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
Claim 32-33, 38, 40, 42, and 45-48 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected an apparatus invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/10/2026.
Claim 48 in the present application appears to have been inadvertently omitted from prior restriction requirement and applicant remarks. However, since Claim 48 depends on claim 32, it will be treated as drawn to the nonelected invention group and withdrawn going forward.
Specification
The abstract of the disclosure is objected to because the sheet presenting the abstract include other parts of the application. 37 C.F.R. 1.72 states that “(b) A brief abstract of the technical disclosure in the specification must commence on a separate sheet, preferably following the claims, under the heading "Abstract" or "Abstract of the Disclosure." The sheet or sheets presenting the abstract may not include other parts of the application or other material”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 19 is/are objected to because of the following informalities:
Claim 19, have multiple periods (.), “seal.” and “body.”. A claim can only have on period.
Appropriate correction is required.
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.
Claim 19 is 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 19 currently recites, “eluting, from the cured ring seal. a therapeutic substance into the human body”, the grammatical error renders the metes and bounds of the claim unclear. Claim 19 also recites the limitation "the human body". There is insufficient antecedent basis for this limitation in the claim.
Claim 19 and 23 is 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. The claims recite, “eluting, from the cured ring seal a therapeutic substance” and “delivering one or more therapeutic substances”, however claim 15 and claim 19 or 23 have no prior establishment that the cured ring seal contains a therapeutic substance, prior to the “eluting” or “delivering” step.
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.
Claim(s) 15-23 and 26-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20090254163 A1 to Gibson (hereinafter “Gibson”).
Regarding Claim 15, Gibson discloses a method (see Abstract: “An apparatus and method for implanting and securing an implanted medical device in a recipient”), comprising:
accessing an opening to a fluidically-sealed body chamber in a body of a recipient (see Para 9-10: “preparing an appropriately configured opening in a reference structure of a recipient for implantation of an stimulating lead assembly”, Para 44: “stimulating lead assembly 118 may be implanted into cochlea 140 through an opening 204” and Para 54 (disclose accessing an opening into the cochlea and cochlear fluid such as perilymph, thereby “fluidically-sealed body chamber”));
positioning a cured ring seal (“expandable portion 240”, see Para 57-62 (made of biocompatible hygroscopic material/polymer such as poly(vinyl alcohol) and dry prior to insertion)) adjacent to tissue surrounding the opening, wherein the cured ring seal includes an aperture extending there through (see Para 29: “expandable portion of the stimulating medical device may be configured to expand during or after implantation”, Para 58: “expandable portion may be a separate collar or ring that may be slid over carrier member 202 by a surgeon prior to surgery. Then during surgery, the surgeon may position the collar or ring in cochleostomy 122”, and Para 46, 52-53, 85, 90, 95 (disclose a separate ring/collar configured to fit over carrier member, that is positioned in/at the cochlea opening, material dry prior to insertion and expend on exposure to moisture/fluid, and made of biocompatible hygroscopic material/polymer such as poly(vinyl alcohol) (see Para 57-59))); and
inserting an implantable component into the fluidically-sealed body chamber via the opening, wherein the implantable component extends though the aperture in the cured ring seal (see Para 10: “opening in a reference structure … inserting said carrier member through said opening in the recipient”, Para 57-58: “expandable portion 240 may be a separate member that is connected (either removably or non-removably) to carrier member 202 … expandable portion 240 may be a collar that may be moved longitudinally along stimulating lead assembly 118. This collar may be positioned on carrier member 202 during manufacture, or, for example, by a surgeon during implantation of stimulating lead assembly 118. For example, expandable portion may be a separate collar or ring that may be slid over carrier member 202”, and Para 43,53, Fig.2B),
wherein the cured ring seal fluidically-seals the opening around the implantable component (see Para 54: “Sealing stimulating lead assembly 118 in cochlea 140 may help prevent cochlear fluid, such as perilymph, from leaking out of cochlea”, also Claim 16).
Regarding Claim 16, Gibson further discloses the method, further comprising:
positioning the cured ring seal adjacent the tissue surrounding the opening before implantation of the implantable component (see Para 58: “collar may be positioned on carrier member 202 during manufacture, or, for example, by a surgeon during implantation of stimulating lead assembly 118. For example, expandable portion may be a separate collar or ring that may be slid over carrier member 202 by a surgeon prior to surgery. Then during surgery, the surgeon may position the collar or ring in cochleostomy 122”, also Para 62-64, 7685 (disclose different techniques to position the expandable portion and implantation of the implantable component)),
wherein the implantable component is inserted into the opening via the aperture in the cured ring seal (see Para 9-10: “a stimulating lead assembly for implantation into a recipient through an opening in a reference structure in the recipient, comprising: an carrier member … at least one stimulation element disposed along said carrier member … an expandable portion … configured to interact with the reference structure when said carrier member is implanted in the recipient … inserting said carrier member through said opening in the recipient”, and Para 42, 74).
Regarding Claim 17, Gibson further discloses the method, wherein the cured ring seal has a bulk formed from a hydrophilic polymer (see Para 59: “expandable portion 240 may comprise a material that expands on exposure to moisture … poly(ethylene glycol)/poly(acrylic acid) (PEG/PAA) … a hyaluronic acid based hydrogel …”).
Regarding Claim 18, Gibson further discloses the method, wherein the cured ring seal has a bulk formed from a hygroscopic polymer (see Para 59: “expandable portion 240 may comprise a material that expands on exposure to moisture … material may be a biocompatible hygroscopic material such as soft hygroscopic polymeric or hydrogel material”).
Regarding Claim 19, Gibson further discloses the method, further comprising:
eluting, from the cured ring seal. a therapeutic substance into the human body (see Para 61: “a beneficial compound may be impregnated within or otherwise releasable from the expandable portion 240 on expansion. For example, an antibacterial drug can be impregnated in the material comprising the expandable portion 240 that may be released (e.g., by dissolving in the presence of a fluid) upon expansion of expandable portion 240”, and Para 30).
Regarding Claim 20, Gibson further discloses the method, wherein positioning the cured ring seal adjacent tissue surrounding the opening comprises:
positioning the cured ring seal adjacent a proximal surface of the tissue surrounding the opening (see Para 29: “The implantable medical device may be positioned adjacent to a reference structure in the recipient. An expandable portion of the stimulating medical device may be configured to expand during or after implantation to abut the reference structure to help secure the stimulating medical device relative to the reference structure”, Para 42-46, Para 52-68: “Inserting unexpanded expandable portion 240 into cochleostomy 122 so that it is adjacent to the boney wall of cochlea 140 and allowing it to expand to abut the boney wall of cochlea 140 …”).
Regarding Claim 21, Gibson further discloses the method, wherein positioning the cured ring seal adjacent the tissue surrounding the opening comprises:
positioning the cured ring seal within the opening such that that an outer surface of the cured ring seal is adjacent the tissue surrounding the opening (see Para 58: “the surgeon may position the collar or ring in cochleostomy 122”, Para 52: “expandable portion 240 may expand so that it contacts the bone of cochlea 140 surrounding cochleostomy 122”, Para 95: “expandable portion 1000 may be positioned in cochleostomy 1022 so that when expanded, expandable portion 1000 will match the shape of cochleostomy 1022” (disclose positioning the expendable portion within the cochleostomy opening, such that upon expansion its outer surface contacts surrounding bone/tissue)).
Regarding Claim 22, Gibson further discloses the method, further comprising:
self-adhering the cured ring seal to the tissue surrounding the opening (see Para 77-79: “interaction produces a longitudinal anchor force that substantially prevents longitudinal movement … of fixation structure 650 out of the recipient … the compression of fixation structure 650 by bone 119 creates the longitudinal anchor force that prevents movement of fixation structure 650 out of cochlea 140” also Para, 53, 82, 93).
Regarding Claim 23, Gibson further discloses the method, further comprising:
delivering one or more therapeutic substances to the fluidically-sealed body chamber via the cured ring seal (see Para 61: “a beneficial compound may be impregnated within or otherwise releasable from the expandable portion 240 on expansion. For example, an antibacterial drug can be impregnated in the material comprising the expandable portion 240 that may be released (e.g., by dissolving in the presence of a fluid) upon expansion of expandable portion 240”).
Regarding Claim 26, Gibson further discloses the method, wherein fluidically-sealed body chamber is a bone chamber of the recipient (see Para 36: “Stimulating lead assembly 118 extends from stimulator unit 120 to cochlea 140 through temporal bone 119”, Para 43-45, 52-53, 76 (bone/boney wall of cochlea)).
Regarding Claim 27, Gibson further discloses the method, wherein fluidically-sealed body chamber is a cochlea of the recipient (see Para 36: “stimulating lead assembly 118 may be inserted into cochlea 140 via a cochleostomy 122 …”), and wherein positioning the cured ring seal adjacent to tissue surrounding the opening comprises:
positioning the cured ring seal adjacent at least one of a round window of the cochlea, an oval window of the cochlea, or a surgically-formed cochleostomy (see para 44: “The aperture may be, for example, oval window 112, round window 121 or a cochleostomy 122”, also Para 67).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISRAT JAHAN whose telephone number is (571)272-8895. The examiner can normally be reached Mon-Fri: 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patel Niketa can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.J./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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