DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 12/31/2025 have been fully considered but they are not persuasive.
Applicant argues: Dacosta does not disclose the limitations of claim 1, being “a first bone engagement surface shaped to match a first contour on a first bone”. [¶135 of Dacosta] describes the shape of the arm itself, not the bone contacting surface 135. Dacosta describes only a generalized surface curvature, not a surface specifically shaped to match a first contour of a first bone as required by claim 1. The claimed “first bone engagement surface” is defined by its specific contour matching relationship to the bone, not merely by the geometry of a supporting arm.
Response: in response to Applicant's argument that Dacosta does not include certain features of Applicant's invention, the limitations on which the Applicant relies (i.e., the first bone engagement surface is defined by its specific contour matching relationship to the bone) are not stated in the claims. Therefore, it is irrelevant whether the reference includes those features or not.
With regards to [¶135 of Dacosta], claim 1 is best understood as requiring a bone engagement surface comprising a bone apposition surface shaped to match a first contour on a first bone of the bone. The office is of the position that:
First, the claim does not provide boundary for neither the “bone apposition surface” nor “the first contour of the first bone”, rendering the claim to be interpreted under the BRI as requiring the bone facing surface to have at least a portion conforming to at least a portion of the bone.
Second, Dacosta discloses in [¶135] that “The first arm 130 may be shaped to provide a bone contacting surface 136 that corresponds to the shape of the bone that it will engage. The first arm 130 may be, for example, curved or arced as it extends between the first side 110 and the second side 112.”. A PHOSITA considering the entirety of Dacosta’s disclosure would understand that the shaping of the arm 130 is to provide bone contacting surface 136 corresponding to the shape of at least a portion of the bone. When giving the terms of Dacosta their ordinary meanings, A PHOSITA would understand that the shape of at least a portion of surface 136 and at least a portion of the corresponding bone share some similarities, such that the shape of the surface portion matches a contour of the first bone portion.
Applicant argues: Dacosta fails to discloses that the bone apposition surface and guide feature at least partially defined based on a CAD model of the first bone.
Response: the office is of the position that the preceding recitation is understood as being directed to a product by process. The office respectfully directs the Applicant to MPEP 2113, which at least in part states that ““[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) ”. In this case, the office respectfully asserts that the final product of the claimed cutting guide is similar to the cutting guide disclosed by Dacosta, wherein both cutting guides have a bone facing surface shaped to match / correspond to a contour / shape of at least a bone portion.
Applicant argues: [Col.1, lines 46 – 54 of Parekh] is functionally descriptive of 3D printed guides that marry 3D printed plates and don not enable the claimed structure. The statement of “guides are placed on the bone (they only fit in one place since they match perfectly the profile of the metatarsal” asserts the intended result – but provides no indication of any surface geometry that is shaped to match a specific contour of a bone.
Response: the office respectfully disagree with Applicant’s interpretation, and respectfully directs the Applicant to i.e. Fig.1A, which shows cutting guide [100] which includes plate sections [102 and 104]. A PHOSITA considering the entirety of Parekh would understand that the entirety of guide [100], which includes plate sections [102 and 104] having bone surfaces designed to match contour of bone and includes features [103, 105, 107, 109, 111, 112, 114, 116, 118 and /or 119], exhibits similar structure to the claimed cutting guide, wherein at least a portion of the plate sections of the guide [100] define bone facing surface shaped to match at least a portion of a contour of a bone.
Applicant argues: Parekh does not disclose a guide having a slot to cut, but small holes to make provisional marks in the bone.
Response: in response to Applicant's argument that Parekh does not include certain features of Applicant's invention, the limitations on which the Applicant relies (i.e., guide having a slot to cut) are not stated in the claims. Therefore, it is irrelevant whether the reference includes those features or not. In this case, a PHOSITA considering the entirety of Parekh would understand that drilling into bone is a species of the genus cutting into bone, wherein drilling into bone results from cutting and removing bone.
Applicant argues: Parekh fails to discloses that the bone apposition surface and guide feature at least partially defined based on a CAD model of the first bone.
Response: the office is of the position that the preceding recitation is understood as being directed to a product by process. The office respectfully directs the Applicant to MPEP 2113, which at least in part states that ““[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) ”. In this case, the office respectfully asserts that the final product of the claimed cutting guide is similar to the cutting guide disclosed by Parekh, wherein both cutting guides have a bone facing surface shaped to match / correspond to a contour / shape of at least a bone portion.
Applicant argues: the combination of Bays and Zajac does not disclose that the bone apposition surface and the first guide feature are “at least partially defined based on a CAD bone model of the first bone”.
Response: in addition to the product by process response presented above, the office is of the position that a PHOSITA would understand that when a cutting guide having a patient specific feature is manufactured according to a predetermined design, the design should include a design for the entire cutting guide including the bone apposition surface and cutting features. Evidence for that can be found for example in the cited reference to Zajac, i.e. [¶251 - ¶253 and Figs. 1 – 3].
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102/103 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.
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2, 4 and 21 – 24 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Dacosta et al. (US Pub. 2019/0336140 A1) / (WO 2019/113394), or alternatively as being unpatentable over Dacosta et al. (US Pub. 2019/0336140 A1) / (WO 2019/113394) in view of Zajac (US Pub. 2009/0099567 A1).
Claim 1, Dacosta discloses a system for correcting a bunion present in one or more bones of a patient's foot [abstract, Figs. 1 - 104], the system comprising:
a cutting guide [100 or 200] comprising: a first bone engagement surface comprising a bone apposition surface [defined by at least a portion of a bone facing surface of 136, 146, 236 or 246] shaped to match a first contour on a first bone of one or more bones of a patient's foot [¶135, i.e. surface 136 / 146 or 236 / 246 corresponds to the shape of the bone it will engage]; and
a first guide feature [at least one or two of 116, 118, 120 and 122, or 216, 218, 220 and 222] that, with the first bone engagement surface overlying the first contour, is positioned to guide resection of the one or more bones as part of a bunion correction osteotomy [¶135];
wherein the bone apposition surface and the first guide feature are at least partially defined based on a CAD bone model of the first bone [Product-by-process limitation, wherein the final product is similar to the product disclosed by Dacosta, for having a bone apposition surface shaped to correspond to the bone, and a guide feature located at a desired orientation relative to the bone]; and
wherein the first bone is selected from a group consisting of: a metatarsus; and a cuneiform [¶134].
Assuming, Applicant to not agree with the preceding interpretation related to the product by process, the office takes alternative interpretation in view of Zajac, wherein Zajac teaches an analogous system [abstract, ¶3, Figs. 39 – 40] comprising a cutting guide [750] having first bone engagement surface comprising a bone apposition surface [defined by at least a surface portion of 760 and at least a surface portion of 792] shaped to match a first contour on a first bone and a second contour on a second bone [bones 752 and 753, Figs. 40 – 41], and a second bone engagement surface [defined by at least a surface portion of 756] shaped to match a second contour on a second bone [753, Figs. 40 - 41], and wherein the bone apposition surface and the first guide feature are at least partially defined based on a CAD bone model of the first bone, the bone model defined based on medical imaging of at least part of the bone of a patient [Fig.1, product by process with a final patient specific product, ¶251].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Dacosta and Zajac, and construct the foot entire cutting guide of Dacosta based on bone model to have bone engagement surface shaped to match contours of corresponding bones and orient at least one guide feature as desired relative to the bones in view of Zajac. One would have been motivated to do so in order to provide a patient specific guide for allowing the user to accurately cut desired portions of the bone according to a pre-operative planning [¶249, Zajac].
Dacosta alone or in combination with Zajac discloses the limitations of claim 1, as above, and further, Dacosta discloses:
Claim 21, wherein the first guide feature is configured to resect the one or more bones to provide dual-plane correction by way of the bunion correction osteotomy [at least two of 116, 118, 120 and 122, or 216, 218, 220 and 222 exhibit substantially identical structure to the claimed guide feature, and therefore inherently capable of providing dual-plane correction].
Claim 22, wherein the first guide feature is configured to resect the one or more bones at a patient-specific angle to provide the dual-plane correction [at least two of 116, 118, 120 and 122, or 216, 218, 220 and 222 exhibit substantially identical structure to the claimed guide feature, and therefore inherently capable of providing dual-plane correction].
Claim 23, wherein the first contour comprises at least a portion of a dorsal surface of the first bone [wherein the bone apposition surface is configured to correspond to at least a dorsal surface portion of the bone].
Claim 4, wherein the cutting guide further comprises a second bone engagement surface shaped to match a portion on a second bone of the one or more bones [defined by at least another portion of a bone facing surface of 136, 146, 236 or 246]
Claim 24, wherein the first bone comprises a first metatarsal bone and the second bone comprises a first cuneiform bone of the patient's foot [¶180 and Figs. 53 – 54, bones 602 and 604].
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Parekh et al. (US Pat. 11,571,312 B1).
Claim 1, Parekh discloses a system for correcting a bunion present in one or more bones of a patient's foot [abstract, Figs. 1 – 7], the system comprising:
a cutting guide [100] comprising: a first bone engagement surface comprising a bone apposition surface [defined by at least a portion of a bone facing surface of guide 100] shaped to match a first contour on a first bone of one or more bones of a patient's foot [col.1 lines 46 – 54]; and
a first guide feature [wire holes 111, 112, 114, 116, 118, and 119] that, with the first bone engagement surface overlying the first contour, is positioned to guide resection of the one or more bones as part of a bunion correction osteotomy [col.1 lines 46 – 54];
wherein the bone apposition surface and the first guide feature are at least partially defined based on a CAD bone model of the first bone [Product-by-process limitation, wherein the final product is similar to the product disclosed by Parekh, for having a bone apposition surface corresponding to the bone, and a guide feature located at a desired orientation relative to the bone]; and
wherein the first bone is selected from a group consisting of: a metatarsus; and a cuneiform [col.2 line 65 – col.3 line 4].
Claim(s) 1 – 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bays et al. (US Pub. 2017/0042599 A1) in view of Zajac (US Pub. 2009/0099567 A1).
Claim 1, Bays discloses a system for correcting a bunion present in one or more bones of a patient's foot [abstract, Figs. 5 – 8 and 20 – 21], the system comprising:
a cutting guide [150] comprising: a first bone engagement surface comprising a bone apposition surface [defined by at least a portion of a bone facing surface of 176 or 178] shaped to match a first portion on a first bone of one or more bones of a patient's foot [Figs. 20 – 21, wherein at least a portion of a bone facing surface of 176 or 178 in combination with at least a portion of a bone facing surface of 154 is configured to match a portion of one of bones 210 and 220]; and
a first guide feature [one of 160 or 164] that, with the first bone engagement surface overlying the first contour, is positioned to guide resection of the one or more bones as part of a bunion correction osteotomy [¶80 - ¶81];
wherein the bone apposition surface and the first guide feature are at least partially defined based on a CAD bone model of the first bone [Product-by-process limitation, wherein the final product is substantially similar to the product disclosed by Bays, for having a bone apposition surface, and a guide feature located at a desired orientation relative to the bone]
wherein the first bone is selected from a group consisting of: a metatarsus; and a cuneiform [210 and/or 220, Fig. 20].
Claim 3, wherein the first bone engagement surface is configured to match a second portion on a second bone of the one or more bones of the patient’s foot [Figs. 20 – 21, wherein at least a portion of a bone facing surface of 154 is configured to match a portion of the other one of bones 210 and 220].
Claim 4, wherein the cutting guide further comprises a second bone engagement surface shaped to match a portion on a second bone of the one or more bones [Figs. 20 – 21, wherein at least a portion of a bone facing surface of the other of 176 or 178 is configured to match a portion of the other one of bones 210 and 220].
Claim 5, wherein the cutting guide further comprises a second guide feature [the other one of 160 or 164] that, with the first bone engagement surface overlying the first bone contour and the second bone engagement surface overlying the second bone contour, is positioned to guide resection of another one of the one or more bones as part of a bunion correction osteotomy [¶80 - ¶81].
Claim 6, wherein the another one of the one or more bones is a bone opposite the first bone within a joint of the patient [210 and/or 220, Fig. 20].
Claim 7, wherein the cutting guide further comprises: a first end having the first bone engagement surface [defined by at least a bone engagement surface portion at one end of 150 by one of 270, Fig. 21A]; a second end having the second bone engagement surface [defined by at least a bone engagement surface portion at the other end of 150 by another one of 270, Fig. 21A]; a first bone attachment feature positioned to secure the first end to the first bone [one end hole configured to receive 270, Fig. 21A]; and a second bone attachment feature positioned to secure the second end to the second bone [another end hole configured to receive 270, Fig. 21A].
Claim 8, wherein at least one of the first bone attachment feature and the second bone attachment feature comprises a plurality of holes configured to accept a plurality of fasteners configured to extend through the holes and into bone [¶103, Fig. 21A].
Claim 9, a joint alignment feature configured to align the cutting guide with a joint between the first bone and the second bone [188, ¶101 - ¶103 and Figs. 19 – 21].
Claim 10, wherein cutting guide comprises: a cuneiform apposition portion configured to lie against a dorsal surface of a cuneiform of the patient’s foot; and a metatarsal apposition portion configured to lie against a dorsal surface of a metatarsal of the patient’s foot [wherein guide 150 has portions to lie against cuneiform and metatarsal of a patient, and Figs. 20 – 21].
Bays does not disclose wherein the first bone engagement surface shaped to match a first contour on a first bone; (as of claim 2) wherein the CAD bone model is defined based on medical imaging of at least part of the one or more bones of a patient's foot; (as of claim 3) wherein the first bone engagement surface is configured to match a second contour on a second bone of the one or more bones of the patient’s foot; (claim 4) wherein the cutting guide further comprises a second bone engagement surface shaped to match a second contour on a second bone of the one or more bones.
Zajac teaches an analogous system [abstract, ¶3, Figs. 39 – 40] comprising a cutting guide [750] having first bone engagement surface [defined by at least a surface portion of 760 and at least a surface portion of 792] shaped to match a first contour on a first bone and a second contour on a second bone [bones 752 and 753, Figs. 40 – 41], and a second bone engagement surface [defined by at least a surface portion of 756] shaped to match a second contour on a second bone [753, Figs. 40 - 41], and wherein the bone apposition surface and the first guide feature are at least partially defined based on a CAD bone model of the first bone, the bone model defined based on medical imaging of at least part of the bone of a patient [Fig.1, product by process with a final patient specific product, ¶251].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Bays and Zajac, and construct the foot entire cutting guide of Bays based on bone model to have bone engagement surface shaped to match contours of corresponding bones and orient at least one guide feature as desired relative to the bones in view of Zajac. One would have been motivated to do so in order to provide a patient specific guide for allowing the user to accurately cut desired portions of the bone according to a pre-operative planning [¶249, Zajac].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Singh et al. (US Pub. 2018/0289423 A1) discloses a related system [Abstract, Figs. 9 – 10].
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL S. HANNA whose telephone number is (571)270-3248. The examiner can normally be reached 8-5 M-F.
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/SAMUEL S HANNA/Primary Examiner, Art Unit 3775