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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/31/2026 has been entered.
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, 5, 7-8 and 10 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. Claim 1 is rejected because the specification, as originally filed, fails to disclose collecting image data of the balloon catheter and tissue by an imaging device during insertion in combination with the steps of subtracting a baseline pressure response determined “without tissue” as now claimed. Applicant asserts support is found in Paragraphs [0057]-[0058], [0069]-[0070] and [0091]-[0095], however, the cited paragraphs disclose subtracting the baseline pressure response from pressure data when filling the balloon with fluid and not during “inserting”.
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, 5, 7-8, 10-16, 18-21, 29-30 and 32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 is rejected because the claim appears to be missing a step of removing the balloon catheter from the tissue in order to determine the baseline pressure response “without tissue”. In other words, it is unclear how the baseline pressure response is determined without tissue if the catheter is still inserted into a lumen of tissue. Claims 11 and 21 follow a similar fact pattern. Paragraph [0070] makes it clear that tissue measurements were performed while the balloon catheter is inserted into tissue followed by removing the catheter from the heart to perform the baseline measurement determination.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 7, 11-16, 18-21 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2016/0067465 to Gerrans et al. “Gerrans” in view of U.S. Patent No. 7,727,226 to Chang et al. “Chang” or U.S. Publication No. 2014/0336689 to Elton et al. “Elton”, either Gerrans and Chang or Gerrans and Elton in further view of U.S. Publication No. 2021/0369185 to Janssen et al. “Jansen” and U.S. Publication No. 2017/0100142 to Look et al. “Look”.
As for Claims 1, 7, 11-13, 18-19, 21 and 29, Gerrans discloses a catheter system and method comprising steps of inserting a balloon catheter into a lumen of tissue (Abstract), providing a fluid into the balloon member via a tube and a pump to cause the balloon catheter to apply force against the tissue (Paragraphs [0013], [0032], [0035], [0055] and [0056]), monitoring a pressure of the fluid (Paragraph [0056]), collecting image data of the balloon catheter by an imaging device during the insertion or providing fluid to determine a size metric of the balloon and in result, a size metric of tissue from the imaging data (Paragraphs [0013] and [0089]) and determining a characteristic of the tissue based on, at least in part, the pressure and size metric (Paragraph [0114]).
However, Gerrans uses a radiopaque fluid inside the balloon as opposed to a radiopaque balloon material as claimed.
Initially, Examiner notes that Gerrans’ system is considered a suitable equivalent to the claimed system given that Applicant discloses various embodiments where the balloon is radio opaque or a radio opaque material is used to fill the balloon. Nonetheless, Chang teaches from within a similar field of endeavor with respect to balloon catheters (Abstract) where the inflatable member can be coated with a radio opaque coating (Column 11, Lines 45-60) or where the balloon can be filled with an imageable radio opaque contrast agent in order to estimate the diameter of an anatomical opening (e.g. size metric of tissue from imaging data; Column 20, Lines 34-60).
Accordingly, one skilled in the art would have been motivated to have modified Gerrans’ balloon catheter have a radio opaque material on it as described by Chang in order to provide an alternative technique to visualize the balloon’s size with imaging. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Regarding the steps of obtaining a “baseline pressure response”, Janssen teaches from within a similar field of endeavor with respect to balloon catheter systems and methods where balloons can be inflated “on the bench” (e.g. without tissue) in order to obtain a baseline pressure response (Paragraphs [0138], [0154], [0195], [0337] and [0417]). Janssen explains this bench pressure data is considered as a target volume for the particular balloon (Paragraph [0417] and [0419]) while Look teaches from within a similar field of endeavor with respect to balloon catheter systems and methods (Abstract) where pressure measurements may be compared with stored pressure data to obtain a pressure differential with respect to a baseline pressure (Paragraphs [0164]-[0165]).
Accordingly, one skilled in the art would have been motivated to have modified the pressure measurements described by Gerrans to use an “on the bench” baseline pressure described by Janssen and to have computed a pressure differential described by Look in order to obtain a true pressure measurement based on anatomical stress. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Regarding Claim 2, Examiner notes the aforementioned inflation causes the catheter to apply force against the tissue inducing at least one radial stress, longitudinal stress, compressive stress or shearing in its broadest reasonable interpretation.
As for Claims 3 and 14, Gerrans’ determination of ostial wall or biological material dimensions, resistance and density of the material is considered to read on the claimed limitations of a stiffness or condition of the tissue in its broadest reasonable interpretation.
With respect to Claim 15, Examiner notes the radio opaque coating is considered to be a pattern in its broadest reasonable interpretation.
Regarding Claim 16, Gerrans discloses monitoring the pressure with a microcontroller and pressure regulator (e.g. “sensor” in its broadest reasonable interpretation; Paragraph [0113]).
Regarding Claim 20, one skilled in the art would appreciate that cancerous tissue is stiffer than normal/healthy tissue. See U.S. Publication No. 2017/0215839 , Paragraph [0008] as evidence. Thus, Gerrans’ system and method would detect an indication of cancerous tissue in its broadest reasonable interpretation.
Claim(s) 5, 10, 16, 30 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gerrans, Chang, Janssen and Look applied to claim 1 above, and further in view of U.S. Publication No. 2010/0113939 to Mashimo et al. “Mashimo”.
With respect to Claim 5, Gerrans, Chang, Janssen and Look disclose a balloon catheter as described above but fail to specify inserting the catheter into the claimed areas.
Mashimo teaches from within a similar field of endeavor with respect to balloon catheter systems and methods (Abstract) where a catheter is inserted into a lumen to infer a characteristic of the tissue based on a pressure measurement and a size metric (Paragraphs [0006]-[0009], [0013], [0024] and [0030]). Mashimo discloses wherein the catheter may be inserted into a hollow lumen of the body including, for example, cardiovascular, gastrointestinal, biliary, pancreatic, respiratory, etc. (Paragraph [0024]).
Accordingly, one skilled in the art would have been motivated to have used the modified catheter system described by Gerrans, Chang, Janssen and Look in other areas of the body as described by Mashimo in order to determine characteristics of tissue anywhere in the body. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Regarding Claims 10, 14 and 30, Mashimo discloses wherein the system can determine a fibrosis condition (Paragraph [0024]; 126 in Fig. 4 and corresponding descriptions) based on the pressure and volume/diameter compliance in its broadest reasonable interpretation.
Alternatively, regarding Claims 16, Mashimo discloses wherein the balloon catheter includes multiple pressure sensors (Abstract).
Alternatively, regarding Claim 20, one skilled in the art would appreciate that cancerous tissue is stiffer than normal/healthy tissue. See U.S. Publication No. 2017/0215839 , Paragraph [0008] as evidence. Thus, the modified system and method described above would detect an indication of cancerous tissue in its broadest reasonable interpretation.
Regarding Claim 32, Mashimo explains that the site may be determined based on pressure and distance measurements used to indicate stiffness in its broadest reasonable interpretation.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gerrans, Chang, Janssen and Look as applied to claim 1 above, and further in view of U.S. Publication No. 2012/0059245 to Buschmann et al. “Buschmann” or U.S. Publication No. 2007/0015994 to Hong et al. “Hong”.
As for Claims 8, Gerrans, Chang, Janssen and Look discloses a catheter system and method including a pressure sensor as described above. However, Gerrans, Chang, Janssen and Look does not expressly disclose filtering the pressure data as claimed.
Buschmann teaches from within a similar field of endeavor with respect to determining an internal condition (Abstract) where filters may be used to block noise (Paragraph [0008]).
Likewise, Hong teaches from within a similar field of endeavor with respect to systems and methods for determining biomechanical properties of internal tissues (Abstract) where pressure sensor signals may be filtered to minimize noisy data (Paragraph [0069]).
Accordingly, one skilled in the art would have been motivated to have modified the catheter system and method described by Gerrans, Chang, Janssen and Look to filter the pressure data as described by Buschmann or Hong in order to enhance the accuracy of the measurement. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 5, 7-8, 10-16, 18-21, 29-30 and 32 have been considered but are moot in view of the updated grounds of rejection necessitated by amendment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797
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