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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, Claims 1-15 in the reply filed on 12/19/2025 is acknowledged. Claims 16-20 have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-2 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “an actuation axis for actuation movement along the actuation axis” which is confusing and unclear because it is not specified as to what is being actuated nor what actuates movement, moreover, the orientation of the axis is not specified so it is unclear whether or not the actuation axis extends longitudinally in relation to the valve shaft, which is how the examiner will interpret the axis.
Claim 1 further recites the limitation "valve-well-suction-source port" in its first appearance. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites “wherein said cylindrical seal member includes circumferential seal elements extending circumferentially around said cylindrical seal member and radially outwardly from the outer surface of said cylindrical seal member proximal and distal to said circumferential seal elements” which is confusing and unclear. According to this limitation, the circumferential seal elements extend around the seal member and radially outward from the surface, however, the limitation further states that the circumferential seal elements are positioned proximal and distal to said circumferential seal elements. Based on the current recitation of the claim, it appears as if the seal elements are positioned proximal and distal to themselves which is indefinite as to the intended structure.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4-10, 13-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Busch et al. (US 20230404377 A1, hereinafter Busch).
Regarding Claim 1, Busch discloses
A valve component (suction valve 5, FIG. 1) for a medical valve assembly (endoscope 1, FIG. 1), said valve component comprising:
a valve shaft (piston unit 9, FIG. 2, 6) extendable through a valve well (housing 8, FIG. 2) of a valve assembly (suction valve 5) and along an actuation axis (longitudinal axis of piston unit) for actuation movement along the actuation axis (depicted in FIG. 2, 6), and
defining a valve-shaft-suction-source port (first (side) opening 17, FIG. 6) extending transverse to the actuation axis (depicted in FIG. 2, 6), and
a valve-shaft-suction-application port (second (bottom) opening 18, FIG. 2) extending axially along the actuation axis (depicted in FIG. 2) and in fluid communication with the valve-shaft-suction-source port (FIG. 3, par. 90 disclose fluid communication between first and second openings); and
a cylindrical seal member (button 14, FIG. 6, 9-10) extending circumferentially around said valve shaft (depicted in FIG. 6) and defining a suction-source communication port (circular hole 26, FIG. 6) in fluid communication with the valve-shaft- suction-source port (FIG. 7, par. 108 disclose internal guiding channel creates fluid communication between the first opening and the button, i.e. opening of button capable of being in fluid communication with first opening);
wherein said valve shaft is axially movable within a valve well (depicted in FIG. 2-3) between an off position in which the valve assembly is in an off configuration with the valve-shaft-suction-source port not in fluid communication with the valve-well-suction-source port (inlet opening 11, FIG. 2, par. 97 disclose valve closed state), and
an on position in which the valve assembly is in an on configuration with the valve-shaft-suction-source port in fluid communication with the valve-well-suction-source port (FIG. 3, par. 98 disclose valve open state).
Regarding Claim 4, Busch discloses
The valve component of claim 1, wherein said valve shaft has a proximal end (first (upper) piston portion 13a, FIG. 2) extending away from the valve well for actuation by a user (FIG. 2, par. 95 disclose upper end of piston is engaged with button which are extending away from housing; par. 25 discloses valve actuation controlled by user pressing button), and
a distal end (second (lower) piston portion 13b) extending within the valve well (depicted in FIG. 2),
said valve assembly further comprising a shaft seal member (inclined portion 33 + flange portion 34, FIG. 7) adjacent the distal end of said valve shaft (depicted in FIG. 7).
Regarding Claim 5, Busch discloses
The valve component of claim 4, wherein said shaft seal member seals between the valve-well-suction-source port and the valve-well-suction-application port (par. 111 discloses inclined portion and flange portion allow an urging effect which presses the wedge-like portion of the fixation ring against the inlet opening, sealing it from the outlet opening, as depicted in FIG. 7-8).
Regarding Claim 6, Busch discloses
The valve component of claim 1, wherein said cylindrical seal member defines one or more suction bleed passages (leakage slits 31, FIG. 6) axially along said cylindrical seal member between said valve shaft and said cylindrical seal member (depicted in FIG. 6).
Regarding Claim 7, Busch discloses
The valve component of claim 6, wherein said one or more suction bleed passages are in fluid communication with air outside the valve assembly to allow air from outside the valve assembly to bleed a suction source in fluid communication with the valve-well- suction-source port when the suction source is running and the valve assembly is in the off configuration (FIG. 7, par. 107 discloses leakage slits allow air from the surroundings to be sucked into the suction valve in the valve closed state).
Regarding Claim 8, Busch discloses
The valve component of claim 7, wherein said valve shaft defines a bleed port (flow channel 19) therethrough in fluid communication with air outside the valve assembly and with the one or more bleed passages (par. 108 discloses flow channel in communication with the leakage slits of the button and leakage flow of outside air enters flow channel).
Regarding Claim 9, Busch discloses
The valve component of claim 8, wherein the one or more bleed passages extend axially through said cylindrical seal member (depicted in FIG. 6), and
said cylindrical seal member seals between the one or more bleed passages therethrough and the valve-well-suction-source port (depicted in FIG. 7).
Regarding Claim 10, Busch discloses
A valve shaft assembly (suction valve 5, FIG. 1) for a valve assembly of a medical device (endoscope 1, FIG. 1), said valve shaft assembly comprising:
a valve shaft (piston unit 9, FIG. 2, 6) having a proximal end (first (upper) piston portion 13a, FIG. 2) configured for engagement by a user (FIG. 2, par. 95 disclose upper end of piston is engaged with button which are extending away from housing; par. 25 discloses valve actuation controlled by user pressing button),
a distal end (second (lower) piston portion 13b), and
a longitudinal axis extending therebetween (longitudinal axis of piston unit 9),
said valve shaft defining a transversely-extending port (first (side) opening 17, FIG. 6) extending transverse to the longitudinal axis (depicted in FIG. 2, 6), and
an axially-extending port (second (bottom) opening 18, FIG. 2) extending axially along longitudinal actuation axis (depicted in FIG. 2), with the transversely-extending port in fluid communication with the axially-extending port (FIG. 3, par. 90 disclose fluid communication between first and second openings); and
a flexible cylindrical seal member (button 14, FIG. 6, 9-10) formed from a sealing material more flexible than said valve shaft (par. 18 discloses shaft can be made of polystyrene which is rigid, par. 117 discloses button may be made of flexible material), and
extending circumferentially around said valve shaft (depicted in FIG. 6) and defining a transversely-extending port (singular leakage slit 31, FIG. 6) in fluid communication with the transversely-extending port in said valve shaft (FIG. 7, par. 108 disclose internal guiding channel creates fluid communication between the first opening and the button).
Regarding Claim 13, Busch discloses
The valve shaft assembly of claim 10, wherein said cylindrical seal member defines one or more suction bleed passages (multiple leakage slits 31, FIG. 6) axially along said cylindrical seal member between said valve shaft and said cylindrical seal member (depicted in FIG. 6).
Regarding Claim 14, Busch discloses
The valve shaft assembly of claim 13, wherein said valve shaft defines a bleed port (flow channel 19) therethrough in fluid communication with the one or more bleed passages (par. 108 discloses flow channel in communication with the leakage slits of the button).
Regarding Claim 15, Busch discloses
The valve shaft assembly of claim 10, further comprising a shaft seal member (inclined portion 33 + flange portion 34, FIG. 7) on said valve shaft adjacent the distal end of said valve shaft (depicted in FIG. 7).
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.
Claim(s) 2-3, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Busch et al. (US 20230404377 A1, hereinafter Busch) in view of Kondo (US 20030181787 A1).
Regarding Claim 2, Busch discloses all of the elements of the current invention disclosed in claim 1, Busch further discloses wherein said cylindrical seal member (14) includes circumferential seal elements (integrated sealing portion 37, FIG. 10) extending circumferentially around said cylindrical seal member (depicted in FIG. 10).
However, Busch does not disclose multiple seal elements which extend radially outwardly from the outer surface of said cylindrical seal member proximal and distal to said circumferential seal elements.
Kondo teaches an analogous cylindrical seal member (active blockade face 116, FIG. 5A-5B) in a valve assembly (suction valve 100, FIG. 1). The seal (116) is formed around a valve member (104) and includes O-rings (112a,112b,112c, i.e. circumferential seal elements) and grooves (118, i.e. circumferential seal elements) which extend circumferentially from the outer surface of the seal members proximally and distally (depicted in FIG. 5A-5B) and act as sealing members/ elements [0065].
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the cylindrical seal member of Busch with the circumferential seal elements of Kondo in order to prevent foreign substances for instance filthy matters, mucus, blood, body fluids from entering the valve shaft during operation inside the human body [Kondo 0065-0066] which the integrated sealing portion (37) of Busch does not do and only accounts for air [Busch 0122], and will prevent increased sliding friction allowing for stable and smooth switching between suction states (i.e., on and off configurations) [Kondo 0047, 065-066].
Regarding Claim 3, Busch, as previously modified by Kondo, discloses all of the elements of the current invention disclosed in claim 2, Busch further discloses a suction source (suction pump/vacuum pump 7, FIG. 1) fluidly in communication with the valve-well-suction-source port (depicted in FIG. 3) and a suction application device (endoscope shaft 3, FIG. 1) fluidly in communication with the valve-well-suction-application port (FIG. 3, par. 83 disclose suction applied to working channel via suction valve).
Kondo further teaches wherein said circumferential seal elements form seals proximal and distal to the valve-shaft-suction-source port and the valve-well-suction-source port to create a sealed space extending circumferentially around said valve shaft (depicted in FIG. 4)
to seal fluid communication through the valve assembly between a suction source and a suction application device (par. 44 discloses the suction source side path (108, i.e. suction source path, FIG. 2) and the suction side path (suction side path 106, i.e. suction application device path, FIG. 2) are sealed off from each other by the cylindrical seal member 116, par. 43 discloses suction paths are cut off via the O-rings, i.e. seal elements, of the seal member 116).
Regarding Claim 11, Busch discloses all of the elements of the current invention disclosed in claim 10, Busch further discloses wherein said cylindrical seal member (14) includes circumferential seal elements (integrated sealing portion 37, FIG. 10) extending circumferentially around said cylindrical seal member (depicted in FIG. 10).
However, Busch does not disclose multiple seal elements which extend radially outwardly from the outer surface of said cylindrical seal member proximal and distal to said circumferential seal elements.
Kondo teaches an analogous cylindrical seal member (active blockade face 116, FIG. 5A-5B) in a valve assembly (suction valve 100, FIG. 1). The seal (116) is formed around a valve member (104) and includes O-rings (112a,112b,112c, i.e. circumferential seal elements) and grooves (118, i.e. circumferential seal elements) which extend circumferentially from the outer surface of the seal members proximally and distally (depicted in FIG. 5A-5B) and act as sealing members/ elements [0065].
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the cylindrical seal member of Busch with the circumferential seal elements of Kondo in order to prevent foreign substances for instance filthy matters, mucus, blood, body fluids from entering the valve shaft during operation inside the human body [Kondo 0065-0066] which the integrated sealing portion (37) of Busch does not do and only accounts for air [Busch 0122], and will prevent increased sliding friction allowing for stable and smooth switching between suction states (i.e., on and off configurations) [Kondo 0047, 065-066].
Regarding Claim 12, Busch, as previously modified by Kondo, discloses all of the elements of the current invention disclosed in claim 2, Kondo further teaches
The valve assembly of claim 11, wherein said circumferential seal elements are configured to define seals proximal and distal to the transversely-extending port of said valve shaft when positioned within a valve well of a valve assembly (depicted in FIG. 4).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABDUL HADI ABBASI whose telephone number is (571)272-4076. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABDUL HADI ABBASI/Examiner, Art Unit 3795
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795