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 1-24 are pending.
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.
Claim(s) 1-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maclennan et al., Cochrane Database Syst Rev., 2004 Oct 18;2004(4):CD002978 in view of US 2003/0077297 (Chen et al.).
Maclennan et al. teaches the combined progesterone/estrogen as effective as estrogen alone in reducing hot flushes in postmenopausal women by the average of 77% (see page 10, col. 2, last two paragraphs).
Maclennan et al. does not expressly teach the administration of estradiol and progesterone and the dosages. Maclennan et al. does not expressly teach the herein claimed excipients. Maclennan et al. does not expressly teach the food consumption by the menopausal women. Maclennan et al. does not expressly teach the patient characteristics recited in the claims.
Chen et al. teaches a pharmaceutical formulation comprising one or more active agents that are fully solubilized (i.e., 100% solubilized), partially solubilized, or suspended in a vehicle (i.e., a solvent system) (Abstract) wherein the solvent system preferably comprises a triglyceride surfactant, including saturated polyglycolized glycerides such as Gelucire® 44/14 (i.e., lauroyl macrogol-32 glyceride or saturated polyglycolized glycerides) (para [0189], [0192], [0193], [0322], and Example 7 at para [0340]) as well as mono- and diglyceride surfactants such as Capmul® MCM (i.e., glyceryl caprylate/caprate) (para [0147] and Example 52 at para [0371]) and wherein the combination of progesterone and estradiol is used for hormone replacement therapy (para [0051]).
Chen et al. teaches the formulation wherein the hormone combination of estradiol and progesterone has a dosage strength preferably ranging from 0.5-2 mg of estradiol and 25-150 mg of progesterone [0366], including exemplary embodiments having 100 mg of progesterone [Examples 37 and 38] and 1 mg of estradiol (Examples 46 and 47), and that the amount of each can be modulated based on actual clinical need as well as other active agents in the composition (para [0366]; see also the examples at para [0360]).
Chen et al. further teaches the formulation wherein the hormones are suspended/solubilized in medium chain oils (e.g., Capryol® 90; Example 37 at [0358] and Example 43 at [0360]; [0362], including an embodiment where 1 mg of estradiol is solubilized in a liquid mixture (i.e., an amount sufficient to be substantially solubilized) containing Capryol® 90 (i.e., 100% of a monoglyceride ester of a caprylic acid) solubilizing agent (para [0362]).
Chen et al. teaches the formulation would reduce the effect of food on absorption and bioavailability of the active agent (see claim 142).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to employ estradiol and progesterone together, in the dosage herein claimed, to treat vasomotor symptoms in menopausal women. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to incorporate the herein claimed excipients and formulation of estradiol/progesterone to treat vasomotor symptoms. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to administer the composition with food.
One of ordinary skill in the art would have been motivated to employ estradiol and progesterone together, in the dosage herein claimed, to treat vasomotor symptoms in menopausal women. It is well-known the estrogen/progesterone combination as effective in treating hot flushes. Employing the 100mg of progesterone and 0.5-2 mg of estradiol in the method of treating hot flushes would be reasonably expected to be effective. As for the employment of 1mg of estradiol, the optimization of result effect parameters (e.g., dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since the dosage range taught in the cited prior art encompasses that of the instant claims, prima facie case of obviousness exists.
One of ordinary skill in the art would have been motivated to incorporate the herein claimed excipients and formulation of estradiol/progesterone to treat vasomotor symptoms. Employing the formulation and herein claimed excipients to deliver the actives (i.e., estradiol and progesterone) would be reasonably expected to impart beneficial effects such as solubilizing the hormonal actives.
One of ordinary skill in the art would have been motivated to administer the composition with food, because food won’t affect the absorption, therefore, regardless of whether the patients is taking the drug with food or not, the absorption and bioavailability will still be effective for treating hot flashes.
The examiner notes that the reduction of the hot flashes would be considered intrinsically present in the method of administering the estradiol/progesterone composition.
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 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over
Claims 1-20 of U.S. Patent No. 8,987,237;
Claims 1-18 of U.S. Patent No. 8,993,549;
Claims1-6 of U.S. Patent No. 8,633,178;
Claims 1-6 of U.S. Patent No. 8,993,548;
Claims 1-23 of U.S. Patent No. 10,639,375;
Claims 1-22 of U.S. Patent No. 11,529,360 ;
Claims 1-23 of U.S. Patent No. 11,166,963; or
Claims 1-30 of U.S. Patent No. 11,110,099;
in view of Chen et al. and Maclennan et al.
Each of the conflicting patents teaches a composition comprising estradiol and progesterone in the herein claimed excipients.
The conflicting patents do not teach the method of treating vasomotor symptoms. The conflicting patents do not teach the exact dosage of estradiol and progesterone.
Maclennan et al. teaches the combined progesterone/estrogen as effective as estrogen alone in reducing hot flushes in postmenopausal women by the average of 77% (see page 10, col. 2, last two paragraphs).
Chen et al. teaches the formulation wherein the hormone combination of estradiol and progesterone has a dosage strength preferably ranging from 0.5-2 mg of estradiol and 25-150 mg of progesterone [0366], including exemplary embodiments having 100 mg of progesterone [Examples 37 and 38] and 1 mg of estradiol (Examples 46 and 47), and that the amount of each can be modulated based on actual clinical need as well as other active agents in the composition (para [0366]; see also the examples at para [0360]).
Chen et al. further teaches the formulation wherein the hormones are suspended/solubilized in medium chain oils (e.g., Capryol® 90; Example 37 at [0358] and Example 43 at [0360]; [0362], including an embodiment where 1 mg of estradiol is solubilized in a liquid mixture (i.e., an amount sufficient to be substantially solubilized) containing Capryol® 90 (i.e., 100% of a monoglyceride ester of a caprylic acid) solubilizing agent (para [0362]).
Chen et al. teaches the formulation would reduce the effect of food on absorption and bioavailability of the active agent (see claim 142).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to employ the estradiol/progesterone composition in the method of treating hot flashes.
One of ordinary skill in the art would have been motivated to employ the estradiol/progesterone composition in the method of treating hot flashes. It is well-known the estrogen/progesterone combination as effective in treating hot flushes. Employing the 100mg of progesterone and 0.5-2 mg of estradiol in the method of treating hot flushes would be reasonably expected to be effective. As for the employment of 1mg of estradiol, the optimization of result effect parameters (e.g., dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The conflicting patents teach various range of the amounts to be in the composition, which encompass the herein claimed dosage of estradiol and progesterone. Prima facie case of obviousness exists in this case.
As for the food consumption in the patients, since food won’t affect the absorption, regardless of whether the patients is taking the drug with food or not, the absorption and bioavailability will still be effective for treating hot flashes.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over
Claims 1-20 of U.S. Patent No. 8,846,648;
Claims 1-15 of U.S. Patent No. 8,846,649;
Claims 5-12 of U.S. Patent No. 8,933,059;
Claims 1-14 of U.S. Patent No. 8,987,238;
Claims 1-12 of U.S. Patent No. 9,006,222;
Claims 1-13 of U.S. Patent No. 9,012,434;
Claims 1-18 of U.S. Patent No. 9,114,145;
Claims 1-15 of U.S. Patent No. 9,114,146;
Claims 1-14 of U.S. Patent No. 9,301,920;
Claims 1-20 of U.S. Patent No. 10,206,932;
Claims 1-16 of U.S. Patent No. 10,675,288; or
Claims 1-17 of U.S. Patent No. 10,806,740;
in view of Chen et al. and Maclennan et al.
Each of the conflicting patents teaches a method of treating menopausal symptoms by administering estrogen and progesterone together.
The conflicting patents do not expressly teach the method of treating vasomotor symptoms. The conflicting patents do not expressly teach the patients consuming food in the method. The conflicting patents do not expressly teach the exact excipients in the composition.
Maclennan et al. teaches the combined progesterone/estrogen as effective as estrogen alone in reducing hot flushes in postmenopausal women by the average of 77% (see page 10, col. 2, last two paragraphs).
Chen et al. teaches the formulation wherein the hormone combination of estradiol and progesterone has a dosage strength preferably ranging from 0.5-2 mg of estradiol and 25-150 mg of progesterone [0366], including exemplary embodiments having 100 mg of progesterone [Examples 37 and 38] and 1 mg of estradiol (Examples 46 and 47), and that the amount of each can be modulated based on actual clinical need as well as other active agents in the composition (para [0366]; see also the examples at para [0360]).
Chen et al. further teaches the formulation wherein the hormones are suspended/solubilized in medium chain oils (e.g., Capryol® 90; Example 37 at [0358] and Example 43 at [0360]; [0362], including an embodiment where 1 mg of estradiol is solubilized in a liquid mixture (i.e., an amount sufficient to be substantially solubilized) containing Capryol® 90 (i.e., 100% of a monoglyceride ester of a caprylic acid) solubilizing agent (para [0362]).
Chen et al. teaches the formulation would reduce the effect of food on absorption and bioavailability of the active agent (see claim 142).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to employ the estradiol/progesterone composition in the method of treating hot flashes.
One of ordinary skill in the art would have been motivated to employ the estradiol/progesterone composition in the method of treating hot flashes. It is well-known the estrogen/progesterone combination as effective in treating hot flushes. Employing the 100mg of progesterone and 0.5-2 mg of estradiol in the method of treating hot flushes would be reasonably expected to be effective. As for the employment of 1mg of estradiol, the optimization of result effect parameters (e.g., dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The conflicting patents teach various range of the amounts to be in the composition, which encompass the herein claimed dosage of estradiol and progesterone. Prima facie case of obviousness exists in this case.
As for the food consumption in the patients, since food won’t affect the absorption, regardless of whether the patients is taking the drug with food or not, the absorption and bioavailability will still be effective for treating hot flashes.
Claims 1-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of copending Application No. 19/028, 531 (‘531) in view of Maclennan et al.
‘531 teaches a method of treating menopausal symptoms by employing a composition of 1mg of estradiol and 100mg of progesterone with the herein claimed excipients (see for example claim 33).
‘531 does not expressly teach a method of treating vasomotor symptoms.
Maclennan et al. teaches the combined progesterone/estrogen as effective as estrogen alone in reducing hot flushes in postmenopausal women by the average of 77% (see page 10, col. 2, last two paragraphs).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the composition of ‘531 to treat vasomotor symptoms.
One of ordinary skill in the art would have been motivated to employ the composition of ‘531 to treat vasomotor symptoms. It is well-known the estrogen/progesterone combination as effective in treating hot flushes. Therefore, employing the 100mg of progesterone and 1 mg of estradiol in the method of treating hot flushes would be reasonably expected to be effective.
This is a provisional nonstatutory double patenting rejection.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAN MING R HUI/Primary Examiner, Art Unit 1627