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 Amendment
The amendment filed January 28, 2026 has been entered. Claims 20, 22-23, 30, 35 have been amended. Claims 1-19 were previously canceled. Currently, claims 20-37 are pending for examination.
Response to Arguments
Applicant's arguments filed January 28, 2026 with respect to the 35 U.S.C. 103 rejections have been fully considered but they are not persuasive.
Applicant argues that Bach-Y-Rita et al. (US 2011/0071439) in view of Goldberg et al. (US 2019/0388560) does not disclose the invention of claim 20 because the “particles (B)” required by the claim are transducers/energy modulators since they are “’activatable by a signal emitted by the removable device (C)’ and convert or modulate said signal” (p. 9), and applicant argues Bach-Y-Rita et al. cannot (p. 8). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., transducers/energy modulators for converting an external source of energy to an electric signal) are not recited 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. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The term “activatable by a signal” of claim 20 does not currently require any specific action to be performed, and certainly not applicant’s argued conversion of a magnetic or mechanical signal into an electric signal. Bach-Y-Rita et al. discloses activation of particles (B) 100 when an input signal applied to transmitter 104 of removable device (C) 106 is transformed into a signal “causing the motion of a corresponding stimulator 100” [0030]). Thus the prior art meets the broad limitation of “particles (B)… activated by a signal emitted by the removable device (C)”.
Applicant argues that the claimed “size of particles (B) is below 100 µm” is not met by the teachings of Goldberg et al. because the prior art does not teach or suggest the use of magnetic nanoparticles by themselves or the administration of magnetic nanoparticles not attached to cells, and Bach-Y-Rita et al. would not turn to Goldberg et al. to modify the size of stimulator 100 to have a size below 100 µm. In response, Bach-Y-Rita et al. discloses the particles (B) 100 are configured for implantation below the skin to stimulate nerve cells ([0030]). Since Goldberg et al. also describes the magnetic particles being fit for a biological purpose (“cells” [0008]), they are considered analogous in the art. Furthermore while Goldberg et al. sets an example of a particle size known in the art, it should not be ignored that that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., INC., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Furthermore contrary to applicant’s argument that the Office action presents a combination of Goldberg et al.’s magnetic particles with Bach-Y-Rita et al.’s device (p. 11), the Office action does not propose replacing particles (B) 100 with those of Goldberg et al., but rather to “select a particle (B) size of below 100 µm as taught by Goldberg et al.”. Arguments have not been presented countering a change in size of Bach-Y-Rita et al.’s particles (B) 100 and why there would not be a reasonable expectation of success or why it would render the prior art invention as being modified unsatisfactory for its intended purpose.
Applicant argues that Bach-Y-Rita et al. in view of Goldberg et al. and Chu et al. (US 2020/0054873) does not disclose the claimed invention because of the deficiencies of claim 20 (p. 11-12) and are unpersuasive for the same reasons as above.
Applicant’s arguments, see pages 6-7, filed January 28, 2026, with respect to the 35 U.S.C. 112 and 101 rejections have been fully considered and are persuasive. The 35 U.S.C. 112 and 101 rejections of claims 30 and 35-36 (112 rejection) and 20-30, 35-36 (101 rejection) have been withdrawn.
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.
Claim(s) 20, 22-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bach-Y-Rita et al. (US 2011/0071439) in view of Goldberg et al. (US 2019/0388560).
Regarding claim 20, Bach-Y-Rita et al. discloses a system (A) (fig. 1) comprising particles (B) 100 and a removable device (C) 106, particles (B) stably interacting (Bach-Y-Rita et al. discloses the particles 100 are configured to move but this movement does not move away from the implantation site ([0034]), nor is it disclosed that these particles degrade after implantation) with biological cells of the dermis and/or epidermis ([0029]), and particles (B) are activatable by a signal emitted by the removable device (C) (“The transmitters 104 are each capable of emitting a signal (e.g., a magnetic field) which, when emitted, causes its adjacent embedded stimulator 100 to move.” [0030]), and the removable device (C) is designed to collect an input signal which is, optionally processed and, used to activate the particles (B) (“an input signal is applied to a transmitter 104, it is transformed into a signal causing the motion of a corresponding stimulator 100” [0030]), the removable device being wearable by a subject (“Several transmitters 104 are then fixed in an array by connecting web 106 made of fabric or some other flexible material capable of closely fitting above the skin 102 in contour-fitting fashion” [0030]).
Bach-Y-Rita et al. discloses the particles (B) are prepared from a material selected from a magnetic material ([0030]) but does not expressly disclose they are prepared from a piezoelectric or magnetoelectric material. However Bach-Y-Rita et al. does teach that diaphragm 212 of particle (B) may be a piezoelectric bimorph bending motor ([0038]), regarded as a piezoelectric or combined magnetic and electric material. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bach-Y-Rita et al. to substitute the purely magnetic material with a piezoelectric or magnetoelectric material as it has been contemplated as a possibility in the prior art, and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Bach-Y-Rita et al. does not expressly disclose wherein the size of particles (B) is below 100 µm in order for the particles (B) to stably interact with biological cells but does teach the particles are sized 0.2mm or less. Goldberg et al. teaches a known size dimension of magnetic nanoparticles within the body ([0005]) are below 100 µm (“5 and 500 nm” [0011]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bach-Y-Rita et al. to select a particle (B) size of below 100 µm as taught by Goldberg et al. since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., INC., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 22, Bach-Y-Rita et al. discloses wherein the removable device (C) is designed to stably interact with particles ([0030], [0033]) and, both the removable device and the particles are not to be located at a biological area of the subject corresponding to fingertips, mouth, lips and foot soles ([0021]).
Regarding claim 23, Bach-Y-Rita et al. discloses wherein the device (C) comprises a collector module (c1) (“computer, ASIC, or other suitable processor” [0031]) for collecting an input signal which is selected from a physical signal (“camera or microphone data”), a chemical signal and a biological signal, the collector module (c1) being capable of processing the signal when required (“processing (by a computer, ASIC, or other suitable processor)”), and a stimulator module (c2) 104 ([0031]).
Regarding claim 24, Bach-Y-Rita et al. discloses wherein the collector module (c1) (“computer, ASIC, or other suitable processor” [0031]) comprises a module (c1’) collecting an input signal (“camera or microphone data”), and a processing module (c1’’) encoding the input signal into an output signal (“processing (by a computer, ASIC, or other suitable processor)”) readable by the stimulator module (c2) 104 (“to convert it into desired signals for transmission by the transmitters 104” [0031]).
Regarding claim 25, Bach-Y-Rita et al. discloses the stimulator module (c2) comprises a source of energy which is selected from a magnetic source, said source using the output signal to activate the particles (B) (“The transmitters 104 are each capable of emitting a signal (e.g., a magnetic field) which, when emitted, causes its adjacent embedded stimulator 100 to move.” [0030]).
Regarding claim 26, Bach-Y-Rita et al. discloses the device (C) is included in jewelry, in clothing or in a medical device (“Several transmitters 104 are then fixed in an array by connecting web 106 made of fabric or some other flexible material capable of closely fitting above the skin 102 in contour-fitting fashion” [0030]).
Regarding claim 27, Bach-Y-Rita et al. discloses wherein the device (C) is a patch or a bandage (“web 106 made of fabric” [0030]).
Regarding claim 28, Bach-Y-Rita et al. discloses wherein particles (B) are incorporated in a composition which is a liquid, a tattoo ink, or a gel, or part of a needle or microneedle or are part of a tip of a needle or microneedle ([0032], [0035]).
Regarding claim 29, Bach-Y-Rita et al. discloses when the source of energy is a magnetic source (“The transmitters 104 are each capable of emitting a signal (e.g., a magnetic field) which, when emitted, causes its adjacent embedded stimulator 100 to move.” [0030]), the particle is prepared from a magnetoelectric material (see claim 20 above).
Regarding claim 30, Bach-Y-Rita et al. discloses a method for sensory enhancement in a healthy subject or for creating new sensory means in a healthy subject comprising providing said healthy subject with a system according to claim 20 (see above) and implanting or injecting particles (B) into a site of said subject ([0032], [0035]) to enhance or allow, when stimulated by the removable device (C), the perception of a physical signal, chemical signal and/or biological signal which are insufficiently or not perceived by a sense of the subject in the absence of stimulation ([0008], [0031]).
Regarding claim 31, Bach-Y-Rita et al. discloses providing touch sensor restoration in a subject at least partially deprived of vision or hearing ([0044]), comprising implanting or injecting a composition of particles 100 into said subject ([0032], [0035]), such that the particles interact with biological cells of the dermis and/or epidermis ([0029]), and activating said particles with an external source of energy (“The transmitters 104 are each capable of emitting a signal (e.g., a magnetic field) which, when emitted, causes its adjacent embedded stimulator 100 to move.” [0030]).
Bach-Y-Rita et al. discloses the particles are prepared from a material selected from a magnetic material ([0030]) but does not expressly disclose they are prepared from a piezoelectric or magnetoelectric material. However Bach-Y-Rita et al. does teach that diaphragm 212 of particle may be a piezoelectric bimorph bending motor ([0038]), regarded as a piezoelectric or combined magnetic and electric material. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bach-Y-Rita et al. to substitute the purely magnetic material with a piezoelectric or magnetoelectric material as it has been contemplated as a possibility in the prior art, and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Bach-Y-Rita et al. does not expressly disclose wherein the size of particles is below 100 µm but does teach the particles are sized 0.2mm or less. Goldberg et al. teaches a known size dimension of magnetic nanoparticles within the body ([0005]) are below 100 µm (“5 and 500 nm” [0011]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bach-Y-Rita et al. to select a particle size of below 100 µm as taught by Goldberg et al. since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., INC., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 32, Bach-Y-Rita et al. discloses wherein the composition is a liquid, a tattoo ink, or a gel ([0032], [0035]).
Regarding claim 33, Bach-Y-Rita et al. disclose wherein the source of energy is selected from a magnetic source ([0030]).
Regarding claim 34, Bach-Y-Rita et al. discloses when the source of energy is a magnetic source (“The transmitters 104 are each capable of emitting a signal (e.g., a magnetic field) which, when emitted, causes its adjacent embedded stimulator 100 to move.” [0030]), the particle is prepared from a magnetoelectric material (see claim 31 above).
Regarding claim 35, Bach-Y-Rita et al. discloses a kit comprising at least two distinct populations of particles 100 together with a tool (“needle (or array of spaced needles)” [0035]) designed to deposit and/or position the particles at a site of the subject’s body (“dermis or subcutaneous layer at the desired depth and location” [0035]) for them to stably interact with biological cells of the dermis and/or epidermis ([0029]), and particles are activable (“The transmitters 104 are each capable of emitting a signal (e.g., a magnetic field) which, when emitted, causes its adjacent embedded stimulator 100 to move.” [0030]).
Bach-Y-Rita et al. discloses the particles are prepared from a material selected from a magnetic material ([0030]) but does not expressly disclose they are prepared from a piezoelectric or magnetoelectric material. However Bach-Y-Rita et al. does teach that diaphragm 212 of particle may be a piezoelectric bimorph bending motor ([0038]), regarded as a piezoelectric or combined magnetic and electric material. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bach-Y-Rita et al. to substitute the purely magnetic material with a piezoelectric or magnetoelectric material as it has been contemplated as a possibility in the prior art, and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Bach-Y-Rita et al. does not expressly disclose wherein the size of particles is below 100 µm but does teach the particles are sized 0.2mm or less. Goldberg et al. teaches a known size dimension of magnetic nanoparticles within the body ([0005]) are below 100 µm (“5 and 500 nm” [0011]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bach-Y-Rita et al. to select a particle size of below 100 µm as taught by Goldberg et al. since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., INC., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 36, Bach-Y-Rita et al. discloses wherein the tool is one or more needles, one or more microneedles, a patch or an injector (“needle (or array of spaced needles)” [0035]).
Regarding claim 37, Bach-Y-Rita et al. discloses a kit comprising particles (B) 100, a removable device (C) 106, and one or several tools selected from a sensor, an electrode, a memory and a processor (“computer, ASIC, or other suitable processor” [0031]), wherein the removable device (C) is wearable by a subject (“Several transmitters 104 are then fixed in an array by connecting web 106 made of fabric or some other flexible material capable of closely fitting above the skin 102 in contour-fitting fashion” [0030]), and particles (B) are ii) activable by a signal emitted by the removable device (C) (“The transmitters 104 are each capable of emitting a signal (e.g., a magnetic field) which, when emitted, causes its adjacent embedded stimulator 100 to move.” [0030]).
Bach-Y-Rita et al. discloses the particles (B) are i) prepared from a material selected from a magnetic material ([0030]) but does not expressly disclose they are prepared from a piezoelectric or magnetoelectric material. However Bach-Y-Rita et al. does teach that diaphragm 212 of particle (B) may be a piezoelectric bimorph bending motor ([0038]), regarded as a piezoelectric or combined magnetic and electric material. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bach-Y-Rita et al. to substitute the purely magnetic material with a piezoelectric or magnetoelectric material as it has been contemplated as a possibility in the prior art, and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Bach-Y-Rita et al. does not expressly disclose wherein the size of particles is below 100 µm but does teach the particles are sized 0.2mm or less. Goldberg et al. teaches a known size dimension of magnetic nanoparticles within the body ([0005]) are below 100 µm (“5 and 500 nm” [0011]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bach-Y-Rita et al. to select a particle size of below 100 µm as taught by Goldberg et al. since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., INC., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bach-Y-Rita et al. (US 2011/0071439) in view of Goldberg et al. (US 2019/0388560) and as evidenced by Chu et al. (US 2020/0054873).
Regarding claim 21, Bach-Y-Rita et al. discloses targeting nerve cells in the dermis ([0029]) but does not expressly disclose wherein the biological cell is selected from a keratinocyte, melanocyte, Merkel cell, Langerhans cell, fibroblast, mast cell, macrophage, lymphocyte and platelet, the LTMR is selected from SAI-LTMR, SAII-LTMR, RAI-LTMR, RAII-LTMR, Aδ-LTMR and C-LTMR and/or the end-organ is selected from Ruffini corpuscle, Meissner corpuscle, Pacinian corpuscle and longitudinal lanceolate ending. This limitation is regarded as directed to a manner of operating the device and not given patentable weight. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). However to expedite prosecution, Chu et al. teaches Merkel cells are neuron-like cells in vertebrate skin, forming close synaptic-like contacts with SAI-LTMRs at the epidermal-dermal junction that directly transduce tactile information into afferent AP signaling ([0426]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the device of Bach-Y-Rita et al. would be capable of stably interacting with biological cells of the dermis and/or epidermis, in particular Merkel cells, as evidenced by Chu et al. teaching that the nerve cells in the dermis described by Bach-Y-Rita et al. are regarded as Merkel cells ([0426]).
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 ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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, David Hamaoui can be reached at (571) 270-5625. 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.
/ERICA S LEE/Primary Examiner, Art Unit 3796
Prosecution Insights