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(s) 1 is/are objected to because of the following informalities:
Claim 1, line 6, “the tip of the catheter”. It should be amended as “the terminating soft tip of the guiding catheter”.
Appropriate correction is required.
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(s) 1-4 is/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 1 recites the limitation "the distal end" in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner notes: claim 1 previously recites “a distal straight or curved portion”, not “a distal end”.
Claim 1 recites the limitation "said guiding catheter" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitations "the catheter" in line 4 and “the catheter” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, the phrase "in accordance with standard types of guiding catheters" renders the claim indefinite because it is unclear which types of guiding catheters are standard types of guiding catheters.
Regarding claim 1, the phrase "the flexible body of the catheter has a lumen" renders the claim indefinite because it is unclear whether “a lumen” is the same as or different from “an internal channel”. For the purpose of compact prosecution, they are interpreted to be the same.
Claims 2-4 are rejected by virtue of depending on claim 1.
Claim 2 recites the limitation "the outer diameter" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the inner diameter" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 3, the phrase "the flexible catheter body" renders the claim indefinite because it is unclear whether this limitation is the same as or different from “the flexible body of the catheter” limitation. For the purpose of compact prosecution, they are interpreted to be the same.
Regarding claim 3, the phrase "from 1.83 to 1.9 inclusive" renders the claim indefinite because it is unclear which unit of measurement for 1.83 to 1.9, whether it is 1.83 to 1.9 mm or a different unit.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101)
Claim 1, line 3 recites “for entering the aorta with a terminating soft tip of the distal end of said guiding catheter”, which positively recites “the aorta” of the human body.
Claims 2-4 are rejected by virtue of depending on claim 1.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Murphy (US 2017/0281913).
Regarding claim 1, Murphy discloses
A multi-purpose catheter extender (104, figs. 1-12 and pars. 0029-0109) made in the form of an elongated flexible body (602, figs. 1-6. Examiner notes: see figs. 1-5 for 602 being moved within vessel 150. See par. 0037 for 602 being formed of a polymer and having a thin wall with a thickness of 0.01 inch to 0.1 inch. Therefore, 602 is an elongated flexible body) with an internal channel (lumen of 104 as disclosed in par. 0036) and having a proximal straight portion (proximal portion of 104 including the proximal collar 105, see fig. 6) and a distal straight or curved portion (distal portion of 104 including the distal end 107, see fig. 6. Examiner notes: since claim 1 uses the language “or”, only one limitation of the two limitations in the “or” statement is positively required for claim 1. See fig. 6 for the distal portion of 104 being straight, and see figs. 1-5 for the distal portion of 104 being curved to follow the first branch 152 and the second branch 154 of the blood vessel 150) for entering the aorta (Examiner notes: the limitation “for entering the aorta” is interpreted as functional limitation. See figs. 1-5 for 104 entering vessel 150 and par. 0028 for the system is used as a delivery system passing through a blood vessel of a patient. Therefore, it is capable of entering the aorta) with a terminating soft tip (608, fig. 6. Examiner notes: see par. 0036 for 608 being formed of a material such as a polymer, with a relatively soft durometer rating compared to a different durometer rating of a material of the shaft) at the distal end (107) of said guiding catheter (104), the curvature of the distal portion of the catheter being in accordance with standard types of guiding catheters (Examiner notes: see figs. 1-5 for 104 being curved to follow the first branch 152 and the second branch 154 of the blood vessel 150), characterised in that the flexible body (602) of the catheter (104) has a lumen (lumen of 104 as disclosed in par. 0036) for a torquer-guided guidewire (Examiner notes: the limitation “for a torquer-guided guidewire” is interpreted as functional limitation, and the limitation “a torquer-guided guidewire” is not positively recited in claim 1. See figs. 1-5 for the lumen of 104 is used for balloon catheter 106; therefore, it is capable of being used for a torquer-guided guidewire) and the tip (608) of the catheter (104) is provided with a sheath (102, see fig. 1), with a hydrophilic lubricant between the sheath and the tip of the catheter for unimpeded movement of the sheath (Examiner notes: see par. 0047 for hydrophilic polymeric coatings on the inner and outer diameter of 104 to induce lubricity).
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.
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murphy (US 2017/0281913).
Regarding claim 2, Murphy discloses the catheter extender of claim 1, as set forth above, except for the outer diameter of the flexible body of the catheter is between 1.98 and 2 mm inclusive.
Murphy discloses the catheter being used in a blood vessel of a patient (par. 0028), but is silent about the size of the catheter. There is no evidence of record that establishes that changing the outer diameter of the flexible body of the catheter would result in a difference in function of the system. Further, a person having ordinary skill in the art, being faced with modifying the outer diameter of Murphy catheter would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed diameter. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the outer diameter of the flexible body of the catheter between 1.98 and 2 mm inclusive as an obvious matter of design choice within the skill of the art.
Regarding claim 3, Murphy discloses the catheter extender of claim 1, as set forth above, except for the inner diameter of the flexible catheter body is from 1.83 and 1.9 inclusive.
Murphy discloses the catheter being used in a blood vessel of a patient (par. 0028), but is silent about the size of the catheter. There is no evidence of record that establishes that changing the inner diameter of the flexible body of the catheter would result in a difference in function of the system. Further, a person having ordinary skill in the art, being faced with modifying the outer diameter of Murphy catheter would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed diameter. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the inner diameter of the flexible catheter body from 1.83 and 1.9 inclusive as an obvious matter of design choice within the skill of the art.
Regarding claim 4, Murphy discloses the catheter extender of claim 1, as set forth above, except for the sheath being made of silicone or polytetrafluoroethylene with a length of 15 to 30 mm.
However, Murphy teaches the device includes low-friction surfaces (par. 0048) such that the device is made from low friction material (e.g. PTFE).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the sheath of Murphy to be made of PTFE material, as taught by Murphy, for the purpose of providing a low-friction surface for the sheath to be used within a blood vessel of a patient (par. 0048 of Murphy).
Murphy discloses the sheath being used in a blood vessel of a patient (par. 0028) and the sheath is used to introduce the catheter into the blood vessel and then the sheath is removed from the patient, but is silent about the length of the sheath. There is no evidence of record that establishes that changing the length of the sheath would result in a difference in function of the system. Further, a person having ordinary skill in the art, being faced with modifying the length of Murphy sheath would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed length. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the length of the sheath between 15 and 30 mm as an obvious matter of design choice within the skill of the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
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/DUNG T ULSH/Primary Examiner, Art Unit 3783