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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The Applicant’s submission filed on 4/21/2026 has been entered.
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.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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, 9-18, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 10,471,251 (Manicka)(previously cited), in view of U.S. Patent Application Publication No. 2005/0288563 (Feliss)(previously cited), and further in view of U.S. Patent Application Publication No. 2010/0019985 (Bashyam)(previously cited), and further in view of U.S. Patent Application Publication No. 2011/0193751 (Golko)(previously cited), and further in view of U.S. Patent Application Publication No. 2009/0234248 (Zand).
Manicka teaches a subcutaneously implantable device comprising: a housing (the housing 102, 402, 502, 602, 702, 802, 902, 1002, 1102, 1202, 1302, 1402, 1502 of Manicka); a clip (the clip 104, 404, 504, 604, 704, 804, 904, 1004, 1104, 1204, 1304, 1404, 1504 of Manicka) attached to the housing that is configured to anchor the device to a muscle, a bone, and/or a first tissue; circuitry (the power sources, the controller, the memory, the transceiver, the sensors, the sensing circuitry, the therapeutic circuitry, and the electrodes of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka) in the housing that is configured to provide monitoring, therapeutic, and/or diagnostic capabilities with respect to an organ, a nerve, the first tissue, and/or a second tissue, wherein the circuitry includes: a first power source (one of the power sources of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25- 50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka); and a transceiver (the transceiver 192 of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka); and a second antenna (the antenna connected to the transceiver 192 of Manicka; col. 14, line 55 to col. 15, line 12).
Manicka teaches that one of the power sources is a rechargeable battery (col. 15, lines 10-20 of Manicka). Feliss teaches that rechargeable batteries 33 are recharged using a receiving coil 92 (FIG. 2 and paragraphs 0045 and 0090 of Feliss). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a receiver coil for recharging the battery of Manicka since it permits recharging of the battery of Manicka in a non-invasive fashion.
Manicka teaches an antenna connected to the transceiver 192 of Manicka (col. 14, line 55 to col. 15, line 12). Bashyam teaches an antenna 102 connected to a transceiver 115 on the housing in the form of a header 100 and a housing 101 (paragraph 0034 and FIG. 2 of Bashyam). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to associate the antenna of Manicka with the housing, as suggested by Bashyam, since an arrangement for the antenna and transceiver is required and Bashyam teaches one such arrangement and/or it provides a suitable connection and protection for the antenna.
The combination teaches or suggests a housing (the housing 102, 402, 502, 602, 702, 802, 902, 1002, 1102, 1202, 1302, 1402, 1502 of Manicka); a clip (the clip 104, 404, 504, 604, 704, 804, 904, 1004, 1104, 1204, 1304, 1404, 1504 of Manicka); circuitry (the power sources, the controller, the memory, the transceiver, the sensors, the sensing circuitry, the therapeutic circuitry, and the electrodes of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka); a first antenna (the receiving coil of the combination); and a second antenna (the antenna connected to the transceiver 192 of Manicka; col. 14, line 55 to col. 15, line 12 of Manicka). Golko teaches an antenna 108 that is attached to an external surface of an attachment member 104 of a clip (paragraphs 0024-0028 and FIGS. 1-4 of Golko).1 It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the antennae of the combination onto the external surface of the attachment portion of the clip of Manicka, as suggested by Golko, since (1) it is simple substitution of one known element for another to obtain predictable results and/or (2) it is a mere rearrangement of parts which does not impact the operation of the device and such a rearrangement has been held to be obvious (See MPEP 2144.04 citing In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice)).
The combination teaches or suggests a housing (the housing 102, 402, 502, 602, 702, 802, 902, 1002, 1102, 1202, 1302, 1402, 1502 of Manicka) and a clip (the clip 104, 404, 504, 604, 704, 804, 904, 1004, 1104, 1204, 1304, 1404, 1504 of Manicka). Zand teaches the use of a clip attached to a housing 1315 which includes a knob structure 1307 so as to adjust the clamping pressure on the tissue (paragraph 0079 and FIG. 13 of Zand). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the knob structure 1307 attached to the housing and clip of Manicka so as to permit adjustment of the clamping pressure of the clip.
With respect to claim 1, the combination teaches or suggests a subcutaneously implantable device comprising:
a housing (the housing 102, 402, 502, 602, 702, 802, 902, 1002, 1102, 1202, 1302, 1402, 1502 of Manicka);
a clip attached to the housing and having an anchoring portion (the clip 104, 404, 504, 604, 704, 804, 904, 1004, 1104, 1204, 1304, 1404, 1504 of Manicka) extending along a length of the housing that is configured to anchor the device to a muscle, a bone, and/or a first tissue of a patient and a mast portion (the knob structure 1307 of Zand) extending along a back end of the housing, wherein the mast portion is configured to cooperate with the anchoring portion to move the anchoring portion vertically with respect to a top side of the housing (the knob structure 1307 of Zand has this ability);
circuitry (the power sources, the controller, the memory, the transceiver, the sensors, the sensing circuitry, the therapeutic circuitry, and the electrodes of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka) in the housing that is configured to provide monitoring, therapeutic, and/or diagnostic capabilities with respect to an organ, a nerve, the first tissue, and/or a second tissue of the patient, wherein the circuitry includes: sensing circuitry and/or therapy circuitry (the therapeutic circuitry of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka); a first power source (one of the power sources of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25- 50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka); and a transceiver (the transceiver 192 of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka);
a first antenna (the receiving coil of the combination) positioned on the anchoring portion of the clip (the receiving coil of the combination is positioned on the attachment portion of the clip; col. 14, line 55 to col. 15, line 12 of Manicka) and in electrical communication with the first power source; and
a second antenna (the antenna connected to the transceiver 192 of Manicka; col. 14, line 55 to col. 15, line 12 of Manicka) positioned on the anchoring portion of the clip (the antenna connected to the transceiver 192 of Manicka is positioned on the attachment portion of the clip; col. 14, line 55 to col. 15, line 12 of Manicka) and in electrical communication with the transceiver;
wherein the anchoring portion of the clip, the first antenna on the anchoring portion of the clip, and the second antenna on the anchoring portion of the clip are configured to be subcutaneously positioned in a body under a skin of the patient (Manicka discloses that the device (including the clip 104, 404, 504, 604, 704, 804, 904, 1004, 1104, 1204, 1304, 1404, 1504 of Manicka) is subcutaneously inserted through the skin (col. 20, line 46 to col. 22, line 66 and col. 23, lines 4-25 of Manicka).
With respect to claim 3, the combination teaches or suggest that “the first antenna and the second antenna are positioned on a top side of the anchoring portion of the clip” since Golko teaches or suggests that the antenna are positioned on an external surface of an attachment member of a clip (paragraphs 0024-0028 and FIGS. 1-4 of Golko)2 and this external surface is considered to be a top side from the perspective of viewing the device from underneath.
With respect to claim 9, the combination teaches or suggests that the first antenna is a recharging coil (the receiving coil of the combination).
With respect to claim 10, the combination teaches or suggests that the first antenna is configured to receive power signals from a first external device and communicate the power signals to the first power source (the receiving coil of the combination is connected to the rechargeable battery of Manicka after receiving energy from an external power coil; paragraph 0090 of Feliss).
With respect to claim 11, the combination teaches or suggests that the circuitry in the housing of the device further includes a second power source (another one of the power sources of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25- 50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka).
With respect to claim 12, Manicka teaches a plurality of power sources (col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25- 50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka). Manicka teaches that one of the power sources is a rechargeable battery (col. 15, lines 10-20 of Manicka). Feliss teaches that rechargeable batteries 33 are recharged using a receiving coil 92 contained within the housing 39 (FIG. 2 and paragraphs 0045 and 0090 of Feliss). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the plurality of power sources of Manicka be rechargeable since it permits longer use of the power sources. Also, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the receiver coil inside the housing of Manicka for recharging all the batteries, as suggested by Feliss, since it permits recharging of all the batteries in a non-invasive fashion. Thus, the combination teaches or suggests that the first antenna is configured to receive power signals and communicate the power signals to the first power source and the second power source (the receiving coil of the combination is connected to the rechargeable batteries after receiving energy from an external power coil; paragraph 0090 of Feliss).
With respect to claim 13, the combination teaches or suggests that the second antenna is a Bluetooth chip, wifi, or cellular antenna (the antenna connected to the transceiver 192 of Manicka uses network interfaces including Bluetooth or WiFi; col. 14, line 55 to col. 15, line 12 of Manicka).
With respect to claim 14, the combination teaches or suggests that the second antenna is configured to receive data signals from a first external device and communicate the data signals to the transceiver (the antenna connected to the transceiver 192 of Manicka has this ability; col. 13, lines 30-45 of Manicka; col. 14, line 55 to col. 15, line 12 of Manicka).
With respect to claim 15, the combination teaches or suggests that the second antenna is configured to receive data signals from a first external device and communicate the data signals to the transceiver to provide instructions to the device regarding the monitoring and therapeutic capabilities of the device (col. 13, lines 30-45 of Manicka; col. 14, line 55 to col. 15, line 12 of Manicka).
With respect to claim 16, the combination teaches or suggests that the device is configured to be anchored to a xiphoid process of the patient (the ability to anchor to the xiphoid process of Manicka; FIGS. 8-9C, 23A-23C, 25A-25B, 28, 32A-32C, 37 of Manicka).
With respect to claim 17, the combination teaches or suggests an electrode (the electrodes of Manicka) that is configured to contact the organ, the nerve, the first tissue, and/or the second tissue; wherein the circuitry in the housing is in electrical communication with the electrode to provide the monitoring, therapeutic, and/or diagnostic capabilities with respect to the organ, the nerve, the first tissue, and/or the second tissue (abstract; col. 1, line 45 to col. 2, line 27; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka).
With respect to claim 18, the combination teaches or suggests subcutaneously implantable device comprising:
a housing (the housing 102, 402, 502, 602, 702, 802, 902, 1002, 1102, 1202, 1302, 1402, 1502 of Manicka);
a clip attached to the housing and having an anchoring portion (the clip 104, 404, 504, 604, 704, 804, 904, 1004, 1104, 1204, 1304, 1404, 1504 of Manicka) extending along a length of the housing that is configured to anchor the device to a muscle, a bone, and/or a first tissue of a patient and a mast portion (the knob structure 1307 of Zand) extending along a back end of the housing, wherein the mast portion is configured to cooperate with the anchoring portion to move the anchoring portion vertically with respect to a top side of the housing (the knob structure 1307 of Zand has this ability);
circuitry (the power sources, the controller, the memory, the transceiver, the sensors, the sensing circuitry, the therapeutic circuitry, and the electrodes of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka) in the housing that is configured to provide monitoring, therapeutic, and/or diagnostic capabilities with respect to an organ, a nerve, the first tissue, and/or a second tissue of the patient, wherein the circuitry includes: sensing circuitry and/or therapy circuitry (the therapeutic circuitry and/or the electrodes of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka); a first power source (one of the power sources of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25- 50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka); and a transceiver (the transceiver 192 of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka); and
at least one antenna (the receiving coil of the combination; the antenna connected to the transceiver 192 of Manicka; col. 14, line 55 to col. 15, line 12 of Manicka) positioned on the anchoring portion of the clip (the receiving coil of the combination and the antenna connected to the transceiver 192 of Manicka are positioned on the clip; col. 14, line 55 to col. 15, line 12 of Manicka) and in electrical communication with the first power source (one of the power sources of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25- 50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka) and the transceiver (the transceiver 192 of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka);
wherein the anchoring portion of the clip and the at least one antenna on the anchoring portion of the clip are configured to be subcutaneously positioned in a body under a skin of the patient (Manicka discloses that the device (including the clip 104, 404, 504, 604, 704, 804, 904, 1004, 1104, 1204, 1304, 1404, 1504 of Manicka) is subcutaneously inserted through the skin (col. 20, line 46 to col. 22, line 66 and col. 23, lines 4-25 of Manicka).
With respect to claim 21, the combination teaches or suggests that the at least one antenna includes a first antenna (the receiving coil of the combination) that is in electrical communication with the first power source (one of the power sources of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25- 50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka) and a second antenna (the antenna connected to the transceiver 192 of Manicka; col. 14, line 55 to col. 15, line 12 of Manicka) that is in electrical communication with the transceiver (the transceiver 192 of Manicka; col. 14, line 55 to col. 15, line 12 of Manicka).
With respect to claim 22, the combination teaches or suggests that the first antenna is configured to receive power signals from a first external device and communicate the power signals to the first power source (the receiving coil of the combination is connected to the rechargeable battery of Manicka after receiving energy from an external power coil; paragraph 0090 of Feliss), and wherein the second antenna is configured to receive data signals from the first external device and/or a second external device and communicate the data signals to the transceiver (the antenna connected to the transceiver 192 of Manicka has this ability; col. 13, lines 30-45 of Manicka; col. 14, line 55 to col. 15, line 12 of Manicka).
With respect to claim 23, the combination teaches or suggests that the device is configured to be anchored to a sternum of the patient (the ability to anchor to the xiphoid process of Manicka; FIGS. 8-9C, 23A-23C, 25A-25B, 28, 32A-32C, 37 of Manicka).
With respect to claim 24, the combination teaches or suggests that the mast portion (the knob structure 1307 of Zand) is configured to move vertically with respect to the top side of the housing to move the anchoring portion vertically with respect to the top side of the housing (paragraph 0079 of Zand), which moves the anchoring portion between an open position and a closed position to increase or decrease an opening between the housing and the anchoring portion to anchor the device to the muscle, the bone, and/or the first tissue by capturing at least a portion of the muscle, the bone, and/or the first tissue in the opening between the housing and the anchoring portion (the knob structure 1307 of Zand has this ability; paragraph 0079 of Zand).
Claims 1, 3, 9-18, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 10,471,251 (Manicka)(previously cited), in view of U.S. Patent Application Publication No. 2005/0288563 (Feliss)(previously cited), and further in view of U.S. Patent Application Publication No. 2010/0019985 (Bashyam)(previously cited), and further in view of U.S. Patent Application Publication No. 2011/0193751 (Golko)(previously cited), and further in view of U.S. Patent No. 3,510,923 (Blake).
Manicka teaches a subcutaneously implantable device comprising: a housing (the housing 102, 402, 502, 602, 702, 802, 902, 1002, 1102, 1202, 1302, 1402, 1502 of Manicka); a clip (the clip 104, 404, 504, 604, 704, 804, 904, 1004, 1104, 1204, 1304, 1404, 1504 of Manicka) attached to the housing that is configured to anchor the device to a muscle, a bone, and/or a first tissue; circuitry (the power sources, the controller, the memory, the transceiver, the sensors, the sensing circuitry, the therapeutic circuitry, and the electrodes of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka) in the housing that is configured to provide monitoring, therapeutic, and/or diagnostic capabilities with respect to an organ, a nerve, the first tissue, and/or a second tissue, wherein the circuitry includes: a first power source (one of the power sources of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25- 50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka); and a transceiver (the transceiver 192 of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka); and a second antenna (the antenna connected to the transceiver 192 of Manicka; col. 14, line 55 to col. 15, line 12).
Manicka teaches that one of the power sources is a rechargeable battery (col. 15, lines 10-20 of Manicka). Feliss teaches that rechargeable batteries 33 are recharged using a receiving coil 92 (FIG. 2 and paragraphs 0045 and 0090 of Feliss). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a receiver coil for recharging the battery of Manicka since it permits recharging of the battery of Manicka in a non-invasive fashion.
Manicka teaches an antenna connected to the transceiver 192 of Manicka (col. 14, line 55 to col. 15, line 12). Bashyam teaches an antenna 102 connected to a transceiver 115 on the housing in the form of a header 100 and a housing 101 (paragraph 0034 and FIG. 2 of Bashyam). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to associate the antenna of Manicka with the housing, as suggested by Bashyam, since an arrangement for the antenna and transceiver is required and Bashyam teaches one such arrangement and/or it provides a suitable connection and protection for the antenna.
The combination teaches or suggests a housing (the housing 102, 402, 502, 602, 702, 802, 902, 1002, 1102, 1202, 1302, 1402, 1502 of Manicka); a clip (the clip 104, 404, 504, 604, 704, 804, 904, 1004, 1104, 1204, 1304, 1404, 1504 of Manicka); circuitry (the power sources, the controller, the memory, the transceiver, the sensors, the sensing circuitry, the therapeutic circuitry, and the electrodes of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka); a first antenna (the receiving coil of the combination); and a second antenna (the antenna connected to the transceiver 192 of Manicka; col. 14, line 55 to col. 15, line 12 of Manicka). Golko teaches an antenna 108 that is attached to an external surface of an attachment member 104 of a clip (paragraphs 0024-0028 and FIGS. 1-4 of Golko).3 It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the antennae of the combination onto the external surface of the attachment portion of the clip of Manicka, as suggested by Golko, since (1) it is simple substitution of one known element for another to obtain predictable results and/or (2) it is a mere rearrangement of parts which does not impact the operation of the device and such a rearrangement has been held to be obvious (See MPEP 2144.04 citing In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice)).
The combination teaches or suggests a housing (the housing 102, 402, 502, 602, 702, 802, 902, 1002, 1102, 1202, 1302, 1402, 1502 of Manicka) and a clip (the clip 104, 404, 504, 604, 704, 804, 904, 1004, 1104, 1204, 1304, 1404, 1504 of Manicka). Blake teaches the use of a clip with jaws that remain parallel throughout their opening and closing movements and permit the surgeon to control the claiming force (col. 1, lines 50-61; FIG. 1 or 7 of Blake). The jaws 10, 11 extend at right angles to the plunger and barrel whereby the jaws have a parallel movement toward and away from each other (col. 2, lines 50-65 of Blake). The jaws are equipped with teeth or a soft, resilient pad to prevent slippage on the claimed object (col. 2, lines 50-65 of Blake). The jaws also have a plunger 12 and a barrel 13 so as to move the jaws (col. 2, lines 50-65 of Blake; col. 3, lines 30-65 of Blake; FIG. 1 or 7 of Blake). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the clip of Blake in place of the clip of Manicka so as to permit the surgeon to control the claiming force.
With respect to claim 1, the combination teaches or suggests a subcutaneously implantable device comprising:
a housing (the housing 102, 402, 502, 602, 702, 802, 902, 1002, 1102, 1202, 1302, 1402, 1502 of Manicka);
a clip (the clip of Blake) attached to the housing and having an anchoring portion (the jaws 10, 11 of Blake) extending along a length of the housing that is configured to anchor the device to a muscle, a bone, and/or a first tissue of a patient and a mast portion extending along a back end of the housing (the plunger 12 of Blake), wherein the mast portion is configured to cooperate with the anchoring portion to move the anchoring portion vertically with respect to a top side of the housing (the plunger 12 of Blake has this ability);
circuitry (the power sources, the controller, the memory, the transceiver, the sensors, the sensing circuitry, the therapeutic circuitry, and the electrodes of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka) in the housing that is configured to provide monitoring, therapeutic, and/or diagnostic capabilities with respect to an organ, a nerve, the first tissue, and/or a second tissue of the patient, wherein the circuitry includes: sensing circuitry and/or therapy circuitry (the therapeutic circuitry of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka); a first power source (one of the power sources of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25- 50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka); and a transceiver (the transceiver 192 of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka);
a first antenna (the receiving coil of the combination) positioned on the anchoring portion of the clip (the receiving coil of the combination is positioned on the attachment portion of the clip; col. 14, line 55 to col. 15, line 12 of Manicka) and in electrical communication with the first power source; and
a second antenna (the antenna connected to the transceiver 192 of Manicka; col. 14, line 55 to col. 15, line 12 of Manicka) positioned on the anchoring portion of the clip (the antenna connected to the transceiver 192 of Manicka is positioned on the attachment portion of the clip; col. 14, line 55 to col. 15, line 12 of Manicka) and in electrical communication with the transceiver;
wherein the anchoring portion of the clip, the first antenna on the anchoring portion of the clip, and the second antenna on the anchoring portion of the clip are configured to be subcutaneously positioned in a body under a skin of the patient (Manicka discloses that the device (including the clip of Blake) is subcutaneously inserted through the skin (col. 20, line 46 to col. 22, line 66 and col. 23, lines 4-25 of Manicka).
With respect to claim 3, the combination teaches or suggest that “the first antenna and the second antenna are positioned on a top side of the anchoring portion of the clip” since Golko teaches or suggests that the antenna are positioned on an external surface of an attachment member of a clip (paragraphs 0024-0028 and FIGS. 1-4 of Golko)4 and this external surface is considered to be a top side from the perspective of viewing the device from underneath.
With respect to claim 9, the combination teaches or suggests that the first antenna is a recharging coil (the receiving coil of the combination).
With respect to claim 10, the combination teaches or suggests that the first antenna is configured to receive power signals from a first external device and communicate the power signals to the first power source (the receiving coil of the combination is connected to the rechargeable battery of Manicka after receiving energy from an external power coil; paragraph 0090 of Feliss).
With respect to claim 11, the combination teaches or suggests that the circuitry in the housing of the device further includes a second power source (another one of the power sources of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25- 50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka).
With respect to claim 12, Manicka teaches a plurality of power sources (col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25- 50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka). Manicka teaches that one of the power sources is a rechargeable battery (col. 15, lines 10-20 of Manicka). Feliss teaches that rechargeable batteries 33 are recharged using a receiving coil 92 contained within the housing 39 (FIG. 2 and paragraphs 0045 and 0090 of Feliss). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the plurality of power sources of Manicka be rechargeable since it permits longer use of the power sources. Also, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the receiver coil inside the housing of Manicka for recharging all the batteries, as suggested by Feliss, since it permits recharging of all the batteries in a non-invasive fashion. Thus, the combination teaches or suggests that the first antenna is configured to receive power signals and communicate the power signals to the first power source and the second power source (the receiving coil of the combination is connected to the rechargeable batteries after receiving energy from an external power coil; paragraph 0090 of Feliss).
With respect to claim 13, the combination teaches or suggests that the second antenna is a Bluetooth chip, wifi, or cellular antenna (the antenna connected to the transceiver 192 of Manicka uses network interfaces including Bluetooth or WiFi; col. 14, line 55 to col. 15, line 12 of Manicka).
With respect to claim 14, the combination teaches or suggests that the second antenna is configured to receive data signals from a first external device and communicate the data signals to the transceiver (the antenna connected to the transceiver 192 of Manicka has this ability; col. 13, lines 30-45 of Manicka; col. 14, line 55 to col. 15, line 12 of Manicka).
With respect to claim 15, the combination teaches or suggests that the second antenna is configured to receive data signals from a first external device and communicate the data signals to the transceiver to provide instructions to the device regarding the monitoring and therapeutic capabilities of the device (col. 13, lines 30-45 of Manicka; col. 14, line 55 to col. 15, line 12 of Manicka).
With respect to claim 16, the combination teaches or suggests that the device is configured to be anchored to a xiphoid process of the patient (the ability to anchor to the xiphoid process of Manicka; FIGS. 8-9C, 23A-23C, 25A-25B, 28, 32A-32C, 37 of Manicka).
With respect to claim 17, the combination teaches or suggests an electrode (the electrodes of Manicka) that is configured to contact the organ, the nerve, the first tissue, and/or the second tissue; wherein the circuitry in the housing is in electrical communication with the electrode to provide the monitoring, therapeutic, and/or diagnostic capabilities with respect to the organ, the nerve, the first tissue, and/or the second tissue (abstract; col. 1, line 45 to col. 2, line 27; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka).
With respect to claim 18, the combination teaches or suggests subcutaneously implantable device comprising:
a housing (the housing 102, 402, 502, 602, 702, 802, 902, 1002, 1102, 1202, 1302, 1402, 1502 of Manicka);
a clip (the clip of Blake) attached to the housing and having an anchoring portion (the jaws 10, 11 of Blake) extending along a length of the housing that is configured to anchor the device to a muscle, a bone, and/or a first tissue of a patient and a mast portion (the plunger 12 of Blake) extending along a back end of the housing, wherein the mast portion is configured to cooperate with the anchoring portion to move the anchoring portion vertically with respect to a top side of the housing (the plunger 12 of Blake has this ability);
circuitry (the power sources, the controller, the memory, the transceiver, the sensors, the sensing circuitry, the therapeutic circuitry, and the electrodes of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka) in the housing that is configured to provide monitoring, therapeutic, and/or diagnostic capabilities with respect to an organ, a nerve, the first tissue, and/or a second tissue of the patient, wherein the circuitry includes: sensing circuitry and/or therapy circuitry (the therapeutic circuitry and/or the electrodes of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka); a first power source (one of the power sources of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25- 50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka); and a transceiver (the transceiver 192 of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka); and
at least one antenna (the receiving coil of the combination; the antenna connected to the transceiver 192 of Manicka; col. 14, line 55 to col. 15, line 12 of Manicka) positioned on the anchoring portion of the clip (the receiving coil of the combination and the antenna connected to the transceiver 192 of Manicka are positioned on the clip; col. 14, line 55 to col. 15, line 12 of Manicka) and in electrical communication with the first power source (one of the power sources of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25- 50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka) and the transceiver (the transceiver 192 of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25-50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka);
wherein the anchoring portion of the clip and the at least one antenna on the anchoring portion of the clip are configured to be subcutaneously positioned in a body under a skin of the patient (Manicka discloses that the device (including the clip of Blake) is subcutaneously inserted through the skin (col. 20, line 46 to col. 22, line 66 and col. 23, lines 4-25 of Manicka).
With respect to claim 21, the combination teaches or suggests that the at least one antenna includes a first antenna (the receiving coil of the combination) that is in electrical communication with the first power source (one of the power sources of Manicka; col. 7, lines 40-58; col. 13, lines 5-52; col. 14, lines 35-45; col. 24, lines 35-60; col. 25, line 55 to col. 26, line 12; col. 27, lines 35-55; col. 29, lines 10-40; col. 30, line 55 to col. 31, line 10; col. 32, lines 25- 50; col. 33, line 63 to col. 34, line 20; col. 35, line 45 to col. 36, line 10; col. 37, line 55 to col. 38, line 10; col. 39, line 55 to col. 40, line 20; col. 42, lines 20-50; col. 44, line 5 to col. 45, line 5 of Manicka) and a second antenna (the antenna connected to the transceiver 192 of Manicka; col. 14, line 55 to col. 15, line 12 of Manicka) that is in electrical communication with the transceiver (the transceiver 192 of Manicka; col. 14, line 55 to col. 15, line 12 of Manicka).
With respect to claim 22, the combination teaches or suggests that the first antenna is configured to receive power signals from a first external device and communicate the power signals to the first power source (the receiving coil of the combination is connected to the rechargeable battery of Manicka after receiving energy from an external power coil; paragraph 0090 of Feliss), and wherein the second antenna is configured to receive data signals from the first external device and/or a second external device and communicate the data signals to the transceiver (the antenna connected to the transceiver 192 of Manicka has this ability; col. 13, lines 30-45 of Manicka; col. 14, line 55 to col. 15, line 12 of Manicka).
With respect to claim 23, the combination teaches or suggests that the device is configured to be anchored to a sternum of the patient (the ability to anchor to the xiphoid process of Manicka; FIGS. 8-9C, 23A-23C, 25A-25B, 28, 32A-32C, 37 of Manicka).
With respect to claim 24, the combination teaches or suggests that the mast portion (the plunger 12 of Blake) is configured to move vertically with respect to the top side of the housing to move the anchoring portion (the jaw 10 of Blake) vertically with respect to the top side of the housing (col. 1, lines 50-61; col. 2, lines 50-65 of Blake; col. 3, lines 30-65 of Blake; FIG. 1 or 7 of Blake), which moves the anchoring portion between an open position and a closed position to increase or decrease an opening between the housing and the anchoring portion to anchor the device to the muscle, the bone, and/or the first tissue by capturing at least a portion of the muscle, the bone, and/or the first tissue in the opening between the housing and the anchoring portion (the plunger 12 of Blake has this ability; col. 1, lines 50-61; col. 2, lines 50-65 of Blake; col. 3, lines 30-65 of Blake; FIG. 1 or 7 of Blake).
Response to Arguments
The Applicant’s arguments filed 4/21/2026 have been fully considered.
Prior art rejections
The Applicant’s arguments with respect to the rejection of claims 1, 3, 9-18, and 21-24 have been considered but are moot because the new grounds of rejection do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In particular, the Applicant’s arguments drawn to the lack of a teaching of the mast portion of the clip is taught by the new reference Zand or the new reference Blake. The remaining arguments will be addressed in turn.
The Applicant asserts that Manicka, Feliss, and Bashyam do not teach the placement of the antennae on the anchoring portion of the claim. The Examiner agrees. The Examiner relies upon Golko for teaching an antenna 108 that is attached to an external surface of an attachment member 104 of a clip (paragraphs 0024-0028 and FIGS. 1-4 of Golko).
The Applicant asserts that Feliss and Bashyam do not disclose the clip. The Examiner agrees. In one rejection, Manicka and Zand teach the clip while Golko teaches the antennae placement. In another rejection, Manicka and Blake teach the clip while Golko teaches the antennae placement
The Applicant asserts that Golko5 does not disclose a medical device that is subcutaneously implanted under a skin of the patient. This position is not persuasive since the combination of Manicka, Feliss, and Bashyam teaches a medical device that is subcutaneously implanted under a skin of the patient. For example, Manicka discloses that the device (including the clip 104, 404, 504, 604, 704, 804, 904, 1004, 1104, 1204, 1304, 1404, 1504 of Manicka) is subcutaneously inserted through the skin (col. 20, line 46 to col. 22, line 66 and col. 23, lines 4-25 of Manicka). Also, Feliss teaches that rechargeable batteries 33 are recharged using a receiving coil 92 (FIG. 2 and paragraphs 0045 and 0090 of Feliss) in an implanted device (paragraphs 0018 and 0034-0035 of Feliss). Further, Bashyam teaches an antenna 102 connected to a transceiver 115 on the housing in the form of a header 100 and a housing 101 in an implanted device (paragraph 0034 and FIG. 2 of Bashyam). One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The Applicant asserts:
PNG
media_image1.png
393
732
media_image1.png
Greyscale
PNG
media_image2.png
169
739
media_image2.png
Greyscale
PNG
media_image3.png
195
732
media_image3.png
Greyscale
This argument is not persuasive. As pointed out above, the combination of Manicka, Feliss, and Bashyam teaches a medical device (with its housing, clip, and antennae) that is subcutaneously implanted under a skin of the patient. For example, Manicka discloses that the device (including the clip 104, 404, 504, 604, 704, 804, 904, 1004, 1104, 1204, 1304, 1404, 1504 of Manicka) is subcutaneously inserted through the skin (col. 20, line 46 to col. 22, line 66 and col. 23, lines 4-25 of Manicka). Also, Feliss teaches that rechargeable batteries 33 are recharged using a receiving coil 92 (FIG. 2 and paragraphs 0045 and 0090 of Feliss) in an implanted device (paragraphs 0018 and 0034-0035 of Feliss). Further, Bashyam teaches an antenna 102 connected to a transceiver 115 on the housing in the form of a header 100 and a housing 101 in an implanted device (paragraph 0034 and FIG. 2 of Bashyam). Golko is merely relied upon to show where an antennae is placed when considering a structure with a housing and clip. That is, Golko is relied upon to show placement of the antennae on the physical structure, not the placing of the antenna subcutaneously under the skin per se.
Also, Zand or Blake is relied upon for teaching the mast portion of the clip.
The Applicant asserts:
PNG
media_image4.png
503
726
media_image4.png
Greyscale
This argument is not persuasive. As pointed out above, the combination of Manicka, Feliss, and Bashyam teaches a medical device (with its housing, clip, and antennae) that is subcutaneously implanted under a skin of the patient. Golko is reasonably pertinent to the problem of placement of the antennae with respect to a structure having a housing and clip. As such, Golko is instructive in deciding such a placement. Because Golko is reasonably pertinent to this problem, it is analogous art.
The Applicant asserts that the problem is much more narrow in that it is the placement of the antenna in a patient’s body to minimize signal loss and signal attenuation. The Applicant at least agrees that the problem is about antenna placement. The factors related to such placement, such as environment, signal attenuation, noise, structural stability, etc., are always present when any antenna installation is considered. As a result, the presence of one or more of these consideration by the inventors/applicant does not negate the instructiveness of the antenna placement teachings of Golko, which must balance these same considerations by nature of being an antenna placement issue.
In view of the above, the combination of Manicka, Feliss, Bashyam, Golko, and Zand renders the claim obvious and therefore not patentable. Also, the combination of Manicka, Feliss, Bashyam, Golko, and Blake renders the claim obvious and therefore not patentable
Claims 3, 9-17, and 23-24 are properly rejected since claim 1 is properly rejected and the prior art teaches or suggests these features of these claims.
Claim 18 and its dependent claims 21-22 are properly rejected for the same reasons that claim 1 is properly rejected and the prior art teaches or suggests the features of these claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 FIG. 2 of U.S. Patent No. 6,118,882 (Haynes)(previously cited) also teaches a transmitting terminal or antenna 24 on an exterior surface of an attachment portion of a clip 20 (see also claim 26 of Haynes). Also, paragraph 0119 of U.S. Patent Application Publication No. 2022/0084663 (Gumbel)(previously cited) teaches that an antennae 1856 may be built into an exterior clip of a communication device 1800 or may reside completely within the housing 1802 of the communication device 1800 (paragraph 0119 of Gumbel).
2 FIG. 2 of Haynes also teaches a transmitting terminal or antenna 24 on an exterior surface of an attachment portion of a clip 20 (see also claim 26 of Haynes). .
3 FIG. 2 of U.S. Patent No. 6,118,882 (Haynes)(previously cited) also teaches a transmitting terminal or antenna 24 on an exterior surface of an attachment portion of a clip 20 (see also claim 26 of Haynes). Also, paragraph 0119 of U.S. Patent Application Publication No. 2022/0084663 (Gumbel)(previously cited) teaches that an antennae 1856 may be built into an exterior clip of a communication device 1800 or may reside completely within the housing 1802 of the communication device 1800 (paragraph 0119 of Gumbel).
4 FIG. 2 of Haynes also teaches a transmitting terminal or antenna 24 on an exterior surface of an attachment portion of a clip 20 (see also claim 26 of Haynes). .
5 The Applicant also refers to the references of Haynes and Gumbel in the argument. However, Haynes and Gumbel were not explicitly used to reject the claims. As such, it is not necessary to directly address the teachings of these references. However, it should be noted that the arguments regarding Golko are equally applicable to Haynes and Gumbel if they were used in prior art rejections.
Prosecution Insights