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 .
Terminal Disclaimer
The terminal disclaimer filed on March 2, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 11,957,900; US 11,980,756; US 12, 151,099 and US app. 18/525,842 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant's arguments filed March 2, 2026 have been fully considered but are moot due to the new grounds of rejection which are necessitated by the currently amended claims.
Election/Restrictions
Newly submitted amended claims (1, 6-8 and 12-13) directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Inventions I (currently amended claims 1, 6-8, 12-13 and 16) and II (claims 11 and 14-15) are directed to related apparatuses. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have materially different designs and modes of operation. Invention I no longer requires a catheter sheath, catheter or sheath. Invention II (as well as previously presented claim 1 on May 9, 2025) requires a sheath disposed over the leads. As such Invention I and Invention II have materially different design and modes of operation. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since applicant has received an action on the merits for the originally presented invention, now presented in Invention II (claims 11 and 14-15), this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 1, 6-8, 12-13 and 16 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 11 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Avellanet et al. (US 7,957,819).
As to claim 11, Avellanet et al. discloses an electrode system connectable to a pacemaker for sequentially pacing both the atrium and ventricle of a human heart comprising: a plurality of insulated electrical leads comprising a first set of three ventricle leads, and a second set of four atrium leads, an catheter sheath disposed over said plurality of leads, the er sheath being retractable from the ventricle leads to deploy the ventricle leads in the ventricle, each of the ventricle and atrial leads having a resiliency and shape to be deployed in contact with the ventricle wall when the sheath is retracted therefrom, the outer catheter sheath also being retractable from the atrium leads to deploy the atrium leads in the atrium, each of the atrium leads having the resiliency and shape to be deployed in contact with the atrium wall when the catheter is retracted (col. 1, line 66 to col. 3, line 23).
Avellanet et al. discloses the invention substantially as claimed with a catheter sheath, but does not explicitly disclose a separate catheter system for the atrial and ventricle leads. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have two separate sheaths, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8 (see MPEP 2144.04). Additionally, it also has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlicnman, 168 USPQ 177, 179. (see MPEP 2144.04)
Therefore, for the reasons stated above, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sheath disposed over the leads to be a separate sheath for the atrial leads and a separate sheath for the ventricle leads in order to provide the predictable results of optimizing insertion and device performance and preventing leads being tangled during implantation.
As to claim 14, the modified Avellanet et al. discloses that there is an outer catheter sheath disposed over a first and second sheath.
As to claim 15, the modified Avellanet et al. discloses that there are 5 ventricle leads and thus include 3 ventricle leads.
NOTE: The examiner does not consider the limitation “exactly” to limit the system to “only” three leads. Should the Applicant wish to claim only 3 leads, the examiner recommends amending the claim language.
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 ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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