DETAILED ACTION
Claim Objections
Applicant is advised that should claim 11 be found allowable, claim 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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:
“stimulus applying units” in claims 1, 2, 5, 7, 8, 9, 13, and 14
“applying member accommodating unit” in claims 3-4
“a holding member” in claim 8
“the insertion protrusion unit” in claim 9
“light stimulus applying member in claims 10-12
“control unit” in claims 5-6 and 13
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.
“stimulus applying units” appears in par. 87 of the Applicant’s Specification as the magnet member and will be interpreted as such.
“applying member accommodating unit” appears in par. 20 as a space.
“a holding member” appears in par. 157-163 as a silicone extension of the housing.
“the insertion protrusion unit” appears in par. 153 as an ear tip made of a flexible material.
“light stimulus applying member” appears in par. 193 as an optical fiber.
“control unit” appears in par. 115 as a microprocessor, CPU, and the like.
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 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 1-14 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.
Claims 1 and 8 recite the limitation "the stimulus applying unit" in lines 3, 5, and 7 for claim 1 and lines 3, 4, and 6 for claim 8. There is insufficient antecedent basis for this limitation in the claims. Claims 1 and 8 disclose two separate housings accommodating the same stimulus applying unit instead of each housing accommodating its own stimulus applying unit.
Claims 1, 2, 5, 7, 8, 9, 13, and 14 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. There is no structure defined for the “stimulus applying units”. In par. 87, it is referred to as a magnet, but the claims then disclose it containing other components such as a battery and control unit.
Claims 3-4 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. The accommodating unit is described as space, which has no structure.
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 1-3, 8-10, and 13-14 are rejected under 35 U.S.C. 101 because 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.
Claims 1-3, 8-10, and 13-14 are 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). “Target portion” includes a body part such as skin, nerve, muscle, etc. For example, the limitation “a first housing which is arranged on one side of the target portion” actively claims the target portion and its relation to the structure. Appropriate correction is required throughout the claims (“adapted to” or “configured to be arranged”).
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) 1-2, 8, and 10-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by La Rovere et al. (PG Pub. 2020/0345970).
Regarding Claim 1, La Rovere discloses a stimulus applying apparatus, comprising:
stimulus applying units (see energy emitters 104 and 105) which are configured to apply a stimulus to a target portion (see par. 22); and
a housing which is coupled to the stimulus applying unit, wherein the housing comprises:
a first housing (see dorsal body 101) which is arranged on one side of the target portion and accommodates the stimulus applying unit (see Fig. 1A); and
a second housing (see ventral module 102) which is arranged on the other side of the target portion and accommodates the stimulus applying unit (see Fig. 1A and 1B), and wherein the stimulus applying unit accommodated in the first housing and the stimulus applying unit accommodated in the second housing are configured to apply magnetic attractive force to each other (see par. 139).
Regarding Claim 2, Le Rovere discloses wherein the stimulus applying unit comprises a magnetic member which is accommodated in the housing and comprises a stimulating electrode which is configured to apply the stimulus to the target portion, and wherein the magnetic member is located to be biased on one side of the housing facing the target portion (see par. 22). The examiner considers for magnetic attraction to occur, magnets necessarily have to face the target portion [emphasis added].
Regarding Claim 8, see rejection of claim 1 above. Le Rovere discloses ventral module 102 as the main housing as it is inserted into the cymba concha trench 145 (see par. 139 and Fig. 1B) and dorsal body 101 as the sub-housing. Le Rovere also discloses a holding member (see connection cable 103) which extends between the main housing and the sub-housing, and is configured to be mounted on another side of the target portion (see Fig. 1B).
Regarding Claim 10, La Rovere discloses wherein the stimulus applying unit
comprises:
a magnetic member which comprises a stimulating electrode and is configured to apply an electrical stimulus to the target portion (see par. 23); and
a light stimulus applying member (see LEDs; par. 24) which is configured to apply an optical stimulus to the target portion (see par. 148).
Regarding Claims 11-12, La Rovere discloses wherein the magnetic member is
arranged in any one or more of the main housing and the sub-housing (see par. 22 and 139), and wherein the light stimulus applying member is arranged to be adjacent to the magnet member in any one or more of the main housing and the sub-housing (see par. 150).
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(s) 3-7 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over La Rovere et al. (PG Pub. 2020/0345970) in view of Jeong (PG Pub. 2025/0144436).
Regarding Claim 3, La Rovere does not elaborate on how the magnetic members are accommodated within the housings. Jeong discloses a similar device wherein the housing (see cases 11-1 through 11-3; Fig. 3) comprises an applying member accommodating unit (the space that holds the magnets) that accommodates the magnetic member (see electromagnetic units 201) and is located adjacent to the target portion (see knee 1), and wherein the applying member accommodating unit
comprises an accommodating space which is formed to be recessed on one surface facing the target portion to accommodate the magnetic member (see Fig. 3). It would have been obvious to one of ordinary skill in the art at the time of the invention to have some type of space for the magnetic member to sit within a recess in the surface of the housing for a smooth and comfortable interface with the target portion (see Fig. 3).
Regarding claim 4, Jeong further discloses wherein the housing comprises a wire-guiding unit which is continuous with the applying member accommodating unit and is formed to extend in a direction opposite to the applying member accommodating unit, and wherein the wire-guiding unit (see coated insulating cables 214) comprises guide hollows that are located therein and are formed to penetrate along an extension direction thereof such that one end in the extension direction communicates with the accommodating space, and the other end in the extension direction communicates with the outside (see Fig. 6). It would have been obvious to one of ordinary skill in the art at the time of the invention to include wire-guiding units because Jeong teaches it allows the application of current to the magnets to polarize them (par. 53 and 62).
Regarding Claim 5, Jeong further discloses wherein the stimulus applying unit comprises a control unit (see controller 100) which is electrically connected to the magnetic member (see electromagnetic units 201) and is configured to apply power and control signals to the magnetic member (see par. 47 and Fig. 2). It would have been obvious to one of ordinary skill in the art at the time of the invention to connect a control unit to the magnetic members because Jeong teaches it helps to control the voltage and current that are applied to the units to activate the cells at the target region (see par. 49).
Regarding Claim 6, Jeong discloses wherein the control unit is located
outside the housing (see Fig. 3), and comprises a conductive wire member (see wire 212) which extends between the control unit and the magnet member and is configured to conduct electricity with the control unit and the magnet member, respectively (see par. 61). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide a wire member between the control unit and the magnet members so the power and control signals can be sent (see par. 60).
Regarding Claim 7, La Rovere discloses wherein the stimulus applying unit
comprises a battery (see par. 156), but does not elaborate on the specific location within the housing. Jeong discloses a battery which is accommodated inside the housing to be adjacent to the magnetic member and is configured to apply power and control signals to the magnetic member (see battery 108; par. 48 and Fig. 4). It would have been obvious to one of ordinary skill in the art at the time of the invention to include the battery unit next to the magnet within the housing to apply power without the need for an external power source (see par. 48).
Regarding Claim 14, see rejections of similarly worded claims 2 and 7 above.
Claim(s) 9 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over La Rovere et al. (PG Pub. 2020/0345970) in view of Goodall et al. (PG Pub. 2018/0021564).
Regarding Claim 9, La Rovere discloses ventral module 102 is inserted in the cymba conchae (see par. 139), but does not elaborate on any protrusion that allows for this. Goodall discloses a similar ear stimulator where the main housing (housing 4328; par. 283 and Fig. 44) comprises an insertion protrusion unit (see earbud 4316) which is formed to protrude toward the target portion, and is inserted into the opening of the target portion (see par. 282), and wherein the stimulus applying unit (see electrode 4312) is arranged on the insertion protrusion unit (see par. 282), and is configured to apply the stimulus to a part that is adjacent to the opening of the target portion (see par. 281). It would have been obvious to one of ordinary skill in the art at the time of the invention to include a protrusion with the stimulus applying unit on it because Goodall teaches it helps secure the electrode in place (see par. 282) for improved contact (see par. 259).
Regarding Claim 13, see rejections of similarly worded claims 2, 5, and 6 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Harper et al. (PG Pub. 2019/0151604) discloses using magnets to hold a stimulator around an auricle of the ear (see par. 8 and 21; Fig. 8A-8B).
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/N.P/Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796