DETAILED ACTION
Non-final Office 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 .
Reissue
For reissue applications filed before September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the law and rules in effect on September 15, 2012. Where specifically designated, these are “pre-AIA ” provisions.
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
This action is responsive to communications: The instant application filed August 16, 2024 which is a reissue of application 16/391,244 (U.S. Patent No. 11,412,980, published August 16, 2022).
Because the instant application was filed on or after September 16, 2012, the statutory provisions of the America Invents Act (“AIA ”) will govern this proceeding.
Claims 1-20 were published in US Patent 11,412,980. A preliminary amendment was filed concurrently with the application on August 16, 2024. By way of the preliminary amendment, original claims 1, 9 and 18 was amended no new claims were added. Therefore, claims 1-20 are currently pending in the application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:.
Reference characters 1110, 1105a, 1105b and 1140 are not found in the specification. See the description of figure 11 in the specification.
Reference character 1410 is not found in the specification. See the description of figure 14 in the specification.
Reference character 1942 is not found in the specification. See the description of figure 19 in the specification.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
In Column 15, lines 21 and 24, “700” is not found in figure 7 or any other drawing.
In Column 20, line 45, “1105” is not found in figure 11 or any other drawing.
The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In Column 6, line 32, “100” should be --110--.
In Column 20, line 43, “flume” should be --fluke--.
In Column 24, line 7, “1704” should be --1706--.
In Column 24, line 7, “1003” should be --1703--.
In Column 25, line 2, “1710” should be --1700--.
In Column 27, line 13, “1708” should be --1750--.
In Column 27, line 20, “1708” should be --1750--.
In Column 27, line 25, “1708” should be --1750--.
In Column 28, line 4, “1708” should be --1750--.
In Column 28, line 10, “1708” should be --1750--.
In Column 36, line 8, “1013” should be --1713--.
In Column 36, line 9, “1708” should be --1750--.
In Column 36, line 22, “1718” should be --1713--.
In Column 41, line 21, “1924” should be --1930--.
In Column 42, line 18, “1316” should be --1916--.
Claims
The present reissue includes original claims 1-20. Independent claims 1, 12 and 17 are reproduced below.
1. (Amended) A device comprising:
a housing having an outer surface configured to affix to a body of a user;
a light source embedded within the housing at a first position, wherein the light source is operable to:
emit a first light into the body at a first wavelength of light corresponding to a wavelength absorbed by sodium; and
emit a second light into the body at a second wavelength of light corresponding to a wavelength absorbed by potassium;
an optical sensor embedded within the housing at a second position, wherein the optical sensor is operable to detect a portion of the first light and the second light [reflected by interstitial fluid of the body at a depth below an exterior surface of a surface of the body of the user];
a first bio-impedance sensor attached to the housing third position at a such that the first bio-impedance sensor is positioned to transmit an electrical current through the body of the user;
a second bio-impedance sensor attached to the housing at a fourth position such that the second bio-impedance sensor is positioned to receive the electrical current transmitted through the body of the user by the first bio-impedance sensor; and a processing device configured to:
determine a sodium to potassium ratio of the user based on the reflected first light and the reflected second light; and determine a physiological condition of the user based a trend of the sodium to potassium ratio over a period of time and the received electrical current.
9. (Amended) An apparatus comprising:
a housing configured to affix to a wrist of a user, wherein the housing comprises a band to affix the housing to the wrist of the user;
a light source embedded within the housing along an inner surface of the band at a first location at a bottom of the band such that the light source is located adjacent to a bottom surface of the wrist when the apparatus is worn by the user, wherein the light source is operable to emit a light into a body of the user at a wavelength of light corresponding to a wavelength absorbed by blood or sub-epidermis tissue of the user;
an optical sensor embedded within the housing along the inner surface of the band at a second location at the bottom of the band such that the optical sensor is positioned to detect a first portion of the light] reflected or backscattered by the blood or the sub- epidermis tissue];
a first bio-impedance sensor embedded within the housing along the inner surface of the band at a third location at the bottom of the band such that the first bio-impedance sensor is positioned to transmit an electrical current through a second portion of the blood or the sub-epidermis tissue of the user;
a second bio-impedance sensor embedded within the housing along the inner surface of the band at a fourth location at the bottom of the band such that the second bio-impedancesensor is positioned to receive the electrical current transmitted through the second portion of the blood or the sub-epidermis tissue of the user by the first bio- impedance sensor; and
a processing device is configured to determine a physiological condition of the user based on the reflected light or the backscatter detected by the optical sensor and the electrical current received by the second bio-impedance sensor.
18. (Amended) A method comprising:
emitting, by a light source affixed to a body at a first position, a first wavelength of light into the body;
receiving, by an optical sensor affixed to the body at a second position, light from a depth below a surface of the body corresponding to blood or sub-epidermis tissue of the b0dy;
receiving, by a bio-impedance sensor affixed to the body at a third position, an electrical current transmitted through the body, wherein:
the first position is at a fixed distance from the second position [to detect backscatter from the depth below the surface of the body], and the first position of the light source is at a first side of a muscular walled tube of the body and the second position of the optical sensor is at a second side of the muscular walled tube such that the light source and the optical sensor straddle the muscular walled tube; and
determining a physiological condition of the body when a current amount of light reflected or backscattered by the blood or the sub-epidermis tissue and received by the optical sensor is different than a previous amount of light reflected or backscattered by the blood or the sub-epidermis tissue and received by the optical sensor and based on the received electrical current.
Claim Objections
Claims 9, 12 and 13 are objected to because of the following informalities:
In claim 9, line 2, “bandto” should be --band to--.
In claim 9, lines 11 and 12, “light] reflected or backscattered by the blood or the sub- epidermis tissue] should be (presumably) -- light [reflected or backscattered by the blood or the sub- epidermis tissue]--.
In claim 9, line 19, “bio-impedancesensor” should be -- bio-impedance sensor--.
In claim 12, line 4 “sensordoes” should be --sensor does--.
In claim 13, lines 1 and 2, should “bio impedance” be --bio-impedance--?
Appropriate correction is required.
Amendments to the drawings, specification and claims must comply with 37 C.F.R. 1.173(b)-(d):
(b) Making amendments in a reissue application. An amendment in a reissue application is made either by physically incorporating the changes into the specification when the application is filed, or by a separate amendment paper. If amendment is made by incorporation, markings pursuant to paragraph (d) of this section must be used. If amendment is made by an amendment paper, the paper must direct that specified changes be made, as follows:
(1) Specification other than the claims. Changes to the specification, other than to the claims, must be made by submission of the entire text of an added or rewritten paragraph, including markings pursuant to paragraph (d) of this section, except that an entire paragraph may be deleted by a statement deleting the paragraph without presentation of the text of the paragraph. The precise point in the specification must be identified where any added or rewritten paragraph is located. This paragraph applies whether the amendment is submitted on paper or compact disc (see §§ 1.52(e)(1) and 1.821(c), but not for discs submitted under § 1.821(e)).
(2) Claims. An amendment paper must include the entire text of each claim being changed by such amendment paper and of each claim being added by such amendment paper. For any claim changed by the amendment paper, a parenthetical expression "amended," "twice amended," etc., should follow the claim number. Each changed patent claim and each added claim must include markings pursuant to paragraph (d) of this section, except that a patent claim or added claim should be canceled by a statement canceling the claim without presentation of the text of the claim.
(3) Drawings. One or more patent drawings shall be amended in the following manner: Any changes to a patent drawing must be submitted as a replacement sheet of drawings which shall be an attachment to the amendment document. Any replacement sheet of drawings must be in compliance with § 1.84 and shall include all of the figures appearing on the original version of the sheet, even if only one figure is amended. Amended figures must be identified as "Amended," and any added figure must be identified as "New." In the event that a figure is canceled, the figure must be surrounded by brackets and identified as "Canceled." All changes to the drawing(s) shall be explained, in detail, beginning on a separate sheet accompanying the papers including the amendment to the drawings.
(i) A marked-up copy of any amended drawing figure, including annotations indicating the changes made, may be included. The marked-up copy must be clearly labeled as "Annotated Marked-up Drawings" and must be presented in the amendment or remarks section that explains the change to the drawings.
(ii) A marked-up copy of any amended drawing figure, including annotations indicating the changes made, must be provided when required by the examiner.
(c) Status of claims and support for claim changes. Whenever there is an amendment to the claims pursuant to paragraph (b) of this section, there must also be supplied, on pages separate from the pages containing the changes, the status (i.e., pending or canceled), as of the date of the amendment, of all patent claims and of all added claims, and an explanation of the support in the disclosure of the patent for the changes made to the claims.
(d) Changes shown by markings. Any changes relative to the patent being reissued which are made to the specification, including the claims, upon filing, or by an amendment paper in the reissue application, must include the following markings:
(1) The matter to be omitted by reissue must be enclosed in brackets; and
(2) The matter to be added by reissue must be underlined, except for amendments submitted on compact discs (§§ 1.96 and 1.821(c) ). Matter added by reissue on compact discs must be preceded with "<U>" and end with "</U>" to properly identify the material being added.
Oath/Declaration
On June 16, 2025 Patent Owner filed 3 declarations:
A first Reissue Application Declaration by the Inventor, signed by Jeffrey M. Lee.
A second Reissue Application Declaration by the Inventor, signed by Devin W. Miller.
A third Reissue Application Declaration by the Assignee, signed by Jared Starling, who is authorized to act on behalf of the Assignee. See the Statement under 37 C.F.R. 3.73(c).
None of the three declarations mentioned above are compliant, Only one declaration is needed: A Reissue Application Declaration by the Assignee, with all 3 inventors listed.
With respect to the Reissue Application Declaration by the Assignee, Patent Owner, or its representatives must check the box “The application for the original patent was filed under 37 CFR 1.46 by the assignee of the entire interest”, which is below the error statement, in order to use the Assignee declaration for a broadening reissue.
Also, it appears that in the Reissue Application Declaration by the Assignee, there is an electronic signature by Jared Starling. It “appears” there is as the information below the signature is too small and blurred to discern what it actually is.
Should this be an electronic signature, the information must be legible and Patent Owner must comply with the Federal Register Notice published March 22, 2024:
https://www.govinfo.gov/content/pkg/FR-2024-03-22/pdf/2024-06126.pdf
See also 37 CFR 1.4(d)(4).
The reissue oath/declaration(s) filed with this application is defective (see 37 CFR 1.175 and MPEP § 1414) because of the following:
From MPEP 1414(II):
“The ‘at least one error’ which is relied upon to support the reissue application must be set forth in the oath/declaration. It is not necessary, however, to point out how (or when) the error arose or occurred. Further, it is not necessary to point out how (or when) the error was discovered. If an applicant chooses to point out these matters, the statements directed to these matters will not be reviewed by the examiner, and the applicant should be so informed in the next Office action. What is needed for the oath/declaration statement as to error is the identification of ‘at least one error’ relied upon. For an application filed on or after September 16, 2012 that seeks to enlarge the scope of the claims of the patent, the reissue oath or declaration must also identify a claim that the application seeks to broaden. A general statement, e.g., that all claims are broadened, is not sufficient to satisfy this requirement. In identifying the error, it is sufficient that the reissue oath/declaration identify a single word, phrase, or expression in the specification or in an original claim, and how it renders the original patent wholly or partly inoperative or invalid. The corresponding corrective action which has been taken to correct the original patent need not be identified in the oath/declaration. If the initial reissue oath/declaration ‘states at least one error’ in the original patent, and, in addition, recites the specific corrective action taken in the reissue application, the oath/declaration would be considered acceptable, even though the corrective action statement is not required…
Likewise, a statement of the error as ‘…the inclusion of claims 3-5 which were unduly broad…’ and then canceling claims 3-5, would not be considered a sufficient "error" statement because applicant has not pointed out what the canceled claims lacked that the remaining claims contain. The statement of what the remaining claims contain need not identify specific limitations, but rather may provide a general identification, such as ‘Claims 3-5 did not provide for any of the tracking mechanisms of claims 6-12, nor did they provide an attachment mechanism such as those in claims 1-2 and 9-16.’” (Emphases examiner).
The error statement (in the Reissue Application Declaration by the Assignee):
“This reissue application is a broadening reissue. The original patent is wholly or partly inoperative or invalid because the claims are overly limiting. For example, the claims recite how the light is reflected in the body.
The reissue application corrects this defect by broadening the independent claims. For example, in the reissue application, neither independent claims 1, 9, nor 18 detecting the reflection of light in the manner claimed.”
does NOT: identify a single word, phrase, or expression in an original patented claim, and how it renders the original patent wholly or partly inoperative or invalid.
The language that is deleted from claim 1 is, for example:
“reflected by interstitial fluid of the body at a depth below an exterior surface of a surface of the body of the user”
Patent Owner only needs to recite one error for a valid error statement. See MPEP 1414(II).
For broadening reissues, either of the following examples as explaining “how” the original patent is rendered wholly or partly inoperative or invalid is acceptable:
The claims are “unduly narrow,” or
The quoted language of the claim to be broadened in the error statement is not necessary for patentability.
Lastly, When filing a new declaration, in response to the above defects, Patent Owner is reminded to check the box that the specification was “filed on _______ as reissue application number ________”, as the specification has been filed.
Claim Rejections - 35 USC § 251
Claims 1-20 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the declaration is set forth in the discussion above in this Office action.
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.
Claim 15 is 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 15 states “The apparatus of claim 9, wherein: the light source is a spectrometer configured to emit light across a defined range of wavelengths of light; and the optical sensor is configured to detect the reflected or backscattered light within the defined range of wavelengths of light.”
However, a spectrometer measures light; not emits light. In the patent specification, both at col. 7, ll. 1-15 and col. 23, ll. 47-67, Patent Owner refers to the spectrometer as one example of a sensor; not that it emits light. Though claim 15 in its present form was originally filed, there is no disclosure, other than claim 15, that a spectrometer can emit light. Should the disclosed spectrometer be capable of emitting light, Patent Owner would have to put that limitation in the specification, per 37 CFR 1.75(d), to give antecedent basis.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 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.
With respect to claim 1, “the reflected first light” and “the reflected second light” lack antecedent basis, as the claim limitation “reflected by interstitial fluid of the body at a depth below an exterior surface of a surface of the body of the user” has been deleted.
With respect to claim 9, “the reflected light or the backscatter” lacks antecedent basis, as the claim limitation “reflected or backscattered by the blood or the sub- epidermis tissue” has been deleted.
With respect to claims 15 and 17, “the reflected light or backscattered light” lacks antecedent basis for the same reason.
Also with respect to claim 15, since a spectrometer measures light; not emits light, it appears that this limitation of claim 15 is confusing.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 14 of U.S. Patent No. 10,307,101 in view of US 2011/0301441 to Bandic et al. (Bandic et al.).
With respect to claim 1 of the application, claim 1 of the ‘101 patent teaches:
18/807,733
1. (Amended) A device comprising:
a housing having an outer surface configured to affix to a body of a user;
Patent 10,307,101
1. An electronic device comprising: a housing having an outer surface shaped to affix to a body of a user, wherein the housing comprises a first cavity, a second cavity, and a third cavity;
a light source embedded within the housing at a first position, wherein the light source is operable to:
a first light source embedded within the first cavity at a first position; wherein the first light source is operable to
emit a first light into the body at a first wavelength of light corresponding to a wavelength absorbed by sodium; and emit a second light into the body at a second wavelength of light corresponding to a wavelength absorbed by potassium;
emit a first light into the body at a first wavelength of light corresponding to a wavelength absorbed by sodium, and a second light source embedded within the second cavity at a second position; wherein: the second light source is operable to emit a second light into the body at a second wavelength of light corresponding to a wavelength absorbed by potassium;
an optical sensor embedded within the housing at a second position, wherein the optical sensor is operable to detect a portion of the first light and the second light;
an optical sensor embedded within the third cavity at a third position, wherein the optical sensor is to detect a portion of the first light and the second light reflected by a muscular-walled tube of the body at a depth below an exterior of the body of the user;
a first bio-impedance sensor attached to the housing third position at a such that the first bio-impedance sensor is positioned to transmit an electrical current through the body of the user;
a second bio-impedance sensor attached to the housing at a fourth position such that the second bio-impedance sensor is positioned to receive the electrical current transmitted through the body of the user by the first bio-impedance sensor; and
a processing device configured to: determine a sodium to potassium ratio of the user based on the reflected first light and the reflected second light; and determine a physiological condition of the user based a trend of the sodium to potassium ratio over a period of time and the received electrical current.
and a processing device is to: determine a sodium to potassium ratio of the user based on the reflected first light and the reflected second light; and determine a hydration condition of the user based a trend of the sodium to potassium ratio over a period of time.
Claim 1 of the ‘101 patent does not claim a first bio-impedance sensor attached to the housing third position at a such that the first bio-impedance sensor is positioned to transmit an electrical current through the body of the user and a second bio-impedance sensor attached to the housing at a fourth position such that the second bio-impedance sensor is positioned to receive the electrical current transmitted through the body of the user by the first bio-impedance sensor.
Bandic et al. teaches a wearable hydration monitor (figure 94) to determine the level of sodium and potassium in a blood stream (para. [0828]) and also teaches (paras. [1565]-[1567]) that “FIG. 148 is a block diagrammatic view of a system facilitating implementation of a process using a pair of electrodes for measurement of skin impedance, designed and implemented in accordance with certain embodiments of the invention.” As there are a pair of electrodes, then there is a first bio-impedance sensor and a second bio-impedance sensor.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the device claimed in claim 1 with a first bio-impedance sensor attached to the housing third position at a such that the first bio-impedance sensor is positioned to transmit an electrical current through the body of the user and a second bio-impedance sensor attached to the housing at a fourth position such that the second bio-impedance sensor is positioned to receive the electrical current transmitted through the body of the user by the first bio-impedance sensor, in view of the teaching of Bandic et al., in order to measure the hydration of a user (See para. [1567]).
With respect to claim 2, claim 1 of the ‘101 patent and Bandic et al. teach wherein: the housing comprises a band configured to affix to the body of the user (Bandic et al.); and the light source and optical sensor are embedded (claim 1 of the ‘101 patent ) into a bottom portion of the band (See figure 94). It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the device claimed in claim 1 of the ‘101 patent with a band configured to affix to the body of the user, in view of the teaching of Bandic et al., in order to affix the device to a user.
With respect to claim 3, Bandic et al. renders obvious the claim language wherein: the housing comprises a band configured to affix to a wrist of the user (Bandic et al.), and claim 1 of the ‘101 patent renders obvious the light source and the optical sensor are embedded into a bottom portion of the band such that the light source and the optical sensor are located adjacent to a bottom surface of the wrist when the device is worn by the user, as claim 1 teaches the light source and optical sensor are embedded in the device and It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the device claimed in claim 1 of the ‘101 patent with a band configured to affix to the body of the user and have light source and the optical sensor are embedded into a bottom portion of the band.
With respect to claim 4, this limitation is met by claim 3 the ‘101 patent: wherein the processing device is further to: compare the first measurement of backscatter of the first wavelength of light to a previous measurement of backscatter of the first wavelength of light; determine a change in a sodium level of the body when an amount of backscatter of the first wavelength of light changes; compare the second measurement of backscatter of the second wavelength of light to a previous measurement of backscatter of the second wavelength of light; and determine a change in a potassium level of the user when an amount of backscatter of the second wavelength of light changes.
With respect to claim 5, this limitation is also met by claim 3 the ‘101 patent. See claim 3 above.
With respect to claim 6, claim 1 of the ‘101 patent teaches to “determine a hydration condition of the user based a trend of the sodium to potassium ratio over a period of time.”
With respect to claim 7, this limitation is also met by claim 5 the ‘101 patent.
With respect to claim 8, this limitation is also met by claim 6 the ‘101 patent.
With respect to claim 9, claim 7 of the ‘101 patent teaches:
18/807,733
9. (Amended) An apparatus comprising:
Patent 10,307,101
7. An apparatus comprising:
a housing configured to affix to a wrist of a user;
a housing;
a light source embedded within the housing along an inner surface of the band at a first location at a bottom of the band such that the light source is located adjacent to a bottom surface of the wrist when the apparatus is worn by the user, wherein the light source is operable to emit a light into a body of the user at a wavelength of light corresponding to a wavelength absorbed by blood or sub-epidermis tissue of the user;
a light source disposed at an edge of the housing in a first position, wherein the light source, when affixed to a surface of a body, is operable to emit light into the body from the first position;
a first optical sensor disposed at the edge of the housing in a second position, the second position being a first fixed distance from the first position to measure a first backscatter of the light from an artery of the body at a first depth below the surface of the body;
an optical sensor embedded within the housing along the inner surface of the band at a second location at the bottom of the band such that the optical sensor is positioned to detect a first portion of the light;
and a second optical sensor disposed at the edge of the housing in a third position, the third position being a second fixed distance from the first position to measure a second backscatter of the light from a vein of the body at a second depth below the surface of the body (first and second optical sensors do this)
a first bio-impedance sensor embedded within the housing along the inner surface of the band at a third location at the bottom of the band such that the first bio-impedance sensor is positioned to transmit an electrical current through a second portion of the blood or the sub-epidermis tissue of the user;
a second bio-impedance sensor embedded within the housing along the inner surface of the band at a fourth location at the bottom of the band such that the second bio- impedance sensor is positioned to receive the electrical current transmitted through the second portion of the blood or the sub-epidermis tissue of the user by the first bio- impedance sensor; and
a processing device is configured to determine a physiological condition of the user based on the reflected light or the backscatter detected by the optical sensor and the electrical current received by the second bio-impedance sensor.
a processing device configured to determine a trend in a hydration condition of the body based on the first backscatter of light and the second backscatter of light.
Claim 7 of the ‘101 patent does not claim the first and second bio-impedance sensors, as claimed above in claim 9.
Bandic et al. teaches a wearable hydration as discussed above and also teaches (paras. [1565]-[1567]) that “FIG. 148 is a block diagrammatic view of a system facilitating implementation of a process using a pair of electrodes for measurement of skin impedance, designed and implemented in accordance with certain embodiments of the invention.” As there are a pair of electrodes, then there is a first bio-impedance sensor and a second bio-impedance sensor.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the device claimed in claim 7 with a first bio-impedance sensor attached to the housing third position at a such that the first bio-impedance sensor is positioned to transmit an electrical current through the body of the user and a second bio-impedance sensor attached to the housing at a fourth position such that the second bio-impedance sensor is positioned to receive the electrical current transmitted through the body of the user by the first bio-impedance sensor, in view of the teaching of Bandic et al., in order to measure the hydration of a user (See para. [1567]).
Further, Bandic et al. teaches the housing comprises a band configured to affix to the body of the user (See figure 94). It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the device claimed in claim 7 of the ‘101 patent with a band configured to affix to the body of the user, in view of the teaching of Bandic et al., in order to affix the device to a user.
With respect to claim 10, this limitation is rendered obvious by claim 8 the ‘101 patent: wherein the housing comprising a cavity disposed on a first plane of an outer surface of the housing, wherein the light source is embedded within the cavity such that a first end of the light source does not extend beyond the first plane of the outer surface of the housing. It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify claim 8 to have a first cavity disposed along the inner surface of the band, wherein the light source is embedded within the first cavity such that an end of the light source does not extend beyond a plane of the inner surface of the band; and a second cavity disposed along the inner surface of the band, wherein the optical sensor is embedded within the second cavity such that an end of the optical sensor does not extend beyond the plane of the inner surface of the band, as claim 8 already taught to have one cavity not extend beyond the plane of the inner surface of the band, to have a second cavity is a mere duplication of parts. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
With respect to claim 11, this limitation is also met by claim 9 the ‘101 patent.
With respect to claim 12, this limitation rendered obvious by claim 8 the ‘101 patent in combination with Bandic et al. Claim 8 of the ‘101 patent is recited above with respect to claim 10 of the application, Bandic et al. teaches a first and a second bio-impedance sensor as described above. It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to provide to claim 8 of the ‘101 patent with a first cavity disposed along the inner surface of the band, wherein the first bio-impedance sensor is embedded within the first cavity such that the first bio-impedance sensor does not extend beyond a plane of the inner surface of the band; and a second cavity disposed along the inner surface of the band, wherein the second bio-impedance sensor is embedded within the second cavity such that the second bio-impedance sensor does not extend beyond the plane of the inner surface of the band, as Bandic et al. teaches the two bio-impedance sensors and Claim 8 of the ‘101 patent teaches that these sensors do not extend beyond the first plane of the outer surface of the housing. Such motivation would be to eliminate any irritations on the skin of a user from any protuberances.
With respect to claim 13, this limitation is rendered obvious by claim 8 the ‘101 patent in combination with Bandic et al., as explained above with respect to claim 12.
With respect to claim 14, this limitation is also met by claim 10 the ‘101 patent.
With respect to claim 15, as best understood, this limitation is also met by claim 7 (“a first optical sensor disposed at the edge of the housing in a second position, the second position being a first fixed distance from the first position to measure a first backscatter of the light from an artery of the body at a first depth below the surface of the body”) and Bandic et al: wherein: the light source is a spectrometer (LED- Bandic et al.) configured to emit light across a defined range of wavelengths of light; and the optical sensor is configured to detect the reflected or backscattered light within the defined range of wavelengths of light (See paras. [0824] and [0828]).
With respect to claim 16, Bandic et al. teaches wherein the defined range of wavelengths of light includes a first wavelength corresponding to sodium of the body and a second wavelength corresponding to potassium of the body (See para. [0828]. Since there are mentioned “or other specific wavelengths” (plural), Bandic et al. is considered to teach a first light and a second light of a wavelength corresponding to a wavelength absorbed by sodium and potassium). It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify claim 7 to have the defined range of wavelengths of light includes a first wavelength corresponding to sodium of the body and a second wavelength corresponding to potassium of the body, in view of the teaching of Bandic et al., in order to monitor the hydration level of a user.
With respect to claim 17, claim 7 of the ‘101 patent teaches determining a hydration condition of the user based on the reflected light or the back scatter detected by the optical sensor and Bandic et al. teaches determining a hydration condition by the electrical current received by the second bio-impedance sensor.
With respect to claim 18, claim 14 of the ‘101 patent teaches:
18/807,733
18. (Amended) A method comprising:
10,370,101
14. A method comprising:
emitting, by a light source affixed to a body at a first position, a first wavelength of light into the body;
emitting, by a light source affixed to a body at a first position, a first wavelength of light into the body;
receiving, by an optical sensor affixed to the body at a second position, light from a depth below a surface of the body corresponding to blood or sub-epidermis tissue of the body;
receiving, by an optical sensor affixed to the body at a second position, light from a depth below a of the body corresponding to a muscular-walled tube of the body, wherein:
receiving, by a bio-impedance sensor affixed to the body at a third position, an electrical current transmitted through the body, wherein:
the first position is at a fixed distance from the second position; and
the first position of the light source is at a first side of a muscular walled tube of the body and the second position of the optical sensor is at a second side of the muscular walled tube such that the light source and the optical sensor straddle the muscular walled tube; and
the first position is at a fixed distance from the second position to detect backscatter from the depth below the surface of the body; and the first position of the light source is at a first side of the muscular walled tube of the body and the second position of the optical sensor is at a second side of the muscular walled tube such that the light source and the optical sensor straddle the muscular walled tube;
determining a physiological condition of the body when a current amount of light reflected or backscattered by the blood or the sub-epidermis tissue and received by the optical sensor is different than a previous amount of light reflected or backscattered by the blood or the sub-epidermis tissue and received by the optical sensor and based on the received electrical current.
determining, by a sensor interface, a current sodium to potassium ratio of the body based on the detected backscatter of the first wavelength of light; comparing, by a processing device, the current sodium to potassium ratio to a previous sodium to potassium ratio of the body; and determining a hydration condition of the body when the current sodium to potassium ratio is different than the previous sodium to potassium ratio.
Claim 14 of the ‘101 patent does not claim a bio-impedance sensor affixed to the body at a third position, an electrical current transmitted through the body, as claimed above in claim 18.
Bandic et al. teaches a wearable hydration as discussed above and also teaches (paras. [1565]-[1567]) that “FIG. 148 is a block diagrammatic view of a system facilitating implementation of a process using a pair of electrodes for measurement of skin impedance, designed and implemented in accordance with certain embodiments of the invention.” As there are a pair of electrodes, then there is a first bio-impedance sensor and a second bio-impedance sensor.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the device claimed in claim 14 with a first bio-impedance sensor affixed to the body at a third position, receiving an electrical current transmitted through the body, in view of the teaching of Bandic et al., in order to measure the hydration of a user (See para. [1567]).
Claims 19 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 10,307,101 in view of US 2011/0301441 to Bandic et al. (Bandic et al.) and US 2017/017484 to Sonner et al. (Sonner et al.).
With respect to claim 19, claim 14 of the ‘101 patent and Bandic et al. do not claim wherein: the light source is embedded within a band affixed to a wrist of the body at a first location at a bottom of the band such that the light source is located adjacent to a bottom surface of the wrist when the band is worn by a user; and the optical sensor is embedded within the band at a second location at the bottom of the band such that the optical sensor is located adjacent to the bottom surface of the wrist when the band is worn by the user.
The publication to Sonner et al. teaches a wearable sweat sensor device (1) may include a plurality of sensors (150, 160, 170, 180) that are embedded in a substrate 100 supports the sensors (See figures 1-3). From para. [0016]: “Therefore, in FIG. 3, the electronics and more robust sensing electrodes, such as impedance electrodes, can be made part of a reusable component (e.g., patch, watch, bracelet, part of a shoulder pad, etc.), while the sensors can be added prior to use and disposed of afterward.”
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to provide claim 14 of the ‘101 patent with a light source is embedded within a band affixed to a wrist of the body at a first location at a bottom of the band such that the light source is located adjacent to a bottom surface of the wrist when the band is worn by a user; and the optical sensor is embedded within the band at a second location at the bottom of the band such that the optical sensor is located adjacent to the bottom surface of the wrist, in view of the teaching of Sonner et al., in order to recess the light source and sensor within the housing to be unobtrusive and not irritating.
With respect to claim 20, claim 14 of the ‘101 patent and Bandic et al. do not claim further comprising: transmitting an electrical current through a portion of the blood or the sub-epidermis tissue of the user by a first bio-impedance sensor embedded within the band along the bottom surface of the band at a third location; and receiving the electrical current transmitted through the portion of the blood or the sub-epidermis tissue of the user by a second bio-impedance sensor embedded within the band along the bottom surface of the band at a fourth location.
Bandic et al. do teach transmitting an electrical current through a portion of the blood or the sub-epidermis tissue of the user by a first bio-impedance sensor and receiving the electrical current transmitted through the portion of the blood or the sub-epidermis tissue of the user by a second bio-impedance sensor, as explained above.
The publication to Sonner et al. teaches a wearable sweat sensor device (1) may include a plurality of sensors (150, 160, 170, 180) that are embedded in a substrate 100 supports the sensors (See figures 1-3), as explained above.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to provide claim 14 of the ‘101 patent, in combination with Bandic et al., with a first bio-impedance sensor embedded within the band along the bottom surface of the band at a third location, and a second bio-impedance sensor embedded within the band along the bottom surface of the band at a fourth location, in view of the teaching of Sonner et al., in order to recess the bio-impedance sensors within the housing to be unobtrusive and not irritating.
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.
Claim(s) 1-7, 9-13 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0301441 to Bandic et al. (Bandic et al.) in combination with US 2017/017484 to Sonner et al. (Sonner et al.).
With respect to claim 1, Bandic et al. teaches a device 9400 comprising:
a housing (See annotated figure 94 below. There is a housing attached to a band.) and having an outer surface configured to affix to a body of a user (para. [0805]: “Embodiments of the WHM 9400 may also have one or more sensors for measuring various body and environmental parameters. Examples of body parameters that could be measured by the wearable skincare device are hydration level, skin turgor, body temperature, hemoglobin antioxidant level, etc.”);
a light source (9402A-D), wh