DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 27, 2025 has been entered.
Status of the Claims
Claims 1-17 were originally filed February 5, 2024.
The amendment received October 28, 2024 amended claims 5-14, cancelled claims 15-17, and added new claims 18-23.
The amendment received March 10, 2025 amended claims 1, 4-14, and 19-23; canceled 18; and added new claim 24.
The amendment received July 28, 2025 and entered with the RCE filed August 27, 2025 amended claims 1, 5, and 24 and added new claims 25-27.
Claims 1-14 and 19-27 are currently pending.
Claims 1, 2, 4-14, and 19-27 are currently under consideration.
Please note: support for the amendment to independent claim 1 is more correctly found in Figure 7 and paragraph 33. Figure 4 and paragraph 30 refer to RSK (i.e. not mAKAPb).
Election/Restrictions
Applicants elected, without traverse, Group I (claims 1-4) in the reply filed on October 28, 2024.
Applicants elected, without traverse, of AAV9 as the species in the reply filed on October 28, 2024. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claim 3 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 28, 2024.
Priority
The present application is a CON of 17/580,692 filed January 21, 2022 (now U.S. Patent 11,931,402) which is a CON of 16/837,633 filed April 1, 2020 (now U.S. Patent 11,229,679) which is a CON of 15/946,238 filed April 5, 2018 (now U.S. Patent 10,617,737) which is a DIV of 14/821,082 filed August 7, 2015 (now U.S. Patent 9,937,228) which is a CON of 14/213,583 filed March 14, 2014 (now U.S. Patent 9,132,174) which claims the benefit of 61/798,268 filed March 15, 2013.
Specification
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.
Duplicate Claim
Applicant is advised that should claim 1 be found allowable, claim 24 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). A difference in function does not specifically alter the structure. If applicants wish to claim a different structure, the structure should be included in the claim to clarify the claim scope.
New Rejections
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 25 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.
Applicants pointed to paragraphs 10 and 72 and Figure 46 to support the limitation of a mAKAPb C-terminal phosphatase binding domain. However, paragraph 10 is silent with regard to a mAKAPb C-terminal phosphatase binding domain. Paragraph 72 is the description for Figure 46. Figure 46 shows a signal transduction pathway. Figure 46 does not refer to specific domains of mAKAPb. Therefore, a mAKAPb C-terminal phosphatase binding domain is not specifically disclosed in the originally filed specification.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 4-14, 19-23, 25, and 27 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 C-terminal domain is. This could be a single amino acid, a specific domain, etc.
Claims 1, 2, 4-14, 19-23, 25, and 27 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 structure is necessary for the function. Does a fragment with 80% homology to amino acids 1696-1835 of SEQ ID NO: 25 provide the function? Can other domains, amino acids, etc. of mAKAPb be present and still have the function?
Claims 24 and 26 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 C-terminal domain is. This could be a single amino acid, a specific domain, etc.
Claims 24 and 26 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 structure is necessary for the function. Does a fragment with 80% homology to amino acids 1696-1835 of SEQ ID NO: 25 provide the function? Can other domains, amino acids, etc. of mAKAPb be present and still have the function?
Claims 25 and 26 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 residues contain the mAKAPb C-terminal phosphatase binding domain.
Claim 27 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 skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what dosage is required to achieve “a clinically significant change in a cardiac myocyte feature of at least about 30 percent”. In addition, the claim reads as an intended use (i.e. administration to a patient).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 27 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 27 depends on claim 5 which depends on independent claim 1. Independent claim 1 requires residues 1696-1835 of SEQ ID NO: 25 and claim 5 requires a carrier. Dependent claim 27 simply refers to an intended use and a desired outcome. Therefore, the claim fails to further limit the structure of claims 1 and/or 5. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. One of skill in the art would not be able to determine the metes and bounds of the presently claimed subject matter. For example, it is unclear what “effective for treating or preventing a disease or condition associated with increased activity of RSK3” requires. The present claims are drawn to a pharmaceutical formulation; therefore, a specific amount should be provided.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112, second paragraph (indefinite), for claims 5-14 were considered but are not persuasive for the following reasons.
Applicants contend that the addition of a carrier negates the rejection.
Applicants’ arguments are not convincing since the limitation of a carrier does not negate the fact that the limitation of “effective for treating or preventing a disease or condition associated with increased activity of RSK3” is indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5-14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 depends on independent claim 1. Claim 6 depends on claim 5. Claims 7 and 8 depend on claim 6. Claims 9-14 depend on claim 5. Independent claim 1 requires the structure of a gene therapy vector encoding a fragment of a mAKAPb wherein the fragment is at least 80% homologous to amino acids 1696-1835 of SEQ ID NO: 25 and does not contain the C-terminal domain. Dependent claims 5-14 refer to a disease (i.e. method of utilizing the fragment of a mAKAPb wherein the fragment is at least 80% homologous to amino acids 1696-1835 of SEQ ID NO: 25 and does not contain the C-terminal kinase domain). Therefore, claims 5-14 fail to further limit the structure of independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112, fourth paragraph (failure to further limit), for claims 5-14 were considered but are not persuasive for the following reasons.
Applicants contend that the addition of a carrier negates the rejection.
Applicants’ arguments are not convincing since the claims still fail to further limit the structure of independent claim 1 besides the addition of a carrier.
New Rejections
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 4-14, and 19-27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Li et al., 2010, The mAKAPb Scaffold Regulates Cardiac Myocyte Hypertrophy via Recruitment of Activated Calcineurin, J Mol Cell Cardiol, 48(2): 387 (18 pages) and Huusko et al., 2012, AAV9-mediated VEGF-B Gene Transfer Improves Systolic Function in Progressive Left Ventricular Hypertrophy, Molecular Therapy, 20(12): 2212-2221 (previously provided).
For present claims 1, 2, 4-14, and 19-27, Li et al. teach mAKAPb fragments including residues 1286-1833 and carriers (please refer to the entire specification particularly Figure 1).
For present claims 1, 2, 4-14, and 19-27, Huusko et al. teach utilizing AAV9 vectors for polypeptide expression and/or gene therapy (please refer to the entire specification particularly the abstract, Materials and Methods).
The claims would have been obvious because a particular known technique (i.e. utilizing AAV9 vectors make constructs which can express polypeptides) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 2, 4-14, and 19-27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dodge-Kafka et al., 2010, cAMP-stimulated Protein Phosphatase 2A Activity Associated with Muscle A Kinase-anchoring Protein (mAKAP) Signaling Complexes Inhibits the Phosphorylation and Activity of the cAMP-specific Phosphodiesterase PDE4D3, The Journal of Biological Chemistry, 285(15): 11078-11086 and Huusko et al., 2012, AAV9-mediated VEGF-B Gene Transfer Improves Systolic Function in Progressive Left Ventricular Hypertrophy, Molecular Therapy, 20(12): 2212-2221 (previously provided).
For present claims 1, 2, 4-14, and 19-27, Dodge-Kafka et al. teach mAKAPb fragments including residues 1286-1833, 1666-2319, 1666-2083, or 1286-2083 and carriers (please refer to the entire specification particularly Figure 3)
For present claims 1, 2, 4-14, and 19-27, Huusko et al. teach utilizing AAV9 vectors for polypeptide expression and/or gene therapy (please refer to the entire specification particularly the abstract, Materials and Methods).
The claims would have been obvious because a particular known technique (i.e. utilizing AAV9 vectors make constructs which can express polypeptides) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 2, 4-14, and 19-27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kapiloff et al., 1999, mAKAP: an A-kinase anchoring protein targeted to the nuclear membrane of differentiated myocytes, Journal of Cell Science, 112: 2725-2736 and Huusko et al., 2012, AAV9-mediated VEGF-B Gene Transfer Improves Systolic Function in Progressive Left Ventricular Hypertrophy, Molecular Therapy, 20(12): 2212-2221 (previously provided).
For present claims 1, 2, 4-14, and 19-27, Kapiloff et al. teach mAKAPb fragments including residues 1666-1886 and 1666-2083 and carriers (please refer to the entire specification particularly Figure 4).
For present claims 1, 2, 4-14, and 19-27, Huusko et al. teach utilizing AAV9 vectors for polypeptide expression and/or gene therapy (please refer to the entire specification particularly the abstract, Materials and Methods).
The claims would have been obvious because a particular known technique (i.e. utilizing AAV9 vectors make constructs which can express polypeptides) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
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 1, 2, 5-14, and 19-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-32 of U.S. Patent No. 9,132,174. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 9,132,174 are drawn to amino acids 1694-1833 of mAKAPb and expression via AAV.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 9,132,174 for claims 1, 2, 5-14, and 19-27 were considered but are not persuasive for the following reasons.
Applicants state that the rejection will be addressed upon indication of otherwise allowable subject matter.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 9,132,174 renders obvious the composition of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Claims 1, 2, 4-14, and 19-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-32 of U.S. Patent No. 9,132,174 in view of Huusko et al., 2012, AAV9-mediated VEGF-B Gene Transfer Improved Systolic Function in Progressive Left Ventricular Hypertrophy, Molecular Therapy, 20(12): 2212-2221.
U.S. Patent No. 9,132,174 claims amino acids 1694-1833 of mAKAPb and expression via AAV.
Huusko et al. teach utilizing AAV9 in gene therapy (please refer to the entire reference particularly the abstract).
All the claimed elements 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 and the combination would have yielded predictable results (i.e. expression of the mAKAPb fragment via AAV9) 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 (i.e. genus of AAV) for another (i.e. species of AAV9) would have yielded predictable results (i.e. expression of mAKAPb fragment via AAV9) 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 (i.e. utilization of AAV9 for expression of polypeptides in mammals) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 9,132,174 in view of Huusko et al. for claims 1, 2, 4-14, and 19-27 were considered but are not persuasive for the following reasons.
Applicants request that the rejection be held in abeyance.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 9,132,174 in view of Huusko et al. renders obvious the composition of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Claims 1, 5-14, and 19-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9,937,228. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 9,937,228 are drawn to amino acids 245-1833 of mAKAPb and expression via a viral-based gene therapy vector.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 9,937,228 for claims 1, 5-14, and 19-27 were considered but are not persuasive for the following reasons.
Applicants state that the rejection will be addressed upon indication of otherwise allowable subject matter.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 9,937,228 renders obvious the compositon of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Claims 1, 2, 4-14, and 19-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9,937,228 in view of Huusko et al., 2012, AAV9-mediated VEGF-B Gene Transfer Improved Systolic Function in Progressive Left Ventricular Hypertrophy, Molecular Therapy, 20(12): 2212-2221.
U.S. Patent No. 9,937,228 are drawn to amino acids 245-1833 of mAKAPb and expression via a viral-based gene therapy vector.
Huusko et al. teach utilizing AAV9 in gene therapy (please refer to the entire reference particularly the abstract).
All the claimed elements 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 and the combination would have yielded predictable results (i.e. expression of the mAKAPb fragment via AAV9) 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 (i.e. genus of viral-based gene therapy vector) for another (i.e. species of AAV9) would have yielded predictable results (i.e. expression of mAKAPb fragment via AAV9) 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 (i.e. utilization of AAV9 for expression of polypeptides in mammals) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 9,937,228 in view of Huusko et al. for claims 1, 2, 4-14, and 19-27 were considered but are not persuasive for the following reasons.
Applicants state that the rejection will be addressed upon indication of otherwise allowable subject matter.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 9,937,228 in view of Huusko et al. renders obvious the composition of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Claims 1, 2, 5-14, and 19-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,617,737. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 10,617,737 are drawn to amino acids 245-1833 of mAKAPb and expression via AAV.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 10,617,737 for claims 1, 2, 5-14, and 19-27 were considered but are not persuasive for the following reasons.
Applicants state that the rejection will be addressed upon indication of otherwise allowable subject matter.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 10,617,737 renders obvious the composition of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Claims 1, 2, 4-14, and 19-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,617,737 in view of Huusko et al., 2012, AAV9-mediated VEGF-B Gene Transfer Improved Systolic Function in Progressive Left Ventricular Hypertrophy, Molecular Therapy, 20(12): 2212-2221.
U.S. Patent No. 10,617,737 claims amino acids 245-1833 of mAKAPb and expression via AAV.
Huusko et al. teach utilizing AAV9 in gene therapy (please refer to the entire reference particularly the abstract).
All the claimed elements 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 and the combination would have yielded predictable results (i.e. expression of the mAKAPb fragment via AAV9) 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 (i.e. genus of AAV) for another (i.e. species of AAV9) would have yielded predictable results (i.e. expression of mAKAPb fragment via AAV9) 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 (i.e. utilization of AAV9 for expression of polypeptides in mammals) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 10,617,737 in view of Huusko et al. for claims 1, 2, 4-14, and 19-27 were considered but are not persuasive for the following reasons.
Applicants state that the rejection will be addressed upon indication of otherwise allowable subject matter.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 10,617,737 in view of Huusko et al. renders obvious the composition of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Claims 1, 2, 4-14, and 19-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,229,679. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 11,229,679 are drawn to AAV9 gene therapy vector encoding a fragment of mAKAPb comprising amino acids 1735-1833. Please note: the claims of U.S. Patent No. 11,229,679 are open to additional amino acid residues being present with the negative proviso excluding the full-length mAKAPb.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 11,229,679 for claims 1, 2, 4-14, and 19-27 were considered but are not persuasive for the following reasons.
Applicants state that the rejection will be addressed upon indication of otherwise allowable subject matter.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 11,229,679 renders obvious the composition of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Claims 1, 2, 4-14, and 19-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,931,402 in view of Huusko et al., 2012, AAV9-mediated VEGF-B Gene Transfer Improved Systolic Function in Progressive Left Ventricular Hypertrophy, Molecular Therapy, 20(12): 2212-2221.
U.S. Patent No. 11,931,402 claims amino acids 1735-1833 of mAKAPb. Please note: the claims of U.S. Patent No. 11,931,402 are open to additional amino acid residues being present.
Huusko et al. teach utilizing AAV9 in gene therapy for polypeptide expression (please refer to the entire reference particularly the abstract).
All the claimed elements 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 and the combination would have yielded predictable results (i.e. expression of the mAKAPb fragment via AAV9 as an alternative to the polypeptide) 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 (i.e. polypeptide of mAKAPb fragment) for another (i.e. polynucleotide expressing mAKAPb fragment via AAV9) would have yielded predictable results (i.e. expression of mAKAPb fragment) 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 (i.e. utilization of AAV9 for expression of polypeptides in mammals) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 11,931,402 in view of Huusko et al. for claims 1, 2, 4-14, and 19-27 were considered but are not persuasive for the following reasons.
Applicants state that the rejection will be addressed upon indication of otherwise allowable subject matter.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 11,931,402 in view of Huusko et al. renders obvious the composition of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Claims 1, 2, 4-14, and 19-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of copending Application No. 18/439,546 in view of Huusko et al., 2012, AAV9-mediated VEGF-B Gene Transfer Improved Systolic Function in Progressive Left Ventricular Hypertrophy, Molecular Therapy, 20(12): 2212-2221.
Copending Application No. 18/439,546 claims fragments of mAKAPb comprising amino acids 1694-1833 and vectors. Please note: the claims of copending Application No. 18/439,546 (reference application) are open to additional amino acid residues being present.
Huusko et al. teach utilizing AAV9 in gene therapy for polypeptide expression (please refer to the entire reference particularly the abstract).
All the claimed elements 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 and the combination would have yielded predictable results (i.e. expression of the mAKAPb fragment via AAV9) 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 (i.e. genus of vector) for another (i.e. species of AAV9) would have yielded predictable results (i.e. expression of mAKAPb fragment via AAV9) 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 (i.e. utilization of AAV9 for expression of polypeptides in mammals) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over copending Application No. 18/439,546 in view of Huusko et al. for claims 1, 2, 4-14, and 19-27 were considered but are not persuasive for the following reasons.
Applicants state that the rejection will be addressed upon indication of otherwise allowable subject matter.
Applicants’ arguments are not convincing since the claimed invention of copending Application No. 18/439,546 in view of Huusko et al. renders obvious the composition of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
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/AMBER D STEELE/Primary Examiner, Art Unit 1658