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 .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maurice (US 2022/0031152) in view of Ramsey (US 2016/0073867) and Kim et al. (US 2020/0253639; hereinafter Kim).
Maurice shows a container arranged and configured to couple to an endoscope for use in an endoscopic procedure (Fig. 8A), the container comprising: a flexible container with a reservoir opening and configured to contain a fluid within a first receptacle thereof, the container is movable between a collapsed storage configuration and an expanded use configuration (flexible fluid source including reservoir opening/hole located at top, where flexibility is considered to allow for collapse/expansion [0043]); a water supply tube including a first end, a second end, and a first lumen extending therethrough, wherein the first lumen is in fluid communication with the first receptacle in the bottom portion of the container and the second end of the water supply tube is positioned external to the container ([0042]-[0044]; Fig. 8A); a gas supply tube including a first end, a second end, and a second lumen extending therethrough, wherein the second lumen is in operative fluid communication with the first receptacle and the second end of the gas supply tube is positioned external to the container ([0042]-[0044]; Fig. 8A); a port positioned adjacent to the top portion of the container and spaced from the reservoir opening, wherein the port is configured to selectively fluidly couple the first receptacle of the container with an external water source (septum port 58a, [0043]).
Maurice fails to show a first opening and a second opening spaced along an outer surface; a port extending through the second opening; the removable cap being removable from the port to place the external water source in fluid communication with the first receptacle.
Maurice fails to show a support structure extending within the first receptacle from a first wall to a second wall; wherein in an absence of a biasing force, the support structure is configured to maintain the container in the expanded use configuration; wherein the support structure comprises a support ring or pole; wherein the support structure comprises a planar reinforcing member movable from a first configuration to a second configuration; wherein when the planar reinforcing member is in the second configuration, the support structure is generally parallel to a bottom surface of the container; wherein when the planar reinforcing member is in a first configuration the container is in the collapsed storage configuration and when the planar reinforcing member is in the second configuration the container is in the expanded use configuration; wherein the support structure extends from a first corner of the container adjacent the top portion thereof to a second corner of the container adjacent the bottom portion of the container; wherein the first corner and the second corner are at opposing lateral sides of the container.
Ramsey discloses a container for use with an endoscope (abstract). Ramsey teaches a removable cap selectively coupled to the port ([0087]); a first opening and a second opening spaced along an outer surface (first opening port 8, second opening 26 with cap 30; Fig. 8; Fig. 12); a port extending through the second opening (neck 28, [0087]); the removable cap being removable from the port to place the external water source in fluid communication with the first receptacle (opening allows the internal volume to be filled with sterile water, [0087]).
Kim discloses systems and methods for tissue capture and removal. Kim teaches a container including a support structure extending within the first receptacle from a first wall to a second wall (stiffeners and reinforcement members; [0130]-[0132], [0148]; Figs. 3B, 6A); wherein in an absence of a biasing force, the support structure is configured to maintain the container in the expanded use configuration (maintain a desired shape or volume; [0130]); wherein the support structure comprises a support ring or pole (Figs. 3B); wherein the support structure comprises a planar reinforcing member movable from a first configuration to a second configuration ([0130]-[0132]); wherein when the planar reinforcing member is in the second configuration, the support structure is generally parallel to a bottom surface of the container (reinforcement members may be provided in any direction as desired by the user, wherein some at least some reinforcement members may be arranged parallel to the bottom surface of the container as desired by the user; [0132], [0148]; Fig. 6A); wherein when the planar reinforcing member is in a first configuration the container is in the collapsed storage configuration and when the planar reinforcing member is in the second configuration the container is in the expanded use configuration ([0148]); wherein the support structure extends from a first corner of the container adjacent the top portion thereof to a second corner of the container adjacent the bottom portion of the container; wherein the first corner and the second corner are at opposing lateral sides of the container (Fig. 7B).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Maurice to provide a second opening spaced along an outer surface from the first opening, for placing an external water source in fluid communication with the first receptacle as taught by Ramsey, as Ramsey teaches that a second opening allows the internal volume to be filled with sterile water ([0087]) and it is desirable to fill the container with water after use to allow the container to be reusable after the initial water volume is used. Furthermore, it would be obvious to provide a removable cap as taught by Ramsey, in order to selectively seal the opening after filling, to prevent the water from exiting the container, and to allow for the opening to be reopened to allow water to be filled in additional procedures.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Maurice and Ramsey to provide additional support for the container as taught by Kim, as Kim teaches that providing support for the container allows the container to assume and maintain a desired shape or volume at the appropriate time to aid in the surgical procedure ([0130]). Furthermore, it would have been obvious to one of ordinary skill in the art, to provide supporting members along any direction of the container desired by the user, in order to obtain the desired shape/volume, and where the direction of the support may be selected by the user without undue experimentation.
Claim(s) 14 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maurice (US 2022/0031152) in view of Ramsey (US 2016/0073867), Verlaak et al. (US 2019/0231971; hereinafter Verlaak), and Bendele et al. (US 2012/0095293; hereinafter Bendele).
Maurice shows a container arranged and configured to couple to an endoscope for use in an endoscopic procedure (Fig. 8A), the container comprising: a flexible container with a reservoir opening and configured to contain a fluid within a first receptacle thereof, the container is movable between a collapsed storage configuration and an expanded use configuration (flexible fluid source including reservoir opening/hole located at top, where flexibility is considered to allow for collapse/expansion [0043]); a water supply tube including a first end, a second end, and a first lumen extending therethrough, wherein the first lumen is in fluid communication with the first receptacle in the bottom portion of the container and the second end of the water supply tube is positioned external to the container ([0042]-[0044]; Fig. 8A); a gas supply tube including a first end, a second end, and a second lumen extending therethrough, wherein the second lumen is in operative fluid communication with the first receptacle and the second end of the gas supply tube is positioned external to the container ([0042]-[0044]; Fig. 8A); a port positioned adjacent to the top portion of the container and spaced from the reservoir opening, wherein the port is configured to selectively fluidly couple the first receptacle of the container with an external water source (septum port 58a, [0043]).
Maurice shows a support structure (outer surface of flexible container 58; Fig. 8A-8B); wherein in an absence of a biasing force, the support structure is configured to maintain the container in the expanded use configuration (outer surface of flexible container 58; Fig. 8A-8B); wherein the support structure comprises a support ring or pole (outer surface of flexible container 58); wherein the support structure comprises a planar reinforcing member movable from a first configuration to a second configuration (at least a portion of the outer surface of flexible container may be considered planar, where the flexibility allows for the structural surface of the container to be movable from a first configuration to a second configuration, Figs. 8A-8B); wherein when the planar reinforcing member is in the second configuration, the support structure is generally parallel to a bottom surface of the container (at least a portion of upper surface of flexible container 58 is parallel to bottom of container; Fig. 8A-8B); wherein when the planar reinforcing member is in a first configuration the container is in the collapsed storage configuration and when the planar reinforcing member is in the second configuration the container is in the expanded use configuration (where the flexibility allows for the structural surface of the container to be movable from a first configuration to a second configuration, Figs. 8A-8B); wherein the support structure extends from a first corner of the container adjacent the top portion thereof to a second corner of the container adjacent the bottom portion of the container (outer surface of flexible container extends from a first corner to a second corner, Figs. 8A-8B); wherein the first corner and the second corner are at opposing lateral sides of the container (outer surface of flexible container 58 including 4 corners supported structurally by walls of the container, where two of the corners may be selected as being opposite; Figs. 8A-8B).
Maurice fails to show a port positioned adjacent to the top portion of the container, wherein the port is configured to selectively fluidly couple a first receptacle of the container with an external water source.
Maurice fails to show a seal extending from the top portion of the container to the bottom portion of the container, the seal configured to divide the container into a first chamber and a second chamber.
Maurice fails to show an actuatable valve disposed between the first chamber and the second chamber; a pressure relief valve in fluid communication with the second chamber; wherein the port is in fluid communication with the first chamber and the second chamber; further comprising a cap configured to be releasably coupled to the port, the cap configured to selectively fluidly couple the first and second chambers; wherein the seal is selectively opened and closed, wherein the when the seal is open the first and second chambers are fluidly coupled and when the seal is closed the first and second chambers are fluidly isolated from one another; wherein the seal comprises a fluid-tight hook and loop fastener.
Ramsey discloses a container for use with an endoscope (abstract). Ramsey teaches a removable cap selectively coupled to the port ([0087]); a first opening and a second opening spaced along an outer surface (first opening port 8, second opening 26 with cap 30; Fig. 8; Fig. 12); a port extending through the second opening (neck 28, [0087]); the removable cap being removable from the port to place the external water source in fluid communication with the first receptacle (opening allows the internal volume to be filled with sterile water, [0087]).
Verlaak discloses a medical packaging container (abstract). Verlaak teaches a seal extending from the top portion of the container to the bottom portion of the container, the seal configured to divide the container into a first chamber and a second chamber (dual-chamber, where the two chambers are considered to be separated by a structure which may be considered a seal, to provide a “dual” type chamber; [0046]).
Bendele discloses a combined irrigation and rinsing tube set including a first and second chamber for holding liquids ([0072]-[0073]). Bendele teaches an actuatable valve disposed between the first chamber and the second chamber ([0074]); a pressure relief valve in fluid communication with the second chamber ([0074]; wherein the port is in fluid communication with the first chamber and the second chamber; further comprising a cap configured to be releasably coupled to the port, the cap configured to selectively fluidly couple the first and second chambers ([0073]); wherein the seal is selectively opened and closed, wherein the when the seal is open the first and second chambers are fluidly coupled and when the seal is closed the first and second chambers are fluidly isolated from one another ([0073]); wherein the seal comprises a fluid-tight hook and loop fastener ([0077]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Maurice to provide a second opening spaced along an outer surface from the first opening, for placing an external water source in fluid communication with the first receptacle as taught by Ramsey, as Ramsey teaches that a second opening allows the internal volume to be filled with sterile water ([0087]) and it is desirable to fill the container with water after use to allow the container to be reusable after the initial water volume is used. Furthermore, it would be obvious to provide a removable cap as taught by Ramsey, in order to selectively seal the opening after filling, to prevent the water from exiting the container, and to allow for the opening to be reopened to allow water to be filled in additional procedures.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Maurice and Ramsey to divide the container into first and second chambers as taught by Verlaak, as Verlaak teaches that a dual-chamber design provides an advantage of a single chamber design in that a dual-chamber design allows for storing two separate components, which can later be mixed as desired by the user when dispensing into the patient’s body ([0046]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Maurice, Ramsey, and Verlaak to utilize valves and fasteners in the dual-chamber system as taught by Bendele to fluidly couple the dual chambers while preventing backflow or other contamination, where valves and fasteners are known means for connecting or separating components of a fluid system.
Allowable Subject Matter
Claims 1-5 are allowed over the prior art of record.
Response to Arguments
Applicant's arguments filed 6/3/26 have been fully considered but they are not persuasive.
In response to applicant’s arguments regarding claim 6, a support structure extending within the first receptacle from a first wall to a second wall, examiner respectfully disagrees. The examiner maintains that it would have been obvious to one of ordinary skill in the art to modify the invention of Maurice to utilize support structures as taught by Kim, as noted in the rejection above:
“It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Maurice and Ramsey to provide additional support for the container as taught by Kim, as Kim teaches that providing support for the container allows the container to assume and maintain a desired shape or volume at the appropriate time to aid in the surgical procedure ([0130]). Furthermore, it would have been obvious to one of ordinary skill in the art, to provide supporting members along any direction of the container desired by the user, in order to obtain the desired shape/volume, and where the direction of the support may be selected by the user without undue experimentation.”
The examiner notes that in modifying the container of Kim which includes a first wall and a second wall, it would be within the level of one of ordinary skill in the art to provide the support members along any direction of the container directed by the user, in order to obtain the desired shape/volume, and where the direction of the support may be selected by the user without undue experimentation, including providing the support extending from a first wall to a second wall.
It is noted that Kim provides a variety of embodiments such as in Fig. 3B and Fig. 6A, in which the supports may be considered to extend from a first wall to a second wall of the container.
As noted by Kim ([0130]), stiffeners may be provided to allow for opening the container, closing the container, or tensioning the container. It would be within the level of one of ordinary skill in the art to provide supports extending from a first wall to a second wall of the container to accomplish these functions.
In response to applicant’s arguments regarding claim 14, examiner respectfully disagrees. As noted in the rejection above:
“It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Maurice, Ramsey, and Verlaak to utilize valves and fasteners in the dual-chamber system as taught by Bendele to fluidly couple the dual chambers while preventing backflow or other contamination, where valves and fasteners are known means for connecting or separating components of a fluid system.”
The examiner maintains that it would be within the level of one of ordinary skill in the art to provide actuatable valves along any appropriate passages of the tubing as desired by one of ordinary skill in the art, to obtain the known benefits of such valves including preventing backflow. The examiner maintains that a valve is common component of fluid tubing systems as evidenced by Bendele, and may be provided in a particular location along the tubing as desired by one of ordinary skill in the art.
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 JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN CWERN/ Primary Examiner, Art Unit 3797
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