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 and Claim Status
Applicants’ amendments and arguments filed 12/31/25 are acknowledged. Any objection or rejection from the 10/2/25 office action that is not addressed below is withdrawn based on the amendments.
Previously, the species of SEQ ID NO:10 was elected and applicants stated that claims 1-2, 6-7 and 17-20 read on the elected species.
Claims to the elected species are rejected as set forth below. Any relevant art that was uncovered during the search for the elected species is cited herein in order to advance prosecution.
Claims 3-5 and 8-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/12/25.
Claims 1-2, 6-7 and 17-20 are being examined.
Priority
The priority information is found in the filing receipt of 2/23/23.
Drawings
The drawings are objected to because pages 5-11 of the specification refer to figures 1-216. However, the current drawings file of record only includes figures 150-216. Figures 1-149 are not included in the same file with figures 150-216 (they seem to have been included as document type ‘Documents submitted with 371 (National Stage) Applications’). The drawings should all be included in one file. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Response to Arguments - Drawings
Applicant's arguments filed 12/31/25 have been fully considered but they are not persuasive.
Although applicants argue that the drawings have been published, MPEP 608.02(i) recognizes that publication standards are not the same. The current issue is that the drawings are not all provided in the ‘drawings’ file. MPEP 608.02(p) recognizes that the USPTO does not make drawing changes.
Claim Rejections - 35 USC § 112
This 112 rejection is a new rejection necessitated by amendment.
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, 6-7 and 17-20 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 that Z1 to Z4 are selected from a group that includes Gly, Phe, Tyr and His. The claim then goes on to refer to various (Z1)e-(Z2)f and (Z3)g-(Z4)h (none of which include Gly, Phe, Tyr or His). 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, claim 1 recites the broad recitation Gly, Phe, Tyr and His as options for Z1 to Z4, and the claim also recites various (Z1)e-(Z2)f and (Z3)g-(Z4)h (none of which include Gly, Phe, Tyr or His) 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. None of dependent claims 2 and 17-20 are included in the instant rejection.
Although unclear, the claims have been given the broadest reasonable interpretation. Since claim 1 expressly recites that Z1 to Z4 are selected from a group that includes Gly, Phe, Tyr and His such residues are interpreted as being acceptable for Z1 to Z4.
Claim 1 has been amended to recite ‘a hydrogen (H) in the benzene ring of Tyr may be substituted’. The chemical formula for benzene is C6H6. Tyrosine does not contain C6H6 (one of the H is replaced with OH and another of the H is replaced with C). Since there are not 6 hydrogens in the ring of tyrosine, it is unclear what are acceptable locations for substitution. For example, it is unclear if the H of the OH group of tyrosine can be substituted. None of dependent claims 2, 6-7 and 17-20 clarify the claim scope.
Response to Arguments -112
Applicant's arguments filed 12/31/25 have been fully considered but they are not persuasive.
Although applicants argue that the claims have been amended, the amended claims are addressed above.
Claim Rejections - 35 USC § 101
Since the claims have been amended, specifically ‘wherein at least three of….’ The rejection is updated to correspond to the instant claims.
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.
Claims 1-2, 6 and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (product of nature) without significantly more. The claim(s) recite(s) peptides/compositions which correspond to products of nature (as discussed in detail below). This judicial exception is not integrated into a practical application because there is no additional elements that apply or use the judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception as discussed below.
This 101 rejection is consistent with the most recent training provided by the office which will be referred to as 'guidance' (see MPEP 2106).
In comparison to the subject matter eligibility test as set forth in the guidance, the claims are drawn to peptides/compositions. Thus the answer to step 1 is yes.
GENBANK entry (retrieved from https://www.ncbi.nlm.nih.gov/protein/MBR6371970.1?report=genbank&log$=protalign&blast_rank=1&RID=UKD5PKAW016 on 3/5/26, 2 pages) teach that DKNWIWVLWN (residues 2-11) correspond to a bacterial protein. Such sequence contains WIWVLW as in claim 6 and comprises formula I where X1 is D; X2 is K; X3 is N; Z1 is I; Z3 is V; Z4 is L; X5 is N; a, b, c, e, g, h, and i are 1; d, f, j, k and l are 0. N’ encompasses a natural N-terminus and C’ encompasses an amine group which could be part of an amide bond. Thus in relation to prong one of step 2a of the guidance the answer is yes because the peptides correspond to fragments of known proteins (i.e. products of nature which are a natural phenomenon).
In relation to prong two of step 2a, the instant claims are product claims and do not require any additional elements that apply the judicial exception in a manner that imposes a meaningful limit on the judicial exception. Thus the answer to prong two of step 2a is no.
The instant claims recite SEQ ID NO:9 which is a fragment of known proteins. The Myriad Supreme Court decision (Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 12-398 (2013)) stated: “Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together” (page 2 and 14). In the instant case, applicants’ claims are not saved by the fact that the peptides of the instant claims correspond to fragments (the protein with severed bonds).
In relation to step 2b, claims 17-20 refer to compositions. The compositions can correspond to the peptide in water which itself is naturally occurring. The claims do not require any additional features that add significantly more to the exceptions.
The instantly claimed compositions are like the novel bacterial mixture of Funk Brothers which contained multiple naturally occurring components, which was held ineligible because each species of bacteria in the mixture (like each component in the peptide composition) continued to have “the same effect it always had”, i.e., it lacked markedly different characteristics. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948), discussed in Myriad Genetics, 133 S. Ct. at 2117 (explaining that the bacterial mixture of Funk Brothers “was not patent eligible because the patent holder did not alter the bacteria in any way”).
Further, there is no evidence of any markedly different characteristic. There is no indication that mixing of the peptide and an excipient (such as water) changes the structure, function or other properties of the peptide or the water. MPEP 2106.04(c) II C recognizes that a change cannot be an inherent or innate characteristic on the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. The claims clearly tie up practical applications. Thus the answer to step 2b is no because there is not adequate evidence to conclude that the claims include significantly more than the judicial exception.
Response to Arguments -101
Applicant's arguments filed 12/31/25 have been fully considered but they are not persuasive.
Although applicants argue that the claims have been amended, the amended claims are addressed above.
Although applicants argue about Ex parte Ezerzer, such decision states “we find that the “markedly different” analysis supports the conclusion that the peptides are patent eligible, we provide a more limited discussion of the judicial exception analysis”. As such, the judicial exception analysis alone does not appear to be the deciding factor.
Although applicants argue that the peptides were synthetically produced compositions, MPEP 2106.04(b) II states:
“It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g., Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 ("Contrary to Myriad's argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible."). “
In the instant case, as set forth in the 101 rejection the subject matter eligibility test for products and processes as set forth in MPEP 2106 (specifically the flowchart in MPEP 2106 III) was followed. Importantly, as set forth in MPEP 2106.04(b) II product of nature exceptions include non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart.
With respect to the Myriad case, MPEP 2106.04(c) states:
“In sum, the claimed genes were different, but not markedly different, from their naturally occurring counterparts (the BRCA genes), and thus were product of nature exceptions.” Thus, any difference from a naturally occurring counterpart does not automatically exclude from being a product of nature. It appears that applicants are requiring a different test or standard as to what is expressly set forth in the MPEP (and is different from what the courts have used).
Although applicants argue about functional properties, MPEP 2106.04(c)II recites how to perform the markedly different characteristic analysis and MPEP 2106.04(c)II A states “Because the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product”. It is unclear what is actually being compared.
Although applicants argue about Myriad, MPEP 2106.04(c) states:
“The Supreme Court concluded that these isolated but otherwise unchanged genes were not eligible, because they were not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring BRCA genes. See, e.g., Myriad, 569 U.S. at 585, 106 USPQ2d at 1977 ("Myriad's patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes … But isolation is necessary to conduct genetic testing") and 569 U.S. at 593, 106 USPQ2d at 1980 (describing how would-be infringers could not avoid the scope of Myriad’s claims). In sum, the claimed genes were different, but not markedly different, from their naturally occurring counterparts (the BRCA genes), and thus were product of nature exceptions.” In the instant case, the peptides and their naturally occurring counterparts share identical amino acid sequences so there is no basis to conclude that anything has been created or altered.
Claim Rejections - 35 USC § 102
Claims were previously rejected based on the reference cited below. Since the claims have been amended, the rejection is updated to correspond to the instant claims.
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) 1-2 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shin SY (‘Design of short indolicidin analogs with enhanced prokaryotic selectivity’ Korean J Microbiol Biotechnol v40(4) 2012 pages 409-413; ‘Shin’; first cited 10/2/25).
Shin teach the peptide RRWAWWAWRR-NH2 (Arg-Arg-Trp-Ala-Trp-Trp-Ala-Trp-Arg-Arg-NH2) (Table 1 where it is named SI-PA). Shin teach antimicrobial activity of the peptide including against bacteria (Table 2) in which peptide solutions were used (paragraph connecting columns 1-2 on page 410).
In relation to the peptide of claims 1-2, Shin teach the peptide RRWAWWAWRR-NH2 (Arg-Arg-Trp-Ala-Trp-Trp-Ala-Trp-Arg-Arg-NH2) (Table 1 where it is named SI-PA) which is of instant formula I where X1, X2, X5 and X6 are Arg; Z1 is Ala; Z3 is Trp; Z4 is Ala; a, b, e, g, h, i and j are 1; c, d, f, k and l are 0 (so at least a, b and j are 1; at least c, d and k are 0). Shin teach antimicrobial activity of the peptide including against bacteria (Table 2). Although unclear, the claims have been given the broadest reasonable interpretation. Since claim 1 expressly recites that Z1 to Z4 are selected from a group that includes Ala, Trp, Gly, Phe, Tyr and His such residues are interpreted as being acceptable for Z1 to Z4.
In relation to claims 17-20, Shin teach antimicrobial activity of the peptide including against bacteria (Table 2) in which peptide solutions were used (paragraph connecting columns 1-2 on page 410).
Response to Arguments -102
Applicant's arguments filed 12/31/25 have been fully considered but they are not persuasive.
Although applicants argue that the claims have been amended, the amended claims are addressed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 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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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658