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 .
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 14-21 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 term “Substantially” in claim 14 is a relative term which renders the claim indefinite. The term “Substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. the phrase "inhibit vibrational energy" is rendered indefinite, because it is unclear as to what degree the vibrational energy is inhibited .
Regarding Claim 16-20: the use of the term “and/or” makes the term “mechanically compliant” unclear. The use of the phrase “and/or” results in confusion regarding the claim construction. Claim 16 recites “transducer and/or reservoir”, it is unclear if the language requires choosing between “operatively coupling the elongate portion with a transducer and/or a reservoir configured to contain at least one medicament” or if the language creates an option between just between transducer and reservoir. This confusion carries over into subsequent claims with particular note of its use in claim 17 multiple times. Clarification is required.
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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2012/0136197 hereinafter Van Gerwen.
In regards to Claim 1: An apparatus comprising:
a first portion configured to be implanted at a first location on or within a recipient's body (Van Gerwen, Figure 1C. Item 127); and
a second portion configured to be implanted on or within the recipient's body and configured to be mechanically coupled to a transducer, the second portion comprising an orifice (Van Gerwen, Paragraph 36; “As illustrated, actuator 127 and rod 129 may be housed in housing 121 with flexible conductor 131 exiting housing 121.”) and an elongate element extending through the orifice (Van Gerwen, Paragraph 37), the elongate element (Van Gerwen, Figure 1C. Item 129 & 131) configured to be in mechanical communication with a second location on or within the recipient's body (Van Gerwen, Figure 1C. Item 135), the second location spaced from the first portion (Van Gerwen, Figure 1C. Item 107 Vs. 127), the first portion and the second portion configured to be implanted with the elongate element in mechanical communication with the second location prior to the second portion being mechanically coupled to the transducer (Van Gerwen, Figure 1C. Item 121 & 150).
In regards to Claim 2: The apparatus of claim 1, wherein the first portion is configured to extend at least partially within a channel or cavity in a skull bone of the recipient, and the second portion is configured to be positioned at least partially within the channel or cavity (Van Gerwen, Figure 5 Item 532; Paragraph 69).
In regards to Claim 3: wherein the second portion comprises a plate with the orifice extending therethrough and the elongate element comprises a rod or wire configured to contact the second location (Van Gerwen, Figure 1C. Item 121, Item 129 & 131; Paragraph 36; “As illustrated, actuator 127 and rod 129 may be housed in housing 121 with flexible conductor 131 exiting housing 121.”).
In regards to Claim 4: wherein the elongate element is configured to be affixed within the orifice after being slidably adjusted within the orifice such that an end of the elongate element contacts the second location (Van Gerwen, Paragraphs 27 &37; Examiner interprets that if conductor can be selected from different lengths, the lengths must be installed by sliding them through the orifice.).
In regards to Claim 5: wherein the first portion is configured to be affixed to a skull bone surface (Van Gerwen, Figure 1 Item 119; Paragraph 36), and the second location is in an inner or middle ear region of the recipient's body (Van Gerwen, Figure 1 Item 105; Paragraph 29).
In regards to Claim 6: wherein the second location is on a cochlea and/or within a cochleovestibular region of the recipient's body (Van Gerwen Figure 1C. Items 140 & 133).
In regards to Claim 7: wherein the second portion is configured to be separate from the first portion while the first portion is being implanted at the first location and the second portion is configured to be affixed to the first portion after the first portion has been implanted at the first location (Van Gerwen, Figure 1C.; Examiner Interprets the device shown in figure to have the ability to be installed in the orientation described).
In regards to Claim 8: wherein the second portion is attached to the first portion (Van Gerwen, Figure 1C Item 131) while the first portion is being implanted at the first location (Van Gerwen, Figure 1C Item 121).
In regards to Claim 9: further comprising vibration isolation material between the first portion and the second portion and/or between the first portion and the first location (Van Gerwen, Paragraph 26).
In regards to Claim 10: wherein the transducer is configured to generate mechanical vibrations that propagate through the elongate element to the second location (Van Gerwen, Paragraph 32; “Transducer”).
In regards to Claim 11: wherein the first portion has a longitudinal axis along which the first portion is configured to extend at least partially through bone tissue (Van Gerwen, Figure 1C; Paragraph 36 “into Bone”).
In regards to Claim 12: wherein the elongate element extends substantially parallel to the longitudinal axis (Van Gerwen, Figure 1C. Item 129).
In regards to Claim 13: wherein the elongate element extends along a direction at a non-zero angle relative to the longitudinal axis (Van Gerwen, Figure 1C. Item 131).
In regards to Claim 14: An apparatus comprising:
a fixation portion configured to be implanted on or within a recipient's body (Van Gerwen, Figure 3 Item 311);
an elongate portion configured to be in mechanical communication with a transducer and a target portion of the recipient's body (Van Gerwen, Figure 1C. Item 129), the elongate portion extending at least partially through the fixation portion and configured to transmit vibrational energy from the transducer to the target portion and/or from the target portion to the transducer (Van Gerwen, Figures 1 & 3 Item 311); and
at least one mechanically compliant portion between the fixation portion and the elongate portion, the at least one mechanically compliant portion configured to substantially inhibit escape of the vibrational energy from the elongate portion to portions of the recipient's body spaced from the target portion and/or to substantially inhibit vibrational energy not from the target portion from reaching the transducer (Figure 3 Item 314).
In regards Claim 15: wherein the at least one mechanically compliant portion comprises at least one flexible material and/or at least one resilient member (Van Gerwen, Paragraph 52; “a sleeve of a material that absorbs vibrations and may be slid over flexible conductor 131 and positioned at an appropriate intermediate position along flexible conductor 131. Member 314 may have an opening through which screw 312 may be inserted.”; Examiner interprets the sleeve material as flexible due to most well-known noise dampening material are flexible.).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 16-19, 21-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0136197 hereinafter Van Gerwen in view of US 6,259,951 hereinafter Kuzma.
In regards to Claim 16: Van Gerwen teaches of a method comprising:
at least partially implanting an assembly on or within a recipient's body (Van Gerwen, Figure 5 Item 550, the assembly comprising a fixation portion (Van Gerwen, Figure 5 Item 544; Paragraph 63) and an elongate portion extending at least partially through the fixation portion (Van Gerwen, Figure 5 Item 531; Paragraph 61), said at least partially implanting comprising affixing the fixation portion to a first location of the recipient's body (Van Gerwen, Paragraph 63; Figure 5 Item 544);
while the fixation portion is affixed to the first location, adjusting a position and/or orientation of the elongate portion to be in operative communication with a second location of the recipient's body (Van Gerwen, Paragraph 68 Figure 5 Item 535).
However, it does not teach while the elongate portion is in operative communication with the second location of the recipient's body, operatively coupling the elongate portion with a transducer and/or a reservoir configured to contain at least one medicament.
Kuzma teaches while the elongate portion is in operative communication with the second location of the recipient's body, operatively coupling the elongate portion with a transducer and/or a reservoir configured to contain at least one medicament (Kuzma, Column 5 Lines 14-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the reservoir configured to contain medication taught in Kuzma to the hearing prosthesis taught in Van Gerwen, the motivation being to inhibit tissue growth and stop the body from rejecting the implant over time.
In regards to Claim 17: A modified Van Gerwen teaches all of claim 16, and during and/or after adjusting the position and/or orientation of the elongate portion, mechanically coupling the elongate portion to the fixation portion (Van Gerwen Paragraph 11).
In regards to Claim 18: A modified Van Gerwen teaches all of claim 16, and wherein operatively coupling the elongate portion with a transducer and/or a reservoir comprises affixing the transducer to the fixation portion and/or the elongate portion such that the transducer is in mechanical communication with the elongate portion (Van Gerwen, Figure 5 Item 529).
In regards to Claim 19: A modified Van Gerwen teaches all of claim 16, and wherein operatively coupling the elongate portion with a transducer and/or a reservoir comprises affixing the reservoir to the fixation portion and/or the elongate portion such that the reservoir is in fluidic communication with the elongate portion (Kuzma, Column 5 Lines 23-30).
In regards to Claim 21: A modified Van Gerwen teaches all of claim 16, and wherein at least partially implanting the assembly comprises affixing the fixation portion to the first location, the first location is at a skull bone surface, and the second location of the recipient's body is at an inner ear region; in a middle ear region, or within a cochleovestibular region of the recipient's body (Kuzma, Figure 5 Items 544 & 535; Paragraph 36 & 37).
In regards to Claim 22: Van Gerwen teaches of an apparatus comprising:
a fixation bracket configured to be affixed at a first location on or within a recipient's body (Van Gerwen, Paragraph 52, Figure 3 Item 311); and
an elongate fluid conduit configured to be at least partially within the fixation bracket, the elongate fluid conduit (Van Gerwen, Paragraph 52, Figure 3 Item 131).
However does not teach of a first end portion configured to be in fluidic communication with a reservoir configured to contain fluid ; and
a second end portion configured to be in fluidic communication with a second location on or within the recipient's body and spaced from the first location, the fixation bracket and the elongate fluid conduit configured to be implanted on or within the recipient's body prior to the reservoir being in fluidic communication with the first end portion.
Kuzma teaches a first end portion configured to be in fluidic communication with a reservoir configured to contain fluid (Kuzma, Column 5 Lines 14-22); and
a second end portion configured to be in fluidic communication with a second location on or within the recipient's body and spaced from the first location, the fixation bracket and the elongate fluid conduit configured to be implanted on or within the recipient's body prior to the reservoir being in fluidic communication with the first end portion (Kuzma, Column 5 Lines 23-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the reservoir that is in fluid communication with a second location taught in Kuzma to the hearing prosthesis taught in Van Gerwen, the motivation being to provide means to deliver medication to ensure the device is not rejected by the user.
In regards to Claim 23: A modified Van Gerwen teaches all of claim 22, and wherein the apparatus further comprises the reservoir and the fluid, and the fluid comprises at least one medicament (Kuzma, Column 5 Lines 23-30).
In regards to Claim 24: wherein the fixation bracket is configured to at least partially contain the reservoir (Kuzma, Column 5 Lines 14-30) (Van Gerwen, Figure 5 Item 544).
In regards to Claim 25: A modified Van Gerwen teaches all of claim 22, and wherein the first location is outside an inner ear region and a middle ear region of the recipient's body and the second location is within the inner and/or middle ear region (Van Gerwen, Paragraphs 36 & 37).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0136197 hereinafter Van Gerwen in view of US 6,259,951 hereinafter Kuzma in further view of US 2011/0152991 hereinafter Dadd.
In regards to Claim 20: A modified Van Gerwen teaches all of claim 16, but does not teach wherein affixing the elongate portion to the fixation portion comprises mechanically deforming one or both of the elongate portion and the fixation portion and/or applying an adhesive to one or both of the elongate portion and the fixation portion.
Dadd teaches wherein affixing the elongate portion to the fixation portion comprises mechanically deforming one or both of the elongate portion and the fixation portion and/or applying an adhesive to one or both of the elongate portion and the fixation portion (Dadd, Figure 8A Item 814; Figure 8D Item 830).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the fixing mechanism taught in Dadd to the hearing prosthesis of a modified Van Gerwen, the motivation being to provide a to ensure that the device does not gain additional tension upon growth of the user.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOE R DIETZ whose telephone number is (571)272-1135. The examiner can normally be reached Mon-Fri 8am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571)-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.R.D./Patent Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791