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.
Response to Amendment
This Office Action is responsive to the amendment filed 07/15/2025 (“Amendment”). Claims 1-9 and 34-42 are currently under consideration. The Office acknowledges the amendments to claim 2, as well as the cancellation of claims 11-33 and the addition of new claims 34-42. Claim 10 remains withdrawn.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
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 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 2 and 34-42 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.
Regarding claim 2, there is insufficient antecedent basis for the recitation of “the patient.”
The term “optimal” in claim 34 is a relative term which renders the claim indefinite. The term “optimal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, what makes an angle optimal? And is it the same for all types of wireless communication?
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 34 recites the broad recitation “wireless … communication,” and the claim also recites “RF communication” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 35-42 are rejected because they depend on rejected claims.
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 1, 3-5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over 2015/0208929 (“Rowland’929”) in view of US Patent Application Publication 2012/0143216 (“Voss”) and US Patent Application Publication 2017/0164845 (“Campbell”).
Regarding claim 1, Rowland’929 teaches [a]n anchoring system for a biomedical sensor (¶ 0040) comprising: a biomedical sensor having a housing with a distal end and a proximal end, wherein the housing comprises a length and a width wherein the length is greater than the width and wherein the biomedical sensor comprises a sensor central axis running along the length of the housing (Fig. 1, implant body 101 being longer than it is wide, and having ends and a sensor axis as shown); and an anchoring system comprising a distal anchor and a proximal anchor (Fig. 1, proximal anchor 102 and distal anchor 103), where the distal anchor is attached to the distal end of the biomedical sensor and the proximal anchor is attached to the proximal end of the biomedical sensor (Fig. 1, as shown - also see Fig. 2, etc.), wherein at least one of the distal anchor or the proximal anchor is formed with an elongated flexible structure so as to accomplish secure placement of the biomedical sensor upon implantation thereof by a catheter device (¶ 0041, wires used to actively secure the implant body 101 in a desired location); wherein said at least one distal and proximal anchors is configured to be placed into a retracted position for catheter delivery, and placed in an expanded position for placement within a vessel (¶ 0048, collapsed and deployed positions - also see Figs. 11 and 12, etc.); wherein said at least one anchor is configured to position said housing against a vessel wall (¶ 0041, securing the implant body 101 against the wall of a blood vessel); wherein said at least one anchor is configured to adapt to at least one anatomical feature of a vessel to prevent movement of said housing (¶ 0041, gently conforming to the walls of the vessel to secure the implant - also see ¶ 0043, accounting for patient anatomy); and … .
Rowland’929 does not appear to explicitly teach wherein one of the distal anchor or the proximal anchor has formed therein a lobe structure arranged in a manner where a first lobe is located on one side of a central lobe and a second lobe is located on another side of the central lobe, wherein the central lobe comprises a lobe central axis, wherein the lobe central axis is perpendicular the sensor central axis, the central lobe is adjacent the biomedical sensor … (although Figs. 1, 2, 21, 22, etc., do show lobes adjacent the sensor and having a central axis perpendicular to a sensor central axis).
Voss teaches using wire anchors to secure an element in the body, including using a single wire to form multiple-lobed clover shaped anchors (¶ 0284).
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 lobes of Rowland’929 clover-shaped (i.e., having two side lobes and a central lobe), as in Voss, with a lobe central axis perpendicular a sensor central axis, as already contemplated by Rowland’929, as the simple substitution of one known lobe arrangement (that of Rowland’929) for another (that of Voss) with predictable results (anchoring a device at a particular site – Voss: ¶ 0284), and for the purpose of being able to anchor the sensor at different sites.
Rowland’929-Voss does not appear to explicitly teach the central lobe is larger than the first and second lobes.
Campbell teaches an anchoring wire that has a large central lobe and two smaller lobes on each side (Fig. 6B).
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 clover-shaped lobes of the combination have different sizes (with a central lobe e.g. being larger than the other lobes), as in Campbell, since such a modification would have involved a mere change in the size/proportion of a component (a change in size or proportion is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955)), as the simple substitution of one lobe arrangement for another with predictable results (enabling anchoring at a particular site based on design choice tailored to the needs of the particular site – Campbell: ¶¶s 0057, 0059, 0063, etc. (discussing providing anchoring vs. strain relief, benefits of asymmetric loops and additional loops, etc.)), based on simple manufacturing variability (where not all lobes can be made with the exact same dimensions, the middle one may at times be larger than the others), and since the quantity and sizes of the lobes are known results-effective variables that can be changed as desired to balance the factors already discussed (Campbell: ¶¶s 0057, 0059, 0063, etc.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the central lobe larger than the others, as in Campbell: Fig. 6B, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 3 and 4, Rowland’929-Voss-Campbell teaches all the features with respect to claim 1, as outlined above. Rowland’929-Voss-Campbell further teaches wherein said at least one anchor is a wire (¶ 0041), wherein said wire is formed to conform to an inner surface of a vessel (Rowland’929: Figs. 1-3, etc., as shown).
Regarding claim 5, Rowland’929-Voss-Campbell teaches all the features with respect to claim 1, as outlined above. Rowland’929-Voss-Campbell further teaches wherein said at least one anatomical feature is a first vessel segment oriented at an angle with respect to an adjoining second vessel segment and the housing includes a sensor surface configured to be positioned along an axis that is positioned towards a patient’s chest and configured to communicate with a wireless sensor reader device (Rowland’929: Fig. 3 shows the angle between vessels, and the sensor has a surface positioned towards the chest because it is 3-dimensional; ¶ 0040, wireless sensor, read by a reader as described in ¶ 0001, which incorporates by reference US Patent 8,493,187 (“Rowland’187”), which discloses in its description related to Fig. 2 using an external reader to read data from an implanted sensor when the reader is in close proximity to the sensor).
Regarding claim 7, Rowland’929-Voss-Campbell teaches all the features with respect to claim 5, as outlined above. Rowland’929-Voss-Campbell further teaches wherein said housing is configured to be located in said first vessel segment, and said at least one anchor is configured to extend into said second vessel segment a distance sufficient to prevent translational or rotational movement of said housing in at least one direction by impeding movement of the housing about said angle formed by said vessel segments (Rowland’929: Fig. 3 and ¶ 0043).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Rowland’929-Voss-Campbell in view of US Patent Application Publication 2018/0177486 (“Gifford”).
Regarding claim 2, Rowland’929-Voss-Campbell teaches all the features with respect to claim 1, as outlined above. Rowland’929-Voss-Campbell does not appear to explicitly teach wherein the biomedical sensor is configured to be implanted in a central venous vessel and the biomedical sensor is designed to be read from the chest of the patient in which the sensor is implanted (although Rowland’929: ¶ 0001 incorporates by reference US Patent 8,493,187 (“Rowland’187”), which discloses in its description related to Fig. 2 using an external reader to read data from an implanted sensor when the reader is in close proximity to the sensor).
Gifford teaches implanting a pressure sensor to monitor pressure in the inferior vena cava (¶ 0083).
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 implant the device of the combination in the inferior vena cava (a central venous vessel), and to use the reader of Rowland’187 to read the sensor from the chest of the patient, in proximity to the sensor, for the purpose of being able to determine a patient’s heart failure status (Gifford: Abstract, ¶ 0083).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Rowland’929-Voss-Campbell in view of US Patent Application Publication 2018/0177486 (“Gifford”) and US Patent Application Publication 2020/0129087 (“Sweeney”).
Regarding claim 6, Rowland’929-Voss-Campbell teaches all the features with respect to claim 5, as outlined above. Rowland’929-Voss-Campbell does not appear to explicitly teach wherein said first vessel segment is a renal vein and said second vessel segment is an inferior vena cava.
Gifford teaches implanting a pressure sensor in the inferior vena cava next to a renal vein, to monitor pressure (¶¶s 0083 and 0084, Fig. 1, etc.).
Sweeney teaches anchoring sensors near the kidneys by using an anchor feature to anchor or hang the device from the renal vein (¶¶s 0175-0180).
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 implant the device of the combination in the inferior vena cava (a central venous vessel), and to use the reader of Rowland’187 to read the sensor from the chest of the patient, in proximity to the sensor, for the purpose of being able to determine a patient’s heart failure status (Gifford: Abstract, ¶ 0083). It would have been obvious to anchor the sensor in the renal vein as well, as in Sweeney, for the purpose of preventing the device from migrating (Sweeney: ¶ 0175), and as the selection of known anchoring means according to design choice (Sweeney: ¶¶s 0176-0180).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Rowland’929-Voss-Campbell in view of US Patent Application Publication 2009/0312650 (“Maile”).
Regarding claims 8 and 9, Rowland’929-Voss-Campbell teaches all the features with respect to claim 7, as outlined above. Rowland’929-Voss-Campbell does not appear to explicitly teach a second biomedical sensor configured to be located in a third vessel segment, wherein said biomedical sensor and said second biomedical sensor are configured to communicate wirelessly with each other or with a wireless sensor reader device positioned outside said vessel containing said biomedical sensor and said second biomedical sensor.
Maile teaches implanting a plurality of remote sensors in a patient’s vasculature for sensing physiologic parameters at multiple regions, and having the sensors communicate with each other or an external device (¶¶s 0020, 0026, 0034, etc.).
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 multiple sensors in the combination as in Maile, for the purpose of being able to monitor across multiple regions (Maile: ¶ 0020), to additionally provide therapies (Maile: ¶ 0020), and since such a modification would have involved a mere duplication of parts. A mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). It would have been obvious to allow the sensors to communicate with each other or an external device, for the purpose of achieving synergies such as using one sensor to trigger another, or using one sensor to trigger a therapy (Maile: ¶¶s 0020, 0042, etc.).
Claims 34, 36-38, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Rowland’929 in view of Voss, Campbell, and US Patent Application Publication 2016/0087331 (“Heppell”).
Regarding claim 34, Rowland’929 teaches [a]n anchoring system for a biomedical sensor (¶ 0040) comprising: a biomedical sensor comprising a housing, wherein the housing comprises a distal end, a proximal end, a length, a width and a sensor central axis running along the length of the housing wherein the length is greater than the width (Fig. 1, implant body 101 being longer than it is wide, and having ends and a sensor axis as shown); and an anchoring system comprising a distal anchor and a proximal anchor (Fig. 1, proximal anchor 102 and distal anchor 103), where the distal anchor is attached to the distal end of the biomedical sensor and the proximal anchor is attached to the proximal end of the biomedical sensor (Fig. 1, as shown - also see Fig. 2, etc.), wherein at least one of the distal anchor or the proximal anchor is formed with an elongated flexible structure configured to secure placement of the biomedical sensor (¶ 0041, wires used to actively secure the implant body 101 in a desired location); wherein said at least one distal and proximal anchors is configured to be placed into a retracted position for catheter delivery, and placed in an expanded position for placement within a vessel (¶ 0048, collapsed and deployed positions - also see Figs. 11 and 12, etc.); wherein said at least one anchor is configured to adapt to at least one anatomical feature of a vessel to prevent movement of said housing (¶ 0041, gently conforming to the walls of the vessel to secure the implant - also see ¶ 0043, accounting for patient anatomy) and … .
Rowland’929 does not appear to explicitly teach wherein one of the distal anchor or the proximal anchor has formed therein a lobe structure arranged in a manner where a first lobe is located on one side of a central lobe and extends outwardly from and is attached to the implant and a second lobe is located on another side of the central lobe and extends outwardly from and is attached to the implant, wherein the central lobe comprises a lobe central axis, wherein the lobe central axis is perpendicular the sensor central axis, the central lobe is adjacent the biomedical sensor … (although Figs. 1, 2, 21, 22, etc., do show lobes adjacent the sensor and having a central axis perpendicular to a sensor central axis).
Voss teaches using wire anchors to secure an element in the body, including using a single wire to form multiple-lobed clover shaped anchors (¶ 0284).
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 lobes of Rowland’929 clover-shaped (i.e., having two side lobes and a central lobe, the side lobes extending outwardly from and attached to the implant), as in Voss, with a lobe central axis perpendicular a sensor central axis, as already contemplated by Rowland’929, as the simple substitution of one known lobe arrangement (that of Rowland’929) for another (that of Voss) with predictable results (anchoring a device at a particular site – Voss: ¶ 0284), and for the purpose of being able to anchor the sensor at different sites.
Rowland’929-Voss does not appear to explicitly teach the central lobe is larger than the first and second lobes.
Campbell teaches an anchoring wire that has a large central lobe and two smaller lobes on each side (Fig. 6B).
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 clover-shaped lobes of the combination have different sizes (with a central lobe e.g. being larger than the other lobes), as in Campbell, since such a modification would have involved a mere change in the size/proportion of a component (a change in size or proportion is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955)), as the simple substitution of one lobe arrangement for another with predictable results (enabling anchoring at a particular site based on design choice tailored to the needs of the particular site – Campbell: ¶¶s 0057, 0059, 0063, etc. (discussing providing anchoring vs. strain relief, benefits of asymmetric loops and additional loops, etc.)), based on simple manufacturing variability (where not all lobes can be made with the exact same dimensions, the middle one may at times be larger than the others), and since the quantity and sizes of the lobes are known results-effective variables that can be changed as desired to balance the factors already discussed (Campbell: ¶¶s 0057, 0059, 0063, etc.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the central lobe larger than the others, as in Campbell: Fig. 6B, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Rowland’929-Voss-Campbell does not appear to explicitly teach wherein said at least one anchor is configured to assume an angle towards a chest of a patient that is optimal for wireless or RF communication (although it is noted that if the prior art teaches the same structure as what is claimed, then it can be considered as performing the same function).
Heppell teaches the importance of orienting an implant so that it can maintain a reliable radio link (¶ 0010). Rowland’929 teaches, in ¶ 0040, configuration as a wireless sensor, which is read by a reader as described in ¶ 0001 (incorporating by reference US Patent 8,493,187 (“Rowland’187”), which discloses in its description related to Fig. 2 using an external reader to read data from an implanted sensor when the reader is in close proximity to the sensor). Rowland’929 also teaches locating the sensor in the chest area (¶¶s 0043, 0055, etc., the pulmonary artery being close to the patient’s chest).
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 anchors such that they allowed the sensor to assume an optimal orientation towards the chest of the patient, for the purpose of creating a reliable radio link with the external reader device (Heppell: ¶ 0010), and as already contemplated by Rowland’929 (¶ 0055, selecting an optimal location and orientation for the device).
Regarding claims 36 and 37, Rowland’929-Voss-Campbell-Heppell teaches all the features with respect to claim 34, as outlined above. Rowland’929-Voss-Campbell-Heppell further teaches wherein said at least one anchor is a wire (¶ 0041), wherein said wire is formed to conform to an inner surface of a vessel (Rowland’929: Figs. 1-3, etc., as shown).
Regarding claim 38, Rowland’929-Voss-Campbell-Heppell teaches all the features with respect to claim 34, as outlined above. Rowland’929-Voss-Campbell-Heppell further teaches wherein said at least one anatomical feature is a first vessel segment oriented at an angle with respect to an adjoining second vessel segment and the housing comprises a sensor surface configured to be positioned along an axis that is positioned towards the chest of the patient and configured to communicate with a wireless sensor reader device (Rowland’929: Fig. 3 shows the angle between vessels, and the sensor has a surface positioned towards the chest because it is 3-dimensional; ¶ 0040, wireless sensor, read by a reader as described in ¶ 0001, which incorporates by reference US Patent 8,493,187 (“Rowland’187”), which discloses in its description related to Fig. 2 using an external reader to read data from an implanted sensor when the reader is in close proximity to the sensor).
Regarding claim 40, Rowland’929-Voss-Campbell-Heppell teaches all the features with respect to claim 38, as outlined above. Rowland’929-Voss-Campbell-Heppell further teaches wherein said housing is configured to be located in said first vessel segment, and said at least one anchor is configured to extend into said second vessel segment a distance sufficient to prevent translational or rotational movement of said housing in at least one direction by impeding movement of the housing about said angle formed by said vessel segments (Rowland’929: Fig. 3 and ¶ 0043).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Rowland’929-Voss-Campbell-Heppell in view of US Patent Application Publication 2018/0177486 (“Gifford”).
Regarding claim 35, Rowland’929-Voss-Campbell-Heppell teaches all the features with respect to claim 34, as outlined above. Rowland’929-Voss-Campbell-Heppell does not appear to explicitly teach wherein the biomedical sensor is configured to be implanted in a central venous vessel and the biomedical sensor is designed to be read from the chest of the patient in which the sensor is implanted (although Rowland’929: ¶ 0001 incorporates by reference US Patent 8,493,187 (“Rowland’187”), which discloses in its description related to Fig. 2 using an external reader to read data from an implanted sensor when the reader is in close proximity to the sensor).
Gifford teaches implanting a pressure sensor to monitor pressure in the inferior vena cava (¶ 0083).
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 implant the device of the combination in the inferior vena cava (a central venous vessel), and to use the reader of Rowland’187 to read the sensor from the chest of the patient, in proximity to the sensor, for the purpose of being able to determine a patient’s heart failure status (Gifford: Abstract, ¶ 0083).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Rowland’929-Voss-Campbell-Heppell in view of US Patent Application Publication 2018/0177486 (“Gifford”) and US Patent Application Publication 2020/0129087 (“Sweeney”).
Regarding claim 39, Rowland’929-Voss-Campbell-Heppell teaches all the features with respect to claim 38, as outlined above. Rowland’929-Voss-Campbell-Heppell does not appear to explicitly teach wherein said first vessel segment is a renal vein and said second vessel segment is an inferior vena cava.
Gifford teaches implanting a pressure sensor in the inferior vena cava next to a renal vein, to monitor pressure (¶¶s 0083 and 0084, Fig. 1, etc.).
Sweeney teaches anchoring sensors near the kidneys by using an anchor feature to anchor or hang the device from the renal vein (¶¶s 0175-0180).
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 implant the device of the combination in the inferior vena cava (a central venous vessel), and to use the reader of Rowland’187 to read the sensor from the chest of the patient, in proximity to the sensor, for the purpose of being able to determine a patient’s heart failure status (Gifford: Abstract, ¶ 0083). It would have been obvious to anchor the sensor in the renal vein as well, as in Sweeney, for the purpose of preventing the device from migrating (Sweeney: ¶ 0175), and as the selection of known anchoring means according to design choice (Sweeney: ¶¶s 0176-0180).
Claims 41 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Rowland’929-Voss-Campbell-Heppell in view of US Patent Application Publication 2009/0312650 (“Maile”).
Regarding claims 41 and 42, Rowland’929-Voss-Campbell-Heppell teaches all the features with respect to claim 40, as outlined above. Rowland’929-Voss-Campbell-Heppell does not appear to explicitly teach a second biomedical sensor configured to be located in a third vessel segment, wherein said biomedical sensor and said second biomedical sensor are configured to communicate wirelessly with each other or with a wireless sensor reader device positioned outside said vessel containing said biomedical sensor and said second biomedical sensor.
Maile teaches implanting a plurality of remote sensors in a patient’s vasculature for sensing physiologic parameters at multiple regions, and having the sensors communicate with each other or an external device (¶¶s 0020, 0026, 0034, etc.).
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 multiple sensors in the combination as in Maile, for the purpose of being able to monitor across multiple regions (Maile: ¶ 0020), to additionally provide therapies (Maile: ¶ 0020), and since such a modification would have involved a mere duplication of parts. A mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). It would have been obvious to allow the sensors to communicate with each other or an external device, for the purpose of achieving synergies such as using one sensor to trigger another, or using one sensor to trigger a therapy (Maile: ¶¶s 0020, 0042, etc.).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 and 34-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 18 of U.S. Patent No. 10,993,669 (reference patent) in view of Rowland’929, Voss, Campbell, Heppell, Gifford, Sweeney, and/or Maile. The features not taught by the reference patent are made up for by Rowland’929, Voss, Campbell, Heppell, Gifford, Sweeney, and/or Maile as outlined above.
Claims 1-9 and 34-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 7 of copending Application No. 17/306,235 (reference application) in view of Rowland’929, Voss, Campbell, Heppell, Gifford, Sweeney, and/or Maile. The features not taught by the reference application are made up for by Rowland’929, Voss, Campbell, Heppell, Gifford, Sweeney, and/or Maile as outlined above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments filed 07/15/2025 have been fully considered, but they are not persuasive. Regarding In re Rose, it is noted with respect to Applicant’s citations that board decisions are not precedential. Further, the modification is simply the resizing of a prior art article. One lob is resized, while the others are unaffected. And, it is unclear why Applicant thinks the anchor structure of claim 1 is different than the anchor structure of Campbell.
The design choice proffered by the Office is based on Campbell’s teaching regarding the benefits of e.g. asymmetric loops and additional loops to tailor the anchor to a particular site. In that regard, Campbell does not only teach using anchors to reduce transferred loads. It may be beneficial for Applicant to claim the anchor structure in more detail, rather than relying largely on functional limitations.
Applicant has not addressed the Office’s routine optimization rationale. All claims remain rejected in light of the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 7 am - 3 pm.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791