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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 11/13/2025 is acknowledged. The applicant also elected iron as the additional component and iron and vitamin C as the combined additional components on 12/02/2025. The traversal is on the ground(s) that the applicant believes that since the inventions are of the same classification that they should be searched together. This is not found persuasive because the inventions are separate and distinct as previously pointed out in the election/restriction. The inventions would require different search queries to properly search each invention. The applicant has amended the claims to be within the same group which was elected and thus those claims will be searched and examined.
The requirement is still deemed proper and is therefore made FINAL.
Claims 26-51 are being examined on the merits.
Priority
The priority date is the filing date of the instant application, October 5, 2023.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on March 13, 2025 and September 4, 2025 are being considered by the examiner. The signed IDS forms are attached with the instant office action.
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.
Claims 26-27, 29, 32-51 are rejected under 35 U.S.C. 103 as being unpatentable over Linda French (Dysmenorrhea, American Family Physician, January 15, 2005, Volume 71, Number 2, pg 285-291).
Regarding claims 26-27, French teaches “Nonsteroidal anti-inflammatory drugs (NSAIDs) are the best-established initial therapy for dysmenorrhea.19 They have a direct analgesic effect through inhibition of prostaglandin synthesis, and they decrease the volume of menstrual flow. These effects probably are common to all NSAIDs” (see NSAIDS, page 287).
French teaches that naproxen at 500-550 mg twice daily is an effective amount (see Table 3).
French also teaches “a single RCT of vitamin E found that 2,500 IU taken daily for five days starting two days before menstruation was more effective than placebo in treating dysmenorrhea.” (see page 289, 1st para.).
“In women who do not desire hormonal contraception, topical heat; TSS; thiamine, vitamin E, or fish oil supplements; a low-fat vegetarian diet; and acupressure are relatively simple and inexpensive alternatives that can be used alone or in combination” (see page 290, 1st para.).
French does not specifically teach providing a combination of each two components however, French discloses wherein each are beneficial for treating dysmenorrhea.
Therefore it would have been obvious to persons having ordinary skill in the art and before the effective filing date to provide a combination of an effective amount of naproxen; and vitamin E and to administer the combination beginning before an onset of menstruation because French teaches each of these components to help treat dysmenorrhea and before the onset of menstruation.
It would have also been obvious to administer acetaminophen as this drug is common and conventionally given for pain relief and to use blister packaging as a pharmaceutical packaging as this is also a common and conventionally package form in the art.
It would have also been obvious to administer the combination at least once a day, twice a day, more than one day before onset of menstruation, administering a plurality of doses, administering one dose being a first dose higher than a subsequent does of the plurality of doses and to administer the naproxen in amounts at least in the amounts claimed because French already teaches treating before menstruation and administering multiple doses a day. Optimizing a dosage amount is well with the purview of any skilled artisan especially given that that treatments effects are known. As discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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 references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Linda French (Dysmenorrhea, American Family Physician, January 15, 2005, Volume 71, Number 2, p 285-291) as applied to claims 26-27, 29, 32-51 above, and further in view of A J Davies et. al. (Reduction by naproxen of excessive menstrual bleeding in women using intrauterine devices, Clinical Trial, Obstet Gynecol, 1981 Jan;57(1):74-8).
French teaches treating menstruation related symptoms by providing effective amounts of naproxen and vitamin E, however is silent on the treatment being for menorrhagia.
Davies teaches in a clinical trial for patients using intrauterine contraceptive devices and experiencing excessive menstrual bleeding, low- and high- dose naproxen reduced menstrual blood loss by 22% and 32% respectively, whereas the change with placebo was minimal. Although the dose had no significant effect on mean menstrual loss, the number of treatment cycles in which menstrual blood loss was reduced by 50% as compared with pretreatment cycles strongly suggested a dose response (see abstract).
Therefore it would have been obvious to persons having ordinary skill in the art and before the effective filing date to also provide the method taught by French for treating menorrhagia because Davies teaches naproxen can reduce blood loss and optimizing the amount of naproxen would be obvious as there may appear to be a dose response for the number of treatment cycles in which blood loss was reduced by 50%.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Linda French (Dysmenorrhea, American Family Physician, January 15, 2005, Volume 71, Number 2, pg 285-291) as applied to claims 26-27, 29, 32-51 above, and further in view of Arvidsson et. al. (Abstract: Iron prophylaxis in menorrhagia, Acta Obstet Gynecol Scan. 1981;60(2):157-60).
French teaches treating menstruation related symptoms by providing effective amounts of naproxen and vitamin e, however is silent on the treatment comprising iron.
Arvidsson teaches “heavy menstrual bleedings frequently lead to iron deficiency. Iron supplementation is usually given to cover the increased losses. In the present study one tablet containing 100 mg of iron (Duroferon R, Durules R) was given daily for 10 days in connection with the menstrual period in 15 women with menorrhagia. The tablets contained 59 Felabelled FeSO4 and the total absorption was measured in a whole-body counter. The mean menstrual blood loss was 117 ml (range 46-259 ml), corresponding to 53 mg of iron (range 21-117 mg). The mean absorption was 81 mg (range 49-145 mg). Individually, 14 of 15 subjects absorbed more iron from the tablets than was lost by the menstrual bleedings. Thus, the iron prophylaxis as applied in the present study seems to be sufficient in most women with menorrhagia” (see abstract).
Therefore it would have been obvious to persons having ordinary skill in the art and before the effective filing date to also provide iron in a method of reducing menstruation relate symptoms because as Arvidsson teaches heavy menstrual bleeding often leads to iron deficiency and iron supplementation is sufficient to treat menorrhagia.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over French (Dysmenorrhea, American Family Physician, January 15, 2005, Volume 71, Number 2, p 285-291) as applied to claims 26-27, 29, 32-51 above, and further in view of James Deeny, (Vitamin C and the Menstrual Function, Ulster Med J, 1940 Oct;9(2):117-122, 123-124).
French teaches treating menstruation related symptoms by providing effective amounts of naproxen and vitamin e, however is silent on the treatment comprising vitamin C.
Deeny teaches Vitamin C also plays a part in regulating the level of hemoglobin in the blood, and it might be postulated that those who exist on a diet deficient in iron are also likely to be deficient in vitamin C, which will result in anemia (see page 117, last para.). Deeny also teaches of improvements of women who were suffering from menorrhagia were given vitamin C and wherein there was diminution in the duration of menstrual periods and an increase in hemoglobin (see summary pages 1233-124).
Therefore it would have been obvious to persons having ordinary skill in the art and before the effective filing date to also provide vitamin C in a treatment for menstrual symptoms because as Deeny teaches it can reduce duration of menstrual periods and an increase in hemoglobin.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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, Terry McKelvey can be reached at 571-272-0775. 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.
JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655