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 1, claims 1-12 in the reply filed on 07/07/2026 is acknowledged.
Applicant’s election of Group 1, claims 1-12 in the reply filed on 07/07/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/27/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Doan (US 5,456,708-hereinafter Doan), in view of Spohn (US 9,901,725-hereinafter Spohn).
Regarding Claim 1: Doan discloses an electrode tip for an implantable cardiac electrode comprising a housing ,tubular header 24 and insulating housing 16, having an electrode lead feed section ,proximal end 12 and housing 16, and an electrode lead receiving section ,distal end 14 and header 24, and a sealing element ,seal assembly 36, arranged between the two, the sealing element sealing the feed section against the receiving section when the helix shaft 34 is arranged within the housing and surrounded by the seal; (Fig 1, col. 4 lines 1-28 ,col. 5 lines 37-59). Doan does not expressly disclose that the sealing element consists of an injection-moldable material forming a non-removable portion that is integral with the housing, since Doan's seal 58 is a separately molded washer sandwiched between metal washers 54, 56; (Fig2, col. 5 lines 41-46).
Spohn teaches overmolding a soft, flexible thermoplastic end element 114 directly onto a tube end so that the resulting seal is integrally formed and non-removable, eliminating the need for separately assembled sealing parts ;(Figs 2 and 3, Col 5 lines 4-49).
It would have been obvious to one of ordinary skill in the art to form Doan's seal assembly by injection, overmolding, the seal material directly into the housing, as taught by the Spohn, in order to reduce the number of discrete parts and assembly steps, consistent with the Spohn stated, advantage of sealing the tube end without separate components.
Doan Figs 1 and 2:
PNG
media_image1.png
184
706
media_image1.png
Greyscale
PNG
media_image2.png
260
230
media_image2.png
Greyscale
Washers 54 ,56 Annular seal element 58
Spohn Figures 2 and 3:
PNG
media_image3.png
682
823
media_image3.png
Greyscale
Regarding Claim 2: Claim 1 is obvious over Doan, et al. and Spohn, et al. as described above. Spohn also discloses that the receiving cavities 144 and 164 of the connector hub receives the overmolded end element, in which the overmolded material is delivered into this cavity through the molding equipment gate/runner during the overmolding step, such as, a sealing chamber and an injection channel to the exterior are inherent to the disclosed overmolding process.
It would have been obvious to configure the housing of modified Doan with a defined sealing chamber and injection channel leading to the exterior, consistent with conventional two-shot/insert injection molding process as Spohn stated to permit the sealing material to be introduced and set in place.
Regarding Claims 3: Doan discloses the seal element is fabricated of silicone rubber or polyurethane which falls within the claimed group of liquid silicone rubber, TPE, TPU, and copolymers thereof; (Col. 5 line 50).
Regarding claims 4,5,6: Doan discloses the housing and the header are made of, fabricated, silicone rubber or polyurethane which falls within the claimed group of liquid silicone rubber, TPE, TPU, and copolymers thereof;(Col 4 line 2). Moreover, Spohn also teaches that the overmolded end element formed of soft plastic material that falls on TPU subgroup; (Col 5 line 26).
Regarding claim 7: Spohn discloses that the overmolded end element (soft, flexible thermoplastic/polyurethane) is received into a connector hub formed as a "conventional injection molded luer connector," which are commonly formed of a comparatively rigid engineering plastic distinct from the soft overmold material;(Col 5 lines52-62).
It would have been obvious that the sealing/overmold material and the housing material are different materials, as is conventional in two-shot overmolded medical connector construction.
Regarding claim 8: Spohn discloses external indicators such as annular grooves 124 formed on the overmolded body, which, when overmolded within a receiving cavity, form a mechanical interlock/undercut resisting axial withdrawal.
It would have been obvious to provide Doan's overmolded seal with such an undercut feature to resist dislocation of the seal during use, as suggested by Spohn groove structure. (Spohn: Col 5 lines 30-45).
Regarding claim 9: Doan discloses an implantable cardiac electrode comprising the electrode tip of claim 1 and an electrode lead helix shaft 34, conductor coil 40 arranged within the lead feed and receiving sections and surrounded by the seal assembly 36 ;(Col. 4 lines 11 -19, Col 6 claim 1).
Regarding claims 10 ,11: Doan discloses a fixation screw helix electrode 30 received within the housing, electrically connected to the lead via shaft 34 and conductor coil 40, used to fix the electrode tip within cardiac tissue by piercing the endocardium. Doan also teaches the electrically conductive connection between the helix shaft 34 and the lead is made via conductor coil 40 within the insulating tube,header, within the lead receiving section (Fig 3 Fig 4 Col. 4, lines 23-43).
PNG
media_image4.png
448
714
media_image4.png
Greyscale
Regarding Claim 12: Doan discloses a post 38 projecting inwardly from the inner wall of the header 24 interposed between adjacent turns of the helix electrode 30, which limits axial movement of the helix fixation screw upon rotation without limiting its rotational/radial movement about the longitudinal axis;(Col. 4 lines 44-50).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMAD HASSAN KANAAN whose telephone number is (571)270-0363. The examiner can normally be reached I work from 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, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MOHAMAD HASSAN KANAAN/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
Prosecution Insights