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/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1 - 11 and 16- 20 are drawn to a piezoelectric actuator for a medical implant.
Group II, claims 12 - 15, drawn to a method applying electrical voltage signals to a piezoelectric element coupled to a mass to impart oscillatory motion.
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
Species A1: The actuator configuration shown in fig. 2A
Species A2: The actuator configuration shown in fig. 2B
Species A3: The actuator configuration shown in fig. 3A
Species A4: The actuator configuration shown in fig. 3B
Species A5: The actuator configuration shown in fig. 3C
Species A6: The actuator configuration shown in fig. 6A
Species A7: The actuator configuration shown in fig. 6B
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claims are generic: 1 – 4, 6, 10 – 15
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention and Species A1-A7 lack unity of invention because even though the inventions of these groups and species each require the technical feature of a piezoelectric element, coupler, and a mass, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Andersson (US 8837760). Andersson teaches a bone conduction device comprising a piezoelectric element, a coupler, and a mass (figure 6, piezoelectric element 160, coupler element 680, and a mass element 684).
During a telephone conversation with Bruce Itchkawitz on 2/9/26 a provisional election was made with traverse to prosecute the invention of a piezoelectric actuator for a medical implant, Group I, and Species A1, claims 1-4, 6-7, and 9-11. Affirmation of this election must be made by applicant in replying to this Office action. Claims 5, 8, 11-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 6 recites the limitation "the at least one plane" in the last line of the claim. There is insufficient antecedent basis for this limitation in the claim. It is recommended that the claim be amended to “non-zero slope relative to one of the at least one plane extending from the coupler to the at least one mass”.
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.
Claim 1, 2, 4, 6-7, 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Andersson (US 8837760) (cited in Applicant’s IDS) in view of Tibbetts (US 4056742).
Regarding claim 1, Andersson teaches an apparatus comprising
At least one actuator configured to generate vibrations (column 5, line 46: “The piezoelectric layers mechanically deform (i.e. expand or contract) in response to application of the electrical signal thereto. This deformation (vibration) causes motion of a mass component attached to the piezoelectric element.”,
the at least one actuator comprising:
a coupler (fig 9, element 980) configured to be in mechanical communication with a fixture(fig 9, element 994A + 900B is being interpreted to be the fixture since it will transmit the vibrations the recipient’s body) ;
at least one mass spaced from the coupler (fig 9, element 994A);
and at least piezoelectric element in mechanical communication with the coupler and the at least one mass (fig 9, element 900B connected to mass 994A and coupling 980)
the at least one piezoelectric element configured to oscillate the at least one mass relative to the coupler in response to received electric voltage signals (Column 5, line 39: “a bone conduction device, such as bone conduction device 100, utilizes a vibrator or actuator to generate a mechanical force for transmission to the recipient's skull….The piezoelectric layers mechanically deform (i.e. expand or contract) in response to application of the electrical signal thereto. This deformation (vibration) causes motion of a mass component attached to the piezoelectric element. The deformation of the piezoelectric element and the motion of the mass component generate a mechanical force that is transferred to the recipient's skull. The direction and magnitude of deformation of a piezoelectric element in response to an applied electrical signal depends on material properties of the layers”)
However, Andersson fails to teach that the piezoelectric element is non-planar.
Tibbetts teaches a piezoelectric film with an alternating curved geometry that would make it a “non-planar piezoelectric element”. (Figure 1, element 1)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the application to modify the structure taught in Andersson (figure 9, element 900B) to have a non-planar piezoelectric element taught in Tibbetts. One of ordinary skill in the art would have been able to recognize that the direction and magnitude of deformation of a piezoelectric element in response to an applied electrical signal depends on material properties of the layers, orientation of the electric field with respect to the polarization direction of the layers, geometry of the layers, etc. Therefore, one of ordinary skill in the art can change features such as shape to have the desired deformation effect in the piezoelectric. See paragraph column 5, line 55 of Andersson.
Regarding claim 2, Andersson teaches the apparatus of claim 1 wherein the fixture and the at least one actuator are configured to be implanted on or within a recipient's body. (column 4, line 62: “In the illustrative arrangement of FIG. 1, anchor system comprises a percutaneous abutment fixed to the recipient's skull bone 136. The abutment extends from bone 136 through muscle 134, fat 128 and skin 132 so that coupling 140 may be attached thereto. Such a percutaneous abutment provides an attachment location for coupling 140 that facilitates efficient transmission of mechanical force. A bone conduction device anchored to a recipient's skull is sometimes referred to as a bone anchored hearing aid (Baha)“)
Regarding claim 4, Andersson teaches the apparatus of claim 1 wherein the at least one mass is affixed to at least one edge portion of the at least one non-planar piezoelectric element. (Figure 9, Element 994A is affixed to the edge portion of piezo element 900B)
Regarding claim 6, Andersson teaches the apparatus of claim 1 but fails to teach wherein the at least one non-planar piezoelectric element has a cross-sectional shape comprising one or more curves in at least one plane extending through the coupler and the at least one mass.
However, Tibbetts teaches wherein the at least one non-planar piezoelectric element has a cross-sectional shape comprising one or more curves (Figure 3) in at least one plane extending through the coupler and the at least one mass. The examiner is modifying piezoelectric element 900B in Andersson to have the curved shape of the piezoelectric in Figure 3 in Tibbetts. Therefore, the non-planar piezoelectric element would comprise one or more curves in a plane extending through the coupling (Anderson, fig 9, element 980) and mass (Anderson, fig 9, element 994A)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the piezoelectric element taught in Andersson to have one or more curves as taught in Tibbetts. One of ordinary skill in the art would have been able to recognize that the direction and magnitude of deformation of a piezoelectric element in response to an applied electrical signal depends on material properties of the layers, orientation of the electric field with respect to the polarization direction of the layers, geometry of the layers, etc. Therefore, one of ordinary skill in the art can change features such as shape to have the desired deformation effect in the piezoelectric. See paragraph column 5, line 55 of Andersson.
Regarding claim 7, Andersson teaches the apparatus of claim 6 but fails to teach wherein the cross-sectional shape comprises a first portion affixed to the coupler and extending substantially perpendicularly to a central axis of the coupler.
However, Tibbetts teaches wherein the cross-sectional shape comprises a first portion affixed to the coupler and extending substantially perpendicularly to a central axis of the coupler. (figure 1, labeled by elements 8,9) The examiner is modifying the piezoelectric element in Andersson (figure 9, element 900B) to have the shape taught in Tibbetts (figure 1, element 1) to connect to the coupling (Andersson, figure 9, element 980) via the perpendicular portion of the piezoelectric film (Tibbetts, figure 1, element 8). Therefore, the cross-sectional shape would comprise a portion affixed to the coupler and extending substantially perpendicular to a central axis (interpreted as a vertical line extending from element 900A, through 900B to the end of the coupling 980 in Anderson figure 9) of the coupler.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the piezoelectric taught in Andersson to have the shape and perpendicular extension taught in Tibbetts. One of ordinary skill in the art would have been able to recognize that this is a known technique to improve similar devices for sound processing and used in bone conduction systems – ex: hearing aid microphone, headphones, and speakers. See column 6, line 6 and column 8, line 21 of Tibbetts.
Regarding claim 9, Andersson and Tibbetts teaches the apparatus of claim 7 but fails to teach wherein the cross-sectional shape comprises at least one second portion affixed to the at least one mass and extending at an angle that is less than or equal to 90 degrees relative to the central axis.
However, Tibbetts teaches wherein the cross-sectional shape comprises at least one second portion affixed to the at least one mass and extending at an angle that is less than or equal to 90 degrees relative to the central axis. (figure 1, elements 8,9) The examiner is modifying the piezoelectric element in Andersson (figure 9, element 900B) to have the shape taught in Tibbetts (figure 1, element 1) to connect to the mass component (Andersson, figure 9, element 994A) via the perpendicular portion of the piezoelectric film (Tibbetts, figure 1, element 9). Therefore, the cross-sectional shape would comprise a portion affixed to the at least one mass and extending at an angle that is less than or equal to 90 degrees relative to a central axis (interpreted as a vertical line extending from element 900A, through 900B to the end of the coupling 980 in Anderson figure 9) of the coupler.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the piezoelectric in Andersson to the piezoelectric taught in Tibbetts. One of ordinary skill in the art would have been able to recognize that this is a known technique to improve similar devices for sound processing and used in bone conduction systems – ex: hearing aid microphone, headphones, and speakers. See column 6, line 6 and column 8, line 21 of Tibbetts.
Regarding claim 10, Andersson fails to teach further comprising a plurality of electrodes affixed to the at least one non-planar piezoelectric element and positioned at portions of the cross-sectional shape having a non-zero slope relative to a plane extending from the coupler to the at least one mass.
However, Tibbetts teaches further comprising a plurality of electrodes affixed to the at least one non-planar piezoelectric element and positioned at portions of the cross-sectional shape having a non-zero slope relative to a plane extending from the coupler to the at least one mass. (Figure 1, Elements S1-S6). The examiner is modifying the piezoelectric element in Andersson (figure 9, element 900B) to have the shape taught in Tibbetts (figure 1, element 1) to connect to the coupling (Andersson, figure 9, element 980) via the perpendicular portion of the piezoelectric film (Tibbetts, figure 1, element 8). Therefore, the cross-sectional shape at the “peak” or “valley” of the non-planar piezoelectric would have a non-zero slope relative to the plane extending from the coupler to the at least one mass. The examiner is interpreting the portions of the piezoelectric that have a non-zero slope to be only the point at the “peak” or “valley” locations of the piezoelectric. Therefore, since the electrodes taught in Tibbetts cover the portions of the piezoelectric “ascending” or “descending” from that peak or valley point they are being interpreted as positioned at portions of the cross-sectional shape having a non-zero slope.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the piezoelectric in Andersson to have the electrodes in the piezoelectric taught in Tibbetts. One of ordinary skill in the art would have been able to recognize the surface electrodes on the film, moreover, are divided, i.e., gapped, in selected locations between adjacent segments to interrelate electrically the separate transducer elements in a prescribed fashion, i.e., series, parallel, or series-parallel. See column 2, line 67 of Tibbetts.
Regarding claim 11, Andersson fails to teach wherein the at least one non-planar piezoelectric element has a length between the coupler and the at least one mass, a width perpendicular to the length, and a thickness perpendicular to the width and the length, the at least one non-planar piezoelectric element having a first natural vibration frequency that is less than a second natural vibration frequency of a planar piezoelectric element having the length, the width, and the thickness.
However, Tibbetts teaches the non-planar piezoelectric element (figure 1, element 1) has a length between the coupler and the at least one mass (along the line 2-2 in figure 1), a width perpendicular to the length (examiner notes this as measuring along element S1), and a thickness perpendicular to the width and the length (the examiner notes this as the distance from the top line between elements 8 and 9 to the element labeled 5G). The examiner also notes that while Tibbetts is silent on whether the natural vibration frequency of the non-planar piezoelectric is lower than the natural vibration frequency of a planar piezoelectric, Tibbetts teaches a non-planar piezoelectric film that has the same structural shape (alternating curvature, sinusoidal) as the elected species in the claim. As noted by applicant in paragraph [0053]-[0054] this structural shape has a first natural vibration frequency that is less than a second natural vibration frequency of a planar piezoelectric element having the same length, the width, and the thickness.. Please see In re Schreiber, 128 F.3d 1473, 44 USPQ2d 1429 (Fed. Cir. 1997), In re Best, 562 F.2d at 1255, 195 USPQ at 43, and MPEP section 2112.01.I.
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the piezoelectric actuator taught in Andersson to have the shape and structure of the piezoelectric film taught in Tibbetts which would yield the film having a first natural vibration frequency that is less than a second natural vibration frequency of a planar piezoelectric element having the same length, width, and thickness. One of ordinary skill in the art would have been able to recognize that the direction and magnitude of deformation of a piezoelectric element in response to an applied electrical signal depends on material properties of the layers, orientation of the electric field with respect to the polarization direction of the layers, geometry of the layers, etc. Therefore, one of ordinary skill in the art can change features such as shape to have the desired deformation effect in the piezoelectric. See paragraph column 5, line 55 of Andersson.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Andersson in view of Tibbetts further in view of Berrang (US 2005/0020873).
Andersson teaches a housing (column 4, line 37: “In the embodiment illustrated in FIG. 1, bone conduction device 100 comprises a housing 125 having a sound input element 126 positioned in, on or coupled to housing 125.”)
However, Andersson fails to teach that the housing is configured to hermetically seal the at least one mass and the at least one non-planar piezoelectric element from an environment surrounding the at least one actuator.
Berrang teaches an implantable hearing device with a housing (fig 1, element 9) is configured to hermetically seal the at least one mass and the at least one non-planar piezoelectric element from an environment surrounding the at least one actuator. (paragraph [0026] “The vibrator of this invention may use an inertial mass, driven by a stack of piezocrystals, encapsulated within a biocompatible hermetic housing.”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the housing taught in Andersson to hermetically seal the actuator from the surrounding environment as taught in Berrang. One of ordinary skill would have been able to recognize that this is a known technique in similar devices that would improve the claimed invention and yield predictable results of protecting device elements from an environment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ohnuki (US 3816774) teaches a curved/sinusoidal piezcoelectric element.
Toda (US 6411015) teaches a curved/sinusoidal piezcoelectric element.
Gerlach (US 9832572) teaches a curved/sinusoidal piezcoelectric element.
Hosoi (US 2012/0244917) teaches mobile telephone with a piezoelectric actuator capable of vibrating in both the x and y direction.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA JOY LACAY DECASTRO whose telephone number is (571)272-8316. The examiner can normally be reached Monday - Friday 9:00 AM - 5:30.
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, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.L.D./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791