DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Election/Restriction
Applicant’s election without traverse of MIGLYOL® 812, GELUCIRE® 44/14, and butylated hydroxy toluene in the reply filed on 6 July 2026, is acknowledged.
Status of Claims
Claims 1-20 are pending in the instant Office Action.
Claims 2-3 and 7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Specifically, claims 2-3 recite embodiments in which the solubilizing agent comprises mono- and di-esters of glycerol and a C6-12 fatty acid which are not equivalent to the elected tri-ester of glycerol with caprylic and capric fatty acids and claim 7 recites embodiments in which the nonionic surfactant is caprylocaproyl macrogol-8 glyceride EP which is not equivalent to the elected lauroyl polyoxyl-32 glycerides. Election was made without traverse in the reply filed on 6 July 2026.
Claims 1, 4-6, and 8-20 are under consideration in the instant Office Action, to the extent of the following elected species:
the specific solubilizing agent is triglycerides of caprylic (C8) and capric (C10) fatty acids (elected as MIGLYOL® 812, see instant spec. para. [0144]);
the specific nonionic surfactant lauroyl polyoxyl-32 glycerides (elected as GELUCIRE® 44/14); and
the specific antioxidant butylated hydroxy toluene.
NOTE: Applicant has elected MIGLYOL® 812 and GELUCIRE® 44/14, each of which are trademarks. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. While Applicant has not recited the trademarks in the instant claims, should Applicant amend the claims, care should be taken not to limit the claims with a trade mark or name as this does not comply with the requirements of 35 U.S.C. § 112(b) (see MPEP § 2173.05(u)).
Drawings
The drawings are objected to because Sheets 7-10 have illegible y-axes and the data points are too low resolution to distinguish data sets. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 5-6, 13-14, and 18 are objected to for the following informalities:
Claims 1, 5-6, 13-14, and 18 are objected to for reciting both “nonionic” and “non-ionic” surfactants. To improve consistency, the claims should be amended to recite only “nonionic” as in claims 1 and 5-6 or “non-ionic” as in claims 13-14 and 18.
Claims 13-14 lack the conjunction “and” at the end of the list each claim recites. The word “and” should be inserted after “composition,” in the third line of each claim.
Applicant is advised that should claim 5 be found allowable, claim 6 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof because “lauroyl polyoxyl-32 glycerides” and “lauroyl macrogol-32 EP” refer to the same species (see Gelucire® 44-14 Fact Sheet from manufacturer Gattefossé). Applicant is also advised that should claim 13 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Appropriate correction is required.
Claim Interpretation
Claim 1 recites the solubilizing agent to comprise “predominantly” C6-12 fatty acid tri-esters of glycerol. The instant spec. discloses in para. [0018] that “predominantly” means “>50 wt %” and Applicant has elected triglycerides of caprylic (C8) and capric (C10) fatty acids, described as MIGLYOL® 812, as the solubilizing agent. Therefore claim 1, as well as claims 4-5 and 8-20 which depend from claim 1, are interpreted as comprising >50% w/w triglycerides of caprylic (C8) and capric (C10) fatty acids as the solubilizing agent.
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.
Claims 1, 4-6, and 8-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (U.S. Patent No. 7,374,779 B2, priority to 11 February 2002, hereafter referred to as Chen).
Chen teaches pharmaceutical formulations and systems for delivery of active agents (Abstract). The formulations comprise a first fraction of an active agent suspended in a vehicle and a second fraction of an active agent solubilized in the vehicle, with the suspended fraction representing 5-80% w/w of the active agent and the solubilized fraction representing 20-95% w/w of the active agent (Abstract and col. 4, lines 24-33). The vehicle is taught to comprise a hydrophilic surfactant, a lipophilic surfactant, a triglyceride, and/or a solubilizer (Abstract, col. 4, lines 33-37, and col. 9, lines 1-5). Chen further teaches their formulations may be in the form of capsules and are preferentially administered orally, which is considered equivalent to the pharmaceutical composition for oral administration recited in instant claims 1 (col. 5, lines 11-25). The capsules are taught to preferably be hard or soft gelatin capsules (col. 48, lines 5-23).
The active agent in the formulations is taught in some embodiments to be the sex hormone progesterone (col. 10, lines 14-54, Examples 37-42 and 44-47, and claims 53-54, 57-58, 120-121, and 124-125), which may be micronized, dispensed in a suspension, and/or solubilized (Example 37). A combination of lipophilic surfactants and triglycerides is taught to be advantageous (col. 21, lines 10-12) and a preferred commercial product comprising surfactants and triglycerides is taught to be Gelucire® 44/14 (col. 44, lines 28-35, col. 45 lines 4-5 and 8-16, and Example 7). Another commercial product comprising triglycerides included in the formulations of Chen is Miglyol® 812 (Examples 4, 41, and 54). The surfactants, triglycerides, and/or solubilizers are taught to be present in an amount from 0.5-100% w/w (col. 46, lines 19-23), with specific examples taught including Example 41 which comprises ~83% w/w Miglyol® 812 and Example 54 which comprises ~55% w/w Miglyol® 812.
Chen also teaches that stabilizing agents may be included in their formulations to increase stability and/or compatibility, that an example of a suitable stabilizing agent is an antioxidant, and that an example of an antioxidant suitable for their formulations is butylated hydroxytoluene (BHT) (col. 56, line 63 - col. 57, line 1 and col. 65, lines 33-36). In Example 46 Chen teaches a composition comprising 75 mg Progesterone in a composition with a total mass of 406 mg. Finally, while Chen does not teach a specific range of masses of progesterone in their compositions, Chen does teach that when fenofibrate is the active agent, the mass of the active agent in the composition may be 10-200 mg in a gelatin capsule (col. 70, lines 56-62).
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). These guidelines apply to the quantities of progesterone and ranges of quantities of progesterone, Gelucire® 44/14, and Miglyol® 812 taught by Chen. In each instance, the quantity taught by Chen falls within the claimed ranges or the ranges taught by Chen encompass the quantities or ranges of quantities claimed in the instant claims.
Chen does not teach the specific percent amounts recited in instant claims 13-14. However, the optimization of a result effective parameter, in this instance the percent composition of progesterone, Gelucire® 44/14, and Miglyol® 812, is considered to be within the skill of a person of ordinary skill in the art. See MPEP § 2144.05.II. “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.” KSR International Co. v. Teleflex Inc., 550 U.S. at 421, 82 USPQ2d at 1397. Chen teaches a range of quantities of progesterone, commercial products comprising surfactants and triglycerides, which in one embodiment is Gelucire® 44/14, and commercial products comprising triglycerides, which in one embodiment may be Miglyol® 812 (vide supra). Chen teaches that the amounts of progesterone (Examples 49-50) and surfactants, triglycerides, and/or solubilizers (col. 46, lines 7-38) are result effective, therefore optimization of the percent composition of the formulations would be motivated. The ordinary artisan would have reason to pursue the known options within the ranges taught by Chen and the recited quantities are therefore also obvious.
Although “picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference...has no place in...a 102, anticipation rejection,” picking and choosing may be entirely proper in an obviousness rejection. In re Arkley, 455 F.2d 586, 587 (CCPA 1972). Addressing the issue of obviousness, the Supreme Court noted that analysis under 35 U.S.C. 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ” (KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007)). The Court further emphasized that “[a] person of ordinary skill is…a person of ordinary creativity, not an automaton” (Id. at 1742).
The only difference between Chen and the instant claims is that Chen does not teach the specific combination of components as claimed in a single embodiment (e.g., a composition comprising progesterone, Gelucire® 44/14, and Miglyol® 812 in the recited quantities and the antioxidant BHT), or with sufficient specificity to be anticipatory. The specific combination of features claimed is disclosed within the teaching of Chen, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Where, as here, the reference does not provide any explicit motivation to select this specific combination of variables, anticipation cannot be found. However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” See MPEP § 2141.I. Consistent with this reasoning, it would have been prima facie obvious to a person having ordinary skill in the art, prior to the effective filing date of the instant application, to have selected various combinations of the various disclosed ingredients from within the teachings of Chen, to arrive at an invention such as the one being sought.
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, 4-6, and 8-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent Nos. 8,633,178, 8,846,648, 8,846,649, 8,987,238, 8,987,237, 8,987,238, 8,933,059, 8,993,548, 8,993,549, 9,006,222, 9,012,434, 9,114,145, 9,114,146, 9,248,136, 9,301,920, 10,052,386, 10,471,148, 10,639,375, 10,675,288, 11,033,626, 11,103,516, 11,110,099, 11,166,963, 11,529,360, 11,793,819, and 11,865,179.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of each patent also recite a pharmaceutical composition comprising a mixture of progesterone, a triglyceride ester of a C6-12 oil, and a nonionic surfactant as recited in the instant claims. The optimization of the quantities of components and the selection of carriers/excipients well known in the art for their known purpose would have been within the capabilities of a person of ordinary skill in the art.
Claims 1, 4-6, and 8-20 are directed to an invention not patentably distinct from the claims of commonly assigned U.S. Patent Nos. 8,633,178, 8,846,648, 8,846,649, 8,987,238, 8,987,237, 8,987,238, 8,933,059, 8,993,548, 8,993,549, 9,006,222, 9,012,434, 9,114,145, 9,114,146, 9,248,136, 9,301,920, 10,052,386, 10,471,148, 10,639,375, 10,675,288, 11,033,626, 11,103,516, 11,110,099, 11,166,963, 11,529,360, 11,793,819, and 11,865,179. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent Nos. 8,633,178, 8,846,648, 8,846,649, 8,987,238, 8,987,237, 8,987,238, 8,933,059, 8,993,548, 8,993,549, 9,006,222, 9,012,434, 9,114,145, 9,114,146, 9,248,136, 9,301,920, 10,052,386, 10,471,148, 10,639,375, 10,675,288, 11,033,626, 11,103,516, 11,110,099, 11,166,963, 11,529,360, 11,793,819, and 11,865,179, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fernandez et al. (Biochim. et Biophys. Acta 2008, 1781, 367.) teach the mechanism via which Gelucire® 44/14 aids oral delivery of poorly water-soluble drugs (Abstract). Particularly relevant to the instant application, Fernandez et al. teach that Gelucire® 44/14 increases the bioavailability of numerous drugs including the sex hormone 17-b estradiol (pg. 368, left col., para. 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sean J. Steinke, Ph.D., whose telephone number is (571) 272-3396. The examiner can normally be reached Mon. - Fri., 09:00 - 17:00 ET.
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/S.J.S./
Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
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