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 § 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 1-15 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).
Applicant positively recites part of a human substantially throughout each claim with the exception of claims 9, 13, and 14. Non-limiting examples are claiming an electrode positioned proximate the LES rather than "configured to be proximate"; positioned within the LES, rather than "configured to be positioned within the LES", etc. Thus, these claims include a human within the scope and are non-statutory.
A claim directed to or including within its scope a human is not considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970). The examiner suggests using the phrase "adapted to be located" when referring to the location of the claimed structures in relation to the targets within the human body such as the LES and gastric cardia.
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 1-4, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jandrall et al. (US 2007/0142884, hereinafter Jandrall'884).
Regarding claims 1 and 16, Jandrall'884 discloses a system and method for increasing a length of a high pressure zone of a lower esophageal sphincter (LES) of a patient (e.g. paragraphs [0029], [0030], [0032], [0036]; claims 9, 15, 24, 31, 34), said system comprising: at least one electrically stimulating electrode positioned proximate the LES (e.g. Fig. 6, energy applying probe 180; abstract; paragraphs [0022], [0038]-[0041]); a waveform generator coupled to said at least one electrode (an energy applying device would necessarily comprise the waveform generator in order to be able to provide the appropriate energy signal); and a controller configured to electrically stimulate an area proximate to the LES to increase the length of said high pressure zone above a threshold level which reduces at least one of a frequency of occurrence or an intensity of gastroesophageal reflux symptoms in said patient (ibid.; abstract; paragraphs [0001], [0023], [0027], [0031], [0041]).
Regarding claims 2, 4 and 17, and further regarding claim 16, Jandrall'884 shows the electrode being positioned within the LES (e.g. paragraph [0027]; Fig. 6 wherein the lead is reasonably considered in the LES, and therefore also within 3 cm of the LES.
Regarding claim 3, and further regarding claim 16, Jandrall'884 discloses wherein the electrode is positioned within the gastric cardia (again as seen in Fig. 6; paragraph [0022]).
Regarding claim 18, Jandrall'884 further discloses the pressure being 15-25 mmHg higher than intragastric pressure, i.e. greater than 5 mm Hg (e.g. paragraph [0032]).
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 of this title, 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.
Claims 5-15, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Jandrall'884.
Regarding claims 5-8, Jandrall'884 discloses the claimed invention except for at least two electrodes or at least 3 electrodes. However the recited targets all lie within the same region and therefore reasonably an electrode in the LES is an electrode in a gastric cardia, and is an electrode within 3 cm of the LES. Therefore inclusion of a second and third such electrode would already read reasonably on the claimed combination of locations without materially changing the nature of the electrode or requiring movement or alteration thereof. It would have been obvious to one having ordinary skill in the art at the time the invention was made to include at least two or at least three electrodes, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art and wherein multi-electrode leads are ubiquitously well-known. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (see MPEP 2144.04).
Regarding claims 9 and 19, Jandrall'884 discloses the invention substantially as claimed including the starting shortened length of the LES high pressure zone which reads on the baseline length prior to stimulation and the longer length during and after successful stimulation which reads on the threshold level and necessarily comprises some percentage of increase over the shorter baseline length, but does not expressly disclose wherein that percentage increase is at least 10%. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Jandrall'884 with the increase from baseline to threshold being at least 10% 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).
Regarding claim 10, Jandrall'884 discloses the invention as claimed, mutatis mutandis, in regard to claims 1 and 9 as cited above. Jandrall'884 further discloses the pressure being 15-25mmHg higher than intragastric pressure, i.e. greater than 5 mm Hg (e.g. paragraph [0032]).
Regarding claims 11 and 12, Jandrall'884 shows the electrode being positioned within the LES (e.g. paragraph [0027]; Fig. 6 wherein the lead is reasonably considered in the LES, and therefore also within 3 cm of the LES. Jandrall'884 discloses wherein the electrode is positioned within the gastric cardia (again as seen in Fig. 6; paragraph [0022]).
Regarding claims 13, 14 and 20, Jandrall'884 discloses at least one sensor for sensing at least one physiological parameter of said patient configured to measure any one or combination of LES high pressure zone length, LES pressure, esophageal pH, inclinometer data, temperature or accelerometer data (e.g. paragraph [0041]; claim 10).
Regarding claim 15, and further regarding claim 20, the above disclosure in paragraph [0041] and claim 10 also indicates that the measure is taken during treatment to determine when the pressure is within normal range to recalibrate and restore the LES, i.e. it is configured to stimulate based on the data sensed by the at least one sensor.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,577,077. The instantly filed claims are identical to the claims originally filed in Application No. 16/528,997 from which the ‘077 patent issued. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims merely represent a narrowed recitation of the instant claims, such that the narrower species necessarily anticipates the broader genus now being claimed.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,406,356. The instantly filed claims are identical to the claims originally filed in Application No. 15/639,590 from which the ‘356 patent issued. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims merely represent a narrowed recitation of the instant claims, such that the narrower species necessarily anticipates the broader genus now being claimed.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,724,510; 1-20 of U.S. Patent No. 9,064,147; claims 1-31 of U.S. Patent No. 8,712,530; claims 1-31 of US Patent No. 8,712,529; claims 1-19 of US Patent No. 8,447,404; and claims 1-14 of US Patent No. 8,447,403. Although the claims at issue are not identical, they are not patentably distinct from each other because each of the above patents relates to a stimulation system for treatment of gastrointestinal reflux symptoms in a patient through electrical stimulation of the LES which increases pressure therein.
Claims 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32-62 of U.S. Patent No. 8,712,530 and claims 32-62 of US Patent No. 8,712,529. Although the claims at issue are not identical, they are not patentably distinct from each other because each of the above patents relates to a method for treatment of gastrointestinal reflux symptoms in a patient through electrical stimulation of the LES which increases pressure therein.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER A FLORY whose telephone number is (571)270-5305. The examiner can normally be reached Monday, Tuesday, and Thursday, 8:30am-4:30pm (PST).
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/CHRISTOPHER A FLORY/Primary Examiner, Art Unit 3792
16 October 2025