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 .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-14 in the reply filed on 09 January 2026 is acknowledged.
Claims 15 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected groups II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09 January 2026.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: means for a user to choose a point of interest and log it in 2D in the memory of the CPU and to thereby determine the work path in claim 1; means to create a reference plane and to calculate a time of flight determination between the time of flight transceivers and the reference plane in claim 3.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 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.
Claims 1-14 are replete with 35 U.S.C. 112(b) errors. Such errors include:
Claim 1 recites the limitation "the user" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the form" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the progress" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the terminal tool" in lines 12-13. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites “further including time of flight transceivers.” It is unclear if the “time of flight transceivers” of claim 3 are the same as or different than the “plurality of time of flight transceivers” in lines 10-11 of claim 1. A further clarifying amendment is required.
Claim 4 recites the limitation "the visible or near infrared spectrum" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the use" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the forward kinematics equations" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the position and trajectory" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the combination of the forward kinematically derived positions and angles" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the time of flight information" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the tool handle" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites “wherein the time of flight transceiver is an optical time of flight transceiver.” It is unclear which “time of flight transceiver” is being referred to since claim 1 previous recites “a plurality of time of flight transceivers.” A further clarifying amendment is required.
Claim 12 recites the limitation "the tool" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the accuracy" in line 2. There is insufficient antecedent basis for this limitation in the claim.
The examiner believes to have pointed out all of the errors. However, applicant is advised to check the claims to make sure no additional errors exist.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 10 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 10 recites “a spiral phantom mounted to guide wires implanted into bone.” It appears the “bone” is positively recited as a limitation of the claim. It is suggested that such be amended to be functionally recited, i.e. configured to be implanted into bone, adapted to be implanted into bone, etc.
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) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al., WO 2020/172397 (IDS filed 01/19/2024) in view of Shelton, IV et al., U.S. PG-Pub 2019/0201136 and Siewerdsen et al., U.S. PG-Pub 2017/0238897.
Regarding claim 1, Nguyen et al. discloses a positional determination and guidance system to guide a user of a surgical tool having a terminal workpiece along a work path in a patient’s body from an initial start point to a determined end point, comprising: a base member (40) at a fixed reference point which supports a two-member robotic arm system comprising a variable-length first arm which is comprises of a link (48) which extends at an angle a and can be extended by a value n from a first length to a second length, and which comprises a length sensor capable of determining the value n, and at least one angular sensor capable of determining angle a (Figs. 1-2 and paragraph [0038]),
a hand-held tool (10) serving as a distal link in a form of a second fixed-length arm which is linked to the first arm, and which has a plurality of angular sensors and a plurality of time of flight transceivers for determining absolute distance relative to a reference plane (Figs. 1-2 and paragraphs [0014], [0038],
a CPU having memory and machine readable code to determine progress of the surgical/terminal tool in 3D along the work path from the initial start point toward the determined end point, means for a user to choose a point of interest and log it in the memory of the CPU and thereby determine the work path (paragraph [0037]), and
a display (47) that informs the user as to the guidance of the terminal workpiece along the work path (Fig. 1 and paragraph [0018]).
Nguyen et al. does not disclose the two-member robotic arm system and the variable-length first arm being a virtual link.
Shelton, IV et al. discloses virtually linking components of its system as such allows control, status and functionality information describing the surgical equipment and patient monitoring equipment to be delivered to a system display, a monitor, and/or a heads up display more effectively (Fig. 136 and paragraphs [1239]-[1240]) as well as permit certain control and status information to flow between a system controller and the components in order to control the functionality of those components (paragraph [1241]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the two-member robotic arm system and the variable-length first arm to be virtual links in view of Shelton, IV et al. to permit control, status and functionality information describing the surgical equipment and patient monitoring equipment to be delivered to a system display, a monitor, and/or a heads up display more effectively and permit certain control and status information to flow between a system controller and the components in order to control the functionality of those components.
Nguyen et al. also does not disclose logging the chosen point of interest in the memory of the CPU in 2D.
Siewerdsen et al. discloses using a 3D-2D registration process to provide “self-calibrated” geometry in order to help provide up-to-date visualization in applications including targeting tissue structures, monitoring anatomical change, and/or verifying interventional device placement (paragraph [0006]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the memory of the CPU of Nguyen et al. to log the chosen point of interest in 2D in view of Siewerdsen et al. to permit providing “self-calibrated” geometry in order to help provide up-to-date visualization in applications including targeting tissue structures, monitoring anatomical change, and/or verifying interventional device placement.
Regarding claim 2, Nguyen et al. as modified in view of Shelton, IV et al. and Siewerdesen et al. discloses using a combination of radio frequency wireless communication and electrical communication to form the virtual link between the hand-held tool and the base member (paragraph [1239 of Shelton, IV et al.).
Regarding claim 3, Nguyen et al. discloses further including time of flight transceivers, means to create a reference plane and to calculate a time of flight determination between the time of flight transceivers and the reference plane (paragraph [0014]).
Regarding claim 4, Nguyen et al. discloses wherein the time of flight generate light pulses in a visible or near infrared spectrum for use in the guidance of the terminal workpiece (paragraph [0011]).
Regarding claim 5, Nguyen et al. discloses wherein the positional information is provided through use of angular measurements provided by MEMS IMU’s used in conjunction with measured and known distances via forward kinematics equations to determine a position and trajectory as a function of time (paragraph [0038]).
Regarding claim 6, Nguyen et al. discloses wherein combination and forward kinematically derived positions and angles are compared to absolute distances and angles as determined by the time of flight transceivers mounted on the distal link (paragraphs [0014] and [0038]).
Regarding claim 7, Nguyen et al. discloses wherein forward and kinematic equations in combination with time of flight information is used by the CPU to perform calculations to derive the positional and angular approach (paragraph [0018]).
Regarding claim 8, Nguyen et al. discloses wherein the tool handle/hand-held tool (10) comprises the distal link (Fig. 6 and paragraphs [0011], [0037]).
Regarding claim 9, Nguyen et al. discloses wherein a time of flight transceiver is an optical time of flight transceiver (paragraph [0008]-[0009]).
Regarding claim 10, Nguyen et al. discloses the invention essentially as claimed except for further including spiral fiducial phantom mounted to guide wire configured to be implanted into bone which are used to determine a 3D reference coordinate system for the system based upon 2D fluoroscopic images.
Siewerdsen et al. discloses using spiral fiducial phantom mounted to wires into bone which are used to determine 3D reference coordinate systems based upon 2D images as such permit adjustments to geometric parameters to improve image quality (paragraphs [0005]-[0007]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Nguyen et al. to include spiral fiducial phantom mounted to guide wire configured to be implanted into bone which are used to determine a 3D reference coordinate system for the system based upon 2D fluoroscopic images in view of Siewerdsen et al. to permit adjustments to geometric parameters to improve image quality during tracking in a coordinate system.
Regarding claim 11, Nguyen et al. further includes video cameras to create video images and where the video images are also used simultaneously in the guidance of the terminal workpiece along the work path (paragraph [0015]).
Regarding claim 12, Nguyen et al. includes use of 2D fluoroscopic imaging to derive the tool work path determined end point (Fig. 9 and paragraphs [0017], [0047]).
Regarding claim 13, Nguyen et al. discloses wherein the length sensor is an optical sensor (Fig. 2 and paragraph [0038]).
Regarding claim 14, Nguyen et al. discloses wherein accuracy of the guidance of the work path to the determined end point is at least +/- 2 degrees (paragraph [0013]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775