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(a)
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.
Claim 10 and 11 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. Claim 10 and 11 recite radiopaque markers located on a distal tip. In claim 1 the distal tip is defined as a structure relating to the support catheter. A distal end is defined as a structure relating to the outer catheter. Thus the claim recitations of claim 10 and 11, by reciting the radiopaque markers on a distal tip, appear to be indicating that the radiopaque markers are located on the support catheter. However, the specification does not support this limitation. Rather the specification appears to indicate that the radiopaque markers are located on the outer catheter and NOT the support catheter. See [0017], [0018]. Therefore, there does not appear to be support for radiopaque markers on the distal tip of the support catheter as is currently claimed.
It appears that the claims should recite the radiopaque markers on a distal end rather than tip such that the markers are associated with the outer catheter as is supported by the specification. For purposes of examination the claims will be interpreted such that the markers are located on a distal end of the outer catheter. Applicant is asked to clean up the claim terms to keep consistency and clarity of the claims.
Claim Rejections - 35 USC § 112(b)
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 11, 16, 17 and all dependents thereof 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 11 recites the limitation "the aspiration catheter" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 3 introduces the outer catheter is an aspiration catheter. Therefore it is being interpreted that the aspiration catheter is the same as the outer catheter.
Claim 11 recites the limitation "the dot markers" in line 1. There is insufficient antecedent basis for this limitation in the claim. It appears the dependency of claim 11 may be incorrect and claim 11 should depend on claim 10 instead of claim 9 which would correct the lack of antecedent basis issue. Therefore, for purposes of examination, claim 11 is being interpreted to depend on claim 10.
Further, claim 11 recites the dot markers are formed around the circumference of the aspiration catheter adjacent the distal tip. However, the term “distal tip” is one that refers to a structure on the support catheter and not the aspiration catheter (outer catheter). Further, as described above in the 112(a) rejection, the radiopaque marker appears to be located on the outer catheter and not the support catheter. Thus claim 11 is unclear whether the marker is located on the outer catheter or support catheter. For purposes of examination, the marker is being interpreted to be on the outer catheter as is supported by the specification and that the claim should recite the marker being on the circumference of the ”OC distal end” which would keep the consistency of the claim terms. Distal end being part of the outer catheter and distal tip being part of the support catheter.
Claim 16 recites “an SC and OC” in method stop B. However, because of its dependency to claim 2, the SC and OC have already been introduced and thus it appears the claims should recite –the SC and OC--.
Claim 17 recites the limitation "the step of collecting and cleaning" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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, 3-4, 6-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goyal (US 2016/0022964 A1).
With regard to claim 1, Goyal discloses A catheter system to aid in navigating a catheter through a vessel having a narrow section or tortuous section of a patient’s vasculature ([0002] “narrowing vessel”, this is functional language and the catheter system would be capable of being used in a narrow section of the vasculature), comprising: an outer catheter (OC) (18, Fig. 3) having an OC distal end (18a) having an OC distal end inner diameter (ID) (inherent) and inner perimeter (IP) (inherent); a support catheter (SC) (14/16) having an SC distal tip end (generally shown at 12e), an SC proximal end (at 16) and an SC expanded section (14b) adjacent the SC distal tip end (12e), the SC expanded section having a distal taper (14a), a proximal taper (14c) and an outer perimeter (OP)(inherent, diameter is shown by D in Fig 3), the OP substantially corresponding to the IP of the OC the expanded section for flattening the OC distal end during catheter placement ([0035], diameter C of the outer catheter is the same as the expanded section diameter D which pushes against the outer catheter thus considered to “flatten” the outer catheter and preventing the outer catheter from kinking or folding).
With regard to claim 3, Goyal discloses wherein the OC is an aspiration catheter (AC) ([0010], provides suction).
With regard to claim 4, Goyal discloses further comprising a microwire (12) configured for movement within the SC (as shown in Fig, 3).
With regard to claim 6, Goyal discloses wherein the distal taper (14a) is 4-12cm ([0037], 2-4cm).
With regard to claim 7, Goyal discloses wherein the proximal taper (14c) is 4-12cm ([0037], 2-4 cm).
With regard to claim 8, Goyal discloses wherein the expanded section (14) is 4-12cm ([0037], total length of 14 is 12-15cm).
With regard to claim 9, Goyal discloses where the expanded section (14b) has a longitudinal axis and a distal end (generally distal of 14a) of the expanded section can twist about the longitudinal axis relative to a proximal end (generally proximal to 14c) of the expanded section ([0021], [0039], the expanded section provides sufficient flexibility for bending and navigating the blood vessel. The claimed limitation recites “can twist” implying language similar to “configured to” which imparts a functional recitation. Therefore the structure must only be capable of performing the recited function. Because the expanded section is designed to be flexible enough for bending it would be capable of twisting about the longitudinal axis between a distal and proximal section).
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) 2, 5, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goyal (US 2016/0022964 A1) in view of Leschinsky et al. (US 6,179,825).
With regard to claim 2, Goyal discloses the claimed invention except for the expanded section having an oval cross-section.
Leschinsky teaches an apparatus for insertion of a catheter similar to the support catheter taught by Goyal. Leschinsky further teaches that this support catheter can be formed as a flexible tube that has an oval cross section and retains this oval shape to minimize obstruction to blood flow (Abstract). Thus the support catheter of Goyal can be shaped as an oval rather than circular in order to minimize blood flow when used. If the support catheter of Goyal is oval shaped it would necessarily push against the outer catheter also making the outer catheter into an oval shape for navigating the blood vessel.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the support catheter of Goyal with the oval shape as taught by Leschinsky for the purpose of minimizing obstruction to the blood flow when being used to insert a catheter (abstract).
With regard to claim 5, Goyal discloses the claimed invention except for the oval cross-section.
Leschinsky teaches the oval cross section support catheter (abstract).
While Leschinksy does not explicitly disclose the specific major to minor ratio, it would be prima facie obvious to optimize the ratio between the major and minor axis to be 1.5:1 because doing so would not alter the overall function of the device. Further claims have not provided significance to the claimed ratio.
With regard to claim 16, Goyal discloses a method of advancing a catheter system through vessels of a patient having a narrowed section ([0002]) with the catheter system of claim 2 (see rejection above) comprising the steps of:
Introducing the catheter system into the patient at an access point ([0015], [0022]);
Advancing an SC (16/14) and OC (18) from the access point towards the narrowed section ([0015], [0022])
Engaging the OC over the expanded section (as shown in Fig. 3, with 18 over 14) to distort the OC distal tip and pushing the supported OC distal tip past the narrowing ([0022], moving the catheter through regions of the patient’s vasculature having a high tortuosity).
However, Goyal does not disclose an oval shape.
Leschinsky teaches an apparatus for insertion of a catheter similar to the support catheter taught by Goyal. Leschinsky further teaches that this support catheter can be formed as a flexible tube that has an oval cross section and retains this oval shape to minimize obstruction to blood flow (Abstract). Thus the support catheter of Goyal can be shaped as an oval rather than circular in order to minimize blood flow when used. If the support catheter of Goyal is oval shaped it would necessarily push against the outer catheter also making the outer catheter into an oval shape for navigating the blood vessel.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the support catheter of Goyal with the oval shape as taught by Leschinsky for the purpose of minimizing obstruction to the blood flow when being used to insert a catheter (abstract).
Claim(s) 10, 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goyal (US 2016/0022964 A1) in view of Chou et al. (US 2019/0351182 A1).
With regard to claim 10, Goyal discloses the claimed invention except for one or more radio-opaque dot markers adjacent the distal tip.
Chou teaches an outer catheter (fig. 2a, element 200), a support catheter (300) disposed within the outer catheter for aiding in inserting the outer catheter into the vasculature specifically tortuous anatomy which is similar to the purpose of Goyal ([0074]). Chou further teaches the outer catheter (200) having a distal end (at 223) and including one or more radio-opaque dot markers adjacent the distal end (224a and 224b).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Goyal with the radio-opaque markers as taught by Chou for the purpose of aiding in navigation and proper positioning of the tip under fluoroscopy ([0134]).
With regard to claim 12, Goyal discloses A catheter system to aid in navigating a catheter through a vessel having a narrow section or tortuous section of a patient’s vasculature ([0002] “narrowing vessel”, this is functional language and the catheter system would be capable of being used in a narrow section of the vasculature), comprising: an outer catheter (OC) (18, Fig. 3) having an OC distal end (18a) having an OC distal end inner diameter (ID) (inherent) and inner perimeter (IP) (inherent); a support catheter (SC) (14/16) having an SC distal tip end (generally shown at 12e), an SC proximal end (at 16) and an SC expanded section (14b) adjacent the SC distal tip end (12e), the SC expanded section having a distal taper (14a), a proximal taper (14c) and an outer perimeter (OP)(inherent, diameter is shown by D in Fig 3), the OP substantially corresponding to the IP of the OC the expanded section for flattening the OC distal end during catheter placement ([0035], diameter C of the outer catheter is the same as the expanded section diameter D which pushes against the outer catheter thus considered to “flatten” the outer catheter and preventing the outer catheter from kinking or folding).
Goyal discloses the claimed invention except for one or more radio-opaque dot markers adjacent the distal tip.
Chou teaches an outer catheter (fig. 2a, element 200), a support catheter (300) disposed within the outer catheter for aiding in inserting the outer catheter into the vasculature specifically tortuous anatomy which is similar to the purpose of Goyal ([0074]). Chou further teaches the support catheter having a distal tip (346) and one or more radio-opaque dot markers (344a and 344b) adjacent the distal tip (see Fig. 2a).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Goyal with the radio-opaque markers as taught by Chou for the purpose of providing the user with information regarding an optimal extension of the distal tip relative to the other portions to minimize the lip at this distal end for advancement through tortuous anatomy ([0187]).
With regard to claim 13, Goyal discloses wherein the distal taper (14a) is 4-12cm ([0037], 2-4cm).
With regard to claim 14, Goyal discloses wherein the proximal taper (14c) is 4-12cm ([0037], 2-4 cm).
With regard to claim 15, Goyal discloses wherein the expanded section (14) is 4-12cm ([0037], total length of 14 is 12-15cm).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goyal (US 2016/0022964 A1) in view of Leschinsky et al. (US 6,179,825) and in further view of Goyal (US 2019/0070387 A1)(hereinafter referred to as Goyal II).
With regard to claim 17, Goya/Leschinsky teaches the claimed invention except for a step of collecting and cleaning recovered blood.
Goyal II teaches a very similar device to that of Goyal (see Fig. 3 of Goyal II) having the outer catheter (18) a support catheter (14) located within the outer catheter to be used to advance the system through a tortuous anatomy ([0072], see also method claim of claim 10), and further teaches the method step of collecting and cleaning recovered blood and reintroducing recovered and cleaned blood back to the patient ([0063] and claim 12, Goyal II).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Goyal/Leschinsky with the method step of collecting and cleaning recovered blood as taught by Goyal II because it is desirable since relatively larger volumes of blood are aspirated during the procedure ([0063]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goyal (US 2016/0022964 A1) in view of Chou et al. (US 2019/0351182 A1) and in further view of Fishcer et al. (WO 2013184782 A2).
With regard to claim 11, Goyal/Chou teach the use of radio-opaque markers but do not teach they form a non-continuous band around the circumference of the aspiration catheter adjacent the distal tip.
Fischer teaches the use of radio-opaque markers than may be formed as rings or as dots (p. 2, ln 3-19). The dot markers would thus form a non-continuous band around the circumference of the aspiration catheter.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Goyal/Chou with the radio-opaque dots as taught by Fischer because these are an obvious substation of a ring marker as is well-known in the art and does not alter the overall function of the device (p. 20, lines 3-19).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783