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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/8/2026 has been entered.
Response to Arguments
Applicant’s amendments and arguments filed 1/8/2026 with respect to the 101 rejections have been fully considered and are persuasive. The 101 rejections have been withdrawn.
Applicant's amendments and arguments filed 1/8/2026 regarding claim 1 have been fully considered but they are not persuasive. Applicant argues that Kolberg requires the device 1 to be separate from the housing. This is incorrect. Kolberg discloses in Col. 8, lines 49-51 explicitly states that the device 1 is integrated as part of the housing. Finally, claim 1 states that the storage area “includes” a negative space, but not that the storage area is ONLY negative space. The entirety of the anterior surface is considered a storage area and it includes negative space 17. The rejection of claim 1 using Kolberg is still considered proper.
Regarding claim 2, the recess 17 is concave, as it has a surface that curves inward.
Regarding claim 3, the posterior surface is a circular plane, and all circles are convex by definition.
New claims 21-24 are addressed below.
Claim Rejections - 35 USC § 112(a)
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 21-24 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.
Claim 21 requires that the “circumferential edge forms an opening into the storage space.” The original specification never disclosed that the circumferential edge forms an opening into the storage space. The openings of the circumferential edge are only disclosed to allow the lead to enter the housing to connect to a power source. Claim 22 depends from claim 21.
Claim 23 recites “wherein the negative space has a volume defined by the anterior surface and an imaginary closing surface that spans the perimeter of the intersection between the circumferential edge and the anterior surface.” The original specification never defined/disclosed the volume 330 in this specific manner. The limitations of claim 24 also were not disclosed in the original specification.
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.
Claims 1-4 and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kolberg et al. (US 9,014,817, hereinafter Kolberg).
Regarding claims 1, 2, 4 and 12-13, Kolberg discloses an IMD 200 as seen in figures 1A-1C. The IMD includes a power source configured to supply electrical impulses to a lead 100 and a housing 201 that encloses the power source (Col. 8, lines 22-48). The housing has a posterior surface opposite an anterior surface with a circular circumferential edge between the posterior and the anterior surface (figure 1B). The anterior surface includes element 1, which defines a concave negative space storage area 17 shaped by the anterior surface for storing excess slack of the lead (Col. 7, line 62-Col. 8 line 8). The proximal end of the lead enters the housing via one or more openings on the circumferential edge to connect to the power source at a second body area and a distal end of the lead having electrical contacts extends to a first body area, with excess amounts of the lead not needed to reach the first body area being stored in the negative space storage area (Col. 8, lines 22-48). As seen in figures 1B and 1C, the lead extends outwardly from the openings of the circumferential edge and returns back into the negative space storage area before extending outwards from the housing to a first body area. Claim 1 states that the storage area “includes” a negative space, but not that the storage area is ONLY negative space. The entirety of the anterior surface is considered a storage area and it includes negative space 17
Regarding claim 3, the posterior surface is a circular plane. It is by definition “convex”.
Regarding claim 14, this is an apparatus claim. Interpretation of apparatus claims are governed by the following principles of law:
"To anticipate a claim, a reference must disclose every element of thechallenged claim and enable one skilled in the art to make the anticipatingsubject matter." PPG Indus. Inc. v. Guardian Indus. Corp, 75 F.3d 1558,1566 (Fed. Cir. 1996).
"[T]he patentability of apparatus or composition claims depends onthe claimed structure, not on the use or purpose of that structure." CatalinaMktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,809 (Fed. Cir.2002).
"It is well settled that the recitation of a new intended use for an oldproduct does not make a claim to that old product patentable." In reSchreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
As such, WHERE the device is implanted is an intended use of the device. The device of Kolberg can be placed in an epidural space and/or a buttock or lower back, if so desired by a user.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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/Eric D. Bertram/Primary Examiner, Art Unit 3796
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