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 3-5, 13, 17-18, 20, and 28-33 are pending. Claims 3, 13, 20, 28, and 33 were amended in the response filed 06/03/2026. Claims 4, 18, 20, 28, and 30-33 are withdrawn. Claims 3, 5, 13, and 17 are presently considered.
Election/Restriction
Applicant's election with traverse of Group I (claims 3-5, 13, and 17-18) and SEQ ID NO: 7 in the reply filed on 06/03/2026 is acknowledged. The traversal is on the grounds that the restriction requirement did not satisfy the grounds of MPEP § 806.05(j), and that the species have similar structures (see, e.g., Reply filed 06/03/2026 at 6-8).
This is not found persuasive because the restriction properly addressed the previously pending claim scope, which was drawn to homologous structures, where sequence homology is distinct in the art relative to sequence identity and sequence similarity1. Notably, two sequences may be homologous but share less than 10% sequence identity; accordingly, Applicant’s traversal is not persuasive because Applicant fails to address or acknowledge that US 5,691,3102 pertained to homologous sequences as previously claimed. Regarding the species election requirement, Applicant erroneously references “the five sequences”, which fails to acknowledge that the prior claim scope read upon potentially millions of “homologous” sequences, not just five. Even following the narrowing amendment filed 6/03/2026 that limited the claim scope to sequence identity, instant claim 3 continues to read upon over 800,000 sequences in total3, wherein each may “further” comprise N- and C-terminal extensions, without limitation. Accordingly, arguments erroneously based upon the incorrect assumption that the claim scope is limited to “five sequences” are not persuasive because such arguments do not actually reflect the current or previously pending claim scope. Furthermore, arguments alleging similar “secondary structures” derived by “disulfide bonds between the cysteine residues” are not persuasive because such structures are not actually required to be shared by all 800,000+ sequences because the instant claims encompass variants sharing only 90% sequence identity, which includes variants lacking any cysteine residues at all in common with instant SEQ ID NOs: 3-7. Accordingly, such arguments are not persuasive because they do not actually reflect the pending claim scope or otherwise provide evidence/admissions that such species are all obvious variants of each other.
The requirement is still deemed proper and is therefore made FINAL.
The originally elected subgenus of patentably indistinct species is understood to be consist of instant SEQ ID NO: 74 (CAS Reg No. 3032754-69-8) in combination with any carrier, which is understood to read upon instant claims 3, 5, 13, and 17. No “at least one modification” was identified as required by instant claim 4; no additional agent as required by claim 18 was identified as present. Accordingly, the originally elected species does not read upon instant claims 4 or 18.
Following extensive search and examination, the originally elected species consisting of instant SEQ ID NO: 7 has been deemed free of the prior art. Per MPEP § 803.02(III)
If the examiner determines that the elected species is allowable over the prior art, the examination of the Markush claim will be extended. If prior art is then found that anticipates or renders obvious the Markush claim with respect to a nonelected species, the Markush claim shall be rejected; claims to the nonelected species would still be held withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species.
Accordingly, Examination was extended to a non-elected species of SEQ ID NO: 35 (CAS Reg No. 3032754-65-4); Following extensive search and examination, the non-elected species was deemed anticipated and/or obvious in view of the prior art as applied below.
Per MPEP § 803.02(III), claims directed to other nonelected species have been withdrawn, and examination has not been extended beyond the species of sequences consisting of instant SEQ ID NO: 7 and SEQ ID NO: 3 at this time.
Claims 20 and 28-33 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. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/03/2026.
Claims 4 and 18 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. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/03/2026.
Accordingly, claims 3, 5, 13, and 17 are presently considered.
Priority
The priority claim to US Provisional 63/407798, filed 9/19/2022 is acknowledged.
Information Disclosure Statement
The IDS filed 10/03/2024 and 06/03/2026 are each acknowledged and presently considered.
Regarding the IDS filed 10/03/2024, Applicant is advised that the MPEP states the following with respect to large information disclosure statements:
Although a concise explanation of the relevance of the information is not required for English language information, applicants are encouraged to provide a concise explanation of why the English-language information is being submitted and how it is understood to be relevant. Concise explanations (especially those which point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more are highly relevant to patentability.
(see MPEP § 609.04(a)(III)).
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant' s attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff' d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974).
(see MPEP § 2004 at item 13).
These statements are in accord with Molins PLC v. Textron, Inc. (33 USPQ 2d 1823 (1995); 48 F.3d 1172 (Fed. Cir. 1995)), which stated that “'burying' a particularly material reference in a prior art statement containing a multiplicity of other references can be probative of bad faith” (Id. at 1831), wherein the case presented a situation where the disclosure was in excess of 700 pages and contained more than 50 references. Here, the instant IDS cites in excess of 2000 pages and contains hundreds of references. Furthermore, numerous references appear to, at best, be tangentially related to the instantly claimed invention.
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Claim 3 is representative of the pending claim scope and is understood to recite and encompass any sequence sharing at least 90% sequence identity to instant SEQ ID NOs: 3-7. Therefore, instant claim three reads upon hundreds of thousands of sequences, including sequences consisting of SEQ ID NO: 46 (CAS Reg No. 3032754-66-5); SEQ ID NO: 57 (CAS Reg No. 3032754-67-6); or SEQ ID NO: 68 (CAS Reg No. 3032754-68-7); as well as all species comprising any one of SEQ ID NOs: 3-7; and as well as any species sharing 90% sequence identity with SEQ ID NOs: 3-7. The claims do not require sequences sharing “at least 90% sequence identity to instant SEQ ID NOs: 3-7” to comprise cysteine residues or maintain any consensus motif.
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
“Consisting of” excludes any elements, step, or ingredient not specified (see, e.g., MPEP § 2111.03(II)). When the phrase "consists of" appears in a clause of the body of a claim, rather than immediately following the preamble, the "consisting of" phrase limits only the element set forth in that clause; other elements are not excluded from the claim as a whole (see, e.g., MPEP § 2111.03(II)).
Additional claim interpretations are discussed below.
Specification
Sequence Listing: The instant disclosure is objected to for not complying with 37 C.F.R. 1.821 as detailed in MPEP §§ 2421–2424. Specifically, the instant application does not comply with 37 C.F.R. 1.821(b)-(e). The instant claims and/or disclosure contain references or disclosures of amino acid sequences that should be accompanied by a sequence listing and identified using "SEQ ID NOs” as prescribed (see, MPEP §§ 2421–2424). Specifically, the instant application discloses a sequence at ¶[0087] of the Specification filed 9/15/2023 that should be accompanied by a SEQ ID NO.
Appropriate correction is required.
Claim Rejections
Claim Rejections - 35 USC § 112(a), Scope of Enablement
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 3, 13, and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for natriuretic peptides comprising a consensus motif of CFGXXXDRIXXXSXLGC9, does not reasonably provide enablement for all possible sequences sharing “at least 90% sequence identity with any one of SEQ ID NOs: 3-7”. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
As explained at MPEP § 2164, the enablement requirement of 35 U.S.C. 112(a) requires that the specification describe both “how to make” and “how to use” the invention. Here, the invention is directed to hundreds of thousands of peptides10, and although it is well-within the ordinary skill in the art to make peptides, it is unclear “how to use” numerous sequences, because’ although sequences sharing the consensus motif of
CFG[GHRL][RK][MLI]DRI[GSN][ASH][QSMV]S[GTN]LGC
would presumably act as natriuretic peptides (see, e.g., US20120108514A1 at ¶[0018], SEQ ID NO: 14, disclosing the art-recognized consensus motif “common to natriuretic peptides”), all other sequences within the scope of instant claims 3, 13, and 17 lacking this consensus motif structure appear to have no known use in the prior art, and the instant specification fails to provide evidence that such peptides do, in fact, act as natriuretic peptides, or otherwise have some other use. Accordingly, the instant application fails to satisfy the requirement of 35 USC §112(a) because it fails to describe “how to use” such claimed polypeptides.
Although the claimed genus at instant claims 3, 13, and 17 circumscribe a genus of hundreds of thousands of different peptide sequences11, the instant specification only exemplifies five highly related sequences (e.g., instant SEQ ID NOs: 3-7), which share substantial sequence identity with one another:
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As shown in the multiple sequence alignment above, instant SEQ ID NOs: 3-7 all comprise invariant subsequences of “SLRRSSCFGHKIDRINHVS” and “LGCNSFRYRITAREDKQGWA” (i.e., 39 invariant residues). Accordingly, relative to instant SEQ ID NO: 3, 39/40 residues appear invariant (97.5%) relative to all other tested sequences. Furthermore, instant SEQ ID NO: 3 shares 40/40 residues (100%) in common with instant SEQ ID NOs: 6 and 7.
This common sequence of 40/40 invariant residues shared among SEQ ID NOs: 3, 6, and 7 is relevant because only SEQ ID NO: 3 (i.e., CRRL 101) and SEQ ID NO: 7 (i.e., CRRL 191) were actually tested and shown to have any natriuretic peptide activity (see, e.g., Specification filed 9/15/2023 at ¶¶[0019]-[0033], [0045], Figs. 2-6, 7C, Fig. 8-Fig. 9). This is relevant because the claimed polypeptides are presumably disclosed for use as natriuretic peptides (see, e.g., Specification filed 9/15/2023 at ¶¶[0004]-[0006], passim), but the prior art teaches that the art-recognized consensus motif “common to natriuretic peptides” is the 17-mer sequence of
CFG[GHRL][RK][MLI]DRI[GSN][ASH][QSMV]S[GTN]LGC
(see, e.g., US’514 at ¶[0018], SEQ ID NO: 14). Critically, instant SEQ ID NOs: 4-5 lack this common 17-mer consensus structure, but instead comprise 18-mer sequences. For purposes of the instant rejection, presumably SEQ ID NOs: 4-5 are enabled. Therefore, for purposes of the instant rejection, an artisan is presumed enabled to make and use natriuretic peptides that (A) comprise both “SLRRSSCFGHKIDRINHVS” and “LGCNSFRYRITAREDKQGWA” (e.g., instant SEQ ID NOs: 3-7) or otherwise (B) comprise the 17-mer consensus motif (encompassing 2,592 species of 17-mers) shared by natriuretic peptides (see, e.g., US’514 at ¶[0018], SEQ ID NO: 14). However, the instant claim scope encompasses hundreds of thousands of sequences12 that do not fall within the subgenera of (A) or (B), and those sequences have no clear use on record or in the prior art, because such sequences would not be recognized as natriuretic peptides on the instant record.
Zero functional sequences and zero functionality has been identified or shown for sequences that do not satisfy (A) or (B) as set forth in the preceding paragraph. This is pertinent as explained above because such peptides would not be reasonably assumed by an artisan to be usable as a natriuretic peptides (see, e.g., Specification filed 9/15/2023 at ¶¶[0004]-[0006], passim; see also, US’514 at ¶[0018], SEQ ID NO: 14). Therefore, it is unclear on the instant record and the prior art how to use the full scope of claimed sequences, because these hundreds of thousands of sequences lack any known usage in view of the prior art.
Therefore, an artisan would be unduly burdened to make and test each sequence (i.e., >>100,000) to assay for functionality, or otherwise to novelly discover additional modifications to the art-recognized consensus sequence, which may or may not even be possible. Although the skill in the art is arguably high, an artisan would not reasonably conclude that a peptide sequence lacking the art-recognized consensus motif “common to natriuretic peptides” would act as a natriuretic peptide in the absence of objective supporting evidence commensurate in scope with the pending claim scope. Here, no such evidence has been made of record.
Therefore, in view of the lack of guidance and working examples, high degree of unpredictability, and failure to address the concerns present in the art, an artisan would be unduly burdened with experimentation in order to practice the full scope of the instantly claimed invention, because the originally filed disclosure fails to describe “how to use” the full scope of claimed polypeptides.
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 potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3, 5, 13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over in view of Meems et al.13 in view of US20120108514A1 (Burnett et al.; May 2, 2012).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claims 3, 5, 13, 17, and natriuretic polypeptides, generally, Meems identifies that “Designer natriuretic Peptides” (NPs) were known in the prior art, wherein such peptides were understood to be “of value in diagnosis, prognosis, and treatment of CV disease” (see, e.g., Meems at title, abs, 5580559 at bridging ¶, Figure 1 on 559). Meems discloses the designer NP of MANP (see, e.g., Meems at 559 at Fig. 1, reproduced in part below):
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This structure has the sequence
SLRRSSCFGGRMDRIGAQSGLGCNSFRYRITAREDKQGWA14,
which shares 83% sequence identity with instant SEQ ID NO: 3:
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Regarding instant claims 13, 17, and a pharmaceutically acceptable excipient, in view of the disclosure that MANP could be utilized for HF (heart failure) and HTN (hypertension) (see, e.g., Meems at 557 at abs, 557 at col I, 564 at col II at §§ “MANP FOR HTN” to 564 at col II at 1st partial ¶), and in view of in vivo testing (see id. at 565 at col I), an artisan would readily envisage the peptide of MANP in combination with a pharmaceutically acceptable excipient as required to arrive at a composition suitable for use in in vivo applications.
The prior art of Meems differs from the pending claim scope as follows: The compound of MANP as disclosed by Meems only differs from instant SEQ ID NO: 3 with respect to the cyclic portion of MANP (i.e., the cyclic portion of MANP is “CFGGRMDRIGAQSGLGC”, but the cyclic portion of instant SEQ ID NO: 3 is “CFGHKIDRINHVSNLGC”). Therefore, the relevant issue is whether or not this difference is obvious in view of the prior art.
This exact cyclic sequence was already known in the art and corresponded to the cyclic portion of another NP, namely DNP: The cyclic portion of instant SEQ ID NO: 3 corresponds directly to the cyclic portion of the NP of DNP (compare instant SEQ ID NO: 3 with Meems at 559 at Figure 1 showing DNP, noting that the cyclic portion of DNP and instant SEQ ID NO: 3 are identical and are each “CFGHKIDRINHVSNLGC”, sharing 100% sequence identity). Both DNP and MANP are natriuretic peptides that target the same receptor, namely pGC-A (see, e.g., Meems at Figure 1 on 559), and therefore would reasonably be understood to be functional equivalents. Accordingly, instant SEQ ID NO: 3 is understood to be a MANP variant, wherein the cyclic portion of DNP is simply substituted in place of the cyclic portion of MANP:
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Therefore, the relevant issue is whether or not such chimeric natriuretic peptides, made by combining different portions of known natriuretic peptides, were routine and predictable in the prior art.
US’514 establishes that it was routine in the art to create chimeric natriuretic peptides by combining an N-terminal tail, ring structure, and C-terminal tail sequence from known natriuretic peptides: US’514 explains that “chimeric natriuretic polypeptides” were well-known in the prior art, circa 2012, and could be crated by combining “a ring structure and cysteine bond from one natriuretic peptide . . . in combination with one or more amino acid segments from another natriuretic polypeptide”, which could include N-terminal and C-terminal tail sequences (see, e.g., US’514 at ¶¶[0018], [0026], Fig. 1A-1B, claims 1, 5-6, 10, 11). Accordingly, simply combining or substituting the ring structure of DNP in place of the ring structure of MANP to obtain a chimeric natriuretic peptide was routine in the prior art, and would have been predicted and expected to yield a natriuretic peptide usable in the methods and applications disclosed by US’514 (see, e.g., US’514 at claims 1, 5-6, 10, 11).
US’514 establishes that the ring structure of natriuretic peptides formed an art-recognized consensus motif: US’514 identifies that the ring structures of “chimeric natriuretic polypeptides” formed an art-recognized consensus motif “common to natriuretic peptides”, namely “CFGXXXDRIXXXSXLGC” (see, e.g., US’514 at ¶[0018], SEQ ID NO: 14). This is pertinent because SEQ ID NO: 14 defines each “X” position as
CFG[GH][RK][MI]DRI[GN][AH][QV]S[GN]LGC
Wherein brackets indicate alternative residues at a single position (see, e.g., US’514 at SEQ ID NO: 14). Accordingly, SEQ ID NO: 14 of US’514 is understood to define a consensus motif of functionally equivalent sequences “common to natriuretic peptides” (see, e.g., US’514 at SEQ ID NO: 14).
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s):
First, the claimed invention is the simple combination of prior art elements (e.g., a known “ring structure”, N-terminal tail, and C-terminal tail of natriuretic polypeptide MANP and DNP as taught by Meems and the US’514) according to known methods of forming “chimeric natriuretic polypeptides” as taught and suggested by US’514, wherein such combination would predictably yield a MANP variant comprising the cyclic portion of DNP and the N- and C-tail of MANP (i.e., instant SEQ ID NO: 3), wherein such resulting “chimeric natriuretic polypeptides” would be predicted and expected to be a natriuretic polypeptide usable in the methods and applications taught and disclosed by the prior art; furthermore, each prior art element would be expected to perform its art-recognized function in combination as it does alone (see, e.g., MPEP § 2143(I)(A)).
Second, or alternatively, the claimed invention is the simple substitution of one known species of consensus motif “common to natriuretic peptides” (i.e., “CFGGRMDRIGAQSGLGC” as present in the NP of MANP) for another species of consensus motif “common to natriuretic peptides” known in the prior art (i.e., “CFGHKIDRINHVSNLGC” as present in the NP of DNP), wherein such simple substitution would yield predictable results, namely a “chimeric natriuretic polypeptides” as taught and suggested by US’514, which would wherein such combination would predictably yield a MANP variant and “chimeric natriuretic polypeptides”, which would be predicted and expected to be a natriuretic polypeptide usable in the methods and applications taught and disclosed by the prior art (see, e.g., MPEP §§ 2143(I)(B); 2144.06(II)).
Accordingly, the claimed invention is obvious under one or more rationales set forth in the MPEP. As noted by the Court, "[W]hen a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious" (see, e.g., KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 , 417 , 127 S. Ct. 1727 , 167 L. Ed. 2d 705 (2007) (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273 , 282 , 96 S. Ct. 1532 , 47 L. Ed. 2d 784 (1976)), and here the claimed invention is the rearrangement of old portions of known natriuretic polypeptides to create a chimeric natriuretic polypeptide that would predictably and expectedly act as a natriuretic polypeptide.
No evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record to date.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well-within the ordinary skill in the natriuretic peptide arts to combine known portions of known natriuretic peptides in known arrangements to predictably and expectedly obtain natriuretic peptides usable in known methods.
Accordingly, claims 3, 5, 13, and 17 are rejected.
Examiner Notes
Examiner notes that claim 4 has not been examined on the merits at this time, but appears to be indefinite as it refers to a modification presumably relative to some structure, but the claim fails to actually identify what structure is being referenced implicitly. Applicant is advised that, upon examination, this would be reasonably expected to raise issues under 35 USC §112.
Examiner notes that claim 28 has not been examined on the merits at this time, but appears to lack enablement with respect to “preventing” any of the enumerated diseases, and “treating” appears to include “preventing” by definition (see Spec. at ¶[0075]). Applicant is advised that, upon examination, this would be reasonably expected to raise issues under 35 USC §112.
Examiner notes that claim 28 has not been examined on the merits at this time, but appears to recite groups (ii) and (iii), which are structurally distinct from instant SEQ ID NOs: 3-7, because groups (ii) and (iii) do not appear to be limited to natriuretic peptides. Applicant is advised that such scope may preclude rejoinder upon identification of allowable subject matter.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 4657891 discloses SEQ ID NO: 1 (corresponding to GenBank: AAA00924.1), which has the sequence of PSDRSALLKSKLRALLAGPRSLRRSSCFGGRIDRIGAQSGLGCNSFRY (see US’891 at SEQ ID NO: 1, claims, figures).
US 4851349 discloses SEQ ID NO: 1 (corresponding to GenBank AAA01886.1), which has the sequence SALLKSKLRALLTAPRSLRRSSCFGGRMDRIGAQSGLGCNSFRY (see, e.g., US’349 at SEQ ID NO: 1, figures, claims).
US 4935492 pertains to cyclic atrial natriuretic peptides (see, e.g., US’492 at title, abs, clams, passim).
US 7754852 B2 - pertains to chimeric natriuretic polypeptides (see, e.g., US’852 at title, abs, Figures, claims, passim), and explicitly teaches and exemplifies that the chimeric portions comprise an N-terminal tail, ring portion, and a C-terminal tail (see, e.g., US’852 at Fig. 1), and that a different cyclic portion could be substituted in place of another (see, e.g., US’852 at Fig. 1; see also id. at col. 7 at lines 29-36).
US 7803901 pertains to natriuretic peptides comprising RITAREDKQGWA, wherein such peptides may comprise a sequence derived from DNP (see, e.g., US’901 at claims).
US 9102707 discloses natriuretic polypeptides, and further identifies that such peptides may be formed in a chimeric manner, wherein the N-terminus tail, ring structure, and C-terminus are treated as modular portions (see, e.g., US’707 at title, abs, Fig. 1 and 16, col 10-11, claims).
US 9079973 discloses natriuretic polypeptides, and further identifies that such peptides may be formed in a chimeric manner, wherein the N-terminus tail, ring structure, and C-terminus are treated as modular portions (see, e.g., US’707 at title, abs, col 6).
US20080153747A1 teaches that natriuretic peptides can be considered tripartite structures having an N-terminal tail, a cyclic portion, and a C-terminal tail, wherein the parts may be interchanged (see, e.g., US’747 at title, abs, Fig. 2, ¶¶[0002]-[0003], [0011], [0024], [0025]-[0030], claims). For example, US’747 notes that natriuretic compounds typically have the structure of
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Accordingly, an artisan readily appreciated, circa 2008, that natriuretic compounds could be treated, formed, and considered as tripartite structures.
US20110282030A1 discloses natriuretic polypeptides, and further identifies that such peptides may be formed in a chimeric manner, wherein the N-terminus tail, ring structure, and C-terminus are treated as modular portions (see, e.g., US’030 at title, abs, passim; see esp. id. at ¶[0092]):
[0092] A polypeptide provided herein can be produced to contain three regions, a first region that includes an N-terminus, a second region that includes a ring structure of a mature natriuretic polypeptide such as a human CNP polypeptide, and third region that includes a C-terminus….
US2014/0005358A1 discloses natriuretic polypeptides, and further identifies that such peptides may be formed in a chimeric manner, wherein the N-terminus tail, ring structure, and C-terminus are treated as modular portions (see, e.g., US’358 at title, abs, passim).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
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/RANDALL L BEANE/Primary Examiner, Art Unit 1654
1 see, e.g., Rost, Twilight zone of protein sequence alignments, Protein Engineering, vol. 12(2):85-94 (1999); cited in Requirement mailed 3/09/2026; at abstract, 85 at col I-II at bridging ¶, noting that proteins may be homologous while sharing less than 10% sequence identity; at 85 at col II at 1st full ¶, defining sequence identity; at 86 at col II at § “Definition of sequence identity and sequence similarity”; at 85 at abs, col I at § Introduction, identifying homology is not equivalent to identity).
2 Cited in Requirement mailed 3/09/2026.
3 E.g., SEQ ID NOs: 3-7 are each ≥40 but < 50 amino acids in length, and therefore claim 3 encompasses approximately 204 or 160,000 variants of each sequence, or approximately 800,000 sequences in total, if sequences are limited to the 20 basic proteinogenic amino acids.
4 SEQ ID NO:7 has the sequence of RALLTAPRSLRRSSCFGHKIDRINHVSNLGCNSFRYRITAREDKQGWA
5 SEQ ID NO:3 has the sequence of SLRRSSCFGHKIDRINHVSNLGCNSFRYRITAREDKQGWA
6 SEQ ID NO:4 has the sequence of SLRRSSCFGHKIDRINHVSSNLGCNSFRYRITAREDKQGWA
7 SEQ ID NO:5 has the sequence of SLRRSSCFGHKIDRINHVSNNLGCNSFRYRITAREDKQGWA
8 SEQ ID NO:6 has the sequence of TAPRSLRRSSCFGHKIDRINHVSNLGCNSFRYRITAREDKQGWA
9 Wherein each “X” is limited to the alternatives residues shown within the brackets as shown in the consensus sequence of CFG[GHRL][RK][MLI]DRI[GSN][ASH][QSMV]S[GTN]LGC.
10 E.g., SEQ ID NOs: 3-7 are each ≥40 but < 50 amino acids in length, and therefore claim 3 encompasses approximately 204 or 160,000 variants of each sequence, or approximately 800,000 sequences in total, if sequences are limited to the 20 basic proteinogenic amino acids.
11 E.g., SEQ ID NOs: 3-7 are each ≥40 but < 50 amino acids in length, and therefore claim 3 encompasses approximately 204 or 160,000 variants of each sequence, or approximately 800,000 sequences in total, if sequences are limited to the 20 basic proteinogenic amino acids.
12 E.g., SEQ ID NOs: 3-7 are each ≥40 but < 50 amino acids in length, and therefore claim 3 encompasses approximately 204 or 160,000 variants of each sequence, or approximately 800,000 sequences in total, if sequences are limited to the 20 basic proteinogenic amino acids.
13 Meems et al., Innovative Therapeutics: Designer Natriuretic Peptides. JACC Basic Transl Sci. 2016 Dec;1(7):557-567. doi: 10.1016/j.jacbts.2016.10.001. PMID: 28497128; PMCID: PMC5423722; hereafter Meems.
14 The double-underlined portion is the N-terminal tail, the single-underlined portion is the C-terminal tail, and the remainder is the cyclic portion.
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