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 9/12/2025 have been fully considered.
Regarding the objection to the drawings, Applicant’s arguments are convincing. The amendments to the drawings overcome the objection and the objection is therefore withdrawn.
Regarding the 112 rejections, Applicant’s arguments are convincing. The amendments to the claims overcome the 112 rejections and the rejections are therefore withdrawn.
Regarding the rejections under 102 and 103, Applicant’s argument have been considered. The examiner agrees that the amendment to claim 11 overcome the prior 102 rejection over Ayala.
Applicant further argues that previously cited Alvarez fails to remedy the deficiencies of Ayala. Applicant argues that Alvarez teaches a drive mechanism only moving the racks and pinions that drive push tubes connected to a single-piece body of the catheter or Alvarez and therefore does not teach or suggest the navigation system configured to translate a pair of opposing members of the bifurcated shaft of the body of the catheter. This argument is not convincing. Ayala teaches the catheter having opposing members that are translated to navigate the catheter, therefore Alvarez is not relied upon to teach these elements. Rather, Alvarez is relied upon to teach a mechanism to alternately translate adjacent elongate members as shown in figs. 4D, 5D. A person of ordinary skill in the art would understand that the electromechanical drive mount taught by Alvarez applied to the device of Ayala would result in the claimed invention, i.e. the manually controlled drive mechanism of Ayala as shown in fig. 24, for example would be replaced with the electromechanical element taught by Alvarez to achieve more precise control and eliminate human error.
Regarding claims 26, Applicant’s arguments are convincing.
Regarding claim 38, Applicant’s arguments are not convincing. Claim 26 recites a method which is interpreted more narrowly that the device claim as recited in claim 38, and additionally, claim 38 does not include all of the limitations of claim 26.
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 12 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 12 recites, in relevant part, “the electromechanical mount is configured to translate a pair of opposing members of the bifurcated shaft body of the catheter relative to each other.” This limitation is also included in claim 11, from which claim 12 depends and therefore it is unclear if this is intended to be a further limitation or is unintentional.
Claim Rejections - 35 USC § 103
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) 11-16, 19-21, 23-25, 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ayala et al (US 8,070,693) in view of Alvarez et al (US 9,254,123).
Regarding claim 11, Ayala discloses a catheter system (fig. 1) comprising: a catheter having a bifurcated shaft body 25/26 and a tip 19 coupled to the bifurcated shaft body (fig. 2; col. 6, lines 32-36); a sheath 94 surrounding a portion of the bifurcated shaft body (fig. 2; col. 7, lines 43-45), the tip extending outwardly from an end of the sheath (fig. 1); and a navigation system 90 operatively coupled to the bifurcated shaft body of the catheter for controlling selective deflection of the tip of the catheter (fig. 24; col. 11, lines 59-61) , where the sheath is adapted to form a delivery channel to an area of tissue (col. 7, lines 10-12: “adapted to form a delivery channel” is interpreted to be a functional limitation, the sheath of Ayala is capable of forming a delivery channel to an area of tissue because it is a hollow member that creates a channel as it passes into the target tissue), the delivery channel configured for access and/or targeted delivery of a therapeutic payload to the area of tissue (col. 7, lines 10-12: configured for access and/or targeted delivery of a therapeutic payload to the area of tissue” is interpreted to be a functional limitation, the delivery channel discussed above is capable of being used for access or targeted delivery to the tissue).
Claim 11 further calls for the navigation system including an electromechanical mount operatively coupled to the catheter and configured to translate a pair of opposing members of the bifurcated shaft body of the catheter relative to each other. Ayala discloses that the navigation system is a mount coupled to the catheter and configured to translate a pair of opposing members of the bifurcated shaft body of the catheter relative to each other (figs. 3, 4, 30; col. 12, lines 27-31). Ayala fails to disclose that the navigation system is an electromechanical mount that causes the translation. Alvarez teaches an electromechanical mount that controls translation of a pair of opposing members to deflect the distal end of a catheter member (figs. 4D-5D; col. 17, lines 58-61). This system is easy to control and reduces user error in controlling the deflection of the catheter. 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 navigation system of Ayala to include an electromechanical mount to control translation of the members as taught by Alvarez to increase ease of use of the device and reduce user error that could result in damage to the tissue.
Regarding claim 12, Ayala discloses that the pair of opposing members of the bifurcated shaft body of the catheter is translated via a drive mechanism, such that catheter flex would be refined to isolate motion of the tip via the sheath, the mount controls articulation of the tip (figs. 3, 4, 30; col. 12, lines 27-31). As discussed above with regard to claim 11, Alvarez teaches an electromechanical mount to control the movements of the drive mechanism which controls articulation of the tip.
Regarding claim 13, Ayala discloses that the mount has an enclosure (housing 90) having an opening with a collar, the sheath is coupled to the collar (fig. 30: the sheath 94 engages the housing 90 at a portion forming the collar). Alvarez teaches that the electromechanically mount houses a motor (col. 18, lines 36-39: torque output system) and a processor (col. 17, lines 58-61: control unit) configured to receive inputs from a drive system (col. 17, lines 58-61), the electromechanical mount configured to translate sliding members of the catheter relative to each other, the mount connectable to the catheter and to the drive system, the electromechanically mount controlling directional movement of the tip of the catheter (col. 17, lines 58-61; col. 18, lines 33-45). 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 Ayala to include the electromechanical mount including a motor and processor receiving inputs from the drive system as taught by Alvarez to provide control for the deflection of the distal tip of the catheter to increase ease of use of the device and prevent user error in controlling the distal tip.
Regarding claim 14, Alvarez further teaches that the electromechanical mount is coupled to a control box and a drive system 106 for controlling movement of the catheter (fig. 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the control box and drive system coupled to the electromechanical mount as taught by Alvarez to provide the means for moving the elements of the electromechanical mount to control the deflection of the distal end of the catheter.
Regarding claim 15, Ayala discloses that the navigation system includes a manual controller 90 (fig. 30), and the catheter is selectively inserted into the manual controller (fig. 30), the controller having at least one stationary element (housing) and at least one translating element 104/106 controlled by the user (fig. 30).
Regarding claim 16, Ayala discloses that the tip is a bidirectional tip (figs. 6, 7), the tip comprising a double beveled tip (fig. 2: the bevel is interpreted to be a double bevel because it includes one bevel on the left half and one bevel on the right half), and configured to provide access to regions of the body for surgical and/or therapeutic interventions (col. 7, lines 10-11).
Regarding claim 19, the limitations “configured to access regions of an eye for surgical and/or therapeutic interventions and the tip is adapted to minimize injury to regions of the eye, including the suprachoroidal space” are interpreted to be intended use limitations. The device of Ayala is sized such that it can be used to access regions of the eye (col. 10, lines 5-10: diameter of 0.4 mm).
Regarding claim 20, the limitation “the sheath includes an internal area for one or more of…” is interpreted to be a functional limitation. The sheath of Ayala has an internal area that can accommodate therapeutic payloads and enable delivery of payloads consistent in size with the internal area of the sheath, and provide access to a light source or another surgical device after removal of the catheter from the sheath.
Regarding claim 21, Ayala discloses that the catheter comprises a first side 25 and a second side 26, wherein the tip moves in a first direction or a second direction based on drive inputs to the first side and the second side (figs. 3, 4, 30). Claim 21 differs from Ayala in calling for the drive inputs to be deliverable via an electromechanical mount. Alvarez teaches an electromechanical mount that controls translation of a pair of opposing members to deflect the distal end of a catheter member (figs. 4D-5D; col. 17, lines 58-61). This system is easy to control and reduces user error in controlling the deflection of the catheter. 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 navigation system of Ayala to include an electromechanical mount to control translation of the members as taught by Alvarez to increase ease of use of the device and reduce user error that could result in damage to the tissue.
Regarding claim 23, the limitations “configured to selectively form a pathway to a target location, and wherein the therapeutic payloads are delivered to the target location through one or more of the pathway or the sheath directly, or by guiding a syringe or other delivery device through one or more of the pathway or the sheath” are interpreted to be functional limitations. The system of Ayala forms a pathway to a target location as the device traverses to the body tissue to the target site, this pathway is capable of receiving the payload.
Regarding claim 24, Ayala discloses that the device includes a hand driven apparatus 90 (fig. 30) for steering the bidirectional tip of the catheter (col. 12, lines 28-31).
Regarding claim 25, the device of Ayala is capable of being discarded and therefore is disposable. Ayala discloses that the sheath selectively constrains catheter flex of the portion of the body disposed within the sheath (figs. 3, 4).
Regarding claim 43, the device of Ayala is capable of being used in any tissue including ophthalmologic, retrobulbar, gastrointestinal, retroperitoneal, otolaryngologic, perivascular, orthopedic, or neurologic areas.
Claim(s) 17, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ayala in view of Alvarez as applied to claim 16 above, and further in view of Berke et al (US 4,561,445).
Claim 17 differs from Ayala in calling for the double beveled tip to have a first side with a first surface area and a second side with a second surface area, the first surface area greater than the second surface, the first and second surface areas adapted to contact tissues. Berke teaches a beveled tip having a double bevel having a first side with a first surface area 14’ and a second side with a second surface area 22, the first surface area larger than the second surface area (fig. 6), the first and second surface areas are adapted to contact tissue and provide less pain during insertion (col. 2, lines 36-45). 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 beveled tip of Ayala to include a double bevel having a first side with a first surface area and a second side with a second surface area, the first surface area greater than the second surface area as taught by Berke to allow the tip to puncture the tissue with less pain.
Claim 18 differs from Ayala in calling for the tip to include various aspect ratios, imparting minimal stress. Berke teaches a tip having multiple aspect ratios, imparting minimal stress to prevent breakage of the tip and to allow the tip to be inserted into the tissue without tearing or stretching the tissue (col. 2, lines 35-44; fig. 6). 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 of Ayala to include various aspect ratios, imparting minimal stress as taught by Berke to prevent breakage of the tip and allow for insertion with minimal tissue damage.
Claim(s) 38-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ayala in view of Berke.
Regarding claim 38, Ayala discloses a catheter tip system comprising a bevel tip 19 adapted to be coupled to a shaft of a catheter 25, 26 (fig. 2), a bifurcated shaft coupled to the tip (fig. 2; col. 6, lines 32-36), and a sheath 94 for receiving a portion of the bifurcated shaft (fig. 2; col. 7, lines 43-45), the bifurcated shaft body is disposed within the sheath providing targeted delivery of a therapeutic payload to an area of tissue via the sheath (col. 7, lines 10-12: configured for access and/or targeted delivery of a therapeutic payload to the area of tissue” is interpreted to be a functional limitation, the delivery channel discussed above is capable of being used for access or targeted delivery to the tissue).
Claim 38 differs from Ayala in calling for an asymmetric double bevel, the tip adapted to provide greater tip contact area preferentially with one tissue, permitting minimizing of pressure preferentially during a surgical procedure. Berke teaches a tip having an asymmetric double bevel (fig. 6), the tip providing greater tip contact area preferentially with one tissue, imparting minimal stress to prevent breakage of the tip and to allow the tip to be inserted into the tissue without tearing or stretching the tissue (col. 2, lines 35-44; fig. 6). 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 of Ayala to include an asymmetric double bevel, imparting minimal stress as taught by Berke to prevent breakage of the tip and allow for insertion with minimal tissue damage.
Regarding claim 39, Ayala further discloses a hand driven apparatus 90 for steering the tip (figs. 3, 4, 30).
Regarding claim 40, Ayala further discloses the tip outwardly extends from an end of the sheath and the bifurcated body is disposed within the sheath (fig. 2) reducing flex of the bifurcated body (fig. 3).
Allowable Subject Matter
Claims 26-29, 31-37 are allowed.
Claims 22, 41 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.
The following is a statement of reasons for the indication of allowable subject matter: see prior office action.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783