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 .
Response to Amendment
This Office action is responsive to the amendment filed June 18, 2026. As directed by the amendment, claims 1 and 19 have been amended, claims 12-17 have been cancelled and claims 21-26 have been added, thus, claims 1-11 and 18-26 are presently pending with claims 10-11, 18 and 20 being previously withdrawn from further consideration.
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: “position sensor being configured to generate a signal indicating a real-time position of the position sensor” in claim 1. See [0037] of specification as filed for corresponding structure - one or more coils.
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 21-24 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 21-24 each recite the limitation "the alveolar ridge". There is insufficient antecedent basis for this limitation in the claim. Note that claim 1 sets forth “a portion of an alveolar ridge” in line 2-3 and makes reference to “the alveolar ridge of the patient” in line 6 of the claim. It is unclear whether recitations in claims 21-24 refer to “the portion of alveolar ridge” or “the alveolar ridge of the patient”, thus rending the claims indefinite. For examination purposes only, and consistent with the elected invention, it is presumed that the recitations in claims 21-24 refer to “the portion of the alveolar ridge”.
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.
Claims 1,3-9, 19 and 21-26 are rejected under under 35 U.S.C. 103 as being unpatentable over previously cited Pesach et al. US 20200121429 A1 (“Pesach”) in view of Dekel et al., US 20230097249 A1 (“Dekel”).
Regarding claim 1 and 19, see Pesach teaches in [0177] “… in some embodiments a tracking device is attached to a tray for collecting impressions and, optionally, the tray is affixed to mouth objects using molding putty. In some embodiments, collecting an impression (e.g. a tooth impression) is combined with attaching a tracking element. For example, in some embodiments, a tray for molding putty includes a tracking element” which reads on an apparatus, comprising:(a) a tray, the tray being configured to correspond to at least a portion of an alveolar ridge of a patient (see tray for collecting impressions would correspond to at least a portion of an alveolar ridge of a patient);(b) a deformable material (see molding putty), the deformable material being configured to receive dentition of the alveolar ridge of the patient and thereby secure the tray relative to the alveolar ridge of the patient (the molding putty would receive dentition of the alveolar ridge of the patient during creation of a tooth impression); and (c) a position sensor (see tracking element) fixed relative to the tray, the position sensor being configured to generate a signal indicating a real-time position of the position sensor within three-dimensional space ([0294] “tracking element is an electromagnet …. tracking element produces a spatially variable electromagnetic field distribution”). The method steps of claim 19 are necessarily performed during collecting an impression that would require securing the apparatus comprising the tray, molding putty and position sensor via engagement of dentition of the patient and the deformable material (i.e., molding putty).
Pesach does not explicitly disclose or rather is silent as to structural details of the tray, specifically, that the tray corresponds to only a portion of an alveolar ridge of the patient. However, Dekel in the same field of endeavor discloses (see e.g., [abstract) “… system includes one or more channeled trays and a moldable thermoplastic material for inserting into a channeled tray. The moldable thermoplastic material is hardenable into an impression part such that when mated to the at least a portion of the human jaw … At least one channeled tray in the system includes a fiducial region detectable in the volumetric CT image in a fixed spatial relation relative to the coupling surface region and at least one channeled tray is pose-trackable by the image guidance system” – the at least one channel tray structure is discussed in [0020] and is adapted to receive at least one tooth, as depicted in Figs. 2A-2D, the tray that receives at least one tooth (i.e., channeled tray) would corresponds to a portion of an alveolar ridge of the patient, see also illustration Fig. 1. Additionally, in view of discussion in [0039-0041], the deformable material (i.e., moldable thermoplastic material) is configured to receive dentition of the portion of the alveolar ridge of the patient (references to surfaces of the human jaw and illustration Fig. 3A showing tooth sockets on portion of the jaw, i.e., alveola ridge molded and illustration Fig. 1).
In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have applied one or more channeled trays of Dekel in the apparatus and/or method of Pesach, to achieve the same end result of collecting tracking data from the patient, to arrive at the claimed invention.
Regarding claims 3-8, see teachings of Pesach, the deformable material is putty, molding putty is elastic and plastic deformable, in view of [0294] the tracking element comprises one or more coils that would generate a signal indicating a real-time position in response to an electromagnetic field and [0299] connection of tracking element may either be wireless communication or alternatively, include cables’s and/or wires connected to an external component for example an external processor.
Regarding claims 21-24, as modified by the channel tray of Dekel, and teachings thereof, see e.g., [0020], each channel tray is “… adapted to receive at least one tooth” (examiner note: teeth are located in both posterior and anterior (i.e. front and back) regions as well as maxillary and mandibular regions (upper and lower jaw), encompasses, a tray that is configured to correspond to only anterior portion or only a posterior portion of the alveola ridge (examiner note: anterior portion of alveolar ridge refers to a portion of and posterior portion of the alveolar ridge refers to the section located towards the back of the mouth, encompassing the molars and premolars – a channel tray of Dekel that is adapted to receive at least one tooth on the front or back section of mouth reads on this claim limitations. The tray is configured to correspond to upper jaw or lower jaw portions, thus reading on the maxillary or mandibular portion of the alveolar ridge. Since Dekel discloses at least one channel tray, the method would include selecting from anterior or posterior region of the alveolar ridge to secure the apparatus or selecting form a maxillary or mandibular region to secure the apparatus.
Regarding claim 9 and 25-26, [as to claim 9] see [0077] of Pesach cited in claim 1 above, the tray of Pesach includes a first side and second side, the molding potty is necessarily on a first side of the tray that receives dentition of alveolar of the patient during taking an impression. While it is not specifically mentioned that the position sensor is positioned on the second side of the tray, it would have been obvious to position the position sensor on the second side of the tray away from the first side, so as not to interfere with the tooth impression.
[As to claim 25-26], see [0299] of Pesach, connection of tracking element may either be wireless communication or alternatively, include cables’s and/or wires connected to an external component for example an external processor, the combination of the tracking element and wireless communication module or cable for wired communication within the sensor reads on a sensor assembly housing, the sensor assembly will be affixed to an opposite side f the tray as the deformable material for substantially similar rationale as discussed in claim 9 above.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been fully considered but are moot in light of a new ground of rejection in light of amendments to the claims.
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 BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797
