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/Restrictions
Applicant’s election of invention I (claims 1-13), species 1c (Figure 3), and species 2e (implant is activated by moving the patient’s jaw) in the reply filed on 08/20/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 14-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/20/26.
Further, claims 7, 9-10, and 12 are withdrawn for being drawn to non-elected species within group 2.
Specification
The disclosure is objected to because of the following informalities:
-[0043] states the piston 371, rod 372, and reservoir 373 can be used as the activation 370, but it is not coupled to the rod and it is unclear how this words, compresses fluid/air, and how it exerts a force
-[0043] states that the piston exerts a force along the longitudinal axis of the post 312 but figure 3 does not show the two elements connected, making this unclear
Appropriate correction is required.
Claim Objections
Claim 5-6 are objected to because of the following informalities:
Claim 5 is objected to for claiming the articulating arm “applies a…force on the mandible bone of the patient”, but it appears as if this might be positively claiming the “mandible bone of the patient”. If this were being positively claimed, the claim would be rejected under 35 U.S.C. 101 for positively claiming a part of the body, which is not allowed. It is also possible, that similar to claim 1 this is intended to indicate that the arm is configured to provide a force on the mandible bone of the patient, but this is not what is claimed. Clarification is required.
Claim 6 is objected to for claiming “wherein the articulating arm, in the active position, the articulating arm applies…”. It appears “the articulating arm” is listed twice within the claim when it should only be listed once.
Appropriate correction is required.
Drawings
The drawings are objected to because:
-the specification [0029] refers to the apparatus 100a including an activation mechanism 170, but the item 170 in the figures 1a-b simply appear to be pointing to the spacer 100a itself.
-items 156, 206b, 708a are in the figures but not the specification.
-items 200, 201, 202, 204, 270, 225, 256, 259, 375, 508, 550, 608, 708, 875, 814 are in the specification but not the figures.
-item 270a,b are described as being “activation mechanisms” but they appear to simply be pointing towards spring 216.
-specification [0038] states the activation mechanism 370 is coupled to the post 312 but figure 3 does not show the activation mechanism 370 coupled to the post 312.
-item 601 is used to both represent the patient and the skull
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 5-6 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 pre-AIA the applicant regards as the invention.
Claim 5 is indefinite for claiming the first biasing force is in a “generally” horizontal direction but it is unclear what a “generally” horizontal direction is, compared to, for example, a horizontal direction or a non-horizontal direction. Without understanding the boundaries of the term, the Examiner cannot determine the boundaries of the claim.
The claim is further unclear for claiming the arm applies a first biasing force AND/or a zero-biasing force, when the disclosure appears to indicate EITHER the arm applies a first biasing force OR a zero-biasing force (see for example, the specification as filed, [0035], [0038], [0056], [0059].). The disclosure does not provide any discussion of there being a first AND zero biasing force in the inactive position, and the Examiner is unclear on how this would occur based on the Examiner’s understanding of the invention.
Claim 6 is indefinite for the same reasons as claim 5, with regards to the “generally” vertical direction.
The claim is further unclear for claiming the arm applies a second biasing force “greater than the first biasing force”, but claim 5, from which this depends, does not actually require there to be a “first biasing force”, making it unclear on what claim requirements must be met if there is a zero-biasing force instead of a first biasing force in the inactive position.
Remaining claims are rejected for depending on a rejected claim.
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: “activation mechanism” in claim 1.
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. In this case, the “activation mechanism” is understood to be: changing angles of the patient’s head, a user applying pressure with fingers, a magnetic/electromagnetic element, the user moving their job, or a piston/rod/pump/reservoir.
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 § 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.
Claim(s) 1-6, 8, 11 is/are rejected under 35 U.S.C. 103a being unpatentable over Touleimat et al. (US 20130331944 A1) hereinafter known as Touleimat in view of Giger et al. (US 20120004692 A1) hereinafter known as Giger.
Regarding claim 1 Touleimat discloses an implant (Figures 1a-b) comprising:
an articulating arm (Figures 1a-b items 120/130/140) including a first end (Figure 1a-b item 128) configured to engage with a pivot point at a mastoid/temporal bone of a patient (Figures 1a and 10 show how the first end 128 engages at the upper part of the jaw of the patient; see also [0059] and [0061]) and a second end (Figure 1a-b item 133) configured to engage with a connector at a mandible bone of the patient (Figures 1a and 9c show how the second end 133 engages at a mandible bone of the patient; see also [0061] where the connection to the lower jaw via screws is discussed),
wherein the arm is configured to be in an active position (Figure 1b) and an inactive position (Figure 1a),
and a method of activation coupled to the articulating arm configured to extend the arm when in the active position ([0063] adjustment screws; see the extension of the arm shown in Figure 1b as compared to Figure 1a),
but is silent with regards to the activation mechanism comprising changing angles of the patient’s head, a user applying pressure with fingers, a magnetic/electromagnetic element, the user moving their jaw, or a piston/rod/pump/reservoir as is required by 35 U.S.C. 112f.
However, regarding claim 1 Giger teaches a lengthening implant (Abstract) which includes an activation mechanism comprising changing angles of the patient’s head, a user applying pressure with fingers, a magnetic/electromagnetic element, the user moving their jaw, or a piston/rod/pump/reservoir (Abstract). Touleimat and Giger are involved in the same field of endeavor, namely adjustable length implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implant of Touleimat by having an activation mechanism such as is taught by Giger in order to allow the adjustment to occur without surgical means, thus resulting in an implant which is easier and safer for the patient to use as it reduces inherent risks that exist within a surgical operation.
Regarding claim 2 the Touleimat Giger Combination teaches the implant of claim 1 substantially as is claimed,
wherein Touleimat further discloses the arm in the active position positions the second end in an anterior direction relative to the first (Figure 1a-b, Figure 9c shows how the second end 133 is pushed anterior to ball end 128).
Regarding claim 3 the Touleimat Giger Combination teaches the implant of claim 2 substantially as is claimed,
wherein Touleimat further discloses the [method of activation] (activation mechanism) causes the arm to extend along a longitudinal axis when in the active position (Figures 1a-ab show the arm extending along a longitudinal axis of the upper part 120 along shaft 126 and along the lower part 130 along shaft 136).
Regarding claim 4 the Touleimat Giger Combination teaches the implant of claim 1 substantially as is claimed,
wherein Touleimat further discloses the inactive position enables posterior displacement of the second end relative to the first (Figure 1a-b shows how the second end 133 is displaced relatively posteriorly compared to the first end 128 as it transitions from inactive to active).
Regarding claim 5 the Touleimat Giger Combination teaches the implant of claim 4 substantially as is claimed,
wherein Touleimat further discloses the arm, in the inactive position (Figure 1a), applies a first biasing force in a horizontal direction OR a zero-biasing force on the mandible bone of the patient (this appears to depend upon the method of implantation as opposed to materially changing the structure of the implant itself).
Regarding claim 6 the Touleimat Giger Combination teaches the implant of claim 5 substantially as is claimed,
wherein Touleimat further discloses the articulating arm, in the active position (Figure 1b), applies a second biasing force greater than the first biasing force and along a vertical direction (it is considered inherent that when implanted, the excess length of the articulating arm would cause greater force in the vertical direction as compared to the shortened position).
Regarding claim 8 the Touleimat Giger Combination teaches the implant of claim 1 substantially as is claimed,
wherein Touleimat further discloses the arm comprises multiple concentric tubes (Figures 1a-b items 120, 130, 140; also references Figures 2, 3c, 4a-b, 5a-d, 6b-c, 8a-d which show all the concentric tubes) that are configured to modify an overall length of the arm ([0014], [0016], [0018], [0019], [0063]),
wherein the arm comprises a collapsed length in the inactive position (Figure 1a), and an extended length in the active position (Figure 1b).
Regarding claim 11 the Touleimat Giger Combination teaches the implant of claim 1 substantially as is claimed,
wherein Touleimat further discloses the connector at the mandible bone is a pivot connector (this does not appear to materially alter the claimed implant, since the “connector” of claim 1 is not positively claimed.).
Claim 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Touleimet and Giger as is applied above, further in view of Johnston (US 20160220331 A1).
Regarding claim 13 the Touleimat Giger Combination teaches the implant of claim 1 substantially as is claimed,
but is silent with regards to the transition between active and inactive positions being engaged by wide opening of the mandible.
However, regarding claim 13 Johnston teaches a mandible appliance that transitions between a shorter and longer position, wherein the transition is engaged by wide opening of the mandible ([0031]). Touleimat and Johnston are involved in the same field of endeavor, namely length-changing appliances for the jaw. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implant of the Touleimat Giger Combination so that the transition between the active and inactive positions of the implant are engaged by wide opening of the mouth as is taught by Johnston since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the person of ordinary skill would find it obvious to choose from any known solution for lengthening a telescoping oral appliance and apply it with reasonable expectation to succeed in lengthening the implant of the Combination.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774
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