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 I, Species A, Sub-Species C, readable on claims 21-34 in the reply filed on 6/8/2026 is acknowledged.
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 21-34 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.
Claim 21 recites the limitation “the atmospheric valve is configured to control flow through an atmospheric channel of the valve well” in Lines 5-6, wherein it’s not clear what can reasonably be interpreted as the atmospheric channel of the valve well since the atmospheric channel is not formed in the valve well, but rather is formed as a component of the valve set, such as atmospheric (1516) of the hat (1558) best seen in Fig. 15C. 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.
Claims 21-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fukushima et al. (US Patent Application Publication No. 2015/0148608, hereinafter Fukushima).
In regard to claim 21, Fukushima discloses a medical device (10, Fig. 1), comprising:
a suction valve set (51-53) including a working channel valve (the valve set (51-53) as a whole functions as a working channel valve with Figs. 9 and 11 showing flow to the working channel being closed and Fig. 10 showing flow to the working channel being open), a balloon valve (the valve set (51-53) as a whole functions as a balloon valve with Figs. 9 and 10 showing flow to the balloon channel being open and Fig. 11 showing flow to the balloon channel being closed), and an atmospheric valve (the valve set (51-53) as a whole functions as an atmospheric valve with Figs 10 and 11 showing flow to the atmospheric channel being closed and Fig. 9 showing flow to the atmospheric channel being open), the working channel valve is configured to control flow through a working channel (28) of a valve well (Fig. 10 illustrates suction fluid from the suction channel (46) communicating with the working channel through the valve set), the balloon valve is configured to control flow through a balloon channel (35) of the valve well (Fig. 11 illustrates suction fluid from the suction channel (46) communicating with the balloon channel through the valve set), and the atmospheric valve is configured to control flow through an atmospheric channel of the valve well (Fig. 9 illustrates suction fluid from the suction channel (46) communicating with the atmosphere through the valve set (51)), the suction valve set configurable between a first state (Fig. 9), a second state (Fig. 10), and a third state (Fig. 11), the first state is configured to place a suction channel (46) in fluid communication with the atmospheric channel (Fig. 9 illustrates suction fluid from the suction channel (46) communicating with the atmosphere through the valve set (51)), the second state is configured to place the suction channel in fluid communication with the working channel (Fig. 10 illustrates suction fluid from the suction channel (46) communicating with the working channel through the valve set), and the third state is configured to place the suction channel in fluid communication with the balloon channel (Fig. 11 illustrates suction fluid from the suction channel (46) communicating with the balloon channel through the valve set); and
a valve interface mechanism (50) including a linkage comprising a top, a bottom, and a tubular structure with an interior (Fig. 3), wherein at least a portion of the tubular structure of the linkage is configured for insertion into the balloon channel of the valve well (Fig. 3 illustrates the linkage connected to the balloon channel), wherein the balloon valve (58) comprises a first radial hole and is configured to extend through at least a portion of the interior of the linkage (Fig. 3).
In regard to claim 22, Fukushima teaches wherein the valve interface mechanism is configured to displace at least a portion of the balloon valve toward the bottom of the linkage to place the suction channel in fluid communication with the balloon channel (Fig. 11).
In regard to claim 23, Fukushima teaches wherein the linkage comprises a second radial hole (via bottom hole of the linkage communicating with opening (56)).
In regard to claim 24, Fukushima teaches wherein the valve interface mechanism is configured to align the first radial hole and the second radial hole to place the suction channel in fluid communication with the balloon channel (Fig. 11 illustrates the bottom hole of the valve interface mechanism fluids aligned with the first radial hole of the balloon valve).
In regard to claim 25, Fukushima teaches wherein the valve interface mechanism is configured to misalign the first radial hole and the second radial hole to block flow through the balloon channel (Figs. 9-10).
In regard to claim 26, Fukushima teaches wherein the valve interface mechanism comprises a set of one or more biasing members configured to bias the first radial hole out of alignment with the second radial hole (via springs (78, 79), Fig. 3).
In regard to claim 27, Fukushima teaches wherein the valve interface mechanism comprises a bowl (84) with a top, a bottom, and a cylindrical portion with an interior and the balloon valve is configured to extend through at least a portion of the interior of the bowl (Fig. 3).
In regard to claim 28, Fukushima teaches wherein the linkage extends from the bottom of the bowl and the tubular structure of the linkage is nonconcentric with the cylindrical portion of the bowl (Fig. 3).
In regard to claim 29, Fukushima teaches wherein the balloon valve is concentric with the linkage and nonconcentric with the bowl when extended through at least a portion of the interior of the bowl and at least a portion of the interior of the linkage (Fig. 3).
In regard to claim 30, Fukushima teaches wherein the bottom of the bowl defines an entirety of each opening of a plurality of openings (via openings (88, 89), Fig. 3).
In regard to claim 31, Fukushima teaches wherein the valve interface mechanism is configured to displace at least a portion of the balloon valve toward the top of the bowl to place the suction channel in fluid communication with the balloon channel (Figs. 9-11).
In regard to claim 32, Fukushima teaches wherein the valve interface mechanism comprises a set of one or more biasing members configured to bias the balloon valve to block flow through the balloon channel (via springs (78, 79), Fig. 3).
In regard to claim 33, Fukushima teaches wherein the linkage comprises at least a portion of the balloon channel (Fig. 3).
In regard to claim 34, Fukushima teaches the valve interface mechanism is configured to displace at least a portion of the balloon valve out of the bottom of the linkage to place the suction channel in fluid communication with the balloon channel (Fig. 11 illustrates the bottom of the balloon valve extending beyond the end of the linkage).
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.
Claims 21-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,161,292 (hereinafter ‘292). Although the claims at issue are not identical, they are not patentably distinct from each other as shown below.
In regard to claim 21, ‘292 discloses a medical device (Claim 1, Line 1), comprising:
a suction valve set including a working channel valve, a balloon valve, and an atmospheric valve, the working channel valve is configured to control flow through a working channel of a valve well, the balloon valve is configured to control flow through a balloon channel of the valve well, and the atmospheric valve is configured to control flow through an atmospheric channel of the valve well, the suction valve set configurable between a first state, a second state, and a third state, the first state is configured to place a suction channel in fluid communication with the atmospheric channel, the second state is configured to place the suction channel in fluid communication with the working channel, and the third state is configured to place the suction channel in fluid communication with the balloon channel (Claim 1, Line 2-15); and
a valve interface mechanism including a linkage comprising a top, a bottom, and a tubular structure with an interior, wherein at least a portion of the tubular structure of the linkage is configured for insertion into the balloon channel of the valve well, wherein the balloon valve comprises a first radial hole and is configured to extend through at least a portion of the interior of the linkage (Claim 1, Lines 17-27, Claim 3, Lines 1-2).
In regard to claim 22, ‘292 teaches wherein the valve interface mechanism is configured to displace at least a portion of the balloon valve toward the bottom of the linkage to place the suction channel in fluid communication with the balloon channel (Claim 2).
In regard to claim 23, ‘292 teaches wherein the linkage comprises a second radial hole (Claim 3).
In regard to claim 24, ‘292 teaches wherein the valve interface mechanism is configured to align the first radial hole and the second radial hole to place the suction channel in fluid communication with the balloon channel (Claim 4).
In regard to claim 25, ‘292 teaches wherein the valve interface mechanism is configured to misalign the first radial hole and the second radial hole to block flow through the balloon channel (Claim 5).
In regard to claim 26, ‘292 teaches wherein the valve interface mechanism comprises a set of one or more biasing members configured to bias the first radial hole out of alignment with the second radial hole (Claim 6).
In regard to claim 27, ‘292 teaches wherein the valve interface mechanism comprises a bowl with a top, a bottom, and a cylindrical portion with an interior and the balloon valve is configured to extend through at least a portion of the interior of the bowl (Claim 1, Lines 17-27).
In regard to claim 28, ‘292 teaches wherein the linkage extends from the bottom of the bowl and the tubular structure of the linkage is nonconcentric with the cylindrical portion of the bowl (Claim 1, Lines 17-27).
In regard to claim 29, ‘292 teaches wherein the balloon valve is concentric with the linkage and nonconcentric with the bowl when extended through at least a portion of the interior of the bowl and at least a portion of the interior of the linkage (Claim 8).
In regard to claim 30, ‘292 teaches wherein the bottom of the bowl defines an entirety of each opening of a plurality of openings (Claim 13).
In regard to claim 31, ‘292 teaches wherein the valve interface mechanism is configured to displace at least a portion of the balloon valve toward the top of the bowl to place the suction channel in fluid communication with the balloon channel (Claim 12).
In regard to claim 32, ‘292 teaches wherein the valve interface mechanism comprises a set of one or more biasing members configured to bias the balloon valve to block flow through the balloon channel (Claim 9).
In regard to claim 33, ‘292 teaches wherein the linkage comprises at least a portion of the balloon channel (Claim 1, Lines 17-27).
In regard to claim 34, ‘292 teaches the valve interface mechanism is configured to displace at least a portion of the balloon valve out of the bottom of the linkage to place the suction channel in fluid communication with the balloon channel (Claim 11).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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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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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 June 20, 2026
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