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
Claim 6 is objected to because of the following informalities: the limitation “moved backwards in one direction by the second drive unit at the same time, and, thus, the catheter is pulled back” should be amended. Use of ‘and, thus, the catheter is pulled back’ does not conform with standard U.S. practice. This language should be rewritten into the claim limitations to positively recite the pullback motion of the catheter.
Claim 7 is objected to because of the following informalities: the limitation “in a state where the clamp part has been inserted in the body part by the second drive unit, and, thus, the female type optical connector is decoupled from the male type optical connector” should be amended. Use of ‘and, thus, the female type optical connector is decoupled from the male type optical connector’ does not conform with standard U.S. practice. This language should be rewritten into the claim limitations to positively recite the decoupling of the female and male optical connectors.
Claim 12 is objected to because of the following informalities: the limitation “a torque coil which is connected to the female type optical connector and allows insertion of the optical fiber on the catheter side and thus emits light;” should be amended. Use of ‘and thus emits light’ does not conform with standard U.S. practice. This language should be rewritten into the claim limitations to positively recite the emission of light.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The claims are replete with idiomatic and grammatical errors, and generally fail to conform with standard U.S. practice. Claims 2-15 are also rejected at least by virtue of dependency upon a rejected base claim.
Claim 1 recites the limitations “A catheter rotary apparatus for OCT, comprising: a rotary junction module which includes […] and a catheter which includes […] a cap part clamped to the body part, wherein the cap part includes: […]” which renders the claim indefinite, because the language does not clearly define what structures are included within which elements. In particular it is unclear whether the ‘rotary junction module’ includes both the ‘catheter’ and the ‘cap part’; or if the ‘rotary junction module’, ‘catheter’ and ‘cap part’ are distinct from each other and individually comprised within the ‘catheter rotary apparatus’; or if the ‘rotary junction module’ is separate from the ‘catheter’, wherein the ‘catheter’ includes the ‘cap part’; or some other combination. It is suggested to amend the claim to conform with standard U.S. practice and correct the informalities using proper indentation and punctuation. For the purposes of examination the broadest reasonable interpretation of the limitations – including those discussed above – is applied to the claim language.
Claim 1 further recites the limitations “A catheter rotary apparatus for OCT, comprising: […] a sample stage side of OCT system to pass at one end […] at one end on the sample stage side of OCT system of the body part and configured to connect the optical fiber on the sample stage side of OCT system and the optical fiber […]”, which renders the claim indefinite. There is insufficient antecedent basis for these limitations in the claim. First, the phrase “at one end” lacks antecedent basis because it is not clear what either of the ‘one ends’ are referring to relative to the other structures (e.g., the same ‘end’, different ‘ends’, the ‘other end’, etc.) recited in the claim. Similarly, the use of ‘OCT system’ is unclear because there is no prior recitation of an ‘OCT system’ which clearly points out what is being claimed – in an interpretation the ‘OCT system’ may refer to the ‘catheter rotary apparatus for OCT’ in the preamble, in another interpretation there is an external ‘OCT system’, etc. The claim must be amended to clearly point out what the ‘OCT system’ is. For the purposes of examination the broadest reasonable interpretation of the limitations – including those discussed above – is applied to the claim language.
Claim 1 further recites the limitations “a motor part which is provided […] and includes a male type optical connector configured to connect the optical fiber on the catheter side and a catheter; and a catheter which includes”, which renders the claim indefinite. There is insufficient antecedent basis for these limitations in the claim. The use of ‘a catheter’ in the body of the ‘motor part’ clause and in the subsequent limitation introduces multiple interpretations: it is unclear if they are the same ‘catheter’, if there are multiple distinct ‘catheters’, which ‘catheter’ refers to ‘a catheter side’, etc. The claim must be amended to clarify what ‘catheter(s)’ is/are included within the ‘catheter rotary apparatus’. For the purposes of examination the broadest reasonable interpretation of the limitations – including those discussed above – is applied to the claim language.
Claim 1 further recites the limitations “a body part including a through part […] an outer cap coupled to a through part formed in the body part” which renders the claim indefinite. There is insufficient antecedent basis for this limitation in the claim. The use of ‘a through part’ lacks antecedent basis in the same manner as discussed regarding the other indefinite limitations above: it is not clear if the ‘through part’ is the same part in each recitation, distinct parts, etc. For the purposes of examination the broadest reasonable interpretation of the limitations – including those discussed above – is applied to the claim language.
Claim 2 recites the limitations “wherein the rotary junction module further includes a clamp part of which one end is inserted into the through part and the other end is located to face the motor part,” which renders the claim indefinite and lacks sufficient antecedent basis. It is not clear what the ‘one end’ and ‘the other end’ are specifically pointing to. It is suggested to amend the claim to clearly define the structure of the ‘clamp part’ relative to the limitations recited in independent claim 1 and the instant claim 2.
Claim 4 recites the limitation “an inner cap coupling which is inserted to be in tight contact with an inner circumferential surface of the through part and of which one end is coupled to the inner cap; and” which renders the claim indefinite. It is unclear what ‘one end’ is referring to, because in distinct interpretations ‘one end’ may point to an aspect of the ‘clamp part’ recited in claim 2 or may point to a new structure recited in claim 4. In the latter interpretation, it is unclear whether ‘one end’ refers to either of the ‘inner cap coupling’ or the ‘inner circumferential surface’. Similar consideration is given to the use of ‘the other end’ recited in the last clause of the claim. It is suggested to amend the claim to clarify the disposition of the structures being claimed relative to each other. For the purposes of examination the broadest reasonable interpretation of the claim language is applied to the limitations.
Claim 5 recites the limitations “a first drive unit connected to the motor part and configured to move the motor part in one direction; and a second drive unit connected to the clamp part and configured to move the clamp part in one direction” which renders the claim indefinite. It is not clear what moving ‘in one direction’ points to with regards to both of the ‘motor part’ and the ‘clamp part’. In distinct interpretations the ‘one direction’ may be the same direction of movement for both the ‘motor part’ and the ‘clamp part’, different directions of movement, or may refer to linear movement or rotational movement in different combinations. It is suggested to amend the claim to clarify what the ‘one direction’ is particularly referring to. For the purposes of examination the broadest reasonable interpretation of the claim language – including those discussed above – is applied to the limitations.
Claim 6 recites the limitation “the motor part is moved backwards in one direction by the first drive unit and the clamp part is moved backwards in one direction by the second drive unit” which renders the claim indefinite. The use of ‘backwards’ in the claim is unclear because there is no prior recitation of a ‘forward’ direction relative to the catheter rotary apparatus. Neither the instant claim 6, nor the prior claims upon which claim 6 is dependent, establish the ‘backwards’ directionality. It is suggested to amend the claim(s) to clarify the motion of the ‘clamp part’ and the ‘motor part’ and the ‘directions’ relative to the catheter rotary apparatus.
Claim 7 recites the limitation “only the motor part is moved backwards in one direction by the first drive unit in a state where the clamp part has been inserted in the body part by the second drive unit” which renders the claim indefinite. The ‘clamp part’ is recited as being inserted within the ‘through part’ (i.e., the ‘body part’) by default (as introduced in claim 2), and furthermore the ‘second drive unit’ is not claimed to have the function of inserting the ‘clamp part’ (as recited in claim 5) – rather the ‘second drive unit’ merely moves the ‘clamp part’ in ‘one direction’. It is suggested to amend the claim(s) to clarify the functions which are performed by the structures at issue, and to describe how these functions (and corresponding structures) perform the coupling/decoupling of the optical connectors.
Claim 10 recites the limitation “the motor part further includes a universal coupler which is coupled to the rotator of the fiber optic rotary joint and configured to rotate the rotator” which renders the claim indefinite. There is insufficient antecedent basis for this limitation in the claim. It is not clear what ‘the rotator’ is pointing to, because there is no prior recitation of a ‘rotator’ in the instant claim 10 or the independent claim 1. For the purposes of examination the broadest reasonable interpretation of the claim language is applied to the limitation.
Claim 12 recites the limitations “a torque coil which is connected to the female type optical connector and allows insertion of the optical fiber on the catheter side and thus emits light; […] a second protective sheath located in the entire torque coil and outside the proximal side” which renders the claim indefinite. It is not clear what structure is facilitating the emission of light from the ‘torque coil’ clause. Furthermore, it is not clear what the disposition of the ‘second protective sheath’ is or how it is distinguished from the ‘first protective sheath’ based on the claim language, as drafted. It is suggested to amend the claim to clearly identify the disposition and aspects of the ‘torque coil’ (i.e., proximal side, protective sheaths, etc.) and the functions of the disposition of the protective sheaths relative to catheter rotary apparatus. For the purposes of examination the broadest reasonable interpretation of the limitations is applied to the claim language.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 10 and 12-15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hutchins et al. (US20200397405A1, 2020-12-24; hereinafter “Hutchins”) as provided by Applicant.
Regarding claim 1, Hutchins teaches a catheter rotary apparatus for OCT (“An interface device” [clm 1]; “the invention relates to a patient interface unit or device (PIU) configured to interface with a data collection probe. […] the data collection probe includes a probe tip configured to collect optical data and ultrasound data with respect to a sample such as a blood vessel.” [0006]; “an interface unit such as a patient interface unit (PIU) configured for use with data collection probes having an optical data collection component” [0046]; [0049-0057, 0084-0093], [fig. 1-10B, 12A-12C]), comprising:
a rotary junction module (“some components of the PIU are rotatable and configured to rotate with the data collection probe in a rotationally balanced and/or synchronized manner while other components of the PIU such as optical fiber section 50 are stationary.” [0051]; “the PIU 40 includes various components that are supported by a frame, carriage, and/or other structural members disposed within the cover 42.” [0053]; “One or more rotary joints are used to couple two rotating signal transmission lines (optical fiber and plurality of coiled conductors such as wires) within the probe to stationary transmission lines within the PIU.” [0084]; [0049-0057, 0084-0093], [fig. 1-10B, 12A-12C]) which includes
a body part including a through part to enable an optical fiber on a sample stage side of OCT system to pass at one end and an optical fiber on a catheter side to pass at the other end (“a cover; an aperture defined by the cover; a stationary section of a sample arm of an interferometer disposed within the cover and comprising a stationary optical fiber section having an endface; a first rotatable connector defining a first bore, the first bore positioned in alignment relative to the aperture and disposed within the cover;” [clm 1]; “the PIU 40 includes various components that are supported by a frame, carriage, and/or other structural members disposed within the cover 42. […] One end of connector 70 faces an aperture 88 of the PIU 40. […] The connector 70 includes a channel configured to receive an optical fiber from the probe 15” [0053]; “The optical fiber section 30 is in optical communication with the data collection probe and rotates with the probe. In turn, the optical fiber section 50 does not rotate and is in optical communication with an optical signal receiver 57.” [0054]; [0049-0057, 0084-0093], [fig. 1-10B, 12A-12C]),
a fiber optic rotary joint provided at one end on the sample stage side of OCT system of the body part and configured to connect the optical fiber on the sample stage side of OCT system and the optical fiber on the catheter side (“a first rotatable connector defining a first bore, […] a sacrificial connector; a second rotatable connector defining a second hole,” [clm 1]; “The PIU 40 can also include an optical coupling device or joint 80 such as fiber optic rotary joint. The optical joint 80 includes a stationary component 80 a and a rotatable component 80 b. The optical fiber section 30 is in optical communication with the data collection probe and rotates with the probe.” [0054]; “A fiber optic rotary joint is configured such that the optical fiber portion of the joint is coaxial with the axis of rotation in one embodiment. This in turn requires the electrical rotary joint to have a central core which defines a cavity, channel or opening to allow passage of an optical fiber or otherwise define an optical path.” [0084]; The PIU includes a fiber optic rotary joint with a channel to connect the optical fibers of the OCT catheter and the stationary transmission line [0049-0057, 0084-0093], [fig. 1-10B, 12A-12C]), and
a motor part which is provided inside the body part and configured to rotate the optical fiber on the catheter side, and includes a male type optical connector configured to connect the optical fiber on the catheter side and a catheter (“a first motor disposed within the cover, the first motor configure to rotate the second rotatable connector.” [clm 1]; “A motor 75 such as a belt driven motor can be used in one embodiment to rotate or pullback probe 15.” [0054]; “a motor (not shown) rotates the imaging core 102, connector 110, PIU interconnect 117, a portion of the transformer 120 and a portion of the fiber optic rotary joint 115.” [0070]; “The inner shell of probe connector 110 has […] one optical connector 150 attached or otherwise optically coupled to an optical fiber of the imaging core 102.” [0075]; “Sacrificial interconnect 143 includes a female optical connector 155 shaped to receive the male optical connector 150.” [0076]; The probe connector 110 includes a male optical connector 150 which is rotated by the motor [0049-0057, 0084-0093], [fig. 1-10B, 12A-12C]); and
a catheter (“The data collection components are configured to be introduced into a patient such as through a blood vessel and rotate therein in one embodiment. The PIU and a disposable data collection probe are configured to connect to and release from each other. […] The data collection probe can include a catheter or one or more sheaths. The probe can further include imaging devices and optical and electrical components such that both IVUS and OCT data can be collected.” [0046]; “The system 10 includes a data collection probe 15.” [0049]; “The rotatable imaging core of the catheter body includes a central optical fiber 230 helically wrapped with electrical wires 232 and encased by a torque cable 233.” [0093]; [0049-0057, 0084-0112], [fig. 1-10B, 12A-12C]) which includes
a female type optical connector connected to the male type optical connector (“The inner shell of probe connector 110 has […] one optical connector 150 attached or otherwise optically coupled to an optical fiber of the imaging core 102. The sacrificial joint 143 has a female (shown) 160 a and male (not shown electrical connector as well as both sides of the optical connector (only one side shown).” [0075]; “Sacrificial interconnect 143 includes a female optical connector 155 shaped to receive the male optical connector 150.” [0076]; [0049-0057, 0084-0093], [fig. 1-10B, 12A-12C]), and
a cap part clamped to the body part (“an elongate probe connector” [clm 6]; “the probe connector 110 is formed from two shells or halves that snap or otherwise connect together.” [0063]; [0049-0057, 0084-0112], [fig. 1-10B, 12A-12C; see fig. 8B reproduced below]),
wherein the cap part includes:
an outer cap coupled to a through part formed in the body part (“The two inner shell halves 110 a, 110 b are positioned on either side of an optical connector 150 mounted on the end to receive the optical fiber.” [0079]; “The rotatable fiber 229 a connects into the rotatable optical connector 211 which can include a connector plate or support 211 a, and the stationary fiber 229 b and 223 connects into an optical signal processing system such as an OCT imaging engine.” [0091]; “To engage the connector, the operator grasps the sterile outer shell 401 of the catheter and mechanically interlocks it into a port 303” [0102]; [0049-0057, 0084-0112], [fig. 1-10B, 12A-12C; see fig. 8B reproduced below]);
an inner cap inserted into the outer cap (“The imaging core 102 is connected to a probe connector 107. This connector 107 can be an elongate member having a cylindrical, conical, partial conical or other geometry.” [0059]; The imaging core connector of the probe connector are nested within the outer shell of connector [0049-0057, 0084-0112], [fig. 1-10B, 12A-12C; see fig. 8B reproduced below]); and
a fixed cap coupled to the female type optical connector and rotated when the female type optical connector is rotated (“a motor (not shown) rotates the imaging core 102, connector 110, PIU interconnect 117, a portion of the transformer 120 and a portion of the fiber optic rotary joint 115.” [0070]; “The imaging core connector 304 is attached to the spinning connector end 305 of the rotary joint.” [0095]; The probe connector 110 coupled to optical connector is rotated by the motor synchronically with the imaging core [0049-0057, 0084-0112], [fig. 1-10B, 12A-12C; see fig. 8B reproduced below]).
PNG
media_image1.png
621
1028
media_image1.png
Greyscale
Connector 110 comprising imaging core connector 327 (i.e., fixed cap), and a section 326 of optical fiber connector 45 (i.e., outer cap) containing imaging core connector 107 (i.e., inner cap) (Hutchins [fig. 8B])
Regarding claim 2, Hutchins teaches the catheter rotary apparatus of Claim 1,
Hutchins further teaching wherein the rotary junction module further includes a clamp part of which one end is inserted into the through part and the other end is located to face the motor part, and the inner cap is coupled to the clamp part (“Optical signals collected using a data collection probe and light received from a light source are transmitted through the optical fiber 213 and an optical fiber (not shown) connected to the rotatable optical fiber connector 211. The rotatable optical fiber connector 211 of FIG. 6A is an exemplary embodiment of connector 45 shown in FIG. 1. The optical fiber connector 211 can include a support plate 211 a” [0086]; [0049-0057, 0084-0112], [fig. 1-10B, 12A-12C; see fig. 6B reproduced below]).
PNG
media_image2.png
644
1027
media_image2.png
Greyscale
The support plate encloses the connector and spans the aperture (Hutchins [fig. 6B])
Regarding claim 3, Hutchins teaches the catheter rotary apparatus of Claim 2,
Hutchins wherein the rotary junction module further includes a drive part coupled to the body part and configured to move the motor part and the clamp part in one direction (“A motor 75 such as a belt driven motor can be used in one embodiment to rotate or pullback probe 15.” [0054]; “During pullback, the imaging core 102, the catheter connector 110, the PIU connector 117 with sacrificial interconnect 143, the fiber optic joint 115 and the rotary electrical joint 120 all slide back together along the bushing rails 127.” [0062]; “pullback is achieved using a pullback motor (not shown) and lead screw 125 to slide a carriage 128 supporting the rotary transformer and the fiber optic rotary joint along bushing rails 127” [0071]; “The linear motion is obtained by mounting a combination rotary joint 301 coupled to a carriage 306 onto a linear rail system 302. The catheter sheath and outer housing (not shown) is rigidly attached to a stationary point 303 on the PIU. The imaging core connector 304 is attached to the spinning connector end 305 of the rotary joint.” [0095]; The pullback motor (i.e., drive part) slides the carriage carrying components between rotary transformer and connector during pullback [0049-0057, 0084-0112], [fig. 1-10B, 12A-12C]).
Regarding claim 4, Hutchins teaches the catheter rotary apparatus of Claim 3,
Hutchins further teaching wherein the clamp part includes:
an inner cap coupling which is inserted to be in tight contact with an inner circumferential surface of the through part and of which one end is coupled to the inner cap (“The rotatable optical fiber connector 211 of FIG. 6A is an exemplary embodiment of connector 45 shown in FIG. 1. The optical fiber connector 211 can include a support plate 211 a” [0086]; [0049-0057, 0084-0112], [fig. 1-10B, 12A-12C; see fig. 6B reproduced below]); and
a drive part coupling coupled to the other end of the inner cap coupling and connected to the drive part (“pullback is achieved using a pullback motor (not shown) and lead screw 125 to slide a carriage 128 supporting the rotary transformer and the fiber optic rotary joint along bushing rails 127” [0071]; “The linear motion is obtained by mounting a combination rotary joint 301 coupled to a carriage 306 onto a linear rail system 302. The catheter sheath and outer housing (not shown) is rigidly attached to a stationary point 303 on the PIU. The imaging core connector 304 is attached to the spinning connector end 305 of the rotary joint.” [0095]; [0049-0057, 0084-0112], [fig. 1-10B, 12A-12C; see fig. 2, 6B reproduced below]).
PNG
media_image3.png
671
1028
media_image3.png
Greyscale
PNG
media_image2.png
644
1027
media_image2.png
Greyscale
The support plate is coupled to the optical fiber connector, and the carriage (i.e., drive part coupling) is coupled to and translates the combination rotary joint (Hutchins [fig. 2, 6B])
Regarding claim 5, Hutchins teaches the catheter rotary apparatus of Claim 3,
Hutchins further teaching wherein the drive part includes:
a first drive unit connected to the motor part and configured to move the motor part in one direction (“pullback is achieved using a pullback motor (not shown) and lead screw 125 to slide a carriage 128 supporting the rotary transformer and the fiber optic rotary joint along bushing rails 127” [0071]; A carriage supports the rotary transformer and fiber optic rotary joint for pullback [0049-0057, 0084-0112], [fig. 1-10B, 12A-12C], [see claim 3, 4 rejections]); and
a second drive unit connected to the clamp part and configured to move the clamp part in one direction (“During pullback, the imaging core 102, the catheter connector 110, the PIU connector 117 with sacrificial interconnect 143, the fiber optic joint 115 and the rotary electrical joint 120 all slide back together along the bushing rails 127.” [0062]; “the PIU provides relative linear motion between the stationary catheter sheath 234 and the spinning imaging core to pullback the imaging core. […] The linear motion is obtained by mounting a combination rotary joint 301 coupled to a carriage 306 onto a linear rail system 302. The catheter sheath and outer housing (not shown) is rigidly attached to a stationary point 303 on the PIU. The imaging core connector 304 is attached to the spinning connector end 305 of the rotary joint” [0095]; The support plate is coupled to the optical fiber connector and linear rail system [0049-0057, 0084-0112], [fig. 1-10B, 12A-12C], [see claim 3, 4 rejections]).
Regarding claim 6, Hutchins teaches the catheter rotary apparatus of Claim 5,
Hutchins further teaching wherein the motor part is moved backwards in one direction by the first drive unit and the clamp part is moved backwards in one direction by the second drive unit at the same time, and, thus, the catheter is pulled back (“During pullback, the imaging core 102, the catheter connector 110, the PIU connector 117 with sacrificial interconnect 143, the fiber optic joint 115 and the rotary electrical joint 120 all slide back together along the bushing rails 127.” [0062]; “pullback is achieved using a pullback motor (not shown) and lead screw 125 to slide a carriage 128 supporting the rotary transformer and the fiber optic rotary joint along bushing rails 127” [0071]; [0049-0057, 0084-0112], [fig. 1-10B, 12A-12C]).
Regarding claim 7, Hutchins teaches the catheter rotary apparatus of Claim 5,
Hutchins further teaching wherein only the motor part is moved backwards in one direction by the first drive unit in a state where the clamp part has been inserted in the body part by the second drive unit, and, thus, the female type optical connector is decoupled from the male type optical connector (“an optical signal coupling subsystem comprising a rotatable optical component and a stationary optical component.” [clm 4]; “an optical signal coupling subsystem comprising a rotatable optical component and a stationary optical component.” [0054]; “the PIU 100 includes a serial arrangement of a plurality of elements configured to receive an optical fiber and reduce rotational inertia when coupled to a data collection probe” [0069]; “One or more rotary joints are used to couple two rotating signal transmission lines (optical fiber and plurality of coiled conductors such as wires) […] each rotary joint is a contactless joint because it is configured to couple an optical signal over an air gap” [0084]; “Once the catheter connector is rotationally engaged, the PIU connector further advances to sequentially engage the optical and electrical connectors and finally to mechanically lock the inner catheter connector to the PIU. Disconnecting the catheter from the PIU is done in a similar manner.” [0103]; The optical decoupling is performed in a sequential manner that is the reverse of the engagement performed to mechanically lock the male/female optical connectors [0049-0057, 0084-0112], [fig. 1-10B, 12A-12C]).
Regarding claim 10, Hutchins teaches the catheter rotary apparatus of Claim 1,
Hutchins further teaching wherein the motor part further includes a universal coupler which is coupled to the rotator of the fiber optic rotary joint and configured to rotate the rotator (“a second rotatable connector defining a second hole, […] a first motor disposed within the cover, the first motor configure to rotate the second rotatable connector.” [clm 1]; “The optical joint 80 includes a stationary component 80 a and a rotatable component 80 b.” [0054]; The optical joint comprises a rotatable component (i.e., universal coupler) which is connected to the motor and configured to rotate [0049-0057, 0084-0112], [fig. 1-10B, 12A-12C], [see claim 1 rejection]).
Regarding claim 12, Hutchins teaches the catheter rotary apparatus of Claim 1,
Hutchins further teaching wherein the catheter further includes:
a torque coil which is connected to the female type optical connector and allows insertion of the optical fiber on the catheter side and thus emits light (“The data collection probe includes a torque wire and a probe tip in one embodiment.” [0069]; “The rotatable imaging core of the catheter body includes a central optical fiber 230 helically wrapped with electrical wires 232 and encased by a torque cable 233.” [0093]; [0084-0112], [fig. 7, 8B]);
a first protective sheath located outside a proximal side of the torque coil (Section 311 of combination catheter pull back section [0084-0112], [fig. 7, 8B; see fig. 8B reproduced below]); and
a second protective sheath located in the entire torque coil and outside the proximal side (“the rotatable imaging core is slidably disposed within the stationary catheter sheath 234.” [0094]; [0084-0112], [fig. 7, 8B; see fig. 8B reproduced below]).
PNG
media_image1.png
621
1028
media_image1.png
Greyscale
Section 311 (i.e., first protective sheath) disposed outside of proximal side of the catheter, stationary catheter sheath (i.e., second protective sheath) running length of torque wire/cable encasing the optical fiber (Hutchins [fig. 8B])
Regarding claim 13, Hutchins teaches the catheter rotary apparatus of Claim 12,
Hutchins further teaching wherein the first protective sheath and the second protective sheath are formed of flexible materials (“a combination catheter pullback section which includes a plurality of subsections or components. In one embodiment, such a subsection or component can include one or more of a flexible catheter body,” [0013]; “This arrangement maintains rotational symmetry, aligns the optical fiber 230 to a combination rotary joint, such as, for example, described and depicted herein, and allows sufficient torque transmission while maintaining the bending flexibility of the catheter.” [0093]; [0084-0112], [fig. 7, 8B], [see claim 12 rejection]).
Regarding claim 14, Hutchins teaches the catheter rotary apparatus of Claim 1,
Hutchins further teaching wherein the outer cap is rotationally coupled to the through part (“The rotatable optical fiber connector 211 of FIG. 6A is an exemplary embodiment of connector 45 shown in FIG. 1.” [0086]; “The rotatable fiber 229 a connects into the rotatable optical connector 211 which can include a connector plate or support 211 a, and the stationary fiber 229 b and 223 connects into an optical signal processing system such as an OCT imaging engine.” [0091]; The optical probe connector 45, 211 is rotatable within the aperture 88 of the housing [0049-0057, 0084-0112], [fig. 1-2, 6A, 8B], [see claim 1 rejection]).
Regarding claim 15, Hutchins teaches the cart catheter rotary apparatus of Claim 1,
Hutchins further teaching wherein a plurality of catching projections is formed on an outer circumferential surface of the outer cap, a plurality of catching grooves is formed on an inner circumferential surface of the through part, and the outer cap is coupled to the through part by the plurality of catching projections and the plurality of catching grooves (“Various shaped channels corresponding to a space within housing 222 are shown as the cavity 250 disposed between the connector 211 and the rotor 219 and outer housing 222.” [0091]; [fig. 1-2, 6A, 8B; see fig. 2 reproduced below]).
PNG
media_image4.png
671
1028
media_image4.png
Greyscale
The connector 211 is disposed within the aperture of PIU cover 105 using projections of the connector set within grooves on the inner surface of the cover (Hutchins [fig. 2], annotated)
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 8-9 and 11 is/are rejected under 35 U.S.C. 103 as being obvious over Hutchins as applied to claim 1 above, in view of Hamm (US20030077043A1, 2003-04-24; hereinafter “Hamm”) as provided by Applicant.
Regarding claim 8, Hutchins teaches the catheter rotary apparatus of Claim 1,
but Hutchins may fail to explicitly teach a motor which has a hollow shape.
However, in the same field of endeavor, Hamm teaches a catheter rotary apparatus (“an OCT connection system comprising two mating assemblies, a motor unit and an OCT catheter connector. The OCT catheter connector mates to the motor unit for coupling optical signals into and out of a catheter optical fiber and for providing drive torque to the catheter optical fiber” [0007]; [0031-0043], [fig. 1-7]);
Hamm further teaching wherein the motor part (“A motor unit” [clm 13]; “The motor unit 3 includes a motor nose 14 with an opening 13 at its distal end, a rotary shaft 2 housed in the motor nose 14, a connector assembly 6 housed in and attached to the rotary shaft 2, and a fiber-to-fiber adapter 10 mounted to the rotary shaft 2 with screws.” [0032]; [0031-0043], [fig. 1-7]) includes:
a motor which has a hollow shape in order for the optical fiber on the catheter side to be inserted into the motor and connected to the male type optical connector (“a hollow motor nose having an opening; a rotary shaft rotatably housed inside the motor nose; […] an optical fiber positioned along the rotational axis of the rotary shaft; and” [clm 13]; “The motor unit 3 also includes a motor optical fiber 4 that runs along the rotational axis of the connector assembly 6.” [0032]; “the OCT catheter connector 1 is mated to the motor unit 3 by inserting the catheter fiber connector 32 into the fiber-to-fiber adapter 10 through the opening 13 in the motor nose 14.” [0034]; [0031-0043], [fig. 1-7]);
a fixed ring coupled to the outside of the motor and having a greater diameter than the motor (“The rotary shaft 2 rotates with two precision bearings 102 and is rotated by a motor 104, which provides drive torque to rotate the shaft 2 and the fiber-to-fiber adapter 10.” [0043]; The motor 104 has an inner ring coupled to rotary shaft 2 and an outer ring [0031-0043], [fig. 1-7; see fig. 7 reproduced below]); and
a housing formed to enclose an outer circumferential surface of the fixed ring (“a hollow motor nose having an opening;” [clm 13]; The motor unit 3 has a motor nose and outer surface (i.e., housing) enclosing the components of the motor unit [0031-0043], [fig. 1-7; see fig. 7 reproduced below]).
PNG
media_image5.png
655
1025
media_image5.png
Greyscale
The motor unit has a motor in coupled to rotary shaft to rotate optical fiber running through rotary axis, an outer ring and housing fixed to outer ring (Hamm [fig. 7], annotated)
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to combine the catheter rotary apparatus taught by Hutchins with the motor which has a hollow shape as taught by Hamm. Given the respective advantages of OCT and IVUS in terms of imaging depth and otherwise, a need exists to develop systems that integrate these two imaging modalities such that their respective advantages may be combined without their associated disadvantages (Hutchins [0004]). The shape of the catheter ferrule is preferably asymmetrical so that there is only a one-way fit of the catheter connector into the motor nose. The one-way fit of the catheter connector into the motor nose is used to ensure that the catheter fiber is properly orientated with the motor fiber (Hamm [0040]).
Regarding claim 9, Hutchins and Hamm teach the catheter rotary apparatus of Claim 8,
Hamm further teaching wherein a plurality of grooves is recessed inwards on the outer circumferential surface of the fixed ring (“The rotary shaft 2 rotates with two precision bearings 102 and is rotated by a motor 104, which provides drive torque to rotate the shaft 2 and the fiber-to-fiber adapter 10.” [0043]; The outer ring of the motor is set in grooves of the housing of the motor unit [0031-0043], [fig. 1-7; see fig. 7 reproduced below], [see claim 8 rejection]).
PNG
media_image6.png
655
1025
media_image6.png
Greyscale
Motor unit of OCT connection system (Hamm [fig. 7], annotated)
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to combine the catheter rotary apparatus taught by Hutchins with the motor which has a hollow shape as taught by Hamm. Given the respective advantages of OCT and IVUS in terms of imaging depth and otherwise, a need exists to develop systems that integrate these two imaging modalities such that their respective advantages may be combined without their associated disadvantages (Hutchins [0004]). The shape of the catheter ferrule is preferably asymmetrical so that there is only a one-way fit of the catheter connector into the motor nose. The one-way fit of the catheter connector into the motor nose is used to ensure that the catheter fiber is properly orientated with the motor fiber (Hamm [0040]).
Regarding claim 11, Hutchins and Hamm teach the catheter rotary apparatus of Claim 8,
Hutchins further teaching wherein the motor part further includes an encoder coupled to one side of the motor and configured to control a rotation speed of the motor (“the invention relates to a combination PIU in which electrical motor noise from a PWM (Pulse Width Modulator), used to control the speed of the motor, is reduced by filtering the edges of the driving pulse waves.” [0015]; [0049-0057, 0084-0112], [fig. 1-10B, 12A-12C]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wang et al. (US20210310790A1, 2021-10-07) teaches an optical coherence tomography device, which is capable of connecting and removing the optical catheter from the drive unit conveniently either manually or automatically [0005].
Sasaki et al. (US20190014987A1, 2019-01-17) teaches a connector structure of an OCT catheter and a medical imaging system [0001].
Cappannari et al. (WO2022094027A1, 2022-05-05) teaches female fiber optic connectors and cable assemblies comprising a female fiber optic connector having a rocker latch arm and methods of making the same [0002].
Susuki et al. (WO2022123669A1, 2022-06-16) teaches a connection mechanism that connects an optical probe used in an optical tomography apparatus and a drive unit that rotates the optical probe [clm 1].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James F. McDonald III whose telephone number is (571)272-7296. The examiner can normally be reached M-F; 8AM-6PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chris Koharski can be reached at 5712727230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
JAMES FRANKLIN MCDONALD III
Examiner
Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797