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
Response to Amendments
The amendments made to the claims 04/01/2026 have been entered.
In view of the amendments made the 102 rejection made in the prior office action has been withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted 02/12/2026 has been considered.
Restriction/Species Election
Claims 26-38 were withdrawn as being drawn to a non-elected invention.
Claims 17-19 were withdrawn as being drawn to non-elected species.
Claim Rejections
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.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 1, 3-9, and 11-16 and 20-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ridall (US 10,064,849, published 2018), in view of Ryde (US2005/0042177), Dodd (US2020/0390710), Villers (Contemporary Pharmacy Practice and Compounding, 4e, Ch. 21 – Colors, Flavors, Sweeteners, and Scents, published 2017), Brinckmann (Herb Profile, Iss. 128, 2020) and Ciriminna (Chemistry Central Journal, 2017, 11:22).
Claim 1 is to a rapidly infusing composition comprising a pharmaceutically acceptable binder and/or excipient system comprising gelatin, a sugar alcohol, and a flavorant, comprising an acidulant, and a PDE.sub.5 inhibitor.
Dependent claims 3-4 specify disintegration times.
Dependent claims 5, 8, and 12 specify concentrations of the gelatin, mannitol, flavorant, and PDE.sub.5 inhibitor.
Dependent claims 6-7 specify mammalian gelatin (claim 6), specifically bovine gelatin (claim 7).
Dependent claim 9 specifies mannitol.
Dependent claim 11 specifies a mixture of citric acid and black cherry flavoring.
Dependent claim 13 specifies a PDE.sub.5 inhibitor in the form of a micronized solid having a D90 diameter of 10 to 80 μm.
Dependent claims 14-16 specify various PDE.sub.5 inhibitors (claim 14), including sildenafil (claim 15), and specifically sildenafil citrate (claim 16).
Dependent claims 20-21 specify further comprising sweeteners (claim 20), specifically a mixture of sucralose and acesulfame-K (acesulfame potassium) (claim 21).
Dependent claims 23-25 specify various conditions including that the PDE.sub.5 inhibitor is not coated or encapsulated (claim 23), wherein the PDE.sub.5 inhibitor is not complexed with ion exchange resin (claim 24), and that the composition is free of alkaline buffering agents (claim 25).
Regarding claims 1, 5-10, 12, and 23-25, Ridall in col. 13, Table 2 teaches a composition comprising bovine gelatin, mannitol, and omeprazole in amounts that are 13%, 11% 0.4% and 75% respectively. Regarding claim 10, Ridall teaches 0.4% by dry mass where the instant claim is drawn to a minimum of 0.5% by dry mass. Ridall in col.2, l. 34-47 contemplates flavorants in “0-0.5% by mass”. Regarding claims 23-25, Ridall’s teaching does not explicitly contemplate coated or encapsulated PDE.sub.5 inhibitor, does not contemplate ion exchange resin, and the composition is free of alkaline buffering agents.
Ridall in col. 10, l. 1-14 contemplates lyophilizing a composition comprising the ingredients above to create a pre-formulation composition.
Ridall in col. 17-18, Tables 11-12 discusses disintegration times ranging from 4 seconds to 1 seconds.
Ridall does not explicitly discuss sildenafil citrate, micronized sildenafil citrate, sweeteners, citrus and black cherry flavoring, and the colorant FD&C blue #2. This is addressed by the combination of Ryde, Dodd, Villiers, Brinckmann, and Ciriminna.
Regrading claims 14-16, Ryde is drawn to free base compositions of sildenafil (title). Ryde throughout the reference and specifically in para. [0009] and [0014] discusses sildenafil citrate. Ryde states “Sildenafil, including sildenafil free base and sildenafil citrate is a phosphodiesterase 5 (PDE5) inhibitor. Ryde continues in para. [0014] where it states “Sildenafil citrate, which is marketed under the tradename VIAGRA® (Pfizer, Inc. USE) in 25, 50, and 100 mg tablets…”.
Regarding claim 13, Dodd is drawn to producing commercial nanoparticle and microparticle powders (title). Dodd in its examples teaches Spex milling used on pharmaceutical compounds (example 1, para. [0359]-[0364]) and on foods (example 11, para. [0402]-[0404]). The size of the particles after milling are taught in Fig. 1 and Fig. 11. The size of the particles in Fig. 1 and Fig. 11 are at least under 2 μm and 20 μm. Additionally, While Ryde and Dodd do not explicitly discuss the micronized sildenafil citrate, the combination of Ryde and Dodd is sufficient that one of ordinary skill in the art could combine the teachings to arrive at micronized sildenafil citrate with D90 diameter in the range of 10μm to 80 μm.
Additionally, Dodd in para. [0005] states “It is known that the rate of dissolution of a particulate drug will increase with increasing surface area. One way of increasing surface area is decreasing particle size.” Dodd continues in para. [0006] where it states “For example, dry milling techniques have been used to reduce particle size and hence influence drug absorption. However, in conventional dry milling the limit of fineness is reached generally in the region of about 100 microns (100,000 nm)…Alternatively, wet grinding may be employed to reduce particle size, but flocculation restricts the lowest particle size limit to approximately 10 microns (10,000 nm).” Therefore, one of ordinary skill could use either the methods taught in Dodd, dry milling, or wet milling to achieve the particle size claimed.
Regarding claims 20-22, Villiers on p. 263, Table 21.4 teaches acesulfame potassium and sucralose as common sweetening agents. Villiers on p. 262, sec. F. Sweeteners states “Table 21.4 gives the articles listed as sweetening agents in the USP 30/NF 25. Although this list is representative of the most commonly used agents, it is not a complete list of all agents used as sweeteners in foods and in drug products and preparations.” This teaching indicates that sucralose and acesulfame are common pharmaceutical sweetening agents.
Villiers continues on p. 265, sec. G. Flavors stating “Most flavors are available either as oils e.g. lemon oil, orange oil) or as alcohol concentrates” Villiers in this section also states “Table 21.4 gives the articles listed as flavors and perfumes in the USP 30/NF 25. Although this list is representative of some commonly used agents, it is not a very complete list of flavors used in foods and in drug products and preparations.” Similar to the sweetening agents, this teaching shows that orange flavoring is a common flavor used in pharmaceuticals.
Regarding claim 22, Villiers on p. 260, table 21.3 teaches dye FD&C blue #2 as a common dye used in pharmaceutical preparations.
Brinckmann on p. 7, right col. para 2 states “Other Prunus species and plant parts also are used in food and medicine such as black cherry (P. serotina)…” This teaching from Brinckmann indicates that black cherry is another flavor additive commonly used in medicine.
Regarding the acidulant of claim 1, Ryde in para. [0165] discusses effervescent agents including citric acid. Ciriminna further discusses the general use of citric acid. Ciriminna in sec. Background states “Citric acid…is an acidulant, preservative, emulsifier, flavorant, sequestrant and buffering agent widely used across many industries especially in food, beverage, pharmaceutical, nutraceutical and cosmetic product. This is further summarized in Table 2 of Ciriminna, shown below.
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Modifying the composition of Ridall to include citric acid would essentially be including a known element within the art into a composition for a predictable effect (see Table 2 above, pharmaceutically active substances).
Ridall teaches a composition comprising mannitol, bovine gelatin, a mint flavoring, and omeprazole. Considering the teachings of Ryde and Dodd, one of ordinary skill would be able to modify the composition of Ridall by replacing the omeprazole with micronized sildenafil citrate. One of ordinary skill in the art could further modify the composition of Ridall via replacing the mint flavoring with a mixture of orange and black cherry flavoring and additionally adding the sweeteners sucralose and acesulfame potassium. These modifications would be obvious as the art teaches that these ingredients are commonly used for other medications.
Therefore it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to modify the composition of Ridall via the teachings of Ryde, Dodd, Villiers, Brinckmann, and Ciriminna to arrive at the instant claims with a reasonably assumption of success. One of ordinary skill in the art would be motivated to mill sildenafil citrate in order to increase dissolution rate. One of ordinary skill would further be motivated to modify the composition of Ridall to include sildenafil citrate in order to more rapidly administer sildenafil citrate. One of ordinary skill would be motivated to make the addition of the sweeteners, flavorants, and colorants as they are known ingredients within the art with predictable effects.
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.
Patents
U.S. Patent 10,918,631
Claims 1-16 and 20-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,918,631 in view of Ryde (US2005/0042177), Dodd (US2020/0390710), Villers (Contemporary Pharmacy Practice and Compounding, 4e, Ch. 21 – Colors, Flavors, Sweeteners, and Scents, published 2017), Brinckmann (Herb Profile, Iss. 128, 2020), and Ciriminna (Chemistry Central Journal, 2017, 11:22.
The reference claims are drawn to a method of making a pharmaceutical composition comprising bovine gelatin, mannitol, a surfactant, a flavorant and an active pharmaceutical ingredient in ranges of dry mass concentrations that read on the instant claims.
Via the teachings of Ryde, Dodd, Villiers, Brinckmann, and Ciriminna, one of ordinary skill in the art would be able to modify the reference method in order to create a composition comprising bovine gelatin, mannitol, flavorants, sweeteners, colorant, and sildenafil citrate.
U.S. Patent 10,064,849
Claims 1-16 and 20-25 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,064,849 in view of Ryde (US2005/0042177), Dodd (US2020/0390710), Villers (Contemporary Pharmacy Practice and Compounding, 4e, Ch. 21 – Colors, Flavors, Sweeteners, and Scents, published 2017), Brinckmann (Herb Profile, Iss. 128, 2020), Ciriminna (Chemistry Central Journal, 2017, 11:22).
The reference claims are drawn to a composition comprising bovine gelatin, mannitol, a flavorant, and a proton pump inhibitor in concentrations of dry mass %.
For similar reasoning as discussed in the 103 rejection above, one of ordinary skill in the art would be able to modify the reference method in order to create a composition comprising bovine gelatin, mannitol, flavorants, sweeteners, colorant, and sildenafil citrate.
U.S. Patent 12,005,053
Claims 1-16 and 20-25 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,005,053 in view of Ryde (US2005/0042177), Dodd (US2020/0390710), Villers (Contemporary Pharmacy Practice and Compounding, 4e, Ch. 21 – Colors, Flavors, Sweeteners, and Scents, published 2017), Brinckmann (Herb Profile, Iss. 128, 2020) and Ciriminna (Chemistry Central Journal, 2017, 11:22).
Reference claims 1-9 are drawn to a veterinary composition comprising bovine gelatin, mannitol, surfactant, and a proton pump inhibitor in concentrations of dry mass % that read on the instant claims. Reference dependent claims 5 and 6 claim disintegration times of 7 seconds or less and 4 seconds or less.
Reference claims 10-19 are drawn to a method of manufacturing the composition of reference claims 1-9.
The arguments made in the 103 rejection above regarding the modification of the composition to include sweeteners, flavorants, colorants, and sildenafil citrate. Similarly, the method claims can be modified to create a composition that would read on the instant claims, as discussed in the double patenting rejection under U.S. Patent 10,918,631.
U.S. Patent 12,496,295
Claims 1-16 and 20-25 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9, and 12 of U.S. Patent No. 12,496,295 (formerly application 18/654,308) in view of Ryde (US2005/0042177), Dodd (US2020/0390710), Villers (Contemporary Pharmacy Practice and Compounding, 4e, Ch. 21 – Colors, Flavors, Sweeteners, and Scents, published 2017) Brinckmann (Herb Profile, Iss. 128, 2020) and Ciriminna (Chemistry Central Journal, 2017, 11:22).
The reference claims are drawn to a pre-formulation comprising bovine gelatin in about 1 to 10% mass%, mannitol in about 1 to 10% mass%, a flavorant in about 0.0 to 0.2 mass% and a proton pump inhibitor in about 10 to 30 mass%.
Via the teachings of Ryde, Dodd, Villiers, Brinckmann, and Ciriminna and for similar reasoning used the 103 rejection above, one of ordinary skill in the art could modify the pre-formulation to arrive at the instant claims with a reasonable assumption of success.
Co-pending applications
18/307,228
Claims 1-16 and 20-25 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-24 and 31-32 of copending Application No. 18/307,228 in view of Ryde (US2005/0042177), Dodd (US2020/0390710), Villers (Contemporary Pharmacy Practice and Compounding, 4e, Ch. 21 – Colors, Flavors, Sweeteners, and Scents, published 2017), Brinckmann (Herb Profile, Iss. 128, 2020) and Ciriminna (Chemistry Central Journal, 2017, 11:22).
The reference claims are drawn to a buccal composition comprising gelatin and a sugar alcohol. Reference claim 22 further claims a flavorant.
Considering the teachings of Ryde, Dodd, Villiers, and Brinckmann, which teach sildenafil citrate, sweeteners, and colorants as additional ingredients, one of ordinary skill in the art would find it obvious to modify the composition of the reference claims to arrive at the instant claims.
This is a provisional nonstatutory double patenting rejection.
18/252,681
Claims 1-16 and 20-25 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 18,252,681 in view of Ryde (US2005/0042177), Dodd (US2020/0390710), Villers (Contemporary Pharmacy Practice and Compounding, 4e, Ch. 21 – Colors, Flavors, Sweeteners, and Scents, published 2017), Brinckmann (Herb Profile, Iss. 128, 2020), Ciriminna (Chemistry Central Journal, 2017, 11:22).
The reference claims 1-18 are drawn to a rapidly infused composition comprising a pharmaceutically acceptable binder and/or excipient system comprising gelatin and mannitol, and vitamins D, A, E, K, B, C, and/or caffeine.
Reference claim 27 is drawn to a process for manufacturing the composition of claims 1-26.
One of ordinary skill in the art would find it obvious to modify the composition of reference claims 1-18 via the teachings of Ryde, Dodd, Villiers, and Brinckmann to arrive at the instant claims. One of ordinary skill would also find it obvious to modify the method of reference claim 27 to create a lyophilized composition (instant claim 2) of the instant claims.
This is a provisional nonstatutory double patenting rejection.
18/252,735
Claims 1-16 and 20-25 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/252,735 in view of Ryde (US2005/0042177), Dodd (US2020/0390710), Villers (Contemporary Pharmacy Practice and Compounding, 4e, Ch. 21 – Colors, Flavors, Sweeteners, and Scents, published 2017), Brinckmann (Herb Profile, Iss. 128, 2020) and Ciriminna (Chemistry Central Journal, 2017, 11:22).
Reference claims 1-14 are drawn to a composition comprising gelatin, a sugar alcohol, and methotrexate. Reference claims 3-4 specify disintegration time. Reference claim 7 specifies bovine gelatin. Reference claim 9 specifies mannitol. Reference claim 15 is drawn to a process for manufacturing the composition of reference claims 1-14.
One of ordinary skill in the art would find it obvious to modify the composition of reference claims 1-15 via the teachings of Ryde, Dodd, Villiers, and Brinckmann to arrive at the instant claims. One of ordinary skill would also find it obvious to modify the method of reference claim 15 to create a lyophilized composition (instant claim 2) of the instant claims.
This is a provisional nonstatutory double patenting rejection.
18/252,688
Claims 1-16 and 20-25 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/252,688 in view of Ryde (US2005/0042177), Dodd (US2020/0390710), Villers (Contemporary Pharmacy Practice and Compounding, 4e, Ch. 21 – Colors, Flavors, Sweeteners, and Scents, published 2017), Brinckmann (Herb Profile, Iss. 128, 2020) and Ciriminna (Chemistry Central Journal, 2017, 11:22).
Reference claims 1-18 are drawn to compositions comprising gelatin, mannitol, and sildenafil citrate. Claim 19 is drawn to a process of manufacturing comprising lyophilizing a solution to achieve the composition of claims 1-18.
One of ordinary skill in the art would find it obvious to modify the composition of reference claims 1-25 via the teachings Ryde, Dodd, Villiers, and Brinckmann to arrive at the instant claims. One of ordinary skill would also find it obvious to modify the method of reference claim 19 to create a lyophilized composition (instant claim 2) of the instant claims.
This is a provisional nonstatutory double patenting rejection.
18/252,707
Claims 1-16 and 20-25 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/252,676 in view of Ryde (US2005/0042177), Dodd (US2020/0390710), Villers (Contemporary Pharmacy Practice and Compounding, 4e, Ch. 21 – Colors, Flavors, Sweeteners, and Scents, published 2017), Brinckmann (Herb Profile, Iss. 128, 2020) and Ciriminna (Chemistry Central Journal, 2017, 11:22).
The reference claims are drawn to a composition comprising a gelatin, a sugar alcohol, and tetrahydrocannabinol (THC), and further comprising a flavorant. The reference claims also claim a process of manufacturing comprising lyophilizing a mixture of the above ingredients.
One of ordinary skill in the art would find it obvious to modify the composition of reference claims 1-20 via the teachings of Ryde, Dodd, Villiers, and Brinckmann to arrive at the instant claims. One of ordinary skill would also find it obvious to modify the method of reference claim 21 to create a lyophilized composition (instant claim 2) of the instant claims.
This is a provisional nonstatutory double patenting rejection.
The addition of Ciriminna to the rejections above has been necessitated by amendments made to the claims.
Response to Arguments
Applicant argues that the references do not explicitly or fairly teach compositions comprising a flavorant in an amount of 0.5 to 10 wt% based on a total weight of the lyophilized rapidly infusing composition. Regarding Ridall, applicant states “Ridall does not disclose a ‘lyophilized rapidly infusing composition, comprising: a pharmaceutically acceptable binder and/or excipient system comprising gelatin, a sugar alcohol, and a flavorant present in an amount of 0.5 to 10 wt.%...’. Therefore Ridall fails to teach, show, suggest or otherwise render obvious claim 1 and claims dependent thereon.”
Similar arguments are applied to Ryde, Dodd, Villiers, and Brinckmann.
Additionally, applicant argues that one of ordinary skill in the art would not be motivated to modify the delivery system of Ridall to incorporate sildenafil because “the extremely bitter taste of PDE5 inhibitors such as sildenafil presents well-known and long-standing formulation challenges I orally dissolving dosage forms. The specification explains that conventional taste-masking approaches for sildenafil ‘[rely] upon strategies that tend to prevent the release or uptake of the drug in the oral cavity, for example through the use of coatings or encapsulation, complexes with ion exchange resins, or pH adjustment strategies using alkaline buffering agents…Such strategies are designed specifically to prevent the bitter active ingredient from contacting the tongue.”
Applicant continues “In contrast, the claimed subject matter employs an entirely different approach in which taste masking is achieved through the rapid disintegration of the composition combined with carefully selected flavor system. As described in the specification, ‘the inventors have discovered that the RITe™ platform…can achieve taste masking by allowing a mixture of flavors to all reach the tongue at essentially the same time,’ such that the bitterness of the PDE5 inhibitor is mitigated by simultaneous arrival of other flavors.”
This is not persuasive because, the RITe™ platform is disclosed in the Ridall and the critical feature is its rapid dissolution. Ridall, col. 4, l. 60 starts “The [rapid] dissolution of the DSI pharmaceutical compositions disclosed herein allows them to also dissolve rapidly when in contact with an animal’s non-keratinous fibers/mucosal cavity, for example, the oral cavity and/or the non-gastric mucosa.” One of ordinary skill would find the rapid dissolution of the sildenafil and flavoring agents such that both arrive simultaneously to a patient to be obvious as the RITe™ is specifically designed for rapid administration.
Regarding the double patenting rejections, applicant argues that “A nonstatutory obviousness-type double patenting rejection is only appropriate where the application and the reference patent or application are commonly owned or subject to an obligation of assignment to the same entity.”
The MPEP section 804 Definition of Double Patenting states
“Some commonality of inventorship or (deemed) ownership must exist between two or more patents or applications before consideration can be given to the issue of double patenting. For example, the patents or applications may have the same inventive entity. The patents or application may also have at least one common (joint) inventor, which covers the situations where at least one patent or application names a solve inventor and the other patent(s) or application(s) names joint inventors and where all the patents or applications name joint inventors.”
Therefore, the rejections are proper and are maintained.
New Rejections
Claim Rejections - 35 USC § 112(d)
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 11 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 1 now states “A lyophilized rapidly infusing composition, comprising: a pharmaceutically acceptable binder and/or excipient system comprising gelatin, a sugar alcohol, and a flavorant present in an amount of 0.5 to 10 wt.% based on a total weight of the lyophilized rapidly infusing composition on a dry basis, the flavorant comprising an acidulant, and a PDE.sub.5 inhibitor.” The specification teaches exemplary acidulants which include citric acid, malic acid, fumaric acid, tartaric acid, ascorbic acid, succinic acid, adipic acid, lactic acid, phosphoric acid, and mixtures thereof…”. No where is “black cherry” recognized as an acidulant. Therefore, the addition of “black cherry flavoring in claim 11 broadens the scope beyond that of 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.
This new rejection has bene necessitated by amendments made to the claims.
Conclusion
No claims 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 LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
Prosecution Insights