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 .
Status of Claims
This action is in response to application 18/636181 filled on 04/15/2024.
Claims 1-30 are currently pending and have been examined.
Detailed Action
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.
Claim 1-30 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-21 of U.S. Patent No. 11957418 and claims 1-22 of U.S. Patent No. 16261464. Although the claims at issue are not identical, they are not patentably distinct from each other because differences between the systems recited in the claims ‘418 and ‘464 and the systems of the instant application would have been obvious by one skilled in the art. For example, claim 1 of ‘418 recites “receiving image data associated with a joint of a subject; generating a three-dimensional model of at least a portion of the joint of the subject using the image data; identifying at least one region of the joint that deviates from a baseline anatomy by comparing at least a portion of the three-dimensional model to a baseline model; generating at least one measurement of a characteristic of the joint at one or more predefined locations using the three-dimensional model and a coordinate system; determining a pathology associated with the joint based on the at least one measurement of the characteristic of the joint; and generating and displaying a visualization for providing guidance for the surgical procedure on the at least one region of the joint, wherein the visualization comprises: a rendering of at least a portion of the three-dimensional model, a spectrum bar graph that comprises at least one representation of the at least one measurement of the characteristic of the joint, and at least one graphical indication indicating the pathology associated with the joint.”
Accordingly, while the language varies slightly as between the two claims, the language in each of these claims is describing a feature that is the same or a mere obvious variation of that recited in the other claim. The remaining claims of the instant application similarly encompass features that one skilled in the art would recognize as the same or obvious variants of features recited in claims 1-19 of ‘646.
Claims 1-30 of the instant application are additionally rendered obvious by claims 1-22 of ‘464 under substantially the same rationale as set forth above.
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.
Claims 1-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1:
Claims 1-30 are drawn to a method and system, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One:
Independent claims 1 and 19 recite generating a 3d model; identifying at least one morphological characteristic of the joint based on the 3D model; generating a displaying a visualization for providing guidance for planning for the surgical procedure including a 3 D rendering of the at least a portion of the 3D model and a visual indication of that at least one morphological characteristic of the joint overlaid on the 3D rendering. As drafted, is a process that, under the broadest reasonable interpretation, covers performance of the limitation in the mind but for recitation of generic computer components. That is, other than reciting a computing system in claim 1 and memory and processor in claim 19, nothing in the claim precludes the step from practically being performed in the mind. For example, but for the implemented by a computer or the processor, this claim encompasses a person rendering a 3D model of a joint; identifying at least one morphological characteristic and so forth. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional element of a computing system and a processor that implements the identified abstract idea. The processor and computing system is recited at a high-level of generality (i.e., a generic computing system performing generic computer functions) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim further recites the additional elements of receiving image data, which is considered limitation directed to insignificant extra-solution activity that does not amount to an inventive concept because the limitation does not impose meaningful limits on the claim such that it is not nominally or tangentially related to the invention. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at Figure 1, and
Paragraph 147, where “The visualization generating subsystem 1704 can be configured to receive imaging data and use some or all of the imaging data for generating a three-dimensional model of at least a portion of the joint of the subject. The subsystem 1704 can identify at least one region of the joint that deviates from a baseline anatomy by comparing at least a portion of the three-dimensional model to a baseline model. The subsystem 1704 can generate a measurement of a characteristic of the joint at one or more predefined locations using the three-dimensional model and a coordinate system; and can generate a three-dimensional rendering of the model, according to the principles described herein. The three-dimensional rendering can include a visual indication of the at least one region of the three-dimensional model that deviates from the baseline, wherein the at least one region is visually indicated according to degree of deviation. The three-dimensional rendering can be a component of a visualization that includes any other relevant information as described herein.”
Paragraph 151, where “Storage 1840 can be any suitable device that provides storage, such as an electrical, magnetic, or optical memory including a RAM, cache, hard drive, or removable storage disk. Communication device 1860 can include any suitable device capable of transmitting and receiving signals over a network, such as a network interface chip or device. The components of the computer can be connected in any suitable manner, such as via a physical bus or wirelessly.”
Paragraph 149, where “FIG. 18 illustrates an example of a computing system, in accordance with some embodiments, for generating visualization according to the principles described herein. System 1800 can be used for one or more of subsystems 1702, 1704, and 1706 of system 1700. System 1800 can be a computer connected to a network, such as network 1708 of system 1700. System 1800 can be a client computer or a server. As shown in FIG. 18, system 1800 can be any suitable type of microprocessor-based system, such as a personal computer, workstation, server, or handheld computing device (portable electronic device) such as a phone or tablet. The system can include, for example, one or more of processor 1810, input device 1820, output device 1830, storage 1840, and communication device 1860. Input device 1820 and output device 1830 can generally correspond to those described above and can either be connectable or integrated with the computer.”
The claims recite the additional element of receiving image data, which amounts to extra-solution activity concerning mere data gathering. The specification (e.g., as excerpted above) does not provide any indication that the additional elements are anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are here). See: MPEP 2106.05(g).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2-18 and 20-30 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 10, 11, and 13-25 and 27-30 is/are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Mahfouz (US 2017/0367766 A1).
As per claim 1, a method for visualizing a morphological characteristic of a joint for planning a surgical procedure on the joint, the method comprising, at a computing system:
Mahfouz teaches:
receiving image data associated with a joint of a subject (Fig. 11-12);
generating a three-dimensional model of at least a portion of the joint of the subject using the image data (Fig. 11-12 and Para. 23 wherein a colored 3d model of a joint is taught);
identifying at least one morphological characteristic of the joint based on the three-dimensional model (Fig. 31 and Para. 144 and 212 wherein visual feedback of joint characteristics is displayed) ; and
generating and displaying a visualization for providing guidance for planning for the surgical procedure on the at least one morphological characteristic of the joint (Para. 149 wherein “ the feedback may be displayed on a display associated with the surgical instrument to guide the surgeon in repositioning the instrument to arrive at the proper orientation and/or position consistent with the pre-operative surgical plan”), wherein the visualization comprises:
a three-dimensional rendering of the at least a portion of the three-dimensional model (Para. 155),
a visual indication of the at least one morphological characteristic of the joint overlaid on the three-dimensional rendering (Para. 204 wherein “all resections relevant to the surgical procedure are visually assisted by overlaying the proposed cutting location and orientation on the anatomy. Additionally, the surgical instrument used for the cutting can be tracked and the true orientation and location of the cut is updated in the AR overlay in real-time.”).
As per claim 2, Mahfouz teaches the method of claim 1, wherein the image data comprises at least one of an MRI scan and a CT scan (Para. 228).
As per claim 3, Mahfouz teaches the method of claim 1, comprising: generating a measurement of the at least one morphological characteristic at one or more predefined locations using the three-dimensional model and a coordinate system (Para. 228).
As per claim 4, Mahfouz teaches the method of claim 3, wherein the three-dimensional rendering comprises a visual indication of the coordinate system (Fig. 12).
As per claim 5, Mahfouz teaches the method of claim 3, further comprising displaying a spectrum bar graph that comprises the representation of the measurement of the at least one morphological characteristic of the joint, wherein regions of the spectrum bar graph are visually-coded to indicate normal and abnormal anatomical measurement ranges (Fig. 76, Para. 275).
As per claim 6, Mahfouz teaches the method of claim 5, further comprising displaying a coordinate system value that is associated with the representation of the measurement (Para. 179).
As per claim 7, Mahfouz teaches the method of claim 3, wherein the visualization comprises the measurement of the characteristic of the joint that is positioned in the visualization according to the one or more predefined locations (Para. 255).
As per claim 10, Mahfouz teaches the method of claim 3, wherein the joint is a hip joint and the measurement of the at least one morphological characteristic comprises at least one of an alpha angle and a lateral center edge angle (Para. 160 and 239).
As per claim 11, Mahfouz teaches the method of claim 1, wherein identifying at least one morphological characteristic of the joint based on the three-dimensional model comprises determining that the at least one morphological characteristic deviates from a baseline anatomy by comparing at least a portion of the three-dimensional model to a baseline model (Para. 144).
As per claim 13, Mahfouz teaches the method of claim 11, wherein the visual indication of the at least one morphological characteristic of the joint is visually indicated according to a degree of deviation from a baseline anatomy (Para. 144 and 286) .
As per claim 14, Mahfouz teaches the method of claim 11, wherein the visualization of the morphological characteristic of the joint comprises a heat map (Fig. 73).
As per claim 15, Mahfouz teaches the method of claim 14, wherein the heat map indicates an amount of tissue to remove to match the baseline anatomy (Para. 222).
As per claim 16, Mahfouz teaches the method of claim 1, wherein the three-dimensional rendering comprises at least one indication of a location of a threshold characteristic value in the rendering (Para. 172).
As per claim 17, Mahfouz teaches the method of claim 16, wherein the at least one indication comprises a curve connecting points that meet the threshold characteristic value (Para. 173).
As per claim 18, Mahfouz teaches the method of claim 17, wherein the joint is a hip joint, the characteristic is an alpha angle, and the threshold characteristic value is 55 degrees, 65 degrees, or 75 degrees (Para. 239 wherein “Thereafter, the talus is navigated to the correct flexion angle (e.g., 20 degrees) and the correct medial-lateral position”. The angle can be 55, 65, or 75).
Claims 12-25 and 27-30recite substantially similar limitations as seen above and hence are rejected for similar rationale as noted above.
Claim Rejections - 35 USC § 103
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 8-9, 12, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahfouz (US 2017/0367766 A1) in view of Chabanas et al. (US 2013/0089253 A1).
As per claim 8, Mahfouz teaches the method of claim 3. Mahfouz does not explicitly teach however Chabanas teaches, wherein the coordinate system comprises clock-face lines (Fig. 3 and Para. 16). It would have been obvious to one of ordinary skill in the art at the time of filling to combine the method and system for evaluating possible shapes of a dynamic orthopedic implant using anatomical shape and kinematic shape as taught in Mahfouz with the measuring system for determining bone resection as taught in Chabanas. The well-known elements described are merely a combination of old elements, and in combination, each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
As per claim 9, Mahfouz teaches the method of claim 3. Mahfouz does not explicitly teach however Chabanas teaches method of claim 8, wherein the representation of the measurement is provided adjacent to at least one of the clock-face lines (Para. 99). The motivation to combine references is the same as seen in claim 8.
As per claim 12, Mahfouz teaches the method of claim 11. Mahfouz does not explicitly teach however Chabanas teaches method of claim 11, wherein the joint is a hip joint and the deviation from the baseline is associated with at least one of a cam-type impingement and a pincer-type impingement (Para. 3). The motivation to combine references is the same as seen in claim 8.
Claim 25 recites substantially similar limitations as seen in claim 12 above and hence is rejected for similar rationale as noted above.
Conclusion
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MAROUN P. KANAAN
Primary Examiner
Art Unit 3687
/MAROUN P KANAAN/ Primary Examiner, Art Unit 3687