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 .
Claim Rejections - 35 USC § 112
The amended claim set was received 11/21/2025. This claim set is accepted and overcome the USC 112 rejections set forth in the previous rejection.
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, 4, 6-7, 10, 11, 14-15, 17, 20-23, and 25-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hirata et al. (US 20090287212 A1) (hereon referred to as Hirata).
Regarding claim 1, Hirata teaches an implantable medical device (201) operational for mitigating radiofrequency (RF)- induced heating (note that it is known in the art that ferrite materials may mitigate RF heating, thereby making any ferrite implant capable of satisfying this requirement), wherein the implantable medical device comprises:
a ferrite material (see Para. [0170]) associated with at least one component of the implantable medical device (201),
wherein the ferrite material represents an exogenous component of the medical device that protrudes out of the at least one component of the medical device (see Para. [0170], noting that the ferrite is present on the outside of the device),
wherein the ferrite material (see Para. [0170]) is operational to reduce the RF-induced heating of the implantable medical device (note that it is known in the art that ferrite materials may mitigate RF heating when compared to other materials, thereby making any ferrite implant capable of satisfying this requirement).
Regarding claim 4, Hirata teaches the implantable medical device of claim 1, wherein the ferrite material is associated with an outer surface of the at least one component of the implantable medical device (see Para. [0170], noting that the entire surface of 222 and 211 is made of Ferrite).
Regarding claim 6, Hirata teaches the implantable medical device of claim 1, wherein the implantable medical device (201) comprises an external fixation medical device (see Para. [0150]).
Regarding claim 7, Hirata teaches the implantable medical device of claim 1, wherein the at least one component (210) of the implantable medical device (201) is partially or completely implantable into the subject (see Para. [0087]).
Regarding claim 10, Hirata teaches the implantable medical device of claim 1, wherein the implantable medical device (201) comprises an external fixation medical device (see Para. [0150]), wherein the at least one component of the implantable medical device comprises a fixator (210) of the external fixation medical device (201).
Regarding claim 11, Hirata teaches a method of mitigating radiofrequency (RF)-induced heating of an implantable medical device (201; note that it is known in the art that ferrite materials may mitigate RF heating, thereby making any ferrite implant capable of satisfying this requirement), said method comprising:
applying a ferrite material to at least one component of an implantable medical device (see Para. [0170]),
wherein the ferrite material represents an exogenous component of the medical device that protrudes out of the at least one component of the medical device (see Para. [0170], noting that the ferrite is present on the outside of the device),
wherein the ferrite material reduces the RF-induced heating of the medical device (note that it is known in the art that ferrite materials may mitigate RF heating, thereby making any ferrite implant capable of satisfying this requirement).
Regarding claim 14, Hirata teaches the method of claim 11, wherein the ferrite material is applied to an outer surface of the at least one component of the implantable medical device (see Para. [0170]).
Regarding claim 15, Hirata teaches the method of claim 11, wherein the implantable medical device (201) comprises an external fixation medical device (see Para. [0150]).
Regarding claim 17, Hirata teaches the method of claim 11, wherein the at least one component (210) of the implantable medical device (201) is partially or completely implantable into the subject (see Para. [0087]).
Regarding claim 20, Hirata teaches the method of claim 11, wherein the implantable medical device (201) comprises an external fixation medical device (see Para. [0150]), wherein the at least one component of the implantable medical device comprises a fixator (210) of the external fixation medical device (201).
Regarding claim 21, Hirata teaches the method of claim 11, wherein the ferrite material reduces RF-induced heating by blocking or minimizing the induced current from RF waves (note that this is a known function of ferrite material, see Para. [0170]).
Regarding claim 22, Hirata teaches the method of claim 11, wherein the ferrite material mitigates RF-induced heating in an environment comprising magnetic resonance (note that this is a known function of ferrite material, see Para. [0170]).
Regarding claim 23, Hirata teaches the method of claim 11, further comprising a step of implanting the implantable medical device (201) into a subject (see Para. [0087]).
Regarding claim 25, Hirata teaches the method of claim 23, wherein the implanting comprises partially implanting the implantable medical device (201) into the subject (see Para. [0087]).
Regarding claim 26, Hirata teaches the method of claim 23, wherein the implanting occurs after the applying step (see Paras. [0170] and [0087], noting that the device is formed of ferrite prior to the implantation thereof).
Regarding claim 27, Hirata teaches the method of claim 23, wherein the subject is a human being (see Para. [0086]).
Regarding claim 28, Hirata teaches the implantable medical device of claim 1, wherein the ferrite material is in a form selected from the group consisting of rings, beads, blocks, or combinations thereof (note that the ferrite material of component 211 is in the form of a bead, see Para. [0130]).
Regarding claim 29, Hirata teaches the method of claim 11, wherein the ferrite material is in a form selected from the group consisting of rings, beads, blocks, or combinations thereof (note that the ferrite material of component 211 is in the form of a bead, see Para. [0130]).
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.
Claims 2-3 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hirata as applied in the rejection of claims 1 and 11 above, and further in view of Klun et al. (US 11104758 B2) (heron referred to as Klun).
Hirata teaches an implantable medical device as outlined in the rejection of claims 1 and 11 above, however fails to teach wherein the ferrite material comprises iron oxide (Fe203) combined with one or more additional metallic elements, wherein the one or more metallic elements comprise iron (Fe), strontium (Sr), barium (Ba), manganese (Mn), nickel (Ni), zinc (Zn), cobalt (Co), and combinations thereof (claims 2 and 12), and wherein the ferrite material is selected from the group consisting of strontium (Sr)-containing ferrites, barium (Ba)-containing ferrites, manganese (Mn)-containing ferrites, nickel (Ni)-containing ferrites, zinc (Zn)-containing ferrites, cobalt (Co)-containing ferrites, Ni, Zn-containing ferrites, Mn, Zn-containing ferrites, magnetite (Fe304), ZnFe204, BaFe12O19 (BaO:6Fe2O3), BaO-2(FeO)- 8(Fe2O3), SrFe12Oi9 (SrO:6Fe2O3), MnZnFe204, NiZnFe204, CoFe204 (CoO-Fe203), Ba2ZnFeisO23, and combinations thereof (claims 3 and 13).
Klun teaches a process of creating an orthodontic device, wherein that process contains steps for creating fibers of said implant or device (see Col. 2, ll. 10-26). Said fibers my comprise a variety of chemical combinations, such as iron oxide with cobalt, or zinc ferrite (see Col. 23, ll. 26-46),
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ferrite of Hirata to comprise iron oxide combined with cobalt, and to comprise zinc-containing ferrite, as taught by Klun, as this would be advantageous for altering the pigment of the implant, which may be necessary for certain surgical applications (see Col. 23, ll. 26-46).
Allowable Subject Matter
Claims 8, 18, and 24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claims 1, 4, 7, 11, 14, 17, 21-23, and 25-29 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 11/21/2025 regarding the rejection of claims 6, 10, 15, and 20 in view of Hirata have been fully considered but they are not persuasive. Applicant argues that Hirata does not teach the requirement for exogenous ferrite as recited in amended claim 1. The office disagrees with this assertion. As outlined in the updated rejection above, Hirata teaches that the entirety of components 222 and 211 may be made of ferrite, thereby teaching the presence of exogenous and protruding ferrite.
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 HOLLY J LANE whose telephone number is (703)756-4702. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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, Eduardo Robert can be reached at 571-272-4719. 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.
/H.J.L./Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773