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 .
Status of Claims
Claims 1-10 are pending in the application. Claims 1-10 are examined herein.
Priority
This application is a 371 of PCT/KR2021/016080 filed 11/05/2021, which claims foreign priority to KOREA, REPUBLIC OF 10-2020-0146677 filed 11/05/2020.
Acknowledgment is made of applicant's claim for foreign priority based on the application filed in the Republic of Korea on 11/05/2020. It is noted that Applicant has not provided an English translation of the certified copy of the foreign priority application as required by 35 U.S.C. 119(b).
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action, 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English applications. See MPEP 2304.01(c) for further information.
Instant claims 1-10 have been afforded an effective filing date of 11/05/2021 as the subject matter of the instant claims are supported by PCT/KR2021/016080 filed 11/05/2021.
Information Disclosure Statement
The information disclosure statement submitted on 05/04/2023 has been considered. The submission is in compliance with the provisions of 37 CFR 1.97.
Drawings Objected To
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via EFS-Web or three sets of color drawings or color photographs, as appropriate, if not submitted via EFS-Web, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim interpretation
The instant claims 1-8 have been interpreted as intended use claims drawn to a product, i.e., a composition (claims 1-8).
According to MPEP 2111.02(II), “The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "‘extraneous’ limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase "which provides improved playing and handling characteristics" in a claim drawn to a head for a lacrosse stick was not a claim limitation).
Therefore, the limitations following the preamble drawn to the intended use of the product - i.e., a composition (claims 1-8), have not been not given patentable weight.
Further, with respect to the preamble of instant claims 9-10 reciting “for preventing, treating or improving Alzheimer's disease or cognitive impairment” and “for improving cognitive function”, respectively, "[C]lear reliance on the preamble during prosecution to distinguish the claimed invention from the prior art transforms the preamble into a claim limitation because such reliance indicates use of the preamble to define, in part, the claimed invention.…Without such reliance, however, a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention." Consequently, "preamble language merely extolling benefits or features of the claimed invention does not limit the claim scope without clear reliance on those benefits or features as patentably significant." See MPEP 2111.02 (II). In the instant claims, the sole step of administering a composition comprising donepezil and sildenafil to a subject in need thereof, will result in preventing, treating or improving Alzheimer's disease/cognitive impairment/improving cognitive function. Therefore, the preamble language “for preventing, treating or improving Alzheimer's disease or cognitive impairment” and “for improving cognitive function” is not patentably significant and does not limit the scope of the claim.
However, it is noted that the prior art applied in the rejections do teach the intended use limitations of the instant claims.
Claim Rejections - 35 USC § 102
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 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 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.
Claims 1, 3-7 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Held (US 2013/0296324 A1, publication date 07 November 2013).
Regarding instant claims 1 and 7, Held teaches compositions comprising: at least one phosphodiesterase-5-inhibitor (PI-5) in combination with one or more medications that include, say, a cholinesterase inhibitor (CI), for use in treating a neurodegenerative disease in a subject (Abstract; Paras. [0098]-[0100]; Claim 1). Held teaches specific embodiments in which the neurodegenerative disease is Alzheimer's disease (Para. [0032]; Para. [0092]) and dementia ([0039]; Para. [0092]). Held teaches “Dementia” to refer to the loss of significant cognitive function (Para. [0238]). Held teaches treating dementia related to Alzheimer’s disease using a combination of PI-5 and CI (Para. [0254]) (treating dementia would result in improving cognitive function). Held teaches the term “treating and “treatment” refers to reduction in severity and/or frequency of symptoms, elimination of symptoms and/or underlying cause, and improvement or remediation of damage (Para. [0092]). Held teaches “treating” also refers to the prevention of the occurrence of symptoms and/or their underlying cause (Para. [0092]). Held teaches embodiments in which the PI-5 is used in combination with at least a cholinesterase inhibitor (CI) (Para. [0124]; Claim 5). Held teaches examples of phosphodiesterase-5-inhibitor (PI-5) to include sildenafil (Viagra) (Para. [0114]; Claim 2) with sildenafil being exemplified in an embodiment (Para. [0114]). Held teaches examples of cholinesterase inhibitors (CI) to include donepezil (Aricept) (Para. [0124]; Claim 5) with Aricept being exemplified in an embodiment (Para. [0125]).
According to MPEP 2131.02(III), “A GENERIC DISCLOSURE WILL ANTICIPATE A CLAIMED SPECIES COVERED BY THAT DISCLOSURE WHEN THE SPECIES CAN BE "AT ONCE ENVISAGED" FROM THE DISCLOSURE”.
In the instant case, a composition comprising donepezil and sildenafil can be clearly envisaged by a person of ordinary skill in the art, given the teachings of Held. Therefore, the teachings of Held anticipate a composition for preventing, treating or improving Alzheimer's disease or cognitive impairment/improving cognitive function comprising: donepezil or a pharmaceutically acceptable salt thereof; and sildenafil or a pharmaceutically acceptable salt thereof, as instantly claimed (claim 1 and claim 7).
Regarding instant claims 3-5, Held teaches the composition comprising the PI-5 and CI may be administered together in the same composition (i.e., a combination composition) or simultaneously or sequentially in two separate compositions (Paras. [0026]-[0027]; Para. [0165]). Held teaches combination compositions thereof (Para. [0027]). Held teaches the PI-5 may be, for example, administered from 2-400 mg per day (Para. [0140]). Held teaches an embodiment when Viagra is the PI-5, Viagra is administered from 10-200 mg per day (Para. [0143]) (this overlaps/encompasses the claimed 2.5 to 50 mg of sildenafil). Held teaches the CI may be, for example, administered from 5-200 mg per day (Para. [0153]). Held teaches an embodiment when Aricept is the CI, the Aricept is administered from 10-20 mg per day (Para. [0153]) (this overlaps/encompasses the claimed 2.5 to 23 mg of donepezil). Therefore, the teachings of Held anticipates the limitations as in instant claims 3-5.
Regarding instant claim 6, Held teaches the compositions are pharmaceutical compositions (Para. [0016-[0017]; Para. [0167]; Para. [0178]).
Regarding instant claims 9-10, Held teaches embodiments directed to methods of treating a neurodegenerative disease in a subject comprising administering to the subject a composition which includes a PI-5 in combination with at least one or more agents, such as, Cholinesterase Inhibitors (CIs) (Para. [0028]; Para. [0100]; Claim 10; Claim 14; Claim 21), wherein the neurodegenerative disease is Alzheimer's disease or dementia (Para. [0032] Para. [0039]; Para. [0042]).
According to MPEP 2131.02(III), “A GENERIC DISCLOSURE WILL ANTICIPATE A CLAIMED SPECIES COVERED BY THAT DISCLOSURE WHEN THE SPECIES CAN BE "AT ONCE ENVISAGED" FROM THE DISCLOSURE”.
In the instant case, the method of instant claims 9-10 comprising administering donepezil and sildenafil in a method of preventing, treating or improving Alzheimer's disease or cognitive impairment/improving cognitive function, can be clearly envisaged by a person of ordinary skill in the art, given the teachings of Held.
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.
Claims 1, 3, 6-7 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prickaerts et al. (Dissociable effects of acetylcholinesterase inhibitors and phosphodiesterase type 5 inhibitors on object recognition memory: acquisition versus consolidation, 24 July 2004, hereinafter Prickaerts).
Regarding instant claims 1, 3, 6-7 and 9-10, Prickaerts teaches phosphodiesterase enzyme type 5 (PDE5) inhibitors and acetylcholinesterase (AChE) inhibitors have cognition-enhancing properties (Abstract). Prickaerts teaches a study of the memory-enhancing effects of the PDE5 inhibitor sildenafil and AChE inhibitors metrifonate and donepezil in the object recognition task to find out whether acquisition or consolidation processes were affected by these drugs (Abstract). Prickaerts teaches donepezil dissolved in 0.1 M sodium citrate buffer (pH 5.5) administered at a dose of 1 mg/kg to rats (Pg. 382, second column, first full paragraph). Prickaerts teaches sildenafil suspended in 1% tylose (methylcellulose) administered at 1, 3, and 10 mg/kg doses to rats (Pg. 382, second column, first full paragraph). Prickaerts teaches the rats of the experimental group that initially had also been treated with sildenafil after the first trial were now used for testing the effects of donepezil treatment 30 min before the first trial (Pg. 382, second column, second full paragraph) (i.e., sildenafil and donepezil administered sequentially). Prickaerts teaches sildenafil given immediately after the first trial clearly improved the memory performance in the object recognition task (Abstract; Pg. 386, first column, last paragraph). Prickaerts teaches donepezil has beneficial effects on the acquisition of information (Abstract; Pg. 387, first column, last paragraph – second column, continued paragraph). Therefore, the teachings of Prickaerts anticipate the limitations drawn to a composition/pharmaceutical composition of donepezil and sildenafil (since citrate buffer and tylose implicitly stand for pharmaceutically acceptable excipients) for use in improving cognition, wherein the donepezil and sildenafil are administered at different times (instant claims 1, 3 and 6-7).
Moreover, Prickaerts teaches the active step of administering donepezil and sildenafil to rats (i.e., a subject in need thereof) that results in improved memory performance (Abstract; Pg. 389, first column, last paragraph). Therefore, the teachings of Prickaerts anticipate the limitations of the instant method claims 9-10, wherein the method results in improving cognitive performance.
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 2 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Held (US 2013/0296324 A1, publication date 07 November 2013) as applied to claims 1, 3-7 and 9-10 above.
The teachings of Held are set forth in the anticipation rejection above and incorporated herein by reference.
Regarding instant claims 2 and 8, Held anticipates the composition of instant claim 1 and instant claim 7. Held does not explicitly teach a weight ratio of donepezil or the pharmaceutically acceptable salt thereof and sildenafil or the pharmaceutically acceptable salt thereof.
Held teaches an exemplary composition for the treatment dementia in a subject that resulted in 95% improvement in the rated dementia (Para. [0310]). Held teaches administering 20 mg Cialis, TID (i.e., a phosphodiesterase-5-inhibitor (PI-5)) and 10 mg Cognex, TID (i.e., a cholinesterase inhibitors (CI)), which amounts to a total daily dose of 30 mg of the cholinesterase inhibitor : 60 mg of the phosphodiesterase-5-inhibitor, a ratio of 1:2. Held teaches although the above provides elective doses with the selected medications, it should be understood that one of ordinary skill in the art should be able to establish comparable doses with other combinations of existing and future SSRI, CI and PI-5 medications using similar titration techniques, depending on choices of half-life and other properties (Para. [0311]). Held teaches appropriate dosages for the drugs used in combination therapy may be optimized based on the patient’s health and response to therapy (Para. [0137]). Held emphasizes the use of equivalents by those skilled in the art through routine experimentation (Para. [0353]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Held, to have formulated a composition comprising optimal amounts of donepezil or a pharmaceutically acceptable salt thereof and sildenafil or a pharmaceutically acceptable salt thereof for use in the treatment of Alzheimer’s disease or cognitive impairment, to arrive at the instant composition with a reasonable expectation of success. Held teaches compositions comprising: at least one phosphodiesterase-5-inhibitor (PI-5) in combination with one or more medications that include, say, a cholinesterase inhibitor (CI), for use in treating a neurodegenerative disease in a subject. Held teaches exemplary embodiments wherein the neurodegenerative disease is Alzheimer’s disease or dementia. Held exemplifies sildenafil (Viagra) as a phosphodiesterase-5-inhibitor (PI-5) of choice and donepezil (Aricept) as a cholinesterase inhibitors (CI) of choice. Held teaches an exemplary composition in the treatment of dementia wherein the ratio of the cholinesterase inhibitor : the phosphodiesterase-5-inhibitor is 1:2. Held teaches appropriate drug combinations and dosages used in the combination therapy may be optimized through routine experimentation by a person of ordinary skill in the art.
Therefore, in light of the foregoing discussion, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed composition, absent any evidence regarding the criticality of the recited ratios.
Claims 2, 4-5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Prickaerts et al. (Dissociable effects of acetylcholinesterase inhibitors and phosphodiesterase type 5 inhibitors on object recognition memory: acquisition versus consolidation, 24 July 2004, hereinafter Prickaerts) as applied to claims 1, 3, 6-7 and 9-10 above, and further in view of Held (US 2013/0296324 A1, publication date 07 November 2013).
The teachings of Prickaerts are set forth in the anticipation rejection above and incorporated herein by reference.
Regarding instant claim 4, Prickaerts teaches the individual compositions of donepezil and sildenafil result in improved memory performance.
According to MPEP 2144.06 (I), "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). In the instant case, since Prickaerts teaches the two compositions as being useful for the same purpose - improving memory performance, it would have been prima facie obvious to one of ordinary skill in the art to have formulated a combination composition of donepezil and sildenafil, to arrive at the instant composition with a reasonable expectation of success.
Regarding instant claim 5, the teachings of Prickaerts render obvious the combination composition of instant claim 4. Prickaerts teaches donepezil dissolved in 0.1 M sodium citrate buffer (pH 5.5) administered at a dose of 1 mg/kg to rats (Pg. 382, second column, first full paragraph) and sildenafil suspended in 1% tylose (methylcellulose) administered at 1, 3, and 10 mg/kg doses to rats (Pg. 382, second column, first full paragraph). Prickaerts do not teach additional doses of donepezil that fall within the instantly claimed dosage ranges.
Held teaches compositions comprising: at least one phosphodiesterase-5-inhibitor (PI-5) in combination with one or more medications that include, say, a cholinesterase inhibitor (CI), for use in treating a neurodegenerative disease in a subject (Abstract; Paras. [0098]-[0100]; Claim 1). Held teaches specific embodiments in which the neurodegenerative disease is dementia ([0039]; Para. [0092]). Held teaches “Dementia” to refer to the loss of significant cognitive function (Para. [0238]). Held teaches treating dementia related to Alzheimer’s disease using a combination of PI-5 and CI (Para. [0254]) (i.e., treating dementia would result in improving cognitive function). Held teaches examples of phosphodiesterase-5-inhibitor (PI-5) to include sildenafil (Viagra) (Para. [0114]; Claim 2) and examples of cholinesterase inhibitors (CI) to include donepezil (Aricept) (Paras. [0124]-[0125]; Claim 5). Held teaches combination compositions thereof (Para. [0027]). Held teaches an embodiment when Viagra (i.e., sildenafil) is the PI-5, Viagra is administered from 10-200 mg per day (Para. [0143]) (this overlaps/encompasses the claimed 2.5 to 50 mg of sildenafil). Held teaches an embodiment when Aricept (i.e., donepezil) is the CI, the Aricept is administered from 10-20 mg per day (Para. [0153]) (this overlaps/encompasses the claimed 2.5 to 23 mg of donepezil). Held teaches appropriate dosages for the drugs used in combination therapy may be optimized based on the patient’s health and response to therapy (Para. [0137]).
According to MPEP 2144.05(II)(A), "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amounts of donepezil and sildenafil, with a reasonable expectation of success, in the absence of evidence to the contrary.
Regarding instant claims 2 and 8, Prickaerts anticipates the composition of instant claim 1 and instant claim 7. Prickaerts do not teach a weight ratio of donepezil or the pharmaceutically acceptable salt thereof and sildenafil or the pharmaceutically acceptable salt thereof.
Held teaches an exemplary composition for the treatment dementia in a subject that resulted in 95% improvement in the rated dementia (Para. [0310]). Held teaches administering 20 mg Cialis, TID (i.e., a phosphodiesterase-5-inhibitor (PI-5)) and 10 mg Cognex, TID (i.e., a cholinesterase inhibitors (CI)), which amounts to a total daily dose of 30 mg of the cholinesterase inhibitor : 60 mg of the phosphodiesterase-5-inhibitor, a ratio of 1:2. Held teaches although the above provides elective doses with the selected medications, it should be understood that one of ordinary skill in the art should be able to establish comparable doses with other combinations of existing and future SSRI, CI and PI-5 medications using similar titration techniques, depending on choices of half-life and other properties (Para. [0311]). Held teaches appropriate dosages for the drugs used in combination therapy may be optimized based on the patient’s health and response to therapy (Para. [0137]). Held emphasizes the use of equivalents by those skilled in the art through routine experimentation (Para. [0353]).
Therefore, in light of the foregoing discussion, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed composition, absent any evidence regarding the criticality of the recited ratios.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-10 are provisionally rejected on the ground of obviousness type nonstatutory double patenting as being unpatentable over claims 1-10 of co-pending Application No 18/035,245 in view of Held (US 2013/0296324 A1, publication date 07 November 2013).
Although the claims at issue are not identical, both sets of claims are drawn to a composition for preventing, treating or improving Alzheimer's disease or cognitive impairment comprising: donepezil or a pharmaceutically acceptable salt thereof; and a second active agent.
The instant claims are drawn to a composition for preventing, treating or improving Alzheimer's disease or cognitive impairment comprising:
(i) donepezil or a pharmaceutically acceptable salt thereof; and
(ii) sildenafil or a pharmaceutically acceptable salt thereof.
The claims of the co-pending Application No 18/035,245 are drawn to a composition for preventing, treating or improving Alzheimer's disease or cognitive impairment comprising:
(i) donepezil or a pharmaceutically acceptable salt thereof; and
(ii) tadalafil or a pharmaceutically acceptable salt thereof.
The claims of the co-pending reference application do not teach sildenafil or a pharmaceutically acceptable salt thereof.
Held teaches compositions comprising: at least one phosphodiesterase-5-inhibitor (PI-5) in combination with one or more medications that include, say, a cholinesterase inhibitor (CI), for use in treating a neurodegenerative disease in a subject (Abstract; Paras. [0098]-[0100]; Claim 1). Held teaches examples of phosphodiesterase-5-inhibitor (PI-5) to include sildenafil (Viagra) (Para. [0114]; Claim 2) with sildenafil being exemplified in an embodiment (Para. [0114]) and tadalafil (Cialis) (Para. [0114]). Moreover, Held teaches appropriate dosages for the drugs used in combination therapy may be optimized based on the patient’s health and response to therapy (Para. [0137]). Held emphasizes the use of equivalents by those skilled in the art through routine experimentation (Para. [0353]).
According to MPEP 2144.06 (II), “An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)”. In the instant case, the taladafil taught by the co-pending reference application and sildenafil of the instant invention are both phosphodiesterase-5-inhibitors and are considered equivalents in the art.
Therefore, one of ordinary skill in the art would have been motivated to substitute the taladafil in the composition of the co-pending application with sildenafil as taught by Held, to arrive at the composition of the instant claims with a reasonable expectation of success. One of ordinary skill in the art would also have been motivated to optimize the dosages of the actives in the combination composition to arrive at the instant ratios.
Therefore, instant claims 1-10 and claims 1-10 of co-pending Application No 18/035,245 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-10 are rejected.
No claims are allowed.
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/P.S.R./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627