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 1-28 were originally filed on June 15, 2022.
The amendment received January 19, 2023 amended claims 1, 2, 6-15, 17-22, and 24-28 and canceled claims 3-5, 16, and 23.
The amendment received July 10, 2025 amended claims 17-21 and 24-28 and added new claims 29-34.
Claims 1, 2, 6-15, 17-22, and 24-34 are currently pending.
Claims 1, 2, 22, 29, and 32 are currently under consideration.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1, 2, 6-15, 22, 29, and 32) in the reply filed on July 10, 2025 and reiterated in the response received December 17, 2025 is acknowledged. The traversal is on the grounds that Lin et al. does not teach a peptide of 8-32 amino acids in length or a retro0inverso form of the peptide. This is not found persuasive because Currie et al. WO 2006/086653 published August 17, 2006 teach retro-inverso peptides comprising CGGC (see the 12mer of SEQ ID NO: 7276 and page 23; see rejection below).
The requirement is still deemed proper and is therefore made FINAL.
Claims 17-21, 24-28, 30, 31, 33, and 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected methods, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on July 10, 2025 and reiterated in the response received December 17, 2025.
Applicant’s election of SEQ ID NO: 14 (KEACARCEE), no N- or C-terminal modifications, and a pharmaceutically acceptable carrier in the reply filed on July 10, 2025 and reiterated in the response received December 17, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 6-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 10, 2025 and reiterated in the response received December 17, 2025.
Please note: in the response received July 10, 2025, applicants’ representative failed to provide the orientation of the peptide of SEQ ID NO: 14. Therefore, it was unclear if SEQ ID NO: 14 was already in the retro-inverso form (i.e. CX3X2X1C; no D amino acids were indicated either) or if SEQ ID NO: 14 was the peptide which was to be converted to the retro-inverso form (i.e. CX1X2X3C as recited in present independent claim 1). This caused a secondary restriction to be mailed on September 18, 2025. After the secondary restriction was mailed, applicants’ representative clarified that SEQ ID NO: 14 is already in the retro-inverso form. However, the D amino acids were not indicated in the secondary response either (see the secondary response received December 17, 2025).
Potential Rejoinder
Applicants elected claims directed to a product. If a product claim is subsequently found allowable, withdrawn process claims that depend from or otherwise include all the limitations of the allowable product claim will be rejoined in accordance with the provisions of MPEP § 821.04. Process claims that depend from or otherwise include all the limitations of the patentable product will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all the criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowed product claim will not be rejoined. See “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. § 103(b),” 1184 O.G. 86 (March 26, 1996). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution either to maintain dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to a rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
The present application is a 371 (National Stage) of PCT/EP2020/086868 filed December 17, 2020 which claims foreign priority to EP 19218611.2 filed December 20, 2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on September 16, 2022; December 18, 2023; November 8, 2024; or December 17, 2025 are being considered by the examiner.
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.
See Figure 10.
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.
Claim Objections
Claim 1 is objected to because of the following informalities: personalization of inanimate objects is not typical in scientific writing (see “its” in (i), (ii), and (iii)). Appropriate correction is required.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3. Any claim requiring a specific percent identity, necessarily requires at least the recited percent identity.
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 1, 2, and 22 are 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. 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. This is a written description rejection.
With regard to the written description requirement, the attention of the Applicant is directed to The Court of Appeals for the Federal Circuit which held that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1405 (1997), quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original) [The claims at issue in University of California v. Eli Lilly defined the invention by function of the claimed DNA (encoding insulin)] (the case is referred to herein as “Lilly”).
Additionally, it is noted that written description is legally distinct from enablement: “Although the two concepts are entwined, they are distinct and each is evaluated under separate legal criteria. The written description requirement, a question of fact, ensures that the inventor conveys to others that he or she had possession of the claimed invention; whereas, the enablement requirement, a question of law, ensures that the inventor conveys to others how to make and use the claimed invention.” See 1242 OG 169 (January 30, 2001) citing University of California v. Eli Lilly & Co.
Although directed to DNA compounds, this Eli Lilly holding would be deemed to be applicable to any compound or a generic of compounds; which requires a representative sample of compounds and/or a showing of sufficient identifying characteristics; to demonstrate possession of the compound or generic(s). In this regard, applicant is further referred to University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997); “Guidelines for Examination of Patent Applications Under the 35 USC 112, first paragraph, ‘Written Description’ Requirement” published in 1242 OG 168-178 (January 30, 2001); and Univ. Of Rochester v G. D. Searle and Co. 249 F. Supp. 2d 216 (W.D.N.Y. 2003) affirmed by the CAFC on February 13, 2004 (03-1304) publication pending.
Additionally, Lilly sets forth a two part test for written description:
A description of a genus of cDNA’s may be achieved by means of a recitation of:
a representative number of cDNA’s, defined by nucleotide sequence, falling within the scope of the genus OR of a recitation of structural features common to the members of the genus.
See Regents of the University of California v. Eli Lilly & Co. 119 F.3d 1559 (Fed. Cir. 1997) at 1569.
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
Additionally, Cf. University of Rochester v G.D. Searle & Co., Inc., Monsanto Company, Pharmacia Corporation, and Pfizer Inc., No. 03-1304, 2004 WL 260813 (Fed. Cir., Feb. 13, 2004) held that:
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.
In the present instance, the specification discloses only limited examples that are not representative of the claimed genus of a “peptide” comprising a retro-inverso form of CX1X2X3C wherein X1 is R, K, I, G, A, or S; X2 is absent, G, A, R, K, I, or S; and X3 is A, G, or S; nor do the claims recite sufficient structural features which are common to members of the genus sufficient to demonstrate possession of the genus. The instant claims define the peptide as having improved stability in plasma compared to a “parent” counterpart without any requirement for what the “parent” is; improved stability in hepatocytes compared to a “parent” counterpart without any requirement for what the “parent” is; or improved ability to pass through the blood brain barrier compared to a “parent” counterpart without any requirement for what the “parent” is. There is no correlation between the structure of the “peptide” comprising a retro-inverso form of CX1X2X3C wherein X1 is R, K, I, G, A, or S; X2 is absent, G, A, R, K, I, or S; and X3 is A, G, or S and the claimed functions. The CAFC held that a functional definition is insufficient to adequately describe a product, therefore, an adequate written description not based on a functional definition is necessary.
The Examiner further notes the present claims stated by Applicant are broader in scope that those that were held to be impermissible in Lilly because, unlike Lilly, Applicants’ claims encompass a vast number of “peptides”. Here, the Applicant claims a variable peptide with only a common core of CXXC or CXXC. The scope of these claims include a large number of sequences due to the variable residues. In addition to the variable residues, the peptide should also contain 4-28 additional amino acids (i.e. core of CXXC with a length of 8-32mer) which can presumably be any amino acids. This could dramatically alter the function of the small peptide core of CXXC or CXXXC. The specification is silent with regard to how to control for the additional amino acids and retain the functions as recited in independent claim 1. In addition, the having improved stability in plasma compared to a “parent” counterpart; improved stability in hepatocytes compared to a “parent” counterpart; or improved ability to pass through the blood brain barrier compared to a “parent” counterpart claim language further exacerbates this problem because the conditions under which the various improvements in stability are not specified. Consequently, there is no teaching that would allow a person of skill in the art to determine a priori that the Applicant was in possession of the full scope of the claimed invention at the time of filing because there is no common structural attributes that can link together all of the claimed peptides which have improved stability in plasma compared to a “parent” counterpart; improved stability in hepatocytes compared to a “parent” counterpart; or improved ability to pass through the blood brain barrier compared to a “parent” counterpart.
While the general knowledge and level of skill in the art for peptides is high, this knowledge and level of skill does not supplement the omitted description because specific, not general, guidance is needed for the “peptide”. Since the disclosure fails to describe the common attributes or characteristics that identify all of the members of the genus or even a substantial portion thereof, and because the genus is vast and highly variant (e.g. variable residues plus the additional 4-28 amino acids), the limited examples in the specification (please refer to SEQ ID NOs: 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20) are insufficient to teach the entire genus.
The specification discloses only limited examples that are not representative of the claimed genus of a “peptide” with a CXXC or CXXC core along with the claimed functions; nor do the claims recite sufficient structural features which are common to members of the genus sufficient to demonstrate possession of the genus. SEQ ID NOs: 2, 6, 14, and 18 have a CARC core; SEQ ID NOs: 4, 8, 16, and 20 have a CGKC core; SEQ ID NO: 10 has a CAGRC core, and SEQ ID NO: 12 has a CGGKC core which is much more limited that the variable sequences present in independent claim 1 and dependent claim 2. Therefore, the teachings in the specification are general teachings relating without guidance as to the individual components of the product. In addition, there are numerous peptides that could be employed in the invention with little direction or guidance for one of skill in the art to practice the claimed invention. The expedient statements in the specification do not relate to an adequate disclosure or how to make and use the claimed invention. Consequently, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to adequately describe the vast genus. Thus, Applicant does not appear to be in possession of the claimed genus.
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, 2, and 22 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. One of skill in the art would not be able to determine the scope of the present peptide. For example, applicants should claim the peptide in the required orientation (i.e. CX3X2X1C) to avoid confusion. Applicants should also indicate which amino acids are in the D form. It is suggested that the preamble is changed to “A retro-inverso peptide”.
Claims 1, 2, and 22 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. One of skill in the art would not be able to determine the scope of the present peptide. For example, it is unclear what the “parent counterpart” is.
Claims 1, 2, and 22 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, independent claim 1 recites the broad recitation 8-32 amino acids, and the claim also recites 8-23 amino acids which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Please note: while the 8-23 amino acids limitation is optional, when the claims does require the limitation, the limitation is the narrower statement.
Claims 1, 2, and 22 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. One of skill in the art would not be able to determine the scope of the present peptide. For example, it is unclear what structure is required for the functions of (i)-(iii).
Claim 2 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. One of skill in the art would not be able to determine the scope of the present peptide. For example, applicants should claim the peptide in the required orientation (see (i), (ii), (iii), (iv)) to avoid confusion.
Claim 2 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. One of skill in the art would not be able to determine the scope of the present peptide. For example, (v) should indicate if the recited peptides of SEQ ID NOs: 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20 are in the retro-inverso form or not.
Claim 2 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. One of skill in the art would not be able to determine the scope of the present peptide. For example, the variable residue numbering is unduly confusing. While it is understood that applicants are attempting to preserve the X1X2X3 numbering from independent claim 1, variable residues should be consecutively claimed (e.g. X1, X2, X3, X4, X5, X6, etc.). See (i) – EX4CX1X2X3, (ii) – X5X6X7X8EX4CX1X2X3CAEX9X10X11, (iii) - X5X6X7X8EX4CX1X2X3CAEX9X10X11, (iv) – X12X13X14X15X16X17X18X19X20X21X22X23VX24ELKX25X26LX5X6X7X8EX4CX1X2X3CAEX9X10X11.
Claim 2 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. One of skill in the art would not be able to determine the scope of the present peptide. For example, it is unclear if the wherein clause is for (v) only or for any of (i)-(v).
Claims 29 and 32 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. . One of skill in the art would not be able to determine the scope of the present peptide. For example, it should be clearly recited in the claims that SEQ ID NOs: 14, 16, 18, and 20 are retro-inverso peptides. Utilization of “retro-inverso peptide” in the preamble is suggested.
Claim Rejections - 35 USC § 102
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.
Claims 1 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Currie et al. WO 2006/086653 published August 17, 2006.
For present claims 1 and 22, Currie et al. teach polypeptides comprising CXXC including SEQ ID NO: 7276 (12mer; CQNGACGGC) wherein carriers are utilized, D amino acids are utilized, and retro-inverso forms of the peptides are utilized to increase stability (please refer to the entire specification particularly pages 8, 13, 14, 20, 23, 44, 45).
Sequence: AOF58985 from: 1 to: 12
# (NOTE: this sequence has 2 duplicates in the database searched.
# See complete list at the end of this report)
# Description:
# ID AOF58985 standard; peptide; 12 AA.
# XX
# AC AOF58985;
# XX
# DT 01-MAY-2008 (first entry)
# XX
# DE Guanylate cyclase C receptor binding peptide SEQ ID NO: 7276.
# XX
# KW guanylate cyclase C receptor activating peptide;
# KW guanylate cyclase C receptor binding peptide; therapeutic;
# KW reproduction disorder; renal disease; pulmonary disease; obesity;
# KW neurological disease; liver disease; irritable bowel syndrome;
# KW inflammation; glaucoma; gastrointestinal disease;
# KW gastroesophageal reflux; gastric motility disorder;
# KW functional bowel disorder; ear disease; dyspepsia; constipation;
# KW congestive heart failure; cancer; benign prostatic hyperplasia;
# KW respiratory-gen.; ophthalmological; neuroprotective; nephrotropic;
# KW laxative; hepatotropic; gastrointestinal-gen.; cytostatic;
# KW cardiovascular-gen.; auditory; antiinflammatory; anorectic.
# XX
# OS Synthetic.
# OS Unidentified.
# XX
# CC PN WO2006086653-A2.
# XX
# CC PD 17-AUG-2006.
# XX
# CC PF 08-FEB-2006; 2006WO-US004768.
# XX
# PR 08-FEB-2005; 2005US-00054072.
# XX
# CC PA (MICR-) MICROBIA INC.
# XX
# CC PI Currie MG, Mahajan-Miklos S, Sun LJ, Kurtz C;
# XX
# DR WPI; 2006-569520/58.
# XX
# CC PT Novel purified polypeptide that activates guanylate cyclase C receptor,
# CC PT useful for treating diseases e.g. gastrointestinal disorders, obesity or
# CC PT congestive heart failure.
# XX
# CC PS Disclosure; SEQ ID NO 7276; 409pp; English.
# XX
# CC The invention relates to a purified polypeptide that activates the
# CC guanylate cyclase C (GC-C) receptor. The GC-C receptor is a key regulator
# CC of fluid and electrolyte balance in the intestine and kidney. The
# CC peptides of the invention bind to the GC-C receptor. Also described: (1)
# CC a composition comprising the polypeptide and a carrier; (2) treating (M1)
# CC a patient suffering from a gastrointestinal disorder, which involves
# CC administering to the patient a composition comprising a complete or
# CC partial agonist of the GC-C receptor; and (3) a nucleic acid encoding the
# CC polypeptide. The polypeptide is useful for treating a gastrointestinal
# CC disorder e.g. gastrointestinal motility disorder, irritable bowel
# CC syndrome, functional gastrointestinal disorder, gastroesophageal reflux
# CC disease, duodenal gastric reflux, functional heartburn, dyspepsia,
# CC functional dyspepsia, nonulcer dyspepsia, gastroparesis, chronic
# CC intestinal pseudo-obstruction or colonic pseudo-obstruction. The
# CC polypeptide is also useful for treating obesity, congestive heart
# CC failure, benign prostatic hyperplasia or constipation, increasing
# CC gastrointestinal motility in a patient, decreasing gastrointestinal pain
# CC or visceral pain in a patient, and increasing the activity of an
# CC intestinal GC-C receptor in a patient. The polypeptide is also useful for
# CC treating neurological disorders, pulmonary diseases, ear disorders,
# CC kidney disease, liver diseases, glaucoma, male or female reproductive
# CC disorders, inflammation or cancer, and identifying, detecting, staging or
# CC diagnosing diseases and conditions of small intestine. The present
# CC sequence represents a GC-C receptor activating peptide used in the
# CC exemplification of the present invention.
# XX
# SQ Sequence 12 AA;
#
# HitCount: 1
#
# Pattern_name Mismatch Pattern
# pattern 0 C[AGS][GARKIS](0,1)[RKIGAS]C
#
#=======================================
Length = 4
Start = position 9 of sequence
End = position 12 of sequence
Pattern = pattern:
C[AGS][GARKIS](0,1)[RKIGAS]C
CQNGACGGC
| |
9 12
Therefore, the teachings of Currie et al. anticipate the presently claimed retro-inverso peptide.
Claim Rejections - 35 USC § 103
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.
Claims 1, 2, 22, 29, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al. WO 2015/134485 published September 11, 2015 and Feng et al., 2016, Inspiration from the mirror: D-amino acid containing peptides in biomedical approaches, Biomol Concepts, 7(3): 179-187.
For present claims 1, 2, 22, 29, and 32, Schwartz et al. teach peptides consisting of EECRACAEK (9mer; 100% identity to the reverse of present SEQ ID NO: 14) and peptide bond modifications which increase stability and carriers (please refer to the entire specification particularly SEQ ID NO: 166; paragraphs 99, 111, 112, 247, 258, 262). Schwartz et al. also teach peptides comprising CKGC, CRAC, etc. (please refer to the entire specification particularly Tables 3, 4; sequence listing).
RESULT 1
BCE12213
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
ID BCE12213 standard; peptide; 9 AA.
XX
AC BCE12213;
XX
DT 05-NOV-2015 (first entry)
XX
DE Human neuroprotective CDNF protein active fragment SEQ ID NO:166.
XX
KW CDNF protein; auditory; cell death;
KW conserved dopamine neurotrophic factor; hearing disorder; hearing loss;
KW nausea; neuroprotective; prophylactic to disease; protein therapy;
KW therapeutic; tinnitus; toxicity; vertigo.
XX
OS Homo sapiens.
XX
CC PN WO2015134485-A1.
XX
CC PD 11-SEP-2015.
XX
CC PF 03-MAR-2015; 2015WO-US018470.
XX
PR 05-MAR-2014; 2014US-0948343P.
PR 25-NOV-2014; 2014US-0084279P.
XX
CC PA (COMM/) COMMISSIONG G.
CC PA (LOWE/) LOWE D A.
CC PA (SCHW/) SCHWARTZ L M.
CC PA (URFE/) URFER R.
XX
CC PI Commissiong G, Lowe DA, Schwartz LM, Urfer R;
XX
DR WPI; 2015-54080W/64.
DR REFSEQ; NP_001025125.
XX
CC PT Treating cell death-related hearing impairment and symptoms e.g. vertigo
CC PT and tinnitus, by administering neuroprotective peptide comprising
CC PT mesencephalic astrocyte-derived neurotrophic factor, or conserved
CC PT dopamine neurotrophic factor.
XX
CC PS Claim 25; SEQ ID NO 166; 110pp; English.
XX
CC The invention relates to a novel method of treating cell death-related
CC hearing impairment and symptoms. The method involves: administering a
CC neuroprotective peptide comprising mesencephalic astrocyte-derived
CC neurotrophic factor (MANF), or its fragment, or administering a
CC neuroprotective peptide comprising conserved dopamine neurotrophic factor
CC (CDNF), or its fragment to a subject in need thereof. The invention
CC further claims a method of preventing or treating ototoxicity. The cell
CC death-related hearing impairment and symptoms are chosen from hearing
CC loss, tinnitus, vertigo, instability or loss of balance and nausea. The
CC method does not cause adverse effects. The present sequence is a fragment
CC of the neuroprotective CDNF protein which is used in a method of treating
CC cell death-related hearing impairment.
XX
SQ Sequence 9 AA;
Query Match 100.0%; Score 51; Length 9;
Best Local Similarity 100.0%;
Matches 9; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EECRACAEK 9
|||||||||
Db 1 EECRACAEK 9
However, Schwartz et al. does not specifically teach retro-inverso peptides.
For present claims 1, 2, 22, 29, and 32, Feng et al. teach making retro-inverso peptides (D amino acids, reverse orientation) to increase stability while retaining activity (please refer to the entire reference particularly the abstract; Introduction).
All the claimed elements were known in the prior art (i.e. peptide EECRACAEK; retro-inverso peptides) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. utilization of D amino acids and reverse order does not alter activity of peptide) and the combination would have yielded predictable results (i.e. increased stability) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because the substitution of one known element (i.e. L amino acids, N-terminus to C-terminus orientation) for another (i.e. D amino acids, C-terminus to N-terminus orientation) would have yielded predictable results (i.e. increased stability) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because a particular known technique (i.e. making retro-inverso peptides) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has a good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc, 82 USPQ2d 1385 (U.S. 2007).
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/AMBER D STEELE/Primary Examiner, Art Unit 1658