DETAILED ACTION
This office action is responsive to the amendment filed 2/27/2026. Claims 1, 5-7, 9-11, 16, and 24-25 are pending and under prosecution.
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 .
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.
No claim elements are interpreted under 112(f).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5-16 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Sarrafzadeh et al (US Pub No. 20150366499) in view of Drinan et al (US Pub No. 20080039700), Lachenbruch et al (US Pub No. 20160338591 – cited by applicant) and Cha (US Pub No. 20180098735) and alternatively, in addition with Tonar et al (US Pub No. 20160310034 – cited by applicant).
In regard to Claim 1, Sarrafzadeh et al disclose apparatus for identifying damaged tissue, said apparatus comprising:
an apparatus body, i.e. substrate, since the electrode pads in Figure 16 necessarily are placed on some base layer, best seen in Figure 16 (0070);
a first sensor 102 and a second sensor 104 disposed on two ends of the apparatus body, best seen in Figure 16 (0070),
each comprising a first electrode 36 and a second electrode 38, best seen in Figure 3 and 16 (0044), and
wherein said first sensor is configured to be placed against a first location on a patient’s skin and said second sensor is configured to be placed at the same time against a second location on said patient’s skin – the integral structure of Figure 16 makes same time placement possible,
wherein said second location is bisymmetric relative to said first location – the device is capable of being placed with the sensors in bisymmetric location,
a circuit 22 (electronics package enclosure that houses interface circuitry -- 0040) electronically coupled to said first electrodes and said second electrodes and configured to measure a first electrical property – capacitance – between said first and second electrodes of said first sensor and to measure a second electrical property – capacitance – between said first and second electrodes of said second sensor and provide information regarding said first and second electrical properties by converting said first electrical property into a first sub-epidermal moisture (SEM) value and said second electrical property into a second SEM value – “Each embedded electrode measures the equivalent sub-epidermal capacitance corresponding and representing the moisture content of the target surface” (0011, 0055).
However, Sarrafzadeh et al do not expressly disclose:
a hinge disposed on said apparatus body between the two ends such that the separation distance between the first sensor and the second sensor may be varied.
a processor electronically coupled to said circuit and configured to receive said information, and a non-transitory computer-readable medium electronically coupled to said processor and comprising instructions stored thereon that, when executed on said processor, perform the steps of: converting said first electrical property into a first sub-epidermal moisture (SEM) value and said second electrical property into a second SEM value,
determining a difference between said first SEM value and said second SEM value, providing an indication that tissue is damaged at one of said first and second locations if said difference is greater than a predetermined threshold.
1) Cha teach that it is well-known in the art to provide a hinge to effectively position analogous skin sensors 122, 124, 162, 164 to a user by providing a clamp 112, 114 to grip the skin, best seen in Figure 7-9 (0129). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Sarrafzadeh et al such that said apparatus body comprises a hinge as taught by Cha to effectively grip the sensors to the user’s skin, wherein in combination, the separation distance between the first sensor and the second sensor may be varied due to the hinge as broadly as has been claimed.
2) Lachenbruch et al teach that it is well-known in the art to provide an analogous SEM device comprising sensor circuitry (0019), a processor 106 (0021), and a non-transitory computer-readable medium (0021) electronically coupled to said processor and comprising instructions stored thereon that, when executed on said processor, perform the steps of determining SEM (0037).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Sarrafzadeh et al such that a processor is electronically coupled to said circuit and configured to receive said information, and a non-transitory computer-readable medium electronically coupled to said processor and comprising instructions stored thereon that, when executed on said processor as taught by Lachenbruch et al to provide a well-known and routine electronic configuration for the sensor of Sarrafzadeh et al such that the SEM values are determined.
3) Lachenbruch et al also teach providing an indication at step 210 – notification to computing device or an alert, best seen in Figure 2 (0021, 0023, 0025, 0040, abst) that the SEM of tissue is greater than a predetermined threshold (abst, 0027, 0031-0037, 0040) – “During the first three days, the individual's levels are within the “normal” range, or do not exceed the threshold values. For example, during the first three days, the individual's SEM is 104 DMU, 120 DMU, and 130 DMU, respectively. However, on the fourth day, the individual's SEM is approximately 185 DMU, which exceeds the threshold value of 150 DMU. Therefore, the server 104 provides an alert indicative of a change in tissue status” (0037), to effectively evaluate the SEM of the tissue and provide an alert as necessary that indicates a tissue status change that indicates tissue damage – “Using the information in database 110, the server 104 can determine whether the information received from the sensor 102 represents a change in tissue status for the individual, whether the change in tissue status exceeds a threshold, and/or whether the tissue status is indicative of an issue such as a pressure ulcer, a wound infection, inflammation, or wound chronicity” (0027).
Drinan et al teach that it is well-known in the art to compare hydration measurements between first and second tissue locations to provide a proper baseline measurement against which to monitor any predetermined threshold change including indication of disease state – “ Measurements made at the different locations can be normalized to account for such differences in baseline measurements,” “hydration measurement results obtained using a first probe at a first location can be stored and compared with hydration measurement results obtained later using a second probe at a second location” (0061-0062). Thus, Drinan et al teach providing skin hydration measurements at the first and second location that are compared so a difference can be determined.
It is noted that applicant’s disclosure states that measurements for SEM are taken at bisymmetric locations to compensate for offset readings or possible common mode effects. This is in line with the teachings of Drinan et al which compares between locations for provide a proper baseline against which to judge the measurement. It is also noted that all comparisons require exceeding a predetermined threshold to indicate the result, as well-known to a skilled artisan.
Alternatively, Tonar et al additionally teach that it is well-known in the art to provide an analogous SEM device for determining a difference between a first SEM value, i.e. maximum, and a second SEM value, and providing an indication that tissue is damaged at one of said first and second locations if said difference is greater than a predetermined threshold – “determining a difference between the maximum average SEM value and each of the average SEM values measured around the anatomical site; and flagging the relative measurement locations associated with a difference greater than a predetermined value as damaged tissue” (0008, see claim 1).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify Sarrafzadeh et al such that a difference between said first SEM value and said second SEM value is determined as taught by Drinan et al and alternatively Tonar et al, and providing an indication that tissue is damaged at one of said first and second locations if said difference is greater than a predetermined threshold as taught by Lachenbruch et al or alternatively Tonar et al, to effectively provide a way to accurately detect the skin tissue damage by comparison to a proper baseline measurement against which to monitor any predetermined threshold change, which is taught by Drinan et al, including indication of damaged tissue at one of said first and second locations, as taught by Lachenbruch et al or alternatively, Tonar et al.
5. Sarrafzadeh et al disclose the apparatus according to claim 1, further comprising a gap 40 between said first 36 and second electrodes 38, best seen in Figure 3 (0044).
6. Sarrafzadeh et al disclose the apparatus according to claim 1, wherein said electrical property comprises one or more of an electrical component selected from the group consisting of a resistance, a capacitance (abst), an inductance, an impedance, and a reluctance.
Claims 7, 9-11, 16, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Sarrafzadeh et al (US Pub No. 20150366499) in view of Drinan et al (US Pub No. 20080039700), and Lachenbruch et al (US Pub No. 20160338591 – cited by applicant) and alternatively, in addition with Tonar et al (US Pub No. 20160310034 – cited by applicant).
In regard to Claim 7, Sarrafzadeh et al disclose an apparatus for identifying damaged tissue, said apparatus comprising:
a substrate 120 configured to be placed against a surface of a patient’s skin, best seen in Figure 16 (0048, 0070),
a plurality of sensors 102, 104 that are disposed on said substrate at a respective plurality of positions, best seen in Figure 16,
wherein each sensor comprises a pair of electrodes 36, 38, best seen in Figure 3 and 16 (0044),
a circuit 22 (electronics package enclosure that houses interface circuitry -- 0040) electronically coupled to said pair of electrodes of each of said plurality of sensors and configured to measure an electrical property – capacitance – between said pairs of electrodes of a portion of said plurality of sensors and provide information regarding said measured electrical properties by converting said plurality of electrical property into a respective plurality of sub-epidermal moisture (SEM) values – “Each embedded electrode measures the equivalent sub-epidermal capacitance corresponding and representing the moisture content of the target surface” (0011, 0055).
However, Sarrafzadeh et al do not expressly disclose a processor electronically coupled to said circuit and configured to receive said information regarding said electrical properties from said circuit and convert said plurality of electrical properties into a respective plurality of sub-epidermal moisture (SEM) values, and a non-transitory computer-readable medium electronically coupled to said processor and comprising instructions stored thereon that, when executed on said processor, perform the steps of:
identifying from said plurality of SEM values a first sensor and a second sensor that are located at first and second positions that are bisymmetric with respect to said patient’s skin, and comparing a first SEM value that is associated with said first sensor with a second SEM value that is associated with said second sensor,
determining a difference between said first SEM value and said second SEM values, and
providing an indication that tissue is damaged at one of said first and second locations if said difference is greater than a predetermined threshold.
It is noted that the SEM values of Sarrafzadeh et al are necessarily bisymmetric when the device is placed accordingly on the body during use.
Lachenbruch et al teach that it is well-known in the art to provide an analogous SEM device comprising sensor circuitry (0019), a processor 106 (0021), and a non-transitory computer-readable medium (0021) electronically coupled to said processor and comprising instructions stored thereon that, when executed on said processor, perform the steps of determining SEM (0037).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Sarrafzadeh et al such that a processor is electronically coupled to said circuit and configured to receive said information regarding said electrical properties from said circuit and convert said plurality of electrical properties into a respective plurality of sub-epidermal moisture (SEM) values, and a non-transitory computer-readable medium electronically coupled to said processor and comprising instructions stored thereon that, when executed on said processor, perform the steps of: identifying from said plurality of SEM values a first sensor and a second sensor that are located at first and second positions that are bisymmetric with respect to said patient’s skin, which are already taught by Sarrafzadeh et al, to provide a well-known and routine electronic configuration for the sensor of Sarrafzadeh et al such that the SEM values are determined.
Lachenbruch et al also teach providing an indication at step 210 – notification to computing device or an alert, best seen in Figure 2 (0021, 0023, 0025, 0040, abst) that the SEM of tissue is greater than a predetermined threshold (abst, 0027, 0031-0037, 0040) – “During the first three days, the individual's levels are within the “normal” range, or do not exceed the threshold values. For example, during the first three days, the individual's SEM is 104 DMU, 120 DMU, and 130 DMU, respectively. However, on the fourth day, the individual's SEM is approximately 185 DMU, which exceeds the threshold value of 150 DMU. Therefore, the server 104 provides an alert indicative of a change in tissue status” (0037), to effectively evaluate the SEM of the tissue and provide an alert as necessary that indicates a tissue status change that indicates tissue damage – “Using the information in database 110, the server 104 can determine whether the information received from the sensor 102 represents a change in tissue status for the individual, whether the change in tissue status exceeds a threshold, and/or whether the tissue status is indicative of an issue such as a pressure ulcer, a wound infection, inflammation, or wound chronicity” (0027).
Drinan et al teach that it is well-known in the art to compare hydration measurements between first and second tissue locations to provide a proper baseline measurement against which to monitor any predetermined threshold change including indication of disease state – “ Measurements made at the different locations can be normalized to account for such differences in baseline measurements,” “hydration measurement results obtained using a first probe at a first location can be stored and compared with hydration measurement results obtained later using a second probe at a second location” (0061-0062). Thus, Drinan et al teach providing skin hydration measurements at the first and second location that are compared.
It is noted that applicant’s disclosure states that measurements for SEM are taken at bisymmetric locations to compensate for offset readings or possible common mode effects. This is in line with the teachings of Drinan et al which compares between locations for provide a proper baseline against which to judge the measurement. It is also noted that all comparisons require exceeding a predetermined threshold to indicate the result, as well-known to a skilled artisan.
Alternatively, Tonar et al additionally teach that it is well-known in the art to provide an analogous SEM device for determining a difference between a first SEM value, i.e. maximum, and a second SEM value, and providing an indication that tissue is damaged at one of said first and second locations if said difference is greater than a predetermined threshold – “determining a difference between the maximum average SEM value and each of the average SEM values measured around the anatomical site; and flagging the relative measurement locations associated with a difference greater than a predetermined value as damaged tissue” (0008, see claim 1).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify Sarrafzadeh et al such that a difference between said first SEM value and said second SEM value is determined as taught by Drinan et al and alternatively Tonar et al, and providing an indication that tissue is damaged at one of said first and second locations if said difference is greater than a predetermined threshold as taught by Lachenbruch et al or alternatively Tonar et al, to effectively provide a way to accurately detect the skin tissue damage by comparison to a proper baseline measurement against which to monitor any predetermined threshold change, which is taught by Drinan et al, including indication of damaged tissue at one of said first and second locations, as taught by Lachenbruch et al or alternatively, Tonar et al.
9. Sarrafzadeh et al in combination with Lachenbruch et al and Drinan et al disclose the apparatus according to claim 7, wherein said instructions further comprise the steps of: determining a difference between said first and second SEM values as taught by the comparison of Drinan et al (0061-0062), determining which of said first and second SEM values is larger than the other also taught by Drinan et al (0061-0062), and providing an indication that tissue is damaged at the location associated with the larger SEM value if said difference is greater than a predetermined threshold as taught by the comparison to threshold by Lachenbruch et al (0037). Also see Tonar et al (0008, claim 1).
10. Sarrafzadeh et al disclose the apparatus according to claim 7, wherein said electrical property comprises one or more of an electrical component selected from the group consisting of a resistance, a capacitance (abst), an inductance, an impedance, and a reluctance.
In regard to Claim 11, Sarrafzadeh et al disclose an apparatus for identifying damaged tissue, said apparatus comprising:
a rigid apparatus body 100 as broadly as has been claimed, best seen in Figure 16;
two sensors comprising a first sensor 102 and a second sensor 104, best seen in Figure 16 (0070),
wherein said two sensors are disposed on two ends of said apparatus body while being aligned on a common plane (device is flat), best seen in Figure 16,
to allow simultaneous positioning of said first sensor on a first location on a patient’s skin and said second sensor on a second location bisymmetric relative to said first location – the integral structure of Figure 16 makes simultaneous positioning possible as well as being capable of being placed with the sensors in bisymmetric location;
wherein said two sensors are maintained at a fixed separation distance and fixed orientation to each other, best seen in Figure 16;
a circuit 22 (electronics package enclosure that houses interface circuitry -- 0040) electronically coupled to each of said two sensors and configured to measure an electrical property – capacitance – from each of said two sensors and to convert said first electrical property measurement to a first sub-epidermal moisture (SEM) value and said second electrical property measurement to a second SEM value – “Each embedded electrode measures the equivalent sub-epidermal capacitance corresponding and representing the moisture content of the target surface” (0011, 0055).
However, Sarrafzadeh et al do not expressly disclose a processor electronically coupled to said circuit and is configured to receive a first electrical property measurement from a first location and a second electrical property measurement from a second location, and to convert said first electrical property measurement to a first sub-epidermal moisture (SEM) value and said second electrical property measurement to a second SEM value;
a non-transitory computer-readable medium electronically coupled to said processor and contains instructions that, when executed on said processor, perform the step of determining a difference between said first SEM value and said second SEM value.
Lachenbruch et al teach that it is well-known in the art to provide an analogous SEM device comprising sensor circuitry (0019), a processor 106 (0021), and a non-transitory computer-readable medium (0021) electronically coupled to said processor and comprising instructions stored thereon that, when executed on said processor, perform the steps of determining SEM (0037).
Drinan et al teach that it is well-known in the art to compare hydration measurements between first and second tissue locations to provide a proper baseline measurement against which to monitor any predetermined threshold change including indication of disease state – “ Measurements made at the different locations can be normalized to account for such differences in baseline measurements,” “hydration measurement results obtained using a first probe at a first location can be stored and compared with hydration measurement results obtained later using a second probe at a second location” (0061-0062). Thus, Drinan et al teach providing skin hydration measurements at the first and second location that are compared so a difference can be determined.
It is noted that applicant’s disclosure states that measurements for SEM are taken at bisymmetric locations to compensate for offset readings or possible common mode effects. This is in line with the teachings of Drinan et al which compares between locations for provide a proper baseline against which to judge the measurement. It is also noted that all comparisons require exceeding a predetermined threshold to indicate the result, as well-known to a skilled artisan.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Sarrafzadeh et al such that a processor electronically coupled to said circuit and configured to receive said information, and a non-transitory computer-readable medium electronically coupled to said processor and comprising instructions stored thereon that, when executed on said processor as taught by Lachenbruch et al to provide a well-known and routine electronic configuration for the sensor of Sarrafzadeh et al such that the SEM values are determined.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify Sarrafzadeh et al such that a difference between said first SEM value and said second SEM value is determined as taught by Drinan et al to effectively provide a way to accurately detect the skin tissue damage by comparison to a proper baseline measurement against which to monitor any predetermined threshold change including indication of disease state.
16. Sarrafzadeh et al disclose the apparatus according to claim 11, wherein each of said two sensors comprises a first electrode 36 and a second electrode 38 separated by a gap 40, best seen in Figure 3 (0044).
24. Sarrafzadeh et al in combination with Lachenbruch et al and Drinan et al disclose the apparatus according to claim 11, wherein said instructions further comprise the step of providing an indication that tissue is damaged at one of said first and second locations if the difference is greater than a predetermined threshold as taught by the comparison of Drinan et al (0061-0062) and the comparison to threshold by Lachenbruch et al (0037).
25. Sarrafzadeh et al in combination with Lachenbruch et al and Drinan et al disclose the apparatus according to claim 11, wherein said instructions further comprise the steps of: determining the greater of said first and second SEM values as taught by the comparison of Drinan et al (0061-0062), and providing an indication that tissue is damaged at the location associated with the greater SEM value if the difference exceeds a predetermined threshold as taught by Lachenbruch et al (0037).
Response to Arguments
The previous 112 rejections are withdrawn in light of applicant’s arguments and the 101 rejection is moot in light of the cancelled claims.
With respect to Claims 1 and 7, applicant contends that the prior art does not “provide or suggest at least determining a difference between said first SEM value and said second SEM value, and providing an indication that tissue is damaged at one of said first and second locations if said difference is greater than a predetermined threshold” (Remarks pg. 12, 15). However, it is submitted that Lachenbruch et al that as cited above (abst, 0021, 0023, 0025, 0027, 0031-0037, and 0040). These citations were not previously presented and therefore not addressed in applicant’s arguments. Tonar et al is also alternatively set forth to teach the same. Applicant also has not provided any arguments why Cha does not make obvious the hinge as set forth above as well. Therefore, the rejection involving Lachenbruch et al and Cha for Claim 1 are maintained above.
Regarding Drinan et al, applicant contends that “adjusting the gain in the measurement is not the same as taking a difference between two SEM values taken at bisymmetric locations on the body” (Remarks pg. 15-16). It is noted that all of the claims are drawn to an apparatus. The structure of Sarrafzadeh et al in Figure 16 allow the placement of the electrodes in a bisymmetric location of the patient, i.e. on the back or the stomach by the midline. Since Sarrafzadeh et al already disclose measuring SEM, this would result in measurement of SEM at bisymmetric locations as broadly as has been claimed. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. It is noted that the structure of Figure 16 in Sarrafzadeh et al is similar to that of applicant’s invention, as broadly as has been claimed. Moreover, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Additionally, Drinan et al does teach a difference of hydration (such as SEM) readings at two locations on the patient – “hydration measurement results obtained using a first probe at a first location can be stored and compared with hydration measurement results obtained later using a second probe at a second location” (0062). Applicant did not address this citation in Drinan et al, which was previously presented. When combined with Drinan et al, this would thus result in determining a difference between the first SEM value and the second SEM value, which are measured by Sarrafzadeh et al when the device is disposed on a bisymmetric location on the patient. Lachenbruch et al or additionally Tonar et al then teach the comparison to a threshold and the indication as described above. Therefore, it is submitted that the use of Drinan et al makes sense and is therefore maintained.
In regard to Claim 11, applicant contends that “claim 11 is not obvious, at least because the Examiner has not shown that Sarrafzadeh, Drinan, and Lachenbruch, whether alone or in combination, provide or suggest two sensors comprising a first sensor and a second sensor, wherein said two sensors are disposed on two ends of said apparatus body while being aligned on a common plane, positioned to allow simultaneous positioning of said first sensor on a first location on a patient's skin and said second sensor on a second location bisymmetric relative to said first location” (Remarks pg. 18). While the rejection previously stated that Sarrafzadeh et al disclosed a first sensor and a second sensor, wherein said two sensors are disposed on two ends of said apparatus body while being aligned on a common plane, applicant does not contend this.
Applicant also states that Sarrafzadeh provides an apparatus that comprises “an array 14 of individual RF electrode sensors 24 and 26 embedded on a flexible biocompatible substrate 16” at (0041) and Figure 1 (Remarks pg. 18). However, it is noted that this citation has not been used in the rejection above because it does not refer to the embodiment in Figure 16. Additionally, despite the rejection previously interpreting Sarrafzadeh et al to provide “a rigid apparatus” as broadly as been claimed, applicant has not provided any arguments to the contrary. It is further noted that the instant invention was subject to an election restriction requirement where applicant elected the embodiment in Figure 4B, which is encompassed by Claim 11 when the hinge is not recited. Thus, said rejections with regard to Claim 11 are maintained above.
Lastly, applicant contends that Sarrafzadeh et al do not show “where Sarrafzadeh provides or suggests that the two sensors are positioned to allow simultaneous positioning of said first sensor on a first location on a patient’s skin and a second sensor on a second location bisymmetric relative to the first location. In fact, the disclosure of Sarrafzadeh does not contain the word ‘bisymmetric’” (Remarks pg. 18). However, this is not persuasive because as mentioned above, it is noted that all of the claims are drawn to an apparatus. The structure of Sarrafzadeh et al in Figure 16 allow the placement of the electrodes in a bisymmetric location of the patient, i.e. on the back or the stomach by the midline such that the first sensor is on a first location on a patient’s skin and the second sensor is on a second location bisymmetric relative to the first location, across the midline. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Thus, the reference does not require a direct disclosure of the bisymmetric placement for the apparatus claims. It is noted that the structure of Figure 16 in Sarrafzadeh et al is similar to that of applicant’s invention in Figure 4B, as broadly as has been claimed. Therefore, the use of Sarrafzadeh et al is maintained.
Attention is also drawn to Chasins (US Pub No. 20150157435), previously presented, which teaches that it is well-known in the art to compare physiological measurements from skin sensors taken at bisymmetric locations on the body to determine the physiological state of body part (0066-0067). Thus, Chasins et al teach the comparison of sensor measurements from bisymmetric skin locations. Libbus et al (US Pub No. 20090076410 - cited by applicant), previously presented, teach that it is well-known in the art to provide skin hydration sensors positioned at bisymmetric locations to provide desired measurements (0114-0116).
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 Huong NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791