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
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.
Claims 18-22, 24-32, and 34-37 are rejected under 35 U.S.C. 103 as being unpatentable over Michaels (US 20110313375 A1) and Felix et al. (US 6626827 B1), hereinafter referred to as “Felix”.
Regarding Claim 18, Michaels teaches a collection system for collecting outflow (a collapsible liner for use in a canister of a medical fluid collection system, see Abstract; Figure 1) comprising:
the collection system comprising:
a collection vessel (a liner assembly 24), including:
a flexible body (bag 58) defining an interior (collection volume of bag 58 having an interior within which medical waste fluid is contained, see Figure 3) and having an open end (top portion 62 having an open end) and a closed end disposed along a longitudinal axis of the flexible body (a closed bottom portion 64), the flexible body transitionable between a collapsed configuration and an expanded configuration (see Figures 1 and 8B); and
a rigid body (lid 26, see Figure 2) including a top plate (upper surface 42) and an outer housing extending from the top plate (flange 46), wherein the open end of the flexible body is sealed to the top plate within the outer housing (the top portion 62 is coupled to the lid 26, see Paragraph [0029]; Figure 1), the top plate including a fluid port (collection port 54) and a vacuum port (vacuum source port 50), the fluid port configured for introduction of surgical fluids through the fluid port, the open end of the flexible body, and into the interior of the flexible body (the collection port 56 is in fluid communication with the collapsible liner 28 and defines an entrance into the collapsible liner 28 for medical waste fluids, see Paragraph [0027]), the vacuum port disposed in fluid communication with the interior of the flexible body to establish vacuum within the interior of the flexible body (the first vacuum source port 50 is fluidly connected with an interior of the liner 28, such that application of a vacuum to the port 50 renders the liner interior below atmospheric pressure, see Paragraph [0024]),
wherein the outer housing of the rigid body is configured to retain the closed end of the flexible body within the outer housing in the collapsed configuration (the liner assembly 24 is collapsed to a maximum extent such that the support element 60a is longitudinally displaced upward and contacts the lid 26, see Figure 8B, Paragraph [0063]) and wherein, in the expanded configuration, the flexible body (58) extends from the outer housing such that the closed end of the flexible body is longitudinally spaced from the outer housing (closed end 64 is longitudinally spaced from the lid 26, see Figure 1).
However, Michaels does not explicitly disclose a collection system for collecting outflow from a hysteroscopic surgical procedure.
Felix teaches a collection system for collecting outflow (fluid management assembly 40 having a collection receptable 110, see Figure 3) from a hysteroscopic surgical procedure (fluid management systems and, more particularly, to an endoscope distention fluid management assembly for use in an endoscopic operative procedure, such as a hysteroscopic surgical procedure, see Col. 1 ln 6-28).
Michaels and Felix are analogous art because both teach a medical fluid collection assembly.
Felix teaches there is need for an improved management assembly for use in an endoscopic, e.g., hysteroscopic, surgical procedure which permits the operative organ to be optimally distended during the entire surgical procedure. The management assembly of the present invention satisfies these and other needs (see Col. 3 ln 45-50). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the collection system of Michaels and further include wherein collection system is configured for collecting outflow from a hysteroscopic surgical procedure, as taught by Felix.
Regarding Claim 19, Michaels and Felix teach all of the limitations, as discussed above in claim 18, and Michaels further teaches wherein the top plate (42) and the outer housing (46) are integrally formed with one another (see Figure 2).
Regarding Claim 20, Michaels and Felix teach all of the limitations, as discussed above in claim 18, and Michaels further teaches wherein the outer housing defines a cylindrical configuration (flange 46 is cylindrical, see Figure 2).
Regarding Claim 21, Michaels and Felix teach all of the limitations, as discussed above in claim 18, and Michaels further teaches wherein the flexible body is expandable and collapsible along the longitudinal axis (longitudinal collapse/expansion of the bag 58 from the bottom portion 64 up to the top portion 62, see Paragraph [0032]).
Regarding Claim 22, Michaels and Felix teach all of the limitations, as discussed above in claim 21, and Michaels further teaches wherein the collection vessel further includes a support structure (support elements 60a, 60b, 60c, and 60d) configured to provide radial support to the flexible body (provided to limit or constrain lateral collapse of the liner 28, see Paragraph [0032]) while enabling longitudinal expansion and collapsing of the flexible body (while allowing longitudinal expansion/collapse, see Paragraph [0032]).
Regarding Claim 24, Michaels and Felix teach all of the limitations, as discussed above in claim 18, and Michaels further teaches wherein the top plate of the collection vessel further includes at least one mounting structure for supporting the collection vessel from a mounting stand (the lid 26 of the liner assembly 24 is sized to be attached and sealed to an open end 30 defined by the canister 22, see Paragraph [0020], Figure 1).
Regarding Claim 25, Michaels and Felix teach all of the limitations, as discussed above in claim 24, and Michaels further teaches the mounting stand (22), wherein the mounting stand is configured to support the collection vessel and retain the collection vessel in the expanded configuration (canister 22 holds the liner assembly 24 in an expanded configuration, see Figure 8A).
Regarding Claim 26, Michaels teaches all of the limitations, as discussed above in claim 18. However, Michaels does not explicitly disclose a surgical instrument; and vacuum tubing coupling the surgical instrument with the outflow port of the top plate.
Felix teaches a collection system for collecting outflow (fluid management assembly 40 having a collection receptable 110, see Figure 3) from a hysteroscopic surgical procedure (fluid management systems and, more particularly, to an endoscope distention fluid management assembly for use in an endoscopic operative procedure, such as a hysteroscopic surgical procedure, see Col. 1 ln 6-28) comprising: a surgical instrument (an endoscope 90 (e.g., hysteroscope), see Figure 3); and vacuum tubing (first fluid carrying member 42) coupling the surgical instrument with the outflow port of the top plate (coupled to the adaptor 80 of canister 110, see Figure 3).
Michaels and Felix are analogous art because both teach a medical fluid collection assembly.
Felix teaches there is need for an improved management assembly for use in an endoscopic, e.g., hysteroscopic, surgical procedure which permits the operative organ to be optimally distended during the entire surgical procedure. The management assembly of the present invention satisfies these and other needs (see Col. 3 ln 45-50). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the collection system of Michaels and further include a surgical instrument and vacuum tubing coupling the surgical instrument with the outflow port of the top plate, as taught by Felix.
Regarding Claim 27, Michaels and Felix teach all of the limitations, as discussed above in claim 24, and Michaels further teaches a vacuum pump (vacuum source, see Paragraph [0024]); and vacuum tubing (a vacuum line (not shown), see Paragraph [0024]) coupling the vacuum pump with the vacuum port of the top plate (first vacuum source port 50 is sized for coupling to a vacuum line and facilitate partial evacuation of the collapsible liner 28 for the purpose of collecting medical waste fluid within the liner 28, see Paragraph [0024]).
Regarding Claim 28, Michaels teaches a collection system for collecting outflow (a collapsible liner for use in a canister of a medical fluid collection system, see Abstract; Figure 1), the collection system comprising:
a collection vessel(a liner assembly 24), including:
a flexible body (bag 58) defining an interior (collection volume of bag 58 having an interior within which medical waste fluid is contained, see Figure 3) and having an open end (top portion 62 having an open end) and a closed end disposed along a longitudinal axis of the flexible body (a closed bottom portion 64), the flexible body transitionable between a collapsed configuration and an expanded configuration (see Figures 1 and 8B); and
a rigid body (lid 26, see Figure 2) including a top plate (upper surface 42) and an inner housing extending from the top plate (flange 46), wherein the open end of the flexible body is sealed to the top plate about the inner housing (the top portion 62 is coupled to the lid 26, see Paragraph [0029]; Figure 1), the top plate including a fluid port (collection port 54) and a vacuum port (vacuum source port 50), the fluid port configured for introduction of surgical fluids through the fluid port, the open end of the flexible body, and into the interior of the flexible body (the collection port 56 is in fluid communication with the collapsible liner 28 and defines an entrance into the collapsible liner 28 for medical waste fluids, see Paragraph [0027]), the vacuum port disposed in fluid communication with the interior of the flexible body to establish vacuum within the interior of the flexible body (the first vacuum source port 50 is fluidly connected with an interior of the liner 28, such that application of a vacuum to the port 50 renders the liner interior below atmospheric pressure, see Paragraph [0024]),
wherein the inner housing of the rigid body is configured to retain the closed end of the flexible body within the inner housing in the collapsed configuration (the liner assembly 24 is collapsed to a maximum extent such that the support element 60a is longitudinally displaced upward and contacts the lid 26, see Figure 8B, Paragraph [0063]) and wherein, in the expanded configuration, the flexible body (58) extends from the inner housing such that the closed end of the flexible body is longitudinally spaced from the inner housing (closed end 64 is longitudinally spaced from the lid 26, see Figure 1).
However, Michaels does not explicitly disclose a collection system for collecting outflow from a hysteroscopic surgical procedure.
Felix teaches a collection system for collecting outflow (fluid management assembly 40 having a collection receptable 110, see Figure 3) from a hysteroscopic surgical procedure (fluid management systems and, more particularly, to an endoscope distention fluid management assembly for use in an endoscopic operative procedure, such as a hysteroscopic surgical procedure, see Col. 1 ln 6-28).
Michaels and Felix are analogous art because both teach a medical fluid collection assembly.
Felix teaches there is need for an improved management assembly for use in an endoscopic, e.g., hysteroscopic, surgical procedure which permits the operative organ to be optimally distended during the entire surgical procedure. The management assembly of the present invention satisfies these and other needs (see Col. 3 ln 45-50). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the collection system of Michaels and further include wherein collection system is configured for collecting outflow from a hysteroscopic surgical procedure, as taught by Felix.
Regarding Claim 29, Michaels and Felix teach all of the limitations, as discussed above in claim 28, and Michaels further teaches wherein the inner housing defines a length (flange 46 has a longitudinal length, see Figure 2).
However, Michaels and Felix do not explicitly disclose wherein the inner housing defines a length of from about 10% to about 50% of a length of the flexible body in the expanded configuration.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the inner housing length of Modified Michaels from what is shown in Figure 2 to between 10% and 50% of a length of the flexible body in the expanded configuration since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [0093] indicating the angle “may” be within the claimed range).
Regarding Claim 30, Michaels and Felix teach all of the limitations, as discussed above in claim 28, and Michaels further teaches wherein the outer housing defines a cylindrical configuration (flange 46 is cylindrical, see Figure 2).
Regarding Claim 31, Michaels and Felix teach all of the limitations, as discussed above in claim 28, and Michaels further teaches wherein the flexible body is expandable and collapsible along the longitudinal axis (longitudinal collapse/expansion of the bag 58 from the bottom portion 64 up to the top portion 62, see Paragraph [0032]).
Regarding Claim 32, Michaels and Felix teach all of the limitations, as discussed above in claim 28, and Michaels further teaches wherein the collection vessel further includes a support structure (support elements 60a, 60b, 60c, and 60d) configured to provide radial support to the flexible body (provided to limit or constrain lateral collapse of the liner 28, see Paragraph [0032]) while enabling longitudinal expansion and collapsing of the flexible body (while allowing longitudinal expansion/collapse, see Paragraph [0032]).
Regarding Claim 34, Michaels and Felix teach all of the limitations, as discussed above in claim 28, and Michaels further teaches wherein the top plate of the collection vessel further includes at least one mounting structure for supporting the collection vessel from a mounting stand (the lid 26 of the liner assembly 24 is sized to be attached and sealed to an open end 30 defined by the canister 22, see Paragraph [0020], Figure 1).
Regarding Claim 35, Michaels and Felix teach all of the limitations, as discussed above in claim 34, and Michaels further teaches the mounting stand (22), wherein the mounting stand is configured to support the collection vessel and retain the collection vessel in the expanded configuration (canister 22 holds the liner assembly 24 in an expanded configuration, see Figure 8A).
Regarding Claim 36, Michaels teaches all of the limitations, as discussed above in claim 28. However, Michaels does not explicitly disclose a surgical instrument; and vacuum tubing coupling the surgical instrument with the outflow port of the top plate.
Felix teaches a collection system for collecting outflow (fluid management assembly 40 having a collection receptable 110, see Figure 3) from a hysteroscopic surgical procedure (fluid management systems and, more particularly, to an endoscope distention fluid management assembly for use in an endoscopic operative procedure, such as a hysteroscopic surgical procedure, see Col. 1 ln 6-28) comprising: a surgical instrument (an endoscope 90 (e.g., hysteroscope), see Figure 3); and vacuum tubing (first fluid carrying member 42) coupling the surgical instrument with the outflow port of the top plate (coupled to the adaptor 80 of canister 110, see Figure 3).
Michaels and Felix are analogous art because both teach a medical fluid collection assembly.
Felix teaches there is need for an improved management assembly for use in an endoscopic, e.g., hysteroscopic, surgical procedure which permits the operative organ to be optimally distended during the entire surgical procedure. The management assembly of the present invention satisfies these and other needs (see Col. 3 ln 45-50). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the collection system of Michaels and further include a surgical instrument and vacuum tubing coupling the surgical instrument with the outflow port of the top plate, as taught by Felix.
Regarding Claim 37, Michaels and Felix teach all of the limitations, as discussed above in claim 28, and Michaels further teaches a vacuum pump (vacuum source, see Paragraph [0024]); and vacuum tubing (a vacuum line (not shown), see Paragraph [0024]) coupling the vacuum pump with the vacuum port of the top plate (first vacuum source port 50 is sized for coupling to a vacuum line and facilitate partial evacuation of the collapsible liner 28 for the purpose of collecting medical waste fluid within the liner 28, see Paragraph [0024]).
Claims 23 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Michaels and Felix. as applied to claim 18 and 28 above, and further in view of Locke et al. (US 20140276488 A1), hereinafter referred to as “Locke”.
Regarding Claim 23 and 33, Michaels and Felix teach all of the limitations as discussed above in claim 18 and 28. However, Michaels and Felix do not explicitly disclose wherein the collection vessel further includes a rigid bottom plate coupled to the flexible body at the closed end of the flexible body.
Locke teaches a collection vessel (canister 102, see Abstract; Figure 2), including: a flexible body (container 104 comprises walls 120) defining an interior (a chamber within the container 104) and having an open end (a proximal end 122 including an opening 123 to the chamber) and a closed end disposed along a longitudinal axis of the flexible body (a distal end 124 that is closed), the flexible body transitionable between a collapsed configuration and an expanded configuration (the walls 120 may have a collapsible portion that allows the container 104 to be compressed to an empty volume and expanded to a filled volume, see Paragraph [0019]), and wherein the collection vessel further includes a rigid bottom plate coupled to the flexible body at the closed end of the flexible body (the walls 120 may also have a non-corrugated or rigid portion that provides a pocket 125 adjacent the distal end 124, see Paragraph [0020]).
Michaels, Felix, and Locke are analogous art because all teach a collection assembly for medical procedures.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the collection vessel of Modified Michaels and further include wherein the collection vessel further includes a rigid bottom plate coupled to the flexible body at the closed end of the flexible body, as taught by Locke. Locke teaches it is beneficial for a rigid portion that provides a pocket 125 adjacent the distal end 124 that may contain gelling agents used to solidify the wound fluids 113 contained within the container 104 (see Paragraph [0020]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wu (US 20100241091 A1) teaches a collection system for collecting outflow (see Abstract), the collection system comprising:
a collection vessel (see Figure 1), including:
a flexible body (flexible inner bag 40) defining an interior and having an open end (41) and a closed end disposed along a longitudinal axis of the flexible body (see Figure 1), the flexible body transitionable between a collapsed configuration and an expanded configuration (see Figures 12-16; Paragraph [0043]); and
a rigid body (cover 30) including a top plate (see Figure 1) and an outer housing extending from the top plate (peripheral lip 31), wherein the open end of the flexible body is sealed to the top plate within the outer housing (see Paragraph [0036]), the top plate including a fluid port (tubular member 35) and a vacuum port (37), the fluid port configured for introduction of surgical fluids through the fluid port, the open end of the flexible body, and into the interior of the flexible body (see Paragraph [0041]), the vacuum port disposed in fluid communication with the interior of the flexible body to establish vacuum within the interior of the flexible body (see Paragraph [0038]),
and wherein, in the expanded configuration, the flexible body extends from the outer housing such that the closed end of the flexible body is longitudinally spaced from the outer housing (see Figure 14).
However, Harpham fails to teach a hysteroscopic surgical procedure and wherein the outer housing of the rigid body is configured to retain the closed end of the flexible body within the outer housing in the collapsed configuration.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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/ERIC RASSAVONG/ (4/8/2026)Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
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