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 . Claims included in prosecution are claims 52-53, 67, and 74-88.
Previous Rejections
Applicants' arguments, filed 11/12/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
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 52-53, 67, 74-81, and 83-85 are rejected under 35 U.S.C. 103 as being unpatentable over DeVries et al. (US 2007/0286819, Dec. 13, 2007) (hereinafter DeVries).
DeVries teaches methods of improving the bioavailability of ethinyl estradiol by orally administering to a patient a solid dosage form containing ethinyl estradiol or a prodrug thereof where that dosage form releases at least some of the ethinyl estradiol or a prodrug thereof in the oral cavity for absorption through the oral mucosa to treat the patient for a predetermined indication such as, for example, hormone replacement therapy or contraception (satisfies the method of the instant claims). The solid dosage forms may be selected from, among others, fast melt tablets and dissolving films (i.e., orodispersible) (satisfies instant claim 52) (Abstract). Typically, the patient is a female (¶ [0014]). The solid dosage form may be administered buccally, sublingually, or gingivally (satisfies claim 53) (¶ [0018]). Orally consumable films that may be used in the aforementioned methods rapidly dissolve upon contact with saliva and provide rapid delivery of the active ingredients (¶ [0024]). In preferred embodiments, the dosage form used is in the form of a fast melt tablet or orally disintegrating tablet. Such tablets will disintegrate rapidly, usually in a matter of seconds, when placed upon the tongue (satisfies time of claim 52 & satisfies claim 67) (¶ [0027]). Preferably, the solid dosage form contains ethinyl estradiol and progestin in an amount effective for oral contraception. Preferably, the dosage form contains about 0.5 μg to about 50 μg of ethinyl estradiol (satisfies ethinyl estradiol of claims 75-81). Preferably, the dosage form also contains at least one progestin in an amount of about 0.3 mg to about 1.5 mg of norethindrone acetate or norethindrone (satisfies norethindrone acetate of claim 80-81) (¶ [0023]). In Example 2, the ethinyl estradiol content in the orally disintegrating tablet was 0.014% (w/w) (satisfies claim 74) (¶ [0055]).
DeVries differs from the instant claims insofar as not explicitly disclosing wherein the dosage form disintegrates in about 30 seconds or less.
However, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, DeVries’ dosage form disintegrates in a matter of seconds. A matter of seconds may be interpreted as any time less than 1 minute/60 seconds. Therefore, this encompasses a disintegration time of 30 seconds or less. Accordingly, because the disintegration time recited in the instant claims overlaps with the disintegration time disclosed by DeVries, the disintegration time disclosed by DeVries meets the instantly recited limitations.
Regarding instant claim 83 reciting capability to be dispensed from a blister pack, DeVries discloses substantially the same method as the instant claims comprising administering substantially the same dosage form containing ethinyl estradiol, which is administered in substantially the same forms using substantially the same administration routes. DeVries also discloses using ethinyl estradiol/norethindrone acetate with a dosage overlapping that of the instant claims and in an amount encompassed by the instant claims. Therefore, when DeVries’ solid dosage form is used to make ethinyl estradiol orally disintegrating tablets, it would have been reasonable for one of ordinary skill in the art to conclude that the tablets of DeVries would have substantially the same property, capability to be dispensed from a blister pack, as the orodispersible dosage forms of the instant claims.
Regarding the amounts and dosages of ethinyl estradiol/norethindrone acetate recited in instant claims 74, 76-81, and 84-85, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(A). As discussed above, DeVries’ dosage form may comprise about 0.5 μg to about 50 μg of ethinyl estradiol and the orally disintegrating tablet of Example 2 contained 0.014% (w/w) ethinyl estradiol. Furthermore, DeVries’ dosage form preferably contains 0.3-1.5 mg norethindrone acetate. Accordingly, because the amounts and dosages recited in the instant claims lie within the amounts and dosages disclosed by DeVries, the amounts and dosages disclosed by DeVries meet the instantly recited limitations.
Response to Arguments
Regarding Applicant’s arguments that pertain to the Declaration submitted Nov. 12, 2025, please refer to the Response to Declaration below.
Response to Declaration by Ryan Loughlin
Regarding Applicant’s argument that DeVries teaches that a chewable tablet is the most preferable type of dosage form, the Examiner submits that a reference is relied upon for all it teaches and suggests, even non-preferred embodiments. See MPEP § 2141.02 (VI). However, in the instant case, DeVries explicitly discloses that a fast melt tablet or orally disintegrating tablet may be preferably used as recited in (¶ [0027]). Furthermore, DeVries discloses Examples 2 and 3 which teach an orally disintegrating tablet and a fast melt tablet, respectively. Most importantly, DeVries discloses that the most preferred solid dosage form is a chewable tablet or an orally disintegrating tablet (¶ [0030]). Accordingly, in view of the DeVries disclosure one of ordinary skill in the art would have been sufficiently motivated to formulate the dosage form to be in the form of an orally disintegrating tablet or a fast melt tablet.
Regarding Applicant’s argument that DeVries’ teaching of a disintegration time of “in a matter of seconds” does not mean that the dosage forms disintegrate in 30 seconds or less, as discussed above, “a matter of seconds” may be reasonably interpreted as any time less than 1 minute/60 seconds. Therefore, this encompasses a disintegration time of 30 seconds or less. Accordingly, the disintegration time recited in the instant claims overlaps with the disintegration time disclosed by DeVries. Furthermore, the exhibit Applicant points to, Exhibit B, disclose that in their testing “Orodispersible tablets disintegrate within 3 min”. This references makes no mention of “in a matter of seconds”. As such, it would not be reasonable for one of ordinary skill in the art to make the assumption, based on Exhibit B, that DeVries’ disclosure of a disintegration time of “in a matter of seconds” would result in a tablets that “disintegrate within 3 min”. Finally, assuming purely arguendo, that Applicant’s definition of “ as much as 180 seconds” or “within 3 min” is the interpretation that one of ordinary skill in the art would be led to for the term “in a matter of seconds”, this would still overlap with the recitation of the instant claims and in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding Applicant’s argument that based on the DeVries disclosure, it is understood that the other dosage forms disclosed, such as fast melt tablets/orally disintegrating tablets, are understood to be inferior or at best no better than a chewable tablet and that a chewable tablet is the most effective way to improve EE bioavailability, the Examiner submits that one of ordinary skill in the art would not have been lead to this understanding since DeVries explicitly discloses that a fast melt tablet or orally disintegrating tablet may be preferably used. Furthermore, DeVries discloses Examples 2 and 3 which teach an orally disintegrating tablet and a fast melt tablet, respectively. One of ordinary skill in the art would not be led to the understanding that a fast melt tablet or an orally disintegrating tablet are inferior simply because a chewable tablet is recited as another preferred form. This designation simply refers to more suitable embodiments among several disclosed embodiments. One of ordinary skill in the art would not be led to the understanding that a fast melt tablet or an orally disintegrating tablet are inferior to a chewable tablet because not only does DeVries not teach away from a fast melt tablet or an orally disintegrating tablet but rather they disclose that the most preferred solid dosage form is an orally disintegrating tablet. As such, in light of the fact that the DeVries disclosure is directed towards improving the bioavailability of ethinyl estradiol for the purpose of female contraception and discloses that a most preferred solid dosage form is an orally disintegrating tablet, one of ordinary skill in the art would reasonably expect an orally disintegrating tablet to be an effective dosage form to improve EE bioavailability.
Regarding the data presented in the Declaration submitted Nov. 12, 2025, an affidavit or declaration must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. See MPEP § 716.02(e).
Applicant does not appear to have compared their compositions to the closest prior art. Instead, Applicant compares their inventive compositions to “commercially available chewable tablets Minastrin 24 Fe and Charlotte 24 Fe”. The Examiner points to the fact that DeVries discloses dosage forms where a fast melt tablet or orally disintegrating tablet may be preferably used and discloses examples of such dosage forms. In fact, DeVries discloses wherein the most preferred solid dosage form is an orally disintegrating tablet. Absent a direct comparison with a comparative formulation of the closest prior art, it is unclear if the alleged improvements are indeed a surprising an unexpected change or if these results fall within the range of expected outcomes in the art, and a meaningful assessment cannot be made. In other words, if an inventive composition is compared to a distant composition, the alleged improvements or advantages may appear disproportionately more significant than they actually are. As such, it is critical to compare an inventive composition with the closest prior art. Applicant’s comparisons with “commercially available chewable tablets Minastrin 24 Fe and Charlotte 24 Fe” do not satisfy the requirement of comparing the claimed subject matter with the closest prior art.
As such, the Examiner finds that the Declaration is insufficient to overcome the rejection of record and the rejection is maintained.
2. Claims 82 and 86-88 are rejected under 35 U.S.C. 103 as being unpatentable over DeVries et al. (US 2007/0286819, Dec. 13, 2007) (hereinafter DeVries) in view of Kumaran et al. (J. Chem. Pharm. Res., 2011, 3(3):169-175) (hereinafter Kumaran).
The teachings of DeVries are discussed above.
DeVries differs from the instant claims insofar as not disclosing wherein the weight of the solid dosage form is about 70 mg to about 90 mg.
However, Kumaran discloses that in orally disintegrating tablets, a small tablet weight can enhance absorption in the buccal area (Page 170, Paragraph 1).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have formulated DeVries’ dosage form to have a small tablet weight, such as about 70 mg to about 90 mg, motivated by the desire to enhance the absorption of the orally disintegrating tablet in the buccal area as taught by Kumaran.
Regarding dosages of ethinyl estradiol/norethindrone acetate recited in instant claims 86, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(A). As discussed above, DeVries’ dosage form may comprise about 0.5 μg to about 50 μg of ethinyl estradiol. Furthermore, DeVries’ dosage form preferably contains 0.3-1.5 mg norethindrone acetate. Accordingly, because dosages recited in the instant claim lie within the dosages disclosed by DeVries, the dosages disclosed by DeVries meet the instantly recited limitation.
Regarding instant claim 88 reciting capability to be dispensed from a blister pack, DeVries in view of Kumaran discloses substantially the same method as the instant claims comprising administering substantially the same dosage form containing ethinyl estradiol, which is administered in substantially the same forms using substantially the same administration routes. DeVries in view of Kumaran also discloses using ethinyl estradiol/norethindrone acetate with a dosage overlapping that of the instant claims and in an amount encompassed by the instant claims. Therefore, when solid dosage form of DeVries in view of Kumaran is used to make ethinyl estradiol orally disintegrating tablets, it would have been reasonable for one of ordinary skill in the art to conclude that the tablets of DeVries in view of Kumaran would have substantially the same property, capability to be dispensed from a blister pack, as the orodispersible dosage forms of the instant claims.
Response to Arguments
Regarding Applicant’s argument the Kumaran does not cure the alleged deficiencies of DeVries, the Examiner submits that Kumaran cures any alleged deficiencies of DeVries where Kumaran teaches that a small tablet weight for orally disintegrating tablets can enhance absorption in the buccal area thereby providing motivation for one of ordinary skill in the art to formulate their orally disintegrating tablets to have a smaller tablet weight.
In light of the foregoing, the Examiner does not find Applicant’s arguments to be persuasive and the rejection is maintained.
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 52-53, 67, and 74-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,178,824.
Although the claims at issue are not identical, they are not patentably distinct from each other because they both disclose an orodispersible solid dosage form that comprises ethinyl estradiol. The difference between the patented and instant claims lies in that the patented claims do not recite a method for oral contraception, but rather, only recite the orodispersible solid dosage form. However, it would have been obvious for one of ordinary skill in the art to have used the orodispersible solid dosage form of the patented claims in the method of the instant claims since they comprise the same active agent.
Response to Arguments
Regarding Applicant’s argument the claims of the ‘824 patent are related to a orodispersible solid dosage forms not a method of contraception, as discussed above, it would have been obvious for one of ordinary skill in the art to have used the dosage forms of the ‘824 patent in a method of contraception such as the one instantly claimed since they both comprise the same active agents. Furthermore, the dosage forms used utilize the actives in the same amounts and comprise the same weight. As such, one of ordinary skill in the art would reasonably expect the dosage forms of the ‘824 patent to be useable in a method of contraception.
Regarding Applicant’s argument about the non- statutory double patenting rejection in light of the restriction set forth the Office Action dated Jan. 30, 2025; the Examiner submits that lack of unity finding is based on the finding that the technical feature of claim 1, the composition claim, was not a special technical feature as it does not make a contribution over the prior art cited in that Office Action. The Office Action made the conclusion that the group of inventions did not form a single general inventive concept since, as discussed above, the shared technical feature was not a “special technical feature”. In other words, the Office Action dated Jan. 30, 2025 made a unity of invention analysis, not an independent and distinct analysis, since this is what is applicable in national stage applications submitted under 35 U.S.C. 371. See MPEP § 1893.03(d). Applicant made the election of Group II without traverse. As such, even though a restriction requirement was made this does not negate the fact that a non- statutory double patenting rejection is proper over the ‘824 patent.
In light of the foregoing, the Examiner does not find Applicant’s arguments to be persuasive and the rejection is maintained.
Conclusion
Claims 52-53, 67, and 74-88 are rejected.
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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/A.A./Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612