DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 3-4, 8, 10-12, 21, 23, 46-47, 49, 53-54, 56, 65, and 68) in the reply filed on 31 August 2026 is acknowledged.
Claims 82 and 84-85 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 31 August 2026.
Claims 1, 3-4, 8, 10-12, 21, 23, 46-47, 49, 53-54, 56, 65, and 68 are under current consideration.
Claim Objections
Claims 4 and 49 are objected to because of the following informalities: the phrase “into to” in line 2 is unclear. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 47 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 47 fails to further limit claim 46 upon which it depends in that claim 47 merely repeats the limitation of claim 46 that the bulking agent is injected into the external urethral sphincter of the subject.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, 8, 21, 23, and 68 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Williams (US 10,420,818 B2; issued 24 September 2019; of record).
Williams discloses a method of treating a sphincter disorder such as incontinence (title; abstract) wherein an intra-sphincter pharmaceutical formulation may include a viscosity-enhancing agent such as collagen (i.e., a bulking agent) to further treat the incontinence (column 6 lines 3-26) wherein the injection may be into one or more sites in the external urethral sphincter (column 6 lines 45-47) wherein the subject is a female (claim 8) wherein incontinence includes female stress urinary incontinence (page 2 first column at bottom) wherein the injection sites are distributed circumferentially around the sphincter (column 6 lines 35-43) wherein the composition can be hydrogel (column 3 lines 53-58) wherein injections can total 2 milliliters (column 7 lines 21-26) wherein the sphincter is regenerated (i.e., an amount of bulking agent sufficient to reconstruct the external urethral sphincter is administered) (column 7 lines 41-47).
Regarding claim 68, the instruction limitation therein does not confer patentability to the anticipated method as it is merely informing the subject/patient rather than requiring a positive step that functionally adds to the claimed method, per MPEP 2112.01(III), and the recitation “of improving longevity” requires no additional steps/functional limitation.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3-4, 8, 21, 23, 46-47, 49, 53, and 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Appell et al. (BJU International, 2006, Vol. 98, Supplement 1, pages 27-30).
Williams discloses a method of treating a sphincter disorder such as incontinence (title; abstract) wherein an intra-sphincter pharmaceutical formulation may include a viscosity-enhancing agent such as collagen (i.e., a bulking agent) to further treat the incontinence (column 6 lines 3-26) wherein the injection may be into one or more sites in the external urethral sphincter (column 6 lines 45-47) wherein the subject is a female (claim 8) wherein incontinence includes female stress urinary incontinence (page 2 first column at bottom) wherein the injection sites are distributed circumferentially around the sphincter (column 6 lines 35-43) wherein the composition can be hydrogel (column 3 lines 53-58) wherein injections can total 2 milliliters (column 7 lines 21-26) wherein the sphincter is regenerated (i.e., an amount of bulking agent sufficient to reconstruct the external urethral sphincter is administered) (column 7 lines 41-47).
Williams does not disclose injection at a position that is about 2-3 cm from the bladder neck as in claim 3, or endoscopic reconstruction as in claim 46.
Appell et al. discloses urethral injections for female stress incontinence (title) wherein injection is about 1.5 cm distal to the bladder neck (page 29 middle column) wherein the injection material must have adequate viscosity (page 27 last column middle) wherein endoscopic injection is less invasive, and is effective and safe (page 27 last column bottom).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Williams and Appell et al. by performing the method of Williams as discussed above and injecting the composition thereof about 1.5 cm distal to the bladder neck as suggested by Appell et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to perform such urethral injection at a location known to be suitable for female stress incontinence urethral injections per Appell et al.
It also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Williams and Appell et al. by performing the method of Williams as discussed above and injecting the composition thereof using endoscopic injection as suggested by Appell et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to perform such urethral injection such that it is less invasive, and is effective and safe as suggested by Appell et al.
Regarding claim 68, the instruction limitation therein does not confer patentability to the anticipated/obvious method as it is merely informing the subject/patient rather than requiring a positive step that functionally adds to the claimed method, per MPEP 2112.01(III), and the recitation “of improving longevity” requires no additional steps/functional limitation.
Claim(s) 1, 3-4, 8, 10-12, 21, 23, 46-47, 49, 53-54, 56, 65, and 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Appell et al. as applied to claims 1, 3-4, 8, 21, 23, 46-47, 49, 53, and 68 above, and further in view of Kasi et al. (International Urogynecology Journal, 26 July 2015, Vol. 27, pages 367-375).
Williams and Appell et al. are relied upon as discussed above.
Williams and Appell et al. do not disclose PAHG as in claim 10.
Kasi et al. discloses injectable agents used for the treatment of women with urinary stress incontinence (abstract) wherein agents include collagen and Bulkamid® PAHG polyacrylamide hydrogel with 2.5% cross-linked polyacrylamide (page 368 first column third full paragraph to bottom) wherein the PAHG is safe and effective (page 372 second column first paragraph).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Williams, Appell et al., and Kasi et al. by using the Bulkamid® PAHG polyacrylamide hydrogel with 2.5% cross-linked polyacrylamide of Kasi et al. substituted for the collagen in the method of Williams in view of Appell et al. as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to use therein an agent known to be safe and effective for treatment of women with urinary stress incontinence as suggested by Kasi et al., also given that it is prima facie obvious to substitute equivalents known for the same purpose per MPEP 2144.06(II).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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