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
Claims 1-2 are objected to because of the following informalities:
In claim 1, in line 29, “third operation electrode” should be replaced with “second insulating layer”. Note that this appears to be a typo in the originally filed claim as paragraph [0054] of Applicant’s specification sets forth it is the “second insulating layer 60B” that is provided with the “third energy release window 08B” and this appears to be consistent with Applicant’s Figure 3.
In claim 2, in line 3, “connector” should be replaced with --- connected ---.
Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities:
Instances in the specification which sets forth that it is the “third operation electrode” which is provided with the “third energy release window” should be changed to set forth that it is the ---second insulating layer--- that is provided with the “third energy release window”. See, for example, line 5 of paragraph [0011] of Applicant’s filed specification which sets forth “the third electrode is provided with a third energy release window”, which should be changed to --- the second insulating layer is provided with a third energy release window ---. The specification should be reviewed for all similar instances. Note that this appears to be a typo in the specification as paragraph [0054] of Applicant’s specification appears to correctly set forth that it is the “second insulating layer 60B” that is provided with the “third energy release window 08B”, which further appears to be correct and consistent with Applicant’s Figure 3.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “intravascular imaging system is configured to assess intravascular imaging and vascular classification…” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
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”. For examination purposes, it is assumed that the “intravascular tomographic imaging system” corresponds to a computer/processor, along with image processing steps/algorithm for performing the assessment, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-7 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 1-7 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.
The term “slightly” in lines 28 and 31 of claim 1 is a relative term which renders the claim indefinite. The term “slightly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, with regards to the limitation “slightly larger”, it is unclear as to what degree/range the second/fourth energy release window has to be larger than the first/third energy release window in order to be considered to be “slightly” larger.
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) and Chen et al. (CN 114903559). 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),
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),
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 slightly 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 third operation electrode (30a 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), wherein the conductive hole (30e) is over the electrode (30a) and thus it could be said that the third operation electrode is “provided” with a third energy release window (30e) (alternatively, in view of the above objections to claim 1 and Applicant’s filed specification, the second insulating layer (30b) is provided with the third energy release window (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 slightly 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).
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.
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.
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).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. in view of Bacich and Chen et al. as applied to claim 1 above, and further in view of Sliwa et al. (US Pub No. 2012/0265062).
With regards to claim 4, as discussed above, the above combined references meet the limitations of claim 1. Further, Wang et al. disclose that the intravascular tomography imaging system comprises an optical coherence tomography (OCT) imaging system and that the balloon imaging catheter comprises a traction wire 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, the above combined references do not specifically disclose that the imaging elements 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]).
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., 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bagaoisan et al. (US Pub No. 2020/0206483) disclose a balloon catheter comprising a syringe for deflating/inflating the balloon (Abstract; paragraphs [0036]-[0037]).
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798