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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14, in the reply filed on 1/29/26 is acknowledged.
Claims 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/29/26.
Applicant’s election without traverse of the following cyclic analog “species” – really a group of patentably indistinct species for initial search and examination given the allowed variables n and m, in the reply filed on 1/29/26 is acknowledged:
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This species/group was searched and found free of the art.
Claim 11 would be allowable if presented in an independent claim, or bases for rejection of the claims from which claim 11 depends from were overcome.
In accordance with MPEP 803.02 III A, the search was extended to a nonelected species, this species being SHDFRDHA, SEQ ID NO: 2, of US 9745347, inventor Rachel Bar-Shavit, published 8/29/2017.
The examiner has withdrawn all claims that do not read on this nonelected species. See MPEP 803.02 III A. The prior art search is not extended unnecessarily to cover all nonelected species. Claims 2-13 are withdrawn as not reading on the above-indicated nonelected species.
Claim Status
Claims 1-21 are pending.
Claims 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/29/26.
Claims 2-13 are withdrawn as not reading on the above-indicated nonelected species.
Claims 1 and 14 are pending and under examination.
Claims 1 and 14 are rejected.
Priority
The instant application, filed 05/24/2023 is a Continuation in Part of 17431867 , filed 08/18/2021, now abandoned
PCT/IL20/50185 Claims Priority from Provisional Application 17431867 , filed 08/18/2021, now abandoned
17431867 is a National Stage entry of PCT/IL2020/050185 , International Filing Date: 02/19/2020
PCT/IL2020/050185 Claims Priority from Provisional Application 62808325 , filed 02/21/2019
PCT/IL2020/050185 Claims Priority from Provisional Application 63345454 , filed 05/25/2022
Information Disclosure Statement
The Examiner has considered the reference(s) provided in the 7/28/23 Information Disclosure Statements (2 forms provided), and provides a signed and dated copy of each herewith.
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 and 14 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.
The claim 1 peptide that comprises an amino acid SZ1Z2FRDZ3 (or a salt or cyclic analog thereof) is unclear and indefinite based on the following:
The metes and bounds of Z1’s “a modified Ala” or “a modified Gly” are unclear because there are no definitions in the specification nor clear indications in the claims in what way(s) the alanine and/or glycine at the Z1 position are modified. Modified in a broad sense can result in entirely different amino acids as well as non-amino acid chemical structures, however this does not appear to be what applicant intends nor what the examples and disclosure are directed to.
The terms "negatively charged amino acid' and "positively charged amino acid' are not clear since amino acid charge depends on the surrounding pH. See Sigma Amino Acid chart, 2014, 3 pages, which on page 2 table shows the pK values of the amino acids, the pKx for the side groups, so that at pH values above or below the respective pKx values the charge of the respective amino acid would differ. Additionally, it is unclear if only a portion, or the net charge, of the amino acid needs to be negatively charged for Z2, and positively charged for Z3.
Claim 1, and claim 14 that depends from claim 1 but do not overcome the above bases for rejection of claim 1, are rejected as indefinite.
Claim 14 recites the limitation "the conjugate thereof" in 2. There is insufficient antecedent basis for this limitation in the claim. This might be due to improper claim dependence, such that amendment to depend from claim 13 would overcome this basis of rejection. However, for purposes of the current examination, claim 14 is interpreted as written, depending directly from claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. Claim 1 recites a genus of peptides that encompass a natural product peptide, this based on applying interpretations of Z1, Z2 and Z3, see rejection immediately above, this natural product set forth in Haavarstein et al., PNAS (1995), 92(24), 11140-4, copy provided, as the peptide H-Glu-Met-Arg-Leu-Ser-Lys-Phe-Phe-Arg-Asp-Phe-Ile-Leu-Gln-Arg-Lys-Lys-OH. This meets a claim 1 peptide that consists of 7 to 25 amino acids where Z1 is so modified to result in a Lysine, Z2 is Phenylalanine, which comprises a local negative charge at the C-terminus above pH 1.83, and as to Z3 where the N-terminus has a positive charge through the middle pH range including pH 5-8. This judicial exception is not integrated into a practical application because only the linear peptide is claimed in claim 1. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional limitations set forth in claim 1, and being the same peptide as found in nature there is no basis for a markedly different characteristic or property.
The following sets forth the analysis:
Step 1: YES, claim 1 is directed to a composition, so one of the four statutory categories.
Step 2A, Prong 1: YES, claim 1 encompasses a natural product, the peptide H-Glu-Met-Arg-Leu-Ser-Lys-Phe-Phe-Arg-Asp-Phe-Ile-Leu-Gln-Arg-Lys-Lys-OH.
Step 2A, Prong 2: NO, claim 1 does not recite additional elements that integrate the judicial exception into a practical application – there is nothing else in the claim.
Step 2B: NO, claim 1 does not recite additional elements that amount to significantly more than the judicial exception - there is nothing else in the claim.
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.
Claim(s) 1 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 9745347, inventor Rachel Bar-Shavit, published 8/29/2017 (‘347).
Claim 1 is direct to a peptide comprising an amino acid sequence SZ₁Z₂FRDZ₃ (SEQ ID NO: 2), a salt or a cyclic analog thereof, wherein said peptide consists of 7 to 25 amino acids, Z₁ is an amino acid residue selected from alanine (Ala), a modified Ala, glycine (Gly), and a modified Gly; Z₂ is a negatively charged amino acid; and Z₃ is a positively charged amino acid.
Based on the lack of clarity and possible breadth of “modified Ala” and “modified Gly”, Z1 encompasses any amino acid, see rejection above. Similarly there is no clear metes and bounds as to what are included or excluded by negatively charged or positively charged amino acids, see rejection above.
The ‘347 teaches the amino acid sequence SHDFRDHA, its SEQ ID NO: 2, see paras 20, 41, 58, and elsewhere.
Because the “modified Ala” and/or “modified Gly” of Z1 encompasses any amino acid, Histidine in the ‘347 SEQ ID NO:2 peptide meets this requirement. Similarly, as to Z3, Histidine comprises at its N-terminus a group that is positively charged across the mid-range of pH values, 5-8. The Z2 aspartic acid not only comprises a negative C-terminus across this pH range, but its side group COOH also is negatively charged across this pH range.
Based on the above, claim 1 lacking clearer meaning of its variable positions, the ‘347 anticipates claim 1.
The ‘347 teaches pharmaceutical compositions of its peptides including that corresponding to SEQ ID NO:2, see paras 20 and 41, and also para 25, so anticipates instant claim 14.
Examiner Comments
To advance prosecution, the examiner notes the following apparent inconsistency in claim 4 that is not under current examination.
Claim 4 appears unclear or an improper dependent claim given that in its (i) the cyclic analog comprises the amino acid sequence of SEQ ID NO:1 appears more expansive as to its Z1 alternatives than claim 1’s SEQ ID NO:2’s Z1. The second, Z1, position of claim 4’s SEQ ID NO:1 appears broader than the Z1 of claim 1’s SEQ ID NO:2 by stating “a hydrophobic amino acid, a modified hydrophobic amino acid, glycine, a modified glycine or histidine”, whereas claim 1’s SEQ ID NO:2’s sequence listing description of its position 2 Z1 is “Ala, modified Ala, Gly, or a modified Gly.” The examiner does not know if this is an oversight or alternatively that, perhaps, both SEQ ID NO:1 and SEQ ID NO:2 peptides are separately part of the peptide of claim 4. Applicant may consider explanation and/or amendment to advance prosecution.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH FISCHER whose telephone number is (571)270-7925, and whose direct facsimile number is (571)270-8925. The examiner can normally be reached on Monday to Friday, 9:00 AM to 5:00 PM, however noting that the examiner will not normally be working on Monday/Tuesday and on Wednesday-Friday on alternating weeks, but will promptly answer messages upon his return to work.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached on 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH FISCHER/Primary Examiner, Art Unit 1658