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 38 is objected to because of the following informalities: In order to read the claim more clearly, and understand that the first side coil, the second side coil, the third side coil, and the fourth side coil are in reference to the same four side coils previously introduced in claim 37, it is suggested to amend claim 38 with a limitation comprising language similar but not limited to, “wherein the four side coils comprise a first side coil, a second side coil, a third side coil, and a fourth side coil.” Then further amend the language in claim 2 to reflect the proper antecedent basis. Another option would be for Applicant to amend claim 37, with language similar to, but not limited to, “wherein the set of coils comprise a first side coil, a second side coil, a third side coil, and a fourth side coil arranged around the tip..” Then again, further amend the language in claim 38 to reflect the proper antecedent basis. Appropriate correction is required.
Claim 41 is objected to because of the following informalities: The term “an” on line 5 should be before the term “Archimedean” in order to be grammatically correct. 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.
Claims 37-52 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.
Regarding claims 37, 39, 41, 42, 43, 45, 46, 47, 49, 50, 51, and 52 all use the term “optionally," which renders each claim indefinite because it is unclear whether the limitations following the term are part of the claimed invention. For the sake of examination, the limitations following the term “optionally” in each of these claims are not considered part of the claimed invention. It is suggested to remove the term “optionally” and the limitations that follow it from all claims. Claims 38-52 are also rejected due to their dependence on the rejected base claim 37.
Regarding claim 48, the claim sets forth a mathematical formula using a number of variable. The claim sets forth what each of the variables represents, except for the variable “α”. Because the mathematical formula cannot be solved without knowing what variable “α” represents, claim 10 is indefinite. For the sake of examination, “α” is defined as “a constant determined using a grid search to find the best fitting” as this is how the variable is defined in Para 119 of the Specification. Therefore, it is suggested to amend claim 10 to include this definition for variable “α” along with the definitions that are already present for variables “I”, “
τ
c
o
i
l
s
”, “
τ
d
e
s
”, and “R” (for example, “α represents a constant determined using a grid search to find the best fitting”).
Regarding claim 48, the phrase “the optimization problem” lacks proper antecedent basis. It is suggested to amend the limitation to state, “the further optimization problem” to maintain consistency with claim 47, which claim 48 directly depends from. Appropriate correction is required.
Regarding claim 49, the phrase “said rod-shaped portion” lacks proper antecedent basis. It is suggested to amend the seven phrases within claim 49 to state, “the flexible substantially rod-shaped portion” to maintain consistency and clarity throughout the claim. Appropriate correction is required.
Regarding claim 17, the phrase “the rod-shaped portion” lacks proper antecedent basis. Although this feature is introduced in claim 16, claim 17 does not depend from claim 16. Therefore, for the sake of examination, claim 17 is interpreted as depending on claim 16 instead of on claim 15. It is suggested to amend claim 17 in this manner to provide antecedent basis for all the features recited in claim 17. Claim 18 is rejected due to its dependence on claim 17.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 37-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 12515019B2 (App. No. 17/816779) in view of Garibaldi et al. (US2007/0088197) and U.S. Patent No. 12558180B2 (App. No. 17/816774) in view of Garibaldi et al. (US2007/0088197).
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of current claims 37, 47-48 is fully disclosed in claims 1, 9 and 15 of U.S. Patent No. 12515019B2 as well as fully disclosed in claim 1 of U.S. Patent No. 12558180B2.
Although both U.S. Patent No. 12515019B2 and U.S. Patent No. 12558180B2 reference a catheter or a medical device in the preamble while the current application specifically references an endoscope, it would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of the current application with the teaching of Garibaldi to include the medical device be an endoscope for the benefit of having the medical device be a device a physician might want to be capable of navigating through a body (Garibaldi – [0032, 0044, 0053]) while still providing “…precise control and high degree of navigational flexibility…” available in “…a less complicated, less expensive, and preferably more compact navigation system…” (Garibaldi – [0006]).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 37-41, 47, and 49 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Garibaldi et al. (PG PUB 2007/0088197).
Re claim 37, Garibaldi discloses an endoscope (medical device 20’ (Fig 4-6; it is noted that all reference characters cited below refer to Fig 4-6 unless otherwise noted)) wherein the endoscope comprises: a tip (24), a set of coils (26,28a,28b,32a,32b) surrounding the tip (as seen in Fig 6), and power wires (40,42,44,46 (seen but not labeled in Fig 4,5; labeled in Fig 1,2) arranged to supply the set of coils with electrical energy (Para 34), wherein the set of coils comprises four side coils arranged around the tip such that a straight line standing orthogonal on a longitudinal direction of the tip crosses a center of the respective side coil (as seen in Fig 4,5; Para 39).
Re claim 38, Garibaldi discloses that a first side coil and a second side coil (28a,28b) are connected in series (Para 39), a third side coil and a fourth side coil (32a,32b) are connected in series (Para 39), the first side coil and the second side coil are arranged respectively on opposite sides of the tip (as seen in Fig 6), and the third side coil and the fourth side coil are arranged respectively on opposite sides of the tip and in-between the first side coil and the second side coil (as seen in Fig 6).
Re claim 39, Garibaldi discloses that a turn number of at least one of the four side coils is between 2 and 40 (as seen in Fig 4,5, the coils have a turn number of ~3.75).
Re claim 40, Garibaldi discloses that wherein the set of coils comprises at least one axial coil (26) arranged around the tip such that a straight line extending in parallel to the longitudinal direction of the tip crosses a center of the at least one axial coil (as seen in Fig 4,5; Para 33).
Re claim 41, Garibaldi discloses that at least one of the coils of the set of coils was manufactured using laser machining, laser lithography and/or manually wound (the claimed phase “was manufactured using laser machining, laser lithography and/or manually wound” is being treated as a product-by-process limitation. It has been held that a product-by-process limitation is not construed as being limited to the product formed by the specific process recited. Therefore, even though Garibaldi is silent as to the process used to manufacture at least one of the coils, it appears that Garibaldi’s product would be the same or similar as that claimed) and/or has an Archimedean spiral coil design (as seen in Fig 4,5) and/or has an in-plane design (as seen in Fig 6).
Re claim 47, Garibaldi discloses a method for controlling a movement of the endoscope according to claim 37 (see the rejection of claim 37 above) in a magnetic field, wherein the method comprises: determining a torque that needs to be applied onto the catheter such that the catheter carries out the movement, determining a minimum current that needs to be supplied to each coil of the set of coils, respectively, to reach the determined torque by solving an optimization problem, and supplying the determined minimum current to each coil of the set of coils, respectively, such that the catheter carries out the movement (Para 35,36).
Re claim 49, Garibaldi discloses that the endoscope comprises a flexible substantially rod-shaped portion (the wall forming the catheter 20 itself) and the movement comprises a deformation of said rod- shaped portion resulting in a movement of a tip of said rod-shaped portion (Para 32) .
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.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Garibaldi et al. (PG PUB 2007/0088197) in view of Rousu et al. (PG PUB 2021/0169366).
Re claim 42, Garibaldi discloses all the claimed features except that the four side coils are arranged on the same circuit board. Rousu, however, teaches an endoscope comprising coils (Rousu -128,140 (Fig 5) that are all arranged on one circuit board 112 Rousu - (Fig 5) for the purpose of providing a simple way of adding the coils into the catheter (Rousu -Para 103). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Garibaldi to include the coils on a circuit board, as taught by Rousu, for the purpose of providing a simple way of adding the coils into the catheter (Rousu -Para 103).
Claim 43-45 are rejected under 35 U.S.C. 103 as being unpatentable over Garibaldi et al. (PG PUB 2007/0088197) in view of Charles R. Slater (US5683388) hereinafter Slater.
Re claim 43, Garibaldi discloses the endoscope according to claim 37 but is silent as further teachings wherein the endoscope includes an end effector connected to the tip of the endoscope, optionally wherein the end effector comprises a further set of coils for actuating the end effector. Salter, in the same field of endeavor, teaches wherein the endoscope includes an end effector (Slater - 50a/b, 146a/b) connected to the tip of the endoscope (Slater – bioptome 10 [col. 1 lines 18-55]), optionally wherein the end effector comprises a further set of coils (Slater – coil 16) for actuating the end effector (Slater - 50a/b, [col. 3 line 63 -col. 4 line27]).
Re claim 44, Garibaldi in view of Slater teach the endoscope according to claim 43, wherein the end effector of the endoscope is configured to be actuated by applying a current to the further set of coils (Slater - [col. 3 line 63 -col. 4 line27]).
Re claim 45, Garibaldi in view of Slater teach the endoscope according to claim 44, wherein:- the end effector includes a grasper with two jaws (Slater - 50a/b, 146a/b) connected pivotably to each other, and- the further set of coils (Slater – coil 16) comprises at least one side coil (Slater – base 152) arranged at each one of the two jaws (Slater – [col. 5 line 40 – col. 6 line 10])
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Garibaldi et al. (PG PUB 2007/0088197) in view of Konwitz et al. (US2009/0076331) hereinafter Konwitz.
Re claim 46, Garibaldi discloses the endoscope according to claim 37, but is silent at disclosing wherein the tip of the endoscope further comprises: a camera, an illumination device, and/or an opening of an irrigation channel extending through the endoscope. However Konwitz, in the same field of endeavor, teaches the tip of the endoscope comprising a camera, an illumination device, and/or an opening of an irrigation channel extending through the endoscope.(Konwitz – [0064] “Embodiments here presented include endoscopes having distal tips of reduced cross-sectional size. The endoscope distal tip is a complex portion of the endoscope, having many internal parts. A tip may contain a camera and associated lenses, passages for optical fibers used for illuminating tissues in the vicinity of the endoscope tip, LEDs for illuminating the work area, fluid channels for irrigation and/or inflation, and optionally one or more operating channels for delivering tools to a treatment area.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Garibaldi with the teachings of Konwitz to include a camera, an illumination device, and/or an opening of an irrigation channel extending through the endoscope at the tip of the endoscope for the benefit of illuminating tissues, illuminating the work area, and providing fluid channels for irrigation/inflation all within a compact distal tip of an endoscope (Konwitz – [0063-0064]).
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Garibaldi et al. (PG PUB 2007/0088197) in view of Maynard (US Pat 5,405,337).
Re claim 49, Garibaldi discloses that the endoscope comprises a flexible substantially rod-shaped portion (the wall forming the catheter 20 itself) and the movement comprises a deformation of said rod- shaped portion resulting in a movement of a tip of said rod-shaped portion (Para 32)except that solving the optimization problem comprises: determining the deformation of said rod-shaped portion that is needed for the movement of the tip of said rod-shaped portion from an actual location to a desired location such that a torque that is required for the deformation of said rod-shaped portion is minimized, and determining the torque that needs to be applied onto the catheter such that the catheter carries out the movement to be equal to the torque that is required for the deformation of said rod-shaped portion. Maynard, however, teaches that solving the further optimization problem comprises: determining the deformation of said rod-shaped portion that is needed for the movement of the tip of said rod-shaped portion from an actual location to a desired location such that a torque that is required for the deformation of said rod-shaped portion is minimized, and determining the torque that needs to be applied onto the catheter such that the catheter carries out the movement to be equal to the torque that is required for the deformation of said rod-shaped portion (Maynard - Col 12, Lines 50-56) for the purpose of making the most effective use of the system (Maynard - inherent in “optimize”, Col 12, Lines 50-56).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Garibaldi to include solving the optimization problem by determining the required deformation and torque, as taught by Maynard, for the purpose of making the most effective use of the system (inherent in “optimize”, Col 12, Lines 50-56).
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Garibaldi et al. (PG PUB 2007/0088197) in view of Maynard (US Pat 5,405,337) in view of Hauck et al. (PG PUB 2007/0198008).
Re claims 50, Garibaldi in view of Maynard disclose all the claimed features for claim 49 except that the deformation that is needed for the movement of the tip of said rod-shaped portion from the actual location to the desired location is determined using a model depicting the nonlinear dynamics of said rod-shaped portion. Hauck, however, teaches using a model depicting nonlinear dynamics of a rod-shaped instrument for determining deformation that is needed to move the rod-shaped portion from the actual location to the desired location (Hauck -Para 15) for the purpose of automating the procedure (Hauck -Para 15). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Garibaldi/Maynard to include using a model, as taught by Hauck, for het purpose of automating the procedure (Hauck -Para 15).
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Garibaldi et al. (PG PUB 2007/0088197) in view of Arenson et al. (US Pat 6,304,769).
Re claim 51, Garibaldi discloses all the claimed features except that the method comprises the step of receiving user input with respect to the movement via a user interface of the endoscope. Arenson, however, teaches a method for controlling movement of a catheter comprising the step of receiving user input with respect to the movement via a user interface of the endoscope (Arenson - step 106 in Fig 4; Col 12, Lines 49-52 and 61-64) for the purpose of allowing a physician to directly control the movement of the catheter (Arenson - Col 12, Lines 61-66). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Garibaldi to include receiving user input with respect to the movement via a user interface of the endoscope, as taught by Arenson, for the purpose of allowing a physician to directly control the movement of the catheter (Arenson - Col 12, Lines 61-66).
Garibaldi discloses all the claimed features except that the method comprises the steps of determining an actual position of the endoscope using medical imaging, and automated controlling of the movement based on the determined actual position. Arenson, however, teaches a method for controlling movement of a endoscope comprising the steps of determining an actual position of the endoscope using medical imaging, and automated controlling of the movement based on the determined actual position (Arenson - steps 102-106 and 116 in Fig 4; Col 12, Line 55 – Col 13, Line 17) for the purpose of allowing a physician to directly control the movement of the catheter (Arenson - Col 12, Lines 61-66). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Garibaldi to include determining an actual position of the catheter using medical imaging and automated controlling of the movement based on the determined actual position, as taught by Arenson, for the purpose of allowing a physician to directly control the movement of the catheter (Arenson - Col 12, Lines 61-66).
Garibaldi discloses all the claimed features except that the method comprises the steps of displaying an actual position of the endoscope and/or a position of the endoscope after carrying out the movement on a display device, wherein the movement is with respect to a tissue. Arenson, however, teaches a method for controlling movement of a endoscope comprising the steps of displaying an actual position of the catheter and/or a position of the catheter after carrying out the movement on a display device (Arenson - “overhead monitor”, Fig 4), wherein the movement is with respect to a tissue (Arenson - Step 104,116 in Fig 4; Col 12, Lines 57-60 and Col 13, Lines 9-12) for the purpose of allowing a physician to directly control the movement of the catheter (Arenson - Col 12, Lines 61-66). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Garibaldi to include displaying an actual position of the catheter and/or a position of the catheter after carrying out the movement with respect to a tissue on a display device, as taught by Arenson, for the purpose of allowing a physician to directly control the movement of the catheter (Arenson - Col 12, Lines 61-66).
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Garibaldi et al. (PG PUB 2007/0088197) in view of Nevo (US Pat 6,594,517).
Re claim 52, Garibaldi discloses all the claimed features except that the magnetic field is produced by a medical imaging device. Nevo, however, teaches using a medical imaging device to provide a magnetic field (Nevo - Col 3, Lines 20-25) since MRI is a preferred methodology for minimal invasive diagnostic and interventional procedures as it is non-invasive, provides high resolution and high contrast between soft tissues, lacks shadowing by bones, enables real-time imaging during a procedure and enables access to the patient due to its open architecture (Nevo - Col 3, Lines 26-33). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Garibaldi to include producing the magnetic field by a medical imaging device, as taught by Nevo, since MRI is a preferred methodology for minimal invasive diagnostic and interventional procedures as it is non-invasive, provides high resolution and high contrast between soft tissues, lacks shadowing by bones, enables real-time imaging during a procedure and enables access to the patient due to its open architecture (Nevo - Col 3, Lines 26-33).
Garibaldi discloses all the claimed features except that the magnetic field is a static magnetic field. Nevo, however, teaches using a static magnetic field in controlling movement of a catheter (Nevo - Col 3, Lines 20-25) because such a magnetic field is a basic, universal component of MRI systems (Nevo - Col 3, Lines 26-38). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Garibaldi to include the magnetic field as a static magnetic field, as taught by Nevo, since such a magnetic field is a basic, universal component of MRI systems (Nevo - Col 3, Lines 26-38).
Allowable Subject Matter
Claim 48 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and rewritten (preferably, in the manner suggested by the Examiner) to overcome the 112(b) rejection set forth above.
The following is a statement of reasons for the indication of allowable subject matter: Claim 47 requires that the “optimization problem” of claim 48 be defined by a specific formula that utilizes the current supplied to each coil, a total torque generated by the coils when supplied with their currents, a torque that needs to be applied onto the catheter for the catheter to carry out the movement, a resistance of each coil, and a constant determined using a grid search to find the best fitting. A method for controlling movement of a catheter using this specific optimization problem could not be found nor was suggested in the prior art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN E MONAHAN whose telephone number is (571)272-7330. The examiner can normally be reached Monday - Friday, 8am - 5pm.
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/MEGAN ELIZABETH MONAHAN/Examiner, Art Unit 3795
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