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 species I (Fig. 1) in the reply filed on October 15, 2025 is acknowledged. Claim 28 has been withdrawn from further consideration since it is directed to non-elected species. Claims 1-3, 7, 9-19, 21, 24, 26 and 31 have been examined on the merits in this office action.
Drawings
The drawings filed on October 15, 2025 have been entered. However, the drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "102" and "106" have both been used to designate the first plate.
The drawings filed on October 15, 2025 are also objected to under 37 CFR 1.83(a) for not showing the feature “pin-and-shank-sleeve coupling” of withdrawn claim 28. The drawings must show every feature of the invention specified in the claims. Therefore, all claimed features must be shown in the drawings or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Claim 21 is 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.
In claim 21, the reference to “length” is not supported by definition of how this dimension is determined (for e.g. by definition of ends of the implant).
In claim 21, the reference to “length” and “axial length” in the same claim renders the claim vague and indefinite because it is unclear how these dimensions are determined (for e.g. the ends of the implant defining the “length” and “axial length” are not defined).
In claim 21, use of a narrower range within a broader range in the same claim renders the claim indefinite since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. One could not tell from such a claim if the narrower range or limitation is a restriction or limitation on the broader range or limitation.
Appropriate correction is required.
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.
Claim(s) 1, 14, 19, 26 and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strozyk et al. (US 10376664).
Regarding claim 1, Strozyk et al. disclose a biocompatible implant for moving bone in a patient's body, the implant including: a first plate or portion 12 configured to be attached to bone at a first location; a second plate or portion (14 and tube 26) configured to be attached to bone at a second location; and a distractor (output driver 24) extending from the first plate and being at least partially contained within the second plate, wherein the distractor houses a drive system including a driver (magnet 20) and a gear system (204, 206) coupled with the driver (magnet 20), and wherein the drive system is configured to cause translation of the second plate 14 relative to the first plate 12 (Fig. 5, col. 6, lines 23-67, cols. 7-8 and col. 9, lines 1-39).
Regarding claim 14, the entirety of the drive system is contained within the distractor (Fig. 5).
Regarding claim 19, Strozyk et al. disclose the first plate to includes a first housing 16 substantially containing the distractor 24 and a first connecting plate 12 extending from the first housing 16, the first connecting plate including a first set
of one or more holes for receiving a bone anchor (Fig. 3); and the second plate includes a second housing including a sleeve 26 and a second connecting plate 14 extending from the sleeve, the second connecting plate including a second set of one or
more holes for receiving a bone anchor wherein the sleeve is sized to axially overlap the distractor (Figs. 1-3 and 5, col. 6, lines 23-67, cols. 7-8 and col. 9, lines 1-61. See marked up Fig. 5 below).
Regarding claim 26, Strozyk et al. disclose an activation tool or controller 30 external to the patient’s body (Fig. 2 and col. 8, lines 7-29).
Regarding claim 31, Strozyk et al. disclose a biocompatible implant for moving bone in a patient's body, the implant including: a first plate or portion 12 configured to be attached to bone at a first location; a second plate or portion (14 and tube 26) configured to be attached to bone at a second location; and a distractor or internal distraction component 24 extending from the first plate and being at least partially contained within the second plate, wherein the distractor houses a drive system including a driver (magnet 20) and a gear system (204, 206) coupled with the driver (magnet 20), and wherein the drive system is configured to cause translation of the second plate 14 relative to the first plate 12 (Fig. 5, col. 6, lines 23-67, cols. 7-8 and col. 9, lines 1-39).
Regarding claim 31, Strozyk et al. also disclose the driver to be located between the proximal end of the implant and the gear system (see marked up Fig. 5 on the following page). The first threaded coupler 24 mates with a second threaded coupler or sleeve 26 on the second portion 14 (Fig. 5).
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In the alternate, claim(s) 1-2, 12, 15, 24 and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Landsberger (US 6113599).
Regarding claim 1, Landsberger discloses a biocompatible implant for moving bone in a patient's body, the implant including: a first plate 212 (Fig. 3) configured to be attached to bone at a first location; a second plate 241 (Fig. 3) configured to be attached to bone at a second location; and a distractor (Fig. 3, 210, 203, 201, 220, 221) extending from the first plate and being at least partially contained (at least a portion of shaft 221 is contained within a housing 230 of the second plate, Fig. 3) within the second plate, wherein the distractor houses a drive system including a driver 201 and a gear system (204, 205) coupled with the driver, and wherein the drive system is configured to cause translation of the second plate relative to the first plate (col. 12, lines 28-67 and col. 13, lines 1-22. Also see marked up Fig. 3 below).
Regarding claim 2, the driver 201 is located axially between the gear system and the first plate (see marked up Fig. 3 below, col. col. 12, lines 28-67 and col. 13, lines 1-22).
Regarding claim 12, further comprising an end cap on an end or proximal end of the distractor for limiting an extent of translation of the second plate 240 relative to the first plate 211 (see marked up Fig. 3 below).
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Regarding claim 15, the distractor has an outer dimension (cross section of wheel gear 205) with a non-circular cross section and wherein the second plate has an inner dimension (inside cross section of housing 230) with a non-circular cross-section.
Regarding claim 24, a majority of an axial extent of the first plate overlaps an axial extent of the distractor, and wherein a portion of the first plate overlaps with the distractor when both the portion of the first plate and a portion of the distractor intersect a plane perpendicular to a length of the distractor (marked up Fig. 5 on the following page).
Regarding claim 31, Landsberger discloses an implant for moving bone in a patient's body, the implant including: a first portion configured to be attached to a bone at a first location; a second portion configured to be attached to the bone at a second location; and an internal distraction component extending from the first portion and at least partially contained within the second portion, the internal distraction component housing a drive system configured to cause translation of the second portion relative to the first portion, wherein an entirety of the drive system is contained within the internal distraction component, wherein the drive system includes a gear system coupled to a driver, wherein the driver is located between a proximal end of the implant and the gear system, and wherein a distal end of the internal distraction component includes a first threaded coupler for mating with a second threaded coupler on the second portion (see marked up Fig. 3 on the following page).
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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.
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Strozyk et al. (US 10376664) in view of Landsberger (US 6113599).
Strozyk et al. disclose all elements of the claimed invention except for a specific reference to the extent of distraction or length of distraction.
Landsberger discloses increasing the length of distraction greater than 40 mm in order to obtain the desired amount of bone growth (col. 18, lines 16-31).
Therefore, it would have been obvious to one of ordinary skill in the art to have considered providing an extent of distraction or distraction length in different ranges depending on the desired amount of bone growth depending on the patient-specific anatomical characteristics since this amounts to choosing from a finite number of identified, predictable solutions (namely, range of distraction lengths) with the reasonable expectation of controlling bone growth.
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Landsberger (US 6113599).
Landsberger discloses increasing the length of distraction greater than 40 mm in order to obtain the desired amount of bone growth (col. 18, lines 16-31).
Therefore, it would have been obvious to one of ordinary skill in the art to have provided various distraction lengths depending on the desired amount of bone growth depending on the patient-specific anatomical characteristics since this amounts to choosing from a finite number of identified, predictable solutions (namely, range of distraction lengths) with a reasonable expectation of controlling bone growth.
Allowable Subject Matter
Claims 3, 7, 9-11, 13 and 16-18 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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January 21, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775