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 . 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.
Information Disclosure Statement
The information disclosure statement filed 20 Feb, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. A small number of references were not found in the application file, and so were not considered. It is noted that there were also a small number of documents that were of too poor a resolution to determine what they stated (mostly what appeared to be photocopies of books). Please be aware that, once the documents are uploaded to the server, they are converted to the format used in the database, often with loss of resolution.
The information disclosure statement filed 26 Feb, 2025 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. Applicants have stated that US 20170020034 is an English language equivalent of JP 2018522022. However, it clearly isn’t. One is four times the page count of the other, the PGPub is drawn to semiconductors, while the Japanese document is clearly discussing peptide sequences, and the figures do not match.
Examiner’s Note
This application has passed from examiner Juan Ortega (AU 1617) to examiner Fred Reynolds (AU 1658).
Election/Restrictions
Applicant’s election without traverse of group I (formulations) in the reply filed on 26 Feb, 2025 is acknowledged.
Applicants elected formulations of C-type natriuretic peptide with a hydrophobic counterion. A search was conducted for this invention, and references that either anticipated it or rendered it obvious were found. As a result, claims 1-3, 5, 8, 12-16, 18, 21, 23, 28, 44, 48, and 50 were examined, and claims 30, 38, and 40 were withdrawn from consideration.
Claims Status
Claims 1-3, 5, 8, 12-16, 18, 21, 23, 28, 30, 38, 40, 44, 48, and 50 are pending.
Claims 30, 38, and 40 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 Feb, 2025.
Claim Objections
Claims 1 and 44 are identical in scope, as are claims 14 and 50.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 5, 8, 12, 13, 15, 16, 18, 21, 23, 28, 44, and 48 are rejected under 35 U.S.C. 101 because they read on a judicial exception, natural phenomenon.
The Supreme Court has given a three part test for eligibility under this statute:
1) Are the claims drawn to a process, machine, manufacture, or composition of matter?
2a) If the first test is passed, does a judicial exception apply?
2b) If a judicial exception applies, is there something beyond the judicial exception?
Applying the test:
The claims are drawn to formulations of C-type natriuretic peptide (CNP), a composition of matter.
2a) CNP is found naturally in blood (Hamma et al, Biochem. Biphys. Res. Comm. (1994) 198(3) p1177-1182, abstract). So are the various fatty acids, such as oleate and palmitate (Abdelmagid et al, PLoS One (2015) 10(2) e0116195, abstract). As is acetate (Hosios et al, Canc. Metabol. (2014) 2:27, 1st page, 2nd column, 2nd paragraph) and calcium (a polyvalent metal cation)(Allison, Nat. Rev. Nephrol. (2012) 8, p552, title). In other words, a formulation comprising all the ingredients of the claims with a pharmaceutically acceptable carrier (such as water or albumin) occurs naturally, as do dried versions (scabs or dried blood).
2b) Blood occurs naturally; as such, there can be nothing beyond the judicial exception.
Claim Rejections - 35 USC § 112(b)
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.
first rejection
Claims 1-3, 5, 8, 12-14, 18, 21, 23, 28, 44, and 50 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The rejected claims all require a hydrophobic counterion. The issue is the term “hydrophobic.” Applicants have defined hydrophobic counterion as a group of electrostatically charged moieties that are hydrophobic in nature (paragraph 90), which does not help. Unfortunately, while the concept of hydrophilicity and hydrophobicity are well known in the art, the cutoff between a hydrophobic and a non-hydrophobic species is not defined in the art. Note that applicants consider acetate an appropriate counterion (claim 15), even though acetate is not normally considered hydrophobic. As a person of skill in the art would not know what the cutoff between a hydrophobic and a non-hydrophobic counterion, there exist embodiments where it is not clear if they meet the claim limitations. This renders the claims indefinite.
second rejection
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 requires a CNP variant, which means different from a reference CNP. However, what the reference CNP to be compared to is not clear. Note that Hisado-Oliva et al (cited by applicants) discloses homologs of this protein, so there is no single “natural” sequence to be compared to.
third rejection
Claim 23 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
One of the members of the Markush group of claim 23 is “crystalline microparticle is resuspended in an aqueous solution.” Resuspended indicates that the particle is intact in the water, solution indicated dissolution. This makes it unclear what is actually claimed.
fourth rejection
Claim 28 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 28 dictates how much of the sequence is released at certain time points. There are three issues with this: 1) the conditions under which the test is carried out are not given. Release from microparticles in the blood will be different than release from the same particles injected subQ, which will be different than an in vitro test, such as through a CaCo2 monolayer, which will be different than the same test when the culture medium is saturated with a hydrophobic anion. This means that an embodiment can either meet or not meet the limitations, depending on a factor not defined by the claim. 2) in a related issue, it is not clear what is meant by “released” in the context of the claim. It could be dissolution, it could be travel to the bloodstream, it could be something else. 3) 90% of the peptide is released by day 7, day 14, or day 31. If an embodiment meets one of these times, but not another, it is not clear if the claim limitations have been met.
fifth rejection
Claims 8 and 28 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.
Claims 8 and 28 modify the numbers in the claim with the adjective “about.” The issue is that applicants have given multiple definitions for this adjective. It can be 1, 2, 3, or 4 standard deviations, it can be the acceptable error, or within a number of percentages between 30 % and 0.05%. As these definitions are not equivalent to each other, it is possible for an embodiment to meet one of these definitions, but not others. This makes it impossible to determine if such an embodiment reads on the claims.
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.
Claim(s) 1-3, 5, 8, 12, 13, 15, 16, 18, 21, 23, 28, 44, 48, and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sharma et al (US 20100035821, cited by applicants). with evidentiary support from the PubChem entry for oleic acid (last modified 15 March, 2025).
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Sharma et al discusses formulations comprising CNP and a hydrophobic counterion for extended plasma lifetime, anticipating claims 1-3, 21, and 44.
Sharma et al discusses formulations with polyvalent metal cations, such as calcium and magnesium, anticipating claim 5.
The hydrophobic counterions discussed by Sharma et al must have a cLogP or pKa within 4 standard deviations of the mean of all organic compounds, anticipating claim 8. Alternatively, the PubChem entry for oleic acid describes a calculated LogP of 6.5.
Sharma et al discusses solid formulations, anticipating claims 12 and 23.
As there are more than one type of CNP, any CNP is a variant of some other CNP, so the compounds of Sharma et al anticipate claim 13.
Sharma et al discuss using acetate as a counterion, anticipating claim 15.
Sharma et al discuss oleate and pamoate, anticipating claims 16 and 48.
Sharma et al discusses formulations with excipients, diluents, or carriers (note the fatty oil), anticipating claim 18.
A set of dissolution conditions can be found that will yield the dissolution profile of claim 28, anticipating it. Alternatively, these are the same formulations, so they will inherently have the same dissolution profile.
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.
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.
Claim(s) 1-3, 5, 8, 12-16, 18, 21, 23, 28, 44, 48, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Wendt et al (US 8,198,242) in view of Sharma et al (US 20100035821, cited by applicants). with evidentiary support from the PubChem entry for oleic acid (last modified 15 March, 2025).
Wendt et al discuss variants of CNP (abstract). Among the sequences discussed is SEQ ID 145 (column 58, line 11), identical with SEQ ID 1 of the examined claims. Note that the reference discusses modifications based on this sequence (column 59, line 48-56, column 60, line 33-55) and is claimed by the authors (claim 1). In other words, this is clearly an important sequence for the authors.
The difference between this reference and the examined claims is that this reference does not discuss a hydrophobic counterion.
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Therefore, it would be obvious to use a fatty acid counterion of Sharma et al to increase the circulation half life of the peptides of Wendt et al. As both references are discussing CNP variants, an artisan in this field would attempt this formulation with a reasonable expectation of success.
As noted above, Sharma et al anticipates claims 1-3, 5, 8, 12, 13, 15, 16, 18, 21, 23, 28, 44, 48, and 50.
Wendt et al discusses SEQ ID 1 as a therapeutic peptide. Sharma et al renders obvious using a hydrophobic counterion, rendering obvious claims 14 and 50.
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.
first rejection
Claims 1-3, 5, 8, 12-16, 18, 21, 23, 28, 44, 48, and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/642,150 (US 20230192799) in view of Sharma et al (US 20100035821, cited by applicants).
Competing claim 1 describes a polypeptide (SEQ ID 1) with a sequence identical to SEQ ID 1 of the examined claims.
The difference between the competing claims and the examined claims is that this reference does not discuss a hydrophobic counterion.
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Therefore, it would be obvious to use a fatty acid counterion of Sharma et al to increase the circulation half life of the peptide of the competing claims. As both references are discussing CNP variants, an artisan in this field would attempt this formulation with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
second rejection
Claims 1-3, 5, 8, 12-16, 18, 21, 23, 28, 44, 48, and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 14 of copending Application No. 18/717,353 (US 20250032576) in view of Sharma et al (US 20100035821, cited by applicants).
Competing claim 1 describes a method of treatment using CNP. Competing claim 14 lists a Markush group of sequences, including SEQ ID 1 (identical with SEQ ID 1 of the examined claims.
The difference between the competing claims and the examined claims is that this reference does not discuss a hydrophobic counterion.
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Therefore, it would be obvious to use a fatty acid counterion of Sharma et al to increase the circulation half life of the peptide of the competing claims. As both references are discussing CNP variants, an artisan in this field would attempt this formulation with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
third rejection
Claims 1-3, 5, 8, 12-16, 18, 21, 23, 28, 44, 48, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,233,106 in view of Sharma et al (US 20100035821, cited by applicants).
Competing claim 1 describes a therapeutic method using one of a Markush group of polypeptide that includes SEQ ID 1, identical to SEQ ID 1 of the examined claims.
The difference between the competing claims and the examined claims is that this reference does not discuss a hydrophobic counterion.
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Therefore, it would be obvious to use a fatty acid counterion of Sharma et al to increase the circulation half life of the peptide of the competing claims. As both references are discussing CNP variants, an artisan in this field would attempt this formulation with a reasonable expectation of success.
fourth rejection
Claims 1-3, 5, 8, 12-16, 18, 21, 23, 28, 44, 48, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,202,819 in view of Sharma et al (US 20100035821, cited by applicants).
Competing claim 1 describes a therapeutic method using one of a Markush group of polypeptide that includes SEQ ID 1, identical to SEQ ID 1 of the examined claims.
The difference between the competing claims and the examined claims is that this reference does not discuss a hydrophobic counterion.
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Therefore, it would be obvious to use a fatty acid counterion of Sharma et al to increase the circulation half life of the peptide of the competing claims. As both references are discussing CNP variants, an artisan in this field would attempt this formulation with a reasonable expectation of success.
fifth rejection
Claims 1-3, 5, 8, 12-16, 18, 21, 23, 28, 44, 48, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,214,015 in view of Sharma et al (US 20100035821, cited by applicants).
Competing claim 1 describes a therapeutic method using one of a Markush group of polypeptide that includes SEQ ID 1, identical to SEQ ID 1 of the examined claims.
The difference between the competing claims and the examined claims is that this reference does not discuss a hydrophobic counterion.
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Therefore, it would be obvious to use a fatty acid counterion of Sharma et al to increase the circulation half life of the peptide of the competing claims. As both references are discussing CNP variants, an artisan in this field would attempt this formulation with a reasonable expectation of success.
sixth rejection
Claims 1-3, 5, 8, 12-16, 18, 21, 23, 28, 44, 48, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,907,834 in view of Sharma et al (US 20100035821, cited by applicants).
Competing claim 1 describes a composition comprising one of a Markush group of polypeptide that includes SEQ ID 5, identical to SEQ ID 1 of the examined claims.
The difference between the competing claims and the examined claims is that this reference does not discuss a hydrophobic counterion.
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Therefore, it would be obvious to use a fatty acid counterion of Sharma et al to increase the circulation half life of the peptide of the competing claims. As both references are discussing CNP variants, an artisan in this field would attempt this formulation with a reasonable expectation of success.
seventh rejection
Claims 1-3, 5, 8, 12-16, 18, 21, 23, 28, 44, 48, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,646,550 in view of Sharma et al (US 20100035821, cited by applicants).
Competing claim 1 describes a therapeutic method using one of a Markush group of polypeptide that includes SEQ ID 5, identical to SEQ ID 1 of the examined claims.
The difference between the competing claims and the examined claims is that this reference does not discuss a hydrophobic counterion.
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Therefore, it would be obvious to use a fatty acid counterion of Sharma et al to increase the circulation half life of the peptide of the competing claims. As both references are discussing CNP variants, an artisan in this field would attempt this formulation with a reasonable expectation of success.
eighth rejection
Claims 1-3, 5, 8, 12-16, 18, 21, 23, 28, 44, 48, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,590,204 in view of Sharma et al (US 20100035821, cited by applicants).
Competing claim 1 describes a composition comprising one of a Markush group of polypeptide that includes SEQ ID 5, identical to SEQ ID 1 of the examined claims.
The difference between the competing claims and the examined claims is that this reference does not discuss a hydrophobic counterion.
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Therefore, it would be obvious to use a fatty acid counterion of Sharma et al to increase the circulation half life of the peptide of the competing claims. As both references are discussing CNP variants, an artisan in this field would attempt this formulation with a reasonable expectation of success.
ninth rejection
Claims 1-3, 5, 8, 12-16, 18, 21, 23, 28, 44, 48, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,911,446 in view of Sharma et al (US 20100035821, cited by applicants).
Competing claim 1 describes a therapeutic method using one of a Markush group of polypeptide that includes SEQ ID 5, identical to SEQ ID 1 of the examined claims.
The difference between the competing claims and the examined claims is that this reference does not discuss a hydrophobic counterion.
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Therefore, it would be obvious to use a fatty acid counterion of Sharma et al to increase the circulation half life of the peptide of the competing claims. As both references are discussing CNP variants, an artisan in this field would attempt this formulation with a reasonable expectation of success.
tenth rejection
Claims 1-3, 5, 8, 12-16, 18, 21, 23, 28, 44, 48, and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18,425,954 (US 20240156914) in view of Sharma et al (US 20100035821, cited by applicants).
Competing claim 1 describes a method of treatment using a Markush group of polypeptides, including SEQ ID 5, with a sequence identical to SEQ ID 1 of the examined claims.
The difference between the competing claims and the examined claims is that this reference does not discuss a hydrophobic counterion.
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Therefore, it would be obvious to use a fatty acid counterion of Sharma et al to increase the circulation half life of the peptide of the competing claims. As both references are discussing CNP variants, an artisan in this field would attempt this formulation with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
eleventh rejection
Claims 1-3, 5, 8, 12-16, 18, 21, 23, 28, 44, 48, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,076,372 in view of Sharma et al (US 20100035821, cited by applicants).
Competing claim 1 describes a therapeutic method using one of a Markush group of polypeptide that includes SEQ ID 5, identical to SEQ ID 1 of the examined claims.
The difference between the competing claims and the examined claims is that this reference does not discuss a hydrophobic counterion.
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Therefore, it would be obvious to use a fatty acid counterion of Sharma et al to increase the circulation half life of the peptide of the competing claims. As both references are discussing CNP variants, an artisan in this field would attempt this formulation with a reasonable expectation of success.
twelfth rejection
Claims 1-3, 5, 8, 12-16, 18, 21, 23, 28, 44, 48, and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/785,340 (US 20240374688) in view of Sharma et al (US 20100035821, cited by applicants).
Competing claim 1 describes a method of treatment using a Markush group of polypeptides, including SEQ ID 5, with a sequence identical to SEQ ID 1 of the examined claims.
The difference between the competing claims and the examined claims is that this reference does not discuss a hydrophobic counterion.
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Therefore, it would be obvious to use a fatty acid counterion of Sharma et al to increase the circulation half life of the peptide of the competing claims. As both references are discussing CNP variants, an artisan in this field would attempt this formulation with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
thirteenth rejection
Claims 1-3, 5, 8, 12, 13, 15, 16, 18, 21, 23, 28, 44, and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,377,884 in view of Sharma et al (US 20100035821, cited by applicants).
Competing claim 1 describes a CNP polypeptide.
The difference between the competing claims and the examined claims is that this reference does not discuss a hydrophobic counterion.
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Therefore, it would be obvious to use a fatty acid counterion of Sharma et al to increase the circulation half life of the peptide of the competing claims. As both references are discussing CNP variants, an artisan in this field would attempt this formulation with a reasonable expectation of success.
fourteenth rejection
Claims 1-3, 5, 8, 12-16, 18, 21, 23, 28, 44, 48, and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,198,242 in view of Sharma et al (US 20100035821, cited by applicants).
Competing claim 1 describes a polypeptide (SEQ ID 145) with a sequence identical to SEQ ID 1 of the examined claims.
The difference between the competing claims and the examined claims is that this reference does not discuss a hydrophobic counterion.
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Therefore, it would be obvious to use a fatty acid counterion of Sharma et al to increase the circulation half life of the peptide of the competing claims. As both references are discussing CNP variants, an artisan in this field would attempt this formulation with a reasonable expectation of success.
fifteenth rejection
Claims 1-3, 5, 8, 12, 13, 15, 16, 18, 21, 23, 28, 44, and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,598,121 in view of Sharma et al (US 20100035821, cited by applicants).
Competing claim 1 describes a Markush group of CNP polypeptides.
The difference between the competing claims and the examined claims is that this reference does not discuss a hydrophobic counterion.
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Therefore, it would be obvious to use a fatty acid counterion of Sharma et al to increase the circulation half life of the peptide of the competing claims. As both references are discussing CNP variants, an artisan in this field would attempt this formulation with a reasonable expectation of success.
sixteenth rejection
Claims 1-3, 5, 8, 12, 13, 15, 16, 18, 21, 23, 28, 44, and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. RE46,707 in view of Sharma et al (US 20100035821, cited by applicants).
Competing claim 1 describes a Markush group of CNP polypeptides.
The difference between the competing claims and the examined claims is that this reference does not discuss a hydrophobic counterion.
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Therefore, it would be obvious to use a fatty acid counterion of Sharma et al to increase the circulation half life of the peptide of the competing claims. As both references are discussing CNP variants, an artisan in this field would attempt this formulation with a reasonable expectation of success.
seventeenth rejection
Claims 1-3, 5, 8, 12, 13, 15, 16, 18, 21, 23, 28, 44, and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. RE48,267 in view of Sharma et al (US 20100035821, cited by applicants).
Competing claim 1 describes a Markush group of CNP polypeptides.
The difference between the competing claims and the examined claims is that this reference does not discuss a hydrophobic counterion.
Sharma et al discuss natriuretic peptides, including CNP (paragraph 7). Counterions for these peptides can include acetate (paragraph 218), but when longer chain fatty acids are used as the counterion, such as oleate or pamoate, circulation half life is increased compared to acetate counterion, possibly due to a decrease in solubility (paragraph 219). Tablet and pill formulations using dicalcium phosphate, magnesium stearate, or a liquid carrier such as a fatty oil (paragraph 225).
Therefore, it would be obvious to use a fatty acid counterion of Sharma et al to increase the circulation half life of the peptide of the competing claims. As both references are discussing CNP variants, an artisan in this field would attempt this formulation with a reasonable expectation of success.
Conclusion
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658