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, 3, 8-13, 22, 24, 25 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 2: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claim recites the broad recitation “below 20 MHz”, and the claim also recites “between 5-15 MHz” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 3: “the electromagnetically transparent part” lacks proper antecedent basis.
Claim 8: “the electrical contact element” and “the respective openings in the feedthrough element” lack proper antecedent basis.
Claim 10: “the second housing part” lacks proper antecedent basis.
Claim 11: “the…first and second housing part” lacks proper antecedent basis.
Claim 12: “the first housing part” and “the electrode lead” lack proper antecedent basis.
Claim 13: “the electrode lead” and “the guide member” lack proper antecedent basis.
Claim 22: “the second, larger cavity” lacks proper antecedent basis.
Claims 24-25: “the support member” lacks proper antecedent basis.
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.
Claim(s) 1-4, 6, 17, 19, 23-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over He (US 2006/0167521) in view of Rahman (US 2008/0172109).
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Regarding claim 1, He discloses substantially the same invention as claimed (Figure 6 shown above for example), including an implantable neuro-modulator device (abstract; Paragraph 1), comprising a hermetically sealed housing (Figure 6; Paragraphs 45, 54-55), wherein a first antenna for communicating with external devices and/or for wirelessly receiving electrical energy is positioned within the housing, defining a first antenna aperture (Paragraphs 28-30).
Further regarding claim 1, He does not disclose multiple antennas as recited. However, Rahman teaches including first and second antennas for communicating with external devices and/or for wirelessly receiving electrical energy, each defining first and second antenna apertures, wherein the first and the second antenna apertures are oriented at a right angle with respect to each other (Figure 13: orthogonal antennas in implantable device 100; Paragraphs 42-43), in order to maximize signal transfer regardless of antenna orientation:
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Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify He as taught by Rahman to include first and second antennas as recited, in order to maximize signal transfer regardless of antenna orientation.
Regarding claims 2-3, He discloses the housing is made of plastic or polymer (Paragraph 54), which would be electromagnetically transparent as recited.
Regarding claim 4, He discloses the housing comprises a first housing part (Figure 6: molded part 86) and a second housing part (Figure 6: header 83), where the first housing part comprises a container which is closed at one end (Figure 6) and has a first sealing ring (Figure 6: metal ring 80) at the opposite or second end. He also discloses the plastic or polymer material allows the housing to be molded in a variety of shapes (Paragraph 50), including a round cross-section (Figure 4).
Regarding claim 6, He discloses the second housing part (Figure 6: 83) comprising a ring and feed-through element as recited (Paragraph 55).
Regarding claim 17, 19, He discloses a rechargeable energy storage device, control unit, and pulse generating means as recited (Figure 1).
Regarding claim 23, He discloses using large aperture antennas (Paragraph 32).
Regarding claims 24-25, the antennas of Rahman are essentially rectangular as recited (Figure 13).
Regarding claim 26, the antenna configuration of Rahman includes antenna selection as recited (Paragraphs 42-43).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over He (US 2006/0167521) and Rahman (US 2008/0172109) in view of Rowland (US 2014/0155710).
Regarding claim 5, He or Rahman do not disclose specifically machining a ceramic material as recited. However, Rowland teaches ceramic materials are recognized for RF transparency in implantable device housings (Paragraph 7) and are typically machined from a monolithic piece of ceramic material (Paragraphs 8-9, 32). Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify He and Rahman as taught by Rowland to include machined ceramic as recited, since such a modification would have amounted to selecting a known suitable material and typical manufacturing process for IMD housings.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over He (US 2006/0167521) and Rahman (US 2008/0172109) in view of Shah (US 2018/0133487).
Regarding claim 7, He or Rahman do not explicitly disclose a lead as recited. However, Shah teaches a feedthrough contact element is typically electrically connected to an electrode lead, in order to deliver electrical stimulation to a target site (Paragraph 16). Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify He and Rahman as taught by Shah to include a lead as recited, in order to deliver electrical stimulation to a target site.
Claim(s) 8-9, 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over He (US 2006/0167521) and Rahman (US 2008/0172109) in view of Waataja (US 2014/0214129).
Regarding claims 8-9, 11-13, He or Rahman do not disclose an overmold as recited. However, Waataja teaches an overmold including a header portion and suture holes (Figures 2A-B; Paragraph 51), in order to facilitate placement of the device. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify He and Rahman as taught by Waataja to include an overmold as recited, in order to facilitate placement of the device.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over He (US 2006/0167521) and Rahman (US 2008/0172109) and Waataja (US 2014/0214129) in view of Boling (US 2012/0290057).
Regarding claim 10, He or Rahman or Waataja do not disclose the angled lead guide member as recited. However, Boling teaches an angled lead guide member as recited (Figure 3; Paragraph 90), in order to optimally position a lead for a particular target. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify He and Rahman and Waataja as taught by Boling to include an angled lead guide member as recited, in order to optimally position a lead for a particular target.
Claim(s) 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over He (US 2006/0167521) and Rahman (US 2008/0172109) in view of Colvin (US 2006/0161204).
Regarding claims 14-16, He and Rahman do not disclose the dimensions as recited. However, Colvin teaches diameters and lengths as recited (Paragraphs 20, 34), in order to suitably size the device for implantation. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify He and Rahman as taught by Colvin to include the dimensions as recited, in order to suitably size the device for implantation.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over He (US 2006/0167521) and Rahman (US 2008/0172109) in view of Schmidt 1 (US 2002/0161404).
Regarding claim 18, He or Rahman do not disclose a solid state battery as recited. However, Schmidt teaches a solid state battery (abstract), in order to avoid liquids or volatile materials which may damage electronics. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify He and Rahman as taught by Schmidt to include a solid state battery as recited, in order to avoid liquids or volatile materials which may damage electronics.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over He (US 2006/0167521) and Rahman (US 2008/0172109) in view of Schmidt 2 (US 2002/0183800).
Regarding claim 20, He or Rahman do not disclose two charging circuits as recited. However, Schmidt 2 teaches two charging circuits as recited (Figure 2), in order to optimize power delivery and conservation. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify He and Rahman as taught by Schmidt 2 to include two charging circuits as recited (Figure 2), in order to optimize power delivery and conservation.
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over He (US 2006/0167521) and Rahman (US 2008/0172109) in view of Knipfer (US 2010/00274309).
Regarding claims 21-22, He or Rahman do not disclose dividers as recited. However, Knipfer teaches subdividing space within a housing, including a larger energy storage compartment, in order to help support respective components (Figures 3-4). Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify He and Rahman as taught by Knipfer to include the configuration as recited, in order to help support respective components.
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 1-26 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/176,550 in view of Rahman (US 2008/0172109). The copending application recites substantially the same invention except for the orthogonal antennas. However, Rahman teaches including first and second antennas for communicating with external devices and/or for wirelessly receiving electrical energy, each defining first and second antenna apertures, wherein the first and the second antenna apertures are oriented at a right angle with respect to each other (Figure 13: orthogonal antennas in implantable device 100; Paragraphs 42-43), in order to maximize signal transfer regardless of antenna orientation. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the copending application as taught by Rahman to include first and second antennas as recited, in order to maximize signal transfer regardless of antenna orientation.
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Barror (US 2017/0100597) shows a microstimulator with ceramic housing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eugene T Wu whose telephone number is (571)270-5053. The examiner can normally be reached M-F 8am-5pm.
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/Eugene T Wu/Primary Examiner, Art Unit 3796