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 without traverse of Group I, claims 1-6, 10 and 32-42 in the reply filed on July 22, 2026, is acknowledged. Accordingly, claims 1-6, 10 and 32-42 have been examined on the merits in this office action and claims 15-22 have been withdrawn from further consideration since they are directed to a non-elected invention.
Claim Objections
Claims 2, 4-6, 10 and 34 are objected to because of the following informalities. In claim 2, Applicant uses contact members instead of adjustable contact members, as previously recited. It is suggested that Applicant use identical terminology to avoid confusion.
In claim 34, it appears “plafond” should be - - platform - - to correct a typographical error.
Appropriate correction is required.
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 3-5, 10 and 32-38 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.
In claim 3, the recitation “..shaft is bounded by opposed ends of the slot” renders the claim vague and indefinite because a slot has no structure. It is suggested that Applicant use alternate language, for e.g. “..opposed ends defining the slot” for clarity.
In claim 4, the recitation “dimensioned” renders the claim vague and indefinite because Applicant’s disclosure does not provide the dimensions or ranges of dimensions to support the stated function.
In claim 5, the recitation “the second set of contact members are dimensioned such that the contact points are spaced apart from a free end of the respective contact members” renders the claim vague and indefinite because it is unclear which respective contact members are being referred to in the claim. For examination purposes, it is assumed that Applicant intended to compare the second set of contact members with the first set of contact members.
In claim 5, the recitation “dimensioned” renders the claim vague and indefinite because Applicant’s disclosure does not provide the dimensions or ranges of dimensions to support the stated function.
In claim 10, the recitation “wherein a total number of the contact members of the second set of contact members is equal for the set of adjustment bodies” renders the claim vague and indefinite because it is unclear what the total number is equal to.
In claim 32, the body of the claim does not recite adequate structure to perform the stated function. It is unclear how the “processing circuitry” operates to control the settings of the alignment guide. How is the “processing circuitry” operated, for e.g. input by a surgeon etc. It is unclear what inputs are provided or received (for e.g. patient-specific images) to determine the resection plane, the orientation of the at least one guide element and the positions of the anatomical points.
In claim 34, the recitation “a medial maximum and a tibial plafond of the articular surface of the tibia” renders the claim vague and indefinite because the scope of the claim is unclear. It is unclear what specific anatomical points are being referred to.
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, 5, 6 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lavallee et al. (US 20060122617 A1).
Regarding claim 1, Lavallee et al. disclose an alignment guide including a cutting guide or guide body 100 (Figs. 2 and 7) carrying a first set of adjustable contact members (screws 26A-26E) dimensioned to contact bone at respective contact points (defined by the tips of the screws, para [0042]), the guide body including at least one guide passage dimensioned to set a trajectory of a pin or guide pin relative to bone (para [0055]); and at least one adjustment body 90 coupled to the guide body 100 (Fig. 7) along an interface, the at least one adjustment body carrying a second set of adjustable contact members (at least one bone contact surface 72 includes a portion 74 that is linked by a curved arm to a driving worm or shaft 82, para [0057]) dimensioned to contact bone at respective contact points, each contact member of the second set of contact members coupled to a respective carrier, and the carrier translatable along a driving worm or guide shaft to set a position of the respective contact member relative to the at least one adjustment body 90 in response to rotation of the guide shaft 82 (paras [0057] and [0061]).
Regarding claim 5, the first set of contact members are dimensioned such that the contact points are established at a free end of the respective contact members; and
the second set of contact members are dimensioned such that the contact points are spaced apart from a free end of the respective contact members (Fig. 5, the cylindrical portion has free ends, and the bone contact portion is spaced from a free end depending on the curvature of the bone).
Regarding claim 6, each contact member of the first and second sets of contact members includes an elongated body extending along a respective contact axis, the contact axes of the first set of contact members (screws 26A-26E) are substantially parallel to each other, and the contact axes of the second set of contact members (74) are substantially parallel to each other.
Claim(s) 39 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGinley et al. (US 7794467).
Regarding claim 39, McGinley et al. disclose an alignment guide assembly for an orthopedic procedure including: a guide body (mechanized cutting block adapter 300, Fig. 9) including at least one guide passage (302, Fig. 9) dimensioned to set a trajectory of a guide element (fixation pins 304) relative to bone; and a set of adjustment bodies (including an adjustable cutting block (Fig. 2), an adjustable transverse cutting block (Fig. 7) or an adjustable femoral block (Fig 8), the first and second adjustment bodies interchangeably mountable to the guide body along an interface (defined by engagement structure 309), each of the adjustment bodies including a set of adjustable contact members (fixation pins) dimensioned to contact bone at respective contact points, the contact members moveable in a first direction relative to the respective adjustment body, and a distribution of the set of contact members of the first adjustment body (adjustable cutting block, Fig. 8) differs from a distribution of the set of contact members of the second adjustment body (transverse cutting block, Fig. 9) relative to a second direction transverse to the first direction (col. 7, lines 27-67, cols. 8-17 and col. 18, lines 1-27).
Regarding claim 40, the guide body 300, Fig. 9) and the respective adjustment body are moveable relative to each other along the interface with respect to the second direction (Fig. 9).
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.
As best understood in light of the rejections under 35 USC 112, claims 32-38 are rejected under 35 U.S.C. 103 as being unpatentable over McGinley et al. (US 7794467) in view of Jaramaz et al. (US 20180296276 A1).
McGinley et al. disclose all elements of alignment guide as discussed previously in this office action. McGinley et al. disclose the adjustable alignment guide can be adapted for manipulation with computer functionality or computer-aided navigating or manipulating device or any combination (col. 8, lines 42-50).
Jaramaz et al. disclose a system for positioning a cut guide utilizing a computer system 900 which includes a processor 902 (including a central and graphics processing unit) and medical imaging is utilized to represent the target bone for placement of the alignment guide on the target bone (paras [0033]-[0034]).
It would have been obvious to one of ordinary skill in the art to have utilized a computer-based system, as taught by Jaramaz et al., for positioning of the alignment guide and the associated adjustment guide or cut guide for resecting portions of the target bone surface for a better surgical outcome.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over McGinley et al. (US 7794467) in view of Schoenefeld et al. (US 9826981).
McGinley et al. disclose all elements of the claimed invention except for the total number of contact members or pins to be equal for the first and second adjustment bodies.
Schoenfeld et al. disclose a bone preparation guide to include any suitable number of pins to accommodate various surface features of a patient’s bone (col. 6, lines 22-29).
It would have been obvious to one of ordinary skill in the art to have provided any number of contact members or pins in the first and second adjustment bodies of McGinley et al. guide, as taught by Schoenfeld et al., in order to fix the bodies to a patient’s bone depending on the surface features of a patient’s bone.
Allowable Subject Matter
Claims 2 and 42 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.
Claims 3, 4 and 10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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.
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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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September 26, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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