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
Applicant’s arguments with respect to claims 1-10 in the Remarks dated 05/04/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The amended claims bring up new grounds of rejection under 35 USC 112(a) for enablement and 35 USC 112(b) for indefiniteness based upon the claimed limitation of maintaining a predetermined strength of an electric field independently of inherent resistance.
On page 9 of the Remarks, Applicant argues that the strength of an independent field is not necessarily dependent on resistance and cites the equation for electric field strength E = V/d. Examiner argues that using Ohm’s law (V = IR), the equation may be rewritten as E = (IR)/d which clearly shows that the strength of the electric field is dependent on resistance. Therefore, the claimed invention raises issues of enablement and indefiniteness for functioning in a manner not in accordance with the laws of physics. See rejections under 35 USC 112(a) and 112(b) further detailed below.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 09/29/2022 and 03/07/2025 have been considered by the examiner.
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 limitation(s) is/are: ‘a control unit adapted to charge one of the first electrode or the second electrodes negatively and to charge the other electrode positively, and the control unit is adapted to directly control a strength of an electric field’ in claim 1.
The “control unit” limitation, as interpreted under 35 U.S.C. § 112(f), corresponds to the control circuit 50 disclosed in the specification, together with its associated single-conductor supply lines 51 and 52, which are configured to establish a potential difference between the electrodes and regulate voltage or current via feedback to maintain a preset electric-field strength (see, e.g., Spec. ¶¶ [0079]–[0082], [0018], [0024]–[0029], Figs. 1–2). This structure, and equivalents thereof, perform the recited functions of charging the electrodes and directly controlling the strength of the induced electric field.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-19 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
See MPEP 2164 which states:
The enablement requirement refers to the requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph that the specification describe how to make and how to use the invention. The invention that one skilled in the art must be enabled to make and use is that defined by the claim(s) of the particular application or patent.
The purpose of the requirement that the specification describe the invention in such terms that one skilled in the art can make and use the claimed invention is to ensure that the invention is communicated to the interested public in a meaningful way. The information contained in the disclosure of an application must be sufficient to inform those skilled in the relevant art how to both make and use the claimed invention. However, to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, it is not necessary to "enable one of ordinary skill in the art to make and use a perfected, commercially viable embodiment absent a claim limitation to that effect." CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1338, 68 USPQ2d 1940, 1944 (Fed. Cir. 2003) (an invention directed to a general system to improve the cleaning process for semiconductor wafers was enabled by a disclosure showing improvements in the overall system).
Detailed procedures for making and using the invention may not be necessary if the description of the invention itself is sufficient to permit those skilled in the art to make and use the invention. A patent claim is invalid if it is not supported by an enabling disclosure.
In making a determination as to whether an application has met the requirements for enablement under 35 U.S.C. 112(a), the following factors enumerated in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue."
These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In the case of the instant application the relevant Wands Factors for enablement are considered below:
(A) The breadth of the claims – The scope/breadth of the claimed invention, specifically the limitation “wherein a predetermined strength of the electric field is maintained independently of inherent resistance,” raises issues of enablement due to the fact that the claimed invention claims to function in a manner which is not reflected in real-world examples. It can be appreciated that the strength of an electric field is inherently dependent on resistance as the equation for electric field strength E = V/d may be rewritten using Ohm’s law (V = IR) as E = (IR)/d which clearly shows a resistive influence on the electric field strength.
(B) The nature of the invention – The nature of the invention, as it pertains to application of electric fields across a material (in this case a biologic material), is well-known and understood. A person of ordinary skill in the art would be able to understand and identify the physics associated with an electric field. The strength of a uniform electric field, which assumes ideal conditions and infinite planes is determined using the ratio of Voltage/distance between electrodes. Applicant asserts in the Remarks dated 05/04/2026 that the electric field strength is not necessarily dependent on the resistance between electrodes, which exhibits a particular dependence on the material properties/composition between the electrodes. However, this assumes that the electric field is in a vacuum and does not apply to the claimed invention, which specifically applies an electric field over an organ, which must introduce resistance between the electrodes.
(C) The state of the prior art – As stated above, the prior art provides an understanding of calculating an ideal electric field strength based on voltage and distance between electrodes. However, the prior art also provides an understanding that an electric field generated in a real-life scenario, spanning across a material, must necessarily introduce resistance which effects the strength of the electric field, and must be compensated for.
May (US 10835734 B1) establishes the generation and use of constant intensity electric fields over varying distances which may be maintained through voltage control/regulation. However, the need to control voltage over a varying distance is due to an increase or decrease in resistance of the material between electrodes, which changes proportionally with distance and necessitates a corresponding increase or decrease in voltage drop between the electrodes.
(D) The level of one of ordinary skill – A person of ordinary skill in the art would be aware of the impacts of material resistance on electric field strength, and the deviation from ideal circumstances that may be introduced when generating an electric field in a real-life scenario.
(E) The level of predictability in the art – One skilled in the art could not readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, because it is, on its face, contrary to generally accepted scientific principals regarding electric fields. The strength of an electric field is inherently dependent on resistance as the equation for electric field strength E = V/d may be rewritten using Ohm’s law (V = IR) as E = (IR)/d which clearly shows a resistive influence on the electric field strength, and contradicts the claimed means of control of electric field strength independent of inherent resistance.
(F) The amount of direction provided by the inventor – In order to comply with the enablement requirement, applicant must include sufficient information that teaches exactly how to use or make the claimed invention. Applicant states in the specification that the strength of the electric field is maintained at a preset value by the control unit independent of external influences, but does not include an adequate amount of direction to reasonably enable one of ordinary skill in the art to use/make the claimed invention.
(G) The existence of working examples – As discussed above, May (US 10835734 B1) establishes an example of maintaining a predetermined electric field intensity over varying distance using voltage control. However, May’s working example does not function independently of external influences, such as resistance of the material between electrodes.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure – The claimed invention as disclosed in the specification would require an undue amount of experimentation in order to make and use the claimed invention due to the claimed method of controlling the strength of an electric field independent of external factors. It would take undue experimentation to create an electric field through the human body which performs like an ideal electric field, and is independent of resistance of material between electrodes.
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 1-19 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.
The limitation of ‘wherein a predetermined strength of the electric field is maintained independently of inherent resistance by controlling/regulating a voltage between the charged first electrode and the charged second electrode for any given distance between the charged first electrode and the charged second electrode’ as recited in the amended claims dated 05/04/2026 is indefinite.
The limitation of controlling electric field strength independently of inherent resistance is unclear as the scope of ‘independently’ as recited in the claim is unclear. ‘Independently’ could be interpreted to mean maintaining the strength of the electric field no matter what the inherent resistance is, or it could be interpreted to mean that the strength of the electric field is not dependent on inherent resistance.
The first interpretation of ‘independently’ is contradicted by Applicant’s arguments in the Remarks dated 05/04/2026. The second interpretation of ‘independently’ is contradicted by the understanding of the laws of physics as they pertain to electric fields.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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/A.J.S./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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