Prosecution Insights
Last updated: April 19, 2026
Application No. 17/848,719

TREATMENT OF PAIN AND/OR PAIN RELATED SYMPTOMS ASSOCIATED WITH DYSMENORRHEA

Final Rejection §102§103§112§DP
Filed
Jun 24, 2022
Examiner
CRAIGO, WILLIAM A
Art Unit
1615
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Alyra Biotech Pty Ltd.
OA Round
2 (Final)
49%
Grant Probability
Moderate
3-4
OA Rounds
3y 4m
To Grant
88%
With Interview

Examiner Intelligence

Grants 49% of resolved cases
49%
Career Allow Rate
357 granted / 725 resolved
-10.8% vs TC avg
Strong +39% interview lift
Without
With
+38.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
55 currently pending
Career history
780
Total Applications
across all art units

Statute-Specific Performance

§101
1.4%
-38.6% vs TC avg
§103
40.2%
+0.2% vs TC avg
§102
14.5%
-25.5% vs TC avg
§112
22.5%
-17.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 725 resolved cases

Office Action

§102 §103 §112 §DP
DETAILED ACTION The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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. Status of the Claims The response and amendment filed 10/08/2025 are acknowledged. Claims 52-57 and 59-62 are pending. Claim 62 is new. Applicant’s election of amitriptyline as species of releasable agent that inhibits TLR4 in the reply filed on 04/03/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). After a search of the prior art, and in the interest of compact prosecution, the species election has been expanded to encompass progesterone as species of releasable agent that inhibits TLR4. Claims 52-57 and 59-62 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn. Withdrawn The rejection of claims 52-61 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention has been withdrawn because of Applicant’s amendment. Response to Arguments Applicant's arguments filed 10/08/2025 have been fully considered but they are not persuasive. Regarding the rejection of claims 52-57 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ramwell, US 3888975 as evidenced by Su, Immunology Letters, 125, 2009. The Office alleges that Ramwell teaches an intrauterine device for drug delivery at a controlled, continuous rate over a prolonged period of time comprising progesterone, which is said to be a TLR4 inhibitor (citing Su). Applicant argues Claim 52 specifies an agent that inhibits Toll-like receptor 4 (TLR4) and that reduces activation of the innate immune system. Applicant argues Ramwell describes an erodible intrauterine device for administering a drug locally into the uterus. Applicant argues the device is intended for delivery of pregnancy-interrupting drugs. Applicant argues the drug is included within a polymer which gradually erodes in the environment of the uterus and releases the drug at a controlled rate. Applicant argues the specification contemplates the preparation of an intrauterine insert containing progesterone but does not demonstrate that such a device is efficacious for inhibiting TLR4 or for activating the innate immune system. This argument is unpersuasive. The claimed invention requires an intrauterine device comprising a releasable agent that inhibits Toll like receptor 4 (TLR4). Ramwell teaches an intrauterine device comprising progesterone which is a releasable agent which inhibits toll like receptor 4 (TLR4) as evidenced by Su. As evident from Su, progesterone is efficacious for inhibiting TLR4 or for activating the innate immune system. Therefore, Ramwell’s intrauterine device meets every limitation of the invention required by claim 52. Applicant argues the Office cannot demonstrate that an allegedly anticipatory reference (e.g., Ramwell), teaches every element of a claim, the Office fails to establish anticipation unless the missing elements are necessarily present. Applicant argues the Office cites Su as evidence that progesterone is a TLR4 inhibitor. Applicant argues Su et al., (2009) teaches that progesterone inhibits the immune response to LPS (a TLR agonist) by modulating TLR signalling. However, Applicant argues Su et al. does not explicitly teach or establish that progesterone inhibits TLR4 or teach that progesterone reduces activation of the innate immune system. Thus, Applicant argues the standard for inherent anticipation ("necessarily present") has not been met, and the rejection should be withdrawn. This argument is unpersuasive. Su clearly states progesterone can significantly inhibit TLR4 (Su, e.g., Abstract). Su clearly states progesterone inhibits Toll-like receptor 4-mediated innate immune response (Su, e.g., Title). Ramwell’s intrauterine device meets every limitation of the invention required by claim 52 because progesterone has the recited functions including inhibiting TLR4 and inhibits innate immune response as claimed. Applicant further notes that Ramwell contemplates long-term release of an agent, but does not demonstrate a device that provided long-term release of progesterone in vivo. For this additional reason, Ramwell does not anticipate. This argument is unpersuasive. The subject matter of claim 52 is directed to a product rather than a method of use. Thus, the limitations of claim 52 if Ramwell teaches an intrauterine device having a releasable agent that inhibits toll like receptor 4. Ramwell’s device has all the structural detail required by claim 52. Therefore, Ramwell’s device, having the same structure is necessarily capable of the claimed properties. Moreover, Ramwell clearly teaches the device is capable of administering drug locally to the uterus at a controlled rate for a prolonged period of time (Ramwell, e.g., Abstract). Ramwell clearly teaches the device is capable of delivery at a continuous rate (Ramwell, e.g., c1:5-10). Regarding the rejection of claims 52-57 and 59-62 under 35 U.S.C. 103 as being unpatentable over Duesterberg, US 20170312219 A1 in view of Evans, Dysmenorrhea, Pelvic Pain, and Endometriosis; Guide to Pain Management in Low-Resource Settings, 2010, and Haapakumpu, US 20040247674. Applicant argues that at the time of the invention, amitriptyline was as an antidepressant with sedative effects, and it was approved for oral administration. Starting from Duesterberg, a person of ordinary skill would not have been motivated to consider other drugs beyond NSAIDs in combination with levonorgestrel, and would not have been motivated to add or substitute amitriptyline for intrauterine delivery. The art had not taught that these were equivalents suitable for substitution. This argument is unpersuasive. Prior to the filing date of the presently claimed invention, amitriptyline was not only known as an antidepressant. This fact is evident from Evans. Evans clearly teaches amitriptyline was known and used for treating pain, specifically in the context of dysmenorrhea. In fact, Evans teaches NSAIDS and amitriptyline were each used together for treating pain, specifically in the context of dysmenorrhea (Evans, e.g., pg. 229, c1 What are the treatment options). Evans clearly teaches amitriptyline was known and used as a neuropathic pain medication (Evans, e.g., pg. 231, c2: How can I treat sharp, stabbing pains). Applicant argues there is nothing in Duesterberg that would direct or motivate the skilled person to include a TLR4 inhibitor (e.g. amitriptyline) on an intrauterine device. Applicant argues Evans is a book chapter discussing a case study of a 25-year-old female with pelvic pain around the time of her period. Applicant argues that on page 230, Evans states that the pain medication of first choice should be an NSAID taken early on in the episode of pain. Applicant argues with respect to mention of amitriptyline, the document suggests prescribing amitriptyline at 5-25mg at night for treating vulval pain. Applicant argues a person of ordinary skill would have understood that the dose is delivered orally and is not a long-term dosage. Applicant argues the document describes that amitriptyline could be prescribed for stabbing pains and bladder symptoms. Applicant argues this would not signal to the skilled person that amitriptyline should be prescribed, especially when the document is read as a whole recommending that the first choice of treatment is NSAIDs. Applicant argues that at most, the document is a suggestion that oral amitriptyline could be tried, but only after taking an NSAID (see page 231, left column). This argument is unpersuasive. Duesterberg clearly teaches an intrauterine device comprising NSAIDS, not only for reduced bleeding, but also for symptoms associated with dysmenorrhea and premenstrual symptoms (Duesterberg, e.g., 0023). Dysmenorrhea is pain associated with menstruation (Evans, e.g., pg. 230: How can I treat prolonged dysmenorrhea). Duesterberg clearly teaches wherein the NSAID is ibuprophen (Duesterberg, e.g., claim 15). This is the same NSAID reported in Evans for use with amitriptyline (Evans, e.g., pg. 230, c2 How can I treat dysmenorrhea on day 1-2 of the menstrual cycle). Therefore, Evans establishes that both NSAIDs such as ibuprophen, and neuropathic pain medications such as amitriptyline were each known and used for treating pain in female patients suffering from dysmenorrhea and may even be used together. Duesterberg had already proposed the technique of locating an orally effective pain medication (Duesterberg, e.g., 0008: drugs used in the therapy, mostly administered orally, consist of compounds reducing menstrual bleeding such as anti-fibrinolytic agents, non-steroidal anti-inflammatory drugs) on an intrauterine device for local administration, e.g., an NSAID such as ibuprophen, for continuous and prolonged therapeutic effectiveness (Duesterberg, e.g., claim 1). Drugs may be administered locally (via intrauterine device) at a much lower dose than needed for systemic administration orally (Duesterberg, e.g., 0074). Since Duesterberg teaches NSAIDS may be located on an intrauterine device for prolonged and continuous release, and this technique is effective for treating acute pain which occurs intermittently, e.g., dysmenorrhea - which is pain present during menstruation, the skilled artisan would have understood from Duesterberg that not only are orally administered pain medications effective when located on an intrauterine device, but they are effective for administration at much lower doses, and the lower effective dose means they can be administered continuously even for intermittent pain, e.g., which occurs only during menstruation (dysmenorrhea) in a safe manner. Applicant argues Haapakumpu teaches a variety of delivery systems including an implant, an intrauterine system, an intracervical system and intravaginal system (see paragraph [0016]). Applicant argues the document suggests myriad different therapeutically active agents that may be incorporated into the system. Applicant acknowledges that Paragraph [0085] mentions amitriptyline, but in the context of its known use as an antidepressant. (See 0085, "Antidepressants including ...."). Applicant argues Haapakumpu lists more than 100 categories of therapeutic agents spanning all variety of indications, with many of the categories (including antidepressants) having multiple examples listed. (See Haapakumpu paragraphs 0066- 0147, spanning seven columns of text. Applicant argues the Office was able to select amitriptyline for its rejection with the benefit of hindsight knowledge of the present invention, but a person of ordinary skill would not have had this benefit, and would not have made this selection when looking for a way to improve upon Duesterberg. This argument is unpersuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, Haapakumpu was not the only reference cited which teaches amitriptyline. Evans clearly teaches amitriptyline was known and used for treating pain, specifically in the context of dysmenorrhea. In fact, Evans teaches NSAIDS and amitriptyline were each used together for treating pain, specifically in the context of dysmenorrhea (Evans, e.g., pg. 229, c1 What are the treatment options). Evans clearly teaches amitriptyline was known and used as a neuropathic pain medication (Evans, e.g., pg. 231, c2: How can I treat sharp, stabbing pains). Haapakumpu teaches intrauterine delivery systems like those of Duesterberg, which devices may be modified for release of any of a variety of therapeutically active agents including, inter alia, amitriptyline (Haapakumpu, e.g., 0085). Said devices may be modified to incorporate multiple active agents for continuous long term intrauterine delivery, e.g., three active agents (Haapakumpu, e.g., 0165) Thus, Haapakumpu was cited for teaching the known technique of formulating multiple drugs on an intrauterine device, including inter alia, amitriptyline (Haapakumpu, e.g., 0085). Haapakumpu would have informed the skilled artisan that formulating amitriptyline on an intrauterine device was likely to be met with success. Moreover, Haapakumpu would have provided the skilled artisan techniques known for formulating multiple drugs on an intrauterine device with a reasonable expectation of success. Applicant’s argument that Haapakumpu provides no enabling disclosure of an intrauterine device comprising amitriptyline is unpersuasive since Haapakumpu clearly names amitriptyline and since Haapakumpu clearly suggests amitriptyline may be formulated on an intrauterine device in a manner similar to other known analgesics, e.g., NSAIDS, such as ibuprophen (Haapakumpu, e.g., 0079). Applicant’s argument that Haapakumpu relates to multiple delivery systems and all of Haapakumpu's examples are directed to implants is unpersuasive. It is agreed that Haapakumpu teaches a number of specific devices which are useful as, or part of, an intrauterine delivery device (Figs. And example 1). For example, Fig. 2 referenced in Haapakumpu, e.g., example 1, e.g., 0172, may be part of an intrauterine device (Haapakumpu, e.g., 0163). Double Patenting Applicant has argued the cited claims cannot be cited in a double patenting rejection since the claims have not issued as a patent. Applicant argues the deficiencies of Duesterberg as a reference. These arguments are unpersuasive. It is acknowledged that the copending application has not issued as a patent and the current Application under examination here has an earlier filing date. Thus, if the double patenting rejection is the only rejection remaining in the current application, and the co-pending application has not been issued, the current rejection could be withdrawn. However, the double patenting rejection is not the only rejection remaining in the current application. Therefore, the rejection is maintained. Duesterberg was cited for teaching an intrauterine device further comprising levonorgestrel. Thus, Duesterberg cures any deficiency in the subject matter of the reference claims with respect to claims 59-60. Rejections Addressing Applicant’s Amendment Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 61 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 61 does not require a releasable sex hormone since the claim appear to be satisfied with the release of other agents which are not sex hormones. The sex hormone is recited in claim 61 as an option rather than a requirement. Therefore, claim 61 does not include all of the limitations of claim 59 from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 52-57 remain rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ramwell, US 3888975 as evidenced by Su, Immunology Letters, 125, 2009. Ramwell teaches an intrauterine device for drug delivery at a controlled, continuous rate, over a prolonged period of time (Ramwell, e.g., c1:5-10) comprising progesterone (Ramwell, e.g., c16: example 1). Progesterone is a TLR4 inhibitor as evidenced by Su. See Su, e.g., Abstract. TLR4 inhibitors are able to achieve the intended results recited in claims 53-56 and 58. Claim 57 refers to an intended use of the device. The recited range reads on zero. Ramwell’s device is capable of being used in the manner recited in claim 57 because, e.g., it is intended to release drugs locally in the uterus over prolonged periods of time (Ramwell, e.g., c15:45-67). Ramwell’s device is clearly capable of releasing no progesterone, e.g., when not in a patient. Ramwell anticipates the subject matter of instant claims 52-58 as evidenced by Su. 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 of this title, 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. Claims 52-57 and 59-62 are rejected under 35 U.S.C. 103 as being unpatentable over Duesterberg, US 20170312219 A1 in view of Evans, Dysmenorrhea, Pelvic Pain, and Endometriosis; Guide to Pain Management in Low-Resource Settings, 2010, and Haapakumpu, US 20040247674. Duesterberg teaches an intrauterine delivery system comprising controlled release levonorgestrel and a sufficient amount of NSAID (Duesterberg, e.g., Abstract, claims). The delivery system is useful for reducing dysmenorrhea and premenstrual symptoms (Duesterberg, e.g., 0023). The device may be modified with additional agents which are used systemically at lower doses (Duesterberg, e.g., 0070-0074). Duesterberg does not expressly teach the intrauterine delivery system comprising amitriptyline. However, amitriptyline was known and used for reducing pain associated with dysmenorrhea as evident from Evans. Evans teaches pain control may require treatment for different types of pain and treatment options include the use of amitriptyline starting at 10 mg (Evans, e.g., pg. 229:c1) or amitriptyline 5-25 mg (Evans, e.g., pg. 231, c1-c2 for sharp stabbing pains, pg. 232, c1 for painful vulva). Evans does not expressly teach an intrauterine device comprising amitriptyline. However, Evans clearly teaches amitriptyline may be systemically administered in combination with an intrauterine device which continuously releases levonorgestrel (Evans, e.g., pg. 229, What are the treatment options?) for the purpose of treating pelvic pain and dysmenorrhea. Haapakumpu teaches intrauterine delivery systems like those of Duesterberg, which devices may be modified for release of any of a variety of therapeutically active agents including, inter alia, amitriptyline (Haapakumpu, e.g., 0085). Said devices may be modified to incorporate multiple active agents for continuous long term intrauterine delivery, e.g., three active agents (Haapakumpu, e.g., 0165) It would have been obvious before the effective filing date of the presently claimed invention to modify an intrauterine device comprising levonorgestrel and an NSAID as understood from Duesterberg by incorporating amitriptyline with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification for improved treatment of dysmenorrhea as suggested by Evans. The skilled artisan would have seen this modification as a combination of active agents expressly known in the prior art for treating the same patients, e.g., those having dysmenorrhea, by modifying a known delivery device for treating the same patients having dysmenorrhea to achieve predictable results. The skilled artisan would have had a reasonable expectation of success because Duesterberg suggests intrauterine devices may incorporate active agents typically administered systemically for intrauterine release at lower doses and because Haapakumpu suggests amitriptyline may be incorporated in intrauterine delivery devices. Amitriptyline is a TLR4 inhibitor as evidenced by the present application and Applicant’s species election. TLR4 inhibitors are able to achieve the intended results recited in claims 53-56 and 58. Claim 57 refers to an intended use of the device. The recited range reads on zero. Haapakumpu teaches release of active agent may range from 0.1 to 300 micrograms per day (Haapakumpu, e.g., 0030). This range provides the skilled artisan a workable range within which to optimize dosing from the device for active agents. Moreover, Evans teaches amitriptyline at a starting dose of 5 mg, and Duesterberg teaches lower doses of systemically administered drugs are effective when administered directly to the uterus. There was ample guidance in the prior art of record allowing the skilled artisan to optimize the release rate of amitriptyline from an intrauterine delivery device to effectively treat dysmenorrhea before the effective filing date of the presently claimed invention. The claimed range overlaps with the range suggested by the prior art. In the case where the claimed ranges “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). MPEP 2144.05. Accordingly, the subject matter of claims 52-57 and 59-62 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. Claim(s) 52-57 and 59-62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 4, 10-14, 31, and 47 of US 17614993 in view of Duesterberg, US 20170312219 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because: The reference application claims an intrauterine device (claim 31) comprising amitriptyline which is useful for treating premenstrual syndrome (claim 1). The claims further encompass intrauterine administration of a sex hormone and/or agent which modulates production and/or activity of a sex hormone (claim 12). The reference application claims do not expressly teach the sex hormone and/or agent which modulates production and/or activity of a sex hormone present on the intrauterine delivery device and is levonorgestrel. However, this defect is cured by the teachings of Duesterberg enumerated above. It would have been obvious before the effective filing date of the presently claimed invention to modify an intrauterine delivery device comprising amitriptyline as claimed by the reference application by including levonorgestrel for continuous delivery as known from Duesterberg with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification because Duesterberg teaches levonorgestrel may be incorporated on intrauterine delivery devices for local delivery to the uterus for effective treatment of premenstrual symptoms including dysmenorrhea. Accordingly, the subject matter of claims 52-57 and 59-62 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary. Conclusion No claim is allowed. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /WILLIAM CRAIGO/Examiner, Art Unit 1615 /Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Read full office action

Prosecution Timeline

Jun 24, 2022
Application Filed
Jul 03, 2025
Non-Final Rejection — §102, §103, §112
Oct 08, 2025
Response Filed
Oct 29, 2025
Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
49%
Grant Probability
88%
With Interview (+38.9%)
3y 4m
Median Time to Grant
Moderate
PTA Risk
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