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 § 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 1-14 are 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. Independent claim 1 recites, “a shaft having…a plurality of grooves”, “a first seal positioned within a first groove of the shaft”, “a second seal positioned within a second groove of the shaft”, and “a third seal positioned within a third groove of the shaft”. It is not clear if the first groove, second groove and third groove are grooves of the plurality of grooves, or if they are grooves separate and distinct from the plurality of grooves. Accordingly, the claims are rendered indefinite. Appropriate correction is required. For purposes of examination, “a first seal positioned within a first groove of the shaft” is interpreted as “a first seal positioned within a first groove of the plurality of grooves of the shaft”, “a second seal positioned within a second groove of the shaft” is interpreted as “a second seal positioned within a second groove of the plurality of grooves of the shaft”, and “a third seal positioned within a third groove of the shaft” is interpreted as “a third seal positioned within a third groove of the plurality of grooves of the shaft” (emphasis added).
Dependent claim 6 recites at least one bushing set within other grooves of the plurality of grooves in which no seal is positioned (emphasis added). The claim only requires one bushing, however, the bushing is recited to be set within other grooves. It is not clear how one bushing can be set in multiple grooves. Accordingly, the claim is rendered in definite. Appropriate correction is required.
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, 7-8 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grudo et al. (US 2013/0303844 A1).
Regarding claim 1, Grudo discloses a disposable valve (200; Fig. 3) for an endoscope, comprising: a shaft (225; Fig. 3) having a longitudinal axis, a passage from a first opening (272; par. [0043]) to a vent (275; par. [0043]), a plurality of grooves (227/222/221/219/217; Fig. 4; par. [0039]) and a plurality of ridges (216/223/224/226; Fig. 4; par. [0039]); an outer cap (235/230; Fig. 4; par. [0039]); an inner ring (Fig. 6 – ring defining 285) having a diaphragm (280; Fig. 6) that extends from an outer circumference of the inner ring to an internal circumference of the outer cap (inner surface of 230); a button cap (245; Fig. 3; par. [0045]) coupled to the shaft (225); a first seal (210; Figs. 3-4; par. [0039]) positioned within a first groove (219; Figs. 3-4) of the shaft (225) on a first side (distal side) of the first opening (272; Figs. 3-5); a second seal (215; Figs. 3-4; par. [0039]) positioned within a second groove (221; Figs. 3-4) of the shaft (225) on a second side (proximal side) of the first opening (272; Figs. 3-5), wherein the second side (proximal side) is on an opposite side of the first opening (272) from the first side (distal side), wherein the first seal (210) and the second seal (215) are positioned distal from the outer cap (235/230; Fig. 3); and a third seal (220; Figs. 3-4; par. [0039]) positioned within a third groove (222; Figs. 3-4) of the shaft (225), wherein the third seal (220) is positioned within the outer cap (235/230; Figs. 3-4).
Regarding claim 7, Grudo discloses the disposable valve of claim 1, wherein one or more of the shaft (225), the first seal (210), the second seal (215), the third seal (230), the outer cap (230/235), the inner ring, and the button cap (245) comprise at least one of polyurethane, polyurea, polyether(amide), thermoplastic elastomeric olefin, copolyester, styrenic thermoplastic elastomer, carbon fiber, glass fiber, ceramics, methacrylates, poly (N-isopropylacrylamide), PEO-PPO-PEO, polycarbonate, ABS, MABS, and silicone (par. [0041]).
Regarding claim 8, Grudo discloses the disposable valve of claim 1, wherein one or more of the shaft (225), the first seal (210), the second seal (215), the third seal (230), the outer cap (230/235), the inner ring, and the button cap (245) comprise at least one of rubber and plastic (par. [0041]).
Regarding claim 14, Grudo discloses the disposable valve of claim 1, wherein the inner ring is a monolithically molded part of the outer cap (235 is over-molded to 230 and the diaphragm 280 and the inner ring are formed on 230 - see par. [0044] and [0047]; by over-molding the 235 and 230, a monolithic outer cap, inner ring and diaphragm is formed as a single unit).
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) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grudo, as applied to claim 1 above, in view of Fukushima et al. (US 2015/0148608 A1).
Regarding claim 2, Grudo discloses the disposable valve of claim 1, but does not specifically disclose wherein at least one hinge extends vertically from the diaphragm. Fukushima teaches an analogous valve (Fig. 8) wherein the outer cap (85; par. [0071]; Fig. 5) comprises an inner ring (defining 88; Fig. 7; par. [0071]), a diaphragm (84a; Fig. 3; a dividing membrane or partition; par. [0072]-[0073]), and at least one hinge extending vertically from the diaphragm (90a/90b; Fig. 7; par. [0073]). Fukushima teaches that the at least one hinge engages a mount (50/63; Figs 2 and 7; par. [0086]) on an endoscope and prevents rotation between the mount and the outer cap (par. [0086]). It would have been obvious to one having ordinary skill in the art to include at least one hinge extending vertically from the diaphragm of Grudo, in order to secure the valve to a mount on the endoscope, as taught by Fukushima.
Regarding claim 3, Grudo in view of Fukushima disclose the disposable valve of claim 2, wherein the at least one hinge (Fukushima: 90a/90b) comprises a tine and a barb (Fukushima: see Fig. 9), but does not specifically disclose wherein the barb has a width of less than 200 microns. At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to make the barb have a width of less than 200 microns because Applicant has not disclosed that a barb width of less than 200 microns provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected modified Grudo's valve, and applicant's invention, to perform equally well with either the width taught by modified Grudo or the claimed less than 200 micron width because both barbs would perform the same function of attaching to components of the device. Therefore, it would have been prima facie obvious to modify Grudo to obtain the invention as specified in claim 3 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of modified Grudo.
Regarding claim 4, Grudo in view of Fukushima disclose the disposable valve of claim 2, wherein the at least one hinge (Fukushima: 90a/90b) is configured to connect to a corresponding mount on the endoscope and prevent vertical displacement of one or more of the first seal, the second seal, and the third seal (vertical displacement does not occur when the valve is not actuated; when the valve is actuated by a user, the seals will be vertically displaced in both the prior art and in Applicant’s invention).
Regarding claim 5, Grudo in view of Fukushima disclose the disposable valve of claim 4, wherein the at least one hinge (Fukushima: 90a/90b) is configured to generate an audible and tactile snap when the at least one hinge is connected to the corresponding mount, thereby indicating that the disposable valve has been seated correctly (intended use; capable of such functioning).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grudo, as applied to claim 1 above, in view of Bellofatto et al. (US 2015/0144215 A1).
Regarding claim 6, Grudo discloses the disposable valve of claim 1, but does not specifically disclose it further comprising at least one bushing set within other grooves of the plurality of grooves in which no seal is positioned, wherein the at least one bushing is configured to center the disposable valve within a channel of the endoscope. Bellofatto teaches an analogous valve (100; Fig. 6) comprising at least one bushing (147a/147b; par. [0041]-[0042]; Fig. 7A) set within other grooves of the plurality of grooves in which no seal is positioned (Figs. 7A-7B), wherein the at least one bushing (147a/147b) is configured to center the disposable valve within a channel of the endoscope (capable of due to its desired profile; see par. [0040]-[0042]). Bellofatto teaches that the at least one bushing provide regions of the shaft that have a larger diameter than the other regions of the shaft (par. [0042]). It would have been obvious to one having ordinary skill in the art to provide the bushing positioning features on the shaft of Grudo in order to obtain the desired diameter in regions of the shaft for positioning within the endoscope.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grudo, as applied to claim 1 above.
Regarding claim 9, Grudo discloses the disposable valve of claim 1, wherein the shaft comprises plastic (par. [0041]) and the button cap comprises plastic (par. [0041]) and the shaft is mechanically bonded to the button cap (par. [0045]). Grudo discloses the claimed invention except for the shaft being made out of machined steel. It would have been obvious to one having ordinary skill in the art to have made the shaft of Grudo out of machined steel, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ416.
Claim(s) 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grudo, as applied to claim 1 above, in view of Ishiguro et al. (US 5,871,441 A).
Regarding claim 10, Grudo discloses the disposable valve of claim 1, but does not specifically disclose it further comprising at least one rib positioned along the internal circumference of the outer cap, and wherein the at least one rib is configured to act as an edge stop to ensure the disposable valve is centered on a corresponding mount on the endoscope. Ishiguro teaches an analogous valve wherein at least one
rib (69; Fig. 10) positioned along the internal circumference of the outer
cap (39) and wherein the at least one rectangular rib is configured to act as an edge stop to ensure the disposable valve is centered on the mount (col. 7, II. 5-40 and col. 10, II. 3-6). It would have been obvious to one having ordinary skill in the art to provide at least one rib on the internal circumference of the outer cap of Grudo, as taught by Ishiguro, thereby assisting and securing coupling of the suction valve to the endoscope mount, as taught by Ishiguro (col. 7, II. 5-40).
Regarding claim 11, Grudo in view of Ishiguro disclose the disposable valve of claim 10, wherein said outer cap with said at least one rib (Ishiguro: 69) and said inner ring are molded as a single component (235 is over-molded to 230 and the diaphragm 280 and the inner ring are formed on 230 - see par. [0044] and [0047]; by over-molding the 235 and 230, a monolithic outer cap, inner ring and diaphragm is formed as a single unit; additionally Ishiguro teaches that the at least one rib 69 is formed on the outer cap 66; col. 7, ll. 5-40).
Regarding claim 12, Grudo in view of Ishiguro disclose the disposable valve of claim 10, wherein the at least one rib is a plurality of ribs (Ishiguro: 69; col. 7, ll. 5-40), and wherein the plurality of ribs are configured to act as stops to center the disposable valve on a port of the endoscope (Ishiguro: 69; col. 7, ll. 5-40 and col. 10, ll. 3-6).
Regarding claim 13, Grudo in view of Ishiguro disclose the disposable valve of claim 10, wherein the at least one rib (Ishiguro: 69; col. 7, ll. 5-40) is at a distal portion of the outer cap (Ishiguro: Fig. 8), extends inward from the internal circumference of the outer cap towards a central longitudinal axis of the shaft (Ishiguro: Fig. 8), and is spaced from the shaft (Ishiguro: Fig. 8).
Allowable Subject Matter
Claims 15-20 are allowed. The following is an examiner’s statement of reasons for allowance: the prior art of record does not disclose, or otherwise render obvious, the method as recited in claim 15, comprising the placing the claimed disposable valve in a port of the endoscope; covering the vent to force air through the air channel in a distal direction to insufflate a body cavity; and actuating the valve by depressing the button cap to move the first opening into the water channel, forcing air into the water container and resulting in water being forced through the water channel in the distal direction. Although the prior art of record teaches the structure of the claimed disposable valve, it does not specifically the disclose the step of actuating the valve by depressing the button cap to move the first opening into the water channel, forcing air into the water container and resulting in water being forced through the water channel in the distal direction, in combination with the other steps of the claimed method.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYNAE E BOLER whose telephone number is (571)270-3620. The examiner can normally be reached Mon - Fri 9:00-5:00.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RYNAE E BOLER/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
8/24/26
Prosecution Insights