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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/17/2026 has been entered.
Status of Claims
Claims 1-2 and 4-20 are pending and examined on the merits.
Claims 1 and 14 are currently amended.
Claim 3 is cancelled.
Response to Amendment
Applicant’s amendments filed 02/17/2026 have been fully considered.
Response to Arguments
Applicant’s arguments filed 02/17/2026 have been fully considered. Applicant amended the independent claim(s) which requires a new ground of rejection. Accordingly, Applicant’s arguments have been considered but they are moot. Specifically, O’Flynn (U.S. Pre Grant Pub. No. 2020/0360174 A1) and Farris (U.S. Patent No. 6,131,736 A) are introduced as primary and secondary references for disclosing and rendering obvious the limitations presented via the amendments. Burtoft (U.S. Pre Grant Pub. No. 2006/0189962 A1) and Gloth (U.S. Patent No. 5,813,973 A) are introduced as secondary references for disclosing and rendering obvious some of the limitations.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-2, 4-13, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over O’Flynn (U.S. Pre Grant Pub. No. 2020/0360174 A1) in view of Farris (U.S. Patent No. 6,131,736 A).
Regarding claim 1, O’Flynn teaches: A urinary catheter collection bag (see Abstract; additionally, para. [0070] teaches that the embodiments described contain features that can be combined by those skilled in the art, therefore, the individual embodiments shown in the figures can have features that are combinable), comprising
a first flexible wall having a perimeter (see for example the wall shown in the figures containing marked lines showing volume; i.e., the wall towards the reader in Fig. 3; see also para. [0046]);
a second flexible wall having a perimeter (see for example the wall opposite the wall shown in the figures containing marked lines showing volume; i.e., the wall away from the reader in Fig. 3; see also para. [0046]);
a perimeter seal (see perimeter seal 12 in Fig. 3 and para. [0047]) joining at least a portion of the perimeter of the first flexible wall to at least a portion of the perimeter of the second flexible wall (see para. [0047]) to define a cavity between the first and second flexible walls (see interior of bag 10 in Fig. 3), the cavity for collecting and retaining urine (see Abstract), the seal defining a boundary of the collection bag (see perimeter seal 12 in para. [0047]);
a port for connecting to a urinary catheter (see port 20 in Fig. 3 and para. [0047]), wherein the port extends through the boundary (see Fig. 3);
a tearable portion located in the first flexible wall and/or the second flexible wall (see tear line 30 in Fig. 3 and para. [0049]; see also at least tear lines 58, 118, 158, and 656 in the other figures and para. [0045]), the tearable portion extending within the boundary of the collection bag (see for example Fig. 3), wherein when the tearable portion is torn to open and expose the cavity for emptying urine from the cavity (see for example para. [0006 and 0049]); and
a tear starting member extending from the tearable portion (see for example tear starting formation 26 at least in Fig. 3).
However, O’Flynn fails to explicitly teach that the tearable portion comprises a tear strip or that the tear starting member extends beyond the boundary of the bag, as required by the claim.
Farris teaches an analogous tearable container (see Fig. 6B) comprising a tear strip (see tear strip 54 at least in Fig. 6B and col. 8, lines 52-64) and a tear starting member (see disruptive member 50 in Fig. 6B and col. 8, lines 52-64) extending beyond the boundary of the bag (see Fig. 6B).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of O’Flynn to incorporate the teachings of Farris by including a tear strip in the form of a weakened and/or perforated portion and a tear starting member extending beyond the boundary of the bag at least to enable a user to grasp the tear starting member in order to pull it along the line of the tear strip which should readily disrupt the tear strip such that the package is opened along the entire length of the tear strip, as taught by Farris (see at least Figs. 6B and 7 and col. 7, line 65 thru col. 8, line 6).
Regarding claim 2, O’Flynn in view of Farris teaches the invention as discussed above in claim 1. Additionally, in the device of O’Flynn in view of Farris, the tear starting member is integral with the first and second flexible walls at least because the tear starting member of Farris is integrally connected with the tearable portion, which is integral with the first and second flexible walls (see for example Fig. 3 of O’Flynn and Fig. 6B of Farris).
Regarding claim 4, O’Flynn in view of Farris teaches the invention as discussed above in claim 1. Additionally, O’Flynn teaches wherein the first flexible wall includes a first top tear line and a second bottom tear line extending from the tear starting member and the second flexible wall includes a top tear line and a bottom tear line extending from the starting member (as shown in Fig. 28, and as broadly recited, each of the first and second walls, which are the walls towards and away from the reader, have a top tear line marked by numeral 752 and a bottom tear line marked by the arrow and adjacent numeral 764).
Regarding claim 5, O’Flynn in view of Farris teaches the invention as discussed above in claim 4. Additionally, O’Flynn teaches wherein the tear lines selectively direct tearing of the first and the second flexible walls (see for example arrow showing direction of the tear in Fig. 28 and para. [0045 and 0059]).
Regarding claim 6, O’Flynn in view of Farris teaches the invention as discussed above in claim 4. Additionally, O’Flynn teaches wherein the tear lines are score lines (para. [0049], at least, teaches a tear line that allows a user to create a generally linear tear along the tear line; therefore, the tear line is a score line).
Regarding claim 7, O’Flynn in view of Farris teaches the invention as discussed above in claim 4. Additionally, O’Flynn teaches wherein the tear lines are defined by a directional tear polymer (see para. [0046]).
Regarding claim 8, O’Flynn in view of Farris teaches the invention as discussed above in claim 4. Additionally, the device of O’Flynn in view of Farris teaches wherein the first top and second bottom tear lines are defined by a tear tape (as described above in claim 1, Farris teaches a tear tape in the form of a tear strip; see col. 8, lines 52-64 of Farris).
Regarding claim 9, O’Flynn in view of Farris teaches the invention as discussed above in claim 4. Additionally, O’Flynn teaches wherein tear lines extend to a cutout in the bag (see for example formation seal 64 in Fig. 4 or tear-stopping formation 756 in Figs. 28-29).
Regarding claim 10, O’Flynn in view of Farris teaches the invention as discussed above in claim 9. Additionally, O’Flynn teaches wherein the cutout comprises a terminus for the tear lines (see at least Figs. 28-29).
Regarding claim 11, O’Flynn in view of Farris teaches the invention as discussed above in claim 9. Additionally, O’Flynn teaches wherein the cutout forms a handle for gripping the bag (as broadly recited, the tear-stopping formation 756 in Figs. 28-29 can be used as a handle for gripping the bag).
Regarding claim 12, O’Flynn in view of Farris teaches the invention as discussed above in claim 4. Additionally, O’Flynn teaches wherein the bag has a generally rectangular shape having a first side boundary and second side boundary and the tear starting member extends from one of the side boundaries (see for example the figures in O’Flynn).
Regarding claim 13, O’Flynn in view of Farris teaches the invention as discussed above in claim 12. Additionally, O’Flynn teaches wherein the first and second tear lines extend from the one of the side boundaries toward the other of the side boundaries (see for example Figs. 28-29).
Regarding claim 15, O’Flynn teaches: A method for emptying a urinary catheter collection bag (see at least Abstract), comprising the steps of:
actuating a starting member (see at least para. [0051] and Fig. 4);
moving the starting member along a score line toward a cutout, such that the bag tears along the score line (para. [0051] and Fig. 4 describe the bag 50 as tearing from tear-starting formation toward handle seal 52 along tear line 58 while stopping at tear-stopping formation 62);
stopping the tear at the cutout (see para. [0051] and Fig. 4), such that the bag does not tear past a second boundary and the tear forms an opening along a portion of the bag (see para. [0051] and Fig. 4);
emptying fluid from the bag, such that urine within the bag may drain through the opening (see at least Abstract).
However, O’Flynn fails to explicitly teach wherein the starting member extends beyond a first boundary of the bag, as required by the claim.
Farris teaches a tear starting member (see disruptive member 50 in Fig. 6B and col. 8, lines 52-64) extending beyond the boundary of the bag (see Fig. 6B).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of O’Flynn to incorporate the teachings of Farris by including a tear strip in the form of a weakened and/or perforated portion and a tear starting member extending beyond the boundary of the bag at least to enable a user to grasp the tear starting member in order to pull it along the line of the tear strip which should readily disrupt the tear strip such that the package is opened along the entire length of the tear strip, as taught by Farris (see at least Figs. 6B and 7 and col. 7, line 65 thru col. 8, line 6).
Regarding claim 16, O’Flynn in view of Farris teaches the invention as discussed above in claim 15. Additionally, O’Flynn teaches wherein the bag comprises a first flexible wall having a perimeter (see for example the wall shown in the figures containing marked lines showing volume; i.e., the wall towards the reader in Fig. 3; see also para. [0046]), a second flexible wall having a perimeter (see for example the wall opposite the wall shown in the figures containing marked lines showing volume; i.e., the wall away from the reader in Fig. 3; see also para. [0046]), and a perimeter seal joining at least a portion of the perimeter of the first flexible wall to at least a portion of the perimeter of the second flexible wall (see perimeter seal 12 in Fig. 3 and para. [0047]).
Regarding claim 17, O’Flynn teaches the invention as discussed above in claim 16. Additionally, O’Flynn teaches wherein the tear starting member is integral with the first and second flexible walls (see at least Fig. 4).
Regarding claim 18, O’Flynn teaches the invention as discussed above in claim 15. Additionally, O’Flynn teaches wherein the cutout forms a handle for gripping the bag (the cutout 62 is fully capable of being used as handles).
Regarding claim 19, O’Flynn teaches the invention as discussed above in claim 15. Additionally, O’Flynn teaches wherein the bag has a generally rectangular shape having a first side boundary and second side boundary and the tear starting member extends from one of the side boundaries (see Fig. 4 and other figures).
Regarding claim 20, O’Flynn teaches the invention as discussed above in claim 19. Additionally, O’Flynn teaches wherein the score lines extend from the one of the side boundaries toward the other of the side boundaries (see Fig. 4).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Burtoft (U.S. Pre Grant Pub. No. 2006/0189962 A1) in view of Gloth (U.S. Patent No. 5,813,973 A).
Regarding claim 14, Burtoff teaches: A urinary collection bag (10 in Figs. 1-4), wherein a surface of the bag includes a drain hole (see para. [0034]); and a port for connection to a catheter (such as at numerals 38, 44, and 46 in Fig. 1 and para. [0032]).
However, Burtoff fails to explicitly teach wherein the drain hole is covered by a water soluble cover member being configured to dissolve after coming into contact with water such that the drain hole is uncovered after the cover member is dissolved, as required by the claim.
Gloth teaches an analogous urinary device (see Abstract) comprising an aperture 80’ (see Figs. 21A-D) and a water soluble plug 94 within the aperture 80’ (see col. 12, lines 39-67) that is configured to dissolve after coming into contact with water (see col. 12, lines 50-52) such that the drain hole is uncovered after the cover member is dissolved (see col. 12, lines 52-55).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burtoff to incorporate the teachings of Gloth by including a water soluble cover member to cover the drain hole at least to enable dissolution of the cover member upon contact with water, as taught by Gloth (see col. 12, lines 39-67), which would enable a user to not touch the collection bag to drain the contents.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 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, Sarah Al-Hashimi can be reached at (571) 272-7159. 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.
/JIHAD DAKKAK/ Examiner, Art Unit 3781
/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
Prosecution Insights