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 .
Response to Amendment
Applicant’s amendments, mailed on 11/24/2025, have been fully considered. Claims 1-5, 12, 14, and 18-20 are pending in this application. Claims 1, 18, and 20 are amended. Claim 19 is cancelled. Claims 6-11. 13, and 15-17 are withdrawn.
Response to Arguments
The Terminal Disclosure, filed on 11/24/2015, overcomes the nonstatutory Double Patenting rejections of record. The double patenting rejections of claims 1-20 has been withdrawn.
Applicant’s amendment of claim 20 overcomes the 35 U.S.C. 112(b) rejection of record. The 112(b) rejection of claim 20 is now withdrawn.
Applicant's arguments filed on 11/24/2025, regarding amended independent claim 1 and claim 18, have been fully considered but they are not persuasive.
Regarding the argument that the prior art combination of Cochrane in view of Sullivan does not teach the amended independent claim 1, the argument is not persuasive. The applicant discusses that the prior art combination of Cochrane in view of Sullivan dose not teach “wherein the first retaining loop and the second retaining loop are configured to interlock with each other such that the first retaining loop is held in place between the user and the second retaining loop”. However, the term “interlock” is not further defined in the specification and the broadest reasonable interpretation of the term “interlock” is interpreted to be “to fit together firmly”, as defined by Cambridge Dictionary (see attached PTO-892). In the prior art of Sullivan, the second retaining loop/annular sealing strip 121 has an adhesive on its inner face to adhere and overlap the strip 115 to firmly fit together the strip 115 inbetween the second retaining loop 121 and the user (Figure 2-3; Column 2, lines 52-56). Thus, the prior art combination of Cochrane in view of Sullivan teaches the amended claim limitation of claim 1.
Regarding the argument that the prior art combination of Cochrane in view of Moss and White does not teach amended independent claim 18, now incorporating the claim limitations of now cancelled claim 19, the argument is not persuasive. More specifically, the applicant argues that Cochrane does not teach the claim limitation “the second end configured to extend past the glans of the penis, and the second opening comprising a flutter valve”. As discussed in the Non-Final Rejection, mailed on 07/24/2025, Cochrane teaches a second end comprising a second opening (second end of first sheath has an opening 18; Pg. 6, line 24 to Pg. 7, line 12 and Pg. 7, lines 9-24; Figure 4 and 5), the second end configured to extend past the glans of the penis (second end of the first sheath extends past glans of penis; Figure 4 and 5). As seen in Figure 5, the second end of the first sheath extends past and covers the glans of the penis, the penis of the user does not extend past the second end of the first sheath. Furthermore, the claim limitations requires “the second end configured to extend past the glans of the penis” and not “an extended portion”, as discussed in pg. 8 of the Remarks, mailed on 11/24/2025, thus the device of claim 18 does not require the structure of an extended portion. The teaching of Moss incorporates a flutter valve at the second opening of the second end of Cochrane (second end of inner plastic bag A contains a flutter valve 15; Figure 4; Column 1, line 68 to Column 2, lines 31-43). The teaching of White incorporates the vent openings at the first end of the first sheath of Cochrane (Figure 1; Paragraph 0020). Thus, the prior art combination of Cochrane in view of Moss and White teaches the claim limitations of amended independent claim 18.
Though overall the same prior art references are used herein, at least applicant’s amended independent claim 1 required a change in the grounds of rejection as detailed below in the prior art rejection.
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 (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 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.
Claim(s) 1-2 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Cochrane (Patent No. EP 00 68 712 A1) in view of in view of Sullivan et al. (Patent No. US 5,013,308 A).
Regarding claim 1, Cochrane teaches a fluid collection device (Page 1, lines 1-2; Figure 4) comprising: a tubular member (condom 16; Page 6, lines 9-12; Figure 4) comprising a first end with a first opening (first end/head region 15 is the end of the condom 16 that is attached to the penis and has a first opening for receiving the genitalia from the user; Page 6, lines 9-12; Figure 4 and 5) and a second end with a second opening (second end is attached to cone 34 and container 30; Page 7, lines 9-24; Figure 4), a portion of the first end configured to be adhesively secured to a user (adhesive 20 is at the first end/head region 15 of the condom 16; Page 6, lines 9-19; Figure 1 and 4) and the second end configured to fold around the first end forming a first sheath and a second sheath wherein the second sheath is outboard of the first sheath and defines an interior volume (second end folds around the first end/head region 15 to form a first sheath that is directly in contact with the penis 22 and inboard of first retaining loop/retaining ring 26 and second sheath outboard of ring 26 that has an internal cylindrical volume; Figure 4 and 5; Page 6, line 24 to Page 7, line 12); a first retaining loop having an inner diameter and an outer diameter (retaining ring/loop 26 has an inner and outer diameter; Page 6, line 31 to Page 7, line 4; Figure 4 and 5), the first retaining loop configured to be positioned outboard of the first sheath and inboard of the second sheath (Page 6, line 24 to Page 7, line 12; Figure 4 and 5). Cochrane does not teach a second retaining loop having an inner diameter and an outer diameter, the inner diameter of the second retaining loop being less than the outer diameter of the first retaining loop.
However, Sullivan teaches a second retaining loop having an inner diameter and an outer diameter (annular sealing strip 121 has an inner and outer diameter; Figure 3; Column 2, lines 52-56), the inner diameter of the second retaining loop being less than the outer diameter of the first retaining loop (annular sealing strip 121 has an inner diameter that is smaller than the outer diameter of the strip 115; Figure 3; Column 2, lines 52-56).
Cochrane and Sullivan are both considered to be analogous to the claimed invention because they are in the same field of male fluid collection devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cochrane to incorporate the teachings of Sullivan and have the second retaining loop of Sullivan be attached to the device of Cochrane. This allows for the device to be adjustably attached to the user and to the other components of the device by the adhesive and the strap and to seal the opening device to the user (Sullivan; Column 2, lines 52-60 and Column 3, lines 23-27).
The combination of Cochrane in view of Sullivan further teaches wherein the first retaining loop and the second retaining loop are configured to interlock with each other such that the first retaining loop is held in place between the user and the second retaining loop (adhesive on the inner face of the second retaining loop/annular sealing strip 121 of Sullivan provides a firm connecting fitment to the first retaining loop 26 of Cochrane to hold the first retaining loop of Cochrane in place between the second retaining loop 131 of Sullivan and the user; Sullivan; Figures 2-3; Column 2, lines 52-60; Cochrane; Page 6, line 31 to Page 7, line 4; Figure 4 and 5).
Regarding claim 2, Cochrane in view of Sullivan teaches the device of claim 1. Cochrane further teaches wherein the second sheath is configured to attach to a fluid collection bag (second sheath outboard of ring 26 is attached to cone 34 and container 30; Page 7, lines 9-24; Figure 4 and 5).
Regarding claim 14, Cochrane in view of Sullivan teaches the device of claim 1. Cochrane further teaches further comprising an adhesive layer positioned at the first end of the tubular member (adhesive 20 is at the first end/head region 15 of the condom 16; Page 6, lines 9-19; Figure 1 and 4).
Claim(s) 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Cochrane (Patent No. EP 00 68 712 A1) in view of Sullivan et al. (Patent No. US 5,013,308 A), as applied to claim 1 above, and further in view of Goulter (Patent No. US 5,618,277 A1).
Regarding claim 3, Cochrane in view of Sullivan teaches the device of claim 1. The combination of Cochrane in view of Sullivan does not teach wherein the second retaining loop is configured to attach to a harness.
However, Goulter teaches wherein the second retaining loop is configured to attach to a harness (rim 34/ second retaining loop is attached to harness/elastic waist band 98 by straps 100; Figure 18; Column 7, lines 50-59).
Cochrane in view of Sullivan and Goulter are both considered to be analogous to the claimed invention because they are in the same field of male fluid collection devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cochrane in view of Sullivan to incorporate the teachings of Goulter and have the second retaining loop with the straps of Cochrane in view of Sullivan be attached to harness of Goulter. This allows for the device to be attached around the waist of the user and prevent the accidental removal of the device from the male genitals, especially for users with spinal injuries with impaired feelings below the waistline (Goulter; Column 7, lines 50-59 and Column 9, lines 31-38).
Regarding claim 4, Cochrane in view of Sullivan and Goulter teaches the device of claim 3. The combination of Cochrane in view of Sullivan and Goulter further teaches further comprising a harness and a strap (harness/waist band 98 of Goulter is tied to the strap ST of Sullivan; Goulter; Figure 18; Column 7, lines 50-59; Sullivan; Figure 3; Column 2, lines 52-56 and Column 3, lines 23-27; see rejection of claim 3 above), the harness configured to be positioned around a user and the strap configured to connect the second retaining loop to the harness (harness/waist band 98 of Goulter is around the waist of the user and the strap ST of Sullivan connects the second retaining loop/strip 121 of Sullivan to the harness of Goulter; Goulter; Figure 18; Column 7, lines 50-59; Sullivan; Figure 3; Column 2, lines 52-56 and Column 3, lines 23-27; see rejection of claim 3 above).
Regarding claim 5, Cochrane in view of Sullivan and Goulter teaches the device of claim 4. The combination of Cochrane in view of Sullivan and Goulter further teaches wherein the strap is elastic (Sullivan; straps ST are elastomeric; Column 3, lines 23-27).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Cochrane (Patent No. EP 00 68 712 A1) in view of Sullivan et al. (Patent No. US 5,013,308 A), as applied to claim 1 above, and further in view of Martin et al. (Publication No. US 2008/0145268 A1).
Regarding claim 12, Cochrane in view of Sullivan teaches the device of claim 1. The combination of Cochrane in view of Sullivan further teaches further comprising a fluid collection bag (container 30/drainage bag; Figure 4; Page 7, lines 9-24). The combination of Cochrane in view of Sullivan does not teach the fluid collection bag comprising tongue and groove seals.
However, Martin teaches the fluid collection bag comprising tongue and groove seals (container 10 contains tongue and groove strips 20.1 and 20.2; Figure 1; Paragraph 0045).
Cochrane in view of Sullivan and Martin are both considered to be analogous to the claimed invention because they are in the same field of fluid containers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cochrane in view of Sullivan to incorporate the teachings of Martin and have the fluid collection bag of Cochrane in view of Sullivan to have tongues and grooves, as taught by Martin. This allows for the bag to be releasably sealable for easy removal of contents, when desired (Martin; Paragraph 0045).
Claim(s) 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cochrane (Patent No. EP 00 68 712 A1) in view of Moss (Patent No. US 3,559,651 A) and White (Publication No. US 2010/0125260 A1).
Regarding claim 18, Cochrane teaches a male urine collection device (Page 1, lines 1-2; Figure 4) comprising: a first sheath with a first end comprising a first opening (first end/head region 15 is the end of the condom 16 that is attached to the penis and has a first opening for receiving the genitalia from the user and first sheath is directly in contact with the penis 22 and inboard of first retaining loop/retaining ring 26; Page 6, lines 9-12 and Page 6, line 24 to Page 7; Figure 4 and 5) and a second end comprising a second opening (second end of first sheath has an opening 18; Page 6, line 24 to Page 7, line 12 and Page 7, lines 9-24; Figure 4 and 5), the first opening configured to allow the penis to be inserted into the first end of the first sheath (first opening allows for insertion of penis into the first end of the first sheath; Figure 4 and 5), the second end configured to extend past the glans of the penis (second end opposite the first end of the first sheath and extends past glans of penis; Figure 4 and 5); and a second sheath attached to the exterior of the first sheath (second sheath is outboard of first sheath and is connected to each other; Figure 4 and 5), the second sheath outboard of the second end of the first sheath and defining an interior volume (second end folds around the first end/head region 15 to form a first sheath that is directly in contact with the penis 22 and inboard of first retaining loop/retaining ring 26 and second sheath outboard of ring 26 that has an internal cylindrical volume; Figure 4 and 5; Page 6, line 24 to Page 7, line 12). Cochrane does not teach the second opening comprising a flutter valve.
However, Moss teaches the second opening comprising a flutter valve (second end of the inner plastic bag A contains a flutter valve 15; Figure 4; Column 1, line 68 to Column 2, line 5 and Column 2, lines 31-43).
Cochrane and Moss are both considered to be analogous to the claimed invention because they are in the same field of male urine collection devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cochrane to incorporate the teachings of Moss and have the flutter valve of Moss to be at the second opening of the device of Cochrane. This allows for the urine to be discharged into the collection bag but does not allow backflow of urine back up the device (Moss; Column 1, line 68 to Column 2, line 5).
The combination of Cochrane in view of Moss does not teach wherein the first end of the first sheath comprises one or more vent openings to allow airflow to a portion of the penis (device 10 has a lower opening 32 to receive a penis and contains vent holes for ventilation; Figure 1; Paragraph 0020).
Cochrane in view Moss and White are both considered to be analogous to the claimed invention because they are in the same field of male urine collection devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cochrane in view of Moss to incorporate the teachings of White and have the vent holes be at the first end of the first sheath of the device of Cochrane. This allows for the ventilation of the male genitalia of the user during daily activities (White; Paragraph 0020).
Regarding claim 20, Cochrane in view of Moss and White teaches the device of claim 18. The combination of Cochrane in view of Moss and White further teaches wherein the second end of the first sheath comprises an adhesive layer (Cochrane; adhesive 20 is at the second end/head region 15 of the first sheath where opening 18 is located; Page 6, lines 9-19; Figure 1 and 4).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781