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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-11 & 20, drawn to a device for diagnosing and treating a temporomandibular joint disorder (TMD), classified in A61B 5/11.
II. Claims 12-19, drawn to a method for diagnosing and treating a temporomandibular joint disorder (TMD), classified in A61B 5/4542.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case Invention II is a process that can be practiced by another materially different apparatus (e.g., any device capable of projecting a pointer and tracking jaw motion) and Invention I can be used for purposes other than the specific method steps recited in Invention II.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Invention requires searching in A61B 5/11 for device level searching of oral diagnostic devices, requiring search queries related to specific dental devices with a chin strap structure connection, etc.
Invention II requires searching in A61B 5/4542 for method level searching of oral diagnostic methods requiring search queries related to threshold methodology steps for determining TMJ irregularities, etc.
-the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries);
-the prior art applicable to one invention would not likely be applicable to another invention; and
-the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these 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.
During a telephone conversation with Alberto Araiza on 16th March 2026 a provisional election was made without traverse to prosecute the invention of Invention I, claims 1-11 & 20. Affirmation of this election must be made by applicant in replying to this Office action. Claims 12-19 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 pointing device configured to project a pointer…’ in claim 1. The limitation of ‘a pointing device configured to project a pointer’ is interpreted to be structured as ‘an optical pointing device… the optical pointing device can be a laser… the pointing device can be a writing instrument such as a pen or a pencil’ described in Para. [0017].
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 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 1-11 & 20 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.
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, claims 1 & 20 recite the broad recitation ‘a stem coupled to the superior end of the chin rest’, and the claim also recites ‘wherein the bottom end of the stem is coupled to the superior end of the chin rest’ 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 1 & 20 recite ‘a device for diagnosing and treating temporomandibular joint (TMJ) disorder (TMD) in a patient’, it is unclear how the device is meant for diagnosing or treating; therefore it is unclear what the scope is or how the scope is meant to be affected by this limitation, it is unclear how the structures claimed are capable of performing these intended use limitations, rendering Claims 1 & 20 indefinite.
Claims 2-11 are rejected for their dependence on a rejected base claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-2, 4-5, 7-10 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over US US 20170312065 A1 to Marshall in view of US 10307233 B1 to Davydov et al. (hereinafter, Davydov).
Regarding Claim 1, Marshall discloses a device for diagnosing and treating a temporomandibular joint (TMJ) disorder (TMD) in a patient (Marshall: Abstract),
the device comprising: a housing configured to receive a pointing device (Marshall: Para. [0058], Fig. 3 item 410),
an oral clasp configured to be insertable into a mouth of the patient (Marshall: Para. [0060], Fig. 3 item 402); and
a pointing device configured to project a pointer on an observation plane in front of the patient (Marshall: Para. [0058], Fig. 3, item 404, 406c),
wherein the pointing device is coupled to the housing (Marshall: Para. [0058], [0060], Fig. 3).
Marshall is silent on a chin rest and a stem.
However, Davydov teaches a chin rest comprising a superior end and an inferior end (Davydov: Col. 2, lines 36-41; Figs. 1 & 2 item 14);
a stem coupled to the superior end of the chin rest (Davydov: Col. 2, lines 36-47; Figs. 1 & 2 item 16),
wherein the stem comprises a top end and a bottom end (Davydov: Col. 2, lines 41-56; Figs. 1 & 2 item 16), and
wherein the bottom end of the stem is coupled to the superior end of the chin rest (Davydov: Col. 2, lines 43-56; Figs. 1 & 2 and
wherein the oral clasp is coupled to the top end of the stem (Davydov: Col. 2, lines 41-43; Figs. 1 & 2).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the device of Marshall to include a chin rest and stem as taught by Davydov to accommodate various heights of human mandibles (Davydov: Col. 2, lines 46-47).
Marshall in view of Davydov is silent on wherein the housing is coupled to the inferior end of the chin rest.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the housing of Marshall in view of Davydov by rearranging the housing to be coupled to the inferior end of the chin rest, this rearrangement would require nothing more than ordinary skill in the art, the particular placement of a housing is held to be an obvious matter of design choice. See MPEP 2144.04 VI. C.
Regarding Claim 2, Marshall in view of Davydov discloses the device of claim 1, Marshall in view of Davydov is silent on the chin rest having a shape of a quarter-sphere.
Applicant’s disclosure provides no reasoning for the shape, thus the shape appears to be a design choice. One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the chin rest of Marshall in view of Davydov to have a shape of a quarter-sphere as a matter of design choice. In this case, it would be obvious to modify the chin rest to accommodate the general shape of a quarter-sphere to yield the predictable results of fitting a chin. See MPEP 2144.04 (IV.)(B.)
Regarding Claim 4, Marshall in view of Davydov discloses the device of claim 1, Marshall teaches wherein the oral clasp is a mouth guard configured to be worn by the patient on at least one tooth of the patient (Marshall: Para. [0044], [0054]).
Regarding Claim 5, Marshall in view of Davydov discloses the device of claim 1, Marshall teaches wherein the pointing device is a laser (Marshall: Para. [0051], [0102]).
Regarding Claim 7, Marshall in view of Davydov discloses the device of claim 1, Marshall teaches wherein the pointing device is permanently coupled to the housing (Marshall: Para. [0060]).
Regarding Claim 8, Marshall in view of Davydov discloses the device of claim 1, Marshall does not explicitly disclose wherein the pointing device is detachable from the housing.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the pointing device of Marshall to be detachable from the housing, as there is no reason provided in Applicant’s specification for this limitation, therefore this limitation is considered obvious as a matter of design choice. If it were considered desirable for any reason to obtain access to the pointing device applied to the housing, it would be obvious to make the pointing device removable for that purpose. See MPEP 2144.04 (V.)(C.)
Regarding Claim 9, Marshall in view of Davydov discloses the device of claim 1, Marshall is silent on wherein the stem is adjustable along a longitudinal axis of the stem.
However, Davydov teaches wherein the stem is adjustable along a longitudinal axis of the stem (Davydov: Col. 2, lines 43-47: Figs. 1 & 2).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the device of Marshall to include the adjustable stem as taught by Davydov to accommodate various heights of human mandibles (Davydov: Col. 2, lines 43-47).
Regarding Claim 10, Marshall in view of Davydov discloses the device of claim 1, Marshall further teaches wherein the device is composed of a plastic material (Marshall: Para. [0098], [0100]).
Regarding Claim 20, Marshall discloses a device for diagnosing and treating a temporomandibular joint (TMJ) disorder (TMD) in a patient (Marshall: Abstract), the device comprising:
a housing configured to receive a pointing device (Marshall: Para. [0058], Fig. 3 item 410),
an oral clasp configured to be insertable into a mouth of the patient (Marshall: Para. [0058], Fig. 3 item 402),
Marshall is silent on a chin rest and a stem.
However, Davydov teaches a chin rest comprising a superior end and an inferior end (Davydov: Col. 2, lines 36-41; Figs. 1 & 2 item 14);
a stem coupled to the superior end of the chin rest (Davydov: Col. 2, lines 36-47; Figs. 1 & 2 item 16),
wherein the stem comprises a top end and a bottom end (Davydov: Col. 2, lines 41-56; Figs. 1 & 2 item 16), and
wherein the bottom end of the stem is coupled to the superior end of the chin rest (Davydov: Col. 2, lines 43-56; Figs. 1 & 2 and
wherein the oral clasp is coupled to the top end of the stem (Davydov: Col. 2, lines 41-43; Figs. 1 & 2).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the device of Marshall to include a chin rest and stem as taught by Davydov to accommodate various heights of human mandibles (Davydov: Col. 2, lines 46-47).
Marshall in view of Davydov is silent on wherein the housing is coupled to the inferior end of the chin rest.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the housing of Marshall in view of Davydov by rearranging the housing to be coupled to the inferior end of the chin rest, this rearrangement would require nothing more than ordinary skill in the art, the particular placement of a housing is held to be an obvious matter of design choice. See MPEP 2144.04 VI. C.
Claim(s) 3 & 11 are rejected under 35 U.S.C. 103 as being unpatentable over Marshall in view of Davydov in further view of US 4272241 A to Crisalli.
Regarding Claim 3, Marshall in view of Davydov discloses the device of claim 1, Marshall is silent on a dental clasp.
However, Crisalli teaches wherein the oral clasp is a dental clasp configured to be worn by the patient on at least one tooth of the patient (Crisalli: Col. 4, lines 48-68).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the oral clasp of Marshall to be a dental clasp as taught by Crisalli to provide a preformed, fitted retention to the patient’s teeth (Crisalli: Col. 4, lines 48-68)
Regarding Claim 11, Marshall in view of Davydov discloses the device of claim 10, Marshall is silent on the plastic material being polylactic acid (PLA) or acrylonitrile butadiene styrene (ABS).
However, Crisalli teaches wherein the plastic material is a polylactic acid (PLA) or acrylonitrile butadiene styrene (ABS) (Crisalli: Col. 6, lines 21-29).
One of ordinary skill in the art at the time the invention was filed to modify the plastic material of Marshall to specify ABS as they are known to be suitable for use in the fabrication of plastic appliance to prevent expansion while heated (Crisalli: Col. 6, 21-29).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Marshall in view of Davydov in further view of US 2009/0315348 A1 to Diebold.
Regarding Claim 6, Marshall in view of Davydov discloses the device of claim 1, Marshall is silent on the pointing device being a writing instrument.
However, Diebold teaches using a writing utensil as a marking implement (Diebold: Para. [0045] “the bottom surface of the shaft tip 170 incorporates a functional component such as a pen, a pencil, a piece of chalk, a paint brush, a magnet, Velcro, a laser pointer, a light source, a camera, a hook, or a suction cup.”).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the pointing device of Marshall to be a writing instrument, by substituting a writing utensil as taught by Diebold to allow the user to engage with the device and disengage with the device using the muscles of the head and neck, without the assistance of others (Diebold: Para. [0012] “…allows the user to engage in using the device and to disengage from the device without the assistance of others… allow the user to engage the muscles of the head and neck to pick up the pointer, manipulate a target object with the pointer, and subsequently drop the pointer from the chin using the muscles of the head and neck when the user has completed a task. ”) and it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case the pointing device of Marshall with that of Diebold with Diebold teaches the elements being alternatives to each other (Diebold: Para. [0045]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAWN CURTIS BROUGHTON whose telephone number is (571)272-2891. The examiner can normally be reached Monday - Friday, 8am-4pm EST..
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791