DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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.
Claim 2 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 2 directs to a method of claim 1, wherein the Hippo pathway activator compound is selected from Verteporfin, Compound 13, DAY10583, CA3, SBI-115 and C19. The use of the name “Compound 13,” is ambiguous and indefinite because it is unclear what is the structure of “compound 13.” The meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be "ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention." In re Packard, 751 F.3d 1307, 1311, 110 USPQ2d 1785, 1787 (Fed. Cir. 2014). See MPEP 2173.05(a)(I). Moreover, the examined specification discloses that compound 13 was identified in screen for compounds that could activate the Hippo pathway but fails to provide any structure or chemical name for compound 13. See specification page 14 paragraph 0091. As a consequence, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically one of ordinary skill in the art would not be reasonably apprised of what compound is compound 13 and would within the scope of the claim. Therefore, given the uncertainty around “compound 13,” claim 2; claim 2 is rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 – 2, and 4 – 5 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication US 2016/0361340 A1 to Meilhac et. al. (Meilhac’340; cited on the ISR dated October 16th, 2024).
Regarding claims 1 – 2, and 4 – 5, Meilhac’340 teach that it is well-known that Hippo kinases and Hippo effectors are required to regulate heart growth during development and that these molecules can also be manipulated to re-activate cardiomyocyte division in the postnatal heart, thus improving heart repair after injury. See page 1 paragraph 0006. Furthermore, Meilhac’340 teach that despite significant therapeutic advances, the prognosis of patients with heart failure remains poor, and current therapeutic approaches are palliative in the sense that they do not address the underlying problem of the loss of cardiac tissue. See page 1 paragraph 0008. Additionally, Meilhac’340 teach the identity of new effectors of the Hippo pathway that participate, in mammals, in heart growth and/or its restriction. See page 1 paragraph 0014.
Thus, Meilhac’340 teach methods of treating and preventing cardiac hypertrophy and heart failure. See page 2 paragraph 0024. See claim 1 limitation for a method of treating cardiomyopathy. Moreover, Meilhac’340 teach that the terms “cardiac hypertrophy” and “mitogenic cardiomyopathy” are equivalent. See page 3 paragraph 0042. Thus, Meilhac’340 teach a method of treating a type of cardiomyopathy that is mitogenic. See claim 1 limitation for a method of treating cardiomyopathy. Furthermore, Meilhac’340 teach preferred embodiments where said mammal is human that suffers from cardiac hypertrophy, that is mitogenic cardiomyopathy. See page 5 paragraph 0081. See claim 4 limitations for a method where the subject is a human. Additionally, Meilhac’340 teach another preferred embodiment where said mammal is a human infant. See page 5 paragraph 0082. See claim 5 limitations for a method where the subject is a human infant. Meilhac’340 teach that the treatment includes administering an inhibitor of Yap1 such as verteporfin. See page 2 paragraph 0024. See claim 1 limitation for a method comprising administering a Hippo pathway activator compound. See claim 2 limitation for a method where the Hippo pathway activator selected is verteporfin.
While the prior art of Meilhac’340 is silent about whether verteporfin is a Hippo pathway activator; products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. See MPEP 2112.01(II). Thus where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01(I).
Therefore, it would have been obvious before the effective filing date of the instant application to use the teachings of Meilhac’340 to administer verteporfin in a method of treating cardiac hypertrophy that is mitogenic cardiomyopathy. One of ordinary skill in the art would have been motivated to make this modification to address the underlying problem of cardiac hypertrophy which is the loss of cardiac tissue through the modulation of the Hipp pathway. One of ordinary skill in the art would have had a reasonable expectation of success because it is well-known in the art that Hippo kinases and Hippo effectors are required to regulate heart growth during development and that these molecules can also be manipulated to re-activate cardiomyocyte division in the postnatal heart, thus improving heart repair after injury.
Claims 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication US 2016/0361340 A1 to Meilhac et. al. (Meilhac’340; cited on the ISR dated October 16th, 2024) as applied above for claims 1 – 2, and 4 – 5, in view of US Patent Application Publication US 2016/0200697 A1 to Rebbaa et. al. (Rebbaa’697; cited on the ISR dated October 16th, 2024).
The teachings of Meilhac’340 as they relate to claim 1, from which claims 3 and 6 depend, are given previously in this office action and are fully incorporated here.
However, Meilhac’340 fails to teach a method where the Hippo pathway activator is C19. See claim 3 limitations. Moreover, Meilhac’340 fails to teach a method where administration is by intravenous infusion, intravenous injection, subcutaneous injection, or orally. See claim 6 limitation.
Nevertheless, Rebbaa’697 teach that adenosine monophosphate-activated protein kinase (AMPK) plays a role in cardiac remodeling, as it pertains to diabetic cardiomyopathy, cardiac hypertrophy, and heart failure, suggesting that there might be therapeutic value in targeting the AMPK signaling pathway to treat cardiovascular diseases. See page 1 paragraph 0007. Specifically, Rebbaa’697 teach compounds, or pharmaceutically acceptable salts or esters thereof, having a structure of:
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. See page 2 paragraph 0012. Morespecifically, Rebbaa’697 teach compound 1e that is C19 of strcture
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. See page 8 paragraoh 0075. See claim 3 limitataion for C19. Futhermore, Rebbaa’697 teach that compounds of the disclosure which include C19 can be administered in pharmacuetical compositions for administration through oral and introvemous. See page 10 paragraoh 0087. See claim 6 limiatation for a method where administration is by intravenous infusion, intravenous injection, subcutaneous injection, or orally.
While the prior art of Rebbaa’697 is silent about whether C19 is a Hippo pathway activator; products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. See MPEP 2112.01(II). Thus where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01(I).
Therefore, it would have been obvious before the effective filing date of the instant application to use the teachings of Meilhac’340 to administer verteporfin in a method of treating cardiac hypertrophy that is mitogenic cardiomyopathy in view of Rebbaa’697 to replace verteporfin for C19. One of ordinary skill in the art would have been motivated to make this modification to address the underlying problem of cardiac hypertrophy which is the loss of cardiac tissue through the modulation of the Hipp pathway. One of ordinary skill in the art would have had a reasonable expectation of success because it is well-known in the art that Hippo kinases and Hippo effectors are required to regulate heart growth during development and that these molecules can also be manipulated to re-activate cardiomyocyte division in the postnatal heart, thus improving heart repair after injury.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication US 2016/0361340 A1 to Meilhac et. al. (Meilhac’340; cited on the ISR dated October 16th, 2024) as applied above for claims 1 – 2, and 4 – 5, in view of Chang et. al. ((2010), Mitogenic cardiomyopathy: A lethal neonatal familial dilated cardiomyopathy characterized by myocyte hyperplasia and proliferation, Human Pathology, 41, 1002 – 1008).
The teachings of Meilhac’340 as they relate to claims 1 and 4, from which claim 7 depend, are given previously in this office action and are fully incorporated here.
However, Meilhac’340 fails to teach a method where the subject suffers from infantile dilated cardiomyopathy. See claim 7 limitation.
Nevertheless, Chang et. al. teach that cardiomyopathies are defined in a recent statement of the American Heart Association as a heterogenous group of diseases of the myocardium associated with mechanical and/ or electrical dysfunction that usually but not invariably exhibit inappropriate ventricular hypertrophy or dilatation and are due to a variety of causes that frequently are genetic. See page 1002 column 2 paragraph 1 and page 1003 column 1 paragraph 1. Chang et. al. teach that dilated cardiomyopathy is the most common clinicomorphologic type of pediatric cardiomyopathy. See page 1003 column 1 paragraph 3. Furthermore, Change et. al. teach clinically and pathologically distinctive familial form of dilated cardiomyopathy that we termed mitogenic cardiomyopathy occurring in early infancy that was invariably fatal and that had a distinctive histology of myocyte hyperplasia with marked proliferative activity. See page 1003 column 1 paragraph 4 and column 2 paragraph 1.
Therefore, it would have been obvious before the effective filing date of the instant application to use the teachings of Meilhac’340 to administer verteporfin in a method of treating cardiac hypertrophy that is mitogenic cardiomyopathy in view of Chang et. al. that is to treat infantile dilated cardiomyopathy. One of ordinary skill in the art would have been motivated to make this modification to address the underlying problem of cardiac hypertrophy which is the loss of cardiac tissue through the modulation of the Hipp pathway. Moreover, one of ordinary skill in the art would have been motivated to make this modification to improve patient outcomes by mitigating or reducing the fatality rate of the disease. One of ordinary skill in the art would have had a reasonable expectation of success because it is well-known in the art that Hippo kinases and Hippo effectors are required to regulate heart growth during development and that these molecules can also be manipulated to re-activate cardiomyocyte division in the postnatal heart, thus improving heart repair after injury.
Conclusion
Claims 1 – 7 are rejected.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
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