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 Objections
Claim 12 is objected to because of the following informalities: in line 9, “the butterfly hinge electrode from pre-deployment state” does not make sense. The examiner suggests adding an “a” before “pre-deployment”. Appropriate correction is required.
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.
Claim 3 is 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 3 requires the device engages subdermal tissue, but subdermal tissue is part of a human organism. The examiner suggests modifying claim 3 such that the device is “capable of” engaging the subdermal tissue.
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) 12 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eaton (US 4,080,961).
Regarding claim 12, Eaton discloses a method for applying a butterfly hinge electrode to subdermal tissue, comprising: provisioning a butterfly hinge electrode (fig 2), comprising a first 30 and second wing 31 positioned adjacent to one another and enclosed in a hinge housing structure 20 (fig 2), and a first 32 and second 33 electrode assembly with one or more needle electrodes on each electrode assembly (fig 2), and a coupling mechanism (point at which 28 and 29 meet), the coupling mechanism coupling the first and the second wings together (fig 1), and a compression assembly 12 (fig 2 vs fig 4); applying the butterfly hinge electrode (Col.2 ll 1-6), wherein applying comprises moving the butterfly hinge electrode from pre-deployment state to a deployment state that engages the one or more needle electrodes to subdermal tissue (Col.2 ll 1-6); and monitoring electrical signals acquired by the one or more needle electrodes on the butterfly hinge electrode (Col.2 ll 9-14).
Regarding claim 14, further comprising extending the first and second wing to a non-parallel configuration, wherein extending moves from the deployment state to the pre-deployment state (fig 2).
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) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eaton (US 4,080,961) in view of Franklin (US 3,029,820).
Regarding claims 18 and 20, while Eaton substantially discloses the invention as claimed, it does not disclose wherein the compression assembly comprises an elastic band nor a spring.
Franklin discloses an electrode assembly which has one end which operates similar to Eaton (40 in fig 4) which includes a spring/elastic band 44 to assist in biasing the device.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Eaton such that the compression assembly includes an elastic band nor a spring as taught by Franklin to allow for greater (if spring pulls inwardly) or lesser (if spring pushes outwardly to counter force applied by compression of Eaton) holding force of the electrodes, as desired.
Regarding claim 19, wherein the deployment state places the one or more needle electrodes into a subdermal layer of a patient (Col.2 ll 1-6).
Allowable Subject Matter
Claims 1, 2 and 4-11 are allowed (with claim 3 allowable once the 101 issue is corrected).
The following is an examiner’s statement of reasons for allowance:
With respect to claim 1, the examiner did not find a teaching or suggestion for modifying closest art Eaton (US 4,080,961) such that it includes a compression assembly attached to the distal end of the first and second wings (the same end that has the first and second electrode assemblies). Other art, such as Higo et al (US 6,006,130; see figs 10a and 10b) suggests a compression assembly (either adjuster 38a/b or spring 37) on the interior end (end opposite the electrode assemblies); or Franklin (US 3,029,820) which has a compression assembly 44 in the middle of the device, but closer to the interior end than the distal end.
Claim 13 is 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.
The examiner did not find a teaching or suggestion for modifying closest art Eaton such that rotating the first and second wing to a parallel configuration, wherein rotating moves from the pre-deployment state to the deployment state as it would render Eaton inoperable for its intended use as the deployment state (fig 4) requires the wings to be non-parallel in order to function.
Claims 15-17 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.
The examiner did not find a teaching or suggestion for modifying closet art Eaton such that it includes locking the coupling mechanism into the hinge housing structure by placing a nodule on the first and second wing into a nodule receptor in the hinge housing structure as the coupling mechanism is disposed in the hinge housing and does not move (other than some minor flexing with the hinge housing as in figs 2 and 4) such that there is no reason to add nodules and nodule receptors absent impermissible hindsight.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783