DETAILED ACTION
The Examiner acknowledges the amendments received 19 January 2026. Claims 1-19 are pending.
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 .
Specification
In view of the amendments received 19 January 2026, the Examiner withdraws the objection to the Abstract.
Response to Arguments
Applicant's arguments filed 19 January 2026, have been fully considered but they are not persuasive. Since the arguments pertain to the amendments to the claims, they will be addressed in the prior art rejection.
Claim Objections
Claims 1 and 19 are objected to because of the following informalities: claims 1 and 19 require “extending along the inner frame along the inner frame” in lines 9-10 and 11, respectively. This appears to be a repetition of the phrase “along the inner frame”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-19 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites the limitation "the electrode site" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the orthopedic implant" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 8-15 and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chang et al (U.S. 2012/002856). Chang discloses (Figures 7A-7D) a circuitry casing (par. 0066) comprising control circuitry and a casing connector; an inner frame (Ti frame) providing internal structure for a portion of the stimulation implant (par. 0053), the inner frame comprising a set of electrode sites (45, 88, 90); a set of conductive paths (flexible cables 94) on the inner frame, where each conductive path has a first portion on a surface of the electrode site and a second portion formed as an electrical conduit extending along the inner frame along the inner frame [sic] and connecting the electrode site to a connector of the casing connector; and an over-coating (“bio-compatible insulator, Parylene”) that is formed around the inner frame, wherein the first portion of each conductive path extends outward from the inner frame through the over-coating to an electrode site (“These interconnections 94 can run along the battery 92 within the center of the BioBolt shank 48 between the electrodes and amplifier circuitry.”) exposed on a surface of the over-coating.
As to the functional language and statement of intended use, these have been carefully considered but are not considered to impart any further structural limitations over the prior art. Since Chang utilizes a neurostimulator (par. 0053) that is placed on a cranium, which is a bone, Chang’s system is therefore capable of being used in as an orthopedic stimulation implant. In addition nothing prevents Chang’s system from being used as an orthopedic stimulation implant. Therefore, they are capable of being used as an orthopedic stimulation implant.
Regarding claim 2, Chang discloses (par. 0066) the set of electrode sites are raised platform structures on the inner frame.
Regarding claim 3, Chang discloses (Figures 7A-7D) the raised platform structures have a ramp from a top surface of the raised platform structure to a recessed surface of the inner frame; and wherein the second portion of the conductive path runs from the recessed surface up the ramp to the top surface of the raised platform structure.
Regarding claim 4, Chang discloses (Figures 7A-7D) a body connector attached to one end of the inner frame; and wherein the second portion of each conductive path is formed as an electrical conduit on the inner frame from the electrode site to a conductive contact point of the body connector; wherein the casing connector mechanically and conductively couples to the body connector.
Regarding claim 5, the method of forming the device is not germane to the issue of patentability of the device itself. Therefore, this limitation has not been given patentable weight.
Regarding claim 6, Chang discloses (par. 0065) the circuitry casing comprises a metal body, and wherein the control circuitry is contained within the outer metal body.
Regarding claim 8, Chang discloses (par. 0064) the inner frame includes at least one antenna coil inset; and further comprising a wire coiled around the antenna coil inset, wherein two ends of the wire are conductively connected to the casing connector.
Regarding claim 9, Chang discloses (par. 0066) the control circuitry is encased within a metal outer body of the circuitry casing, and wherein the control circuitry is arranged as a folded circuit system.
Regarding claim 10, Chang discloses (par. 0066) the control circuitry is an at least partially flexible printed circuit board.
Regarding claim 11, Chang discloses (par. 0069) the inner frame comprises a defined channel tunnel from a surface of a first electrode site of the set of electrode sites to a connection point to the casing connector, wherein a first conductive path of the set of conductive paths is conductively connected from the first electrode site to the connection point through the defined channel tunnel.
Regarding claim 12, Chang discloses (par. 0069) a body connector attached to one end of the inner frame; and wherein the second portion of each conductive path is formed as an electrical conduit on the inner frame from the electrode site to a conductive contact point of the body connector; wherein the casing connector mechanically and conductively couples to the body connector; and wherein the defined channel tunnel extends from one end of the second portion of the first conductive path to a first conductive contact point of the body connector.
Regarding claim 13, Chang discloses (par. 0069) a body connector attached to one end of the inner frame; and wherein the second portion of each conductive path is formed as an electrical conduit on the inner frame from the electrode site to a conductive contact point of the body connector; wherein the casing connector mechanically and conductively couples to the body connector; and wherein the defined channel tunnel is defined from a first side of the inner frame where the first electrode site is positioned to a second side of the inner frame where the second portion of the first conductive path is positioned, wherein a conductive connection is established between the first electrode site to the second portion of the first conductive path through the defined channel tunnel.
Regarding claim 14, Chang discloses (par. 0069) the inner frame comprises a recessed channel defining a path between a first electrode site of the set of electrode sites to a connection point, wherein for a first conductive path of the set of conductive paths, the second portion of the first conductive path is formed by conductive material deposited into the recessed channel.
Regarding claim 15, the method of forming the device is not germane to the issue of patentability of the device itself. Therefore, this limitation has not been given patentable weight.
Regarding claim 17, Chang discloses (par. 0066) the inner frame is made of conductive material; and further comprising an insulating layer between the inner frame and the set of conductive paths.
Regarding claim 18, Chang discloses (Figures 7A-7D) the inner frame is comprised of at least two side panels that combine to form the inner frame.
Regarding claim 19, Chang discloses (Figures 7A-7D) a circuitry casing (par. 0066) with a casing connector; an inner frame (Ti frame) providing internal structure for a portion of the orthopedic implant (par. 0053), the inner frame comprising a set of electrode sites (45, 88, 90), where the set of electrode sites are raised platform structures; a body connector attached to one end of the inner frame and that electrically couples to the casing connector; a set of conductive paths (flexible cables 94) on the inner frame, where each conductive path has a first portion on a surface of the electrode site and an electrical conduit portion extending along the inner frame along the inner frame [sic] and connecting the electrode site to a connector of the body connector and thereby connected to the control circuitry through the casing connector; and over-coating (“bio-compatible insulator, Parylene”) that is formed around the inner frame, wherein the first portion of each conductive path extends outward from the inner frame through the over-coating to an electrode site exposed on a surface of the over-coating (“These interconnections 94 can run along the battery 92 within the center of the BioBolt shank 48 between the electrodes and amplifier circuitry.”).
As to the functional language and statement of intended use, these have been carefully considered but are not considered to impart any further structural limitations over the prior art. Since Chang utilizes a neurostimulator (par. 0053) that is placed on a cranium, which is a bone, Chang’s system is therefore capable of being used in as an orthopedic (stimulation) implant. In addition nothing prevents Chang’s system from being used as an orthopedic (stimulation) implant. Therefore, they are capable of being used as an orthopedic (stimulation) implant.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al (U.S. 2012/002856). Chang discloses the claimed invention except for the over-coating is molded polyetheretherketone. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the polymer coating of Chang, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 16, Chang discloses the claimed invention except for the set of conductive paths are patterned conductive foil adhered to surfaces of the inner frame. It would have been obvious to one of ordinary skill in the art at the time of the invention to provide conductive foil for the conductive paths, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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 DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792