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 .
Status of the Application
The Art Unit location of your application in the USPTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Art Unit 1675, Examiner Christina Borgeest.
Election/Restrictions
Applicant's election with traverse of Group I (claims 16-21, 25 and 28-30) in the reply filed on 09/26/2025 is acknowledged. The traversal is on the grounds that (1) Vuong et al. do not teach or suggest a controlled ovarian stimulation protocol and (2) claim 16 links Groups I-III. While Applicant’s argument concerning the teachings of Vuong and colleagues are not persuasive, it is persuasive that claim 16 links Groups I-III. Thus, the restriction requirement mailed 07/28/2025 is hereby vacated.
In view of the withdrawal of the restriction requirement, Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 16-25 and 28-30 are under examination.
Claim Interpretation
Claim 23 recites the method of claim 16, further comprising triggering final follicular maturation by administering human chorionic gonadotropin (hCG) or a gonadotropin-releasing hormone agonist (GnRH agonist), optionally supplemented with hCG. The claim is interpreted as reading upon the following embodiments:
triggering final follicular maturation by administering hCG; or
triggering final follicular maturation by administering GnRH agonist; or
triggering final follicular maturation by administering hCG and a GnRH agonist.
Claim Objections
Claim 1 is objected to because of the following informalities. The term “polycystic ovarian syndrome” should be spelled out followed by the abbreviation, “PCOS”, in parentheses as is done with AMH and HP-hMG.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-25 and 28-30 are rejected 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
(i) Claim 16, line 5 recites “having a serum [AMH] level 35.7 ± 0.5 pmol/L (≥ 5.0 ± 0.2 ng/ml)”, which is vague, because there is no relational operator preceding “35.7”. According to the specification the symbol “≥” should precede “35.7” (see p. 3, line 19).
(ii) Claims 17 and 30 recite hormone levels “prior to treatment/stimulation”, which is vague because it is not clear whether the phrase is referring to baseline characteristics prior to controlled ovarian stimulation (COS) or on the day of hCG stimulation of final follicle maturation to trigger ovulation (see p. 17, lines 10-19 of the instant specification). Further, rendering the meaning unclear is that claim 16, from which claims 17, 22 and 30 depend, recite “prior to treatment”. Thus claims 17, 22 and 30 also lack antecedent basis for “treatment/stimulation”.
(iii) Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation. Regarding claim 24, the phrase “e.g.” (exempli gratia) in lines 4, 8, 13 and 18 means “for example”, which renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 24 also recites “optionally” in lines 3, 4, 7, 12, 13 and 17. The term “optionally” requires some analysis before concluding whether or not the language is indefinite. The phrase “implanting a fresh blastocyst (optionally selected based on, e.g…” in part (a), line 4 and part (c), line 13 is indefinite because in the context of the phrase and in combination with the “e.g.”, it reads upon exemplary language. In contrast, in parts (b)-(d), the phrase “optionally assessing chromosomal quality of the blastocyst(s)” reads upon a method step that can be performed or skipped, and is therefore clear.
Claims 17-25 and 28-30 are also included in this rejection for depending upon an indefinite claim without resolving the indefiniteness.
Notice for all US Patent Applications filed on or after March 16, 2013: 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.
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.
Claims 16-25 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Arce (US2016/0250296) in view of Spieth et al. (Neuropsychiatric Disease and Treatment 2016:12 1341-1349), Zhu et al. (Medicine (2016) 95:28(e4193)) and Tal et al. (American Journal of Obstetrics and Gynecology, 2014; 211: 59.e1-59.e8). The first factor to consider when making a rejection under 35 U.S.C. 103(a) is to determine the scope and contents of the prior art. Arce teaches an assisted reproductive technology protocol “for women at risk of a high response to controlled ovarian stimulation [COS], comprising administering an amount of highly purified menotropin (HP-hMG) effective to stimulate follicle development to a woman selected as being at risk of a high ovarian response to controlled ovarian stimulation, wherein the selected woman has a serum anti-Mullerian hormone (AMH) level greater than or equal to 5.0±0.5 ng/ml” (see paragraph [0010] and claim 1), thereby teaching limitations in claim 16. Arce reports baseline patient characteristics in those patients with ≥ 5.2 ng/ml AMH, including estradiol, is higher than 145 pmol/L (see Table 1 at paragraph [0089]), thereby teaching the limitations of claims 17 and 30.
Arce contemplates administering HP-hMG “at a dose of from about 75 IU or 100 IU to about 300 IU/day, or from about 100 to about 200 IU/day, for from about 1 to about 20 days, such as for at least 5 days” and that “a starting dose is 150 IU/day for the first 5 days, which may be adjusted thereafter” (see claims 14-15 and paragraph [0042]), thereby meeting the limitations of claims 19 and 20). Arce teaches that the method results in an increased proportion of euploid blastocysts and ongoing pregnancy rate as compared to a comparable method using recombinant follicle-stimulating hormone (rFSH) as the gonadotropin (see claim 12-13; paragraphs [0007], [0012] and [0054]), thereby meeting the limitations of claim 21. Arce also teaches administering a GnRH antagonist such as ganirelix beginning on day 6 of treatment (see paragraph [0081]), thereby meeting the limitation of claim 22.
Arce teaches the limitations of claims 23 and 24 (paragraph [0076]):
Any of these methods may further comprise administering an amount of hCG effective to trigger ovulation, harvesting oocytes from the woman, in vitro fertilization of harvested oocytes (such as intra-cytoplasmic sperm injection (ICSI)), assessing the chromosomal quality of blastocysts obtained from the woman after in vitro fertilization of oocytes harvested from the woman, blastocyst transfer of a blastocyst determined to be a euploid blastocyst (such as fresh transfer), and/or freezing a blastocyst determined to be a euploid blastocyst.
Regarding the age and physical characteristics of the intended female subjects, Arce teaches that the women are not anovulatory, and are between 21-35 years old with a BMI of 18-30 kg/m2 prior to treatment (see paragraph [0030]), thereby meeting limitations of claim 25.
The second factor to consider is to ascertain the differences between the prior art and the instant claims. Arce do not teach the patient has been diagnosed with oligo-ovulation or polycystic ovarian syndrome (PCOS), and in fact, stipulates that an exclusion criterion is PCOS (see paragraph [0100]). Nevertheless, Arce is describing a prospective clinical trial, and it was understood in the art prior to the filing of the invention that clinical trials have specific inclusion and exclusion criteria to achieve internal and external validity (see pages 1343-1344 of Spieth and colleagues). Further, the prior art teaches that administering menotropin to patients to PCOS patients experiencing oligo-ovulation as part of controlled ovarian stimulation protocols was known in the art. See, for instance, Zhu et al., who teach a controlled ovarian stimulation protocol in PCOS patients in which 150 IU hMG is administered daily followed by a GnRH agonist/hCG beginning on day 6 to trigger ovulation once follicles reach 18 mm (see p. 1, left column; p. 2, left column under “2.2.1. Controlled ovarian stimulation and allocation”). Tal et al. also confirm that the patient population with PCOS has high AMH levels and is at risk for OHSS (see abstract; p. 59.e6). Regarding patient characteristics, Tal et al. teach that women with PCOS and serum AMH ranging from 5-14 ng/mL (i.e., ≥ 35.7 pmol/L) have serum testosterone levels of 42.8 ng/dL and 56.2 (i.e., higher than 1.10 nmol/L) and those with AMH levels ranging from 10-14 ng/mL have LH levels of 8.6 IU/L (see p. 59.e4, Table 1).
It would have been obvious to the person of ordinary skill in the art at the time of the filing of the invention to modify the teachings of Arce by applying the methods described therein to PCOS patients because Arce et al. explicitly teach administering an HP-hMG to stimulate follicle development to a woman selected as being at risk of a high ovarian response to COS, wherein the selected woman has a serum AMH level greater than or equal to 5.0±0.5 ng/ml (see claim 1) and it was well established in the prior art that high AMH levels are associated with PCOS and risk of OHSS (see abstract; p. 59.e6 of Tal and colleagues). The person of ordinary skill in the art would have been motivated to use the COS protocol disclosed in Arce in a PCOS population based upon the characteristics of PCOS patients, whose symptoms, high AMH levels and risk of OHSS, overlap with the those described in Arce. Furthermore, the person of ordinary skill in the art could have reasonably expected success because Arce teach that the methods using HP-hMG in COS protocols “results in fewer eggs but a higher proportion of euploid blastocysts as compared to comparable methods using rFSH” (see paragraph [0124]).
Thus, the claims do not contribute anything non-obvious over the prior art.
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.
US Patents 10,413,592, 11,351,228 and 11,679,145
Claims 16-25 and 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following in view of Arce (US2016/0250296), Zhu et al. (Medicine (2016) 95:28(e4193)) and Tal et al. (American Journal of Obstetrics and Gynecology, 2014; 211: 59.e1-59.e8):
Claims 1-24 of U.S. Patent No. 10,413,592;
Claims 1-32 of U.S. Patent No. 11,351,228; and
Claims 1-19 of U.S. Patent No. 11,679,145
The claims of the reference patents recite assisted reproductive technology methods comprising selecting a woman at risk of a high ovarian response to controlled ovarian stimulation (COS) and determined to have a serum anti-Müllerian hormone (AMH) level greater than or equal to 5.0±0.5 ng/ml and administering to the selected woman an amount of highly purified menotropin (HP-hMG) in doses and schedules that overlap with the doses recited in the instant claims, and administering hCG to trigger ovulation, wherein the woman is in need of treatment for infertility and COS. In addition, the claims of the reference patents recite harvesting oocytes from the woman, performing in vitro fertilization of harvested oocytes, assessing chromosomal quality of blastocysts obtained therefrom and transferring a blastocyst (either fresh or frozen) determined to be euploid.
The claims of the reference patents do not recite the patient has been diagnosed with oligo-ovulation or polycystic ovarian syndrome (PCOS), the hormone levels recited in instant claims 17 and 30 or the age and physical characteristics in claim 25. Regarding oligo-ovulation and PCOS, Zhu et al. teach a controlled ovarian stimulation protocol in PCOS patients in which 150 IU hMG is administered daily followed by a GnRH agonist/hCG beginning on day 6 to trigger ovulation once follicles reach 18 mm (see p. 1, left column; p. 2, left column under “2.2.1. Controlled ovarian stimulation and allocation”). Tal et al. also confirm that the patient population with PCOS has high AMH levels and is at risk for OHSS (see abstract; p. 59.e6).
Regarding patient characteristics, Tal et al. teach that women with PCOS and serum AMH ranging from 5-14 ng/mL (i.e., ≥ 35.7 pmol/L) have serum testosterone levels of 42.8 ng/dL and 56.2 (i.e., higher than 1.10 nmol/L) and those with AMH levels ranging from 10-14 ng/mL have LH levels of 8.6 IU/L (see p. 59.e4, Table 1). Further, Arce teaches that the women are between 21-35 years old with a BMI of 18-30 kg/m2 prior to treatment (see paragraph [0030]), thereby meeting limitations of claim 25. Further, Arce reports baseline patient characteristics in those with higher than 5.2 ng/ml AMH, including serum estradiol level, is higher than 145 pmol/L (see Table 1 at paragraph [0089]), thereby teaching the limitations of claims 17 and 30.
It would have been obvious to the person of ordinary skill in the art at the time of the filing of the invention that the methods set forth in the reference patents could be applied to PCOS patients because it was well established in the prior art that high AMH levels are associated with PCOS and risk of OHSS (see abstract; p. 59.e6 of Tal and colleagues). The person of ordinary skill in the art would have been motivated to use the COS protocol of the reference patent claims in a PCOS population based upon the characteristics of PCOS patients, whose symptoms, high AMH levels and risk of OHSS, overlap with the those recited in the reference claims. Furthermore, the person of ordinary skill in the art could have reasonably expected success because Arce teach that the methods using HP-hMG in COS protocols “results in fewer eggs but a higher proportion of euploid blastocysts as compared to comparable methods using rFSH” (see paragraph [0124]).
Thus, when read in light of the prior art, the instant claims are not patentably distinct from those of the reference patents.
17/928,176
Claims 16-25 and 28-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, 4, 5, 7-15, 22 and 30-33 of copending Application No. 17/928,176 in view of Arce, Zhu et al. and Tal et al. (All the references are cited above). The claims of the reference application recite a method of treating infertility in a patient, wherein the patient is not anovulatory, comprising selecting a patient identified as having a serum having a serum AMH level ≥ 35.7 ± 0.5 pmol/L (≥ 5.0 ± 0.2 ng/ml) prior to treatment/stimulation, conducting COS by administering a daily dose of 75-450 IU HP-hMG to the selected patient from day one of treatment, further comprising administering a GnRH antagonist on day 6 and triggering final follicular maturation with hCG or hCG/GnRH agonist, wherein the treatment increases the probability of live birth. Claim 15 of the reference application recites the same limitations regarding oocyte harvesting as instant claim 24 and the same patient characteristics as instant claim 25.
The claims of the reference application do not recite the patient has been diagnosed with oligo-ovulation or PCOS or the hormone levels recited in instant claims 17 and 30. Regarding oligo-ovulation and PCOS, Zhu et al. teach a COS protocol in PCOS patients in which 150 IU hMG is administered daily followed by a GnRH agonist/hCG beginning on day 6 to trigger ovulation once follicles reach 18 mm (see p. 1, left column; p. 2, left column under “2.2.1. Controlled ovarian stimulation and allocation”). Tal et al. also confirm that the patient population with PCOS has high AMH levels and is at risk for OHSS (see abstract; p. 59.e6).
Regarding patient characteristics, Tal et al. teach that women with PCOS and serum AMH ranging from 5-14 ng/mL (i.e., ≥ 35.7 pmol/L) have serum testosterone levels of 42.8 ng/dL and 56.2 (i.e., higher than 1.10 nmol/L) and those with AMH levels ranging from 10-14 ng/mL have LH levels of 8.6 IU/L (see p. 59.e4, Table 1). Further, Arce reports baseline patient characteristics in those with higher than 5.2 ng/ml AMH, including serum estradiol level, is higher than 145 pmol/L (see Table 1 at paragraph [0089]), thereby teaching the limitations of claims 17 and 30.
It would have been obvious to the person of ordinary skill in the art at the time of the filing of the invention that the methods set forth in the reference application could be applied to PCOS patients because it was well established in the prior art that high AMH levels are associated with PCOS and risk of OHSS (see abstract; p. 59.e6 of Tal and colleagues). The person of ordinary skill in the art would have been motivated to use the COS protocol of the reference application claims in a PCOS population based upon the characteristics of PCOS patients, whose symptoms, high AMH levels and risk of OHSS, overlap with the those recited in the reference claims. Furthermore, the person of ordinary skill in the art could have reasonably expected success because Arce teach that the method using HP-hMG in COS protocols “results in fewer eggs but a higher proportion of euploid blastocysts as compared to comparable methods using rFSH” (see paragraph [0124]).
Thus, when read in light of the prior art, the instant claims are not patentably distinct from those of the reference application. Although this is still technically a provisional nonstatutory double patenting rejection, it will not remain so as a Notice of Allowance was mailed in this case on 04/09/2026.
18/814,230
Claims 16-25 and 28-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-37 of copending Application No. 18/814,230 in view of Arce, Zhu et al. and Tal et al. (All the references are cited above). The claims of the reference application recite an assisted reproductive technology method for treating a woman at risk of a high ovarian response to in vitro fertilization after COS, comprising: selecting a woman at risk of a high ovarian response to COS having a serum AMH level greater than or equal to 5.0 + 0.5 ng/ml prior to stimulation; and then administering to the selected woman 75 IU/day to about 300 IU/day of HP-hMG, i.e., 150 IU for at least 5 days followed by 225 IU for at least one day and kits therefore.
The claims of the reference application do not recite the patient has been diagnosed with oligo-ovulation or PCOS, the hormone levels recited in instant claims 17 and 30 or the age and physical characteristics in claim 25. Regarding oligo-ovulation and PCOS, Zhu et al. teach a COS protocol in PCOS patients in which 150 IU hMG is administered daily followed by a GnRH agonist/hCG beginning on day 6 to trigger ovulation once follicles reach 18 mm (see p. 1, left column; p. 2, left column under “2.2.1. Controlled ovarian stimulation and allocation”). Tal et al. also confirm that the patient population with PCOS has high AMH levels and is at risk for OHSS (see abstract; p. 59.e6).
Regarding patient characteristics, Tal et al. teach that women with PCOS and serum AMH ranging from 5-14 ng/mL (i.e., ≥ 35.7 pmol/L) have serum testosterone levels of 42.8 ng/dL and 56.2 (i.e., higher than 1.10 nmol/L) and those with AMH levels ranging from 10-14 ng/mL have LH levels of 8.6 IU/L (see p. 59.e4, Table 1). Further, Arce reports baseline patient characteristics in those with higher than 5.2 ng/ml AMH, including serum estradiol level, is higher than 145 pmol/L (see Table 1 at paragraph [0089]), thereby teaching the limitations of claims 17 and 30. In addition, Arce teaches that the women are between 21-35 years old with a BMI of 18-30 kg/m2 prior to treatment (see paragraph [0030]), thereby meeting limitations of claim 25.
It would have been obvious to the person of ordinary skill in the art at the time of the filing of the invention that the methods set forth in the reference application could be applied to PCOS patients because it was well established in the prior art that high AMH levels are associated with PCOS and risk of OHSS (see abstract; p. 59.e6 of Tal and colleagues). The person of ordinary skill in the art would have been motivated to use the COS protocol of the reference application claims in a PCOS population based upon the characteristics of PCOS patients, whose symptoms, high AMH levels and risk of OHSS, overlap with the those recited in the reference claims. Furthermore, the person of ordinary skill in the art could have reasonably expected success because Arce teach that the methods using HP-hMG in COS protocols “results in fewer eggs but a higher proportion of euploid blastocysts as compared to comparable methods using rFSH” (see paragraph [0124]).
Thus, when read in light of the prior art, the instant claims are not patentably distinct from those of the reference patent. This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675
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