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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1 and 75-93 is/are pending. Claim(s) 93 is/are withdrawn. Claim(s) 2-74 is/are canceled.
Response to Arguments
Applicant’s arguments, filed 5/29/2026, with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive. The 35 USC 112(b) rejections of claim 1 have been withdrawn due to Applicant’s amendments.
Applicant’s arguments with respect to claim(s) 1 and 75-92 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.
Applicant argues the amended claim language is not taught by the prior art. New prior art is used herein for all claims.
Election/Restrictions
Newly submitted claim 93 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons.
Group I: a voice generation system (e.g. claims 1, 75-92)
Group II: a method of generating a voice (e.g. claim 93)
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of see following, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Ahmadi F, Noorian F, Novakovic D, van Schaik A (2018) A pneumatic Bionic Voice prosthesis-Pre-clinical trials of controlling the voice onset and offset. PLoS ONE 13(2): e0192257. https://doi.org/10.1371/journal.pone.0192257. [provided by Applicant with the 5/2/2023 IDS]
Ahmadi, et al teaches a voice generation system (e.g. abstract, Figure 2) comprising:
a housing (e.g. Figure 3, outer structure) having
a first opening (e.g. Figure 3, stoma end),
a second opening (e.g. Figure 3, mouth end),
an air passage between the first and the second openings (e.g. abstract, page 3, Method section),
a first air pressure at or near the second opening (there is inherently such a pressure at this end),
a second air pressure corresponding to an oral cavity (there is inherently such a pressure at this end; e.g. page 2, second to last paragraph, coupled to the mouth; Figure 2, mouth end; page 4, step B), PAL driven by difference between stoma and intra-oral pressures),
the second air pressure corresponds to the first air pressure (e.g. page 6, first and second lines; as there is no voice when negative and the driving pressure, Pg, is the difference in the stoma and mouth pressures, which varies with time, there must be a time where there is a Pg of zero when switching from no sound to sound that varies with time; thus, at this point the first and second air pressures correspond to one another),
a moveable member within the housing/air channel (e.g. Figure 3, reed),
a transducer (e.g. Figure 2, page 4, A) component storing the model) configured to convert vibrations of the moveable member into an electrical signal (e.g. page 4, A)),
a speaker (e.g. Figure 2, page 4, A), miniature loudspeaker) configured to produce a sound in the oral cavity of a user (e.g. page 4, A)),
an air pump (e.g. Figure 2, page 4, A), micro-blower) configured to generate airflow (e.g. page 4, A)),
a controller (e.g. Figure 2, control unit) configured to control the air pump (e.g. page 4, C)).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 93 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Allowable Subject Matter
Claims 78 and 81 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 84-86 and 92 are allowable over the prior art, but are otherwise rejected as detailed below.
The prior art lacks a speaker located within the housing in the combination of features as claimed in claim 1, a regulator and controller located within the housing in the combination of features as claimed in claim 1, and the air pump and the moveable member within a second housing in the combination of features as claimed in claim 1.
Claim Objections
Claims 1, 76, 80, 85, and 89 are objected to because of the following informalities:
Claim 1, line 12 recites “an air pump or micro-blower”, which should be “an air pump or a micro-blower”.
Claim 76, line 3 recites “of user’s lung”, which should be “of a lung of the user”.
Claim 80, line 2 recites “or air pressure”, which should be “or an air pressure”.
Claim 80, line 4 recites “or chest”, which should be “or a chest”.
Claim 80, line 6 recites “neck stoma”, which should be “a neck stoma”.
Claim 80, line 10 recites “vibration sensor”, which should be “a vibration sensor”.
Claim 82, line 2 recites “to neck”, which should be “to a neck”.
Claim 85, line 1 recites “claim 84;” which should be “claim 84,”.
Claim 89, line 3 recites “of user’s mouth”, which should be “a mouth of the user”.
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, 75-76, 79-80, 82, 84-89, and 91-92 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, 75-76, 79-80, 82, 86-87, and 91-92 each recite “the air pump” or “the pump”. It is unclear if the language should be “the air pump or the mirco-blower” as introduced in claim 1. For purposes of examination the Examiner considers this language to be “the air pump or the micro-blower”.
Claim 79, line 2 recites “an airflow”. It is unclear if this is the same or different than the instance introduced in claim 1. For purposes of examination the Examiner considers this language to be “the airflow”.
Claim 79, line 3 recites “the airflow”. It is unclear which instance is being referred back to, that introduced in claim 1 or that introduced in claim 79.
Claim 80, each of lines 4-5, 6-7, 7, recites “an air pressure” or “air pressure”. It is unclear if this is the (first) air pressure of claim 1 or a different air pressure.
Claim 80, line 7 recites “ a neck stoma”. It is unclear if this is the same or different than the instance in the preceding line. For purposes of examination the Examiner considers this language to be “the neck stoma”.
Claim 80, lines 10-11 recites “the air flow/air pressure”. It is unclear if these instances are the same or different than those introduced earlier in the claim or in claim 1.
Claim 84, line 3 recites “the air pressure”. It is unclear if this is the first or the second air pressure or a different air pressure.
Claims 88, lines 3 and 6 and Claim 89, line 1 each recites “sound interference”. It is unclear if this is the same instance as introduced in claim 88, line 2 or different instance(s). For purposes of examination the Examiner considers this language to be “the sound interference”.
Claim(s) 85 is rejected as dependent from a rejected claim.
Claim Interpretation - 35 USC § 112, 6th paragraph
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
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.
Claim limitation “see Table I below” has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “see Table I below” coupled with functional language “see Table I below” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. see Table I below.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) see Table I below has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation: see Table I below.
Table I: Language Invoking 112(f)
Claim(s)
Placeholder
Functional Language
Corresponding Structure
1, 75, 86, 88, 92
member
movable
[0044] within housing; vibrates
[0126] in an air channel
[0143] device in Figure 9
[0159] membrane
[0181] mechanical model of vocal folds as a silicone membrane
[0234] a simple or complicated mechanical model of the vocal folds such as synthetic multi-layer silicone model of vocal folds; made of silicone, natural rubber, or any other flexible material; single or multiple layers; one or more vibrating elements; non-uniform 3D pattern
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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.
Ahmadi F, Noorian F, Novakovic D, van Schaik A (2018) A pneumatic Bionic Voice prosthesis-Pre-clinical trials of controlling the voice onset and offset. PLoS ONE 13(2): e0192257. https://doi.org/10.1371/journal.pone.0192257. [provided by Applicant with the 5/2/2023 IDS]
Claim(s) 1, 75-77, 79-80, 82-83, and 88-91 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahmadi, et al.
Regarding Claim 1, Ahmadi, et al teaches a voice generation system (e.g. abstract, Figure 2) comprising:
a housing (e.g. Figure 3, outer structure; annotated Figure 3 below, not including the attached tube) comprising a first opening (e.g. Figure 3, stoma end) and a second opening (e.g. Figure 3, mouth end), wherein the voice generation system is configured such that during use, a first air pressure at or near the second opening (there is inherently such a pressure at this end; stoma end) corresponds to a second air pressure corresponding to an oral cavity of the user (there is inherently such a pressure at this end; e.g. page 2, second to last paragraph, coupled to the mouth; Figure 2, mouth end; page 4, step B), PAL driven by difference between stoma and intra-oral pressures; the tube connects the second end of the housing to the mouth and has the same pressure because the tube is an open air passage) (e.g. page 6, first and second lines; as there is no voice when negative and the driving pressure, Pg, is the difference in the stoma and mouth pressures, which varies with time, there must be a time where there is a Pg of zero when switching from no sound to sound that varies with time; thus, at this point the first and second air pressures correspond to one another),
a moveable member located within the housing (e.g. Figure 3, reed) and configured to vibrate in response to air flowing in the air passage (e.g. page 5, first paragraph, the reed oscillates and therefore vibrates, during respiration (air flowing)),
a transducer (e.g. Figure 2, page 4, A) component storing the model) configured to convert vibrations of the moveable member into an electrical signal (e.g. page 4, A)),
a speaker (e.g. Figure 2, page 4, A), miniature loudspeaker) configured to convert the electrical signal into sound to output the sound into the oral cavity of a user (e.g. page 4, A)),
an air pump or micro-blower (e.g. Figure 2, page 4, A), micro-blower) configured to generate an airflow in the housing and output the airflow in the oral cavity (e.g. page 4, A; the air pump is able to generate air flow and thus able to do so in the housing; as placed this function is able to be met at the mouth end of the housing)); and
a controller (e.g. Figure 2, control unit) configured to control the air pump to generate air flow (e.g. page 4, C)).
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Annotated Figure 3, Ahmadi
Regarding Claim 75, the first opening is configured to be in communication with a neck stoma of the user and/or the pump (e.g. Figure 3; page 5, second paragraph) wherein a respiratory air flow and/or the air flow of the air pump is in communication with and/or drives vibration of the moveable member (e.g. page 5, first paragraph, the reed oscillates and therefore vibrates, during respiration (air flowing)).
Regarding Claim 76, the controller is configured to control the air pump to generate the airflow using sensed or simulated air flow or air pressure of user's lung or at a neck stoma of the user and/or the second air pressure in an oral cavity (e.g. page 4, A), C)).
Regarding Claim 77, the second opening is configured to be in the oral cavity of the user such that in use the first air pressure at or near the second opening corresponds to the second air pressure in the oral cavity of the user (discussed supra for claim 1); and /or wherein the voice generation system, further comprising a tube having a first end connected to the housing around the second opening (e.g. annotated Figure 3 above), wherein a second end of the tube is configured to be inserted into the oral cavity of the user (e.g. Figure 3).
Regarding Claim 79, the housing is configured to connect to an airflow source (e.g. Figure 3; as the housing has openings on each end, it is able to be connected to an airflow source), the airflow source being configured to generate an airflow and to output the airflow into the oral cavity of the user (the housing is able to be connected to an airflow source having these features);
wherein the first opening is configured to be in communication with a neck stoma of the user and/or with the pump such that the first air pressure at the first opening corresponds to the air pressure of the pump and/or the second air pressure at the neck stoma of the user (since the first opening is open, it is able to be communicated with each of these airflows; the first opening being connected to the stoma is explicitly taught as discussed supra for claim 1).
Regarding Claim 80, the controller simulates and controls the air flow or air pressure of the pump using any or a combination of a range of sensors comprising: b) and/or a pressure/flow sensor attached to neck stoma of the user to sense an air pressure/airflow of the lungs or air pressure/airflow at a neck stoma of the user; c) and/or a pressure sensor configured to sense the second air pressure in the oral cavity of the user (e.g. page 4, A), B); only one option claimed is required due to the “or” language).
Regarding Claim 82, the housing is configured to attach to neck or around the neck of the user such that the first opening is in communication with a neck stoma (discussed supra for claim 1; only one option claimed is required due to the “or” language).
Regarding Claim 83, there is a first pressure/vibration sensor configured to sense an air pressure at or close to the first opening of the housing (e.g. Figure 2, “S” box, Figure 2 caption) and a second pressure sensor configured to sense an air pressure at or close to the second opening (e.g. Figure 2, “M” box, Figure 2 caption).
Regarding Claim 88, there is a processing system wherein the processing system is configured to reduce sound interference received at the transducer (e.g. page 7, The Data Set and Pre-processing sections), and wherein the processing system is configured to reduce sound interference based on at least one electrical signal received from: the transducer configured to convert vibrations of the moveable member, and/or at least one interference transducer for receiving sound interference (e.g. page 7, The Data Set and Pre-processing sections).
Regarding Claim 89, wherein the sound interference at the transducer comprises sound outputted by the speaker, and/or speech that is generated when sound outputted by the speaker is modulated by movement of user's mouth (e.g. page 7, The Data Set and Pre-processing sections).
Regarding Claim 90, the voice generation system is configured to be used hands free (e.g. Figures 2-3; the device is in the mouth or stoma/mouth; the tube in the mouth can hold the housing without the use of hands; the component in the mouth is anchored in place and thus hands-free).
Regarding Claim 91, the first opening is configured to be in communication with a neck stoma of the user or the pump such that the air pressure at the first opening corresponds to the air pressure of the pump and/or the air pressure at the neck stoma of the user (the first opening is at the stoma and thus its unaltered pressure corresponds to that of the neck stoma).
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 87 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahmadi, et al as discussed supra and further in view of Baraff (US 5,326,349).
Regarding Claim 87, Ahmadi discloses the invention substantially as claimed but fails to teach the air pump, the speaker, and a pressure sensor are fixed to a denture unit configured to be secured to the oral cavity of the user.
Baraff teaches a dental prosthetic, dentures, having oral components of a voice generation system mounted threreon/therein (e.g. Figures 1, 8; column 7, lines 8-28).
Baraff and Ahmadi are concerned with the same field of endeavor as the claimed invention, namely voice generation systems having multiple components in the oral cavity.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Agmadi such that the air pump, the speaker, and a pressure sensor are fixed to a denture unit configured to be secured to the oral cavity of the user as taught by Baraff in order provide a voice generation system for patients lacking teeth (e.g. Baraff, column 9, lines 31-56).
Relevant Prior Art
US 2014/0358551 to Liu, et al teaches a pneumatic artificial larynx (e.g. Figure 2) having a housing (e.g. Figure 2, formed by the outermost surfaces, not including components mounted thereon). There is a speaker (e.g. [0023], sound generator #7), but the speaker is in the mouth and not within the housing (e.g. Figure 2).
US 6,735,315 B1 to Ifukube, et al teaches a voice generation system placed adjacent the vocal cords on the neck (e.g. Figures 2-3).
US 2024/0081980 A1 to Tohara, et al teaches a voice generation system located in the airway/oral cavity (e.g. Figure 7). Tohara is relevant, but not prior art.
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 LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 10/10/2026
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