CTNF 18/828,165 CTNF 99319 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 07-06 AIA 15-10-15 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. Claim Objections 07-29-01 AIA Claim 19 is objected to because of the following informalities: "an middle layer" in line 6 should read as "a middle layer" . Appropriate correction is required. Drawings The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the stent configured for implantation within a blood vessel, an implantable sensor operatively coupled to the collapsible coil antenna, and a collapsible coil antenna carried by the stent and deformable with the stent must be shown or the features canceled from the claim(s). No new matter should be entered. 06-22 Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-103 AIA The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. 07-23-aia AIA 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. 07-21-aia AIA Claim s 2-15 and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over US 20200289257 A1 (hereafter --Marquez--), in view of US 20090248105 A1 (hereafter --Keilman--) . Regarding Claim 19, Marquez discloses a wirelessly powered implantable sensor, comprising: a sensor (320, see paragraph [0100]), and a collapsible coil antenna (see paragraph [0015]), wherein the collapsible coil antenna is adapted to wirelessly harvest power and provide the harvested power to the sensor (see paragraph [0008], [0015], and [0101] denoting that the transmitter assembly can comprise an antenna coil that is collapsible for catheter delivery, and that the transmitter assembly can be configured to wirelessly receive power from a power transmitter external to the patient, and therefore would be able to provide said power to the sensor). Marquez fails to disclose a drawn filled tube having three layers where the three layers are: an inner most layer being a conductive layer a middle layer; being a jacket layer; and an outer layer being an insulation layer. Keilman discloses an implantable vascular anchoring system (see Abstract) with a collapsible coil antenna (see paragraph [0054]). Keilman teaches the collapsible coil antenna comprising a drawn filled tube having three layers (see Figure 10-10A, 206+208, when within Figure 1, see also paragraph [0054]), where the three layers are: an inner most layer being a conductive layer (see Figure 1, 104, see also paragraph [0032]); a middle layer being a jacket layer (see Figure 1, 106, see also paragraph [0032]); and an outer layer being an insulation layer (see Figure 1, 108, see also paragraph [0032]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the collapsible coil antenna to have three layers, where the three layers are: an inner most layer being a conductive layer an middle layer; being a jacket layer; and an outer layer being an insulation layer, as by doing so would enable the antenna to have a majority of electrical current to flow through a low resistivity conductive core (see paragraph [0050]), whilst having the middle layer serve both a support role and an antenna role for the enhanced implantable antenna system (see paragraph [0032]), and while also being further encased by an external electrical insulator (see paragraph [0032]). Regarding Claim 2, Marquez as modified discloses wirelessly powered implantable sensor of claim 19. Marquez as modified fails to disclose wherein the conductive layer is made of a material selected from the group consisting of: copper, gold, and silver. Keilman teaches wherein the conductive layer is made of a material selected from the group consisting of: copper, gold, and silver (see paragraphs [0049] and [0050]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the collapsible coil antenna to have the conductive layer is made of a material selected from the group consisting of: copper, gold, and silver, as silver exhibit excellent electrical conductivity (see paragraph [0049]), silver or copper can enable most of the electrical current will flow through the conductive core rather than the tubular support structure (see paragraph [0049]), and gold offers higher radiopacity than silver or copper, while retaining relatively low resistivity (see paragraph [0050]). Regarding Claim 3, Marquez as modified discloses wirelessly powered implantable sensor of claim 19. Marquez as modified fails to disclose wherein the jacket layer is made of a material selected from the group consisting of: stainless steel, nitinol, and cobalt chrome. Keilman teaches wherein the jacket layer is made of a material selected from the group consisting of: stainless steel, nitinol, and cobalt chrome (see paragraph [0049]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the collapsible coil antenna to have the jacket layer is made of a material selected from the group consisting of: stainless steel, nitinol, and cobalt chrome, Nitinol is known to have an additional advantage in that they have shape memory properties, and can be "shape-set" to a desired geometry (see paragraph [0034]), nitinol enables the layer to serve both a support role and an antenna role for the enhanced implantable antenna system (see paragraph [0032]), and as well as provides greater implantation adaptability and accommodation for the enhanced implantable antenna (see paragraph [0031]). Regarding Claim 4, Marquez as modified discloses wirelessly powered implantable sensor of claim 19. Marquez as modified fails to disclose wherein the insulation layer is made of a material selected from the group consisting of: polyurethane and parylene C. Keilman teaches wherein the insulation layer is made of a material selected from the group consisting of: polyurethane and parylene C (see paragraph [0035]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the collapsible coil antenna to have the insulation layer is made of parylene C, as parylene is known to provide electrical insulation as taught by Keilman (see paragraph [0035]). Regarding Claim 5, Marquez as modified discloses wirelessly powered implantable sensor of claim 19, wherein the collapsible coil antenna is capable of expanding from a collapsed state (see paragraph [0015] denoting that the coil can be collapsed, which means it can return back to its original expanded state, as well as paragraphs [0095] and [0207]) denoting the whole system is expanded at the delivery site). Regarding Claim 7, Marquez as modified discloses the wirelessly powered implantable sensor of claim 19, wherein the collapsible coil antenna is capable of being used to wirelessly communicate sensor (see paragraphs [0024], [0101], and [0107]). Regarding Claim 8, Marquez as modified discloses the wirelessly powered implantable sensor of claim 19, wherein the collapsible coil antenna is part of an assembly further comprising a stent (see paragraphs [0103] denoting the valve structure 307 can include one or more leaflets, frames, bands, rings, and/or the like, such as may be consistent with a prosthetic aortic valve device as described herein and [0120] denoting there is a stent portion of a valve implant, as well as paragraph [0136] denoting the valve component has a stent member). Regarding Claim 9, Marquez as modified discloses the wirelessly powered implantable sensor of claim 19, wherein the collapsible coil antenna is part of an assembly further comprising an artificial heart valve (see paragraph [0100]-[0102]). Regarding Claim 10, Marquez as modified discloses the wirelessly powered implantable sensor of claim 19, wherein the collapsible coil antenna is configured to collapse during an implantation procedure during delivery to a target implantation site, and expanded at the target implantation site (see paragraph [0015], [0095], and [0207]). Regarding Claim 11, Marquez as modified discloses the wirelessly powered implantable sensor of claim 19, wherein the drawn filled tube is formed into a crown shape (see paragraphs [0008], [0023], and [0103] denoting that the coil can be wrapped around or integrated with the frame or sealing ring of the valve, the circular shape resembling a crown). Regarding Claim 12, Marquez as modified discloses the wirelessly powered implantable sensor of claim 19, wherein the collapsible coil antenna is connected to at least one implantable medical device (see paragraphs [0082] and [0172]). Regarding Claim 13, Marquez as modified discloses the wirelessly powered implantable sensor of claim 12, wherein the at least one implantable medical device is a pacemaker (see paragraphs [0082] and [0172]). Regarding Claim 14, Marquez as modified discloses the wirelessly powered implantable sensor of claim 12, wherein the at least one implantable medical device is a sensor (see paragraph [0024], [0082], [0083], and [0115]). Regarding Claim 15, Marquez as modified discloses the wirelessly powered implantable sensor of claim 19. Marquez as modified fails to disclose wherein the drawn filled tube has a diameter of 0. 1mm to 35mm. Marquez discloses wherein the drawn filled tube have a diameter of 15mm to 35mm (see paragraph [0147]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have wherein the drawn filled tube has a diameter of 15mm to 35mm. Doing so would can advantageously provide a relatively long path for the coil with a relatively large antenna aperture (i.e., diameter), thereby providing a relatively greater transmission range of the antenna; antenna read/transmit range can have a substantially linear relationship with antenna aperture in certain embodiments. Greater antenna range may be beneficial in embodiments disclosed herein in view of the space that will necessarily be present between the valve and the exterior of the patient's body, as well as the general convenience provided through relatively less strict distance/range requirements (see paragraph [0147]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the drawn filled tube have a diameter of 15mm to 35mm to between 0.1mm to 35mm as claimed, since in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim , 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff , 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see paragraph [0032]). Regarding Claim 20, Marquez as modified discloses the wirelessly powered implantable sensor pacemaker of claim 19, wherein the sensor provides recorded data to an external device via the collapsible coil antenna (see paragraphs [0024] and [0107]). Regarding Claim 21, Marquez discloses a wirelessly powered implantable sensor, comprising: stent configured for implantation within a blood vessel (see paragraphs [0103] denoting the valve structure 307 can include one or more leaflets, frames, bands, rings, and/or the like, such as may be consistent with a prosthetic aortic valve device as described herein and [0120] denoting there is a stent portion of a valve implant, as well as paragraphs [0014], [0103], and [0136] denoting the valve component has a stent member); a collapsible coil antenna carried by the stent and deformable with the stent (see paragraphs [0008] and [0025]) between a radially collapsed delivery configuration and a radially expanded deployed configuration (see paragraph [0015]), the collapsible coil antenna comprising a drawn filled tube (see paragraphs [0013] and [0121]) formed into a crown-shaped coil structure (see paragraphs [0008], [0023], and [0103] denoting that the coil can be wrapped around or integrated with the frame or sealing ring of the valve, the circular shape resembling a crown), and an implantable sensor operatively coupled to the collapsible coil antenna, the collapsible coil antenna being adapted to transmit sensor data from the implantable sensor to an external device (see paragraphs [0024], [0101], and [0107]). Marquez fails to disclose an inner conductive core of a first metal; a tube of a second metal covering the inner conductive core a middle layer being a jacket layer; and an outer insulation layer. Keilman discloses an implantable vascular anchoring system (see Abstract) with a collapsible coil antenna (see paragraph [0054]). Keilman teaches the collapsible coil antenna comprising an inner conductive core of a first metal (see Figure 1, 104, see also paragraph [0032]); a tube of a second metal covering the inner conductive core a middle layer being a jacket layer (see Figure 1, 106, see also paragraph [0032]); and an outer insulation layer (see Figure 1, 108, see also paragraph [0032]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the collapsible coil antenna to have three layers, an inner conductive core of a first metal; a tube of a second metal covering the inner conductive core an middle layer being a jacket layer; and an outer insulation layer, as by doing so would enable the antenna to have a majority of electrical current would flow through a low resistivity conductive core (see paragraph [0050]), whilst having the middle layer serve both a support role and an antenna role for the enhanced implantable antenna system (see paragraph [0032]), and while also being further encased by an external electrical insulator (see paragraph [0032]). Regarding Claim 6, Marquez as modified discloses the wirelessly powered implantable sensor of claim 21, wherein the collapsible coil antenna is capable of being used to wirelessly harvest power (see paragraphs [0015] denoting can comprise an antenna coil, and that it can wirelessly receive power from a power transmitter external to the patient [0085], [0101], [0106], and [0107]). Regarding Claim 22, Marquez as modified discloses the wirelessly powered implantable sensor of claim 21, wherein: the tube of the second metal comprises a superelastic shape memory alloy (see paragraphs [0030], [0032],[0034], and [0049]). The limitation “ the drawn filled tube forming the crown-shaped coil structure is configured to undergo repeated radial compression and expansion with the stent while maintaining electrical continuity of the inner conductive core” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the reference disclosing that the coil antenna is capable of being compressed for delivery (see paragraph [0015]) while still providing its purpose once expanded at the delivery site, the coil antenna is capable of undergoing repeated radial compression and expansion with the stent while maintaining electrical continuity of the inner conductive core. Regarding Claim 23, Marquez discloses wirelessly powered implantable sensor, comprising: a collapsible coil antenna adapted for implantation within a body lumen and to transition between a collapsed delivery configuration and an expanded deployed configuration (see paragraph [0015]), the collapsible coil antenna comprising a drawn filled tube (see paragraphs [0013] and [0121]), and an implantable sensor electrically coupled to the collapsible coil antenna (see paragraphs [0024], [0101], and [0107]), wherein the collapsible coil antenna conveys sensor-generated data from the implantable sensor to the external source (see paragraphs [0024], [0101], and [0107]), and wherein drawn filled tube is an expandable loop structure (see paragraphs [0008], [0023], and [0103] denoting that the coil can be wrapped around or integrated with the frame or sealing ring of the valve, the circular shape resembling a loop structure, see also paragraph [0015] denoting that the coil is collapsible, and therefore would be capable of being expanded to its previous position). The limitation “wherein the collapsible coil antenna defines an inductive interface that receives wireless power from an external source to power the implantable sensor” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the fact that the implant can comprise an antenna coil (see paragraph [0015]), and that it can wirelessly receive power from a power transmitter external to the patient [0085], [0101], [0106], and [0107], therefore capable of transmitting power to the sensor), the implant is capable of defining an inductive interface that receives wireless power from an external source to power the implantable sensor. Marquez fails to disclose arranged as an expandable loop structure having an undulating annular shape, as well as a conductive core extending along a length of the drawn filled tube; a metallic jacket coaxially surrounding the conductive core; and an electrically insulating outer layer. Keilman discloses an implantable vascular anchoring system (see Abstract) with a collapsible coil antenna (see paragraph [0054]). Keilman teaches a conductive core extending along a length of the drawn filled tube (see Figure 1, 104, see also paragraph [0032]); a metallic jacket coaxially surrounding the conductive core (see Figure 1, 106, see also paragraph [0032]); and an electrically insulating outer layer (see Figure 1, 108, see also paragraph [0032]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the collapsible coil antenna to have a conductive core extending along a length of the drawn filled tube; a metallic jacket coaxially surrounding the conductive core; and an electrically insulating outer layer, as by doing so would enable the antenna to have a majority of electrical current would flow through a low resistivity conductive core (see paragraph [0050]), whilst having the middle layer serve both a support role and an antenna role for the enhanced implantable antenna system (see paragraph [0032]), and while also being further encased by an external electrical insulator (see paragraph [0032]). Marquez further fails to disclose the coil antenna having an undulating annular shape. Keilman teaches the coil antenna having an undulating annular shape (see paragraph [0060], see also Figure 10). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the drawn filled tube of the coil antenna to have an undulating annular shape, since such a modification would have involved a mere change in the shape of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) . 07-21-aia AIA Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over US 20200289257 A1 (hereafter --Marquez--), in view of US 20090248105 A1 (hereafter --Keilman--), as applied to claim 19 above, in even further view of US 20170228627 A1 (hereafter --Geissler--) . Regarding Claim 16, Marquez as modified discloses the wirelessly powered implantable sensor collapsible coil antenna of claim 19. Marquez as modified fails to disclose wherein the drawn filled tube has a diameter of 7mm and a height of 5mm. Marquez discloses wherein the drawn filled tube have a diameter of 14mm or less (see paragraph [0147]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have wherein the drawn filled tube has a diameter of 14mm or less. Doing so would can advantageously provide a relatively long path for the coil with a relatively large antenna aperture (i.e., diameter), thereby providing a relatively greater transmission range of the antenna; antenna read/transmit range can have a substantially linear relationship with antenna aperture in certain embodiments. Greater antenna range may be beneficial in embodiments disclosed herein in view of the space that will necessarily be present between the valve and the exterior of the patient's body, as well as the general convenience provided through relatively less strict distance/range requirements (see paragraph [0147]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the drawn filled tube have a diameter of 14mm or less to 7mm as claimed, since in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim , 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff , 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see paragraph [0032]). Marquez as modified further fails to disclose wherein the drawn filled tube has a height of 5mm. Geissler discloses an implantable medical device that comprises of a coil antenna (see Abstract and paragraph [0053]). Geissler teaches the coil antenna having a height from about 0.5 mm to about 5 mm (see paragraph [0053]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have wherein the drawn filled tube have a height between 0.5mm and 5mm. Doing so would be obvious since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the drawn filled tube have a height of 0.5 to 5mm to 5 mm as claimed, since in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see paragraph [0032]) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US-7425200-B2: This reference discloses an implant that contains a sensor and a coil antenna. US-20070156205-A1: This reference discloses an implant that contains a sensor and a coil antenna. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET. 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, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /PARIS MARIE BLASS/Examiner, Art Unit 3774 /SARAH W ALEMAN/Primary Examiner, Art Unit 3774 Application/Control Number: 18/828,165 Page 2 Art Unit: 3774 Application/Control Number: 18/828,165 Page 3 Art Unit: 3774 Application/Control Number: 18/828,165 Page 4 Art Unit: 3774 Application/Control Number: 18/828,165 Page 5 Art Unit: 3774 Application/Control Number: 18/828,165 Page 6 Art Unit: 3774 Application/Control Number: 18/828,165 Page 7 Art Unit: 3774 Application/Control Number: 18/828,165 Page 8 Art Unit: 3774 Application/Control Number: 18/828,165 Page 9 Art Unit: 3774 Application/Control Number: 18/828,165 Page 10 Art Unit: 3774 Application/Control Number: 18/828,165 Page 11 Art Unit: 3774 Application/Control Number: 18/828,165 Page 12 Art Unit: 3774 Application/Control Number: 18/828,165 Page 13 Art Unit: 3774 Application/Control Number: 18/828,165 Page 14 Art Unit: 3774 Application/Control Number: 18/828,165 Page 15 Art Unit: 3774
Prosecution Insights