Detailed Action
This is the final office action for US application number 18/504,511. Claims are evaluated as filed on July 24, 2026.
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 .
Response to Arguments
Applicant's arguments filed July 24, 2026 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument with regards to the drawing objections that Figs. 6 and 7 show instrument 600 which is disclosed in paragraph 72 to comprise at least one adjustable mechanism 604, 604a, 604b, 604c, 604d (Remarks p. 8-9), Examiner agrees that Figs. 6 and 7 show instrument 600 with adjustable mechanisms. However, as noted in the drawing objections, there does not appear to be shown any structure that reads on the entirety of the features of the claimed “second surgical instrument” that is both patient specific and comprises an adjustable mechanism. That is, as shown in Fig. 6 and 7, instrument 600 comprises the adjustable mechanisms, but as shown in Figs. 6A and 7A, the only portion of 600 that contacts the patient is 605, which appears to be flat/planar. It does not appear that an adjustable instrument that lacks surface contours capable of matching a particular bone can be reasonably construed to be patient specific. Thus, the claimed patient specific instrument with an adjustment mechanism of claims 2-4, 6, 11, 12, and 14 does not appear to be shown.
With regards to Applicant’s argument that a term is not a nonce term merely because it is broad or capable of multiple embodiments (Remarks p. 9), Examiner notes that MPEP 2181(I) “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)”. That is, a nonce term is a term with no specific structural meaning.
With regards to Applicant’s argument that an interface is a surface forming a common boundary between two bodies and one would readily understand such limitations to refer to surfaces or surface regions (Remarks p. 9), Examiner notes that this is confusing based on Applicant’s remarks dated December 11, 2025, which provided that “interface” is a term of art that is well known to mean a physical connection point where two components meet, transmit forces, control movement, etc. and may include mating surfaces, shafts, flanges, etc. to allow for controlled interaction between two components; thus, as used in the specification and claims the various “interfaces” are not generic but are specific features of the guides that allow for controlled interaction that, for example, are contoured to interact with patient-specific anatomy to provide secure, consistent interaction and are not generic but tangible structural features on page 7 therein. Thus, Applicant’s intended “interface” when the record is viewed as a whole is unclear. As previously noted, by Applicant’s own admission interfaces may include many different structures that provide a function; thus, “interfaces” has been appropriately interpreted as a generic placeholder as such has no specific structural meaning. Also as previously noted, if there is a specific structure that Applicant’s intends for “interface” to refer to, Applicant may amend to claim that structure or a structural feature thereof in order for the claimed limitation to be interpreted based on a broadest reasonable interpretation, which is described in MPEP 2111.
With regards to Applicant’s argument that “a first bone contact interface configured to contact a first bone of a patient” is sufficient structural context as it identifies a specific region of the instrument (the bone-contacting surface), its geometric requirement (capable of contacting bone), and its structural relationship to the anatomy and similar remarks for “connection interface configured to selectively engage with” another interface (Remarks p. 10), Examiner notes that while these claimed abilities provide context, such does not provide structure. As provided by MPEP 2181 “sufficient structure, material, or acts for performing the claimed function” must be recited for a limitation to not invoke interpretation of 35 USC 112f. Instead, “a first bone contact interface configured to contact a first bone of a patient” provides a first interface capable of bone contact that is capable of contacting a first bone of a patient, i.e. the only structure mentioned is an “interface” that is capable of performing the recited functions; where Applicant has argued that the “interface” is a physical connection point where two components meet, transmit forces, control movement, etc. and may include mating surfaces, shafts, flanges, etc. (December 11, 2025 Remarks) and a surface forming a common boundary between two bodies and one would readily understand such limitations to refer to surfaces or surface regions (Instant Remarks p. 9).
With regards to Applicant’s argument that the specification provides abundant disclosure for each “interface” (Remarks p. 10-11), Examiner agrees and notes that no specification objections or new matter objections have been provided here or previously and thus the purpose of this argument is unclear.
With regards to Applicant’s argument that the specification discloses in paragraph 86 that the connection or mating interfaces are generally rectangular protrusions, slots, or protrusions that mate with each other which is precisely the sufficient structure to rebut 112f (Remarks p.11), Examiner notes that this has not been claimed and therefore is not able to rebut the claim interpretation under 35 USC 11f.
With regards to Applicant’s argument that specification paragraph 73 discloses that the adjustable mechanism of claims 2 and 14 is a linkage, knob, or adjuster, which is a specific structural description and not a generic placeholder (Remarks p. 11), Examiner agrees that a linkage and a knob are known structures and it has not been asserted that such are generic placeholders. Instead, what has been claimed is “adjustable mechanism”, where “mechanism” is a generic placeholder that has only been modified with functional limitations and is therefore properly interpreted under 35 USC 112f.
With regards to Applicant’s argument that “external guiding elements” is part of claim 6 of a negative limitation that the instruments are positionable without such element as k-wires or guide wires in specification paragraph 92, which is a structural characterization of what is absent from the assembly and not a functional placeholder (Remarks p. 11), Examiner agrees that k-wires or guide wires are known structures and it has not been asserted that such are generic placeholders. Instead, what has been claimed is “external guiding elements”, where “elements” is a generic placeholder that has only been modified with functional limitations and is therefore properly interpreted under 35 USC 112f.
With regards to Applicant’s argument that Applicant is prepared to amend “interface” to “surface” as supported by the specification in at least paragraphs 53, 52, and 60 (Remarks p. 12), Examiner notes that a surface is a known structure and would thus be interpreted under BRI. Given the varying definitions/interpretations of “interface” that Applicant has argued, clarity of the claim scope will be most clear on the record if the claims are amended to reflect the intended structure.
With regards to Applicant’s argument that claim 13 requires that the instruments be patient-specific and Honiball’s block 20.2 that is surgeon selected from pre-manufactured blocks to be appropriate to a specific patient misapplies the well-established meaning of “patient-specific” in the art as the specification refers to manufacture from patient-specific anatomical data so that the geometry conforms to a particular unique bony anatomy (Remarks p. 12-13), Examiner notes that manufacture from patient-specific anatomical data so that the geometry conforms to a particular unique bony anatomy has not been claimed. Further, it appears that Applicant is either reading the specification into the claims or applying an overly narrow interpretation of the claim language. As provided by MPEP 2111.01(I) “Under a broadest reasonable interpretation (BRI), words of the claim must be given their plain meaning…. the best source for determining the meaning of a claim term is the specification … The words of the claim must be given their plain meaning unless the plain meaning is inconsistent with the specification…. Ordinary, simple English words whose meaning is clear and unquestionable, absent any indication that their use in a particular context changes their meaning, are construed to mean exactly what they say.” Thus, selecting a block/instrument based on a patient’s specific needs renders the block/instrument to be a non-random instrument that in some capacity best fits the patient needs and is thereby properly interpreted to read on the BRI of “patient-specific” as claimed.
With regards to Applicant’s argument that Honiball does not disclose the sequential method steps of claim 13 (Remarks p. 13-14), Examiner notes that there are no sequential method steps recited in claim 13. Per MPEP 2111.01(II) “the court held that it was improper to read a specific order of steps into method claims where, as a matter of logic or grammar, the language of the method claims did not impose a specific order on the performance of the method steps”.
With regards to Applicant’s argument in regards to claim 13 that Honiball described pre-surgical preparation and does not describe an operative sequence in which one instrument is removed from a second instrument that remains engaged with bone (Remarks p. 14), Examiner notes that such has not been claimed. Instead, claim 13 provides instruments, connects the instruments, and removes an instrument. There is no limitation requiring the one instrument to remain while the other is removed. Further, it is unclear how one can reasonably assert that Honiball performs steps with structures engaging the bone pre-surgery and not operatively or how it is intended claim 13 differentiates between pre- and intra- operative steps.
With regards to Applicant’s argument that the mapping of Siegler’s block 150 is flawed as the rear surface of the block 150 that merely faces the bone is not the same as a bone contact interface configured to contact bone (Remarks p. 15), Examiner agrees and notes that the rejection as provide is under 35 USC 103 over Siegler (US 2020/0085452) in view of Chao (US 2013/0296874); where Seigler discloses that the rear surface of the block 150 faces the bone but is silent at so said surface actually contacting the bone and Chao teaches a similar block that specifically contacts the bone to achieve a desired alignment as detailed in the below rejection and on pages 15-18 of the non-final rejection dated January 27, 2026.
With regards to Applicant’s argument that Seigler’s instruments are reusable which would need to be redesigned for use on another patient if made to physically contact the bone in a patient-specific manner so one would not be motivated to make the combination (Remarks p. 15-16), Examiner notes that it is unclear where the assertion is founded that Seigler’s instruments are reusable as Applicant has provided no reference for this purported disclosure. Instead, Siegler specifically discloses that “surface portions 112, 122 of the talar and the tibial components 110, 120 may be formed by using a computer-based model, such as a 3D model, or two or more 2D pictures of the relevant sections of the patient's tibia and talus.” (¶98). Further, “Once the cutting, sawing, or other procedure requiring the cutting guide 150 is complete, the cutting guide 150 is removable as shown in FIGS. 9B and 9C to allow for visualization of the bone, joint and talar component, and provide access to the talar component to insert a talar cutting guide if desired.” (¶111). Thus, there appears no support for the assertion that one would destroy the invention of Seigler by modifying 150 to contact the second bone of the patient and be patient specific as specifically taught and motivated by Chao.
With regards to Applicant’s argument that Chao’s teaching of patient-specific guides is directed to the first instrument and not a separate interchangeable cutting block (Remarks p. 15-16), Examiner notes that, as detailed below and on pages 17-18 of the non-final office action dated January 27, 2026, the second surgical instrument of Chao is the guide box of ¶61 as shown in Figs. 8A-11, 14-16C, 19, and 22 and disclosed to be patient-specific in ¶s 9, 46, 58, 62, 65-66, 73, and 74. For example, Figs. 9 and 10 very clearly show that the surface 290 is variably contoured and paragraph 9 specifically states that “The tibial cutting guide boxes can include a patient-specific contact surface configured to conform to a portion of the anterior surface of the tibia.”. Further, paragraph 46 discloses that “The boxes may be designed to include various patient specific contact surfaces to easily mate with the anterior surface of the bone.... The guide boxes may also be designed to make cuts that are parallel, non-parallel, perpendicular, or non-perpendicular to other cuts.”, paragraph 61 discloses that “FIGS. 8A-8C depict isometric perspective views of various embodiments of different tibial guide boxes that can be used with various features disclosed herein”, and paragraph 62 discloses that “FIGS. 9 and 10 depict the bottom and top plan views, respectively, of a tibial guide box.”.
With regards to Applicant’s argument in regards to claim 4 that Chao’s angle adjustment and ability to reposition the cutting slot does not disclose two distinct and independent adjustable mechanisms each operating in a separate plane oriented 90 degrees from each other (Remarks p. 16), Examiner notes that this has not been claimed and has therefore not been considered. Instead, claim 4 provides “the at least two adjustable mechanisms are configured to reposition the aperture in two distinct planes that are oriented 90 degrees relative to each other”. As noted with regards to claim 3, the two adjustable mechanisms capable of repositioning the aperture are shown in Figs. 8A-8C as disclosed in ¶61. As noted, Chao ¶s 64, 66, and 68 further describe the claimed capability of repositioning of the aperture to achieve varying angles of the cut planes, i.e. in two distinct planes (e.g. vertical and horizontal) that are oriented 90 degrees to each other; where paragraph 64 additionally provides “FIG. 13A depicts various cut guide slot angulations that, when used in conjunction with a tibial guide box as described herein, can generally be employed to alter the resulting varus or valgus angles of one or more tibial cut planes. FIG. 13B depicts one alternative embodiment of a guide tool that incorporates an adjustment mechanism 322 that can be employed and adjusted to alter the cut angle. The adjustment mechanism could include a screw thread or other mechanism that allows a wide variation in the cut plane angle, which could include larger wedges to accommodate more severe varus/valgus angles. In various embodiment, the guide tool with the adjustable mechanism could be sized and configured to fit into the standard guided slots as shown in FIG. 13A.”
With regards to Applicant’s argument that claims 6 and 8 remain patentable as applicant’s specification explains that the ability to position instruments without external guiding elements is a direct result of patient-specific bone contact surfaces that lock the assembly to the patient anatomy and the combination of Siegler and Chao fails to disclose a patient-specific second instrument as recited in claim 1 (Remarks p. 17), Examiner refers Applicant to the above response to the arguments regarding Siegler and Chao. In summary, such is explicitly taught by Chao as shown in Figs. 8A-11, 14-16C, 19, and 22 and disclosed to be patient-specific in ¶s 9, 46, 58, 62, 65-66, 73, and 74.
Information Disclosure Statement
In regards to the information disclosure statement filed November 26, 2025, due to large volume of information submitted by applicant, applicant is required to identify any specific references within the large volume which they may be aware of that may be relevant to the claimed invention. This requirement is necessary since there appear to be a number of references in the large volume that are not at all relevant to the claimed invention, including the knee joint prostheses (US 4,207,627, US 2011/0106268, US 2008/0140214, etc.), spinal implants (US 2106/0270920, US 8,840,668, US 8,709,083, etc.), and an airway stent (Ratnovsky NPL). As such, the 52 US documents, 7 FOR documents, and 14 NPL documents currently cited have received only a cursory review as the relevance of such documents to the instant application has not been established.
Examiner reminds Applicant that per MPEP 609 “applicants and other individuals substantively involved with the preparation and/or prosecution of the application have a duty to submit to the Office information which is material to patentability as defined in 37 CFR 1.56” (bold font added for emphasis). As disclosed, the instant applicant is related to a surgical alignment guide for total ankle replacement and use thereof and therefore documents submitted on an IDS should be material to patentability of such a disclosure.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the second surgical instrument that has a third bone contact interface, is patient specific, and comprises an adjustable mechanism of claims 2-4 and 6; the second surgical instrument that has a third bone contact interface, is patient specific, and comprises an adjustable mechanism of claims 11 and 12; and the second surgical instrument that is patient specific and comprises an adjustable mechanism of claim 14 must be shown 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 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 limitations are: “a first bone contact interface” in claim 1 line 3, “a second bone contact interface” in claim 1 line 4, “a first connection interface” in claim 1 line 6, “a third bone contact interface” in claim 1 line 8, “second a connection interface” in claim 1 line 9; “an adjustable mechanism” in claim 2 line 2; “at least two adjustable mechanisms” in claim 3 line 2; “external guiding elements” in claim 6 lines 2-3; “a first bone contact interface” in claim 9 line 3, “a second bone contact interface” in claim 9 line 4, “a first connection interface” in claim 9 line 6, “a third bone contact interface” in claim 9 line 9, “second a connection interface” in claim 9 line 11, “a third connection interface” in claim 10 line 3; “an adjustable mechanism” in claim 11 line 2; “at least two adjustable mechanisms” in claim 12 line 2; “a first bone contact interface” in claim 13 line 5, “a second bone contact interface” in claim 13 line 6, “a first connection interface” in claim 13 line 8, “an adjustable mechanism” in claim 14 lines 2-3; “a second connection interface” in claim 15 line 2, and “a third connection interface” in claim 15 line 3.
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.
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 § 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.
Claim(s) 13-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Honiball (WO 2014/020561 as provided with the PTO-892 dated March 25, 2025).
As to claim 13, Honiball discloses a method of aligning surgical instruments relative to a patient (Figs. 5-8, p. 7 line 26 – page 8 line 6 and p. 8 lines 8-19), the method comprising: providing a first surgical instrument (20.1) and a second surgical instrument (20.2, Figs. 5 and 8, p. 9 lines 20-22, p. 11 lines 19-26), the first surgical instrument including a first bone contact interface (16) capable of contacting a first bone of a patient (12, Fig. 8, p. 7 line 26 – page 8 line 6), a second bone contact interface (25) capable of contacting a second bone of the patient (14, Fig. 8, p. 8 lines 8-19), and a first connection interface (opening forming dovetail joint 27, Figs. 5 and 8, p. 9 lines 20-22) capable of mechanically linking the first surgical instrument with the second surgical instrument (20.2, Figs. 5 and 8, p. 9 lines 20-22, p. 11 lines 19-26), connecting the first surgical instrument with the second surgical instrument (20.2, Figs. 5 and 8, p. 9 lines 20-22, p. 11 lines 19-26), and arranging the first surgical instrument and the second surgical instrument in contact with the first bone of the patient (Fig. 8, page 10 lines 16-20); and removing the first surgical instrument from the second surgical instrument (p. 11 lines 19-26), wherein the first surgical instrument is patient-specific (at 16 and 25, Fig. 8, p. 7 line 26 – page 8 line 18) and the second surgical instrument is patient specific (Fig. 8; p. 11 lines 18-26 disclose the flexibility of providing differently configured blocks/instruments for 20.2 from which the surgeon can select an appropriate one and mount via the dove tail joint where each blocks/instrument 20.2 has a differently positioned cutting guide slot/aperture, i.e. appropriate to the specific patient).
As to claim 14, Honiball discloses that the second surgical instrument comprises an aperture (46) for guiding a third surgical instrument (Figs. 5 and 8, p. 10 lines 10-12), and an adjustable mechanism (differently configured blocks with different positions of 46 of p. 11 lines 19-25. p. 11 lines 19-25) capable of repositioning the aperture relative to an anatomy of the patient (p. 11 lines 19-25).
As to claim 15, Honiball discloses that the second surgical instrument comprises a second connection interface (protrusion forming dovetail joint 27, Figs. 5 and 8, p. 9 lines 20-22, p. 11 lines 19-26) capable of selectively engaging with both the first connection interface of the first surgical instrument and a third connection interface of a third surgical instrument (if one chooses to use it as such due to the shown structure of the dovetail joint protrusion, Fig. 5 and 8).
As to claim 16, Honiball discloses that the first connection interface is at least partially defined on an outer end surface of the first surgical instrument (Fig. 5).
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 of this title, 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) 1-4, 6, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siegler (US 2020/0085452) in view of Chao (US 2013/0296874).
As to claims 1-4, 6, and 8, Siegler discloses a surgical guide (Figs. 6A, 6B, and 9A-9C, ¶s 103, 104, and 111) comprising: a first surgical instrument (110, 120, Figs. 6A and 6B) comprising: a first bone contact interface (surface of 110 shown with a grid pattern in Fig. 6A, Fig. 6A, abstract) capable of contacting a first bone of a patient (Fig. 6A, ¶104, i.e. as shown in Figs. 4 and 5 and disclosed in ¶102 for an alternate embodiment), and a second bone contact interface (surface of 120 shown with a grid pattern in Fig. 6A, Fig. 6A, abstract) capable of contacting a second bone of the patient (Fig. 6A, ¶103, i.e. as shown in Figs. 4 and 5 and disclosed in ¶102 for an alternate embodiment), and a first connection interface (130 and portion of 120 adjacent 130, Figs. 6A and 6B); and a second surgical instrument (150, Figs. 9A-9C) comprising: a third bone facing surface (rear surface of 150 as best shown in Fig. 9B, Fig. 9B) capable of facing the second bone of the patient (Figs. 9A-9C, ¶103, i.e. as shown in Figs. 4 and 5 and disclosed in ¶102 for an alternate embodiment), a second connection interface (outer perimeter surfaces of 150 as shown in Figs. 9A-9C, Figs. 9A-9C) capable of selectively engaging with the first connection interface (Figs. 9A-9C, ¶111), and an aperture (opening shown in the central portion of 150 in Figs. 9A-9C, Figs. 9A-9C, ¶111 discloses that 150 is a cutting guide used in cutting, sawing, or other procedure) capable of guiding a third surgical instrument (instrument used to perform the cutting, sawing, or other procedure with guide 150 in ¶111, ¶111), wherein the first surgical instrument is patient-specific (Fig. 6A, abstract). As to claim 2, Siegler discloses that the second surgical instrument further comprises an adjustable mechanism capable of repositioning the aperture relative to the first bone of the patient (Figs. 9A-9C, ¶111). As to claim 3, Siegler discloses that the adjustable mechanism includes at least two adjustable mechanisms capable of repositioning the aperture (Figs. 9A-9C, ¶111). As to claim 6, Siegler discloses that the first surgical instrument and the second surgical instrument are capable of being positioned relative to the patient without any external guiding elements (due to the bone contacting interfaces contouring with the bone anatomy, Fig. 6a, ¶111). As to claim 8, Siegler discloses that the first surgical instrument is capable of contacting a tibia and a talus of the patient such that the first surgical instrument is oriented in a predetermined manner (Fig. 6A, ¶103).
Siegler is silent to the third bone facing surface being a third bone contact interface configured to contact the second bone of the patient and that the second surgical instrument is patient specific. As to claim 4, Siegler is silent to the at least two adjustable mechanisms are configured to reposition the aperture in two distinct planes that are oriented 90 degrees relative to each other.
Chao teaches a similar surgical guide (Figs. 1-11, 14-16C, and 18-23) comprising: a first surgical instrument (25, Figs. 1-7, 16A-16C, and 18-23) comprising: a first bone contact interface (70, 190, ¶s 55 and 58) capable of contacting a first bone portion of a patient (Figs. 18-23, ¶s 55 and 58), and a second bone contact interface (120, 190, Figs. 2 and 5, ¶s 55 and 58) capable of contacting a second bone portion of the patient (Figs. 18-23, ¶s 55 and 58), and a first connection interface (130 and the opening 130 is shown positioned within in Figs. 3, 4, and 16A-16C, Figs. 3, 4, and 16A-16C); and a second surgical instrument (guide box of ¶61, Figs. 8A-11, 14-16C, 19, and 22) comprising: a third bone contact interface (surface with 290 label in Fig. 10, i.e. central portion of the rear surface of the guide box as shown in Fig. 14, Figs. 9, 10, and 14, ¶s 58, 62, and 74) capable of contacting the second bone of the patient (Figs. 8A-10, 14-16B, 19, and 22, ¶s 58, 62, and 74), a second connection interface (dovetail slot/groove 260 of Fig. 9, i.e. shown in Figs. 16A-16C receiving 130 and peripheral walls of the guide box, Figs. 8A-11, 14-16C, 19, and 22, ¶62) capable of selectively engaging with the first connection interface (Figs. 16A-16B, 19, and 22, ¶s 56 and 62), and an aperture (cutting guide slot of ¶81, i.e. openings shown in Figs. 8A-8C, ¶s 61 and 81, where ¶61 discloses use to cut the tibia) capable of guiding a third surgical instrument (reciprocating saw or similar cutting device of ¶81, i.e. tool used to cut the tibia, ¶s 61 and 81, where ¶61 discloses cutting the tibia and ¶81 discloses cutting the tibia with a reciprocating saw or similar cutting device fitted through a cutting guide slot of the guide box), wherein the first surgical instrument is patient-specific (Figs. 16A-16B, 19, and 22, ¶s 8, 45, 55, and 58) and the second surgical instrument is patient specific (Figs. 8A-10, 14-16A, 19, and 22, ¶s 9, 46, 58, 62, 65-66, 73, and 74). As to claim 2, Chao teaches that the second surgical instrument further comprises an adjustable mechanism capable of repositioning the aperture relative to the first bone of the patient (Figs. 8A-8C, ¶61). As to claim 3, Chao teaches that the adjustable mechanism includes at least two adjustable mechanisms capable of repositioning the aperture (Figs. 8A-8C, ¶61). As to claim 4, Chao teaches that the at least two adjustable mechanisms are capable of repositioning the aperture in two distinct planes that are oriented 90 degrees relative to each other (¶s 64, 66, and 68).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify/specify the third bone facing surface and the second surgical instrument as disclosed by Siegler to contact the second bone of the patient and be patient specific as taught by Chao in order to easily mate with the surface of the bone (Chao ¶46), to achieve the degree of deformity correction necessary for desired alignment (Chao ¶68), for example with varus/valgus deformities/angles (Chao ¶s 64 and 66), and to fit a cutting device through a cutting guide slot to cut the bone (Chao Figs. 18-23, ¶81) in a known and stable manner.
Allowable Subject Matter
Claims 7 and 17 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 9-12 are allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Monday through Thursday, 6:30am-4pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMY R SIPP/Primary Examiner, Art Unit 3775
Prosecution Insights