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 .
Claims 1-10 are pending and under examination.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-10 in the reply filed on 9/3/2026 is acknowledged.
Claims 11-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/3/2026.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification does not use the term “spacer” while claims 1 and 4-6 do use this term. As such, the specification does not provide proper antecedent basis for the claimed subject matter.
Claim Rejections - 35 USC § 112(b)
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 1-10 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.
Regarding claim 1, it is unclear which element is the “spacer,” in view of the specification. This term does not appear in the specification, nor does any element that would be described as performing such a function explicitly in the specification.
Examiner notes that this issue has been extensively discussed (see the prosecution history of parent Application No. 17/443,613; now US Patent No. 12,147,214) and these claims were amended as interpreted below, in view of the specification as filed, as to overcome both this rejection and the above objection to the specification.
For purposes of compact prosecution, the term will be interpreted in view of the specification as “sleeve” which is read as a material covering a fin or covering another “sleeve” which does provide a “spacer” function, but the term “spacer” does not appear in the specification as-filed.
The “sleeve” is also described in the specification as what allows for the “rake angle” (see par. 0099, of the Specification, as filed) and uses nearly the same language as what is in claim 1.
Claim 1 also recites “when added, the spacer affords a rake angle.” This limitation lacks antecedent basis because there are two spacers introduced in the claim, and so it is unclear which of the two spacers is being referred to by “the” spacer.
Because claims 2-10 depend from claim 1 and incorporate all of the same limitations, they are similarly rejected under the same rationale.
Regarding claim 6, Claim 6 recites the limitation "the spacer" in line 1. There is insufficient antecedent basis for this limitation in the claim for the same reasons described above for claim 1.
Regarding claim 10, the claim recites “Duracetal” which is a registered trade mark or trade name. If [a] trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). As such, the claim is indefinite.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-10 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claims 2-10, the claims are drafted to “the device of claim 1” which fails to include all of the limitations of the claim 1 since claim 1 is a method claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Liptak et al. (WO 2015/103084 A1), hereinafter Liptak, in view of Hofmann (US 2015/0157491).
Regarding claims 1 and 3-4, Liptak discloses a method of manufacturing a set of splints (par. 0051) or mandibular advancement devices (Title), comprising:
(a) preparing a 3D electronic model of patient’s dentition (par. 0021); (b) converting the model to a data set (par. 0021); (c) obtaining a set of clinical options (par. 0052, 0057); (d) incorporating the clinical options and data in the CAD design software (par. 0052-0053);
(d) automatedly manufacturing the devices (par. 0052-0054), which have an upper and lower splint, with each of the upper and lower splint having a fin (as described in the cited passage), or a post for a fin to attach thereto, and each of the upper and lower post or fin is located a distance from the back of the upper and lower splint as is claimed (par. 0037, reference’s claim 1).
Liptak does not explicitly disclose that the structure of the devices includes a first and second spacer as is required in limitation (f).
However, with respect to the rake angle, the “fin” can also produce the “rake angle” with respect to the occlusal (biting) plane (as is explained in par. 0038) and Liptak further discloses a 90 degree angle for this value (par. 0038). Liptak does not explicitly disclose the “spacer” (sleeve) covering the fin as is recited in claim 1, but as is explained in par. 0050, leaves a “gap” between the fin and the tooth, meaning that the structure does not preclude a “sleeve.” The 90 degree angle is an example that falls between 80 and 100 degrees, as recited in the claim.
However, Hofmann discloses a similar type of occlusal splint (Hofmann, abstract) for sleep apnea, and also discloses a series of “exchangeable positioning means” (‘sleeves’) (22) (Hofmann, Figs. 1, 3-4, 6, 8-10) where a lower case letter denotes a different type of “sleeve” (Hofmann, par. 0054-0066) which are both secured in place on pins (15l, 15r) (par. 0058) (Fig. 8) in centering recess (25) (par. 0065). Hofmann further explains that each of the positioning means (22) has a “guiding surface” (24) complementary to the outer side of the upper/lower splint (Fig. 3).
Hofmann provides advantages for its arrangement (par. 0010) as to influence the other splint’s position (par. 0017) and no longer require a complex adjusting device (par. 0019). Hofmann further explains (Hofmann, par. 0020) that the adjusting can be done without a second visit to the doctor or dentist. Therefore, it would have been obvious to one of ordinary skill in the art to have further specified that each of the “fins” above has a “sleeve” on it as to produce a more “adjustable” device as described in Hofmann by placing a sleeve over the fins above in Liptak as is claimed.
Regarding claim 2, Liptak/Hofmann discloses the subject matter of claim 1 and further discloses that the upper and lower splints are manufactured according to a digital design (Liptak, par. 0030-0031).
Regarding claim 4, Liptak/Hofmann discloses the subject matter of claim 3 (and 1) above, but does not explicitly describe this combination as Hofmann appears to produce “sleeves” primarily for a “lower” splint in claims 1/3 above. However, one of ordinary skill in the art could have flipped the orientation above (in claims 1 and 3) and produced this identical arrangement (by reversing the names to call the “upper” the “lower” and vice versa). As such, this is considered met by the description above for claim 3.
Regarding claim 5, Liptak/Hofmann discloses the subject matter of claim 1 and Liptak discusses (par. 0039) a “digital library” of fins that are selected to produce the device.
Regarding claims 6-7, Liptak/Hofmann discloses the subject matter of claim 1, and as described above, the “centering recess (25)” and “centering pin (15)” from Hofmann (Hofmann, par. 0061, 0065) appears to meet the broadest reasonable interpretation of the claimed “friction lock mechanism.”
Regarding claims 8-9, Liptak/Hofmann discloses the subject matter of claim 1, and further discloses splint design (Liptak, par. 0030) and fins (Liptak, par. 0039). Claim 9 is considered “contingent” upon choosing of “titration mechanisms” in claim 8 as is discussed in MPEP 2111. Claim 8 only requires choosing “two or more” of the selections. Thus, claim 9 can be met without choosing “titration mechanisms” and choosing the above selection.
Regarding claim 10, Liptak/Hofmann discloses the subject matter of claim 8, and further discloses at least one of the same polymers (PEEK) as is listed in the claim (Liptak, par. 0026).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW D GRAHAM whose telephone number is (469)295-9232. The examiner can normally be reached Monday - Friday 7:30AM-4:00PM (CST).
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/ANDREW D GRAHAM/Primary Examiner, Art Unit 1742
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