DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the set of claims received on 20 November 2024. Claims 1-20 are currently pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Drawings
The drawings received on 20 November 2024 are accepted by the examiner.
Double Patenting
Statutory
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 5-9 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 and 5-8 of prior U.S. Patent No. 12,161,424. This is a statutory double patenting rejection.
Note: The only apparent difference is that claim 5 (i.e. by the inclusion of the limitations of claim 1) of the current application recites “system for determining” in line 1 of claim 1, and claim 1 of the patent recites “system for assessing” in line 1. However, the term “assessing” is defined as to determine the value, significance, or extent of (definition retrieved from https://www.thefreedictionary.com/assessing). Therefore, claims 5-9 of the current application and claims 1 and 5-8 of the patent are being interpreted as including identical subject matter.
Claims 16-18 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 11 and 15-16 of prior U.S. Patent No. 12,161,424. This is a statutory double patenting rejection.
Note: The only apparent difference is that claim 16 (i.e. by the inclusion of the limitations of claim 12) of the current application recites “method of determining” in line 1 of claim 12, and claim 11 of the patent recites “method of assessing” in line 1. However, the term “assessing” is defined as to determine the value, significance, or extent of (definition retrieved from https://www.thefreedictionary.com/assessing). Therefore, claims 16-18 of the current application and claim 11 and 15-16 of the patent are being interpreted as including identical subject matter.
Non-Statutory
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 1-4 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 9 of U.S. Patent No. 12,161,424. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are merely broader than the patent claims.
Claims 12-15 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-14 and 18 of U.S. Patent No. 12,161,424. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are merely broader than the patent claims.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 12,161,424. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claim is merely broader than the patent claim.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (i.e. a mental process) without significantly more.
Claims 1-11 and 20 are directed toward a system for determining a laxity result for a joint during a surgical procedure (i.e. a machine). Claims 12-19 are directed toward a method for determining a laxity result for a joint during a surgical procedure (i.e. a process). Hence, the claims are directed to one of the four statutory categories (i.e. process, machine, manufacture, or composition of matter) (STEP 1: YES).
However, claims that fall within one of the four subject matter categories may nevertheless be ineligible if they encompass laws of nature, physical phenomena, or abstract ideas (see Diamond v. Chakrabarty, 447 U.S. 309 (1980)).
The representative claims recite the following:
Independent claim 1 is directed to “a system for determining a laxity result for a joint during a surgical procedure, the system comprising: a navigation system configured to obtain location information related to the joint; a display; and a processor operably connected to the navigation system and the display, the processor is configured to: collect, based on the location information, a first set of motion information related to movement of the joint through a first range of motion after insertion of one or more trial components to the joint and while a first portion of the joint is in contact with a second portion of the joint, collect, based on the location information, a second set of motion information related to movement of the joint through a second range of motion after the insertion of the one or more trial components to the joint and while the first portion of the joint is separated from the second portion of the joint, determine a laxity result for the joint based on a difference between the first set of motion information and the second set of motion information, and cause the laxity result to be displayed on the display.”
Independent claim 12 is directed to “a method of determining a laxity result for a joint during a surgical procedure, the method comprising: inserting one or more trial components into the joint based on a surgical plan; collecting, from a navigation system, a first set of motion information related to movement of the joint through a first range of motion while a first portion of the joint is in contact with a second portion of the joint; collecting, from a navigation system, a second set of motion information related to movement of the joint through a second range of motion while the first portion of the joint is separated from the second portion of the joint; determining a laxity result for the joint based on a difference between the first set of motion information and the second set of motion information; and displaying the laxity result on a display device.”
Independent claim 20 is directed to “a system for determining a laxity result for a joint during a surgical procedure, the system comprising: a navigation system configured to obtain location information related to the joint; a display; a processor operably connected to the navigation system and the display; and a non-transitory, computer-readable medium storing instructions that, when executed, cause the processor to: collect, based on the location information, a first set of motion information related to movement of the joint through a first range of motion while a first portion of the joint is in contact with a second portion of the joint, wherein the first set of motion information is collected after insertion of one or more trial components to the joint, collect, based on the location information, a second set of motion information related to movement of the joint through a second range of motion while the first portion of the joint is separated from the second portion of the joint, wherein the second set of motion information is collected after the insertion of the one or more trial components to the joint, determine a laxity for the joint based on a difference between the first set of motion information and the second set of motion information, and cause information related to the laxity to be displayed on the display.”
The underlined portions of the claims recite an abstract idea because each portion includes one or more mental processes (e.g., observations, evaluations, and/or judgments) that can be performed in the mind or with the aid of pen and paper. (STEP 2A, PRONG 1: YES. The claimed invention recites an abstract idea.).
This judicial exception is not integrated into a practical application because the claims (i.e. at least claims 1, 12 and 17) recite generic steps of collecting information, determining results, causing results to be displayed without adding meaningful limitations to the system for surgery without using optical trackers. Additional claims (i.e. claims 2-11 and 13-19) further define the abstract idea (e.g. determining results, comparing results, obtaining a plan, revising a plan, receiving input, updating results, determining differences, plotting differences, and comparing curves). The instant claims do no actually provide any surgical intervention, but rather they provide for planning such a procedure.
The claims recite the additional elements of a navigational system, a display (device), a processor, one or more trial components, a tibial component of a trial component, a femoral component of a trial component, an input device, a non-transitory computer-readable medium storing instructions (i.e. claims 1-20) including functional language related thereto (e.g. to perform functions...obtaining location information). The additional elements are not sufficient to amount to significantly more than the judicial exception because they do not (1) improve the functioning of a computer or other technology, (2) are not applied with any particular machine, (3) do not effect a transformation of a particular article to a different state, (4) do not effect a particular treatment or prophylaxis for a disease or medical condition, and (5) are not applied in any meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claimed invention, as a whole, is more than a drafting effort designed to monopolize the exception (see MPEP §§ 2106.04(d)-(d)(2) and 2106.05(a)-(c), (e)-(h)). Therefore, the claims are directed to the judicially recognized exception of an abstract idea. (STEP 2A, PRONG 2: NO. The claimed invention is directed to an abstract idea.)
The claims encompass the following additional element(s) or combination of elements in the claim(s) other than the abstract idea per se: a navigational system, a display (device), a processor, one or more trial components, a tibial component of a trial component, a femoral component of a trial component, an input device, a non-transitory computer-readable medium storing instructions. Viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself.
The above-identified additional elements (i.e. a navigation system, a display (device), a processor, an input device, a non-transitory computer-readable medium storing instructions) are generically claimed computer components which enable the above-identified abstract idea to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification:
[0007]There is provided a system for determining bone laxity during a surgical procedure to replace at least a portion of a bone joint with an implant. The system includes a tracked probe comprising at least one probe marker, the tracked probe configured to provide an indication of at least one anatomical landmark on a bone during the surgical procedure; and a computer assisted surgical system (CAS). The CAS includes a navigation system configured to track the tracked probe and at least one bone marker during the surgical procedure and a processing device operably connected to the navigation system and a computer readable medium. The computer readable medium is configured to store one or more instructions that, when executed, cause the processing device to receive location information related to a position of the tracked probe and the at least one bone marker from the navigation system, generate a surgical plan comprising a post-operative laxity assumption, collect first motion information related to movement of the joint through a first range of motion, collect second motion information related to movement of the joint through a second range of motion, determine a post-operative laxity for the joint, compare the post-operative laxity for the joint and the post-operative laxity assumption to determine laxity results for the surgical procedure, and cause the laxity results to be displayed on a display operably connected to the processing device.
[0045]FIG. 1 illustrates a block diagram for certain embodiments of a surgical system 100, which includes a computer system 110 that provides a display 115 for viewing location data provided by optical trackers 120 as read by an infrared camera system 130. In certain implementations, the computer 110 can include various components such as a processing device and a computer readable medium configured to store one or more instructions that, when executed, cause the processing device to perform one or more tasks. For example, the instructions can be configured to cause the processing device to calculate bone laxity and determine bone laxity results for a surgical procedure as discussed, for example, in reference to FIG. 10 below.
[0046]The optical trackers 120 and infrared camera system 130 can provide data indicating the precise location of the bones in the knee joint at any given time. In certain embodiments, the infrared camera system 130 can detect tracking spheres located on the optical trackers 120 in order to gather location data regarding the patient’s femur and tibia on which a knee replacement procedure is to be performed. It is to be appreciated that embodiments of the described subject matter can be implemented by various types of operating environments, computer networks, platforms, frameworks, computer architectures, and/or computing devices.
[0049]As noted above, in certain embodiments, the surgical system 100 can also include one or more processors and memory devices, as well as various input devices, output devices, communication interfaces, and/or other types of devices. The computer system 110 as described herein can include a combination of hardware and software.
[0068]In certain embodiments, the surgical plan can be implemented by one or more computing devices such as computers, PCs, server computers configured to provide various types of services and/or data stores in accordance with aspects of the described subject matter. Components can be implemented by software, hardware, firmware or a combination thereof.
Accordingly, in light of applicant’s specification, the claimed term “processor” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that this limitation requires no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the processor. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The use of one or more trial components (i.e. claims 1, 12 and 20), a tibial component of a trial component (i.e. claims 3 and 14), a femoral component of a trial component (i.e. claims 3 and 14) does not amount to significantly more, and is well-understood, routine, and conventional. The dependent claims merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the claimed functions/steps are performed.
The recitation of the above-identified additional limitations in claims 1-20 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit/generate/provide/output data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
Taking the claimed elements individually yields no difference from taking them in combination because each element simply performs its respective function as discussed above. The claims do not purport to improve the functioning of a computer itself, nor do they effect an improvement in any other technology or technical field. Instead, the additional features merely amount to an instruction to apply the abstract idea using generic, functional, and conventional components well-known in the art. Viewed as a whole, these additional claim elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. (STEP 2B: NO. The claimed invention does not add significantly more and is not eligible subject matter.)
Therefore, claims 1-20 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter (see Alice Corporation Pty. Ltd. v. CLS Bank International, et al., 573 U.S. 208 (2014)).
Note: It appears that amending the independent claims to include, for example, “wherein one or more bone cuts are made based upon the determined laxity result” (see paragraph 0062 of the current specification for support) would add significantly more and overcome the rejections under 35 U.S.C. 101.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775