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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of anticipation-type nonstatutory double patenting as being unpatentable over Claim 1 of copending Application No. 18/967,157(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because all elements in Claim 1 of the present patent application are claimed in Claim 1 of copending Application 18/967,157, such that this is an anticipation-type nonstatutory double patenting rejection. This is a provisional nonstatutory double patenting rejection because the patentably indistinct Claim 1 in copending Application No. 18/967,157 has not been patented.
A comparison of Claim 1 in the present Application 18/955,410 and Claim 1 in copending Application No. 18/967,157 is shown in chart below:
Current Application 18/955,410
Co-Pending Application 18/967,157
Claim 1.
Claim 1.
A suction valve assembly for a medical device, comprising:
A suction valve assembly for a medical device, comprising:
a valve body having a top, a bottom, and a side surface, the valve body having a central channel extending vertically between a vent opening in the top and a working opening in the bottom, the valve body also having a suction source opening in the side surface open to the central channel;
a valve body having a top, a bottom, and a side surface, the valve body having a central channel extending vertically between a plurality of vent openings in the top and a working opening in the bottom, the valve body also having a suction source opening in the side surface open to the central channel;
a flap seal positioned at the bottom of the valve body, the flap seal resiliently biased to seat against the valve body to obstruct fluid flow through the working opening into the central channel; and
a flap seal positioned at the bottom of the valve body, the flap seal resiliently biased to seat against the valve body to obstruct fluid flow through the working opening into the central channel; and
a sliding shaft with a side surface surrounding a hollow interior, the side surface having an upper opening and a lower opening both open to the hollow interior, the sliding shaft moving within the central channel of the valve body between:
a sliding shaft having a central bore, a side surface, and a plurality of vent channels, each vent channel corresponding to a different one of the plurality of vent openings in the valve body, the side surface having a side channel open to the central bore, the sliding shaft moving within the central channel of the valve body between:
an upper position where a first part of the side surface of the sliding shaft, including at least an upper portion of the upper opening, extends above the vent opening in the top of the valve body, and
an upper position where each of the plurality of vent channels is adjacent to and in fluid communication with its corresponding vent opening, where the side opening is above and not in fluid communication with the suction source opening, and where the flap seal is seated against the valve body to obstruct fluid flow through the working opening into the central channel, and
a lower position where the first part of the side surface of the sliding shaft, including at least the upper portion of the upper opening, is entirely below the vent opening in the top of the valve body, and where a second part of the sliding shaft extends below the working opening in the bottom of the valve body, the sliding shaft unseating the flap seal to allow fluid flow through the working opening into the central channel.
a lower position where the side opening is adjacent and in fluid communication with the suction source opening, and where a second part of the sliding shaft extends below the working opening in the bottom of the valve body, the sliding shaft unseating the flap seal to allow fluid flow through the working opening into the central channel.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 13 is provisionally rejected on the ground of obvious-type nonstatutory double patenting as being unpatentable over Claim 12 of copending Application No. 18/967,157 in view of Ng (US PGPUB 2022/0221069 – “Ng”). As shown in the chart below, Claim 13 of current Application No. 18/955,410 claims the same features of Claim 12 in copending Application No. 18/967,157, except for the feature of “wherein the lower opening in the side surface of the sliding shaft is adjacent and open to the suction source opening in the side surface of the valve body in both the upper and lower positions”.
Current Application 18/955,410
Co-Pending Application 18/967,157
Claim 13.
Claim 12.
An endoscopic surgical device, comprising:
An endoscopic surgical device, comprising:
an endoscopic probe having a working channel;
an endoscopic probe having a working channel;
a source of suction and a suction valve assembly, comprising:
a suction valve assembly, comprising:
a valve body having a top, a bottom, and a side surface, the valve body having a central channel extending vertically between a vent opening in the top and a working opening in the bottom, the working opening in fluid communication with the working channel of the endoscopic probe, the valve body also having a suction source opening in the side surface open to the central channel;
a valve body having a top, a bottom, and a side surface, the valve body having a central channel extending vertically between a plurality of vent openings in the top and a working opening in the bottom in fluid communication with the working channel of the endoscopic probe, the valve body also having a suction source opening in the side surface open to the central channel,
a flap seal positioned at the bottom of the valve body, the flap seal resiliently biased to seat against the valve body to obstruct fluid flow through the working opening into the central channel; and
a flap seal positioned at the bottom of the valve body, the flap seal resiliently biased to seat against the valve body to obstruct fluid flow through the working opening into the central channel, and
a sliding shaft with a side surface surrounding a hollow interior, the side surface having an upper opening and a lower opening both open to the hollow interior, the sliding shaft moving within the central channel of the valve body between:
a sliding shaft having a central bore, a side surface, and a plurality of vent channels, each vent channel corresponding to a different one of the plurality of vent openings in the valve body, the side surface having a side channel open to the central bore, the sliding shaft moving within the central channel of the valve body between:
an upper position where a first part of the side surface of the sliding shaft, including at least an upper portion of the upper opening, extends above the vent opening in the top of the valve body, and
an upper position where each of the plurality of vent channels is adjacent to and in fluid communication with its corresponding vent opening, where the side opening is above and not in fluid communication with the suction source opening, and where the flap seal is seated against the valve body to obstruct fluid flow through the working opening into the central channel, and
a lower position where the first part of the side surface of the sliding shaft, including at least the upper portion of the upper opening, is entirely below the vent opening in the top of the valve body, and where a second part of the sliding shaft extends below the working opening in the bottom of the valve body, the sliding shaft unseating the flap seal to allow fluid flow through the working opening into the central channel;
a lower position where the side opening is adjacent and in fluid communication with the suction source opening, and where a second part of the sliding shaft extends below the working opening in the bottom of the valve body, the sliding shaft unseating the flap seal to allow fluid flow through the working opening into the central channel; and
wherein the lower opening in the side surface of the sliding shaft is adjacent and open to the suction source opening in the side surface of the valve body in both the upper and lower positions, when the sliding shaft of the valve is in the lower position, it provides suction to the working channel of the endoscopic probe from the suction source opening, through the valve body, and into the working channel opening.
a source of suction in fluid communication with the suction source opening of the suction valve assembly, such that, when the sliding shaft of the valve is in the lower position, it provides suction to the working channel of the endoscopic probe from the suction source opening, through the valve body, and into the working channel opening.
Ng is analogous art in the field of medical suction that teaches wherein the lower opening (Ng FIG. 5, opening 22) in the side surface of the sliding shaft (Ng FIG. 5, shaft 2) is adjacent and open to the suction source opening (Ng FIG. 5, suction source opening 12) in the side surface of the valve body in both the upper position (Ng FIG. 9) and lower position (Ng FIG. 10).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Ng’s opening 22 with the invention claimed in Claim 12 of copending Application No. 18/967,157. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a smooth transition between a first stage (Ng FIG. 9) and a second stage (Ng FIG. 10) in a suction valve, such that sudden/punctuated suction within the patient does not occur (see also Ng paragraph [0034]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 feature of “wherein the lower opening in the side surface of the extends the full length of the side surface” claimed in lines 1-2 of Claim 2 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Neither side opening 318 in FIG. 3E nor side/bottom opening 416 in FIG. 4C of the present patent application shows the lower opening in the side surface extending the full length of the side surface. For purposes of examination, Examiner will interpret this feature as “wherein the lower opening in the side surface of the sliding shaft extends along the side surface”.
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 Objections
Claim 3 is objected to because of the following informalities: lines 1-2, “the lower opening in the side surface of the extends” appears to be missing words, and should read as “the lower opening in the side surface of the sliding shaft extends”. Appropriate correction by Applicant is required.
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 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.
Claims 1 and 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Ogino (US Patent 5,840,015 – “Ogino”) in view of Yoshimoto et al. (US Patent 5,322,263 – “Yoshimoto”).
Regarding Claim 1, Ogino discloses:
A suction valve assembly (Ogino FIG. 1, suction passage controlling apparatus 3) for a medical device (Ogino Abstract, “An apparatus for controlling a suction passage in an endoscope”), comprising:
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a valve body (Examiner-annotated Ogino FIG. 3 shown above, cylinder 31) having a top (Ogino FIG. 3, cylinder top of cylinder 31), a bottom (Ogino FIG. 3, cylinder bottom of cylinder 31), and a side surface (Ogino FIG. 3, cylinder side surface of cylinder 31), the valve body having a central channel (Ogino FIG. 3, inner peripheral surface 31c of cylinder 31) extending vertically between a vent opening in the top (Ogino FIG. 3, opening in cylinder top through which outside air passes, as shown by arrow “A”) and a working opening in the bottom (Ogino FIG. 3, second connection hole 31b connected to insertion pipe 5), the valve body also having a suction source opening in the side surface (Ogino FIG. 3, first connection hole 31a connected to suction tube 4) open to the central channel;
a sliding shaft (Ogino FIG. 1, piston 34) with a side surface surrounding a hollow interior (Ogino FIG. 1, interior of piston 34 that is in fluid communication with axially elongated hole 47 in piston 34), the side surface having an upper opening (Ogino FIG. 1, axially elongated hole 47) and a lower opening (Ogino FIG. 3, open end 44b) both open to the hollow interior (Ogino col. 4 lines 21-24, “The portion of the piston 34 that is located within the cylinder 31 is provided with a communication hole 44 which opens into the lower end of the piston 34, as indicated by 44a in FIG. 1”), the sliding shaft moving within the central channel of the valve body (Ogino FIG. 3 and Ogino FIG. 1 showing movement of piston 34) between:
an upper position where a first part of the side surface of the sliding shaft, including at least an upper portion of the upper opening, extends above the vent opening in the top of the valve body (Ogino FIG. 3, showing axially elongated hole 47 extending above cylinder top, thus allowing suction air to pass through axially elongated hole 47 as indicated by arrow “A”), and
a lower position where the first part of the side surface of the sliding shaft, including at least the upper portion of the upper opening, is entirely below the vent opening in the top of the valve body (Ogino FIG. 1, showing axially elongated hole 47 and surrounding area of piston 34 below the cylinder top shown in Ogino FIG. 3).
Ogino does not explicitly disclose:
a flap seal positioned at the bottom of the valve body, the flap seal resiliently biased to seat against the valve body to obstruct fluid flow through the working opening into the central channel; and
where a second part of the sliding shaft extends below the working opening in the bottom of the valve body, the sliding shaft unseating the flap seal to allow fluid flow through the working opening into the central channel.
Yoshimoto is analogous art in the field of medical suction that teaches:
a flap seal (Yoshimoto FIG. 18, closing film 10a) positioned at the bottom of the valve body (Yoshimoto FIG. 18, bottom of outer cylinder 8), the flap seal resiliently biased to seat against the valve body to obstruct fluid flow through the working opening into the central channel (Yoshimoto FIG. 18, showing closing film 10a in a closed position to prevent fluids from sucking channel 7 leading to insertion portion 1 in Yoshimoto FIG. 5 from entering the interior of operating member 12); and
where a second part of the sliding shaft extends below the working opening in the bottom of the valve body, the sliding shaft unseating the flap seal to allow fluid flow through the working opening into the central channel (Yoshimoto FIG. 20, showing lower end part 12c of operating member 12 pushing through slit 11 of valve body 10; Yoshimoto col. 11 lines 61-63, “the interior of the inner cylinder 9 will communicate with the sucking channel 7 and the dirt and body fluids will begin to be sucked”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Yoshimoto’s flap with the suction valve assembly disclosed by Ogino. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a suction valve having a sliding shaft/piston that does not cause leakage when putting a suction source in fluid communication with an insertion portion, and reduces the cost and complexity of the system (see Yoshimoto col. 4 line 68-col 5 line 7; “operating member 12 is provided so as to be free to advance and retreat within the inner cylinder 9 and is pushed into the slit 11 of the valve body 10 so as to open the slit. Therefore, no valve seat is required to be provided in the outer cylinder 8. Therefore, the inner surface of the outer cylinder 8 can be made in a simple form easy to wash and the contagion by bad washing can be prevented”)
Regarding Claim 4, Ogino in view of Yoshimoto teaches the features of claim 1, as described above.
Ogino further discloses a button cap (Ogino FIG. 1, operation button 36) attached to the sliding shaft (Ogino FIG. 1, piston 34) and moving between the upper (Ogino FIG. 3) and lower positions (Ogino FIG. 1) with the sliding shaft.
Regarding Claim 5, Ogino in view of Yoshimoto teaches the features of claim 1, as described above.
Ogino further discloses a lid (Ogino FIG. 3, shoulder portion 34f of piston 34) attached to the sliding shaft and moving between the upper (Ogino FIG. 3) and lower positions (Ogino FIG. 1) with the sliding shaft, the lid seated against the vent opening of the valve body (Ogino FIG. 1, showing shoulder portion 34f pressed against inner flange 39b) when in the lower position to obstruct fluid flow through the vent opening into the central channel (Ogino col. 3 line 65 – col. 4 line 2, “A shoulder portion 34f of the piston 34, connected to the small diameter portion 34d, abuts against the inner flange 39b of the cylindrical receptacle 39 to restrict the axial movement of the piston 34.”; Examiner interprets the pressing of shoulder portion 34f against inner flange 39b occurs when axially elongated hole 47 is no longer in fluid (suction) communication with the outside air, since inner flange 39b is part of the passageway for airflow “A” shown in Ogino FIG. 3.).
Regarding Claim 6, Ogino in view of Yoshimoto teaches the features of claim 1, as described above.
Ogino further discloses a spring member (Ogino FIG. 3, coil spring 38) biasing the valve into the upper position (Ogino FIG. 3, showing piston 34 in the upper position).
Regarding Claim 7, Ogino in view of Yoshimoto teaches the features of claim 1, as described above.
Yoshimoto further teaches wherein the flap seal (Yoshimoto FIG. 19, closing film 10a; Yoshimoto col. 3 lines 63-67, “valve body 10 made of an elastic material, such as rubber. This valve body 10 is substantially cylindrical and is provided in the lower part with a dome-like closing film 10a closing an opening at the lower end of the inner cylinder 9) is made of a flexible material having a lower durometer than the sliding shaft (Yoshimoto FIG. 19, operating member 12 and operating part 13; Yoshimoto col. 11 lines 49-54, “when the operating part 13 is pushed to push in the operating member 12 downward against the elastic force of the cover 117, as shown in FIG. 19, the lower end part 12c of the operating member 12 will contact the closing film 10a and will tend to push open the slit 11 of the valve body 10”; Examiner interprets this as teaching that the closing film 10a has a lower durometer than the operating member 13, since the operating member 13 would not be able to push open slit 11 if it had a lower/equal durometer than/as the closing film 10a).
Claims 2-3 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ogino (US Patent 5,840,015 – “Ogino”) in view of Yoshimoto et al. (US Patent 5,322,263 – “Yoshimoto”) and Ng (US PGPUB 2022/0221069 – “Ng”).
Regarding Claim 2, Ogino in view of Yoshimoto teaches the features of claim 1, as described above.
Ogino in view of Yoshimoto does not explicitly teach wherein the lower opening in the side surface of the sliding shaft is adjacent and open to the suction source opening in the side surface of the valve body in both the upper and lower positions.
Ng is analogous art in the field of medical suction that teaches wherein the lower opening (Ng FIG. 5, opening 22) in the side surface of the sliding shaft (Ng FIG. 5, shaft 2) is adjacent and open to the suction source opening (Ng FIG. 5, suction source opening 12) in the side surface of the valve body in both the upper position (Ng FIG. 9) and lower position (Ng FIG. 10).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Ng’s opening 22 for Ogino’s open end 44b shown in Ogino FIG. 1 in the suction valve assembly taught by Ogino in view of Yoshimoto. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable result of a smooth transition between a first stage (Ng FIG. 9) and a second stage (Ng FIG. 10), such that sudden/punctuated suction within the patient does not occur (see also Ng paragraph [0034]).
Regarding Claim 3, Ogino in view of Yoshimoto teaches the features of claim 1, as described above.
Ogino further discloses wherein the lower edge of a lower opening (Examiner-annotated Ogino FIG. 3 shown above, lower opening) aligns with a lower edge of the suction source (Ogino FIG. 3, suction pipe 4) opening in the upper position.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to align the lower edge of Ogino’s lower opening with the lower edges of the suction source, while in the upper position in the suction valve assembly taught by Ogino in view of Yoshimoto. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a suction valve assembly aligns a suction port with a suction source in a manner that retains suction force therethrough.
Ogino in view of Yoshimoto does not explicitly teach wherein an upper edge of the lower opening aligns with an upper edge of the suction source opening in the lower position.
Ng is analogous art in the field of medical suction that teaches wherein an upper edge of the lower opening (Ng FIG. 5, opening 22) in the side surface of the sliding shaft (Ng FIG. 5, shaft 2) aligns with an upper edge (Ng FIG. 10, upper edge of opening 22) of the suction source opening (Ng FIG. 5, suction source opening 10) in the lower opening (Ng FIG. 10, showing upper edge of opening 22 aligned with upper edge of suction source opening 10).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Ng’s opening 22 with Ogino’s open end 44b shown in Ogino FIG. 1 in the suction valve assembly taught by Ogino in view of Yoshimoto. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a suction valve assembly the provides a smooth transition between a first stage (Ng FIG. 9) and a second stage (Ng FIG. 10), such that sudden/punctuated suction within the patient does not occur (see also Ng paragraph [0034]).
Regarding Claim 12, Ogino in view of Yoshimoto teaches the features of claim 1, as described above.
Ogino in view of Yoshimoto does not explicitly teach wherein the lower opening in the side wall of the sliding shaft is a slot extending to a bottom surface of the sliding shaft.
Ng is analogous art in the field of medical suction that teaches wherein the lower opening (Ng FIG. 5, opening 22) in the side wall of the sliding shaft (Ng FIG. 5, shaft 2) is a slot extending to a bottom surface of the sliding shaft (Ng FIG. 5, showing opening 22 extending to the bottom surface of shaft 2).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Ng’s opening 22 for Ogino’s open end 44b shown in Ogino FIG. 1 in the suction valve assembly taught by Ogino in view of Yoshimoto. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable result of a smooth transition between a first stage (Ng FIG. 9) and a second stage (Ng FIG. 10), such that sudden/punctuated suction within the patient does not occur (see also Ng paragraph [0034]).
Regarding Claim 13, Ogino discloses:
An endoscopic surgical device (Ogino FIG. 2, endoscope 6) comprising:
an endoscopic probe (Ogino FIG. 2, insertion portion 1) having a working channel (Ogino FIG. 2, working lumen 5);
a source of suction (Ogino FIG. 2, suction pipe 4; Ogino col. 3 lines 27-30, “suction pipe 4 (on the suction side, i.e., the left end as viewed in FIG. 2) is connected at one end thereof to the cylinder 31 and at the other end to an external suction device (not shown)”); and
a suction valve assembly (Ogino FIG. 1, suction passage controlling apparatus 3), comprising:
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a valve body (Examiner-annotated Ogino FIG. 3 shown above, cylinder 31) having a top (Ogino FIG. 3, cylinder top of cylinder 31), a bottom (Ogino FIG. 3, cylinder bottom of cylinder 31), and a side surface (Ogino FIG. 3, cylinder side surface of cylinder 31), the valve body having a central channel (Ogino FIG. 3, inner peripheral surface 31c of cylinder 31) extending vertically between a vent opening in the top (Ogino FIG. 3, opening in cylinder top through which outside air passes, as shown by arrow “A”) and a working opening in the bottom (Ogino FIG. 3, second connection hole 31b connected to insertion pipe 5), the working opening in fluid communication with the working channel of the endoscopic probe (Ogino FIG. 3, showing insertion pipe 5 in fluid communication with second connection hold 31b), the valve body also having a suction source opening in the side surface (Ogino FIG. 3, first connection hole 31a connected to suction tube 4) open to the central channel;
a sliding shaft (Ogino FIG. 1, piston 34) with a side surface surrounding a hollow interior (Ogino FIG. 1, interior of piston 34 that is in fluid communication with axially elongated hole 47 in piston 34), the side surface having an upper opening (Ogino FIG. 1, axially elongated hole 47) and a lower opening (Ogino FIG. 3, open end 44b) both open to the hollow interior (Ogino col. 4 lines 21-24, “The portion of the piston 34 that is located within the cylinder 31 is provided with a communication hole 44 which opens into the lower end of the piston 34, as indicated by 44a in FIG. 1”), the sliding shaft moving within the central channel of the valve body (Ogino FIG. 3 and Ogino FIG. 1 showing movement of piston 34) between:
an upper position where a first part of the side surface of the sliding shaft, including at least an upper portion of the upper opening, extends above the vent opening in the top of the valve body (Ogino FIG. 3, showing axially elongated hole 47 extending above cylinder top, thus allowing suction air to pass through axially elongated hole 47 as indicated by arrow “A”), and
a lower position where the first part of the side surface of the sliding shaft, including at least the upper portion of the upper opening, is entirely below the vent opening in the top of the valve body (Ogino FIG. 1, showing axially elongated hole 47 and surrounding area of piston 34 below the cylinder top shown in Ogino FIG. 3), and
when the sliding shaft of the valve is in the lower position (Ogino FIG. 1), it provides suction to the working channel of the endoscopic probe from the suction source opening, through the valve body, and into the working channel opening (Ogino FIG. 1, showing suction fluid pathway from the insertion pipe 5 through the cylinder 31 and out the suction pipe 4).
Ogino does not explicitly disclose:
a flap seal positioned at the bottom of the valve body, the flap seal resiliently biased to seat against the valve body to obstruct fluid flow through the working opening into the central channel; and
where a second part of the sliding shaft extends below the working opening in the bottom of the valve body, the sliding shaft unseating the flap seal to allow fluid flow through the working opening into the central channel.
Yoshimoto is analogous art in the field of medical suction that teaches:
a flap seal (Yoshimoto FIG. 18, closing film 10a) positioned at the bottom of the valve body (Yoshimoto FIG. 18, bottom of outer cylinder 8), the flap seal resiliently biased to seat against the valve body to obstruct fluid flow through the working opening into the central channel (Yoshimoto FIG. 18, showing closing film 10a in a closed position to prevent fluids from sucking channel 7 leading to insertion portion 1 in Yoshimoto FIG. 5 from entering the interior of operating member 12); and
where a second part of the sliding shaft extends below the working opening in the bottom of the valve body, the sliding shaft unseating the flap seal to allow fluid flow through the working opening into the central channel (Yoshimoto FIG. 20, showing lower end part 12c of operating member 12 pushing through slit 11 of valve body 10; Yoshimoto col. 11 lines 61-63, “the interior of the inner cylinder 9 will communicate with the sucking channel 7 and the dirt and body fluids will begin to be sucked”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Yoshimoto’s flap with the suction valve assembly disclosed by Ogino. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a suction valve having a sliding shaft/piston that does not cause leakage when putting a suction source in fluid communication with an insertion portion, and reduces the cost and complexity of the system (see Yoshimoto col. 4 line 68-col 5 line 7; “operating member 12 is provided so as to be free to advance and retreat within the inner cylinder 9 and is pushed into the slit 11 of the valve body 10 so as to open the slit. Therefore, no valve seat is required to be provided in the outer cylinder 8. Therefore, the inner surface of the outer cylinder 8 can be made in a simple form easy to wash and the contagion by bad washing can be prevented”)
Ogino in view of Yoshimoto does not explicitly teach wherein the lower opening in the side surface of the sliding shaft is adjacent and open to the suction source opening in the side surface of the valve body in both the upper and lower positions.
Ng is analogous art in the field of medical suction that teaches wherein the lower opening (Ng FIG. 5, opening 22) in the side surface of the sliding shaft (Ng FIG. 5, shaft 2) is adjacent and open to the suction source opening (Ng FIG. 5, suction source opening 12) in the side surface of the valve body in both the upper position (Ng FIG. 9) and lower position (Ng FIG. 10).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Ng’s opening 22 for Ogino’s open end 44b shown in Ogino FIG. 1 in the suction valve assembly taught by Ogino in view of Yoshimoto. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable result of a smooth transition between a first stage (Ng FIG. 9) and a second stage (Ng FIG. 10), such that sudden/punctuated suction within the patient does not occur (see also Ng paragraph [0034]).
Regarding Claim 14, Ogino in view of Yoshimoto and Ng teaches the features of Claim 13, as described above.
Ogino further discloses an endoscopic handle (Ogino FIG. 2, manipulating portion 2) having a suction valve location (Ogino FIG. 2, suction passage controlling apparatus 3) with an inner wall (Ogino FIG. 2,interior of suction cylinder 31), the side surface of the valve body of the suction valve assembly pressing tightly against the inner wall of the suction valve location of the endoscopic handle (Ogino FIG. 1, showing suction passage controlling apparatus within suction cylinder 31).
Regarding Claim 15, Ogino in view of Yoshimoto and Ng teaches the features of Claim 13, as described above.
Ogino further discloses wherein when the sliding shaft of the valve is in the upper position, the source of suction is in fluid communication with the vent opening of the valve assembly such that the source of suction is open to room air (Ogino FIG. 3, showing suction passage controlling apparatus 3 in an upper position, such that fluid path “A” passes from the room air to the suction tube 4).
Regarding Claim 16, Ogino in view of Yoshimoto and Ng teaches the features of Claim 13, as described above.
Yoshimoto further teaches wherein the flap seal (Yoshimoto FIG. 19, closing film 10a; Yoshimoto col. 3 lines 63-67, “valve body 10 made of an elastic material, such as rubber. This valve body 10 is substantially cylindrical and is provided in the lower part with a dome-like closing film 10a closing an opening at the lower end of the inner cylinder 9) is made of a flexible material having a lower durometer than the sliding shaft (Yoshimoto FIG. 19, operating member 12 and operating part 13; Yoshimoto col. 11 lines 49-54, “when the operating part 13 is pushed to push in the operating member 12 downward against the elastic force of the cover 117, as shown in FIG. 19, the lower end part 12c of the operating member 12 will contact the closing film 10a and will tend to push open the slit 11 of the valve body 10”; Examiner interprets this as teaching that the closing film 10a has a lower durometer than the operating member 13, since the operating member 13 would not be able to push open slit 11 if it had a lower/equal durometer than/as the closing film 10a).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Ogino (US Patent 5,840,015 – “Ogino”) in view of Yoshimoto et al. (US Patent 5,322,263 – “Yoshimoto”) Fukushima et al. (US PGPUB 2015/0148608 – “Fukushima”).
Regarding Claim 8, Ogino in view of Yoshimoto teaches the features of claim 1, as described above.
Ogino in view of Yoshimoto does not explicitly teach an alignment pin inserted into the valve body.
Fukushima is analogous art in the field of medical suction that teaches an alignment pin (Fukushima FIG. 3, engagement projection 91) inserted into the valve body (Fukushima FIG. 3, lower plate 84a of valve cylinder 50).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Fukushima’s engagement projection 91, which fits into the engagement groove 67 of the piston rod 67 shown in Fukushima FIG. 3, with the suction valve assembly taught by Ogino in view of Yoshimoto. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a suction valve assembly having a piston/sliding shaft that maintains a desired orientation relative to suction ports, vents, working ports, etc. in the interior of the valve body (see Fukushima paragraph [0074], “an engagement projection 91 (key projection) in the anti-rotation device for the piston rod is formed on an inner surface of the center hole 88 to project toward the axis radially. The engagement projection 91 is engaged with the engagement groove 67 of the piston rod 51 for blocking rotation.”).
Regarding Claim 9, Ogino in view of Yoshimoto and Fukushima teaches the features of claim 8, as described above.
Fukushima further teaches wherein the alignment pin (Fukushima FIG. 3, engagement projection 91) is received by an alignment groove (Fukushima FIG. 3, engagement groove 67) in the surface of the sliding shaft (Fukushima FIG. 3, piston rod 51).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ogino (US Patent 5,840,015 – “Ogino”) in view of Yoshimoto et al. (US Patent 5,322,263 – “Yoshimoto”), Ng (US PGPUB 2022/0221069 – “Ng”), and Fukushima et al. (US PGPUB 2015/0148608 – “Fukushima”).
Regarding Claim 17, Ogino in view of Yoshimoto and Ng teaches the features of Claim 13, as described above.
Ogino in view of Yoshimoto and Ng does not explicitly teach the suction valve assembly further comprising an alignment pin inserted into the valve body.
Fukushima is analogous art in the field of medical suction that teaches an alignment pin (Fukushima FIG. 3, engagement projection 91) inserted into the valve body (Fukushima FIG. 3, lower plate 84a of valve cylinder 50).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Fukushima’s engagement projection 91, which fits into the engagement groove 67 of the piston rod 67 shown in Fukushima FIG. 3, with the suction valve assembly disclosed by taught by Ogino in view of Yoshimoto and Ng. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a suction valve assembly having a piston/sliding shaft that maintains a desired orientation relative to suction ports, vents, working ports, etc. in the interior of the valve body (see Fukushima paragraph [0074], “an engagement projection 91 (key projection) in the anti-rotation device for the piston rod is formed on an inner surface of the center hole 88 to project toward the axis radially. The engagement projection 91 is engaged with the engagement groove 67 of the piston rod 51 for blocking rotation.”).
Regarding Claim 18, Ogino in view of Yoshimoto, Ng, and Fukushima teaches the features of Claim 17, as described above.
Fukushima further teaches wherein the alignment pin (Fukushima FIG. 3, engagement projection 91) is received by an alignment groove (Fukushima FIG. 3, engagement groove 67) in the surface of the sliding shaft (Fukushima FIG. 3, piston rod 51).
Allowable Subject Matter
Claims 10 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding Claims 10 and 19, no combination of the identified prior art teaches or suggests wherein the alignment pin is received by the upper opening of the sliding shaft. The closest identified prior art is Fukushima et al. (US PGPUB 2015/0148608 – “Fukushima”), which teaches wherein the alignment pin (Fukushima FIG. 3, engagement projection 91) is received by an alignment groove (Fukushima FIG. 3, engagement groove 67) in the surface of the sliding shaft (Fukushima FIG. 3, piston rod 51). There is no teaching or suggestion in Fukushima nor any combination of the cited prior art of aligning an opening that leads to a hollow core of the sliding shaft with an alignment pin. Furthermore, doing so would likely result in damage to the walls of the opening, rather than using the groove taught by Fukushima.
As such, there is no reason or suggestion provided in the prior art to modify the above prior art to teach the limitations as claimed above, and the only reason to modify the references would be based on Applicant's disclosure, which is impermissible hindsight reasoning.
Claims 11 and 20 are further deemed allowable, based on their dependence on respective Claims 10 and 19.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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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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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
Prosecution Insights