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 .
Response to Arguments
Applicant's arguments filed 12/1/2025 have been fully considered but they are not persuasive. The applicant argues that DeWitt et al. does not teach the claimed solvent range because it does not teach PEBA in the composition. Amano et al. teaches dissolving PEBA in a solvent in para 0057 to apply or cast the PEBA solution over a catheter and/or ultrasonic transducer (para 0005), where the polymer solution containing the PEBA is dissolved in a mixture of one or more solvents in para 0057, which includes a base solvent with the polymer and solvent having a set concentration range in para 0057. In para 0057, the concentration range is taught, as broadly claimed, in Amano. Further, DeWitt teaches a wide range of concentrations of similar polymers to that of Amano in paras 0089-0090, of which the remainder would be solvent in the composition and within the claimed range. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Therefore, for at least these reasons, the rejections are maintained. New grounds of rejection are due to amendments.
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 1, 3-8 and 10 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 amended limitation includes a concentration range, but does not make it clear if the weight percent is that of the PEBA or the solvent. Appropriate correction in the claim is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amano et al. (US 2012/0253296 A1) in view of Ryan et al. (US 2022/0395255 A1) and DeWitt et al. (US 2006/0083772 A1).
As to claim 1, Amano et al. teaches dissolving PEBA in a solvent in para 0057 to apply or cast the PEBA solution over a catheter and/or ultrasonic transducer (para 0005), where the polymer solution containing the PEBA is dissolved in a mixture of one or more solvents in para 0057, which includes a base solvent with the polymer and solvent having a set concentration range in para 0057. Amano et al. does not explicitly teach that the solution is cast over an imaging window of a piezoelectric micromachined transducer array which is within a distal end of an ultrasonic catheter.
In the same catheter field of endeavor, Ryan teaches of a Piezoelectric Micromachined Ultrasonic Transducer (pMUT) array (fig. 1 transducers 18 may be PMUTs [0083]) wherein the pMUT array comprises a plurality of pMUT array elements (fig. 18b transducers 1802 [0154]) arranged on a substrate (fig. 18B flex circuit 1823 [0154]), and an insulating material 1820 to provide electrical isolation. The layer 1818 acts as a sealant that also acts to dampen surface lateral waves as in para 0151 and 0155. This sealant material is coated over the distal end as claimed as shown in Figure 17B or 18C which would include an imaging ‘window’ as broadly claimed as this is the section where the ultrasonic images are formed.
Therefore, it would have been obvious to use the sealing coating of Amano et al. as the sealing coating of Ryan as all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions (both are biocompatible and protective), and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)
Amano et al. does not teach that the PEBAX is dissolved in butanol and propanol. DeWitt et al. teaches that these solvents are useful for coating medical devices, in particular when other functionalities via bioactive agents in the mixture are desired (para 0110). Therefore, it would have been obvious to one of ordinary skill the art to modify Amano to include the solvents taught by DeWitt in order to have a solvent that is are useful for coating medical devices, in particular when other functionalities via bioactive agents in the mixture are desired. Further, DeWitt teaches a wide range of concentrations of polymers in paras 0089-0090, of which the remainder would be solvent in the composition and within the claimed range.
As to claims 3-7, Ryan teaches of a Piezoelectric Micromachined Ultrasonic Transducer (pMUT) array (fig. 1 transducers 18 may be PMUTs [0083]) wherein the pMUT array comprises a plurality of pMUT array elements (fig. 18b transducers 1802 [0154]) arranged on a substrate (fig. 18B flex circuit 1823 [0154]), and an insulating material 1820 to provide electrical isolation. The layer 1818 acts as a sealant that also acts to dampen surface lateral waves as in para 0151 and 0155. This sealant material is coated over the distal end as claimed as shown in Figure 17B or 18C which would include an imaging ‘window’ as broadly claimed as this is the section where the ultrasonic images are formed. Further, any physical results such as lubrication, bonding, etc. are considered to naturally flow from the combination of references taught here.
Claim(s) 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amano et al. in view of DeWitt et al. (US 2006/0083772 A1)
As to claim 1, Amano et al. teaches dissolving PEBA in a solvent in para 0057 to apply or cast the PEBA solution over a catheter and/or ultrasonic transducer (para 0005), where the polymer solution containing the PEBA is dissolved in a mixture of one or more solvents in para 0057, which includes a base solvent with the polymer and solvent having a set concentration range in para 0057. Amano et al. uses the coating to cover the catheter, thus achieves a desired diameter of coating on the catheter for its purposes in para 0131-0132. The Examiner takes official notice that the use of a stirrer and beaker is extremely common and obvious in the art for solution methods.
Amano et al. does not teach that the PEBAX is dissolved in butanol and propanol. DeWitt et al. teaches that these solvents are useful for coating medical devices, in particular when other functionalities via bioactive agents in the mixture are desired (para 0110). Therefore, it would have been obvious to one of ordinary skill the art to modify Amano to include the solvents taught by DeWitt in order to have a solvent that is are useful for coating medical devices, in particular when other functionalities via bioactive agents in the mixture are desired.
Regarding the temperature, DeWitt et al. modifies its temperature in solution depending on the type of all of the solution components in para 0041-0042; Amano et al. teaches similar modifications in para 0025 to prevent deformation. It would have been obvious to a person having ordinary skill in the art at the time the invention was made to include the temperature as claimed, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 105 USPQ 223 (CCPA 1955).
Further, DeWitt teaches a wide range of concentrations of polymers in paras 0089-0090, of which the remainder would be solvent in the composition and within the claimed range.
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 KELLY M GAMBETTA whose telephone number is (571)272-2668. The examiner can normally be reached M-F 9-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Meeks can be reached at 571-272-1423. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KELLY M. GAMBETTA
Primary Examiner
Art Unit 1715
/KELLY M GAMBETTA/ Primary Examiner, Art Unit 1718
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