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 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 2 – 4, 9 – 11, and 16 – 18 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 pre-AIA the applicant regards as the invention.
The term "partly normalize" in claims 2, 9 and 16 is a relative term which renders the claim indefinite. The term "partly normalize" 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. It is not readily understood from the claims or instant Disclosure what would constitute normalization of a function of the LES. It is also unclear the extent or degree of such a normalization effect which would be considered partly or partial in nature.
Claims 3 – 4, 10 – 11, and 17 – 18 are rejected as being dependent upon rejected claims 2, 9, and 16. They do not cure the deficiencies of the rejected claims.
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 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 – 5, 7 – 12 and 14 – 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (US PGPUB 2011/0034967 – in IDS).
Regarding claims 1, 8, and 15, Chen discloses a method of implanting electrodes in a patient in order to treat Gastroesophageal reflux (e.g. ¶ 7, 94, 216), comprising: implanting a first electrode in an anterior proximal wall of an esophagus (e.g. ¶ 26 – 29, 33, 84, 118 – 120, 135, 140, 153, and 216); and implanting a second electrode proximate a right lateral wall of said esophagus (e.g. ¶ 119, 121, 137, 152, and 217; Figs. 21 – 23). Figs. 21-23 are considered to disclose the various orientations being claimed, e.g. the first electrode being either positioned axially or transversely along/relative to the length of the esophagus, and the second electrode being either parallel and distal, or parallel and at the same height as the first electrode.
Regarding claims 2, 9 and 16, Chen discloses connecting said first and second electrodes to a pulse stimulator configured to supply a stimulation pulse to said first and second electrodes (e.g. Fig. 12, pulse generator; ¶ 130, 137, 216); and operating said first and second electrodes in combination to deliver electrical stimulation to at least partly normalize a function of a lower esophageal sphincter (LES) of said patient post-stimulation (e.g. ¶ 88, 216; stimulatory electrodes maintain optimum level of e.g. GI pressure at the esophageal sphincter to treat GERD).
Regarding claims 3, 10 and 17, Chen discloses wherein the pulse amplitude is equal to or less than 15 mAmp (e.g. ¶ 55, 96, 121).
Regarding claims 4, 11, and 18, Chen discloses wherein the pulse stimulator is configured to detect a LES pressure derived from one of an impedance sensor or electrical activity based sensor (e.g. ¶ 88, 129).
Regarding claims 5, 12 and 19, Chen discloses wherein the second electrode is separated from said first electrode by a distance equal to or less than 1.5cm (e.g. ¶ 118, 119, 143).
Regarding claims 7 and 14, Chen discloses obtaining a measurement of LES pressure proximate an implantation area before, during, or after stimulation (e.g. ¶ 88, 129); modifying an implantation configuration of said first and second electrodes based on said measurement; and repeating obtaining the said measurement until a desired LES pressure profile is achieved (e.g. ¶ 24, 25, 88, 116, 117).
Claim Rejections - 35 USC § 102/103
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 6, 13 and 20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Chen.
Regarding claims 6, 13 and 20, Chen discloses an electrode placement on the greater curvature 2 cm above the pylorus which is considered to read on the claimed location of being more than 1mm away from a vagal trunk. Alternatively, Chen’967 discloses throughout the desire for the provided stimulation to indirectly activate vagal afferents associated with the desired implantation sites of the stimulation electrodes (e.g. ABSTRACT; ¶ 2, 31, 218) and the limited range of electrode spacing and placements cited above as well as the criticality and result-effective nature of stimulation parameters including electrode placement. Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Chen with the electrode placement more than 1 mm away from the vagal trunk, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796