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 .
Priority
The present application is a National Stage entry of International application PCT/EP2023/055017 filed 02/28/2023, which claims the benefit of Foreign application EP22382182.8 filed 03/01/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 08/29/2024, in the matter of Application N° 18/842,742. Said documents have been entered on the record. The claim set under review was filed 05/01/2025. The Examiner further acknowledges the following:
Claims 1-20 are pending.
Claims 1-20 are presented for examination and rejected as set forth below.
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.
Claims 1-11 and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Perrin (US20150290222A1), and in further view of Boissonneault (US6667050B1) and FDA (PIND 146207, 2021; publication date of 3/25/2021, compares to priority date of 03/01/2022).
Applicant’s claims are directed to an oral chewable tablet comprising 3.4 mg - 3.7 mg (see independent instant claims 1, 2, or 3). Furthermore, there is a method (instant claims 14-15) and kit (instant claim 16) claim.
Perrin teaches a pharmaceutical composition comprising an active contraceptive drug (abstract), that is inclusive of tablet forms [0266].
Regarding claims 1-2, 4, and 6, and 17-19: Perrin teaches a progesterone-only contraceptive of about 2-6 mg or about 4 mg (Perrin – claims 12, 15-16) or 3.5 mg of drospirenone (reads on amounts of claims 1-3, 9, 11, 17) [0230], that may comprise drospirenone as the only active (reads on “does not comprise estrogen” of instant claims 2, 4, and 19) (Perrin – claim 13) and pharmaceutical excipients (Perrin – claim 1), that includes tablet formulations [0266].
Perrin teaches an in vitro dissolution test (i.e., similarly to instant claim 1), whereby the method/apparatus is appropriate for the formulation (i.e., using USP XXIII Paddle Method in 900 mL water at 37° C, using apparatus 2 at 50 rpm stirring rate [0159] (i.e., highly comparable to the test conditions of instant claim 1), whereby no more than about 50% of said active contraceptive drug initially present is dissolved within 30 minutes (i.e., encompassing the instant value of NMT 20-40% dissolved within 30 minutes of claim 1) (Perrin – claim 1)), and ensures good oral bioavailability of the formulation composition [0009, 0044, 0078-0079].
Regarding claim 3: Perrin teaches the Cmax value for drospirenone is associated with tolerance of patients [0009, 0100-0101] and is in a preferred from 15 ng/mL to 30 ng/mL that is effective in patient treatment (reads on instant claim 3) ([0023, 0163]), after a single daily dose [0039, 0149].
Regarding claims 5 and 20: Perrin teaches a d50 particle size for the active drug ranging from about 10 μm to about 60 μm (Perrin – claim 8), whereby the dosage form is nonlimiting [0266] and can be achieved by compression or granulation [0288].
Regarding claims 7-11 (i.e., notably the amounts of ingredients): Perrin teaches 3.5 mg of drospirenone [0230], or about 5 wt% active [0271] (i.e., 7(i), 9(a), 11(a)). Perrin generally teaches about 80-99 wt% pharmaceutical excipients, including the instant ingredients: microcrystalline cellulose [0269] (i.e., 7(ii), 9(b), 10(i), 11(b)), anhydrous lactose [0269] (i.e., 7(iii), 9(c), 10(ii), 11(c)), silicon dioxide [0269] (i.e., 8(i), 9(d), 10(iii), 11(d)), magnesium stearate [0269] (i.e., 8(ii), 9(e), 10(iv), 11(e)), the optional flavoring excipient [0268] (i.e., 9(f), 11(f)) (i.e., these ingredients account for the general ingredient classes of instant claims 7-11 such as binder, filler, glidant, and lubricant). With regard to the obviousness of ingredient amounts: note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)). Thus, the ingredient amounts of claims 7-11 are made obvious by Perrin.
Regarding claims 14-15: Perrin teaches a method of daily administration of the drug formulation for contraception (abstract; Perrin – claim 23).
Regarding claim 16: Perrin teaches a kit [0002-0004] that comprises 24 daily dosage units comprising an effective amount of a contraceptive composition as described herein and, optionally, 4 daily dosage units of a pharmaceutically acceptable placebo [0369].
In summary, Perrin teaches an oral 3.5 mg drospirenone (only active) tablet composition, with a particular modified release profile (by dissolution test and in patients), including a method of treatment and kit. However, Perrin does not specify a chewable tablet form (all instant claims), and the instant hardness (instant claim 2).
Boissonneault teaches chewable oral contraceptives (abstract) that can include drospirenone (Boissonneault – claim 9). Boissonneault teaches oral contraceptive delivery systems (especially, palatable chewables, noted in col 3, paragraph 3-4 and col 9, lines 35-49) improve compliance (abstract, ‘background of invention’). Moreover, Boissonneault teaches that “overall size of the tablet may be any tablet size that incorporates the desired contraceptively effective amount of the oral contraceptive agent and the carrier and is still chewable and palatable. In a preferred embodiment, the size of the tablet is small…” (col 7, last paragraph). Boissonneault also teaches 5-15 kiloponds (i.e., 1 kilopond = 1 kilogram-force = 9.8 Newtons), which converts to a range of 49-147 Newtons (reads on the instant 15-100N hardness values of instant claim 2), which is sufficiently hard for blister packaging (Boissonneault – claim 34) and is still palatable and chewable (col 8, paragraph 1). With regard to the numerical range, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (see 2144.05(I)). See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Further note, Boissonneault provides no general restriction on tablet size, and further prefers smaller tablet sizes, because smaller tablets are more likely than larger tablets to be accepted as chewables and encourage compliance (col 7, last paragraph).
FDA, additionally, teaches chewable oral contraceptives that include drospirenone in 3.5 mg chewable table formulation (pg 3). FDA teaches 3.5 mg chewable tablet is therapeutically equivalent to Slynd 4 mg tablet (pg 3). Note, the Examiner is unclear regarding the relationship of Laboratorios Leon Farma SA (see FDA reference; publication date of 3/25/2021, compares to priority date of 03/01/2022), and the instant Applicant/Inventors. Thus, the applied reference (i.e., FDA) may have common Inventors/Applicants with the instant application. Based upon the earlier publication date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(1), but may fall within the grace period afforded the instant claims. Please refer to MPEP 717.01 for information regarding how a reference may be disqualified as prior art under 102(b)(1)(A) or (B).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Perrin’s oral contraceptive tablet formulation by making it into a chewable oral contraceptive, including a suitable hardness, as taught by Boissonneault, because Boissonneault teaches oral chewable contraceptive delivery systems improve compliance (‘background of invention’), and especially palatable chewables (col 3, paragraph 3-4 and col 9, lines 35-49). Furthermore, Perrin teaches that tablets in general are appropriate dosage forms for an oral contraceptive [0266]. With regard to the hardness modification (to read on instant claim 2), Boissonneault teaches the 5-15 kiloponds (i.e., converted to 49-147 Newtons) is sufficiently hard for blister packaging (Boissonneault – claim 34) and is still palatable and chewable (col 8, paragraph 1), which are important characteristics to retain in the formulation (col 3, paragraph 3-4 and col 9, lines 35-49).
Finally, the FDA disclosure teaches 3.5 mg chewable tablet is therapeutically equivalent to Slynd 4 mg tablet (pg 3). Therefore, using less active agent to obtain therapeutic equivalence is an expected benefit of the disclosed formulation.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Perrin (US20150290222A1), Boissonneault (US6667050B1) and FDA (PIND 146207, 2021), as applied to claims 1-11 and 14-20 above, and in further view of Robinson (US20030049316A1).
As discussed above, the combined Prior Art teaches a chewable 3.5 mg drospirenone (only) tablet composition, for oral contraception. However, the Prior Art does not teach explicitly the instant diameter and thickness of the tablet (instant claims 12-13).
Robinson teaches soft chewable tablet formulations that comprise an active ingredient (abstract). Robinson teaches suitable diameter of 7-19 mm and thickness of 2-12 mm (Robinson – claim 7). The 7-19 mm thickness range effectively reads on the 4-6 mm instant range, because 7 mm is 17% from 6 mm, which is suitably close according to Titanium Metals: A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP 2144.05 (I)). See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (indicating that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close). Specifically, the concentration of component compositions claimed by the appellees in Titanium Metals differed from the values disclosed by the prior art by as much as 17% of the claimed values, and in the absence of evidence tending to establish different results were achieved by such a miniscule difference in concentrations, were upheld to be obvious permutations of the art disclosed. Id. Furthermore, Robinson teaches “about” 7 mm, which indicates some variability around the value 7.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined Prior Art’s chewable oral contraceptive tablet by specifying the diameter and thickness of the table to the instant ranges, as taught by Robinson, because these sizes are typical of the Art.
Moreover, Boissonneault teaches that “overall size of the tablet may be any tablet size that incorporates the desired contraceptively effective amount of the oral contraceptive agent and the carrier and is still chewable and palatable. In a preferred embodiment, the size of the tablet is small…” (col 7, last paragraph). Thus, although Boissonneault does not teach explicit size values for chewable tablet size (i.e., Boissonneault uses mg as a way of discussing tablet size instead), Boissonneault provides no general restriction on table size, and further prefers smaller tablet sizes, because smaller tablets are more likely than larger tablets to be accepted as chewables and encourage compliance (col 7, last paragraph).
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over, and in further view of Perrin (US20150290222A1), Boissonneault (US6667050B1) and FDA (PIND 146207, 2021), and Robinson (US20030049316A1):
claims 8-11 and 18-20 of copending Application No. 18/682,824 (reference application)
Although the claims at issue are not identical, they are not patentably distinct from each other because all claim sets teach a composition comprising drospirenone of 2.5-3.5 mg amounts. The copending applications differ only significantly by not including the chewable aspect and other technical features of the table formulation.
This is remedied by the secondary references above, who teach the chewable feature of oral contraceptives and other details of oral chewable formulations (see 103 rejection above for teaching of limitations and rationale for combination).
This is a provisional nonstatutory double patenting rejection.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over, and in further view of Perrin (US20150290222A1), Boissonneault (US6667050B1) and FDA (PIND 146207, 2021), and Robinson (US20030049316A1):
claims 1-40 of Patent No. US9603860
claims 1-39 of Patent No. US10179140
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets teach 2.5 mg to 5.5 mg drospirenone tablet formulations. Patent No. ‘860 and ‘140 differ only significantly by not including the chewable aspect and other technical features of the table formulation.
This is remedied by the secondary references above, who teach the chewable feature of oral contraceptives and other details of oral chewable formulations (see 103 rejection above for teaching of limitations and rationale for combination).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJAN PRAGANI whose telephone number is (703)756-5319. The examiner can normally be reached 7a-5p EST (M-Th).
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/R.P./Examiner, Art Unit 1614 7/13/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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