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 .
DETAILED ACTION
Response to Amendment
The amendment filed on 1/07/2026 has been received and claims 1-25 are pending.
Election/Restrictions
Claims 4-5 and 18-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/20/2024.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schafer (20150283277).
As to Claim 1, Schafer (‘277) discloses a method for selectively killing or diminishing viability of a pathogen infecting a mammalian subject tissue (see entire document, particularly Figures 14-16), the method comprising:
contacting a mammalian subject tissue (132) with one or more acoustic transducers (40; 140, 142; 158a, 158b; 182) (see entire document, particularly Figures 1-2 and 14-16, p. 9 [0093], pp. 9-10 [0094]); and
administering greater than ten thousand cycles of pressure variation below a threshold for cavitation of the mammalian subject tissue, whereby the greater than ten thousand cycles of pressure variation is sufficient to kill or diminish viability of a pathogen infecting the mammalian subject tissue without harming the mammalian subject tissue. (see entire document, particularly Figure 13, p. 4 [0056]-[0058], p. 7 [0075] and [0078], p. 8 [0081], [0084] and [0087]-[0088], p. 9 [0090] and [0091] – last 7 lines, p. 10 [0095], p. 11 [0103] in which Schafer (‘277) teaches that the one or more ultrasound transducers are utilized for a treatment “at a levels effective to disrupt targeted bacteria cells…while remaining safe for use on human tissue” where “ranges of various parameters characterizing effective yet safe levels of ultrasound” is determined and used such as at “a time-averaged sound intensity that is generally low enough to maintain a safe treatment…for use on human tissue covered by the bacteria” and to repeat cycles of pressure variations “for the full extent of the treatment period” (see entire document, particularly p. 4 [0056]-[0058], p. 7 [0075]) which discloses an application/administration below a threshold (i.e. above which is not “safe”) and Schafer (‘277) also teaches use of parameters as disclosed in p. 8 [0087]-[0088] and p. 9 [0090] along with Figure 13 (e.x. 100 Hz (i.e. pulses or cycles) for 20-60 minutes) which discloses administration of greater than ten thousand cycles of pressure variations (e.x. by providing pressure pulses at 100 Hz (i.e. 100 pulses or cycles of pressure variation per second) for 60 minutes which would provide 360,000 cycles, which is greater than 10000, cycles of pressure variation).
As to Claims 2-3, Schafer (‘277) discloses that the pathogen is a bacterium (see entire document, particularly Figure 13, p. 4 [0056]-[0058]) which is a cell intrinsically having an internal static pressure of greater than 20 kPa above that of the mammalian subject tissue.
As to Claim 8, Schafer (‘277) discloses that the one or more acoustic transducers are external to the mammalian subject tissue (see Figures 14-16).
As to Claim 9, Schafer (‘277) discloses that the one or more acoustic transducers (40; 140, 142; 158a, 158b; 182) penetrate the mammalian subject tissue to make acoustic contact with a targeted tissue or an internal structure (see Figures 14-16).
As to Claim 10, Schafer (‘277) discloses that the one or more acoustic transducers (40; 140, 142; 158a, 158b; 182) are shaped and excited to irradiate an extracorporeal fluid with greater than ten thousand cycles of pressure variation (see entire document, particularly Figures 14-16, p. 10 [0094]), wherein the amplitude, frequency, and number of the greater than ten thousand cycles of pressure variation diminish pathogen viability without causing excessive heating of the mammalian subject tissue (see entire document, particularly Figure 13, p. 4 [0056]-[0058], p. 7 [0075] and [0078], p. 8 [0081], [0084] and [0087], p. 9 [0090] and [0091] – last 7 lines, p. 10 [0094]-[0095], p. 11 [0103]).
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.
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.
Claim(s) 6-7 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Schafer (20150283277).
As to Claims 6-7, while Schafer (‘277) discloses that the pressure cycles are applied at specific mammalian subject tissue sites without causing excessive heating, Schafer (‘277) does not specifically teach that finite element acoustic analysis is utilized to select the shape, frequency, amplitude, and orientation of the one or more acoustic transducers. However, it would have been well within the purview of one of ordinary skill in the art before the effective filing date of the claimed invention to provide any known analysis methods such as finite element acoustic analysis in the method of Schafer as a known analysis means in order to determine the optimal parameters for the process. Only the expected results would be attained.
As to Claim 11, while Schafer (‘277) does not appear to specifically teach that the cycles of pressure variation are selected to enable, accelerate, or potentiate the action of an antimicrobial pharmaceutical agent, it was well known in the art that administration of cycles of acoustic pressure variations enable, accelerate, or potentiate the action of a pharmaceutical agent such as an antimicrobial pharmaceutical agent and thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to tailor the number of cycles of pressure variations to additionally enhance the action of an antimicrobial pharmaceutical agent so as to ensure full treatment that cures a pathogenic infection in the mammalian subject tissue. Only the expected results would be attained.
As to Claims 12-13, while Schafer (‘277) does not appear to specifically teach that the mammalian subject tissue geometry and composition are determined by tomographic biomedical imaging, it was well known in the art before the effective filing date of the claimed invention to utilize biomedical imaging such as tomographic biomedical imaging to provide visualization of an area of interest for medical treatment to determine location and extent of a disease/condition and thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a step of biomedical imaging such as tomographic biomedical imaging in the method of Schafer as a known medical procedure/step in order to provide a visualization of the infected area desired for treatment so as to ensure correct and optimal placement of the one or more acoustic transducers of Schafer for a treatment. Only the expected results would be attained.
Claim(s) 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Schafer (20150283277) as applied to claim 1 above, and further in view of Xu (20190328354).
Schafer (‘277) is relied upon for disclosure described in the rejection of claim 1 under 35 U.S.C. 102(a)(1).
As to Claim 14, Schafer (‘277) does not appear to specifically tech that the one or more acoustic transducers are arranged in a conformable piezoelectric transducer array, comprising: a silicone elastomer substrate and a silicone elastomer superstrate; a plurality of piezoelectric transducer elements disposed between the silicone elastomer substrate and the silicone elastomer superstrate; a first electrical interconnect layer electrically interconnecting a first surface of the plurality of piezoelectric transducer elements adjacent to the silicone elastomer substrate; and a second electrical interconnect layer electrically interconnecting a second surface of the plurality of piezoelectric transducer elements adjacent to the silicone elastomer superstrate.
It was known in the art before the effective filing date of the claimed invention to provide one or more acoustic transducer that are arranged in a conformable piezoelectric transducer array, comprising: a silicone elastomer substrate and a silicone elastomer superstrate; a plurality of piezoelectric transducer elements disposed between the silicone elastomer substrate and the silicone elastomer superstrate; a first electrical interconnect layer electrically interconnecting a first surface of the plurality of piezoelectric transducer elements adjacent to the silicone elastomer substrate; and a second electrical interconnect layer electrically interconnecting a second surface of the plurality of piezoelectric transducer elements adjacent to the silicone elastomer superstrate. Xu (‘354) discloses one or more acoustic transducers (100) arranged in a conformable piezoelectric transducer array (see Figures 1A-1H), comprising:
a silicone elastomer substrate (i.e. silicone elastomer below 205 and 210 – see Figure 1B) and a silicone elastomer superstrate (240);
a plurality of piezoelectric transducer elements (110, 220) disposed between the silicone elastomer substrate (i.e. silicone elastomer below 205 and 210 – see Figure 1B) and the silicone elastomer superstrate (240) (see Figures 1B-1D, p. 4 [0099]);
a first electrical interconnect layer (215) electrically interconnecting a first surface of the plurality of piezoelectric transducer elements adjacent to the silicone elastomer substrate; and
a second electrical interconnect layer (230) electrically interconnecting a second surface of the plurality of piezoelectric transducer elements (220) adjacent to the silicone elastomer superstrate (240),
in order to allow conformal contact to nonplanar surfaces that accommodates the externally applied strain with limited strain on above components themselves (see entire document, particularly Figures 1A and 1G-1H, pp. 3-4 [0097], p. 5 [0104] – lines 1-2).
It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide a silicone elastomer substrate and a silicone elastomer superstrate; a plurality of piezoelectric transducer elements disposed between the silicone elastomer substrate and the silicone elastomer superstrate; a first electrical interconnect layer electrically interconnecting a first surface of the plurality of piezoelectric transducer elements adjacent to the silicone elastomer substrate; and a second electrical interconnect layer electrically interconnecting a second surface of the plurality of piezoelectric transducer elements adjacent to the silicone elastomer superstrate in the one or more acoustic transducers of Schafer as known components in order to allow application of the one or more acoustic transducers to nonplanar surfaces that is rigid locally but soft globally as shown by Xu.
As to Claim 15, Xu (‘354) discloses that at least one of the plurality of piezoelectric transducer elements comprises a composite material (see entire document, particularly Figures 1B-1D, p. 4 [0099]).
As to Claim 16, Xu (‘354) discloses that each of the plurality of piezoelectric transducer elements comprises a composite material (see entire document, particularly Figures 1B-1C and 1E-1G, p. 4 [0099]).
As to Claim 17, Xu (‘354) discloses that the first and second electrical interconnect layers (215, 230) have a patterned island and bridge structure (see Figure 1B) that includes a plurality of islands electrically interconnected by bridges (see Figures 1C, 1E and 1G), each of the plurality of piezoelectric transducer elements (110, 220) being supported by one of the plurality of islands (see Figures 1A-1H).
Thus, Claims 14-17 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Schafer (‘277) and Xu (‘354).
Response to Arguments
Applicant's arguments filed 1/07/2026 have been fully considered but they are not persuasive. Specifically, as to applicant’s argument on pp. 7-8 of Remarks that “Schafer describes methods…for using both mechanical and electromagnetic energy” and that “the claimed method uses only ultrasound energy”, examiner points out that the feature upon which applicant relies (i.e., use of only mechanical/ultrasound energy) is not required in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims a. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, examiner points out that the claimed invention utilizes language that is open to/inclusive of other steps which may include other sterilization means/steps and does not exclude any particular (additional) sterilization means/steps.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following references relate either to the field of the invention or subject matter of the invention, but are not relied upon in the rejection of record: 8303898, 20110213281.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M YOO whose telephone number is (571)272-6690. The examiner can normally be reached Monday - Friday, 9:00 am - 5:00 pm EST.
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/REGINA M YOO/ Primary Examiner, Art Unit 1758