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
Filing Receipt and Priority
The filing receipt states that the instant application is a 371 of PCT/US2021/058038, filed 11/04/2021.
The filing receipt also states that the above PCT application claims benefit of provisional applications dated back to 11/16/2020.
Of the applications listed in the filing receipt, the PCT application is the only application that supports the instant application. All other applications are drawn to compositions that do not require any of the vitamins D, A, E, K, B, C and caffeine and/or packaging for said compositions.
Therefore the instant effective filing date is 11/04/2021.
Information Disclosure Statement
The information disclosure statement received 05/11/2023 has been considered.
Moreover., Applicant has an obligation to call the most pertinent prior art to the attention of the U.S. Patent and Trademark Office in a proper fashion. Burying one reference in one hundred other IDS references is like citing nothing. PENN YAN BOATS, INC. v. SEA LARK BOATS, INC. 175 USPQ 260 (S.D. Fla. 1972). Golden Valley Microwave Foods, Inc. v. Weaver Popcorn Co. Inc., 24 USPQ2d 1801 (U.S. Dist. N. Dist. IN 1992).
Restriction/Species Election
Applicant’s election of Group I with traverse in the remarks filed 11/20/2025 is acknowledged. Applicant’s additional election with traverse of the following species is also acknowledged. The elected species are: i) vitamin D3, ii) mannitol.
Response to Traverse
Applicant argues that “The claims as drafted are directed to a single general inventive concept of a rapidly infusing composition and are therefore examinable together. The compositions of claims 1-50 share common features of a pharmaceutically acceptable binder and/or excipient system comprising mammalian gelatin and a sugar alcohol. And at least one supplement…”. Instant claim 1 shows listing of supplements.
This is not persuasive as, as indicated in the restriction requirement of 10/09/2025, the technical feature does not make a contribution over the art in view of Makino (US 5,720,974).
Regarding the species elections, applicant argues that “a search for any one of the elected species in each of the species groups would yield references applicable to all of the species in each of the respective species groups.”
This is not persuasive as each of the species claimed (Vitamins D, A, E, K, B, C, and caffeine) have sufficiently different chemical structures and properties that they are not considered alternatives of each other within the art. For example, the chemical structures of Vitamin D (elected) and caffeine are shown below.
Vitamin D and Caffeine
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These differences are significant and art applicable to one species would not be applicable to another. Applicant indicated how these species are alternatives of each other.
The restriction is made final.
At examiner’s discretion, search and examination has been expanded to include Vitamins D3 and D2.
Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 25 and 26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 25 and 26 recite “derivative/analog”. The term is indefinite as it is not clear if applicant is referring to the derivative of cannabidiol (CBD), an analog of CBD, both a derivative and an analog, or if “derivative” is simply another term for “analog”.
Examiner suggests amending the claims to remove the”/” and replace it with appropriate conjunctive language.
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.
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) 1-11 and 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ridall (US 10,064,849, published 2018, priority date 05/02/2012) in view of Wilson (Proceedings of the Nutrition Society, 2017, 76, 392-399) and Millar (Br. J. Clin. Pharmacol. 2019;85:1888-1900).
Independent claim 1 is drawn to a rapidly infusing composition comprising a pharmaceutically acceptable binder and/or excipient system comprising mammalian gelatin and a sugar alcohol and vitamin D.
Dependent claim 2 specifies that the composition is lyophilized.
Dependent claims 3 and 4 specify a property of the composition wherein the composition has a disintegration time approximately 1 to 30 seconds (claim 3) or 1 to 5 seconds (claim 4) in deionized water maintained at 37oC ± 2oC.
Dependent claims 6, 8, 9, 11, 24, and 25 are drawn to embodiments wherein mammalian gelatin is bovine gelatin (claim 6), the sugar alcohol comprises mannitol (claim 8), the composition comprises a vitamin D compound (claim 9) which is either vitamin D3 and/or vitamin D2 (claim 11), wherein the composition further comprises at least a sweetener, a flavorant, and a colorant (claim 24), and further comprising cannabidiol (CBD) (claim 26).
Dependent claims 5, 7, 10, and 26 are drawn to specific concentrations of the ingredients above.
Ridall in col. 13, table 2 teaches a composition below.
Ridall composition
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Ridall in col. 9, l. 51-57 discusses lyophilizing the composition of its invention.
Ridall in col. 14, Table 6 lists disintegration times.
Ridall Table 6
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Ridall in col. 12, Table 1 teaches a listing of ingredients and their role within the composition.
Ridall Table 1
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With the above teaching, one of ordinary skill would recognize that omeprazole is the only active pharmaceutical ingredient within this composition and that the other ingredients act together to deliver the active pharmaceutical ingredient. One of ordinary skill in the art would therefore be able to modify the composition by replacing the omeprazole with any other ingredient intended for delivery.
Additionally, Ridall in col. 3, l. 26-44 discusses advantages of its composition which are “administering a DSI (direct systemic introduction) pharmaceutical composition of the invention provides for faster onset of the therapy, diminished occurrences of the side-effects due to nonuniformity of bioavailability of the active pharmaceutical ingredient, and/or more accurate dosing.”
Ridall does not discuss vitamin D3, vitamin D2, or CBD. This is addressed by the combination of Wilson and Millar.
Wilson is drawn to fortification strategies involving vitamins D2 and D3 (title). Wilson in its abstract states “The role of vitamin D in supporting the growth and maintenance of the skeleton is robust; with recent research also suggesting a beneficial link between vitamin D and other non-skeletal health outcomes, including immune function, cardiovascular health and cancer. Despite this, vitamin D deficiency remains a global public health issue…”.
Wilson on p. 393, sec. Sources of vitamin D states “Vitamin D is the generic term used for both Vitamin D2 and vitamin D3, also known as ergocalciferol and cholecalciferol, respectively.” Wilson continues “Other sources [of vitamin D] include supplements or fortified foods…”.
Millar on p. 1989, left. col. 3 states “Hemp-derived CBD is commercially available and is currently used as a health and food supplement commonly for anxiety and pain relief.”
As stated above, one of ordinary skill in the art would be able to modify the composition by replacing the omeprazole with vitamin D3 and/or D2 (herein after Vitamin D). One of ordinary skill would further be able to include CBD into the composition. As both vitamin D and CBD are considered supplements, one of ordinary skill would find it obvious to combine both supplements into a composition. The MPEP section 2144.05 states:
“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) (citations omitted)
Ridall teaches that benefits of its invention are “faster onset of the therapy, diminished occurrences of the side-effects due to nonuniformity of bioavailability of the active pharmaceutical ingredient, and/or more accurate dosing.” These benefits are properties of the composition, sans omeprazole. Additionally, one of ordinary skill would be able to modify the composition to have concentrations of Vitamin D and CBD within the ranges claimed.
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 have modified the composition of Ridall via the teachings of Wilson and Millar to arrive at the instant claims with a reasonable assumption of success. One of ordinary skill would be motivated to make the modification in order to take advantage of the faster onset time, diminished side-effects, and/or more accurate dosing provided by the carrier composition of Ridall.
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 1-11 and 24-26 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 Wilson (Proceedings of the Nutrition Society, 2017, 76, 392-399) and Millar (Br. J. Clin. Pharmacol. 2019;85:1888-1900).
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 Wilson and Millar, 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, surfactant, a flavorant, vitamin D, and CBD.
U.S. Patent 10,064,849
Claims 1-11 and 24-26 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 Wilson (Proceedings of the Nutrition Society, 2017, 76, 392-399) and Millar (Br. J. Clin. Pharmacol. 2019;85:1888-1900).
The reference claims are drawn to a composition comprising bovine gelatin, mannitol, a surfactant, 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, surfactant, a flavorant, vitamin D, and CBD.
U.S. Patent 12,005,053
Claims 1-11 and 24-26 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 Wilson (Proceedings of the Nutrition Society, 2017, 76, 392-399) and Millar (Br. J. Clin. Pharmacol. 2019;85:1888-1900).
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 claims 1-9.
The arguments made in the 103 rejection above regarding the modification of the composition to include vitamin D and CBD are incorporated here. 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 1-11 and 24-26 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 Wilson (Proceedings of the Nutrition Society, 2017, 76, 392-399) and Millar (Br. J. Clin. Pharmacol. 2019;85:1888-1900).
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. To 0.2 mass% and a proton pump inhibitor in about 10 to 30 mass%.
Via the teachings of Wilson and Millar 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 1-11 and 24-26 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 Wilson (Proceedings of the Nutrition Society, 2017, 76, 392-399) and Millar (Br. J. Clin. Pharmacol. 2019;85:1888-1900).
The reference claims are drawn to a buccal composition comprising gelatin, a sugar alcohol, and CBD. Reference claim 22 further claims a flavorant.
Considering the teachings of Wilson and Millar, which teach Vitamin D and CBD as supplements, respectively, one of ordinary skill in the art would find it obvious to modify the composition of the reference claims to include vitamin D.
This is a provisional nonstatutory double patenting rejection.
18/252,688
Claims 1-11 and 24-26 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 Wilson (Proceedings of the Nutrition Society, 2017, 76, 392-399) and Millar (Br. J. Clin. Pharmacol. 2019;85:1888-1900).
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 further comprising nicotine.
Reference claim 19 are drawn to a process for manufacturing the composition of claims 1-18 via dissolving the gelatin and mannitol in water to form a solution, adding the nicotine, and then lyophilizing the solution.
One of ordinary skill in the art would find it obvious to modify the composition of reference claims 1-18 via the teachings of Wilson and Millar 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.
18/252,735
Claims 1-11 and 24-26 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 Wilson (Proceedings of the Nutrition Society, 2017, 76, 392-399) and Millar (Br. J. Clin. Pharmacol. 2019;85:1888-1900).
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 Wilson and Millar 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.
18/252,676
Claims 1-11 and 24-26 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 18/252,676 in view of Wilson (Proceedings of the Nutrition Society, 2017, 76, 392-399) and Millar (Br. J. Clin. Pharmacol. 2019;85:1888-1900).
Reference claims 1-25 are drawn to compositions comprising gelatin, mannitol, and a PDE.sub.5 inhibitor. Claim 26 is drawn to a process of manufacturing comprising lyophilizing a solution to achieve the composition of claims 1-25.
One of ordinary skill in the art would find it obvious to modify the composition of reference claims 1-25 via the teachings of Wilson and Millar to arrive at the instant claims. One of ordinary skill would also find it obvious to modify the method of reference claim 26 to create a lyophilized composition (instant claim 2) of the instant claims.
This is a provisional nonstatutory double patenting rejection.
18/252,707
Claims 1-11 and 24-26 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 Wilson (Proceedings of the Nutrition Society, 2017, 76, 392-399) and Millar (Br. J. Clin. Pharmacol. 2019;85:1888-1900).
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 Wilson and Millar 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.
Conclusion
No claims allowed.
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.
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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
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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