DETAILED ACTION
This Office Action is responsive to the Amendment filed 5 February 2026.
Claims 1-20 are now pending. The Examiner acknowledges the amendments to claims
1, 5-7, 10-12, 14, 15, 17, 18 and 20.
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 .
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: “wireless smart device” in claim 6; and “remote mobile device” in claim 12.
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 Objections
Claims 1, 6, 9, 10 and 16 are objected to because of the following informalities:
At line 4 of claim 1, it is suggested that the claim language clarify that the first and second electrode containment portions are disposed on respective opposite sides of the central body portion such as by -- first and second electrode containment portions disposed on respective opposite sides of the central body portion--; or -- first and second electrode containment portions disposed respectively on opposite sides of the central body portion--. Claim 10 at lines 5-6 are suggested to also be amended accordingly. Claim 10 at lines 7-8 are suggested to also be amended accordingly with respect to “first and second hinge portions extending along a length of and parallel to the central body portion” (respectively). Claims 9 and 16 should also be amended accordingly.
At line 15 of claim 1, “the first electrode disposed” should apparently read –wherein the first electrode is disposed--; and at line 16, “the second electrode disposed” should apparently read –wherein the second electrode is disposed--.
In claim 6, “smart device-configured” should apparently read –smart device configured--; and “that is communication” should apparently read –that is in communication--.
Appropriate correction is required.
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 1-9 and 15 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 1 at lines 8-11 recites “…first and second hinge portions extending between the central body portion and the first and second electrode containment portions…”. Based on this recitation, it is unclear if first and second hinge portions extend between the central body portion and the first electrode containment portion, in addition to first and second hinge portions extending between the central body portion and the second electrode containment portion, or if a respective hinge portion (the first hinge portion, for instance) extends between the central body portion and the first electrode containment portion, with a second hinge portion extending between the central body portion and the second electrode containment portion. Further clarification is required for a proper understanding of the recitation.
Claim 1 at line 15 recites “the electrical stimulation”. It is unclear which “electrical stimulation” is being referenced as line 11 recites “electrical stimulations”. A suggested amendment to line 15 is –the electrical stimulations--.
Claim 5 at line 3 recites the limitation "the electrical stimulation generated by the circuitry". There is insufficient antecedent basis for this limitation in the claim.
Claim 15 at line 2 recites the limitation "the power to the therapy circuitry". There is insufficient antecedent basis for this limitation in the claim. A suggested amendment is –power to the therapy circuitry--.
Allowable Subject Matter
Claims 1-9 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claim 15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 10-14 and 16-20 are allowable over the prior art of record upon resolution of the aforementioned objections. The following is a statement of reasons for the indication of allowable subject matter: regarding claims 10-14 and 16-20, while the prior art teaches a reusable system for altering an approaching ejaculation event, comprising: a housing comprising: an elongate central body portion, first and second electrode containment portions; first and second hinge portions; wherein the first electrode containment portion is configured to be displaceable relative to an axis of the central body portion at the first hinge portion and the second electrode containment portion is configured to be displaceable relative to an axis of the central body portion at the second hinge portion, circuitry within the housing configured to deliver electrical stimulation; a power supply in operative communication with the circuitry; a controller configured to communicate with the circuitry and control and alter a stimulation patter of the electrical stimulation; and one or more electrode pairs disposed on a portion of the housing, the prior art of record does not teach or fairly suggest a reusable system for altering an approaching ejaculation event as claimed by Applicant, wherein the first and second electrode containment portions are disposed on opposite sides, respectively, of the central body portion; and wherein the first and second hinge portions extend along a length of and parallel to the central body portion, respectively.
Response to Arguments
Applicant’s arguments filed 5 February 2026 with respect to the objection to the Specification have been fully considered and are persuasive in light of the amendments.
Applicant’s arguments filed 5 February 2026 with respect to the rejection of claims 14 and 15 under 35 U.S.C. 112(a) have been fully considered and are persuasive in light of the amendments.
Applicant’s arguments filed 5 February 2026 with respect to the rejection of claims 1-20 under 35 U.S.C. 112(b) have been fully considered and are persuasive, however new grounds of rejection are presented above in response to the amendments.
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 CHRISTINE HOPKINS MATTHEWS whose telephone number is (571)272-9058. The examiner can normally be reached Monday - Friday, 7:30 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A Marmor, II can be reached on (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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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791