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 .
Response to Amendment
The amendment filed September 9, 2025 has been entered. Claim 1 has been amended. Claims 2, 4, 7, 18-19, 22-23 have been canceled. Claims 24-27 are new. Currently, claims 1, 3, 5-6, 8-17, 20-21, 24-27 are pending for examination.
Response to Arguments
Applicant's arguments filed September 9, 2025 have been fully considered but they are not persuasive. Applicant argues on pages 14-17 that Manicka (US 2020/0077953) in view of Chekanov (US 6,201,991) and Ball et al. (US 2022/0201411) do not disclose the invention as claimed in claim 1, specifically:
a first anchoring arm attached to a first side of the housing that is configured to anchor the device to a first rib
a second anchoring arm attached to a second side of the housing, the second side of the housing being opposite the first side of the housing, that is configured to anchor the device to a second rib, wherein the first anchoring arm and the second anchoring arm are sized and shaped to hold the subcutaneous device in position on the first rib and the second rib and the housing is configured to fit in an intercostal space between the first rib and the second rib
Applicant argues (1) Ball et al.’s flexible connecting wings 506 include a zig-zag shape and therefore are not shaped to hold a device in position on a first rib and a second rib as now required by claim 1 (p. 15-16), and (2) a person of ordinary skill in the art would not have any rational reason to modify the teachings of Manicka, where a clip is employed to anchor a device to a structural body component, to employ the flexible wings of Ball et al. as a mechanism for anchoring the device to a pair of ribs (p. 17).
In response to Applicant’s argument (1), Ball et al. teaches a device that comprises a first and second anchoring arm 506 attached to opposite sides of a housing of a device 500 (fig. 5A), the first and second anchoring arms configured to anchor the device in position on portions of bone 208 such that the housing is configured to fit in a space 207 between the bone (fig. 5B). Ball et al. teaches bone screws 507 are provided with anchoring the first and second anchoring arms to portions of bone 208 ([0028]). If what applicant argues holds true, the zig-zag shaped anchoring arms would be incapable of anchoring the device in position where the housing is configured to fit in the space between the bone in Ball et al.’s own invention which is not true. The zig-zag shape of the anchoring arms are not designed to break away, do not prevent the securement to bone 208 via bone screws 507, and do not impede the housing to fit in a space between bone. Nothing structural in Ball et al. prevents turning to the prior art to modify Manicka to incorporate the first and second anchoring arms 506 in the manner set forth by the previous Office action resulting in a structure that comprises a first anchoring arm and the second anchoring arm are sized and shaped to hold the subcutaneous device in position on the first rib and the second rib and the housing is configured to fit in an intercostal space between the first rib and the second rib. Therefore despite Applicant’s insistence, the argument that the flexible connecting wings of Ball et al. are not shaped to hold a device in position on a first rib and a second rib as now required by claim 1 is unpersuasive.
In response to Applicant’s argument (2), in one embodiment Manicka’s clip 104 secures the device to the xiphoid process X (fig. 8, [0146]) but does not state the clip must only be secured to this location in order for the prong of Manicka to maintain contact with the organ it is touching. Instead, Manicka envisions a variety of structures clip 104 can be attached to, including bone, muscle or tissue ([0106]). The argument that a person of ordinary skill in the art would not have any rational reason to modify the teachings of Manicka to use the anchoring arms disclosed by Ball et al. for anchoring the device to a pair of ribs is unpersuasive as Applicant has not argued against the rationale provided in the previous Office action of “it appears to be an equivalent structure for attaching to bone tissue ([0028]) but would provide more superior securement of the subcutaneously implantable device via multiple bone screws 507 as compared to a singular anchoring clip”. Applicant argues, “It is important for the prong of Manicka to maintain contact with the organ it is touching, and such movement would likely prevent contact from being maintained” (p.17), inferring the zig-zag anchoring arms of Ball et al. would result in the prong of Manicka moving around, “as the housing from which the prong extends would vibrate along with the flexible wings securing it to the structural body component” (p. 17). Manicka states the disclosed prong is intended to allow some flexibility, for example to allow the prong to move with a heart as it beats, if the prong is positioned against the pericardium ([0149-0150]). Therefore it appears the prior art does support the prong maintaining contact even if there is some movement on either end of the prong structure, including any movement provided by the flexible zig-zag shape of the anchoring arms. Therefore Applicant’s argument that the anchoring of the housing of Manicka, which is important to its function, “would be seriously compromised” (p. 17) by employing the flexible wings of Ball et al. to secure the housing to the ribs is unpersuasive.
Applicant is reminded that “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Since claim 1 and its dependents are directed to apparatus claims, a structural difference must be provided between the claimed invention and the prior art. The limitation, “wherein the first anchoring arm and the second anchoring arm are sized and shaped to hold the subcutaneous device in position on the first rib and the second rib” would have required only a matter of design choice to modify the size and shape of the first and second anchoring arm disclosed in Manicka in view of Ball et al. to an effective size and shape to hold the subcutaneous device in position on the first rib and the second rib since such a modification would have involved a mere change in size and shape of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Claim Objections
Claim 24 is objected to because of the following informalities: Claim 24 recites the limitation, “the subcutaneous device” in line 3, but claim 1 for which the claim directly depends, recites “a subcutaneously implantable device”. Appropriate correction is required.
Claim 26 is objected to because of the following informalities: Claim 26 recites the limitation, “the subcutaneous device” in line 4, but claim 1 for which the claim depends, recites “a subcutaneously implantable device”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3, 5-6, 8-16, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manicka (US 2020/0077953) in view of Chekanov (US 6,201,991) and Ball et al. (US 2022/0201411).
Regarding claim 1, Manicka discloses a subcutaneously implantable device comprising: a housing 702; a first prong 706a ([0124]) with a proximal end attached to a bottom side 720 of the housing, which is opposite a top side 718 of the housing, and a distal end extending away from the bottom side of the housing (fig. 24a, c) such that the first prong is capable of extending through the intercostal space between a first rib and a second rib (“[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original)); a first electrode 772a on the distal end of the first prong that is configured to be positioned adjacent to the first blood vessel ([0216], fig. 24a); and circuitry in the housing in electrical communication with the first electrode that is configured to deliver electrical stimulation using the first electrode ([0106]) to create an electric field (an electric field is inherently generated with electrical stimulation).
Manicka does not expressly disclose the first prong extends through the intercostal space between a first rib and a second rib is configured to be positioned adjacent to a first blood vessel, and the first electrode creating an electric field around the first blood vessel. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). Manicka does disclose the positioning of first prong is flexible and can vary in orientation (fig. 24c-d), and one of ordinary skill in the art before the effective filing date of the claimed invention would think it obvious that the first prong would be capable of being positioned in a variety of locations such as extending through the intercostal space between a first rib and a second rib to be positioned adjacent to a first blood vessel. Furthermore, Chekanov teaches positioning a subcutaneously implantable device comprising: an electrode 22 configured to be positioned adjacent to a first blood vessel 16; and delivering electrical stimulation using the first electrode to create an electric field around the first blood vessel (col. 2, lines 35-43). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try using the device of Manicka where the electrode on the first prong is positioned to create an electric field around a first blood vessel taught by Chekanov in order to provide therapy for more effectively preventing and treating atherosclerosis.
Manicka discloses an anchoring clip 704 attached to the housing that is configured to anchor the device to a muscle, a bone, and/or a first tissue (“Clip 704 is configured to anchor subcutaneous device 700 to xiphoid process X and sternum S” [0220]), but does not expressly disclose a first anchoring arm attached to a first side of the housing that is configured to anchor the device to a first rib; a second anchoring arm attached to a second side of the housing, the second side of the housing being opposite the first side of the housing, that is configured to anchor the device to a second rib, such that the housing is configured to fit in an intercostal space between the first rib and the second rib. Ball et al. teaches an implantable medical device where first and second anchoring arms 506 are attached to a first and second side of a housing (fig. 5a), the second side of the housing being opposite the first side of the housing, the first anchoring arm configured to anchor the device to a first bone and the second anchoring arm configured to anchor the device to a second bone, such that the housing fits in a gap 207 between the first bone and the second bone (fig. 5b). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Manicka and substitute the anchoring clip 704 for the first and second anchoring arms, attached to first and second sides of the housing, respectively, as taught by Ball et al. as it appears to be an equivalent structure for attaching to bone tissue ([0028]) but would provide more superior securement of the subcutaneously implantable device via multiple bone screws 507 as compared to a singular anchoring clip. Such a modification would also be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as being capable of having the first anchoring arm configured to anchor the device to a first rib; and capable of having the second anchoring arm configured to anchor the device to a second rib, such that the housing fits in an intercostal space between the first rib and the second rib, as the instant application states, “First anchoring arm 304A and second anchoring arm 304B can be anchored to the same structural body component A (i.e., the same muscle, bone, or tissue) or to different structural body components A (i.e., different muscles, bones, or tissues) positioned on opposite sides of housing 302” ([0087] of the published application), indicating that providing anchoring arms to secure to different muscle, bone or tissue is merely a matter of where the housing of the device is intended to be implanted, and the surrounding tissues adjacent to the housing. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Furthermore the limitation, “wherein the first anchoring arm and the second anchoring arm are sized and shaped to hold the subcutaneous device in position on the first rib and the second rib” would have required only a matter of design choice to modify the size and shape of the first and second anchoring arm disclosed in Manicka in view of Ball et al. to an effective size and shape to hold the subcutaneous device in position on the first rib and the second rib since such a modification would have involved a mere change in size and shape of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 3, Manicka in view of Ball et al. disclose the first anchoring arm comprises at least one tine 507 configured to pierce the first rib.
Regarding claim 5, Manicka in view of Ball et al. disclose wherein the second anchoring arm comprises at least one tine 507 configured to pierce the second rib.
Regarding claim 6, Manicka in view of Ball et al. disclose the first anchoring arm and the second anchoring arm are integrally formed with the housing (fig. 5a).
Regarding claim 8, Manicka discloses the first prong is made of a stiff material that is capable of pushing through tissue in a body of a patient ([0124]).
Regarding claim 9, Manicka discloses the first prong is made of a material selected from the group consisting of nickel titanium (Nitinol), silicone, polyurethane, stainless steel, titanium, epoxy, polyurethane with metallic reinforcements, and any combination thereof ([0124]).
Regarding claim 10, Manicka discloses a base portion 764a on the proximal end of the first prong; an arm portion 768a extending from the base portion; and a therapeutic portion 770a extending from the arm portion and terminating at the distal end of the first prong, wherein the first electrode 772a is positioned on the therapeutic portion of the first prong (fig. 24a).
Regarding claim 11, Manicka in view of Chekanov discloses the electrical stimulation that is provided using the first electrode is pulsating electrical stimulation to create a pulsating electric field between and around the first electrode and the housing (col. 2, lines 17-23, 36-52).
Regarding claim 12, Manicka in view of Chekanov discloses wherein a frequency of the pulsating electrical stimulation is between 1 pulse per minute and 30 pulses per minute (“The electrical impulse can be emitted at a rate of 30-120 beats per minute” col. 2, lines 66-67).
Regarding claim 13, Manicka in view of Chekanov discloses wherein the amplitude of the pulsating electrical stimulation is between 0.5 volts and 4.0 volts (col. 2, lines 65-66) at a pulse width of 250 milliseconds to 1000 milliseconds (col. 2, lines 65-66).
Regarding claim 14, Manicka discloses a second prong 706B with a proximal end attached to the housing and a distal end extending away from the housing that is configured to be positioned adjacent to a second blood vessel; and a second electrode 772B on the distal end of the second prong that is configured to be positioned adjacent to the second blood vessel; wherein the circuitry in the housing 702 is in electrical communication with the second electrode (fig. 24A). Manicka in view of Chekanov discloses delivering electrical stimulation using an electrode to create an electric field (col. 2, lines 35-43) around a blood vessel.
Regarding claim 15, Manicka in view of Chekanov discloses the electrical stimulation that is provided using the first electrode and the second electrode is pulsating electrical stimulation to create a pulsating electric field between and around the first electrode and the second electrode (col. 2, lines 17-23, 36-52).
Regarding claim 16, Manicka in view of Chekanov discloses the electrical stimulation that is provided using the first electrode is pulsating electrical stimulation to create a pulsating electric field between and around the first electrode and the housing and a pulsating electric field between and around the second electrode and the housing (col. 2, lines 17-23, 36-52).
Regarding claim 21, Manicka in view of Ball et al. disclose the first anchoring arm is attached to the first side of the housing adjacent the top side of the housing, and the second anchoring arm is attached to the second side of the housing adjacent the top side of the housing (fig. 5a).
Regarding claim 25, Manicka in view of Ball et al. disclose the first anchoring arm 506 comprises: a body extending form the first side of the housing; and an opening extending through the body from a top side of the body to a bottom side of the body and configured to allow the first anchoring arm to receive a fixation mechanism 507 (“bone screws”) to secure the first anchoring arm to bone; and the second anchoring arm 506 comprises: a body extending from the second side of the housing; and an opening extending through the body from a top side of the body to a bottom side of the body and configured to allow the second anchoring arm to receive a fixation mechanism 507 (“bone screws”) to secure the second anchoring arm to bone (fig. 5a). As stated previously, the limitation of the bone being either the first rib or the second rib is regarded as intended use. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding claim 26, Manicka in view of Ball et al. disclose the first anchoring arm comprises at least one tine 507 configured to pierce the first rib, and the second anchoring arm comprises at least one tine 507 configured to pierce the second rib such that the first anchoring arm and the second anchoring arm hold the subcutaneous device in position on the first rib and the second rib (fig. 5b; applicant has not provided any structural limitation regarding “tine” and the relationship between the anchoring arm; for the limitation “first rib” and “second rib”- see rejection of claim 25).
Claim(s) 1, 24 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manicka (US 2020/0077953) in view of Chekanov (US 6,201,991) and Gibson (US 8,774,929).
Regarding claim 1, Manicka discloses a subcutaneously implantable device comprising: a housing 702; a first prong 706a ([0124]) with a proximal end attached to a bottom side 720 of the housing, which is opposite a top side 718 of the housing, and a distal end extending away from the bottom side of the housing (fig. 24a, c) such that the first prong is capable of extending through the intercostal space between a first rib and a second rib (“[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original)); a first electrode 772a on the distal end of the first prong that is configured to be positioned adjacent to the first blood vessel ([0216], fig. 24a); and circuitry in the housing in electrical communication with the first electrode that is configured to deliver electrical stimulation using the first electrode ([0106]) to create an electric field (an electric field is inherently generated with electrical stimulation).
Manicka does not expressly disclose the first prong extends through the intercostal space between a first rib and a second rib is configured to be positioned adjacent to a first blood vessel, and the first electrode creating an electric field around the first blood vessel. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). Manicka does disclose the positioning of first prong is flexible and can vary in orientation (fig. 24c-d), and one of ordinary skill in the art before the effective filing date of the claimed invention would think it obvious that the first prong would be capable of being positioned in a variety of locations such as extending through the intercostal space between a first rib and a second rib to be positioned adjacent to a first blood vessel. Furthermore, Chekanov teaches positioning a subcutaneously implantable device comprising: an electrode 22 configured to be positioned adjacent to a first blood vessel 16; and delivering electrical stimulation using the first electrode to create an electric field around the first blood vessel (col. 2, lines 35-43). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try using the device of Manicka where the electrode on the first prong is positioned to create an electric field around a first blood vessel taught by Chekanov in order to provide therapy for more effectively preventing and treating atherosclerosis.
Manicka discloses an anchoring clip 704 attached to the housing that is configured to anchor the device to a muscle, a bone, and/or a first tissue (“Clip 704 is configured to anchor subcutaneous device 700 to xiphoid process X and sternum S” [0220]), but does not expressly disclose a first anchoring arm attached to a first side of the housing that is configured to anchor the device to a first rib; a second anchoring arm attached to a second side of the housing, the second side of the housing being opposite the first side of the housing, that is configured to anchor the device to a second rib, such that the housing is configured to fit in an intercostal space between the first rib and the second rib. Gibson teaches an implantable medical device 38 where first and second anchoring arms 39 are attached to a first and second side of a housing (fig. 5), the second side of the housing being opposite the first side of the housing, the first anchoring arm configured to anchor the device to a first bone and the second anchoring arm configured to anchor the device to a second bone (“securing of the unit to the skull via surgical screws 36” col. 5, lines 59-60), such that the housing fits in a gap 35 between the first bone and the second bone (“mastoid cavity” col. 5, lines 55-57). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Manicka and substitute the anchoring clip 704 for the first and second anchoring arms, attached to first and second sides of the housing, respectively, as taught by Gibson as it appears to be an equivalent structure for attaching to bone tissue (col. 5, lines 49-62) but would provide more superior securement of the subcutaneously implantable device via multiple bone screws 36 as compared to a singular anchoring clip. Such a modification would also be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as being capable of having the first anchoring arm configured to anchor the device to a first rib; and capable of having the second anchoring arm configured to anchor the device to a second rib, such that the housing fits in an intercostal space between the first rib and the second rib, as the instant application states, “First anchoring arm 304A and second anchoring arm 304B can be anchored to the same structural body component A (i.e., the same muscle, bone, or tissue) or to different structural body components A (i.e., different muscles, bones, or tissues) positioned on opposite sides of housing 302” ([0087] of the published application), indicating that providing anchoring arms to secure to different muscle, bone or tissue is merely a matter of where the housing of the device is intended to be implanted, and the surrounding tissues adjacent to the housing. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Furthermore the limitation, “wherein the first anchoring arm and the second anchoring arm are sized and shaped to hold the subcutaneous device in position on the first rib and the second rib” would have required only a matter of design choice to modify the size and shape of the first and second anchoring arm disclosed in Manicka in view of Gibson to an effective size and shape to hold the subcutaneous device in position on the first rib and the second rib since such a modification would have involved a mere change in size and shape of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 24, Manicka in view of Gibson disclose wherein the first anchoring arm is a first curved anchoring arm, and the second anchoring arm is a second curved anchoring arm (fig. 5; anchoring arms 39 show a curved appearance; “The flanges 39 are formed so as to be relatively robust whilst also sufficiently malleable so that the entire faceplate 37 can be formed to the shape of the skull surrounding the mastoid cavity by the surgeon using finger pressure only.” col. 6, lines 13-16; suggesting anchoring arms are capable of becoming curved to align with the shape of the skull) such that the first curved anchoring arm and the second curved anchoring arm hold the subcutaneous device in position on the bone. The limitation of the bone being either the first rib or the second rib is regarded as intended use. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding claim 27, Manicka discloses a subcutaneously implantable device comprising: a housing 702; a first prong 706a ([0124]) with a proximal end attached to a bottom side 720 of the housing, which is opposite a top side 718 of the housing, and a distal end extending away from the bottom side of the housing (fig. 24a, c) such that the first prong is capable of extending through the intercostal space between a first rib and a second rib (“[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original)); a first electrode 772a on the distal end of the first prong that is configured to be positioned adjacent to the first blood vessel ([0216], fig. 24a); and circuitry in the housing in electrical communication with the first electrode that is configured to deliver electrical stimulation using the first electrode ([0106]) to create an electric field (an electric field is inherently generated with electrical stimulation).
Manicka does not expressly disclose the first prong extends through the intercostal space between a first rib and a second rib is configured to be positioned adjacent to a first blood vessel, and the first electrode creating an electric field around the first blood vessel. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). Manicka does disclose the positioning of first prong is flexible and can vary in orientation (fig. 24c-d), and one of ordinary skill in the art before the effective filing date of the claimed invention would think it obvious that the first prong would be capable of being positioned in a variety of locations such as extending through the intercostal space between a first rib and a second rib to be positioned adjacent to a first blood vessel. Furthermore, Chekanov teaches positioning a subcutaneously implantable device comprising: an electrode 22 configured to be positioned adjacent to a first blood vessel 16; and delivering electrical stimulation using the first electrode to create an electric field around the first blood vessel (col. 2, lines 35-43). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try using the device of Manicka where the electrode on the first prong is positioned to create an electric field around a first blood vessel taught by Chekanov in order to provide therapy for more effectively preventing and treating atherosclerosis.
Manicka discloses an anchoring clip 704 attached to the housing that is configured to anchor the device to a muscle, a bone, and/or a first tissue (“Clip 704 is configured to anchor subcutaneous device 700 to xiphoid process X and sternum S” [0220]), but does not expressly disclose a first curved anchoring arm attached to a first side of the housing that is shaped to anchor the device to a first rib, the first curved anchoring arm comprising a first body extending from the first side of the housing; a first opening extending through the first body from a top side of the first body to a bottom side of the first body; and at least one tine extending from the bottom side of the first body and configured to pierce the first rib; a second curved anchoring arm attached to a second side of the housing, the second side of the housing being opposite the first side of the housing, that is shaped to anchor the device to a second rib, the second curved anchoring arm comprising: a second body extending from the second side of the housing; a second opening extending through the second body from a top side of the second body to a bottom side of the second body; and at least one tine extending from the bottom side of the second body and configured to pierce the second rib; wherein the first curved anchoring arm and the second curved anchoring arm are sized and shaped to hold the subcutaneous device in position on the first rib and the second rib, and the housing is configured to fit in an intercostal space between the first rib and the second rib. Gibson teaches an implantable medical device 38 where a first curved anchoring arm 39 and a second curved anchoring arm 39 (fig. 5; anchoring arms 39 show a curved appearance; “The flanges 39 are formed so as to be relatively robust whilst also sufficiently malleable so that the entire faceplate 37 can be formed to the shape of the skull surrounding the mastoid cavity by the surgeon using finger pressure only.” col. 6, lines 13-16; suggesting anchoring arms are capable of becoming curved to align with the shape of the skull) is attached to a first and second side of a housing (fig. 5), the second side of the housing being opposite the first side of the housing, the first curved anchoring arm comprising: a first body extending from the first side of the housing (fig. 6); a first opening (“a slit or hole” col. 6, line 50) extending through the first body from a top side of the first body to a bottom side of the first body; and at least one tine 36 extending from the bottom side of the first body and configured to pierce a first bone (“securing of the unit to the skull via surgical screws 36” col. 5, lines 59-60); a second curved anchoring arm comprising: a second body extending from the second side of the housing (fig. 6); a second opening (“a slit or hole” col. 6, line 50) extending through the second body from a top side of the second body to a bottom side of the second body; and at least one tine 36 extending from the bottom side of the second body and configured to pierce a second bone (“securing of the unit to the skull via surgical screws 36” col. 5, lines 59-60); wherein the housing is configured to fit in a gap 35 between the first bone and the second bone (“mastoid cavity” col. 5, lines 55-57). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Manicka and substitute the anchoring clip 704 for the first and second anchoring arms, attached to first and second sides of the housing, respectively, as taught by Gibson as it appears to be an equivalent structure for attaching to bone tissue (col. 5, lines 49-62) but would provide more superior securement of the subcutaneously implantable device via multiple tines 36 as compared to a singular anchoring clip. Such a modification would also be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as being capable of having the first anchoring arm configured to anchor the device to a first rib; and capable of having the second anchoring arm configured to anchor the device to a second rib, such that the housing fits in an intercostal space between the first rib and the second rib, as the instant application states, “First anchoring arm 304A and second anchoring arm 304B can be anchored to the same structural body component A (i.e., the same muscle, bone, or tissue) or to different structural body components A (i.e., different muscles, bones, or tissues) positioned on opposite sides of housing 302” ([0087] of the published application), indicating that providing anchoring arms to secure to different muscle, bone or tissue is merely a matter of where the housing of the device is intended to be implanted, and the surrounding tissues adjacent to the housing. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Furthermore the limitation, “wherein the first anchoring arm and the second anchoring arm are sized and shaped to hold the subcutaneous device in position on the first rib and the second rib” would have required only a matter of design choice to modify the size and shape of the first and second anchoring arm disclosed in Manicka in view of Gibson to an effective size and shape to hold the subcutaneous device in position on the first rib and the second rib since such a modification would have involved a mere change in size and shape of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Allowable Subject Matter
Claims 17 and 20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 17 is directed to a method of preventing and treating atherosclerosis, the method comprising anchoring a housing of a subcutaneous device to a first rib using a first anchoring arm attached to a first side of the housing and to a second rib using a second anchoring arm attached to a second side of the housing, the second side of the housing being opposite the first side of the housing, such that the housing fits in an intercostal space between the first rib and the second rib; and transmitting electrical stimulation from the housing to a first electrode on a distal end of a first prong positioned adjacent to a first blood vessel thereby creating an electric field around the first blood vessel, wherein the first prong has a proximal end attached to a bottom side of the housing, which is opposite a top side of the housing, and the distal end extends away from the bottom side of the housing such that the first prong extends through the intercostal space between the first rib and the second rib. Chekanov (US 6,201,991), Manicka (US 2020/0077953) and Ball et al. (US 2022/0201411) all disclose portions of the claimed invention but do not disclose the method of preventing and treating atherosclerosis, comprising anchoring a housing of a subcutaneous device to a first rib using a first anchoring arm attached to a first side of the housing and to a second rib using a second anchoring arm attached to a second side of the housing, the second side of the housing being opposite the first side of the housing, such that the housing fits in an intercostal space between the first rib and the second rib; and transmitting electrical stimulation from the housing to a first electrode on a distal end of a first prong positioned adjacent to a first blood vessel thereby creating an electric field around the first blood vessel, wherein the first prong has a proximal end attached to a bottom side of the housing, which is opposite a top side of the housing, and the distal end extends away from the bottom side of the housing such that the first prong extends through the intercostal space between the first rib and the second rib. Rys (US 2018/0272122) discloses placing a device in the intercostal space between two ribs, but does not disclose anchoring a housing of the device to a first rib using a first anchoring arm attached to a first side of the housing and to a second rib using a second anchoring arm attached to a second side of the housing, the second side of the housing being opposite the first side of the housing. Forsell (US 2011/0196193) teaches anchoring a device to ribs but does not disclose the method of anchoring is with a first and second anchoring arm in the manner claimed.
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.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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