DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 13, 2026 has been entered.
This Office action is responsive to an amendment filed December 17, 2025. Claims 23, 25, 27-44 are pending. Claims 1-22, 24 & 26 have been canceled. Claims 23, 28 & 42 have been amended. Claims 38-41 are withdrawn.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 23, 25, 27, 31-34, 37 & 42-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sitti et al. (US 2013/0303847) (“Sitti” hereinafter) in view of Andreoni et al. (US 2011/0306937) (“Andreoni” hereinafter), Van Dam et al. (US 2009/0118641) (“Van Dam” hereinafter), Ries (US 2005/0062562) further in view Iddan et al. (US 2013/0172672) (“Iddan” hereinafter).
In regards to claim 23, Sitti discloses a magnetically actuated capsule endoscope 10, the magnetically actuated capsule endoscope 10 comprising:
a body having a top housing part 18 and a bottom housing part 30;
a permanent magnet (16, 24) arranged within the top housing part 18;
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a plurality of deformable members 20 extending from the top housing part 18 to an end of the bottom housing part 30; and
wherein the plurality of deformable members 20 are configured to repeatedly expand and contract in order to prepare a biopsy (see at least abstract, figs. 1A-I and par 0008, 0076-0083, 0085, 0131-0133 & 0168-0170).
Sitti discloses a capsule endoscope 10, as described above, that fails to explicitly teach a capsule endoscope comprising a needle projecting from the top housing part towards the bottom housing part and surrounded by the plurality of deformable members, wherein the plurality of deformable members are configured to repeatedly expand and contract to respectively cover and uncover a tip of said needle.
However, Andreoni teaches that it is known to provide a device comprising a needle 14 projecting from the top housing part towards the bottom housing part and surrounded by the shield 16, wherein the shield 16 is configured to repeatedly expand and contract to respectively cover and uncover a tip of said needle 14 (see at least abstract, figs. 1-6 and par 0013-0025).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the capsule endoscope of Sitti comprising a needle projecting from the top housing part towards the bottom housing part, as taught by Andreotti, and surrounded by the plurality of deformable members as taught by Sitti, wherein the plurality of deformable members are configured to repeatedly expand and contract, as taught by Sitti, to respectively cover and uncover a tip of said needle as taught by Andreoni since such a modification would amount to applying a known technique (i.e., as taught by Andreoni) to a known device (i.e., as taught by Sitti) ready for improvement to achieve a predictable result such as providing an electronically controllable injection needle shield which surrounds the needle point and prevents any contact with the needle, except when the needle is injected into skin or tissue--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Sitti as modified by Andreoni disclose a capsule endoscope 10, as described above, that fails to explicitly teach a capsule endoscope including a needle comprising 19 gauge (G) to 25 G; wherein said biopsy is a fine-needle aspiration biopsy using a fine-needle capillary technique, in which the needle is passed into the tissue, and five to ten successive fast jabbing movements in and out of the tissue are performed.
However, Van Dam teaches that it is known to provide an endoscopic biopsy device including a needle comprising 19 gauge (G) to 25 G (see at least par 0003 & 0040); wherein said biopsy is a fine-needle aspiration biopsy using a fine-needle capillary technique, in which the needle is passed into the tissue, and five to ten successive fast jabbing movements in and out of the tissue are performed (see also par 0002-0010 & 0041).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the capsule endoscope of Sitti as modified by Andreoni including a needle comprising 19 gauge (G) to 25 G; wherein said biopsy is a fine-needle aspiration biopsy using a fine-needle capillary technique, in which the needle is passed into the tissue, and five to ten successive fast jabbing movements in and out of the tissue are performed as taught by Van Dam since such a modification would amount to applying a known technique (i.e., as taught by Van Dam) to a known device (i.e., as taught by Sitti) ready for improvement to achieve a predictable result such as achieving diagnostic certainty with a minimal number of instrument passes, thus achieving excellent results with minimal trauma to the patient (see at least par 0006 of Van Dam)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Sitti as modified by Andreoni and Van Dam discloses a capsule endoscope 10, as described above, that fails to explicitly teach a capsule endoscope wherein a magnetic field gradient selected in the range of 0.5 T/m to 2 T/m is applied on the permanent magnet while simultaneously a magnetic field selected in the range of 30 mT to 70 mT is applied on the permanent magnet for orientation stabilization.
However, Ries teaches that it is known to provide a capsule endoscope 10
wherein a magnetic field gradient of 80 mT/m or 130 mT/m is applied on the permanent magnet 11 while simultaneously a magnetic field selected in the range of 50 mT to 75 mT is applied on the permanent magnet 11 for orientation stabilization (see at least abstract, figs. 1-5 and par 0012, 0027-0029 & 0039-0046).
Sitti discloses (see at least par 0282 & 0293-0294) that the magnetic field strength needs to be optimized to create “very distinct” critical forces for shape deformation, shape recovery, and drug release of the capsule endoscope and as such the magnetic field gradient applied to the device is disclosed to be a result effective variable in that the critical forces generated by the external magnetic field need to be very distinct to selectively achieve local drug release. Ries discloses (see at least par 0029) that the magnetic field gradient and magnetic field applied to the permanent magnet needs to be optimized to “adjust forces in the three co-ordinate directions, which forces are derived from the position control, are converted into magnetic fields and gradients and also into further coil currents which exert these forces on the magnet element so as to counteract errors in the nominal position and to stabilize the position of the permanent magnet” and as such the magnetic field gradient and magnetic field of the device is disclosed to be a result effective variable in that said magnetic field and magnetic field gradient exert adequate torque and force on the magnet element to control the position and/or orientation of the capsule. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Sitti as modified by Andreoni, Van Dam and Ries by making the magnet field gradient and magnetic field to be in the range of 0.5 T/m to 2 T/m and 30 mT to 70 mT, respectively, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Sitti as modified by Andreoni, Van Dam and Ries discloses a capsule, as described above, that fails to explicitly teach a capsule wherein the end of the bottom housing part comprises a locating pad comprising a plurality of fibers, and wherein the fibers of the locating pad facilitate the attachment and positioning of the magnetically actuated capsule endoscope to an inner surface of a GI tract.
However, Iddan teaches that it is known to provide a device wherein the end of the bottom housing part comprises a locating pad 10 comprising a plurality of fibers (8, 8’), and wherein the fibers (8, 8’) of the locating pad 10 facilitate the attachment and
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positioning of the magnetically actuated capsule endoscope to an inner surface of a GI tract (see at least abstract, figs. 1A-B, 2 & 4A-B and par 0068-0071, 0079 & 0081-0082).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the capsule endoscope of Sitti as modified by Andreoni, Van Dam and Ries wherein the end of the bottom housing part comprises a locating pad comprising a plurality of fibers, and wherein the fibers of the locating pad facilitate the attachment and positioning of the magnetically actuated capsule endoscope to an inner surface of a GI tract as taught by Iddan since such a modification would amount to applying a known technique (i.e., as taught by Iddan) to a known device (i.e., as taught by Sitti) ready for improvement to achieve a predictable result such as anchoring the capsule endoscope to the GI tract tissue (see at least par 0077 & 0079 of Iddan)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 25, Sitti as modified by Andreoni, Van Dam and Ries discloses the magnetically actuated capsule endoscope in accordance with claim 23, that fails to explicitly teach a capsule endoscope wherein the locating pad forms the end of the bottom housing part and has an aperture present therein for the needle. However, However, Iddan teaches that it is known to provide a device wherein the locating pad 10 forms the end of the bottom housing part and has an aperture (openings 38, 38’ or opening covered by septum 90) present therein for the needle (see at least abstract, figs. 1A-B, 2, 4A-B & 11 and par 0068-0071, 0079, 0081-0082 & 0130). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the capsule endoscope of Sitti as modified by Andreoni, Van Dam and Ries wherein the locating pad forms the end of the bottom housing part and has an aperture present therein for the needle as taught by Iddan since such a modification would amount to applying a known technique (i.e., as taught by Iddan) to a known device (i.e., as taught by Sitti) ready for improvement to achieve a predictable result such as anchoring the capsule endoscope to the GI tract tissue (see at least par 0077 & 0079 of Iddan)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 27, Sitti discloses the magnetically actuated capsule endoscope 10 in accordance with claim 23, further comprising at least one camera 12 or camera system 12, wherein a first camera or camera system is provided at an end of the top housing part 18 and is configured to record at least one of images and videos of an environment of the magnetically actuated capsule endoscope 10 (see at least par 0077).
In regards to claim 31, Sitti discloses the magnetically actuated capsule endoscope 10 in accordance with claim 23, wherein each of the plurality of deformable members 20 is configured to contract on the application of a pre-defined externally applied magnetic field (see at least par 0079).
In regards to claim 32, Sitti discloses the magnetically actuated capsule endoscope 10 in accordance with claim 31, wherein the externally applied magnetic field induces a contraction force of greater than 0.4 N at the plurality of deformable members 20 (see par 0133, 0162, 0166, 0182-0183 & 0267).
In regards to claim 33, Sitti discloses the magnetically actuated capsule endoscope 10 in accordance with claim 23,388796-00006 (M11727PWOUS) wherein each of the plurality of deformable members 20 has an inherent restoring force of at most 0.45 N and is configured to adopt a fully expanded state when no external magnetic field is applied or a partially expanded state if an external magnetic field is applied that induces a contraction force of less than 0.45 N at each of the plurality of deformable members 20 (see at least figs. 4A-C and par 0096-0097).
In regards to claim 34, Sitti discloses the magnetically actuated capsule endoscope 10 in accordance with claim 23, wherein the magnetically actuated capsule endoscope 10 is configured to be moved in an externally applied magnetic field and wherein the plurality of deformable members 20 are configured to contract on the application of a pre-defined magnetic field gradient, with the magnetic field gradient utilized for the deformation of the plurality of deformable members 20 being larger than the magnetic field gradient used to move the magnetically actuated capsule endoscope 10 (see at least par 0079, 0282 & 0293-0294).
In regards to claim 37, Sitti and Van Dam discloses the magnetically actuated capsule endoscope 10 in accordance with claim 23, that fails to explicitly teach a capsule endoscope wherein, in the completely uncovered state, i.e., in the fully contracted state of the deformable members, the tip of the needle projects by at least 5 mm from the end of the bottom housing part. However, Andreoni teaches that it is known to provide a device wherein, in the completely uncovered state, i.e., in the fully contracted state of the deformable members (22, 46, 72), the tip of the needle 14 projects from the end of the bottom housing part (see at least abstract, figs. 1-6 and par 0013-0025). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the capsule endoscope of Sitti as modified by Van Dam wherein, in the completely uncovered state, i.e. in the fully contracted state of the deformable members, the tip of the needle projects from the end of the bottom housing part as taught by Andreoni since such a modification would amount to applying a known technique (i.e., as taught by Andreoni) to a known device (i.e., as taught by Sitti) ready for improvement to achieve a predictable result such as providing an electronically controllable injection needle shield which surrounds the needle point and prevents any contact with the needle, except when the needle is injected into skin or tissue --See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Sitti as modified by Andreoni and Van Dam discloses a capsule endoscope that fails to explicitly teach a capsule wherein the tip of the needle projects by at least 5 mm from the end of the bottom housing part. However, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the capsule endoscope of Sitti as modified by Andreoni and Van Dam wherein the tip of the needle projects by at least 5 mm from the end of the bottom housing part as claimed in order to provide a needle penetration depth that is suitable for access to most of the organs of the gastrointestinal tract whose thickness is ubiquitously known to be no more than 5-6 mm thick when not distended (see at least par 0004 of US 2006/0069349).
In regards to claim 42, Sitti discloses a method of actuating a magnetically actuated capsule endoscope 10, the magnetically actuated capsule endoscope 10 comprising:
a body having a top housing part 18 and a bottom housing part 30;
a permanent magnet (16, 24) arranged within the top housing part 18;
a plurality of deformable members 20 extending from the top housing part 18 to an end of the bottom housing part 30; and,
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the method comprising the steps of:
applying a magnetic field in order to move (i.e., through rolling locomotion) the magnetically actuated capsule endoscope 10 through a workspace (see at least par 0282 & 0293-0294),
positioning the magnetically actuated capsule endoscope 10 at a desired location within the GI tract (i.e., using localization); and
changing the magnetic field to have at least one of a different field strength and a different magnetic field gradient in order to prepare a biopsy (see at least abstract, figs. 1A-I and par 0008, 0076-0083, 0085, 0131-0133, 0168-0170, 0282 & 0293-0294).
Sitti discloses a method, as described above, that fails to explicitly teach a method comprising providing a needle projecting from the top housing part and surrounded by the plurality of deformable members, wherein the plurality of deformable members are configured to repeatedly expand and contract to respectively cover and uncover a tip of said needle; and changing the magnetic field to have at least one of a different field strength and a different magnetic field gradient in order to cause the tip of the needle to be repeatedly projected beyond the end of the bottom housing part.
However, Andreoni teaches that it is known to provide a method comprising providing a needle 14 projecting from the top housing part and surrounded by the shield 16, wherein the shield 16 are configured to repeatedly expand and contract to respectively cover and uncover a tip of said needle 14 (see at least abstract, figs. 1-6 and par 0013-0025).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Sitti comprising providing a needle projecting from the top housing part, as taught by Andreoni, and surrounded by the plurality of deformable members as taught by Sitti, wherein the plurality of deformable members are configured to repeatedly expand and contract, as taught by Sitti, to respectively cover and uncover a tip of said needle as taught by Andreoni, and changing the magnetic field to have at least one of a different field strength and a different magnetic field gradient, as taught by Sitti, in order to cause the tip of the needle to be repeatedly projected beyond the end of the bottom housing part as taught by Andreoni since such a modification would amount to applying a known technique (i.e., as taught by Andreoni) to a known device (i.e., as taught by Sitti) ready for improvement to achieve a predictable result such as providing very distinct critical forces to effect drug release (see at least par 0293 of Sitti) by moving an injection needle from within a protective collar which surrounds the needle point and prevents any contact with the needle, except when the needle is injected into skin or tissue --See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Sitti as modified by Andreoni disclose a method, as described above, that fails to explicitly teach a capsule endoscope including a needle comprising 19 gauge (G) to 25 G; wherein said biopsy is a fine-needle aspiration biopsy using a fine-needle capillary technique, in which the needle is passed into the tissue, and five to ten successive fast jabbing movements in and out of the tissue are performed.
However, Van Dam teaches that it is known to provide an endoscopic biopsy device including a needle comprising 19 gauge (G) to 25 G (see at least par 0003 & 0040); wherein said biopsy is a fine-needle aspiration biopsy using a fine-needle capillary technique, in which the needle is passed into the tissue, and five to ten successive fast jabbing movements in and out of the tissue are performed (see also par 0002-0010 & 0041).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Sitti as modified by Andreoni including a needle comprising 19 gauge (G) to 25 G; wherein said biopsy is a fine-needle aspiration biopsy using a fine-needle capillary technique, in which the needle is passed into the tissue, and five to ten successive fast jabbing movements in and out of the tissue are performed as taught by Van Dam since such a modification would amount to applying a known technique (i.e., as taught by Van Dam) to a known device (i.e., as taught by Sitti) ready for improvement to achieve a predictable result such as achieving diagnostic certainty with a minimal number of instrument passes, thus achieving excellent results with minimal trauma to the patient (see at least par 0006 of Van Dam)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Sitti as modified by Andreoni and Van Dam discloses a method, as described above, that fails to explicitly teach a method wherein a magnetic field gradient selected in the range of 0.5 T/m to 2 T/m is applied on the permanent magnet while simultaneously a magnetic field selected in the range of 30 mT to 70 mT is applied on the permanent magnet for orientation stabilization.
However, Ries teaches that it is known to provide a method wherein a magnetic field gradient of 80 mT/m or 130 mT/m is applied on the permanent magnet 11 while simultaneously a magnetic field selected in the range of 50 mT to 75 mT is applied on the permanent magnet 11 for orientation stabilization (see at least abstract, figs. 1-5 and par 0012, 0027-0029 & 0039-0046).
Sitti discloses (see at least par 0282 & 0293-0294) that the magnetic field strength needs to be optimized to create “very distinct” critical forces for shape deformation, shape recovery, and drug release of the capsule endoscope and as such the magnetic field gradient applied to the device is disclosed to be a result effective variable in that the critical forces generated by the external magnetic field need to be very distinct to selectively achieve local drug release. Ries discloses (see at least par 0029) that the magnetic field gradient and magnetic field applied to the permanent magnet needs to be optimized to “adjust forces in the three co-ordinate directions, which forces are derived from the position control, are converted into magnetic fields and gradients and also into further coil currents which exert these forces on the magnet element so as to counteract errors in the nominal position and to stabilize the position of the permanent magnet” and as such the magnetic field gradient and magnetic field of the device is disclosed to be a result effective variable in that said magnetic field and magnetic field gradient exert forces on the magnet element to control the position of the capsule. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the method of Sitti as modified by Andreoni, Van Dam and Ries by making the magnetic field gradient and magnetic field to be in the range of 0.5 T/m to 2 T/m and 30 mT to 70 mT, respectively, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Sitti as modified by Andreoni, Van Dam and Ries discloses a method, as described above, that fails to explicitly teach a method wherein the end of the bottom housing part comprises a locating pad comprising a plurality of fibers to facilitate attaching the end of the bottom housing part to an inner surface of a GI tract and bringing the plurality of fibers into attached relation with the inner surface of the GI tract.
However, Iddan teaches that it is known to provide a method wherein the end of the bottom housing part comprises a locating pad 10 comprising a plurality of fibers (8, 8’) to facilitate attaching the end of the bottom housing part to an inner surface of a GI
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tract; and bringing the plurality of fibers (8, 8’) into attached relation with the inner surface of the GI tract (see at least abstract, figs. 1A-B, 2 & 4A-B and par 0068-0071, 0079 & 0081-0082).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Sitti as modified by Andreoni, Van Dam and Ries wherein the end of the bottom housing part comprises a locating pad comprising a plurality of fibers to facilitate attaching the end of the bottom housing part to an inner surface of a GI tract and bringing the plurality of fibers into attached relation with the inner surface of the GI tract as taught by Iddan since such a modification would amount to applying a known technique (i.e., as taught by Iddan) to a known device (i.e., as taught by Sitti) ready for improvement to achieve a predictable result such as anchoring the capsule endoscope to the GI tract tissue (see at least par 0077 & 0079 of Iddan)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 43, Sitti as modified by Andreoni, Van Dam and Ries discloses a method, as described above, that fails to explicitly teach a method wherein the magnetic field applied in order to move the magnetically actuated capsule endoscope through the workspace has a magnetic field strength selected in the range of 5 mT to 9 mT; and/or wherein on positioning the magnetically actuated capsule endoscope at a desired location a magnetic field having a desired strength selected in the range of 30 mT to 70 mT and a selected desired orientation, with the desired orientation being selected in accordance with a desired direction of orientation of the needle at the desired location. However, Ries teaches that it is known to provide a method wherein the magnetic field applied in order to move the magnetically actuated capsule endoscope 10 through the workspace has a magnetic field strength selected in the range of 50-75 mT; and/or wherein on positioning the magnetically actuated capsule endoscope 10 at a desired location a magnetic field having a desired strength selected to be 80 mT/m or 130 mT/m and a selected desired orientation (see at least abstract, figs. 1-5 and par 0012, 0027-0029 & 0039-0046). Sitti discloses (see at least par 0282 & 0293-0294) that the magnetic field strength needs to be optimized to create “very distinct” critical forces for shape deformation, shape recovery, and drug release of the capsule endoscope and as such the magnetic field gradient applied to the device is disclosed to be a result effective variable in that the critical forces generated by the external magnetic field need to be very distinct to selectively achieve local drug release. Ries discloses (see at least par 0029) that the magnetic field gradient and magnetic field applied to the permanent magnet needs to be optimized to “adjust forces in the three co-ordinate directions, which forces are derived from the position control, are converted into magnetic fields and gradients and also into further coil currents which exert these forces on the magnet element so as to counteract errors in the nominal position and to stabilize the position of the permanent magnet” and as such the magnetic field gradient and magnetic field of the device is disclosed to be a result effective variable in that said magnetic field and magnetic field gradient exert forces on the magnet element to control the position of the capsule. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the method of Sitti as modified by Andreoni, Van Dam and Ries by making the magnetic field strength to be in the range of 5 mT to 9 mT to move the magnetically actuated capsule endoscope thorugh the workspace and 30 mT to 70 mT to position the magnetically actuated capsule endoscope at a desired location as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 44, Sitti as modified by Andreoni and Van Dam discloses the method in accordance with claim 42, that fails to explicitly teach a method wherein the magnetic field applied to effect a repetitive expansion and contraction deformation of the plurality of deformable members in order to cause the needle to be repeatedly moved beyond the end of the bottom housing part has a magnetic field strength selected in the range of 30 mT to 70 mT and a sinusoidally varied magnetic field inducing a force applied at the deformable members selected in the range of 0.5 to 0.8 N. However, Ries teaches that it is known to provide a method wherein the magnetic field applied in order to move the magnetically actuated capsule endoscope 10 through the workspace has a magnetic field strength selected in the range of 50-75 mT; and/or wherein on positioning the magnetically actuated capsule endoscope 10 at a desired location a magnetic field having a desired strength selected to be 80 mT/m or 130 mT/m and a selected desired orientation (see at least abstract, figs. 1-5 and par 0012, 0027-0029 & 0039-0046). Sitti discloses (see at least par 0282 & 0293-0294) that the magnetic field strength needs to be optimized to create “very distinct” critical forces for shape deformation, shape recovery, and drug release of the capsule endoscope and as such the magnetic field gradient applied to the device is disclosed to be a result effective variable in that the critical forces generated by the external magnetic field need to be very distinct to selectively achieve local drug release. Ries discloses (see at least par 0029) that the magnetic field gradient and magnetic field applied to the permanent magnet needs to be optimized to “adjust forces in the three co-ordinate directions, which forces are derived from the position control, are converted into magnetic fields and gradients and also into further coil currents which exert these forces on the magnet element so as to counteract errors in the nominal position and to stabilize the position of the permanent magnet” and as such the magnetic field gradient and magnetic field of the device is disclosed to be a result effective variable in that said magnetic field and magnetic field gradient exert forces on the magnet element to control the position of the capsule. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the method of Sitti as modified by Andreoni, Van Dam and Ries by making the magnetic field strength to be in the range of 30 mT to 70 mT and a sinusoidally varied magnetic field inducing a force applied at the deformable members selected in the range of 0.5 to 0.8 N as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sitti (‘847) in view of Andreoni (‘937), Van Dam (‘641), Ries (‘562) and Iddan (US 2013/0172672) further in view of Tanaka (US 2008/0294143).
Sitti as modified by Andreoni, Van Dam, Ries and Iddan discloses a magnetically actuated capsule endoscope 10 in accordance with claim 27, that fails to explicitly teach a capsule endoscope further comprising a second camera or camera system that is arranged in the region of the needle and is configured to record images and/or videos from a region around the tip of the needle.
However, Tanaka teaches that it is known to provide a capsule endoscope further comprising a camera or camera system 8 that is arranged in the region of the needle 4 and is configured to record images and/or videos from a region around the tip of the needle 4 (see at least figs. 3 & 5-12; par 0051-0058). Moreover, the Office takes Official notice that it is known to provide a capsule with a second camera unit (see US 2011/0166416).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the capsule endoscope of Sitti as modified by Andreoni, Van Dam, Ries and Iddan further comprising a second camera or camera system, as claimed, that is arranged in the region of the needle and is configured to record images and/or videos from a region around the tip of the needle as taught by Tanaka in order to detect a position relation between a biological tissue surface in the desired part and the injection needle since it is known to provide a capsule with a second camera.
Claim(s) 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sitti (‘847) in view of Andreoni (‘937), Van Dam (‘641), Ries (‘562) and Iddan (US 2013/0172672) further in view of Tearney et al. (US 2016/0338578) (“Tearney” hereinafter).
In regards to claim 29, Sitti as modified by Andreoni, Van Dam, Ries and Iddan discloses the magnetically actuated capsule endoscope 10 in accordance with claim 23, that fails to explicitly teach a capsule endoscope further comprising a tether, with the tether being configured to effect a removal of the magnetically actuated capsule endoscope through the application of a force. However, Tearney teaches that it is known to provide a capsule endoscope 102 further comprising a tether 112, with the tether 112 being configured to effect a removal of the magnetically actuated capsule endoscope 102 through the application of a force (see at least abstract, figs. 1-6 and par 0026 & 0031). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the capsule endoscope of Sitti as modified by Andreoni, Van Dam, Ries and Iddan further comprising a tether, with the tether being configured to effect a removal of the magnetically actuated capsule endoscope through the application of a force as taught by Tearney since Tearney teaches that tetherless endoscope capsule (see figs. 4 & 6 thereof) is known alternative to a tethered capsule (see at least figs. 3 & 5 thereof).
In regards to claim 30, Sitti as modified by Andreoni, Van Dam, Ries and Iddan discloses the magnetically actuated capsule endoscope 10 in accordance with claim 29, that fails to explicitly teach a capsule endoscope wherein the tether is configured as a conduit for electric cables configured to transmit and/or receive signals and/or energy to components of the magnetically actuated capsule endoscope. However, Tearney teaches that it is known to provide a capsule endoscope wherein the tether 112 is configured as a conduit for electric cables configured to transmit and/or receive signals and/or energy to components of the magnetically actuated capsule endoscope 102 (see at least abstract, figs. 1-6 and par 0026 & 0031). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the capsule endoscope of Sitti as modified by Andreoni, Van Dam, Ries and Iddan wherein the tether is configured as a conduit for electric cables configured to transmit and/or receive signals and/or energy to components of the magnetically actuated capsule endoscope as taught by Tearney since Tearney teaches that tetherless endoscope capsule (see figs. 4 & 6 thereof) is known alternative to a tethered capsule (see at least figs. 3 & 5 thereof).
Claim(s) 35-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sitti (‘847) in view of Andreoni (‘937), Van Dam (‘641), Ries (‘562) and Iddan (US 2013/0172672) further in view of Imran et al. (US 2017/0066824) (“Imran” hereinafter).
In regards to claim 35, Sitti as modified by Andreoni, Van Dam, Ries and Iddan discloses the magnetically actuated capsule endoscope 10 in accordance with claim 23, that fails to explicitly teach a capsule endoscope wherein the magnetically actuated capsule endoscope is encapsulated by a shell, with the shell being configured to dissolve in a liquid environment after a pre- defined time. However, Imran teaches that it is known to provide a capsule endoscope wherein the magnetically actuated capsule endoscope is encapsulated by a shell, with the shell being configured to dissolve in a liquid environment after a pre- defined time (see at least abstract, figs. 2-8c and par 0012, 0014, 0020-0022 & 0025-0026). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the capsule endoscope of Sitti as modified by Andreoni, Van Dam, Ries and Iddan wherein the magnetically actuated capsule endoscope is encapsulated by a shell, with the shell being configured to dissolve in a liquid environment after a pre- defined time as taught by Imran since since such a modification would amount to applying a known technique (i.e., as taught by Imran) to a known device (i.e., as taught by Sitti) ready for improvement to achieve a predictable result such as allowing the targeted delivery of a therapeutic agent in a preselected portion of the intestinal tract (see at least par 0012 of Imran)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 36, Sitti as modified by Andreoni, Van Dam, Ries and Iddan discloses the magnetically actuated capsule endoscope 10 in accordance with claim 35, that fails to explicitly teach wherein the pre-defined time is selected in the range of 10 s to 10 min. However, Imran discloses (see at least par 0012) that the predefined time needs to be optimized to “allow the targeted delivery of a therapeutic agent in a selected portion of the intestinal tract” and as such predefined time of dissolution of the shell of the device is disclosed to be a result effective variable in that it allows the targeted delivery of a therapeutic agent in a preselected portion of the intestinal tract. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Sitti as modified by Andreoni, Van Dam, Ries, Iddan and Imran by making the predefined time be selected in the range of 10 s to 10 min as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant’s arguments with respect to claim(s) 23, 25, 27-37 & 42-44 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/RENE T TOWA/Primary Examiner, Art Unit 3791