Detailed Action
This is the first office action on the merits for US application number 18/604,938.
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 with traverse of Invention I, the product of claims 1-15, in the reply filed on December 17, 2025 is acknowledged. The traversal is on the ground(s) that there is no search burden.
The argument that there is no search burden as there are overlapping elements and a proper examination would necessitate searching art relevant to both claim groups is not found persuasive because although there would be some overlap in searching fields, simultaneously searching a method with a device would be burdensome since searching the structural features highlighted in the device claims is inherently different than searching for the provision of even similar combinations of structural features highlighted in the method claims and vice versa, not to mention the actual active method steps being claimed. Thus, even though prior art that is relevant to the device may anticipate the method and vice versa, the manner in which methods are searched typically is not similar to that of the device.
The requirement is still deemed proper and is therefore made FINAL.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/576,913, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 63/576,913 fails to provide adequate support for the angled slots of claims 6 and 14, the flattened sides of claims 9, 10, and 12, and for inserting the blade to remove at least one bone end portion “without the need for any additional securement to the two adjacent bones” of claim 11 lines 11-13.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
As to claim 11, the specification appears to lack proper antecedent basis for inserting the blade to remove at least one bone end portion “without the need for any additional securement to the two adjacent bones” of claim 11 lines 11-13. This is a negative limitation, i.e. the claim is requiring that the blade removing at least one bone end portion without the need for any additional securement to the two adjacent bones. Negative limitations are not per se improper, but they must be supported by the originally filed disclosure. As provided by MPEP 2173.05(i), any negative limitation or exclusionary proviso must have basis in the original disclosure; if alternative elements are positively recited in the specification, they may be explicitly excluded in the claims; and the mere absence of a positive recitation is not basis for an exclusion. The specification is silent regarding the blade removing at least one bone end portion without the need for any additional securement to the two adjacent bones. As noted above, the absence of a positive recitation is not a proper basis of support for a negative limitation. Additionally, since the specification is silent on the matter of the blade removing at least one bone end portion with additional securement to the two adjacent bones, then the “alternative elements” rationale discussed above in the MPEP is not applicable. Thus, the specification fails to provide proper antecedent basis for inserting the blade to remove at least one bone end portion “without the need for any additional securement to the two adjacent bones” of claim 11 lines 11-13. Examiner suggests cancelling this limitation or amending the specification accordingly in a manner supported by original claim 11.
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 “an orthopedic bone saw blade” of claim 1 lines 12-13, the “the wedge block further includes two opposing top and bottom faces that are angled with respect to each other and that extend between the two angled side faces to form a truncated wedge shape” of claim 3 lines 1-3, and “an orthopedic bone saw blade” of claim 12 lines 18-19must 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 limitation(s) is/are: “a wedge coupling part” in claim 1 line 3, “a handle coupling part” in claim 1 line 7, “a guide coupling part” in claim 1 line 11, “a wedge coupling part” in claim 12 line 3, “a handle coupling part” in claim 12 line 9, and “a guide coupling part” in claim 12 line 17.
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 Objections
Claim(s) 1, 5, 11, and 12 is/are objected to because of the following informalities:
Claim 1 line 19 should read “to remove at least one bone end portion[[,]] to form bone end edges”.
Claim 5 line 2 should read “the guide coupling part is positioned between at least two of the plurality of guide slots”.
Claim 11 line 11 should read “at least one of the plurality of guide slots”.
Claim 12 line 28 should read “to remove at least one bone end portion[[,]] to form bone end edges”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-15 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
As to claims 1-11, “serrations that dig into joint cartilage” of claim 1 line 5 appears to claim the human body as “joint cartilage”. Examiner suggests amending as “serrations [[that]]configured to dig into joint cartilage to address this rejection and will interpret these limitations as meaning that the serrations are capable of digging into joint cartilage.
As to claims 12-15, “serrations that dig into joint cartilage” of claim 12 line 5 appears to claim the human body as “joint cartilage”. Examiner suggests amending as “serrations [[that]]configured to dig into joint cartilage to address this rejection and will interpret these limitations as meaning that the serrations are capable of digging into joint cartilage.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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(s) 1-15 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 is unclear with regards to “it” in line 12 and “them” in line 13 and to what they are intended to refer. Also, claim recites/recite the limitation "the way" in line 13. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “wherein the guide block includes a plurality of guide slots configured to receive an orthopedic bone saw blade
Claim(s) 1 is/are unclear with regards to “wherein in use, the wedge of the joint-repositioning tool is inserted between the two adjacent bones of the joint to reposition at least one of the bones, and then the cutting guide of the saw-guide tool is used to guide the orthopedic bone saw blade to remove at least one bone end portion to form bone end edges that are substantially parallel so the bones are now substantially aligned” in lines 16-20 as such appears to be reciting a method step in a product claim. Examiner is interpreting this as referring to the product being configured to or configured for performing such functions and suggests amending to clarify.
Claim(s) 3 is/are unclear with regards to “wherein in use in the first configuration forming the joint-repositioning orthopedic surgery tool, the truncated wedge repositions at least one of the bones in two planes” as such appears to be reciting a method step in a product claim. Examiner is interpreting this as referring to the product being configured to or configured for performing such functions and suggests amending to clarify.
Claim(s) 6 is/are unclear with regards to “at least two of the plurality of guide slots of the cutting guide are angled with respect to each other” in lines 1-2 for “the cutting guide of the saw-guide tool is used to guide the orthopedic bone saw blade to remove at least one bone end portion, to form bone end edges that are substantially parallel so the bones are now substantially aligned” of claim 1 lines 19-20 and how the cutting guide can be configured to guide the saw blade to form substantially parallel bone ends if the guide slots are angled with respect to one another . Examiner is interpreting this broadly and suggests amending to clarify.
Claim(s) 8 is/are unclear with regards to “the guide block includes an opening that receives the projection coupling part” in lines 1-2 that is in addition to the guide coupling part of claim 1 line 11 from which claim 8 depends as well as support for an opening in addition to the aperture of claim 7 or a projection coupling part in addition to the at least one projection of claim 7. Examiner is interpreting this as referring to, and suggests amending as, “system of claim [[7]]1, wherein the guide coupling part includes an opening that receives [[the]]a projection of the wedge coupling part”.
Claim(s) 9 is/are unclear with regards to “the guide block opening” in line 1 and “the wedge coupling part includes a projection” in lines 2-3 and if these are intended to refer to or be in addition to the opening and the projection of claim 8 from which claim 9 depends and where support for such can be found. Examiner is interpreting this as referring to, and suggests amending as, “wherein the guide coupling part opening includes a flattened side and the wedge coupling part includes a flattened side”.
Claim(s) 10 is/are unclear with regards to “the guide block opening” in line 1, antecedence support for “the wedge coupling”, and “the wedge coupling includes a projection” in lines 2-3 and if these are intended to refer to or be in addition to the opening and the projection of claim 8 from which claim 10 depends and where support for such can be found. Examiner is interpreting this as referring to, and suggests amending as, “wherein the guide coupling part opening includes a flattened side, the wedge coupling part includes a flattened side”.
Claim(s) 10 is/are unclear with regards to “the guide block opening” in lines 3 and 6 and if this is intended to refer to the guide coupling part of claim 1 line 11 that comprises an opening in claim 8. Examiner is interpreting this as referring to, and suggests amending as, “the guide
Claim 12 is unclear with regards to “it” in line 18 and “them” in line 19 and to what they are intended to refer. Also, claim recites/recite the limitation "the way" in line 19. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “wherein the guide block includes a plurality of guide slots configured to receive an orthopedic bone saw blade
Claim(s) 12 is/are unclear with regards to “wherein in use, the wedge of the joint-repositioning tool is inserted between the two adjacent bones of the joint to reposition at least one of the bones, and then the cutting guide of the saw-guide tool is used to guide the orthopedic bone saw blade to remove at least one bone end portion to form bone end edges that are substantially parallel so the bones are now substantially aligned” in lines 25-29 as such appears to be reciting a method step in a product claim. Examiner is interpreting this as referring to the product being configured to or configured for performing such functions and suggests amending to clarify.
Claim(s) 13 is/are unclear with regards to “wherein in use in the first configuration forming the joint-repositioning orthopedic surgery tool, the truncated wedge repositions at least one of the bones in two planes” as such appears to be reciting a method step in a product claim. Examiner is interpreting this as referring to the product being configured to or configured for performing such functions and suggests amending to clarify.
Claim(s) 14 is/are unclear with regards to “at least two of the plurality of guide slots of the cutting guide are angled with respect to each other” in lines 1-2 for “the cutting guide of the saw-guide tool is used to guide the orthopedic bone saw blade to remove at least one bone end portion, to form bone end edges that are substantially parallel so the bones are now substantially aligned” of claim 12 lines 27-29 and how the cutting guide can be configured to guide the saw blade to form substantially parallel bone ends if the guide slots are angled with respect to one another . Examiner is interpreting this broadly and suggests amending to clarify.
Claim(s) 15 is/are unclear with regards to “the wedge coupling part includes a projection, the guide coupling part includes an aperture” in lines 1-3 that are in addition to “wherein the wedge coupling part, the handle coupling part, and the cutting guide coupling part include at least one projection and at least one aperture that mate with each other” of claim 12 lines 22-23 and where support can be found for the two claimed projections and apertures. Claim 15 is further unclear with regards to “the guide block includes an opening” in line 4 that is in addition to the disclosed opening of the guide coupling part previously claimed as an aperture as well as to what “it” refers in line 4 and support for “the guide block opening” in lines 5-6, 7, and 10. Examiner is interpreting this as intended to refer to the one disclosed aperture/opening of the guide coupling part and wedge coupling part projections and suggests amending to clarify.
Claim(s) 2, 4, 5, 7, and 11 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
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) 1-8 and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2017/0014173, hereinafter “Smith”) in view of Saw et al. (US 2015/0071885, hereinafter “Saw”) and McCormack et al. (US 2010/0069912, hereinafter “McCormack”).
The claimed phrases “form”, “to form”, “formed”, or the like are being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claims 1, 3-8, and 11, Smith discloses an orthopedic surgical system (188, 150, Figs. 5, 19-23, 35-36B, ¶117-120) capable of reducing an angular deformity in a joint (shown in Figs. 19-23), the system comprising: a wedge (188) including a wedge block (372) and a wedge coupling part (see illustration of Fig. 35, i.e. lower portion of 370 as shown in Fig. 35, Fig. 35 and 36B), wherein the wedge block has a triangular shape (lower portion as shown in Fig. 36B, Fig. 36B) and includes two opposing side faces that are angled with respect to each other (Fig. 36B) and that are each capable of abutting joint cartilage (shown in Fig. 19 for an alternate embodiment, Figs. 35 and 36B, ¶94) capable of securing the wedge in place to and between two adjacent bones of the joint (shown in Fig. 19 for an alternate embodiment, Figs. 35 and 36B, ¶94; also as evidenced by ¶41 of Bays et al. in US 2017/0079669 disclosure that the thickness of the wedge block 62 is such that the wedge block fits snuggly into the space between two bones and is sized to alter, such as expand, the space between two bones when inserted and have a thickness that tapers in a direction proceeding toward the tip of the wedge block (e.g., a wedge-shaped keel)); a handle (see illustration of Fig. 35, i.e. lower portion of 370 as shown in Fig. 35, Fig. 35 and 36B) including an elongated extension member (see illustration of Fig. 35, Fig. 35) and a handle coupling part (see illustration of Fig. 35, Fig. 35), wherein the handle coupling part mates with the wedge coupling part (Fig. 35) capable of mounting the handle to the wedge in a first configuration of the system (Fig. 35) capable of forming a joint-repositioning orthopedic surgery tool (Fig. 35, shown in Fig. 19 for an alternate embodiment, Figs. 35 and 36B, ¶94; also as evidenced by ¶41 of Bays et al. in US 2017/0079669 disclosure that the thickness of the wedge block 62 is such that the wedge block fits snuggly into the space between two bones and is sized to alter, such as expand, the space between two bones when inserted); and a cutting guide (150) including a guide block (150, Figs. 5, 36A, and 36B) and a guide coupling part (170, Figs. 36A and 36B), wherein the guide block includes a plurality of guide slots (160, 164) capable of receiving an orthopedic bone saw blade (“tissue removing instrument” of ¶73, Fig. 22, ¶73), wherein the guide coupling part mates with the wedge coupling part (Fig. 36B) capable of removably mounting the cutting guide to the wedge (Fig. 36B, ¶117-120) in a second configuration of the system (Fig. 36B) capable of forming a saw-guide orthopedic surgery tool (Fig. 36B), wherein in use, the wedge of the joint-repositioning tool is inserted between the two adjacent bones of the joint (shown in Fig. 19 for an alternate embodiment, Figs. 35 and 36B, ¶94) capable of repositioning at least one of the bones (shown in Fig. 19 for an alternate embodiment, Figs. 35 and 36B, ¶94; also as evidenced by ¶41 of Bays et al. in US 2017/0079669 disclosure that the thickness of the wedge block 62 is such that the wedge block fits snuggly into the space between two bones and is sized to alter, such as expand, the space between two bones when inserted and have a thickness that tapers in a direction proceeding toward the tip of the wedge block (e.g., a wedge-shaped keel)), and then the cutting guide of the saw-guide tool is used to guide the orthopedic bone saw blade (shown in Fig. 22 for an alternate embodiment, Figs. 35 and 36B, ¶91) capable of removing at least one bone end portion (¶91) to form bone end edges that are substantially parallel (¶s 73, 74, 91, and 99) so the bones are now substantially aligned (¶s 91 and 107). As to claim 3, Smith discloses that the wedge block further includes two opposing top and bottom faces (Fig. 36B) that are angled with respect to each other (Fig. 36B) and that extend between the two angled side faces (Fig. 36B) capable of forming a truncated wedge shape (Fig. 36B), wherein in use in the first configuration forming the joint-repositioning orthopedic surgery tool, the truncated wedge repositions at least one of the bones in two planes (Fig. 19, ¶107). As to claim 4, Smith discloses that the handle further comprises a proximal head (see “Head” in illustration of Fig. 35, Fig. 35) from which the extension member extends (Fig. 35), wherein the head is larger in cross-sectional area than the extension member (Fig. 35) capable of defining a proximal strike surface (upper surface of the head as shown in Figs. 35 and 36B, Figs. 35 and 36B) that can be forcefully impacted to drive the wedge into the joint when the system is in the first configuration forming the joint-repositioning orthopedic surgery tool (Figs. 19, 35, and 36B). As to claim 5, Smith discloses that the guide coupling part is positioned between at least two of the plurality of guide slots (Fig. 36B) when the cutting guide is mounted to the wedge in the second configuration forming the saw-guide orthopedic surgery tool (Figs. 5, 36A, and 36B). As to claim 6, Smith discloses that at least two of the plurality of guide slots of the cutting guide are angled with respect to each other (Figs. 5, 36A, and 36B, ¶s 73 and 74; where ¶74 discloses that the slots may be parallel or skewed), wherein in use, the two adjacent bones need not be aligned with each other when using the saw-guide orthopedic surgery tool to remove at least one bone end portion (Figs. 36A and 36B, ¶s 118-120). As to claim 7, Smith discloses that the wedge coupling part and the cutting guide coupling part include at least one projection (see illustration of Fig. 35, Fig. 35) and at least one aperture (170, Figs. 5 and 36A) that mate with each other (Fig. 35). As to claim 8, Smith discloses that the guide coupling part includes an opening (170) that receives a projection of the wedge coupling part (see illustration of Fig. 35, Figs. 35 and 36B). As to claim 11, Smith discloses a method of reducing an angular deformity in a joint using the orthopedic surgical system of claim 1 (Figs. 5, 19-23, 35-36B, ¶117-120), the method comprising: configuring the system into the first configuration with the handle mounted to the wedge (Fig. 35) to form the joint-repositioning tool (Fig. 35); inserting the wedge of the joint-repositioning tool between the two adjacent bones of the joint (Fig. 19) to reposition at least one of the bones (shown in Fig. 19 for an alternate embodiment, Figs. 35 and 36B, ¶94; also as evidenced by ¶41 of Bays et al. in US 2017/0079669 disclosure that the thickness of the wedge block 62 is such that the wedge block fits snuggly into the space between two bones and is sized to alter, such as expand, the space between two bones when inserted and have a thickness that tapers in a direction proceeding toward the tip of the wedge block (e.g., a wedge-shaped keel)) and to secure the wedge in position into the joint cartilage (shown in Fig. 19 for an alternate embodiment, Figs. 35 and 36B, ¶94; also as evidenced by ¶41 of Bays et al. in US 2017/0079669 disclosure that the thickness of the wedge block 62 is such that the wedge block fits snuggly into the space between two bones and is sized to alter, such as expand, the space between two bones when inserted and have a thickness that tapers in a direction proceeding toward the tip of the wedge block (e.g., a wedge-shaped keel)); reconfiguring the system into the second configuration (Fig. 36B), while the wedge remains secured in the joint (Figs. 20 and 36B), with the cutting guide mounted to the wedge to form the saw-guide tool (Figs. 20 and 36B); and inserting the orthopedic bone saw blade through at least one of the plurality of guide slots (Fig. 22) and to remove at least one bone end portion without the need for any additional securement to the two adjacent bones (Fig. 22, ¶120 discloses a locking mechanism to lock the rotational angle of the wedge and cutting guide).
Smith is silent to the two opposing side faces each including serrations configured to dig into bone, wherein the handle coupling part mounting capable of removably mounting the handle to the wedge. As to claim 11, Smith is silent to the serrations dug into the joint cartilage.
Saw teaches a similar orthopedic surgical system (100, 220, 308, 324, Figs. 2-18) capable of reducing an angular deformity in a joint (Fig. 19-31), the system comprising: a wedge (324) including a wedge block (365) and a wedge coupling part (372c, 372b, Figs. 16 and 17), wherein the wedge block has a triangular shape (Figs. 16 and 17) and includes two opposing side faces (Fig. 17) that are angled with respect to each other (Fig. 17) and that each include serrations (381) capable of digging into cartilage (¶100 discloses providing a grip on a bone surface) capable of securing the wedge in place to and between two adjacent bone portions (Fig. 28, ¶100);
a handle (372a, Figs. 16 and 17) including an elongated extension member (upper portion of handle as shown in Fig. 17, Fig. 17) and a handle coupling part (lower portion of handle as shown in Fig. 17, Fig. 17), wherein the handle coupling part mates with the wedge coupling part (Fig. 17) capable of mounting the handle to the wedge in a first configuration of the system (Figs. 16 and 17) to form a joint-repositioning orthopedic surgery tool (Figs. 16-18 and 28); and a cutting guide (308) including a guide block (310) and a guide coupling part (329), wherein the guide coupling part mates with the wedge coupling part (Fig. 12) capable of mounting the cutting guide to the wedge (Fig. 12) in a second configuration of the system to form a cut-guide orthopedic surgery tool (Figs. 12, 28, and 29), wherein in use, the wedge of the joint-repositioning tool is inserted between the two adjacent bone portions of the joint (Fig. 28) capable of repositioning at least one of the bone portions (Fig. 28). As to claim 11, Saw teaches a method of reducing an angular deformity in a joint using the orthopedic surgical system of claim 1 (Figs. 2-31), the method comprising: configuring the system into the first configuration with the handle mounted to the wedge (Figs. 16 and 17) to form the joint-repositioning tool (Figs. 16 and 17); inserting the wedge of the joint-repositioning tool between the two adjacent bone portions of the joint (Fig. 28) to reposition at least one of the bone portions (Fig. 28) and to secure the wedge in position into the joint (Fig. 28, ¶100); reconfiguring the system into the second configuration (Figs. 12, 13, and 28), while the wedge remains secured in the joint (Fig. 28), with the cutting guide mounted to the wedge to form the cut-guide tool (Fig. 28).
McCormack teaches a similar orthopedic surgical system (Figs. 9A-9C) capable of reducing an angular deformity in a joint (Figs. 9A-9C, abstract, ¶128), the system comprising: a wedge (90, 92, 93) including a wedge block (90) and a wedge coupling part (92), wherein the wedge block has a shape (Figs. 9A-9C) and includes two opposing side faces (Figs. 9A-9C) that are angled with respect to each other (Figs. 9A-9C), the wedge coupling part comprising a threaded protrusion (portion of 92 shown extending from the wedge block in Fig. 9A, Fig. 9A); a handle (91, 86, 87) including an elongated extension member (86) and a handle coupling part (91), wherein the handle coupling part mates with the wedge coupling part (Figs. 9B and 9C, ¶s 124, 126, and 127) capable of removably mounting the handle to the wedge in a first configuration of the system (¶127) capable of forming a joint-repositioning orthopedic surgery tool (Fig. 9C, ¶128); the handle coupling part comprising a threaded receptacle (¶s 124 and 126); and wherein in use, the wedge of the joint-repositioning tool is inserted between the two adjacent bones of the joint (Figs. 9B and 9C) capable of repositioning at least one of the bones (Figs. 9B and 9C, ¶128). As to claim 7, Smith discloses that the wedge coupling part and the handle coupling part include at least one projection (92) and at least one aperture (threaded receptacle of the nut 91 disclosed in ¶s 124 and 126, ¶s 124 and 126) that mate with each other (Fig. 9A).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the side faces of the wedge block as disclosed by Smith by adding serrations and varying the wedge block size/shape as taught by Saw in order to grip a desired bone surface (Saw ¶100) and accommodate the bone size of the patient and condition of the patient (Saw ¶s 91 and 99). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the handle coupling part mounting of the wedge coupling part with the handle coupling part as disclosed by Smith to be removable mounting of a threaded protrusion of the wedge coupling part with a threaded receptacle of the handle coupling part as taught by McCormack in order to insert the distraction mechanism in the bone joint (Fig. 9B) for distraction purposes so that an implant can be positioned in the bone joint to retain the distraction while the distraction mechanism is removed (McCormack ¶127), i.e. to select a known mounting of a handle to a distraction device (McCormack Figs. 3, 6A-11C, 13A-17C, and 26A-26C).
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As to claim 2, the combination of Smith, Saw, and McCormack discloses the invention of claim 1 as well as the wedge block includes a distal leading tip (lower end portion of the wedge block as shown in Fig. 36B, Fig. 36B) formed by the two angled side faces (Fig. 36B) that are each capable of abutting joint cartilage (shown in Fig. 19 for an alternate embodiment, Figs. 35 and 36B, ¶94) capable of securing the wedge in place to and between two adjacent bones of the joint (shown in Fig. 19 for an alternate embodiment, Figs. 35 and 36B, ¶94; also as evidenced by ¶41 of Bays et al. in US 2017/0079669 disclosure that the thickness of the wedge block 62 is such that the wedge block fits snuggly into the space between two bones and is sized to alter, such as expand, the space between two bones when inserted and have a thickness that tapers in a direction proceeding toward the tip of the wedge block (e.g., a wedge-shaped keel)).
The combination of Smith, Saw, and McCormack is silent to a proximal base face opposite the leading tip, wherein the wedge coupling is on the base face.
Saw further teaches that the wedge block includes a distal leading tip (lower end portion of the wedge block as shown in Figs. 16 and 17, Figs. 16 and 17) formed by the two angled side faces (Figs. 16 and 17), and a proximal base face (upper end portion of the wedge block as shown in Figs. 16 and 17, Figs. 16 and 17) opposite the leading tip (as defined, Figs. 16 and 17), wherein the wedge coupling is on the base face (Figs. 16 and 17).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the wedge block as disclosed by the combination of Smith, Saw, and McCormack by adding a proximal base face opposite the leading tip and for the wedge coupling to extend from the base face as taught by Saw in order to use a known transition from the wedge block to the wedge coupling part (Saw Figs. 16 and 17) to select any shape that is suitable for attaching the wedge to the cutting guide (Saw ¶99) that enables the wedge to grip a desired bone surface (Saw ¶100) and accommodate the bone size of the patient and condition of the patient (Saw ¶s 91 and 99).
As to claims 12-14, Smith discloses an orthopedic surgical system (188, 150, Figs. 5, 19-23, 35-36B, ¶117-120) capable of reducing an angular deformity in a joint (shown in Figs. 19-23), the system comprising: a wedge (188) including a wedge block (372) and a wedge coupling part (see illustration of Fig. 35, i.e. lower portion of 370 as shown in Fig. 35, Fig. 35 and 36B), wherein the wedge block has a triangular shape (lower portion as shown in Fig. 36B, Fig. 36B) and includes two opposing side faces that are angled with respect to each other (Fig. 36B) and that are each capable of abutting joint cartilage (shown in Fig. 19 for an alternate embodiment, Figs. 35 and 36B, ¶94) capable of securing the wedge in place to and between two adjacent bones of the joint (shown in Fig. 19 for an alternate embodiment, Figs. 35 and 36B, ¶94; also as evidenced by ¶41 of Bays et al. in US 2017/0079669 disclosure that the thickness of the wedge block 62 is such that the wedge block fits snuggly into the space between two bones and is sized to alter, such as expand, the space between two bones when inserted and have a thickness that tapers in a direction proceeding toward the tip of the wedge block (e.g., a wedge-shaped keel)), wherein the wedge block includes a distal leading tip (lower end portion of the wedge block as shown in Fig. 36B, Fig. 36B) formed by the two angled side faces (Fig. 36B) that are each capable of abutting joint cartilage (shown in Fig. 19 for an alternate embodiment, Figs. 35 and 36B, ¶94) capable of securing the wedge in place to and between two adjacent bones of the joint (shown in Fig. 19 for an alternate embodiment, Figs. 35 and 36B, ¶94; also as evidenced by ¶41 of Bays et al. in US 2017/0079669 disclosure that the thickness of the wedge block 62 is such that the wedge block fits snuggly into the space between two bones and is sized to alter, such as expand, the space between two bones when inserted and have a thickness that tapers in a direction proceeding toward the tip of the wedge block (e.g., a wedge-shaped keel)); a handle (see illustration of Fig. 35, i.e. lower portion of 370 as shown in Fig. 35, Fig. 35 and 36B) including an elongated extension member (see illustration of Fig. 35, Fig. 35) and a handle coupling part (see illustration of Fig. 35, Fig. 35), wherein the handle coupling part mates with the wedge coupling part (Fig. 35) capable of mounting the handle to the wedge in a first configuration of the system (Fig. 35) capable of forming a joint-repositioning orthopedic surgery tool (Fig. 35, shown in Fig. 19 for an alternate embodiment, Figs. 35 and 36B, ¶94; also as evidenced by ¶41 of Bays et al. in US 2017/0079669 disclosure that the thickness of the wedge block 62 is such that the wedge block fits snuggly into the space between two bones and is sized to alter, such as expand, the space between two bones when inserted), wherein the handle further comprises a proximal head (see “Head” in illustration of Fig. 35, Fig. 35) from which the extension member extends (Fig. 35), wherein the head is larger in cross-sectional area than the extension member (Fig. 35) capable of defining a proximal strike surface (upper surface of the head as shown in Figs. 35 and 36B, Figs. 35 and 36B) that can be forcefully impacted to drive the wedge into the joint when the system is in the first configuration forming the joint-repositioning orthopedic surgery tool (Figs. 19, 35, and 36B); and a cutting guide (150) including a guide block (150, Figs. 5, 36A, and 36B) and a guide coupling part (170, Figs. 36A and 36B), wherein the guide block includes a plurality of guide slots (160, 164) capable of receiving an orthopedic bone saw blade (“tissue removing instrument” of ¶73, Fig. 22, ¶73), wherein the guide coupling part mates with the wedge coupling part (Fig. 36B) capable of removably mounting the cutting guide to the wedge (Fig. 36B, ¶117-120) in a second configuration of the system (Fig. 36B) capable of forming a saw-guide orthopedic surgery tool (Fig. 36B), wherein the the wedge coupling part and the cutting guide coupling part include at least one projection (see illustration of Fig. 35, Fig. 35) and at least one aperture (170, Figs. 5 and 36A) that mate with each other (Fig. 35), and wherein in use, the wedge of the joint-repositioning tool is inserted between the two adjacent bones of the joint (shown in Fig. 19 for an alternate embodiment, Figs. 35 and 36B, ¶94) capable of repositioning at least one of the bones (shown in Fig. 19 for an alternate embodiment, Figs. 35 and 36B, ¶94; also as evidenced by ¶41 of Bays et al. in US 2017/0079669 disclosure that the thickness of the wedge block 62 is such that the wedge block fits snuggly into the space between two bones and is sized to alter, such as expand, the space between two bones when inserted and have a thickness that tapers in a direction proceeding toward the tip of the wedge block (e.g., a wedge-shaped keel)), and then the cutting guide of the saw-guide tool is used to guide the orthopedic bone saw blade (shown in Fig. 22 for an alternate embodiment, Figs. 35 and 36B, ¶91) capable of removing at least one bone end portion (¶91) to form bone end edges that are substantially parallel (¶s 73, 74, 91, and 99) so the bones are now substantially aligned (¶s 91 and 107). As to claim 13, Smith discloses that the wedge block further includes two opposing top and bottom faces (Fig. 36B) that are angled with respect to each other (Fig. 36B) and that extend between the two angled side faces (Fig. 36B) capable of forming a truncated wedge shape (Fig. 36B), wherein in use in the first configuration forming the joint-repositioning orthopedic surgery tool, the truncated wedge repositions at least one of the bones in two planes (Fig. 19, ¶107). As to claim 14, Smith discloses that at least two of the plurality of guide slots of the cutting guide are angled with respect to each other (Figs. 5, 36A, and 36B, ¶s 73 and 74; where ¶74 discloses that the slots may be parallel or skewed), wherein in use, the two adjacent bones need not be aligned with each other when using the saw-guide orthopedic surgery tool to remove at least one bone end portion (Figs. 36A and 36B, ¶s 118-120).
Smith is silent to the two opposing side faces each including serrations configured to dig into bone, a proximal base face opposite the leading tip, wherein the wedge coupling is on the base face, and wherein the handle coupling part mounting capable of removably mounting the handle to the wedge.
Saw teaches a similar orthopedic surgical system (100, 220, 308, 324, Figs. 2-18) capable of reducing an angular deformity in a joint (Fig. 19-31), the system comprising: a wedge (324) including a wedge block (365) and a wedge coupling part (372c, 372b, Figs. 16 and 17), wherein the wedge block has a triangular shape (Figs. 16 and 17) and includes two opposing side faces (Fig. 17) that are angled with respect to each other (Fig. 17) and that each include serrations (381) capable of digging into cartilage (¶100 discloses providing a grip on a bone surface) capable of securing the wedge in place to and between two adjacent bone portions (Fig. 28, ¶100), wherein the wedge block includes a distal leading tip (lower end portion of the wedge block as shown in Figs. 16 and 17, Figs. 16 and 17) formed by the two angled side faces (Figs. 16 and 17), and a proximal base face (upper end portion of the wedge block as shown in Figs. 16 and 17, Figs. 16 and 17) opposite the leading tip (as defined, Figs. 16 and 17), wherein the wedge coupling is on the base face (Figs. 16 and 17); a handle (372a, Figs. 16 and 17) including an elongated extension member (upper portion of handle as shown in Fig. 17, Fig. 17) and a handle coupling part (lower portion of handle as shown in Fig. 17, Fig. 17), wherein the handle coupling part mates with the wedge coupling part (Fig. 17) capable of mounting the handle to the wedge in a first configuration of the system (Figs. 16 and 17) to form a joint-repositioning orthopedic surgery tool (Figs. 16-18 and 28); and a cutting guide (308) including a guide block (310) and a guide coupling part (329), wherein the guide coupling part mates with the wedge coupling part (Fig. 12) capable of mounting the cutting guide to the wedge (Fig. 12) in a second configuration of the system to form a cut-guide orthopedic surgery tool (Figs. 12, 28, and 29), wherein in use, the wedge of the joint-repositioning tool is inserted between the two adjacent bone portions of the joint (Fig. 28) capable of repositioning at least one of the bone portions (Fig. 28).
McCormack teaches a similar orthopedic surgical system (Figs. 9A-9C) capable of reducing an angular deformity in a joint (Figs. 9A-9C, abstract, ¶128), the system comprising: a wedge (90, 92, 93) including a wedge block (90) and a wedge coupling part (92), wherein the wedge block has a shape (Figs. 9A-9C) and includes two opposing side faces (Figs. 9A-9C) that are angled with respect to each other (Figs. 9A-9C), the wedge coupling part comprising a threaded protrusion (portion of 92 shown extending from the wedge block in Fig. 9A, Fig. 9A); a handle (91, 86, 87) including an elongated extension member (86) and a handle coupling part (91), wherein the handle coupling part mates with the wedge coupling part (Figs. 9B and 9C, ¶s 124, 126, and 127) capable of removably mounting the handle to the wedge in a first configuration of the system (¶127) capable of forming a joint-repositioning orthopedic surgery tool (Fig. 9C, ¶128); the handle coupling part comprising a threaded receptacle (¶s 124 and 126); wherein the wedge coupling part and the handle coupling part include at least one projection (92) and at least one aperture (threaded receptacle of the nut 91 disclosed in ¶s 124 and 126, ¶s 124 and 126) that mate with each other (Fig. 9A), and wherein in use, the wedge of the joint-repositioning tool is inserted between the two adjacent bones of the joint (Figs. 9B and 9C) capable of repositioning at least one of the bones (Figs. 9B and 9C, ¶128).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the side faces of the wedge block as disclosed by Smith by adding serrations and varying the wedge block size/shape as taught by Saw in order to grip a desired bone surface (Saw ¶100) and accommodate the bone size of the patient and condition of the patient (Saw ¶s 91 and 99). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the wedge block as disclosed by Smith by adding a proximal base face opposite the leading tip and for the wedge coupling to extend from the base face as taught by Saw in order to use a known transition from the wedge block to the wedge coupling part (Saw Figs. 16 and 17) to select any shape that is suitable for attaching the wedge to the cutting guide (Saw ¶99) that enables the wedge to grip a desired bone surface (Saw ¶100) and accommodate the bone size of the patient and condition of the patient (Saw ¶s 91 and 99). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the handle coupling part mounting of the wedge coupling part with the handle coupling part as disclosed by Smith to be removable mounting of a threaded protrusion of the wedge coupling part with a threaded receptacle of the handle coupling part as taught by McCormack in order to insert the distraction mechanism in the bone joint (Fig. 9B) for distraction purposes so that an implant can be positioned in the bone joint to retain the distraction while the distraction mechanism is removed (McCormack ¶127), i.e. to select a known mounting of a handle to a distraction device (McCormack Figs. 3, 6A-11C, 13A-17C, and 26A-26C).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable Smith, Saw, and McCormack in view of Peterson et al. (US 2019/0183516, hereinafter “Peterson”).
As to claim 9, the combination of Smith, Saw, and McCormack discloses the invention of claim 8 as well as in the second configuration the guide block is mounted to the wedge block in a fixed angular position (¶120 discloses a locking mechanism to lock the rotational angle of the wedge and cutting guide).
The combination of Smith, Saw, and McCormack is silent to the guide coupling part opening includes a flattened side and the wedge coupling part projection includes a flattened side.
Peterson teaches a similar surgical device (Figs. 1A-1B, ¶20) capable of use in/on bone (¶20) comprising: a first coupling part (106) and a second coupling part (110); wherein the first coupling part comprises a projection (Figs. 1A and 1B) that includes a flattened side (130A, 140B, Figs. 1A and 1B, ¶67), wherein the second coupling part comprises an opening (110p Figs. 1A and 1B) that includes a flattened side (“flat portions” of ¶73, ¶73); wherein in a configuration the second coupling part is mounted to the first coupling part in a fixed angular position (Fig. 1A, ¶73).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the projection and opening as disclosed by the combination of Smith, Saw, and McCormack by adding a flattened side as taught by Peterson in order to use means of blocking relative axial rotation between the projection and the opening (Peterson ¶73; Smith ¶120).
Allowable Subject Matter
Claims 10 and 15 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, as suggested or consistent with the interpretation set forth in this Office action and to include all of the limitations of the base claim and any intervening claims if rewritten as suggested or consistent with the interpretation set forth in this Office action 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 for the base claim and any intervening claims.
Conclusion
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/AMY R SIPP/Primary Examiner, Art Unit 3775