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
Applicant’s amendment filed on 10/29/2025, wherein claims 14, 16, 27 have been amended, and claims 21-26, 28-30 have been cancelled.
Election/Restrictions
Applicant’s elect without traverse simvastatin as the species for HMG-CoA reductase inhibitor.
Claims 14, 16, 27, 31-33 are examined herein on the merits.
Any rejection from the previous office action which is not restated herein, is withdrawn.
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.
1) Claims 14, 16, 27, 31 are rejected under 35 U.S.C. 103 as being unpatentable over Namazi (Experimental Dermatology, 2004, pages 337-339, PTO-1449), in view of Flender (US 5,179,086, PTO-1449).
Namazi et al. teaches that HMG-CoA reductase inhibitors such as atorvastatin, simvastatin, lovastatin prove invaluable in the treatment of dermatological disorder such as psoriasis. See abstract. It is taught that topical or systemic use of statins, either alone or in combination with topical cholesterol may prove beneficial against psoriasis. See page 338, column 2, line 34-page 339 column 1, line 1.
Namazi et al. does not explicitly teaches administering simvastatin in combination with cholesterol to a patient suffering from psoriasis i.e does not provide an example.
Flender teaches topical ointments containing cholesterol for the treatment of dermatoses, in particular psoriasis. See abstract; claims.
It would have been obvious to a person of ordinary skill in the art to co-administer topically HMG-CoA reductase inhibitor simvastatin and cholesterol to a patient suffering from psoriasis because 1) Namazi et al. teaches that HMG-CoA reductase inhibitors such as atorvastatin, simvastatin, lovastatin prove invaluable in the treatment of dermatological disorder such as psoriasis; and Namazi et al. teaches that topical or systemic use of statins, either alone or in combination with topical cholesterol may prove beneficial against psoriasis; and 2) Flender teaches topical ointments containing cholesterol for the treatment of psoriasis. One of ordinary skill in the art would have been motivated to co-administer topically HMG-CoA reductase inhibitor simvastatin and cholesterol to a patient suffering from psoriasis with reasonable expectation of success of treating psoriasis with at least additive therapeutic effect.
It would have been obvious to a person of ordinary skill in the art to co-administer simultaneously, concurrently or sequentially as a combined preparation as in instant claim 16 an HMG-CoA reductase inhibitor simvastatin and cholesterol to a patient suffering from psoriasis because 1) Namazi et al. teaches that HMG-CoA reductase inhibitors such as atorvastatin, simvastatin, lovastatin prove invaluable in the treatment of dermatological disorder such as psoriasis; and Namazi et al. teaches that topical or systemic use of statins, either alone or in combination with topical cholesterol may prove beneficial against psoriasis; and 2) Flender teaches topical ointments containing cholesterol for the treatment of psoriasis. One of ordinary skill in the art would have been motivated to co-administer simultaneously, concurrently or sequentially as a combined preparation an HMG-CoA reductase inhibitor simvastatin and cholesterol to a patient suffering from psoriasis with reasonable expectation of success of treating psoriasis with at least additive therapeutic effect.
It would have been obvious to a person of ordinary skill in the art to co-administer topically HMG-CoA reductase inhibitor simvastatin and cholesterol to a patient suffering from psoriasis; wherein said patient has a variant in one or more genes as in instant claims 14, 31 because 1) Namazi et al. teaches that HMG-CoA reductase inhibitors such as atorvastatin, simvastatin, lovastatin prove invaluable in the treatment of dermatological disorder such as psoriasis; and Namazi et al. teaches that topical or systemic use of statins, either alone or in combination with topical cholesterol may prove beneficial against psoriasis; and 2) Flender teaches topical ointments containing cholesterol for the treatment of psoriasis. One of ordinary skill in the art would have been motivated to co-administer topically HMG-CoA reductase inhibitor simvastatin and cholesterol to a patient suffering from psoriasis; wherein said patient has a variant in one or more genes as in instant claim 14, 31 with reasonable expectation of success of treating psoriasis with at least additive therapeutic effect.
Response to Arguments
Applicant's arguments filed on 10/29/2025 have been fully considered but they are not persuasive as discussed above and those found below.
Applicant argues that Namazi “refers, without distinction, to a wide range of potential HMG-CoA reductase inhibitors ("atorvastatin, cerivastatin, fluvastatin, pravastatin, lovastatin and simvastatin...". Applicant’s arguments have been considered, but not found persuasive. It is pointed out that it has been well-established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches, when viewed in light of the admitted knowledge in the art, to person of ordinary skill in the art. See M.P.E.P. § 2123. Namazi et al. teaches that HMG-CoA reductase inhibitors such as atorvastatin, simvastatin, lovastatin prove invaluable in the treatment of dermatological disorder such as psoriasis (see abstract); and Namazi et al. teaches that topical or systemic use of statins, either alone or in combination with topical cholesterol may prove beneficial against psoriasis. See page 338, column 2, line 34-page 339 column 1, line 1.
Applicant argues that Namazi “refers to a wide range of potential diseases that might be targeted by one or more of the potential inhibitors ("a multiplicity of immunological, dermatologic disorders, especially those characterized by ingress of activated leucocytes into the skin, such as mycosis…….”. Applicant’s arguments have been considered, but not found persuasive. It is pointed out that it has been well-established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches, when viewed in light of the admitted knowledge in the art, to person of ordinary skill in the art. See M.P.E.P. § 2123. Namazi et al. teaches that HMG-CoA reductase inhibitors such as atorvastatin, simvastatin, lovastatin prove invaluable in the treatment of dermatological disorder such as psoriasis (see abstract); and Namazi et al. teaches that topical or systemic use of statins, either alone or in combination with topical cholesterol may prove beneficial against psoriasis. See page 338, column 2, line 34-page 339 column 1, line 1.
Applicant argues that Namazi “lacks any experimental evidence (example) of efficacy of any particular HMG-CoA reductase inhibitor against any particular clinical indication”. Applicant’s arguments have been considered, but not found persuasive. It is pointed out that it has been well-established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches, when viewed in light of the admitted knowledge in the art, to person of ordinary skill in the art. See M.P.E.P. § 2123. Namazi et al. teaches that HMG-CoA reductase inhibitors such as atorvastatin, simvastatin, lovastatin prove invaluable in the treatment of dermatological disorder such as psoriasis (see abstract); and Namazi et al. teaches that topical or systemic use of statins, either alone or in combination with topical cholesterol may prove beneficial against psoriasis. See page 338, column 2, line 34-page 339 column 1, line 1.
Applicant argues that “In contrast to the teachings of Namazi, presently amended claim 14 is directed specifically to treatment of psoriasis, involves administration specifically of simvastatin and cholesterol, and is performed specifically on patients having a defined genetic profile, namely characterized by a variant in one or more genes that are known in the art to be associated with cholesterol metabolism and hence who have abnormal cholesterol metabolism (see, e.g., the present application at page 1 lines 24 to 29, page 7 lines 5 to 9, page 7 line 25 to page 10 line 8 and page 12 lines 3 to 11). Furthermore, Experimental Examples 1 and 3 in the instant specification both indicate a trend for cholesterol deficiency in some psoriasis patients and provide an indication that the present combination therapy, involving specifically both simvastatin and cholesterol, is particularly beneficial in such patients……” Applicant’s arguments have been considered. Namazi et al. teaches that HMG-CoA reductase inhibitors such as atorvastatin, simvastatin, lovastatin prove invaluable in the treatment of dermatological disorder such as psoriasis. See abstract. Namazi et al. teaches that topical or systemic use of statins, either alone or in combination with topical cholesterol may prove beneficial against psoriasis. See page 338, column 2, line 34-page 339 column 1, line 1. Flender teaches topical ointments containing cholesterol for the treatment of dermatoses, in particular psoriasis. See abstract; claims. One of ordinary skill in the art would have been motivated to co-administer topically HMG-CoA reductase inhibitor simvastatin and cholesterol to a patient suffering from psoriasis; wherein said patient has a variant in one or more genes associated with cholesterol metabolism as in instant claim 14, 31 with reasonable expectation of success of treating psoriasis with at least additive therapeutic effect because 1) Namazi et al. teaches that HMG-CoA reductase inhibitors such as atorvastatin, simvastatin, lovastatin prove invaluable in the treatment of dermatological disorder such as psoriasis; and Namazi et al. teaches that topical or systemic use of statins, either alone or in combination with topical cholesterol may prove beneficial against psoriasis; and 2) Flender teaches topical ointments containing cholesterol for the treatment of psoriasis. Further, Applicant’s remarks that “instant specification both indicate a trend for cholesterol deficiency in some psoriasis patients and provide an indication that the present combination therapy, involving specifically both simvastatin and cholesterol, is particularly beneficial in such patients”, it is pointed out that instant claim 14 recites “said patient has a variant in one or more genes selected from ….”, and Applicant did not provide any data administering to patients who has a variant in one or more genes as in instant claim 14. Further, if said variant in one or more genes in claim 14 are associated with cholesterol metabolism, Flender teaches topical ointments containing cholesterol for the treatment of dermatoses, in particular psoriasis.
Applicant argues that “Namazi does not teach or suggest a method of treating psoriasis utilizing simvastatin and cholesterol, still less on a patient having the presently recited genetic profile, as in amended claim 14.” Applicant’s arguments have been considered, but not found persuasive because Applicant is arguing against an individual reference when the rejection is based on combination of references as discussed above. Flender teaches topical ointments containing cholesterol for the treatment of dermatoses, in particular psoriasis. Namazi et al. teaches that HMG-CoA reductase inhibitors such as atorvastatin, simvastatin, lovastatin prove invaluable in the treatment of dermatological disorder such as psoriasis. See abstract. Namazi et al. teaches that topical or systemic use of statins, either alone or in combination with topical cholesterol may prove beneficial against psoriasis. See page 338, column 2, line 34-page 339 column 1, line 1. It would have been obvious to a person of ordinary skill in the art to co-administer topically HMG-CoA reductase inhibitor simvastatin and cholesterol to a patient suffering from psoriasis; wherein said patient has a variant in one or more genes as in instant claims 14, 31 because 1) Namazi et al. teaches that HMG-CoA reductase inhibitors such as atorvastatin, simvastatin, lovastatin prove invaluable in the treatment of dermatological disorder such as psoriasis; and Namazi et al. teaches that topical or systemic use of statins, either alone or in combination with topical cholesterol may prove beneficial against psoriasis; and 2) Flender teaches topical ointments containing cholesterol for the treatment of psoriasis. Further, if said variant in one or more genes in claim 14 are associated with cholesterol metabolism, Flender teaches topical ointments containing cholesterol for the treatment of dermatoses, in particular psoriasis. That is administration of cholesterol to a patient suffering from psoriasis and with abnormal cholesterol will treat psoriasis, since Flender teaches topical ointments containing cholesterol for the treatment of psoriasis.
Applicant argues that “further in view of the lack of any concrete pointer in Namazi towards the specific combination of active agents, specific clinical condition and specific genetic characteristics of the patient, still less all in combination”. Applicant’s arguments have been considered, but not found persuasive as discussed above. Namazi et al. teaches that HMG-CoA reductase inhibitors such as atorvastatin, simvastatin, lovastatin prove invaluable in the treatment of dermatological disorder such as psoriasis i.e Namazi teaches specific statin. See abstract. Namazi et al. teaches that topical or systemic use of statins, either alone or in combination with topical cholesterol may prove beneficial against psoriasis i.e Namazi teaches combination statin and cholesterol for beneficial against psoriasis. See page 338, column 2, line 34-page 339 column 1, line 1. Further, Applicant’s remarks that “instant specification both indicate a trend for cholesterol deficiency in some psoriasis patients and provide an indication that the present combination therapy…”, it is pointed out that instant claim 14 recites “said patient has a variant in one or more genes selected from ….”, and Applicant did not provide any data administering to patients who has a variant in one or more genes as in instant claim 14. Furthermore, if said variant in one or more genes in claim 14 are associated with cholesterol metabolism, Flender teaches topical ointments containing cholesterol for the treatment of dermatoses, in particular psoriasis. Namazi (Experimental Dermatology, 2004, pages 337-339, PTO-1449), in view of Flender (US 5,179,086, PTO-1449) renders obvious instant claims.
Applicant argues that “Flender is silent on any combination therapy…… and is further silent on treatment of patients having the genetic characteristics recited in presently amended claim 14”. Applicant’s arguments have been considered, but not found persuasive because Applicant is arguing against an individual reference when the rejection is based on combination of references as discussed above. As discussed above Namazi (Experimental Dermatology, 2004, pages 337-339, PTO-1449), in view of Flender (US 5,179,086, PTO-1449) renders obvious instant claims.
2) Claims 32, 33 are rejected under 35 U.S.C. 103 as being unpatentable over Namazi (Experimental Dermatology, 2004, pages 337-339, PTO-1449), in view of Flender (US 5179086, PTO-1449) as applied to claims 14, 16, 27, 31 above, and further in view of CARLSSON et al. (WO 2012/150892, PTO-1449).
Namazi and Flender are applied as discussed above.
Namazi does not teach employment of vitamin D agent.
CARLSSON et al. teaches a lipid layer forming composition for topical treatment of psoriasis comprising a pharmacologically effective amount of an agent for the treatment of psoriasis. See abstract. It is taught that the active agents include vitamin D3, calcitriol. See page 2, para 1; claims 1, 9, 10, 11.
It would have been obvious to a person of ordinary skill in the art to further administer vitamin D3 or calcitriol in addition to administration topically of HMG-CoA reductase inhibitor simvastatin and cholesterol to a patient suffering from psoriasis because CARLSSON et al. teaches a lipid layer forming composition for topical treatment of psoriasis comprising a pharmacologically effective amount of an agent for the treatment of psoriasis; the active agents include vitamin D3, calcitriol. One of ordinary skill in the art would have been motivated to further administer vitamin D3 or calcitriol in addition to administration topically of HMG-CoA reductase inhibitor simvastatin and cholesterol to a patient suffering from psoriasis with reasonable expectation of success of obtaining at least an additive therapeutic effect.
Response to Arguments
Applicant's arguments filed 10/29/2025 have been fully considered but they are not persuasive as discussed above and those found below.
CARLSSON et al. was employed for its teachings that a lipid layer forming composition for topical treatment of psoriasis comprising a pharmacologically effective amount of an agent for the treatment of psoriasis; the active agents include vitamin D3, calcitriol. One of ordinary skill in the art would have been motivated to further administer vitamin D3 or calcitriol in addition to administration topically of HMG-CoA reductase inhibitor simvastatin and cholesterol to a patient suffering from psoriasis with reasonable expectation of success of obtaining at least an additive therapeutic effect.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHOBHA KANTAMNENI, Ph.D whose telephone number is (571)272-2930. The examiner can normally be reached on Monday to Friday; 8.00 am-4.30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel, Ph.D can be reached on 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHOBHA KANTAMNENI/Primary Examiner, Art Unit 1627