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 Objections
Claim 16 is objected to because of the following informalities: On line 7, the term “the” in the phrase “the periphery” should be replaced with the term “a” since this is the first time this feature is recited. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: On line 10, the term “the” in the phrase “the circumference” should be replaced with the term “a” since this is the first time this feature is recited. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claim 1 has been amended to recite that the opening cover of each of the at least two openings is “within the opening”. The Remarks filed with the amendment do not set forth where support in the original disclosure can be found for the amendment. The original disclosure does not appear to support an opening cover being “within” its respective opening as this arrangement is neither described in the specification nor shown in the drawings. Rather, the specification and the drawings only appear to support the opening cover being radially outward to the opening (see Para 67,77 which each describe cover(s) 241 being located radially outward from opening(s) 231 in Fig 2); one of ordinary skill in the art would not interpret the arrangement of these cover(s) to be “within” the opening(s). Accordingly, the amended limitation constitutes new matter. Claims 2-15 are rejected due to their dependence on claim 1.
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 1-19 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.
Independent claim 1 has been amended to recite “each of the at least two openings in the distal portion of the catheter body comprising an opening cover within the opening and including at least one slit”. As written, it is unclear if the “at least one slit” belong to the “at least two openings” or belongs to the “opening cover”. Based on the disclosure, it appears that the slit belongs to the opening cover. Therefore, this is the interpretation applied to the claim for the sake of examination. It is suggested to amend claim 1 to recite “each of the at least two openings in the distal portion of the catheter body comprising an opening cover within the opening, the opening cover [[and]] including at least one slit”. in order to overcome this rejection. Claims 2-15 are rejected due to their dependence on claim 1.
Independent claim 16 has been amended to recite “each opening comprising an opening cover bound to the periphery of the opening and comprising a hole and a proximal slit”. As written, it is unclear if the “hole” and the “proximal slit” belong to the “opening” or belong to the “opening cover”. Based on the disclosure, it appears that the hole and the slit belong to the opening cover. Therefore, this is the interpretation applied to the claim for the sake of examination. It is suggested to amend claim 16 to recite “each opening comprising an opening cover bound to the periphery of the opening, the opening cover [[and]] comprising a hole and a proximal slit” in order to overcome this rejection. Claims 17-19 are rejected due to their dependence on claim 16.
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 1 and 3-15 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (PG PUB 2016/0058489) in view of McFerran (PG PUB 2005/0065498) and Fischell (US Pat 6,783,522).1
Regarding Claim 1, Fischell ‘489 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; 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). Fischell ‘489 discloses that each opening can be covered by a movable flap or that a slit could be present that coupld be opened (Para 189), but does not explicitly disclose that each opening comprises an opening cover within the opening that includes at least one slit.
McFerran, however, teaches providing a catheter body 12 (Fig 1) with an opening 44 (Fig 5-8) and an opening cover 50 (Fig 6-8) including a slit 58 (Fig 6-8) for the purpose of providing a substantially fluid-tight seal around an element passed therethrough (Para 37) and sealing the opening when nothing is passed through the opening (Para 40). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Fischell ‘489 to include opening covers that each include a slit over the openings, as taught by McFerran, for the purpose of providing a substantially fluid-tight seal around the needle guiding elements passed therethrough (Para 37) and sealing the openings when nothing is passed through the openings (Para 40). McFerran does not explicitly disclose that the opening cover is “within” the opening.
Fischell ‘522, however, teaches providing an opening cover 17 (Fig 2,3) over an opening 16+18 (Fig 3) of a catheter body 14 (Fig 2,3) such that the opening cover is within the opening (as seen in Fig 3, the opening cover 17 is within the outer half 16 of opening 16+18) for the purpose of precluding the formation of blood clots on the outer surface of the catheter (Col 2, Lines 20-24). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Fischell ‘489 to include McFerran’s opening covers so that they are within the openings, as taught by Fischell ‘522, for the purpose of precluding the formation of blood clots on the outer surface of the catheter (Col 2, Lines 20-24).
Regarding Claim 3, Fischell ‘489 as modified by McFerran in the rejection of claim 1 above discloses all the claimed features with McFerran teaching that the at least one slit comprises a proximal slit (as seen in Fig 6, the slit 58 extends in the longitudinal direction and therefore can be considered both a “proximal slit” and a “distal slit”; it Is noted that the claim does not state what the slit is “proximal” relative to). The motivation cited in claim 1 also applies to this claim.
Regarding Claim 4, Fischell ‘489 as modified by McFerran in the rejection of claim 1 above discloses all the claimed features with McFerran teaching that the at least one slit comprises a longitudinal slit (as seen in Fig 6). The motivation cited in claim 1 also applies to this claim.
Regarding Claims 5 and 6, Fischell ‘489 as modified by McFerran in the rejection of claim 1 above incorporates McFerran’s opening covers 50 being placed over Fischell ‘489’s openings 131 (which are comparable to McFerran’s openings 44); therefore, Fischell ‘489 as modified by McFerran results in the distal portion of the catheter body comprising two layers including an inner layer (104 of Fischell ‘489, 28 of McFerran) that includes the openings 131 and an outer layer (50 of McFerran) which forms the opening covers (as seen in Fig 6-8 of McFerran).
Regarding Claim 7, Fischell ‘489 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 ‘489 discloses wherein the middle tube (103) is adapted to move longitudinally with respect to the outer tube (102) (parag. [0220]).
Regarding Claim 9, Fischell ‘489 discloses wherein the inner tube (105) is adapted to move longitudinally with respect to the middle tube (103) (parag. [0220]).
Regarding Claim 10, Fischell ‘489 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 ‘489 discloses 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 ‘489 as modified by McFerran in the rejection of claim 1 above discloses all the claimed features with McFerran teaching that the slits in the opening covers increase the reliability for extension and retraction of the at least two needle guiding elements (since at least some degree of circumferential support (whether it be small or large) is inherently provided to the guiding element 66 by the cover 50 due to the frictional contact between the guiding element and the cover since it is disclosed in Para 37 that a fluid-tight seal is formed between the outer surface of the guiding element 66 and the cover 50 when the guiding element is extending therethrough).
Regarding Claim 13, Fischell ‘489 as modified by McFerran in the rejection of claim 1 above discloses all the claimed features with McFerran teaching that the slits in the opening covers guide the at least two needle guiding elements through the opening covers (since at least some degree of circumferential support (whether it be small or large) is inherently provided to the guiding element 66 by the cover 50 due to the frictional contact between the guiding element and the cover since it is disclosed in Para 37 that a fluid-tight seal is formed between the outer surface of the guiding element 66 and the cover 50 when the guiding element is extending therethrough).
Regarding Claim 14, Fischell ‘489 discloses that the slits in the opening covers protect the at least two needle guiding elements from surface damage as the at least two needle guiding elements are advanced and retracted from the catheter body (parag. [0189] – “a slit that could be opened to make the outer surface of the PTAC smooth for better delivery into the renal artery”).
Regarding Claim 15, Fischell ‘489 discloses a distal tapered section (106), wherein the distal portion of the catheter body is coupled to the distal tapered section (Fig.2). Fischell ‘489 does not appear to explicitly 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 ‘489 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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Fischell (US 2016/0058489)/McFerran (US 2005/0065498)/Fischell (US Pat 6,783,522) in view of Blanchard et al. (PG PUB 2007/0161940).
Re Claim 2, Fischell ‘489 as modified by McFerran and Fischell ‘522 in the rejection of claim 1 above discloses all the claimed features except that the opening cover comprises a hole in addition to the slit. Blanchard, however, teaches a catheter having an opening cover 155 (Fig 8-10) that includes a hole (defined by the interior of dome structure 165 which has reinforced area 220 formed thereon, as seen in Fig 9) in addition to a slit 160 (Fig 8-10) for the purpose of assisting in returning the slit to its closed, neutral position when not acted upon (Para 52). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify McFerran’s opening cover to include a hole in addition to its slit, as taught by Blanchard, for the purpose of assisting in returning the slit to its closed, neutral position when not acted upon (Para 52).
Claims 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell (US 2016/0058489) in view of McFerran (US 2005/0065498) and Blanchard et al. (PG PUB 2007/0161940).
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; 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 discloses that each opening can be covered by a movable flap or that a slit could be present that could be opened (Para 189), but does not explicitly disclose that each opening comprises an opening cover bound to the periphery of the opening and comprising a hole and a proximal slit.
McFerran, however, teaches providing a catheter body 12 (Fig 1) with an opening 44 (Fig 5-8) and an opening cover 50 (Fig 6-8) bound to the periphery of the opening (Para 36, wherein the cover is bound to the periphery of the opening via extrusion, heat-shrinking, adhesive, or thermal bonding) and including a slit 58 (Fig 6-8) for the purpose of providing a substantially fluid-tight seal around an element passed therethrough (Para 37) and sealing the opening when nothing is passed through the opening (Para 40). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Fischell to include opening covers that each include a slit over the openings, as taught by McFerran, for the purpose of providing a substantially fluid-tight seal around the needle guiding elements passed therethrough (Para 37) and sealing the openings when nothing is passed through the openings (Para 40). McFerran does not explicitly disclose that the opening cover also comprises a hole in addition to the proximal slit.
Blanchard, however, teaches a catheter having an opening cover 155 (Fig 8-10) that includes a hole (defined by the interior of dome structure 165 which has reinforced area 220 formed thereon, as seen in Fig 9) in addition to a slit 160 (Fig 8-10) for the purpose of assisting in returning the slit to its closed, neutral position when not acted upon (Para 52). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify McFerran’s opening cover to include a hole in addition to its proximal slit, as taught by Blanchard, for the purpose of assisting in returning the slit to its closed, neutral position when not acted upon (Para 52).
Regarding Claim 17, Fischell discloses 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 Claims 18 and 19, Fischell as modified by McFerran in the rejection of claim 16 above incorporates McFerran’s opening covers 50 being placed over Fischell’s openings 131 (which are comparable to McFerran’s openings 44); therefore, Fischell as modified by McFerran results in the distal portion of the catheter body comprising two layers including an inner layer (104 of Fischell, 28 of McFerran) that includes the openings 131 and an outer layer (50 of McFerran) which forms the opening covers (as seen in Fig 6-8 of McFerran).
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); 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 discloses that each opening can be covered by a movable flap or that a slit could be present that could be opened (Para 189), but does not explicitly disclose that each opening comprises an opening cover comprising a hole and a longitudinal slit, wherein each opening cover provides circumferential support around the circumference of the corresponding needle guiding element.
McFerran, however, teaches providing a catheter body 12 (Fig 1) with an opening 44 (Fig 5-8) and an opening cover 50 (Fig 6-8) including a longitudinal slit 58 (Fig 6-8) that provides circumferential support around the circumference of an element extending therethrough (since at least some degree of circumferential support (whether it be small or large) is inherently provided to the guiding element 66 by the cover 50 due to the frictional contact between the guiding element and the cover (“advanced through the slit”, Para 45)) for the purpose of sealing the opening when nothing is passed through the opening (Para 40). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Fischell to include opening covers that each include a slit over the openings, as taught by McFerran, for the purpose of providing a substantially fluid-tight seal around the needle guiding elements passed therethrough (Para 37) and sealing the openings when nothing is passed through the openings (Para 40). McFerran does not explicitly disclose that the opening cover also comprises a hole in addition to the slit.
Blanchard, however, teaches a catheter having an opening cover 155 (Fig 8-10) that includes a hole (defined by the interior of dome structure 165 which has reinforced area 220 formed thereon, as seen in Fig 9) in addition to a slit 160 (Fig 8-10) for the purpose of assisting in returning the slit to its closed, neutral position when not acted upon (Para 52). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify McFerran’s opening cover to include a hole in addition to its proximal slit, as taught by Blanchard, for the purpose of assisting in returning the slit to its closed, neutral position when not acted upon (Para 52).
Regarding Claim 21, Fischell and McFerran as modified by Blanchard in the rejection of claim 20 above discloses all the claimed features with Blanchard teaching that the longitudinal slit is proximal to the hole (as seen in Fig 9, the slit 160 is near (i.e. proximal to) the hole). The motivation cited in the rejection of claim 20 also applies to this claim.
Regarding Claim 22, Fischell as modified by McFerran in the rejection of claim 20 above discloses all the claimed features with McFerran teaching that the opening cover protects the three needle guiding elements (as the covers seal the openings that the guiding elements are in, Para 40). The motivation cited in the rejection of claim 20 also applies to this claim.
Regarding Claim 23, Fischell discloses wherein the distal portion (106) of the catheter body is coupled to a distal tapered section (Fig.2). Fischell does not appear to explicitly disclose a distal portion of the catheter body is coupled to a distal tapered section over a length of at least 5 mm. 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 5 mm, 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).
Response to Arguments
Applicant's arguments filed 6/29/2026 have been fully considered. Applicant’s arguments amount to the assertion that the newly claimed subject matter is not disclosed in the prior art of record that was utilized in the rejections in the last Office Action (Fischell and McFerran) without specifically pointing out how the language of the claims patentably distinguishes them from the references. The Examiner agrees with this assertion regarding the subject matter of independent claim 1, but does not agree with this assertion regarding the subject matter of independent claim 16 because McFerran’s cover 50 is “bound to” the periphery of the opening 44 (as seen in Fig 6-8 and described in Para 36 which recites that the cover is “extruded over” the opening, “heat-shrunk” over the opening, or uses “adhesive or thermal bonding” to attach over the opening) and regarding the subject matter of independent claim 20 because at least some degree of “circumferential support” (whether it be small or large) is inherently provided to the guiding element 66 by the cover 50 due to the frictional contact between the guiding element and the cover since it is disclosed in Para 37 that a fluid-tight seal is formed between the outer surface of the guiding element 66 and the cover 50 when the guiding element is extending therethrough). Additionally, it is noted that the newly cited Fischell ‘522 reference teaches the opening cover being “within the opening” as required by claim 1.
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 KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571)272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 Since two Fischell references are cited in the rejections of claims 1-15, PG PUB 2016/0058489 will be referred to as “Fischell ‘489” in the rejections and US Pat 6,783,522 will be referred to as “Fischell ‘522” in the rejections.
Prosecution Insights