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 .
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 12-16 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.
Claim 12 is a single claim which claims both an apparatus and a method step. Such is indefinite because it is not directed to the system, but the actions of a user, which creates confusion as to when direct infringement occurs. See MPEP 2173.05(p). The accessory is only claimed as intended use throughout the claim, but then at the end of claim 12 has “the positive stop comprising an annular aperture having a diameter that abuts an outer diameter of the accessory”, thus requiring the step/action of abutting the accessory with the positive stop.
Claim Rejections - 35 USC § 102
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, 9, 12-15, 17 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khanicheh et al (US 2019/0022354).
Regarding claim 1, Khanicheh discloses a catheter port for introducing an accessory (figs 18-19B), comprising: a body (portion of 190 that is straight, see annotated figure) comprising a proximal end, a distal end, a longitudinal axis extending therethrough, and a main channel 192 extending along the longitudinal axis along a length of the body (fig 19B), wherein the main channel is substantially coaxial with a lumen of a catheter (fig 18); an extension (see annotated figure) extending from the body, the extension comprising an accessory channel (figs 18 and 19B) extending through the extension, the accessory channel in fluid communication with the main channel (fig 18; ¶109), and the accessory channel configured to accept the accessory (such as a guidewire – fig 18); a positive stop (funnel portion between 192 and 194) disposed along the accessory channel, the positive stop configured to abut a distal end of the accessory (intended use, capable of such depending on accessory used); and a slit 196 extending from the distal end of the body to the proximal end of the body, the slit extending through the extension and in fluid communication with the accessory channel (fig 18).
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Regarding claim 2, wherein the slit is configured to receive a tool laterally removable from the main channel through the slit and out of the catheter port (¶110).
Regarding claim 3, wherein the extension comprises a pair of guides disposed on opposing sides of the slit along the body about the longitudinal axis (two different sides of extension, separated by slit 196).
Regarding claim 5, wherein the accessory channel comprises a larger lateral width dimension at a proximal portion that is smaller than a lateral width dimension at a distal portion (fig 19B due to stop).
Regarding claim 6, wherein a proximal end of the accessory channel comprises a funnel-shape having a maximum lateral width dimension that is larger than the remainder of the accessory channel (fig 19B).
Regarding claim 8, wherein the positive stop comprises an annular aperture having a diameter that abuts an outer diameter of the accessory and is large enough to accept a diameter of a tool disposed within the accessory (fig 19B).
Regarding claim 9, wherein the extension comprises at least one concave portion along an outer surface of the extension (due to lip of inlet 194, the portion between the lip and body is concave).
Regarding claim 12, Khanicheh discloses a catheter port (figs 18-19B) for introducing an accessory, comprising: a body (see annotated figure above) comprising a proximal end, a distal end, a longitudinal axis extending therethrough (fig 19B), and a main channel 192 extending along the longitudinal axis along a length of the body (fig 19B), wherein the main channel is substantially coaxial with a lumen of a catheter 160 (fig 18); an extension (see annotated figure above) extending from the body, the extension comprising an accessory channel extending through the extension, the accessory channel in fluid communication with the main channel (fig 19B), and the accessory channel configured to accept the accessory (device is capable of such, see fig 18 for example); and a positive stop disposed along the accessory channel (funnel portion seen in fig 19B), the positive stop comprising an annular aperture having a diameter that abuts an outer diameter of the accessory and is large enough to accept a diameter of a tool disposed within the accessory (fig 19B, see 112 rejection above).
Regarding claim 13, further comprising a slit 196 extending from the distal end of the body to the proximal end of the body, the slit extending through the extension and in fluid communication with the accessory channel (fig 18).
Regarding claim 14, wherein the extension comprises a pair of guides disposed on opposing sides of the slit along the body about the longitudinal axis (opposing sides of extension divided by slit 196).
Regarding claim 15, wherein the accessory channel comprises a larger lateral width dimension at a proximal portion that is smaller than a lateral width dimension at a distal portion (fig 19B).
Regarding claim 17, Khanicheh catheter system, comprising: a catheter port comprising: a body (see annotated figure above) comprising a proximal end, a distal end, a longitudinal axis extending therethrough (fig 19B), and a main channel 192 extending along the longitudinal axis along a length of the body; an extension extending from the body (see annotated figure), the extension comprising an accessory channel 194 extending through the extension, the accessory channel in fluid communication with the main channel (fig 19B); and a positive stop disposed along the accessory channel (funneled section); a catheter 160 disposed through the main channel of the port (fig 18); and an accessory 200 insertable within the accessory channel such that the accessory abuts the positive stop (fig 18, narrowest portion of funnel will contact/abut a portion of the guidewire 200).
Regarding claim 19, wherein the catheter port comprises a slit 196 extending from the distal end of the body to the proximal end of the body, the slit extending through the extension and in fluid communication with the accessory channel (fig 19A).
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.
Claim(s) 7 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khanicheh et al (US 2019/0022354) in view of Knapp (US 2004/0204629).
Regarding claim 7, while Khanicheh substantially discloses the invention as claimed, it does not disclose wherein the main channel further comprises at least one of a distal shoulder configured to abut a distal end of an aperture of the catheter and a proximal shoulder configured to abut a proximal end of the aperture of the catheter.
Figs 18 and 19A of Khanicheh shows that the catheter 140 attaches to a proximal fitting, but is unclear how catheter 160 is seated within the body.
Knapp discloses a catheter port with body and extension where wherein the main channel further comprises at least one of a distal shoulder configured to abut a distal end of an aperture of the catheter and a proximal shoulder configured to abut a proximal end of the aperture of the catheter (fig 17).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Khanicheh such that the main channel further comprises at least one of a distal shoulder configured to abut a distal end of an aperture of the catheter and a proximal shoulder configured to abut a proximal end of the aperture of the catheter as taught by Knapp to anchor the catheter and port together so they do not separate or rotate with respect to each other.
Regarding claim 18, while Khanicheh wherein the main channel further comprises a shoulder configured to extend into a lumen of the catheter such that the shoulder abuts an end of a radial aperture of the catheter.
Knapp discloses a similar arrangement with a body and extension and which comprises a shoulder configured to extend into a lumen of the catheter such that the shoulder abuts an end of a radial aperture of the catheter.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Khanicheh such that it comprises a shoulder configured to extend into a lumen of the catheter such that the shoulder abuts an end of a radial aperture of the catheter as taught by Knapp to anchor the catheter and port together so they do not separate or rotate with respect to each other.
Claim(s) 10, 16 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khanicheh et al (US 2019/0022354) in view of Jang et al (US 5,935,114).
Regarding claims 10, 16 and 20, while Khanicheh substantially discloses the invention as claimed, it does not disclose wherein the extension comprises a flap forming a funnel-shape extending along and laterally from the body, the flap having a larger lateral width dimension of the funnel-shape towards the proximal end than a lateral width dimension of the funnel-shape towards the distal end, and wherein the slit is disposed along a terminal proximal end of the flap and laterally along the funnel-shape.
Jang discloses a catheter which has an extension 12 (fig 1A) extending from a body 124 and which comprises a flap forming a funnel-shape extending along and laterally from the body, the flap having a larger lateral width dimension of the funnel-shape towards the proximal end than a lateral width dimension of the funnel-shape towards the distal end, and wherein the slit is disposed along a terminal proximal end of the flap and laterally along the funnel-shape (fig 1A).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Khanichech such that the extension includes a portion which comprises a flap forming a funnel-shape extending along and laterally from the body, the flap having a larger lateral width dimension of the funnel-shape towards the proximal end than a lateral width dimension of the funnel-shape towards the distal end, and wherein the slit is disposed along a terminal proximal end of the flap and laterally along the funnel-shape (the section proximal of the funnel shape) as taught by Jang to allow easier insertion of the guidewire into the extension and widening/narrowing of the extension entry as desired.
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 examiner did not find a teaching or suggestion for modifying closest art Khanicheh such that the body comprises a thinned portion along a wall of the main channel, the thinned portion disposed along the length of the body opposing the slit such that the body and the pair of guides comprise an open configuration wherein the pair of guides are positioned away from each other about the thinned portion and a closed position wherein the pair of guides are positioned towards each other about the thinned portion. Alokaili (US 2003/0130620) fig 13 was considered as a secondary reference as it has a thinned portion 23 around which two sides pivot to engage a catheter (the port having two sides, a body and an extension), but it was missing the critical limitation of “the thinned portion disposed along the length of the body opposing the slit”, such that any rejection of claim 4 would be based on impermissible hindsight.
Claim 11 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 examiner did not find a teaching or suggestion for modifying closest art Khanicheh in view of Jang such that the flap further comprises a thinned portion along a wall of the flap, the thinned portion extending along the flap where the flap extends laterally from the body absent impermissible hindsight
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783