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
Applicant’s election without traverse of Group I, claims 1-13 in the reply filed on 8/11/2026 is acknowledged.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-13 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
In regards to claim 1, the recitation of an electrical lead assembly “received in an associated body passage” inferentially includes the “associated body passage” in the apparatus claim. As the “associated body passage” is part of the human body, this introduces ineligible subject matter. It is respectfully suggested to recite something like a lead assembly “receivable” or “configured to be received” in the body passage (or similar), and such language would avoid this rejection.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Rashidi (US 2022/0355098, hereinafter “Rashidi”).
In regards to claim 1, Rashidi discloses an electrical lead assembly received in an associated body passage (abstract, Fig. 1), the lead assembly comprising:
a) an electrical signal lead sized for receipt in the associated body passage, the lead having a proximal end and a distal end (Fig. 1, “conductive lead” 110);
b) a sheath (Fig. 1, “sheath” 120) having an outer surface configured and sized for receipt in the associated body passage and an inner surface received over the lead, the sheath having a first end adjacent the distal end of the lead (Fig. 1, par. 0072) and extending continuously to a second end adjacent the proximal end of the lead (par. 0073, “The sheath 120 extends over substantially an entire length of the lead 110”) with the first end of the sheath having a portion secured to the lead adjacent the distal end thereof wherein the secured portion includes an annular fold of the sheath thereby forming the secured portion of the first end of the sheath (Figs. 1 and 2, par. 0087).
In regards to claim 2, the sheath and the secured portion of the first end thereof are formed integrally as a one-piece member (par. 0089, “the lead assembly 104 is modified, specifically through addition of an integrated feature 120 that facilitates removal of the lead assembly from the body passage”; par. 0103).
In regards to claim 3, the lead assembly is removable from the associated body passage by application of a tensile force to the proximal end of the lead whereupon the annular fold moves progressively towards the proximal end separating the outer surface of the sheath and enabling the lead and sheath to be removed from the associated body passage (Fig. 36; par. 0103; “the lead assembly is self-extracting. In this embodiment, an inner surface of the sheath inner portion 1424 is preferably bonded to the outer surface of the lead 1410”).
In regards to claim 4, the secured portion of the first end of the sheath is attached to the lead by one of (i) adhesive, (ii) weldment, and (iii) mechanical fastening (par. 0103; “A bonding agent 1450 may be a weld such as an ultrasonic weld, adhesive, etc.”).
In regards to claim 5, the sheath is formed of a physiologically biocompatible material (par. 0073, “The sheath 120 is formed from a physiologically biocompatible material, such as a polymer material”).
In regards to claim 6, the sheath is formed of a polymeric material (par. 0073, “The sheath 120 is formed from a physiologically biocompatible material, such as a polymer material”).
In regards to claim 7, the sheath is formed of a flexible polymeric material (par. 0073, “The sheath 120 is formed from a physiologically biocompatible material, such as a polymer material”; par. 0096, “the flexible material used to form the sheath”).
In regards to claim 8, the secured portion of the first end of the sheath is attached to the lead by sonic welding (par. 0103; “A bonding agent 1450 may be a weld such as an ultrasonic weld, adhesive, etc.”).
In regards to claim 9, the secured portion of the first end of the sheath is attached to the lead by one of clamp bands and snap rings (Fig. 37, par. 0106 – the ring 1560 is a band that clamps the sheath to the lead).
In regards to claim 10, the secured portion of the first end of the sheath is attached to the lead by annular physiologically biocompatible adhesive (par. 0103; “A bonding agent 1450 may be a weld such as an ultrasonic weld, adhesive, etc.”).
In regards to claim 11, the sheath is formed as an integral one-piece continuous member (par. 0017, “the first and second portions of the sheath are an integral, one-piece, continuous component where the first portion of the sheath is a continuous extension of the second portion of the sheath”).
In regards to claim 12, the assembly is removable from the associated body passage by application of a tensile force to the proximal end of the lead whereupon the annular fold moves progressively towards the proximal end of the lead and the lead and sheath are extracted from the associated body passage (Fig. 36; par. 0103; “the lead assembly is self-extracting. In this embodiment, an inner surface of the sheath inner portion 1424 is preferably bonded to the outer surface of the lead 1410”).
In regards to claim 13, the annular fold of the sheath extends inwardly from an outer surface of the sheath to form the secured portion of the first end of the sheath (e.g., Figs. 1, 2, 36).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Winek et al. (US 2022/0118262) is another example of a lead assembly that appears to anticipate at least claim 1 (see Figs. 2A and 2B).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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