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 .
Status of Claims
This office action is responsive to the application filed 23 December 2025.
Claims 1-23 are presently pending in this application.
Drawings
The drawings are objected to for the following reasons:
The figures appear to be pixelated and blurry. All lines should be solid, dark, and continuous.
Multiple views in same figure without labeling (Fig. 4)
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
“Detail A”
“L1”
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 4-8, 10, and 11 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims the alternative only. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
Claims 1, 16, and 18 objected to because of the following informalities:
Claim 1 – “which is made of” (pg. 11, lines 11 and 21) is unclear as to what is being modified
Claim 1 – “made of” (pg. 11, line 33) is unclear as to what is being modified
Claim 1 – “push and pull” (pg. 12, ln 1) is unclear as to what is being push and pulled
Claim 16 – “on the connecting part of catheter” (pg. 14, line 7)
Claim 18 – “connecting part of catheter” (pg. 14, line 15)
Appropriate correction is required.
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.
Claims 13, 19, and 20 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 13 recites the limitation “one or more side branch(s)” (pg. 13, ln 29), referring to branches of the human heart.
Claim 19 recites the limitation “the coronary arteries” (pg. 14, ln 21).
Claim 20 recites the limitation “the coronary sinus” (pg. 14, ln 26).
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 1-23 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 following limitations, which there is insufficient antecedent basis for in the claim:
"The external surface" (pg. 1, ln 8).
"The self/mechanically expandable stent frame" (pg. 1, ln 7-8).
"The cross-section" (pg. 1, ln 10).
"The blood perfusion lumen" (pg. 1, ln 10).
"The distal vessel or tissues" (pg. 1, ln 11).
"the balloon catheter system" (pg. 1, ln 13).
"the balloon" (pg. 1, ln 17).
"the balloon catheter" (pg. 1, ln 18).
"the external surface of the inner lumen" (pg. 1, ln 21).
"the total system" (pg. 1, ln 23).
"the connection part" (pg. 1, ln 25-26).
"the system" (pg. 1, ln 26).
"the crimped form" (pg. 1, ln 32).
"the desired location" (pg. 1, ln 32).
"the catheter" (pg. 2, ln 3).
"the inflation and deflation of the balloon" (pg. 2, ln 3).
Claims 2, 4-9, 11, 13-16, and 19-21 recite the following limitations, which there is insufficient antecedent basis for in each claim:
Claim 2
"The self-expandable structure" (pg. 12, ln 12-13).
Claim 4
"The surface of the balloon" (pg. 12, ln 22).
Claim 5
"The balloon surface" (pg. 12, ln 27).
Claim 6
"the external surface" (pg. 12, ln 31).
"The internal surface" (pg. 12, ln 32).
Claim 7
"the guidewire lumen" (pg. 13, ln 2).
Claim 8
"the balloon lumen" (pg. 13, ln 6).
"the internal frame" (pg. 13, ln 7).
"the amount of perfusion" (pg. 13, ln 8-9).
Claim 9
"the resistance" (pg. 13, ln 11).
Claim 11
"the pressure" (pg. 13, ln 21).
Claim 13
"the invention" (pg. 13, ln 29).
Claim 14
“the device” (pg. 13, ln 32)
"the side branches" (pg. 13, ln 34).
Claim 15
"the side branch fenestration holes" (pg. 14, ln 1-2).
"the amount of perfusion" (pg. 14, ln 2-3).
Claim 16
"the diameter of the fenestration holes" (pg. 14, ln 6).
Claim 19
"the center of the device" (pg. 14, ln 20).
"the coronary arteries" (pg. 14, ln 21).
Claim 20
"the coronary sinus" (pg. 14, ln 26).
Claim 21
"the calibration" (pg. 14, ln 29).
"the cross-section of the funneled part" (pg. 14, ln 29-30).
"the funneled part" (pg. 14, ln 30).
"the pressure changes and gradient" (pg. 14, ln 21).
Regarding claims 12, 13, and 17, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Interpretation
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
For the purposes of examination, the invention is interpreted to generally describe a perfusion balloon catheter comprising:
an internal lumen attached to an external surface of a self/mechanically expandable stent frame;
a guidewire lumen;
a radiopaque marker band;
a kink-resistant inflation lumen;
a connecting strut of the self/mechanically expandable stent frame;
a balloon catheter main shaft;
one or more fenestration holes;
a connecting part between two or more balloons; and
an external sleeve.
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)(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.
Claims 1-22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Koo et al. (Foreign Patent Publication No. WO 2017192912 A1), hereinafter Koo.
Regarding claims 1, Koo teaches a perfusion balloon catheter (Fig. 1) comprising: an internal lumen (Fig. 2, internal lumen of balloons 102) attached to an external surface of a self/mechanically expandable stent frame (Fig. 2, catheter 101); a guidewire lumen (Fig. 9, guidewire 910 passes within the lumen of the catheter 101; para. 117); a radiopaque marker band (Fig. 19A-C, indication means 105 is a radio-opaque marker; para. 155); a kink-resistant inflation lumen (Fig. 17B-C, infusion tube 1707); a connecting strut (Fig. 23, wires 107) of the self/mechanically expandable stent frame (Fig. 2, catheter 101); a balloon catheter main shaft (Fig. 1, device 100); one or more fenestration holes (Fig. 23, at least one apertures 106); a connecting part (Fig. 23, membrane 1703) between two or more balloons (Fig. 23, first and second balloons 102 and 103); and an external sleeve (catheter may comprise an outer sheath; para. 117).
Regarding claim 2, Koo teaches the catheter above, wherein the self/mechanically expandable stent frame (Fig. 2, catheter 101) has an enlargement structure (inflation can occur via disturbing saline infusion pressure; para. 0020) to expand the internal lumen (Fig. 2, internal lumen of balloons 102).
Regarding claim 3, Koo teaches the catheter above, wherein the internal lumen (Fig. 2, internal lumen of balloons 102) is disposed over the balloon catheter main shaft (Fig. 2, balloon 102 is disposed over the device 100).
Regarding claim 4, Koo teaches the catheter above, wherein the catheter (Fig. 1) is coated (the first balloon may be coated with a contrast-media absorber; para. 0134).
Regarding claim 5, Koo teaches the catheter above, wherein a drug can be release from either of the catheter (device 100 can comprise an infusion tube comprising side apertures for infusion of medication; para. 0021 and 0100).
Regarding claim 6, Koo teaches the catheter above, wherein the catheter (Fig. 1) can release a drug from a surface of the device (device 100 can comprise an infusion tube comprising side apertures for infusion of medication; para. 0021 and 0100).
Regarding claim 7, Koo teaches the catheter above, wherein the guidewire lumen (Fig. 9, guidewire 910 passes within the lumen of the catheter 101; para. 117) can release a inject media (Fig. 10, a flow pump 1011 can generate flow towards a subject; para. 0118-0119).
Regarding claim 8-11, Koo teaches the catheter above, further comprising a balloon lumen (Fig. 2, internal lumen of balloon 103).
Regarding claim 12, Koo teaches the catheter above, wherein the connecting part (Fig. 23, membrane 1703) comprises the one or more fenestration holes (Fig. 23, at least one apertures 106).
Regarding claim 13, Koo teaches the catheter above, wherein the catheter (Fig. 1) can be used.
Regarding claim 14, Koo teaches the catheter above, wherein the catheter (Fig. 1) comprises a structure (Fig. 1).
Regarding claim 15 and 16, Koo teaches the catheter above, wherein the one or more fenestration holes (Fig. 23, at least one apertures 106) can comprise different diameters (aperture 106 openings can be controlled by wire 107; para. 0156).
Regarding claim 17, Koo teaches the catheter above, wherein the catheter (Fig. 1) can be used.
Regarding claim 18, Koo teaches the catheter above, wherein the connecting part (Fig. 23, membrane 1703) comprises anti-coagulation coating or surface treatment (anticoagulation medication may be on the surface of the membrane 1703; para. 0023).
Regarding claim 19 and 21, Koo teaches the catheter above, wherein the catheter (Fig. 1) comprises a funnel (Fig. 17A, device may be cone-shaped; para. 0140).
Regarding claim 20, Koo teaches the catheter above, wherein the catheter (Fig. 1) can be detached (balloons may be removed; para. 0116).
Regarding claim 22, Koo teaches the catheter above, wherein the self/mechanically expandable stent frame (Fig. 2, catheter 101) is comprised of nitinol (tubes may be comprised of nitinol; para. 0030).
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 23 is rejected under 35 U.S.C. 103 as being unpatentable over Koo in view of Salahieh et al. (Foreign Patent Publication No. 2018226991 A1), hereinafter Salahieh.
Regarding claim 23, Koo teaches the catheter above.
Koo does not expressly disclose that the internal lumen is comprised of nitinol.
Salahieh teaches an internal lumen (expandable member; para. 0100) comprised of nitinol (expandable member can be made of nitinol; para. 0100).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the internal lumen of Koo to comprise nitinol as taught by Salahieh in order to allow for deformability (Salahieh: para. 0100).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI GONZALEZ whose telephone number is (703)756-5908. The examiner can normally be reached 7:30am - 4:00pm (CT).
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/LEI GONZALEZ/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783