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 .
DETAILED ACTION
Claims 1, 6, 8, 11 and 14 are pending in the present application.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/25/2025 has been entered.
Previous Claim Rejections - 35 USC § 103
Claims 1-4 and 6-8 were previously rejected under 35 U.S.C. 103 as being unpatentable over KR 10-2009-0084439 (Choi et al.), in view of US 2005/0182106 A1 (Kondo et al.) and US 2008/0241240 A1 (Kim et al.).
Applicant has amended the claims and traversed the rejection on grounds the instantly claimed combination of noranhydroicaritin and a statin-based drug provides superior, unexpected results with respect to a therapeutic effect for cardiovascular and metabolic disease as well as reducing PCSK9 expression, among other biomarkers. Applicant argues cardiovascular and metabolic diseases recited in claim 1 are primarily caused by a distinct mechanism, lipid imbalances, compared complications from diabetes resulting from hyperglycemia. Applicant submits the instantly claimed combination improves statin-related side effects and one of skill in the art would not have arrived at the unpredictable effect from the combination of Choi, Kondo or Kim.
The Examiner has considered the amendment and traversal fully but must disagree for the following reasons.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). See MPEP 2145, Section IV as well. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). See MPEP 2144, Section IV.
It is noted that the features upon which Applicant relies (i.e. noranhydroicaritin as PCSK9 modulator, effect of claimed composition on lipid-metabolism disorder and reduction of statin-induced PCSK9 upregulation) are not recited in the rejected claims and, therefore, these features do not carry any weight in terms of an obviousness analysis. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Choi discloses desmethylanhydroicaritin (also known as noranhydroicaritin; CAS Registry Number: 28610-31-3) as compound (1) in claims 1 and 6 of Choi.
It appears that given the constituents would result in the instant properties, the prior art compositions could anticipate the instant claims where "Products of identical chemical composition can not have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. See MPEP 2112.01, Section II. As Choi discloses a composition comprising noranhydroicaritin having the same structure as presently claimed, the properties alleged by Applicant would be expected to be present in the disclosure of Choi.
Although applicant may have a different motivation for including a compound of Chemical formula (1) and a statin-based drug, as a modulator of PCSK9, this does not alter the conclusion of obviousness based on the combination of references, which provides the motivation to prepare a treatment for cardiovascular and metabolic diseases, including arteriosclerosis, comprising a compound of Chemical formula (1) and a statin-based drug.
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). See MPEP 716.02 (d) and MPEP 716.02 (e).
Applicant refers to alleged unexpected results; however, even if the results were considered unexpected, the results would not be commensurate in scope with the scope claims. Further, the results provided do not occur over the entire claimed range (a method for treating a select group of cardiovascular or metabolic disease comprising any amount or dosage of a composition comprising a combination of a compound of Chemical Formula (1) and a statin-based drug) of present claim 1.
The combination of Choi, Kondo and Kim disclose compositions suitable for the treatment of cardiovascular and metabolic diseases, such as atherosclerosis, coronary arteriosclerosis, hypertension and angina. Choi discloses composition comprising noranhydroicaritin, compound of instant claim 1, while Kim and Kondo disclose compositions comprising statins, such as atorvastatin, rosuvastatin, pitavastatin, pravastatin, simvastatin, or fluvastatin, each within a method for treating cardiovascular and metabolic diseases.
It remains prima facie obvious for one of skill in the art to form an additional composition comprising noranhydroicaritin and statins for the purpose of treating cardiovascular and metabolic diseases, such as atherosclerosis. As the prior art provides methods and working examples for the disclosed compositions, there would be a reasonable expectation of success.
Therefore, the previous rejection of 08/25/2025 is maintained in an amended form due to Applicant’s amendment and remarks filed 11/25/2025.
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.
Claims 1, 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over KR 10-2009-0084439 (Choi et al.), in view of US 2005/0182106 A1 (Kondo et al.) and US 2008/0241240 A1 (Kim et al.).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Choi discloses a pharmaceutical composition comprising desmethylanhydroicaritin, also known as noranhydroicaritin, as an active ingredient for preventing and treating diabetic complications (i.e. arteriosclerosis, hypertension, etc.) (see present claim 1). See compound (1) on pages 1 and 11, claims 1 and 6 of Choi as well as the results from examples 2-4. Choi discloses noranhydroicaritin as also suitable for the treatment of arteriosclerosis, hypertension, cerebrovascular infarction, stroke, myocardial infarction, angina pectoris, nephropathy, neuropathy, diabetic retinopathy, cataract or glaucoma.
Choi teaches another object of the present invention is to provide the health functional food for prevention and improvement of the diabetic complication comprising desmethylanhydroicaritin, also known as noranhydroicaritin, as an active ingredient. See page 18 as well as claims 9-10.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Choi does not teach a method of treating a cardiovascular and metabolic disease, further comprising a statin-based drug. Choi does not teach where the statin-based drug exhibits HMG-CoA reductase inhibitory activity or is atorvastatin, rosuvastatin, pitavastatin, pravastatin, simvastatin, or fluvastatin.
Finding of prima facie obviousness --- rationale and motivation (See
MPEP § 2142-2143)
Kondo teaches the use of statins for the treatment and prevention of arteriosclerosis. See paragraphs 2, 14, 16, 18-20, 23, 27, 136 as well as claims 12-13 and 17-21. Kondo also teaches compositions comprising statins, including atorvastatin, pravastatin, simvastatin, etc., and pyridoxine for mitigating blood lipid levels and treatment and prevention of cardiovascular diseases, such as arteriosclerosis.
Kim discloses HMG-CoA reductase inhibitors (statins), such as simvastatin, as suitable for the treatment of hypertension, angina pectoris, atherosclerosis, arteriosclerosis, complex hypertension, hyperlipidemia, hypercholesterolemia, myocardial infarction, cardioplegia, heart failure or ischemic heart disease. See paragraphs 8-11, 57-58, 65 and claim 36. Kim also discloses where statins of the invention comprise simvastatin, lovastatin, atorvastatin, pitavastatin, rosuvastatin, fluvastatin, pravastatin.
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Choi, Kondo and Kim disclose compositions suitable for the treatment of cardiovascular and metabolic diseases, such as atherosclerosis, coronary arteriosclerosis, hypertension and angina. Choi discloses composition comprising noranhydroicaritin, compound of instant claim 1, while Kim and Kondo disclose compositions comprising statins, such as atorvastatin, rosuvastatin, pitavastatin, pravastatin, simvastatin, or fluvastatin, each within a method for treating cardiovascular and metabolic diseases.
It appears that given the constituents would result in the instant properties, the prior art compositions could anticipate the instant claims where "Products of identical chemical composition can not have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. See MPEP 2112.01, Section II. As Choi discloses a composition comprising noranhydroicaritin having the same structure as presently claimed, the properties alleged by Applicant would be expected to be present in the disclosure of Choi.
It would have been prima facie obvious for one of skill in the art to form an additional composition comprising noranhydroicaritin and statins for the purpose of treating cardiovascular and metabolic diseases, such as atherosclerosis. As the prior art provides methods and working examples for the disclosed compositions, there would be a reasonable expectation of success.
Conclusion
Claims 1, 6 and 8 are rejected.
Claims 11 and 14 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626