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
Claims 14-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/27/2026.
Applicant’s election without traverse of Group I, claims 1-13 and 17-20, in the reply filed on 7/27/2026 is acknowledged.
Applicant's election with traverse of Species A, Figs. 1-9, in the reply filed on 7/27/2026 is acknowledged. The traversal is on the ground(s) that Species A-C are all directed to the same field of use and show different arrangements of similar finger loops and flexible portion components. Therefore, it does not seem that the examiner would need to conduct separate searches for claims to these embodiments or to search in disparate fields. This is not found persuasive because of the recognized divergent subject matter in each of these embodiments. For example, a separate field of search would be necessary for the embodiment of Species A which requires a tip portion with “a cap”, and “a bow”, and “a break-away segment”, which is not required for the embodiments of Species B-C. Species B requires a separate field of search including a distal “fingertip loop”, “a tapered portion”, “an intermediate loop”, and a proximal “finger loop” proximal of a “proximal flexible portion”, not required by Species A or C. Species C requires a separate field of search including “a proximal finger loop” connected “distal” of a “proximal flexible portion” which is not required for the embodiments of Species A or B. In other words, due to the different arrangements of the species discussed above, each invention can be shown to have formed a separate subject for inventive effort.
The requirement is still deemed proper and is therefore made FINAL.
Claims 6, 8-13 and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/27/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “20” has been used to designate both “cap” and “loop” ([0033]; [0054]; [0058]; [0062]-[0063]). Similarly, reference character “24” has been used to designate both “bow portion” and “tapered portion” ([0033]; [0054]; [0057]). 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.
Claim Objections
Claim 3 is objected to because of the following informalities: Claim 3 recites “across fingertip” in line 3 which should read “across the fingertip”. 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.
Claim(s) 1-2 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lonky (US 2017/0215798 A1).
Regarding claim 1, Lonky discloses a device (Fig. 2) for facilitating the insertion of a catheter (catheter 105) through a cervix (abstract; see for example, Fig. 1), comprising: a shaft (portion of sheath 110 proximal to proximal finger clip 235) defining a passageway (lumen through which catheter 105 is inserted; Fig. 2), wherein the passageway is sized to accept insertion of the catheter (Fig. 2); a finger loop (proximal finger clip 235) connected with the shaft (110) and positioned to connect the shaft with a finger of a practitioner (Fig. 2; [0061]); a flexible portion (portion of sheath 110 in between finger clips 235 which is flexible as sheath 100 and catheter 105 are flexible; Fig. 2; [0057]) connected with a distal end of the shaft (Fig. 2); and a tip portion (portion of sheath 110 distal to distal finger clip 235 and distal finger clip 235) connected with a distal end of the flexible portion (Fig. 2), wherein the tip portion is adapted to mechanically couple with a fingertip of the finger (via distal finger clip 235), wherein the tip portion is shaped to be inserted at least partially through the cervix along with the fingertip (see for example, Fig. 1), wherein the flexible portion allows the tip portion to be articulated relative to the shaft by movement of the finger (due to flexibility of the sheath 110 and users manipulation of a finger, as a single finger is able to orient the catheter by flexing and angling the sheath; [0062]-[0063]), and wherein the passageway, the flexible portion, and the tip portion define an insertion path sized to accept passage of the catheter (105) through the device (Fig. 2).
Regarding claim 2, Lonky discloses wherein the shaft (110) further comprises an opening (opening 1160; Fig. 11) along its length to allow the catheter (105) to exit the passageway in a radial direction relative to the insertion path as sheath 110 may include an opening 1160 to allow easy removal of the sheath 110 from the catheter; [0074]), wherein the finger loop (proximal finger clip 235) comprises a first gap (fenestration gap) to allow the catheter (105) to exit from within the finger loop in the radial direction (Figs. 2, 11; [0074]), and wherein the tip portion (including distal finger clip 235) includes a second gap (fenestration gap) to allow the catheter (105) to exit the tip portion in the radial direction (Figs. 2, 11; [0074]).
Regarding claim 7, Lonky discloses wherein the catheter comprises one or two balloons (it is noted that the “catheter” is only functionally claimed in claim 1; therefore, the device only needs to be capable of facilitating the insertion of a catheter comprising one or two balloons and Lonky discloses the device facilitates the insertion of a catheter 105, which may be a cervical dilation or balloon catheter or Foley balloon catheter; [0044]; [0008]; [0061]).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lonky (US 2017/0215798 A1) in view of Taddeo et al. (US 9,486,563 B2).
Regarding claim 3, Lonky discloses wherein the tip portion comprises a cap (distal finger clip 235) adapted to at least partially encircle the fingertip (Fig. 2), but fails to disclose a bow portion extending distal from the cap, wherein the bow portion is adapted to extend across the fingertip.
However, Taddeo teaches a device (Figs. 1-5) comprising: a shaft (tube 2) defining a passageway (lumen in 2; Figs. 1-5) and a tip portion that may include a finger loop (finger part 3; Fig. 1), similar to that of Lonky, or alternatively, the tip portion may include a cap (proximal looped end of finger part 6; Figs, 4C, 5) adapted to at least partially encircle the fingertip (Fig. 5) and a bow portion (distal lateral portion of 6) extending distal from the cap, wherein the bow portion is adapted to extend across the fingertip (Fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tip portion of Lonky to comprise a cap and a bow portion extending distal from the cap across the fingertip as taught by Taddeo in order to prevent the fingertip from extending distally past the tip portion, preventing inadvertent injury to a patient.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lonky (US 2017/0215798 A1) in view of Wykes (US 2017/0007356 A1).
Regarding claim 5, Lonky fails to disclose an extension portion, wherein a distal end of the extension portion is adapted to connect with a proximal end of the shaft and wherein the insertion path extends through the extension portion.
However, Wykes teaches a device (Fig. 7) with finger loop portions (front bridge structure 220 and back bridge structure 222) and a shaft (cable 210) extending proximally therefrom (Fig. 7), wherein device includes an extension portion (wrist strap 270 and coupler 280), wherein a distal end of the extension portion is adapted to connect with a proximal end of the shaft (at coupler 280) and wherein the insertion path extends through the extension portion (at coupler 280; Fig. 7; [0035]) for the purpose of ensuring that the shaft is supported by any length of a hand ([0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Lonky to include a wrist strap extension adapted to connected with a proximal end of the shaft as taught by Wykes in order to secure and support the shaft and catheter therein with respect to the users hand, no matter the length of the users hand.
Allowable Subject Matter
Claim 4 is 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.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Lonky (US 2017/0215798 A1) in view of Taddeo et al. (US 9,486,563 B2), does not disclose or fairly suggest, either singly or in combination of any of the prior art of record, the claimed invention of dependent claim 4, which recites, inter alia “wherein the bow portion includes a break-away segment”. While Taddeo includes a bow portion, it does not break-away from the tip portion. One of ordinary skill in the art would not have been motivated to include a break-away bow portion at the tip portion as doing so could cause the bow portion to break-away within the body of a patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Harari (US 2021/0128136 A1), Williams (US 10,182,843 B2), Hwan (KR 101513912 B1) and Teggatz et al. (US 2011/057031 A1) are noted for teaching finger attachments.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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