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 .
This office action is in response to the reply filed on 1/7/2026, wherein claims 1-2, 9 and 14 were amended; claim 8 was canceled; and claims 20-21 were added. Claims 1-7 and 9-21 are pending.
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 1-7 and 9-21 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 is rendered indefinite by the limitation “bee-cell-hole pattern” since it is unclear what structure is being encompassed by the limitation. For examination purposes, Examiner interprets “bee-cell-hole pattern” as honeycomb hole pattern or hexagonal hole pattern, as shown in Applicant’s figures.
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 1-7, 9-15 and 20-21 rejected under 35 U.S.C. 103 as being unpatentable over So et al. (US 2015/0297294) in view of Pratt et al. (US 2017/0029198).
Regarding claim 1, So discloses a protective casing (at 1) capable of holding a thin-film lead paddle of a surgical lead, the thin-film lead paddle being connected to a lead cable through an interconnection portion or the thin-film lead paddle being made in one piece with the lead cable, the protective casing comprising: a housing (at 10/30) comprising or including a first part (at 10) and at least a second part (at 30), the housing being capable of enclosing at least a part of a thin-film lead paddle of the surgical lead, wherein each of the first and second parts includes a first surface (upward facing surface of 10 in Fig. 1; and bottom facing surface of 30 in Fig. 1) and a second surface (downward facing surface of 10 in Fig. 1; and upward facing surface of 30 in Fig. 1), the second surfaces of the first and second parts being at least partially in contact to one another and/or in contact with the thin-film lead paddle during use (as shown in Fig. 3), and wherein the first part and/or the second part forming the housing include(s) a hole pattern structure (at 20 in Fig. 1) comprising end-to-end holes connecting the first surface with the second surface, allowing fluids and/or gasses to enter the protective casing and leave the protective casing. So discloses the claimed invention except for the specific shape of the hole pattern structure.
However, Pratt teaches a casing (at 10 in Fig. 1) comprising a plurality of openings (at 24), wherein the openings are arranged in a honeycomb (or hexagonal) hole pattern structure for the purpose of being very strong in resisting pressure applied thereto (See [0034]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hole pattern structure of So to be honeycomb (or hexagonal) shaped as taught by Pratt in order to increase the strength of the parts.
Regarding claim 2, So discloses at least one of the first and second parts forming the housing is permeable to fluids and/or gases (at openings 20), when the thin-film lead paddle of the surgical lead is placed in the protective casing and being sterilized and/or tested in the protective casing.
Regarding claim 3, So discloses the first and second parts are detachable (See Fig. 1), or the first and second parts are connected to one another through a connection means (at 28/26).
Regarding claim 4, So discloses the housing is made in one piece (the housing is considered to be “one piece” since it is connected as a single unit as shown in Fig. 3).
Regarding claim 5, So discloses the protective casing comprises at least one locking element (at 16/32) for holding the first and second parts in place with respect to one another to form the housing.
Regarding claim 6, So discloses the at least one locking element is formed integral with at least one of the first and second parts forming the housing.
Regarding claim 7, So discloses the at least one locking element comprises or consists of at least one clip element (at 16/32), especially wherein the clip element is configured to hold the first and second parts in place by clipping.
Regarding claim 9, So discloses the hole pattern structure is formed over almost the entire first surface and/or almost the entire second surface of the first part and/or the second part (as shown in Fig. 1).
Regarding claim 10, So discloses the first part and the second part forming the housing are made of a biocompatible polymer material ([0102]).
Regarding claim 11, So discloses the polymer material is Polyethylene ([0104].
Regarding claim 12, So discloses the first and second parts forming the housing comprise a respective recessed portion (at 40/38) formed on the second surface, especially wherein the recessed portion of the first part and the recessed portion of the second part define a cavity for housing an interconnection portion when the first and second parts are held in place to form the housing.
Regarding claim 13, So discloses at least one part among the first and second parts comprises a form-fit protrusion (at 16) and the other part among the first and second parts comprises a form-fit recess (at 32), wherein the form-fit protrusion and the form-fit recess are configured to engage with each other for a form-fit when the first and second parts are held in place to form the housing.
Regarding claim 14, So discloses the protective casing comprises an adjustment zone (at 40/38) capable of holding the lead cable, wherein the adjustment zone is at least partially formed by the first and second parts, wherein the adjustment zone is formed by adjustment zone recesses (See recesses at 40, 39 and recess between 28 and 28 in Fig. 1) in frame structures of the first and second part.
Regarding claim 15, So discloses the protective casing further includes an optical inspection window (one of the openings 20).
Regarding claim 20, So discloses at least one locking element for holding the first and second parts in place with respect to one another to form the housing, and wherein the at least one locking element comprises a first clip (at 16) and a second clip (at 32).
Regarding claim 21, So discloses at least one locking element (at 16/32 and 26/28) for holding the first and second parts in place with respect to one another to form the housing, and wherein, for each of the at least one locking element, there is a respective recess in the first part and the second part, and wherein each of the at least one locking element fits into the respective recess.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over So et al. (US 2015/0297294) in view of Pratt et al. (US 2017/0029198) as applied to claim 1 above, in view of Provencher et al. (US 2016/0015598). As described above, So-Pratt discloses the claimed invention except for the RFID. However, Provencher teaches it is well known in the art to provide a casing with an RFID for the purpose of providing the user with information associated with the casing ([0038]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the casing of So-Pratt with an RFID as taught by Provencher in order to provide the user with information associated with the casing.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over So et al. (US 2015/0297294) in view of Pratt et al. (US 2017/0029198) as applied to claim 1 above, in view of Antonini et al. (US 2020/0316371).
Regarding claim 17, So-Pratt discloses the claimed invention except for the specific contents of the protective casing. However, Antonini teaches a medical device comprising a surgical lead (1) including a thin-film lead paddle (5) and a lead cable in one piece. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the casing of So-Pratt with a medical device as taught by Antonini in order to protect the medical device prior to use. Further regarding claim 18, So-Pratt-Antonini discloses a protection element (at 24) made of a soft material (the polymer material of So is considered soft since it has some degree of softness) especially arranged and/or provided at the connection point between the housing and the lead cable of the surgical lead.
Regarding claim 19, So-Pratt-Antonini discloses a method for handling a surgical lead comprising a thin-film lead paddle, comprising at least the steps of covering the thin-film lead paddle with a protective casing, especially wherein the protective casing is a protective casing according to claim 1; and handling the thin-film lead paddle while being in the protective casing.
Response to Arguments
In view of Applicant's amendment, the search has been updated, and new prior art has been identified and applied. Applicant's arguments have been considered but are moot in view of the new ground(s) of rejection.
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 STEVEN A REYNOLDS whose telephone number is (571)272-9959. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anthony Stashick can be reached at (571) 272-4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEVEN A. REYNOLDS/Primary Examiner, Art Unit 3735