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 .
Receipt is acknowledged of IDS filed on 03/12/2026
Claims 1, 13, 21, 27, and 200 have been amended.
Claims 1, 13, 14, 21, 27, 40, 59, 79, 80, 82, 88, 131, 196, and 199-203 are pending.
Claims 2-12, 15-20, 22-26, 28-39, 41-58, 60-78, 81, 83-87, 89-130, 132-195 and 197-198 are cancelled.
Claims 80, 82, 88 and 131 are withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
Claims 1, 13, 14, 21, 27, 40, 59, 79, and 196, and 199-203 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 74 of copending Application No. 17/798,874 in view of BIESALSKI (US 5,112,598).
The Application recites an aqueous pharmaceutical composition comprising a surfactant and vitamin A palmitate (claim 1),
Wherein:
95% or more of the vitamin A palmitate of the aqueous pharmaceutical composition comprises particles formed by the vitamin A palmitate and the surfactant in the configuration of micelles (claim 1).
Vitamin A palmitate is present in the aqueous pharmaceutical composition at a concentration of 0.3% w/w to 3.0% w/w (claim 1)
The weight of the surfactant present in the aqueous pharmaceutical composition is 4.0 to 5.0 times the weight of the vitamin A palmitate present in the aqueous pharmaceutical composition (claim 1)
each of the micelles has a diameter of less than or equal to 500 nm (claim 1).
The composition is designed for oral administration (claim 74).
The application does not teach having the composition in a liquid aerosol form.
BIESALSKI teaches a composition comprising retinal palmitate/vitamin A palmitate (claim 24) and that having a composition as an aerosol allows the composition to reach the desired active sites (column 3, paragraph 1).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate having the composition as an aerosol. The person of ordinary skill in the art would have been motivated to make those modifications, because aerosol administration is a form of oral administration, and reasonably would have expected success because the references are in the same field of endeavor such as composition to deliver vitamin A and furthermore it is known in the art that various forms of administration can be used for pharmaceutical compositions.
This is a provisional nonstatutory double patenting rejection.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 13, 14 , 40, 59, 79, 196, 199 and 201 are rejected under 35 U.S.C. 103 as being unpatentable over SUPERSAXO (US 7,871,642 B2) and AQUANOVA (DE202004003241U1).
Regarding claim 1, SUPERSAXO teaches an aqueous composition comprising vitamin A palmitate and polysorbate 80, which reads on surfactant (Column 11, Example 17), which reads on an aqueous pharmaceutical composition comprising a palmitate and at least one surfactant.
The aqueous composition is a nanodispersion, such as mixed micelles (column 1, paragraph 4), which reads the vitamin A palmitate of the aqueous pharmaceutical composition comprises particles formed by the vitamin A palmitate and the at least one surfactant in the configuration of micelles;
the vitamin A palmitate is present in the micelles at a concentration of 0.45% and in the aqueous pharmaceutical composition at a concentration of 0.10% (example 17 and 24);
The particles have a diameter of less than 30 nm (claim 5),
and the aqueous pharmaceutical formulation is in liquid aerosol form (example 24).
Regarding claim 13, 14 and 59, SUPERSAXO teaches using polysorbate 80 (Column 11, Example 17), which is a non-natural surfactant.
Regarding claim 40, SUPERSAXO teaches “…the pharmaceutical end formulation can also contain other components, for example…preservatives” (column 6, paragraph 8), which means the composition can also NOT require a preservative.
Regarding claim 79, SUPERSAXO teaches the composition comprises vitamin A palmitate and polysorbate 80, which reads on surfactant (Column 11, Example 17 and 24) and is in an aqueous form (column 6, paragraph 6).
Regarding claim 196, SUPERSAXO teaches the vitamin A palmitate is present in the micelles at a concentration of 0.45% and in the aqueous pharmaceutical composition at a concentration of 0.10% (example 17 and 24).
Regarding claim 201, SUPERSAXO teaches the composition is at a pH of 7.4 using a phosphate buffer (column 14, example 24), which reads on adjusting the pH by additional of a pharmaceutically acceptable acid and pharmaceutically acceptable base.
SUPERSAXO does not teach having 95% or more of the vitamin A palmitate in the configuration of micelles.
AQUANOVA teaches an aqueous solution comprising vitamin A palmitate/retinol palmitate and polysorbate 80 (claims 1, 2, 3). The mixture of retinol palmitate and polysorbate 80 forms micelles only with no free palmitate (Page 2, paragraph 2), which reads on 95% or more of the vitamin A palmitate of the aqueous pharmaceutical composition comprises particles formed by the vitamin A palmitate and the at least one surfactant in the configuration of micelles. The use of micelles to deliver vitamin A increases bioavailability (Page 2, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate having 95% or more of the vitamin A palmitate in the configuration of micelles. The person of ordinary skill in the art would have been motivated to make those modifications, because it increases bioavailability, and reasonably would have expected success because the references are in the same field of endeavor such as aqueous solutions comprising vitamin A and polysorbate.
Additional disclosures: SUPERSAXO teaches the composition is used to treat vitamin deficiency disease (column 6, paragraph 10). The polysorbate 80 is used as an emulsifier (column 4, paragraph 13), which is essential for forming micelles.
Regarding claims 1 and 199, The reference does not specifically teach the concentration/ratio of vitamin A palmitate and polysorbate 80 as claimed by the Applicant. The concentration/ratio of vitamin A palmitate and polysorbate 80 is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal concentration/ratio of vitamin A palmitate and polysorbate 80 in order to best achieve desired results, such as having enough vitamin A to achieve the goal of treating a vitamin deficiency and the optimal concentration of polysorbate 80 for the formation of the micelles in the composition. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the concentration of vitamin A palmitate and polysorbate 80 would have been obvious at the time of Applicant’s invention.
Claims 1, 13, 14, 27, 40, 59, 79, 196, 199 and 201 are rejected under 35 U.S.C. 103 as being unpatentable over SUPERSAXO (US 7,871,642 B2) and AQUANOVA (DE202004003241U1) in view of BAYBUTT (WO 2018/045174).
SUPERSAXO and AQUANOVA teach Applicant’s invention as discussed above. SUPERSAXO further teaches that additional components can be added to the composition (column 6, paragraph 9).
SUPERSAXO and AQUANOVA do not teach adding an additional active agent, such as vitamin E.
Regarding claim 27, BAYBUTT teaches a composition that comprises vitamin a retinol/vitamin palmitate and vitamin E that can be given as an aerosol (abstract). The aerosol can be used as a nutritional supplement (page 3, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate vitamin E. The person of ordinary skill in the art would have been motivated to make those modifications, because it adds an additive effect of being able to treat vitamin deficiency for two different vitamins, and reasonably would have expected success because the references are in the same field of endeavor such as vitamin A palmitate aerosols used for vitamin deficiency.
Claims 1, 13, 14 , 21, 27, 40, 59, 79, 196, 199 and 200-201 are rejected under 35 U.S.C. 103 as being unpatentable over SUPERSAXO (US 7,871,642 B2), AQUANOVA (DE202004003241U1) and BAYBUTT (WO 2018/045174) in view of CRODA ( Super Refined™ Polysorbate 80. 2015.).
SUPERSAXO, AQUANOVA and BAYBUTT teach Applicant’s invention as discussed above.
SUPERSAXO, AQUANOVA and BAYBUTT do not teach using a polysorbate with 98% oleic acid.
Regarding claims 21 and 200, CRODA teaches that super refined polysorbate 80, which is polysorbate 80 with a high concentration of oleic acid, is beneficial because it has decreased cellular irritation and an improved taste profile for oral liquid medicines to enhance palatability (Page 11, paragraph 3). Applicant’s specification teaches that super refined polysorbate 80 available from CRODA is up to 100% oleic acid (Applicant’s specification, page 57, paragraph 1).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate super refined polysorbate 80. The person of ordinary skill in the art would have been motivated to make those modifications, because it has decreased cellular irritation and enhances palatability for liquid oral formulations, such as a liquid aerosol, and reasonably would have expected success because it is a specific form of polysorbate 80 and polysorbate 80 is used in the prior art.
Claims 1, 13, 14 , 21, 27, 40, 59, 79, 196, and 199-203 are rejected under 35 U.S.C. 103 as being unpatentable over SUPERSAXO (US 7,871,642 B2), AQUANOVA (DE202004003241U1), BAYBUTT (WO 2018/045174) and CRODA (Super Refined™ Polysorbate 80. 2015.) in view of PHARMAGUIDLINE (Preparation of Buffer Solutions. 2012 via Wayback Machine).
SUPERSAXO, AQUANOVA, BAYBUTT and CRODA teach Applicant’s invention as discussed above. SUPERSAXO further teaches the composition has a pH of 7.4 using a phosphate buffer (column 14, example 24), which is made from potassium dihydrogen phosphate (an acid) and disodium hydrogen phosphate (a base).
SUPERSAXO, AQUANOVA, BAYBUTT and CRODA do not teach adjusting the pH specifically by the addition of hydrochloric acid and/or sodium hydroxide.
Regarding claims 202 and 203, PHARMAGUIDLINE teaches that buffers can be made from various acids and bases, including hydrochloric acid and/or sodium hydroxide (page 1, paragraph 3).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate adjusting the pH using hydrochloric acid and/or sodium hydroxide. The person of ordinary skill in the art would have been motivated to make those modifications, because various acids/base combinations can be used to make buffers, and reasonably would have expected success because using various buffers is commonly known in the art to adjust the pH.
Response to Arguments
Applicant argues, the composition as an aerosol showed unexpected results as being superior to oral administration.
Examiner does not find the argument persuasive. In order to overcome a prima facie case of obviousness, it is incumbent upon the Applicant to provide comparative test evidence that demonstrates unexpected superiority of the claimed compositions versus the closest prior art compositions, and not simply an advantage predictable from the prior art. See In re Chapman, 148 USPQ 711, 715 (CCPA, 1966). Moreover, such proffered comparisons must be commensurate in scope with the breadth of the claims. See In re Clemens, 206 USPQ 289, 296 (CCPA, 1980) and In re Coleman, 205 USPQ 1172, 1175 (CCPA 1980).
In the instant case, BIESALSKI teaches a composition comprising retinal palmitate/vitamin A palmitate (claim 24) and that having a composition as an aerosol allows the composition to reach the desired active sites (column 3, paragraph 1).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate having the composition as an aerosol. The person of ordinary skill in the art would have been motivated to make those modifications, because aerosol administration is a form of oral administration, and reasonably would have expected success because the references are in the same field of endeavor such as composition to deliver vitamin A and furthermore it is known in the art that various forms of administration can be used for pharmaceutical compositions.
This “superior effect” is taught by the prior art.
For a complete discussion of unexpected results, Applicants are referred to MPEP 716.02 et seq.
Applicant argues, Vitamin a palmitate and polysorbate 80 are not result effect parameter that a person of ordinary skill in the art would routinely optimize and that the cited explanation is too generic.
Examiner does not find the argument persuasive because the reasoning to optimize the parameters is stated by the art and would lead one of ordinary skill in the art to optimize the parameters as discussed above. Furthermore, the Applicant has not provided evidence of the criticality of the claimed ratio.
Applicant argues that SUPERSAXO’s composition contains water and is created at room temperature, while AQUANOVA has no evidence that it contains water and is prepared using heat. Therefor there would have been no reasonable expectation of success of arriving at the claimed subject matter.
The Examiner finds Applicant’s argument unpersuasive, because in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this instance, as discussed in the rejection, it would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate having 95% or more of the vitamin A palmitate in the configuration of micelles. The person of ordinary skill in the art would have been motivated to make those modifications, because it increases bioavailability, and reasonably would have expected success because the references are in the same field of endeavor such as aqueous solutions comprising vitamin A and polysorbate.
Furthermore, the claims do not require “water”, nor does the obvious rational rely on the addition or absence of water. The claims do not require a method of making, since they are drawn to a composition, nor does the obvious rational rely on the method of making involving or not involving heat.
Conclusion
No claims are allowable.
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 SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/ Primary Examiner, Art Unit 1618
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