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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/27/2023, 12/2/2023, 9/9/2024, and 11/24/2024 is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, line 15, “preprogmmed” should be –preprogrammed--.
Appropriate correction is required.
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: “muscle stimulating element” and “programmable controller configured and operable to activate…frequencies” in claims 1, 25, and 26; and “cooling device” in claim 22.
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.
Based on Applicant’s specification, “muscle stimulating element” are EMS coils (see pages 7), “programmable controller configured and operable to activate…frequencies” is some type of computer hardware and/or software (structure not explicit in specification or drawings but wording in the specification suggests that the controller is either computer hardware, software, or a combination of both); and “cooling device” includes one or more of Peltier elements, fan devices, or circulating liquid cooling devices (see page 4).
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 14-28 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.
Regarding claims 14 and 25, the phrase "pad-like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "-like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim 14 recites the limitation "the first side" and “the second side” in line 3. There is insufficient antecedent basis for this limitation in the claim. These should read as –a first side of the two sides—and –a second side of the two sides--.
Claim 14 recites the limitation “it” in line 4. It is not clear what the pronoun refers to.
Claims 15-28 inherit the deficiencies of claim 14 or 25 and are likewise rejected.
Claim 16 recites the limitation "the skin" in lines 2-3, “the form” in lines 3-4 and “the surface of the electrode” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “in the form of a thin film or retina layer” in lines 3-4. Due to the parentheses, it is not clear if this limitation is supposed to be part of the claim or is meant to show an example.
Claim 16 recites the limitation “an outer layer of conductive gel adhesive may be applied…skin tissue” in lines 4-5. This makes the limitation unclear as it cannot be determined if the conductive gel adhesive is being claimed due to its optional nature.
Claims 17-18 inherit the deficiencies of claim 16 and are likewise rejected.
Claim 17 recites the limitation "the formation" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the muscle fibers" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "the level" in line 2 and “the desired level” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation “the treatment regime” in lines 3-4. It is not clear which regime is being referred to as there can be more than one treatment regime.
Claim 24 recites the limitation “the treatment regime” in lines 3-4. It is not clear which regime is being referred to as there can be more than one treatment regime.
Claim 25 recites the limitation “according to claim 1” in line 2. This is unclear because it refers to a claim that has been cancelled.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 25 recites the broad recitation “a pad-like structure or applicator or pad”, and the claim also recites “the pad” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 26-28 inherit the deficiencies of claim 25 and are likewise rejected.
Claim 28 recites the limitation "the muscle fibers" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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 16 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). Claim 16 recites the limitation “a layer of adhesive gel contacts the skin” in lines 2-3, which is a positive recitation to a human organism. Amending the claim to --a layer of adhesive gel configured to contact the skin-- would overcome the rejection.
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) 25, 27, and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2018/0001107 (Schwarz et al., hereinafter Schwarz).
In regards to claim 25, Schwarz discloses an applicator that uses magnetic fields to treat a patient (title and abstract; paragraphs 10-133). Schwarz describes providing an applicator to a patient’s skin (paragraphs 58) with a coil/muscle stimulating element attached in a case that stimulates the muscles (abstract; paragraphs 11, 31-34, 39, 58, 72-91), thus making it operable to generate a signal that stimulates muscles in vicinity of the skin tissue. Paragraphs 12, 60, 64-69, and 76 suggest combining radiofrequency and magnetic treatment where the applicator would include an electrode to apply RF energy and the activation of the RF electrode and the muscle stimulating element at a frequency to provide a treatment regime that includes skin tightening, skin rejuvenation, and fat reduction.
In regards to claims 27 and 28, Schwarz discloses the limitations of claim 25. In addition, Schwarz discloses that electric current is induced by the pulsed magnetic treatment (paragraph 53), which makes the muscle stimulating element configured to generate an electrical signal that stimulates a motor neuron that innervates one or more muscles, thus meeting the limitations of claim 27. Schwarz further states the intensity of the magnetic fields being applied in paragraph 50, which falls within the range considered as high-intensity in Applicant’s specification, thus meeting the limitations of claim 28.
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) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0001107 (Schwarz et al., hereinafter Schwarz) as applied to claim 25 above, and further in view of US 2016/0346561 (Ron Edoute et al., hereinafter Edoute).
In regards to claim 26, Schwarz discloses the elements of claim 25 and further shows application of treatment regimens to the skin tissue via the activation of the muscle stimulating element and the RF electrode (paragraphs 12, 60, 64-69, and 76). While Schwarz suggests a control unit, Schwarz does not disclose the presence of a programmable controller to activate the electrodes and the muscle stimulating elements. In a related area, Edoute discloses a device used for skin rejuvenation that uses a combination of RF diathermy using electrodes and electromagnetic pulses using stimulation coils (title; abstract; paragraphs 14-593; in particular figures 1, 2, 6, and 7). Edoute describes a control system in paragraphs 31, 43, 60-62, 81, 115, 126, 134, 138, 148, 178, 202, 208, 279-283 that controls the pulses for electromagnetic frequency generation and RF tissue diathermy for simultaneous, sequential, or combination applications. Paragraph 54 and 337 states a medical equipment standard for programmable medical systems so that the device controller is programmable. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the device of Schwarz to use a programmable controller as taught by Edoute in order to allow for control of the RF and electromagnetic therapies for simultaneous, sequential, or combination applications.
Conclusion
The examiner notes that, though no art has been applied against claims 14-24 at this time, they are not presently allowable. The question of prior art will be revisited upon resolution of the numerous issues noted above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791