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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 16 October 2025 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 16 October 2025. As directed by the amendment: Claims 15, 24, 25, and 35 have been amended, claims 1-14 and 26 are cancelled. Claims 15-25 and 27-35 currently stand pending in the application.
The claim amendments are sufficient to overcome the claim objections listed in the previous action, which are accordingly withdrawn.
Response to Arguments
Applicant's arguments filed 16 October 2025 have been fully considered but they are not persuasive. As to the nonstatutory double patenting rejections, Applicant contends that instant claim 25 does not include “attaching a coupling member to the first translation mechanism, wherein the coupling member is configured to receive at least one resection guide”. Examiner respectfully submits that ‘823 recites a coupling member as secured as part of the first translation mechanism; although ’823 does not recite that the coupling member is configured to receive at least one resection guide, this is language of intended use and the coupling member in ‘823 is intended for that purpose.
Applicant’s arguments with respect to claims 15 and 24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments with respect to claim 25 have been fully considered but they are not persuasive. Applicant contends that Harris (US 9,445,823) in view of Steffensmeier (US 7,641,661) discloses the cutting surface coupled to the portion of the tool that is positioned at an opposite end to where the tool translates in a medial-lateral direction, and therefore Harris/Steffensmeier fail to disclose “attaching a coupling member to the first translation mechanism, wherein the coupling member is configured to receive at least one resection guide”. Examiner respectfully submits that the arms of the clamp in Harris and Steffensmeier are a coupling member. The coupling member is fully capable of receiving at least one resection guide, which is interpreted as language of intended use. The coupling member is fully capable of receiving at least one resection guide adjacent to it or through it, for a surgery comprising, for example, both ankle and knee modifications.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 15, 16, and 35 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent Application Publication No. US 2018/0263639 to McGinley et al. (hereinafter, “McGinley”).
As to claim 15, McGinley discloses a method of using an alignment guide system (380; aligns at least a drill), FIG. 101, comprising: obtaining the alignment guide system, FIG. 101; coupling the alignment guide system to a tibia of a patient (par. [0294]), wherein the alignment guide system is coupled to a distal end of the tibia between a midpoint of the tibia and an ankle joint of the patient, FIG. 101, and wherein the entire alignment guide system is located between the midpoint of the tibia and the ankle joint of the patient, FIG. 101; and translating the alignment guide system in at least one of a medial-lateral direction, a distal-proximal direction, and a varus-valgus direction to position the alignment guide system over the ankle joint (in placing the alignment guide system over the pins 287, the alignment guide system must be aligned over so as to slide over the pins, and therefore is translated, from a starting position on a surgical tray or in the surgeon’s hand, in at least one of a medial-lateral direction, a distal-proximal direction, and a varus-valgus direction into position over the pins so that once slid onto the pins, the system is over the ankle joint as in FIG. 101).
As to claim 16, McGinley discloses the method of claim 15, further comprising: releasably coupling a pair of pins (287) with the alignment guide system and the tibia of the patient (the pins are releasably coupled with the alignment guide system when the alignment guide system is slid over the pins, and the pins are releasably coupled with the tibia when inserted therein) so as to releasably couple the alignment guide system with the tibia of the patient (par. [0294]), FIG. 101, wherein each pin of the pair of pins is inserted into the distal end of the tibia between the midpoint of the tibia and the ankle joint, FIG. 101.
As to claim 35, McGinley discloses method of claim 15, wherein the translating of the alignment guide system comprises: translating the alignment guide system in the medial-lateral direction, the distal-proximal direction, and the varus-valgus direction to position the alignment guide system over the ankle joint (in placing the alignment guide system over the pins 287, the alignment guide system must be aligned over so as to slide over the pins, and therefore is translated, from a starting position on a surgical tray or in the surgeon’s hand, in a direction comprising compound movement with vectors in all of the medial-lateral, distal-proximal, and varus-valgus directions; translating could comprise 0 degree or amount of translation in any or all of the directions).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over McGinley in view of U.S. Patent Application Publication No. US 2009/0234360 to Alexander.
As to claim 24, McGinley discloses a method of using an alignment guide system (380; aligns at least a drill), FIG. 101, comprising: obtaining the alignment guide system, FIG. 101; coupling the alignment guide system to a tibia of a patient (par. [0294]), wherein the alignment guide system is coupled to a distal end of the tibia between a midpoint of the tibia and an ankle joint of the patient, FIG. 101, and wherein the entire alignment guide system is located between the midpoint of the tibia and the ankle joint of the patient, FIG. 101; determining a desired position in a medial-lateral direction (the desired position is aligned over the pins 287, with the position having medial-lateral coordinates); translating the alignment guide system to achieve the desired position in the medial-lateral direction (in placing the alignment guide system over the pins 287, the alignment guide system must be aligned over so as to slide over the pins, and therefore is translated, from a starting position on a surgical tray or in the surgeon’s hand, to achieve the desired position which has medial-lateral coordinates, the desired position being aligned over the pins); determining a desired position in a distal-proximal direction (the desired position is aligned over the pins 287, with the position having distal-proximal coordinates); translating the alignment guide system to achieve the desired position in the distal-proximal direction (in placing the alignment guide system over the pins 287, the alignment guide system must be aligned over so as to slide over the pins, and therefore is translated, from a starting position on a surgical tray or in the surgeon’s hand, to achieve the desired position which has distal-proximal coordinates, the desired position being aligned over the pins); determining a desired position in a varus-valgus direction (the desired position is aligned over the pins 287, with the position having varus-valgus coordinates); and translating the alignment guide system to achieve the desired position in the varus-valgus direction (in placing the alignment guide system over the pins 287, the alignment guide system must be aligned over so as to slide over the pins, and therefore is translated, from a starting position on a surgical tray or in the surgeon’s hand, to achieve the desired position which has varus-valgus coordinates, the desired position being aligned over the pins).
McGinley is silent as to coupling a laser with at least a portion of the alignment guide system.
Alexander teaches releasably coupling a laser (3) with at least a portion of an alignment guide system (6) (par. [0093]), FIG. 11A, to ensure that the system is appropriately aligned in relation to the bone (par. [0063]). Alexander also teaches that the laser can be attached to existing alignment guide systems (par. [0027]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide McGinley with a laser that is releasably coupled to the alignment guide system to increase accuracy by ensuring that the system is appropriately aligned in relation to the bone.
Claims 25, 27, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 9,445,823 to Harris et al. (hereinafter, “Harris”) in view of U.S. Patent No. US 7,641,661 to Steffensmeier et al. (hereinafter, “Steffensmeier”).
As to claim 25, Harris discloses a method of assembling an alignment guide system (2), FIGS. 1-4, comprising: obtaining a second translation mechanism (18, including 22, and 20), and a third translation mechanism (10); and coupling the third translation mechanism at a proximal end of the second translation mechanism (via 22 and 8; where the proximal end of the system is interpreted at 10 and the distal end of the system is interpreted at 14), FIG. 3; wherein: the second translation mechanism is configured to translate the alignment guide system in a distal-proximal direction (col. 4 / lines 1-38, col. 7 / lines 3-6), FIG. 3; and wherein the third translation mechanism is configured to translate the alignment guide system in a varus-valgus direction (col. 6 / lines 27-37), FIG. 10.
Harris is silent as to obtaining a first translation mechanism; coupling the first translation mechanism at a distal end of the second translation mechanism; attaching a coupling member to the first translation mechanism, wherein the coupling member is configured to receive at least one resection guide; wherein the first translation mechanism is configured to translate the alignment guide system in a medial-lateral direction (claim 25).
Steffensmeier teaches a first translation mechanism (344, 332) configured to translate in a medial-lateral direction (col. 6 / lines 5-14), FIG. 3, relative to a tibia to permit medial-lateral translation of the ankle clamp relative to the mounting post; attaching a coupling member (350) to the first translation mechanism.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Harris’ bone clamp (14) with a first translation mechanism configured to translate in the medial-lateral direction, and manipulating the first translation mechanism to translate the alignment guide system in the medial-lateral direction relative to the tibia of the patient, to allow repositioning of the clamp relative to the second translation mechanism based on the shape of the bone so that the second translation mechanism can remain aligned with the bone axis (Harris, col. 7 / lines 7-11) even if the end of the bone at the clamp is off-axis, ensuring proper placement of the cutting guide surface. The first translation mechanism would be provided by a sliding dovetail interaction where the clamp connects to the shaft (one dovetail on the clamp and complementary dovetail on the shaft) that is coupled to the second translation mechanism (Harris, at 20). Based on the directional system above, the first translation mechanism is coupled at a distal end of the second translation mechanism. The pivoting arms of the clamp (Harris, 14) comprise a coupling member that is attached to the first translation mechanism. The coupling member is fully capable of receiving at least one resection guide, which is interpreted as language of intended use. The coupling member is fully capable of receiving at least one resection guide adjacent to it or through it, for a surgery comprising, for example, both ankle and knee modifications.
As to claim 27, Harris discloses the method of claim 25, wherein the second translation mechanism comprises a housing (22 and 120), the housing comprising: at least one threaded recess (through 120) (col. 5 / lines 52-67); and a coupling stem (18).
As to claim 28, Harris discloses the method of claim 27, further comprising coupling the third translation mechanism with the housing of the second translation mechanism by: inserting at least one alignment pin (8) into the at least one threaded recess of the housing (col. 5 / lines 52-67) (the third translation mechanism 10 is coupled with the housing of the second translation mechanism via alignment pin 8): and inserting the coupling stem into at least one coupling hole (in 20).
Harris is silent as to the housing comprising the at least one coupling hole and inserting a coupling stem into the at least one coupling hole of the housing.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the housing with the at least one coupling hole and inserting a coupling stem into the at least one coupling hole of the housing, with the coupling hole and the coupling stem comprising the telescoping parts of the second translation mechanism, since the mere reversal of the essential working parts of a device involves only routine skill in the art. The housing would have a coupling hole into its end (where 18 is located in FIG. 3) to receive a coupling stem (where 20 is located in FIG. 3), for telescoping interaction as required by Harris. The coupling fastener (44) would pass through the housing into the coupling hole to lock the inserted coupling stem in place.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Harris in view of Steffensmeier (hereinafter, “Harris/Steffensmeier”), as applied to claims 17-21, 25, 27, 28, and 35 above, and further in view of U.S. Patent No. US 4,893,619 to Dale et al. (hereinafter, “Dale”) and U.S. Patent No. US 11,446,072 to Abedian et al. (hereinafter, “Abedian”).
As to claim 29, Harris/Steffensmeier disclose inserting a coupling fastener (Harris, 44) through a fastener hole in the housing of the second translation mechanism so as to engage the coupling stem (Harris, col. 4 / lines 29-34), FIG. 4.
Harris/Steffensmeier are silent as to a through hole in the coupling stem.
Dale teaches inserting a coupling fastener (110) through a fastener hole in a housing so as to engage a through hole (100) in a coupling stem (30) (col. 4 / lines 33-56), FIGS. 1-2.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the coupling stem in Harris/Steffensmeier with a through hole that is engaged by a tip of the coupling fastener disclosed in Harris, to allow distal-proximal translation while preventing undesirable relative rotation of the telescoping parts.
Harris/Steffensmeier are silent as to inserting a locking pin in a first hole of the housing so as to retain the coupling fastener within the fastener hole.
Abedian teaches inserting a coupling fastener (150) through a fastener hole (612) in a housing (600), FIGS. 10-11; and inserting a locking pin (622) in a first hole (630) of the housing, FIG. 10, so as to retain the coupling fastener within the fastener hole (col. 8 / lines 13-31), FIG. 11.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the method of Harris/Steffensmeier with a step of inserting a locking pin in a first hole of the housing so as to retain the coupling fastener within the fastener hole, by providing a locking pin and providing a complementarily sized and located first hole through a sidewall of the housing that receives the locking pin orthogonally alongside the coupling fastener to retain the coupling fastener within the fastener hole, to prevent unintentional backout of the coupling fastener and increase the security of the lock between the telescoping parts of the second translation mechanism.
Claims 30-34 are rejected under 35 U.S.C. 103 as being unpatentable over Harris/Steffensmeier in view of Dale and Abedian (hereinafter, “Harris/Steffensmeier/Dale/Abedian”), as applied to claim 29 above, and further in view of U.S. Patent Application Publication No. US 2016/0367270 to Garlock et al. (hereinafter, “Garlock”).
As to claim 30, Harris/Steffensmeier/Dale/Abedian disclose further comprising: coupling a translating member (Harris, 124) with an adjustment housing of the third translation mechanism.
As to claim 34, Harris/Steffensmeier/Dale/Abedian disclose the method of claim 32, further comprising: securing the third translation mechanism to a pin (Harris, 130) inserted in a tibia of a patient.
Harris/Steffensmeier/Dale/Abedian are silent as to aligning a channel disposed within the translating member with an arm of the housing (claim 30); further comprising: positioning a pair of protrusions of the translating member adjacent a pair of translating surfaces of the adjustment housing, wherein the adjustment housing comprises a pair of slots adjacent the translating surfaces, wherein each of the pair of protrusions comprises a first through hole and a second through hole, wherein the first through holes share a common first longitudinal axis and the second through holes share a second longitudinal axis (claim 31); further comprising: placing locking pins at least partially within each of the first and second through holes such that at least a portion of each locking pin is disposed within one of the pair of slots of the adjustment housing (claim 32); further comprising: arranging the translating member in an unlocked position such that the adjustment housing is moveably coupled with the translating member via the locking pins; positioning the translating member and the adjustment housing in a desired position; and locking the translating member to the adjustment housing using a fastener (claim 33); further comprising: securing the third translation mechanism to a pin inserted in a tibia of a patient (claim 34).
As to claim 30, Garlock teaches coupling a translating member (28) with an adjustment housing (24) by aligning a channel (depression adjacent 68) disposed within the translating member with an arm (48) of the housing (par. [0023], [0028]), FIGS. 2A, 3A, and 5A.
As to claim 31, Garlock teaches further comprising: positioning a pair of protrusions (68) of the translating member adjacent a pair of translating surfaces (laterally adjacent to inner surfaces of 48’s or side surfaces creating slot 54) of the adjustment housing (par. [0028], [0033]), FIGS. 2A and 5A, wherein the adjustment housing comprises a pair of slots (54) adjacent the translating surfaces.
As to claim 32, Garlock teaches the method of claim 31, further comprising: placing a locking pin (32) such that at least a portion of each locking pin is disposed within one of the pair of slots of the adjustment housing (par. [0025), FIG. 2A.
As to claim 33, Garlock teaches the method of claim 32, further comprising: arranging the translating member in an unlocked position such that the adjustment housing is moveably coupled with the translating member via the locking pin; positioning the translating member and the adjustment housing in a desired position; and locking the translating member to the adjustment housing using a fastener (threaded end of 32) (par. [0025]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Harris/Steffensmeier/Dale/Abedian to have a translating member as taught by Garlock, and to modify the housing to be as taught by Garlock, so that the translating member is sandwiched between sides of the housing so that the sliding of the third translation mechanism occurs accurately without relative twisting or torquing. The translating member would have a pair of protrusions that are each received in slots on each side of the adjustment housing to guide the translation. The locking pin would pass through the translating member, stabilizing the translating member for sliding along the slot while also connecting to the member (Harris, 8) as required by Harris.
It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to place the locking pin through the protrusion, since rearranging parts of an invention involves only routine skill in the art, and threading the locking pin into the protrusion which protrudes through the slots in the adjustment housing would mean there is no gap between the head of the locking pin and the translating member, so that the locking pin can be tightened down during locking without overtightening or stripping.
It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide two locking pins, since the mere duplication of the essential working parts of a device involves only routine skill in the art, and two pins would prevent twisting and torquing of the translating member relative to the adjustment housing. Then, each protrusion would have a first through hole and a second through hole, wherein the first through holes share a common first longitudinal axis and the second through holes share a second longitudinal axis so that the first holes receive the first pin and the second holes receive the second pin. The pins would be received in holes in the member (Harris, 8) while the third translation mechanism (the adjustment housing as modified above) slides along the pins.
Allowable Subject Matter
Claims 17-23 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.
REASONS FOR ALLOWANCE
The following is an examiner’s statement of reasons for allowance: None of the searched, pertinent prior art clearly shows by itself, or in combination with each other, a method as claimed in claims 17-23. The closest prior art to McGinley (US 2018/0263639) discloses a method of using an alignment guide system, FIG. 42, wherein the alignment guide system is located between the midpoint of the tibia and the ankle joint and comprises a first translation mechanism (121a,b) configured to translate in a medial-lateral direction (par. [0165]); and a second translation mechanism (111) coupled to the first translation mechanism, the second translation mechanism translates in the distal-proximal direction (par. [0164]), but is silent as to a third translation mechanism that translates in the varus-valgus direction.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,304,823. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus more specific. Thus, the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the “generic” invention is anticipated by the “species.” See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims. Because the directional system can be interpreted based on the location of the practitioner or the patient, the limitations in the instant claim 25 regarding the distal and proximal ends are rendered obvious by ‘823. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to couple the first translation mechanism at a distal end of the second translation mechanism and the third at the proximal end of the second, so that the translation mechanisms are coupled in sequence and do not interfere with each other. ‘823 recites a coupling member as secured as part of the first translation mechanism; although ’823 does not recite that the coupling member is configured to receive at least one resection guide, this is language of intended use and the coupling member in ‘823 is intended for that purpose.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775