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 .
Priority
The application is a National Stage entry under 35 USC 371 of PCT/CN2023/072522 (17 January 2023), which claims benefit to CN 202210163396.6 (filed 22 February 2022).
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, Applicant is advised that no certified translation has been filed of record, in the event that a certified translation may be needed in order to perfect priority against possible intervening prior art.
Formal Matters
Claims 1-27 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4 July 2025 has been considered by the examiner. A signed copy is attached.
Drawings - Objection
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters “14a” and “14b” have been used to designate three figures. Similarly, FIGs “15a” and “15b” have been used to designate three figures. Because each of these figures appears to show a catheter engaged in a different function, it is suggested that the individual figures be individually labeled (e.g. FIGs 14a, 14b, 14c, and FIGs 15a, 15b, and 15c). Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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 2, 3, 7-10, 12, 14, 15, 18-27 are objected to because of the following informalities: the claims are dependent claims and as such the first English language article in the claim should be the word “The”, rather than the English language article “A”, which denotes a broader group than the more limited dependency established by the word “The”. Dependent claims should refer back to the claim on which they are dependent. Compare claims 4-6, 11, 16, and 17, where the claims correctly begin with the English language article “The”. Appropriate correction is required.
In the interests of compact prosecution, the examiner is interpreting claims 2-27 as dependent claims whose dependencies are drawn to the claims indicated in the preamble of the claims, as in “The medical catheter according to claim …”.
Claim 3 is objected to because of the following informalities: claim 3 recites: “the sensor array can guide the through hole of the coaxial rotating device with the through hole to align…”. This phrase is awkward. There are two recitations of “the through hole” that make the claim. For the purpose of compact prosecution, the claim will be interpreted to read “the sensor array can guide the through hole of the coaxial rotating device using
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 2 is 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 2, line 2 recites the phrase “that is”, which renders the claim unclear and confusing. It is unclear whether Applicant is requiring that the sensor array can independently send and receive signals or whether signal properties and emission time can be independently controlled or all of the aforementioned.
Applicant is referred to Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (2008). A five member expanded panel of the Board held that "if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 USC 112, second paragraph, as indefinite."
Claim 13 is 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 13 recites the limitation "the fixing device" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 refers to a “fixation device.” Compare claim 12, which “the fixation device”.
Claim 14 is 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 claim 14, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claims 1-8, 10-12, 14-16, 18-24, 26, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Makower, US 20030236542 (25 December 2003), as evidenced by Acker et al., US 5,558,091 (24 September 1996).
Regarding independent claim 1, Makower teaches a medical catheter (FIG 2, 11), including a proximal end (15) and a distal end (17), the distal end of embodiment includes:
a sensor array (FIG 4a, 121/121pp) for displaying the condition of an inner wall within a lumen (imaging transducer 89, ¶53);
a coaxial rotating device (FIG 4b, rotatable imaging transducer 81r, ¶40)
which can rotate independently relative to other parts of the catheter (¶40),
has a through hole (port 29), connected to the outside of the catheter (11), and
is used to establish a channel between a target branch bifurcation lumen and the lumen of the catheter (FIGs 5C, 7B);
a fixation device (marker structure 101) used to fix the relative position of the distal end of the catheter and the inner wall within the lumen to ensure a stable process of establishing a channel between the target branch bifurcation lumen and the lumen of the catheter (¶44);
and the sensor array (FIG 4a, 121/121pp) can guide a distal hole (distal laterally directed outlet port, ¶3), of the coaxial rotating device (81r) with the through hole (port 29) to align with the target branch bifurcation lumen (¶44).
Regarding claim 2, Makower teaches [the] a medical catheter as claimed in claim 1, as set forth above, wherein each individual sensor unit (121) in the sensor array (FIG 4a, 121/121pp) can independently send and receive signals, that is, signal properties and emission time can be independently controlled (¶38).
Regarding claim 3, Makower teaches [the] a medical catheter as claimed in claim 1, as set forth above, wherein the sensor array (FIG 4a, 121/121pp) can guide the through hole (port 29) of the coaxial rotating device with the through hole (port 29) to align with the target branch bifurcation lumen by entirely displaying an inner wall contour of the inner wall within the lumen (¶44).
As set forth above, claim 3 is interpreted to read “the sensor array can guide the through hole of the coaxial rotating device using
Regarding claim 4, Makower teaches the medical catheter according to claim 3, as set forth above, wherein the sensor array (FIG 4a, 121/121pp) can guide the distal hole (distal laterally directed outlet port, ¶3) of the coaxial rotating device (81r) with the through hole (port 29) to align with the target bifurcation lumen by partially displaying the inner wall contour (¶¶44, 48).
Regarding claim 5, Makower teaches the medical catheter according to claim 1, as set forth above, wherein a detection device of the sensor array (FIG 4a, 121/121pp) can be radially uniformly distributed at the distal end of the catheter (FIGs 4a, 5C, 7B; ¶38, operative to image 360 degrees).
Regarding claim 6, Makower teaches the medical catheter according to claim 1, as set forth above, the detection device of the sensor array (FIG 4a, 121/121pp) can be distributed in any fan-shaped area or radial arrangement around the catheter (FIG 4a).
Regarding claim 7, Makower teaches [the] a medical catheter according to claim 3, as set forth above, wherein the sensor array (FIG 4a, 121/121pp) is an ultrasonic transducer array (¶38), used to transmit and receive ultrasonic signals for detecting the inner wall contour of the lumen (¶38).
Regarding claim 8, Makower teaches [the] a medical catheter as claimed in claim 7, as set forth above, wherein an ultrasonic transducer array (81, ¶38) adjacent to a second ultrasonic transducer array (81r, ¶40) transmits and receives signals one after another, and additional ultrasonic transducer arrays on both sides (FIG 4a; ¶40), or opposite sides from the adjacent ultrasonic transducer arrays of the catheter (FIG 4a), transmit and receive signals at the same time to improve imaging efficiency (¶38, multiplex circuit 83).
Regarding claim 10, Makower teaches [the] a medical catheter as claimed in claim 1, as set forth above, wherein the sensor array (FIG 4a, 121/121pp) is an electromagnetic sensor (¶53) or a photoelectric sensor (¶53, incorporating by reference Acker et al., US Patent 5,558,091, col 9, line 58), used to directly feedback position information of the distal end of the rotatable device relative to the catheter body (¶38).
Regarding claim 11, Makower teaches [the] a medical catheter according to claim 1, as set forth above, wherein the sensor array (FIG 4a, 121/121pp) is an optical sensor (¶53, incorporating by reference Acker et al., US Patent 5,558,091, col 9, line 58).
Regarding claim 12, Makower teaches [the] a medical catheter as claimed in claim 1, as set forth above, wherein said fixation device is a balloon (FIG 7C, balloon 310, ¶67).
Regarding claim 14, Makower teaches [the] a medical catheter according to claim 1, as set forth above, wherein the fixation device can be a nickel-titanium stent or a multi-link mechanism (FIG 5F, stent 208, ¶¶62, 68) composed of hard materials (¶62, “stents lined with expanded PTFE grafts) with good biocompatibility (¶62, “stent 208 provides a scaffold which maintains the sub-intimal tract 205 in an open condition capable of carrying blood past the obstruction O”), including, for example, titanium alloy or stainless steel.
Regarding claim 15, Makower teaches [the] a medical catheter as claimed in claim 1, as set forth above, wherein the fixation device (balloon catheter 206, stent 208) has a driving end (handle 19) at the proximal end (15) of the catheter (11), and the fixation device (balloon catheter 206, stent 208) can be manually (¶48) or automatically driven to switch states (¶60, after catheter 11 has been placed in the correct rotational orientation, with the aid of the orientation element, the penetrator 85 is advanced into the artery lumen downstream of the occlusion as shown in FIG 5C) or deform to determine the distal end of the catheter and the lumen, and to stabilize the relative position of the catheter and lumen forming the channel (¶61, 62).
Regarding claim 16, Makower teaches [the] a medical catheter according to claim 1, as set forth above, wherein a rotation mode of the coaxial rotation device can be manual (rotatable imaging transducer 81r, ¶40; claim 1).
Regarding claim 18, Makower teaches [the] a medical catheter as claimed in claim 1, as set forth above, wherein the coaxial rotation device can rotate independently relative to other parts of the catheter, and its rotation angle can be controlled (rotatable imaging transducer 81r, ¶40; claim 1).
Regarding claim 19, Makower teaches [the] a medical catheter as claimed in claim 1, as set forth above, wherein said coaxial rotation device (rotatable imaging transducer 81r, ¶40), the catheter (11) and the proximal end (15) of the coaxial rotation device (81r, ¶40) are connected with a mechanical structure (FIGs 5C, 7C), and the proximal end (15) and distal end (17) of the coaxial rotation device (81r) are connected with a flexible shaft (11) that can rotate together or synchronously (11), such that the directional rotation of the coaxial rotating device and the distal hole (distal laterally directed outlet port, ¶3) on the coaxial rotating device (81r), can be rotated so that the through hole (port 29) is angularly aligned with the target branch bifurcation lumen to form the channel, and establishes a positional relationship connection between the through hole (port 29) and the target branch bifurcation lumen forming the channel (¶44).
Regarding claim 20, Makower teaches [the] a medical catheter according to claim 1, as set forth above, wherein the relative angular relationship between the coaxial rotation device (81r) and the catheter (11) can be provided by the proximal structure and/or the distal position sensor group (101) (¶48).
Regarding claim 21, Makower teaches [the] a medical catheter as claimed in claim 1, as set forth above, wherein the relative angular relationship between the coaxial rotating device (81r) and the catheter (11) can be transmitted via real time data to instruct an operator (¶38, multiplex circuit 83).
Regarding claim 22, Makower teaches [the] a medical catheter as claimed in claim 1, as set forth above, wherein the coaxial rotation device (81r) can guide a microcatheter or a guidewire (FIG 7B, 202) to pass through a proximal inlet (FIG 3a; inlet port 37) and out of the through hole (port 29) through the distal hole (distal laterally directed outlet port, ¶3) (FIG 7B).
Regarding claim 23, Makower teaches [the] a medical catheter as claimed in claim 1, as set forth above, wherein the distal end of the catheter (distal end 17; distal tip 55) includes a distal positioning device (101; ¶44).
Regarding claim 24, Makower teaches [the] a medical catheter as claimed in claim 23, as set forth above, wherein the distal positioning device (101; ¶44) of the catheter is a radiopaque material (33; ¶33).
Regarding claim 26, Makower teaches [the] a medical catheter as claimed in claim 23, as set forth above, wherein the distal positioning device (101; ¶44) at the distal end of the catheter is a set of orthogonally placed coils (FIG 3C, 103/103pp, ¶44).
Regarding claim 27, Makower teaches [the] a medical catheter as claimed in claim 23, as set forth above, wherein the distal positioning device (101; ¶44) of the catheter (11) is a series of electrodes capable of transmitting electrical signals (¶53, electro-anatomical mapping system).
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over of Makower, US 20030236542 (25 December 2003) in view of Lupotti, “Quantitative Blood Flow as assessed by Intravascular Ultrasound” Dissertation (11 September 2002), 200pp (https://repub.eur.nl/pub/31957/020911_Lupotti, Fermin Armando.pdf) (Last Accessed 1/8/2026).
Regarding claim 9, Makower teaches [the] a medical catheter as claimed in claim 7, as set forth above.
Makower does not specifically teach wherein the ultrasonic transducer array (121, ¶38) resolves lumen bifurcations with a diameter of approximately 0.3mm to meet the desired requirement.
However, Makower expressly discloses that the phased array transducer and accompanying circuitry and imaging console may be obtained from Jomed Inc., of Rancho Cordova, Calif (¶38).
Lupotti teaches the Jomed Inc, intravascular ultrasound catheter of Jomed Inc., at FIG 1.1. (p. 4). At p. 14, last paragraph, Lupotti discloses that “the majority of IVUS signals is [are] acquired in the near field of the ultrasound beam (0.1~4 mm).”
Lupotti teaches the standard IVUS resolution expected from the Jomed ultrasonic transducer array. Lupotti’s work was also accomplished using the same ultrasound transducer array equipment used in Makower. Accordingly, one of ordinary and routine skill in the art before the effective filing date of the invention, considering the IVUS resolution range would understand that a range of 0.1-4mm would be well within the capabilities of the ultrasonic transducer array taught by Makower without undue experimentation.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over of Makower, US 20030236542 (25 December 2003) in view of CN 1391489 A (15 January 2003) and English language translation as US 20040148006 (29 July 2004).
Regarding claim 13, Makower teaches [the] a medical catheter according to claim 1, as set forth above.
Makower does not teach wherein the fixing device is an elastic bracket, using the term “elastic bracket”.
Davidson (as CN 1391489 A) teaches “bracket position sensors and method of use thereof (Title), where a “bracket” is defined as a device which can be implanted in the vessel of the body in the lumen, so that the collapse of the vessel wall, separation, partial blockage, impairment, disease, or abnormal dilation or narrow part reinforcement” (Background of the Invention). However, English language version, Davidson ‘006 refers to these brackets as stents. To the extent that “elastic bracket” refers to stents, Makower expressly teaches where the fixation device is a stent (Abstract) and as stent 208 (¶62), including pressure-expandable (elastic) stents (¶62).
The instant disclosure does not define an “elastic bracket”, but FIGs 5, 9, 14B (both images), and 15b (both images) appear to show it as functionally reinforcing a lumen. Accordingly, the examiner broadly interprets the term “elastic bracket” as a stent.
However, the examiner also realizes that the term may be a matter of language translation, as evidenced by both of the Davidson publications.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over of Makower, US 20030236542 (25 December 2003) in view of Weitzner et al., US 20070239105 (11 October 2007).
Regarding claim 17, Makower teaches [the] a medical catheter according to claim 1, as set forth above.
Makower does not teach wherein a rotation mode of the coaxial rotation device (81r) can be driven by a computer-controlled motor.
Weitzner teaches a coaxial catheter system (FIG 3, 10/20/30; ¶42) comprising an electronic controller configured (72, ¶46) for directing the motor array (70, ¶46) to cause the first drive mechanism to axially rotate the outer medical implement to cause the second drive mechanism to axially rotate the inner medical implement relative to each other in response to at least one command (Abstract).
Makower and Weitzner both teach in the same field of coaxial medical catheters. Although Makower discloses the claimed base medical catheter, Makower does not teach that the coaxial rotation device can be driven by a computer-controlled motor. Weitzner specifically addresses coaxial catheters driven by computer-controlled motor arrays. Because Makower teaches manually driven catheters, a person of ordinary skill in the art seeking to automate catheter functions, including drive and actuation systems, would reasonably consult Weitzner’s computer-controlled coaxial catheter solution. Weitzner’s electronic controller system configured for directing the motor array can be reasonably incorporated at the proximal end of Makower’s architecture, automating the rotation mode of coaxial rotation device 81r, while the distal end of Makower’s coaxial catheter without redesigning Makower’s core distal architecture and functions. Because both references address the same engineering problem (coaxial medical catheters with improved control functions) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (automating a drive system of a coaxial catheter), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over of Makower, US 20030236542 (25 December 2003) in view of Mistry et al. US 20020198559 (26 December 2002).
Regarding claim 25, Makower teaches [the] a medical catheter as claimed in claim 23, as set forth above.
Makower does not teach wherein the distal (17) positioning device (101; ¶44) of the catheter (11) achieves the desired effect by spraying radiopaque material.
Mistry teaches balloon catheters comprising at least one radiopaque region (¶4) where radiopaque ink material will be sprayed onto the balloon to function as marker bands on the balloon itself rather than on the catheter inner shaft (¶11). Mistry teaches that this eliminates waste due to misaligned marker bands and reduces the device profile (¶11).
Although Makower discloses base catheter (11), balloon catheter 300, and balloon 310 as a distal positioning devices for luminal expansion (FIGs 7B, 7C), Makower does not teach spraying radiopaque material as a means of visualizing the distal balloon. Instead, Makower relies on the imageable marker structure fixedly attached to catheter 13 (¶44) and on the imaging elements 121 mounted on catheter 11 (¶48).
Mistry specifically addresses the benefits of added markings by the spraying of radiopaque material. Because Makower includes imageable marker structures 101 and discloses the importance of visualization and alignment (¶44), a person of ordinary skill in the art seeking to improve the visualization of the balloon expansion positioning and balloon (device) profile in the relevant lumen, would reasonably consult Mistry’s sprayed radiopaque material solution. Mistry’s sprayed radiopaque material can be incorporated alongside Makower’s balloon device for improving distal positioning of devices for luminal expansion using known assembly methods and without redesigning Makower’s core device. Because the references address the same engineering problem (improved medical device placement) a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Conclusion
No claim is allowed.
The prior art made of record and not presently relied upon is considered pertinent to applicant's disclosure:
Makower, US 5,830,222 (3 November 1998) teaches the same subject matter as Makower, US 20030236542 (25 December 2025), as set forth above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-9pm CST) and R-F (9am-3pm CST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771