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 Species B in the reply filed on November 17th 2025 is acknowledged.
Claim 12 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 17th 2025.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63246835, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. There is a lack of support in the provisional application for the subject matter of claim 11. The provisional application discloses that “Although the remaining disclosure describes the cable take-up assembly 60 as an integrated component of the lumen interruption mechanism 36, and thus a combined functionality component, the cable take-up assembly 60 could also be a separate component located elsewhere within the control assembly 10 without departing from the scope of the subject disclosure.” ([0030]) but does not disclose that the cable take-up assembly is disposed on the center gear. Accordingly, claim 11 is not entitled to the benefit of the prior application.
Specification
The disclosure is objected to because of the following informalities:
in paragraph [0040], the union reservoir hub is incorrectly referenced as numeral 30, this should be corrected to 40,
in the last line of paragraph [0052], the electronics cable is incorrectly referenced as numeral 36, this should be corrected to 26, and
in line 9 of paragraph [0065], the pull wire is incorrectly referenced as numeral 105, this should be corrected to 107.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: numerals 22, 24, and 26 are not provided in the drawings. 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. 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.
The drawings are objected to because the threaded gear 122 is incorrectly referenced as numeral 112 in Fig. 23. 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 13 is objected to because of the following informalities:
Regarding claim 13, “spook” should be corrected to “spool”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gray (US 20210235973 A1).
Regarding claim 1, Gray discloses a control assembly for a catheter having at least one working component (medical device 1 controlling catheter 24 having a tool 3 disposed in working channel 12, [0024], [0029], and [0049] & Fig. 1A and 4; “Port 11 may lead to proximal working channel 12, through which various tools may be introduced.”, [0027]; the tool is being interpreted as a working component), the control assembly comprising:
a housing extending along an axis between a proximal housing end and a distal housing end to define a housing compartment therebetween (proximal portion 10, distal portion 20, and strain relief 23 are being interpreted as defining a housing extending along an axis and defining a housing compartment therebetween, [0025]-[0026] & Fig. 1A-1B; proximal portion 10 is being interpreted as a proximal housing end and strain relief 23 is being interpreted as a distal housing end);
a control case disposed within said housing compartment adjacent said proximal housing end (supports 15, which are disposed within the housing compartment and adjacent proximal portion 10, are being interpreted as a control case, [0028] & Fig. 1A-1B);
a catheter shaft extending within said housing compartment from said control case to a distal tip (catheter 24, which may encompass all of distal working channel 22, extends within strain relief 23 from supports 15 to a distal end of catheter 24, [0024]-[0025] and [0031] & Fig. 1A-1B) and rotatable about the axis during operation of the control assembly (shaft 24 is configured to rotate about the axis during operation of medical device 1, [0031] & Fig. 1A-1B);
at least one channel component of the catheter (working channel 22 and channel 12 are being interpreted as a channel component of catheter 24, [0028]-[0029] & Fig. 1A-1B) extending from a static portion disposed adjacent said proximal housing end in coupled and stationary relationship relative to said control case (channel 12 is being interpreted as a static portion, [0028] & Fig. 1B; channel 12 is adjacent proximal housing 10 and in coupled and stationary relationship relative to supports 15, [0028]-[0029] and [0031] & Fig. 1B) to a dynamic portion extending along and rotatable about the axis simultaneously with said catheter shaft (channel 22 is being interpreted as a dynamic portion, [0029]-[0030] & Fig. 1B; channel 22 extends along catheter 24 and is rotatable about the axis simultaneously with catheter 24; “…the proximal portion of shaft 24 is fixedly clamped to distal portion 20, so that shaft 24 (and working channel 22) rotates, as distal handle portion 20 rotates clockwise or counter-clockwise, relative to proximal handle portion 10.”, [0031] & Fig. 1B); and
a lumen interruption mechanism disposed in said control case (guide 14 disposed in supports 15, [0028] & see Fig. 1B) and extending from a proximal mechanism end disposed in communication with said static portion of said at least one channel component to a distal mechanism end disposed in communication with said dynamic portion of said at least one channel component (the proximal end of guide 14 may be molded with channel 12, [0028] & Fig. 1B; the distal end of guide 14, including recess 16, communicating with channel 22, [0029] & Fig. 1B) for transitioning said at least one channel component from said static portion to said dynamic portion (“Guide 14 and lumen 14′ serve as a transition between the distal end of channel 12 of proximal portion 10 and the proximal end of a distal working channel 22 of distal portion 20.”, [0029] & Fig. 1B).
Regarding claim 2, Gray discloses all the limitations of claim 1. Gray discloses a gyro 50 that may be included in medical device 1. Gray further discloses the control assembly further comprising: said lumen interruption mechanism includes
a cap fixed to said control case and disposed in a static condition relative to said housing (proximal gyro 51 is fixed to guide 14, which is fixed to supports 15, and disposed in a static condition relative to proximal portion 10, [0044] & Fig. 3A) and
a hub rotatably coupled to said cap and rotatable about the axis (distal gyro 55 rotatably interlinked with proximal gyro 51 and rotatable about the axis, [0044] & Fig. 3A);
said cap defining at least one cap inlet coupled with said static portion of said at least one channel component (the proximal opening of gyro 51 in which guide 14 is disposed is being interpreted as a cap inlet, [0044] & Fig. 3A; channel 12 is indirectly coupled to the internal opening of gyro 51 through guide 14); said hub defining at least one hub outlet disposed in communication with said at least one cap inlet and coupled with said dynamic portion of said at least one channel component (the distal opening of gyro 55 holding channel 22 is being interpreted as a hub outlet, see Fig. 3A; the distal opening of gyro 55 and the proximal opening of gyro 51 are disposed in communication with each other);
wherein said hub rotates simultaneously with said dynamic portion of said at least one channel component during rotation of said catheter shaft to maintain a relative position of said dynamic portion relative to said catheter shaft and prevent kinking of said dynamic portion of said at least one channel component during rotation about the axis (“Distal gyro 55 may be fixed around channel 22 so that it may be rotatable with channel 22, relative to proximal gyro 51.”, [0044] & Fig. 3A; gyro 55 rotates along with channel 22 and catheter 24 and is capable of preventing kinking of channel 22 during rotation).
Allowable Subject Matter
Claims 3-11 and 13-20 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Furnish (US-20160074625-A1), Rezac (US-20140228800-A1), Cahill (US-20200359879-A1), Konstorum (US-20140012075-A1), Park (US-20140276393-A1), Terwiske (US-20140012194-A1), Morris (US-20160074624-A1), Booker (US-20210338984-A1), Scheibe (US-20180264231-A1), Drysen (US-20040181135-A1), Begemann (US-8690761-B2), Wardle (US-4750477-A), Akiba (US-5810718-A), Muller (US-5486155-A), HELGESON (WO-2021071692-A1), and DORN (DE-19819432-A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783