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 .
Election/Restrictions
Applicant’s election of Group II claims 11-20 in the reply filed on 05/01/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 13 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The recitation “… the dual-mode ultrasound transducer is positioned outside of the subjects skull or in at least partially outside of nervous system tissue” positive recites the “subject skull” or “nervous system tissue”, relative to the transducer, i.e., for the claim to be met, the subject skull or nervous system tissue is required and/encompassed by the scope of claim. Since Applicant intent is understood, it is suggested to amend to… the dual-mode ultrasound transducer is configured/adapted to be positioned to overcome this rejection.
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 13 and 17 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 13 recites the limitation "the subjects skull". There is insufficient antecedent basis for this limitation in the claim. Claim 13 further recites in part “is positioned” regarding to the dual-mode ultrasound transducer, it cannot be readily determined from the claims, which if any of the recited element(s) in the claim, positions the dual-mode transducer, thus rendering the scope of the claim unclear.
Regarding claim 17, it cannot be readily determined from the claims, which if any of the recited element(s) in the claim, determines the ISPTA, thus rendering the scope of the claim unclear.
According to MPEP 2173.05(p).ll, "a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011 )."Also see IPXL Holdings v. Amazon.com (Fed. Cir. 2005). The following portion of the claim(s) is/are indefinite for this reason:
In claim 13: “wherein the dual-mode ultrasound transducer is positioned …”; and
In claim 17: "wherein ISPTA … is determined".
The limitations noted above each make it unclear as to whether the relevant limitations are positively recited and part of the claimed invention, while it also recites a step in an apparatus claim. Functional language should be attributed to a structure (e.g. Structure A configured to/capable of perform(ing) function X). Steps, limitations disconnected from structural elements and language dependent on structures that are not positively recited, make the claims unclear as to their scope.
Claim Rejections - 35 USC § 102
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 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.
Claims 11 and 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Applicant cited Li et al., "Image-Guided Dual-Target Neuromodulation of the Mouse Brain Using Array Ultrasound" (“Li-2018”) as evidenced by Applicant cited Li et al., “Improved Anatomical Specificity of Nain-Invasive Neuro-stimulation by High Frequency (5MHz) Ultrasound” hereinafter “Li-2016”.
Regarding claim 11, Li-2018 discloses system (page 1584, right column, first full paragraph and continuing to page 1585, Fig. 2 (a)) comprising: a dual-mode ultrasound transducer configured to deliver focused ultrasound energy; and a controller operably coupled to the dual-mode ultrasound transducer, the controller configured to drive the dual-mode ultrasound transducer to deliver focused ultrasound energy (page 1586. Fig. 5 text “Size of the acoustic focus of the dual-mode transducer”, see illustration Fig. 5(a), two focus locations are illustrated).
In regards to the recitation to cause heating of target nervous system tissue for at least about 150 seconds tissue to reversibly modulate neural activity, this recitation is directed to functional language or a capability of the claimed system (i.e. effects imparted by the claimed system). it is to be noted here that the claims under examinations are directed to an apparatus (system). A claim term is functional when it recites a feature “by what it does rather than by what it is”. Additionally, “A functional limitation is often used in association with an element, ingredient, or step of a process to define a particular capability or purpose that is served by the recited element, ingredient or step. In Innova/Pure Water Inc. v. Safari Water Filtration Sys. Inc., 381 F.3d 1111, 1117-20, 72 USPQ2d 1001, 1006-08 (Fed. Cir. 2004) (MPEP 2173.05(g)). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. See In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). In the instant case, the system of Li-2018 comprise a pulse generator that comprise a field-programmable gate array (FGPA) - see cited paragraph in page 1584, the system of Li-2018 is therefore programmable to deliver focused ultrasound for at least 150 seconds.
In regards to cause heating of target nervous system tissue, in page 1588, paragraph bridging left and right column, with reference to Fig. 6, 5 Mhz ultrasound stimulation was applied; further, in page 1584, left column, third full paragraph, “This study is the first to utilize array technology specifically for dual-target neuromodulation in small animals. Our previous study successfully applied 5-MHz ultrasound for neuromodulation with improved anatomical specificity in the mouse brain [31]”. It is examiner’s position that ultrasound neuromodulation in Li-2018 would cause heating the target nervous tissue as citation 31 in Li-2018 discloses the effects of 5 MHz stimulation. Citations 31 is Li-2016, in page 5 of Li-2016, section titled “Evaluation of temperature and safety”,5Mhz stimulation is causes heating, in view of peak temperature of 1.6oC, and the teaching that the temperature may vary, by varying duration of stimulus. As such, the system of Li-2018 is capable of causing heating of target nervous tissue, by varying duration of the 5 Mhz ultrasound stimulus via the programmable (FPGA) pulse generator.
Regarding claim 13, see 35 U.S.C 112(b) rejections above, in view of Li-2018, page 1584, the dual-mode transducer is capable of or is configured to be positioned outside of a subject’s skull.
Regarding claims 14 and 15, see discussion in claim 11 above with reference to Li-2016, by adjusting the parameters of the programmable pulse generator, the delivered ultrasound energy will be configured to heat the target tissue to a temperature above 2oC and for a duration of at least 180 seconds as desired, i.e., the system of Li-2018 is configured i.e., programable, to adjust the parameters of the focused ultrasound energy to heat the nervous tissue more than 2 degrees or to deliver the focused ultrasound energy for at least 180 seconds, if desired.
Regarding claims 16 and 18, these recitations are directed to a property of the focused ultrasound energy, examiner notes that the programmable pulse generator is programmable, hence configured to generate the property and/or effect of the focused ultrasound energy recited in the claims at the target nervous tissue, i.e., the pulse generator is programmable such that the ISPTA, at target nervous tissue will be above 0.3 W/cm2, the pulse generator is programmable such that the focused ultrasound energy will have a duty cycle of 10%, as these limitations are attributes to a property of the focused ultrasound energy that are adjustable by the programmable pulse generator.
Regarding claim 17, see 35 U.S.C 112(b) rejections above, in view of Li-2016, page 7, fifth paragraph regarding the 5 MHz neuromodulation being safe for brain tissue, infers that the ISPTA of the delivered focused ultrasound energy does not damage target nervous system tissue.
Regarding claim 19, the carrier frequency of 5 MHz in LI-2018 as discussed in claim 11 above, is at least 1 Mhz.
Regarding claim 20, see Fig. 5 in page 1586 of Li-2018, the depicted focal spots are less than 5 mm in at least two dimensions. Examiner further notes that the programmable pulse generator of Li-2018 is configured to adjust the focal spot to meet this claim limitation.
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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Li-2018 as evidenced by Li-2016.
Regarding claim 12, as discussed in claim 1 above, Li-2018 does not explicitly disclose at least one other dual-mode transducer to provide the focused ultrasound energy, however, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art at the time the invention was made to duplicate the dual-mode ultrasound transducer in order to perform the same function of the disclosed dual-mode transducer considering that it is well-known and common practice to use more than one ultrasound transducer to target a nerve tissue for stimulation, and/or since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8 MPEP 2144.04 (VI-B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797
Prosecution Insights