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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/8/2023 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 12/22/2025 is acknowledged. The traversal is on the ground(s) that there is no serious search and/or examination burden as required by MPEP 808. However, this is a 371 application, which is governed by the Unity of Invention rules, and not US Restriction practice. Therefore MPEP 808 is irrelevant and the applicant’s arguments are meritless. Unity of Invention has no serious search/burden requirement. See MPEP Chapters 823 and 1800. Claims 9-21 remain withdrawn.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 6 and 7 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 6 recites that each pedicle screw “is coupled” to a veterbra of the spine. This positively recites the human body as a structural limitation of the claim. Claim 7 depends from claim 6 and is rejected by its association.
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 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hua (US 2014/0194720).
The claims are directed to apparatus claims, whose interpretation is governed using the following principles of law:
"To anticipate a claim, a reference must disclose every element of thechallenged claim and enable one skilled in the art to make the anticipatingsubject matter." PPG Indus. Inc. v. Guardian Indus. Corp, 75 F.3d 1558,1566 (Fed. Cir. 1996).
"[T]he patentability of apparatus or composition claims depends onthe claimed structure, not on the use or purpose of that structure." CatalinaMktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,809 (Fed. Cir.2002).
"It is well settled that the recitation of a new intended use for an oldproduct does not make a claim to that old product patentable." In reSchreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
Regarding claim 1, Hua discloses a system comprising a plurality of screws that can be considered pedicle screws and are configured to engage a spine of a patient, if so desired by a user (par. 0032, 0040, 0081). Each screw implant includes a plurality of electrodes and each screw implant is connected to a power source and a controller such that current can be steered in varying directions by activating different electrodes at different times (par. 0039-0041).
Regarding claims 2-7, Hua discloses an embodiment with at least nine screws (figure 7 and par. 0057) and each screw is configured to be placed in any vertebra and/or any perispinal region (par. 0032, 0081), such that the controller is configured to selectively supply power to the screws (par. 0040). The current steered from one screw to another will then be caused to be directed across the associated vertebra and/or perispinal region in which they are configured to be implanted. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. IN this case, any screw is configured to be placed in any vertebra or perispinal location.
Regarding claim 8, since the entirety of the screw is conductive, one can designate any smooth surface extending across no more than 90 degrees of the screw as the first electrode, as seen in the annotated figure below:
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eric D. Bertram/Primary Examiner, Art Unit 3796