DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/28/2023 & 9/18/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
3. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
Regarding claim 19 the recitation “…duration determining module for determining a duration during which sensor information is collected and transferred from the one or more sensors to the patient monitoring platform;” contains generic the place holder “module” and associated functional language but will NOT be treated as invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Regarding claim 19 the recitation “…analysis module for analyzing sensor information received from the one or more sensors on the patient account via an external device,” contains generic the place holder “module” and associated functional language but will NOT be treated as invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Regarding claim 19 the recitation “…communications module for communicating corrective steps from the external device to the patient or the implant via the patient account based on the analysis of the sensor information.” contains generic the place holder “module” and associated functional language but will NOT be treated as invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-5, 7, 9, 11-16, 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bae (US 11389111 B2) in view of Armbruster (US 20210059554 A1).
Regarding claims 1, 9, 11-13, 15-17 and 19 Bae teaches creating a patient account on a patient monitoring platform (Interpreted as smart phone 13, Fig. 4, 6A, 7a-8d); determining sensor information (Col. 2 lines 40-60, Col. 3 lines 37-60) to be measured from one or more sensors 10 14 disposed on an implant 16 coupled to a patient 2 using the patient account (Interpreted as smart phone app Fig. 4, 6A, 7a-8d) ; determining a duration during which sensor information is collected and transferred from the one or more sensors to the patient monitoring platform (Implied functionality of a signal processing sensor system (i.e determing a time / duration of operating) ; analyzing sensor information received from the one or more sensors 14 on the patient account via an external device (Col. 4 lines 1-65) (Fig. 4). Bae does not disclose communicating corrective steps from an external device to a patient or an implant via the patient account based on the analysis of the sensor information. Armbruster teaches an monitoring electrical device for monitoring implants and / or patients. Armbruster further discloses communicating corrective steps from an external device to a patient or an based on the analysis of the sensor information (Interpreted as data sent to patient from “Clinical system” [0064][[0073]).
It would have been obvious to a person having ordinary skill in the art implant and patient monitoring systems before the effective date of the claimed invention to modify the monitoring system taught by Bae to further include transmitted data that communicates corrective steps from an external device to a patient or an implant based on the analysis of the sensor information as taught by Armbruster for the purpose of effectively and efficiently deliver diagnoses , treatment plans or the like to a patient wearing an implant.
Regarding claims 2 & 7 Bae as modified by Armbruster discloses measuring sensor information from any of a pH sensor, a temperature sensor, an accelerometer, a gyroscope, an inertial measurement unit, a Hall sensor, and a pressure sensor (Col. 3 lines 1-20) disposed on the implant 16.
Regarding claims 3 & 4 Bae as modified by Armbruster discloses the implant is a knee joint (femur, tibial) implant (Inherent col. 1 lines 20-39).
Regarding claim 5 Bae as modified by Armbruster discloses the femoral component includes one or more magnets and the one or more sensors are disposed in the tibial component (Col. 4 lines 59 – col. 5 lines 1-5).
Regarding claim 14 Bae as modified by Armbruster discloses the step of communicating corrective steps is communicated to a patient's personal device (fig. 4).
Claim(s) 6, 8, 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bae (US 11389111 B2) in view of Armbruster (US 20210059554 A1) as applied to claims 1-5, 9-11 & 16 above, and further in view of DiSilvestro et al (US 20180235514 A1).
Regarding claims 6, 8, 21 & 22 Bae as modified by Armbruster teaches all of the basic features of the claimed invention. Bae as modified by Armbruster does not explicitly disclose sensor information that includes any of a knee flexion angle, knee varus-valgus rotation, knee internal-external rotation, knee medial-lateral translation, superior-inferior translation, anterior-posterior translation, and time derivatives thereof and the implant is any of a hip implant, shoulder implant, and ankle implant. DiSilvestro et al teaches an orthopedic post operative monitoring system that sensor information includes any of a knee flexion angle, knee varus-valgus rotation, knee internal-external rotation, knee medial-lateral translation, superior-inferior translation, anterior-posterior translation, and time derivatives thereof. [0017] [0024] [0027] [0029] and the implant is any of a hip implant, shoulder implant, and ankle implant. [0035]
It would have been obvious to a person having ordinary skill in the art of orthopedic implant monitoring before the effective filing date of the claimed invention to modify the implant monitoring devices taught by Bae and Armbruster to further include sensor information that includes any of a knee flexion angle, knee varus-valgus rotation, knee internal-external rotation, knee medial-lateral translation, superior-inferior translation, anterior-posterior translation, and time derivatives and an implant that is any of a hip implant, shoulder implant, and ankle implant thereof as taught by DiSilvestro et al for the purpose of effectively monitoring the performance of an implantable orthopedic sensing system for monitoring post operative joint performance.
Claim(s) 10, 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bae (US 11389111 B2) in view of Armbruster (US 20210059554 A1) as applied to claims 1-5, 9-11 & 16 above, and further in view of Wiedenhoefer et al (US 20160302721 A1).
Regarding claims 10, 18 & 20 Bae as modified by Armbruster teaches all of the basic features of the claimed invention. Bae as modified by Armbruster does not explicitly disclose analyzing sensor information received from the one or more sensors includes using an algorithm to evaluate patient condition and implant condition from the sensor information. Wiedenhoefer et al discloses an orthopedic implant monitoring system that discloses analyzing sensor information 704 received from the one or more sensors 102 includes using an algorithm to evaluate patient condition and implant condition from the sensor information 704 [0082].
It would have been obvious to a person having ordinary skill in the art of orthopedic implant monitoring before the effective filing date of the claimed invention to modify the implant monitoring devices taught by Bae and Armbruster to further include analyzing sensor information received from the one or more sensors includes using an algorithm to evaluate patient condition and implant condition from the sensor information as taught by Wiedenhoefer et al for the purpose of optimally analyzing sensor information derived from a joint monitoring implant.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 12097044 B2 Devices, systems and methods for monitoring knee replacements
US 9259179 B2 Prosthetic knee joint measurement system including energy harvesting and method therefor
US 20060142670 A1 System and method for determining patient follow-up subsequent to an orthopaedic procedure
US 20050010299 A1 Joint endoprosthesis system for therapeutic treatment, has sensor and electronic components affixed to prosthetic components to maintain record about number of times patient moves joint in particular way e.g. walking
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDRE J ALLEN whose telephone number is (571)272-2174. The examiner can normally be reached Mon-Fri. 9am-5PM.
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, Kristina M Deherrera can be reached at (303) 297-4237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDRE J ALLEN/Primary Examiner, Art Unit 2855
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