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/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-22, drawn to a system for simulating stabilizing a head of a patient, classified in A61B90/14.
II. Claims 23-28, drawn to a method of simulating stabilizing a head of a patient, classified in A61B2090/365.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the apparatus can be used in a materially different method such as actually stabilizing the head of a patient.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The claims by virtue of being method vs. apparatus claims would require different search strategies (text vs. images) and different keyword and class searches.
During a telephone conversation with Barry Visconte on 4/10/25 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-22. Affirmation of this election must be made by applicant in replying to this Office action. Claims 23-28 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Interpretation
“Computing device” is interpreted as a computer (which broadly encompasses e.g. smart phones, tablet computers, etc.) in line with its commonly understood meaning.
Claims 1, 12, 13 recite an/the application “for correlating” respective positions. This is the intended use of the application, which itself is not positively recited in these claims, and thus the limitation is met by any application capable of such use.
Similarly, claim 10 recites “software for simulating stabilizing the head of the patient” which is met by software capable of such intended use.
Claim 2 recites “the application is configured to educate or train a user to use the skull clamp to stabilize the head of the patient.” The limitation “educate or train” is thus the intended use or result of the application. Due to the claim language, the application may be any application which is configured (i.e. programmed) in any way to be capable of achieving the result of educating or training a user to use the skull clamp to stabilize the head of the patient. There is no limit on the way the user is educated or trained, and to some degree this is a process which occurs internally in a user—i.e., information must be presented to a user, but whether they are educated or trained is largely user-dependent.
Claim 3 recites “the application allows depiction of the skull clamp…” This limitation and that of claims 4 and 17 relate to the intended use of the application, and are limited only to a device configurable with an application which is capable of being used in the claimed manner.
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.
Claim(s) 1-2, 5, 7-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hladio et al. [US 2019/0183590 A1, hereinafter “Hladio”].
Hladio discloses:
Claim 1: A system for simulating stabilizing a head of a patient [Par. 0005], the system comprising:
(a) a skull clamp [108, Fig. 7]; and
(b) an adapter assembly [“connector” 202] connectable with the skull clamp at a defined position and orientation relative to the skull clamp [Fig. 7], wherein the adapter assembly is configured to selectively [Par. 0079] receive a computing device [114, connected to camera 102 via the cable shown in Fig. 7. See e.g. Fig. 1] configured to access an application [programming on computer 114] for correlating a first position and a first orientation of the computing device with a second position and a second orientation of the skull clamp [“As described further herein, software in computing unit 114 may be configured to perform a registration so as to register the positional relationship between the tracker 114 and the patient's anatomy 112 [emphasis added] and thereafter track the pose of the patient's anatomy 112 in the field of view (working volume) of the camera 102,” Par. 0082. See also “Claim interpretation” above. This application is capable of correlating positions and orientations since it performs the registration function, and orientation is tracked as described in Par. 0065].
Claim 2: The system of claim 1, wherein the application [on computer 114] is configured to educate or train a user to use the skull clamp to stabilize the head of the patient [the software on the computer is configured to track the patient’s anatomy once registration is complete. Thus it will show when a head is stabilized or not, and a user may learn from that information how to improve their stabilization of the patient’s head].
Claim 5: The system of claim 1, wherein the skull clamp comprises a first arm and a second arm [Fig. 2] that are adjustable relative to each other to adjust a distance between the first arm and the second arm [Par. 0072, Fig. 2]
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Claim 7: The system of claim 1, wherein the skull clamp comprises two or more stabilization assemblies [Fig. 2], wherein each of the two or more stabilization assemblies comprises a stabilizing feature [204] configured to contact the head of the patient to stabilize the head of the patient.
Claim 8: The system of claim 1, wherein the adapter assembly defines a void space that allows the user to grasp a portion of the skull clamp directly without contacting the adapter assembly [Annotated Fig. 7 below].
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Claim 9: The system of claim 1, wherein the computing device includes a processor [inherent in a computing unit], a set of executable instructions, a memory configured to store the set of executable instructions [inherent in a computing unit], and a display [Par. 0071], wherein the set of executable instructions is capable of providing access to the application [Par. 0082].
Claim 10:
(c) the computing device [114] selectively connectable with the adapter assembly; and (d) the application [the program on computing device 114 programmed to perform the following procedure] accessible from the computing device, wherein the application comprises a simulation software for simulating stabilizing the head of the patient using the skull clamp [as set forth with respect to claim 1 above].
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(s) 6, 12-13, 18, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hladio.
Re. claim 6, Hladio discloses the system of claim 1, but it is unclear whether or not a portion of the adapter assembly is formed unitarily with the skull clamp. However, making at least a portion of the adapter assembly is formed unitarily with the skull clamp is an obvious modification readily made by one of ordinary skill in the art: Applicant has not alleged any new or unexpected results, so the use of a unitary construction does not confer patentability. See MPEP 2144.04.V.B.
Re. claim 12, Hladio discloses a system as set forth with respect to claim 1, including the skull clamp and adapter assembly.
Hladio teaches a second adapter assembly [706], but fails to teach the second adapter assembly configured to selectively receive a second computing device. However, duplicating the first adapter assembly and computing device to thus add a second adapter assembly and a second computing device amounts to a duplication of parts. The addition of a second (or, here, third) adapter assembly which receives a second computing device does not result in new and unexpected results, therefore It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to duplicate the first adapter assembly. See MPEP 2144.04.VI.B. Regarding the second computing device configured to communicate with the first computing device, when two computing devices are used, allowing them to communicate with each other allows for the system to be controlled by one operator and thus one of ordinary skill would reasonably be apprised of the benefits of this configuration as claimed.
Re. claim 13, Hladio discloses The system as set forth above with respect to claim 12, with the second computing device having been duplicated from the first as set forth above. Given this, the second computing device is configured to access the application for correlating a third position and a third orientation of the second computing device with the second position and the second orientation of the skull clamp [the second computing device is necessarily located in a different position from the first, so the same correlation process will necessarily result in a third position and orientation of the second computing device being correlated with the above second position and orientation of the skull clamp as claimed. Furthermore, note that “For correlating…” is the intended use of the application].
Re. claim 18, Hladio discloses the system substantially as set forth with respect to claim 7 above.
Re. claim 20, Hladio discloses the system substantially as set forth with respect to claim 8 above. Because the first adapter assembly has been duplicated to form the second, the second adapter assembly will also define a void space as claimed.
Claim(s) 3-4, 11, 17, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hladio in view of Steinberg [US 20020107573 A1].
Re. claim 3, Hladio discloses: the application allows depiction of the skull clamp and the second position and the second orientation of the skull clamp within an augmented reality environment that shows the second position and the second orientation of the skull clamp relative to the head of the patient [Par. 0115-0116.]. Hladio fails to teach the use of virtual reality. However, Steinberg teaches, in a surgical apparatus, a virtual reality environment showing the position and orientation of a medical device relative to a patient [Pars. 0972-0974]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Hladio by using, instead of an augmented reality environment, a virtual reality environment, to view the position and orientation of the skull clamp, in order to allow an operator to be remote [Steinberg Par. 0964].
Re. claim 4, Hladio-Steinberg teaches a depiction which is capable of showing a skull clamp without the adapter assembly [see at least Hladio Par. 0065: “The computing unit 114 performs the necessary processing to calculate the position and orientation (pose) of the instrument 110 with respect to the patient's anatomy 112 (i.e. brain), and to display clinically relevant information to the surgeon,” Par. 0065]..
Re. claim 11, Hladio discloses a display in communication with the computing device, wherein the display is configured to depict a augmented reality environment where the skull clamp and the head of the patient are represented virtually, and movement of the skull clamp correlates to movement of the skull clamp represented virtually in the augmented reality environment [“calculating the pose of at least one instrument 110 and displaying a representation of that instrument 110 on the computing unit 114 in relation to a medical image of the patient's anatomy 112 (i.e. head),” Par. 0071, in an augmented reality environment, Pars. 0115-0116]. Hladio fails to teach the use of virtual reality. However, Steinberg teaches, in a surgical apparatus, a virtual reality environment showing the position and orientation of a medical device relative to a patient [Pars. 0972-0974]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Hladio by using, instead of an augmented reality environment, a virtual reality environment, to view the position and orientation of the skull clamp, in order to allow an operator to be remote [Steinberg Par. 0964].
Re. claim 17, Hladio as modified discloses the system substantially as set forth with respect to claim 3 above.
Re. claim 21, Hladio discloses the system substantially as set forth with respect to claim 4 above.
Claim(s) 14-16, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hladio in view of Bieger et al. [US 2001/0035871 A1, hereinafter “Bieger”]
Re. claim 14, Hladio discloses the system of claim 13 but fails to disclose correlating the first and third position/orientation. However, Bieger teaches, in a surgical imaging system, an application is configured to correlate the first position and the first orientation of the first computing device with the third position and the third orientation of the second computing device [Pars. 0022-0023]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Hladio to configure the app to correlate the first and third positions/orientations as taught by Bieger in order to allow the position data to be superimposed together [Bieger Par. 0025].
Re. claim 15, Bieger further teaches the correlation of the first position and the first orientation of the first computing device with the third position and the third orientation of the second computing device indicates a distance [the relative positions of/in the two coordinate systems are determined, which necessarily results in the determination of a distance (if one point is translated into a second coordinate system, the location of its origin must be displaced by a certain amount. The magnitude of this displacement is the distance in question)]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Hladio to configure the app to correlate the first and third positions/orientations to indicate a distance as taught by Bieger in order to allow the position data to be superimposed together [Bieger Par. 0025]. Regarding this distance being between the first and second arm of the skull clamp, given the teaches of Hladio and Bieger taken together (see e.g. claims 14 and 19 above) one of ordinary skill would reasonably be apprised of the benefits of this configuration as claimed.
Re. claim 16, Hladio discloses the system substantially as set forth with respect to claim 5 above.
Re. claim 19, Hladio discloses the system substantially as set forth with respect to claim 6 above. For the same reasons as set forth with respect to this claim and the portion of the first adapter assembly being formed unitarily with the first arm, it likewise would have been obvious for at least a portion of the second adapter assembly to be formed unitarily with the second arm. Regarding the second adapter assembly being on the second arm, this would have been obvious; see e.g. Fig. 7, and because it amounts to selecting one form a limited list of options for arms [first or second] for placement.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hladio in view of Vancraen et al. [US 20120234329 A1, hereinafter “Vancraen”].
Re. claim 22, Hladio discloses the system of claim 12 but fails to teach the skull clamp being a rapid prototype or 3D printed. However, Vancraen teaches, in a system comprising a structure for stabilizing, the structure is generated by rapid prototyping or 3D printing [Par. 0025]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Hladio by forming the skull clamp to be a rapid prototype or a 3D printed skull clamp as taught by Vancraen in order to allow the device to be generated “directly from medical images of the patient” [Vancraen Par. 0025].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Schuele discloses: A system for simulating stabilizing a head of a patient [Par. 0002], the system comprising:
(a) a skull clamp [100, Fig. 1]; and
(b) an adapter assembly [“navigation adapter” 300] connectable with the skull clamp at a defined position and orientation relative to the skull clamp [Fig. 1], wherein the adapter assembly is configured to selectively receive a device [Pars. 0042-0043].
Wehrle discloses, in a stabilizer medical instrument, an adapter assembly is configured to selectively [Par. 0091] receive a computing device [computer 42] configured to access an application for correlating a first position and a first orientation of the computing device [Par. 0092] with a second position and a second orientation of the medical instrument [Par. 0095].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-Th 8am to 5pm ET; F 9 am to 1 pm.
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, JACKIE HO can be reached on (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771