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
The Applicant filed Amendments to the Claims and Remarks on July 31, 2026 in response to the Examiner’s Requirement for Restriction/Election, mailed March 3, 2026.
Amendments to the Claims
At this time, of the elected claims, claims 46-50 and 55-56 are pending. Claims 1-3, 5-7, 11-14, 17-19, 22-29, 34-35, 39-41, 44, 46-50, 53, and 55-56 have been amended. Claims 8-10, 15-16, 30-33, 37-38, 45, 51-52, and 54 have been cancelled. The Applicant has added no new claims. The Applicant asserts that no new matter is added. Of the elected claims, claim 46 is in independent form. (Remarks, pg. 11)
Response to Election/Restriction
The Applicant stated, “Without acquiescing to the Examiner's reasons, the Applicant elects Group III - Claims 46 to 50 and 55 to 56, without traverse.” (Remarks, pg. 12)
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract uses legal phraseology, “said” in line 6. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see pg. 3, paragraph [0006]). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “computing unit” in claims 46, 55, and 56 and “about” in claims 47-50.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
According to paragraph [0064] of the instant Specification, "a computing unit is a device that processes data, for example, microcontrollers, microprocessors, DSCs (Digital Signal Controllers), fPGAs (field Programmable Gate Arrays), CPLDs (Complex Programmable Logic Devices), ASICs (Application Specific Integrated Circuits), SoCs (Systems on Chip), PSoCs (Programmable Systems on Chip), computers, servers, tablets, cellular telephones, smart phones and computer units known to those skilled in the art, and combinations of these." For the purpose of examination, "computing unit" will be interpreted as such.
According to paragraph [0139] of the instant Specification, " As used herein, "about" refers to +20% to -20% variation." For the purpose of examination, "about" will be interpreted as such.
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 46-50 and 55-56 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 46 recites the limitation “an arrangement of electromagnetic transducers…” and then recites “applying an electric field stimulus to a tissue through an arrangement of electromagnetic transducers.” The use of the article ”a” in each reference to electromagnetic transducers implies multiple different sets of transducers instead of the same set. It is unclear if Applicant is using the first claimed set of transducers for the stimuli or a second, different set of transducers. The metes and bounds are unclear.
Additionally, Claim 46 claims a device in the preamble but then claims a method in the body. It is unclear if Applicant is attempting to claim a device or a method with the claim limitations. The metes and bounds are unclear.
Claims 47-50, 55 and 56 are rejected due to their dependence on indefinite Claims 46.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 46-50 and 55-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 39-43 and 45-46 of U.S. Patent No. 11,826,568. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application would be anticipated by the claims of the patent.
The table below has the instant and patented claims copied, with similarities underlined.
Instant Application No. 18/505,665
U.S. Patent No. 11,826,568
Claim 46. A device for stimulating a tissue with electromagnetic fields, the device comprising:
a computing unit;
an external power source connected to the computing unit;
a decoupling circuit connected to the external power source and to the computing unit; and
an arrangement of electromagnetic transducers connected to the computing unit and to the decoupling circuit, the arrangement is configured to be disposed over the tissue;
wherein the computing unit implements a method for stimulating a tissue with electromagnetic fields, the method comprising the stages of:
a) applying an electric field stimulus to a tissue through an arrangement of electromagnetic transducers that receives an activation signal, a frequency of which varies from an initial tissue stimulation frequency (f.sub.ie) to a final tissue stimulation frequency (f.sub.fe) with increments or decrements in steps of a frequency delta (Δf.sub.e) during a time delta (Δt.sub.e);
b) measuring a tissue impedance response to the stimulus of stage (a);
c) establishing a reference level with the tissue impedance response measured in stage (b);
d) establishing a tolerance (NT) to the reference level established in stage (c);
e) determining lower tissue stimulation frequencies (f.sub.bx) as the point where the tissue impedance response falls below the NT established in stage (d); and
f) determining upper tissue stimulation frequencies (f.sub.tx) as the point where the tissue impedance response returns to the NT established in stage (d); wherein the f.sub.tx are greater than the f.sub.bx and "x" is a natural number greater than or equal to 1.
Claim 39. A device for stimulating a tissue with electromagnetic fields, the device comprising:
at least one processor;
an external power source connected to the at least one processor;
a decoupling circuit connected to the external power source and to the at least one processor;
an arrangement of electromagnetic transducers connected to the at least one processor and to the decoupling circuit, the arrangement configured to be disposed over the tissue; and
at least one non-transitory computer-readable media storing computer-executable instructions that, when executed by the at least one processor perform a method for stimulating the tissue with electromagnetic fields, the method comprising the stages of:
a) applying an electric field stimulus to the tissue through the arrangement of electromagnetic transducers that receives an activation signal, a frequency of which varies from an initial tissue stimulation frequency (f.sub.ie) to a final tissue stimulation frequency (f.sub.fe) with increments or decrements in steps of a frequency delta (Δf.sub.e) during a time delta (Δt.sub.e);
b) measuring a tissue impedance response to the electric field stimulus of stage (a);
c) establishing a reference level with the tissue impedance response measured in stage (b);
d) establishing a tolerance (NT) to the reference level established in stage (c);
e) determining lower tissue stimulation frequencies (f.sub.bx) as a point where the tissue impedance response falls below the NT established in stage (d);
f) determining upper tissue stimulation frequencies (f.sub.tx) as a point where the tissue impedance response returns to the NT established in stage (d); wherein the f.sub.tx are greater than the f.sub.bx and “x” is a natural number greater than or equal to 1;
g) determining stimulation frequency bands based on the f.sub.bx determined in stage (e) along with the f.sub.tx determined in stage (f);
h) applying the electric field stimulus to the tissue through the arrangement of electromagnetic transducers that receive an activation signal, the frequency of which varies by the stimulation frequency bands determined in stage (g) with increments or decrements in steps of a Δf.sub.e during the Δt.sub.e;
i) establishing a maximum stimulation time (t.sub.max);
j) measuring the tissue impedance response to the electric field stimulus of stage (h); and
k) verifying that the tissue impedance response measured in stage (j) in the stimulation frequency bands determined in stage (g) returns to the NT established in stage (d) or exceeds the t.sub.max.
Claim 47. The device of claim 46, wherein the NT is between about 25% and about 50%.
Claim 40. The device of claim 39, wherein the NT is between about 25% and about 50%.
Claim 48. The device of claim 46, wherein the fie and the Δf.sub.e are between about 0.1 Hz and about 1000 kHz.
Claim 41. The device of claim 39, wherein the fie and the Δf.sub.e are between about 0.1 Hz and about 1000 kHz.
Claim 49. The device of claim 46, wherein the Δf.sub.e is a value between about 0.1 Hz and about 1 kHz.
Claim 42. The device of claim 39, wherein the Δf.sub.e is a value between about 0.1 Hz and about 1 kHz.
Claim 50. The device of claim 46, wherein the Δt.sub.e is between about 1 second and about 1 hour.
Claim 43. The device of claim 39, wherein the Δt.sub.e is between about 1 second and about 1 hour.
Claim 55. The device of claim 46, further comprising a plurality of oscillators connected to the computing unit, wherein each of the plurality of oscillators has an activation signal output.
Claim 45. The device of claim 39, further comprising a plurality of oscillators connected to the at least one processor, wherein each of the plurality of oscillators has an activation signal output.
Claim 56. The device of claim 55, wherein the computing unit is connected to a peripheral device selected from the group consisting of: a memory unit, a database, a hard drive, a keyboard, a camera, a touchscreen display, a scanner, a display, and a print.
Claim 46. The device of claim 39, wherein the at least one processor is connected to a peripheral device selected from the group consisting of: a memory unit, a database, a hard drive, a keyboard, a camera, a touchscreen display, a scanner, a display, and a printer.
Regarding instant, independent claim 46, the claim language independent claim 39 of U.S. Patent No. 11,826,568 teaches all components of the instant claim, except for: a computing unit. However, one having ordinary skill in the art at the effective filing date of the invention would understand that the “at least one processor” of U.S. Patent No. 11,826,568 is analogous to the computing unit of the instant application, as the instant Specification defines a computing unit as “a device that processes data, for example, microcontrollers, microprocessors…” (instant [0064]).
Regarding claims 47-50, the claim language claims 40-43 of U.S. Patent No. 11,826,568 teaches all components of the instant claims identically.
Regarding claims 55-56, the claim language independent claim 45-46 of U.S. Patent No. 11,826,568 teaches all components of the instant claim, except for: the computing unit. However, one having ordinary skill in the art at the effective filing date of the invention would understand that the “at least one processor” of U.S. Patent No. 11,826,568 is analogous to the computing unit of the instant application, as the instant Specification defines a computing unit as “a device that processes data, for example, microcontrollers, microprocessors…” (instant [0064]).
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.
Claims 46-50 and 55-56 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the abstract idea without significantly more.
Step 1
Claims 46-50 and 55-56 recite a device and therefore a product.
Therefore, the claims fall within the statutory categories.
Step 2A, Prong 1
Claim 46 recites the limitations of:
“d) establishing a tolerance (NT) to the reference level established in stage (c)”;
“e) determining lower tissue stimulation frequencies (f.sub.bx) as the point where the tissue impedance response falls below the NT established in stage (d)”; and
“f) determining upper tissue stimulation frequencies (f.sub.tx) as the point where the tissue impedance response returns to the NT established in stage (d); wherein the f.sub.tx are greater than the f.sub.bx and "x" is a natural number greater than or equal to 1”.
The limitations of , as drafted, describe a process that, under its broadest reasonable interpretation, includes performance of the limitation in the mind except for the limitation of “a computing unit” to perform the abstract steps. For the limitation of “a computing unit”, paragraph [0064] of the instant Specification, "a computing unit is a device that processes data, for example, microcontrollers, microprocessors, DSCs (Digital Signal Controllers), fPGAs (field Programmable Gate Arrays), CPLDs (Complex Programmable Logic Devices), ASICs (Application Specific Integrated Circuits), SoCs (Systems on Chip), PSoCs (Programmable Systems on Chip), computers, servers, tablets, cellular telephones, smart phones and computer units known to those skilled in the art, and combinations of these." Therefore, the limitation of “a computing unit” would be nothing more than a generic computer.
That is, nothing in the claim precludes the steps from practically being performed in the human mind. MPEP 2106.04(a)(2)(III) states that the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. For example, aside from the recitations of “computing unit” language, the claim encompasses computing and evaluating parameters associated with lower tissue stimulation frequencies (f.sub.bx) and upper tissue stimulation frequencies (f.sub.tx) (mental process), which are never further applied within the Applicant’s claims.
Step 2A, Prong 2
Claim 46 recites “a computing unit to perform the abstract steps. The claim further recites the additional elements of “an external power source”, “a decoupling circuit” and “an arrangement of electromagnetic transducers”.
The limitation of “a computing unit” reads on a computer implemented system and method and are recited at a high level of generality, i.e., as a generic processor, performing a generic computer function of processing data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional limitation does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
For the additional elements of “an external power source”, “a decoupling circuit”, “an arrangement of electromagnetic transducers”, the limitations are recited at a high level of generality would be nothing more than generic computer components and structure that generically links the abstract idea to another technological environment or field of use.
The additional element of “a) applying an electric field stimulus to a tissue through an arrangement of electromagnetic transducers that receives and activation signal” amounts t insignificant, extra-solution activity since the stimuli merely sets up the environment for which the data is gathered and the determinations are made. See MPEP §2161.04(d)(2)(c). The additional elements of “b) measuring a tissue impedance response to the stimulus of stage (a)” and “c) establishing a reference level with the tissue impedance response measured in stage (b)” amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. (See MPEP 2106.04(d)(2), example C.)
Step 2B
As discussed with respect to Step 2A Prong Two, the limitation of “a computing unit” reads on a computer implemented system and method and are recited at a high level of generality, i.e., as a generic processor, performing a generic computer function of processing data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional limitation does not amount to significantly more than the abstract idea itself.
For the additional elements of “an external power source”, “a decoupling circuit”, “an arrangement of electromagnetic transducers”, the limitations are recited at a high level of generality would be nothing more than generic computer components and structure that generically links the abstract idea to another technological environment or field of use.
The additional element of “a) applying an electric filed stimulus to a tissue through an arrangement of electromagnetic transducers that receives and activation signal” amounts t insignificant, extra-solution activity since the stimuli merely sets up the environment for which the data is gathered and the determinations are made. See MPEP §2161.04(d)(2)(c). The additional elements of “b) measuring a tissue impedance response to the stimulus of stage (a)” and “c) establishing a reference level with the tissue impedance response measured in stage (b)” amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. (See MPEP 2106.04(d)(2), example C.) None of the additional elements, alone or in combination, amount to significantly more than the abstract idea itself.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The specification in [0059], [0064], and [0192] does not provide any indication that the computer is anything other than a generic, off-the-shelf computer component. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim, as a whole, amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
Dependent claims 47-50 and 55-56 further limit the abstract idea already indicated in independent claim 46 and they are ineligible for the same reasons provided for claim 46 above.
For these reasons, there is no inventive concept in the claims and thus they are ineligible.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Butters et al. (WO 2014/145284);
Perez et al. (US 2018/0000347);
Cory et al. (US 2006/0085049);
Kobayashi (US 2001/0023362);
Marzano et al. (US 2014/0168917);
John et al. (US 8,788,044); and
Kuck et al. (US 2016/0331262).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY G SCHLUETER whose telephone number is (703)756-4601. The examiner can normally be reached M-F 9:00am-5:30pm EST.
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/M.G.S./Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
