DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/12/2026 has been entered.
Response to Arguments
Applicant's arguments filed 06/12/2026 have been fully considered but they are not persuasive.
Applicant argues: the claim now requires a specific contour matching relationship between the first bone engagement surface and the first bone, wherein the bone apposition surface has a patient specific shape corresponding to the CAD bone model of the first bone. Neither Dacosta nor Parekh does disclose such relationship.
Response: Applicant is apparently invoking his rights as an inventor to be his own lexicographer, arguing that he defined "patient-specific" in the specification in a way that requires specific limitations to be read into the term. Although a patentee may be his own lexicographer, the patent specification must support his asserted definition. Applicant did not explicitly define terms anywhere in the specification in ways that support his current assertions. The text does not implicitly suggest that the words should be interpreted to convey the restricted interpretation that he now asserts.
The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.). See also In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997).
In this case, the office is of the position that claim 1 in part calls for “the bone apposition surface at least partially defines the bone engagement surface and has a patient-specific shape that corresponds to a CAD bone model of the first bone”. A PHOSITA giving the claim its BRI should understand that the claim requires a guide having at least a surface portion i.e. 136” corresponding to / matching the shape of a portion of the bone to be treated, which is disclosed by Dacosta ¶135, and therefore, would correspond to / match a CAD representation of the bone to be treated.
Moreover, the office is of the position that the preceding recitation is understood as being directed to a product by process, which is having a guide with a surface portion to match a CAD bone model, and the CAD bone model is understood to be used during the formation of the guide. 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 cutting guide claimed in the present application is similar, or at least substantially similar, to the cutting guides disclosed by Dacosta or Parekh, as explained in the Office Action. Specifically, both references disclose cutting guides having a bone-facing surface portion shaped to match or correspond to the contour of at least a portion of the bone to be treated. A PHOSITA would understand a CAD bone model as a representation of the bone to be treated. Accordingly, a cutting guide having a surface configured to match the contour of the bone to be treated would likewise have a surface corresponding to the contour of the CAD bone model representing that bone. In other words, if the final cutting guide includes a surface portion matching the bone to be treated, it inherently includes a surface portion matching the corresponding CAD bone model of that bone. Note: the CAD model is not a positively recited element of the claimed system.
In view of the preceding explanation, the rejection is deemed proper and hereby maintained.
With regards to the newly added claimed directed to the guide with two bone engaging surfaces, these claims have been withdrawn by original presentation.
Election/Restrictions
Newly submitted claims 26 – 36 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the invention originally claimed was directed to a guide with a single bone engagement surface; however, the new claims are directed to a guide having two bone engagement surface, which is similar to the invention of species 2 that was not elected in the response filed on 05/12/2025.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 26 – 36 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 bone apposition surface is further shaped to match a second contour on a second bone, of claim 3 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 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.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claim 3, the recitation of the bone apposition surface is further shaped to match a second contour on a second bone has no support in the original disclosure, wherein the bone apposition surface of claim 3 refers to the first bone engagement surface and shaped to match a first contour on a first bone according to claim 1, the specification does not disclose such configuration, i.e. ¶68 of the publication differentiate between the apposition surface 342 and 344, there is no indication that one of the apportion surfaces shaped to match the contour of two bones. Applicant may provide support for the amendments, or amend the claim to be consistent with the original disclosure to overcome this rejection.
For the sake of examination, the preceding limitation is interpreted as referring to wherein a second bone apposition surface is shaped to match a second contour on a second bone.
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 – 4, 21, 23 and 25 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 at least partially defines the first bone engagement surface and has a patient-specific shape that corresponds to a CAD bone model of the first bone [this limitations is treated as product-by-process limitation, wherein the final claimed product is similar or substantially similar to the product disclosed by Dacosta, for having a bone apposition surface at least partially defining the first bone engagement surface and shaped to correspond to the first bone contour thereby defining a patient-specific shape corresponding to the treated bone or alternatively a CAD bone model representing the treated bone if CAD bone model was used / generated during the process of designing / manufacturing the guide, and the guide feature located at a desired orientation relative to the bone(s) to make desired cuts to the bone(s) to achieve desired correction for the deformities]; 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 / 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], 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], a first guide feature [766], 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, wherein the method requires the steps of generating CAD bone model to fabricate the patient specific instrument, ¶248 - ¶266].
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 2, wherein the first guide feature defines a patient-specific resection trajectory having a position and orientation relative to the bone apposition surface that corresponds to a planned bunion correction osteotomy defined relative to the CAD bone model of the first bone, and wherein the CAD bone model is defined based on medical imaging of at least part of the one or more bones of the patient’s foot [¶130 - ¶132, wherein at least one or two of 116, 118, 120 and 122, or 216, 218, 220 and 222 defines a trajectory having a desired position and orientation relative to the apposition surface designed according to a plan for treating a patient. Though Dacosta does not discloses the steps of making the guide with the guide feature using CAD bone model defined based on images of the bone, the final of Dacosta is identical / substantially identical to the claimed guide. Moreover, Zajac teaches a product by process, wherein a CAD bone model is used and defined based on medical imaging of the bone to be treated].
Claim 3, wherein the bone apposition surface is further shaped to match a second contour on a second bone of the one or more bones of the patient’s foot [defined by at least another portion of a bone facing surface of 136, 146, 236 or 246 differ from the apposition surface of the first bone engagement surface].
Claim 4, wherein the cutting guide further comprises a second bone engagement surface comprising a second bone apposition surface shaped to match a portion on a second bone of the one or more bones of the patient’s foot [defined by at least another portion of a bone facing surface of 136, 146, 236 or 246 differ from the apposition surface of the first bone engagement surface]
Claim 21, wherein the first guide feature comprises a slot defining a resection plane having a patient-specific position and patient-specific orientation relative to the bone apposition surface, the patient-specific position and patient-specific orientation corresponding to the bunion osteotomy configured to correct the bunion in both a lateral direction and at least one of a plantar direction and a dorsal direction [at least one or two of 116, 118, 120 and 122, or 216, 218, 220 and 222 defines a slot defining a resection plane ¶130 - ¶132, and the guide of Dacosta exhibits substantially identical structure to the claimed guide and configured for correcting joint deformities, and therefore inherently capable of performing the claimed functions if one desires to do so].
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, Figs. 53 – 54].
Claim 25, wherein the patient-specific position and the patient specific orientation of the resection plane are defined based on the CAD bone model of the first bone and a planned reorientation of a metatarsal bone relative to a cuneiform bone [though Dacosta does not specify the process of making the guide, the claimed guide exhibits substantially identical structure to the final product / guide disclosed by Dacosta, and intended to correct joint deformities and desired reorientation of bones of the joint according to a planned procedure].
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 at least partially defines the first bone engagement surface and has a patient-specific shape that corresponds to 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, col.1 / II.25 – 54], 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 – 5 and 7 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 at least partially defines the first bone engagement surface [Fig. 20], and
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 bone apposition surface is further shaped to substantially correspond to 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 substantially correspond to 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 comprising a second bone apposition surface shaped to substantially 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 substantially match a portion of the other one of bones 210 and 220].
Claim 5, wherein the first guide feature comprises a first slot [one of 160 or 164], and wherein the cutting guide further comprises a second guide feature comprising a second slot [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 the bunion correction osteotomy [¶80 - ¶81].
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].
Bays does not disclose wherein the first bone apposition surface has patient-specific shape that corresponds to a CAD bone model of the first bone; (as of claim 2) wherein the first guide feature defines a patient-specific resection trajectory having a position and orientation relative to the bone apposition surface that corresponds to a planned bunion correction osteotomy defined relative to the CAD bone model of the first bone and wherein the CAD bone model is defined based on medical imaging of at least part of the one or more bones of the patient's foot; (as of claim 3) wherein the bone apposition surface is further shaped 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 comprising a second bone apposition 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, wherein the method requires the steps of generating CAD bone model to fabricate the patient specific instrument, ¶248 - ¶266].
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].
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Singh et al. (US Pub. 2018/0289423 A1).
Claim 1, Singh discloses a system for correcting a bunion present in one or more bones of a patient's foot [abstract, Figs. 1 – 40], the system comprising:
a cutting guide [i.e. 432, Fig.9] comprising: a first bone engagement surface comprising a bone apposition surface [defined by at least a portion of a bone facing surface of guide 432] shaped to match a first contour on a first bone of one or more bones of a patient's foot [¶93 - ¶94]; and
a first guide feature [i.e. at least one of slots 437] 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 [¶93];
wherein the bone apposition surface at least partially defines the first bone engagement surface and has a patient-specific shape that corresponds to a CAD bone model of the first bone [Product-by-process limitation, wherein the final product is similar to the product disclosed by Singh, for having a bone apposition surface corresponding to the bone, and a guide feature located at a desired orientation relative to the bone, Figs. 2 and 9, ¶76 - ¶88, Singh discloses steps for making a guide using CAD bone model and images / scans], and
wherein the first bone is selected from a group consisting of: a metatarsus; and a cuneiform [Fig.9].
Conclusion
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
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