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 Objections
Claims 1-11 and 14-16 are objected to because of the following informalities:
In claims 1-2, line 1-2, and claim 14, line 1, “the transit through the gastro-intestinal tract” should read –a transit through a gastro-intestinal tract–.
In claim 1, the last “wherein” clause, line 2, “the magnetic response field” should read –a magnetic response field–.
In claim 1, the last “wherein” clause, lines 3-4, “the coil system configured for determining whether the presence of a sensing device” should read, for example, –the tracking system configured for determining whether the sensing device is present-- or --a coil system configured for determining whether the sensing device is present–.
In claims 3-11, line 1, the “sensing device” should read the –system–.
In claims 5-6, line 2 and line 3, respectively, “the sensor” should read –the sensing device–.
In claim 6, line 3, “the gastric tract” should read – the gastrointestinal tract–.
In claim 8, line 3, “a casing” should read –the casing–.
In claim 9, “the ratio of the diameter of filament to the diameter of magnetic object may be a constant, wherein the constant be” should read –a ratio of a diameter of the filament to the diameter of the first magnetic object is a constant, wherein the constant is–.
In claim 11, line 3, “a diameter” should read –the diameter–.
In claim 14, lines 2-3, “the sensing devices of claim 1” should read, for example, –sensing devices, wherein each sensing device is the sensing device of claim 1–.
In claims 15-16, line 1, “the method of claim 12” should read –the method of claim 14–.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 15-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims does not fall within at least one of the four categories of patent eligible subject matter because it is directed to software per se (see MPEP 2106.03).
Claim 15 recites the “computer program comprising instructions”. All elements in the claims are non-structural (software). As the courts' definitions of machines, manufactures and compositions of matter indicate, a product must have a physical or tangible form in order to fall within one of these statutory categories. Digitech, 758 F.3d at 1348, 111 USPQ2d at 1719. Thus, the Federal Circuit has held that a product claim to an intangible collection of information, even if created by human effort, does not fall within any statutory category. Digitech, 758 F.3d at 1350, 111 USPQ2d at 1720 (claimed “device profile” comprising two sets of data did not meet any of the categories because it was neither a process nor a tangible product). Similarly, software expressed as code or a set of instructions detached from any medium is an idea without physical embodiment. See Microsoft Corp. v. AT&T Corp., 550 U.S. 437, 449, 82 USPQ2d 1400, 1407 (2007); see also Benson, 409 U.S. 67, 175 USPQ2d 675 (An "idea" is not patent eligible). Thus, a product claim to a software program that does not also contain at least one structural limitation (such as a “means plus function” limitation) has no physical or tangible form, and thus does not fall within any statutory category.
Claim 16 recites the “computer readable storage medium comprising instructions”. All elements in the claims are non-structural (software) with the computer readable storage medium that may be transitory. The specification does not exclude transitory forms of signal transmission. As the courts' definitions of machines, manufactures and compositions of matter indicate, a product must have a physical or tangible form in order to fall within one of these statutory categories. Digitech, 758 F.3d at 1348, 111 USPQ2d at 1719. Thus, the Federal Circuit has held that a product claim to an intangible collection of information, even if created by human effort, does not fall within any statutory category. Digitech, 758 F.3d at 1350, 111 USPQ2d at 1720 (claimed “device profile” comprising two sets of data did not meet any of the categories because it was neither a process nor a tangible product). Similarly, software expressed as code or a set of instructions detached from any medium is an idea without physical embodiment. See Microsoft Corp. v. AT&T Corp., 550 U.S. 437, 449, 82 USPQ2d 1400, 1407 (2007); see also Benson, 409 U.S. 67, 175 USPQ2d 675 (An "idea" is not patent eligible). Thus, a product claim to a software program that does not also contain at least one structural limitation (such as a “means plus function” limitation) has no physical or tangible form, and thus does not fall within any statutory category.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 and 14-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 1-2 recite the "a mammal, such as a human” in line 2, which is an exemplary claim language. This recitation makes the claim indefinite because the intended scope of this claim(s) is unclear. Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. See MPEP 2173.05(d). For examination purposes, Examiner of record takes this to be “a mammal”.
Claim 1 recites the “sensing system” in lines 2-3, the "tracking system” in the last “wherein” clause, line 1, and the “coil system” in the last “wherein” clause, line 3. It is unclear whether or not those are referring to different systems or are the same. For examination purposes, Examiner of record takes this to be the “sensing system”.
Claims 3, 6, and 10-11 recite the "preferably” in line 2, 2, 2, and 3, respectively, while claim 9 recites the “more preferably” in line 3, which is an exemplary claim language. This recitation makes the claim indefinite because the intended scope of this claim(s) is unclear. Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. See MPEP 2173.05(d). For examination purposes, Examiner of record will not consider the recitations that state preferences.
Claim 14 recites the "a mammal, such as a human” in lines 1-2, which is an exemplary claim language. This recitation makes the claim indefinite because the intended scope of this claim(s) is unclear. Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. See MPEP 2173.05(d). Additionally, the claim recites “for oral consumption by a subject” in line 3. It is unclear whether or not this is a reference to the “mammal”. For examination purposes, Examiner of record takes this to be “a mammalian subject” and “for oral consumption by the mammalian subject”.
Claims dependent upon the rejected claims above, but not directly addressed, are also rejected because they inherit the indefiniteness of the claim(s) they respectively depend upon.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 7-11, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Gleich et al (US20200397510), hereinafter Gleich, in view of Imran (US20040162501), hereinafter Imran.
Regarding claim 1, Gleich teaches a system (100) (Fig. 4) for monitoring and/or diagnosing the gastro-intestinal tract of a mammal (100) (“FIG. 1 schematically and exemplarily shows an embodiment of a marker device 501 for being attached to a medical device for being tracked by a tracking system used during surgery, in particular minimally invasive surgery on a human being, in particular a patient. The marker device 501 comprises a sensing unit with two magnetic object 507, 508.” [0083] “To that end, FIG. 4 shows at least one marker device 501 that is attached to an ultrasound probe 610 to track the position of said ultrasound probe 610 during an ultrasound measurement on a patient 100.” [0108]; Figs. 1, 4, 5A-B, and 20), such as a human (100) (Fig. 4), comprising sensing device (501) (3001) and a sensing system (1501) (“These mechanical oscillations are used by the tracking system to generate the electrical response signals that are used for deriving the position (and orientation) of the marker device.” [0012] “All devices with a diameter of 0.3 mm or larger will enable real-time tracking (more than 10 readings per second) at a distance of more than 30 cm with a high accuracy.” [0116]; “The tracking system 1501 comprises basically at least one field generator of magnetic fields and at least one magnetic field sensor, i.e. a transducer for transducing a magnetic or electromagnetic field generated by the induced oscillations of the magnetic object of the sensing unit into electrical response signals.” [0126]; Figs. 11-12), wherein the sensing device comprises a casing (3002); and
a first magnetic object (508) (3004) with a permanent magnetic moment (“a magnetic sphere.” [0119]; Figs. 2 and 10), wherein the first magnetic object is coupled to the casing in such a way, that it is configured for oscillating around an equilibrium position (“The magnetic object 508 is suspended from an attachment portion 506, such as a filament, and is thus free to perform a rotational motion about the main axis of the sensing unit.” [0084]; “The attractive force determines the resonance frequency of the oscillation, which for a spherical suspended magnet is given by …” [0085]; “in order to allow for a rotational oscillation of the magnetic object 3004 excited by the external magnetic or electromagnetic field resulting in a respective magnetic torque” [0119]; Fig. 10) when excited by a magnetic or an electromagnetic excitation field (“Also in FIG. 10 the marker device 3001 comprises a casing 3002 and a magnetic object 3004 being arranged within the casing 3002 such that it is rotatable out of an equilibrium orientation if an external magnetic torque is acting on the magnetic object 3004… the casing 3002 is cylindrical and the magnetic object 3004 is rotatable around a virtual rotational axis centrally traversing the magnetic object 3004, wherein the magnetic object 3004 is rotationally symmetric with respect to the virtual rotational axis. In particular, in this embodiment the magnetic object 3004 is a magnetic sphere.” [0119]; Fig. 10);
and
wherein the sensing device comprises a second magnetic object (507) (3003) configured for providing a restoring force to the first magnetic object (“In equilibrium, the magnetic objects 507, 508, respectively, align with anti-parallel orientation of their magnetization. An external magnetic field pulse can be used to start a resonance rotational oscillation.” [0085] “The marker device 3001 further comprises a restoring torque unit 3003 being adapted to provide a restoring torque to force the magnetic object 3004 back into the equilibrium orientation if an external magnetic or electromagnetic field has rotated the magnetic object 3004 out of the equilibrium orientation, in order to allow for a rotational oscillation of the magnetic object 3004 excited by the external magnetic or electromagnetic field resulting in a respective magnetic torque. In this embodiment the casing 3002 is cylindrical and the magnetic object 3004 is rotatable around a virtual rotational axis centrally traversing the magnetic object 3004, wherein the magnetic object 3004 is rotationally symmetric with respect to the virtual rotational axis. In particular, in this embodiment the magnetic object 3004 is a magnetic sphere.” [0119]);
wherein a distance (0.5 mm ) (a distance corresponds to half a minimum dimension, i.e., 1 mm/2 = 0.5 mm [0048]) from a center of the first magnetic object to an outer surface of the casing is at least equal to a diameter (“0.5 mm” [0168]) of the first magnetic object (“a minimum dimension being smaller than or equal to 1 mm.” [0048]; “a NdFeB marker device having a magnetic sphere with a sphere diameter of 0.5 mm” [0168])
and wherein the tracking system comprises at least one coil (“multi-coil tracking systems” [0034]; “the field(s) generated by the send coil(s).” [0179]) for generating the magnetic or electromagnetic excitation field (“This results in a rotational oscillation of the magnetic object excited by the external magnetic torque from the external magnetic or electromagnetic field.” [0051]) configured for detecting the magnetic response field generated by the sensing device ( “the rotational oscillations may particularly ultimately result in respective induction signals, whereby these induction signals depend on the spatial position and orientation of the marker device in the external magnetic or electromagnetic field.” [0052]); and
a controller for controlling the coil system (“multi-coil tracking systems” [0034]; “the field(s) generated by the send coil(s).” [0179]) configured for determining the presence of a sensing device in a target detection space (“the computer program is run on a computer controlling the tracking system” [0062]; “To that end, FIG. 4 shows at least one marker device 501 that is attached to an ultrasound probe 610 to track the position of said ultrasound probe 610 during an ultrasound measurement on a patient 100.” [0108] “With enough sensors, the position can be determined with only two coils.” [0174]; “with a large set of coils (e.g. >=6), both sensor position and orientation can be reconstructed” [0189]; “a position determination unit for determining the position of the marker device on the basis of the one or more electrical response signals” [0239]).
Gleich does not teach monitoring and/or diagnosing the transit through the gastro-intestinal tract.
However, in the intestinal tract treatment and diagnostic systems field of endeavor, Imran discloses a capsule and method for treating or diagnosing conditions or diseases of the intestinal tract, which is analogous art. Imran teaches monitoring and/or diagnosing the transit through the gastro-intestinal tract (“A diagnostic capsule may sense a number of parameters” [0030]; “a diagnostic capsule for which position and corresponding diagnostic information are tracked along the length of the intestinal tract.” [0034] “The present invention provides an improved method and device for tracking an autonomous capsule as well as a method and device for tracking and diagnosing the gastrointestinal tract, preferably using a tracking device.” [0183]).
Therefore, based on Imran’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Gleich to have the system for monitoring and/or diagnosing the transit through the gastro-intestinal tract, as taught by Imran, in order to improve medical care for gastrointestinal diseases.
Regarding claim 2, Gleich teaches a system (100) (Fig. 4) for monitoring and/or diagnosing the gastro-intestinal tract of a mammal (100) (“FIG. 1 schematically and exemplarily shows an embodiment of a marker device 501 for being attached to a medical device for being tracked by a tracking system used during surgery, in particular minimally invasive surgery on a human being, in particular a patient. The marker device 501 comprises a sensing unit with two magnetic object 507, 508.” [0083] “To that end, FIG. 4 shows at least one marker device 501 that is attached to an ultrasound probe 610 to track the position of said ultrasound probe 610 during an ultrasound measurement on a patient 100.” [0108]; Figs. 1, 4, 5A-B, and 20), such as a human (100) (Fig. 4), comprising sensing device (501) (3001) and a sensing system (1501) (“These mechanical oscillations are used by the tracking system to generate the electrical response signals that are used for deriving the position (and orientation) of the marker device.” [0012] “All devices with a diameter of 0.3 mm or larger will enable real-time tracking (more than 10 readings per second) at a distance of more than 30 cm with a high accuracy.” [0116]; “The tracking system 1501 comprises basically at least one field generator of magnetic fields and at least one magnetic field sensor, i.e. a transducer for transducing a magnetic or electromagnetic field generated by the induced oscillations of the magnetic object of the sensing unit into electrical response signals.” [0126]; Figs. 11-12), wherein the sensing device comprises a casing (3002); and
a first magnetic object (508) (3004) with a permanent magnetic moment (“a magnetic sphere.” [0119]; Figs. 2 and 10), wherein the first magnetic object is coupled to the casing in such a way, that it is configured for oscillating around an equilibrium position (“The magnetic object 508 is suspended from an attachment portion 506, such as a filament, and is thus free to perform a rotational motion about the main axis of the sensing unit.” [0084]; “The attractive force determines the resonance frequency of the oscillation, which for a spherical suspended magnet is given by …” [0085]; “in order to allow for a rotational oscillation of the magnetic object 3004 excited by the external magnetic or electromagnetic field resulting in a respective magnetic torque” [0119]; Fig. 10) when excited by a magnetic or an electromagnetic excitation field (“Also in FIG. 10 the marker device 3001 comprises a casing 3002 and a magnetic object 3004 being arranged within the casing 3002 such that it is rotatable out of an equilibrium orientation if an external magnetic torque is acting on the magnetic object 3004… the casing 3002 is cylindrical and the magnetic object 3004 is rotatable around a virtual rotational axis centrally traversing the magnetic object 3004, wherein the magnetic object 3004 is rotationally symmetric with respect to the virtual rotational axis. In particular, in this embodiment the magnetic object 3004 is a magnetic sphere.” [0119]; Fig. 10);
and
wherein the sensing device comprises a second magnetic object (507) (3003) configured for providing a restoring force to the first magnetic object (“In equilibrium, the magnetic objects 507, 508, respectively, align with anti-parallel orientation of their magnetization. An external magnetic field pulse can be used to start a resonance rotational oscillation.” [0085] “The marker device 3001 further comprises a restoring torque unit 3003 being adapted to provide a restoring torque to force the magnetic object 3004 back into the equilibrium orientation if an external magnetic or electromagnetic field has rotated the magnetic object 3004 out of the equilibrium orientation, in order to allow for a rotational oscillation of the magnetic object 3004 excited by the external magnetic or electromagnetic field resulting in a respective magnetic torque. In this embodiment the casing 3002 is cylindrical and the magnetic object 3004 is rotatable around a virtual rotational axis centrally traversing the magnetic object 3004, wherein the magnetic object 3004 is rotationally symmetric with respect to the virtual rotational axis. In particular, in this embodiment the magnetic object 3004 is a magnetic sphere.” [0119]); and
wherein a distance (0.5 mm ) (a distance corresponds to half a minimum dimension, i.e., 1 mm/2 = 0.5 mm [0048]) from a center of the first magnetic object to an outer surface of the casing is at least equal to a diameter (“0.5 mm” [0168]) of the first magnetic object (“a minimum dimension being smaller than or equal to 1 mm.” [0048]; “a NdFeB marker device having a magnetic sphere with a sphere diameter of 0.5 mm” [0168]).
Gleich does not teach monitoring and/or diagnosing the transit through the gastro-intestinal tract.
However, in the intestinal tract treatment and diagnostic systems field of endeavor, Imran discloses a capsule and method for treating or diagnosing conditions or diseases of the intestinal tract, which is analogous art. Imran teaches monitoring and/or diagnosing the transit through the gastro-intestinal tract (“A diagnostic capsule may sense a number of parameters” [0030]; “a diagnostic capsule for which position and corresponding diagnostic information are tracked along the length of the intestinal tract.” [0034] “The present invention provides an improved method and device for tracking an autonomous capsule as well as a method and device for tracking and diagnosing the gastrointestinal tract, preferably using a tracking device.” [0183]).
Therefore, based on Imran’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Gleich to have the system for monitoring and/or diagnosing the transit through the gastro-intestinal tract, as taught by Imran, in order to improve medical care for gastrointestinal diseases.
Regarding claim 3, Gleich modified by Imran teaches the sensing device of claim 2, wherein Gleich teaches that the distance from the center of the magnetic object to the outer surface of the casing (the distance along the “length of the marker device” [0116]) is at least equal to twice of that of the diameter of the magnetic object (“In the following, it is assumed that the length of the marker device is always about twice the diameter.” [0116]; In fig. 1, the distance in the z axis direction is over twice of that of the diameter).
Regarding claim 4, Gleich modified by Imran teaches the sensing device of claim 2, wherein Gleich teaches that a filling material is provided over an inner side of the casing, wherein the filling material comprises at least one of: epoxy resin, and/or polymer material group (“polymer.” [0207]), and/or a material from an acryloyl group (“In FIG. 20, the sensing unit 4001 comprises a magnetic object 4008 being a permanent magnet suspended via an attachment portion 4006, such as a filament which is preferentially a high strength wire, from a hard wall 4010 of a casing 4002. The hard wall 4010 is preferentially made of a metal or a polymer that is insensitive to external pressure influences. Further, also the remaining part of the casing 4002 might be made … of a polymer.” [0207]).
Regarding claim 5, Gleich modified by Imran teaches the sensing device of claim 2.
Gleich does not teach that the casing further comprises a cage defining an outer shape of the sensor.
However, in the intestinal tract treatment and diagnostic systems field of endeavor, Imran discloses a capsule and method for treating or diagnosing conditions or diseases of the intestinal tract, which is analogous art. Imran teaches that the casing further comprises a cage (12) (62) defining an outer shape of the sensor (“the inventive capsule includes an encasing at least a portion of which is dissolvable in fluids in the intestinal tract. The encasing may selectively dissolve depending on the pH of the tract.” [0047] “As shown in FIG. 19, a dissolvable encasing 62 is provided over the capsule body 61. This encasing 62 can be formed of the same material as the encasing 12 in the embodiment shown in FIG. 15.” [0154] “Where a dissolvable encasing is utilized for encapsulating the elongate member and electrode(s), the encasing is readily dissolved by the fluids within the stomach or duodenum, permitting the flexible elongate member carrying the stimulation electrode to be deployed.” [0161]).
Therefore, based on Imran’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Gleich to have the casing that further comprises a cage defining an outer shape of the sensor, as taught by Imran, in order to improve medical care for gastrointestinal diseases by permitting the sensor to be deployed.
Regarding claim 7, Gleich modified by Imran teaches the sensing device of claim 2.
Gleich does not teach that an outer surface of the cage is provided with a gastrointestinal resistance coating.
However, in the intestinal tract treatment and diagnostic systems field of endeavor, Imran discloses a capsule and method for treating or diagnosing conditions or diseases of the intestinal tract, which is analogous art. Imran teaches that an outer surface of the cage (12) (62) is provided with a gastrointestinal resistance coating (“the inventive capsule includes an encasing at least a portion of which is dissolvable in fluids in the intestinal tract. The encasing may selectively dissolve depending on the pH of the tract.” [0047] “As shown in FIG. 19, a dissolvable encasing 62 is provided over the capsule body 61. This encasing 62 can be formed of the same material as the encasing 12 in the embodiment shown in FIG. 15.” [0154] “Where a dissolvable encasing is utilized for encapsulating the elongate member and electrode(s), the encasing is readily dissolved by the fluids within the stomach or duodenum” [0161]).
Therefore, based on Imran’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Gleich to have an outer surface of the cage that is provided with a gastrointestinal resistance coating, as taught by Imran, in order to improve medical care for gastrointestinal diseases by permitting the sensor to be deployed.
Regarding claim 8, Gleich modified by Imran teaches the sensing device of claim 2, wherein Gleich teaches that at least the first magnetic object is configured to be attached to the casing via a filament (“The casing 3002 is cylindrical, wherein the cylindrical casing 3002 comprises two end surfaces 3030, 3031 and wherein the further magnetic object 3003 is fixedly attached to a first end surface 3030” [0122]), and
the second magnetic object is either configured to be fixed to a casing by a fixing material or attached to the casing via a second filament (“The casing 3002 is cylindrical, wherein the cylindrical casing 3002 comprises two end surfaces 3030, 3031 and wherein the further magnetic object 3003 is fixedly attached to a first end surface 3030” [0122]; “In FIG. 20, the sensing unit 4001 comprises a magnetic object 4008 being a permanent magnet suspended via an attachment portion 4006, such as a filament which is preferentially a high strength wire, from a hard wall 4010 of a casing 4002. The hard wall 4010 is preferentially made of a metal or a polymer that is insensitive to external pressure influences. Further, also the remaining part of the casing 4002 might be made of metal or of a polymer. The casing 4002 might be filled with gas or it might provide a vacuum space. A further magnetic object 4007 is fixed via glue 4011 to an inner end surface of the casing 4002.” [0207]).
Regarding claim 9, Gleich modified by Imran teaches the sensing device of claim 8, wherein Gleich teaches that the ratio of the diameter of filament to the diameter of magnetic object may be a constant, wherein the constant would be in the range from 1:1 to 1:1000 (seen Fig. 10).
Regarding claim 10, Gleich modified by Imran teaches the sensing device of claim 8, wherein Gleich teaches that the filament and/or fixing material is of polymer material group (“light curing glues … UHMWPE fibers.” [0098]) (“Several glue types can be used. Economic are light curing glues. They should have a low viscosity to fill the hole with the treads simply by capillary force. Additionally or alternatively, the attachment portion can be fixed to the magnetic object 508 by mechanical means, e.g. by having a knot in the thread or some other thick portion in the tread like a glue droplet or a heat generated (melted) bead. The latter is especially easily made in UHMWPE fibers.” [0098]).
Regarding claim 11, Gleich modified by Imran teaches the sensing device of claim 2, wherein Gleich teaches that a distance between the first magnetic object and the second magnetic object is less than 10% of a diameter of the first magnetic object (the distance is 1/8th of the diameter in Fig. 10, which is close to the claimed 10%. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. MPEP 2144.05. I.).
Regarding claim 14, Gleich modified by Imran teaches the sensing device of claim 1.
While teaching a method of monitoring (Fig. 4), Gleich does not teach a method of monitoring the transit through the gastro-intestinal tract of a mammal, the method comprising administering the sensing devices for oral consumption by a subject.
However, in the intestinal tract treatment and diagnostic systems field of endeavor, Imran discloses a capsule and method for treating or diagnosing conditions or diseases of the intestinal tract, which is analogous art. Imran teaches a method of monitoring the transit through the gastro-intestinal tract of a mammal, the method comprising administering the sensing devices for oral consumption by a subject (“As illustrated in FIGS. 3A and 3B, a first embodiment of a capsule 110 comprises a liquid impermeable and airtight capsule body 111. In general, the capsule of the present invention is sized so that it is capable of being ingested for passage through the intestinal tract. For adult human use, a preferred embodiment of the capsule is to be sized so that it has a length ranging from about 1.5 to 2.5 cm and having a diameter of about 8 mm or less. For children and larger and smaller animals, the capsule can be appropriately sized.” [0091]. “In use, the capsule 180 is delivered after a diagnostic capsule having a diagnostic sensor has been passed through the intestinal tract to obtain a map of sensed parameters along the length of the tract.” [0138]; “Where it is necessary for the patient to ingest a capsule each time food is ingested by the patient, the patient can have additional capsules on hand and ingest a capsule with each meal.” [0172]; Fig. 10).
Therefore, based on Imran’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Gleich to have a method of monitoring the transit through the gastro-intestinal tract of a mammal, the method comprising administering the sensing devices for oral consumption by a subject, as taught by Imran, in order to improve medical care for gastrointestinal diseases by permitting the sensor to be deployed.
Regarding claim 15, Gleich modified by Imran teaches the method of claim 14.
Gleich teaches a computer program comprising instructions (“the software system” [0226]) which, when the program is executed by a computer, cause the computer to carry out the method (“It is therefore an object of the present invention to provide an improved tracking system and an improved marker device, a respective medical device, a tracking method and a computer program for tracking the marker device.” [0006]; “The control of the tracking system can be implemented as program code means of a computer program” [0236]).
Regarding claim 16, Gleich modified by Imran teaches the method of claim 14.
Gleich teaches a computer readable storage medium comprising instructions (“the software system” [0226]. “A computer program may be stored/distributed on a suitable medium, such as an optical storage medium or a solid-state medium” [0237]), which, when executed by a computer, cause the computer to carry out the method (“The control of the tracking system can be implemented as program code means of a computer program” [0236]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Gleich and Imran as applied to claim 2, and further in view of Duan (US 20190029615), hereinafter Duan.
Regarding claim 6, Gleich modified by Imran teaches the sensing device of claim 2.
Gleich as modified by Imran does not teach that the sensing device is arranged to have a density from 945 to 1155 kg/m³, and preferably from 1000 to 1050 kg/m³ to allow the sensor to pass through the gastric tract.
However, in the intestinal tract treatment and diagnostic systems field of endeavor, Duan discloses a capsule for measuring motility of a target area and a method for making the capsule, which is analogous art. Duan teaches that the sensing device is arranged to have a density from 945 to 1155 kg/m³, to allow the sensor to pass through the gastric tract (“The number, shape and/or sizes of the cavities of the third element are adjustable to make the weights of the first, the second and the third identification markers consistent, and the density of the three identification markers 20 as close as possible to the density of chyme in the gastrointestinal tract, so as to achieve a better simulation effect. In the preferred embodiment of the present invention, the density of the identification marker 20 is set to be between 1.0-1.7 g/cm.sup.3 in accordance with the density of the chyme in the gastrointestinal tract of about 1.09 g/cm.sup.3. That is, the density of the three identification markers 20 is between 1.0-1.7 g/cm.sup.3.” [0065]).
Therefore, based on Duan’ teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the combined invention of Gleich and Imran to have the sensing device that is arranged to have a density from 945 to 1155 kg/m³ to allow the sensor to pass through the gastric tract, as taught by Duan, in order to improve medical care for gastrointestinal diseases. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, the claimed range of 945 to 1155 kg/m³, overlaps with the range disclosed by Duan of between 1.0-1.7 g/cm.sup.3.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXEI BYKHOVSKI whose telephone number is (571)270-1556. The examiner can normally be reached on Monday-Friday: 8:30am - 5:00pm.
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/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798
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