DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/14/2026 has been entered.
AIA Status of the Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, filed 4/14/2026, have been fully considered.
Applicant traverses the rejection of claims under 35 U.S.C. 103(a). As argued by Applicant, since claim 16 was not previously rejected, “independent claim 8, which includes the elements of former claim 16, and independent claim 17... should not be subject to the obviousness rejection” (Applicant Arguments, Page 5). For largely the same reason, Applicant traverses the rejections based on the ground of nonstatutory double patenting.
The rejections have all been modified to address the limitation.
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.
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 8, 10-11 and 14 are rejected under 35 U.S.C. 103(a) as being unpatentable over Neuroendocrine Biosciences (Elagolix Successful in Six Month Lilac Petal Study; Safety and Efficacy Confirmed in Patients with Endometriosis, 7/29/2009; of record) in view of Gruppo Italiano (Human Reproduction 16:2688-2671, 2001) and Ashweek et al (US 2010/0184741) collectively or, alternatively, all in further view of Bittner et al (Fertility and Sterility 95:2390-2394, 2011; of record) and Wellbery (Am Fam Physician 60:1753-1762, 1999; of record).
As amended, claim 8 is drawn to a method of managing moderate to severe pain associated with endometriosis in a premenopausal adult human female patient suffering from dyspareunia associated with endometriosis, the method comprising:
(a) providing a dosage form comprising 150 mg or 200 mg elagolix;
(b) selecting a dosage regimen suitable to mitigate decreases in bone mineral density (BMD) in the patient, wherein the selected dosage regimen – which does not comprise administration of add-back therapy – comprises:
(i) once daily oral administration of the dosage form comprising 150 mg of elagolix to the patient for a time period of more than six months; or
(ii) twice daily oral administration to the patient of the dosage form comprising 200 mg of elagolix to the patient for a time period not to exceed six months;
to manage the moderate to severe pain associated with endometriosis;
wherein:
when the selected dosing regimen comprises once daily oral administration of the dosage form comprising 150 mg of elagolix to the patient, the patient exhibits no more than a 2% reduction from baseline in lumbar spine bone mineral density (BMD) at six months and no more than 8% reduction from baseline in lumbar spine BMD at 24 months; or
when the selected dosing regimen comprises twice daily oral administration to the patient of the dosage form comprising 200 mg of elagolix to the patient, the patient exhibits no more than an 8% reduction from baseline in lumbar spine BMD at six months.
Neurocrine Biosciences teaches a six month “Lilac Petal Study”, comprising a “six month treatment period” comprising administration of “orally-active... GnRH receptor antagonist” (Paragraph 1) “elagolix 150 mg once daily” (Paragraph 2) – where there is no disclosure of any add-back therapy – to patients with endometriosis, resulting in “clinically meaningful efficacy” (Paragraph 1) wherein, “[f]rom an efficacy standpoint, the exploratory daily pain scales for Dysmenorrhea and Non-Menstrual Pelvic Pain demonstrated that women had minimal endometriosis pain symptoms at month six (mean scores of approximately 0.5… of the 0-3 scales)” and “revealed that 80% of elagolix 150 mg subjects… were ‘Much Improved’ or ‘Very Much Improved’ after six months of treatment” (Paragraph 4; see also Paragraph 4: “[t]he core pain dimension of the EHP-5 [Endometriosis Health Profile] documented the marked improvement of endometriosis-related pain”). And, as further taught by Neurocrine Biosciences there was “minimal impact on BMD (-0.80% mean change from baseline, femur; -0.66% mean change from baseline, spine)” (Paragraph 2).
As such, the method of Neurocrine Biosciences differs from the instantly claimed method as follows:
Neurocrine Biosciences does not teach treatment of endometriosis in patient suffering from dyspareunia associated with endometriosis;
Neurocrine Biosciences teaches treatment for a time period of six months as opposed to for a time period of more than six months; and
Neurocrine Biosciences does not disclose that the patient exhibits no more than an 8% reduction from baseline in lumbar spine BMD at 24 months.
Yet, as to (A): as taught by Gruppo Italiano, “[o]ut of a total of 469 women studied... Dysmenorrhoea was present in 77% of women with ovarian endometriosis, 88% of those with endometriosis of the peritoneum, 92% of those with endometriosis of ovary and peritoneum, and in all 15 [100%] with endometriosis of the rectovaginal septum” (Page 2669, Columns 1-2).
And, as further taught by Ashweek et al, disclosing “GnRH receptor antagonists... which have utility in the treatment of a variety of sex-hormone related conditions” (Abstract) including “endometriosis... [and] dyspareunia” (Paragraph 0010).
As such, in further view of Gruppo Italiano and Ashweek et al, it would have been obvious to apply the method of Neurocrine Biosciences (for managing moderate to severe pain associated with endometriosis in a premenopausal adult human female patient) to women also suffering from dyspareunia associated with endometriosis. It would have been obvious to do so considering that between 77% and 100% of women suffering from endometriosis also suffer from dyspareunia associated with endometriosis (as taught by Gruppo Italiano) and further considering that “GnRH receptor antagonists... have utility in the treatment of a variety of sex-hormone related conditions” including “endometriosis... [and] dyspareunia” (as taught by Ashweek et al).
As to (B): it would have been obvious to extend the time period of treatment from six months (as taught by Neurocrine Biosciences) to more than six months (as claimed) for either or both of the following reasons:
FIRST, as discussed by MPEP 2144.05, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (citing Titanium Metals Corp. of America v. Banner, 778 F.2d 775 (Fed. Cir. 1985)). In the instant case, extending the time period of treatment from six months (as taught by Neurocrine Biosciences) to six months and one day (i.e., more than six months) is close enough so as to be prima facie obvious; and/or
SECOND, as taught by Neurocrine Biosciences, elagolix is a “GnRH receptor antagonist” (Paragraph 1). As taught by Bittner et al, the GnRH-antagonist Cetrorelix “inhibited ovulation in mice” (Abstract), an outcome Bittner extends to “other GnRH antagonists” (Page 2394, Column 2). And, as taught by Wellbery – discussing the treatment of endometriosis – “[m]edical treatment designed to interfere with ovulation generally provides effective pain relief, but the recurrence rate following cessation of therapy is high” (Abstract). Accordingly, it would have been prima facie obvious to extend the time period of treatment from six months (as taught by Neurocrine Biosciences) to more than six months (as claimed) to provide ongoing pain relief with a reasonable expectation of success.
And, as to (C): while the fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic (In re Rijckaert, 9 F.3d 1531 (Fed. Cir. 1993); see also In re Robertson, 169 F.3d 743 (Fed. Cir. 1999), “[i]nherency may not be established by probabilities or possibilities”), it is well settled that “inherency may supply a missing claim limitation in an obviousness analysis” so long as “the limitation at issue necessarily must be present or the natural result of the combination of elements explicitly disclosed by the prior art” (PAR Pharm., Inc. v. TWI Pharm., Inc. 773 F.3d 1186 (Fed. Cir. 2014)). “If… the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient” (quoting In re Oelrich, 666 F.2d 578 (C.C.P.A. 1981). Thus, as stated by the court in PAR Pharm., Inc. v. TWI Pharm., Inc., “inherency... is present… when the limitation at issue is the ‘natural result’ of the combination of prior art elements” (Id.). And, as stated by the court in In re Dillon (919 F.2d 688 (Fed. Cir. 1990)), “it is not necessary in order to establish a prima facie case of obviousness… that there be a suggestion in or expectation from the prior art that the claimed [invention] will have the same or similar utility as one newly discovered by applicant”.
While the court in PAR Pharm., Inc. v. TWI Pharm., Inc. further indicates that “the concept of inherency must be limited when applied to obviousness” and “[a] party must… meet a high standard in order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis”, it must also be remembered that the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent Applicant may present previously unmeasured characteristics. As such, a prior art disclosure of a product or method “appearing to be substantially identical” to that instantly claimed, and rationale or evidence “tending to show inherency”, shifts the burden to the Applicant to prove otherwise (MPEP 2112 (IV)-(V)). As stated in In re Best, Bolton, and Shaw (562 F2d 1252 (CCPA 1977)), “[w]here… the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product” (see also In re Fitzgerald 619 F2d 67 (CCPA 1980): the burden is shifted to the applicants to “prove that subject matter shown to be in the prior art does not possess characteristic relied on”).
This is especially true in cases where the newly discovered, inherent limitation is claimed functionally rather than structurally. For example, in In re Kubin (561 F.3d 1351 (Fed. Cir. 2009)), discussing claims drawn to an isolated nucleic acid molecule encoding a polypeptide “wherein the polypeptide binds CD48”, the court stated that there is “no obligation to predicate [an] obviousness finding on factual findings regarding a prior art teaching of [the polypeptide’s] binding to the CD48 protein” – the limitation is “not an additional requirement imposed by the claims on the [polypeptide], but rather a property necessarily present in” the polypeptide. As stated by the court in Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344 (Fed. Cir. 2012), “[t]o hold otherwise would allow any formulation – no matter how obvious – to become patentable merely by testing and claiming an inherent property” (discussing claims drawn to methods of administering an active agent “wherein upon oral administration… an initial serum concentration of the [active agent] greater than about 0.1 µg / ml is obtained at any time within about 30 minutes after administration” and further noting that “[t]he initial blood serum concentration resulting from administering [the active agent] is an inherent property of the formulation, and an obvious formulation cannot become nonobvious simply by administering it to a patient and claiming the resulting serum concentrations”).
In the instant case, the claimed and prior art methods are substantially identical. As such, absent evidence to the contrary, it is asserted that orally administering 150 mg elagolix daily for 6 months and 1 day to patients with endometriosis (in the absence of add-back therapy) to manage the moderate to severe pain associated with said endometriosis therein (wherein as Neurocrine Biosciences there was “minimal impact on BMD (-0.80% mean change from baseline, femur; -0.66% mean change from baseline, spine)” following six months of treatment) would necessarily result in the patient exhibiting no more than an 8% reduction from baseline in lumbar spine BMD at 24 months.
Accordingly, claim 8 is rejected as prima facie obvious.
Claims 10-11 are drawn to the method of claim 8, wherein the method reduces dysmenorrhea and non-menstrual pelvic pain in the patient (claim 10), more specifically without an increase in use of a concomitant medication for the treatment of endometriosis-related pain by the patient (claim 11).
Neurocrine Biosciences teaches that “[f]rom an efficacy standpoint, the exploratory daily pain scales for Dysmenorrhea and Non-Menstrual Pelvic Pain demonstrated that women had minimal endometriosis pain symptoms at month six (mean scores of approximately 0.5… of the 0-3 scales)” and “revealed that 80% of elagolix 150 mg subjects… were ‘Much Improved’ or ‘Very Much Improved’ after six months of treatment” (Paragraph 4). And, since Neurocrine Biosciences does not teach the use of a concomitant medication for the treatment of endometriosis-related pain, it is evident that the reduction in dysmenorrhea and non-menstrual pelvic pain occurred without an increase in use of a concomitant medication for the treatment of endometriosis-related pain.
Accordingly, claims 10-11 are also rejected as prima facie obvious.
Claim 14 is drawn to the method of claim 8 wherein said patient has a history of low-trauma fractures or a history of a condition associated with a decrease in BMD.
Neurocrine Biosciences teaches a six month “Lilac Petal Study”, comprising a “six-month treatment period” comprising administration of “elagolix 150 mg once daily” (Paragraph 2) to patients with endometriosis, resulting in “clinically meaningful efficacy” (Paragraph 1) – including “the marked improvement of endometriosis-related pain” (Paragraph 4) – with “minimal impact on BMD (-0.80% mean change from baseline, femur; -0.66% mean change from baseline, spine)” (Paragraph 2).
Although Neurocrine Biosciences does not teach the management of pain in a patient having a history of low-trauma fractures or a history of a condition associated with a decrease in BMD, it would have been prima facie obvious to extend the method to this patient population. It would have been obvious to do so in order to manage moderate to severe pain associated with endometriosis in said patient without exacerbating the condition associated with a decrease in BMD, given the treatment’s “minimal impact on BMD”.
As such, claim 14 is rejected as prima facie obvious.
Claim 15 is rejected under 35 U.S.C. 103(a) as being unpatentable over Neuroendocrine Biosciences (Elagolix Successful in Six Month Lilac Petal Study; Safety and Efficacy Confirmed in Patients with Endometriosis, 7/29/2009; of record) in view of Gruppo Italiano (Human Reproduction 16:2688-2671, 2001) and Ashweek et al (US 2010/0184741) collectively or, alternatively, all in further view of Bittner et al (Fertility and Sterility 95:2390-2394, 2011; of record) and Wellbery (Am Fam Physician 60:1753-1762, 1999; of record) as applied to the rejection of claims 8, 10-11 and 14 above, in further view of Stewart (US 2003/0171288; of record).
Claim 15 is drawn to the method of claim 8 wherein the method further comprises administration of supplementary calcium, vitamin D, or a combination thereof.
As discussed above, Neurocrine Biosciences alone or, alternatively, in further view of Bittner et al and Wellbery, teach the method of claim 8, in particular wherein it would have been obvious to extend the method to the treatment of a patient having a history of low-trauma fractures or a history of a condition associated with a decrease in BMD, as recited by claim 14.
However, the prior art do not teach the further administration of calcium and/or vit D.
Yet, as taught by Stewart, in conditions such a “[o]steoporosis… a disease characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased susceptibility to fracturs of the hip, spine, and wrist… the mainstays of therapy are oral calcium supplements [and] vitamin D”, wherein “[t]hese drugs are effective in slowing bone mineral loss and even cause moderate increases in lumber spine bone mineral density in the range of 2%” (Paragraph 0006).
Accordingly, in further view of Stewart, it would have been prima facie obvious to further include the administration of supplementary calcium, vitamin D, or a combination thereof. It would have been obvious to do so in order to slow bone mineral loss in said patients, in particular those patients having a history of low-trauma fractures or a history of a condition associated with a decrease in BMD, with a reasonable expectation of success.
As such, claim 15 is also rejected as prima facie obvious.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 8, 10-11, 14-15 and 22-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10,537,572 in view of Neuroendocrine Biosciences (Elagolix Successful in Six Month Lilac Petal Study; Safety and Efficacy Confirmed in Patients with Endometriosis, 7/29/2009; of record) in view of Gruppo Italiano (Human Reproduction 16:2688-2671, 2001) and Ashweek et al (US 2010/0184741) collectively or, alternatively, all in further view of Bittner et al (Fertility and Sterility 95:2390-2394, 2011) and Wellbery (Am Fam Physician 60:1753-1762, 1999), and in view of Stewart (US 2003/0171288; of record).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of the ‘572 patent is drawn to the treatment of endometriosis comprising orally administering once daily elagolix in an amount of 150 mg.
It would have been obvious to administer elagolix as taught by the ‘572 patent for a time period as needed (i.e., for a period of more than six months, 12 months, and/or 18 months, all of which are embraced by the ‘572 claims) to the patient for the management of moderate to severe pain associated with endometriosis based further on Neuroendocrine Biosciences which, as discussed above, teach “clinically meaningful efficacy” (Paragraph 1), including “the marked improvement of endometriosis-related pain” (Paragraph 4), in said patients. Furthermore, it is necessarily the case that carrying out said administration would avoid the reduction in BMD as recited by the claims.
Additionally, it would have been obvious to extend the method to the treatment of patients also suffering from dyspareunia associated with endometriosis, in further view of Gruppo Italiano and Ashweek et al, as discussed above; and to patients having a history of low-trauma fractures or a history of a condition associated with a decrease in BMD, in particular by further administering supplementary calcium, vitamin D, or a combination thereof in view of Stewart, as discussed above.
Claims 8, 10-11, 14-15 and 22-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10,537,572 in view of Neuroendocrine Biosciences (Elagolix Successful in Six Month Lilac Petal Study; Safety and Efficacy Confirmed in Patients with Endometriosis, 7/29/2009; of record) in view of Gruppo Italiano (Human Reproduction 16:2688-2671, 2001) and Ashweek et al (US 2010/0184741) collectively or, alternatively, all in further view of Bittner et al (Fertility and Sterility 95:2390-2394, 2011) and Wellbery (Am Fam Physician 60:1753-1762, 1999), and in view of Stewart (US 2003/0171288; of record).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of the ‘351 patent is drawn to the treatment of endometriosis comprising orally administering once daily elagolix in an amount of 150 mg.
It would have been obvious to administer elagolix as taught by the ‘351 patent for a time period as needed (i.e., for a period of more than six months, 12 months, and/or 18 months, all of which are embraced by the ‘572 claims) to the patient for the management of moderate to severe pain associated with endometriosis based further on Neuroendocrine Biosciences which, as discussed above, teach “clinically meaningful efficacy” (Paragraph 1), including “the marked improvement of endometriosis-related pain” (Paragraph 4), in said patients. Furthermore, it is necessarily the case that carrying out said administration would avoid the reduction in BMD as recited by the claims.
Additionally, it would have been obvious to extend the method to the treatment of patients also suffering from dyspareunia associated with endometriosis, in further view of Gruppo Italiano and Ashweek et al, as discussed above; and to patients having a history of low-trauma fractures or a history of a condition associated with a decrease in BMD, in particular by further administering supplementary calcium, vitamin D, or a combination thereof in view of Stewart, as discussed above.
Claims 8, 10-11, 14-15 and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,344,551 in view of Stewart (US 2003/0171288; of record).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-2 of the ‘551 patent are drawn to management of moderate to severe pain in endometriosis (claim 1) and managing dyspareunia associated with endometriosis (claim 2) comprising orally administering twice daily elagolix in an amount of 200 mg each for a period of time not to exceed 6 months. And it is necessarily the case that carrying out said administration would avoid the reduction in BMD as recited by the instant claims.
Additionally, it would have been obvious to extend the method to the treatment of patients having a history of low-trauma fractures or a history of a condition associated with a decrease in BMD, in particular by further administering supplementary calcium, vitamin D, or a combination thereof in view of Stewart, as discussed above.
Claims 8, 10-11, 14-15, 17-19 and 22-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-6 of U.S. Patent No. 11,690,845 in view of Gruppo Italiano (Human Reproduction 16:2688-2671, 2001), Ashweek et al (US 2010/0184741) and Stewart (US 2003/0171288).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1 and 5-6 of the ‘845 patent are drawn to management of moderate to severe pain in endometriosis comprising orally administering once daily elagolix in an amount of 150 mg or twice daily elagolix in an amount of 200 mg.
At the outset, it would have been obvious to determine the period of time to carry out said administration, including 150 mg once daily for a period of more than six months, 12 months, and/or 18 months, or 200 mg twice daily for a period of time not to exceed six months, all of which are embraced by the ‘845 claims. And it is necessarily the case that carrying out said administration would avoid the reduction in BMD as recited by the claims.
Additionally, it would have been obvious to extend the method to the treatment of patients also suffering from dyspareunia associated with endometriosis, in further view of Gruppo Italiano and Ashweek et al, as discussed above; and to patients having a history of low-trauma fractures or a history of a condition associated with a decrease in BMD, in particular by further administering supplementary calcium, vitamin D, or a combination thereof in view of Stewart, as discussed above.
Claims 8, 10-11 and 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11,690,854 in view of Neuroendocrine Biosciences (Elagolix Successful in Six Month Lilac Petal Study; Safety and Efficacy Confirmed in Patients with Endometriosis, 7/29/2009; of record) in view of Gruppo Italiano (Human Reproduction 16:2688-2671, 2001) and Ashweek et al (US 2010/0184741) collectively or, alternatively, all in further view of Bittner et al (Fertility and Sterility 95:2390-2394, 2011) and Wellbery (Am Fam Physician 60:1753-1762, 1999), and in view of Stewart (US 2003/0171288).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-2 of the ‘854 patent are drawn to management of moderate to severe pain in endometriosis comprising orally administering once daily elagolix in an amount of 155.2 mg for up to 6 months (i.e., an amount which is considered sufficiently close to 150 mg elagolix as to be prima facie obvious) wherein it would have been obvious to carry out said administration for more than six months in view of Neuroendocrine Biosciences alone or, alternatively, in further view of Bittner et al and Wellbery, for the reasons discussed above. And it is necessarily the case that carrying out said administration would avoid the reduction in BMD as recited by the claims.
Additionally, it would have been obvious to extend the method to the treatment of patients also suffering from dyspareunia associated with endometriosis, in further view of Gruppo Italiano and Ashweek et al, as discussed above; and to patients having a history of low-trauma fractures or a history of a condition associated with a decrease in BMD, in particular by further administering supplementary calcium, vitamin D, or a combination thereof in view of Stewart, as discussed above.
Claims 8, 10-11, 14-15 and 22-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,707,464 in view of Gruppo Italiano (Human Reproduction 16:2688-2671, 2001), Ashweek et al (US 2010/0184741) and of Stewart (US 2003/0171288).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of the ‘464 patent is drawn to management of moderate to severe pain in endometriosis comprising orally administering once daily elagolix in an amount of 150 mg for 24 months, wherein (as recited by claim 5) the method further comprises administering supplementary calcium and/or vitamin D. And it is necessarily the case that carrying out said administration would avoid the reduction in BMD as recited by the claims.
Additionally, it would have been obvious to extend the method to the treatment of patients also suffering from dyspareunia associated with endometriosis, in further view of Gruppo Italiano and Ashweek et al, as discussed above; and to patients having a history of low-trauma fractures or a history of a condition associated with a decrease in BMD, in view of Stewart, as discussed above.
Conclusion
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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