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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
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 applications, Application No. 15/416975, Application No. 15/675104, Application No. 17/008819 and Application No. 17/807823, fail 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. The prior-filed applications fail to provide adequate support for the limitation of “the at least one thread comprising a thread diameter formed from patient-specific data.” Such support is found in previously filed provisional application no. 63/535123 (filed 08/29/2023). Therefore, the current application will be examined as having an effective filing date of 08/29/2023.
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, “further comprising a marker to position the first and second axis of the device in a specific orientation” of claim 21 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.
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: The “internal channel is composed of a first radius and a second radius, and wherein the first radius is larger than the second radius” of claim 7 and “further comprising a marker to position the first and second axis of the device in a specific orientation” of claim 21 should be added to the specification.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 8, 11-20 and 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frey et al., U.S. PG-Pub 2020/0397491 (previously cited in PTO-1449 dated 06/20/2025) in view of Castro, U.S. PG-Pub 2023/0255690.
Regarding claims 1, 2, 8, and 11-20, Frey et al. discloses a device configured for fixation to a particular anatomical feature comprising: a shaft having a proximal portion and a distal portion, the shaft comprising at least one thread; the shaft further comprising at least a first porous gradient and second porous gradient; the first porous gradient being located towards the distal end of the shaft and containing a first porosity; and the second porous gradient being located proximal to the first porous gradient and containing a second porosity; wherein a density of the first porous gradient is greater than a density of the second porous gradient; and a depth of the at least first and second porous gradient is variable (Figs. 10-13 and paragraph [0064]).
Frey et al. does not disclose the at least one thread comprising a thread diameter formed from patient-specific data; wherein the thread diameter is variable with the variability is determined based on patient images selected from X-ray, MRI, CT, presurgical implant trajectory, a location of cortical bone in a patient’s boney anatomy determined by patient imaging; and does not disclose a shaft diameter being variable based on patient images selected from X-ray, MRI, CT, presurgical implant trajectory, and a location of cortical bone in a patient’s boney anatomy determined by patient imaging.
Castro discloses a device (600) having a shaft with a variable thread diameter and a variable shaft diameter that are determined based X-ray, MRI, CT, presurgical implant trajectory, a location of cortical bone in a patient’s anatomy determined by patient imaging, and a location of cortical bone in a patient’s boney anatomy determined by the patient imaging as such permits contact surface area of the screw threads and the bone to increase, thus increasing construct stability and durability (Fig. 3 and paragraphs [0060] and [0142]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one thread and diameter of the shaft of Frey et al. to be variable based on patient images selected from X-ray, MRI, CT, presurgical implant trajectory, and a location of cortical bone in a patient’s boney anatomy determined by patient imaging in view of Castro to permit an increased contact surface area of the threads and bone in order to increase construct stability and durability.
Regarding claims 3, 4 and 22-25, Frey et al. discloses further comprising an internal channel extending substantially an entire length of the shaft; wherein the at least first and second porous gradients are exposed to the internal channel and configured to receive graft material; wherein the device is fabricated by additive manufacturing; wherein the at least first and second porous gradient and the at least one thread comprise cupping channels (80) configured to collect biological material; and the internal channel is comprised of a porous matrix (Figs. 10-13, 15A, 15B and paragraphs [0006], [0016], [0064], [0065]).
Claim(s) 5-7, 9, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frey et al., U.S. PG-Pub 2020/0397491 in view of Castro, U.S. PG-Pub 2023/0255690 as applied above, and further in view of Biedermann et al., U.S. PG-Pub 2011/0137352.
Regarding claims 5-7, 9 and 10, Frey et al. in view of Castro discloses the invention essentially as claimed except for wherein the internal channel is substantially cylindrical; wherein a diameter of the internal channel is variable; wherein the internal channel is composed of a first radius and a second radius, and wherein the first radius is larger than the second radius; wherein a proximal portion of the internal channel comprises a first smaller diameter and a distal portion of the internal channel comprises a second larger diameter; and wherein the second inner diameter is located proximal to a distal tip of the device and configured to collect biological material.
Biedermann et al. discloses a device having a variable internal channel with a proximal portion of the internal channel (72’) has a first smaller diameter and a second distal portion of the internal channel (internal diameter at 4’) has a second larger diameter located proximal to a distal tip of the device and configured to collect biological material; wherein the internal channel is composed of a first radius (radius of internal channel at 4’) and a second radius (radius of 72’), wherein the first radius is larger than the second radius (Fig. 6) for guiding a guide wire therethrough (paragraph [0044]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the internal channel of Frey et al. such that the internal channel is substantially cylindrical; a diameter of the internal channel is variable; the internal channel is composed of a first radius and a second radius, and the first radius is larger than the second radius; wherein a proximal portion of the internal channel comprises a first smaller diameter and a distal portion of the internal channel comprises a second larger diameter; and wherein the second inner diameter is located proximal to a distal tip of the device and configured to collect biological material further in view of Biedermann et al. to permit guiding of a guide wire therethrough for more accurate placement within a patient while providing for a greater volume of tissue ingrowth or tissue collection within the device.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frey et al., U.S. PG-Pub 2020/0397491 in view of Castro, U.S. PG-Pub 2023/0255690 as applied above, and further in view of Nebosky et al., U.S. Patent 8,475,505.
Regarding claim 21, Frey et al. in view of Castro discloses the invention essentially as claimed except for further comprising a marker to position a first and second axis of the device in a specific orientation.
Nebosky et al. discloses a device having a marker to indicate position and orientation (Col. 5 lines 24-42).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Frey et al. to include a marker to position a first and second axis of the device in a specific orientation further in view of Nebosky to permit indication and position of the device to a surgeon during implantation within a patient.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 11-20 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 10, 13 and 19 of U.S. Patent No. 11,376,049 in view of Castro, U.S. PG-Pub 2023/0255690.
Regarding claims 1-3, 11-20 and 22, claims 1, 2, 10, 13 and 19 of U.S. Patent No. 11,376,049 recite the claimed invention except for the at least one thread comprising a thread diameter formed from patient-specific data; wherein the thread diameter is variable with the variability is determined based on patient images selected from X-ray, MRI, CT, presurgical implant trajectory, a location of cortical bone in a patient’s boney anatomy determined by patient imaging; and does not disclose a shaft diameter being variable based on patient images selected from X-ray, MRI, CT, presurgical implant trajectory, and a location of cortical bone in a patient’s boney anatomy determined by patient imaging.
Castro discloses a device (600) having a shaft with a variable thread diameter and a variable shaft diameter that are determined based X-ray, MRI, CT, presurgical implant trajectory, a location of cortical bone in a patient’s anatomy determined by patient imaging, and a location of cortical bone in a patient’s boney anatomy determined by the patient imaging as such permits contact surface area of the screw threads and the bone to increase, thus increasing construct stability and durability (Fig. 3 and paragraphs [0060] and [0142]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify claims 1, 2, 10, 13 and 19 of U.S. Patent No. 11,376,049 such that at least one thread and diameter of the shaft are variable based on patient images selected from X-ray, MRI, CT, presurgical implant trajectory, and a location of cortical bone in a patient’s boney anatomy determined by patient imaging in view of Castro to permit an increased contact surface area of the threads and bone in order to increase construct stability and durability.
Claims 1-3 and 11-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 14 and 17 of U.S. Patent No. 11,925,400 in view of Castro, U.S. PG-Pub 2023/0255690.
Regarding claims 1-3 and 11-20, claims 1, 9, 14 and 17 of U.S. Patent No. 11,925,400 recite the claimed invention except for the at least one thread comprising a thread diameter formed from patient-specific data; wherein the thread diameter is variable with the variability is determined based on patient images selected from X-ray, MRI, CT, presurgical implant trajectory, a location of cortical bone in a patient’s boney anatomy determined by patient imaging; and does not disclose a shaft diameter being variable based on patient images selected from X-ray, MRI, CT, presurgical implant trajectory, and a location of cortical bone in a patient’s boney anatomy determined by patient imaging.
Castro discloses a device (600) having a shaft with a variable thread diameter and a variable shaft diameter that are determined based X-ray, MRI, CT, presurgical implant trajectory, a location of cortical bone in a patient’s anatomy determined by patient imaging, and a location of cortical bone in a patient’s boney anatomy determined by the patient imaging as such permits contact surface area of the screw threads and the bone to increase, thus increasing construct stability and durability (Fig. 3 and paragraphs [0060] and [0142]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify claims 1, 9, 14 and 17 of U.S. Patent No. 11,925,400 such that at least one thread and diameter of the shaft are variable based on patient images selected from X-ray, MRI, CT, presurgical implant trajectory, and a location of cortical bone in a patient’s boney anatomy determined by patient imaging in view of Castro to permit an increased contact surface area of the threads and bone in order to increase construct stability and durability.
Response to Arguments
Applicant's arguments filed 08 January 2026, with respect to the objection of the specification have been fully considered but they are not persuasive. Applicant contends the limitations of claims 7 and 21 do not need to be added to the specification because the claims are part of the specification and thereby already provide written support for the subject matter since they already appear in the original disclosure. Though it is true the claims are part of the original disclosure, the claims are not part of the specification. Furthermore, MPEP 2173.03 recites “The specification should ideally serve as a glossary to the claim terms so that the examiner and the public can clearly ascertain the meaning of the claim terms. Correspondence between the specification and claims is required by 37 CFR 1.75(d)(1), which provides that claim terms must find clear support or antecedent basis in the specification so that the meaning of the terms may be ascertainable by reference to the specification. Glossaries of terms used in the claims are a helpful device for ensuring adequate definition of terms used in claims. If the specification does not provide the needed support or antecedent basis for the claim terms, the specification should be objected to under 37 CFR 1.75(d)(1).” Therefore, the specification is still objected to for lacking prior antecedent basis for the subject matter of claims 7 and 21.
Applicant further disputes that original claim language needs to be added elsewhere, by amendment or otherwise, in order to comply with 35 U.S.C. 112. However, such argument is moot since there is not a 35 U.S.C. 112 rejection currently present.
Applicant's arguments filed 08 January 2026, regarding the priority analysis, have been fully considered but they are not persuasive. Applicant contends application 15/675104 provides written support for a screw having a thread diameter formed from patient-specific data and provides paragraph [0046] a support. Wherein paragraph [0046] recites “The implant length and diameter may be pre-surgically planned to match the anatomical size of the patient’s anatormy.” However, a broader disclosure of pre-planning a “diameter” of the screw/implant is not an explicit recitation nor explicit support for a narrower limitation of “at least one thread comprising a thread diameter formed from patient-specific data” as currently recited by claim 1 of the present application. For such reason, the present application is maintained as having an effective filing date of 08/29/2023 as described under the “Priority” heading above.
Applicant's arguments filed 08 January 2026, regarding the rejection of claim 1 under 35 U.S.C. 103, have been fully considered but they are not persuasive. Applicant contends Frey et al., U.S. PG-Pub 2020/0397491 and Castro, U.S. PG-Pub 2023/0255690 are not prior art. However, as pointed out in the response to argument of the priority analysis above, the current application is being treated as having an effective filing date of 08/29/2023. Therefore, Frey et al. and Castro are prior art as having publication/filing dates eligible under 35 U.S.C. 102(a)(1) and 102(a)(2). For such reason the claims remain rejection under 35 U.S.C. 103 to Frey et al. in view of Castro.
Applicant's arguments filed 08 January 2026, regarding the non-statutory double patenting rejections, have been fully considered but they are not persuasive. Applicant contends neither Frey or Castro are prior art to the presently claimed invention. However, as pointed out in the response to argument of the priority analysis above, the current application is being treated as having an effective filing date of 08/29/2023. Therefore, Castro is prior art as having publication/filing dates eligible under 35 U.S.C. 102(a)(1) and 102(a)(2) and is usable as a secondary reference to modify prior patent numbers 11376049 and 11925400. For such reason the non-statutory double patenting rejections remain.
Conclusion
THIS ACTION IS MADE FINAL. 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 Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775