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 .
Note Regarding Prior Art
Examiner cites particular sections, columns, line numbers, paragraphs and figures, in the references as applied to the claims below for the convenience of the Applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the Applicant fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 – 6, 10 – 16, 19 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hyldahl et al. (Cite No. 2 (on page 2) on the IDS filed 3/2/2026 by Applicant; hereinafter “Hyldahl”).
Regarding claim 1, Hyldahl teaches a method of performing Doubly Labeled Water (DLW) analysis (section 2.4), the method comprising:
providing, to a user, a DLW dose for the user to ingest, the DLW dose including deuterium and oxygen-18, wherein an amount of the deuterium is less than 0.12 grams per kilogram (g/kg) of body water of the user, and wherein an amount of the oxygen-18 is less than 0.18 g/kg of body water of the user (section 2.4; Table 1);
receiving, from the user, a non-cooled shipment of urine samples collected in connection with ingestion of the DLW dose, wherein the urine samples remain uncooled after collection and during transit for a period of up to 24 days (section 2.4: urine samples were stored in sterile screw-cap storage vials at ambient temperature and recovered on day 11); and
processing the urine samples with a liquid water isotope analyzer to determine one or more metabolic parameters of the user (section 2.4: energy expenditure).
Regarding claim 2, Hyldahl teaches the method of claim 1, wherein: the DLW dose includes approximately 0.035 g/kg body water of deuterium and approximately 0.070 g/kg body water of oxygen-18 (section 2.4: it is implicit that providing any customized DLW dose based on a user body weight is standard in DLW analysis).
Regarding claim 3, Hyldahl teaches the method of claim 1, further comprising:
providing a first mailed kit to the user, the first mailed kit including an initial DLW dose of less than 0.12 g/kg of body water of the deuterium and less than 0.18 g/kg of body water of the oxygen-18 (section 2.4: it is implicit that providing a mailed kit comprising any number of necessary number of vials is a minor change which comes within the scope of the customary practice followed by persons of ordinary skill in the art, especially as the advantages thus achieved can be readily contemplated in advance);
measuring rates of carbon dioxide (CO2) turnover and water (H2O) turnover from an analysis of urine collected for the initial DLW dose (section 2.4: energy expenditure);
determining a subsequent DLW dose for the user having reduced amounts of the deuterium and the oxygen-18 based on the CO2 turnover and the H2O turnover; and providing a second mailed kit to the user including the subsequent DLW dose.
Regarding claim 4, Hyldahl teaches the method of claim 3, wherein: the first mailed kit includes three vials including a first vial for storing urine collected before ingestion of the DLW dose, a second vial for storing urine collected approximately four to six hours after ingestion of the DLW dose, and a third vial for storing urine collected approximately one week after ingestion of the DLW dose (section 2.4: it is implicit that providing a mailed kit comprising any number of necessary number of vials is a minor change which comes within the scope of the customary practice followed by persons of ordinary skill in the art, especially as the advantages thus achieved can be readily contemplated in advance).
Regarding claim 5, Hyldahl teaches the method of claim 4, wherein: the first mailed kit includes a box configured to house the three vials for shipment in an uncooled state (section 2.4: it is implicit that providing a mailed kit comprising any number of necessary number of vials is a minor change which comes within the scope of the customary practice followed by persons of ordinary skill in the art, especially as the advantages thus achieved can be readily contemplated in advance).
Regarding claim 6, Hyldahl teaches the method of claim 4, further comprising: providing, to each of a plurality of users, the first mailed kit including the DLW dose and the three vials (section 2.4: it is implicit to incorporate features related to applying the DLW analysis to a plurality of users, and/or calibrating that are minor changes which come within the scope of the customary practice followed by persons of ordinary skill in the art, especially as the advantages thus achieved can be readily contemplated in advance);
receiving the three vials from each of the plurality of users;
processing urine samples from a plurality of first vials of the plurality of users in a first liquid water isotope analyzer (section 2.4: energy expenditure);
processing urine samples from a plurality of second vials of the plurality of users in a second liquid water isotope analyzer (section 2.4: energy expenditure); and
processing urine samples from a plurality of third vials of the plurality of users in a third liquid water isotope analyzer (section 2.4: energy expenditure).
Regarding claim 10, Hyldahl teaches the method of claim 1, further comprising: receiving body weight information of each user of a plurality of users; and providing, to each user, a customized amount of deuterium and oxygen-18 in the DLW dose based on the body weight information (section 2.4: it is implicit that providing any customized DLW dose based on a user body weight is standard in DLW analysis).
Regarding claim 11, Hyldahl teaches a method of performing Doubly Labeled Water (DLW) analysis, the method comprising:
providing, to each of a plurality of users, a DLW dose for the user to ingest, the DLW dose including deuterium and oxygen-18, wherein an amount of the deuterium is less than 0.12 grams per kilogram (g/kg) of body water of the user, and wherein an amount of the oxygen-18 is less than 0.18 g/kg of body water of the user (section 2.4: it is implicit that providing any customized DLW dose based on a user body weight is standard in DLW analysis);
receiving, from each user, three vials of urine collected in connection with ingestion of the DLW dose (section 2.4: urine samples were stored in sterile screw-cap storage vials at ambient temperature and recovered on day 11); and
measuring samples of the three vials with one or more liquid water isotope analyzers to determine one or more metabolic parameters of each user (section 2.4: energy expenditure).
Regarding claim 12, Hyldahl teaches the method of claim 11, wherein: the DLW dose includes less than 0.08 g/kg of deuterium and less than 0.12 g/kg of oxygen-18 (section 2.4: it is implicit that providing any customized DLW dose based on a user body weight is standard in DLW analysis).
Regarding claim 13, Hyldahl teaches the method of claim 11, wherein: the DLW dose includes approximately 0.035 g/kg body water of deuterium and approximately 0.070 g/kg body water of oxygen-18 (section 2.4: it is implicit that providing any customized DLW dose based on a user body weight is standard in DLW analysis).
Regarding claim 14, Hyldahl teaches the method of claim 11, further comprising: providing a first mailed kit to a user (section 2.4: it is implicit that providing a mailed kit comprising any number of necessary number of vials is a minor change which comes within the scope of the customary practice followed by persons of ordinary skill in the art, especially as the advantages thus achieved can be readily contemplated in advance), the first mailed kit including an initial DLW dose of less than 0.12 g/kg of body water of the deuterium and less than 0.18 g/kg of body water of the oxygen-18 (section 2.4: it is implicit that providing any customized DLW dose based on a user body weight is standard in DLW analysis);
measuring rates of carbon dioxide (CO2) turnover and water (H2O) turnover from an analysis of urine collected for the initial DLW dose (section 2.4: energy expenditure);
determining a subsequent DLW dose for the user having reduced amounts of the deuterium and the oxygen-18 based on the CO2 turnover and the H2O turnover (section 2.4: it is implicit that features related to applying the DLW analysis to a plurality of users, and/or calibrating that are minor changes which come within the scope of the customary practice followed by persons of ordinary skill in the art, especially as the advantages thus achieved can be readily contemplated in advance); and
providing a second mailed kit to the user including the subsequent DLW dose (section 2.4: it is implicit that providing a mailed kit comprising any number of necessary number of vials is a minor change which comes within the scope of the customary practice followed by persons of ordinary skill in the art, especially as the advantages thus achieved can be readily contemplated in advance).
Regarding claim 15, Hyldahl teaches the method of claim 11, wherein: the three vials include a first vial for storing urine collected before ingestion of the DLW dose (section 2.4: urine samples were stored in sterile screw-cap storage vials at ambient temperature and recovered on day 11), a second vial for storing urine collected approximately four to six hours after ingestion of the DLW dose, and a third vial for storing urine collected approximately one week after ingestion of the DLW dose (section 2.4: it is implicit to incorporate features related to applying the DLW analysis to a plurality of users, timing of urine sample collection, and/or calibrating that are minor changes which come within the scope of the customary practice followed by persons of ordinary skill in the art, especially as the advantages thus achieved can be readily contemplated in advance).
Regarding claim 16, Hyldahl teaches the method of claim 15, further comprising: measuring (section 2.4: energy expenditure), with a first liquid water isotope analyzer, urine samples from a plurality of first vials of the plurality of users (section 2.4: it is implicit to incorporate features related to applying the DLW analysis to a plurality of users, and/or calibrating that are minor changes which come within the scope of the customary practice followed by persons of ordinary skill in the art, especially as the advantages thus achieved can be readily contemplated in advance);
measuring, with a second liquid water isotope analyzer, urine samples from a plurality of second vials of the plurality of users; and
measuring, with a third liquid water isotope analyzer, urine samples from a plurality of third vials of the plurality of users.
Regarding claim 19, Hyldahl teaches the method of claim 16, wherein: the liquid water isotope analyzers measure the urine samples in parallel to determine the one or more metabolic parameters of each user (section 2.4: energy expenditure).
Regarding claim 20, Hyldahl teaches the method of claim 11, further comprising: receiving body weight information of each of the plurality of users; and providing, to each user, a customized amount of deuterium and oxygen-18 in the DLW dose based on the body weight information (section 2.4: it is implicit that providing any customized DLW dose based on a user body weight is standard in DLW analysis).
Allowable Subject Matter
Claims 7 – 9, 17 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 7, Hyldahl and the additional cited prior art neither teaches nor fairly suggests the method of claim 6, wherein processing urine samples further comprises:
processing a first group of three calibrated standard water samples before and after processing one or more first vials of urine samples, wherein an isotopic composition of the first group of standard water samples spans less than 153.2 per mil in deuterium and less than 18.5 per mil in oxygen-18;
processing a second group of three calibrated standard water samples before and after processing one or more second vials of urine samples, wherein an isotopic composition of the second group of standard water samples spans less than 274.8 per mil in deuterium and less than 36.4 per mil in oxygen-18; and
processing a third group of three calibrated standard water samples before and after processing one or more third vials of urine samples, wherein an isotopic composition of the second group of standard water samples spans less than 191.0 per mil in deuterium and less than 26.3 per mil in oxygen-18.
Regarding claim 17, Hyldahl and the additional cited prior art neither teaches nor fairly suggests the method of claim 16, further comprising:
measuring a first group of three calibrated standard water samples before and after measuring one or more first vials of urine samples, wherein an isotopic composition of the first group of standard water samples spans less than 153.2 per mil in deuterium and less than 18.5 per mil in oxygen-18;
measuring a second group of three calibrated standard water samples before and after measuring one or more second vials of urine samples, wherein an isotopic composition of the second group of standard water samples spans less than 274.8 per mil in deuterium and less than 36.4 per mil in oxygen-18; and
measuring a third group of three calibrated standard water samples before and after measuring one or more third vials of urine samples, wherein an isotopic composition of the second group of standard water samples spans less than 191.0 per mil in deuterium and less than 26.3 per mil in oxygen-18.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
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