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 21, 29-30 and 32 are objected to because of the following informalities: Claim 21 is objected to because of the double comma in line 3. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7 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 7 is rejected because it is unclear if “an image” is “the image data” now in Claim 1. Claim 32 is rejected because it is unclear how the locating step is performed using “only” tissue stiffness measurements when the tissue stiffness measurement includes using pressure and diameter changes (via imaging). For the purpose of advancing prosecution, Examiner will assume this limitation to be met when tissue fibrosis is located with the acquired pressure and volume/diameter compliance data to infer stiffness.
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”.
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 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 and Chang as 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 and Chang 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 and Chang 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 and Chang 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 and Chang discloses a catheter system and method including a pressure sensor as described above. However, Gerrans and Chang 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 and Chang to filter the pressure data as described by Buschmann or Hong in order to enhance the accuracy of the measurement. Such a modification merely involve 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
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.
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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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797
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