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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/06/2025, 04/15/2024, 10/30/2023, 09/22/2023, 01/06/2023, and 05/25/2022 were considered by the examiner.
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.
Claims 1 and 5-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fischell (US 2016/0058486).
Regarding Claim 1, Fischell discloses a catheter (100; Fig.2) for fluid delivery into tissue outside of an interior wall of a target vessel of a human body (first sentence in parag. [0150]) (Figs.8-10), the catheter comprising: a catheter body (body of PTAC 100) comprising at least two openings (131) in a distal portion of the catheter body (Fig.2) and a central axis extending in a longitudinal direction (lines 4-6 in parag. [0150]), the catheter body comprising a fluid injection lumen (133); each of the at least two openings (131) in the distal portion of the catheter body comprising an opening cover (movable flap cover) including at least one slit (parag. [0189]); at least two needle guiding elements (115) adapted to advance distally and expand outwardly through the opening covers of the at least two openings in the distal portion of the catheter body toward the interior wall of the target vessel (parags. [0188]-[0189]) (Figs.8-10); and at least two injection needles (119) adapted to be advanced outwardly through the at least two needle guiding elements to penetrate the interior wall of the target vessel (last sentence in parag. [0190]) (Figs.8-10), the at least two injection needles (119) having a distal opening (117) for fluid delivery into the tissue outside of the interior wall of the target vessel (lines 21-25 in parag. [0151]) (Figs.8-10).
Regarding Claim 5, Fischell discloses the catheter of claim 1, and further discloses wherein the distal portion of the catheter body comprises two layers including an inner layer (102) and an outer layer (104) (Figs.2-3).
Regarding Claim 6, Fischell discloses the catheter of claim 5, and further discloses wherein the opening covers are formed in the outer layer (104) (Figs.3-4) (parag. [0189]).
Regarding Claim 7, Fischell discloses the catheter of claim 1, and further discloses wherein a portion of the catheter body further comprises three concentric tubular structures including an outer tube (102), a middle tube (103) and an inner tube (105) (Figs.3-5) (parag. [0191]).
Regarding Claim 8, Fischell discloses the catheter of claim 7, and further discloses wherein the middle tube (103) is adapted to move longitudinally with respect to the outer tube (102) (parag. [0220]).
Regarding Claim 9, Fischell discloses the catheter of claim 7, and further discloses wherein the inner tube (105) is adapted to move longitudinally with respect to the middle tube (103) (parag. [0220]).
Regarding Claim 10, Fischell discloses the catheter of claim 7, and further discloses wherein a proximal portion of at least one of the three concentric tubular structures is formed from a metal hypotube (Fig.18) (parag. [0308]).
Regarding Claim 11, Fischell discloses the catheter of claim 1, and further discloses comprising at least one radiopaque marker (122) located on at least one of the following: a. the catheter body, b. at least one needle guiding element (115) (Fig.2) (first sentence in parag. [0188]), or c. at least one injection needle.
Regarding Claim 12, Fischell discloses the catheter of claim 1, and further discloses wherein the slits (131) in the opening covers increase the reliability for extension and retraction of the at least two needle guiding elements (115) (parag. [0189]).
Regarding Claim 13, Fischell discloses the catheter of claim 1, and further discloses wherein the slits (131) in the opening covers guide the at least two needle guiding elements (115) through the opening covers (parag. [0189]).
Regarding Claim 14, Fischell discloses the catheter of claim 1, and further discloses wherein the slits (131) in the opening covers protect the at least two needle guiding elements (115) from surface damage (smooth for better delivery) as the at least two needle guiding elements are advanced and retracted from the catheter body (parag. [0189]).
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.
Claims 2-4 and 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell (US 2016/0058486); in view of McFerran (US 2005/0065498).
Regarding Claim 2, Fischell discloses all the limitations of claim 1 above.
Fischell does not appear to disclose an opening cover comprises a hole. Fischell discloses either a hole/opening or a slit.
McFerran teaches it was known in the art to have a hole 44 and a slit 58 as seen in Figs.5-6 (parag. [0038]). Fischell would be modified by substituting the opening cover (movable flap cover) with the polymer sheath 50 of McFerran placed over openings 131.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Fischell to incorporate the teachings of McFerran to substitute the opening cover (movable flap cover) (in Fischell) with the sheath 50 having the slit in order to provide fluid-tight seal (parag. [0037]).
Regarding Claim 3, Fischell discloses the catheter of claim 1, and McFerran further teaches wherein the at least one slit comprises a proximal slit (58) (Figs.5-6).
Regarding Claim 4, Fischell discloses the catheter of claim 1, and McFerran further teaches wherein the at least one slit comprises a longitudinal slit (58) (Figs.5-6).
Regarding Claim 16, Fischell discloses a catheter (100) for fluid delivery into tissue outside of an interior wall of a target vessel of a human body (first sentence in parag. [0150]) (Figs.8-10), the catheter comprising: a catheter body (body of PTAC 100) comprising at least two openings (131) in the distal portion of the catheter body (Fig.2) and a central axis extending in a longitudinal direction (lines 4-6 in parag. [0150]), the catheter body comprising a fluid injection lumen (133); at least two openings (131) in the distal portion of the catheter body, each opening comprising an opening cover (movable flap cover) comprising a hole (131) (parag. [0189]); and at least two injection needles (119) adapted to be advanced outwardly through the holes in the opening covers of the at least two openings to penetrate the interior wall of the target vessel (last sentence in parag. [0190]) (Figs.8-10), the at least two injection needles (119) having a distal opening (117) for fluid delivery into the tissue outside of the interior wall of the target vessel (lines 21-25 in parag. [0151]) (Figs.8-10).
Fischell does not appear to disclose an opening cover comprises a proximal slit. Fischell discloses either a hole/opening or a slit.
McFerran teaches it was known in the art to have a hole 44 and a proximal slit 58 as seen in Figs.5-6 (parag. [0038]). Fischell would be modified by substituting the opening cover (movable flap cover) with the polymer sheath 50 of McFerran placed over openings 131.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Fischell to incorporate the teachings of McFerran to substitute the opening cover (movable flap cover) (in Fischell) with the sheath 50 having the proximal slit in order to provide fluid-tight seal (parag. [0037]).
Regarding Claim 17, Fischell as modified discloses the catheter of claim 16, and further discloses comprising at least two needle guiding elements (115) adapted to advance distally and expand outwardly through the opening covers of the at least two openings (parags. [0188]-[0189]), wherein the at least two injection needles (119) are adapted to be advanced outwardly through the at least two needle guiding elements (last sentence in parag. [0190]).
Regarding Claim 18, Fischell as modified discloses the catheter of claim 16, and further discloses wherein the distal portion of the catheter body comprises two layers including an inner layer (104) and an outer layer (modified/added sheath 50). Modifying Fischell with the sheath 50 (in McFerran) over openings 131 in Fischell would have the sheath 50 as the outer layer and the openings 131 would be formed in the inner layer 104.
Regarding Claim 19, Fischell as modified discloses the catheter of claim 18, and further discloses wherein the opening covers are formed in the outer layer and at least two openings are formed in the inner layer. Modifying Fischell with the sheath 50 (in McFerran) over openings 131 in Fischell would have the sheath 50 as the outer layer and the openings 131 would be formed in the inner layer 104.
Regarding Claim 20, Fischell discloses a catheter (100) for fluid delivery through into tissue outside of an interior wall of a target vessel of a human body (first sentence in parag. [0150]) (Figs.8-10), the catheter comprising: a catheter body (body of PTAC 100) comprising three openings (131) in the distal portion of the catheter body (lines 6-8 in parag. [0226]) and a central axis extending in a longitudinal direction (lines 4-6 in parag. [0150]), the catheter body comprising a fluid injection lumen (133), wherein each of the three openings (131) in the distal portion of the catheter body comprise an opening cover (movable flap cover) comprising a hole (parag. [0189]); three needle guiding elements (115) adapted to advance distally and expand outwardly through the holes in the opening cover of the three openings in the distal portion of the catheter body toward the interior wall of the target vessel (Figs.8-10) (parags. [0188]-[0189]), three injector tubes (119) with distal injection needles adapted to be advanced outwardly through the three needle guiding elements (115) to penetrate the interior wall of the target vessel (last sentence in parag. [0190]) (Figs.8-10), the three injection needles (119) having a distal opening (113) for fluid delivery into the tissue outside of the interior wall of the target vessel (lines 21-25 in parag. [0151]) (Figs.8-10).
Fischell does not appear to disclose an opening cover comprises a proximal slit. Fischell discloses either a hole/opening or a slit.
McFerran teaches it was known in the art to have a hole 44 and a proximal slit 58 as seen in Figs.5-6 (parag. [0038]). Fischell would be modified by substituting the opening cover (movable flap cover) with the polymer sheath 50 of McFerran placed over openings 131.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Fischell to incorporate the teachings of McFerran to substitute the opening cover (movable flap cover) (in Fischell) with the sheath 50 having the proximal slit in order to provide fluid-tight seal (parag. [0037]).
Regarding Claim 21, Fischell as modified discloses the catheter of claim 20, and McFerran further teaches wherein the longitudinal slit is proximal to the hole (the modified slit 58/sheath 50 from McFerran would be added proximally above openings 131 in Fischell).
Regarding Claim 22, Fischell as modified discloses the catheter of claim 20, and further discloses wherein the opening cover protects the three needle guiding elements (there are three openings 131 (lines 6-8 in parag. [0226]) wherein the number of openings 131 correspond to the number of guiding elements 115 (lines 3-5 in parag. [0200]).
Regarding Claim 23, Fischell as modified discloses the catheter of claim 20, and further discloses wherein the distal portion (106) of the catheter body is coupled to a distal tapered section (Fig.2).
Fischell does not appear to disclose a distal portion of the catheter body is coupled to a distal tapered section over a length of at least 5mm.
It would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to have the length in modified Fischell to have a distal portion of the catheter body is coupled to a distal tapered section over a length of at least 5mm, since it has been held that “where the only difference between the prior art and the claims was recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the catheter of Fischell would not operate differently with the claimed length. Further applicant places no criticality on the length claimed, indicating simply that the length “can” has the claimed length (specification; line 10 in page 20).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Fischell (US 2016/0058486).
Regarding Claim 15, Fischell discloses the catheter of claim 1, and further discloses comprising a distal tapered section (106), wherein the distal portion of the catheter body is coupled to the distal tapered section (Fig.2).
Fischell does not appear to disclose a distal portion of the catheter body is coupled to a distal tapered section over a length of at least 5mm.
It would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to have the length in modified Fischell to have a distal portion of the catheter body is coupled to a distal tapered section over a length of at least 5mm, since it has been held that “where the only difference between the prior art and the claims was recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the catheter of Fischell would not operate differently with the claimed length. Further applicant places no criticality on the length claimed, indicating simply that the length “can” has the claimed length (specification; line 10 in page 20).
Conclusion
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/T.I./ Examiner, Art Unit 3783 /BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783