DETAILED ACTION
Notice of 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 Claims
The amendments filed 9/09/2025 have been entered.
Response to Arguments
Applicant’s arguments, filed 9/09/2025, have been fully considered.
Applicant first traverses the rejection of claims 1-4, 7-11 and 14-15 under 35 U.S.C. 103(a) based primarily on Neuroendocrine Biosciences (Elagolix Successful in Six Month Lilac Petal Study; Safety and Efficacy Confirmed in Patients with Endometriosis, 7/29/2009; of record). Applicant argues that the prior art, alone or in combination, do not “teach or suggest the ‘time period of more than six months’ recited in independent claims 1 and 8 for the once daily administration of 150 mg elagolix and that such a time period of administration would have run counter to the knowledge and expectations of a POSITA at the time of filing the present application” (Applicant Arguments, Page 6). In particular, Applicant argues that, at the time of the invention, side effects of estrogen deprivation included “primarily bone mineral density (BMD) loss and severe hot flushes (sic)” thereby limiting their use and prolonged administration (Applicant Arguments, Page 6).
The argument is not found persuasive. As discussed in the basis of the rejection, Neurocrine Biosciences teaches a six month “Lilac Petal Study”, comprising a “six month treatment period” comprising administration of “orally-active” (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 “minimal impact on BMD (-0.80% mean change from baseline, femur; -0.66% mean change from baseline, spine)” (Paragraph 2). It is MAINTAINED that treatment for a period of six months and one day (under MPEP 2144.05 or based further on Bittner et al and Wellbery) would similarly be expected minimally impact on BMD.
Applicant, however, further argues that, regarding MPEP 2144.05, “a prima facie case of obviousness for… amounts that are merely close to those in the prior art may exist because ‘those proportions are so close that prima facie one skilled in the art would have expected them to have the same properties’” (Applicant Arguments, Page 7). Applicant argues that, “in view of the safety concerns associated with the prolonged administration of GnRH antagonists at the time of filing of the present application, and in the absence of safety data beyond the six-month period, a person of ordinary skill in the art would not have expected the safety profile of the two dosing periods – six months versus six months and one day – to have the same safety profile” (Applicant Arguments, Page 7).
The argument is not found persuasive. A person of ordinary skill in the art would reasonably expect administration of elagolix – which, when administered for a period of six months, resulted in “minimal impact on BMD (-0.80% mean change from baseline, femur; -0.66% mean change from baseline, spine)” – to exhibit the same safety profile when administered for one more day. The fact that other GnRH antagonists exhibit safety concerns would not have deterred this thinking in view of the fact that elagolix, specifically, resulted in “minimal impact on BMD (-0.80% mean change from baseline, femur; -0.66% mean change from baseline, spine)”.
Applicant additionally argues that it would not have been obvious to extend the treatment for a period of one additional day based on Bittner et al and Wellbery (Applicant Arguments, Page 7). As argued by Applicant, “Bittner describes the administration of the GnRH antagonist, cetrorelix, for no more than 5 days” and “warns of potential adverse reproductive side effects from the prolonged administration of cetrorelix” (Applicant Arguments, Page 7). And, similarly, “Wellbery also recognized hypoestrogenic side effects associated with prolonged administration of GnRH agonists” (Applicant Arguments, Page 7).
The argument is not found persuasive. Bittner et al and Wellbery demonstrate a need for ongoing treatment using GnRH antagonists. Despite this, it may not have been obvious to extend treatment utilizing the GnRH antagonists discussed by Bittner et al for the concerns identified by Applicant. However, the fact that prolonged administration of other GnRH antagonists exhibit safety concerns would not have deterred a person of ordinary skill in the art from extending treatment using elagolix for a single day in view of the fact that elagolix, specifically, was not shown to exhibit those safety concerns at six months.
Applicant next traverses the rejections of claims on the grounds of nonstatutory double patenting. Applicant argues that the ‘572, ‘351 and ‘845 patents do not recite administration for a time period of more than six months (Applicant Arguments, Pages 8-9).
While it is accurate that these claims do not recite, verbatim, continuing “administration… daily for a time period of more than six months”, each of the patents embrace administration for a time period of more than six months, more than 12 months, and more than 18 months.
Applicant further argues that the ‘551 and ‘854 patents recite that administration for “a time period not to exceed 6 months” (‘551 claims) and administration “daily for up to 6 months” (‘854 claims). Additionally, Applicant argues that dependent claims 3-5 of the ‘551 patent recite administration of add-back therapy.
Regarding extending treatment for a single day beyond the 6 month time period recited in the ‘551 and ‘854 claims, the argument is not found persuasive for the same reasons discussed above. Furthermore, claim 1 of the ‘551 patent clearly does not require add-back therapy and includes methods not comprising add-back therapy.
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 1-4, 7-11 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) alone or, alternatively, in further view of Bittner et al (Fertility and Sterility 95:2390-2394, 2011) and Wellbery (Am Fam Physician 60:1753-1762, 1999).
Claim 1 is drawn to a method of managing moderate to severe pain associated with endometriosis in a premenopausal adult human female patient, the method comprising:
(a) oral administration to the patient of 150 mg elagolix; and
(b) continuing said oral administration once daily for a time period of more than six months (more specifically, wherein the time period does not exceed 24 months (claim 2)) to manage the moderate to severe pain associated with endometriosis;
wherein:
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; and
the method does not comprise administration of add-back therapy.
Neurocrine Biosciences teaches a six month “Lilac Petal Study”, comprising a “six month treatment period” comprising administration of “orally-active” (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 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): 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 (B): 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, as taught by Neurocrine Biosciences alone or, alternatively, in further view of Bittner et al and Wellbery, would necessarily result in the patient exhibiting no more than an 8% reduction from baseline in lumbar spine BMD at 24 months.
Accordingly, claims 1-2 are rejected as prima facie obvious.
Claims 3-4 are drawn to the method of claim 1, wherein the method reduces dysmenorrhea and non-menstrual pelvic pain in the patient (claim 3), more specifically without an increase in use of a concomitant medication for the treatment of endometriosis-related pain by the patient (claim 4).
As discussed above, 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 3-4 are also rejected as prima facie obvious.
Claim 7 is drawn to the method of claim 1, wherein the patient does not have osteoporosis.
Since there is nothing in Neurocrine Biosciences to indicate that the patients had osteoporosis, claim 7 is also rejected as prima facie obvious.
As amended, claim 8 (drafted independently) is drawn to a method of managing moderate to severe pain associated with endometriosis in a premenopausal adult human female patient, 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 as needed;
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; and
wherein (as recited by claim 10) the method reduces dysmenorrhea and non-menstrual pelvic pain in the patient.
As thus recited, claims 8-10 overlap in scope with the method of claims 1-3 addressed above. Accordingly, for the same reasons as discussed above regarding claims 1-3, claims 8-10 are also rejected as prima facie obvious.
Claim 11 is drawn to the method of claim 8, wherein the method reduces dysmenorrhea and non-menstrual pelvic pain in the patient without an increase in use of a concomitant medication for the treatment of endometriosis-related pain by the patient.
As discussed above, 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, claim 11 is 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.
As discussed above, 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) alone or, alternatively, in further view of Bittner et al (Fertility and Sterility 95:2390-2394, 2011) and Wellbery (Am Fam Physician 60:1753-1762, 1999) as applied to the rejection of claims 1-4, 7-11 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 1-4, 7-11, 14-15 and 20-23 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) alone or, alternatively, 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 to a 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. And, in doing so, it would have been obvious to carry out said treatment for a period of more than six months, 12 months, and/or 18 months, all of which are embraced by the ‘572 claims. 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 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 1-4, 7-11, 14-15 and 20-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,682,351 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) alone or, alternatively, 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 to a 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. And, in doing so, it would have been obvious to carry out said treatment for a period of more than six months, 12 months, and/or 18 months, all of which are embraced by the ‘351 claims. 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 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 1-4, 7-11 and 14-17 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 Neuroendocrine Biosciences (Elagolix Successful in Six Month Lilac Petal Study; Safety and Efficacy Confirmed in Patients with Endometriosis, 7/29/2009; of record) alone or, alternatively, 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.
Regarding instant claims 8-11 and 14-17, claim 1 of the ‘551 patent is drawn to management of moderate to severe pain in endometriosis 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.
And, regarding instant claims 1-4 and 7, it would have been further obvious reduce the dosage of elagolix from 200 mg twice daily to 150 mg once daily based further on Neuroendocrine Biosciences which, as discussed above, teaches “clinically meaningful efficacy” (Paragraph 1), including “the marked improvement of endometriosis-related pain” (Paragraph 4), in said patients when administering 150 mg elagolix once daily, further noting “the superior bone safety profile” when administering 150 mg elagolix compared to 250 mg elagolix (Paragraph 5), and to extend the treatment period to more than six months as discussed above.
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 1-4, 7-11 and 14-23 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 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 for a period of more than six months, 12 months, and/or 18 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 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 1-4, 7-11 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) alone or, alternatively, 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 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. And it is necessarily the case that carrying out said administration would avoid the reduction in BMD as recited by the claims.
Claims 1-4, 7-11, 14-15 and 20-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,707,464.
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.
Conclusion
The new ground(s) of rejection presented in this Office action are necessitated by Applicant’s amendments to the claims. 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 extension fee 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 date of this final action.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611