DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed May 8th, 2026 has been entered. Claims 1-15 have been amended. Claims 1-20 are now pending in the application, with claims 16-20 withdrawn. The previous 35 U.S.C. 112(b) rejections for Claim 1 are withdrawn in light of Applicant's amendment.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the valve-shaft-suction-application port must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 2-3, 5 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 2 recites the limitation “circumferential seal elements extending circumferentially… and radially outwardly from an outer surface of portions of the cylindrical seal member” which is confusing and unclear. According to this limitation, the circumferential seal elements extend around the seal member and radially outward from the surface of a portion of the seal member, 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. The amendments made do not alleviate this indefiniteness as it is still unclear what the circumferential seal elements are positioned proximal and distal in relation to.
Claims 3, 5 recite the limitation "valve-well-suction-application port" in its first appearance. There is insufficient antecedent basis for this limitation in the claims.
Examiner’s Comments
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
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 Fukushima et al. (US 20150148608 A1, hereinafter Fukushima).
Regarding Claim 1, Fukushima discloses
A valve component (valve shaft 66 + valve cylinder 50, FIGS. 2-4) for a medical valve assembly (suction button unit 29, FIG. 3), the valve component comprising:
a valve shaft (valve shaft 66, FIGS. 3-4) extendable through a valve well (valve cylinder 50, FIGS. 2-3) of a valve assembly (suction button unit 29, FIG. 3) and along an actuation axis (par. 85 discloses rotation of valve shaft about axis in the valve cylinder), and
defining a valve-shaft-suction-source port (upper hole opening 71 + upper passage hole 74, FIGS. 3-5) extending transverse to the actuation axis (depicted in FIG. 5), and
a valve-shaft-suction-application port (flow path surface 72, FIGS. 3-5) extending axially along the actuation axis and in fluid communication with the valve-shaft-suction-source port (FIGS. 3-5, par. 62 discloses flow path surface extends in axial direction; par. 67 discloses flow path surface cooperates with upper passage hole for fluid connection); and
a cylindrical seal member (cap device 52 + button housing 75, FIG. 5) extending circumferentially around the valve shaft and defining a suction-source communication port (plurality of wall vents 89, FIG. 6) in fluid communication with the valve-shaft- suction-source port (par. 72 discloses wall vents create flow path between upper passage hole and cap device);
wherein the valve shaft is axially movable within a valve well (valve cylinder 50, FIGS. 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 a valve-well-suction-source port (suction port hole 57, FIGS. 3, 9-10) of the valve well (FIGS. 3, 9, par. 93-95 disclose inactive state with no fluid communication), 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. 10, par. 95 disclose active position where flow path surface is in communication with suction port hole).
Regarding Claim 4, Fukushima discloses
The valve component of claim 1,
wherein the valve shaft has a proximal end (button cap 47, FIG. 3) extending away from the valve well for actuation by a user (FIG. 3, par. 94-95 disclose button cap is depressed, i.e. actuated by user), and
a distal end (small diameter portion 66b, FIGS. 3-5) extending within the valve well (depicted in FIG. 3),
the valve assembly further comprising a shaft seal member (seal packing 53, FIGS. 3-5) adjacent the distal end of the valve shaft (depicted in FIGS. 3-5).
Regarding Claim 5, Fukushima discloses
The valve component of claim 4, wherein the shaft seal member seals between the valve-well-suction-source port and the valve-well-suction-application port (discharge port hole 56, FIG. 3, par. 92 disclose suction conduit and discharge conduit are closed from communication via tight sealing by the seal packing).
Regarding Claim 6, Fukushima discloses
The valve component of claim 1, wherein the cylindrical seal member defines one or more suction bleed passages (plurality of wall vents 89 + plurality of cap vents 95, FIGS. 5-6) axially along the cylindrical seal member between the valve shaft and the cylindrical seal member (depicted in FIG. 5).
Regarding Claim 7, Fukushima discloses
The valve component of claim 6, wherein the 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 (par. 72 discloses plurality of wall vents create flow path between upper passage hole and cap device for flow of air in the inactive state, i.e. off configuration, par. 76 discloses cap vents are open to the atmosphere and the valve assembly is opened to the atmosphere via cap vents and wall vents).
Regarding Claim 8, Fukushima discloses
The valve component of claim 7, wherein the valve shaft defines a bleed port (lower passage hole 73, FIG. 4) therethrough in fluid communication with air outside the valve assembly and with the one or more bleed passages (par. 93 discloses lower passage hole is opened to the atmosphere along with the wall vents and cap vents, i.e. fluid communication).
Regarding Claim 9, Fukushima discloses
The valve component of claim 8,
wherein the one or more bleed passages extend axially through the cylindrical seal member (depicted in FIGS. 5-6), and
the cylindrical seal member seals between the one or more bleed passages therethrough and the valve-well- suction-source port (depicted in FIG. 3).
Regarding Claim 10, Fukushima discloses
A valve shaft assembly (valve shaft 66 + valve cylinder 50, FIGS. 2-4) for a valve assembly (suction button unit 29, FIG. 3) of a medical device (ultrasonic endoscope apparatus 10, FIG. 1), the valve shaft assembly comprising:
a valve shaft (valve shaft 66, FIGS. 3-4) having a proximal end (button cap 47, FIGS. 1-3) configured for engagement by a user (par. 94-95 disclose button cap is depressed, i.e. actuated by user),
a distal end (small diameter portion 66b, FIGS. 3-5), and
a longitudinal axis extending therebetween (par. 85 discloses rotation of valve shaft about axis in the valve cylinder),
the valve shaft defining a transversely-extending port (upper hole opening 71 + upper passage hole 74, FIGS. 3-5) extending transverse to the longitudinal axis (depicted in FIG. 5), and
an axially-extending port (flow path surface 72, FIGS. 3-5) extending axially along longitudinal actuation axis (depicted in FIG. 5),
with the transversely-extending port in fluid communication with the axially-extending port (par. 67 discloses flow path surface cooperates with upper passage hole for fluid connection); and
a flexible cylindrical seal member (cap device 52 + button housing 75, FIG. 5) formed from a sealing material more flexible than said valve shaft (par. 59 discloses valve shaft comprises metal, par. 71 discloses button housing comprises resin), and
extending circumferentially around the valve shaft and defining a transversely-extending port (plurality of wall vents 89, FIG. 6) in fluid communication with and longitudinally aligned with the transversely-extending port in the valve shaft (FIGS. 3-5, par. 72 discloses wall vents create flow path between upper passage hole and cap device).
Regarding Claim 13, Fukushima discloses
The valve shaft assembly of claim 10, wherein the cylindrical seal member defines one or more suction bleed passages (plurality of wall vents 89 + plurality of cap vents 95, FIGS. 5-6) axially along the cylindrical seal member between the valve shaft and the cylindrical seal member (depicted in FIG. 5).
Regarding Claim 14, Fukushima discloses
The valve shaft assembly of claim 13, wherein the valve shaft defines a bleed port (lower passage hole 73, FIG. 4) therethrough in fluid communication with the one or more bleed passages (par. 93 discloses lower passage hole is opened to the atmosphere along with the wall vents and cap vents, i.e. fluid communication).
Regarding Claim 15, Fukushima discloses
The valve shaft assembly of claim 10, further comprising a shaft seal member (seal packing 53, FIGS. 3-5) on the valve shaft adjacent the distal end of the valve shaft (depicted in FIGS. 3-5).
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 Fukushima et al. (US 20150148608 A1, hereinafter Fukushima) in view of Kondo (US 20030181787 A1).
Regarding Claim 2, Fukushima discloses all of the elements of the current invention disclosed in claim 1, however, Fukushima does not disclose wherein the cylindrical seal member includes circumferential seal elements extending circumferentially around the valve shaft and radially outwardly from an outer surface of portions of the cylindrical seal member proximal to and distal to the 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 Fukushima 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], and 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, Fukushima, as previously modified by Kondo, discloses all of the elements of the current invention disclosed in claim 2, Fukushima further discloses
wherein the circumferential seal elements form seals (seal packing 53, FIG. 3) 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 to seal fluid communication through the valve assembly between a suction source (suction conduit 28, FIG. 3) fluidly in communication with the valve-well-suction-source port and a suction application device (discharge conduit 35, FIG. 3) fluidly in communication with the valve-well-suction-application port (discharge port hole 56, FIG. 3, par. 92 disclose suction conduit and discharge conduit are closed from communication via tight sealing by the seal packing).
Regarding Claim 11, Fukushima discloses all of the elements of the current invention disclosed in claim 10, however, Fukushima does not disclose wherein the cylindrical seal member includes circumferential seal elements extending circumferentially around said cylindrical seal member and radially outwardly from the outer surface of the cylindrical seal member proximal and distal to the 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 Fukushima 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], and 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, Fukushima, as previously modified by Kondo, discloses all of the elements of the current invention disclosed in claim 11, Fukushima further discloses
wherein the circumferential seal elements are configured to define seals (seal packing 53, FIG. 3) proximal and distal to the transversely-extending port of the valve shaft when positioned within a valve well of a valve assembly (FIG. 3, par. 92 disclose suction conduit and discharge conduit are closed from communication via tight sealing by the seal packing).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABDUL HADI ABBASI whose telephone number is (571)272-4076. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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
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