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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claim 13 recites “a proximal balloon system, comprising: a post-dilatory noncompliant balloon positioned along the elongated catheter shaft distal to the perfusion-style balloon” in lines 12-14. However, the specification states perfusion-style balloon 105 is distal to post-dilatory noncompliant balloon 405 ([0060]; Fig. 4) as the balloon catheter 400 comprises “the perfusion-style balloon (distal balloon) 105 and the post-dilatory noncompliant balloon (a proximal balloon) 405” ([0062]). While paragraph [0062] further states that the distal balloon may comprise a post-dilatory noncompliant balloon and the proximal balloon may comprise a perfusion-style balloon, the distal balloon 105 is still distal to the proximal balloon 405. Therefore, the specification fails to provide proper antecedent basis for the proximal balloon system being positioned distal to the distal balloon system along the elongated catheter shaft as claimed.
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 5 and 13-20 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.
Regarding claims 5 and 13, the phrase "perfusion-style balloon" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "perfusion-style"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(b). The addition of the word “perfusion-style” to otherwise definite expression “balloon” extends the scope of the expression so as to render it indefinite in a manner similar to that of the addition of the word “type”. It is unclear what “perfusion-style” is intended to convey or cover beyond the term “balloon”, as understood by one skilled in the art. In other words, it is unclear how similar to or different from a balloon or how closely resembling a balloon the “perfusion-style” balloon may be while still remaining within the metes and bounds of the claim (e.g., have channels built in or a central lumen, etc.). The recitation is not rendered clear in light of the specification because the specification repeats the term “perfusion-style balloon” without providing any explanation which would limit the bounds of the term “perfusion-style”. The specification does reference that the “perfusion-style balloon” is element 105, however, the drawings are schematic in style, are of insufficient quality to clearly and definitively define the exact structure of what constitutes “perfusion-style”, and cannot be reasonably or sufficiently relied upon to define the full intended scope which the broadening relative modifier “style” conveys or encompasses beyond the term “balloon”. It is also noted that the term “perfusion-style balloon” does not appear to be a structural term of art which implicitly or inherently indicates a specific and particular structure in the art.
Claim 13 recites “a distal balloon system, comprising: a perfusion-style balloon” in lines 9-10 and “a proximal balloon system, comprising: a post-dilatory noncompliant balloon positioned along the elongated catheter shaft distal to the perfusion-style balloon” in lines 12-14. However, a distal balloon system would by general definition be distal to a proximal balloon system and the specification states perfusion-style balloon 105 is distal to post-dilatory noncompliant balloon 405 ([0060]; Fig. 4) as the balloon catheter 400 comprises “the perfusion-style balloon (distal balloon) 105 and the post-dilatory noncompliant balloon (a proximal balloon) 405” ([0062]). While paragraph [0062] further states that the distal balloon may comprise a post-dilatory noncompliant balloon and the proximal balloon may comprise a perfusion-style balloon, the distal balloon system is still distal to the proximal balloon system. Therefore, it is unclear if applicant has intended to claim the proximal balloon system i.e., the post-dilatory noncompliant balloon being distal to the distal balloon system i.e., the perfusion-style balloon or that the distal balloon system comprises the post-dilatory noncompliant balloon and the proximal balloon system comprises the perfusion-style balloon, or that the post-dilatory noncompliant balloon of the proximal balloon system is positioned proximal to the perfusion-style balloon of the distal balloon system. Based on paragraph [0062] and Fig. 4, the limitation has been interpreted to read “a proximal balloon system, comprising: a post-dilatory noncompliant balloon positioned along the elongated catheter shaft proximal to the perfusion-style balloon” for the purposes of examination. Appropriate clarification is required.
Claims 14-20 are rejected based on their dependency to rejected claim 13.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 17 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 17 fails to further limit the subject matter of claim 13, from which it depends as claim 13 recites “a perfusion-style balloon positioned along the elongated catheter shaft and tapered toward the distal end of the elongated catheter shaft” in lines 9-10. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-8, 11 and 13-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sardesai et al. (US 2021/0046291 A1).
Regarding claim 1, Sardesai discloses a perfusion dilatation catheter (catheter 100; Fig. 1), comprising: an elongated catheter shaft (shaft 101), comprising a proximal end and a distal end (Fig. 1), configured to: enclose a plurality of lumens (including at least first lumen 104, second lumen 105, and third lumen 106; Fig. 1; [0053]), comprising: a proximal balloon inflation lumen (third lumen 106); and a distal balloon inflation lumen (first lumen 104); and house at least one inflation port (ports through connectors 111) configured to supply at least one inflation medium through the proximal balloon inflation lumen and the distal balloon inflation lumen ([0055]); a proximal balloon system, comprising: a proximal balloon (anchoring balloon 109) positioned along the elongated catheter shaft (Fig. 1); and the proximal balloon inflation lumen (106; as 106 communicates with anchoring balloon 109; [0053]); and a distal balloon system, comprising: a distal balloon (orienting balloon 107) positioned along the elongated catheter shaft (Fig. 1), distal to the proximal balloon (Fig. 1); and the distal balloon inflation lumen (104; as 104 communicates with orienting balloon 107; [0053]).
Regarding claim 2, Sardesai discloses wherein the proximal balloon (109) and the distal balloon (107): are affixed to an outer surface of the elongated catheter shaft (Fig. 1); and are separated by a set distance (Fig. 1).
Regarding claim 3, Sardesai discloses wherein the set distance is approximately 10- 15 mm (as the gap between the distal end of the anchoring balloon and the proximal end of the orienting balloon may be in the range of about 10 mm; [0065]).
Regarding claim 4, Sardesai discloses wherein: the at least one inflation port (111) comprises a first inflation port (111 at the proximal end of 106; Fig. 1) and a second inflation port (111 at the proximal end of 104; Fig. 1), the first inflation port (111 at end of 106) is configured to supply the at least one inflation medium through the proximal balloon inflation lumen (106) to the proximal balloon (109; as 106 communicates with anchoring balloon 109; [0053]), and the second inflation port (111 at end of 104) is configured to supply the at least one inflation medium through the distal balloon lumen to the distal balloon (107; as 104 communicates with orienting balloon 107; [0053]).
Regarding claim 5, Sardesai discloses wherein the distal balloon (107) comprises a perfusion-style balloon (interpreted as a balloon and orienting balloon is compliant; [0065]).
Regarding claim 6, Sardesai discloses wherein the distal balloon (107) is tapered toward the distal end of the elongated catheter shaft (Fig. 1).
Regarding claim 7, Sardesai discloses wherein the distal balloon (107) has an inflated diameter of approximately 15-20 mm (as the orienting balloon expands to diameters in the range of 12-18 mm upon inflation; [0013]).
Regarding claim 8, Sardesai discloses wherein the proximal balloon (109) comprises a post-dilatory noncompliant balloon (as the anchoring balloon is non-compliant; [0065]).
Regarding claim 11, Sardesai discloses wherein the plurality of lumens comprises a lumen (second lumen 105) configured to receive a curved-tipped guidewire (as the transporter catheter is configured to track over a guidewire that may have a variety of shapes in lumen 105; [0053]; [0066]).
Regarding claims 13 and 17, Sardesai discloses a perfusion dilatation catheter (catheter 100), comprising: an elongated catheter shaft (shaft 101), comprising a proximal end and a distal end (Fig. 1), configured to: enclose a plurality of lumens (first lumen 104, second lumen 105, and third lumen 106), comprising: a proximal balloon inflation lumen (106); and a distal balloon inflation lumen (104); and house at least one inflation port (ports through connectors 111) configured to supply at least one inflation medium through the proximal balloon inflation lumen and the distal balloon inflation lumen ([0053]; [0055]); a distal balloon system, comprising: a perfusion-style balloon (compliant orienting balloon 107; [0066]) positioned along the elongated catheter shaft (Fig. 1) and tapered toward the distal end of the elongated catheter shaft (Fig. 1); and the distal balloon inflation lumen (104); and a proximal balloon system, comprising: a post-dilatory noncompliant balloon (noncompliant anchoring balloon 109; [0066]) positioned along the elongated catheter shaft (Fig. 1), proximal to the perfusion-style balloon (Fig. 1); and the proximal balloon inflation lumen (106).
Regarding claim 14, Sardesai discloses wherein the perfusion-style balloon (107) and the post-dilatory noncompliant balloon (109): are affixed to an outer surface of the elongated catheter shaft (Fig. 1); and are separated by a set distance (Fig. 1).
Regarding claim 15, Sardesai discloses wherein the set distance is approximately 10- 15 mm (as the gap between the distal end of the anchoring balloon and the proximal end of the orienting balloon may be in the range of about 10 mm; [0065]).
Regarding claim 16, Sardesai discloses wherein: the at least one inflation port (111) comprises a first inflation port (111 at the proximal end of 106; Fig. 1) and a second inflation port (111 at the proximal end of 104; Fig. 1), the first inflation port (111 at end of 106) is configured to supply the at least one inflation medium through the proximal balloon inflation lumen (106) to the post-dilatory noncompliant balloon (109; as 106 communicates with anchoring balloon 109; [0053]), and the second inflation port (111 at end of 104) is configured to supply the at least one inflation medium through the distal balloon lumen to the perfusion-style balloon (107; as 104 communicates with orienting balloon 107; [0053]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 9-10 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sardesai et al. (US 2021/0046291 A1).
Regarding claim 9, Sardesai fails to explicitly disclose wherein the proximal balloon has an inflated diameter of approximately 15-20 mm.
However, Sardesai teaches that the distal balloon has an inflated diameter of approximately 15-20 mm (as the orienting balloon expands to diameters in the range of 12-18 mm upon inflation; [0013]) and both the distal (107) and proximal (109) balloons appear to have the same outer inflated diameter in 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 modify proximal balloon to have an inflated diameter of approximately 15-20 mm in light of the teachings of Sardesai in order to effectively anchor the proximal balloon within vasculature.
Regarding claim 10, Sardesai discloses wherein: the distal balloon (107) comprises a proximal end and a distal end (Fig. 1), and the distal end of the distal balloon is approximately 3 mm from the distal end of the elongated catheter shaft ([0074]) but fails to explicitly disclose the distal end of the distal balloon is approximately 8-10 mm from the distal end of the elongated catheter shaft.
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 distal balloon of Sardesai to be approximately 8-10 mm from the distal end of the elongated catheter shaft since it has been held that “where the only difference between the prior art and the claims was a 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 perfusion dilation catheter of Sardesai would not operate differently with the claimed distance of the distal balloon from the distal end of the elongated catheter shaft and since the distal balloon would still inflate at the modified distance, the catheter would function appropriately having the claimed distance. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the distance “may” be within the claimed ranges (specification pp. [0016]).
Regarding claim 18, Sardesai discloses the perfusion-style balloon has an inflated diameter of approximately 15-20 mm (as the orienting balloon expands to diameters in the range of 12-18 mm upon inflation; [0013]), but fails to explicitly disclose wherein the post-dilatory noncompliant balloon has an inflated diameter of approximately 15-20 mm.
However, Sardesai teaches that the perfusion-style balloon has an inflated diameter of approximately 15-20 mm (as the orienting balloon expands to diameters in the range of 12-18 mm upon inflation; [0013]) and both the perfusion-style (107) and post-dilatory noncompliant (109) balloons appear to have the same outer inflated diameter in 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 modify post-dilatory noncompliant balloon to have an inflated diameter of approximately 15-20 mm in light of the teachings of Sardesai in order to effectively anchor the post-dilatory noncompliant balloon within vasculature.
Regarding claim 19, Sardesai discloses wherein: the perfusion-style balloon (107) comprises a proximal end and a distal end (Fig. 1), and the distal end of the perfusion-style balloon is approximately 3 mm from the distal end of the elongated catheter shaft ([0074]) but fails to explicitly disclose the distal end of the perfusion-style balloon is approximately 8-10 mm from the distal end of the elongated catheter shaft.
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 perfusion-style balloon of Sardesai to be approximately 8-10 mm from the distal end of the elongated catheter shaft since it has been held that “where the only difference between the prior art and the claims was a 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 perfusion dilation catheter of Sardesai would not operate differently with the claimed distance of the perfusion-style balloon from the distal end of the elongated catheter shaft and since the perfusion-style balloon would still inflate at the modified distance, the catheter would function appropriately having the claimed distance. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the distance “may” be within the claimed ranges (specification pp. [0016]).
Claim(s) 12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sardesai et al. (US 2021/0046291 A1) in view of Perkins (US 2020/0276038 A1).
Regarding claims 12 and 20, Sardesai discloses wherein the plurality of lumens comprises a wire lumen (guidewire lumen 105) configured to receive a wire (guidewire) through the elongated catheter shaft to the distal end of the elongated catheter shaft ([0053]), but fails to disclose a plurality of wire lumens.
However, Perkins teaches a balloon catheter (100; Fig. 1) with a plurality of lumens (154, 150, 158, 160, 164; Fig. 4A) having a plurality of ports (115; Fig. 1), with first (150) and second (154) lumens inflating first and second distal balloons ([0046]), a guidewire lumen (164; [0037]) and additional wire lumens (158, 160) configured to receive wires (light fibers; [0047]).
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 plurality of lumens of Sardesai to comprise a plurality of wire lumens as taught by Perkins in order to allow for light fibers to be extended through the elongated catheter shaft to better illuminate the treatment site.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Teeslink et al. (US 2010/0280451 A1) is noted for teaching a perfusion occlusion catheter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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/SARAH A LONG/Primary Examiner, Art Unit 3771