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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitations are interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 46, 53-54, 57-60, 64, 95-98, and 100-101 are rejected under 35 U.S.C. 102(a)(1) as being anticipate by U.S. Patent Application Publication No. 2013/0296738 (Swain)(previously cited).
Rejection based on FIG. 11 of Swain
With respect to claim 46, Swain teaches an ingestible apparatus for collecting a sample from a target area of a gastrointestinal (GI) tract of a subject, the ingestible apparatus comprising:
a housing defining a sample compartment (the leak proof chamber 1160 of Swain), the housing comprising a sealing surface (the sealing frame 1170 of Swain) having an access port (the porthole window formed by the sealing frame 1170 of Swain; paragraph 0059 of Swain) formed therein, and the sample compartment being communicable with the access port;
a stopper (the protruding part 1162 of Swain) configured to seal the access port;
an actuation assembly (the actuating mechanism of paragraph 0058 of Swain, the spring 1130, the cam 1140, and the hinge 1150 of Swain) connected to the stopper, the actuation assembly being configured with a first working position where the access port is open (the harvesting mode of Swain; paragraph 0058 of Swain) and a second working position where the access port is sealed with the stopper (the non-harvesting mode of Swain; paragraph 0058 of Swain); and
a mucosal-layer brush (the brush 1120 of Swain),
wherein the mucosal-layer brush is configured to spring outward and extend beyond a perimeter of the housing at the first working position of the actuation assembly (the brush 1120 of Swain is so configured in the harvesting mode of Swain; the brush 1120 springs outward since the spring 1130 moves the brush so that the bristles of the brush extend outside the housing in the harvesting mode; see paragraphs 0058-0059 of Swain), and
wherein the mucosal-layer brush is configured to retract within the sample compartment in the second working position of the actuation assembly (see the bristle of the brush 1120 retracted within the porthole window formed by the sealing frame 1170 in FIG. 11 of Swain; paragraphs 0057-0058 of Swain).
With respect to claim 53, Swain teaches that the mucosal-layer brush is configured for collecting the sample (the brush 1120 of Swain is so configured in the harvesting mode of Swain; see paragraphs 0058-0059 of Swain).
With respect to claim 54, Swain teaches that the stopper is connected to an end of the mucosal-layer brush (the protruding part 1162 is connected to an end of the brush 1120 of Swain).
With respect to claim 57, Swain teaches that the mucosal-layer brush is distributed radially around at least a portion of the housing (the brush 1120 of Swain is so radially distributed; see FIG. 11 of Swain).
With respect to claim 58, Swain teaches that the mucosal-layer brush comprises one or more bristles (the brush 1120 of Swain has bristles; see FIG. 11 of Swain).
With respect to claim 59, Swain teaches that the mucosal-layer brush further comprises a stem (the rod 1132 of Swain), wherein the one or more bristles are connected to the stem (the brush 1120 of Swain is connected to the rod 1132 of Swain; paragraph 0057 of Swain).
With respect to claim 60, Swain teaches that the one or more bristles are elongate members (the bristles of the brush 1120 of Swain are elongate members; see FIG. 11 of Swain).
With respect to claim 64, Swain teaches that the mucosal-layer brush is connected to the actuation assembly (the brush 1120 is connected to the spring 1130, the cam 1140, and the hinge 1150 of Swain; paragraphs 0058-0059 of Swain).
With respect to claim 95, Swain teaches that the actuation assembly comprises a spring (the spring 1130 of Swain).
With respect to claim 96, Swain teaches that the one or more bristles are spring loaded (the brush 1120 is connected to the spring 1130 of Swain; paragraphs 0058-0059 of Swain).
With respect to claim 97, Swain teaches an ingestible apparatus for collecting a sample from a target area of a gastrointestinal (GI) tract of a subject, the ingestible apparatus comprising:
a housing defining a sample compartment(the leak proof chamber 1160 of Swain), the housing comprising a sealing surface (the sealing frame 1170 of Swain) having an access port (the porthole window formed by the sealing frame 1170 of Swain; paragraph 0059 of Swain) formed therein, and the sample compartment being communicable with the access port;
a stopper (the protruding part 1162 of Swain) configured to seal the access port;
an actuation assembly (the actuating mechanism of paragraph 0058 of Swain, the spring 1130, the cam 1140, and the hinge 1150 of Swain) connected to the stopper, the actuation assembly being configured with a first working position where the access port is open (the harvesting mode of Swain; paragraph 0058 of Swain) and a second working position where the access port is sealed with the stopper (the non-harvesting mode of Swain; paragraph 0058 of Swain); and
a mucosal-layer brush (the brush 1120 of Swain),
wherein the stopper is connected to an end of the mucosal-layer brush (the protruding part 1162 is connected to an end of the brush 1120 of Swain), and
wherein the mucosal-layer brush is configured to spring outward and extend beyond a perimeter of the stopper at the first working position of the actuation assembly (the brush 1120 of Swain is so configured in the harvesting mode of Swain; the brush 1120 springs outward since the spring 1130 moves the brush so that the bristles of the brush extend outside the housing and away from the perimeter of the protruding part 1162 in the harvesting mode; see paragraphs 0058-0059 of Swain), and wherein the mucosal-layer brush is configured to retract within the access port in the second working position of the actuation assembly (see the bristle of the brush 1120 retracted within the porthole window formed by the sealing frame 1170 in FIG. 11 of Swain; paragraphs 0057-0058 of Swain).
With respect to claim 98, Swain teaches an ingestible apparatus for collecting a sample from a target area of a gastrointestinal (GI) tract of a subject, the ingestible apparatus comprising:
a housing defining a sample compartment (the leak proof chamber 1160 of Swain), the housing comprising a sealing surface (the sealing frame 1170 of Swain) having an access port (the porthole window formed by the sealing frame 1170 of Swain; paragraph 0059 of Swain) formed therein, and the sample compartment being communicable with the access port;
a stopper (the protruding part 1162 of Swain) configured to seal the access port;
an actuation assembly (the actuating mechanism of paragraph 0058 of Swain, the spring 1130, the cam 1140, and the hinge 1150 of Swain) connected to the stopper, the actuation assembly being configured with a first working position where the access port is open (the harvesting mode of Swain; paragraph 0058 of Swain) and a second working position where the access port is sealed with the stopper (the non-harvesting mode of Swain; paragraph 0058 of Swain); and
a mucosal-layer brush (the brush 1120 of Swain) comprising one or more spring-loaded bristles (the brush 1120 of Swain has bristles and is spring-loaded due to the spring 1130) and a stem (the rod 1132 of Swain),
wherein the one or more spring-loaded bristles are connected to the stem (the brush 1120 of Swain is connected to the rod 1132 of Swain; paragraph 0057 of Swain), and
wherein the spring-loaded bristles are configured to radially extend beyond the housing when the actuation assembly is in the first working position (the bristles of the brush 1120 extending radially from the housing in the harvesting position; paragraphs 0057-0058 of Swain) and configured retract within the access port in the second working position of the actuation assembly (see the bristle of the brush 1120 retracted within the porthole window formed by the sealing frame 1170 in FIG. 11 of Swain; paragraphs 0057-0058 of Swain).
With respect to claim 100, Swain teaches that the mucosal-layer brush extends beyond the stopper (the brush 1120 of Swain extends beyond the protruding part 1162 of Swain since they extend in different directions on the circular sampling wheel 1110).
With respect to claim 101, Swain teaches that the mucosal-layer brush extends radially beyond the stopper (the brush 1120 of Swain extends radially beyond the protruding part 1162 of Swain since they extend in different directions on the circular sampling wheel 1110).
Claims 46, 52-54, 57-60, 64-66, 97, and 100-101 are rejected under 35 U.S.C. 102(a)(1) as being anticipate by WO 2018/017658 (Stevens)(previously cited).
With respect to claim 46, Stevens teaches an ingestible apparatus for collecting a sample from a target area of a gastrointestinal (GI) tract of a subject, the ingestible apparatus comprising:
a housing defining a sample compartment (the chamber 7 of Stevens), the housing comprising a sealing surface (the circular flap 2 of Stevens) having an access port (the port formed by the circular flap 2 of Stevens) formed therein, and the sample compartment being communicable with the access port;
a stopper (the stopper cap 3 of Stevens) configured to seal the access port;
an actuation assembly (the piston mechanism 11 and 14 of Stevens) connected to the stopper, the actuation assembly being configured with a first working position where the access port is open (FIG. 3 of Stevens) and a second working position where the access port is sealed with the stopper (FIGS. 1 and 4 of Stevens); and
a mucosal-layer brush (the sponge/gauze/brushes 6 of Stevens),
wherein the mucosal-layer brush is configured to spring outward and extend beyond a perimeter of the housing at the first working position of the actuation assembly (the sponge/gauze/brushes 6 of Stevens is so configured in FIG. 3 of Stevens; the sponge/gauze/brushes 6 of Stevens are configured to spring outward to the extent that the sponge/gauze/brushes 6 of Stevens are released from confinement (see page 10 of the attached definition from www.merriam-webster.com) and extend beyond the perimeter of the chamber 7 of Stevens), and
wherein the mucosal-layer brush is configured to retract within the sample compartment in the second working position of the actuation assembly (the sponge/gauze/brushes 6 of Stevens is so configured in FIGS. 1 and 4 of Stevens).
With respect to claim 52, Stevens teaches that the actuation assembly further comprises a rigid or flexible piston (the piston mechanism 11 and 14 of Stevens).
With respect to claim 53, Stevens teaches that the mucosal-layer brush is configured for collecting the sample (the sponge/gauze/brushes 6 of Stevens is so configured in FIG. 3 of Stevens).
With respect to claim 54, Stevens teaches that the stopper is connected to an end of the mucosal-layer brush (the stopper cap 3 is connected to an end of the sponge/gauze/brushes 6 of Stevens).
With respect to claim 57, Stevens teaches that the mucosal-layer brush is distributed radially around at least a portion of the housing (the sponge/gauze/brushes 6 of Stevens is so radially distributed; see FIGS. 1 and 3-4 of Stevens).
With respect to claim 58, Stevens teaches that the mucosal-layer brush comprises one or more bristles (the brushes 6 of Stevens).
With respect to claim 59, Stevens teaches that the mucosal-layer brush further comprises a stem (the stem of the brushes 6 of Stevens), wherein the one or more bristles are connected to the stem (the brushes 6 of Stevens is connected to the stem; FIGS. 1 and 3-4 of Stevens).
With respect to claim 60, Stevens teaches that the one or more bristles are elongate members (the brushes 6 of Stevens; FIGS. 1 and 3-4 of Stevens).
With respect to claim 64, Stevens teaches that the mucosal-layer brush is connected to the actuation assembly (the sponge/gauze/brushes 6 is connected to the piston mechanism 11 and 14 of Stevens).
With respect to claim 65, Stevens teaches that the mucosal-layer brush comprises a fluid-absorbent material (the sponge/gauze 6 of Stevens).
With respect to claim 66, Stevens teaches that the housing further comprises at least one inlet port (the port 13 of Stevens) communicable with an exterior environment, the at least one inlet port being communicable with the access port (the port 13 of Stevens is communicable with the port formed by the circular flap 2 of Stevens).
With respect to claim 97, Stevens teaches an ingestible apparatus for collecting a sample from a target area of a gastrointestinal (GI) tract of a subject, the ingestible apparatus comprising:
a housing defining a sample compartment (the chamber 7 of Stevens), the housing comprising a sealing surface (the circular flap 2 of Stevens) having an access port (the port formed by the circular flap 2 of Stevens) formed therein, and the sample compartment being communicable with the access port;
a stopper (the stopper cap 3 of Stevens) configured to seal the access port;
an actuation assembly (the piston mechanism 11 and 14 of Stevens) connected to the stopper, the actuation assembly being configured with a first working position where the access port is open (FIG. 3 of Stevens) and a second working position where the access port is sealed with the stopper (FIGS. 1 and 4 of Stevens); and
a mucosal-layer brush (the sponge/gauze/brushes 6 of Stevens),
wherein the stopper is connected to an end of the mucosal-layer brush (the stopper cap 3 is connected to an end of the sponge/gauze/brushes 6 of Stevens), and
wherein the mucosal-layer brush is configured to spring outward and extend beyond a perimeter of the stopper at the first working position of the actuation assembly (the sponge/gauze/brushes 6 of Stevens is so configured in FIG. 3 of Stevens; the sponge/gauze/brushes 6 of Stevens are configured to spring outward to the extent that the sponge/gauze/brushes 6 of Stevens are released from confinement (see page 10 of the attached definition from www.merriam-webster.com) and extend beyond the perimeter of the chamber 7 of Stevens), and wherein the mucosal-layer brush is configured to retract within the access port in the second working position of the actuation assembly (the sponge/gauze/brushes 6 of Stevens is so configured in FIGS. 1 and 4 of Stevens).
With respect to claim 100, Stevens teaches that the mucosal-layer brush extends beyond the stopper (the sponge/gauze/brushes 6 of Stevens extends beyond the stopper cap 3 of Stevens; FIG. 3 of Stevens).
With respect to claim 101, Stevens teaches that the mucosal-layer brush extends radially beyond the stopper (the sponge/gauze/brushes 6 of Stevens extends radially beyond the stopper cap 3 of Stevens; FIG. 3 of Stevens).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 46, 53-54, 57, and 64-65 are rejected under 35 U.S.C. 103 as being unpatentable over Swain.
Rejection based on FIG. 12 of Swain
Swain teaches an ingestible apparatus for collecting a sample from a target area of a gastrointestinal (GI) tract of a subject, the ingestible apparatus comprising: a housing defining a sample compartment (the leak proof chamber 1250 of Swain), a stopper (the outer surface of the sampling wheel 1210 of Swain; paragraph 0062 of Swain) configured to seal the access port, an actuation assembly (the motor of paragraph 0061 of Swain) connected to the stopper, and a mucosal-layer brush (the sampling cavities with the porous material 1222 of Swain). Swain teaches that the spring 1130, the cam 1140, and the hinge 1150of Swain may be used in place of the motor (paragraphs 0025 and 0058-0059 of Swain). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the spring 1130, the cam 1140, and the hinge 1150of Swain in place of the motor since it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 46, Swain teaches or suggests an ingestible apparatus for collecting a sample from a target area of a gastrointestinal (GI) tract of a subject, the ingestible apparatus comprising:
a housing defining a sample compartment (the leak proof chamber 1250 of Swain), the housing comprising a sealing surface (the sealing frame in FIG. 12 of Swain; paragraph 0062 of Swain) having an access port (the porthole window 1202 of Swain) formed therein, and the sample compartment being communicable with the access port;
a stopper (the outer surface of the sampling wheel 1210 of Swain; paragraph 0062 of Swain) configured to seal the access port;
an actuation assembly (the actuating mechanism of paragraph 0058 of Swain, the spring 1130, the cam 1140, and the hinge 1150 of Swain ) connected to the stopper, the actuation assembly being configured with a first working position where the access port is open (when a sampling cavity is exposed; paragraphs 0061-0062 of Swain; FIG. 12 of Swain) and a second working position where the access port is sealed with the stopper (when the outer surface of the sampling wheel 1210 seals; paragraphs 0061-0062 of Swain; FIG. 13 of Swain); and
a mucosal-layer brush (the sampling cavities with the porous material 1222 of Swain),
wherein the mucosal-layer brush is configured to spring outward and extend beyond a perimeter of the housing at the first working position of the actuation assembly (the sampling cavities with the porous material 1222 is so configured when a sampling cavity is exposed; paragraphs 0061-0062 of Swain; FIG. 12 of Swain; the sampling cavities with the porous material 1222 springs outward since the spring 1130 moves the sampling cavities with the porous material 1222 so that they extend outside the housing in the harvesting mode; see paragraphs 0058-0059 of Swain), and
wherein the mucosal-layer brush is configured to retract within the sample compartment in the second working position of the actuation assembly (see the sampling cavities with the porous material 1222 in FIG. 13 of Swain).
With respect to claim 53, Swain teaches or suggests that the mucosal-layer brush is configured for collecting the sample (the sampling cavities with the porous material 1222 is so configured when a sampling cavity is exposed; paragraphs 0061-0062 of Swain; FIG. 12 of Swain).
With respect to claim 54, Swain teaches or suggests that the stopper is connected to an end of the mucosal-layer brush (the outer surface of the sampling wheel 1210 is connected to the sampling cavities with the porous material 1222).
With respect to claim 57, Swain teaches or suggests that the mucosal-layer brush is distributed radially around at least a portion of the housing (the sampling cavities with the porous material 1222 of Swain is so radially distributed; see FIG. 11 of Swain).
With respect to claim 64, Swain teaches or suggests that the mucosal-layer brush is connected to the actuation assembly (the sampling cavities with the porous material 1222 is connected to the actuating mechanism of paragraph 0058 of Swain, the spring 1130, the cam 1140, and the hinge 1150 of Swain).
With respect to claim 65, Swain teaches or suggests that the mucosal-layer brush comprises a fluid-absorbent material (the sampling cavities with the porous material 1222).
Claims 46, 52-54, 64, 95, and 97 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2003/0167000 (Mullick)(previously cited), in view of Stevens, and further in view of U.S. Patent Application Publication No. 2017/0030882 (Skoda)(previously cited).
Mullick teaches an ingestible capsule with a retractable cytology brush (FIG. 10 and paragraph 0047 of Mullick). FIG. 10 of Mullick discloses a specialized tool 300 that can include a retractable cytology brush for use in the gastrointestinal system (paragraph 0080 of Mullick). Stevens teaches the use of a break away seal 1 on the external channel and a stopper cap 3 on the distal end of a sampling brush 6 (FIGS. 1 and 3-4 of Stevens; pages 3-4 of Stevens) so as to expose the brush at the appropriate sampling time and to contain the sample after the collection procedure is finished. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a break away seal on the external casing and a stopper cap on the distal end of the retractable cytology brush of Mullick so as to expose the brush at the appropriate sampling time and to contain the sample after the collection procedure is finished.
The combination does not teach the particulars of the actuation assembly for protruding and retracting the brush. Skoda teaches such an actuation assembly in the form of a spring loaded actuator 1550 attached to a plunger 1552 so as to urge a tool external to the housing 1502 (paragraph 0123 and FIG. 15 of Skoda). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the actuation mechanism of Skoda as the actuation mechanism for the retractable brush of Mullick since (1) an actuation mechanism is required and Skoda teaches one such mechanism and/or (2) it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 46, the combination teaches or suggests that an ingestible apparatus for collecting a sample from a target area of a gastrointestinal (GI) tract of a subject, the ingestible apparatus comprising:
a housing defining a sample compartment (the space inside the capsule housing to which the brush retracts; FIG. 10 of Mullick), the housing comprising a sealing surface (the external surface of the housing on which the stopper cap contacts) having an access port (the port to which the brush protrudes and retracts; FIG. 10 of Mullick) formed therein, and the sample compartment being communicable with the access port;
a stopper (the stopper cap suggested by Stevens) configured to seal the access port;
an actuation assembly (the actuation mechanism of Skoda) connected to the stopper, the actuation assembly being configured with a first working position where the access port is open (the extension of the brush of Mullick) and a second working position where the access port is sealed with the stopper (the retraction of the brush of Mullick); and
a mucosal-layer brush (the brush of Mullick),
wherein the mucosal-layer brush is configured to spring outward (using the actuation mechanism of Skoda) and extend beyond a perimeter of the housing at the first working position of the actuation assembly (see the brush exits the housing), and
wherein the mucosal-layer brush is configured to retract within the sample compartment in the second working position of the actuation assembly (the brush is retracted inside the housing during the retraction of the brush of Mullick).
With respect to claim 52, the combination teaches or suggests that the actuation assembly further comprises a rigid or flexible piston (the plunger 1552 of Skoda).
With respect to claim 53, the combination teaches or suggests that the mucosal-layer brush is configured for collecting the sample (the brush is so configured).
With respect to claim 54, the combination teaches or suggests that the stopper is connected to an end of the mucosal-layer brush (the stopper is at the distal end of the brush).
With respect to claim 64, the combination teaches or suggests that the mucosal-layer brush is connected to the actuation assembly (the brush of Mullick is so connected to the actuation assembly of Skoda).
With respect to claim 95, the combination teaches or suggests that the actuation assembly comprises a spring (the spring loaded actuator 1550 of Skoda has a spring).
With respect to claim 97, the combination teaches or suggests an ingestible apparatus for collecting a sample from a target area of a gastrointestinal (GI) tract of a subject, the ingestible apparatus comprising:
a housing defining a sample compartment (the space inside the capsule housing to which the brush retracts; FIG. 10 of Mullick), the housing comprising a sealing surface (the external surface of the housing on which the stopper cap contacts) having an access port (the port to which the brush protrudes and retracts; FIG. 10 of Mullick) formed therein, and the sample compartment being communicable with the access port;
a stopper (the stopper cap suggested by Stevens) configured to seal the access port;
an actuation assembly (the actuation mechanism of Skoda) connected to the stopper, the actuation assembly being configured with a first working position where the access port is open (the extension of the brush of Mullick) and a second working position where the access port is sealed with the stopper (the retraction of the brush of Mullick); and
a mucosal-layer brush (the brush of Mullick),
wherein the stopper is connected to an end of the mucosal-layer brush (the stopper is at the distal end of the brush), and
wherein the mucosal-layer brush is configured to spring outward (using the actuation mechanism of Skoda) and extend beyond a perimeter of the stopper at the first working position of the actuation assembly (see the relative dimensions of the brush relative to the stopper in Stevens), and wherein the mucosal-layer brush is configured to retract within the access port in the second working position of the actuation assembly (the brush is retracted inside the housing during the retraction of the brush of Mullick).
Claims 57-60, 96, 98, and 100-101 are rejected under 35 U.S.C. 103 as being unpatentable over Mullick, in view of Stevens, and further in view of Skoda, and further in view of U.S. Patent No. 5,899,850 (Ouchi)(previously cited).
Mullick teaches an ingestible capsule with a retractable cytology brush (FIG. 10 and paragraph 0047 of Mullick). FIG. 10 of Mullick discloses a specialized tool 300 that can include a retractable cytology brush for use in the gastrointestinal system. (paragraph 0080 of Mullick). Stevens teaches the use of a break away seal 1 on the external channel and a stopper cap 3 on the distal end of a sampling brush 6 (FIGS. 1 and 3-4 of Stevens; pages 3-4 of Stevens) so as to expose the brush at the appropriate sampling time and to contain the sample after the collection procedure is finished. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a break away seal on the external casing and a stopper cap on the distal end of the retractable cytology brush of Mullick so as to expose the brush at the appropriate sampling time and to contain the sample after the collection procedure is finished.
The combination does not teach the particulars of the actuation assembly for protruding and retracting the brush. Skoda teaches such an actuation assembly in the form of a spring loaded actuator 1550 attached to a plunger 1552 so as to urge a tool external to the housing 1502 (paragraph 0123 and FIG. 15 of Skoda). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the actuation mechanism of Skoda as the actuation mechanism for the retractable brush of Mullick since (1) an actuation mechanism is required and Skoda teaches one such mechanism and/or (2) it is a simple substitution of one known element for another to obtain predictable results.
Mullick teaches an ingestible capsule with a retractable cytology brush (FIG. 10 and paragraph 0047 of Mullick). Ouchi teaches a form of bristles and a stem for a cytology brush (the bristles 2 of Ouchi; col. 5, line 65 to col. 6, line 15 of Ouchi). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the bristles of Ouchi on a stem as the working end of the brush of Mullick since (1) a form of working end is required and Ouchi teaches one such working end and/or (2) it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 57, the combination teaches or suggests that the mucosal-layer brush is distributed radially around at least a portion of the housing (the bristles of Ouchi).
With respect to claim 58, the combination teaches or suggests that the mucosal-layer brush comprises one or more bristles (the bristles of Ouchi).
With respect to claim 59, the combination teaches or suggests that the mucosal-layer brush further comprises a stem (the stem suggested by Ouchi), wherein the one or more bristles are connected to the stem (the bristles and stem of Ouchi).
With respect to claim 60, the combination teaches or suggests that the one or more bristles are elongate members (the bristles of Ouchi).
With respect to claim 96, the combination teaches or suggests that the one or more bristles are spring loaded (the spring loaded actuator 1550 of Skoda spring loads the bristles of Ouchi).
With respect to claim 98, the combination teaches or suggests an ingestible apparatus for collecting a sample from a target area of a gastrointestinal (GI) tract of a subject, the ingestible apparatus comprising:
a housing defining a sample compartment (the space inside the capsule housing to which the brush retracts; FIG. 10 of Mullick), the housing comprising a sealing surface (the external surface of the housing on which the stopper cap contacts) having an access port (the port to which the brush protrudes and retracts; FIG. 10 of Mullick) formed therein, and the sample compartment being communicable with the access port;
a stopper (the stopper cap suggested by Stevens) configured to seal the access port;
an actuation assembly (the actuation mechanism of Skoda) connected to the stopper, the actuation assembly being configured with a first working position where the access port is open (the extension of the brush of Mullick) and a second working position where the access port is sealed with the stopper (the retraction of the brush of Mullick); and
a mucosal-layer brush (the brush of Mullick) comprising one or more spring-loaded bristles (the bristles of Ouchi; the spring loaded actuator 1550 of Skoda spring loads the bristles of Ouchi) and a stem (the stem of Ouchi),
wherein the one or more spring-loaded bristles are connected to the stem (the bristles and stem of Ouchi), and
wherein the spring-loaded bristles are configured to radially extend beyond the housing (the brush exits the housing) when the actuation assembly is in the first working position and configured retract within the access port in the second working position of the actuation assembly (the brush is retracted inside the housing during the retraction of the brush of Mullick).
With respect to claim 100, the combination teaches or suggests the mucosal-layer brush extends beyond the stopper (see the relative dimensions of the brush relative to the stopper in Stevens).
With respect to claim 101, the combination teaches or suggests the mucosal-layer brush extends radially beyond the stopper (see the relative dimensions of the brush relative to the stopper in Stevens).
Claims 62-63 are rejected under 35 U.S.C. 103 as being unpatentable over Mullick, in view of Stevens, and further in view of Skoda, and further in view of Ouchi, and further in view of U.S. Patent Application Publication No. 2019/0274663 (Rees)(previously cited).
Rees teaches a sealing material 24 that is configured to encapsulate the whole device (paragraph 0027 of Rees) so as to ensure that the device is protected until it is exposed at a predetermined region of the GI tract. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a sealing material 24 to encapsulate the whole device since the device will be protected until it is exposed at a predetermined region of the GI tract.
With respect to claim 62, the combination teaches or suggests an isolating structure configured to dissolve in a gastrointestinal content of the GI tract of the subject, wherein the housing and the one or more bristles are enclosed within the isolating structure (the sealing material 24 of Rees).
With respect to claim 63, the combination teaches or suggests an actuation assembly with a spring loaded actuator 1550 attached to a plunger 1552, the actuation assembly being movable between a first working position where the access port is open (the extension of the brush of Mullick) and a second working position where the access port is sealed with the stopper (the retraction of the brush of Mullick). Rees teaches the use of a dissolvable element 10 to block the actuation of a spring (paragraphs 0020-0021 of Rees). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a dissolvable element 10 to block the actuation of the spring loaded actuator of the combination since (1) it ensures activation at the correct time in the GI tract and/or (2) it is a simple substitution of one known element for another to obtain predictable results. Thus, the combination teaches or suggests that the one or more bristles are compressed or spring loaded by the isolating structure (the dissolvable element to block the actuation of the spring loaded actuator).
Claims 62-63 are rejected under 35 U.S.C. 103 as being unpatentable over Mullick, in view of Stevens, and further in view of Skoda, and further in view of Ouchi, and further in view of U.S. Patent Application Publication No. 2019/0298318 (Cinquin)(previously cited).
Cinquin also teaches a dissolvable material that is configured to encapsulate the whole device (paragraph 0008 of Cinquin). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a dissolvable material to encapsulate the whole device since the device will be protected until it is exposed at a predetermined region of the GI tract.
With respect to claim 62, the combination teaches or suggests an isolating structure configured to dissolve in a gastrointestinal content of the GI tract of the subject, wherein the housing and the one or more bristles are enclosed within the isolating structure (the dissolvable material of Cinquin).
With respect to claim 63, the combination teaches or suggests an actuation assembly with a spring loaded actuator 1550 attached to a plunger 1552, the actuation assembly being movable between a first working position where the access port is open (the extension of the brush of Mullick) and a second working position where the access port is sealed with the stopper (the retraction of the brush of Mullick). Cinquin teaches the use of a dissolvable element 9 to block the actuation of a spring (paragraphs 0051-0054 of Cinquin). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a dissolvable element to block the actuation of the spring loaded actuator of the combination since (1) it ensures activation at the correct time in the GI tract and/or (2) it is a simple substitution of one known element for another to obtain predictable results. Thus, the combination teaches or suggests that the one or more bristles are compressed or spring loaded by the isolating structure (the dissolvable element to block the actuation of the spring loaded actuator).
Claim 99 is rejected under 35 U.S.C. 103 as being unpatentable over Mullick, in view of Stevens, and further in view of Skoda, and further in view of Ouchi, and further in view of Rees.
Mullick teaches an ingestible capsule with a retractable cytology brush (FIG. 10 and paragraph 0047 of Mullick). Ouchi teaches a form of bristles and a stem for a cytology brush (the bristles 2 of Ouchi; col. 5, line 65 to col. 6, line 15 of Ouchi). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the bristles of Ouchi on a stem as the working end of the brush of Mullick since (1) a form of working end is required and Ouchi teaches one such working end and/or (2) it is a simple substitution of one known element for another to obtain predictable results.
Rees teaches a sealing material 24 that is configured to encapsulate the whole device (paragraph 0027 of Rees) so as to ensure that the device is protected until it is exposed at a predetermined region of the GI tract. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a sealing material 24 to encapsulate the whole device since the device will be protected until it is exposed at a predetermined region of the GI tract. Rees teaches the use of a dissolvable element 10 to block the actuation of a spring (paragraphs 0020-0021 of Rees). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a dissolvable element 10 to block the actuation of the spring loaded actuator of the combination since (1) it ensures activation at the correct time in the GI tract and/or (2) it is a simple substitution of one known element for another to obtain predictable results. Thus, the combination teaches or suggests an isolating structure configured to receive the mucosal-layer brush and housing (the sealing material 24 of Rees), and wherein the isolating structure is configured to dissolve and release the mucosal-layer brush to radially extend from the housing (the dissolvable element to block the actuation of the spring loaded actuator).
Claim 99 is rejected under 35 U.S.C. 103 as being unpatentable over Mullick, in view of Stevens, and further in view of Skoda, and further in view of Ouchi, and further in view of Cinquin.
Mullick teaches an ingestible capsule with a retractable cytology brush (FIG. 10 and paragraph 0047 of Mullick). Ouchi teaches a form of bristles and a stem for a cytology brush (the bristles 2 of Ouchi; col. 5, line 65 to col. 6, line 15 of Ouchi). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the bristles of Ouchi on a stem as the working end of the brush of Mullick since (1) a form of working end is required and Ouchi teaches one such working end and/or (2) it is a simple substitution of one known element for another to obtain predictable results.
Cinquin also teaches a dissolvable material that is configured to encapsulate the whole device (paragraph 0008 of Cinquin). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a dissolvable material to encapsulate the whole device since the device will be protected until it is exposed at a predetermined region of the GI tract. Cinquin teaches the use of a dissolvable element 9 to block the actuation of a spring (paragraphs 0051-0054 of Cinquin). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a dissolvable element to block the actuation of the spring loaded actuator of the combination since (1) it ensures activation at the correct time in the GI tract and/or (2) it is a simple substitution of one known element for another to obtain predictable results. Thus, the combination teaches or suggests an isolating structure configured to receive the mucosal-layer brush and housing (the dissolvable material of Cinquin), and wherein the isolating structure is configured to dissolve and release the mucosal-layer brush to radially extend from the housing (the dissolvable element to block the actuation of the spring loaded actuator).
Response to Arguments
The Applicant's arguments filed 10/21/2025 have been fully considered.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 10/21/2025, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
Prior art rejections based Swain
Upon further reflection on the teachings of Swain, the Applicant’s arguments are not persuasive. In particular, the Applicant’s arguments regarding Swain related to the embodiment of FIG. 1 of Swain, but the rejections are based on the embodiments of FIGS. 11 and 12. As such, the Applicant’s arguments are not commensurate with the rejections.
Also, at least some of the grounds of rejections based on Swain have been change in view of the new claim amendments.
Prior art rejections based on Stevens
The Applicant asserts that the device of Stevens does not include a brush that springs outward or is spring loaded. Upon further reflection on the teachings of Stevens, the Applicant’s argument is not persuasive. Stevens includes a brush that springs outward. In particular, Stevens teaches that the mucosal-layer brush is configured to spring outward and extend beyond a perimeter of the housing at the first working position of the actuation assembly since the sponge/gauze/brushes 6 of Stevens are released from confinement (see page 10 of the attached definition from www.merriam-webster.com) and extend beyond the perimeter of the chamber 7 of Stevens (FIG. 3 of Stevens).
Prior art rejections based on Mullick, Stevens, and Skoda
The Applicant’s arguments did not directly address these rejections. Upon further reflection upon these references, the rejections are deemed to be proper.
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 MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791