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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on applications
filed in GB on 07/31/2020 and 12/21/2020. It is noted, however, that applicant has not filed a
certified copy of GB2011995.4 and GB2020209.9, respectively, as required by 37 CFR 1.55.
Response to Amendment
The amendment filed on June 15, 2026 was considered by the examiner. Claims 29-56 are pending in the application.
Claim Interpretation
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: a power supply arrangement and at least one alerting device in claim 29.
Prong 1: “arrangement” and “device” are generic placeholders. See MPEP 2181 §I, subsection A, ¶1.
Prong 2: the transition word “to” is used, followed by functional language:
“a power supply arrangement configured to provide power to the deformation sensing arrangement”; and
“at least one alerting device configured to provide an audible and/or visual alert to a user”.
Prong 3: there is not sufficient structure to modify the generic placeholders “arrangement” and “device”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The examiner interprets the capacitor (specification pg. 6, ¶2-3 and pg. 17, ¶2), battery (specification pg. 10, ¶2 and pg. 21, ¶5), and external power (specification pg. 24, ¶4 – pg. 26, ¶2) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the power supply arrangement.
The examiner interprets the user device (specification pg. 20, last paragraph – pg. 21, ¶2; Fig. 2b); and mobile device, smartphone, tablet, computer, and smartwatch (specification pg. 6, ¶4) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the at least one alerting device.
If applicant does not intend 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 29, 42, 48, and 51 are objected to because of the following informalities:
in claim 29, line 28: “indicative of deformation” should be inserted after “measurement”;
in claim 29, line 35: “indicative of deformation” should be inserted after “measurement”;
in claim 29, line 43: a comma should be inserted after “pose”;
in claim 42, line 18: “indicative of deformation” should be inserted after “measurement”;
in claim 48, line 1: “indicative of deformation” should be inserted after “measurement”;
in claim 48, line 2: “the plurality of” should be inserted before “measurements”; and
in claim 51, line 2: “indicative of deformation” should be inserted after “measurement”.
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 29-56 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.
Claim 29 recites “wherein obtaining the measurement comprises selecting, from the plurality of Bragg gratings, one or more Bragg gratings located closest to the injury location” in lines 35-36. A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. See MPEP § 2173.03. For the same reasons, the features claimed are new matter. In this case, the specification details that “The selection may be programmed e.g. around the time of implantation based on visualisation of where the fracture or injury is in relation to the sensor or the processor may determine or learn the sensor or combination of sensors giving the best signal, for example in a training or initial stage then use this combination for future measurements for consistency” (see specification pg. 3 ln. 18-28). The claim however, requires the selection to happen at the time of measurement (i.e., after implantation over a period of 12 weeks). As such, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
Claims 30-53 are rejected by virtue of their dependence from claim 29.
Claim 48 recites “applying a weighting function to measurements from a plurality of Bragg gratings so as to determine measurements from one or more Bragg gratings located closest to the injury location” in lines 2-3. A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. See MPEP § 2173.03. For the same reasons, the features claimed are new matter. In this case, the specification details that “the processor may apply a weighting function to signals from multiple sensors to emphasise signals from the sensor closes to the injury or fracture”; however, the selection is based on visualization (see specification pg. 3 ln. 18-28). As such, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
Claim 51 recites “applying a weighting function to measurements from a plurality of Bragg gratings so as to determine measurements from one or more Bragg gratings located closest to the injury location” in lines 2-4. A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. See MPEP § 2173.03. For the same reasons, the features claimed are new matter. In this case, the specification details that “the processor may apply a weighting function to signals from multiple sensors to emphasise signals from the sensor closes to the injury or fracture”; however, the selection is based on visualization (see specification pg. 3 ln. 18-28). As such, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
Claim 54 recites “selecting, from the plurality of Bragg gratings, one or more Bragg gratings located closest to the injury location, resulting in selected one or more Bragg gratings” in lines 8-9. A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. See MPEP § 2173.03. For the same reasons, the features claimed are new matter. In this case, the specification details that “The selection may be programmed e.g. around the time of implantation based on visualisation of where the fracture or injury is in relation to the sensor or the processor may determine or learn the sensor or combination of sensors giving the best signal, for example in a training or initial stage then use this combination for future measurements for consistency” (see specification pg. 3 ln. 18-28). The claim however, requires the selection to happen at the time of measurement (i.e., after taking a predetermined pose). As such, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
Claim 55 is rejected by virtue of its dependence from claim 54.
Claim 55 recites “wherein the selected one or more Bragg gratings are based on the signal responses” in line 5. The specification details that “the processor may determine or learn the sensor or combination of sensors giving the best signal, for example in a training or initial stage then use this combination for future measurements for consistency” (emphasis added) (see specification pg. 3 ln. 18-28). There is no disclosure in the specification for the selected Bragg grating, which from claim 54, lines 8-9 is closest to the injury site, based on signal responses. The specification only discloses the sensor or combination of sensors giving the best signal. As such, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
Claim 56 recites “select, from the plurality of Bragg gratings, one or more Bragg gratings located closest to the injury location, resulting in selected one or more Bragg gratings” in lines 8-9. A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. See MPEP § 2173.03. For the same reasons, the features claimed are new matter. In this case, the specification details that “The selection may be programmed e.g. around the time of implantation based on visualisation of where the fracture or injury is in relation to the sensor or the processor may determine or learn the sensor or combination of sensors giving the best signal, for example in a training or initial stage then use this combination for future measurements for consistency” (see specification pg. 3 ln. 18-28). The claim however, requires the selection to happen at the time of measurement (i.e., after taking a predetermined pose). As such, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
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 26-56 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.
Claim 29 recites “wherein obtaining the measurement comprises selecting, from the plurality of Bragg gratings, one or more Bragg gratings located closest to the injury location” in lines 35-36. A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. See MPEP § 2173.03. In this case, the specification details that “The selection may be programmed e.g. around the time of implantation based on visualisation of where the fracture or injury is in relation to the sensor or the processor may determine or learn the sensor or combination of sensors giving the best signal, for example in a training or initial stage then use this combination for future measurements for consistency” (see specification pg. 3 ln. 18-28). The claim however, requires the selection to happen at the time of measurement (i.e., after implantation over a period of 12 weeks). The inconsistency between what is claimed (i.e., the selection to happen at the time of measurement) and what appears to be required for the selection (i.e., around the time of implantation) renders claim 29 indefinite.
Claims 30-53 are rejected by virtue of their dependence from claim 29.
Claim 42 recites “a predetermined pose” in line 5, but it is not clear if this recitation is the same as, related to, or different from the recitation “a predetermined pose” in claim 1, line 40. The similar phraseology and context of the claim suggest that the recitations are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the predetermined pose”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claims 43-44 are rejected by virtue of their dependence from claim 42.
Claim 48 recites “a plurality of Bragg gratings” in line 2, but it is not clear if this recitation is the same as, related to, or different from the recitation “a plurality of Bragg gratings” in claim 1, line 10. The similar phraseology and context of the claim suggest that the recitations are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the plurality of Bragg gratings”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 48 recites “applying a weighting function to measurements from a plurality of Bragg gratings so as to determine measurements from one or more Bragg gratings located closest to the injury location” in lines 2-3. A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. See MPEP § 2173.03. In this case, the specification details that “the processor may apply a weighting function to signals from multiple sensors to emphasise signals from the sensor closes to the injury or fracture”; however, the selection is based on visualization (see specification pg. 3 ln. 18-28). The inconsistency between what is claimed (i.e., the weighting to determined the Bragg gratings located closest to the injury location) and what appears to be required for the weighted function (i.e., the Bragg gratings weighted after the closeness relationship already determined, such as via visualization) renders claim 48 indefinite.
Claim 49 recites the term “around” in line 2, which is a relative term which renders the claim indefinite. The term “around” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear how much time around the time of implantation the sensor closest may be selected.
Claim 49 recites the limitation “the time of implantation” in line 2. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to “a time of implantation” would overcome this rejection. The claim is being read as such for the purposes of examination.
Claim 50 recites the limitation “the measurement indicative of stress and/or pressure” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Appropriate clarification is required.
Claim 51 recites “a plurality of Bragg gratings” in lines 2-3, but it is not clear if this recitation is the same as, related to, or different from the recitation “a plurality of Bragg gratings” in claim 1, line 10. The similar phraseology and context of the claim suggest that the recitations are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the plurality of Bragg gratings”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 51 recites “applying a weighting function to measurements from a plurality of Bragg gratings so as to determine measurements from one or more Bragg gratings located closest to the injury location” in lines 2-4. A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. See MPEP § 2173.03. In this case, the specification details that “the processor may apply a weighting function to signals from multiple sensors to emphasise signals from the sensor closes to the injury or fracture”; however, the selection is based on visualization (see specification pg. 3 ln. 18-28). The inconsistency between what is claimed (i.e., the weighting to determined the Bragg gratings located closest to the injury location) and what appears to be required for the weighted function (i.e., the Bragg gratings weighted after the closeness relationship already determined, such as via visualization) renders claim 51 indefinite.
Claim 52 recites the term “around” in line 3, which is a relative term which renders the claim indefinite. The term “around” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear how much time around the time of implantation the sensor closest may be selected.
Claim 52 recites the limitation “the time of implantation” in line 3. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to “a time of implantation” would overcome this rejection. The claim is being read as such for the purposes of examination.
Claim 53 recites the limitation “the measurement indicative of stress and/or pressure” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Appropriate clarification is required.
Claim 54 recites “selecting, from the plurality of Bragg gratings, one or more Bragg gratings located closest to the injury location, resulting in selected one or more Bragg gratings” in lines 8-9. A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. See MPEP § 2173.03. In this case, the specification details that “The selection may be programmed e.g. around the time of implantation based on visualisation of where the fracture or injury is in relation to the sensor or the processor may determine or learn the sensor or combination of sensors giving the best signal, for example in a training or initial stage then use this combination for future measurements for consistency” (see specification pg. 3 ln. 18-28). The claim however, requires the selection to happen at the time of measurement (i.e., after taking a predetermined pose). The inconsistency between what is claimed (i.e., the selection to happen at the time of measurement) and what appears to be required for the selection (i.e., around the time of implantation) renders claim 54 indefinite.
Claim 55 is rejected by virtue of its dependence from claim 54.
Claim 56 recites “select, from the plurality of Bragg gratings, one or more Bragg gratings located closest to the injury location, resulting in selected one or more Bragg gratings” in lines 8-9. A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. See MPEP § 2173.03. In this case, the specification details that “The selection may be programmed e.g. around the time of implantation based on visualisation of where the fracture or injury is in relation to the sensor or the processor may determine or learn the sensor or combination of sensors giving the best signal, for example in a training or initial stage then use this combination for future measurements for consistency” (see specification pg. 3 ln. 18-28). The claim however, requires the selection to happen at the time of measurement (i.e., after taking a predetermined pose). The inconsistency between what is claimed (i.e., the selection to happen at the time of measurement) and what appears to be required for the selection (i.e., around the time of implantation) renders claim 55 indefinite.
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 54-56 are rejected under 35 U.S.C. 101 because the claimed invention is directed towards abstract ideas without significantly more.
Claim 54 interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification, the recitation “selecting, from the plurality of Bragg gratings, one or more Bragg gratings located closest to the injury location, resulting in selected one or more Bragg gratings” (see specification pg. 3 ln. 18-28) is being interpreted as mathematical calculations/evaluations and/or judgements/opinions (i.e., a medical professional determining which sensor is closest). The recitation “deriving a measurement indicative of strain from the selected one or more Bragg gratings” (see specification pg. 22 ln. 5-18) as mathematical calculations/evaluations and/or judgements/observations (i.e., a medical professional deriving strain measurements from the one or more Bragg gratings). The claim is implemented by a generic computer as indicated in the specification (see generally pg. 4-8 for the use of the processor).
Claim 56 interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification, the recitation “select, from the plurality of Bragg gratings, one or more Bragg gratings located closest to the injury location, resulting in selected one or more Bragg gratings” (see specification pg. 3 ln. 18-28) is being interpreted as mathematical calculations/evaluations and/or judgements/opinions (i.e., medical professional determining which sensor is closest). The recitation “derive a measurement indicative of strain from the selected one or more Bragg gratings” (see specification pg. 22 ln. 5-18) as mathematical calculations/evaluations and/or judgements/observations (i.e., a medical professional deriving strain measurements from the one or more Bragg gratings). The claim is implemented by a generic computer in the claim, line 6, and in the specification (see generally pg. 4-8 for the use of the processor).
Step 1: This part of eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. Claim 54 recites a method, which is directed towards a process (a statutory category of invention). Claim 56 recited a system, which is directed towards a machine/manufacture (a statutory category of invention). Step 1: YES.
Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(a)(2)(III). The courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper” to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). The “mental processes” abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgements, and opinions. As discussed in the claim interpretation section, the limitations include, under the BRI, mathematical calculations/evaluations and judgements/observations/opinions of the data. Accordingly, the limitations as seen in claims 54 and 56 recite judicial exceptions (abstract ideas that fall within the mental process grouping). No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
Furthermore, as explained in MPEP 2106.04(a)(2)(I). The courts consider mathematical calculations, when the claim is given its BRI in light of the specification, as falling within the “mathematical concept” grouping of abstract ideas. A claim does not have to recite “calculating” in order to be considered a mathematical calculation. For example, a step of “determining” a variable or number using a mathematical method, or “performing” a mathematical operation, may also be considered a mathematical calculation when the BRI of the claim in light of the specification encompasses a mathematical calculation. As discussed in the claim interpretation section, the limitations include, under the BRI, mathematical calculations/evaluations. Accordingly, the limitations as seen in claims 54 and 56 recite judicial exceptions (abstract ideas that fall within the mathematical calculations grouping of mathematical concepts).
Alternatively or additionally, these steps describe the concept of using implicit mathematical formulas (i.e., calculations to determine a likelihood score) to derive a conclusion based on input of data, which corresponds to concepts identified as abstract ideas by the courts (Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)). The concept of the recited limitations identified as mathematical concepts above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas.
In particular, claim 54 recites the following elements, which are part of the abstract idea (i.e., the algorithm):
a method for monitoring strain on an internal bone of a patient having an injury at an injury location, the method comprising:
alerting a user to indicate that the patient should adopt a predetermined pose;
once the patient has adopted the predetermined pose, wirelessly transmitting a trigger signal to the implantable sensing device;
powering the optical fiber in response to the trigger signal;
selecting, from the plurality of Bragg gratings, one or more Bragg gratings located closest to the injury location, resulting in selected one or more Bragg gratings;
deriving a measurement indicative of strain from the selected one or more Bragg gratings; and
wirelessly transmitting measurement data based on the measurement indicative of the strain to a remote server.
Furthermore claim 56 recites the following elements, which are part of the abstract idea (i.e., the algorithm):
monitoring strain on an internal bone of a patient having an injury at an injury location, the system comprising:
select, from the plurality of Bragg gratings, one or more Bragg gratings located closest to the injury location, resulting in selected one or more Bragg gratings;
derive a measurement indicative of strain from the selected one or more Bragg gratings; and once the patient has adopted a predetermined pose, wirelessly transmit measurement data based on the measurement to a remote device via the wireless transceiver.
Step 2A Prong One: YES.
Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the judicial exceptions into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exceptions, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exceptions into a practical application. Claims 54 and 56 recite elements directed towards a generic computer (i.e., the processor and wireless transmission, etc.). Note that claims 54 and 56 do not positively recite the remote server/device; rather, the generic computer merely obtains/receives the data. This is insignificant extra-solution activity (i.e., pre-solution activity) well known in the art, and recited at a high level of generality, see MPEP 2106.05(g). Therefore, the method/devices are merely instructions to implement an abstract idea on a generic computer or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
The claims also recite an optical fiber having a plurality of Bragg gratings. The optical fiber having a plurality of Bragg gratings does not integrate the abstract ideas into a practical application because this is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g) using generic components.
Step 2A Prong Two: NO.
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with Step 2A Prong Two, claims 54 and 56 recite elements directed towards a generic computer (i.e., the processor and wireless transmission, etc.). The method/device utilizing a generic computer do not qualify as significantly more because these limitations are 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’l, 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 Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
The claims also recite an optical fiber having a plurality of Bragg gratings. The optical fiber having a plurality of Bragg gratings does not qualify as significantly more because this is simply appending well- understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exceptions. For example, Ding et al. (US Patent Application Publication 2020/0188036) teaches a fiber optic tracking sensor for surgical procedures (see abstract and ¶[0002]-[0003]; Figs. 1-2), and that optical fibers typically used in these systems include a number of sensing sections along their length known as fiber Bragg gratings (see ¶[0004]). Therefore, the optical fiber having a plurality of Bragg gratings cannot be seen as significantly more.
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 includes 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. Step 2B: NO.
Claims 54 and 56 are not eligible.
Claim 55 depends from claim 54, and merely further defines the abstract ideas of claim 54. The claim recites no additional element that integrates the judicial exceptions into a practical application. The claim recites no additional element that adds an inventive concept to the claim and/or amounts to significantly more than the recited exception. The method utilizing a generic computer does not qualify as significantly more because these limitations are 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’l, 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 Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken 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 includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome.
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.
The succeeding art rejections to the claims under 35 U.S.C. § 103 below are made with the claims as best understood and interpreted in light of the preceding rejections under 35 U.S.C. § 112 above.
Claims 54 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Mikhail et al. (US Patent Application Publication 2022/0022807 – cited in prior action), hereinafter Mikhail, in view of Buescher et al. (US Patent Application Publication 2016/0374561 – cited in prior action), hereinafter Buescher.
Regarding Claim 54, Mikhail teaches a system for monitoring an internally fixated bone fracture through the use of strain sensors (see abstract; Fig. 2). Mikhail teaches a method for monitoring strain on an internal bone of a patient having an injury at an injury location using an implantable sensing device comprising sensors (see abstract, ¶[0027]-[0028] the monitoring of a bone fracture utilizing strain gauges; Fig. 2), the method comprising:
alerting a user to indicate that the patient should adopt a predetermined pose (¶[0038] the display 88 of the user device for providing visual cues to the patient; Fig. 5);
once the patient has adopted the predetermined pose, wirelessly transmitting a trigger signal to the implantable sensing device (¶[0032]-[0040] the wireless reader 42 interacts with the implanted sensor, the wireless reader 42 may send a signal to start the measurement via a portable computing device 72, the portable computing device 72 may receive data from the implanted sensor, ¶[0039]-[0040] the portable computing device 72 receives the indication 114 to start measurement, the processor 80 may instruct user on how to position their body for measurement, the position may be confirmed via actuation of a button by the user and/or automatically through orientation data acquired from an accelerometer or an inertial measurement unit; Figs. 3-6);
powering the implantable sensing device in response to the trigger signal (see ¶[0040]-[0041] once the indication is received, the antenna is energized, once the user’s position is verified, the measurement data is received);
deriving a measurement indicative of strain from the sensors (¶[0026]-[0028] the primary load sensor 52 senses the load carried by the plate 12 at the fracture 50, and the at least one reference load sensor 54 senses load carried by the plate 12 at location(s) spaced from the fracture 50, the load sensors 52/54 may include a strain gauge 60, that has an electrical property that varies in an established manner with an amount of strain experienced by the gauge/plate at that location; Fig. 2); and
wirelessly transmitting measurement data based on the measurement indicative of the strain to a remote server (¶[0022]-[0023] the data server receives patient data 24 through the use of the user device 72, data is sent over the internet through local or wide area networks, ¶[0034] communications may utilize Wi-Fi).
Mikhail is silent regarding that the implantable sensing device comprising an optical fiber having a plurality of Bragg gratings, selecting, from the plurality of Bragg gratings, one or more Bragg gratings located closest to the injury location, resulting in selected one or more Bragg gratings; deriving a measurement indicative of strain from the selected one or more Bragg gratings.
Buescher teaches a bone healing monitoring system with an implantable and biocompatible optical fiber (see abstract and ¶[0006]-[0007] and ¶[0067]-[0069]; Figs. 1 and 6A); the optical fiber itself may be implanted (see ¶[0047] the sleeve may be attached to bone, the optical fiber inside the sleeve, ¶[0048] the optical fiber itself may be attached to bone; Figs. 3A, 4A, and 5A); and that the optical fiber may be attached to a bone plate via adhesive (see ¶[0061]-[0062]). Buescher teaches a single multimodal optical fiber having a plurality of Bragg gratings spaced along a length of the multimodal optical fiber (¶[0035]-[0036] the optical fiber 20 includes Bragg mirror sensors 26 along the length of the optical fiber; Fig. 1),
the plurality of Bragg gratings being configured to sense strain (¶[0008], ¶[0018], ¶[0036], and ¶[0041] the Bragg mirror sensors are capable of measuring strain; Fig. 6A),
each Bragg grating of the plurality of Bragg gratings being configured to reflect light with a different range of wavelengths (¶[0008] and ¶[0035]-[0036] each Bragg mirror sensor may be tuned to a different bandwidth of light, so that the multiplex signal from the plurality of sensors may be demuxed by a processor),
the single multimodal optical fiber having at least one further Bragg grating configured to sense temperature (¶[0008], ¶[0018], ¶[0036], and ¶[0041] the Bragg mirror sensors are capable of measuring temperature, an embodiment with a plurality of strain Bragg mirror sensors and one temperature Bragg mirror sensor is possible).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the optical fiber strain and temperature sensors of Buescher as the strain sensors of Mikhail because (1) it is the simple substitution of one known element for another to obtain predictable results and/or (2) the sensing arrangement of strain and temperature measurements of Buescher helps to monitor for complications as a wound heals (see Buescher ¶[0002]-[0007]). Here, the modified Mikhail teaches that the Bragg gratings would occupy the locations of the load sensor 52 sense at the plate 12 at the fracture 50, and the at least one reference load sensor 54 at location(s) at the plate 12 spaced from the fracture 50.
The modified Mikhail further teaches that obtaining the measurement comprises selecting, from the plurality of Bragg gratings, one or more Bragg gratings located closest to the injury location (see Mikhail ¶[0004]-[0005] the implant is placed at the location by the medical professional, Fig. 1; see Buescher abstract, ¶[0006], ¶[0035]-[0036], and ¶[0047]-[0048] the implantable optical fiber with Bragg gratings). Here, the Bragg gratings positioned adjacent to the injury are selected. This is commensurate with the selection of the present application as described in the specification. The specification details that “The selection may be programmed e.g. around the time of implantation based on visualisation of where the fracture or injury is in relation to the sensor” (see specification pg. 3 ln. 18-28). Therefore, the Bragg gratings implanted adjacent injury, which would necessarily include visual confirmation, fall under the BRI of the claimed recitation.
Regarding Claim 56, Mikhail teaches a system for monitoring an internally fixated bone fracture through the use of strain sensors (see abstract; Fig. 2). Mikhail teaches a system for monitoring strain on an internal bone of a patient having an injury at an injury location (see abstract, ¶[0027]-[0028] the monitoring of a bone fracture utilizing strain gauges; Fig. 2), the system comprising:
an implantable sensing device (¶[0022] and [0025]-[0026] the bone plate 12, ¶[0026]-[0028] the primary load sensor 52 senses the load carried by the plate 12 at the fracture 50, and the at least one reference load sensor 54 senses load carried by the plate 12 at location(s) spaced from the fracture 50, the load sensors 52/54 may include a strain gauge 60, that has an electrical property that varies in an established manner with an amount of strain experienced by the gauge/plate at that location; Fig. 2) comprising:
sensors configured to sense strain (¶[0026] the primary load sensor 52 senses the load carried by the plate 12 at the fracture 50, and the at least one reference load sensor 54 senses load carried by the plate 12 at location(s) spaced from the fracture 50, ¶[0028]-[0029] the communication circuitry 62 may receive and store measurements from the sensor; Fig. 2); and
a wireless transceiver (¶[0028] the antenna 64, ¶[0031]-[0034] the wireless communication may be implemented through RFID, NFC, or BLE; Fig. 2); and
a processor (¶[0028]-[0029] the communication circuitry 62; Fig. 2) configured to:
power the implantable sensing device in response to a trigger signal (see ¶[0040]-[0041] once the indication is received, the antenna is energized, once the user’s position is verified, the measurement data is received);
derive a measurement indicative of strain from the sensors (¶[0026]-[0028] the primary load sensor 52 senses the load carried by the plate 12 at the fracture 50, and the at least one reference load sensor 54 senses load carried by the plate 12 at location(s) spaced from the fracture 50, the load sensors 52/54 may include a strain gauge 60, that has an electrical property that varies in an established manner with an amount of strain experienced by the gauge/plate at that location; Fig. 2); and
once the patient has adopted a predetermined pose (¶[0032]-[0040] the wireless reader 42 interacts with the implanted sensor, the wireless reader 42 may send a signal to start the measurement via a portable computing device 72, the portable computing device 72 may receive data from the implanted sensor, ¶[0038] the display 88 of the user device for providing visual cues to the patient, ¶[0039]-[0040] the portable computing device 72 receives the indication 114 to start measurement, the processor 80 may instruct user on how to position their body for measurement, the position may be confirmed via actuation of a button by the user and/or automatically through orientation data acquired from an accelerometer or an inertial measurement unit; Figs. 3-6);
wirelessly transmitting measurement data based on the measurement a remote server via the wireless transceiver (¶[0022]-[0023] the data server receives patient data 24 through the use of the user device 72, data is sent over the internet through local or wide area networks, ¶[0034] communications may utilize Wi-Fi).
Mikhail is silent regarding that the implantable sensing device comprising an optical fiber having a plurality of Bragg gratings, select, from the plurality of Bragg gratings, one or more Bragg gratings located closest to the injury location, resulting in selected one or more Bragg gratings; derive a measurement indicative of strain from the selected one or more Bragg gratings.
Buescher teaches a bone healing monitoring system with an implantable and biocompatible optical fiber (see abstract and ¶[0006]-[0007] and ¶[0067]-[0069]; Figs. 1 and 6A); the optical fiber itself may be implanted (see ¶[0047] the sleeve may be attached to bone, the optical fiber inside the sleeve, ¶[0048] the optical fiber itself may be attached to bone; Figs. 3A, 4A, and 5A); and that the optical fiber may be attached to a bone plate via adhesive (see ¶[0061]-[0062]). Buescher teaches a single multimodal optical fiber having a plurality of Bragg gratings spaced along a length of the multimodal optical fiber (¶[0035]-[0036] the optical fiber 20 includes Bragg mirror sensors 26 along the length of the optical fiber; Fig. 1),
the plurality of Bragg gratings being configured to sense strain (¶[0008], ¶[0018], ¶[0036], and ¶[0041] the Bragg mirror sensors are capable of measuring strain; Fig. 6A),
each Bragg grating of the plurality of Bragg gratings being configured to reflect light with a different range of wavelengths (¶[0008] and ¶[0035]-[0036] each Bragg mirror sensor may be tuned to a different bandwidth of light, so that the multiplex signal from the plurality of sensors may be demuxed by a processor),
the single multimodal optical fiber having at least one further Bragg grating configured to sense temperature (¶[0008], ¶[0018], ¶[0036], and ¶[0041] the Bragg mirror sensors are capable of measuring temperature, an embodiment with a plurality of strain Bragg mirror sensors and one temperature Bragg mirror sensor is possible).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the optical fiber strain and temperature sensors of Buescher as the strain sensors of Mikhail because (1) it is the simple substitution of one known element for another to obtain predictable results and/or (2) the sensing arrangement of strain and temperature measurements of Buescher helps to monitor for complications as a wound heals (see Buescher ¶[0002]-[0007]). Here, the modified Mikhail teaches that the Bragg gratings would occupy the locations of the load sensor 52 sense at the plate 12 at the fracture 50, and the at least one reference load sensor 54 at location(s) at the plate 12 spaced from the fracture 50.
The modified Mikhail further teaches that obtaining the measurement comprises selecting, from the plurality of Bragg gratings, one or more Bragg gratings located closest to the injury location (see Mikhail ¶[0004]-[0005] the implant is placed at the location by the medical professional, Fig. 1; see Buescher abstract, ¶[0006], ¶[0035]-[0036], and ¶[0047]-[0048] the implantable optical fiber with Bragg gratings). Here, the Bragg gratings positioned adjacent to the injury are selected. This is commensurate with the selection of the present application as described in the specification. The specification details that “The selection may be programmed e.g. around the time of implantation based on visualisation of where the fracture or injury is in relation to the sensor” (see specification pg. 3 ln. 18-28). Therefore, the Bragg gratings implanted adjacent injury, which would necessarily include visual confirmation, fall under the BRI of the claimed recitation.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Mikhail in view of Buescher as applied to claim 54 above, and further in view of NYCZ (US Patent Application Publication 2009/0187120), hereinafter NYCZ.
Regarding Claim 55, Mikhail in view of Buescher teach the method of claim 54 as stated above. The modified Mikhail further teaches after implanting the implantable sensing device, determining signal responses indicative of strain at the injury location of the plurality of Bragg gratings (see Mikhail ¶[0005]-[0007] and ¶[0026], the reference load/strain sensor 54 vs the primary load/strain sensor 52, the primary sensor 41 corresponds to the injury, and the reference is spaced apart from the injury, the load sensors 52/54 may include a strain gauge 60, that has an electrical property that varies in an established manner with an amount of strain experienced by the gauge/plate at that location, Fig. 2; see Buescher ¶[0008], ¶[0018], ¶[0036], and ¶[0041], the Bragg mirror sensors are capable of measuring strain, ¶[0036] the multiplex signal sent back from multiple sensors may be demuxed by a processor, Fig. 6A).
The modified Mikhail does not specifically teach that the selected one or more Bragg gratings are based on the signal responses.
NYCZ teaches implantable sensors and methods for detecting changes in soft tissues (see abstract and Figs. 1-3), for attachment and sensing in bone (see ¶[0008]-[0011] and ¶[0021]; Fig. 1), in which the sensors may be utilized to tell location of the sensors and changes in the tissue (see ¶[0027]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the location determination of NYCZ with the modified Mikhail because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results and/or (2) the modified Mikhail requires a sensor location determination modality and NYCZ teaches one such sensor location determination modality.
Claims 29-30, 32-37, 39-40, 42-44, 46-47, 49-50, and 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over Mikhail, in view of Buescher, and further in view of Windolf (US Patent Application Publication 2022/0395223 – cited in prior action).
Regarding Claim 29, Mikhail teaches a system for monitoring an internally fixated bone fracture through the use of strain sensors (see abstract; Fig. 2). Mikhail teaches a system for monitoring strain on a musculoskeletal element of a patient having an injury at an injury location (see abstract, ¶[0027]-[0028] the monitoring of a bone fracture utilizing strain gauges; Fig. 2),
arranged to perform monitoring at least once a week, over a period of at least 12 weeks, or at least 12 times (¶[0055] the measurements may occur more than once a week), the system comprising:
an implantable load-bearing fixation and sensing device comprising: an elongate implantable reinforcement structure (¶[0022] and [0025]-[0026] the bone plate 12; Fig. 2);
a deformation sensing arrangement physically coupled to the reinforcement structure to be at least partially implanted in the patient, the deformation sensing arrangement configured to sense strain along the elongate implantable reinforcement structure (¶[0026]-[0028] the primary load sensor 52 senses the load carried by the plate 12 at the fracture 50, and the at least one reference load sensor 54 senses load carried by the plate 12 at location(s) spaced from the fracture 50, the load sensors 52/54 may include a strain gauge 60, that has an electrical property that varies in an established manner with an amount of strain experienced by the gauge/plate at that location; Fig. 2);
a power supply arrangement configured to provide power to the deformation sensing arrangement (¶[0030] the power device 66; Fig. 2);
a short-range wireless transceiver configured to communicate digital data using a first protocol (¶[0028] the antenna 64, ¶[0031]-[0034] the wireless communication may be implemented through RFID, NFC, or BLE; Fig. 2); and
a processor configured to control the power supply arrangement to power the deformation sensing arrangement (¶[0028]-[0029] the communication circuitry 62; Fig. 2),
to obtain a plurality of measurements from the plurality of sensors to derive from the plurality of measurements a measurement indicative of deformation associated with stress or movement in the vicinity of the injury location (¶[0026] the primary load sensor 52 senses the load carried by the plate 12 at the fracture 50, and the at least one reference load sensor 54 senses load carried by the plate 12 at location(s) spaced from the fracture 50, ¶[0028]-[0029] the communication circuitry 62 may receive and store measurements from the sensor; Fig. 2),
to communicate via the short-range wireless transceiver to an external user device, to receive a first signal to trigger the processor to control the power supply arrangement to power the deformation sensing arrangement and to transmit a second signal based on said measurement to the external user device (¶[0032]-[0040] the wireless reader 42 interacts with the implanted sensor, the wireless reader 42 may send a signal to start the measurement via a portable computing device 72, the portable computing device 72 may receive data from the implanted sensor; Figs. 3-6);
the external user device (the reading device 42 and the portable computing device 72; Fig. 3) comprising:
a first communication interface configured when positioned externally of the patient to send the first signal to trigger the processor to power the deformation sensing arrangement and obtain the measurement indicative of deformation in the vicinity of the injury location, and to receive the second signal using the first protocol (see ¶[0032]-[0040] the wireless reader 42 interacts with the implanted sensor, may send a signal to start the measurement via user device 72, the portable computing device 72 may receive data from the implanted sensor, ¶[0031]-[0034] the wireless communication may be implemented through RFID, NFC, or BLE; Figs. 3-6);
a second communication interface configured to communicate measurement data based on the second signal to a remote server (¶[0022]-[0023] the data server receives patient data 24 through the use of the user device 72, data is sent over the internet through local or wide area networks, ¶[0034] communications may utilize Wi-Fi); and
at least one alerting device configured to provide an audible and/or visual alert to a user to indicate that the patient should adopt a predetermined pose (¶[0038] the display 88 of the user device for providing visual cues to the patient; Fig. 5);
wherein the external user device is configured to determine whether the patient has adopted the predetermined pose using one or more sensors and/or one or more indications from the user that the patient has adopted the predetermined pose (¶[0039]-[0040] the portable computing device 72 receives the indication 114 to start measurement, the processor 80 may instruct user on how to position their body for measurement, the position may be confirmed via actuation of a button by the user and/or automatically through orientation data acquired from an accelerometer or an inertial measurement unit; Fig. 5) and
wherein the first communication interface is configured to send the first signal to trigger the processor to control the power supply arrangement to power the deformation sensing arrangement once the patient has adopted the predetermined pose (see ¶[0040]-[0041] once the indication is received, the antenna is energized, once the user’s position is verified, the measurement data is received).
Mikhail is silent regarding the deformation sensing arrangement comprises a single multimodal optical fiber having a plurality of Bragg gratings configured to sense strain, each of the Bragg gratings fixed to the reinforcement structure at a respective location spaced along a length of the multimodal optical fiber and configured to reflect light with a different range of wavelengths, each respective location being indicated by a particular range of wavelengths being reflected by a particular Bragg grating located at that respective location, the single multimodal optical fiber having at least one further Bragg grating configured to sense temperature.
Buescher teaches a bone healing monitoring system with an implantable and biocompatible optical fiber (see abstract and ¶[0006]-[0007] and ¶[0067]-[0069]; Figs. 1 and 6A); the optical fiber itself may be implanted (see ¶[0047] the sleeve may be attached to bone, the optical fiber inside the sleeve, ¶[0048] the optical fiber itself may be attached to bone; Figs. 3A, 4A, and 5A); and that the optical fiber may be attached to a bone plate via adhesive (see ¶[0061]-[0062]). Buescher teaches a single multimodal optical fiber having a plurality of Bragg gratings spaced along a length of the multimodal optical fiber (¶[0035]-[0036] the optical fiber 20 includes Bragg mirror sensors 26 along the length of the optical fiber; Fig. 1),
the plurality of Bragg gratings being configured to sense strain (¶[0008], ¶[0018], ¶[0036], and ¶[0041] the Bragg mirror sensors are capable of measuring strain; Fig. 6A),
each Bragg grating of the plurality of Bragg gratings being configured to reflect light with a different range of wavelengths (¶[0008] and ¶[0035]-[0036] each Bragg mirror sensor may be tuned to a different bandwidth of light, so that the multiplex signal from the plurality of sensors may be demuxed by a processor),
the single multimodal optical fiber having at least one further Bragg grating configured to sense temperature (¶[0008], ¶[0018], ¶[0036], and ¶[0041] the Bragg mirror sensors are capable of measuring temperature, an embodiment with a plurality of strain Bragg mirror sensors and one temperature Bragg mirror sensor is possible).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the optical fiber strain and temperature sensors of Buescher as the strain sensors of Mikhail because (1) it is the simple substitution of one known element for another to obtain predictable results and/or (2) the sensing arrangement of strain and temperature measurements of Buescher helps to monitor for complications as a wound heals (see Buescher ¶[0002]-[0007]). Here, the modified Mikhail teaches that the Bragg gratings would occupy the locations of the load sensor 52 sense at the plate 12 at the fracture 50, and the at least one reference load sensor 54 at location(s) at the plate 12 spaced from the fracture 50.
The modified Mikhail teaches circuitry on the implant device (see ¶[0028]-[0029]); however, the modified Mikhail does not specifically teach that the sensor is supplied power selectively.
Windolf teaches a device for affixing to an implant with an included strain sensor (see abstract; Fig. 1). Windolf teaches only collecting measurements when movement is detected (see ¶[0041]) or based on a schedule (see ¶[0047]) for the purpose of energy savings. This reads on the broadest reasonable interpretation (BRI) of power supplied selectively (see specification pg. 4, ¶2, the measuring only when required).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the selective power logic of Windolf with the modified Mikhail because (1) it is the application of a known technique with a known device ready for improvement to yield predictable results and/or (2) only measuring when necessary would save energy (see Windolf ¶[0041]).
The modified Mikhail further teaches that obtaining the measurement comprises selecting, from the plurality of Bragg gratings, one or more Bragg gratings located closest to the injury location (see Mikhail ¶[0004]-[0005] the implant is placed at the location by the medical professional, Fig. 1; see Buescher abstract, ¶[0006], ¶[0035]-[0036], and ¶[0047]-[0048] the implantable optical fiber with Bragg gratings). Here, the Bragg gratings positioned adjacent to the injury are selected. This is commensurate with the selection of the present application as described in the specification. The specification details that “The selection may be programmed e.g. around the time of implantation based on visualisation of where the fracture or injury is in relation to the sensor” (see specification pg. 3 ln. 18-28). Therefore, the Bragg gratings implanted adjacent injury, which would necessarily include visual confirmation, fall under the BRI of the claimed recitation.
Regarding Claim 30, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. The modified Mikhail further teaches the processor includes processing logic for selectively determining a representative measure of strain along the elongate implantable reinforcement structure in the vicinity of the injury location (see Mikhail ¶[0005]-[0007] and ¶[0026], the reference load/strain sensor 54 vs the primary load/strain sensor 52, the primary sensor 41 corresponds to the injury, and the reference is spaced apart from the injury, the load sensors 52/54 may include a strain gauge 60, that has an electrical property that varies in an established manner with an amount of strain experienced by the gauge/plate at that location, Fig. 2; see Buescher ¶[0008], ¶[0018], ¶[0036], and ¶[0041], the Bragg mirror sensors are capable of measuring strain, ¶[0036] the multiplex signal sent back from multiple sensors may be demuxed by a processor, Fig. 6A).
Regarding Claim 32, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. Mikhail further teaches the audible and/or visual alert to the user comprises at least one of a textual and/or audio instruction, a graphic, an animation, a light, or a sound (see ¶[0038], the visual cues; Fig. 5).
Regarding Claim 33, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. The modified Mikhail further teaches the musculoskeletal element is a fractured internal bone (see Mikhail abstract and ¶[0004]-[0005] the system is for monitoring a fracture in a bone, it is an implantable fixation device; Fig. 2),
wherein the elongate implantable load-bearing fixation and sensing device is encapsulated in a biocompatible housing or coating (see Mikhail ¶[0031] for the incorporated reference US Patent Application Publication 2019/0038214, ¶[0076] the cover for the sensor is a biocompatible material, there is no modification of Mikhail, as the sensors of Mikhail are designed for in vivo use; see Buescher ¶[0006] the optical fiber is biocompatible, ¶[0047]-[0048] the optical fiber is designed for in vivo use), and
wherein the implantable reinforcement structure is an implantable bone reinforcement structure fully implanted in the patient (see abstract and ¶[0004]-[0005] the system is for monitoring a fracture in a bone, it is an implantable fixation device, Fig. 2; see Buescher abstract, ¶[0006], and ¶[0047]-[0048] the optical fiber is implantable).
Regarding Claim 34, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. Mikhail further teaches the external user device is provided by an application running on a mobile device (see ¶[0033], the portable computing device 72; Fig. 3).
Regarding Claim 35, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. Mikhail further teaches the first communication interface is configured to use a short-range wireless communication protocol (see ¶[0031]-[0034], the wireless communication may be implemented through RFID, NFC, or BLE); and
the second communication interface is configured to use a wireless, wired or mobile, local area or wide area communication protocol (see ¶[0022]-[0023], the data server receives the patient data 24 through the use of the user device 72, which is sent out over the internet through local or wide area network, ¶[0034] wireless communications may include Wi-Fi); and
the remote server is configured to communicate with the external user device using the wireless, wired or mobile, local area or wide area communication protocol (see ¶[0022]-[0023] the data server receives the patient data 24 through the use of the user device 72, which is sent out over the internet through local or wide area network, ¶[0034] wireless communications may include Wi-Fi).
Regarding Claim 36, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. Mikhail further teaches the power supply arrangement is arranged to receive power from an external power source (¶[0030] the energy source may include wireless charging via radio waves, ¶[0033] the power transmission circuitry 78 may include inductive charging, ¶[0040] the antenna 70 is energized via the power transmission circuitry 78, the antenna 70 energizes the sensors 52/54; Fig. 4).
Regarding Claim 37, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. Mikhail further teaches the power supply arrangement comprises a battery (see ¶[0031] for the incorporated reference US Patent Application Publication 2019/0038214, ¶[0038] the sensor may comprise a power device 106, which may be a battery; Figs. 2 and 7).
Regarding Claim 39, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. Mikhail further teaches the remote server is configured to determine a healing condition of the injury based on the measurement data by comparing the measurement data with one or more thresholds and/or one or more reference signals (¶[0049] a trendline 146 of a patient’s healing progress over time may be constructed, ¶[0051] the trajectory range 158 of the patient’s trendline 146 may be constructed based off of qualitative/quantitate data from the patient’s medical record, and empirical data taken from prior patients, determined via the data server 20).
Regarding Claim 40, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. The modified Mikhail further teaches the deformation sensing arrangement is physically coupled to the reinforcement structure using an adhesive (see Buescher ¶[0062] the optical fiber may be attached to a bone plate via adhesive), and wherein the adhesive provides a housing or coating (the adhesive placed on the bone plate would be considered a coating). Here, the context to which the adhesive is used in Buescher suggests that the adhesive itself is biocompatible. Otherwise, it would not have been in use in the in vivo application of Buescher (see ¶[0047] and ¶[0061]-[0062]) and in the manner disclosed in Buescher. Thus, one of ordinary skill in the art would have understood the adhesive of Buescher would have been biocompatible.
Regarding Claim 42, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. The modified Mikhail further teaches a method for monitoring strain on an internal bone of a patient at least once a week, over a period of at least 12 weeks, or at least 12 times (see Mikhail ¶[0055] the measurements can occur more than once a week),
using the system of claim 29 (see Mikhail, Buescher, and Windolf in claim 29 above), the method comprising:
providing on the at least one alerting device the audible and/or visual alert to the user to indicate that the patient should adopt a predetermined pose (see Mikhail ¶[0038], the display 88 of the user device for providing visual cues to the patient; Fig. 5);
determining, by the external user device, whether the patient has adopted the predetermined pose using the one or more sensors and/or one or more indications from the user that the patient has adopted the predetermined pose (see Mikhail ¶[0039]-[0040], the portable computing device 72 receives the indication 114 to start measurement, the processor 80 may instruct user on how to position their body for measurement, the position may be confirmed via actuation of a button by the user and/or automatically through orientation data acquired from an accelerometer or an inertial measurement unit; Fig. 5);
wirelessly transmitting, via the first communication interface of the external user device to the implantable load-bearing fixation and sensing device, the first signal to trigger the processor to control the power supply arrangement to power the deformation sensing arrangement once the patient has adopted the predetermined pose (see Mikhail ¶[0032]-[0040], the wireless reader 42 interacts with the implanted sensor, the wireless reader 42 may send a signal to start the measurement via a portable computing device 72, the portable computing device 72 may receive data from the implanted sensor; Figs. 3-6);
receiving the first signal at the implantable load-bearing fixation and sensing device and, in response, controlling the power supply arrangement to power the deformation sensing arrangement (see Mikhail ¶[0040]-[0041], once the indication is received, the antenna is energized, once the user’s position is verified, the measurement data is received);
deriving, using the deformation sensing arrangement, the measurement indicative of strain of the elongate implantable reinforcement structure (see Mikhail ¶[0005]-[0007] and ¶[0026], the reference load/strain sensor 54 vs the primary load/strain sensor 52, the primary sensor 41 corresponds to the injury, and the reference is spaced apart from the injury, the load sensors 52/54 may include a strain gauge 60, that has an electrical property that varies in an established manner with an amount of strain experienced by the gauge/plate at that location, Fig. 2; see Buescher ¶[0008], ¶[0018], ¶[0036], and ¶[0041], the Bragg mirror sensors are capable of measuring strain, ¶[0036] the multiplex signal sent back from multiple sensors may be demuxed by a processor, Fig. 6A),
wherein deriving the measurement comprises selecting, from the plurality of Bragg gratings, one or more Bragg gratings located closest to the injury location (see Mikhail ¶[0004]-[0005] the implant is placed at the location by the medical professional, the placement would be selection of the closest sensor, Fig. 1; see Buescher abstract, ¶[0006], ¶[0035]-[0036], and ¶[0047]-[0048] the implantable optical fiber with Bragg gratings);
wirelessly transmitting the second signal encoding said derived measurement from the processor to the first communication interface of the external user device (see Mikhail ¶[0032]-[0040], the wireless reader 42 interacts with the implanted sensor, the wireless reader 42 may send a signal to start the measurement via a portable computing device 72, the portable computing device 72 may receive data from the implanted sensor; Figs. 3-6);
communicating the measurement data based on the derived measurement from the second communication interface of the external user device to a-the remote server (see Mikhail ¶[0022]-[0023], the data server receives patient data 24 through the use of the user device 72, data is sent over the internet through local or wide area networks, ¶[0034] the communications can utilize Wi-Fi).
Regarding Claim 43, Mikhail in view of Buescher and Windolf teaches the method of claim 42 as stated above. Mikhail further teaches determining, by the remote server, a healing condition of the injury based on the measurement data (¶[0009]-[0010], the healing trajectory, ¶[0049]-[0053] the healing trajectory 158 may be determined through statistics/machine learning via the data server 20; Fig. 7);
determining a second pose for the patient to adopt (¶[0040] and ¶[0045]-[0047] the second posture may be considered the load-bearing position/posture);
sending instructions on the second pose (¶[0038] the visual cues, the load-bearing measurement 98; Fig. 5); and
updating, by the external user device, the audible and/or visual alert such that it indicates that the patient should adopt the second pose (¶[0038] the visual cues, the load-bearing measurement 98; Fig. 5);
wherein wirelessly transmitting the first signal to trigger the processor to control the power supply arrangement to power the deformation sensing arrangement is performed once the patient has adopted the second pose (¶[0041] the measurements are performed once the confirmation that the user is in position is received, ¶[0047] the measurements are performed once it is determined that enough load is applied to the bone).
The modified Mikhail teaches determining a second pose for the patient to adopt, but not specifically that the remote server performs this determination based on the healing condition, and the remote server subsequently sending instructions based on the determination.
Here, Mikhail teaches updating the healing prediction over time as measurements are recorded, and contemplates utilizing such data for providing guidance on recommended physical therapy treatment (see ¶[0052]). The specification of the present application details that updating the pose can include making sure that enough load is being applied to the sensor in that pose (see specification pg. 13, ¶2-3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine if enough load has been applied during the second, load-bearing posture, utilizing the server implemented machine learning model and healing data because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) determining if enough load is present would indicate that the measurements are accurate/useful in the evaluation of the healing of the injury.
Furthermore, the BRI of the present claim for the recitation of “pose” would include performing a particular exercise or activity, which cycles through multiple poses (see specification pg. 5, ¶4). Mikhail teaches that the server can recommend physical therapy treatment based on the measurements, through the server implemented machine learning model. And, because physical therapy reads upon a particular exercise or activity which cycles through multiple poses, Mikhail therefore teaches determining a second pose based off of the healing data. In this situation, the first pose would be considered the non-load/load bearing poses; and the second pose would be considered the recommended physical therapy treatment.
Regarding Claim 44, Mikhail in view of Buescher and Windolf teaches the method of claim 43 as stated above. Mikhail further teaches determining the healing condition comprises the remote server (see ¶[0051] machine learning model implemented through data server 20):
training a learning engine using a training dataset (see ¶[0051] machine learning model is trained with experiential evidence drawn from prior patients, may be supervised or unsupervised learning);
providing input data including the measurement data to the learning engine (¶[0051]-[0052] the patient’s healing progress, most recent measurement, and qualitative/quantitative data entered into machine learning model); and
receiving as output from the learning engine the healing condition, the output being a classification or a value indicative of treatment progress (¶[0051]-[0052] the healing trajectory 150/158).
Regarding Claim 46, Mikhail in view of Buescher and Windolf teaches the system of claim 39 as stated above. Mikhail further teaches the remote server comprises a learning engine trained using a training dataset (see ¶[0051], machine learning model is trained with experiential evidence drawn from prior patients, may be supervised or unsupervised learning),
the learning engine configured to receive input data including the measurement data (¶[0051]-[0052] the patient’s healing progress, most recent measurement, and qualitative/quantitative data entered into machine learning model), and
to provide as output the healing condition (¶[0051]-[0052] the healing trajectory 150/158).
Regarding Claim 47, Mikhail in view of Buescher and Windolf teaches the modified system of claim 39 as stated above. Mikhail further teaches the remote server is configured to transmit the healing condition to the external user device (¶[0053] healing trajectory 158 may be displayed to patient on display 88, see Fig. 1 the portable device 72 and server 22 can transmit/receive signals to one another), and
wherein the external user device is configured to update the audible and/or visual alert such that it indicates that the patient should adopt a second pose (¶[0040] and [0045]-[0047] the second posture may be considered the load-bearing position/posture, ¶[0038] the visual cues, the load-bearing measurement 98; Fig. 5),
wherein the first communication interface is configured to send the first signal to trigger the processor to control the power supply arrangement to power the deformation sensing arrangement once the patient has adopted the second pose (¶[0041] the measurements are performed once the confirmation that the user is in position is received, ¶[0047] the measurements are performed once it is determined that enough load is applied to the bone).
The modified Mikhail teaches determining a second pose for the patient to adopt, but not specifically that second pose is determined based off of the healing condition.
Here, Mikhail teaches updating the healing prediction over time as measurements are recorded, and contemplates utilizing such data for providing guidance on recommended physical therapy treatment (see ¶[0052]). The specification of the present application details that updating the pose can include making sure that enough load is being applied to the sensor in that pose (see specification pg. 13, ¶2-3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine if enough load has been applied during the second, load-bearing posture, utilizing the healing data because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) determining if enough load is present would indicate that the measurements are accurate/useful in the evaluation of the healing of the injury.
Furthermore, the BRI of the present claim for the recitation of “pose” would include performing a particular exercise or activity, which cycles through multiple poses (see specification pg. 5, ¶4). Mikhail teaches that the server can recommend physical therapy treatment based on the measurements, through the server implemented machine learning model. And, because physical therapy reads upon a particular exercise or activity which cycles through multiple poses, Mikhail therefore teaches determining a second pose based off of the healing data. In this situation, the first pose would be considered the non-load/load bearing poses; and the second pose would be considered the recommended physical therapy treatment.
Regarding Claim 49, Mikhail in view of Buescher and Windolf teaches the modified system of claim 29 as stated above. The modified Mikhail further teaches selecting the one or more Bragg gratings closest to the injury location comprises programming the selection around the time of implantation based on visualisation of where the injury is in relation to the deformation sensing arrangement (see Mikhail ¶[0004]-[0005] the implant is placed at the location by the medical professional, the placement would be selection of the closest sensor, Fig. 1; see Buescher abstract, ¶[0006], ¶[0035]-[0036], and ¶[0047]-[0048] the implantable optical fiber with Bragg gratings).
Regarding Claim 50, Mikhail in view of Buescher and Windolf teaches the modified system of claim 39 as stated above. The modified Mikhail further teaches the measurement data comprises the measurement indicative of stress and/or pressure derived using the deformation sensing arrangement (¶[0026] the primary load sensor 52 senses the load carried by the plate 12 at the fracture 50, and the at least one reference load sensor 54 senses load carried by the plate 12 at location(s) spaced from the fracture 50, ¶[0028]-[0029] the communication circuitry 62 may receive and store measurements from the sensor; Fig. 2).
Regarding Claim 52, Mikhail in view of Buescher and Windolf teaches the method of claim 42 as stated above. Mikhail further teaches selecting the one or more Bragg gratings closest to the injury location by programming the selection around the time of implantation based on visualisation of where the injury is in relation to the deformation sensing arrangement (see Mikhail ¶[0004]-[0005] the implant is placed at the location by the medical professional, the placement would be selection of the closest sensor, Fig. 1; see Buescher abstract, ¶[0006], ¶[0035]-[0036], and ¶[0047]-[0048] the implantable optical fiber with Bragg gratings).
Regarding Claim 53, Mikhail in view of Buescher and Windolf teaches the method of claim 42 as stated above. The modified Mikhail further teaches the measurement data comprises the measurement indicative of stress and/or pressure derived using the deformation sensing arrangement (¶[0026] the primary load sensor 52 senses the load carried by the plate 12 at the fracture 50, and the at least one reference load sensor 54 senses load carried by the plate 12 at location(s) spaced from the fracture 50, ¶[0028]-[0029] the communication circuitry 62 may receive and store measurements from the sensor; Fig. 2).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Mikhail in view of Buescher and Windolf as applied to claim 29 above, and further in view of Edmund Optics Worldwide (“Photonic-electronic integrated circuits”, Edmund Optics Inc., published on September 05, 2018, published at www.edmundoptics.com/knowledge-center/trending-in-optics/photonic-electronic-integrated-circuits/ - cited in prior action), hereinafter Edmund.
Regarding Claim 31, Mikhail in view of Buescher and Windolf teach the system of claim 29 as stated above. Mikhail teaches utilizing integrated circuits for the components of the implanted sensor (see Mikhail ¶[0031] incorporated reference US Patent Application Publication 2019/0038214, ¶[0039] the integrated circuit); but does not specifically teach that the circuit is a photonic integrated circuit.
Edmund teaches about photonic integrated circuits, including their use for medical devices (see pg. 1-2).
Accordingly, it would have been obvious to utilize the photonic integrated circuit of Edmund as the integrated circuit of the modified system of Mikhail because photonic integrated circuits provide higher speeds, greater bandwidth, and lower energy loss over conventional circuits (see Edmund pg. 1).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Mikhail in view of Buescher and Windolf as applied to claim 29 above, and further in view of Puttlitz et al. (US Patent Application Publication 2019/0162606 – cited in prior action), hereinafter Puttlitz.
Regarding Claim 38, Mikhail in view of Buescher and Windolf teach the system of claim 29 as stated above. Mikhail further teaches the processor is configured to control the power supply arrangement to power the deformation sensing arrangement (¶[0032]-[0040] the wireless reader 42 interacts with the implanted sensor, the wireless reader 42 may send a signal to start the measurement via a portable computing device 72, the portable computing device 72 may receive data from the implanted sensor; Figs. 3-6) and create a log of readings in a memory (¶[0008] and ¶[0022] the storage of measurements in memory), and
wherein the processor is configured to transmit the log of readings upon receiving a request from the external user device (¶[0032]-[0040] the wireless reader 42 interacts with the implanted sensor, may send a signal to start the measurement via user device 72, the portable computing device 72 may receive data from the implanted sensor, ¶[0031]-[0034] the wireless communication may be implemented through RFID, NFC, or BLE, ¶[0022]-[0023] the data server receives patient data 24 through the use of the user device 72, data is sent over the internet through local or wide area networks, ¶[0034] communications may utilize Wi-Fi).
The modified Mikhail does not provide specific limits on the timing of the energizing of the deformation sensing arrangement for measurements, specifically that the power supply arrangement is configured to provide power to the deformation sensing arrangement for a predetermined length of time of no more than 10 ms for each reading. However, the duration of powering the deformation sensing arrangement is parameter that would have been optimized based on the time needed to make a measurement, or desired performance. As such, the duration of powering the deformation sensing arrangement is a results-effective variable that would have been optimized through routine experimentation based on the time needed to make a measurement. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to power the deformation sensing arrangement for a duration so that it may make a measurement as required by the system. Thus, the power supply arrangement configured to provide power to the deformation sensing arrangement for a predetermined length of time of no more than 10 ms for each measurement would have been obvious.
The modified Mikhail is silent regarding the processor is configured to power up the sensor at predetermined intervals and create a log of readings.
Puttlitz teaches measuring the strain of off a structural member with an antenna spaced from the structural member, such as a target object is deformed, so that deformation is recorded from the structural member and is output via the antenna (see abstract; Figs. 1-3). Puttlitz teaches performing measurements at predetermined intervals (see ¶[0054]; Fig. 8), including the storage of associated data (see ¶[0017]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the performance of measurements at predetermined interval logic of Puttlitz with the modified system of Mikhail because (1) it is the application of a known technique with a known device ready for improvement to yield predictable results and/or (2) recording measurements at predetermined intervals can help the user plan for and remember to perform measurements.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Mikhail in view of Buescher and Windolf as applied to claim 29 above, and further in view of Luna Innovations, previously Micron Optics (“Grating Based Temperature Sensors – Temperature Calibration and Thermal Response”, 11/2008, published at lunainc.com/sites/default/files/assets/files/resource-library/TemperatureCalibration-FBGSensors-r2.pdf – cited in prior action), hereinafter Luna.
Regarding Claim 41, Mikhail in view of Buescher and Windolf teach the system of claim 29 as stated above. The modified Mikhail teaches that the at least one further Bragg grating is capable of measuring temperature (see Buescher ¶[0008], ¶[0018], ¶[0036], and ¶[0041]), but not specifically what temperature range that these sensors are capable of measuring.
Luna teaches about the importance of calibrating fiber Bragg grating (FBG) temperature sensors (see pg. 1 ¶1-2), and that FBG temperature sensors can measure in a range of -40 ºC to 120 ºC or -200 ºC to 275 ºC (see pg.4-5 § Calibration Technique); in which, either temperature range covers the claimed recitation of around 25 ºC to 50 ºC.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the FBG temperature sensors of Luna with the modified system of Mikhail because (1) it is the simple substitution of one known element for another to obtain predictable results and/or (2) calibrated FBG temperature sensors provide accurate temperature measurements over a wide temperature range (see Luna pg. 1 ¶2).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Mikhail in view of Buescher and Windolf as applied to claim 36 above, and further in view of Hannan et al. (“Energy harvesting for the implantable biomedical devices: issues and challenges”, Biomedical Engineering OnLine, 13:79, published June 20, 2014 – cited in prior action).
Regarding Claim 45, Mikhail in view of Buescher and Windolf teach the modified system of claim 36 as stated above. Mikhail further teaches a capacitor configured to charge inductively using an energetic signal from the external power source (¶[0033] the power transmission circuitry 78 can include inductive charging, ¶[0040] the antenna 70 is energized via the power transmission circuitry 78, the antenna 70 energizes the sensors 52/54, Fig. 4; see ¶[0031] for the incorporated reference US Patent Application Publication 2019/0038214, ¶[0038] and ¶[0058] the sensor may comprise a power device 106 which may charge a capacitor),
wherein the energetic signal is a radio-frequency signal (¶[0030] the energy source can include wireless charging via radio waves).
The modified Mikhail does not provide specific limits on charging, specifically the energetic signal has a power of around 500 µW or less and is transmitted for a duration of around 2 seconds or less.
Hannan teaches about the harvesting of energy via different means and sources for implanted medical devices (see abstract). Hannan teaches for inductive energy harvesting, RF waves may be harvested at low power (less than a milliwatt) at frequencies below 20 MHz to avoid tissue heating, utilizing capacitors in the receiving circuit (see pg.10-12 § Inductive energy harvesting).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the RF signal energy harvesting scheme of Hannan with the modified system of Mikhail because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) utilizing charging at the power of Hannan would avoid tissue heating (see Hannan pg. 10 § Inductive energy harvesting ¶1).
Further, the amounted of time for recharging will depend upon the amount of charging required and the rate of charging. Accordingly, the amount of power and transmission duration are parameters that would have been optimized based on the power requirements of the sensors needed in order to make measurements, the amount of charging required and the rate of charging, and desired performance. As such, the power and transmission duration are results-effective variables that would have been optimized through routine experimentation based on the power requirements of the sensors needed to take measurements, the amount of charging required and the rate of charging, and desired performance. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to give the energetic signal an appropriate power and transmission duration so that the sensors may make their measurements as required by the system. Thus, the energetic signal having a power of around 500 µW or less and is transmitted for a duration of around 2 seconds or less would have been obvious.
Claims 48 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Mikhail in view of Buescher and Windolf as applied to claims 29 and 42 above, respectively, and further in view of Rafii-Tari et al. (US Patent Application Publication 2021/0059764), hereinafter Rafii-Tari.
Regarding Claim 48, Mikhail in view of Buescher and Windolf teach the modified system of claim 29 as stated above. The modified Mikhail is silent regarding obtaining the measurement further comprises applying a weighting function to measurements from a plurality of Bragg gratings so as to determine measurements from one or more Bragg gratings located closest to the injury location.
Rafii-Tari teaches systems and methods for weight-based registration of location sensors (see abstract) to be utilized in a robotic system (see generally ¶[0047]-[0065]; Figs. 1-6), in which weights may be assigned to the different sensor positions based on their location (i.e., Bragg sensor on fiber) and the model points (i.e., the skeleton model, for the injury), so that points closer to the model have heavier weights improving accuracy (see ¶[0187]-[0195]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the location weighting of Rafii-Tari with the modified Mikhail because (1) it is the application of a known technique with a known device ready for improvement to yield predictable results and/or (2) the heavier weighting when closer would help to improve accuracy (see Rafii-Tari ¶[0194]).
Regarding Claim 51, Mikhail in view of Buescher and Windolf teach the method of claim 42 as stated above. The modified Mikhail is silent regarding obtaining the measurement further comprises applying a weighting function to measurements from a plurality of Bragg gratings so as to determine measurements from one or more Bragg gratings located closest to the injury location.
Rafii-Tari teaches systems and methods for weight-based registration of location sensors (see abstract) to be utilized in a robotic system (see generally ¶[0047]-[0065]; Figs. 1-6), in which weights may be assigned to the different sensor positions based on their location (i.e., Bragg sensor on fiber) and the model points (i.e., the skeleton model, for the injury), so that points closer to the model have heavier weights improving accuracy (see ¶[0187]-[0195]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the location weighting of Rafii-Tari with the modified Mikhail because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results and/or (2) the heavier weighting when closer would help to improve accuracy (see Rafii-Tari ¶[0194]).
Response to Arguments
Applicant’s arguments, objections to the claims
Applicant’s arguments, see pg. 13, filed June 15, 2026, with respect to the objections of claims 29-31, 35, 38, and 40 have been fully considered and are persuasive. Therefore, the objections have been withdrawn. However, upon further consideration, new objections are made that were necessitated by Applicant’s amendment filed on June 15, 2026.
Applicant’s arguments, 35 U.S.C. § 112(b)
Applicant’s arguments, see pg. 12-13, filed June 15, 2026, with respect to the rejections of claims 29-47 under 35 U.S.C. § 112(b) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection under 35 U.S.C. § 112 are made that were necessitated by Applicant’s amendment filed on June 15, 2026.
Applicant’s arguments, 35 U.S.C. § 103
Applicant’s arguments, see pg. 13-17, filed June 15, 2026, with respect to the rejections of claims 29-47 under 35 U.S.C. § 103 have been fully considered and are NOT persuasive. Applicant has made several arguments concerning the newly amended recitations relating to selecting in claim 29 and claims 48-56. The examiner respectfully disagrees with such arguments. Note that such arguments are put forth with the claims as best understood in view of the 35 U.S.C. § 112 rejections above. With respect to the selection of claim 29 and the dependent claim based on visualization, such arguments are not persuasive. As explained above, the modified Mikhail further teaches that obtaining the measurement comprises selecting, from the plurality of Bragg gratings, one or more Bragg gratings located closest to the injury location (see Mikhail ¶[0004]-[0005] the implant is placed at the location by the medical professional, Fig. 1; see Buescher abstract, ¶[0006], ¶[0035]-[0036], and ¶[0047]-[0048] the implantable optical fiber with Bragg gratings). Here, the Bragg gratings positioned adjacent to the injury are selected. This is commensurate with the selection of the present application as described in the specification. The specification details that “The selection may be programmed e.g. around the time of implantation based on visualisation of where the fracture or injury is in relation to the sensor” (see specification pg. 3 ln. 18-28). Therefore, the Bragg gratings implanted adjacent injury, which would necessarily include visual confirmation, fall under the BRI of the claimed recitation. With respect to the weighting function, the amendment necessitated the new grounds of rejection in view of Rafii-Tari et al. (US Patent Application Publication 2021/0059764).
Applicant next argues that the modified Mikhail does not teach the power supplied selectively. The examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the processor may maintain the power supply arrangement in a low power state) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant next argues that a person of ordinary skill in the art would not have been motivated to combine Beuscher with Mikhail, specifically the external probe of Beuscher. The examiner respectfully disagrees. The combination above did not combine the external probe of Beuscher, rather the optical fiber Bragg sensing arrangement in the implanted device of Mikhail. Therefore, Applicant’s arguments are not persuasive.
Therefore, Applicant’s arguments are not persuasive and the rejections to the claims under 35 U.S.C. § 103 are maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN D. MORONESO whose telephone number is (571)272-8055. The examiner can normally be reached M-F: 8:30AM - 6:00 PM, MST.
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/J.D.M./ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791
