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 1-17 were originally filed January 4, 2024.
The amendment received April 22, 2024 canceled claims 1-8; amended claims 9, 10, and 13-15; and added new claims 18-29.
The amendment received July 23, 2026 amended claim 29 and added new claim 30.
Claims 9-30 are currently pending.
Claims 9, 11-13, 16, 17, 19-22, and 25-29 are currently under consideration.
Election/Restrictions
Applicant's election with traverse of increasing natriuretic activity, human, SEQ ID NO: 5, administering to a mammal an effective amount of a composition comprising SEQ ID NO: 5 and identifying a mammal as being in need of increased natriuretic activity, dose of 0.01 ng/kg to 50 mg/kg, intravenous administration, cardiovascular disease, and no additional reagents as the species in the reply filed on July 23, 2026 is acknowledged.
The traversal is on the grounds that the species are not patentably distinct from one another (e.g. separate field of search and patentably distinct); a structural feature, functional difference, or other evidence has not been provided; that no generic claim could be allowable; the species require different searches; and that a single inventive concept is present.
This is not found persuasive because the present claims refer to different patient populations (e.g. requiring increased natriuretic activity, cardiovascular disease, and metabolic disorders) wherein a search of one patient population may not be coextensive with another patient population; different mammals wherein a search of one mammal may not be coextensive with a search of another mammal (e.g. in vivo animal model verses human, etc.); the polypeptide while having a common core of SEQ ID NO: 1 refers to various additions, deletions, and/or substitutions wherein a search of one polypeptide may not be coextensive with another polypeptide (e.g. a deletion mutation may not be found in an addition, etc.); a search of one method may not be coextensive with a search of another method; the claims refer to different disorders (e.g. requiring increased natriuretic activity, cardiovascular disease, and metabolic disorders) wherein a search of one disorder may not be coextensive of another disorder; a search of one dose may not be coextensive with a search for another dose; a search of one administration route may not be coextensive with a search of another administration route; and a search of a method with a single reagent may not be coextensive with a search of a method with additional reagents. Thus, the species are considered to have separate fields of search and to be patentably distinct.
However, if applicant disagrees, applicant is invited to clearly state on the record which species are obvious variants of each other.
The present application is not a 371 (National Stage), therefore, a single inventive concept (e.g. Lack of Unity) is not the basis for the species requirement.
The species are independent or distinct because the species are structurally and/or functionally different. In addition, the species are not obvious variants of each other based on the current record.
Futhermore,
(a) the species require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(b) the species may have a separate status in the art;
(c) the species may raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112; and/or
(d) the species are structurally and/or functionally different.
The requirement is still deemed proper and is therefore made FINAL.
Please note: SEQ ID NO: 5 is not part of the present claims and, therefore, is not required for any rejection of record.
Please note: dose of 0.01 ng/kg to 50 mg/kg is not a single, specific species. Therefore, only the range was searched.
Please note: cardiovascular disease is a subgenus and not a single, specific species, therefore, the subgenus was searched.
Claims 10, 14, 15, 18, 23, 24, and 30 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. Applicant timely traversed the restriction (election) requirement in the reply filed on July 23, 2026.
Priority
The present application claims status as a DIV of 17/359,088 filed June 25, 2021 (now U.S. Patent 11,897,931) which claims status as a DIV of 16/348,652 filed May 9, 2019 (now U.S. Patent 11,072,642) which is a 371 (National Stage) of PCT/US2017/060808 filed November 9, 2017 which claims the benefit of 62/419,611 filed November 9, 2016.
Please note: present claims 15 and 23 do not have priority to present 17/359,088 because 17/359,088 only refers to 5 conservative amino acid substitutions (e.g. not “at least one” conservative substitution in residues 1-6).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on September 27, 2024 and July 23, 2026 are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: in the first line of the specification, U.S. Patent 11,897,931 and U.S. Patent 11,072,642 should be added.
Appropriate correction is required.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See page 13.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 20 and 26 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 new matter rejection.
Support in the originally filed specification is not present for the open-ended range of “greater than” 0.01 ng/kg.
Claims 21 and 27 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 new matter rejection.
Support in the originally filed specification is not present for the open-ended range of “less than” 50 mg/kg.
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 9, 11-13, 16, 17, 19-22, and 25-29 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 claims. For example, it is unclear what the metes and bounds of “set forth in” are (e.g. open, closed, etc.).
Claims 9, 11-13, 16, 17, 19-22, and 25-29 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 claims. For example, it is unclear if only 6 subtractions or substitutions can be present (i.e. the combination of the open ended range of “at least one” with “within positions 1-6” may contradict each other). In addition, the combination of “at least one” addition within residues 1-6 is unclear (e.g. is there a length limit regarding the “addition” at the N-terminus, etc.).
Claims 12 and 17 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 claims. For example, it is unclear how identifying the mammal as being in need of increased natriuretic activity (claim 12) or the treatment (claim 17) is performed. Is the identification simply a mental step, reviewing patient records, etc.? Are additional method steps required? In the case of claim 17, the mammal is already known to have a cardiovascular disorder or a metabolic disorder so it appears claim 17 fails to further limit the scope of present claim 13.
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 9, 11-13, 16, 17, 19-22, and 25-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burnett et al. WO 2011/005939 published January 13, 2011.
For present claims 9, 11-13, 16, 17, 19-22, and 25-29, Burnett et al. teach methods of administering a fusion of SEQ ID NO: 5 and SEQ ID NO: 13 (i.e. present SEQ ID NO: 1); SEQ ID NO: 6 (present SEQ ID NO: 1), SEQ ID NO: 15 (S1T substitution of present SEQ ID NO: 1), SEQ ID NO: 16 (L2I substitution of present SEQ ID NO: 1), SEQ ID NO: 17 (R3K substitution of present SEQ ID NO: 1), SEQ ID NO: 18 (R4K substitution of present SEQ ID NO: 1), and SEQ ID NO: 19 (S5T substitution of present SEQ ID NO: 1) with conservative amino acid substitutions or other substitutions and with at least 85% identity to increase natriuretic activity, cardiovascular disorders including arrhythmia, atrial fibrillation, hypertension, etc. in mammals including human wherein the polypeptides are administered intravenously at doses of 0.01 ng/kg to 50 mg/kg; methods of diagnosing a cardiac arrhythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder); and methods of determining whether a mammal is predisposed to develop a cardiac arrythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder) (please refer to the entire specification particularly the abstract; pages 1-4, 6-13, 17, 18, 27, 30-33, 36-40; Figures 1A, 1B, 5B; Table 1).
Therefore, the teachings of Burnett et al. anticipate the presently claimed methods.
Claims 9, 11-13, 16, 17, 19-22, and 25-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. WO 2014/127120 published August 21, 2014.
For present claims 9, 11-13, 16, 17, 19-22, and 25-29, Chen et al. teach methods of administering SEQ ID NO: 7 (present SEQ ID NO: 1), SEQ ID NO: 17 (present SEQ ID NO: 1 with a C-terminal addition), or SEQ ID NO: 18 (present SEQ ID NO: 1 with an 18mer N-terminal addition) with conservative amino acid substitutions or other substitutions and with at least 85% identity to increase natriuretic activity, cardiovascular disorders, and metabolic disorders including diabetes in mammals including human wherein the polypeptides are administered intravenously at doses of 0.01 ng/kg to 50 mg/kg; wherein the mammals are identified as requiring increases natriuretic activity or require treatment (e.g. known to be diabetic, have a cardiovascular disorder, etc.) (please refer to the entire specification particularly the abstract; pages 3, 7-13, 20-22, 25; Table 1; Example 3).
Therefore, the teachings of Chen et al. anticipate the presently claimed methods.
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 9, 11-13, 16, 17, 19-22, and 25-29 are rejected under 35 U.S.C. 103 as being unpatentable over Burnett et al. WO 2011/005939 published January 13, 2011 and Iwamoto et al. WO 2014/115797 published July 31, 2014 (English language CA 2899232 is utilized for the citations below).
For present claims 9, 11-13, 16, 17, 19-22, and 25-29, Burnett et al. teach methods of administering a fusion of SEQ ID NO: 5 and SEQ ID NO: 13 (i.e. present SEQ ID NO: 1); SEQ ID NO: 6 (present SEQ ID NO: 1), SEQ ID NO: 15 (S1T substitution of present SEQ ID NO: 1), SEQ ID NO: 16 (L2I substitution of present SEQ ID NO: 1), SEQ ID NO: 17 (R3K substitution of present SEQ ID NO: 1), SEQ ID NO: 18 (R4K substitution of present SEQ ID NO: 1), and SEQ ID NO: 19 (S5T substitution of present SEQ ID NO: 1) with conservative amino acid substitutions or other substitutions and with at least 85% identity to increase natriuretic activity, cardiovascular disorders including arrhythmia, atrial fibrillation, hypertension, etc. in mammals including human wherein the polypeptides are administered intravenously at doses of 0.01 ng/kg to 50 mg/kg; methods of diagnosing a cardiac arrhythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder); and methods of determining whether a mammal is predisposed to develop a cardiac arrythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder) (please refer to the entire specification particularly the abstract; pages 1-4, 6-13, 17, 18, 27, 30-33, 36-40; Figures 1A, 1B, 5B; Table 1).
As a general knowledge reminder, residues 1-28 of present SEQ ID NO: 1 are human ANP (hANP) and residues 29-40 of present SEQ ID NO: 1 is a result of a heterozygous frameshift mutation causing a 12 amino acid extension to the C-terminus of hANP (fsANP) which is resistant to proteolytic degradation. See the abstract and Figure 1 of Dickey et al., 2009, A Familial Mutation Renders Atrial Natriuretic Peptide Resistant to Proteolytic Degradation, The Journal of Biological Chemistry, 284(29): 19196-19202.
For present claims 9, 11-13, 16, 17, 19-22, and 25-29, Iwamoto et al. teach that residues 1-6 of ANP are not necessary for function and can be deleted (e.g. present SEQ ID NO: 5 wherein the serine at either residue 5 or 6 is deleted) hANP (2-28), hANP (3-28), etc. (please refer to the entire specification particularly paragraphs 19, 23, 28, 31, 35, 37, 41, 51, 52).
All the claimed elements (deletion of any of residues 1-6 of hANP) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (deletion of any of residues 1-6 does not alter function) and the combination would have yielded predictable (still functions as hANP) results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (one hANP) for another (deletion of any of residues 1-6 of hANP) would have yielded predictable results (still functions as hANP) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (deletion of any of residues 1-6 of hANP) 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 good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 9, 11-13, 16, 17, 19-22, and 25-29 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. WO 2014/127120 published August 21, 2014 Iwamoto et al. WO 2014/115797 published July 31, 2014 (English language CA 2899232 is utilized for the citations below).
For present claims 9, 11-13, 16, 17, 19-22, and 25-29, Chen et al. teach methods of administering SEQ ID NO: 7 (present SEQ ID NO: 1), SEQ ID NO: 17 (present SEQ ID NO: 1 with a C-terminal addition), or SEQ ID NO: 18 (present SEQ ID NO: 1 with an 18mer N-terminal addition) with conservative amino acid substitutions or other substitutions and with at least 85% identity to increase natriuretic activity, cardiovascular disorders, and metabolic disorders including diabetes in mammals including human wherein the polypeptides are administered intravenously at doses of 0.01 ng/kg to 50 mg/kg; wherein the mammals are identified as requiring increases natriuretic activity or require treatment (e.g. known to be diabetic, have a cardiovascular disorder, etc.) (please refer to the entire specification particularly the abstract; pages 3, 7-13, 20-22, 25; Table 1; Example 3).
As a general knowledge reminder, residues 1-28 of present SEQ ID NO: 1 are human ANP (hANP) and residues 29-40 of present SEQ ID NO: 1 is a result of a heterozygous frameshift mutation causing a 12 amino acid extension to the C-terminus of hANP (fsANP) which is resistant to proteolytic degradation. See the abstract and Figure 1 of Dickey et al., 2009, A Familial Mutation Renders Atrial Natriuretic Peptide Resistant to Proteolytic Degradation, The Journal of Biological Chemistry, 284(29): 19196-19202.
For present claims 9, 11-13, 16, 17, 19-22, and 25-29, Iwamoto et al. teach that residues 1-6 of ANP are not necessary for function and can be deleted (e.g. present SEQ ID NO: 5 wherein the serine at either residue 5 or 6 is deleted) hANP (2-28), hANP (3-28), etc. (please refer to the entire specification particularly paragraphs 19, 23, 28, 31, 35, 37, 41, 51, 52).
All the claimed elements (deletion of any of residues 1-6 of hANP) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (deletion of any of residues 1-6 does not alter function) and the combination would have yielded predictable (still functions as hANP) results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (one hANP) for another (deletion of any of residues 1-6 of hANP) would have yielded predictable results (still functions as hANP) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (deletion of any of residues 1-6 of hANP) 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 good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9, 11-13, 16, 17, 19-22, and 25-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 19/688,807 in view of Burnett et al. WO 2011/005939 published January 13, 2011 and Iwamoto et al. WO 2014/115797 published July 31, 2014 (English language CA 2899232 is utilized for the citations below).
Copending Application No. 19/688,807 claims methods of treating a mammal including a human with heart failure with natriuretic peptides with additions, deletions, or substitutions.
Burnett et al. teach methods of administering a fusion of SEQ ID NO: 5 and SEQ ID NO: 13 (i.e. present SEQ ID NO: 1); SEQ ID NO: 6 (present SEQ ID NO: 1), SEQ ID NO: 15 (S1T substitution of present SEQ ID NO: 1), SEQ ID NO: 16 (L2I substitution of present SEQ ID NO: 1), SEQ ID NO: 17 (R3K substitution of present SEQ ID NO: 1), SEQ ID NO: 18 (R4K substitution of present SEQ ID NO: 1), and SEQ ID NO: 19 (S5T substitution of present SEQ ID NO: 1) with conservative amino acid substitutions or other substitutions and with at least 85% identity to increase natriuretic activity, cardiovascular disorders including arrhythmia, atrial fibrillation, hypertension, etc. in mammals including human wherein the polypeptides are administered intravenously at doses of 0.01 ng/kg to 50 mg/kg; methods of diagnosing a cardiac arrhythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder); and methods of determining whether a mammal is predisposed to develop a cardiac arrythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder) (please refer to the entire specification particularly the abstract; pages 1-4, 6-13, 17, 18, 27, 30-33, 36-40; Figures 1A, 1B, 5B; Table 1).
As a general knowledge reminder, residues 1-28 of present SEQ ID NO: 1 are human ANP (hANP) and residues 29-40 of present SEQ ID NO: 1 is a result of a heterozygous frameshift mutation causing a 12 amino acid extension to the C-terminus of hANP (fsANP) which is resistant to proteolytic degradation. See the abstract and Figure 1 of Dickey et al., 2009, A Familial Mutation Renders Atrial Natriuretic Peptide Resistant to Proteolytic Degradation, The Journal of Biological Chemistry, 284(29): 19196-19202.
Iwamoto et al. teach that residues 1-6 of ANP are not necessary for function and can be deleted (e.g. present SEQ ID NO: 5 wherein the serine at either residue 5 or 6 is deleted) hANP (2-28), hANP (3-28), etc. (please refer to the entire specification particularly paragraphs 19, 23, 28, 31, 35, 37, 41, 51, 52).
All the claimed elements (hANP of present SEQ ID NO: 1, deletion of any of residues 1-6 of hANP) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (hANP functions as a natriuretic polypeptide; deletion of any of residues 1-6 does not alter function) and the combination would have yielded predictable (still functions as hANP) results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (one natriuretic polypeptide; one hANP) for another (hANP; deletion of any of residues 1-6 of hANP) would have yielded predictable results (still functions as hANP) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (natriuretic polypeptide can treat cardiovascular disorders; deletion of any of residues 1-6 of hANP) 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 good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 9, 11-13, 16, 17, 19-22, and 25-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, 8, 12, 13, 24, 28, 31-35, 39, and 42-44 of copending Application No. 19/584,180 in view of Burnett et al. WO 2011/005939 published January 13, 2011 and Iwamoto et al. WO 2014/115797 published July 31, 2014 (English language CA 2899232 is utilized for the citations below).
Copending Application No. 19/584,180 claims methods of increasing natriuretic activity or treating a mammal with cardiovascular or metabolic disorders with natriuretic peptides with additions, deletions, or substitutions.
Burnett et al. teach methods of administering a fusion of SEQ ID NO: 5 and SEQ ID NO: 13 (i.e. present SEQ ID NO: 1); SEQ ID NO: 6 (present SEQ ID NO: 1), SEQ ID NO: 15 (S1T substitution of present SEQ ID NO: 1), SEQ ID NO: 16 (L2I substitution of present SEQ ID NO: 1), SEQ ID NO: 17 (R3K substitution of present SEQ ID NO: 1), SEQ ID NO: 18 (R4K substitution of present SEQ ID NO: 1), and SEQ ID NO: 19 (S5T substitution of present SEQ ID NO: 1) with conservative amino acid substitutions or other substitutions and with at least 85% identity to increase natriuretic activity, cardiovascular disorders including arrhythmia, atrial fibrillation, hypertension, etc. in mammals including human wherein the polypeptides are administered intravenously at doses of 0.01 ng/kg to 50 mg/kg; methods of diagnosing a cardiac arrhythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder); and methods of determining whether a mammal is predisposed to develop a cardiac arrythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder) (please refer to the entire specification particularly the abstract; pages 1-4, 6-13, 17, 18, 27, 30-33, 36-40; Figures 1A, 1B, 5B; Table 1).
As a general knowledge reminder, residues 1-28 of present SEQ ID NO: 1 are human ANP (hANP) and residues 29-40 of present SEQ ID NO: 1 is a result of a heterozygous frameshift mutation causing a 12 amino acid extension to the C-terminus of hANP (fsANP) which is resistant to proteolytic degradation. See the abstract and Figure 1 of Dickey et al., 2009, A Familial Mutation Renders Atrial Natriuretic Peptide Resistant to Proteolytic Degradation, The Journal of Biological Chemistry, 284(29): 19196-19202.
Iwamoto et al. teach that residues 1-6 of ANP are not necessary for function and can be deleted (e.g. present SEQ ID NO: 5 wherein the serine at either residue 5 or 6 is deleted) hANP (2-28), hANP (3-28), etc. (please refer to the entire specification particularly paragraphs 19, 23, 28, 31, 35, 37, 41, 51, 52).
All the claimed elements (hANP of present SEQ ID NO: 1, deletion of any of residues 1-6 of hANP) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (hANP functions as a natriuretic polypeptide; deletion of any of residues 1-6 does not alter function) and the combination would have yielded predictable (still functions as hANP) results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (one natriuretic polypeptide; one hANP) for another (hANP; deletion of any of residues 1-6 of hANP) would have yielded predictable results (still functions as hANP) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (natriuretic polypeptide can treat cardiovascular disorders; deletion of any of residues 1-6 of hANP) 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 good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 9, 11-13, 16, 17, 19-22, and 25-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-34 of copending Application No. 19/193,423 in view of Burnett et al. WO 2011/005939 published January 13, 2011 and Iwamoto et al. WO 2014/115797 published July 31, 2014 (English language CA 2899232 is utilized for the citations below).
Copending Application No. 19/193,423 claims methods of treating a mammal including a human with hypertension with natriuretic peptides of SEQ ID NO: 3 (present SEQ ID NO: 1) and peptides with additions at residues 1-6 (see SEQ ID NO: 9), substitutions (see SEQ ID NOs: 10, 13, 14), or deletions (see SEQ ID NO: 12 – present SEQ ID NO: 5) intravenously at 1 mg/kg to 10 mg/kg.
Burnett et al. teach methods of administering a fusion of SEQ ID NO: 5 and SEQ ID NO: 13 (i.e. present SEQ ID NO: 1); SEQ ID NO: 6 (present SEQ ID NO: 1), SEQ ID NO: 15 (S1T substitution of present SEQ ID NO: 1), SEQ ID NO: 16 (L2I substitution of present SEQ ID NO: 1), SEQ ID NO: 17 (R3K substitution of present SEQ ID NO: 1), SEQ ID NO: 18 (R4K substitution of present SEQ ID NO: 1), and SEQ ID NO: 19 (S5T substitution of present SEQ ID NO: 1) with conservative amino acid substitutions or other substitutions and with at least 85% identity to increase natriuretic activity, cardiovascular disorders including arrhythmia, atrial fibrillation, hypertension, etc. in mammals including human wherein the polypeptides are administered intravenously at doses of 0.01 ng/kg to 50 mg/kg; methods of diagnosing a cardiac arrhythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder); and methods of determining whether a mammal is predisposed to develop a cardiac arrythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder) (please refer to the entire specification particularly the abstract; pages 1-4, 6-13, 17, 18, 27, 30-33, 36-40; Figures 1A, 1B, 5B; Table 1).
As a general knowledge reminder, residues 1-28 of present SEQ ID NO: 1 are human ANP (hANP) and residues 29-40 of present SEQ ID NO: 1 is a result of a heterozygous frameshift mutation causing a 12 amino acid extension to the C-terminus of hANP (fsANP) which is resistant to proteolytic degradation. See the abstract and Figure 1 of Dickey et al., 2009, A Familial Mutation Renders Atrial Natriuretic Peptide Resistant to Proteolytic Degradation, The Journal of Biological Chemistry, 284(29): 19196-19202.
Iwamoto et al. teach that residues 1-6 of ANP are not necessary for function and can be deleted (e.g. present SEQ ID NO: 5 wherein the serine at either residue 5 or 6 is deleted) hANP (2-28), hANP (3-28), etc. (please refer to the entire specification particularly paragraphs 19, 23, 28, 31, 35, 37, 41, 51, 52).
All the claimed elements (hANP of present SEQ ID NO: 1, deletion of any of residues 1-6 of hANP) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (hANP functions as a natriuretic polypeptide; deletion of any of residues 1-6 does not alter function) and the combination would have yielded predictable (still functions as hANP) results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (one natriuretic polypeptide; one hANP) for another (hANP; deletion of any of residues 1-6 of hANP) would have yielded predictable results (still functions as hANP) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (natriuretic polypeptide can treat cardiovascular disorders; deletion of any of residues 1-6 of hANP) 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 good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 9, 11-13, 16, 17, 19-22, and 25-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-200 of copending Application No. 19/158,761 in view of Burnett et al. WO 2011/005939 published January 13, 2011 and Iwamoto et al. WO 2014/115797 published July 31, 2014 (English language CA 2899232 is utilized for the citations below).
Copending Application No. 19/158,761 claims methods of treating a mammal including a human with hypertension and metabolic syndrome with natriuretic peptides (SEQ ID NOs: 3 – present SEQ ID NO: 1; SEQ ID NO: 12 – present SEQ ID NO: 5; substitutions – SEQ ID NOs: 13 and 14) at 0.1 mg/kg to 5 mg/kg intravenously.
Burnett et al. teach methods of administering a fusion of SEQ ID NO: 5 and SEQ ID NO: 13 (i.e. present SEQ ID NO: 1); SEQ ID NO: 6 (present SEQ ID NO: 1), SEQ ID NO: 15 (S1T substitution of present SEQ ID NO: 1), SEQ ID NO: 16 (L2I substitution of present SEQ ID NO: 1), SEQ ID NO: 17 (R3K substitution of present SEQ ID NO: 1), SEQ ID NO: 18 (R4K substitution of present SEQ ID NO: 1), and SEQ ID NO: 19 (S5T substitution of present SEQ ID NO: 1) with conservative amino acid substitutions or other substitutions and with at least 85% identity to increase natriuretic activity, cardiovascular disorders including arrhythmia, atrial fibrillation, hypertension, etc. in mammals including human wherein the polypeptides are administered intravenously at doses of 0.01 ng/kg to 50 mg/kg; methods of diagnosing a cardiac arrhythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder); and methods of determining whether a mammal is predisposed to develop a cardiac arrythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder) (please refer to the entire specification particularly the abstract; pages 1-4, 6-13, 17, 18, 27, 30-33, 36-40; Figures 1A, 1B, 5B; Table 1).
As a general knowledge reminder, residues 1-28 of present SEQ ID NO: 1 are human ANP (hANP) and residues 29-40 of present SEQ ID NO: 1 is a result of a heterozygous frameshift mutation causing a 12 amino acid extension to the C-terminus of hANP (fsANP) which is resistant to proteolytic degradation. See the abstract and Figure 1 of Dickey et al., 2009, A Familial Mutation Renders Atrial Natriuretic Peptide Resistant to Proteolytic Degradation, The Journal of Biological Chemistry, 284(29): 19196-19202.
Iwamoto et al. teach that residues 1-6 of ANP are not necessary for function and can be deleted (e.g. present SEQ ID NO: 5 wherein the serine at either residue 5 or 6 is deleted) hANP (2-28), hANP (3-28), etc. (please refer to the entire specification particularly paragraphs 19, 23, 28, 31, 35, 37, 41, 51, 52).
All the claimed elements (hANP of present SEQ ID NO: 1, deletion of any of residues 1-6 of hANP) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (hANP functions as a natriuretic polypeptide; deletion of any of residues 1-6 does not alter function) and the combination would have yielded predictable (still functions as hANP) results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (one natriuretic polypeptide; one hANP) for another (hANP; deletion of any of residues 1-6 of hANP) would have yielded predictable results (still functions as hANP) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (natriuretic polypeptide can treat cardiovascular disorders; deletion of any of residues 1-6 of hANP) 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 good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 9, 11-13, 16, 17, 19-22, and 25-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-12, 14-20, and 22-24 of copending Application No. 18/689,132 in view of Burnett et al. WO 2011/005939 published January 13, 2011 and Iwamoto et al. WO 2014/115797 published July 31, 2014 (English language CA 2899232 is utilized for the citations below).
Copending Application No. 18/689,132 claims methods of determining and treating a mammal including a human with cardiovascular or cardiometabolic disorders with natriuretic peptides (MANP; SEQ ID NO: 1 – present SEQ ID NO: 1).
Burnett et al. teach methods of administering a fusion of SEQ ID NO: 5 and SEQ ID NO: 13 (i.e. present SEQ ID NO: 1); SEQ ID NO: 6 (present SEQ ID NO: 1), SEQ ID NO: 15 (S1T substitution of present SEQ ID NO: 1), SEQ ID NO: 16 (L2I substitution of present SEQ ID NO: 1), SEQ ID NO: 17 (R3K substitution of present SEQ ID NO: 1), SEQ ID NO: 18 (R4K substitution of present SEQ ID NO: 1), and SEQ ID NO: 19 (S5T substitution of present SEQ ID NO: 1) with conservative amino acid substitutions or other substitutions and with at least 85% identity to increase natriuretic activity, cardiovascular disorders including arrhythmia, atrial fibrillation, hypertension, etc. in mammals including human wherein the polypeptides are administered intravenously at doses of 0.01 ng/kg to 50 mg/kg; methods of diagnosing a cardiac arrhythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder); and methods of determining whether a mammal is predisposed to develop a cardiac arrythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder) (please refer to the entire specification particularly the abstract; pages 1-4, 6-13, 17, 18, 27, 30-33, 36-40; Figures 1A, 1B, 5B; Table 1).
As a general knowledge reminder, residues 1-28 of present SEQ ID NO: 1 are human ANP (hANP) and residues 29-40 of present SEQ ID NO: 1 is a result of a heterozygous frameshift mutation causing a 12 amino acid extension to the C-terminus of hANP (fsANP) which is resistant to proteolytic degradation. See the abstract and Figure 1 of Dickey et al., 2009, A Familial Mutation Renders Atrial Natriuretic Peptide Resistant to Proteolytic Degradation, The Journal of Biological Chemistry, 284(29): 19196-19202.
Iwamoto et al. teach that residues 1-6 of ANP are not necessary for function and can be deleted (e.g. present SEQ ID NO: 5 wherein the serine at either residue 5 or 6 is deleted) hANP (2-28), hANP (3-28), etc. (please refer to the entire specification particularly paragraphs 19, 23, 28, 31, 35, 37, 41, 51, 52).
All the claimed elements (hANP of present SEQ ID NO: 1, deletion of any of residues 1-6 of hANP) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (hANP functions as a natriuretic polypeptide; deletion of any of residues 1-6 does not alter function) and the combination would have yielded predictable (still functions as hANP) results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (one natriuretic polypeptide; one hANP) for another (hANP; deletion of any of residues 1-6 of hANP) would have yielded predictable results (still functions as hANP) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (natriuretic polypeptide can treat cardiovascular disorders; deletion of any of residues 1-6 of hANP) 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 good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 9, 11-13, 16, 17, 19-22, and 25-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-5, 13, 17, 18, 20, and 28-33 of copending Application No. 18/467,797 in view of Burnett et al. WO 2011/005939 published January 13, 2011 and Iwamoto et al. WO 2014/115797 published July 31, 2014 (English language CA 2899232 is utilized for the citations below).
Copending Application No. 18/467,797 claims methods of treating a mammal including a human with cardiovascular disorders including hypertension or metabolic disorders with natriuretic peptides (SEQ ID NOs: 3-7 wherein SEQ ID NOs: 6 and 7 have N-terminal additions).
Burnett et al. teach methods of administering a fusion of SEQ ID NO: 5 and SEQ ID NO: 13 (i.e. present SEQ ID NO: 1); SEQ ID NO: 6 (present SEQ ID NO: 1), SEQ ID NO: 15 (S1T substitution of present SEQ ID NO: 1), SEQ ID NO: 16 (L2I substitution of present SEQ ID NO: 1), SEQ ID NO: 17 (R3K substitution of present SEQ ID NO: 1), SEQ ID NO: 18 (R4K substitution of present SEQ ID NO: 1), and SEQ ID NO: 19 (S5T substitution of present SEQ ID NO: 1) with conservative amino acid substitutions or other substitutions and with at least 85% identity to increase natriuretic activity, cardiovascular disorders including arrhythmia, atrial fibrillation, hypertension, etc. in mammals including human wherein the polypeptides are administered intravenously at doses of 0.01 ng/kg to 50 mg/kg; methods of diagnosing a cardiac arrhythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder); and methods of determining whether a mammal is predisposed to develop a cardiac arrythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder) (please refer to the entire specification particularly the abstract; pages 1-4, 6-13, 17, 18, 27, 30-33, 36-40; Figures 1A, 1B, 5B; Table 1).
As a general knowledge reminder, residues 1-28 of present SEQ ID NO: 1 are human ANP (hANP) and residues 29-40 of present SEQ ID NO: 1 is a result of a heterozygous frameshift mutation causing a 12 amino acid extension to the C-terminus of hANP (fsANP) which is resistant to proteolytic degradation. See the abstract and Figure 1 of Dickey et al., 2009, A Familial Mutation Renders Atrial Natriuretic Peptide Resistant to Proteolytic Degradation, The Journal of Biological Chemistry, 284(29): 19196-19202.
Iwamoto et al. teach that residues 1-6 of ANP are not necessary for function and can be deleted (e.g. present SEQ ID NO: 5 wherein the serine at either residue 5 or 6 is deleted) hANP (2-28), hANP (3-28), etc. (please refer to the entire specification particularly paragraphs 19, 23, 28, 31, 35, 37, 41, 51, 52).
All the claimed elements (hANP of present SEQ ID NO: 1, deletion of any of residues 1-6 of hANP) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (hANP functions as a natriuretic polypeptide; deletion of any of residues 1-6 does not alter function) and the combination would have yielded predictable (still functions as hANP) results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (one natriuretic polypeptide; one hANP) for another (hANP; deletion of any of residues 1-6 of hANP) would have yielded predictable results (still functions as hANP) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (natriuretic polypeptide can treat cardiovascular disorders; deletion of any of residues 1-6 of hANP) 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 good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 9, 11-13, 16, 17, 19-22, and 25-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 5,583,108 in view of Burnett et al. WO 2011/005939 published January 13, 2011 and Iwamoto et al. WO 2014/115797 published July 31, 2014 (English language CA 2899232 is utilized for the citations below).
U.S. Patent No. 5,583,108 claims a natriuretic polypeptide.
Burnett et al. teach methods of administering a fusion of SEQ ID NO: 5 and SEQ ID NO: 13 (i.e. present SEQ ID NO: 1); SEQ ID NO: 6 (present SEQ ID NO: 1), SEQ ID NO: 15 (S1T substitution of present SEQ ID NO: 1), SEQ ID NO: 16 (L2I substitution of present SEQ ID NO: 1), SEQ ID NO: 17 (R3K substitution of present SEQ ID NO: 1), SEQ ID NO: 18 (R4K substitution of present SEQ ID NO: 1), and SEQ ID NO: 19 (S5T substitution of present SEQ ID NO: 1) with conservative amino acid substitutions or other substitutions and with at least 85% identity to increase natriuretic activity, cardiovascular disorders including arrhythmia, atrial fibrillation, hypertension, etc. in mammals including human wherein the polypeptides are administered intravenously at doses of 0.01 ng/kg to 50 mg/kg; methods of diagnosing a cardiac arrhythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder); and methods of determining whether a mammal is predisposed to develop a cardiac arrythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder) (please refer to the entire specification particularly the abstract; pages 1-4, 6-13, 17, 18, 27, 30-33, 36-40; Figures 1A, 1B, 5B; Table 1).
As a general knowledge reminder, residues 1-28 of present SEQ ID NO: 1 are human ANP (hANP) and residues 29-40 of present SEQ ID NO: 1 is a result of a heterozygous frameshift mutation causing a 12 amino acid extension to the C-terminus of hANP (fsANP) which is resistant to proteolytic degradation. See the abstract and Figure 1 of Dickey et al., 2009, A Familial Mutation Renders Atrial Natriuretic Peptide Resistant to Proteolytic Degradation, The Journal of Biological Chemistry, 284(29): 19196-19202.
Iwamoto et al. teach that residues 1-6 of ANP are not necessary for function and can be deleted (e.g. present SEQ ID NO: 5 wherein the serine at either residue 5 or 6 is deleted) hANP (2-28), hANP (3-28), etc. (please refer to the entire specification particularly paragraphs 19, 23, 28, 31, 35, 37, 41, 51, 52).
All the claimed elements (hANP of present SEQ ID NO: 1, deletion of any of residues 1-6 of hANP; methods of utilizing ANP as a treatment for cardiovascular disease) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (hANP functions as a natriuretic polypeptide; deletion of any of residues 1-6 does not alter function) and the combination would have yielded predictable (still functions as hANP; treatment of a cardiovascular disease) results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (one natriuretic polypeptide; one hANP) for another (hANP; deletion of any of residues 1-6 of hANP) would have yielded predictable results (still functions as hANP) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (natriuretic polypeptide can treat cardiovascular disorders; deletion of any of residues 1-6 of hANP) 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 good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 9, 11-13, 16, 17, 19-22, and 25-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 8,063,191 in view of Burnett et al. WO 2011/005939 published January 13, 2011 and Iwamoto et al. WO 2014/115797 published July 31, 2014 (English language CA 2899232 is utilized for the citations below).
U.S. Patent No. 8,063,191 claims a nucleic acid encoding a natriuretic polypeptide and a host cell for expressing the natriuretic polypeptide of SEQ ID NO: 2 (present SEQ ID NO: 1).
Burnett et al. teach methods of administering a fusion of SEQ ID NO: 5 and SEQ ID NO: 13 (i.e. present SEQ ID NO: 1); SEQ ID NO: 6 (present SEQ ID NO: 1), SEQ ID NO: 15 (S1T substitution of present SEQ ID NO: 1), SEQ ID NO: 16 (L2I substitution of present SEQ ID NO: 1), SEQ ID NO: 17 (R3K substitution of present SEQ ID NO: 1), SEQ ID NO: 18 (R4K substitution of present SEQ ID NO: 1), and SEQ ID NO: 19 (S5T substitution of present SEQ ID NO: 1) with conservative amino acid substitutions or other substitutions and with at least 85% identity to increase natriuretic activity, cardiovascular disorders including arrhythmia, atrial fibrillation, hypertension, etc. in mammals including human wherein the polypeptides are administered intravenously at doses of 0.01 ng/kg to 50 mg/kg; methods of diagnosing a cardiac arrhythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder); and methods of determining whether a mammal is predisposed to develop a cardiac arrythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder) (please refer to the entire specification particularly the abstract; pages 1-4, 6-13, 17, 18, 27, 30-33, 36-40; Figures 1A, 1B, 5B; Table 1).
As a general knowledge reminder, residues 1-28 of present SEQ ID NO: 1 are human ANP (hANP) and residues 29-40 of present SEQ ID NO: 1 is a result of a heterozygous frameshift mutation causing a 12 amino acid extension to the C-terminus of hANP (fsANP) which is resistant to proteolytic degradation. See the abstract and Figure 1 of Dickey et al., 2009, A Familial Mutation Renders Atrial Natriuretic Peptide Resistant to Proteolytic Degradation, The Journal of Biological Chemistry, 284(29): 19196-19202.
Iwamoto et al. teach that residues 1-6 of ANP are not necessary for function and can be deleted (e.g. present SEQ ID NO: 5 wherein the serine at either residue 5 or 6 is deleted) hANP (2-28), hANP (3-28), etc. (please refer to the entire specification particularly paragraphs 19, 23, 28, 31, 35, 37, 41, 51, 52).
All the claimed elements (hANP of present SEQ ID NO: 1, deletion of any of residues 1-6 of hANP; methods of utilizing ANP as a treatment for cardiovascular disease) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (hANP functions as a natriuretic polypeptide; deletion of any of residues 1-6 does not alter function) and the combination would have yielded predictable (still functions as hANP; treatment of a cardiovascular disease) results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (one natriuretic polypeptide; one hANP) for another (hANP; deletion of any of residues 1-6 of hANP) would have yielded predictable results (still functions as hANP) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (natriuretic polypeptide can treat cardiovascular disorders; deletion of any of residues 1-6 of hANP) 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 good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 9, 11-13, 16, 17, 19-22, and 25-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 7,803,901 in view of Burnett et al. WO 2011/005939 published January 13, 2011 and Iwamoto et al. WO 2014/115797 published July 31, 2014 (English language CA 2899232 is utilized for the citations below).
U.S. Patent No. 7,803,901 claims a natriuretic polypeptide of SEQ ID NO: 1 which is a fragment of present SEQ ID NO: 1.
Burnett et al. teach methods of administering a fusion of SEQ ID NO: 5 and SEQ ID NO: 13 (i.e. present SEQ ID NO: 1); SEQ ID NO: 6 (present SEQ ID NO: 1), SEQ ID NO: 15 (S1T substitution of present SEQ ID NO: 1), SEQ ID NO: 16 (L2I substitution of present SEQ ID NO: 1), SEQ ID NO: 17 (R3K substitution of present SEQ ID NO: 1), SEQ ID NO: 18 (R4K substitution of present SEQ ID NO: 1), and SEQ ID NO: 19 (S5T substitution of present SEQ ID NO: 1) with conservative amino acid substitutions or other substitutions and with at least 85% identity to increase natriuretic activity, cardiovascular disorders including arrhythmia, atrial fibrillation, hypertension, etc. in mammals including human wherein the polypeptides are administered intravenously at doses of 0.01 ng/kg to 50 mg/kg; methods of diagnosing a cardiac arrhythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder); and methods of determining whether a mammal is predisposed to develop a cardiac arrythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder) (please refer to the entire specification particularly the abstract; pages 1-4, 6-13, 17, 18, 27, 30-33, 36-40; Figures 1A, 1B, 5B; Table 1).
As a general knowledge reminder, residues 1-28 of present SEQ ID NO: 1 are human ANP (hANP) and residues 29-40 of present SEQ ID NO: 1 is a result of a heterozygous frameshift mutation causing a 12 amino acid extension to the C-terminus of hANP (fsANP) which is resistant to proteolytic degradation. See the abstract and Figure 1 of Dickey et al., 2009, A Familial Mutation Renders Atrial Natriuretic Peptide Resistant to Proteolytic Degradation, The Journal of Biological Chemistry, 284(29): 19196-19202.
Iwamoto et al. teach that residues 1-6 of ANP are not necessary for function and can be deleted (e.g. present SEQ ID NO: 5 wherein the serine at either residue 5 or 6 is deleted) hANP (2-28), hANP (3-28), etc. (please refer to the entire specification particularly paragraphs 19, 23, 28, 31, 35, 37, 41, 51, 52).
All the claimed elements (hANP of present SEQ ID NO: 1, deletion of any of residues 1-6 of hANP; methods of utilizing ANP as a treatment for cardiovascular disease) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (hANP functions as a natriuretic polypeptide; deletion of any of residues 1-6 does not alter function) and the combination would have yielded predictable (still functions as hANP; treatment of a cardiovascular disease) results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (one natriuretic polypeptide; one hANP) for another (hANP; deletion of any of residues 1-6 of hANP) would have yielded predictable results (still functions as hANP) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (natriuretic polypeptide can treat cardiovascular disorders; deletion of any of residues 1-6 of hANP) 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 good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 9, 11-13, 16, 17, 19-22, and 25-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 9,193,777 in view of Burnett et al. WO 2011/005939 published January 13, 2011 and Iwamoto et al. WO 2014/115797 published July 31, 2014 (English language CA 2899232 is utilized for the citations below).
U.S. Patent No. 9,193,777 claims a method of treating cardiac arrhythmia in a mammal via administering SEQ ID NO: 6 (present SEQ ID NO: 1) with 2 amino acid additions, subtractions, or substitutions.
Burnett et al. teach methods of administering a fusion of SEQ ID NO: 5 and SEQ ID NO: 13 (i.e. present SEQ ID NO: 1); SEQ ID NO: 6 (present SEQ ID NO: 1), SEQ ID NO: 15 (S1T substitution of present SEQ ID NO: 1), SEQ ID NO: 16 (L2I substitution of present SEQ ID NO: 1), SEQ ID NO: 17 (R3K substitution of present SEQ ID NO: 1), SEQ ID NO: 18 (R4K substitution of present SEQ ID NO: 1), and SEQ ID NO: 19 (S5T substitution of present SEQ ID NO: 1) with conservative amino acid substitutions or other substitutions and with at least 85% identity to increase natriuretic activity, cardiovascular disorders including arrhythmia, atrial fibrillation, hypertension, etc. in mammals including human wherein the polypeptides are administered intravenously at doses of 0.01 ng/kg to 50 mg/kg; methods of diagnosing a cardiac arrhythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder); and methods of determining whether a mammal is predisposed to develop a cardiac arrythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder) (please refer to the entire specification particularly the abstract; pages 1-4, 6-13, 17, 18, 27, 30-33, 36-40; Figures 1A, 1B, 5B; Table 1).
As a general knowledge reminder, residues 1-28 of present SEQ ID NO: 1 are human ANP (hANP) and residues 29-40 of present SEQ ID NO: 1 is a result of a heterozygous frameshift mutation causing a 12 amino acid extension to the C-terminus of hANP (fsANP) which is resistant to proteolytic degradation. See the abstract and Figure 1 of Dickey et al., 2009, A Familial Mutation Renders Atrial Natriuretic Peptide Resistant to Proteolytic Degradation, The Journal of Biological Chemistry, 284(29): 19196-19202.
Iwamoto et al. teach that residues 1-6 of ANP are not necessary for function and can be deleted (e.g. present SEQ ID NO: 5 wherein the serine at either residue 5 or 6 is deleted) hANP (2-28), hANP (3-28), etc. (please refer to the entire specification particularly paragraphs 19, 23, 28, 31, 35, 37, 41, 51, 52).
All the claimed elements (hANP of present SEQ ID NO: 1, deletion of any of residues 1-6 of hANP) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (hANP functions as a natriuretic polypeptide; deletion of any of residues 1-6 does not alter function) and the combination would have yielded predictable (still functions as hANP) results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (one natriuretic polypeptide; one hANP) for another (hANP; deletion of any of residues 1-6 of hANP) would have yielded predictable results (still functions as hANP) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (natriuretic polypeptide can treat cardiovascular disorders; deletion of any of residues 1-6 of hANP) 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 good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 9, 11-13, 16, 17, 19-22, and 25-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 8,835,601 in view of Burnett et al. WO 2011/005939 published January 13, 2011 and Iwamoto et al. WO 2014/115797 published July 31, 2014 (English language CA 2899232 is utilized for the citations below).
U.S. Patent No. 8,835,601 claims a natriuretic polypeptide of SEQ ID NO: 8 (present SEQ ID NO: 1).
Burnett et al. teach methods of administering a fusion of SEQ ID NO: 5 and SEQ ID NO: 13 (i.e. present SEQ ID NO: 1); SEQ ID NO: 6 (present SEQ ID NO: 1), SEQ ID NO: 15 (S1T substitution of present SEQ ID NO: 1), SEQ ID NO: 16 (L2I substitution of present SEQ ID NO: 1), SEQ ID NO: 17 (R3K substitution of present SEQ ID NO: 1), SEQ ID NO: 18 (R4K substitution of present SEQ ID NO: 1), and SEQ ID NO: 19 (S5T substitution of present SEQ ID NO: 1) with conservative amino acid substitutions or other substitutions and with at least 85% identity to increase natriuretic activity, cardiovascular disorders including arrhythmia, atrial fibrillation, hypertension, etc. in mammals including human wherein the polypeptides are administered intravenously at doses of 0.01 ng/kg to 50 mg/kg; methods of diagnosing a cardiac arrhythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder); and methods of determining whether a mammal is predisposed to develop a cardiac arrythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder) (please refer to the entire specification particularly the abstract; pages 1-4, 6-13, 17, 18, 27, 30-33, 36-40; Figures 1A, 1B, 5B; Table 1).
As a general knowledge reminder, residues 1-28 of present SEQ ID NO: 1 are human ANP (hANP) and residues 29-40 of present SEQ ID NO: 1 is a result of a heterozygous frameshift mutation causing a 12 amino acid extension to the C-terminus of hANP (fsANP) which is resistant to proteolytic degradation. See the abstract and Figure 1 of Dickey et al., 2009, A Familial Mutation Renders Atrial Natriuretic Peptide Resistant to Proteolytic Degradation, The Journal of Biological Chemistry, 284(29): 19196-19202.
Iwamoto et al. teach that residues 1-6 of ANP are not necessary for function and can be deleted (e.g. present SEQ ID NO: 5 wherein the serine at either residue 5 or 6 is deleted) hANP (2-28), hANP (3-28), etc. (please refer to the entire specification particularly paragraphs 19, 23, 28, 31, 35, 37, 41, 51, 52).
All the claimed elements (hANP of present SEQ ID NO: 1, deletion of any of residues 1-6 of hANP; methods of utilizing ANP as a treatment for cardiovascular disease) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (hANP functions as a natriuretic polypeptide; deletion of any of residues 1-6 does not alter function) and the combination would have yielded predictable (still functions as hANP; treatment of a cardiovascular disease) results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (one natriuretic polypeptide; one hANP) for another (hANP; deletion of any of residues 1-6 of hANP) would have yielded predictable results (still functions as hANP) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (natriuretic polypeptide can treat cardiovascular disorders; deletion of any of residues 1-6 of hANP) 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 good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 9, 11-13, 16, 17, 19-22, and 25-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 9,938,334 in view of Burnett et al. WO 2011/005939 published January 13, 2011 and Iwamoto et al. WO 2014/115797 published July 31, 2014 (English language CA 2899232 is utilized for the citations below).
U.S. Patent No. 9,938,334 claims a method of treating a metabolic disorder (diabetes) via administering natriuretic polypeptides to a mammal.
Burnett et al. teach methods of administering a fusion of SEQ ID NO: 5 and SEQ ID NO: 13 (i.e. present SEQ ID NO: 1); SEQ ID NO: 6 (present SEQ ID NO: 1), SEQ ID NO: 15 (S1T substitution of present SEQ ID NO: 1), SEQ ID NO: 16 (L2I substitution of present SEQ ID NO: 1), SEQ ID NO: 17 (R3K substitution of present SEQ ID NO: 1), SEQ ID NO: 18 (R4K substitution of present SEQ ID NO: 1), and SEQ ID NO: 19 (S5T substitution of present SEQ ID NO: 1) with conservative amino acid substitutions or other substitutions and with at least 85% identity to increase natriuretic activity, cardiovascular disorders including arrhythmia, atrial fibrillation, hypertension, etc. in mammals including human wherein the polypeptides are administered intravenously at doses of 0.01 ng/kg to 50 mg/kg; methods of diagnosing a cardiac arrhythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder); and methods of determining whether a mammal is predisposed to develop a cardiac arrythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder) (please refer to the entire specification particularly the abstract; pages 1-4, 6-13, 17, 18, 27, 30-33, 36-40; Figures 1A, 1B, 5B; Table 1).
As a general knowledge reminder, residues 1-28 of present SEQ ID NO: 1 are human ANP (hANP) and residues 29-40 of present SEQ ID NO: 1 is a result of a heterozygous frameshift mutation causing a 12 amino acid extension to the C-terminus of hANP (fsANP) which is resistant to proteolytic degradation. See the abstract and Figure 1 of Dickey et al., 2009, A Familial Mutation Renders Atrial Natriuretic Peptide Resistant to Proteolytic Degradation, The Journal of Biological Chemistry, 284(29): 19196-19202.
Iwamoto et al. teach that residues 1-6 of ANP are not necessary for function and can be deleted (e.g. present SEQ ID NO: 5 wherein the serine at either residue 5 or 6 is deleted) hANP (2-28), hANP (3-28), etc. (please refer to the entire specification particularly paragraphs 19, 23, 28, 31, 35, 37, 41, 51, 52).
All the claimed elements (hANP of present SEQ ID NO: 1, deletion of any of residues 1-6 of hANP) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (hANP functions as a natriuretic polypeptide; deletion of any of residues 1-6 does not alter function) and the combination would have yielded predictable (still functions as hANP) results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (one natriuretic polypeptide; one hANP) for another (hANP; deletion of any of residues 1-6 of hANP) would have yielded predictable results (still functions as hANP) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (natriuretic polypeptide can treat cardiovascular disorders; deletion of any of residues 1-6 of hANP) 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 good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 9, 11-13, 16, 17, 19-22, and 25-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,897,931 in view of Burnett et al. WO 2011/005939 published January 13, 2011 and Iwamoto et al. WO 2014/115797 published July 31, 2014 (English language CA 2899232 is utilized for the citations below).
U.S. Patent No. 11,897,931 claims a nucleic acid encoding a natriuretic polypeptide and a host cell for expressing the natriuretic polypeptide of SEQ ID NO: 5 (present SEQ ID NO: 5).
Burnett et al. teach methods of administering a fusion of SEQ ID NO: 5 and SEQ ID NO: 13 (i.e. present SEQ ID NO: 1); SEQ ID NO: 6 (present SEQ ID NO: 1), SEQ ID NO: 15 (S1T substitution of present SEQ ID NO: 1), SEQ ID NO: 16 (L2I substitution of present SEQ ID NO: 1), SEQ ID NO: 17 (R3K substitution of present SEQ ID NO: 1), SEQ ID NO: 18 (R4K substitution of present SEQ ID NO: 1), and SEQ ID NO: 19 (S5T substitution of present SEQ ID NO: 1) with conservative amino acid substitutions or other substitutions and with at least 85% identity to increase natriuretic activity, cardiovascular disorders including arrhythmia, atrial fibrillation, hypertension, etc. in mammals including human wherein the polypeptides are administered intravenously at doses of 0.01 ng/kg to 50 mg/kg; methods of diagnosing a cardiac arrhythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder); and methods of determining whether a mammal is predisposed to develop a cardiac arrythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder) (please refer to the entire specification particularly the abstract; pages 1-4, 6-13, 17, 18, 27, 30-33, 36-40; Figures 1A, 1B, 5B; Table 1).
As a general knowledge reminder, residues 1-28 of present SEQ ID NO: 1 are human ANP (hANP) and residues 29-40 of present SEQ ID NO: 1 is a result of a heterozygous frameshift mutation causing a 12 amino acid extension to the C-terminus of hANP (fsANP) which is resistant to proteolytic degradation. See the abstract and Figure 1 of Dickey et al., 2009, A Familial Mutation Renders Atrial Natriuretic Peptide Resistant to Proteolytic Degradation, The Journal of Biological Chemistry, 284(29): 19196-19202.
Iwamoto et al. teach that residues 1-6 of ANP are not necessary for function and can be deleted (e.g. present SEQ ID NO: 5 wherein the serine at either residue 5 or 6 is deleted) hANP (2-28), hANP (3-28), etc. (please refer to the entire specification particularly paragraphs 19, 23, 28, 31, 35, 37, 41, 51, 52).
All the claimed elements (hANP of present SEQ ID NO: 1, deletion of any of residues 1-6 of hANP; methods of utilizing ANP as a treatment for cardiovascular disease) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (hANP functions as a natriuretic polypeptide; deletion of any of residues 1-6 does not alter function) and the combination would have yielded predictable (still functions as hANP; treatment of a cardiovascular disease) results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (one natriuretic polypeptide; one hANP) for another (hANP; deletion of any of residues 1-6 of hANP) would have yielded predictable results (still functions as hANP) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (natriuretic polypeptide can treat cardiovascular disorders; deletion of any of residues 1-6 of hANP) 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 good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 9, 11-13, 16, 17, 19-22, and 25-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,072,642 in view of Burnett et al. WO 2011/005939 published January 13, 2011 and Iwamoto et al. WO 2014/115797 published July 31, 2014 (English language CA 2899232 is utilized for the citations below).
U.S. Patent No. 11,072,642 claims a natriuretic polypeptide of SEQ ID NO: 5 (present SEQ ID NO: 5), SEQ ID NO: 6 (S1T, S5T, and S6T substitutions), and SEQ ID NO: 15 (addition between residues 1 and 2).
Burnett et al. teach methods of administering a fusion of SEQ ID NO: 5 and SEQ ID NO: 13 (i.e. present SEQ ID NO: 1); SEQ ID NO: 6 (present SEQ ID NO: 1), SEQ ID NO: 15 (S1T substitution of present SEQ ID NO: 1), SEQ ID NO: 16 (L2I substitution of present SEQ ID NO: 1), SEQ ID NO: 17 (R3K substitution of present SEQ ID NO: 1), SEQ ID NO: 18 (R4K substitution of present SEQ ID NO: 1), and SEQ ID NO: 19 (S5T substitution of present SEQ ID NO: 1) with conservative amino acid substitutions or other substitutions and with at least 85% identity to increase natriuretic activity, cardiovascular disorders including arrhythmia, atrial fibrillation, hypertension, etc. in mammals including human wherein the polypeptides are administered intravenously at doses of 0.01 ng/kg to 50 mg/kg; methods of diagnosing a cardiac arrhythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder); and methods of determining whether a mammal is predisposed to develop a cardiac arrythmia (i.e. need for increased natriuretic activity or treatment of a cardiovascular disorder) (please refer to the entire specification particularly the abstract; pages 1-4, 6-13, 17, 18, 27, 30-33, 36-40; Figures 1A, 1B, 5B; Table 1).
As a general knowledge reminder, residues 1-28 of present SEQ ID NO: 1 are human ANP (hANP) and residues 29-40 of present SEQ ID NO: 1 is a result of a heterozygous frameshift mutation causing a 12 amino acid extension to the C-terminus of hANP (fsANP) which is resistant to proteolytic degradation. See the abstract and Figure 1 of Dickey et al., 2009, A Familial Mutation Renders Atrial Natriuretic Peptide Resistant to Proteolytic Degradation, The Journal of Biological Chemistry, 284(29): 19196-19202.
Iwamoto et al. teach that residues 1-6 of ANP are not necessary for function and can be deleted (e.g. present SEQ ID NO: 5 wherein the serine at either residue 5 or 6 is deleted) hANP (2-28), hANP (3-28), etc. (please refer to the entire specification particularly paragraphs 19, 23, 28, 31, 35, 37, 41, 51, 52).
All the claimed elements (hANP of present SEQ ID NO: 1, deletion of any of residues 1-6 of hANP; methods of utilizing ANP as a treatment for cardiovascular disease) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (hANP functions as a natriuretic polypeptide; deletion of any of residues 1-6 does not alter function) and the combination would have yielded predictable (still functions as hANP; treatment of a cardiovascular disease) results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (one natriuretic polypeptide; one hANP) for another (hANP; deletion of any of residues 1-6 of hANP) would have yielded predictable results (still functions as hANP) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (natriuretic polypeptide can treat cardiovascular disorders; deletion of any of residues 1-6 of hANP) 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 good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 2007/035600
U.S. Patent 7,803,901
Song et al., 2015, Atrial natriuretic peptide in cardiovascular biology and disease (NPPA), Gene, 569: 1-6.
Potter et al., 2009, Natriuretic Peptides: Their Structures, Receptors, Physiologic Functions and Therapeutic Applications, Handb Exp Pharmacol, 191: 341-366.
McKie et al., 2009, A Human Atrial Natriuretic Peptide Gene Mutation Reveals a Novel Peptide with Enhanced Blood Pressure-Lowering, Renal-Enhancing, and Aldosterone-Suppressing Actions, Journal of the American College of Cardiology, 54(11): 1024-1032.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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