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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a first deployment mechanism” in at least claim 8 and others;
“a second deployment mechanism” in at least claim 8 and others
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 4-6, 10, 18 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mullick US 2003/0167000A1 and further in view of Nakanishi WO2020100321, Iddan US2003/0214579, and Grundfest US5662587.
Mullick discloses for claim 2, “A device suitable for ingestion by a living body, the device comprising:
a capsule (capsule 40 of superseding embodiment fig 1-3, of the eighth embodiment; fig 10; 0079-0080) that has a cylindrical body interconnected between a first end and a second end;
an intervention tool (treatment tool 300 with retractable lever 304; fig 10; 0079-0080) that is configured to extend through an aperture in the capsule (fig 10), collect a sample from a structure in the living body, and retract through the aperture in the capsule (0079-0080);
an optical sensor (imaging array/CCD 48; fig 2; 0059) that is configured to generate data as the device traverses a gastrointestinal tract of the living body;
an antenna (0056);
a processor (internal microprocessor 0022, 0087) that is configured to cause transmission of at least some of the data to a receiver located outside the living body via the antenna (0087); and
a transceiver (transmitter 50 Fig.2 and capsule can include a receiver enabling external controller to transmit instruction to the capsule 0054 or including an on board receiver 0062; Fig.1-2) that is configured to modulate the data prior to transmission by the antenna”.
Mullick does not disclose “a plurality of rotors, each of which is situated in a different one of a plurality of channels defined through the capsule”. Nakanishi teaches a plurality of propulsors in the form of rotors (fig 3; [0060-0062]) for a capsule endoscope. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Nakanishi into the invention of Mullick in order to configure the capsule e.g. as claimed i.e. in reference to the plurality of propulsors because it allows control and movement of the capsule in liquids.
Mullick does not disclose “wherein each channel of the plurality of channels has (i) an inlet that is located in the cylindrical body of the capsule and (ii) an outlet that is located in the first end of the capsule”. Iddan teaches in the same field of endeavor, a propulsion channel in a capsule where a duct inlet (212A) is configured on the side of the cylindrical body (fig 6). [0092-0097] also describes the inlet can be configured as a single inlet, i.e. not requiring a dual inlet per propulsion channel/propeller. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Iddan into the invention of Mullick in order to configure the capsule e.g. as claimed, in particular providing the inlet of each of the propeller channels on the cylindrical side body because it allows for a more compact propulsion design creating space within the capsule for other systems and components (see anterior space of the capsule in fig 6).
Mullick does not disclose “a storage bay in which to store the sample collected by the intervention tool”. Grundfest teaches in the same field of endeavor in fig 2, a retracted biopsy tool with integral tissue storage cavity 26 (5:49-51). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Grundfest into the invention of Mullick in order to configure the device e.g. as claimed because it provide instant storage of an acquired biological sample and securing the sample for later analysis when the capsule exits from the body.
Mullick discloses for claim 4, “The device of claim 2, wherein the intervention tool includes at least one of a biopsy mechanism (0080 biopsy forceps), a needle, a cutting mechanism, a pushing mechanism, a pulling mechanism, a grasping mechanism, a cauterization mechanism, or a delivery mechanism”.
Mullick discloses for claim 5, “The device of claim 2, wherein the intervention tool includes a biopsy mechanism (0080 biopsy forceps), and wherein the processor is further configured to: receive first input indicative of an instruction to employ the biopsy mechanism to gather the sample from the structure, cause the biopsy mechanism to extend through the aperture toward the structure, and cause the biopsy mechanism to retract from the structure through the aperture in the capsule (0087 describes a microprocessor to control the capsule’s functions, including the biopsy mechanism)”.
Mullick discloses for claim 6, “The device of claim 2
wherein the second end is a hemispherical end including the aperture and an opening filled with a transparent material (fig 2),
wherein the optical sensor (48; fig 2; 0055) is positioned within the hemispherical end and configured to generate the data based on energy reflected by the structure through the transparent material, and wherein the device further comprises:
a light source (illumination device 46; fig 2; 0055) that is positioned within the hemispherical end and that is configured to emit electromagnetic radiation through the transparent material towards the structure.
Mullick discloses for claim 10, “The device of claim 2, wherein the intervention tool includes a delivery mechanism in which a material is stored (the tool involves a simple swap to a needle 400 which includes materials such as epinephrine stored within [0081]), and wherein the processor is further configured to: receive input indicative of an instruction to release the material into the living body, and cause the delivery mechanism to release at least some of the material stored therein (processor received input remotely indicative of instruction to cause the release of the material from the needle into human body Fig 1, 11, 0006, 0081-0087)”.
Modified Mullick (as provided in claim 2) discloses for claim 18, “A device suitable for ingestion by a living body, the device comprising: a capsule (capsule 40 of superseding embodiment fig 1-3, of the eighth embodiment; fig 10; 0079-0080) with a cylindrical body that is interconnected between a first end and a second end; a plurality of rotors (Nakanishi: fig 3; [0060-0062]), each of which is situated in a different one of a plurality of channels defined through the capsule, wherein each channel of the plurality of channels has (i) an inlet that is located in the cylindrical body of the capsule (Iddan: fig 6; 0092-0097) and (ii) an outlet that is located in the first end of the capsule (Iddan: fig 6; 0092-0097); a sensor (imaging array/CCD 48; fig 2; 0059) that is configured to generate data based on electromagnetic radiation that is emitted by a source, reflected by a structure in the living body, and detected by the sensor; an intervention tool (treatment tool 300 with retractable lever 304; fig 10; 0079-0080) that is configured to, based on the data, manipulate the structure in the living body after extending through an aperture in the capsule; and a storage bay in which to store a sample of the structure acquired by the intervention tool (Grundfest: fig 2, a retracted biopsy tool with integral tissue storage cavity 26; 5:49-51)”.
Claim(s) 3, 11-15, 19, 21, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mullick, Nakanishi, Iddan, and Grundfest as applied to claim 2 above, and further in view of Velis US20210060296 and Swain US20080199065.
Mullick does not disclose for claim 3:
“The device of claim 2, wherein the storage bay is one of a plurality of storage bays in which to store a plurality of samples collected by the intervention tool”. Velis teaches in the same field of endeavor, providing multiple sample tools (multiple forceps 255; fig 23B; 0083). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Velis into the invention of Mullick in order to configure the device e.g. as claimed, specifically providing multiple tools with corresponding storage bays because it allows collecting multiple samples.
“and wherein each of the plurality of storage bays includes a vacuum element to remove a respective one of the plurality of samples from the intervention tool”. Swain teaches in the same field of endeavor, a suction function associated with storage chambers 0034. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Swain into the invention of Mullick in order to configure the device e.g. as claimed because it helps to secure the sample in the chamber (0034).
Modified Mullick (as provided in claim 3) discloses for claim 11, “A device suitable for ingestion by a living body, the device comprising: a capsule (capsule 40 of superseding embodiment fig 1-3, of the eighth embodiment; fig 10; 0079-0080) with a first hemispherical end, a second hemispherical end, and a cylindrical body interconnected between the first and second hemispherical ends; multiple intervention tools (Velis: multiple forceps 255; fig 23B; 0083 and corresponding storage bays) that are (i) each independently actuatable, and (ii) each configured to extend through a corresponding aperture of multiple apertures in the first hemispherical end of the capsule, manipulate a structure in the living body, and retract through the corresponding aperture of the multiple apertures in the first hemispherical end of the capsule (treatment tool 300 with retractable lever 304; fig 10; 0079-0080); an optical sensor (imaging array/CCD 48; fig 2; 0059) that is configured to generate data as the device traverses a gastrointestinal tract of the living body; an antenna (0056); a processor (internal microprocessor 0022, 0087) that is configured to cause transmission of at least some of the data to a receiver located outside the living body via the antenna; and a transceiver (transmitter 50 Fig.2 and capsule can include a receiver enabling external controller to transmit instruction to the capsule 0054 or including an on board receiver 0062; Fig.1-2) that is configured to modulate the data prior to transmission by the antenna”.
Modified Mullick discloses for claim 12, “The device of claim 11, wherein the processor is further configured to: cause, via the antenna (0056), transmission of the data to a receiver located outside the living body in real time, receive, via the antenna, a first input indicative of a request to employ a first intervention tool of the multiple intervention tools to acquire a first sample, generate, in response to receiving the first input, a first instruction that causes the first intervention tool to extend through a first aperture of the multiple apertures toward the structure, receive, via the antenna, a second input indicative of an acknowledgment that the first intervention tool acquired the first sample, and generate, in response to receiving the second input, a second instruction that causes the first intervention tool to retract through the first aperture from the structure (0022, 0087 describes the microprocessor configured to control the operation of the capsule from the physician’s instructions input via the radio-frequency receiver)”.
Modified Mullick discloses for claim 13, “The device of claim 11, further comprising: a plurality of storage bays to store a respective plurality of samples collected by the multiple intervention tools, wherein each of the plurality of storage bays correspond to one of the multiple intervention tools (Velis: multiple forceps 255; fig 23B; 0083 and corresponding storage bays), and wherein the plurality of storage bays each include a vacuum element to remove the respective plurality of samples from the corresponding intervention tool (Swain: 0034)”.
Mullick discloses for claim 14, “The device of claim 11, wherein each of the multiple intervention tools includes at least one of a biopsy mechanism (0080 biopsy forceps), a needle, a cutting mechanism, a pushing mechanism, a pulling mechanism, a grasping mechanism, a cauterization mechanism, or a delivery mechanism”.
Mullick discloses for claim 15, “The device of The device of wherein the first hemispherical end includes an opening filled with a transparent material (fig 2), wherein the optical sensor (48; fig 2; 0055) is positioned within the first hemispherical end and configured to generate the data based on energy reflected by the structure through the transparent material, and wherein the device further comprises: a light source (illumination device 46; fig 2; 0055) that is positioned within the first hemispherical end and that is configured to emit electromagnetic radiation through the transparent material towards the structure”.
Modified Mullick discloses for claim 19, “The device of claim 18 wherein the storage bay is one of a plurality of storage bays in which to store a plurality of samples collected by the intervention tool (Velis: multiple forceps 255; fig 23B; 0083 and corresponding storage bays), and wherein each storage bay of the plurality of storage bays includes a vacuum element to remove a respective one of the plurality of samples from the intervention tool (Swain: 0034).
Modified Mullick discloses (as provided in claim 3) for claim 21, “A method for controlling (internal microprocessor 0022, 0087) a device (capsule 40 of superseding embodiment fig 1-3, of the eighth embodiment; fig 10; 0079-0080) that is ingested by a living body and that includes (i) an optical sensor (imaging array/CCD 48; fig 2; 0059), (ii) an intervention tool (treatment tool 300 with retractable lever 304; fig 10; 0079-0080), and (iii) a storage bay (Grundfest: retracted biopsy tool with integral tissue storage cavity 26, 5:49-51), the method comprising: forwarding, by a processor, data generated by the optical sensor to a transmitter for modulation onto an antenna (0056) for wireless transmission to a receiver located outside of the living body (transmitter 50 Fig.2 and capsule can include a receiver enabling external controller to transmit instruction to the capsule 0054 or including an on board receiver 0062; Fig.1-2); receiving input that is indicative of a request to deploy the intervention tool (0087 describes instructions relayed from the physician); causing the intervention tool to extend through an aperture in a structural body of the device toward a structure inside the living body, collect a sample from the structure, and retract through the aperture into the structural body of the device (0080 describes collection of a sample with various types of tools including a biopsy tool); and initiating a vacuum element that pulls the sample into the storage bay (Swain: 0034)”.
Modified Mullick discloses for claim 22, “The method of claim 21, wherein the device further includes (iv) a second intervention tool (Velis: multiple forceps 255; fig 23B; 0083 and corresponding storage bays) and (v) a second storage bay (Velis: multiple forceps 255; fig 23B; 0083 and corresponding storage bays), and wherein the method further comprises: receiving second input that is indicative of a request to deploy the second intervention tool (internal microprocessor 0022, 0087); causing the second intervention tool to extend through a second aperture in the structural body of the device toward a second structure inside the living body, collect a second sample from the second structure, and retract through the second aperture into the structural body of the device (0080 describes collection of a sample with various types of tools including a biopsy tool); and initiating a second vacuum element that pulls the second sample into the second storage bay (Swain: 0034)”.
Claim(s) 7, 8, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mullick, Nakanishi, Iddan, and Grundfest as applied to claim 2 above, and further in view of Jin US2004/0050394.
Mullick does not disclose for claim 7, “The device of claim 2, further comprising: a barrier that is configured to inhibit exposure of the intervention tool to the living body through complete occlusion of the aperture while the barrier is in a first position”.
Jin in the art of ingestible navigable capsule teaches an ingestible capsule includes medical treatment tools such as instrument 40 Fig. 4a capable of being controlled remotely, and collecting tissue sample when extends out of the capsule, and retract back into the capsule with a door closing behind [0019].
It would have been obvious at one of ordinary skill in the art before the effective filing date of the claimed invention to have modify Mullick to include a barrier such as a door, taught by Jin, as a barrier, which in a closed position inhibit exposure of the intervention tool when the instrument is inside the capsule, and open by a deployment mechanism (in response to command for biopsy action), which the intervention tool (biopsy tool) being extended from the capsule through an aperture to perform the biopsy action, to avoid contamination of the inside of the capsule.
Modified Mullick discloses for claim 8, “The device of claim 7, further comprising: a first deployment mechanism (Mullick: retractable lever 304; fig 10) that is configured to move the intervention tool (300; fig 10), through the aperture in the capsule (Jin: fig 4a), between a first position and a second position, wherein when the intervention tool is in the first position, the intervention tool resides entirely inside the capsule, and wherein when the intervention tool is in the second position, at least part of the intervention tool resides outside the capsule while the first deployment mechanism resides inside the capsule (Jin: fig 4a; 0019); and a second deployment mechanism (Jin: door controlling mechanism 0019) that is configured to move the barrier to a second position prior to the intervention tool being extended through the aperture by the first deployment mechanism, wherein the aperture is at most partially occluded while the barrier is in the second position”.
Modified Mullick discloses for claim 16, “The device of claim 11, further comprising: a barrier (Jin: 0019 collecting tissue sample when extends out of the capsule, and retract back into the capsule with a door closing behind) configured to inhibit exposure of a first intervention tool of the multiple intervention tools to the living body while the barrier is in a first position, wherein a first aperture of the multiple apertures is completely occluded while the barrier is in the first position; a first deployment mechanism (Mullick: retractable lever 304; fig 10) configured to move the first intervention tool, through the first aperture in the capsule (Jin: fig 4a), between a first position and a second position, wherein when the first intervention tool is in the first position, the first intervention tool resides entirely inside the capsule (Jin: fig 4a), and wherein when the first intervention tool is in the second position, at least part of the first intervention tool resides outside the capsule while the first deployment mechanism resides inside the capsule; and a second deployment mechanism configured to move the barrier to a second position prior to the first intervention tool being extended from the capsule through the first aperture by the first deployment mechanism, wherein the first aperture is at most partially occluded while the barrier is in the second position (Jin: fig 4a; 0019-0020)”.
Claim(s) 9, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mullick, Nakanishi, Iddan, Grundfest, Velis, and Swain as applied to claim 3 above, and further in view of Trovato US20090306633.
Modified Mullick discloses (as provided in claim 3) for claim 9, “The device of claim 2, further comprising: a plurality of intervention tools (Velis: forceps 255; fig 23B; 0083 with corresponding storage bays), each of which is mounted to a different one of a plurality of modular bays, wherein the plurality of bays are arranged radially about a central axis of the capsule (Mullick: fig 10 shows a tool arranged at a periphery of the capsule, where the multiple modified tools would be placed radially about the circumference)”.
Modified Mullick does not disclose wherein the plurality of bays are “modular”. Trovato teaches in the same field of endeavor, modular components for a capsule including a reservoir (0017-0018). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Trovato into the invention of Mullick in order to configure the device e.g. as claimed, specifically providing modular reservoir bays because it provides the added advantage of a plug and play feature with more flexibility and compatibility.
Modified Mullick discloses (as provided in claim 3) for claim 17, “The device of claim 11, wherein each of the multiple intervention tools is mounted to a different one of multiple modular (Trovato: 0017-0018) bays that are arranged radially about a central axis of the capsule (Mullick: fig 10 shows a tool arranged at a periphery of the capsule, where the multiple modified tools would be placed radially about the circumference)”.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mullick, Nakanishi, Iddan, and Grundfest as applied to claim 18 above, and further in view of Gazdinski US20150182145.
Mullick does not disclose for claim 20, “The device of claim 18 wherein the sensor is an infrared sensor, and wherein the electromagnetic radiation that is emitted by the source and that is detected by the sensor is electromagnetic radiation in an infrared range”. Gazdinski teaches in the same field of endeavor, providing and infrared imaging sensor and illumination source (0061, 0348). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Gazdinski into the invention of Mullick in order to configure the device e.g. as claimed because it provides spectral imaging allowing images that presents information not available under white light imaging.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mullick, Nakanishi, Iddan, Grundfest, Velis, and Swain as applied to claim 21 above, and further in view of Katayama US20110166416 .
Modified Mullick discloses for claim 23, “The method of claim 21, wherein the device further includes (iv) a second storage bay that (Velis: multiple forceps 255; fig 23B; 0083 and corresponding storage bays), with the storage bay, is part of a radial arrangement of storage bays (Mullick: fig 10 shows a tool arranged at a periphery of the capsule, where the multiple modified tools would be placed radially about the circumference), and wherein the method further comprises: receiving second input that is indicative of a request to deploy the intervention tool (internal microprocessor 0022, 0087); causing the intervention tool to extend through the aperture in the structural body of the device toward a second structure inside the living body, collect a second sample from the second structure, and retract through the aperture into the structural body of the device (0079-0080); and initiating the vacuum element that pulls the second sample into the second storage bay (Swain: 0034)”.
Mullick does not disclose “causing the radial arrangement of storage bays to rotate, such that the second storage bay is made accessible”. Katayama teaches in the same field of endeavor, a rotating cylindrical configuration of multiple storage bins where there is only a single access opening in the capsule housing (figs 17-18). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Katayama into the invention of Mullick in order to configure the method e.g. as claimed because it provides the advantage of a single housing opening for the capsule storage chambers, minimizing the points of failure that exist in modified Mullick having multiple tools and storage bins with each with their own corresponding openings which can leak or mechanically fail.
Response to Arguments
Applicant provides no arguments with respect to the pending claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO892. Additionally, applicant is advised to review Katayama in light of potential new amendments since it appears this a particularly relevant reference with respect to the different functions of the invention.
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 JAE K WOO whose telephone number is (571)272-0837. The examiner can normally be reached M-F 8:30-2:30p, 6p-9p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jae Woo/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
7/1/26
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