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
The amendment filed 12/11/2025 has been entered. Claims 1 has been amended. Claims 1-16 remain pending in this application.
Response to Arguments
Applicant’s amendments overcome the 112(b) rejections and such rejections are therefore withdrawn.
Applicant's arguments filed 12/11/2025 have been fully considered but they are not persuasive.
Claim 1 has been amended to recite that the particulate matter is captured and the irrigation liquid is returned without the particulate matter.
Applicant argues that Baldwin does not disclose a drainage chamber and discloses that the kidney stones are removed by an endoscopic instrument. However, Baldwin discloses that the system removes particulates (¶ 0050) and is thus considered to be a drainage chamber. Further, as discussed in the rejection below, such limitations of amended claim 1 relate to the intended use of the system, of which Baldwin is capable of performing.
Accordingly, claim 1 remains obvious over Baldwin.
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.
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.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baldwin (Pub. No.: US 2015/0119645 A1).
Regarding claim 1, Baldwin discloses (fig. 1-6) an organ flush and drainage pressure regulating apparatus (cap system 400) for at least limiting an increase of pressure within a body organ during a liquid irrigation procedure (abstract) in which liquid is flushed there through in achieving a medical objective by means of an organ working instrument that in performing its working action passes along an organ access sheath (2) of which a leading end is positioned into such organ (¶ 0042) while a source of supply of irrigation liquid (irrigation source 416) as at a high elevation causes a pressure increasing tendency (¶ 0044), the apparatus comprising:
a unit wall (wall portion 12) defining drainage body (cap 4) and enclosing a drainage zone comprising a drainage chamber (fig. 4-5, ¶ 0051);
a coupling passage extending through a wall of the drainage body that is compatibly dimensioned to enable sealable engagement of the drainage body against unintentional release to a trailing end of such access sheath (¶ 0052);
an instrument insertion aperture (opening 8) extending from and in alignment with the coupling passage through the wall of the body to enable the insertion of such organ working instrument there and through the coupling passage along such access sheath once the body is coupled for use (¶ 0053); and
a drainage cum charging stub (inflow port 30) along which irrigation liquid flows whether returning along or becoming charged to such access sheath on passing along the drainage zone during an organ working action (¶ 0056), wherein the drainage cum charging stub is connected to the drainage body at a drainage location (fig. 5);
wherein the instrument insertion aperture is formed with a penetrable sealing means (sealing feature 10, ¶ 0054) that maintains a sealing effect against such organ working instrument once inserted along the instrument insertion aperture allowing pressure to be controlled and stabilized (¶ 0054) to cause a passive flushing of irrigation liquid by maintaining the elevation of the source of irrigation liquid and a drained liquid release outlet (fluid can flow passively by gravity and pressure gradients ¶ 0056), and
wherein a bottom of the drainage chamber is configured to be lower than the drainage location, during operative use (fig. 3, 5).
Baldwin fails to explicitly disclose that a bottom of the drainage chamber is sized to enable particulate matter to be captured in the drainage chamber while allowing returning irrigation liquid to flow to the drainage cum charging stub without the particulate matter.
However, such limitation of claim 1 relates to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The bottom of the drainage chamber of Baldwin is configured to be lower than the drainage location during operative use (fig. 3, 5) and is sized such that particulate matter passes through (¶ 0050) and is therefore capable of enabling particulate matter to be captured in the drainage chamber while allowing returning irrigation liquid to flow to the drainage cum charging stub without the particulate matter due to the position of the bottom of the drainage chamber and gravity on the particulate matter and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to enable the drainage chamber of Baldwin to capture particulate matter to in the drainage chamber while allowing returning irrigation liquid to flow to the drainage cum charging stub without the particulate matter in order to allow the irrigation fluid to be recirculated such that the irrigation bottle does not need to be changed during operation (¶ 0050).
Regarding claim 2, Baldwin discloses wherein the sealing means is in the form of a membrane type penetrable resilient member extending transverse to the direction of the organ working instrument along the drainage body (fig. 5), and wherein the membrane type penetrable resilient member is formed with a central location for instrument penetration (¶ 0054, fig. 3), and wherein the membrane penetrable resilient member forms an inner lip when penetrated that urges sealably against such organ working instrument once inserted along the resilient member (¶ 0054).
Regarding claim 3, Baldwin discloses wherein the drainage body is formed with a low pressure relief function to enable the ingress of environmental air into the drainage zone in performing a pressure stabilizing effect in the case of an excessive syphoning pressure reduction effect during operative use of the equipment (the sealing feature 10 can be a slit valve or a flap valve thereby allowing ingress of environmental air ¶ 0054).
Regarding claim 4, Baldwin discloses wherein the low pressure relief function is incorporated into the sealing means (¶ 0054).
Regarding claim 5, Baldwin discloses wherein the sealing means is in the form a membrane type penetrable resilient member extending transverse to the direction of insertion of the organ working instrument along the drainage body (fig. 5), and wherein the membrane type penetrable resilient member is formed with a central location for instrument penetration (fig. 3, ¶ 0054), and wherein the membrane type penetrable resilient member forms an inner lip when penetrated that urges sealably against such organ working instrument once inserted along the resilient member while its resilience is selected to also perform a low pressure relief cracking function once exposed to a pressure of below a sealing member associated minimum (¶ 0054).
Regarding claim 6, Baldwin discloses wherein the resilience of the sealing member is selected to perform a low pressure relief cracking function once exposed to a pressure of below a sealing member associated minimum in response to its becoming retracted from its inner end into creating an air flow path between the member and the organ working instrument enabling the ingress of air there along until the chamber associated pressure is stabilized again (¶ 0054).
Regarding claim 7, Baldwin discloses wherein the liquid drainage body is formed with a guiding formation extending away from the sealing means along which the organ working instrument is guidable into and through the instrument insertion aperture once becoming positioned for use (fig. 4, ¶ 0051, funnel shaped cap).
Regarding claim 8¸ Baldwin discloses wherein the guiding formation is in the form of a guiding funnel that is integrally formed with the liquid drainage body apexing in close vicinity of the instrument insertion aperture (fig. 4, ¶ 0051).
Regarding claim 9, Baldwin discloses wherein the coupling passage extends along a mouth that is sealably engageable with a funnel type inlet forming the trailing end of the organ access sheath in response to being socketably receivable into the flared end region of such funnel type inlet in being couplable against unintentional release to the trailing end of such access sheath (fig. 4-5, ¶ 0051).
Regarding claim 10, Baldwin discloses wherein the mouth is dimensioned to be connected to the inlet funnel of an ureteric access sheath (fig. 3-5).
Regarding claim 11¸ Baldwin discloses wherein the drainage cum charging stub is connected to the drainage location to perform a drainage function along which irrigation liquid as returning along such access sheath during an organ working action is drained from the drainage zone via the drainage location (¶ 0050-¶ 0056).
Regarding claim 12, Baldwin discloses wherein the drainage location is spaced from the coupling passage to enable it to be operated at an elevated position in relation to the coupling passage during operative use of the apparatus in limiting the ingress of particulate matter thereto in the case of such becoming removed from the organ in response to the operation of the organ working instrument also involving such action having the effect of in such matter becoming accumulated within the drainage zone (fig. 5, ¶ 0051-¶ 0056).
Regarding claim 13, Baldwin discloses wherein the drainage cum charging stub is connected to a supply source (irrigation source 416, ¶ 0056) and via which the irrigation liquid is charged from the supply source along the coupling passage through the organ access sheath to and through the organ from which the irrigation liquid is flushed along the organ working instrument to an end in the location of collected drained liquid (¶ 0051-¶ 0056).
Regarding claim 14, Baldwin discloses wherein the drainage cum charging stub is connectable by a flexible tube serving either as drainage or charging tube (¶ 0055-¶ 0056).
Regarding claim 15, Baldwin discloses wherein the unit wall is formed about a central axis extending along the drainage zone, the coupling passage and the instrument insertion aperture as fitted with the sealing means with the drainage cum charging stub extending laterally with respect to the axis from the drainage body (fig. 4-5).
Regarding claim 16, Baldwin discloses wherein the drainage chamber is in the form of a tubular drainage chamber defined intermediate of the coupling passage and the sealing means (fig. 4-5)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Stuba (Pub. No.: US 2020/0163657 A1) discloses an apparatus having a drainage chamber configured to capture particulate matter.
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 MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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/MEAGAN NGO/Examiner, Art Unit 3781
3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781