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 Objections
Claim 7 is objected to because of the following informalities:
Claim 7, ‘…the capacitor layer’, should likely be preceded with ‘wherein’ so that it reads ‘wherein the capacitor layer…’ for consistency.
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.
Claims 1-10 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 recites ‘An implantable rotator cuff muscle suture spacer…comprising: a pressure sensor… comprising: a base layer… and an integrated spacer, attached to the pressure sensor… and the base layer is folded to form the pressure sensor’, it is unclear how the base layer is folded to form the pressure sensor while also containing the limitation that the pressure sensor comprises the base layer, this limitation contradicts itself, rendering Claim 1 indefinite. Further, it is unclear if the integrated spacer is the same limitation as previously recited ‘implantable rotator cuff muscle suture spacer’, or if the integrated spacer is a new and separate limitation.
Regarding Claim 4, the claim recites ‘wherein the first electrode region and the second electrode region are a flexible metal film electrode’, it is unclear whether the intent is to state that the first electrode region and the second electrode region collectively make up a flexible metal film electrode, or if the first electrode region and the second electrode region comprise a flexible metal film electrode, rendering Claim 4 indefinite. Examiner interprets the indefinite limitation to mean that the electrode regions each comprise a flexible metal film electrode
Regarding Claim 5, the claim recites ‘in a plan view’, it is unclear what this limitation is meant to limit with respect to the scope of the claim, rendering claim 5 indefinite. Examiner interprets the indefinite limitation as a typo, since this language is often used when referring to figures in specifications.
Regarding Claim 6, the claim recites ‘…mentioned above...’, it is unclear whether this is meant to refer to the first electrode region and the second electrode region or further limit their position within the structure of the invention. Examiner interprets the inclusion of ‘mentioned above’ to refer back to the introduction of the electrode regions in Claim 1, however this reference is redundant, as the claim already refers back to Claim 1 per its’ dependence on Claim 5. The claim should likely read ‘wherein the first electrode region and the second electrode region are disposed at corresponding upper and lower positions to form an electrode pair to obtain induced capacitance.’
Claims 2-10 are rejected for their dependence on an independent claim rejected under 35 U.S.C. § 112(b).
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) 1 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over US 6111520 A to Allen et al. (hereinafter, Allen) in view of US 20170189092 A1 to Bonutti et al. (hereinafter, Bonutti) in further view of US 20220142768 A1 to Harant et al. (hereinafter, Harant).
Regarding Claim 1, Allen discloses
a pressure sensor (Allen: Col. 6, line 10 ‘a pressure sensor 100’; Fig. 1), formed by a semiconductor manufacture procedure (Examiner’s Note: Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP § 2113-I.), comprising:
a base layer, made of a polymer material, and having flexibility (Allen: Col. 6, lines 11-13; Col. 6, lines 52-58 ‘polymer thin films’);
an electrode layer, deposited on the base layer (Allen: Fig. 1, items 106, 116, 122, 132, and 134 combined), wherein the electrode layer further comprises:
a first electrode region (Allen: Col. 7, line 37 ‘The first conductor 106’; Fig. 1, item 106);
a second electrode region (Allen: Col. 7, lines 38-39 ‘the second conductor 116’; Fig. 1, item 116); and
an inductance coil region, wherein the first electrode region and the second electrode region are connected to each other through the inductance coil region (Allen: Col. 7, lines 37-41; Fig. 1, items 122, 132, and 134 combined); and
a capacitor layer, coated on the base layer and above the electrode layer to form a dielectric (Allen: Fig. 1, items 104, 108, 114, and 118 combined; Col. 9, lines 30-32 ‘layers… act as a dielectric in a capacitor… formed by the first and second conductors’).
Allen does not explicitly disclose the inductance coil region surrounding the second electrode region
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the inductance coil region of Allen by rearranging its position to surround the second electrode region. Such a modification would save space for integrated circuitry. It has been held to be within the ability of one skilled in the art to rearrange parts of an invention for optimization purposes. See MPEP 2144.04 VI. C.
Further, Allen does not explicitly disclose a rotator cuff muscle suture spacer, an integrated spacer having a plurality of suture drill holes, wherein the base layer further has a fold line, and the base layer is folded.
However, Benutti teaches an implantable rotator cuff muscle suture spacer (Benutti: Para. [0004]; Para. [0226] ‘a spacer made of PEEK may be bonded to a metallic implant outside the body. The spacer and implant may be placed in the body.’ Para. [0431]),
an integrated spacer having a plurality of suture drill holes (Benutti: Para. [0226] ‘a spacer made of PEEK may be bonded to a metallic implant outside the body. The spacer and implant may be placed in the body.’; Para. [0299]).
One of ordinary skill at the time the invention was filed would have found it obvious to modify the pressure sensor of Allen by combining the pressure sensor with a suture spacer for implantation as taught by Benutti in order to combine known elements to achieve predictable results, in this case, measuring pressure within the rotator cuff via an implant (Benutti: Para. [0431] ‘Using intracorporeal metal welding and soldering, electrical and electronic components can be implanted and repaired in the body. For example, batteries from a pacemaker or other pump may be replaced; temperature, pH, or pressure sensors may be connected or reconnected’).
Allen in view of Benutti does not explicitly disclose wherein the base layer further has a fold line, and the base layer is folded.
However, Harant teaches wherein the base layer further has a fold line, and the base layer is folded (Harant: Para. [0003] ‘Most intraocular lenses used in cataract surgery may be folded and inserted through the same tiny opening that was used to remove the natural crystalline lens.’; Para. [0052] ‘When considering designs for an intraocular lens comprising a pressure sensor… Exemplary folding or bending lines are illustrated in the design’).
One of ordinary skill in the art would have found it obvious to modify the base layer of Allen to include a folding line, and fold the base layer as taught by Harant to fit into the tiny openings of the incisions and once implanted, the implant will unfold to its full size (Harant: Para. [0003] ‘…may be folded and inserted through the same tiny opening that was used to remove the natural crystalline lens. Once in the eye, the lens may unfold to its full size. ’).
Regarding Claim 5, Allen in view of Benutti in view of Harant discloses the implantable rotator cuff muscle suture spacer with pressure sensing according to claim 1. Allen in view of Benutti does not explicitly disclose wherein the base layer is folded to form the pressure sensor having a U-shape.
However, Harant teaches wherein the base layer is folded to form the pressure sensor having a U-shape. (Harant: Para. [0003] ‘Most intraocular lenses used in cataract surgery may be folded and inserted through the same tiny opening that was used to remove the natural crystalline lens.’; Para. [0052] ‘When considering designs for an intraocular lens comprising a pressure sensor… Exemplary folding or bending lines are illustrated in the design’; Note: Folding the layer would result in a U-shape).
One of ordinary skill in the art would have found it obvious to modify the base layer of Allen to include folding the base layer having a U-shape as taught by Harant to fit into the tiny openings of the incisions and once implanted, the implant will unfold to its full size (Harant: Para. [0003] ‘…may be folded and inserted through the same tiny opening that was used to remove the natural crystalline lens. Once in the eye, the lens may unfold to its full size. ’).
Regarding Claim 6, Allen in view of Benutti in view of Harant discloses the implantable rotator cuff muscle suture spacer with pressure sensing according to claim 5. Allen further discloses wherein the first electrode region and the second electrode region are disposed at corresponding upper and lower positions to form an electrode pair to obtain induced capacitance (Allen: Col. 7, lines 7-34; Fig. 1, items 106, 116).
Regarding Claim 7, Allen in view of Benutti in view of Harant discloses the implantable rotator cuff muscle suture spacer with pressure sensing according to claim 6. Allen further discloses wherein the capacitor layer is changed through external pressure, so that the induced capacitance between the electrode pair is changed to obtain a pressure sensing value (Allen: Col. 7, lines 30-36).
Regarding Claim 8, Allen in view of Benutti in view of Harant discloses the implantable rotator cuff muscle suture spacer with pressure sensing according to claim 7. Allen further discloses wherein when the induced capacitance changes, a resonant frequency is changed by utilizing an LC circuit oscillation technique to calculate the pressure sensing value (Allen: Col. 7, line 41-58; Col. 7, line 66-Col. 8, line 9).
Claim(s) 2, 3, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of Benutti in view of Harant in further view of US 20130041235 A1 to Rogers et al. (hereinafter, Rogers).
Regarding Claim 2, Allen in view of Benutti in view of Harant discloses the implantable rotator cuff muscle suture spacer with pressure sensing according to claim 1. Allen in view of Benutti in view of Harant does not explicitly disclose wherein the base layer is a flexible Parylene substrate.
However, Rogers teaches wherein a flexible parylene substrate (Rogers: Para. [0030] ‘the barrier layer comprises PDMS, polyimide, SU-8, parylene, parylene C’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the base layer of Allen to specify being a flexible parylene substrate as taught by Rogers as one known technique in a range of many suitable materials for biocompatibility (Rogers: Para. [0055] ‘ A range of materials are useful for flexible or stretchable substrates…a biocompatible material or a bioinert material.’).
Regarding Claim 3, Allen in view of Benutti in view of Harant in view of Rogers discloses the implantable rotator cuff muscle suture spacer with pressure sensing according to claim 2. Allen in view of Benutti in view of Harant does not explicitly disclose wherein the flexible Parylene substrate is one or a combination of Parylene C, Parylene D, and Parylene N.
However, Rogers teaches wherein the flexible Parylene substrate is one or a combination of Parylene C, Parylene D, and Parylene N (Rogers: Para. [0030] ‘the barrier layer comprises PDMS, polyimide, SU-8, parylene, parylene C’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the base layer of Allen to specify being one or a combination of Parylene C, Parylene D, and Parylene N as taught by Rogers as one known technique in a range of many suitable materials for biocompatibility (Rogers: Para. [0055] ‘ A range of materials are useful for flexible or stretchable substrates…a biocompatible material or a bioinert material.’).
Regarding Claim 10, Allen in view of Benutti in view of Harant discloses the implantable rotator cuff muscle suture spacer with pressure sensing according to claim 1. Allen in view of Benutti in view of Harant does not explicitly disclose wherein the capacitor layer is a porous polydimethylsiloxane film.
However, Rogers teaches wherein the capacitor layer is a porous polydimethylsiloxane film (Rogers: Para. [0030] ‘the barrier layer comprises PDMS, polyimide, SU-8, parylene, parylene C’); Para. [0067] ‘each of the stretchable or flexible electrical interconnects comprise a metal film encapsulated in a polymer layer, for example a thin metal film (e.g., thickness equal to or less than 500 microns) encapsulated in PDMS.’.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the capacitor layer of Allen to specify being a porous polydimethylsiloxane film as taught by Rogers as one known technique in a range of many suitable materials for biocompatibility (Rogers: Para. [0055] ‘ A range of materials are useful for flexible or stretchable substrates…a biocompatible material or a bioinert material.’).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of Benutti in view of Harant in further view of US 20060271128 A1 to Keuninckx.
Regarding Claim 4, Allen in view of Benutti in view of Harant discloses the implantable rotator cuff muscle suture spacer with pressure sensing according to claim 1. Allen in view of Benutti in view of Harant do not explicitly disclose wherein the first electrode region and the second electrode region are a flexible metal film electrode.
However, Keuninckx discloses wherein the first electrode region and the second electrode region are a flexible metal film electrode (Keuninckx: Para. [0034]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the electrodes of Allen to be the flexible metal film electrodes taught by Keuninckx since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. MPEP 2144.07
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of Benutti in view of Harant in further view of US 20130098170 A1 to Lee et al. (hereinafter, Lee).
Regarding Claim 9, Allen in view of Benutti in view of Harant discloses the implantable rotator cuff muscle suture spacer with pressure sensing according to claim 1. Allen in view of Benutti in view of Harant further discloses of the implantable rotator cuff muscle suture spacer with pressure sensing (See Claim 1 above).
Allen in view of Benutti in view of Harant does not explicitly disclose wherein the pressure sensor forms mutual inductance through an external coil and the inductance coil in a manner of wireless sensing to obtain the pressure sensing value of the device with pressure sensing.
However, Lee teaches wherein the pressure sensor forms mutual inductance through an external coil and the inductance coil in a manner of wireless sensing to obtain the pressure sensing value (Lee: Para. [0056]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the pressure sensor of Allen to specify forming mutual inductance with an external coil as taught by Lee to allow for wireless pressure sensing of an inside of a body from outside the body in a simple manner (Lee: Para. [0018] and [0056])
Conclusion
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791