DETAILED ACTION
Claims 1-22 are pending and hereby under examination.
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 .
Information Disclosure Statement
The information disclosure statement filed 4/26/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the foreign patent documents and non-patent literature referred to therein have not been considered.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4, line 1, “clam” should read “claim”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-18 recite having “algorithms”, “selecting an algorithm”, and “receiving data … utilizing the algorithm”. However, there is no disclosure as to what the algorithm is, what the algorithm does, and/or what equation(s) the algorithm uses to make a measurement or determination of a value. Applicant’s specification paragraphs 0139 – 0144 refer to generic “algorithms” such as kinematic and classification algorithms in a “software package”; however, there is no clear step or method on how these algorithms are used and what they are. How does the classification algorithm determine which size the implant is? How are the algorithms changed, calibrated, or selected based on sizes of the implants? How do the sizes of the implants inform the algorithm to make further calculations or to decide what algorithm is used to make further calculations? As such, it appears the limitations directed towards selecting an algorithm and using the algorithm do not have proper written description support in the instant specification.
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 1-22 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.
Regarding claim 1, the preamble of the claim is directed towards a method of performing surgery, but the body of the claim is directed to receiving data and selecting an algorithm, not performing any type of surgery. Therefore, it is unclear as to what controls the metes and bounds of the claim between the preamble and the body of the claim as the body of the claim does not result in the preamble. Claims 2-11 are also rejected due to their dependence on claim 1.
Regarding claim 1, it is unclear what the algorithm is chosen from and how the first and second information is used to select an algorithm. Are there multiple algorithms, and where are they stored? It is also unclear how the algorithm is “utilized” to receive data from the first and second implants. Is the algorithm used to calculate the data, or is the algorithm used to select which data to receive from the implants? What calculations or equations does the algorithm use to make these determinations? For examination purposes, the claim will be interpreted such that one algorithm is used and the first and second information are used in that algorithm to determine data of the implants.
Regarding claims 1-11, the claim is directed towards a method. However, the claims fail to recite any structure capable of performing the method. Thus, it is unclear how the method is performed without sufficient structure recited for performing said steps.
Regarding claims 12-18, the claim is directed towards a joint replacement system. However, the claims fail to recite what the system does. For example, the processor includes different algorithms based on the size of the first and second implants. The processor also receives kinematic information. Is the processor calculating a value with one of the algorithms? Is one of the algorithms chosen to perform a task? Further, are the reader and marker configured to measure kinematic information to send to the processor? It is unclear what the relationship is between the processor/algorithms and the first and second implants with the marker and reader.
Regarding claim 19, it is unclear what is required to meet the limitation of the claim with regard to the step of “reviewing data obtained by the processor”. Is there a calculation that is performed, or is the processor simply reviewing data with no output or determination made? For examination purposes, any calculation made with the size data will meet the claim. Claims 20-22 are also rejected due to their dependence on claim 19.
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 1-11 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.
Analysis of independent claim 1:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a computer implemented method, which describes one of the four statutory categories of patentable subject matter, i.e., a method.
Therefore, further consideration is necessary regarding claims.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 1 recites an abstract idea. In particular, the claims generally recite
the following:
selecting an algorithm based on the first and second information (claim 1);
This element in claim 1 is drawn to an abstract idea since it is directed towards mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).
“selecting an algorithm based on the first and second information” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably review characteristics of an implant and select an algorithm to further determine data of the implants. There is nothing to suggest an undue level of complexity in “selecting an algorithm based on the first and second information”.
Prong Two: Claim 1 does not recite additional elements that integrate the exception into a practical application. Therefore, the claims are "directed to" the abstract idea. The additional elements merely:
Add insignificant extra-solution activity (the pre-solution activity of: using generic data gathering components (e.g., "receiving first information related to a first implant" and "receiving first information related to a first implant"); the post-solution activity of: (e.g. “receiving data from the first and second implants utilizing the algorithm”)).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 1 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to implementing the abstract ideas on generic processing components, the pre-solution activity of using generic data-gathering components, and generic post-solution activities, which merely facilitate the abstract idea.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, “an implant” as disclosed in the Applicant’s specification is “A joint implant according to this aspect, may include a first implant coupled to a first bone of a joint and a second implant coupled to a second bone of the joint” (Paragraph 0015), “knee joint implant” (Paragraph 0097), “a spinal implant” (Paragraph 0120), “hip implant” (Paragraph 0121), and “shoulder implant” (Paragraph 0126).
These additional elements do not qualify as significantly more because this limitation is simply appending well understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well understood, routine and conventional activity previously known in the industry (see Electric PowerGroup, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014); SAP Am. v. lnvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements include a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of the dependent claims:
Claims 2-11 depend from the independent claims. Dependent claims 2-11 merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“wherein the algorithm is included in a software package in communication with the reader” (claim 7)),
Further describe the pre-solution activity (“wherein the first information is a size of the first implant and the second information is a size of the second implant” (claim 2), “wherein the first implant is implanted on a first bone and the second implant is implanted on a second bone” (claim 3), “wherein the first implant includes a marker and the second implant includes a reader” (claim 4), and “wherein the marker is a magnet and the reader is a magnetic sensor” (claim 5), “wherein the magnetic sensor is a Hall sensor assembly including at least one Hall sensor” (claim 6), “wherein the first and second information is manually inputted” (claim 9), “wherein the information as to the first and second sizes is received from an RFID chip” (claim 10), and “wherein the first and second information is determined by magnetic readings” (claim 11)), and
Further describe the post-solution activity (“wherein the data includes kinematic information” (claim 8)).
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. The result of the abstract idea does not cause the computing device and/or application to perform different.
Therefore, claims 1-11 are rejected as being directed to non-statutory subject matter.
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.
Claims 1-7, 9, 11, 19-20, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DiSilvestro (US 20050010301 – cited by Applicant).
Regarding claim 1, DiSilvestro teaches a method of performing surgery, the method comprising the steps of:
receiving first information (Paragraph 0059, measuring magnetic flux density between the magnet 26 and Hall effect transducer 28) related to a first implant (Fig. 1, femoral component 24);
receiving second information (Paragraph 0059, measuring magnetic flux density between the magnet 26 and Hall effect transducer 28; Paragraph 0072 and Fig. 2, wherein the joint space d3 and thickness of the bearing d4 can be calculated and d1 and d2 are known) related to a second implant (Fig. 1, tibial bearing 16);
selecting an algorithm based on the first and second information (Paragraph 0095, a suitable algorithm could be used to determine a distance corresponding with this perturbation in the magnetic field”); and
receiving data from the first and second implants utilizing the algorithm (Paragraph 0054, wherein by measuring the distance, a measurement of the extent of wear can be calculated).
Regarding claim 2, DiSilvestro further teaches wherein the first information is a size of the first implant (Paragraph 0059, measuring magnetic flux density between the magnet 26 and Hall effect transducer 28; Fig. 1, femoral component 24) and the second information is a size of the second implant (Paragraph 0059, measuring magnetic flux density between the magnet 26 and Hall effect transducer 28; Paragraph 0072 and Fig. 2, wherein the joint space d3 and thickness of the bearing d4 can be calculated and d1 and d2 are known; Fig. 1, tibial bearing 16).
Regarding claim 3, DiSilvestro further teaches wherein the first implant is implanted on a first bone and the second implant is implanted on a second bone (Fig. 1, tibial bearing 16 and femoral component 24).
Regarding claims 4-6, DiSilvestro further teaches wherein the first implant includes a marker wherein the marker is a magnet (Fig. 1, signal source 26; Paragraph 0058, “the signal source 26 comprises a permanent magnet”), and the second implant includes a reader, wherein the reader is a magnetic sensor such as a Hall sensor assembly including at least one Hall sensor (Fig. 1, sensor 28; Paragraph 0059, “the sensor 28 is a Hall effect transducer”).
Regarding claim 7, DiSilvestro further teaches wherein the algorithm is included in a software package in communication with the reader (Paragraph 0062, wherein the system includes components such as a transmitter; Paragraph 0092).
Regarding claim 9, DiSilvestro further teaches wherein the first and second information is manually inputted (Paragraph 0074, wherein the surgeon/technician would determine the base measurement for the distance d3).
Regarding claim 11, DiSilvestro further teaches wherein the first and second information is determined by magnetic readings (Paragraph 0097).
Regarding claim 19, DiSilvestro teaches a surgical procedure comprising the steps of:
implanting a first implant on a first bone, the first implant including a marker (Fig. 1, signal source 26 comprising a magnet affixed to distal femoral component 24);
implanting a second implant on a second bone, the second implant including a reader, the reader configured to detect the marker (Fig. 1, sensor 28 comprising a Hall effect transducer affixed to the proximal tibial component 18);
connecting the reader with a processor (Fig. 2 and paragraphs 0065/0070, sensor 28 connected to transmitter 36 on PCB 34 which are connected to interpretation device 42);
providing the processor with a first size of the first implant and a second size of the second implant (Paragraph 0059, measuring magnetic flux density between the magnet 26 and Hall effect transducer 28; Paragraph 0072 and Fig. 2, wherein the joint space d3 and thickness of the bearing d4 can be calculated and d1 and d2 are known); and
reviewing data obtained by the processor, where the data is based upon the first and second sizes (Paragraph 0070).
Regarding claim 20, DiSilvestro further teaches wherein the first and second sizes are manually inputted (Paragraph 0074, wherein the surgeon/technician would determine the base measurement for the distance d3).
Regarding claim 22, DiSilvestro further teaches wherein the providing step includes receiving the first and second sizes from magnetic readings (Paragraph 0097).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over DiSilvestro as applied to claim 1 above, and further in view of Johannaber (US 20180116805 – cited by Applicant).
Regarding claim 8, DiSilvestro fails to explicitly disclose calculating kinematic information.
However, Johannaber teaches a system and method for assessing hip arthroplasty components wherein the implant includes magnets and hall sensors (Fig. 13, hall effect sensor 1306 and magnetic sphere 1302) to measure rotation and motion for the components (Paragraph 0073; Paragraph 0076; Paragraph 0099). Johannaber discusses this type of assessment is beneficial for assessing joint stability, range of motion and risk of impingement (Paragraph 0020). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant of DiSilvestro with the method of measuring kinematic information of Johannaber to assess joint stability, range of motion, and risk of impingement.
Claims 10 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over DiSilvestro as applied to claim 2 and 19, respectively, above, and further in view of Berger (US 20050247319).
Regarding claims 10 and 21, DiSilvestro discloses a RF transmitter (Paragraph 0052) but fails to disclose an RFID chip for holding information regarding the sizes of the implants.
However, Berger teaches a medical implant device wherein an RFID tag is affixed on a medical implant (Paragraph 0032) and carries information related to dimensions and measurements of the implant (Paragraph 0013). Berger discusses including an RFID tag is useful for automatic device identification, monitoring and patient information. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant of DiSilvestro with the RFID tag of Berger to automatically identify information such as implant dimensions and measurements.
Claims 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over DiSilvestro and Johannaber.
Regarding claims 12-13 and 17, DiSilvestro teaches a joint replacement system comprising:
a first implant having a marker (Fig. 1, signal source 26 comprising a magnet affixed to distal femoral component 24);
a second implant having a reader to detect the marker (Fig. 1, sensor 28 comprising a Hall effect transducer affixed to the proximal tibial component 18), and
a processor in communication with the second implant (Fig. 2 and paragraphs 0065/0070, sensor 28 connected to transmitter 36 on PCB 34 which are connected to interpretation device 42).
While DiSilvestro discloses using an algorithm (Paragraph 0097), DiSilvestro fails to disclose the processor including different algorithms based on the size of the first and second implants and calculating kinematic information.
However, Johannaber teaches a method for assessing hip arthroplasty wherein the sensor and magnetic combination used for measuring kinematic information (Paragraphs 0055, 0073, 0076 and 0099) may be calibrated based on the distance between the two while in implants to assess a risk of impingement (Paragraph 0028). Thus, the combination of DiSilvestro and Johannaber would necessarily disclose having multiple algorithms for use based on the calculated offsets. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implants of DiSilvestro to incorporate the method of measuring kinematics and calibrating the sensors to assess risk of impingement.
Regarding claim 14, DiSilvestro as modified further discloses wherein the first implant is a femoral implant and the second implant is a tibial implant (Fig. 1, femoral component 24 and tibial component 18).
Regarding claims 15-16, DiSilvestro as modified further discloses wherein the marker is a magnet (Fig. 1, signal source 26; Paragraph 0058, “the signal source 26 comprises a permanent magnet”) and the reader is a magnetic sensor, wherein the magnetic sensor is a Hall sensor assembly including at least one Hall sensor (Fig. 1, sensor 28; Paragraph 0059, “the sensor 28 is a Hall effect transducer”).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over DiSilvestro and Johannaber as applied to claim 12 above, and further in view of Berger.
Regarding claim 18, DiSilvestro as modified discloses a RF transmitter (Paragraph 0052) but fails to disclose an RFID chip for holding information regarding the sizes of the implants.
However, Berger teaches a medical implant device wherein an RFID tag is affixed on a medical implant (Paragraph 0032) and carries information related to dimensions and measurements of the implant (Paragraph 0013). Berger discusses including an RFID tag is useful for automatic device identification, monitoring and patient information. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant of DiSilvestro as modified by Johannaber with the RFID tag of Berger to automatically identify information such as implant dimensions and measurements.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791