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 .
Election/Restrictions
During a telephone conversation with Matthew Juren on 8/4/25 a provisional election was made without traverse to prosecute the invention of group I, claims 1-14. Claims 15-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Affirmation of this election was made by applicant in the reply of 11/17/25 and the election is made Final.
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, 13 and 21-23 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.
In claim 1, “a lead body comprising a terminal end, an electrode end, and a polymer substrate disposed throughout an inner cavity of said lead body” is not clear as to whether the polymer substrate is the lead body itself, or if the lead body and polymer substrate are two different elements. In line 10, “is and” is vague and seems to be misworded.
In claims 21-23, “said laser weld is applied to…” is vague and sounds like a method step rather than a structural limitation and it is unclear what structure is being recited. The claim already has the laser weld that connects the conductor to the band and therefore it is unclear what “said laser weld is applied to the electrical conductor…” is trying to limit. It is also unclear if this requires the laser to be applied to the conductor, or if all that is required is the electrode/terminal band is connected somehow to the conductor by a laser weld.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 13, and 21-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The subject matter not described in the original disclosure is “a lead body comprising a terminal end, an electrode end, and a polymer substrate disposed throughout an inner cavity of said lead body”, in combination with the other elements/functions in the claim(s).
As set forth above in the 112b rejection, it is unclear if the applicant is claiming two separate elements or one element.
The disclosure does not relate the “lead body” to any particular reference numeral or particular element. While the disclosure does state the “lead body” has a terminal end and electrode end, it is not clear what is considered the lead body and if the polymer substrate is the lead body itself or two separate elements. Further, it is unclear where the specification discloses “a lead body comprising a terminal end, an electrode end, and a polymer substrate disposed throughout an inner cavity of said lead body”.
Paragraph 46 does discuss using another polymer/plastic coating over a polymer structure, but then states the two are “thermally reflowed into one polymer structure”.
For claims 21-23, the subject matter not described in the original disclosure is “wherein the laser weld is applied to the electrical conductor disposed between the terminal [electrode] band and the respective inner band”, in combination with the other elements in the claim(s).
The original disclosure (e.g. paras. 11, 42, etc.) discussed applying a laser weld to fasten the bands to the conductor, but did not disclose exactly how it is applied, such as directly to the conductor or to the band. It is also unclear, as set forth above in the 112b, what the claim limitation is trying to claim and/or claim structurally.
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 (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 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 1 is rejected under 35 U.S.C. 102a1 as being anticipated by Swoyer et al (6026567). As set forth above in the 112b, it is unclear what is meant by claim 1’s use of “a lead body comprising a terminal end, an electrode end, and a polymer substrate disposed throughout an inner cavity of said lead body”.
For the use of one element of a lead body/polymer substrate, Swoyer discloses a lead 10 is a polymer body/substrate (e.g. col. 2, lines 20-22, etc.) and therefore does have an inner polymer substrate throughout an inner cavity of the lead body. In the alternative, for two separate elements, Swoyer discloses a polymer lead body (e.g. col. 2, lines 20-22, etc.) but also there is an insulative polymer/TPFE conductor 210 (e.g. figures 1, 5, from pin 36 to tip 16, col. 3, lines 6-9 and 52-63, col 2, lines 48-67, etc.) that runs the entire length of the lead body lumen.
--The lead body having a terminal/connector end (e.g. figure 5, etc.) with an outer ring (e.g. element 34, figure 6, etc.) and inner ring (e.g. element 214, figure 7, etc.) with conductor 108 having no insulation for mechanical and electrical contact when the outer and inner ring are mated(e.g. col. 4, lines 30-35, etc.).
Similarly Swoyer discloses the electrode end having an outer ring electrode (e.g. element 14, figure 2, etc.) with inner ring (e.g. element 102, etc.) where the conductor lacks insulation for mechanically and electrically connecting the conductor to the electrode outer and inner ring.
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.
Claims 13 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Swoyer. As discussed above in the 112b rejection, it is unclear what is being claimed in claims 21-23. As best interpreted by the examiner, Swoyer discloses the claimed invention and mechanically and electrically connecting the conductor to the terminal/electrode outer band to the inner band, except for fastening the conductor to the terminal or electrode band using laser welding, such as the laser weld applied to the conductor for connection. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Swoyer, with fastening the conductor to the terminal or electrode band using laser welding, such as the laser weld applied to the conductor for connection, as is well known and common knowledge in the art (mpep 2144I, 2144.03), since it would provide the predictable results of a redundant connection using conventional electrical connection techniques to provide a secure connection between the elements, or substituting one type of conventional electrical and mechanical connection for another easily applied conventional connection using laser welding. In addition, or in the alternative, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the fastening of the conductor to the terminal or electrode band using laser welding, such as the laser weld applied to the conductor for connection, because Applicant has not disclosed that fastening the conductor to the terminal or electrode band using laser welding, such as the laser weld applied to the conductor for connection provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with compressing the conductor between the electrode/terminal outer band and inner band as taught by Swoyer, because it provides an effective and easy way to electrically and mechanically connect elements. Therefore, it would have been an obvious matter of design choice to modify Swoyer to obtain the invention as specified in the claim(s).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection necessitated by amendment. The argument that the claimed polymer substrate disposed throughout an inner cavity of the lead body is distinct from Swoyer’s electrically insulative material disposed on the surface on an outer surface of said electrical conductor is not persuasive and does not point out specifically why this polymer material on the conductor, as disclosed in Swoyer, does not meet the claimed limitation of a polymer substrate throughout an inner cavity of the lead body. The examiner has addressed this claim limitation in the 102 rejection. The cited prior art made of record is considered pertinent to applicant's disclosure and shows several pieces of evidence teaching the well-known use of laser welding to mechanically and electrically connect conductors to other elements such as electrodes or terminals.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George R Evanisko/Primary Examiner, Art Unit 3792 1/29/26