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 Objections
Claims 1, 15 and 27 are objected to because of the following informalities:
Claim 1, lines 11-12: in “the movement”, the recitation of “the” should be deleted;
Claim 15, line 8: “a catheter” should be replaced with –the catheter–;
Claim 15, line 14: “connection mechanism” should be replaced with –connector–;
Claim 15, lines 11-12: in “the movement”, the recitation of “the” should be deleted;
Claim 27, line 20: –the– should be inserted before the first instance of “fluid”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No limitations were interpreted under 35 U.S.C. §112(f).
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.
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 1-5, 8-12, 15-18, 20-24, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0085199 A1 (Schlumpf ‘199) (previously cited) and evidenced by US 12,161,452 B2 (Schlumpf ‘452) (previously cited).
With regards to claim 1, Schlumpf ‘199 discloses a diagnostic manometry device (Figs. 7-18 and ¶ [0059] depict a connector assembly 80 for an anatomical manometry system in use with a catheter sub-assembly 2 of Figs. 2C-2F), comprising: a catheter including a plurality of lumens (Fig. 2D and ¶ [0039] depicts the catheter 2 comprising one or more secondary lumens 30); and a fluid charger configured to operatively couple with the catheter (¶ [0059] depicts a connector assembly 80 for operatively connecting to catheter sub-assembly 2, wherein connector assembly 80 comprises a charging mechanism 90), the fluid charger including: a plurality of fluid pressure chambers within a housing (Figs. 11, 12B, and 16 and ¶ [0068] depict charging mechanism 90 comprising a plurality of bellows 110 for permitting passage of the pressure transmission medium from 90 toward the catheter lumen; Fig. 8 depicts the components of the connector within an outer housing 82, which indicates the bellows 110 are within the housing 82), each fluid pressure chamber of the plurality of fluid pressure chambers configured to be in fluid communication with a respective lumen of the plurality of lumens when the catheter is operatively coupled with the fluid charger (¶ [0068] depict each bellow coupled to a respective radial channel 100, a respective axial channel, and a respective catheter lumen); a plurality of pressure sensors (¶ [0082] disclose Figs. 16-17 depicting a plurality of pressure sensors 701. The Examiner notes that Fig. 16-17 of Schlumpf ‘199 depict sensor assembly 88 instead of pressure sensors 701. Corrected Figs. 16-17 of Schlumpf ‘452 depict pressure sensors 701 replacing 88, wherein pressure sensors 701 are connected to respective bellows 110), each pressure sensor of the plurality of pressure sensors located and configured to measure a fluid pressure change in a respective fluid pressure chamber of the plurality of fluid pressure chambers (¶ [0082] depicts each pressure sensor 701 receiving a pressure measurement from the catheter lumen 30 when the bellows 110 pressurize the catheter balloons 40); and a charging mechanism including a component movably coupled with the housing for causing movement of fluid simultaneously from the fluid pressure chambers of the plurality of fluid pressure chambers into the respective lumens of the plurality of lumens when the catheter is operatively coupled with the fluid charger (Figs. 10 and 12A and ¶¶ [0063], [0071], [0080] depict a connector interface 84 (which is a movable component) coupled to a manifold 86; ¶ [0071] discloses that rotation of connector interface 84 relative to manifold 86 may permit an axial displacement of manifold 86 relative to the bellow housing 114 so as to simultaneously actuate each bellow positioned on the bellow housing 114).
The above embodiment of Schlumpf ‘199 is silent regarding whether the fluid charger further comprises a plurality of pistons and a plurality of piston chambers, each piston chamber sized and configured to receive a respective piston of the plurality therein in a fluid-tight manner, each piston and respective piston chamber defining a respective fluid pressure chamber of the plurality therebetween .
In a related embodiment, Schlumpf ‘199 teaches the fluid charger further comprises a plurality of pistons and a plurality of piston chambers (Fig. 4B and ¶¶ [0052]-[0055] depict a plurality of pistons 9 within charger housing 604, wherein the charger housing 604 forms or is a plurality of piston chambers), each piston chamber sized and configured to receive a respective piston of the plurality therein in a fluid-tight manner (Fig. 4B and ¶ [0052] discloses a seal component 10 on the charging piston 9 for providing a fluid-tight seal), each piston and respective piston chamber defining a respective fluid pressure chamber of the plurality therebetween (Fig. 4B and ¶¶ [0052]-[0055] depict the piston 9 and charger housing 604 being fluid pressure chambers for facilitating pressure changes and measurements). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid charger of the above embodiment of Schlumpf ‘199 to incorporate that the fluid charger further comprises a plurality of pistons and a plurality of piston chambers, each piston chamber sized and configured to receive a respective piston of the plurality therein in a fluid-tight manner, each piston and respective piston chamber defining a respective fluid pressure chamber of the plurality therebetween as taught by the embodiment of Fig. 4B of Schlumpf ‘199. Because both the bellows and the piston arrangement are capable of charging each balloon simultaneously (see ¶¶ [0052]-[0055] and ¶ [0068] of Schlumpf ‘199), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 2, the above combination of Schlumpf ‘199 evidenced by Schlumpf ‘452 discloses the diagnostic manometry device of claim 1. Schlumpf ‘199 further discloses the plurality of lumens comprises at least four lumens (Fig. 2D depicts a the plurality of lumens 30 comprising at least four lumens).
With regards to claim 3, the above combination of Schlumpf ‘199 evidenced by Schlumpf ‘452 discloses the diagnostic manometry device of claim 2. Schlumpf ‘199 further discloses the plurality of lumens comprises at least ten lumens (Fig. 2D depicts a the plurality of lumens 30 comprising at least ten lumens).
With regards to claim 4, the above combination of Schlumpf ‘199 evidenced by Schlumpf ‘452 discloses the diagnostic manometry device of claim 1. Schlumpf ‘199 further discloses the catheter comprises a plurality of pressure transmission chambers (Figs. 2C, 2E and ¶¶ [0040]-[0041] depict balloons 40), each pressure transmission chamber of the plurality of pressure transmission chambers in fluid communication with a respective lumen of the plurality of lumens (¶¶ [0040]-[0041] depict each balloon coupled to an opening 46 of a secondary (or monitor) lumen 30).
With regards to claim 5, the above combination of Schlumpf ‘199 evidenced by Schlumpf ‘452 discloses the diagnostic manometry device of claim 4. Schlumpf ‘199 further discloses each pressure transmission chamber comprises an expandable cylindrical balloon carried concentrically along the catheter (Figs. 2C, 2E and ¶¶ [0040]-[0041] depict balloons 40 arranged concentrically along the catheter; ¶ [0043] discloses the balloons 40 being formed from a unitary cylindrical sleeve, which means that the balloons 40 are cylindrical).
With regards to claim 8, the above combination of Schlumpf ‘199 evidenced by Schlumpf ‘452 teaches or suggests the diagnostic manometry device and fluid charger of claim 1.
The above combination teaches or suggests that the charging mechanism is configured to enable relative movement between the plurality of pistons and the plurality of piston chambers in unison so as to simultaneously change volumes of the fluid pressure chambers of the plurality defined between the respective pistons and piston chambers (Figs. 10 and 12A and ¶¶ [0063], [0071], [0080] of Schlumpf ‘199 depict rotation of connector interface 84 relative to manifold 86 may permit an axial displacement of manifold 86 relative to the bellow housing 114 so as to simultaneously actuate each bellow positioned on the bellow housing 114. The above combination of the embodiments of Schlumpf ‘199 teaches or suggests the rotation of ¶ [0071] causing the simultaneous relative movement of the pistons and the piston chambers of Fig. 4B).
With regards to claim 9, the above combination of Schlumpf ‘199 evidenced by Schlumpf ‘452 teaches or suggests the diagnostic manometry device and fluid charger of claim 8.
The above combination teaches or suggests the component is moveable between a first position and a second position, movement of the component from the first position to the second position causing the relative movement between the plurality of pistons and the plurality of piston chambers, (Figs. 10 and 12A and ¶¶ [0063], [0071], [0080] of Schlumpf ‘199 depict rotation of connector interface 84 between locked and charged positions causes relative movement of the manifold 86. The above combination of the embodiments of Schlumpf ‘199 teaches or suggests the rotation of ¶¶ [0071], [0075]-[0080] causing the simultaneous relative movement of the pistons and the piston chambers of Fig. 4B), wherein the component is rotatably coupled with the housing (Fig. 8 depicts a connection between connector interface 84 and the housing 82 that allows for rotation of the interface 84).
With regards to claim 10, the above combination of Schlumpf ‘199 evidenced by Schlumpf ‘452 teaches or suggests the diagnostic manometry device and fluid charger of claim 9. The above combination teaches or suggests the charging mechanism further comprises a base member (Figs. 10 and 12A of Schlumpf ‘199 depict a manifold 86).
The above combination is silent regarding whether the plurality of pistons or the plurality of piston chambers being rigidly connected to the base member.
In a related embodiment, Schlumpf ‘199 teaches a base member (Figs. 1B and 3 and ¶¶ [0049]-[0050] depict a connector sub-assembly comprising a front coupler 5 and a manifold block 6), one of the plurality of pistons and the plurality of piston chambers being rigidly connected to the base member (Fig. 4A, 4B and ¶¶ [0050], [0052]-[0053] depict the manifold block 6 comprising longitudinal channels/charger housing 604 for charging the catheter balloons). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the base member of Figs 10, 12A of Schlumpf ‘199 to incorporate the plurality of piston chambers being rigidly connected to the base member as taught by the embodiments of Figs. 1B, 3, 4A,4B of Schlumpf ‘199. The motivation would have been to provide a location for the piston chambers that is suitable for charging the catheter.
With regards to claim 11, the above combination of Schlumpf ‘199 evidenced by Schlumpf ‘452 teaches or suggests the diagnostic manometry device and fluid charger of claim 10.
The above combination teaches or suggests the component of the charging mechanism is operatively coupled with the base member of the charging mechanism such that movement of the component from the first position to the second position causes the base member to move in a direction parallel to longitudinal axes of the pistons and respective piston chambers (Figs. 10 and 12A and ¶¶ [0063], [0071], [0080] of Schlumpf ‘199 depict rotation of connector interface 84 relative to manifold 86 may permit an axial displacement of manifold 86 relative to the bellow housing 114 so as to simultaneously actuate each bellow positioned on the bellow housing 114. The above combination of the embodiments of Schlumpf ‘199 teaches or suggests the rotation of ¶¶ [0071], [0075]-[0080] causing the simultaneous relative movement of the pistons and the piston chambers of Fig. 4B along their longitudinal axes).
With regards to claim 12, the above combination of Schlumpf ‘199 evidenced by Schlumpf ‘452 teaches or suggests the diagnostic manometry device and fluid charger of claim 11.
The above combination teaches or suggests the component of the charging mechanism comprises a rotatable disc (Figs. 10 and 12A and ¶¶ [0063], [0071], [0080] of Schlumpf ‘199 depict the connector interface 84 being a rotatable disc), at least a portion of the rotatable disc being exposed on an exterior of the fluid charger so as to enable a user to rotate the rotatable disc about a rotational axis thereof between the first position and the second position (Fig 10 of Schlumpf ‘199 depicts an upper surface of connector interface 84 being exposed so as to enable a user to rotate the connector interface), rotation of the rotatable disc between the first position and the second position causing translational movement of the base member in a direction parallel to the rotational axis of the rotatable disc and parallel to the longitudinal axes of the pistons and respective piston chambers (Fig. 12 A and ¶¶ [0063], [0071], [0080] of Schlumpf ‘199 depict rotation of connector interface 84 between locked position “L” and charged position “C” causing movement of the manifold 86 in a direction parallel to the rotational axis “O” and parallel to the bellows The above combination of the embodiments of Schlumpf ‘199 teaches or suggests the rotation of ¶¶ [0071], [0075]-[0080] causing the simultaneous relative movement of the of the manifold 86 in a direction parallel to the pistons and the piston chambers of Fig. 4B).
With regards to claim 15, Schlumpf ‘199 discloses a fluid charger for use with a diagnostic manometry device (Figs. 7-18 and ¶ [0059] depict a connector assembly 80 for an anatomical manometry system in use with a catheter sub-assembly 2 of Figs. 2C-2F), comprising: a housing (Figs. 7-8 and ¶ [0060] depict an outer housing 82); a catheter connector configured to couple with a proximal end of a catheter including lumens defined within a body of the catheter (Fig. 10 and ¶ [0060] depict a proximal coupler 81 connected to catheter 2; Fig. 2F and ¶ [0061] depict the proximal coupler 81); fluid pressure chambers within the housing (Figs. 11, 12B, and 16 and ¶ [0068] depict charging mechanism 90 comprising a plurality of bellows 110 for permitting passage of the pressure transmission medium from 90 toward the catheter lumen; Fig. 8 depicts the components of the connector within an outer housing 82, which indicates the bellows 110 are within the housing 82), each fluid pressure chamber in fluid communication with a respective fluid conduit leading to the catheter connector so as to fluidly couple each fluid pressure chamber with a respective lumen of a catheter when the catheter is operatively connected to the fluid charger (¶ [0068] depict each bellow coupled to a respective radial channel 100, a respective axial channel, and a respective catheter lumen); pressure sensors for measuring fluid pressure changes in the fluid pressure chambers (¶ [0082] disclose Figs. 16-17 depicting a plurality of pressure sensors 701. The Examiner notes that Fig. 16-17 of Schlumpf ‘199 depict sensor assembly 88 instead of pressure sensors 701. Corrected Figs. 16-17 of Schlumpf ‘452 depict pressure sensors 701 replacing 88, wherein pressure sensors 701 are connected to respective bellows 110); and a charging mechanism including a component movably coupled with the housing, the movement of the component relative to the housing causing movement of fluid simultaneously from the fluid pressure chambers through the fluid conduits toward the catheter connector (Figs. 10 and 12A and ¶¶ [0063], [0071], [0080] depict a connector interface 84 coupled to a manifold 86; ¶ [0071] discloses that rotation of connector interface 84 relative to manifold 86 may permit an axial displacement of manifold 86 relative to the bellow housing 114 so as to simultaneously actuate each bellow positioned on the bellow housing 114).
The above embodiment of Schlumpf ‘199 is silent regarding whether the fluid charger further comprises a plurality of pistons and a plurality of piston chambers, each piston chamber sized and configured to receive a respective piston of the plurality therein in a fluid-tight manner, each piston and respective piston chamber defining a respective fluid pressure chamber of the plurality therebetween .
In a related embodiment, Schlumpf ‘199 teaches the fluid charger further comprises a plurality of pistons and a plurality of piston chambers (Fig. 4B and ¶¶ [0052]-[0055] depict a plurality of pistons 9 within charger housing 604, wherein the charger housing 604 forms or is a plurality of piston chambers), each piston chamber sized and configured to receive a respective piston of the plurality therein in a fluid-tight manner (Fig. 4B and ¶ [0052] discloses a seal component 10 on the charging piston 9 for providing a fluid-tight seal), each piston and respective piston chamber defining a respective fluid pressure chamber of the plurality therebetween (Fig. 4B and ¶¶ [0052]-[0055] depict the piston 9 and charger housing 604 being fluid pressure chambers for facilitating pressure changes and measurements). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid charger of the above embodiment of Schlumpf ‘199 to incorporate that the fluid charger further comprises a plurality of pistons and a plurality of piston chambers, each piston chamber sized and configured to receive a respective piston of the plurality therein in a fluid-tight manner, each piston and respective piston chamber defining a respective fluid pressure chamber of the plurality therebetween as taught by the embodiment of Fig. 4B of Schlumpf ‘199. Because both the bellows and the piston arrangement are capable of charging each balloon simultaneously (see ¶¶ [0052]-[0055] and ¶ [0068] of Schlumpf ‘199), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 16, the above combination of Schlumpf ‘199 evidenced by Schlumpf ‘452 discloses the diagnostic manometry device of claim 15. Schlumpf ‘199 further discloses the fluid pressure chambers include at least four fluid pressure chambers (¶ [0069] discloses bellows 110 being commonly actuatable to permit simultaneously charging each balloon 40 of the plurality of balloons; Fig. 2E depicts at least four balloons)
With regards to claim 17, the above combination of Schlumpf ‘199 evidenced by Schlumpf ‘452 discloses the diagnostic manometry device of claim 15. Schlumpf ‘199 further discloses the fluid pressure chambers include at least ten fluid pressure chambers (¶ [0069] discloses bellows 110 being commonly actuatable to permit simultaneously charging each balloon 40 of the plurality of balloons; Fig. 2E depicts at least ten balloons).
With regards to claim 18, the above combination of Schlumpf ‘199 evidenced by Schlumpf ‘452 discloses the diagnostic manometry device of claim 1. Schlumpf ‘199 teaches a fluid connector in fluid communication with another fluid conduit leading to the catheter connector so as to couple with another lumen of a catheter when the catheter is operatively connected to the fluid charger, the fluid connector and another fluid conduit not in fluid communication with any fluid pressure chamber of the fluid charger (Fig. 2G depicts proximal coupler 81 comprising a central aperture connected to a central lumen 17 of catheter 17; Figs. 10, 11, 16 depict apertures through connector interface 84 and manifold 86 which are aligned with the central axis of the catheter, wherein the apertures are capable of conducting a fluid to the central aperture of the proximal coupler 81; Fig. 11 depicts the aperture through manifold 86 not being in fluid communication with the bellows).
With regards to claim 20, the above combination of Schlumpf ‘199 evidenced by Schlumpf ‘452 teaches or suggests the diagnostic manometry device and fluid charger of claim 15.
The above combination teaches or suggests that the charging mechanism is configured to enable relative movement between the plurality of pistons and the plurality of piston chambers in unison so as to simultaneously change volumes of the fluid pressure chambers of the plurality defined between the respective pistons and piston chambers (Figs. 10 and 12A and ¶¶ [0063], [0071], [0080] of Schlumpf ‘199 depict rotation of connector interface 84 relative to manifold 86 may permit an axial displacement of manifold 86 relative to the bellow housing 114 so as to simultaneously actuate each bellow positioned on the bellow housing 114. The above combination of the embodiments of Schlumpf ‘199 teaches or suggests the rotation of ¶ [0071] causing the simultaneous relative movement of the pistons and the piston chambers of Fig. 4B).
With regards to claim 21, the above combination of Schlumpf ‘199 evidenced by Schlumpf ‘452 teaches or suggests the diagnostic manometry device and fluid charger of claim 20.
The above combination teaches or suggests the component is moveable between a first position and a second position, movement of the component from the first position to the second position causing the relative movement between the plurality of pistons and the plurality of piston chambers (Figs. 10 and 12A and ¶¶ [0063], [0071], [0080] of Schlumpf ‘199 depict rotation of connector interface 84 between locked and charged positions causes relative movement of the manifold 86. The above combination of the embodiments of Schlumpf ‘199 teaches or suggests the rotation of ¶¶ [0071], [0075]-[0080] causing the simultaneous relative movement of the pistons and the piston chambers of Fig. 4B), wherein the component is rotatably coupled with the housing (Fig. 8 depicts a connection between connector interface 84 and the housing 82 that allows for rotation of the interface 84).
With regards to claim 22, the above combination of Schlumpf ‘199 evidenced by Schlumpf ‘452 teaches or suggests the diagnostic manometry device and fluid charger of claim 21. The above combination teaches or suggests the charging mechanism further comprises a base member (Figs. 10 and 12A of Schlumpf ‘199 depict a manifold 86).
The above combination is silent regarding whether the plurality of pistons or the plurality of piston chambers being rigidly connected to the base member.
In a related embodiment, Schlumpf ‘199 teaches a base member (Figs. 1B and 3 and ¶¶ [0049]-[0050] depict a connector sub-assembly comprising a front coupler 5 and a manifold block 6), the plurality of pistons or the plurality of piston chambers being rigidly connected to the base member (Fig. 4A, 4B and ¶¶ [0050], [0052]-[0053] depict the manifold block 6 comprising longitudinal channels/charger housing 604 for charging the catheter balloons). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the base member of Figs 10, 12A of Schlumpf ‘199 to incorporate the plurality of piston chambers being rigidly connected to the base member as taught by the embodiments of Figs. 1B, 3, 4A,4B of Schlumpf ‘199. The motivation would have been to provide a location for the piston chambers that is suitable for charging the catheter.
With regards to claim 23, the above combination of Schlumpf ‘199 evidenced by Schlumpf ‘452 teaches or suggests the diagnostic manometry device and fluid charger of claim 22.
The above combination teaches or suggests the component of the charging mechanism is operatively coupled with the base member of the charging mechanism such that movement of the component from the first position to the second position causes the base member to move in a direction parallel to longitudinal axes of the pistons and respective piston chambers (Figs. 10 and 12A and ¶¶ [0063], [0071], [0080] of Schlumpf ‘199 depict rotation of connector interface 84 relative to manifold 86 may permit an axial displacement of manifold 86 relative to the bellow housing 114 so as to simultaneously actuate each bellow positioned on the bellow housing 114. The above combination of the embodiments of Schlumpf ‘199 teaches or suggests the rotation of ¶¶ [0071], [0075]-[0080] causing the simultaneous relative movement of the pistons and the piston chambers of Fig. 4B along their longitudinal axes).
With regards to claim 24, the above combination of Schlumpf ‘199 evidenced by Schlumpf ‘452 teaches or suggests the diagnostic manometry device and fluid charger of claim 23.
The above combination teaches or suggests the component of the charging mechanism comprises a rotatable disc (Figs. 10 and 12A and ¶¶ [0063], [0071], [0080] of Schlumpf ‘199 depict the connector interface 84 being a rotatable disc), at least a portion of the rotatable disc being exposed on an exterior of the fluid charger so as to enable a user to rotate the rotatable disc about a rotational axis thereof between the first position and the second position (Fig 10 of Schlumpf ‘199 depicts an upper surface of connector interface 84 being exposed so as to enable a user to rotate the connector interface), rotation of the rotatable disc between the first position and the second position causing translational movement of the base member in a direction parallel to the rotational axis of the rotatable disc and parallel to the longitudinal axes of the pistons and respective piston chambers (Fig. 12 A and ¶¶ [0063], [0071], [0080] of Schlumpf ‘199 depict rotation of connector interface 84 between locked position “L” and charged position “C” causing movement of the manifold 86 in a direction parallel to the rotational axis “O” and parallel to the bellows The above combination of the embodiments of Schlumpf ‘199 teaches or suggests the rotation of ¶¶ [0071], [0075]-[0080] causing the simultaneous relative movement of the of the manifold 86 in a direction parallel to the pistons and the piston chambers of Fig. 4B).
With regards to claim 27, Schlumpf ‘199 discloses method of performing a diagnostic manometry procedure on a patient (Figs. 7-18 and ¶ [0059] depict a connector assembly 80 for an anatomical manometry system in use with a catheter sub-assembly 2 of Figs. 2C-2F; MPEP 2112.02 discloses that a prior art device anticipates a claimed process if the device carries out the process during normal and usual operation. The Examiner asserts that the device of Schlumpf ‘199, in its normal and usual operation, would necessarily perform the claimed method. Also see ¶ [0058]), comprising: coupling a catheter including a plurality of lumens to a fluid charger (Figs. 7-18 and ¶ [0059] depict a connector assembly 80 for an anatomical manometry system in use with a catheter sub-assembly 2 of Figs. 2C-2F; Fig. 2D and ¶ [0039] depicts the catheter 2 comprising one or more secondary lumens 30), the fluid charger including: a plurality of fluid pressure chambers within a housing (Figs. 11, 12B, and 16 and ¶ [0068] depict charging mechanism 90 comprising a plurality of bellows 110 for permitting passage of the pressure transmission medium from 90 toward the catheter lumen; Fig. 8 depicts the components of the connector within an outer housing 82, which indicates the bellows 110 are within the housing 82), each fluid pressure chamber of the plurality of fluid pressure chambers in fluid communication with a respective lumen of the plurality of lumens upon the coupling of the catheter to the fluid charger (¶ [0068] depict each bellow coupled to a respective radial channel 100, a respective axial channel, and a respective catheter lumen); a plurality of pressure sensors(¶ [0082] disclose Figs. 16-17 depicting a plurality of pressure sensors 701. The Examiner notes that Fig. 16-17 of Schlumpf ‘199 depict sensor assembly 88 instead of pressure sensors 701. Corrected Figs. 16-17 of Schlumpf ‘452 depict pressure sensors 701 replacing 88, wherein pressure sensors 701 are connected to respective bellows 110), each pressure sensor of the plurality of pressure sensors located and configured to measure a fluid pressure change in a respective fluid pressure chamber of the plurality of fluid pressure chambers (¶ [0082] depicts each pressure sensor 701 receiving a pressure measurement from the catheter lumen 30 when the bellows 110 pressurize the catheter balloons 40); and a charging mechanism including a component movably coupled with the housing (Fig. 8 depicts a connection between connector interface 84 and the housing 82 that allows for rotation of the interface 84), movement of the component relative to the housing causing movement of fluid simultaneously from the fluid pressure chambers of the plurality of fluid pressure chambers into the respective lumens of the plurality of lumens (Figs. 10 and 12A and ¶¶ [0063], [0071], [0080] depict a connector interface 84 coupled to a manifold 86; ¶ [0071] discloses that rotation of connector interface 84 relative to manifold 86 may permit an axial displacement of manifold 86 relative to the bellow housing 114 so as to simultaneously actuate each bellow positioned on the bellow housing 114); inserting the catheter into a body of patient (¶¶ [0045],[0058] discloses insertion of the catheter within the patient); manipulating the charging mechanism so as to simultaneously move fluid from the fluid pressure chambers of the plurality of fluid pressure chambers into the respective lumens of the plurality of lumens (Figs. 10 and 12A and ¶¶ [0063], [0071], [0080] depict a connector interface 84 coupled to a manifold 86; ¶ [0071] discloses that rotation of connector interface 84 relative to manifold 86 may permit an axial displacement of manifold 86 relative to the bellow housing 114 so as to simultaneously actuate each bellow positioned on the bellow housing 114); and detecting changes in pressure in the fluid pressure chambers of the plurality of fluid pressure chambers using the pressure sensors of the plurality of pressure sensors (¶ [0037] discloses pressure transducers 7 and electrical connections connected to the catheter 2 may permit measurement of the anatomical features of interest).
The above embodiment of Schlumpf ‘199 is silent regarding whether the fluid charger further comprises a plurality of pistons and a plurality of piston chambers, each piston chamber sized and configured to receive a respective piston of the plurality therein in a fluid-tight manner, each piston and respective piston chamber defining a respective fluid pressure chamber of the plurality therebetween .
In a related embodiment, Schlumpf ‘199 teaches the fluid charger further comprises a plurality of pistons and a plurality of piston chambers (Fig. 4B and ¶¶ [0052]-[0055] depict a plurality of pistons 9 within charger housing 604, wherein the charger housing 604 forms or is a plurality of piston chambers), each piston chamber sized and configured to receive a respective piston of the plurality therein in a fluid-tight manner (Fig. 4B and ¶ [0052] discloses a seal component 10 on the charging piston 9 for providing a fluid-tight seal), each piston and respective piston chamber defining a respective fluid pressure chamber of the plurality therebetween (Fig. 4B and ¶¶ [0052]-[0055] depict the piston 9 and charger housing 604 being fluid pressure chambers for facilitating pressure changes and measurements). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid charger of the above embodiment of Schlumpf ‘199 to incorporate that the fluid charger further comprises a plurality of pistons and a plurality of piston chambers, each piston chamber sized and configured to receive a respective piston of the plurality therein in a fluid-tight manner, each piston and respective piston chamber defining a respective fluid pressure chamber of the plurality therebetween as taught by the embodiment of Fig. 4B of Schlumpf ‘199. Because both the bellows and the piston arrangement are capable of charging each balloon simultaneously (see ¶¶ [0052]-[0055] and ¶ [0068] of Schlumpf ‘199), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 28, the above combination of Schlumpf ‘199 evidenced by evidenced by Schlumpf ‘452 discloses the fluid is a gas (¶ [0037] discloses charging the catheter balloons 40 with air).
With regards to claim 29, the above combination of Schlumpf ‘199 evidenced by evidenced by Schlumpf ‘452 teaches or suggests movement of the plurality of pistons with the piston chambers decreases a volume of the plurality of fluid pressure chambers (Fig. 4B depicts pistons 9, wherein movement causes a decrease in volume of the fluid pressure chambers of the charger housing 604)
Claim 6 are rejected under 35 U.S.C. 103 as being unpatentable over Schlumpf ‘199 and evidenced by Schlumpf ‘452, as applied to claim 1 above, and in view of US 2005/0043649 A1 (Urie) (Previously cited)
With regards to claim 6, Schlumpf ‘199 evidenced by Schlumpf ‘452 discloses the diagnostic manometry device of claim 1. See the above rejection under 35 U.S.C. §102. Schlumpf ‘199 teaches the catheter comprises an additional lumen, the additional lumen not configured to be in fluid communication with a fluid pressure chamber of the plurality of fluid pressure chambers of the fluid charger (Fig. 2D and ¶¶ [0039]-[0040] depict a central lumen 17 that is not in fluid communication with lumens 30).
Schlumpf ‘199 is silent regarding whether the additional lumen is fluidly coupled with an inflatable balloon.
In the same field of endeavor of manometry, Urie teaches an additional lumen is fluidly coupled with an inflatable balloon (Fig. 2a and ¶ [0037] discloses a balloon 108 filled by a central lumen 103). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the distal end of the catheter of Schlumpf ‘199 and with a balloon that is configured to be filled by a central lumen as taught by Urie. Because both distal ends are suitable for manometry catheters (¶ [0037] of Urie; ¶ [0038] of Schlumpf ‘199), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claims 13 and 25 is rejected under 35 U.S.C. 103 as being unpatentable over Schlumpf ‘199 and evidenced by Schlumpf ‘452, as applied to respective claim 1 and 15 above, and in view of US 2020/0164184 A1 (McKinney) (previously cited)
With regards to claims 13 and 25, Schlumpf ‘199 evidenced by Schlumpf ‘452 teaches or suggests the diagnostic manometry device and fluid charger of respective claims 1 and 15.
Schlumpf ‘199 is silent regarding whether each pressure sensor of the plurality of pressure sensors comprises a digital pressure sensor configured to provide a digital output signal indicative of a pressure detected by the pressure sensor.
In a system relevant to the problem of monitoring pressure in a balloon catheter, McKinney teaches a pressure sensor being either digital or analog (¶ [0301] teaches a digital or analog pressure sensor being used), wherein the digital pressure sensor is configured to provide a digital output signal indicative of a pressure detected by the pressure sensor (The Examiner notes that digital pressure sensors necessarily provide a digital output signal indicative of a pressure detected by the pressure sensor; see analogous sensor of ¶ [0233]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the pressure sensor of Schlumpf ‘199 with the digital pressure sensor of McKinney. Because both sensors are suitable for providing pressure readings, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claims 14 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Schlumpf ‘199, evidenced by Schlumpf ‘452, and in view of McKinney, as applied to respective claims 13 and 25 above, and further in view of US 2023/0414221 A1 (Franklin) (previously cited)
With regards to claims 14 and 26, the above combination of Schlumpf ‘199, evidenced by Schlumpf ‘452, and in view of McKinney teaches or suggests the diagnostic manometry device and fluid charger of respective claims 13 and 25.
The above combination is silent regarding whether the fluid charger further comprises a digital signal processor configured to receive the digital output signal from each pressure sensor of the plurality of pressure sensors through a serial peripheral interface bus between the digital signal processor and the plurality of pressure sensors.
In a system relevant to the problem of monitoring pressure using sensors, Franklin teaches a sensing system comprising a digital signal processor configured to receive the digital output signal from each pressure sensor of the plurality of pressure sensors through a serial peripheral interface bus between the digital signal processor and the plurality of pressure sensors (¶ [0093] teaches a sensor signal conditioner (SSC) unit which produces digital data and stores the data until read by a processor unit; ¶ [0095] teaches a processor unit configured to communicate to the SSCs via data bus protocols, such as an I2C bus, a serial peripheral interface (SPI), one-wire (OWI) or the like). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid charger of the above combination to incorporate a digital signal processor configured to receive the digital output signal from each pressure sensor of the plurality of pressure sensors through a serial peripheral interface bus between the digital signal processor and the plurality of pressure sensors as taught by Franklin. The motivation would have been to provide a removable processor unit for providing on-board processing capabilities.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Schlumpf ‘199, evidenced by Schlumpf ‘452, as applied to respective claim 15 above, and further in view of US 2016/0029912 A1 (Stimpson).
With regards to claim 30, the above combination is silent regarding whether the fluid conduits each pass through a respective piston.
In the same field of endeavor of fluid chargers, Stimpson teaches a fluid pressure chamber in fluid communication with a respective fluid conduit leading to a respective catheter lumen (Fig. 4 and ¶¶ [0039]-[0040] depict a space within chamber 609 adjacent stoper assembly 622 when the stopper assembly 622 is inserted into the chamber 609, the space in fluid communication with an axial bore 626 through 624), a piston and piston chamber (Fig. 4 and ¶ [0036] depict a piston in the form of a combination of a push-in stopper 624 and rubber seal 628, and a piston chamber 609), the piston chamber sized and configured to receive the piston therein in a fluid-tight manner (Fig. 4 and ¶ [0040] depict a gas-tight seal between rubber seal 628 and chamber 609), the piston and piston chamber defining a fluid pressure chamber within the piston chamber adjacent the piston (Fig. 4 and ¶¶ [0039]-[0040] depict a space within chamber 609 adjacent stoper assembly 622 when the stopper assembly 622 is inserted into the chamber 609), wherein the fluid conduits each pass through a respective piston (Fig. 4 depicts an axial bore 626 which passes through the piston). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the fluid conduit and piston arrangement of the above combination of Schlumpf ‘199 with the fluid conduit and piston arrangement of Stimpson. Because both elements are capable of charging a balloon of a catheter (¶ [0040] of Stimpson; ¶¶ [0052]-[0055] of Schlumpf ‘199), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Response to Arguments
Claim Interpretation
In view of the claim amendments filed 02/06/2026, no limitations were interpreted under 35 U.S.C. §112(f).
Claim Rejections 35 U.S.C. §112(b)
In view of the claim amendments filed 02/06/2026, the claim rejections under 35 U.S.C. §112(b) were withdrawn.
Prior Art Rejections
There are new grounds of rejections necessitated by the claim amendments filed 02/06/2026. To the extent that the Applicant’s arguments are not applicable to the current prior art rejections, the examiner makes the following comments.
Applicant's arguments filed have been fully considered but they are not persuasive.
Applicant asserts that Schlumpf ‘199 does not describe at least “each pressure sensor of the plurality of pressure sensors located and configured to measure a fluid pressure change in a respective fluid pressure chamber” and “each piston and respective piston chamber defining a respective fluid pressure chamber of the plurality therebetween” of claim 1. Specifically, the Applicant asserts that Schlumpf ‘199 teaches piston chambers (e.g., charger housing 604) with the pressure transducers 7 located in a separate chamber (e.g., transducer housing 603), which is not defined by the pistons 9 and the piston chambers (e.g., charger housing 604) of Fig. 3. Pages 11-12 of the response filed 02/06/2026.
This argument is not persuasive.
First, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a pressure sensor located within a fluid pressure chamber) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The broadest reasonable interpretation of the limitation indicates that each pressure sensor is located in a position that allows it to measure a fluid pressure change in a respective fluid pressure chamber. Although Schlumpf ‘199 depict pressure transducers 7 located in a separate transducer housings 603, the locations of 603 are in fluidic communication with the charger housing 604 via transverse channels 602 and allow for the pressure changes within 604 to reach and be sensed by the transducers 7 in housing 603. See Figs. 3, 4B and ¶ [0055]. Specifically, paragraph [0055] indicates the pressure transducer 7 and charging piston 9 are in free communication with each other through the sealed path formed by transverse channels 601, 602 from catheter pressure lumen 30 to the charger housing 604. Therefore, Schlumpf ‘199 teaches pressure transducers located and configured to measure a fluid pressure change in a respective fluid pressure chamber.
Second, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The above combination of the embodiments of Schlumpf ‘199 which teaches the above limitations. Specifically, paragraph [0082] of Schlumpf ‘199 discloses Figs. 16-17 depicting a plurality of pressure sensors 701. Corrected Figs. 16-17 of Schlumpf ‘452 depict pressure sensors 701 replacing 88, wherein pressure sensors 701 are fluidically connected to respective bellows 110. Paragraph [0082] of Schlumpf ‘199 further teaches each pressure sensor 701 receiving a pressure measurement from the catheter lumen 30 when the bellows 110 pressurize the catheter balloons 40. The pressure sensors 701 are located in a chamber which is analogous to either the channel 604 or 603 of Figs. 3, 4B of Schlumpf ‘199. Figs. 3 and 4B of Schlumpf ‘199 teaches the plurality of pistons and the plurality of piston chambers. And it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid charger of the above embodiment of Schlumpf ‘199 to incorporate that the fluid charger further comprises the plurality of pistons and a plurality of piston chambers as taught by the embodiment of Fig. 4B of Schlumpf ‘199, wherein the pressure transducers are located and configured to measure a fluid pressure change in a respective fluid pressure chamber, for the reasons listed in the above rejection.
Applicant asserts that Schlumpf ‘452 does not provide any additional evidence to the disclosure of Schlumpf ‘199 because the two disclosures are identical. Page 12 of the response filed 02/06/2026.
This argument is not persuasive because the disclosures are not identical. Paragraph [0082] of Schlumpf ‘199 discloses Figs. 16-17 depicting a plurality of pressure sensors 701. However, Figs. 16-17 of Schlumpf ‘199 depict sensor assembly 88 instead of pressure sensors 701. Corrected Figs. 16-17 of Schlumpf ‘452 depict pressure sensors 701 replacing 88, wherein pressure sensors 701 are connected to respective bellows 110. Therefore, Schlumpf ‘452 provides clarifies the relationship between the pressure sensors 701 and its related components in Figs. 16-17.
Applicants arguments regarding claims 15-18 on page 13 of the response and claims 27 and 28 on pages 13-14 of the response are moot because of the new grounds of rejections. Applicant further asserts that Schlumpf ‘199 teaches separate pressure chambers (e.g., transducer housing 603) not defined by pistons 9 or the piston chambers (e.g., charger housing 604), but these arguments are not persuasive for the same reasons that the arguments regarding claim 1 are not persuasive.
Applicant’s arguments regarding the dependent claims on pages 15-21 of the response filed 02/06/2026 are not persuasive because the above combination of Schlumpf ‘199 does not have the alleged deficiencies of the independent claims 1, 15, and 27 for the reasons listed above.
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.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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