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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/14/2026 has been entered.
Claims 58 and 60-73 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Information Disclosure Statement
The information disclosure statement filed 01/14/2026 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language.
Specifically, NPL 139 and 140 are in a foreign language and do not include a concise explanation of relevance. As such, these references have been placed in the application file, but the information referred to therein has not been considered.
Response to 37 CFR 1.132 Declaration
The declaration under 37 CFR 1.132 filed 01/14/2026 is insufficient to overcome the rejection of claims 58 and 60-73 based upon 35 U.S.C. 103.
The instant declaration provides data for the post-void residual (PVR) urine volume for patients administered vibegron having 90% bladder obstructions (Qmax<10) or 67% bladder obstructions (Qmax ≥10 and <15). For patients with a 90% bladder obstruction, there is an approximately 20% increase in the mean post-volume at 12 weeks, and an approximately 24% increase in median post-void volume at 12 weeks. For patients with a 67% obstruction, there is an approximately 4% increase in the mean post-volume at 12 weeks, and an approximately 15% increase in median post-void volume at 12 weeks. See Tables A-B, pgs. 2-3 of the Declaration.
On pg. 7, Remarks, Applicant provides Table 2 from Ichihara which provides PVR urine volume data for Tamsulosin monotherapy and tamsulosin and mirabegron therapy in patients with OAB symptoms who have benign prostatic obstructions.
On pg. 8, Remarks, Applicant provides Table 3 from Nitti which provides PVR urine volume data for 50mg and 100mg mirabegron in BOO subjects with urinary tract infections.
On pg. 9, Remarks, Applicant provides Table C, a summary table, comparing the above data:
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As can be seen from this table, vibegron exhibits a lower PVR urine volume as compared to mirabegron in patients with bladder outlet obstruction (pg. 8, Remarks, lst paragraph). “. . .as can be seen from Tables A, B, and C above, administration of 75 mg vibegron resulted in only a minimal increase of PVR urine volume over 12 weeks, which stands in contrast to the art-identified risk of increased PVR urine volume when treating OAB in subjects with BOO with other OAB medications. As such. . .a POSA. . .i) would not have a reason to combine the cited art and, even if combined, ii) a POSA would not have had a reasonable expectation of success in treating OAB in a subject with BOO as recited in claim 58. . .as nothing in Berger, Banakhar, and/or Asafo suggests that vibegron could treat OAB in subjects with BOO without increasing PVR urine volume, a POSA would not have had a reason to treat the claimed subjects with a reasonable expectation of success, based on the risks identified in the art of increasing PVR urine volume.”
In Table 1, Banakhar, obstruction is taught as contributing to urinary retention (pg. 979, Banakhar). As such, on pg. 9, Remarks, Applicant argues “Considering the scope and content of the art, because Banakhar discloses obstruction from BOO contributes to urinary retention, a POSA considering treatment of OAB in a subject with BOO would not consider an OAB treatment that may cause further urinary retention.”
Regarding these arguments, while the examiner agrees that Banakhar teaches that obstruction contributes to urinary retention and that vibegron is shown to slightly increase PVR urine volume, this argument is not found persuasive. First, it is respectfully pointed out that in Tables A and B in the Declaration, it is not clear if the “Placebo” is administered to patients with a Qmax<10 (Table A) and a Qmax ≥10 and <15 (Table B) since no Qmax value is entered in the “Placebo” column. As such, it is not clear if the patient population of “Placebo” and “Vibegron 75mg” in the Tables A and B is the same. If “Placebo” in Tables A and B is a patient that has Qmax values in the normal, un-obstructed range, then the differences in PVR would be expected.
Next, it is respectfully pointed out that Ballstaedt (Bladder Post Void Residual Volume, NCBI Bookshelf, NIH, published 2025, PTO-892) teaches the following regarding PVR in adults:
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. In view of this chart provided by Ballstaedt, the PVR values for patients with Qmax<10 (Table A) and a Qmax ≥10 and <15 (Table B) in Tables A and B of the instant Declaration, are within a normal range, and not even close to being “suggestive of” or “considered” urinary retention. As such, the data provided by Declarant is not persuasive to overcome the 35 USC 103 rejection.
Moreover, while the tables provided in the Declaration demonstrate that vibegron results in a lower PVR than other known beta3 adrenergic agonists that treat OAB in BOO, i.e., mirabegron, since the PVR values in patients administered mirabegron and those administered vibegron, are not close to being “suggestive of “or “considered” urinary retention, the decrease in PVR demonstrated by vibegron is not an unexpected result.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
35 USC 103
To advance prosecution, the prior art rejections have been modified. While Berger continues to be relied upon as the primary reference, new secondary references are added to more clearly establish the relationship between OAB in BOO patients, and the role of urinary retention in BOO patients.
Double Patenting
Applicant No. 18/951,194 is abandoned. As such, the provisional Double Patenting rejection over this application is withdrawn.
The remainder of the Double Patenting rejections have been modified in view of the new secondary references applied in the modified prior art rejections.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 58, 60-64, and 67-73 are rejected under 35 U.S.C. 103 as being unpatentable over US 8,247,415 to Berger (published 2012, IDS of 12/20/2022) in view of Knutson (BPH with Coexisting Overactive Bladder Dysfunction-An Everyday Urological Dilemma, Neurology and Urodynamics, published 2001, PTO-892) and Muruganandham (Acute urinary retention in benign prostatic hyperplasia: Risk factors and current management, Indian Jn of Urology, published 2007, PTO-892).
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Berger teaches a method of treating overactive bladder (OAB), urinary incontinence, urinary urgency, and urge urinary incontinency by administering vibegron (Col. 222, claims 7 and 10). See pg. 2 of the specification for the structure of vibegron.
Regarding OAB, Berger teaches that while it is most often idiopathic, it is also secondary to bladder outlet obstruction (Col. 1, lines 60-67), and Berger teaches its compounds as treating both OAB and benign prostate hyperplasia, which is a bladder outlet obstruction (Col. 15, lines 16-44).
Oral administration is taught (Col. 15, lines 45-52; Col. 16, lines 41-49, 50-67; Col. 17, lines 1-21).
Berger teaches that when treating OAB, vibegron is administered at a daily dosage of from 0.01mg/kg-100mg/kg, which in a 70 kg adult human, is about 0.7-3500mg, and teaches that the dosage regimen may be adjusted to provide the optimal therapeutic response (Col. 15, line 58-Col. 16, line 2). In the case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art” a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claim 58, while Berger teaches a method of treating OAB by orally administering 0.7-3500mg vibegron, and it teaches a method of treating benign prostatic hyperplasia by administering one of its compounds, such as vibegron, it differs from that of the instantly claimed invention in that it does not explicitly teach treating a patient with both OAB and bladder outlet obstruction (BOO).
Knutson teaches that the aim of its study is to describe the rate of coexisting overactive bladder in patients with bladder outlet obstruction caused by benign prostatic hyperplasia. Knutson found that 45% of BOO patients were found to also have OAB. When comparing BOO patients with BOO patients exhibiting OAB, there is no differences in TRUS-volume, Q-max, IPS score, or PVR. These findings indicate that BOO is a progressive disease, and perhaps in itself contributes to the development of OAB (abstract; Summary & Conclusions, pgs. 245-246). It is further found that the rate of OAB increased significantly with increasing obstruction (pg. 242, last full paragraph).
Knutson further teaches that BOO combined with OAB is very common (pg. 241, 1st full paragraph), and that most patients with BOO + OAB will be relieved of their symptoms of OAB if the BOO decreases. However, if the patient’s major symptoms are caused by the OAB, but not by BOO, relieving the BOO by decreasing the size of the prostate will not help the patient (pg. 241, 1st full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select patients with BOO caused by benign prostatic hyperplasia and OAB, as the patients treated by the methods of Berger, to arrive at a method of treating OAB in a subject with BOO. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Berger teaches vibegron as treating both overactive bladder and benign prostatic hyperplasia,
-Knutson teaches benign prostatic hyperplasia as causing BOO,
-Knutson teaches that 45% of BOO patients also have OAB, and
-Knutson teaches that treating BOO does not necessarily treat OAB.
As such, an ordinary skilled artisan would have been motivated to make such a selection, to predictably arrive at a method that treats both the overactive bladder symptoms in a patient with BOO, and the benign prostatic hyperplasia causing the BOO, thus treating both conditions at once and increasing the patient’s quality of life.
Further regarding claim 58, while the combination of Berger and Knutson teaches a method of treating OAB in BOO caused by benign prostatic hyperplasia, by orally administering a therapeutically effective amount of vibegron per day, it differs from that of the instantly claimed invention in that it does not specifically teach 75 mg vibegron/day.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the amount of vibegron in the combination of Berger and Knutson to arrive at 75 mg vibegron. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Berger teaches a daily dosage of 0.7mg to about 3500 mg vibegron for the treatment of OAB,
-Berger teaches that the dosage regimen may be adjusted to provide the optimal therapeutic response, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP 2144.05(II).
As such, an ordinary artisan would have been motivated to administer 75 mg vibegron to predictably arrive at an optimum dosage amount of vibegron that provides the optimal therapeutic response for the treatment of OAB and the benign prostatic hyperplasia in BOO patients.
Further regarding claim 58 and regarding claim 60, while the combination of Berger and Knutson, teaches a method of treating OAB in patients with BOO caused by benign prostatic hyperplasia, by orally administering 75mg vibegron/day, it differs from that of the instantly claimed invention in that it does not teach monitoring the subject for signs and/or symptoms of urinary retention.
Muruganandham teaches that acute urinary retention (AUR) is one of the most significant, uncomfortable, and inconvenient events associated with benign prostatic hyperplasia(abstract). Benign prostatic hyperplasia is the cause of AUR in at least 65% of men presenting with AUR. “Acute urinary retention represents one of the most significant and painful events in the natural history of benign prostatic hyperplasia. . .Acute urinary retention is associated with significant anxiety, discomfort and patient inconvenience” (abstract; pg. 347, Col. 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add a step of monitoring a subject for signs and symptoms of urinary retention, in the combined method of Berger and Knutson, to arrive at the instant claims 58 and 60. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-both Muruganandham and the combination of Berger and Knutson are directed toward treating patients with benign prostatic hyperplasia, and
-Muruganandham teaches urinary retention as one of the most significant, uncomfortable, and inconvenient events in benign prostatic hyperplasia that results in pain and anxiety.
As such, an ordinarily skilled artisan would have been motivated to make such an addition, to predictably arrive at a method that minimizes the onset of and thus negative effects of urinary retention.
Regarding claim 61 and 62, Muruganandham teaches that benign prostatic hyperplasia is the cause of urinary retention in at least 65% of men. As such, it would reasonably be expected that the patient population in the combined method of Berger, Knutson, and Muruganandham, would comprise both patients experiencing urinary retention and patient not experiencing urinary retention, since Muruganandham teaches that benign prostatic hyperplasia is the cause of urinary retention in at least 65% of men.
Regarding claims 63 and 73, Berger teaches vibegron as treating urinary incontinence, urinary urgency, urge urinary incontinency.
Regarding claim 64, Berger teaches that the compounds can take a wide variety of forms depending on the form of preparation for administration, e.g., oral or parenteral, and Berger specifically teaches powders, capsules and tablets. (Col. 16, lines 50-67). Though Berger does not explicitly teach a crushed unit dose, Berger teaches that the compounds can take a wide variety of forms and teaches powder forms. As such, an ordinarily skilled artisan would have been motivated to modify the tablet form of the vibegron in the combined method of Berger, Knutson and Muruganandham, to a crushed form, to predictably arrive at a form that is easily swallowed and which effectively treats OAB symptoms in patients with BOO.
Regarding claim 67, Berger teaches the dosage as a daily dosage.
Regarding claim 68, Berger teaches the dosages “in the case of a 70 kg adult human” (Col. 15, line 65; See also Col. 15, lines 25, 46).
Regarding claim 69, the combination of Berger, Knutson and Muruganandham teaches a method of treating OAB in BOO caused by benign prostatic hyperplasia. Since only males have prostates, the limitation of “the subject is male,” is met.
Regarding claims 70-71, Berger teaches administration of vibegron in its free base form or its salt form (Col. 22, claim 10; Col. 19, lines 15-40; Col. 139, Example 100).
Regarding claim 72, Berger teaches tablets and specifically teaches tablets and capsules as the most advantageous oral dosage unit forms (Col. 15, lines 45-52; Col. 16, lines 50-Col. 17, lines 5).
Claims 65-66 are rejected under 35 U.S.C. 103 as being unpatentable over US 8,247,415 to Berger (published 2012, IDS of 12/20/2022) in view of Knutson (BPH with Coexisting Overactive Bladder Dysfunction-An Everyday Urological Dilemma, Neurology and Urodynamics, published 2001, PTO-892) and Muruganandham (Acute urinary retention in benign prostatic hyperplasia: Risk factors and current management, Indian Jn of Urology, published 2007, PTO-892), as applied to claims 58, 60-64, and 67-73 above, and further in view of McLachlan (Meal and Medicines, Australian Prescriber, published 2006, PTO-892 of 03/10/2025).
Berger, Knutson, and Muruganandham are applied as discussed above and incorporated herein.
While the combination of Berger, Knutson, and Muruganandham teaches a method of treating OAB in patients with BOO by administering 75 mg vibegron/day, and monitoring the subject for signs and/or symptoms of urinary retention, it differs from that of the instantly claimed invention in that it does not teach administration with a meal or more than two hours prior to a meal.
McLachlan teaches that food and its constituents may have a significant effect on both the rate and extent of absorption of drugs after oral administration (pg. 40, “Summary”).
McLachlan teaches that understanding the possible clinical implications of taking medicines with or without meals is important for achieving quality use of medicines. Although the effect of food is not clinically important for many drugs, there are food-drug interactions which may have adverse consequences. Often these interactions can be avoided by advising the patient to take their medicines at the same time with respect to meals (pg. 40, “Introduction”).
McLachlan teaches that prescribing a drug regimen that fits with the patient’s daily routine (which is usually centered around mealtimes) can enhance the patient’s adherence to treatment. This leads to the general recommendation that patients should take their medicines at prescribed and consistent times relative to their meals. This is despite the fact that the absorption of some medicines may be significantly reduced when taken with food. Some medicines are taken with food to minimize the risk of gastrointestinal adverse effects (pg. 42, “Taking medicines with meals to help adherence, tolerability, and efficacy”).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the combined method of Berger, Knutson, and Muruganandham, by administering the vibegron with a meal or more than two hours before a meal, to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-McLachlan teaches that prescribing a drug regimen that fits in with the patient’s daily routine, such as mealtimes, can enhance the patient’s adherence to treatment,
-McLachlan teaches that administering a drug with meals can minimize the risk of gastrointestinal adverse effects, and
-McLachlan teaches that food and its constituents may have a significant effect on both the rate and extent of absorption of drugs after oral administration.
As such, an ordinarily skilled artisan would have been motivated to administer the vibegron in the combined method of Berger, Knutson, and Muruganandham, with a meal or more than two hours prior to a meal, to predictably arrive at a method that increases a patient’s adherence to treatment, that minimizes the risk of gastrointestinal adverse effects, and that has the greatest impact and absorption of the drug and hence, therapeutic effect.
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 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/apply/applying-online/eterminal-disclaimer.
Claims 58 and 60-73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 11-12 of U.S. Patent No. 12,102,638 (2024, IDS of 12/24/2024) in view of Berger (published 2012, IDS of 12/20/2022) in view of Knutson (BPH with Coexisting Overactive Bladder Dysfunction-An Everyday Urological Dilemma, Neurology and Urodynamics, published 2001, PTO-892) and Muruganandham (Acute urinary retention in benign prostatic hyperplasia: Risk factors and current management, Indian Jn of Urology, published 2007, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘638 claims a method of treating OAB in a human by administering 75 mg/day of vibegron or a salt thereof (claim 1).
Regarding claims 63 and 73,‘638 claims treating one or more symptoms selected from urge urinary incontinence, urinary urgency, urinary frequency, nocturia, or a combination thereof (claims 2-3).
Regarding claim 65, ‘638 claims administration once per day and administration with a meal or without a meal (claims 4-5).
Regarding claim 66, an artisan having ordinary skill in the art would have been motivated to optimize the timing of the administration of the meal and the vibegron, to optimize the therapeutic effectiveness, while minimizing any negative side-effects, of the vibegron.
Regarding claim 64, ‘638 claims a crushed tablet (claim 8).
Regarding claims 68-69, ‘638 claims female and male subjects (claims 11-12).
Regarding claim 72, ‘638 claims a tablet (claim 7), wherein a tablet form connotes oral administration.
Regarding claim 58, while ‘638 teaches a method of treating OAB by orally administering 75 mg/day vibegron, it differs from that of the instantly claimed invention in that it does not teach treating the OAB in a patient with BOO.
Berger and Knutson are applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select patients with BOO and OAB as the patients treated by the methods of ‘638, to arrive at a method of treating OAB in a subject with BOO. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘638 claims a method of treating OAB by administering 75mg vibegron,
-Berger teaches vibegron as treating both overactive bladder and benign prostatic hyperplasia, and
-Knutson teaches that benign prostatic hyperplasia causes BOO and that 45% of BOO patients have OAB.
As such, an ordinary skilled artisan would have been motivated to make such a selection, to predictably arrive at a method that treats the overactive bladder symptoms in a patient with BOO that is caused by benign prostatic hyperplasia, and that treats the benign prostatic hyperplasia causing the bladder outlet obstruction, thus treating both conditions at once and increasing the patient’s quality of life.
Further regarding claim 58 and regarding claim 60, while the combination of Berger and Knutson, teaches a method of treating OAB in patients with BOO by orally administering 75mg vibegron/day, it differs from that of the instantly claimed invention in that it does not teach monitoring the subject for signs and/or symptoms of urinary retention.
Muruganandham is applied as discussed above and incorporated herein.
Muruganandham teaches that acute urinary retention is one of the most significant in benign prostatic hyperplasia(abstract). Benign prostatic hyperplasia is the cause of AUR in at least 65% of men presenting with AUR. “Acute urinary retention represents one of the most significant and painful events in the natural history of benign prostatic hyperplasia. . .Acute urinary retention is associated with significant anxiety, discomfort and patient inconvenience” (pg. 347, Col. 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add a step of monitoring a subject for signs and symptoms of urinary retention, in the combined method of ‘638, Berger, and Knutson, to arrive at the instant claim 58. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-both Muruganandham and the combination of ‘638, Berger, and Knutson are directed toward treating patients with benign prostatic hyperplasia, and
-Muruganandham teaches urinary retention as one of the most significant, uncomfortable, and inconvenient events in benign prostatic hyperplasia and teaches that it results in pain and anxiety.
As such, an ordinarily skilled artisan would have been motivated to make such an addition, to predictably arrive at a method that monitors for symptoms and/or signs urinary retention and to avoid the anxiety, discomfort and inconvenience of urinary retention.
Regarding claim 61 and 62, Muruganandham teaches that benign prostatic hyperplasia is the cause of urinary retention in at least 65% of men. As such, it would reasonably be expected that the patient population in the combined method of ‘638, Berger, Knutson, and Muruganandham, would comprise both patients experiencing urinary retention and patient not experiencing urinary retention, since Muruganandham teaches that benign prostatic hyperplasia is the cause of urinary retention in at least 65% of men.
Regarding claim 67, ‘638 claim “75 mg per day of vibegron” (claim 1).
Regarding claims 70-71, ‘638 claims and Berger teaches administration of vibegron in its free base form or its salt form, to treat OAB (‘638-claim 1; Berger--Col. 22, claim 10; Col. 19, lines 15-40; Col. 139, Example 100).
Claims 58 and 60-73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 11-12 of U.S. Patent No. 12,357,363 (PTO-892) in view of Berger (published 2012, IDS of 12/20/2022) in view of Knutson (BPH with Coexisting Overactive Bladder Dysfunction-An Everyday Urological Dilemma, Neurology and Urodynamics, published 2001, PTO-892) and Muruganandham (Acute urinary retention in benign prostatic hyperplasia: Risk factors and current management, Indian Jn of Urology, published 2007, PTO-892).
Note: This rejection was previously a provisional rejection made over copending application no. 17/311,239. This application has now issued into Patent No. 12,357,363.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 58 and 68-69, and 71,‘636 claims a method of treating OAB in a human male by orally administering 60-90mg/day of vibegron, wherein the subject is on pharmacological therapy for benign prostatic hyperplasia (claims 1, 26). ‘636 claims 75mg vibegron (claim 9).
Regarding claims 58, 63, 68-69, 71, and 73, ‘636 claims a method of treating OAB in a male by orally administering 75mg/day vibegron, wherein the symptoms comprise urge urinary incontinence, urgency, and urinary frequency, wherein the subject is on pharmacological therapy for benign prostatic hyperplasia (claims 19-20).
Regarding claims 63 and 73,‘636 claims treating one or more symptoms selected from urge urinary incontinence, urinary urgency, urinary frequency, nocturia, or a combination thereof (claims 2-3, 11).
Regarding claim 67, ‘636 claims administration once per day (claim 10).
Regarding claim 71, 636 claims vibegron.
Regarding claim 58, while ‘636 teaches a method of treating OAB by administering 75 mg/day vibegron, in a patient with benign prostatic hyperplasia, it differs from that of the instantly claimed invention in that it does not teach the patient as having a BOO.
Berger and Knutson are applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select patients with BOO caused by benign prostatic hyperplasia, and OAB as the patients treated by the methods of ‘636, to arrive at a method of treating OAB in a subject with BOO. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘636 claims a method of treating OAB in a patient with benign prostatic hyperplasia by administering 75mg/day vibegron,
-Berger vibegron as treating both overactive bladder and benign prostatic hyperplasia, and
-Knutson teaches that benign prostatic hyperplasia causes BOO, and that 45% of BOO patients also have OAB.
As such, an ordinary skilled artisan would have been motivated to make such a selection, to predictably arrive at a method that treats the overactive bladder symptoms and the benign prostatic hyperplasia in patients with BOO, thus treating both conditions at once and increasing the patients’ qualities of life.
Further regarding claim 58 and regarding claim 60, while the combination of ‘636, Berger, and Knutson, teaches a method of treating OAB in patients with BOO caused by benign prostatic hyperplasia, by orally administering 75 mb vibegron/day, it differs from that of the instantly claimed invention in that it does not teach monitoring the subject for signs and/or symptoms of urinary retention.
Muruganandham is applied as discussed above and incorporated herein.
Muruganandham teaches that acute urinary retention is one of the most significant in benign prostatic hyperplasia(abstract). Benign prostatic hyperplasia is the cause of AUR in at least 65% of men presenting with AUR. “Acute urinary retention represents one of the most significant and painful events in the natural history of benign prostatic hyperplasia. . .Acute urinary retention is associated with significant anxiety, discomfort and patient inconvenience” (pg. 347, Col. 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add a step of monitoring a subject for signs and symptoms of urinary retention, in the combined method of ‘636, Berger, and Knutson, to arrive at the instant claim 58. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-both Muruganandham and the combination of ‘636, Berger, and Knutson are directed toward treating patients with benign prostatic hyperplasia, and
-Muruganandham teaches urinary retention as one of the most significant, uncomfortable, and inconvenient events in benign prostatic hyperplasia that results in pain and anxiety.
As such, an ordinarily skilled artisan would have been motivated to make such an addition, to predictably arrive at a method that minimizes the onset of and thus effects of urinary retention.
Regarding claim 61 and 62, Muruganandham teaches that benign prostatic hyperplasia is the cause of urinary retention in at least 65% of men. As such, it would reasonably be expected that the patient population in the combined method of ‘636, Berger, Knutson, and Muruganandham, would comprise both patients experiencing urinary retention and patient not experiencing urinary retention, since Muruganandham teaches that benign prostatic hyperplasia is the cause of urinary retention in at least 65% of men.
Regarding claim 64, Berger teaches that the compounds can take a wide variety of forms depending on the form of preparation for administration, e.g., oral or parenteral, and Berger specifically teaches powders, capsules and tablets. (Col. 16, lines 50-67). Though Berger does not explicitly teach a crushed unit dose, Berger teaches that the compounds can take a wide variety of forms and teaches powder forms. As such, an ordinarily skilled artisan would have been motivated to modify the tablet form of the vibegron in the combined method of ‘636, Berger, Knutson and Muruganandham, to a crushed form, to predictably arrive at a form that is easily swallowed and which effectively treats OAB symptoms in patients with BOO.
Regarding claims 65 and 66, an artisan having ordinary skill in the art would have been motivated to optimize the timing of the administration of vibegron and a meal, to optimize the therapeutic effectiveness, while minimizing any negative side-effects, of vibegron.
Regarding claims 70 and 72, Berger teaches salt forms of vibegron and teaches vibegron administered as a tablet.
Claims 58, 60-73 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 28-31 of copending Application No. 19/190,296 (reference application, claim set dated 10/02/2025) in view of Berger (published 2012, IDS of 12/20/2022) in view of Knutson (BPH with Coexisting Overactive Bladder Dysfunction-An Everyday Urological Dilemma, Neurology and Urodynamics, published 2001, PTO-892) and Muruganandham (Acute urinary retention in benign prostatic hyperplasia: Risk factors and current management, Indian Jn of Urology, published 2007, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 58, 67, and 71, ‘296 claims a method of treating OAB by orally administering about 60-90mg vibegron, per day (claim 1). In the case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art” a prima facie case of obviousness exists. See MPEP 2144.05. ‘296 specifically claims 75 mg vibegron (claim 4).
Regarding claims 63, and 73, ‘296 claims treating one or more symptoms selected from urge urinary incontinence, urinary urgency, urinary frequency, nocturia, or a combination thereof (claims 5-6).
Regarding claims 68-69, ‘296 claims male and female human subjects (claims 7-9).
Regarding claim 58, while ‘296 teaches a method of treating OAB by orally administering 75 mg/day vibegron, it differs from that of the instantly claimed invention in that it does not teach the patient as having a BOO.
Berger and Knutson are applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select patients with BOO and OAB as the patients treated by the methods of ‘296, to arrive at a method of treating OAB in a subject with BOO. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘296 claims a method of treating OAB by administering 75mg vibegron,
-Berger teaches vibegron as treating both overactive bladder and benign prostatic hyperplasia, and
-Knutson teaches that BOO is caused benign prostatic hyperplasia and that 45% of BOO patients have OAB.
As such, an ordinary skilled artisan would have been motivated to make such a selection, to predictably arrive at a method that treats both the overactive bladder symptoms in a patient and the benign prostatic hyperplasia which causes the bladder outlet obstruction, thus treating both conditions at once and increasing the patient’s quality of life.
Further regarding claim 58 and regarding claim 60, while the combination of ‘296, Berger and Knutson teaches a method of treating OAB in patients with BOO by orally administering 75 mb vibegron/day, it differs from that of the instantly claimed invention in that it does not teach monitoring the subject for signs and/or symptoms of urinary retention.
Muruganandham is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add a step of monitoring a subject for signs and symptoms of urinary retention, in the combined method of ‘296, Berger, and Knutson, to arrive at the instant claim 58. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-both Muruganandham and the combination of ‘296, Berger, and Knutson are directed toward treating patients with benign prostatic hyperplasia, and
-Muruganandham teaches urinary retention as one of the most significant, uncomfortable, and inconvenient events in benign prostatic hyperplasia that results in pain and anxiety.
As such, an ordinarily skilled artisan would have been motivated to make such an addition, to predictably arrive at a method that minimizes the onset of and thus effects of urinary retention.
Regarding claim 61 and 62, Muruganandham teaches that benign prostatic hyperplasia is the cause of urinary retention in at least 65% of men. As such, it would reasonably be expected that the patient population in the combined method of ‘296, Berger, Knutson, and Muruganandham, would comprise both patients experiencing urinary retention and patient not experiencing urinary retention, since Muruganandham teaches that benign prostatic hyperplasia is the cause of urinary retention in at least 65% of men.
Regarding claim 64, Berger teaches that the compounds can take a wide variety of forms depending on the form of preparation for administration, e.g., oral or parenteral, and Berger specifically teaches powders, capsules and tablets. (Col. 16, lines 50-67). Though Berger does not explicitly teach a crushed unit dose, Berger teaches that the compounds can take a wide variety of forms and teaches powder forms. As such, an ordinarily skilled artisan would have been motivated to modify the tablet form of the vibegron in the combined method of ‘296, Berger, Knutson and Muruganandham, to a crushed form, to predictably arrive at a form that is easily swallowed and which effectively treats OAB symptoms in patients with BOO.
Regarding claims 65 and 66, an artisan having ordinary skill in the art would have been motivated to optimize the timing of the administration of vibegron and a meal, to optimize the therapeutic effectiveness, while minimizing any negative side-effects, of vibegron.
Regarding claims 70 and 72, Berger teaches salt forms of vibegron and teaches vibegron administered as a tablet.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 58 and 60-73 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 16-20 of copending Application No. 19/236,766 (reference application, claim set dated 06/12/2025) in view of Berger (published 2012, IDS of 12/20/2022) in view of Knutson (BPH with Coexisting Overactive Bladder Dysfunction-An Everyday Urological Dilemma, Neurology and Urodynamics, published 2001, PTO-892) and Muruganandham (Acute urinary retention in benign prostatic hyperplasia: Risk factors and current management, Indian Jn of Urology, published 2007, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 58, ‘766 claims a method of treating OAB in a subject with benign prostatic hyperplasia by orally administering about 60-90mg vibegron, per day (claim 1). In the case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art” a prima facie case of obviousness exists. See MPEP 2144.05. ‘766 claims 75 mg vibegron (claim 4).
Regarding claims 63 and 73, ‘766 claims treating one or more symptoms selected from urge urinary incontinence, urinary urgency, urinary frequency, nocturia, or a combination thereof (claims 5-6).
Regarding claim 65, ‘766 claims administration with and without a meal (claims 17-18).
Regarding claim 66, an artisan having ordinary skill in the art would have been motivated to optimize the timing of the administration of the meal and the vibegron, to optimize the therapeutic effectiveness, while minimizing any negative side-effects, of the vibegron.
Regarding claim 67, ‘766 claims administration once per day (claim 16).
Regarding claims 68-69, ‘766 claims male human subjects (claims 7-9).
Regarding claims 70-71, ‘766 claims vibegron administered as a free base and a salt (claims 19-20).
Regarding claim 58, while ‘766 teaches a method of treating OAB in a subject with benign prostatic hyperplasia by orally administering about 60-90mg vibegron, per day, it differs from that of the instantly claimed invention in that it does not teach the patient as having a BOO.
Berger and Knutson are applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select patients with BOO and OAB as the patients treated by the methods of ‘766, to arrive at a method of treating OAB in a subject with BOO. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘766 claims a method of treating OAB in a patient with benign prostatic hyperplasia by administering 75mg/day vibegron,
-Berger teaches vibegron as treating both overactive bladder and benign prostatic hyperplasia, and
-Knutson teaches that benign prostatic hyperplasia causes BOO, and that 45% of BOO patients also have OAB.
As such, an ordinary skilled artisan would have been motivated to make such a selection, to predictably arrive at a method that treats the overactive bladder symptoms and the benign prostatic hyperplasia in patients with BOO, thus treating both conditions at once and increasing the patients’ qualities of life.
Further regarding claim 58 and regarding claim 60, while the combination of ‘766, Berger, and Knutson, teaches a method of treating OAB in patients with BOO caused by benign prostatic hyperplasia, by orally administering 75 mb vibegron/day, it differs from that of the instantly claimed invention in that it does not teach monitoring the subject for signs and/or symptoms of urinary retention.
Muruganandham is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add a step of monitoring a subject for signs and symptoms of urinary retention, in the combined method of ‘766, Berger, and Knutson, to arrive at the instant claim 58. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-both Muruganandham and the combination of ‘766, Berger, and Knutson are directed toward treating patients with benign prostatic hyperplasia, and
-Muruganandham teaches urinary retention as one of the most significant, uncomfortable, and inconvenient events in benign prostatic hyperplasia that results in pain and anxiety.
As such, an ordinarily skilled artisan would have been motivated to make such an addition, to predictably arrive at a method that minimizes the onset of and thus effects of urinary retention.
Regarding claim 61 and 62, Muruganandham teaches that benign prostatic hyperplasia is the cause of urinary retention in at least 65% of men. As such, it would reasonably be expected that the patient population in the combined method of ‘766, Berger, Knutson, and Muruganandham, would comprise both patients experiencing urinary retention and patient not experiencing urinary retention, since Muruganandham teaches that benign prostatic hyperplasia is the cause of urinary retention in at least 65% of men.
Regarding claim 64, Berger teaches that the compounds can take a wide variety of forms depending on the form of preparation for administration, e.g., oral or parenteral, and Berger specifically teaches powders, capsules and tablets. (Col. 16, lines 50-67). Though Berger does not explicitly teach a crushed unit dose, Berger teaches that the compounds can take a wide variety of forms and teaches powder forms. As such, an ordinarily skilled artisan would have been motivated to modify the tablet form of the vibegron in the combined method of ‘766, Berger, Knutson and Muruganandham, to a crushed form, to predictably arrive at a form that is easily swallowed and which effectively treats OAB symptoms in patients with BOO.
Regarding claim 72, Berger teaches salt forms of vibegron and teaches vibegron administered as a tablet.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 58 and 60-73 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 16-20 of copending Application No. 19/402,207 (reference application, claim set dated 11/26/2025) in view of Berger (published 2012, IDS of 12/20/2022) in view of Knutson (BPH with Coexisting Overactive Bladder Dysfunction-An Everyday Urological Dilemma, Neurology and Urodynamics, published 2001, PTO-892) and Muruganandham (Acute urinary retention in benign prostatic hyperplasia: Risk factors and current management, Indian Jn of Urology, published 2007, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 58, ‘207 claims a method of treating OAB in a subject with benign prostatic hyperplasia by orally administering about 60-90mg vibegron, per day (claim 1). In the case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art” a prima facie case of obviousness exists. See MPEP 2144.05. ‘207 claims 75 mg vibegron (claim 4).
Regarding claims 63 and 73, ‘207 claims treating one or more symptoms selected from urge urinary incontinence, urinary urgency, urinary frequency, nocturia, or a combination thereof (claims 5-6).
Regarding claim 65, ‘207 claims administration with and without a meal (claims 17-18).
Regarding claim 66, an artisan having ordinary skill in the art would have been motivated to optimize the timing of the administration of the meal and the vibegron, to optimize the therapeutic effectiveness, while minimizing any negative side-effects, of the vibegron.
Regarding claim 67, ‘207 claims administration once per day (claim 16).
Regarding claims 68-69, ‘207 claims male human subjects (claims 7-9).
Regarding claims 70-71, ‘207 claims vibegron administered as a free base and a salt (claims 19-20).
Regarding claim 58, while ‘207 teaches a method of treating OAB in a subject with benign prostatic hyperplasia by orally administering about 75 mg vibegron, per day, it differs from that of the instantly claimed invention in that it does not teach the patient as having a BOO.
Berger and Knutson are applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select patients with BOO and OAB as the patients treated by the methods of ‘207, to arrive at a method of treating OAB in a subject with BOO. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘207 claims a method of treating OAB in a patient with benign prostatic hyperplasia by administering 75mg/day vibegron,
-Berger teaches vibegron as treating both overactive bladder and benign prostatic hyperplasia, and
-Knutson teaches that benign prostatic hyperplasia causes BOO, and that 45% of BOO patients also have OAB.
As such, an ordinary skilled artisan would have been motivated to make such a selection, to predictably arrive at a method that treats the overactive bladder and the benign prostatic hyperplasia in patients with BOO, thus treating both conditions at once and increasing the patients’ qualities of life.
Further regarding claim 58 and regarding claim 60, while the combination of ‘207, Berger, and Knutson, teaches a method of treating OAB in patients with BOO caused by benign prostatic hyperplasia, by orally administering 75 mb vibegron/day, it differs from that of the instantly claimed invention in that it does not teach monitoring the subject for signs and/or symptoms of urinary retention.
Muruganandham is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add a step of monitoring a subject for signs and symptoms of urinary retention, in the combined method of ‘207, Berger, and Knutson, to arrive at the instant claim 58. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-both Muruganandham and the combination of ‘207, Berger, and Knutson are directed toward treating patients with benign prostatic hyperplasia, and
-Muruganandham teaches urinary retention as one of the most significant, uncomfortable, and inconvenient events in benign prostatic hyperplasia that results in pain and anxiety.
As such, an ordinarily skilled artisan would have been motivated to make such an addition, to predictably arrive at a method that minimizes the onset of and thus effects of urinary retention.
Regarding claim 61 and 62, Muruganandham teaches that benign prostatic hyperplasia is the cause of urinary retention in at least 65% of men. As such, it would reasonably be expected that the patient population in the combined method of ‘207, Berger, Knutson, and Muruganandham, would comprise both patients experiencing urinary retention and patient not experiencing urinary retention, since Muruganandham teaches that benign prostatic hyperplasia is the cause of urinary retention in at least 65% of men.
Regarding claim 64, Berger teaches that the compounds can take a wide variety of forms depending on the form of preparation for administration, e.g., oral or parenteral, and Berger specifically teaches powders, capsules and tablets. (Col. 16, lines 50-67). Though Berger does not explicitly teach a crushed unit dose, Berger teaches that the compounds can take a wide variety of forms and teaches powder forms. As such, an ordinarily skilled artisan would have been motivated to modify the tablet form of the vibegron in the combined method of ‘207, Berger, Knutson and Muruganandham, to a crushed form, to predictably arrive at a form that is easily swallowed and which effectively treats OAB symptoms in patients with BOO.
Regarding claim 72, Berger teaches vibegron administered as a tablet.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/LAUREN WELLS/Examiner, Art Unit 1622
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