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 .
Information Disclosure Statement
The information disclosure statements filed on 1/18/22 and 7/2/24 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 “elastic member having a second hole portion” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 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 “a catheter main body” is indefinite because it is not clear if the aforementioned recitation is referring to the “a catheter” in the preamble or an additional catheter. For examination purposes the aforementioned recitation is being interpreted as “the catheter main body.”
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.
Regarding claim 9, the recitation “a catheter” is indefinite because it is not clear if the “a catheter” is the same or different structure from the “a catheter” which is functionally recited in claim 1.
Regarding claim 10, there is lack of antecedent basis for “the sensor.”
Claims 2-10 are rejected as they depend from, and therefore incorporate the claimed subject matter from claims rejected under this statute.
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, 3, 5-6, 8-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suehara et al. (Pub. No. 2020/0022636) as listed on the IDS dated 07/02/2024.
Regarding claim 1, Suehara et al. teaches a branched connector (26, Figs. 1 and 3) used in a catheter (18/80, Fig. 1), the branched connector (26) comprising: a first end portion (1st end portion of 600, see Fig. 1 below) to which a catheter main body (18) is attached (see Fig. 1) and having a first hole portion (604, Fig. 3) communicating with the catheter main body (18, see Figs. 1, 3 and [0058] where 604 is in communication with 42) being formed; and a second end portion (610, Fig. 3) including an elastic member (642, Fig. 3, see [0063]) and having a second hole portion (opening hole of 632, Fig. 3) for inserting a wire-like instrument being formed in the elastic member (a wire-like instrument formed in 642 is insertable within 632]), wherein, the second hole portion (opening hole of 632) communicates with the first hole portion (604, see Fig. 3, [0060] and [0062]) and has a flow passage area smaller (cross-sectional flow path area of lumen of 632 absent 642) than a flow passage area of the first hole portion (cross-sectional flow path area of 604, see Fig. 1; it is the examiner’s position that as a result of an instrument being insertable within 642 to inject a fluid 632 has a flow passage area and Fig. 3 illustrates that the cross-sectional flow path area of 632 is smaller than the cross-sectional flow path area of 604).
Examiner’s Annotated Fig. 1
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Regarding claim 3, Suehara et al. teaches further comprising: a main body portion (body of 600, Fig. 3) including the first end portion (1st end portion, Fig. 1 above): and a sensor connection port portion (602, Fig. 3) including the second end portion (610), wherein the sensor connection port portion (602) is provided with a joint portion (608, Fig, 3) for detachably coupling to the main body portion (body of 600, see [0059]).
Regarding claim 5, Suehara et al. teaches wherein the joint portion (608) is formed in a cylindrical shape (see Fig. 3 illustrating the inner portion along 608 being cylindrical) including a flange portion (614, Fig. 3).
Regarding claim 6, Suehara et al. teaches wherein the 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 main body portion (body of 600, see Fig. 3).
Regarding claim 8, Suehara 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. teaches a catheter (18/80, Fig. 1) comprising the branched connector according to claim1 (see rejection of claim 1 above).
Regarding claim 10, Suehara 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 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) 2 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 Ueda et al. (Pub. No. 2016/0015958).
Regarding claim 2, Suehara et al. does not teach wherein the elastic member is formed of silicone rubber. However, Ueda et al. teaches an elastic member (3, Fig. 1) formed of silicone rubber (see [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the valve taught by Suehara et al. by forming the valve from silicone rubber as taught by Ueda et al. because Ueda et al. teaches that it is known in the art to form a valve from silicone rubber which is an art effective equivalent for rubber (see [0031]) 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]).
Claim(s) 4 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 Korogi et al. (Pub. No. 2006/019164) in view of Schmidt et al. (Patent No. 4,881,542).
Regarding claim 4, Suehara et al. does not teach wherein the main body portion and the sensor connection port portion are formed of an elastic member, and the joint portion is formed of a resin material. However, Korogi et al. teaches a main body portion (main body portion, Fig. 2 below) and the sensor connection port portion (sensor connection portion Fig. 2 below) are formed, and the joint portion (joint portion Fig. 2 below) is formed of a resin material (see [0078] where the hub is formed form a thermoplastic resin).
[AltContent: textbox (main body portion)][AltContent: textbox (joint body portion)][AltContent: ]Examiner’s Annotated Fig. 2
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device taught by Suehara et al. by forming the hub from a thermoplastic resin as taught by Korogi et al. because Korogi et al. teaches that it is known in the art to form a hub from such material (see [0078]). 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]).
Suehara et al. in view of Korogi et al. does not specifically teach that the thermoplastic resin is elastic. However, Schmidt et al. teaches a thermoplastic resin that is elastic (see Col. 6, lines 25- 30).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device taught by Suehara et al. in view of Korogi et al. by forming elements 600 and 602 from a thermoplastic synthetic resin as taught by Schmidt et el. for providing a hub that is elastic and pliable (see Coo. 6, lines 25-30). Further, Suehara in view of Korogi et al. teaches that the valve can be formed from rubber (see [0063]) and various changes and modifications can be made to the device (see Suehar et al.[0140]).
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 Bonham et al. (Pub. No. 2019/0091461 as listed on the IDS dated 07/02/2024 ).
Regarding claim 7, Suehara 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. 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]).
Conclusion
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
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