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
Applicant’s amendments with respect to claims filed on 11/25/2025 have been entered. Claims 1 and 4-10 remain pending in this application and are currently under consideration for patentability under 37 CFR 1.104. Claims 2-3 have been canceled.
The amendments and remarks filed on 11/25/2025 are sufficient to cure some of the previous 35 U.S.C.112 (b) rejections set forth in the Non-Final office action mailed on 08/18/2025.
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 and 4-10 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.
Regarding claim 1, the recitation “to which a catheter main body is attached” is indefinite because it is not clear if applicant is attempting to positively recite the catheter main body or functionally recite the catheter main body as a result of the “a catheter” not being positively recited in claim 1. For examination purposes the aforementioned recitation has been interpreted as a functional recitation. To overcome this rejection the examiner suggests amending the aforementioned limitation to recite “configured to attach to the catheter main body . . .”
Claims 2 and 4-10 are rejected as they depend from and therefore incorporate the claimed subject matter from claims rejected under this statute.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Suehara et al. (Pub. No. 2020/0022636) as listed on the IDS dated 07/02/2024 in view of Ciccone et al. (Pub. No. 2018/0256878).
Regarding claim 1, Suehara et al. teaches a branched connector (26, Figs. 1 and 3) used in a catheter (18/80, Fig. 1) having a catheter main body (body of 18/80), the branched connector (26) comprising: a connector main body portion (600, Fig. 1) including a first end portion (1st end portion of 600, see Fig. 1 below) to which the catheter main body (body of 18) is attached (see Fig. 1, it should be noted that the catheter is not positively recited) and having a first hole portion (portion of 604 to the left of 608, Fig. 3) communicating with the catheter main body (body of 18, see Figs. 1, 3 and [0058] where 604 is in communication with 42); and a sensor connection port portion (602, Fig. 1) including a second end portion (610, Fig. 3) having a second hole portion (lumen of 610, Fig. 3) for inserting a wire-like instrument, wherein, the sensor connection port portion (602) is provided with a joint portion (612, Fig. 3) formed in a cylindrical shape (see Fig. 3 illustrating 612 being cylindrical) for detachably coupling to the main body portion (600, see Fig. 3. 612 is capable of being detachable coupled to 600 via 614); the second hole portion (lumen of 610) is formed as a circular-shape hole (see Fig. 3 where the lumen of 610 is circular shaped hole); the second hole portion (lumen of 610) communicates with the first hole portion (portion of 604 to the left of 608, see Fig. 3, [0060] and [0062]) and has a flow passage area (flow passage area610a, Fig. 3 below) smaller than a flow passage area (flow passage area604) of the first hole portion (portion of 604 to the left of 608); an inclined surface (inclined surface, Fig. 3), an opening portion (opening of 600 along 614, see Fig. 3) of which is reduced in a funnel shape (funnel shape formed by 614 it should be noted that the opening tapers as a result of 614; hence, it is funnel shaped) toward the first hole portion (portion of 604 to the left of 608), is formed in the first end portion (1st end portion of 600, see Fig. 1 below); a flow passage area (flow passage area612, Fig. 3 below) of the joint portion (612) is larger than a flow passage area (flow passage area610b, Fig. 3 below) of the second hole portion (lumen of 610); and in the state that the connector main body portion (600) and the sensor connection port portion (602) are coupled (see Fig. 3), the second hole portion (lumen of 610), the joint portion (612), and the first hole portion (portion of 604 to the left of 608) are located on a straight line (central longitudinal axis of 600/602), so that the instrument inserted from the second hole portion is guided by the joint portion toward the first hole portion or the inclined surface (an instrument is capable of being inserted withing the lumen of 610 guided 612 towards the portion of 604 to the left of 608).
Examiner’s Annotated Fig. 1
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Examiner’s Annotated fig. 3
[AltContent: textbox (flow passage area610a)][AltContent: arrow][AltContent: rect][AltContent: textbox (flow passage area612)][AltContent: arrow][AltContent: textbox (flow passage area604)][AltContent: arrow][AltContent: textbox (flow passage area610b)][AltContent: arrow][AltContent: rect][AltContent: rect][AltContent: rect]
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Suehara et al. does not teach wherein the second hole portion is formed by silicone rubber; however, Ciccone et al. teaches a connector (1, Fig. 1), the branched connector (1) comprising: a connector main body portion (4, Fig. 2H) including a first end portion (distal end of 4) and having a first hole portion (61, see Fig. 2H); and a connection port portion (62, Fig. 2H) including a second end portion (2nd end portion, Fig. 2H below) having a second hole portion (lumen of 6 along the 2nd end portion and 62, see Fig. 2H) for inserting a wire-like instrument wherein (see Fig. 2H, a wire is insertable withing the lumen of 6), the connection port portion (6) is provided with a joint portion (joint portion, Fig. 2H below) formed in a cylindrical shape (see Fig. 2H below illustrating the joint portion formed as a cylindrical shape) for detachably coupling to the main body portion (4); the second hole portion (lumen of 6 along the 2nd end portion and 62) is formed as a circular-shape hole (see Fig. 2H illustrating the lumen of 6 along the 2nd end portion and 62 formed as a circular shape) by silicone rubber (see [0097).
Examiner’s Annotated Fig. 2H
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the material of the hub taught by Suehara et al. by forming the hub from a silicon rubber as taught by Ciccone et al. because Ciccone et al. teaches that resin and silicon rubber are art effective equivalent materials for forming a connector/hub and Suehara et al. teaches that at least a portion of the hub may be formed from a rubber such as silicone (see [0051] and [0058]) and that various changes and modifications may be made to the device (see [0140]).
Regarding claim 4, Suehara et al. in view of Ciccone et al. teaches wherein the connector main body portion and the sensor connection port portion are formed of an elastic material (see Ciccone et al. [0097] and rejection of claim 1 above) but does not specifically teach wherein the joint portion is formed of a resin material. However, Ciccone et al. teaches a connector (1, Fig. 1) that may be formed from an elastic material (silicone rubber, see [0097]) and a resin material (resins, see [0097]).
It would have been obvious to one of ordinary skill in the art to form the hub taught by Suehara et al from a combination of silicone rubber and resin as taught by Ciccone et al. because Ciccone et al. teaches that it is known in the art to form a connector/hub from a combination of materials consisting of silicon rubber and resin (see [0097]) and Suehara et al. teaches that at least a portion of the hub may be formed from a rubber such as silicone (see [0051] and [0058]) and that various changes and modifications may be made to the device (see [0140]).
Regarding claim 5, Suehara et al. in view of Ciccone et al. teaches wherein the joint portion (612) includes a flange portion (626, Fig. 3).
Regarding claim 6, Suehara et al. in view of Ciccone et al. teaches wherein the connector main body portion (body of 600) is provided with a drainage pipe (606, Fig. 3) communicating with the first hole portion (604) and branching in a direction (angled direction of 606, see Fig. 3) crossing a direction (horizontal direction of 602, see Fig. 3) in which the sensor connection port portion (602) is inserted into the connector main body portion (body of 600, see Fig. 3).
Regarding claim 8, Suehara et al. in view of Ciccone et al. teaches wherein the first end portion (1st end portion, Fig. 1 above) includes a cylindrical shape portion (see Fig. 1 above) for attaching another catheter (the 1st end portion in Fig. 1 above can attach to another catheter via 606, see Fig. 3).
Regarding claim 9, Suehara et al. in view of Ciccone et al. teaches a catheter (18/80, Fig. 1) comprising the branched connector according to claim 1 (see rejection of claim 1 above).
Regarding claim 10, Suehara et al. in view of Ciccone et al. teaches wherein an outer side (outer surface of 610 where 660, 638 and 640 are located, see Fig. 3) of the second end portion (610) is provided with a transmitting portion (90/91/ 96,/97,/100), Fig. 3) for transmitting a detection result by the sensor (660, 638, 640 see [0069]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Suehara et al. (Pub. No. 2020/0022636 as listed on the IDS dated 07/02/2024) in view of Ciccone et al. (Pub. No. 2018/0256878) in view of Bonham et al. (Pub. No. 2019/0091461 as listed on the IDS dated 07/02/2024 ).
Regarding claim 7, Suehara et al. in view of Ciccone et al. does not teach wherein the sensor connection port portion is provided with a valve for opening and closing a channel connecting the joint portion and the second end portion. However, Bonham et al. teaches a connection portion (101, Fig. 2A) provided with a valve (205, Fig. 2) for opening and closing a channel (lumen of 101) connecting a joint portion (9917, Fig. 1, see [0260]) and the second end portion (101).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Suehara et al. in view of Ciccone et al. by adding the check valve to the lumen of 602 for preventing urine backflow thereby minimizing microbial migration in a direction opposite of intended flow (see [0264]). Further, Suehara teaches that the valve can be formed from rubber (see [0063]) and various changes and modifications can be made to the device (see [0140]).
Response to Arguments
Applicant’s arguments with respect to claim(s) filed on 11/18/2025 have been considered but are moot because the new ground of rejection does not rely only on Suehara as applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
For clarity of the record the examiner would like to note that applicant did not provide detailed arguments as to why Suehara does not teach the amended claim language and it is the Examiner’s position that Suehara in view of Ciccone et al. teaches amended claim 1 (see rejection above).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 TIFFANY LEGETTE-THOMPSON whose telephone number is (571)270-7078. The examiner can normally be reached 7:00 am - 4:00 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, Srilakshmi Kumar can be reached at 571-272-7769. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIFFANY LEGETTE-THOMPSON
Supervisory Patent Examiner
Art Unit 1723
/TIFFANY LEGETTE/Supervisory Patent Examiner, Art Unit 1723
