ, which is the same CPP found in the instant SEQ ID NO: 4, to a subject in need thereof (Abstract; [0033, 0041, 0089]).
Thus, regarding claim 11, Dal teaches that hyperglycemia and hyperlipidemia are associated with chronic oxidative stress and reactive oxygen species that can be treated through administration of antioxidants. Gupta teaches that the peptide VKEAMAPK is an antioxidant. Based on these teachings, it would be obvious to use the VKEAMAPK peptide taught by Gupta in a method of treating hyperglycemia and hyperlipidemia as taught by Dal in order to directly combat one of the underlying causes of hyperglycemia and hyperlipidemia. One would have a reasonable expectation of success given that Dal teaches a variety of antioxidants from different sources can treat hyperglycemia and hyperlipidemia.
Further, Xie teaches a method of treating hyperglycemia and dyslipidemia comprising administering to a subject in need thereof a therapeutic polypeptide fused to a CPP, such as GRKKRRQRRRPPQ of the instant SEQ ID NO: 4, to reduce oxidative stress or ROS. Therefore, it would be prima facie obvious to fuse the antioxidant peptide VKEAMAPK of Gupta to the CPP GRKKRRQRRRPPQ taught by Xie, the combination of which would result in the instant SEQ ID NO: 4, in order to improve the transport of the peptide across the plasma membrane and into cells. One skilled in the art would have a reasonable expectation of success as the CPP GRKKRRQRRRPPQ had been shown by Xie to enhance the activity of other peptide therapeutics used to reduce ROS.
Allowable Subject Matter
Claims 9 and 12 are allowed.
As stated in the prior Office Action, the instant SEQ ID NO: 2-5 consist of the sequence “VKEAMAPK”, derived from β-casein, fused N-terminally to variants of the cell penetrating peptide HIV TAT. The closest prior art indicates that VKEAMAPK exhibits antioxidant properties comparable to other antioxidant compounds. However, there are no teachings, suggestions, or motivations in the prior art that would motivate one to select the fragment “VKEAMAPK” for use in a method of treating obesity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara E Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658 /FRED H REYNOLDS/Primary Examiner, Art Unit 1658