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
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.
Claims 1-3 and 5-7 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.
With regards to claim 1, in lines 4-5, the limitation “the intravascular tomographic imaging system is configured to assess intravascular imaging and vascular calcification”, interpreted under 35 USC 112(f), fails to comply with the written description requirement as the limitations are unbounded functional limitations which cover all ways of performing the respective functions and inventor has not provided sufficient disclosure to show possession of such an invention. Paragraph [0058] of Applicant’s filed specification does set forth that “The intravascular tomographic imaging system may be, for example, an F series product from NANJING FORRSMANN MEDICAL TECHNOLOGY CO., LTD., for example, an intravascular tomographic imaging system (F-2), having an intravascular imaging function and a vascular calcification assessing function”. However, this does not provide sufficient detail as to the corresponding structure for the claimed “intravascular tomographic imaging system”. The specification further fails to provide, in sufficient detail, steps/algorithm setting forth how the intravascular imaging and vascular calcification assessment is performed. See MPEP 2161.01, Section I.. The limitations therefore fail to comply with the written description requirement.
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 1-3 and 5-7 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.
With regards to claim 1, claim limitation “intravascular tomographic imaging system is configured to assess intravascular imaging and vascular calcification” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Paragraph [0058] of Applicant’s filed specification does set forth that “The intravascular tomographic imaging system may be, for example, an F series product from NANJING FORRSMANN MEDICAL TECHNOLOGY CO., LTD., for example, an intravascular tomographic imaging system (F-2), having an intravascular imaging function and a vascular calcification assessing function”. However, this does not provide sufficient detail as to the corresponding structure for the claimed “intravascular tomographic imaging system. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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) 1-3, 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN 114983521) in view of Bacich (US Pub No. 2015/0142045), Chen et al. (CN 114903559) and Sliwa et al. (US Pub No. 2012/0265062). Note that English translations of Wang et al. and Chen et al. are referred to in the below rejection.
With regards to claim 1, Wang et al. disclose a multi-channel pulsed high-voltage parameter-controllable shock wave lithotripsy balloon imaging system, comprising
a high-voltage connector (110, 110a) (pg. 10, 2nd-5th paragraphs, referring to the connecting wire (110) and connector (110a), referring the connecting line (110) connecting the shock wave lithotripsy catheter to the host (100) and pulse current module which generates high voltage pulses, wherein the distal end of the connecting wire (110) has a connector (110a); Figure 1),
an intravascular tomographic imaging system (“ultrasonic imaging module” and/or host (100)) (pg. 3, 7th paragraph, referring to the ultrasonic imaging module; pg. 10, 2nd-3rd paragraphs, referring to the host (100) comprising the ultrasonic imaging module connected with the ultrasonic imaging member (50) and ultrasonic imaging member (50) receiving the ultrasonic echo signal which is transmitted back to the host (100) through the connecting line (110); Figure 1),
a multi-channel pulsed high-voltage parameter-adjustable module (i.e. “pulse current module”) (pg. 10, 2nd-3rd paragraphs, referring to the pulse current module which is connected with the electrode group (30) and generates a high voltage pulse; pg. 10, 5th paragraph, referring to the display module (100a) being a touch screen for realizing user interaction, wherein buttons can be used for selecting and setting the treatment parameter, such as treatment process, pulse width, frequency, etc., and therefore the pulsed high-voltage can be adjusted; Figure 1) and
a balloon imaging catheter (20, 43b; Figure 2) (pg. 4, 3rd to last paragraph-last paragraph, referring to the first balloon 20, pg. 9, 3rd full paragraph, referring to the second balloon (43b) matched with the ultrasonic imaging member (50); Figures 1-2, 5),
wherein
the multi-channel pulsed high-voltage parameter-adjustable module comprises a high-voltage adjustable module, a pulse-width adjustable module, a repetition-frequency adjustable module and a pulse-burst-count adjustable module (pg. 10, 2nd-3rd paragraphs, referring to the pulse current module which is connected with the electrode group (30) and generates a high voltage pulse; pg. 10, 5th paragraph, referring to the display module (100a) being a touch screen for realizing user interaction, wherein buttons can be used for selecting and setting the treatment parameter, such as treatment process, pulse width, frequency, etc., and therefore the pulsed high-voltage can be adjusted [note that adjusting pulse width and frequency would result in adjustment of pulse-burst count]; Figure 1),
the balloon imaging catheter is connected to the multi-channel pulsed high- voltage parameter-adjustable module via the high-voltage connector (pg. 10, 2nd-5th paragraphs, referring to the connecting wire (110) and connector (110a), referring the connecting line (110) connecting the shock wave lithotripsy catheter to the host (100) and pulse current module which generates high voltage pulses, wherein the distal end of the connecting wire (110) has a connector (110a); pg. 4, 3rd to last paragraph-last paragraph, referring to the balloon (20); Figures 1-2, wherein the balloon imaging catheter (20) is connected to the multi-channel pulsed high-voltage parameter-adjustable module (100, 100a) via the high-voltage connector (110, 110a)),
the injection port (11) is configured to inject a shock wave transmission medium (“physiological saline”) into an operation balloon (20/20a), wherein the transmission medium comprises: saline (pg. 5, 2nd-4th paragraphs, referring to using the injection port (11) to provide the containing cavity (20a) with physiological saline, ensuring the balloon (20) to expand; Figures 1-2, 5);
the balloon imaging catheter (Figures 1-3, 5) comprises:
an imaging catheter body (i.e. 40, 90) (pg. 8, referring to the shock wave lithotripsy catheter comprising a mounting structure (40) and a guide assembly (90), together forming an imaging catheter “body”; Figures 1-3, 5),
the operation balloon (20, 43b) (pg. 4, 3rd to last paragraph-last paragraph, referring to the first balloon (20); pg. 9, 3rd full paragraph, referring to the second balloon (43b); Figures 1-3, 5),
multiple sets of electrode pairs (30, 33) (pg. 7, 3rd to last paragraph-pg. 8, first paragraph, referring to the first electrode (31) which comprises conductive first electrode sleeve 30a and second electrode sleeve 30c, wherein the two electrode sleeves form an “electrode pair”; Figures 2, 4-5),
the multiple sets of electrode pairs comprises at least a first operation electrode pair (i.e. first electrode (30) comprising of first electrode sleeve (30a) and second electrode sleeve (30c)) (pg. 7, 3rd to last paragraph-pg. 8, first paragraph, referring to the first electrode (31) which comprises conductive first electrode sleeve 30a and second electrode sleeve 30c, wherein the two electrode sleeves form an “electrode pair”; Figures 2, 4-5) and a second operation electrode pair (i.e. second electrode (33) comprising of first electrode sleeve (30a) and second electrode sleeve (30c)) (pg. 7, 3rd to last paragraph-pg. 8, first paragraph, referring to the first electrode (31) which comprises conductive first electrode sleeve 30a and second electrode sleeve 30c, wherein the two electrode sleeves form an “electrode pair”; Figures 2, 4-5) and
a sheath (10) (pg. 4, 3rd to last paragraph, referring to the sheath tube (10); Figures 1-2, 5),
wherein the imaging catheter body comprises an imaging window (40, 43, and/or, the body of balloon (20)) (pg. 5, first paragraph, referring to the mounting structure (40) forming at least a portion of the outer wall of the mounting cavity (40a) made of acoustic material so that the ultrasonic imaging member (50) emits or receives the ultrasonic wave smoothly through the mounting structure (40), thus serving as an “imaging window; pg. 8, 2nd to last paragraph, referring to the second mounting portion (43) comprises a second mounting tube (43a) matched with the ultrasonic imaging member (50); Figures 2, 4-5, note that the ultrasonic wave would necessarily pass through an area of the first balloon (20), and thus the first balloon (20) may also serve as an “imaging window”);
the operation balloon (20a, 43b) comprises an operation area (40a or area within balloon (20) in which ultrasonic imaging member (50) resides), the operation balloon is provided in the imaging window, and the operation balloon is provided with a first operation balloon pin and a second operation balloon pin (pg. 9, 3rd full paragraph-last full paragraph, referring to the second balloon (43b), wherein a mounting cavity (40a) is formed in the second balloon (43b), so the second balloon (43b) is made of acoustic material; pg. 4, 3rd to last paragraph, referring to the first balloon (20) being connected to the distal end of the sheath tube (10) by crimping, gluing, hot forming method, thus providing a sealing connection, wherein the sealing connection at both sides of the balloon (20) encompasses the first and second operation balloon “pins” as they pin/connect the balloon to the sheath tube; Figures 2, 4-5),
wherein the first operation balloon pin and the imaging window form an enclosed space (pg. 4, 3rd to last paragraph, referring to the first balloon (20) being connected to the distal end of the sheath tube (10) by crimping, gluing, hot forming method, thus providing a sealing connection, wherein the sealing connection at both sides of the balloon (20) encompasses the first and second operation balloon pins as they pin/connect the balloon to the sheath tube; Figures 2, 4-5), and
the second operation balloon pin and a circumferential wall of the sheath (10) form an enclosed space (pg. 4, 3rd to last paragraph, referring to the first balloon (20) being connected to the distal end of the sheath tube (10) by crimping, gluing, hot forming method, thus providing a sealing connection, wherein the sealing connection at both sides of the balloon (20) encompasses the first and second operation balloon pins as they pin/connect the balloon to the sheath tube; Figures 2, 4-5, note that the crimping/gluing connection of the sheath (10) to the balloon (20) forms an enclosed space (i.e. interior of balloon (20));
the first operation electrode pair (31) and the second operation electrode pair (33) are provided in the operation area (i.e. interior enclosed area) of the operation balloon (20) and on an outer wall of the imaging window (43) (pg. 7, 3rd to last full paragraph-last full paragraph, referring to the first electrode (31) and the second electrode (33) being opposite to the ultrasonic imaging member (50) two sides; Figures 2, 4-5, wherein the electrode pairs (31, 33) are provided in the operation area/interior of the balloon (20) and are also on the outer wall of the imaging window (43));
the first operation electrode pair (31) comprises: a first operation electrode (30a), a second operation electrode (30c) and a first insulating layer (30b) (pg. 7, 3rd to last paragraph-pg. 8, first paragraph, referring to the first electrode (31) which comprises conductive first electrode sleeve 30a and second electrode sleeve 30c, wherein the two electrode sleeves form an “electrode pair”, and further comprises an insulating sleeve (30b); Figures 2, 4-5);
the second operation electrode pair (33) comprises: a third operation electrode
(30a), a fourth operation electrode (30c) and a second insulating layer (30b) (pg. 7, 3rd to last paragraph-pg. 8, first paragraph, referring to the first electrode (31) which comprises conductive first electrode sleeve 30a and second electrode sleeve 30c, wherein the two electrode sleeves form an “electrode pair”, and further comprises an insulating sleeve (30b); Figures 2, 4-5),
wherein the first operation electrode (31) is provided on the imaging window (43)
(see Figures 2 and 5),
the first insulating layer (30b) is provided on the first operation electrode (30a of
the first electrode) (pg. 7, 3rd to last paragraph-pg. 8, first paragraph, see Figure 4, wherein the insulating layer (30b) is on the electrode sleeve (30a)),
the second operation electrode (30c) is provided on the first insulating layer (30b)
(pg. 7, 3rd to last paragraph-pg. 8, first paragraph, see Figure 4, wherein the electrode sleeve (30c) is on the insulating layer (30b)),
the first insulating layer (30b) is provided with a first energy release window (30e)
(pg. 7, 3rd to last paragraph-pg. 8, first paragraph, referring to the insulting sleeve (30b) being provided with a conductive hole (30e), see Figure 4), and
the second operation electrode (30c of the first electrode (31)) is provided with
second energy release window (30d) (pg. 7, 3rd to last paragraph-pg. 8, first paragraph, referring to the second pole sleeve (30c) being provided with a discharge hole (30d); see Figure 4),
wherein the second energy release window (30d) is larger than the first
energy release window (30e) (pg. 7, 3rd to last paragraph-pg. 8, first paragraph, referring to the aperture size of the discharge hole (30d) being larger than the aperture size of the conductive hole (30e); Figure 4), and
the first energy release window (30e of electrode (31)) and the second energy
release window (30d of electrode (31)) are coaxial and co-directional (see Figure 4);
the second insulating layer ((30b) of the second electrode (33)) is provided with a third energy release window (30e) ((pg. 7, 3rd to last paragraph-pg. 8, first paragraph, referring to the insulting sleeve (30b) being provided with a conductive hole (30e), see Figure 4), and
the fourth operation electrode (30c of the second electrode (33)) is provided with a fourth energy release window (30d) (pg. 7, 3rd to last paragraph-pg. 8, first paragraph, referring to the second pole sleeve (30c) being provided with a discharge hole (30d); see Figure 4),
wherein the fourth energy release window is larger than the third energy
release window (pg. 7, 3rd to last paragraph-pg. 8, first paragraph, referring to the aperture size of the discharge hole (30d) being larger than the aperture size of the conductive hole (30e); Figure 4), and
the third energy release window (30e of electrode (33)) and the fourth energy release window (30d of electrode (33)) are coaxial and co-directional (see Figure 4),
wherein the balloon imaging catheter comprises a traction wire, wherein the traction wire is connected to the imaging elements (pg. 5, 3rd to last paragraph, referring to the ultrasonic imaging member (50) may also be an optical coherence tomography imaging member; pg. 7, 3rd-4th paragraphs, referring to the wire electrically connected to the imaging elements (50, 70); Figures 2-3, 5).
However, Wang et al. do not specifically disclose that the system further comprises a flange connector and that the injection portion comprises a Luer taper, wherein the intravascular tomographic imaging system is configured to assess intravascular imaging and vascular calcification and the balloon imaging catheter is connected to the intravascular tomographic imaging system via the flange connector.
Additionally, Wang et al. do not specifically disclose that the transmission medium in the operation balloon comprises a contrast agent.
Furthermore, though Wang et al. do disclose that the intravascular tomography imaging system comprises an optical coherence tomography (OCT) imaging system (pg. 5, 3rd to last paragraph, referring to the ultrasonic imaging member (50) may also be an optical coherence tomography imaging member), Wang et al. do not specifically disclose that the imaging elements of the balloon imaging catheter comprises an optical lens, an optical fiber and an optical lens base, wherein the optical lens is connected to the optical fiber.
Bacich discloses a balloon system for accessing body lumens and cavities,
wherein a syringe filled with inflation media, such as saline, air, gas or combinations thereof, can be in fluid communication with a balloon (Abstract; paragraphs [0119], [0122], paragraph [0122], referring to the syringe 74, which, as depicted in Figure 4, comprises of the conical design syringe fitting at the distal end, which is known as the luer taper (i.e. also known as “luer slip”)). Further a coupling connector (204) can have one or more flanges configured to releasably attach to the distal terminal end of the outer catheter (4) (paragraph [0217]-[0218], [0221]; Figure 12).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to substitute the connector between the balloon imaging catheter and the intravascular tomographic imaging system of Wang et al. with a flange connector, as taught by Bacich, as the substitution of one known connector for another yields predictable results (i.e. providing a connection between the two elements) to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
Additionally, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to substitute the injection portion of Wang et al. with a Luer taper, as taught by Bacich, as the substitution of one known injection portion for another yields predictable results (i.e. providing an inflation medium) to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
However, the above combined references do not specifically disclose that the intravascular tomographic imaging system is configured to assess intravascular imaging and vascular calcification and that the transmission medium in the operation balloon comprises a contrast agent.
Further, the above combined references do not specifically disclose that the imaging elements of the balloon imaging catheter comprises an optical lens, an optical fiber and an optical lens base, wherein the optical lens is connected to the optical fiber.
Chen et al. discloses an integrated optical coherence tomography of shock wave balloon catheter and system, integrating the OCT detection and shock wave treatment, wherein the system can perform OCT detection and shock wave treatment in one operation (Abstract; pg. 2, 2nd – 4th paragraphs). Their system comprises an OCT image collecting and processing module which processes the image transmitted by the imaging component and visually outputs (pg. 3, last paragraph-pg. 4, 2nd paragraph). The system is further used to check whether the vascular calcification is broken using the feedback information of the imaging component, thereby shortening the treatment time and reducing the harm of the operation to the patient (pg. 2, 2nd full paragraph; pg. 2, last paragraph; pg. 6, 2nd to last full paragraph). The system further comprises a balloon (1), wherein the balloon is filled with conductive liquid comprising a mixed solution of physiological saline and contrast agent (pg. 5, 4th paragraph).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to substitute the transmission medium of the above combined references with a transmission medium comprising of saline and a contrast agent, as taught by Chen et al., as the substitution of one known transmission medium for another yields predictable results (i.e. effective conductive/transmission aid) to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substation and the results are reasonably predictable.
Additionally, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the intravascular tomographic imaging system of the above combined references be configured to assess intravascular imaging and vascular calcification, as taught by Chen et al., in order to shorten the treatment time and reduce the harm of the operation to the patient (pg. 2, 2nd full paragraph; pg. 2, last paragraph; pg. 6, 2nd to last full paragraph).
However, the above combined references do not specifically disclose that the imaging elements of the balloon imaging catheter comprises an optical lens, an optical fiber and an optical lens base, wherein the optical lens is connected to the optical fiber.
Sliwa et al. disclose an optical coherence tomography (OCT) catheter for performing high performance elastographic deformation mapping of tissues and plaques, wherein the OCT catheter can comprise a closed balloon (90) disposed around the distal portion of the catheter and being filled with a liquid transparent to OCT wavelengths (Abstract; paragraphs [0007], [0036]; Figures 1-3). The distal portion (24) of the catheter (20) comprises an OCT imaging sensor (34), wherein the OCT imaging sensor includes a movable reflector/mirror (70) to receive light, typically via an optical fiber (72), from a light source, an optical lens (76) to focus the OCT beam (60) at a distance (paragraphs [0024], [0027]; Figures 1-3, in particular see Figures 1 and 2a which depict the optical lens base).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the imaging elements of the above combined references comprise an optical lens, an optical fiber and an optical lens base, wherein the optical lens is connected to the optical fiber, as taught by Sliwa et al., in order to perform high performance elastographic deformation mapping of tissues and plaques and further to focus the OCT beam at a distance, thereby accurately imaging a desired target (Abstract; paragraphs [0024], [0027]).
With regards to claim 2, Wang et al. disclose that the balloon imaging catheter comprises: a first lead wire and a second lead wire, wherein the first lead wire is connector to the first operation electrode and the third operation electrode, and the second lead wire is connected to the second operation electrode and the fourth operation electrode (pg. 10, 2nd full paragraph-4th paragraph, referring to the shock wave lithotripsy catheter connecting wire (110) which can comprise a plurality of wires; pg. 7, 2nd to last paragraph, referring to the first pole sleeve (30a) and the second pole sleeve (30c) of each of the first electrode (31) and the second electrode (33) being respectively connected to the positive/negative electrode of the high voltage pulse power supply, the connection using a “lead”/wire (i.e. first lead wire, second lead wire) passing through the mounting structure (40) or the liquid channel (13); Figures 1-2, 4-5).
With regards to claim 3, Wang et al. disclose that the balloon imaging catheter comprises: an electrical connector, and the first lead wire and the second lead wire extend along a direction from the operation balloon to the electrical connector and are connected to the electrical connector (pg. 10, 2nd paragraph, 4th paragraph, referring to the shock wave lithotripsy catheter connecting wire (110) having a distal end connecting with a connector (110), wherein the connector (110a) contains a control chip (i.e. and thus corresponds to an “electrical connector”); Figures 1-5).
With regards to claim 5, Wang et al. disclose that a front end (41) of the imaging catheter body is provided with a first rapid exchange port, and a front end (43) of the imaging window is provided with a second rapid exchange port (pg. 2, 3rd to last paragraph, referring to the liquid guide hole being set on the first mounting part (41) located in the sheath tube (i.e. front end of catheter body) and the liquid guide hole (40b) further being set in the second mounting part (43) located in the containing cavity, the ultrasonic imaging piece being set in the second mounting part (i.e. imaging window); pg. 5, 2nd to last paragraph; pg. 5, last two paragraphs, referring to the first mounting part (41) and the second mounting part (43); Figures 1-5).
With regards to claim 7, Wang et al. disclose the first operation electrode, the second operation electrode, the third operation electrode, and the fourth operation electrode are made of tungsten, platinum-iridium alloy or stainless steel alloy, the first operation electrode and the third operation electrode are in an annular shape, a disk shape or a square sheet shape, and the second operation electrode and the fourth operation electrode are in an annular shape, a semi-annular shape or an annular shape provided with a wire slot (pg. 7, last two lines, referring to the first pole sleeve (30a) and the second pole sleeve (30b) [of the first electrode 31 and of the second electrode 33] being made of conductive material, “such as steel”; See Figures 1-2 and 4-5, wherein the electrodes (31, 33, or 30) are annular in shape).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. in view of Bacich and Chen et al. and Sliwa et al., as applied to claim 5 above, and further in view of Bonnette et al. (US Patent No. 6,875,193).
With regards to claim 6, as discussed above, the above combined references meet the limitations of claim 5. Wang et al. further disclose that the balloon imaging catheter comprises: a second developing ring (80a) and a third developing ring (80b), wherein the second developing ring (80a) and the third developing ring (80b) are provided at two ends inside the operation balloon (20, 20a), respectively, the second developing ring (80a) is provided adjacent to the first operation electrode pair (31), and the third developing ring (80b) is provided adjacent to the second operation electrode pair (32/33) (pg. 8, 3rd paragraph, referring to the first locating piece (80a) and the second locating piece (80b) being set on two sides of the ultrasonic imaging piece (50), wherein the locating pieces (80a, 80b) form rings, as depicted in Figure 2).
However, the above combined references do not specifically disclose that the catheter further comprises a first developing ring, wherein the first developing ring is provided adjacent to the second rapid exchange port.
Bonnette et al. disclose a rapid exchange fluid jet thrombectomy device for removal of unwanted tissue comprising of a catheter which includes an exhaust tube support ring (60) provided adjacent a plurality of outflow orifices (74a-74n) (Abstract; column 13, lines 32-63; Figures 1-3). The exhaust tube support ring (58) provides support and/or reinforcement along the distal exhaust tube (32) in the regions of the inflow and outflow orifices (76a-76n) and (74a-74n), respectively, and further maintain the diameter of the tube (32), thus providing torsional support (column 13, lines 49-63; Figure 3).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the catheter of the above combined references further comprises a first developing ring, wherein the first developing ring is provided adjacent to the second rapid exchange port, as taught by Bonnette et al., in order to provide support and reinforcement for the catheter, thus providing torsional support (column 13, lines 49-63).
Response to Arguments
Applicant's arguments filed April 22, 2026 have been fully considered but they are not persuasive.
With regards to the rejections under 35 USC 112(a) and 35 USC 112(b) with respect to the limitation “intravascular tomographic imaging system is configured to assess intravascular imaging and vascular classification”, Applicant submits that a person skilled in the art could clearly understand the structure function and connection relationship of the intravascular tomographic imaging system as outlined in paragraphs [0042] and [0056] of the US published application. Applicant asserts that the cited paragraphs show that the specification discloses specific components of the intravascular tomographic imaging system (e.g., the connection between the shock wave lithotripsy balloon imaging catheter and the intravascular tomographic imaging system) and therefore the scope of protection is definite and complies with the provisions of 35 USC 112(f).
Examiner respectfully disagrees and first notes that paragraph [0042] refers to the balloon imaging catheter being connected to the intravascular tomographic imaging system through the flange connector, but a connection of the intravascular tomographic imaging system does not connote the structure of the intravascular tomographic imaging system. Paragraph [0056] does disclose that the “multi-channel pulsed high-voltage parameter-adjustable module is a high-voltage generator module built in the intravascular tomographic imaging system”, and therefore it is clear that the intravascular tomographic imaging system includes the multi-channel pulsed high-voltage parameter-adjustable “module”, but it is not clear that the “module” performs the function of assessing “intravascular imaging and vascular classification” and further, even if it were clear that such a “module” perform the above function, the term “module” itself does not connote structure and therefore paragraph [0056] is insufficient for understanding the structure of the “intravascular tomographic imaging system”.
The 35 USC 112(a) and 35 USC 112(b) rejections of the above limitation are therefore maintained.
In pgs. 8-10, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. The arguments appear to state the limitations the individual references do not teach, but the arguments do not specifically point out how the individual references, alone or in combination with the other cited references, do not meet the limitations. For example, with regards to Wang, in pgs. 8-9 of the filed arguments, Applicant notes that Wang does not disclose “a multi-channel pulsed high-voltage parameter-controllable shock wave lithotripsy balloon imaging system, comprising a high-voltage connector, a flange connector...”, etc., but the above rejection does address how Wang does not meet these limitations and/or how the combined references fail to teach the limitations. Applicant states in pg. 9 that cited portions of the Wang reference are “fundamentally different from the tomographic (optical ) imaging system of the present application, which operates with different core components, operating conditions, and an optical fiber interface through a “flange connector” “, but, as set forth in the above rejection, Wang does disclose that the intravascular tomography imaging system comprises an optical coherence tomography (OCT) imaging system (pg. 5, 3rd to last paragraph, referring to the ultrasonic imaging member (50) may also be an optical coherence tomography imaging member) and further the limitations directed to the “flange connector”, etc. are rejected under the combination of references which Applicant does not appear to address. With regards to Bacich, Applicant describes the everting balloon system and states that “Bachich does not disclose or suggest the above recited limitations in amended claim 1”. However, the above rejection sets forth how Bachich does teach the flange connector and Luer taper and Applicant does not appear to specifically address how the cited portions of Bachich do not teach these limitations. With regards to Chen, Applicant states that Chen fails to remedy the deficiencies of Wang and Bacich, but does not appear to specifically address how the cited portions of Chen do not teach the saline limitation or assessing intravascular imaging and vascular calcification limitations. With regards to Sliwa, Applicant asserts that Sliwa does mention optical components but does not disclose the “above-recited limitations in claim 1”. However, Applicant does not specifically discuss how the cited portions of Sliwa do not teach the optical lens, the optical fiber etc. as set forth in the above rejection of claim 1. Examiner respectfully refers Applicant to the above rejection as a response as to how the above combination of references meet the limitations.
Applicant further argues that the cited art addresses different technical objectives, different application scenarios and different functional requirements and do not recognize or address the technical problem solved by the present application, which is namely, the “inability to perform real-time treatment on observed intravascular calcified lesions while conducting real-time, specific observation of the intravascular calcified lesions during interventional therapy for intravascular calcified lesions”.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “real-time treatment on observed intravascular calcified lesions…”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Further, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Examiner respectfully refers Applicant to the above rejection as to how the above combined references teach the recited limitations of the claims.
Further, Applicant argues that there are concrete technical incompatibilities between Wang and Sliwa, wherein the structural, operational, and environmental incompatibilities present clear technical barriers that would have discouraged a person of ordinary skill in the art from combining the references in the manner proposed by the Office Action.
However, as set forth in the above rejection, the rejection is not suggesting modifying Wang to adopt the catheter or balloon structure of Sliwa. Rather, the above rejection sets forth that the imaging elements of the above combined references be modified to comprise an optical lens, an optical fiber and an optical lens base, wherein the optical lens is connected to the optical fiber, as taught by Sliwa et al., in order to perform high performance elastographic deformation mapping of tissues and plaques and further to focus the OCT beam at a distance, thereby accurately imaging a desired target (Abstract; paragraphs [0024], [0027]). Examiner emphasizes that Wang does disclose that their intravascular tomography imaging system can comprise of an optical coherence tomography (OCT) imaging system (pg. 5, 3rd to last paragraph, referring to the ultrasonic imaging member (50) may also be an optical coherence tomography imaging member) but does not specifically set forth the particular imaging elements that would correspond to the OCT imaging system. Since both Wang and Sliwa are directed to OCT imaging systems, it would be reasonable to one of ordinary skill in the art to have the imaging elements of the OCT imaging system of Wang comprise of the optical imaging elements (i.e. optical lens, etc.) of the OCT imaging system of Sliwa.
The claims therefore remain rejected under the previously applied prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798
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