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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/23/2025 has been entered.
Claim Status
Claims 13-16 are previously withdrawn.
Claims 1-4, 7-12, 17-18, and 21-28 are rejected.
No claims are allowable.
New Claim Rejections - 35 USC § 112(b)
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.
Claim 7 is 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.
Claim 7 is indefinite because it is unclear which of the recited components and/or combinations of components are required and which are optional. The claim appears to be missing a proper conjunctive term such as “and” or “or.” Alternatively, if the claim does include the proper conjunctive term, it is not placed so that the recited components are clearly regarded as required and/or optional.
New 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.
1. Claims 1-4, 7, 9-12, 17-18, and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Myers et al., (US 2008/0050422 A1, Feb. 28, 2008) (hereinafter Myers) in view of in view of Iwashita et al. (US 2015/0246943 A1, Sept. 03, 2015) (cited by Examiner on Form 892 07/23/2025) (hereinafter Iwashita).
Myers discloses a fast-dissolving film (i.e., thin film) product containing at least one drug; and a water soluble polymer composition administered to the oral cavity of a subject in need of the drug (Abstract). Water soluble polymers include hydroxypropylmethyl cellulose (HPMC) ([0083]), polyethylene oxide, and polyvinyl alcohol ([0085]). The polymer plays an important role in affecting the viscosity of the film and generally the viscosity of the matrix will vary from about 400 cps to about 100,000 cps ([0098]). The molecular weight of the PEO may range from about 100,000 to 900,000 Dalton ([0105]). To achieve the desired film properties, the level and/or molecular weight of PEO in the polymer component may be varied. Modifying the PEO content affects properties such as tear resistance, dissolution rate, and adhesion tendencies ([0102]) and PEO desirably ranges from about 20% to 100% by weight in the polymer component ([0103]). To balance the properties of adhesion prevention, fast dissolution rate, and good tear resistance, desirable film compositions may include about 50% to 75% low molecular weight PEO, with the remainder of the polymer component containing a hydrophilic cellulosic polymer (HPC or HPMC) ([0107]). The active agents may be incorporated into the film compositions of the present invention in a controlled release form. ([0111]). The active agents that may be incorporated into the films include pharmaceutical actives ([0113]) such as contraceptives ([0119]). The method of making the films involves combining a water soluble polymer, a polar solvent and an active agent to form a matrix, which is then formed into a film and dried in a controlled manner ([0117]). The composition may comprise organic plasticizers with low molecular weights, such as glycerol ([0148]).
Myers differs from the instant claims insofar as not disclosing ulipristal acetate as an active agent.
However, Iwashita discloses a micronized ulipristal acetate ([0061]). The invention further relates to a pharmaceutical composition comprising an ulipristal acetate substance and a pharmaceutically acceptable excipient ([0021]). The ulipristal acetate substance is useful as a contraceptive agent ([0089]). The pharmaceutical composition may comprise from 0.01% to 80% by weight of ulipristal acetate ([0097]). The pharmaceutical composition may be an oral dosage form, for example, film preparations ([0098]). The excipient may be a binder ([0099) and binders include hydroxypropyl methylcellulose (HPMC) and polyvinyl alcohol (PVA), used alone or in combination ([0100]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Myers discloses wherein the pharmaceutical film composition comprises a contraceptive. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated 0.01% to 80% by weight of micronized ulipristal acetate into the film of Myers since it is a known and effective contraceptive and weight for pharmaceutical compositions, as taught by Iwashita.
Regarding the limitation of claim 1 reciting wherein in the case where the water-soluble polymer is selected from poly(ethylene oxide), the amount of water-soluble polymer is 40-70% by weight, based on the total weight of the oral thin film, as discussed above, Myers teaches that in order to achieve the desired film properties, the level and/or molecular weight of PEO in the polymer component may be varied. Modifying the PEO content affects properties such as tear resistance, dissolution rate, and adhesion tendencies and PEO desirably ranges from about 20% to 100% by weight in the polymer component. Accordingly, one of ordinary skill in the art would have arrived at the claimed amount of poly(ethylene oxide) through routine experimentation to achieve the desired film properties such as tear resistance, dissolution rate, and adhesion tendencies as taught by Myers.
Regarding claims 11 and 12, the limitation “wherein after storing of the oral thin film at a temperature of 40 °C and 75% relative humidity for 6 months the amount of the degradation product N-demethyl ulipristal acetate (DMUA) is less than 1% by weight based on the initial amount of ulipristal acetate in the oral thin film before storage,” as noted on pages 15-16 of the instant specification, PEO-based films comprising ulipristal acetate has less than 1% DMUA after stability testing. Accordingly, since prior art discloses a PEO-based film comprising ulipristal acetate, the PEO-based film of the prior art would necessary have less than 1% DMUA after the claimed stability testing.
Regarding the limitations of claim 22, as discussed above, Myers teaches that in order to balance the properties of adhesion prevention, fast dissolution rate, and good tear resistance, desirable film compositions may include about 50% to 75% low molecular weight PEO, with the remainder of the polymer component containing a hydrophilic cellulosic polymer (HPC or HPMC). Accordingly, one of ordinary skill in the art would have arrived at the claimed amount of HPMC through routine experimentation to balance the properties of adhesion prevention, fast dissolution rate, and good tear resistance as taught by Myers.
Regarding claim 23, as discussed above, Myers teaches that the polymer plays an important role in affecting the viscosity of the film and generally the viscosity of the matrix will vary from about 400 cps to about 100,000 cps. Accordingly, one of ordinary skill in the art would have arrived at the claimed amount of poly(vinyl alcohol) through routine experimentation to arrive at the desired viscosity of the film as taught by Myers.
2. Claims 8 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Myers et al., (US 2008/0050422 A1, Feb. 28, 2008) (hereinafter Myers) in view of in view of Iwashita et al. (US 2015/0246943 A1, Sept. 03, 2015) (cited by Examiner on Form 892 07/23/2025) (hereinafter Iwashita) further in view of Li et al. (US 2013/0273162 A1, Oct. 17, 2013) (hereinafter Li).
As discussed above Myers and Iwashita make obvious the limitations of claim 1 but do not teach wherein the water-soluble polymer is selected from poly(vinyl alcohol) 4-88, hydroxypropyl methylcellulose 603, hydroxypropyl methylcellulose 60SH50 or a mixture of hydroxypropyl methylcellulose 603 and hydroxypropyl methylcellulose 60SH50 in a weight ratio of hydroxypropyl methylcellulose 603 to hydroxypropyl methylcellulose 60SH50 of 2/1 to 1.5/1.
However, Li discloses a drug delivery oral wafer or edible oral film dosage that includes a controlled release layer containing enteric-release beads dispersed in a polymer matrix (Abstract). Non-limiting exemplary polymers suitable for use as the controlled-release matrix polymer include one or more of cellulose and/or derivatives thereof ([0015]). Advantageously, the inventive oral film dosages incorporate a film-forming mixture containing both lower and higher viscosity cellulose derivatives. The inventive oral film strips may incorporate a mixture of lower and higher viscosity HPMCs, for example. An exemplary range for the lower viscosity cellulose derivatives is from about 1.5 to 25 mPas. An exemplary range for the higher viscosity cellulose derivative is from about greater than 25 to 100 mPas. HPMC having a viscosity of 3 mPas is commercially available as PHARMACOAT® 603 and HPMC having a viscosity of 50 is commercially available as METOLOSE® 60 SH50. The lower viscosity cellulose derivative is generally present within the film-forming mixture in a greater amount than the higher viscosity cellulose derivative. The lower viscosity cellulose derivative may be present within the film-forming mixture in any effective weight ratio in comparison to the higher viscosity cellulose derivative, such as a weight ratio ranging from about 1.5:1 to 6:1, particularly about 2.0:1 to 4:1, such as about 3:1 (lower viscosity cellulose derivative: higher viscosity cellulose derivative).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Myers discloses wherein the polymer of the controlled release pharmaceutical film composition is hydroxypropyl methylcellulose (HPMC). Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated a mixture of PHARMACOAT® 603 (i.e., hydroxypropyl methylcellulose 603) and METOLOSE® 60 SH50 (i.e., hydroxypropyl methylcellulose 60SH50) in a weight ratio of 2.0:1 into the film of Myers since it is a known and effective HPMC used for controlled release pharmaceutical films, as taught by Li.
3. Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Myers et al., (US 2008/0050422 A1, Feb. 28, 2008) (hereinafter Myers) in view of in view of Iwashita et al. (US 2015/0246943 A1, Sept. 03, 2015) (cited by Examiner on Form 892 07/23/2025) (hereinafter Iwashita) further in view of Kucera et al. (US 2018/0280302 A1, Oct. 04, 2018) (hereinafter Kucera).
As discussed above Myers and Iwashita make obvious the limitations of claim 1 but do not teach wherein the poly(vinyl alcohol) has a molecular weight in the range of 20,000 to 40,000 Dalton and a degree of hydrolysis of 84 to 92 mol-% or a molecular weight in the range of 25,000 to 35,000 Dalton and a degree of hydrolysis of 86 to 90 mol-%.
However, Kucera discloses a method for producing storage-stable solid dispersions of poorly soluble pharmaceutically active compounds comprising polyvinyl alcohol as carrier matrix (Abstract). Polyvinyl alcohol (PVA) is a synthetic water-soluble polymer that possesses excellent film-forming properties ([0009]). A composition is prepared by thermokinetic compounding comprising one or more pharmaceutical active ingredient(s), which is (are) homogeneously dispersed in a polyvinyl alcohol matrix ([0032]) and may be in a film dosage form ([0034]). The United States Pharmacopeia-National Formulary mandates that an acceptable polyvinyl alcohol for use in pharmaceutical dosage forms must have a percentage of hydrolysis between 85 and 89% ([0056]) and the comprising pharmaceutically acceptable PVA has a degree of hydrolysis between 85-89% according to the United Stated Pharmacopoeia, and a molecular weight in the range of 14,000 g/mol to 250,000 g/mol (i.e., 14,000 Dalton to 250,000 Dalton) (Claim 2).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Myers discloses wherein the polymer of the pharmaceutical film composition is polyvinyl alcohol (PVA). Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated PVA having a degree of hydrolysis between 85-89% and a molecular weight in the range of 14,000 g/mol to 250,000 g/mol (i.e., 14,000 Dalton to 250,000 Dalton) into the film of Myers since it is a known and effective PVA used for pharmaceutical films, as taught by Kucera.
Response to Applicant’s Arguments
Applicant’s arguments have been considered but are moot because new rejections necessitated by Applicant’s amendments have been made.
Modified 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.
1. Claims 1-4, 7-12, 17-18, and 21-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 11, and 20 of copending Application No. 18/692,408 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because co-pending claims 1, 3, and 11 are directed to an oral thin film comprising at least one matrix layer, wherein the at least one matrix layer comprises at least one polyvinyl alcohol and at least one polyvinyl alcohol having a higher average molecular weight wherein said at least one polyvinyl alcohol having a lower average molecular weight and said at least one polyvinyl alcohol having a higher average molecular weight are present in the matrix layer in a total amount of 15 to 70 wt% based on the total weight of the matrix layer and at least one active pharmaceutical ingredient. The co-pending dependent claims further limit the composition wherein the at least one polyvinyl alcohol having a lower average molecular weight and the at least one polyvinyl alcohol having a higher average molecular weight are present in the matrix layer in a total amount of from 20 to 55 wt% and wherein the at least one active pharmaceutical ingredient or a pharmaceutically acceptable salt thereof is present in the matrix layer in an amount of 10 to 60 wt% based on the total weight of the matrix layer. The composition of the instant claims comprises ulipristal acetate as an active pharmaceutical ingredient and a polymer matrix of polyvinyl alcohol in amounts overlapping the ranges of the co-pending claims, thus making the inventions patentably indistinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2. Claims 1-4, 7-12, 17-18, and 21-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 9-10 of co-pending Application No. 17/918,771 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims are directed to an oral thin film, comprising a polymer matrix and ulipristal acetate dispersed in the polymer matrix, wherein the matrix polymer is poly(ethylene oxide), wherein the at least one water-insoluble, ulipristal acetate is present in an amount of 10 to 60% by weight, and further comprising glycerol. The composition of the instant claims comprises ulipristal acetate as an active pharmaceutical ingredient and a polymer matrix of poly(ethylene oxide) further comprising glycerol, in amounts overlapping the ranges of the co-pending claims, thus making the inventions patentably indistinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicant argues that the double patenting rejection should be removed when the present application is deemed to contain allowable subject matter. Applicant’s argument has been fully considered but found not to be persuasive because no acceptable terminal disclaimer has been filed and approved at this time.
With regard to claims 1-4, 7-12, 17-20 and 22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 9-10 of co-pending Application No. 17/918,771 (reference application):
No arguments were noted in the Applicant’s remarks dated 10/23/2025. However, the rejection is maintained because no acceptable terminal disclaimer has been filed and approved at this time.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha J Knight whose telephone number is (571)270-3760. The examiner can normally be reached Monday - Friday 8:30 am to 5:00 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.J.K./ Examiner, Art Unit 1614
/TRACY LIU/ Primary Examiner, Art Unit 1614