DETAILED ACTION
This office action is in response to the amendment filed 9/22/2024. As directed by the amendment, claims 1, 19, 24, and 28 have been amended, claims 20-21, 25-27 and 29-35 have been cancelled, and no claims have been newly added. Thus, claims 1-19, 22-24 and 28 are presenting pending in this application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-19, 22-24 and 28 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claims 1, 24, and 28, lines 6-7 of claims 1 and 24 recites, “by providing micro-indentations in the barrier product” and lines 12-13 recites “so that the exterior surface provides micro indentations in the barrier product”. It is unclear how to determine the metes and bounds of a size of an indention that would comprise a “micro-indention”. Furthermore, applicant’s disclosure discloses that the micro-protrusions are provided by a blunt tip or a rivet-shaped tip, and therefore it is unclear how a blunt tip or rivet-shaped can provide an indentation on a micro scale.
Claims 2-19, and 22-23 are rejected for being either directly or indirectly depending from a rejected claim base.
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 of this title, 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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-3, 5, 14-16, 19, and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lipsner (1,923,317) in view of West (2018/0042806).
Regarding claim 1, Lipsner discloses a medical device (massage device), comprising a handle (4) (hollow handle); a roller arm (3) (hollow goose-neck); and a roller head (1) (massage head) (page 1, lines 89-93), wherein an exterior surface of the roller head (1) is configured to enhance adhesion of a barrier product to an area of mammal skin near a wound opening (device is configured to provide a massage with a roller surface (page 1, lines 9-15), and therefore, because the exterior surface of the roller head is configured to apply pressure to a user’s skin, it would be capable of being used in wound care for enhancing adhesion to a barrier product having a pressure-sensitive adhesive to an area of skin near a wound opening).
Lipsner does not disclose an exterior surface of the roller head comprises one or more protrusions extending therefrom, wherein the protrusions have a blunt tip or a rivet shaped tip.
However, West teaches a massage roller including a roller head (10) (roller), wherein the roller head (10) includes protrusions (15) (nubs) extending from the exterior surface of the roller head (10) and having a blunt tip (nubs (15) are rounded rectangular in shape) (para [0015]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Lipsner by providing the roller head with protrusions extending from the exterior surface of the roller head and having a blunt tip as taught by West in order to help the massaging of a person’s muscles as the roller head rolls over them, allowing for a deeper massage (West, para [0015]). The now-modified Lipsner’s device is considered to be capable of performing of function of enhancing adhesion of a barrier product of an area of mammal skin by providing micro indentations in the barrier product, as the modified Lipsner’s device includes protrusions (15 of West) (nubs) extending from the exterior surface of the roller head (10 of West) and having a blunt tip (West, para [0015]), and therefore, if the device of modified Lipsner is rolled on an adhesive barrier product, the protrusions would provide micro indentations in the barrier and therefore enhance adhesion of the barrier product to an area of animal skin near a wound opening.
Regarding claim 2, Lipsner in figs 1-2 discloses the handle (4) comprises: a handle body (body of hollow handle) having a proximal end (left end towards the butt of the handle) and a distal end (right end of handle adjacent to threaded nipple (11)); and a handle nozzle (11) (threaded nipple) on the distal end of the handle body (4), wherein the handle nozzle (11) is configured to receive a roller arm attachment on the roller arm (3) (as shown in fig 2, roller arm (3) includes a roller arm attachment comprising a threaded portion disposed on a proximal portion of roller arm (3) to connect it to handle nozzle (11)) (page 1, lines 102-106).
Regarding claim 3, Lipsner in fig 2 discloses the roller arm attachment is positioned on a proximal end of the roller arm (3) (as shown in fig 2, roller arm attachment comprising a threaded portion is disposed on a proximal portion of roller arm (3) to connect it to handle nozzle (11)) (page 1, lines 102-106).
Regarding claim 5, Lipsner in fig 2 discloses the handle body (4) defines a hollow interior space for receiving wiring and/or electronics (as shown in fig 2 of Lipsner, hollow handle (4) defines a hollow interior space for receiving wiring (9) (flexible leads)) (page 1, lines 97-101).
Regarding claim 14, Lipsner discloses the handle (4) has an exterior surface configured for manual gripping (as shown in fig 1, handle (4) has an outer surface that can be gripped by a user).
Regarding claim 15, Lipsner discloses the roller arm (3) comprises: an angled roller arm body (3) (as shown in fig 2, roller arm (3) has a goose-neck shape having angled bends) extending from a connector end (proximal end connected to the nipple (10) (page 1, lines 101-105) to a mounting end (distal end connected to large headed screw (11)) (page 2, lines 11-15).
Regarding claim 16, Lipsner discloses the roller arm body (3) is configured to extend from the connector end and bend around the roller head (1) so that the mounting end fits within an opening in the roller head (1) (large headed screw (11) in the mounting end first into a recess at the end of the roller head (1)) (page 2, lines 11-15).
Regarding claim 19, Lipsner discloses a roller head.
Lipsner does not disclose the roller head comprises protrusions arranged in a staggered pattern on the exterior surface of the roller head.
However, West teaches a massage roller including a roller head (10) (roller), wherein the roller head (10) includes protrusions (15) (nubs) (para [0015]), and as shown in fig 1, are shown to be arranged in a staggered pattern on the exterior surface of the roller head (10).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Lipsner by providing the roller head with protrusions arranged in a staggered pattern on the exterior surface of the roller head as taught by West in order to help the massaging of a person’s muscles as the roller head rolls over them, allowing for a deeper massage (West, para [0015]).
Regarding claim 22, Lipsner discloses the roller head (1) has an opening on at least one side thereof for receiving a mounting portion (11) (large-headed screw) of the roller arm (1) (as shown in fig 2, roller includes a recessed portion to receive a large-headed screw (11) and therefore includes an opening to allow the large-headed screw (11) and spindle portion (2) of roller arm (1) to extend through the roller head (1)) (page 2, lines 11-15).
Regarding claim 23, Lipsner discloses the roller head (1) is removable from the roller arm (3) (roller head (1) is held in place by a large-headed screw (11) and the position of the roller head (1) can be reversed, and therefore, the roller head (1) is removable from the roller arm (3) by unscrewing the large-headed screw (11) to reverse the position of the roller head (1)) (page 2, lines 11-15).
Claim 4, 8, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lipsner and West as applied to claim 2 above, and further in view of Yi (2020/0268593).
Regarding claim 4, modified Lipsner discloses a handle body and a nozzle.
Modified Lipsner does not disclose the handle body and the handle nozzle are releasably attachable.
However, Yi teaches a massage roller device including a handle body (1) (connecting body), the handle body (1) including a battery (11), a control chip (12), and a switch (9), a nozzle (4) (fixing bolt cap), a roller arm (2) (support), and a roller head (3) (massage roller) (para [0018]), wherein the handle body (1), the nozzle (4), and the roller arm (2) are releasable attachable using a screw connection, with wires (13) and interconnecting pieces (14) configured to provide an electrical connection between the handle body (1), nozzle (4), and roller arm (2) (para [0024]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Lipsner configuring the handle body and the handle nozzle to be releasably attachable by providing a screw connection with wires and interconnecting pieces as taught by Yi in order to allow different rollers to be changed according to a user’s form, and to allow respective parts of the roller device to be detachably cleaned (Yi, para [0024]).
Regarding claim 8, modified Lipsner discloses a roller arm attachment.
Modified Lipsner does not disclose the roller arm attachment comprises an electrical connector.
However, Yi teaches a massage roller device including a handle body (1) (connecting body), the handle body (1) including a battery (11), a control chip (12), and a switch (9), a nozzle (4) (fixing bolt cap), a roller arm (2) (support), and a roller head (3) (massage roller) (para [0018]), wherein the handle body (1), the nozzle (4), and the roller arm (2) are releasable attachable using a screw connection, with wires (13) and interconnecting pieces (14) configured to provide an electrical connection between the handle body (1), nozzle (4), and roller arm (2) (para [0024]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Lipsner by providing the roller arm attachment with an electrical connection including a screw connection with wires and interconnecting pieces as taught by Yi in order to allow different rollers to be changed according to a user’s form, and to allow respective parts of the roller device to be detachably cleaned (Yi, para [0024]).
Regarding claim 11, modified Lipsner in fig 1 discloses the handle nozzle (10) has a proximal end configured to connect to the distal end of the handle body (4), and the handle nozzle has a distal end having a distal end portion configured to mate with the attachment on the roller arm (3) (page 1, lines 102-106)
Modified Lipsner does not disclose the distal end of the handle nozzle further comprises an electrical connector for engaging an electrical connector on the attachment on the roller arm.
However, Yi teaches a massage roller device including a handle body (1) (connecting body), the handle body (1) including a battery (11), a control chip (12), and a switch (9), a nozzle (4) (fixing bolt cap), a roller arm (2) (support), and a roller head (3) (massage roller) (para [0018]), wherein the handle body (1), the nozzle (4), and the roller arm (2) are releasable attachable using a screw connection, with wires (13) and interconnecting pieces (14) configured to provide an electrical connection between the handle body (1), nozzle (4), and roller arm (2) (para [0024]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Lipsner by providing the distal end of the handle nozzle further with an electrical connector for engaging an electrical connector on the attachment on the roller arm as taught by Yi in order to allow different rollers to be changed according to a user’s form, and to allow respective parts of the roller device to be detachably cleaned (Yi, para [0024]).
Claims 9-10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lipsner, West and Yi as applied to claims 8 and 11 above, and further in view of Siddhartha (2004/0193080).
Regarding claim 9, modified Lipsner discloses the handle body defines a hollow interior space for receiving wiring and/or electronics (Lipsner, fig 1, page 1, lines 97-102) , and as shown in figs 1 and 4 of Yi, the electrical connector in the roller arm (2 of Yi) is shown to be a male screw connector configured to receive a female connector in the nozzle (3 of Yi) in electrical communication with the electronics (11, 12 of Yi) positioned within the hollow interior space of the handle body (1 of Yi) (para [0024]).
Modified Lipsner does not disclose the roller arm attachment electrical connector is a female connector configured to receive a male connector in electrical communication with the electronics positioned within the hollow interior space of the handle body.
However, Siddhartha teaches a massage device including a handle end portion (10) (para [0024]), a handle nozzle (42), and a massage body (30) (vibrator body), wherein a connector on the massage body includes a connector on a base end (32) (para [0030]), and as shown in fig 5B the handle nozzle (42) including a male connector (102) (male thread pattern) configured to connect to a base end of the massage body (30) (para [0030]), and therefore, the connector on the massage body (30) is a female connector.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Lipsner so that the roller arm attachment electrical connector is a female connector configured to receive a male connector in electrical communication with the electronics positioned within the hollow interior space of the handle body as taught by Siddhartha, as the feature of providing a male screw thread pattern on a handle nozzle configured to connect to a female screw thread pattern on a massage device would be an obvious rearrangement of parts, as the arrangement is known in the art, and it appears that the device of modified Lipsner would perform equally well to provide a connection between the handle nozzle and the roller arm attachment. See MPEP 2144.04(VI)(C).
Regarding claim 10, modified Lipsner discloses handle (4 of Lipsner) includes a hollow interior space for receiving wiring and/or electronics (as shown in fig 1 of Lipsner, the handle (4 of Lipsner) is hollow to receive flexible leads (9)) (page 1, lines 97-101).
Modified Lipsner does not disclose the electronics are one or more of a heating element, a power source, a lighting element, and/or a motor.
However, Yi teaches a massage roller device including a handle body (1) (connecting body), the handle body (1) including a battery (11), a control chip (12), and a switch (9) (para [0018]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Lipsner by substituting the flexible lead power source with a power source comprising electronics including a battery, a control chip and a switch disposed within the hollow interior space of the handle body as taught by Yi in order to allow the device to be portable so that a user can use the device without requiring the device to be plugged in.
Regarding claim 12, modified Lipsner discloses in figs 1 and 4 of Yi, the electrical connector in the roller arm (2 of Yi) is shown to be a male screw connector configured to receive a female connector in the nozzle (3 of Yi) (Yi, para [0024]).
Modified Lipsner does not discloses an electrical connector on the distal end of the handle nozzle is a male connector and the electrical connector on the attachment of the roller arm is a female connector.
However, Siddhartha teaches a massage device including a handle end portion (10) (para [0024]), a handle nozzle (42), and a massage body (30) (vibrator body), wherein a connector on the massage body includes a connector on a base end (32) (para [0030]), and as shown in fig 5B the handle nozzle (42) including a male connector (102) (male thread pattern) configured to connect to a base end of the massage body (30) (para [0030]), and therefore, the connector on the massage body (30) is a female connector.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Lipsner so that the roller arm attachment electrical connector is a female connector configured to receive a male connector in electrical communication with the electronics positioned within the hollow interior space of the handle body as taught by Siddhartha, as the feature of providing a male screw thread pattern on a handle nozzle configured to connect to a female screw thread pattern on a massage device would be an obvious rearrangement of parts, as the arrangement is known in the art, and it appears that the device of modified Lipsner would perform equally well to provide a connection between the handle nozzle and the roller arm attachment. See MPEP 2144.04(VI)(C).
Claims 6-7 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lipsner and West as applied to claims 1 and 5 above, and further in view of Nan (2006/0069329).
Regarding claim 6, modified Lipsner discloses a handle body.
Modified Lipsner does not disclose the handle body has a removable inner sleeve surrounding the interior space.
However, Nan teaches a massage device including a handle body (18) (proximal portion of body (12) (para [0023]), wherein the handle body (18) includes a removable battery compartment (20), and as shown in fig 8, the removable battery compartment (20) includes an inner sleeve shown as a hollow housing (54) (para [0030]), which surrounds an interior space (17A) (hollow cavity) of the handle body (18) (figs 5, 9, para [0024]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Lipsner by substituting the flexible lead power source with a power source comprising a removable battery compartment with a hollow housing forming a sleeve surrounding the interior space of the handle body as taught by Nan in order to allow the device to be portable so that a user can use the device without requiring the device to be plugged in, and enabling one or more batteries to be installed or removed simultaneously, and providing a water-tight seal upon engagement with the handle (Nan, para [0004]).
Regarding claim 7, modified Lipsner disclose a handle body having a proximal end.
Modified Lipsner does not disclose the proximal end of the handle body has a removable end cap thereon.
However, Nan teaches a massage device including a handle body (18) (proximal portion of body (12) (para [0023]), wherein the handle body (18) includes a removable battery compartment (20), wherein the removable battery compartment (20) includes an end cap (57) (cap member) configured to connect to a proximal end (17b) (open end) of the handle body (18) (fig 9, para [0030])
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Lipsner by substituting the wired power source with a power source comprising a removable battery compartment with an end cap removable from the proximal end of the handle body as taught by Nan in order to allow the device to be portable so that a user can use the device without requiring the device to be plugged in, and enabling one or more batteries to be installed or removed simultaneously, and providing a water-tight seal upon engagement with the handle (Nan, para [0004]).
Regarding claim 13, modified Lipsner disclose a handle having a proximal end.
Modified Lipsner does not disclose a proximal end of the handle has a removable end cap thereon.
However, Nan teaches a massage device including a handle body (18) (proximal portion of body (12) (para [0023]), wherein the handle body (18) includes a removable battery compartment (20), wherein the removable battery compartment (20) includes an end cap (57) (cap member) configured to connect to a proximal end (17b) (open end) of the handle body (18) (fig 9, para [0030])
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Lipsner by substituting the wired power source with a power source comprising a removable battery compartment with an end cap removable from the proximal end of the handle body as taught by Nan in order to allow the device to be portable so that a user can use the device without requiring the device to be plugged in, and enabling one or more batteries to be installed or removed simultaneously, and providing a water-tight seal upon engagement with the handle (Nan, para [0004]).
Claim 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lipsner and West as applied to claim 1 above, and further in view of Ackerman (2,565,109).
Regarding claim 18, modified Lipsner discloses a handle and a handle nozzle.
Modified Lipsner does not disclose the handle body and the handle nozzle are formed as a unitary single piece body.
However, Ackerman teaches a massaging device including a handle (24), wherein the handle (24) includes handle body (longitudinal portion of handle (24)) and a handle nozzle (26) (tubular passage) configured to connect to a roller arm attachment (25) (tubular extension) on a roller arm (19) (member) (col 2, ln 17-21), and as shown in fig 1, the handle (24) and tubular passage (26) is shown to be made of a single piece of material, and therefore, the handle body and the handle nozzle (26) are formed as a unitary single piece body.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Lipsner so that the handle body and the handle nozzle are formed as a unitary single piece body, as a handle formed with a handle body and a handle nozzle formed as a unitary single piece body is known in the art, and it appears that a handle with a handle body and a handle nozzle made as an integral unit and formed as a unitary single piece body would perform equally well to connect to a roller arm and be gripped by a user. See MPEP 2144.04(V)(B).
Claim 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lipsner in view of West and Nicholson (2011/0313333).
Regarding claim 24, Lipsner discloses a medical device kit comprising a medical device (massage device), comprising a handle (4) (hollow handle); a roller arm (3) (hollow goose-neck); and a roller head (1) (massage head) (page 1, lines 89-93), wherein an exterior surface of the roller head (1) is configured to enhance adhesion of a barrier product to an area of mammal skin near a wound opening (device is configured to provide a massage with a heated roller surface (page 1, lines 9-15), and therefore, because the exterior surface of the roller head is configured to apply pressure to a user’s skin, it would also be capable of enhancing adhesion to a barrier product having a pressure-sensitive adhesive to an area of skin near a wound opening).
Lipsner does not disclose an exterior surface of the roller head is configured to enhance adhesion of a barrier product to an area of mammal skin near a wound opening by providing micro indentations in the barrier product.
However, West teaches a massage roller including a roller head (10) (roller), wherein the roller head (10) includes protrusions (15) (nubs) extending from the exterior surface of the roller head (10) and having a blunt tip (nubs (15) are rounded rectangular in shape) (para [0015]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Lipsner by providing the roller head with protrusions extending from the exterior surface of the roller head and having a blunt tip as taught by West in order to help the massaging of a person’s muscles as the roller head rolls over them, allowing for a deeper massage (West, para [0015]). The now-modified Lipsner’s device is considered to be capable of performing of function of enhancing adhesion of a barrier product of an area of mammal skin by providing micro indentations in the barrier product, as the modified Lipsner’s device includes protrusions (15 of West) (nubs) extending from the exterior surface of the roller head (10 of West) and having a blunt tip (West, para [0015]), and therefore, if the device of modified Lipsner is rolled on an adhesive barrier product, the protrusions would provide micro indentations in the barrier and therefore enhance adhesion of the barrier product to an area of animal skin near a wound opening.
The now-modified Lipsner’s device does not disclose instructions for using the medical device.
However, Nicholson teaches a massage kit, wherein the massage kit includes a massage device (210) (massage implement) and instructions (a set of instructions and/or diagrams) for using the massage device (210) (para [0078]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the medical device kit of modified Lipsner by providing instructions for using the medical device as taught by Nicholson in order to provide guidelines on how to use the device (Nicholson, para [0078]).
Claim 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Geng (2002/0019602) in view of Merckel et al (2022/0062059), Caldirola (2014/0148744), and West, with Hunter (2019/0274914) and applicant’s admitted prior art provided as evidence.
Regarding claim 28, Geng discloses a method of applying a barrier product (2) (wound dressing) for wound care and/or for increasing adhesion of a barrier product to skin of a mammal in an area near a wound, comprising: applying the barrier product (2) to an area of mammal skin near a wound opening W so as to adhesively contact the area of the mammal skin near the wound area (second portion (12) adheres to an area of skin near wound opening W) (para [0031]); applying pressure to the barrier product (2) in the area of the mammal skin near the wound area (wound dressing (2) is pressed against the skin so that the second portion (12) of the backing material adheres to the individual while the first portion 10 covers the wound (para [0031]).
Geng does not disclose the method steps of providing a medical device, comprising a handle; a roller arm; and a roller head, wherein an exterior surface of the roller head is configured to enhance adhesion of a barrier product to an area of mammal skin near a wound opening and manually contacting the roller head to the barrier product and rolling the roller head across the barrier product in the area of the mammal skin near the wound area.
However, Merckel teaches a method for applying a wound dressing to a skin of a patient, wherein a device comprising a roller is provided (metal roll is used to apply a test material for a wound dressing), applying a barrier product (test material for a wound dressing) to an area of mammal skin, and manually contacting the roller head to the barrier product and rolling the roller head across the barrier product in the area of the mammal skin (test materials of a wound dressing is applied by a technician and pressed to the skin with the use of a metal roll by rolling it back and forth) (para [0103]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of Geng by providing the method steps of providing a roller, and manually contacting the roller to the barrier product and rolling the roller across the barrier product in the area of the mammal skin as taught by Merckel, in order to provide a known method of pressing a barrier product to the skin of a patient (Merckel, para [0103]). The now-modified Geng’s method discloses that the roller head is rolled across the barrier product in the area of the mammal skin near the wound area, as Geng discloses that pressure is applied to the barrier product (2) in the area of the mammal skin near the wound area (wound dressing (2) is pressed against the skin so that the second portion (12) of the backing material adheres to the individual while the first portion 10 covers the wound (para [0031]) and Merkell discloses using the roller is rolled across the barrier product in the area of the mammal skin (para [0103]), and therefore the roller head is rolled across the barrier product in the area of the mammal skin near the wound area.
The now-modified Geng’s method does not disclose the roller comprises a handle, a roller arm, and a roller head.
However, Caldirola teaches a medical device comprising a handle (2), a roller arm (4) (rod), and a roller head (6) (roller) (para [0014]), and including a signal means intended comprising a graduated scale (36) to provide a signal indicative of the pressure level or of the compression force exerted on the roller (paras [0025]-[0026]) wherein an exterior surface of the roller head (2) is configured to enhance adhesion of a barrier product to an area of mammal skin near a wound opening (roller head (2) is configured to exert a pressure (para [0022]) and therefore is configured to enhance adhesion of a barrier product to an area of mammal skin near a wound opening by pressing a barrier product the skin of a mammal), wherein the device is configured so that the roller head is roller in an area of mammal skin to exert pressure on a mammal’s skin (para [0002]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of modified Geng by modifying the roller to comprise a handle; a roller arm; a roller head; and a signal means intended to provide a signal indicative of the pressure level or of the compression force exerted on the roller, during treatment, wherein an exterior surface of the roller head is configured to enhance adhesion of a barrier product to an area of mammal skin near a wound opening and (c) manually contacting the roller head to the barrier product and rolling the roller head across the barrier product in the area of the mammal skin near the wound area as taught by Caldirola in order to allow a user to determine a pressure applied by the roller while it is used (Caldirola, para [0004]).
The now-modified Geng’s method does not disclose the exterior surface of the roller provides micro indentations in the barrier product.
However, West teaches a massage roller including a roller head (10) (roller), wherein the roller head (10) includes protrusions (15) (nubs) extending from the exterior surface of the roller head (10) and having a blunt tip (nubs (15) are rounded rectangular in shape) (para [0015]). Furthermore, applicant’s disclosure in paragraph [0018] of the specification discloses that commonly and widely practiced methods used by healthcare professionals and patients alike to increase and secure adhesion, and try to achieve sufficient contact between one of the above-noted barrier compounds or adhesives and the skin include creating multiple areas of micro-indentation around the perimeter of the applied barrier, which is considered to be applicant admitted prior art because paragraph [0018] discloses the providing multiple areas of micro-indentation is a commonly and widely practiced method, and therefore would have been known by one of ordinary skill in that art at the time of the effective filing date of the invention. In the alternative, Hunter et al teaches a device and method for treating a patient, including a manipulating head (1114) to a patient having a plurality of blunt tips (1116) (para [0083], wherein the manipulating head (1114) can be applied to a patient at a wound, and where skin integrity is disrupted, placing the manipulating head adjacent to the disrupted site (para [0007]), to reduce pain and enhance wound healing or repair at the injured site (para [0008]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of modified Geng by configuring the exterior surface to protrusions extending from the exterior surface of the roller head and having a blunt tip to provides micro indentations in the barrier product as taught by West, because, as evidenced by applicant’s admitted prior art, the feature of providing micro indentations in a barrier product is known in the art to enhance adhesion of a barrier product (Specification, para [0018]), and the roller device of modified Geng modified with the protrusions of West would be operable to provide micro indentations in the barrier product using the roller device. In the alternative, although it is unclear whether applicant’s disclosure in para [0018] constitutes applicant admitted prior art, Hunter teaches that the feature of using a manipulator head with an exterior surface comprising a plurality of protrusions having a blunt tip at an area adjacent to a disrupted site to reduce pain and enhance wound healing or repair at the injured site (Hunter, para [0008]) is known in the art, and the roller device of modified Geng modified with the protrusions of West would be operable to provide micro indentations in the barrier product when the roller device is used at an area adjacent to a skin disrupted site to reduce pain and enhance wound healing or repair at the injured site.
Response to Arguments
Applicant's arguments filed 9/22/2025 have been fully considered but they are not persuasive.
Applicant argues on page 6, third full paragraph-page 7, second full paragraph of applicant’s remarks, Lipsner’s device is configured to reduce fatty tissue and has not suggestion or guidance for use of its massage device for applying a barrier product in the application of ostomy bags. In response to applicant's argument that Lipsner does not recite the use of the device for applying a barrier product, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the roller of Lipsner is capable of being used for wound care, as the roller is capable of being roller over an adhesive bandage, and application of pressure would assist in allow the bandage to adhere to a user’s skin. Therefore, the rejection is maintained.
Applicant argues on page 7, third full paragraph of applicant’s remarks, that Lipsner does not disclose the roller having any particular shape on its surface for providing micro indentations or protrusions. However, applicant’s argument is moot in view of the new grounds of rejection further in view of West, which teaches a massage roller including a roller head (10) (roller), wherein the roller head (10) includes protrusions (15) (nubs) extending from the exterior surface of the roller head (10) and having a blunt tip (nubs (15) are rounded rectangular in shape) (para [0015]). Therefore, it would have been obvious the skilled artisan, upon seeing West’s disclosure, to modify the device of Lipsner by providing the roller head with protrusions extending from the exterior surface of the roller head and having a blunt tip as taught by West in order to help the massaging of a person’s muscles as the roller head rolls over them, allowing for a deeper massage (West, para [0015]). The now-modified Lipsner’s device is considered to be capable of performing of function of enhancing adhesion of a barrier product of an area of mammal skin by providing micro indentations in the barrier product, as the modified Lipsner’s device includes protrusions (15 of West) (nubs) extending from the exterior surface of the roller head (10 of West) and having a blunt tip (West, para [0015]), and therefore, if the device of modified Lipsner is rolled on an adhesive barrier product, the protrusions would provide micro indentations in the barrier and therefore enhance adhesion of the barrier product to an area of animal skin near a wound opening. Therefore, the rejection is maintained.
Applicant argues on page 8, first full paragraph-page 9, first full paragraph of applicant’s remarks, that it would not have been obvious to combine the teaching of Yi with the device of Lipsner because Yi is directed to a cosmetic treatment device that uses Jade, which is not a common material used in a medical roller. However, Yi is considered to be within the same field of endeavor as Lipsner roller massage device, and Yi discloses that the invention relates to therapeutic massage devices (Yi, para [0002]). Furthermore, Yi is considered to be reasonably pertinent to the particular problem with which the invention was concerned, as applicant discloses that the device may have removable and interchangeable roller heads for use in different applications (Specification, para [0084]), and Yi discloses that the benefit of configuring the handle body and the handle nozzle to be releasably attachable is to allow different rollers to be changed according to a user’s form (Yi, para [0024]). The fact that Yi discloses that the roller material is made of Jade is not relied upon in the rejection, as Yi teaches the benefit of configuring the handle body and the handle nozzle are releasably attachable in order to allow different rollers to be changed according to a user’s form, and to allow respective parts of the roller device to be detachably cleaned (Yi, para [0024]), and therefore one of ordinary skill in the art would be motivated to apply the teaching of configuring the handle body and the handle nozzle to be releasably attachable by providing a screw connection with wires and interconnecting pieces in order to achieve a similar benefit to the device of Lipsner. Therefore, the rejection is maintained.
Applicant argues on page 9, second full paragraph of applicant’s remarks, that Yi does not disclose a roller head with protrusions, and the use of the protrusions to increase the adhesion of barrier products. However, as discussed above, because Lipsner and West disclose the feature of a roller head with protrusions, and which is capable of performing of the function of the use of the protrusions to increase the adhesion of barrier products, the rejection is maintained.
Applicant argues on page 9, third full paragraph-page 10, second full paragraph of applicant’s remarks, that the device of Siddhartha is directed to a vibrator assembly and therefore one of ordinary skill in the art would not to look to the device of Siddhartha to modify the device of Lipsner. However, both Lipsner and Siddhartha are massage devices and therefore are considered to be analogous art with respect to one another. Furthermore, Siddhartha is not relied upon for the vibrational mechanism, but for the feature of the electrical connector of the roller arm attachment being a female connector configured to receive a male connector in electrical communication with the electronics positioned within the hollow interior space of the handle body, which, as discussed above, is considered to be an obvious rearrangement of parts. See MPEP 2144.04(VI)(C).
Applicant argues on page 10, third and fourth full paragraphs of applicant’s remarks, that Siddhartha does not disclose a roller head with protrusions, and the use of the protrusions to increase the adhesion of barrier products. However, as discussed above, because Lipsner and West disclose the feature of a roller head with protrusions, and which is capable of performing of the function of the use of the protrusions to increase the adhesion of barrier products, the rejection is maintained.
Applicant argues on page 11, first and second full paragraphs of applicant’s remarks, that the device of Nan is directed to a waterproof sexual massage device with a vibratory element and therefore one of ordinary skill in the art would not to look to the device of Siddhartha to modify the device of Lipsner. However, both Lipsner and Nan are massage devices and therefore are considered to be analogous art with respect to one another. Furthermore, Nan is not relied upon for the vibrational mechanism, but for the feature of a removable inner sleeve comprising a battery compartment surrounding the interior space of the handle assembly, which would provide the benefit of allowing the massage roller device to be powered by a battery and so that the user can use the device without requiring the device to be plugged in, and Nan’s arrangement would provide the additional benefit of enabling one or more batteries to be installed or removed simultaneously, and providing a water-tight seal upon engagement with the handle (Nan, para [0004]). Therefore, the rejection is maintained.
Applicant argues on page 11, third paragraph of applicant’s remarks, that Nan does not disclose a roller head with protrusions, and the use of the protrusions to increase the adhesion of barrier products. However, as discussed above, because Lipsner and West disclose the feature of a roller head with protrusions, and which is capable of performing of the function of the use of the protrusions to increase the adhesion of barrier products, the rejection is maintained.
Applicant argues on page 12, first full paragraph-third full paragraph of applicant’s remarks, that the device of Ackerman is not in the field of wound care and the presence of a roller arm alone does not direct one of ordinary skill in the art to combine Lipsner and Ackerman. However, both Lipsner and Ackerman are massage devices and therefore are considered to be analogous art with respect to one another and the feature of forming the handle body and a handle nozzle formed as a unitary single piece body is known in the art, and it appears that a handle with a handle body and a handle nozzle made as an integral unit and formed as a unitary single piece body would perform equally well to connect to a roller arm and be gripped by a user. See MPEP 2144.04(V)(B). Therefore, the rejection is maintained.
Applicant argues on page 12, fourth full paragraph of applicant’s remarks, that neither Ackerman nor Lipsner disclose the ability to releasable attach the roller arm. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the ability to releasable attach the roller arm) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, the rejection is maintained.
Applicant argues on page 13, first full paragraph of applicant’s remarks, that Ackerman does not disclose a roller head with protrusions, and the use of the protrusions to increase the adhesion of barrier products. However, as discussed above, because Lipsner and West disclose the feature of a roller head with protrusions, and which is capable of performing of the function of the use of the protrusions to increase the adhesion of barrier products, the rejection is maintained.
Applicant argues on page 13, second and third full paragraphs of applicant’s remarks that West discloses a massage roller that is held together at both ends, which would not be considered for use around a wound site because the large area of the roller head is not maneuverable like the claimed invention. However, West is relied upon to teach the use of protrusions extending from the exterior surface of the roller head, which would achieve the benefit of allowing for a deeper massage (West, para [0015]), and therefore, the device of modified Lipsner discloses the features of claim 1 above. Therefore, the rejection is maintained.
Applicant argues on page 13, fourth full paragraph-page 14, first full paragraph of applicant’s remarks, that West discloses that the nubs are used to provide deep tissue massage and not optimized for the application of a barrier product on a sensitive wound site, and also does not disclose the exterior surface enhancing adhesion by providing micro indentions to enhance the application of the barrier product. However, the modified Lipsner’s device is considered to be capable of performing of function of enhancing adhesion of a barrier product of an area of mammal skin by providing micro indentations in the barrier product, as the modified Lipsner’s device includes protrusions (15 of West) (nubs) extending from the exterior surface of the roller head (10 of West) and having a blunt tip (West, para [0015]), and therefore, if the device of modified Lipsner is rolled on an adhesive barrier product, the protrusions would provide micro indentations in the barrier and therefore enhance adhesion of the barrier product to an area of animal skin near a wound opening. Therefore, the rejection is maintained.
Applicant argues on page 14, second full paragraph-page 15, third full paragraph of applicant’s remarks, that Masuda’s massager is a massage roller with a magnetic therapeutic effect with two hand grips, and therefore it would not have been obvious to combine Masuda with Lipsner. However, claim 21 has been cancelled and therefore applicant’s argument is moot.
Applicant argues on page 15, fourth full paragraph-page 16, first full paragraph of applicant’s remarks, that Nicholson has a different structure from that of Lipsner and one would not combine Lipsner and Nicholson because if their distinct structures. However, Nicholson is relied upon to teach the benefit of providing instructions for using a therapeutic massage device, and therefore, it would have been obvious to modify Lipsner’s device by providing instructions in order to provide guidelines on how to use the device (Nicholson, para [0078]). Therefore, the rejection is maintained.
Applicant argues on page 16, second and third full paragraphs of applicant’s remarks, that Nicholson does not disclose a roller head with protrusions, and the use of the protrusions to increase the adhesion of barrier products. However, as discussed above, because Lipsner and West disclose the feature of a roller head with protrusions, and which is capable of performing of the function of the use of the protrusions to increase the adhesion of barrier products, the rejection is maintained.
Applicant argues on page 16, fourth full paragraph-page 17, first full paragraph of applicant’s remarks, that Geng is directed to the barrier product itself and does not disclose a device aimed at improved adhesion of a barrier product. Although Geng does not disclose a device aimed at improved adhesion of a barrier product, Geng teaches the method steps of applying a barrier product near a wound and applying pressure to adhesively contact the area of the mammal skin near a wound opening, and the other prior art relied in the rejection disclose the method steps of using a roller device. Therefore, the rejection is maintained.
Applicant argues on page 17, second full paragraph of applicant’s remarks, that Merckle discloses an absorbent wound dressing that is applied by manual pressure. However, Merckle also discloses that a roller may be provide to apply pressure to a wound dressing by contacting the roller across the barrier product (test materials of a wound dressing is applied by a technician and pressed to the skin with the use of a metal roll by rolling it back and forth) (para [0103]), and therefore, Merckle teaches that the use of a roller to apply pressure to a wound dressing to a user’s skin is known in the art. Therefore, the rejection is maintained.
Applicant argues on page 17, third and fourth full paragraphs of applicant’s remarks, that Caldirola is directed to a device for lymphatic drainage, and is not comparable to the device of applicant’s invention which is aimed at increasing the adhesion of a barrier surface by providing micro indentions. However, the prior art discloses that a roller may be used by pressing a roller back and forth on the skin of a patient (Merckle, para [0103]), and therefore it would have been obvious to use the roller of Caldirola order to provide the benefit of allowing a user to determine a pressure applied by the roller while it is used (Caldirola, para [0004]). Therefore, the rejection is maintained.
Applicant argues on page 18, first and second paragraphs of applicant’s remarks, that the prior art does not disclose an exterior surface configured to enhance adhesion by providing micro indentations by having protrusions that may be rivet shaped to form micro indentions in the barrio compound. However, applicant’s argument is moot in view of the new grounds of rejection further in view of West, which teaches a massage roller including a roller head (10) (roller), wherein the roller head (10) includes protrusions (15) (nubs) extending from the exterior surface of the roller head (10) and having a blunt tip (nubs (15) are rounded rectangular in shape) (para [0015]). Furthermore, applicant’s disclosure in paragraph [0018] of the specification discloses that commonly and widely practiced methods used by healthcare professionals and patients alike to increase and secure adhesion, and try to achieve sufficient contact between one of the above-noted barrier compounds or adhesives and the skin include creating multiple areas of micro-indentation around the perimeter of the applied barrier, which is considered to be applicant admitted prior art because paragraph [0018] discloses the providing multiple areas of micro-indentation is a commonly and widely practiced method, and therefore would have been known by one of ordinary skill in that art at the time of the effective filing date of the invention. In the alternative, Hunter et al teaches a device and method for treating a patient, including a manipulating head (1114) to a patient having a plurality of blunt tips (1116) (para [0083], wherein the manipulating head (1114) can be applied to a patient at a wound, and where skin integrity is disrupted, placing the manipulating head adjacent to the disrupted site (para [0007]), to reduce pain and enhance wound healing or repair at the injured site (para [0008]). Therefore, it would have been obvious to the skilled artisan, upon seeing the disclosures of West, applicant’s admitted prior art, and Hunter, to modify the method of modified Geng by configuring the exterior surface to protrusions extending from the exterior surface of the roller head and having a blunt tip to provides micro indentations in the barrier product as taught by West, because, as evidenced by applicant’s admitted prior art, the feature of providing micro indentations in a barrier product is known in the art to enhance adhesion of a barrier product (Specification, para [0018]), and the roller device of modified Geng modified with the protrusions of West would be operable to provide micro indentations in the barrier product using the roller device. In the alternative, although it is unclear whether applicant’s disclosure in para [0018] constitutes applicant admitted prior art, Hunter teaches that the feature of using a manipulator head with an exterior surface comprising a plurality of protrusions having a blunt tip at an area adjacent to a disrupted site to reduce pain and enhance wound healing or repair at the injured site (Hunter, para [0008]) is known in the art, and the roller device of modified Geng modified with the protrusions of West would be operable to provide micro indentations in the barrier product when the roller device is used at an area adjacent to a skin disrupted site to reduce pain and enhance wound healing or repair at the injured site. Therefore, the rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS YOUNG SUL whose telephone number is (571)270-5260. The examiner can normally be reached on Monday-Friday 8:30 am-5 pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justine Yu can be reached on 571-272-48354835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785
/COLIN W STUART/Primary Examiner, Art Unit 3785