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 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.
Claims 11-13, 15-18, 24-26 are 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.
Claim 11 calls for the scaffold to be “semi-rigid when in said expanded configuration”; the specification as filed does not address the rigidity of any element of any disclosed embodiment, let alone calling for a scaffold to be “semi-rigid” at any time. Defining the scaffold as having a closed-cell geometry does not inherently ascribe any characteristics of rigidity or flexibility to the scaffold, and the disclosure does not define a closed-cell geometry as having any particular structural characteristics beyond an ability to be resheathed and redeployed (paragraph [00046] as filed), which does not have any inherent relationship to rigidity. As such, the disclosure of the instant invention does not reasonably convey possession of a medical device comprising a “semi-rigid” scaffold when in an expanded configuration at the time the invention was filed.
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 11-13, 15-18, 24-26 are 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.
The term “semi-rigid” in claim 11 is a relative term which renders the claim indefinite. The term “semi-rigid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As there is no discussion or disclosure of any element being “semi-rigid”, it is entirely unclear what degree of rigidity would be sufficient to consider any element as being “semi-rigid”.
Claim Rejections - 35 USC § 102
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.
Claim(s) 11-13, 16-18, 24, 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Opie (US 2018/0236221).
Regarding claim 11, Opie discloses an implantable medical device comprising:
an expandable scaffold (element 144) configured for insertion into a blood vessel of a head or brain (paragraph [0011]);
wherein the expandable scaffold is capable of transitioning between a collapsed configuration (paragraph [0010]) and an expanded cylindrical configuration (paragraph [0115], [0075], [0196]);
wherein said scaffold is formed in a closed-cell geometry (figures 5D-7E) such that the scaffold is “semi-rigid” when in said expanded configuration and as such is adapted to avoid any damage to said blood vessel (paragraph [0010], as the device is configured to be expanded in a blood vessel and not damage it, it thus meets the conditions for being considered “semi-rigid” upon expansion); and
at least one electrode array comprising a plurality of electrically isolated electrodes configured to record or stimulate electrical activity in brain tissue, wherein the electrode array is positioned on the scaffold (paragraph [0085], [0089], [0195]).
Regarding claim 12, Opie further discloses that each of the electrodes comprises at least one of gold, silver, platinum, or platinum-iridium (paragraph [0162]).
Regarding claim 13, Opie further discloses that the at least electrode array is connected via one or more wired connectors to a transcutaneous connector to an externally wearable computer unit or the electrode array is connected via one or more wired connectors to a subcutaneous connector to a subcutaneously implanted computer unit (paragraphs [0062], [0129]).
Regarding claim 16, Opie further discloses that the scaffold and electrode array can be collapsed and retrieved from the blood vessel (paragraph [0161]).
Regarding claim 17, Opie further discloses that the electrode array has a length between about 20 to about 60 mm (paragraph [0189]) and a diameter between about 4 mm to about 12 mm (see figures 7A-7E, given a length of 20mm the corresponding diameter as shown would be between “about 4mm” and “about 12mm”).
Regarding claim 18, Opie further discloses that the device is configured so as to remain in place in an ambulatory patient for hours, days, or weeks (paragraph [0005], [0162]).
Regarding claim 24, Opie further discloses that the at least one electrode array is arranged on the scaffold in a cylindrically symmetrical grid array such that the at least one electrode array is adapted to be turned with the scaffold and is agnostic to the degree of rotation of the expandable scaffold within a blood vessel (figure 7E).
Regarding claim 26, Opie further discloses that the closed-cell geometry is adapted such that it allows the scaffold to collapse after expansion (paragraph [0069], “a collapsible and expandible stent”).
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.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Opie in view of Carlton (US 2009/0204192).
Regarding claim 15, Opie further discloses that the scaffold and at least one electrode array may be repositioned in the blood vessel after deployment (paragraph [0161]) but does not disclose this being responsive to real-time positioning information, the real-time positioning information comprising at least one of real-time imaging, and electrophysiologic data. Carlton teaches an implantable medical device configured for insertion into a blood vessel of a head or brain (paragraph [0025]), the device comprising a plurality of electrodes configured to record or stimulate electrical activity in brain tissue (paragraph [0035]), where the device is configured to be repositioned after an initial deployment responsive to real-time imaging and/or electrophysiologic positioning information (paragraphs [0047]-[0049]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Opie and used real-time imaging and/or electrophysiologic data to provide positioning information for repositioning the device after deployment, as taught by Carlton, in order to ensure that the device is properly located to achieve desired results.
Response to Arguments
Applicant's arguments filed 15 December 2025 have been fully considered but they are not persuasive.
Regarding the rejections under 112, Applicant asserts that it would not be possible to resheath and redeploy a stent/scaffold multiple times without the scaffold being semi-rigid; as rigidity has not been discussed at any point in the disclosure, there is no inherent relationship between rigidity (stiffness) and the ability to expand/contract a scaffold, particularly as other physical aspects such as its viscoelasticity, elastic modulus, or hardness, could also impact an object’s ability to be repeatedly deformed. As there is no disclosure whatsoever of a closed-cell geometry inherently resulting in a “semi-rigid” structure or any disclosure of what degree or measure of rigidity is considered “semi-rigid”, Applicant’s assertion that the mere existence of a closed-cell geometry resolves all of these issues is unpersuasive.
The Examiner notes that Applicant’s remarks filed 15 December 2025 do not appear to address any of the art rejections of the claims under Opie or Opie as modified by Carlton.
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.
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/KAREN E TOTH/ Examiner, Art Unit 3791