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 . 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 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.
Election/Restrictions
Applicant’s election without traverse of Invention II (claims 14-20) in the reply filed on 01/07/2026 is acknowledged. Applicant’s election with traverse of Species II and Species III is also acknowledged. The traversal is on the grounds that there would not be a serious search burden. The Office disagrees, as the anchor structures of Species I and II are entirely different, having different locations and different structures. The anchor features 704 and 804 are completely different. Further, the method associated with Species III and IV (Figs. 10 and 11) is entirely different, as the catheter/implant has to travel along different paths to reach the implantation location. These differences require the use of different search queries that would not likely produce art for the other species.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-13 (now cancelled) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Accordingly, claims 14-33 (with claims 21-33 newly added) are currently under consideration.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 27 is objected to because of the following informalities: the recitation of “wherein sensor implant comprises” should instead read –wherein the sensor implant device comprises--.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “sensor implant device” in claims 14, 16-18, 21, 22, 24, 29-31, and 33, and “anchoring features” in claims 14, 17-21, 23-26, 29, 30, 32, and 33.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof (e.g. for “sensor implant device,” as shown in Fig. 8B; for “anchoring features,” as shown in Fig. 8B).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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.
Claims 14, 19, 20, and 29 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US Patent Application Publication 2014/0213916 (“Doan”).
Regarding claim 14, Doan discloses [a] method comprising: percutaneously delivering a sensor implant device within a catheter to a tissue wall (Figs. 22A-22D and/or 23A-23G, delivering sensor device 100 within a sheath 2204 to wall 110), the sensor implant device comprising one or more anchoring features held in a compressed form by the catheter (Figs. 22A and 23A, anchoring element 104); piercing the tissue wall to embed the sensor implant device at least partially within the tissue wall (¶ 0105, a passage formed in a septal wall of the heart by a needle – also see ¶ 0137, etc.); and removing the sensor implant device from the catheter, wherein the one or more anchoring features are configured to assume an expanded form following removal from the catheter (Figs. 22B-22D and 23B-23G).
Regarding claim 19, Doan discloses all the features with respect to claim 14, as outlined above. Doan further discloses wherein the one or more anchoring features move freely between the compressed form and the expanded form (¶ 0139, rebounding to the unfolded configuration, ¶ 0146, etc.).
Regarding claim 20, Doan discloses all the features with respect to claim 14, as outlined above. Doan further discloses wherein the one or more anchoring features are biased in the expanded form (¶ 0139, elastically rebounding, ¶ 0146, etc. – also see ¶ 0087).
Regarding claim 29, Doan discloses [a] method of anchoring a sensor implant device within a tissue wall, the method comprising: percutaneously delivering a sensor implant device to a tissue wall (Figs. 22A-22D and/or 23A-23G, delivering sensor device 100 within a sheath 2204 to wall 110), the sensor implant device comprising a sensor component (e.g. Fig. 22A, sensor 102) and one or more anchoring features that flexibly move between a compressed form and an expanded form (Figs. 22A-22D and/or 23A-23G, anchoring element 104)); and piercing the tissue wall to embed the sensor implant device at least partially within the tissue wall (¶ 0105, a passage formed in a septal wall of the heart by a needle – also see ¶ 0137, etc.), wherein the one or more anchoring features are biased to assume the expanded form within the tissue wall to anchor the sensor implant device to the tissue wall (Figs. 22B-22D and 23B-23G).
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.
Claims 15, 16, 32, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2014/0213916 (“Doan”) in view of US Patent Application Publication 2002/0077555 (“Schwartz”).
Regarding claim 15, Doan teaches all the features with respect to claim 14, as outlined above. Doan does not appear to explicitly teach wherein the catheter comprises a pointed tip, and piercing the tissue wall is performed using the pointed tip of the catheter.
Schwartz teaches using a needle catheter with a pointed tip to create an opening in a heart wall, and then introducing a sensor through the opening (¶ 0111).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the catheter of Doan have a pointed piercing tip, as in Schwartz, for the purpose of simplifying the components of the delivery/retrieval system by e.g. eliminating the need for dilator 2116 and needle 2120 (Doan: ¶ 0131, Figs. 21A-21C), and as the simple substitution of one sensor delivery method for another with predictable results (Schwartz: ¶ 0111, anchoring of the sensor device at the target location).
Regarding claim 16, Doan teaches all the features with respect to claim 14, as outlined above. Doan does not appear to explicitly teach wherein the sensor implant device comprises a pointed tip, and wherein piercing the tissue wall is performed using the pointed tip of the sensor implant device.
Schwartz teaches a sensor implant device comprising a pointed tip configured to pierce a tissue wall (Fig. 4, ¶ 0074, piercing tip 55).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the sensor implant device of Doan with a pointed tip, as in Schwartz, for the purpose of simplifying the components of the delivery/retrieval system by e.g. eliminating the need for dilator 2116 and needle 2120 (Doan: ¶ 0131, Figs. 21A-21C), for the purpose of firmly anchoring the sensor (Schwartz: ¶ 0074), and as the simple substitution of one sensor delivery method for another with predictable results (Schwartz: Fig. 4, ¶¶s 0073, 0074, etc.).
Regarding claim 32, Doan teaches all the features with respect to claim 29, as outlined above. Doan does not appear to explicitly teach wherein the one or more anchoring features are spring-loaded.
Schwartz teaches using spring-loading to bias anchors towards a deployed configuration (Fig. 13B, ¶ 0123 – also see ¶ 0121 and Fig. 12A, showing the deployed position).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to spring-load the anchors of Doan as in Schwartz, for the purpose of facilitating movement towards the deployed position (Schwartz: ¶ 0123), for allowing greater anchor material choices (Schwartz: ¶ 0126), and as the simple substitution of one type of biasing arrangement for another with predictable results (Schwartz: ¶¶s 0029, 0126, etc.).
Regarding claim 33, Doan teaches all the features with respect to claim 29, as outlined above. Doan does not appear to explicitly teach wherein the sensor implant device comprises a conical end portion, and wherein the one or more anchoring features are coupled to the conical end portion of the sensor implant device.
Schwartz teaches a sensor implant device comprising a conical end portion having anchoring features coupled thereto (Fig. 4, ¶ 0074, tissue barbs 59).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the sensor implant device of Doan with a conical end portion having anchoring features, as in Schwartz, for the purpose of firmly anchoring the sensor (Schwartz: ¶ 0074), and as the simple substitution of one sensor implantation method for another with predictable results (Schwartz: Fig. 4, ¶¶s 0073, 0074, etc.).
Claims 17, 18, 30, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2014/0213916 (“Doan”) in view of US Patent Application Publication 2002/0077555 (“Schwartz”) and US Patent Application Publication 2007/0021665 (“Hettrick”).
Regarding claim 17, Doan teaches all the features with respect to claim 14, as outlined above. Doan does not appear to explicitly teach wherein the one or more anchoring features are positioned to lay against a surface of the sensor implant device in the compressed form.
Schwartz teaches a sensor implant device that uses a barbed anchoring feature (Fig. 4, ¶ 0074).
Hettrick teaches a barbed anchoring feature that is positioned to lay against a surface of its carrier in the compressed form (Fig. 6B, ¶ 0029).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the sensor implant device of Doan with a barbed anchoring feature, as in Schwartz, for the purpose of simplifying the components of the delivery/retrieval system by e.g. eliminating the need for dilator 2116 and needle 2120 (Doan: ¶ 0131, Figs. 21A-21C), for the purpose of firmly anchoring the sensor (Schwartz: ¶ 0074), and as the simple substitution of one sensor delivery method for another with predictable results (Schwartz: Fig. 4, ¶¶s 0073, 0074, etc.). It would have been obvious to make the anchoring feature of the combination lay against the sensor implant device in the compressed form, as in Hettrick, for the purpose of making forward movement easier, as well as enabling selective retraction (Hettrick: ¶ 0029).
Regarding claim 18, Doan teaches all the features with respect to claim 14, as outlined above. Doan does not appear to explicitly teach wherein the sensor implant device comprises one or more receptors, and wherein the one or more anchoring features are sized to fit within the one or more receptors in the compressed form.
Schwartz teaches a sensor implant device that uses a barbed anchoring feature (Fig. 4, ¶ 0074).
Hettrick teaches a barbed anchoring feature that is positioned to lay against a surface of its carrier (in e.g. a receptor) in the compressed form (Fig. 6B, ¶ 0029, tine 220b could be fully retracted within prong 200’).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the sensor implant device of Doan with a barbed anchoring feature, as in Schwartz, for the purpose of simplifying the components of the delivery/retrieval system by e.g. eliminating the need for dilator 2116 and needle 2120 (Doan: ¶ 0131, Figs. 21A-21C), for the purpose of firmly anchoring the sensor (Schwartz: ¶ 0074), and as the simple substitution of one sensor delivery method for another with predictable results (Schwartz: Fig. 4, ¶¶s 0073, 0074, etc.). It would have been obvious to make the anchoring feature of the combination lay against the sensor implant device (in e.g. a receptor) in the compressed form, as in Hettrick, for the purpose of making forward movement easier, as well as enabling selective retraction (Hettrick: ¶ 0029).
Regarding claim 30, Doan teaches all the features with respect to claim 29, as outlined above. Doan does not appear to explicitly teach wherein the sensor implant device comprises one or more receptors, and wherein the one or more anchoring features are sized to fit within the one or more receptors in the unexpanded form.
Schwartz teaches a sensor implant device that uses a barbed anchoring feature (Fig. 4, ¶ 0074).
Hettrick teaches a barbed anchoring feature that is positioned to lay against a surface of its carrier (in e.g. a receptor) in the compressed form (Fig. 6B, ¶ 0029, tine 220b could be fully retracted within prong 200’).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the sensor implant device of Doan with a barbed anchoring feature, as in Schwartz, for the purpose of simplifying the components of the delivery/retrieval system by e.g. eliminating the need for dilator 2116 and needle 2120 (Doan: ¶ 0131, Figs. 21A-21C), for the purpose of firmly anchoring the sensor (Schwartz: ¶ 0074), and as the simple substitution of one sensor delivery method for another with predictable results (Schwartz: Fig. 4, ¶¶s 0073, 0074, etc.). It would have been obvious to make the anchoring feature of the combination lay against the sensor implant device (in e.g. a receptor) in the compressed form, as in Hettrick, for the purpose of making forward movement easier, as well as enabling selective retraction (Hettrick: ¶ 0029).
Regarding claim 31, Doan-Schwartz-Hettrick teaches all the features with respect to claim 30, as outlined above. Doan-Schwartz-Hettrick further teaches wherein the one or more receptors are situated at an end portion of the sensor implant device (Hettrick: Fig. 6B – also see Schwartz: Fig. 4, an end portion).
Claims 21 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2014/0213916 (“Doan”) in view of US Patent Application Publication 2021/0220609 (“Arndt”).
Regarding claim 21, Doan teaches [a] method of implanting a sensor implant device within a tissue wall (¶ 0105, a passage formed in a septal wall of the heart by a needle – also see ¶ 0137, etc.) …, the method comprising: percutaneously delivering a sensor implant device within a catheter to a tissue wall (Figs. 22A-22D and/or 23A-23G, delivering sensor device 100 within a sheath 2204 to wall 110) …, the sensor implant device comprising one or more anchoring features that flexibly move between a compressed form and an expanded form (Figs. 22A-22D and/or 23A-23G, anchoring element 104); piercing the tissue wall to embed the sensor implant device at least partially within the tissue wall (¶ 0105, a passage formed in a septal wall of the heart by a needle – also see ¶ 0137, etc.); and removing the sensor implant device from the catheter, wherein the one or more anchoring features are biased to assume the expanded form following removal from the catheter to anchor the sensor implant device within the tissue wall (Figs. 22B-22D and 23B-23G, ¶ 0139, etc.).
Doan does not appear to explicitly teach the implantation being within a tissue wall separating a left atrium and a coronary sinus.
Arndt teaches implanting a pressure sensor probe in the tissue wall separating the left atrium and the coronary sinus (¶ 0008).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to locate the sensor of Doan in the tissue wall separating the left atrium and coronary sinus, as in Arndt, for the purpose of measuring pressure in the left atrium directly while avoiding a transseptal puncture, thereby lowering risk (Arndt: ¶ 0008).
Regarding claim 25, Doan-Arndt teaches all the features with respect to claim 21, as outlined above. Doan-Arndt further teaches wherein the one or more anchoring features move freely between the compressed form and the expanded form (Doan: ¶ 0139, rebounding to the unfolded configuration, ¶ 0146, etc.).
Regarding claim 26, Doan-Arndt teaches all the features with respect to claim 21, as outlined above. Doan-Arndt further teaches wherein the one or more anchoring features are biased in the expanded form (Doan: ¶ 0139, elastically rebounding, ¶ 0146, etc. – also see ¶ 0087).
Regarding claim 27, Doan-Arndt teaches all the features with respect to claim 21, as outlined above. Doan-Arndt further teaches wherein sensor implant comprises an implant body and a sensor component (Doan: Figs. 22A and 23A, sensor device 100 including a housing and sensor 102 – also see Fig. 2 and ¶ 0064).
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Doan-Arndt in view of US Patent Application Publication 2002/0077555 (“Schwartz”).
Regarding claim 22, Doan-Arndt teaches all the features with respect to claim 21, as outlined above. Doan-Arndt does not appear to explicitly teach wherein the sensor implant device comprises a conical end portion and a pointed tip, and wherein piercing the tissue wall is performed using the pointed tip of the sensor implant device.
Schwartz teaches a sensor implant device comprising a conical end portion and a pointed tip configured to pierce a tissue wall (Fig. 4, ¶ 0074, piercing tip 55).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the sensor implant device of the combination with a conical end portion and pointed tip, as in Schwartz, for the purpose of simplifying the components of the delivery/retrieval system by e.g. eliminating the need for dilator 2116 and needle 2120 (Doan: ¶ 0131, Figs. 21A-21C), for the purpose of firmly anchoring the sensor (Schwartz: ¶ 0074), and as the simple substitution of one sensor delivery method for another with predictable results (Schwartz: Fig. 4, ¶¶s 0073, 0074, etc.).
Regarding claim 23, Doan-Arndt-Schwartz teaches all the features with respect to claim 22, as outlined above. Doan-Arndt-Schwartz further teaches wherein the one or more anchoring features are disposed along the conical end portion (Schwartz: Fig. 4, tissue barbs 59).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Doan-Arndt in view of US Patent Application Publication 2002/0077555 (“Schwartz”) and US Patent Application Publication 2007/0021665 (“Hettrick”).
Regarding claim 24, Doan-Arndt teaches all the features with respect to claim 21, as outlined above. Doan-Arndt does not appear to explicitly teach wherein the sensor implant device comprises one or more receptors, and wherein the one or more anchoring features are sized to fit within the one or more receptors in the compressed form.
Schwartz teaches a sensor implant device that uses a barbed anchoring feature (Fig. 4, ¶ 0074).
Hettrick teaches a barbed anchoring feature that is positioned to lay against a surface of its carrier (in e.g. a receptor) in the compressed form (Fig. 6B, ¶ 0029, tine 220b could be fully retracted within prong 200’).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the sensor implant device of the combination with a barbed anchoring feature, as in Schwartz, for the purpose of simplifying the components of the delivery/retrieval system by e.g. eliminating the need for dilator 2116 and needle 2120 (Doan: ¶ 0131, Figs. 21A-21C), for the purpose of firmly anchoring the sensor (Schwartz: ¶ 0074), and as the simple substitution of one sensor delivery method for another with predictable results (Schwartz: Fig. 4, ¶¶s 0073, 0074, etc.). It would have been obvious to make the anchoring feature of the combination lay against the sensor implant device (in e.g. a receptor) in the compressed form, as in Hettrick, for the purpose of making forward movement easier, as well as enabling selective retraction (Hettrick: ¶ 0029).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Doan-Arndt in view of US Patent Application Publication 2004/0116992 (“Wardle”).
Regarding claim 28, Doan-Arndt teaches all the features with respect to claim 27, as outlined above. Doan-Arndt does not appear to explicitly teach wherein the sensor component is disposed at an end portion of the implant body and has a greater width relative to the implant body.
Wardle teaches a sensor implant device comprising a sensor component disposed at an end portion of an implant body and having a greater width relative to the implant body (Fig. 8, sensor 120 (including pressure sensing face 162) having a greater width than lead-attachment interface 164 and e.g. lead 226 as shown in Fig. 20).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a sensor component having a greater width relative to the implant body in the combination as in Wardle, for the purpose of achieving lead-based implantation as well (Wardle: ¶¶s 0068, 0080, 0097 (enabling pacing), etc. – also see Arndt: ¶¶s 0004, 0021, 0027, etc.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791