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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 2/12/24 has/have been acknowledged and is/are being considered by the Examiner.
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 1-22 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the housing" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-12 are rejected for inheriting the same deficiencies as claim 1.
Claims 2-11 each recite “an implantable pulse generator”. This is vague as it is unclear if the “an implantable pulse generator” is the same as the “an implantable pulse generator” from claim 1, or is each instance a separate new limitation.
Claim 12 recites “a tissue stimulator”. This is vague as it is unclear if the “a tissue stimulator” is the same as the “a tissue stimulator” from claim 11, or is a separate new limitation.
Claim 13 recites the limitation "the housing" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 14-22 are rejected for inheriting the same deficiencies as claim 13.
Claims 14-21 each recite “an implantable pulse generator”. This is vague as it is unclear if the “an implantable pulse generator” is the same as the “an implantable pulse generator” from claim 13, or is each instance a separate new limitation.
Claim 22 recites “a tissue stimulator”. This is vague as it is unclear if the “a tissue stimulator” is the same as the “a tissue stimulator” from claim 21, or is a separate new limitation.
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) 1-2, 9-11, 13-14 and 19-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Flynn et al. (U.S. Pat. 5,906,634 hereinafter “Flynn”).
Regarding claim 1, Flynn discloses an implantable pulse generator (e.g. 10; see Fig. 3) for use with an electrode lead (e.g. 12) having a lead connector (e.g. 14) with lead pins (e.g. 38), the implantable pulse generator (e.g. 10) comprising: an electronics housing (e.g. 30) including an electronics container; stimulation circuitry within the housing (e.g. 34); a plurality of feedthrough pins (e.g. 32), operably connected to the stimulation circuitry, that extend through the housing (Col. 5; ll. 25-37); an electrical connector (e.g. 16) including a plurality of pin receptacles (e.g. 36), configured to receive the lead pins and a plurality of conductive members respectively located within the pin receptacles (e.g. see Fig. 3; Col. 5, ll. 25-37); and a plurality of flexible wires (e.g. 22) that respectively connect one of the conductive members to one of the feedthrough pins (e.g .Col. 5, ll. 25-37).
Regarding claim 2, Flynn discloses wherein the plurality of pin receptacles comprises a plurality of circumferentially spaced of pin receptacles (e.g. see Fig. 3).
Regarding claim 9, Flynn further discloses wherein the implantable pulse generator defines a length, a width that is less than the length, and a thickness that is less than the width (e.g. see Fig. 1); the electrical connector and all of the feedthrough pins are part of a header assembly (e.g. 16); and the header assembly and the electronics container each occupy a respective portion of the width along the same portion of the length (e.g. see Fig. 1). It is noted that the connection 16 is called a headerless connection, but it has the same construction as a header and further performs all of the same functions as a header and therefore, constitutes a header.
Regarding claim 10, Flynn further discloses wherein the header assembly and the electronics container each occupy about 50% of the width along the same portion of the length (e.g. see Fig. 1).
Regarding claim 11, Flynn further discloses comprising: an implantable pulse generator as claimed in any one of claim 1 (e.g. 100); and an electrode lead (e.g. 12) including an elongate lead body having a proximal end and a distal end, a plurality of electrically conductive contacts associated with the distal end of the lead body (e.g. Col. 2, ll. 58-62; “pacing or defibrillation signals transmitted through the an electrically coupled lead to heart tissue”), and a lead connector associated with proximal end of the lead body (e.g. 14; Fig. 3A) and having a plurality of pins configured to be received by the pin receptacles (e.g. 38).
Regarding claim 13, Flynn discloses an implantable pulse generator (e.g. see Fig. 1), comprising: an electronics housing (e.g. 30) including an electronics container (e.g. see Fig. 1); stimulation circuitry (e.g. 24) within the housing; a plurality of feedthrough pins (e.g. 32), operably connected to the stimulation circuitry, that extend through the cover (e.g. see Fig. 1; Col. 5. ll. 25-36); an electrical connector (e.g. 16) including a plurality of connector pins (e.g. 32); and a plurality of flexible wires (e.g. 22) that respectively connect one of the connector pins to one of the feedthrough pins (e.g. see Figs. 1-3).
Regarding claim 14, Flynn further discloses wherein the plurality of connector pins comprises a plurality of circumferentially spaced of connector pins (e.g. see Figs. 1 and 6).
Regarding claim 18, Flynn further discloses wherein the connector pins (e.g. 32) include a compressible portion and a post (e.g. Col. 6, ll. 4-8; [pin and compressible o-ring]).
Regarding claim 19, Flynn further discloses a plurality of seals respectively associated with the plurality of connector pins (e.g. Col. 3, ll. 19-29; Col. 6, ll. 4-8).
Regarding claim 20, Flynn further discloses the electrical connector and all of the feedthrough pins (e.g. 32) are part of a header assembly (e.g. 16); and the header assembly includes a receptacle (e.g. 24) that provides access to the electrical connector and a seal within the receptacle (e.g. Col. 3, ll. 19-29; Col. 6, ll. 4-8).
Regarding claim 21, Flynn further discloses: an implantable pulse generator (e.g. 10) as claimed in claim 13; and an electrode lead (e.g. 12) including an elongate lead body having a proximal end and a distal end, a plurality of electrically conductive contacts associated with the distal end of the lead body (e.g. Col. 2, ll. 58-62; “pacing or defibrillation signals transmitted through the an electrically coupled lead to heart tissue”), and a lead connector associated with proximal end of the lead body and having a plurality of pin receptacles (e.g. 14; Fig. 3A) and a plurality of conductive tubes located within the pin receptacles (e.g. 38).
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) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flynn et al. (U.S. Pat. 5,906,634 hereinafter “Flynn”).
Regarding claims 6-8, Flynn discloses that the system can either be a female connector as shown in figure 3 or a male connector as shown in figure 1. Flynn further discloses that the system can be external to the device or recessed within the device. Flynn further discloses that the connection can be recessed with corresponding gaskets and o-rings to seal the assembly within the opening of the housing. While Flynn only shows the recessed system with the male connector for the purposes of sealing the assembly within the case, they also disclose that the embodiments are interchangeable and that various modification are available without departing from the scope of the invention (e.g. Col. 8, ll. 15-24). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to recess the female connection of Figure 3 into the device as shown in Figure 17, so that the center post (e.g. 20) is located within the recess so that the connection is sealed within opening of the housing.
Claim(s) 3-5 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flynn as applied to claims 1-2, 9-11, 13-14 and 19-21 above, and further in view of Coffed et al. (U.S. Pat. 7,630,768 hereinafter “Coffed”).
Regarding claims 3-5 and 15-17, Flynn discloses the claimed invention except for the connector being angled to the side allowing for the feedthrough pins to extend in one direction and the connector pins extending in a different direction that is perpendicular. However, Coffed teaches that it is known to connect the lead parallel to the housing (e.g. see Fig. 7) allowing for the feedthrough pins to extend in one direction (e.g. 40, 50, 60, 70) and the connector pins (e.g. 112, 114) extending in a different direction (e.g. Fig. 5) that is perpendicular as set forth in Figure 7 to provide a connector that is connected parallel to the housing for compact implantation. 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 Flynn, with side mounted connectors as taught by Coffed, since such a modification would provide the predictable results of a connector that is connected parallel to the housing for compact implantation.
Claim(s) 12 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flynn as applied to claims 1-2, 9-11, 13-14 and 19-21 above, and further in view of Black (U.S. Pub. 2015/0209575).
Flynn discloses the claimed invention except for explicitly stating the type of lead being a cuff. However, Black teaches that it is known to use cuff electrodes as set forth in Paragraph 41 to provide a known means of lead types that are suitable for implantable device. 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 Flynn, with cuff electrodes as taught by Black, since such a modification would provide the predictable results of using well-known electrode types including cuff electrodes that can be connected and are suitable for implantable electrical stimulation systems.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/Primary Examiner, Art Unit 3796