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 and Amendment Filed
Applicant’s response and amendment, filed February 27, 2026, has been entered and made of record.
Previously Set Forth Rejections
All of the rejections set forth in the previous Office action (mailed December 1, 2025) are hereby maintained and are reiterated below.
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) 2-22, 25 and 27-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Linli Shi et al., “A fiber optoacoustic emitter with controlled ultrasound frequency for cell membrane sonoporation at submillimeter spatial resolution”, Photoacoustics, Vol. 20, September 30, 2020 (hereinafter “Shi et al.”)1 in view of Harmer et al. (U.S. Patent Application Publication No. 2014/0018663).
In regard to claims 2, 9, 10, 21, 22, 25, Shi discloses a method of stimulating cells via an optoacoustic material (a method of neuron stimulation via a fiber-based optoacoustic emitter FOE having a tapered tip shape to focus the wave via a concave structure; see Abstract; Figs. 1a-1c and section 2.5) comprising: providing the optoacoustic material, the optoacoustic material having optical absorbers and an expansion matrix configured to generate an ultrasound (a material layer converts light energy into acoustic waves via optoacoustic effect, having an absorption/thermal expansion layer composed of nanoparticles with high light absorption coefficient as the absorbers, e.g., multi-wall carbon nanotubes MWCNTs, and PDMA polymer with high thermal expansion coefficient for the expansion comprising a nanoparticle polymer matrix, wherein a fiber-based optoacoustic transmitter FOE generated ultrasound; Abstract; Fig. 1 and sections 2.1 and 3); embedding the optoacoustic material to form an optoacoustic film, and configured to stimulate neural growth in response to the ultrasound (different concentrations of CNTs were used in a mixture to fine-tune the ultrasound frequency to form a fiber-based optoacoustic emitter FOE coating of CNTs/PDMS expansion layers, wherein cells treated with the FOW undergo frequency dependent ultrasound sonoporation including membrane pores releasing, thus stimulation of neuron growth; Figs. 4, 6d and sections 2.3, 2.5); and generating the ultrasound by emitting laser pulses to the optoacoustic film to stimulate neural growth in response to the ultrasound (a 3 ns Q-switched laser used as the laser source to an optical fiber to generate focused ultrasound for bio-modulation wherein the fiber-based optoacoustic emitter may be used for neurostimulation, and cells treated with the FOA undergo frequency dependent ultrasound sonoporation including membrane pores releasing, thus responsive stimulation of neuron growth; Abstract, Figs. 1a-1c and sections 1, 2.1, 2.3, 2.5 and 4.2. Shi et al. lack the explicit teaching of a fibroin hydrogel. However, Harmer et al. teach the medical use of a fibroin hydrogel (polymer hydrogels including silk fibroin; para. 0058) to serve as a tissue marker for ultrasound imaging and therapy (see para. 0027). Harmer et al. thus demonstrate that the use of a hydrogel of silk fibroin as a means to enhance ultrasound imaging and therapy where the hydrogel is biodegradable and based on natural products (see paras. 0057-0058 of Harmer et al.) is well known in the art. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to modify the method of Shi et al. to include a hydrogel of silk fibroin in order to enhance the ultrasound imaging and provide a bioabsorbable matrix of nanoparticle materials using biodegradable hydrogels based on natural products. In regard to claims 3, 11 and 27, see Figs. 1 and 5 and sections 2.1 and 2.4 of Shi et al. In regard to claims 4, 5, 12, 13, 28 and 29, see section 2.5 of Shi et al. In regard to claims 6 and 14, see Figs. 1a-1c and sections 4.2 and 4.3 of Shi et al. In regard to claims 7, 8 and 30 see Abstract of Shi et al. In regard to claim 15, see Abstract and section 2.1 of Shi et al. In regard to claim 16, see Abstract of Shi et al. In regard to claim 17, see sections 2.1 and 4.1 of Shi et al. In regard to claim 18, see Figs. 1a-1c and sections 1, 2.1 and 4.2 of Shi et al. In regard to claims 19 and 20, see Fig. 1a-1c and sections 1, 2.1 and 4.2 of Shi et al.
Claim(s) 23, 24 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Linli Shi et al., “A fiber optoacoustic emitter with controlled ultrasound frequency for cell membrane sonoporation at submillimeter spatial resolution”, Photoacoustics, Vol. 20, September 30, 2020 (hereinafter “Shi et al.”)2 in view of Harmer et al. (U.S. Patent Application Publication No. 2014/0018663) and further in view of McGowan et al. (U.S. Patent Application Publication No. 2020/0129195).
In regard to claims 23, 24 and 26, as noted above, Shi et al. teach carbon nanotubes. However, McGowan et al. teach a similar photoacoustic catheter 100 with a photoacoustic transducer including a light-absorbing material and a thermal expansion matrix (see para. 0091). Suitable light-absorbing materials are carbon nanotubes and candle soot (see para. 0091). Suitable thermal expansion materials can include PDMS (see para. 0093). McGowan et al. thus demonstrate that candle soot is an art-recognized equivalent to carbon nanotubes for use as a light absorbing material embedded in a PDMS matrix. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to substitute the candle soot taught by McGowan et al. for the carbon nanotubes in Shi et al. as the two elements are art-recognized equivalents to serve as a light-absorbing material.
Response to Arguments
Applicant's arguments filed February 27, 2026 have been fully considered but they are not persuasive.
Applicant argues that Shi does not disclose the formation of an optoacoustic film, much less one without PDMS, in which the expansion matrix is formed from fibroin hydrogel (see page 6 of the 2/27/26 response). Applicant also argues that Shi fails to disclose the use or targeted ultrasound to stimulate neural growth (see page 6 of the 2/27/26 response). Applicant also argues that Harmer is not concerned with optoacoustic properties at all and would not provide one of skill in the art with any information regarding the suitability of hydrogels, including fibroin hydrogel, as an expansion matrix for use in creating an optoacoustic film and Harmer does not disclose the use of targeted ultrasound to stimulate neural growth (see pages 6-7 of the 2/27/26 response). Applicant also argues that McGowan does not teach or suggest the embedding of the light-absorbing material in an expansion matrix to form an optoacoustic film, especially not an expansion matrix comprising a fibroin hydrogel and provides no guidance regarding stimulating neural growth with targeted ultrasound (see page 7 of the 2/27/26 response).
Regarding Shi, the examiner agrees that Shi does not teach the formation of an optoacoustic film in which the expansion matrix is formed from fibroin hydrogel. However, as is noted above, Harmer is utilized as a teaching of the medical use of a fibroin hydrogel (see para. 0058). The examiner disagrees that Shi is not combineable with Harmer because Harmer is not concerned with optoacoustic properties. As is noted above, Harmer clearly teaches using a fibroin hydrogel in a medical setting particularly one involving ultrasound, which necessarily involves issues of optoacoustics and enhancing optoacoustics. The examiner also disagrees that Shi does not disclose the use of ultrasound to stimulate neural growth (see, e.g., sections 1, 2.1, 2.3, 2.5 and 4.2 of Shi) and furthermore, Harmer is utilized as a teaching of the use of fibroin hydrogel and it is thus immaterial whether Harmer teaches stimulating neural growth since Shi teaches this feature. Similarly, McGowan is used as a teaching of candle soot at a light absorbing material embedded in a PDMS matrix and it is immaterial whether McGowan teaches a fibroin matrix as Harmer teaches this feature. It is well settled that 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).
Conclusion
THIS ACTION IS MADE FINAL. 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 BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
1 At the bottom of this reference, it states that the publication was available online on September 30, 2020.
2 At the bottom of this reference, it states that the publication was available online on September 30, 2020.