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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/29/2026 has been entered.
Response to Arguments
Applicant's arguments filed 01/29/2026 have been fully considered but they are not persuasive. Applicant argues the device of Clasbrummel is a permanent implant and would not be considered to constitute an endoprosthetic spacer. Examiner takes the stance the implant of Clasbrummel could be removed following implant due to any number of reasons (i.e. infection, mechanical failure, dislocation), and therefore it was temporary would be considered relevant.
Applicant’s arguments with respect to Liao in claim(s) 28-45 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 47 objected to because of the following informalities: "a transparent material" in lines 1-2 should real "the transparent material". Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 49 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.
Claim 49 recites the limitation "the filter" in lines 1, 2 and 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 49 recites “a sensor” in lines 1-2. It is unclear if this is separate and additional sensor from the “at least one sensor” or the “optical sensor” in claim 1.
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.
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(s) 28-35, 38-47 and 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clasbrummel (US 2019/0298263 A1) in view of Faccioli (US 2022/0273465)
Regarding claim 28, Clasbrummel teaches an endoprosthetic spacer (100, implant, fig. 1) for administering a therapeutic treatment (¶ [0093]), the endoprosthetic spacer comprising:
a body (101, bone fixation shaft, fig. 1) that is configured to replace at least a part of a bone (fig. 1);
a sensor assembly comprising at least one sensor (104, sensor, fig. 2);
a communication module (107, data transmission unit, fig. 2) configured to transmit a signal (¶ [0120]); and
a controller (106, control unit, fig. 2) configured to read out a sensor signal from the at least one sensor and to transmit an output signal via the communication module (¶ [0050]-[0055]),
wherein the body comprises a transparent material (glass, ¶ [0118]) and the at least one sensor comprises an optical sensor (electronic image sensor, ¶ [0119]).
Clasbrummel fails to teach a sensor embedded in the transparent material. However, Faccioli teaches a spacer that includes a sensor embedded in transparent material (¶ [0090] and ¶ [0115]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Clasbrummel to include the sensor is embed in the transparent material as taught by Faccioli in order for the sensor to be in a portion impermeable to biological fluids of a patient (Faccioli, ¶ [0090]).
Regarding claim 29, Clasbrummel further discloses the optical sensor comprises a camera (¶ [0043] and [0120]).
Regarding claim 30, Clasbrummel further discloses the optical sensor is configured to perform a spectroscopic measurement (abstract, ¶ [0109]).
Regarding claim 31, Clasbrummel further discloses the sensor assembly comprises a light source (105, light source, fig. 2) and the optical sensor is configured to adjust one or both of a wavelength of light emitted by the light source and a wavelength of light detected by the optical sensor to perform the spectroscopic measurement (¶ [0087]). The filtering of the light will adjust the wavelength of the detected by the optical sensor.
Regarding claim 32, Clasbrummel further discloses the sensor assembly comprises one or both of an ambient sensor that is configured to determine an ambient parameter and a biomarker sensor that is configured to detect a biomarker (¶ [0004]).
Regarding claim 33, Clasbrummel further discloses the body is configured to replace at least a part of a joint (¶ [0094]-[0096]).
Regarding claim 34, Clasbrummel further discloses the endoprosthetic spacer is configured to release one or both of a diagnostic substance and a pharmaceutical substance (¶ [0092]-[0093]).
Regarding claim 35, Clasbrummel further discloses a dispenser having a reservoir (depot) configured to store one or both of the diagnostic substance and the pharmaceutical substance (¶ [0092]), wherein the dispenser is configured to release one or both of a predetermined amount of the diagnostic substance and a predetermined amount of the pharmaceutical substance from the reservoir (¶ [0093]). Since the dispenser can only releases the amount of drug in the reservoir it is a predetermined amount.
Regarding claim 38, Clasbrummel further discloses a light source (105, light sources, fig. 2) configured to emit light, wherein the light source is configured to emit light in two different wavelength ranges (¶ [0008]).
Regarding claim 39, Clasbrummel further discloses the controller is configured to control administering of the therapeutic treatment based on one or both of the sensor signal and a command signal, wherein the communication module is configured to receive the command signa (¶ [0093]). The controller sends a signal for the drug to be released from the depot. The controller will decide to administer the drug when inflammation is detected by the light sensor.
Regarding claim 40, Clasbrummel discloses a non-transitory computer-readable medium (receiving chip, ¶ [0019]) storing instructions that, when executed by a processor (computer, ¶ [0019]), cause the processor to:
read out a sensor signal from a sensor (104, sensor, fig. 2) in an endoprosthetic spacer (100, implant, fig. 1) comprising a body (101, bone fixation shaft, fig. 1) that is configured to replace at least a part of a bone (fig. 1), wherein the body comprises a transparent material (glass, ¶ [0118]);
generate an output signal for transmission via a communication module (¶ [0052]) of the endoprosthetic spacer, wherein the output signal is based on the sensor signal (¶ [0052], data); and
determine a control signal for controlling administering of a therapeutic treatment (¶ [0093]) by the endoprosthetic spacer.
Clasbrummel fails to teach a sensor embedded in the transparent material. However, Faccioli teaches a spacer that includes a sensor embedded in transparent material (¶ [0090] and ¶ [0115]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Clasbrummel to include the sensor is embed in the transparent material as taught by Faccioli in order for the sensor to be in a portion impermeable to biological fluids of a patient (Faccioli, ¶ [0090]).
Regarding claim 41, Clasbrummel further discloses the control signal comprises one or more of an amount of a diagnostic substance to be released from the endoprosthetic spacer, an amount of a pharmaceutical substance to be re-leased from the endoprosthetic spacer and an amount of light to be emitted from the endoprosthetic spacer (¶ [0093]).
Regarding claim 42, Clasbrummel discloses a method of manufacturing an endoprosthetic spacer (100, implant, fig. 1) for administering a therapeutic treatment (¶ [0093]), the method comprising:
providing at least one sensor (104, sensor, fig. 2);
providing a controller (106, control unit, fig. 2) that is configured to read out a sensor signal from the at least one sensor and to transmit an output signal via a communication module ([00050]-[0055]); and
forming a body (101, bone fixation shaft, fig. 1) of the endoprosthetic spacer comprising the at least one sensor (figs, 1-2) and the controller (figs. 1-2), wherein the body is configured to replace at least a part of a bone (fig. 1) and to administer the therapeutic treatment (¶ [0093]), wherein:
providing the at least one sensor comprises providing an optical sensor (electronic image sensor, ¶ [0119]);
the body comprises a transparent material (glass, ¶ [0118]).
Clasbrummel fails to teach a sensor embedded in the transparent material. However, Faccioli teaches a spacer that includes a sensor embedded in transparent material (¶ [0090] and ¶ [0115]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Clasbrummel to include the sensor is embed in the transparent material as taught by Faccioli in order for the sensor to be in a portion impermeable to biological fluids of a patient (Faccioli, ¶ [0090]).
Regarding claim 43, Clasbrummel further discloses providing one or both of an optical sensor comprising a camera (¶ [0043] and [0120]) and an optical sensor configured to perform a spectroscopic measurement (abstract, ¶ [0109]).
Regarding claim 44, Clasbrummel further discloses providing one or both of a diagnostic substance and a pharmaceutical substance in the body (¶ [0092]-[0093]).
Regarding claim 45, Clasbrummel further discloses providing one or both of the diagnostic substance and the pharmaceutical substance comprises providing a dispenser with a reservoir (depot) storing one or both of the diagnostic substance and the pharmaceutical substance (¶ [0092]), wherein the dispenser is configured to release one or both of a predetermined amount of the diagnostic substance and a predetermined amount of the pharmaceutical sub- stance from the reservoir (¶ [0093]). Since the dispenser can only releases the amount of drug in the reservoir it is a predetermined amount.
Regarding claim 46, Clasbrummel fails to teach the transparent material is polymethylmethacrylate. However, Faccioli further teaches said transparent material comprises polymethylmethacrylate (¶ [0090]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Clasbrummel to include the transparent material is polymethylmethacrylate as taught by Faccioli in order for the sensor to be in a portion impermeable to biological fluids of a patient (Faccioli, ¶ [0090]).
Regarding claim 46, Clasbrummel fails to teach the entire body comprises a transparent material. However, Faccioli further teaches the entire body comprises a transparent material (¶ [0090]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Clasbrummel to include the entire body comprises a transparent material as taught by Faccioli in order for the sensor to be in a portion impermeable to biological fluids of a patient (Faccioli, ¶ [0090]).
Regarding claim 49, Clasbrummel further teaches the filter is arranged adjacent to a sensor (104, image sensor, fig. 5), wherein the sensor is configured to detect objects or substances absorbed by the filter upon the extracted fluid passing through the filter (functional language). The phrase “the sensor is configured to detect objects or substances absorbed by the filter upon the extracted fluid passing through the filter” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the camera of the optic sensor is considered to be capable of detecting objects or substances absorbed by the filter upon the extracted fluid passing through the filter.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clasbrummel in view of Faccioli as applied to claim 28 above, and further in view of Southworth (US 2004/0111162 A1).
Regarding claim 36, Clasbrummel in view of Faccioli fails to teach a microfluidic circulation system. However, Southworth discloses a prosthetic orthopedic head for a joint replacement that includes a microfluidic circulation system (¶ [0003]) that is configured to extract a fluid from an environment of the endoprosthetic spacer (36, inlet valve, fig. 1) and to subsequently re- lease the extracted fluid to the environment of the endoprosthetic spacer (56, outlet valve, fig. 2). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the endoprosthetic spacer of Clasbrummel and Faccioli to include a microfluidic circulation system as taught by Southworth in order to remove debris from the synovial fluid (¶ [0003], Southworth).
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clasbrummel in view of Faccioli as applied to claim 28 above, and further in view of Hamblin (Can osteoarthritis be treated with light?).
Regarding claim 37, Clasbrummel further discloses a light source (105, light source, fig. 2) configured to emit light (¶ [0008]).
Clasbrummel in view of Faccioli fails to teach the therapeutic treatment comprises applying light using the light source. However, Hamblin teaches it is known in the art that low-level laser light therapy (LLLT) reduces inflammatory cell infiltration and inflammatory cytokines. Using a laser light that emits an 810nm LLLT would act as a therapeutic treatment (abstract, Hamblin). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the endoprosthetic spacer of Clasbrummel and Faccioli to emit a low level laser light with 810 nm wavelength as a therapeutic treatment as taught by Hamblin in order to produce reductions in inflammatory cell infiltration and inflammatory cytokines (abstract, Hamblin).
Claim(s) 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clasbrummel in view of Faccioli and Southworth as applied to claim 36 above, and further in view of Barr (US 2010/0305493 A1).
Regarding claim 48, Clasbrummel in view of Faccioli fail to teach a microfluidic circulation system configured to pump the extracted fluid through a filter. However, Southworth further teaches the microfluidic circulation system is configured to pump the extracted fluid through a filter (¶ [0022], 48, fluid filter, fig. 2). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the endoprosthetic spacer of Clasbrummel and Faccioli to include a microfluidic circulation system configured to pump the extracted fluid through a filter as taught by Southworth in order to remove debris from the synovial fluid (¶ [0003], Southworth).
Clasbrummel in view of Faccioli and Southworth fail to teach the filter is coated with an antibiotic. However, Barr teaches a device for controlling the flow of fluid from a human body that includes coating the filter with an antibiotic (¶ [0035]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the filter of Clasbrummel, Faccioli and Southworth to include being coated with an antibiotic as taught by Barr in order to prevent the growth of an undesirable bacterial deposit (Barr, ¶ [0035]). Examiner notes the filter is not positively claimed. The filter is recited under a functional recitation which is a statement of intended use. For the antibiotic to have patentable weight the filter must be positively recited.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
Prosecution Insights