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 .
Detailed Action
This is in response to the amendment filed 06/02/2025.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/02/2025 has been entered.
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 10, 20 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.
Claims 10 and 20 refer to the shaft component having a smooth surface from the flexible introducer component to its tip “to reduce tissue” It is unclear to the what is meant by “reduce tissue”.
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.
Claim(s) 1-9, 11-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0038990 (Prior et al.) in view of U.S. Patent Number 6,273,882 (Whittier et al.), U.S. Patent Number 6,004,341 (Zhu et al.), U.S. Patent Publication Number 2010/0030057 (Gavriely et al.), U.S. Patent Number 5,916,232 (Hart), of U.S. Patent Number 5,893,369 (LeMole et al.),
Regarding claims 1-4, 7, Prior et al. discloses as shown in Figure 24 a surgical instrument capable of use in performing a mid-urethral procedure requiring placement of a mesh prosthetic within a female body, comprising: a flexible introducer component (body 1310, see paragraph [0148]), the flexible introducer component including two scissor members (spring legs 1334 are interpreted as scissor members because they pivoting handles in the shape of what one ordinary skill in the art would understand scissor handles to be, see paragraph [0148]) configured to allow a surgeon or a robot arm to hold the scissor members, the flexible introducer component including a channel opening extending through its length, from a distal end to a proximal end; and a shaft component (shaft 1210, see paragraph [0148]) configured to be insertable within the channel opening and capable of pulling a mesh prosthetic; the scissor members capable of being used to control a direction and magnitude of force required to precisely navigate and position the mesh prosthetic pulled by the shaft component, the shaft component movable within the channel opening of the flexible introducer component until the scissor members are compressed to cause a locking member (tooth 1332, see paragraph [0148]) of at least one of the scissor members to engage and grip the shaft component and arrest movement thereof to be capable of properly position the mesh prosthetic at an appropriate location within the female body. See paragraph [0148].
Prior et al. fails to disclose the channel opening is shaped as a triangular orifice, the tip of the shaft component includes a pressure sensor configured to provide measurements taken at predetermined intervals to a measurement system, or the instrument monitoring system, the shaft component being a triangular shape, and the flexible introducer component being made from acetal, polyamide, polyethene, polyvinylchloride, and being sterilizable at a high temperature.
Whittier et al., from a related field of endeavor teaches a similar instrument where a scissor member is known alternative to a pivoting member. See col. 7, lines 52-57.
Alternatively, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the instrument disclosed by Whittier et al. by substituting the shape of the spring legs 1334 for the scissor handles disclosed by Whittier et al. because it would only require the simple substitution of one known another alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Zhu et al., from related field of endeavor teaches a similar instrument with a similar shaft component (150) as shown in Figure 17 where the tip of the shaft component includes a pressure sensor configured to provide measurements taken at predetermined intervals to a measurement system for the purpose of measuring pressure on the outside of the shaft component. See col. 13, lines 7-22.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the instrument disclosed by Prior et al. in view of Whittier et al. to incorporate the pressure sensor positioned at the tip of the shaft component and measurement system taught by Zhu in order to measuring pressure on the outside of the shaft component.
Prior fails to disclose comprising: an instrument monitoring system coupled to the measurement system and configured to receive measurements from the measurement system, the instrument monitoring system further comprising a navigation guidance module configured to provide data to guide movement of the surgical instrument within a human body.
Wenderow et al., from a relate field of endeavor teaches a similar instrument, which includes a navigation guidance module (monitors 304, 306, see paragraph [0034]) configured to provide data to guide movement of the surgical instrument within a human body, wherein the navigation guidance module is capable of providing real time navigation data to a surgeon or a robot arm, for the purpose of displaying data from a measurement system. See paragraph [0035]
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the instrument disclosed by Prior to include the monitors taught by Wenderow et al. such that an instrument monitoring system coupled to the measurement system and configured to receive measurements from the measurement system, the instrument monitoring system further comprising a navigation guidance module configured to provide data to guide movement of the surgical instrument within a human body in order to displaying data from a measurement system.
Gavriely et al., from a related field of endeavor teaches a similar introducer component as shown in Figure 1A, wherein a channel opening is shaped as a triangular orifice for the purpose of configuring the introducer component to have a higher bending stiffness, resistance to collapse and prevention of kinking. See paragraph [0026].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the instrument disclosed by Prior to make the channel opening shaped as a triangular orifice in order to configure the introducer component to have a higher bending stiffness, resistance to collapse and prevention of kinking.
Hart, from the same field of endeavor teach a similar instrument as shown in Figure 1, where the instrument includes a similar shaft component (shaft 20, see col. 5, lines 4-15) being triangular shape, where the triangle shaped shaft component has a smooth surface capable of reducing tissue during passe of the shaft component and a curvature and tip radius that is capable of maintaining contact with a posterior aspect of the pubic bone. See col. 6, lines 40-58.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the instrument disclosed by Prior et al. by substituting the shape of the shaft component disclosed by Prior et al. for the triangle shape taught by Hart because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
LeMole et al., from the same field of endeavor teaches a similar surgical instrument as shown in Figure 3, where the flexible introducer component (collar 10) is made from a bio-compatible plastic material taken from a group including acetal, polyamide, polyethylene, polyvinylchloride; said plastic material being sterilizable at high temperature. See col. 5, lines 16-19.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the instrument disclosed by Prior et al. to substitute the material of the body 1310 disclosed by Prior et al. for the material (polyethylene) of the body taught by LeMole et al. because it would only require the simple substitution of one known material for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Regarding claims 5, 6 since they only refer to limitations recited in the alternative and Prior et al. in view of Whittier et al., Zhu and Wenderow et al. disclose the other alternative, the Office interprets Prior et al. in view of Whittier et al., Zhu and Wenderow et al. as teaching the limitations.
Regarding claims 8, 9 Prior et al. fails to disclose the scissor members include one large member and one small member and the locking mechanism is affixed to the large member.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the scissor members taught by Prior et al. such that one was a large member and one was a small member as a matter of engineering design choice.
Applicant has not disclosed the sizes of the scissor members relative to one another provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0056] of the specification. One of ordinary skill in the art, furthermore, would have expected Prior et al.’s scissor members, and applicant’s invention, to perform equally well regardless of their size relative to another or the claimed one large one and one small one because both relative dimensions would perform the same function of providing a structure for a robot or operator to grab and pivot equally well considering the relative dimensions disclosed.
So modified, Prior et al. is considered to disclose the locking mechanism is affixed to the large member, the locking mechanism affixed to the large scissor member has a protruding member configured to grip the shaft component as the introducer component is moved up and down on the shaft component by a surgeon's hand or a robot's, because a locking mechanism (tooth 1332, see paragraph [0148]) is affixed to both, so it would necessarily be affixed to the larger member.
Regarding clam 11-17, 20 Prior et al. discloses as shown in Figure 24 a method for constructing a surgical instrument for navigation into a human body, comprising: forming a flexible introducer component (body 1310, see paragraph [0148]), the flexible introducer component including two scissor members (spring legs 1334 are interpreted as scissor members because they pivoting handles in the shape of what one ordinary skill in the art would understand scissor handles to be, see paragraph [0148]) configured to allow a surgeon or a robot arm to hold the scissor members, the flexible introducer component including a channel opening extending through its length, from a distal end to a proximal end; and inserting a shaft component (shaft 1210, see paragraph [0148]) within the channel opening, the shaft component movable within the channel opening of the flexible introducer component until the scissor members are compressed to cause a locking member (tooth 1332, see paragraph [0148]) of at least one of the scissor members to engage and grip the shaft component and arrest movement thereof.
Whittier et al., from a related field of endeavor teaches a similar instrument where a scissor member is known alternative to a pivoting member. See col. 7, lines 52-57.
Alternatively, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Whittier et al. by substituting the shape of the spring legs 1334 for the scissor handles disclosed by Whittier et al. because it would only require the simple substitution of one known another alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Prior et al. fails to disclose the channel opening is shaped as a triangular orifice.
Zhu et al., from related field of endeavor teaches a similar instrument with a similar shaft component (150) as shown in Figure 17 where the tip of the shaft component includes a pressure sensor configured to provide measurements taken at predetermined intervals to a measurement system for the purpose of measuring pressure on the outside of the shaft component. See col. 13, lines 7-22.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Prior et al. in view of Whittier et al. to position at least one pressure sensor at the tip of the shaft component and measurement system taught by Zhu in order to measuring pressure on the outside of the shaft component.
Prior fails to disclose comprising: coupling an instrument monitoring system to the measurement system and configured to receive measurements from the measurement system, the instrument monitoring system further comprising a navigation guidance module configured to provide data to guide movement of the surgical instrument within a human body.
Wenderow et al., from a relate field of endeavor teaches a similar instrument, which includes a navigation guidance module (monitors 304, 306, see paragraph [0034]) configured to provide data to guide movement of the surgical instrument within a human body, wherein the navigation guidance module is capable of providing real time navigation data to a surgeon or a robot arm, for the purpose of displaying data from a measurement system. See paragraph [0035]
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Prior to couple the monitors taught by Wenderow et al. such that an instrument monitoring system coupled to the measurement system and configured to receive measurements from the measurement system, the instrument monitoring system further comprising a navigation guidance module configured to provide data to guide movement of the surgical instrument within a human body in order to displaying data from a measurement system.
Gavriely et al., from a related field of endeavor teaches a similar introducer component as shown in Figure 1A, wherein a channel opening is shaped as a triangular orifice for the purpose of configuring the introducer component to have a higher bending stiffness, resistance to collapse and prevention of kinking. See paragraph [0026].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Prior to make the channel opening shaped as a triangular orifice in order to configure the introducer component to have a higher bending stiffness, resistance to collapse and prevention of kinking.
Hart, from the same field of endeavor teach a similar instrument as shown in Figure 1, where the instrument includes a similar shaft component (shaft 20, see col. 5, lines 4-15) being triangular shape. See col. 6, lines 40-58.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the instrument disclosed by Prior et al. by substituting the shape of the shaft component disclosed by Prior et al. for the triangle shape taught by Hart because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
LeMole et al., from the same field of endeavor teaches a similar surgical instrument as shown in Figure 3, where the flexible introducer component (collar 10) is made from a bio-compatible plastic material taken from a group including acetal, polyamide, polyethylene, polyvinylchloride; said plastic material being sterilizable at high temperature. See col. 5, lines 16-19.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the instrument disclosed by Prior et al. to substitute the material of the body 1310 disclosed by Prior et al. for the material (polyethylene) of the body taught by LeMole et al. because it would only require the simple substitution of one known material for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Regarding claim 14, 17 Prior fails to disclose comprising: an instrument monitoring system coupled to the measurement system and configured to receive measurements from the measurement system, the instrument monitoring system further comprising a navigation guidance module configured to provide data to guide movement of the surgical instrument within a human body.
Wenderow et al., from a relate field of endeavor teaches a similar method, which includes a navigation guidance module (monitors 304, 306, see paragraph [0034]) configured to provide data to guide movement of the surgical instrument within a human body, wherein the navigation guidance module is capable of providing real time navigation data to a surgeon or a robot arm, for the purpose of displaying data from a measurement system. See paragraph [0035]
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Prior to include the monitors taught by Wenderow et al. such that an instrument monitoring system coupled to the measurement system and configured to receive measurements from the measurement system, the instrument monitoring system further comprising a navigation guidance module configured to provide data to guide movement of the surgical instrument within a human body in order to displaying data from a measurement system
Regarding claims 15, 16 since they only refer to limitations recited in the alternative and Prior et al. in view of Whittier et al., Zhu and Wenderow et al. disclose the other alternative, the Office interprets Prior et al. in view of Whittier et al., Zhu and Wenderow et al. as teaching the limitations.
Regarding claims 18, 19 Prior et al. fails to disclose the scissor members include one large member and one small member and the locking mechanism is affixed to the large member.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the scissor members taught by Prior et al. such that one was a large member and one was a small member as a matter of engineering design choice.
Applicant has not disclosed the sizes of the scissor members relative to one another provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0056] of the specification. One of ordinary skill in the art, furthermore, would have expected Prior et al.’s scissor members, and applicant’s invention, to perform equally well regardless of their size relative to another or the claimed one large one and one small one because both relative dimensions would perform the same function of providing a structure for a robot or operator to grab and pivot equally well considering the relative dimensions disclosed.
So modified, Prior et al. is considered to disclose the locking mechanism is affixed to the large member, the locking mechanism affixed to the large scissor member has a protruding member configured to grip the shaft component as the introducer component is moved up and down on the shaft component by a surgeon's hand or a robot's, because a locking mechanism (tooth 1332, see paragraph [0148]) is affixed to both, so it would necessarily be affixed to the larger member.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0038990 (Prior et al.) in view of U.S. Patent Number 6,273,882 (Whittier et al.), U.S. Patent Number 6,004,341 (Zhu et al.), U.S. Patent Publication Number 2010/0030057 (Gavriely et al.), U.S. Patent Number 5,916,232 (Hart), U.S. Patent Number 5,893,369 (LeMole et al.), as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2017/0245885 (Lenker)
Regarding claim 10, Prior et al. fails to disclose wherein the shaft component has a curvature.
Lenker, from the same field of endeavor teaches a surgical instrument as shown in Figure 13, where the shaft component has a curvature, for the purpose of matching the curvature in the body. See paragraph [0182].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the instrument disclosed by Prior such that the shaft component has a curvature in order to configure the shaft component to match the curvature in the body
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0038990 (Prior et al.) in view of U.S. Patent Number 6,273,882 (Whittier et al.), U.S. Patent Number 6,004,341 (Zhu et al.), U.S. Patent Publication Number 2010/0030057 (Gavriely et al.), U.S. Patent Number 5,916,232 (Hart), U.S. Patent Number 5,893,369 (LeMole et al.), as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2017/0245885 (Lenker)
Regarding claim 20, Prior et al. fails to disclose wherein the shaft component has a curvature.
Lenker, from the same field of endeavor teaches a surgical instrument as shown in Figure 13, where the shaft component has a curvature, for the purpose of matching the curvature in the body. See paragraph [0182].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the instrument disclosed by Prior such that the shaft component has a curvature in order to configure the shaft component to match the curvature in the body
Response to Arguments
Applicant's arguments filed 06/02/2025, see pages 10-17 have been fully considered but are moot in view of the new grounds of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771