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.
Claim 5, 8 is 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.
Claim 5 recites “the equation: e<d/2 and e≥1 mm”. It is unclear what ‘d’ and ‘e’ are.
Claim 8 recites “the first active area” and “the second active area”. There is insufficient antecedent basis for this limitation.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3, 7, 9-14, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rusu et al. (US 2015/0196224 A1 – cited by Applicant), hereinafter Rusu, in view of He (US 2007/0232877 A1).
Regarding Claim 1, Rusu teaches: an implantable sensor for determining glucose level based on electric impedance in tissue of a living being (title; abstract; paragraph 0001), the implantable sensor comprising:
a housing (Examiner notes that a housing is implied in the case of an implantable sensor),
two current injecting electrodes for injecting current into the tissue (paragraph 0088),
two voltage sensing electrodes for measuring impedance in the tissue, whereby the two voltage sensing electrodes are arranged separately from the two current injecting electrodes and in between the current injecting electrodes (paragraph 0089),
a coil for powering the implantable glucose sensor via a power source (paragraph 0086),
a circuit board arranged within the housing, the circuit board being electrically connected to the two voltage sensing electrodes and the two current injecting electrodes and the coil (figure 6; element 61), the coil being arranged on top of the circuit board (Examiner notes that “top” is relative an thus any direction can be considered to be “top”),
a communication unit for transferring and receiving data packages, the communication unit being connected to the circuit board (figure 4-6; element 62),
the housing comprising the two voltage sensing electrodes and the two current injecting electrodes on an outer surface (figure 6 shows electrodes on the outside).
Rusu does not mention characterized by further comprising a ferrite sheet arranged in between the coil and the circuit board, whereby the ferrite sheet has the same or a larger extension as the coil as seen in a plane defined by the circuit board.
He teaches a ferrite sheet arranged in between the coil and the circuit board, whereby the ferrite sheet has the same or a larger extension as the coil as seen in a plane defined by the circuit board (paragraph 0050; figure 4 and 6). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the sensor to include a ferrite sheet arranged in between the coil and the circuit board, whereby the ferrite sheet has the same or a larger extension as the coil as seen in a plane defined by the circuit board in order to enhance magnetic performance, reduce losses, and improve efficiency.
Regarding Claim 3, Rusu in view of He teach: The implantable sensor according to claim 1, wherein the ferrite sheet is arranged on one side of the circuit board and wherein the two current injecting electrodes and the two voltage sensing electrodes are arranged on an opposite side of the circuit board (Rusu – figure 6; the power and electrodes are on opposite sides, and thus the ferrite layer would be on the side of the power coil).
Regarding Claim 7, Rusu in view of He teach: The implantable sensor according to claim 1, but do not mention wherein the two current injecting electrodes comprise a first active area made of conductive material and wherein the voltage sensing electrodes comprise a second active area made of conductive material, wherein the first active area is bigger than the second active area. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date to modify the sensor wherein the two current injecting electrodes comprise a first active area made of conductive material and wherein the voltage sensing electrodes comprise a second active area made of conductive material, wherein the first active area is bigger than the second active area as it has been held that changes in size/proportion would be obvious to one of ordinary skill (MPEP 2144.04 IV.A).
Regarding Claim 9, Rusu in view of He teach: The implantable sensor according to claim 7, but do not mention wherein the two current injecting electrodes have a longitudinal shape, such as for example an elliptic longitudinal shape or a rectangular longitudinal shape. It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the sensor wherein the two current injecting electrodes have a longitudinal shape, such as for example an elliptic longitudinal shape or a rectangular longitudinal shape as it has been held that changes in shape is a matter of obvious design choice and take only routine skill in the art (MPEP 2144.04 IV.B.)
Regarding Claim 10, Rusu in view of He teach: The implantable sensor according to claim 1, but do not mention wherein the housing is shaped harmonic and rounded off and convex on at least one side. It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the sensor wherein the housing is shaped harmonic and rounded off and convex on at least one side as it has been held that changes in shape is a matter of obvious design choice and take only routine skill in the art (MPEP 2144.04 IV.B.)
Regarding Claim 11, Rusu in view of He teach: The implantable sensor according to claim 1, but do not mention wherein an other side of the housing is flat and wherein the voltage sensing electrodes and the current injecting electrodes are arranged on said other side, which is flat. It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the sensor wherein an other side of the housing is flat and wherein the voltage sensing electrodes and the current injecting electrodes are arranged on said other side, which is flat as it has been held that changes in shape is a matter of obvious design choice and take only routine skill in the art (MPEP 2144.04 IV.B.)
Regarding Claim 12, Rusu in view of He teach: The implantable sensor according to claim 1, but do not mention wherein the housing is of an ellipsoid shape. It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the sensor wherein the housing is of an ellipsoid shape as it has been held that changes in shape is a matter of obvious design choice and take only routine skill in the art (MPEP 2144.04 IV.B.)
Regarding Claim 13, Rusu in view of He teach: The implantable sensor according to claim 1, but do not mention wherein outer dimensions of the implantable sensor correspond to a length of 5 mm to 60 mm or 5 mm to 40 mm, a width of 5 mm to 25 mm or 11 mm to 15 mm, and a thickness of 1 mm to 15 mm or 2 mm to 5 mm. It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the sensor wherein outer dimensions of the implantable sensor correspond to a length of 5 mm to 60 mm or 5 mm to 40 mm, a width of 5 mm to 25 mm or 11 mm to 15 mm, and a thickness of 1 mm to 15 mm or 2 mm to 5 mm as it has been held that changes in shape is a matter of obvious design choice and take only routine skill in the art (MPEP 2144.04 IV.B.)
Regarding Claim 14, Rusu in view of He teach: The implantable sensor according to claim 1, wherein the sensor is an implantable glucose sensor (Rusu – paragraph 0001).
Regarding Claim 17, Rusu in view of He teach: The implantable sensor according to claim 1, wherein the implantable sensor is an implantable glucose sensor and wherein a glucose concertation in the tissue is determined by correlating a measured impedance to a database containing impedance values and corresponding glucose concentrations (Rusu - abstract; paragraph 0001; paragraph 0016-0024).
Claim(s) 2, 5, 6, 8, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rusu in view of He, further in view of Kassab (US 2012/0053441 A1 – cited by Applicant).
Regarding Claim 2, Rusu in view of He teach: The implantable sensor according to claim 1, but do not mention explicitly wherein a distance between the two current injecting electrodes on the outer surface is in a range from 5 mm to 12 mm, 6 to 10 mm, or 7 to 9 mm.
Kassab teaches wherein a distance between the two current injecting electrodes on the outer surface is in a range from 5 mm to 12 mm, 6 to 10 mm, or 7 to 9 mm (paragraph 0114-0115). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the sensor to include wherein a distance between the two current injecting electrodes on the outer surface is in a range from 5 mm to 12 mm, 6 to 10 mm, or 7 to 9 mm as the substitution of one distance for another would have yielded predictable results to one of ordinary skill. Further Examiner notes that it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art (In re Aller, 105 USPQ 233; MPEP 2144.05 II A).
Regarding Claim 5, Rusu in view of He teach: The implantable sensor according to claim 1, but do not mention wherein the relationship between the distance between the two current injecting electrodes and a distance between one of the two voltage sensing electrodes and a closest injecting electrode and a distance between the other of the two voltage sensing electrodes and the other of the two current injecting electrodes, respectively follows the equation:
e<d/2 and e≥1 mm.
Kassab teaches wherein a distance between the two current injecting electrodes on the outer surface is in a range from 5 mm to 12 mm, 6 to 10 mm, or 7 to 9 mm (paragraph 0114-0115). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the sensor to include wherein the relationship between the distance between the two current injecting electrodes and a distance between one of the two voltage sensing electrodes and a closest injecting electrode and a distance between the other of the two voltage sensing electrodes and the other of the two current injecting electrodes, respectively follows the equation: e<d/2 and e≥1 mm as the substitution of one distance for another would have yielded predictable results to one of ordinary skill. Further Examiner notes that it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art (In re Aller, 105 USPQ 233; MPEP 2144.05 II A).
Regarding Claim 6, Rusu in view of He teach: The implantable sensor according to claim 1, but do not mention wherein the voltage sensing electrodes are arranged in between the current injecting electrodes and wherein a distance between one of the two voltage sensing electrodes and a closest current injecting electrode and a distance between the other of the two voltage sensing electrodes and a closest current injecting electrode is in a range from 1 mm to 4 mm or 1.5 mm to 3 mm.
Kassab teaches wherein the voltage sensing electrodes are arranged in between the current injecting electrodes and wherein a distance between one of the two voltage sensing electrodes and a closest current injecting electrode and a distance between the other of the two voltage sensing electrodes and a closest current injecting electrode is in a range from 1 mm to 4 mm or 1.5 mm to 3 mm (paragraph 0114-0115). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the sensor to include wherein the voltage sensing electrodes are arranged in between the current injecting electrodes and wherein a distance between one of the two voltage sensing electrodes and a closest current injecting electrode and a distance between the other of the two voltage sensing electrodes and a closest current injecting electrode is in a range from 1 mm to 4 mm or 1.5 mm to 3 mm as the substitution of one distance for another would have yielded predictable results to one of ordinary skill. Further Examiner notes that it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art (In re Aller, 105 USPQ 233; MPEP 2144.05 II A).
Regarding Claim 8, Rusu in view of He teach: The implantable sensor according to claim 1, but do not mention wherein the first active area and the second active area are made of a bio-compatible conductive material such as gold, titan, platinum or any alloy thereof.
Kassab teaches wherein the first active area and the second active area are made of a bio-compatible conductive material such as gold, titan, platinum or any alloy thereof (paragraph 0061). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the sensor to include wherein the first active area and the second active area are made of a bio-compatible conductive material such as gold, titan, platinum or any alloy thereof as the substitution of one material for another would have yielded predictable results to one of ordinary skill.
Regarding Claim 15, Rusu in view of He teach: The implantable sensor according to claim 1, but do not mention wherein the two current injecting electrodes and the two voltage sensing electrodes are arranged along a straight line, wherein the straight line is straight in two dimensions, such as in a top-down view onto the implantable sensor.
Kassab teaches wherein the two current injecting electrodes and the two voltage sensing electrodes are arranged along a straight line, wherein the straight line is straight in two dimensions, such as in a top-down view onto the implantable sensor. It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the sensor wherein the two current injecting electrodes and the two voltage sensing electrodes are arranged along a straight line, wherein the straight line is straight in two dimensions, such as in a top-down view onto the implantable sensor as the substitution of one configuration for another would have yielded predictable results to one of ordinary skill. Further Examiner notes that it has been held that rearrangement of part takes only routine skill in the art, and is an obvious design choice (MPEP 2144.04 VI C).
Regarding Claim 16, Rusu in view of He teach: The implantable sensor according to claim 1, but do not mention wherein the voltage sensing electrodes are arranged symmetrically in between the injecting electrodes and wherein a distance between one of the two voltage sensing electrodes and a closest current injecting electrode and a distance between the other of the two voltage sensing electrodes and a closest current injecting electrode is in a range from 1 mm to 4 mm or 1.5 mm to 3 mm.
Kassab teaches wherein the voltage sensing electrodes are arranged symmetrically in between the injecting electrodes and wherein a distance between one of the two voltage sensing electrodes and a closest current injecting electrode and a distance between the other of the two voltage sensing electrodes and a closest current injecting electrode is in a range from 1 mm to 4 mm or 1.5 mm to 3 mm (paragraph 0114-0115). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the sensor wherein the voltage sensing electrodes are arranged symmetrically in between the injecting electrodes and wherein a distance between one of the two voltage sensing electrodes and a closest current injecting electrode and a distance between the other of the two voltage sensing electrodes and a closest current injecting electrode is in a range from 1 mm to 4 mm or 1.5 mm to 3 mm as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art (In re Aller, 105 USPQ 233; MPEP 2144.05 II A).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rusu in view of He, further in view of Koyama (US 2008/0079565 A1 – cited by Applicant).
Regarding Claim 4, Rusu in view of He teach: The implantable sensor according to claim 1, but do not mention wherein the circuit board comprises at least two flexible integrated parts, a first flexible integrated part for connecting the coil to the circuit board and a second flexible integrated part for connecting the current injecting electrodes and the voltage sensing electrodes to the circuit board.
Koyama teaches that the components of an implantable can be made of flexible plastic (paragraph 0119-0121). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the sensor wherein the circuit board comprises at least two flexible integrated parts, a first flexible integrated part for connecting the coil to the circuit board and a second flexible integrated part for connecting the current injecting electrodes and the voltage sensing electrodes to the circuit board to protect components from the stresses of implantation.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12642459. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims overlap in scope with the patented claims, where the differences in scope are obvious variants over one another.
Conclusion
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791
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