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 .
Response to Arguments
Applicant's arguments filed 4/13/2026 have been fully considered.
Regarding the rejections over Mosler, Applicant argues that Mosler fails to teach the first recess and the second recess comprising a generally semicircular profile that is sized to grip and frictionally engage the catheter, rather Mosler teaches pincher points that grasp the catheter. This argument is convincing. Therefore, the rejection is withdrawn. However, upon further consideration in light of the amendments to the claims, a new rejection is made in view of Fasano et al (US 2015/0141914).
Regarding the rejections over Ros Fabrega, Applicant argues that Ros Fabrega fails to disclose the grip aperture sized to receive and frictionally engaged the catheter. This argument is convincing and therefore the rejection is withdrawn. However, upon further consideration in light of the amendments to the claims, a new rejection is made in view of Fasano et al (US 2015/0141914).
Drawings
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 body further comprising a proximal attachment end configured to attach to a handle device of a catheter assembly (claim 14), the body comprising a distal attachment end configured to attach to a valve of a catheter assembly (claim 15), and the body comprises a tip proximate the distal end configured to serve as an insertion tool (claim 16), in combination with the elements of claim 1 from which these claims depend, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. . The elements recited in claims 14-16 are shown in fig. 4, however claim 1 is drawn to a different embodiment and it is not apparent how various elements of these embodiments could be combined to arrive at the invention of claims 14-16.
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.
Claim 21 is 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 that the first recess and the second recess “can each comprise a textured inner surface”. The limitation “can” renders the claim indefinite because it is not clear if this is a required feature or an optional feature or what is the scope of “can comprise” a textured inner surface.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3, 4, 8, 14-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fasano et al (US 2015/0141914).
Regarding claim 1, Fasano discloses an apparatus to grip a catheter shaft (figs. 1A, B), the apparatus comprising: a body including a proximal end and extending along a central axis to a distal end (fig. 1A), and comprising: a first handle portion 2a defining a first recess 9a comprising a generally semicircular profile extending along the central axis of the body from the proximal end to the distal end (fig. 1A); a second handle portion 2b defining a second recess 9b comprising a generally semicircular profile extending along the central axis of the body from the proximal end to the distal end such that the first recess is aligned with the second recess (fig. 1A), and a catheter shaft grip aperture extending along the central axis of the body from the proximal end to the distal end, formed from the alignment of the first recess and the second recess (fig. 1B; page 3, para. 0059), the catheter shaft grip aperture being sized to receive and frictionally engage the catheter shaft to transfer rotation force applied to the body to the catheter shaft (page 3, paras. 0057-0059).
Regarding claim 3, Fasano discloses that the catheter shaft grip aperture comprises: a relaxed state where the catheter shaft grip aperture receives the catheter shaft and is freely movable along the catheter shaft (fig. 1A); and a grip state, where a force applied to the body causes the catheter shaft grip aperture to frictionally engage the catheter shaft (fig. 1B; page 3, para. 0057).
Regarding claim 4, Fasano discloses that the first handle portion comprising a first connector 5a extending outwardly from the first handle portion, and the second handle portion comprising a second connector 5b configured to receive the first connector and attach the first handle portion and the second handle portion to each other (fig. 1A; page 3, para. 0050).
Regarding claim 8, Fasano discloses a handle portion further comprising a second recess extending into the handle portion generally perpendicularly to the central axis; and the other handle portion further comprising a protrusion extending outwardly from handle portion generally perpendicularly to the central axis, wherein the second recess is configured to receive the protrusion to facilitate alignment of the first handle portion with the second handle portion (see fig. 1A annotated below). Note that the designation “first handle portion” and “second handle portion” are arbitrary with regard to claim 1 and claim 8 and therefore the designation of first and second handle portions are reversed from what was described above with regard to claim 1 when looking at fig. 1A of Fasano with regard to claim 8.
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Regarding claim 14, the limitation “the body further comprises a proximal attachment end configured to attach to a handle device of a catheter assembly” is interpreted to be an intended use limitation. The proximal end of the device Fasano is capable of being received a catheter handle.
Regarding claim 15, the limitation “the body further comprises a distal attachment end configured to attach to a valve of a catheter assembly” is interpreted to be an intended use limitation. The distal end of the body is capable of being attached to a valve of a catheter assembly.
Regarding claim 16, the limitation “the body further comprises a tip proximate the distal end configured to serve as an insertion tool” is interpreted to be an intended use limitation. Fasano discloses that the body includes a distal tip end, the distal tip end grips the catheter and therefore is capable of being used as an insertion tool for inserting the catheter.
Regarding claim 17, Fasano discloses a handle for gripping a catheter shaft (figs. 1A, 1B), the handle comprising: a first handle portion 2a defining a first channel 9a comprising a generally semicircular profile extending from a proximal end to a distal end of the first handle (fig. 1A); and a second handle portion 2b defining a second channel 9b comprising a generally semicircular profile extending from a proximal end to a distal end of the second handle (fig. 1A), the first handle portion and the second handle portion attachable to each other to form a handle including an aperture extending therethrough formed by the first channel and the second channel (fig. 1B; page 3, para. 0057), the aperture sized to receive the catheter shaft and frictionally engage the catheter shaft to transfer rotation force applied to the body to the catheter shaft (fig. 1B; page 3, paras. 0057-0059).
Regarding claim 18, Fasano discloses that the first handle portion 2a comprises a first connector 5a extending outwardly from the first handle portion (fig. 1A), and the second handle portion 2b comprising a second connector 5b configured to receive the first connector and attach the first handle portion and the second handle portion to each other (fig. 1A, 1B; page 3, para. 0050).
Regarding claim 19, Fasano discloses that the first connector 5a comprises a first male connector disposed proximate the proximal end of the first handle portion 2a (fig 1A), and the second connector 5b comprises a first female connector disposed proximate the proximal end of the second handle portion 2b (fig. 1A), wherein the first handle portion 2a further comprises a second male connector 5a extending outwardly from the first handle portion and disposed proximate the distal end of the first handle portion (fig. 1A), and the second handle portion 2b comprises a second female connector 5b disposed proximate to the distal end of the second handle portion and configured to receive the second male connector to attach the first handle portion and the second handle portion to each other (fig. 1B).
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Claim Rejections - 35 USC § 103
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) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fasano in view of Parker (US 2017/0238829).
Regarding claim 20, Fasano discloses a method of manipulating a catheter shaft using an attachable handle (figs. 1A, 1B), the method comprising: aligning a first handle portion 2b with the catheter shaft 100 (fig. 1A); inserting the catheter shaft 100 into a first recess 9b of the first handle portion (fig. 1A), the first recess comprising a generally semicircular profile extending along a central axis from a proximal end to a distal end of the first handle portion (fig. 1A); aligning a second handle portion 2a with the first handle portion (fig. 1B); attaching the second handle portion to the first handle portion to form a handle (fig. 1B; page 3, para. 0059), the second handle portion including a second recess 9a comprising a generally semicircular profile extending along a central axis from a proximal end to a distal end of the second handle portion such that the first recess and the second recess form an aperture through the handle (fig. 1A), the aperture being sized to receive the catheter shaft and frictionally engage the catheter shaft to transfer rotation force applied to the body to the catheter shaft (fig. 1B; page 3, paras. 0057-0059).
Fasano discloses the step of gripping the handle and manipulating the catheter shaft, but fails to specifically disclose the step of rotating the handle. Parker teaches a catheter grip including the step of gripping the handle and manipulating the catheter shaft by rotating the handle to rotate the shaft so the user may ensure proper placement of the catheter with the patient (abstract). 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 method of Fasano to include the step of rotating the handle as taught by Parker to allow the user to ensure proper placement of the catheter within the patient.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fasano in view of Burkett (US 2015/0105650).
Claim 21 differs from Fasano in calling for the first recess and the second recess can each comprise a textured inner surface configured to engage the catheter shaft. Burkett teaches a gripper handle wherein the inner engaging surface can include texture to provide improved gripping (page 4, para. 0049). 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 recesses of Fasano to include textured inner surfaces as taught by Burkett to provide additional gripping capabilities to ensure that the catheter does not slip.
Allowable Subject Matter
Claim 5 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 prior art fails to teach or fairly suggest the first connector comprises a first male connector disposed proximate the proximal end and the second connector comprises a first female connector disposed proximate the proximal end, wherein the first handle portion further comprises a second male connector extending outwardly from the first handle portion and disposed proximate the distal end, wherein the second handle portion further comprises a second female connector disposed proximate the distal end and configured to receive the second male connector to attach the first handle portion and the second handle portion to each other, and wherein the first male connector and the second male connector are configured to be pinched toward one another to disengage the first male connector from the first female connector and the second male connector from the second female connector, in combination with the features of the invention, substantially as claimed.
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 LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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