DETAILED ACTION
In application filed on 02/27/2023, Claims 1-5,7-12 and 19-25 are pending. The claim set submitted on 06/04/2026 is considered because this is the most recent claim set with some preliminary amendments. Claims 1-5, 7-12 and 19-25 are considered in the current 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 .
Claim Objections
Claims 1 and 21-25 are objected to because of the following informalities:
Claim 1 recites “a stable non-radioactive isotope labeled endogenous molecule” in line 2-3 and “non-radioactive isotope labeled endogenous molecule” in line 5.
In light of the consistent recitation of “the stable non-radioactive isotope label” in Claims 2-10, Examiner suggests that the limitation “a stable non-radioactive isotope labeled endogenous molecule” and “non-radioactive isotope labeled endogenous molecule” in Claim 1 should be recited as “an endogenous molecule to which a stable non-radioactive isotope label is added.
Appropriate correction is required.
Claim 21 recites “the method of Claim 15”. Examiner submits that Claim 15 is cancelled and it appears that claim 21 should be recited to be dependent on Claim 19 or Claim 20.
For the purpose of expedited examination, Examiner interprets the “the method of Claim 15”) as “the method of Claim 19” or “the method of Claim 20”.
Appropriate correction is required.
Further, the numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
The Misnumbered claim 23 (New) been renumbered as claim 24; The Misnumbered claim 24 (New) been renumbered as claim 25; and The Misnumbered claim 25 (New) been renumbered as claim 26.
Appropriate correction is required.
Further, Claims 1, 22 and 25 recites “the step…”. It appears that this limitation should be recited as “a step”.
Appropriate correction is required.
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, 4-5, 7-8 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Bateman et al. (US20130115716A1).
Regarding Claim 1, Bateman teaches a method for determining medication adherence (See Abstract…A method for determining A.beta. turnover in blood includes the use of a labeled amino acid to assess the turnover rate; See Para 0010…a method for determining Aβ metabolism in blood), comprising
the step of administering to a patient in need thereof a stable non-radioactive isotope labeled endogenous molecule (See Para 0047…subjects were administered a labeled amino acid (13C6 leucine..; Under BRI, amino acid is the endogenous molecule; See Para 0014…an amino acid may be labeled with a stable non-radioactive isotope. Non-limiting examples may include 2H, 13C, 15N, 17O, 18O, 33S, 34S, or 36S.);
obtaining a sample from the patient's blood, urine, saliva and/or hair (See Para 0047…and then blood samples were taken every hour for 0-15 hr,).
While Bateman teaches that Amino acids may be labeled using any method known in the art, as long as the amino acid may be incorporated into Aβ and allows the detection of the turnover of Aβ in the blood (Para 0014),
Bateman does not explicitly teach assaying the sample for a concentration of the non-radioactive isotope labeled endogenous molecule in the sample ( where the labeled amino acid is the stable non-radioactive isotope labeled endogenous molecule).
However, Bateman further teaches assaying (‘analyzing’) the sample(‘blood’) for a concentration of the non-radioactive isotope labeled endogenous molecule (‘amount of labeled Aβ in blood’) in the sample (See Para 0028… analyzing the sample to determine the turnover of Aβ in blood. Generally speaking, analyzing the sample encompasses (a) detecting and quantifying labeled and unlabeled Aβ in a blood sample; Also See Claim 1… (c) determining the amount of labeled Aβ and/or unlabeled Aβ in the blood sample, wherein the amount of labeled Aβ and/or unlabeled Aβ is used to determine the turnover of Aβ in the blood sample.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bateman to incorporate assaying the sample for a concentration of the non-radioactive isotope labeled endogenous molecule in the sample, for the benefit of a) detecting and quantifying labeled and unlabeled Aβ in a blood sample and (b) deriving the turnover of Aβ from the quantity of labeled and unlabeled Aβ in the blood sample (Bateman, Para 0028), allowing for better treatments be developed and delivered at the earliest stage of the Alzheimer disease (Bateman, Para 0004).
Regarding Claim 4, the method of Claim 1 is obvious over Bateman.
Bateman teaches that the stable non-radioactive isotope label (See Para 0014…a stable non-radioactive isotope. Non-limiting examples may include 2H, 13C, 15N, 17O, 18O, 33S, 34S, or 36S. ) is added (See Para 0014… an amino acid may be labeled with a stable non-radioactive isotope) to the endogenous molecule (referred to as an amino acid [Para 0014]) at a dosage level between about 0.1 mg to about 50 mg (See Para 0021… the amount may be between about 0.01 mg/kg/hr to about 4.5 mg/kg/hr. For instance, the amount may be about 0.001, 0.005, 0.01, 0.15, 0.2, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, or 4.5 mg/kg/hr; See Para 0047… subjects were administered a labeled amino acid (13C6 leucine; infused over 9 hours with a 10 minute primed infusion 2 mg/kg, followed by 2 mg/kg/hour for 8 hours and 50 minutes).
Regarding Claim 5, the method of Claim 4 is obvious over Bateman.
Bateman teaches that the stable non-radioactive isotope label (See Para 0014…a stable non-radioactive isotope. Non-limiting examples may include 2H, 13C, 15N, 17O, 18O, 33S, 34S, or 36S) further comprises at least one of a stable isotope of carbon, nitrogen or oxygen (See Para 0014…a stable non-radioactive isotope. Non-limiting examples may include 2H, 13C, 15N, 17O, 18O, 33S, 34S, or 36S).
Regarding Claim 7, the method of Claim 1 is obvious over Bateman.
Bateman teaches that the stable non-radioactive isotope label (See Para 0014…a stable non-radioactive isotope. Non-limiting examples may include 2H, 13C, 15N, 17O, 18O, 33S, 34S, or 36S) is added to an amino acid (See Para 0014… an amino acid may be labeled with a stable non-radioactive isotope).
Regarding Claim 8, the method of Claim 1 is obvious over Bateman.
Bateman teaches that the stable non-radioactive isotope label (See Para 0014…a stable non-radioactive isotope. Non-limiting examples may include 2H, 13C, 15N, 17O, 18O, 33S, 34S, or 36S) is added (See Para 0014…amino acids may be labeled using any method known in the art, as long as the amino acid may be incorporated into Aβ and allows the detection of the turnover of Aβ in the blood.) to a protein (See Para 0009…As used herein, “Aβ” refers to total amyloidβ, an amyloidβ isoform such as Aβ38, Aβ40, or Aβ42).
Regarding Claim 22, Bateman teaches a method for determining medication adherence (See Abstract…A method for determining A.beta. turnover in blood includes the use of a labeled amino acid to assess the turnover rate; See Para 0010…a method for determining Aβ metabolism in blood), comprising
the step of administering to a patient in need thereof an endogenous molecule having a one or more stable non-radioactive isotope labeled atoms in the endogenous molecule (See Para 0047…subjects were administered a labeled amino acid (13C6 leucine..; Under BRI, amino acid is the endogenous molecule; See Para 0014…an amino acid may be labeled with a stable non-radioactive isotope. Non-limiting examples may include 2H, 13C, 15N, 17O, 18O, 33S, 34S, or 36S.);
obtaining a sample from the patient (See Para 0047…and then blood samples were taken every hour for 0-15 hr, from the subjects),
While Bateman teaches that Amino acids may be labeled using any method known in the art, as long as the amino acid may be incorporated into Aβ and allows the detection of the turnover of Aβ in the blood (Para 0014),
Bateman does not explicitly teach assaying the sample for a concentration of the non-radioactive isotope labeled endogenous molecule (where the labeled amino acid is the stable non-radioactive isotope labeled endogenous molecule).
However, Bateman further teaches assaying (‘analyzing’) the sample(‘blood’) for a concentration of the non-radioactive isotope labeled endogenous molecule (‘amount of labeled Aβ in blood’) (See Para 0028… analyzing the sample to determine the turnover of Aβ in blood. Generally speaking, analyzing the sample encompasses (a) detecting and quantifying labeled and unlabeled Aβ in a blood sample; Also See Claim 1… (c) determining the amount of labeled Aβ and/or unlabeled Aβ in the blood sample, wherein the amount of labeled Aβ and/or unlabeled Aβ is used to determine the turnover of Aβ in the blood sample.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bateman to incorporate assaying the sample for a concentration of the non-radioactive isotope labeled endogenous molecule, for the benefit of a) detecting and quantifying labeled and unlabeled Aβ in a blood sample and (b) deriving the turnover of Aβ from the quantity of labeled and unlabeled Aβ in the blood sample (Bateman, Para 0028), allowing for better treatments be developed and delivered at the earliest stage of the Alzheimer disease (Bateman, Para 0004).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Bateman et al. (US20130115716A1) as applied to claim 1 above, and further in view of Karger et al. (EP1637163A1).
Regarding Claim 2, the method of Claim 1 is obvious over Bateman.
Bateman teaches that the stable non-radioactive isotope label (See Para 0014…a stable non-radioactive isotope. Non-limiting examples may include 2H, 13C, 15N, 17O, 18O, 33S, 34S, or 36S. ) is added (See Para 0014… an amino acid may be labeled with a stable non-radioactive isotope) to the endogenous molecule (referred to as an amino acid [Para 0014]).
Bateman does not teach the stable non-radioactive isotope label as an excipient.
In the analogous art of a composition comprising an agent for the prevention, alleviation, treatment or diagnosis of a disease and a pharmaceutically acceptable excipient, wherein said excipient is enriched with at least one type of a stable rare isotopes as a indicator of compliance with an administration plan, Karger teaches the stable non-radioactive isotope label (See Para 0011… The term "stable rare isotopes" in the context of the present invention defines an naturally occurring isotope which is stable (non-radioactive) and having a natural abundance of less than 10 percent relative to the total abundance of the given element. Examples for stable rare isotopes comprise 2H, 13C, 15 N, 17O and 18O.) as an excipient (See Para 0008… a pharmaceutically acceptable excipient, wherein said excipient is enriched with at least one type of a stable rare isotopes as a indicator of compliance with an administration plan for the composition).
Karger further discloses the term "stable rare isotopes" in the context of the present invention defines an naturally occurring isotope which is stable (non-radioactive) and having a natural abundance of less than 10 percent relative to the total abundance of the given element. Examples for stable rare isotopes comprise 2H, 13C, 15 N, 17O and 18O (Para 0011).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bateman to incorporate the stable non-radioactive isotope label as an excipient, as taught by Karger for the benefit of having the a stable rare isotopes used in enriching the excipient as a quantitative indicator of compliance with an administration plan (Karger, Para 0001), allowing for the provision of the methods for determination of the compliance with an administration plan for a composition and uses of compositions of the invention (Karger, Abstract).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bateman et al. (US20130115716A1) as applied to claim 1 above, and further in view of Notte et al. (US20130175444A1).
Regarding Claim 3, the method of Claim 1 is obvious over Bateman.
Bateman teaches that the stable non-radioactive isotope label (See Para 0014…a stable non-radioactive isotope. Non-limiting examples may include 2H, 13C, 15N, 17O, 18O, 33S, 34S, or 36S. ) is added (See Para 0014… an amino acid may be labeled with a stable non-radioactive isotope) to the endogenous molecule (referred to as an amino acid [Para 0014]).
Bateman does not teach the stable non-radioactive isotope label as a spray.
In the analogous art of microscope methods and systems, particularly as they relate to relatively light isotopes, minority isotopes or both, Notte teaches the stable non-radioactive isotope label (See claim 123… ions of an isotope of a noble gas; See Para 0003… The isotope can be a relatively light isotope, a minority isotope, or both. An example of such an isotope is He-3.) as a spray (‘sputter’) (See Claim 140… the ions sputter the sample).
Notte further teaches that any type of sample can be used. Examples of samples include biological samples (e.g., tissue, nucleic acids, proteins, carbohydrates, lipids and cell membranes), pharmaceutical samples (e.g., a small molecule drug), frozen water (e.g., ice), read/write heads used in magnetic storage devices, and metal and alloy samples (Para 0062).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bateman to incorporate that the stable non-radioactive isotope label as a spray, as taught by Notte for the benefit of modifying the sample (Notte, Para 0062), allowing for using ions of an isotope of a noble gas to investigate and/or modify a sample (Notte, Para 0003) towards sample detection (Notte, Para 0056).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bateman et al. (US20130115716A1) as applied to claim 1 above, and further in view of Dennis et al. (US20070224128A1).
Regarding Claim 9, the method of Claim 1 is obvious over Bateman.
Bateman does not explicit teach that the stable non-radioactive isotope label is added to an enzyme.
In the analogous art of novel methods for monitoring subject adherence in taking prescribed drugs by detecting markers in exhaled breath after a subject takes the prescribed drug, Dennis teaches that the stable non-radioactive isotope label (referred to as Molecular beacons [Para 0112]) is added to an enzyme (See Para 0112… are attached to natural or synthetic ligands (such as aptamers, enzymes, antibodies, etc.)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bateman to incorporate that the stable non-radioactive isotope label is added to an enzyme, as taught by Dennis for the benefit of providing fluorescence signal increases in the presence of particular target sequences (Dennis’128, Para 0112), allowing for the provision of systems and methods for non-invasive monitoring of subject adherence in taking drug(s) by analyzing a subject's exhaled breath for the presence of a marker indicative of drug absorption, distribution, metabolism, and/or excretion in the subject's body (Dennis, Para 0039).
Claims 10-11 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Bateman et al. (US20130115716A1) as applied to claim 1 above, and further in view of Jimenez et al. (US20100196308A1).
Regarding Claim 10, the method of Claim 1 is obvious over Bateman.
Bateman does not explicit teach that the stable non-radioactive isotope label is added to a vitamin.
In the analogous art of the use of vitamin D compounds, such as vitamin D3, or analogs and/or metabolites thereof, to modulate bone marrow progenitors and stromal cells prior to the administration of antineoplastic agents, Jimenez teaches that the stable non-radioactive isotope label (See Para 0107… Examples of isotopes suitable for inclusion in the compounds of the invention comprises isotopes of hydrogen, such as 2H and 3H, carbon, such as 13C and 14C, chlorine, such as 36Cl, fluorine, such as 18F, iodine, such as 123I and 125I, nitrogen, such as 13N and 15N, oxygen, such as 15O, 17O and 18O, phosphorus, such as 32P, and sulphur, such as 35S) is added to a vitamin (See Para 0107… isotopically-labeled vitamin D compounds).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bateman to incorporate that the stable non-radioactive isotope label is added to a vitamin, as taught by Jimenez for the benefit of preventing or reducing chemotherapy-induced myelosuppression in a subject being treated with a chemotherapeutic agent which induces myelosuppression by administering to the subject an effective amount of a vitamin D compound or …(Jimenez, Para 0009), allowing for the use of vitamin D compounds, such as vitamin D3 and analogs thereof, having calcemic and non-calcemic activity, administered in a pharmaceutically acceptable manner prior to the administration of anti-neoplastic drugs to treat solid tumors and/or leukemia (Jimenez, Para 0002).
Regarding Claim 11, the method of Claim 1 is obvious over Bateman.
Bateman does not teach that the endogenous molecule is selected from the group consisting of adenine, vitamin D, thyroxine, hypoxanthine, uracil, creatine, and pyridoxine.
In the analogous art of the use of vitamin D compounds, such as vitamin D3, or analogs and/or metabolites thereof, to modulate bone marrow progenitors and stromal cells prior to the administration of antineoplastic agents, Jimenez teaches that the endogenous molecule (See Para 0002… vitamin D compounds, such as vitamin D3 and analogs ;See Para 0107… isotopically-labeled vitamin D compounds, thereby teaching “endogenous molecule”) is selected from the group consisting of adenine, vitamin D, thyroxine, hypoxanthine, uracil, creatine, and pyridoxine (See Para 0002… vitamin D compounds, such as vitamin D3 and analogs ;See Para 0107… isotopically-labeled vitamin D compounds).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bateman to incorporate that the endogenous molecule is selected from the group consisting of adenine, vitamin D, thyroxine, hypoxanthine, uracil, creatine, and pyridoxine, as taught by Jimenez for the benefit of preventing or reducing chemotherapy-induced myelosuppression in a subject being treated with a chemotherapeutic agent which induces myelosuppression by administering to the subject an effective amount of a vitamin D compound or …(Jimenez, Para 0009), allowing for the use of vitamin D compounds, such as vitamin D3 and analogs thereof, having calcemic and non-calcemic activity, administered in a pharmaceutically acceptable manner prior to the administration of anti-neoplastic drugs to treat solid tumors and/or leukemia (Jimenez, Para 0002).
Regarding Claim 23, the method of Claim 22 is obvious over Bateman.
Bateman does not teach that the endogenous molecule is selected from the group consisting of adenine, vitamin D, thyroxine, hypoxanthine, uracil, creatine, and pyridoxine.
In the analogous art of the use of vitamin D compounds, such as vitamin D3, or analogs and/or metabolites thereof, to modulate bone marrow progenitors and stromal cells prior to the administration of antineoplastic agents, Jimenez teaches that the endogenous molecule (See Para 0002… vitamin D compounds, such as vitamin D3 and analogs ;See Para 0107… isotopically-labeled vitamin D compounds, thereby teaching “endogenous molecule”) is selected from the group consisting of adenine, vitamin D, thyroxine, hypoxanthine, uracil, creatine, and pyridoxine (See Para 0002… vitamin D compounds, such as vitamin D3 and analogs ;See Para 0107… isotopically-labeled vitamin D compounds).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bateman to incorporate that the endogenous molecule is selected from the group consisting of adenine, vitamin D, thyroxine, hypoxanthine, uracil, creatine, and pyridoxine, as taught by Jimenez for the benefit of preventing or reducing chemotherapy-induced myelosuppression in a subject being treated with a chemotherapeutic agent which induces myelosuppression by administering to the subject an effective amount of a vitamin D compound or …(Jimenez, Para 0009), allowing for the use of vitamin D compounds, such as vitamin D3 and analogs thereof, having calcemic and non-calcemic activity, administered in a pharmaceutically acceptable manner prior to the administration of anti-neoplastic drugs to treat solid tumors and/or leukemia (Jimenez, Para 0002).
Claims 12 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Bateman et al. (US20130115716A1) as applied to claim 1 above, and further in view of Rohan et al. (US20200253885A1).
Regarding Claim 12, the method of Claim 1 is obvious over Bateman.
Bateman does not teach that the medication further comprises an HIV pre- exposure prophylaxis medication.
In the analogous art of pharmaceutical vehicles for use in delivering therapeutic compositions to patients, more particularly, the present invention relates to films for the delivery of antiviral compositions to patients, Rohan teaches that the medication further comprises an HIV pre- exposure prophylaxis medication. (See Para 0004… Microbicides may be candidates applied vaginally or rectally for protection from sexually transmitted infections, including human immunodeficiency virus (HIV) infection. Preexposure prophylaxis (PrEP) with oral Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)/emtricitabine reduces HIV acquisition in women who demonstrate high adherence to the daily medication.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Dennis to incorporate that the medication further comprises an HIV pre- exposure prophylaxis medication, as taught by Rohan for the benefit of demonstrating the reduction of HIV acquisition in women who demonstrate high adherence to the daily medication (Rohan, Para 0004), further disclosing the effectiveness of microbicides which may be candidates applied vaginally or rectally for protection from sexually transmitted infections, including human immunodeficiency virus (HIV) infection (Rohan, Para 0004).
Regarding Claim 25 (Examiner views claim as claim 26 in light of the objection), the method of Claim 22 is obvious over Bateman.
Bateman does not teach the step of administering an HIV pre- exposure prophylaxis medication to the patient.
In the analogous art of pharmaceutical vehicles for use in delivering therapeutic compositions to patients, more particularly, the present invention relates to films for the delivery of antiviral compositions to patients, Rohan teaches that the step of administering an HIV pre- exposure prophylaxis medication (See Para 0004… Microbicides may be candidates applied vaginally or rectally for protection from sexually transmitted infections, including human immunodeficiency virus (HIV) infection. Preexposure prophylaxis (PrEP) with oral Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)/emtricitabine reduces HIV acquisition in women who demonstrate high adherence to the daily medication.) to the patient (See Claim 130-0131… wherein the film releases at least 50% of the antiretroviral composition within 10 minutes of being placed intravaginally or intrarectally in a patient…).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bateman to incorporate the step of administering an HIV pre- exposure prophylaxis medication to the patient, as taught by Rohan for the benefit of demonstrating the reduction of HIV acquisition in women who demonstrate high adherence to the daily medication (Rohan, Para 0004), further disclosing the effectiveness of microbicides which may be candidates applied vaginally or rectally for protection from sexually transmitted infections, including human immunodeficiency virus (HIV) infection (Rohan, Para 0004).
Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Bateman et al. (US20130115716A1) as applied to claim 1 above, and further in view of Grossman et al. (US20080241840A1) and further in view of Byun et al. (US20220119426A1).
Regarding Claim 19, the method of Claim 1 is obvious over Bateman.
Bateman does not teach that the stable non-radioactive isotope labeled endogenous molecule further comprises adenine.
In the analogous art of a composition for detecting a tau protein comprising a modified detector molecule having two ends, a first end capable of binding the tau protein and a second end comprising a single-stranded DNA template, wherein the template is capable of being replicated by an RNA polymerase, Grossman teaches that the stable non-radioactive isotope labeled endogenous molecule further comprises 5+ adenine (See Para 0162… adenine can be labeled with a radioactive label or a fluorescence label, or any other suitable label that can be detected.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bateman to incorporate that the stable non-radioactive isotope labeled endogenous molecule further comprises adenine, as taught by Grossman for the benefit of facilitating the detection of an antibody-antigen complex (Grossman, Para 0159), allowing to optimize the sensitivity and specificity of protein detection assays while also reducing the time and cost of these assays (Grossman, Para 0013).
The combination of Bateman and Grossman does not explicitly 5+ adenine.
In the analogous art of compounds, compositions, and method useful for treating a viral infection, such as human immunodeficiency virus (HIV) and/or hepatitis B virus (HBV) infection, are disclosed, Byun teaches 5+ adenine (See Para 0827-0828.. [adenine-13C5]).
Under BRI, the mass of adenine is 135.13 Da while the mass of Adenine-13C5 is 140.09, which shows an mass shift of 5+ , thereby teaching “5+ adenine”. The respective masses of both Adenine-13C5 and adenine are evidenced by PubChem in the pertinent art by not cited section of the office action.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination of Bateman and Grossman to incorporate the use of “5+ adenine”, as taught Byun for the benefit of determining the level of TFV-DP loading in PBMCs in the presence of human serum using LC-MS/MS (Byun, Para 0827), allowing for the provision of improved treatments for HIV and other viral infections (Byun, Para 0003).
Regarding Claim 20, the method of Claim 19 is obvious over Bateman in view of Grossman further in view of Byun.
The combination of Bateman, Grossman and Byun does not explicitly teach that the 5+ adenine is present at a dosage level between about 0.1 mg to about 50 mg.
However, MPEP § 2144.05, Part II, Subpart B holds that a particular parameter that is recognized as a result effective variable (“a variable that achieves a recognized result”) would be one, but not the only motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. During clinical trials, the selection of optimal experimental conditions including drug or API dosage assists in providing a Dose-response (D/R) relationship to manage adverse drug reactions, providing proof of the concept, to define the dose for phase III clinical trial.
Thus, the 5+ adenine being present at a dosage level between about 0.1 mg to about 50 mg is a result effective variable.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize that the 5+ adenine is present at a dosage level between about 0.1 mg to about 50 mg, as taught Byun for the benefit of determining the level of TFV-DP loading in PBMCs in the presence of human serum using LC-MS/MS (Byun, Para 0827), allowing for the provision of improved treatments for HIV and other viral infections (Byun, Para 0003).
Regarding Claim 21, the method of Claim 15 (interpreted as Claim 19) is obvious over Bateman in view of Grossman further in view of Byun.
The combination of Bateman and Grossman does not teach that the 5+ adenine includes a non- radioactive isotope of carbon, nitrogen and/or oxygen.
In the analogous art of compounds, compositions, and method useful for treating a viral infection, such as human immunodeficiency virus (HIV) and/or hepatitis B virus (HBV) infection, are disclosed, Byun teaches that the 5+ adenine (See Para 0827-0828.. [adenine-13C5]). Under BRI, the mass of adenine is 135.13 Da while the mass of Adenine-13C5 is 140.09, which shows an mass shift of 5+ , thereby teaching “5+ adenine”. The respective masses of both Adenine-13C5 and adenine are evidenced by PubChem in the pertinent art by not cited section of the office action) includes a non- radioactive isotope of carbon, nitrogen and/or oxygen (See Para 0827-0828…13C5]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination of Bateman and Grossman to incorporate the use of “5+ adenine”, as taught Byun for the benefit of determining the level of TFV-DP loading in PBMCs in the presence of human serum using LC-MS/MS (Byun, Para 0827), allowing for the provision of improved treatments for HIV and other viral infections (Byun, Para 0003).
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Bateman et al. (US20130115716A1) in view of Jimenez et al. (US20100196308A1) as applied to claim 23 above, and further in view of Grossman et al. (US20080241840A1) and further in view of Byun et al. (US20220119426A1).
Regarding Claim 23 (Examiner views claim as claim 24 in light of the objection), the method of Claim 23 is obvious over Bateman in view of Jimenez.
Bateman does not teach that the stable non-radioactive isotope labeled endogenous molecule further comprises adenine.
In the analogous art of a composition for detecting a tau protein comprising a modified detector molecule having two ends, a first end capable of binding the tau protein and a second end comprising a single-stranded DNA template, wherein the template is capable of being replicated by an RNA polymerase, Grossman teaches that the stable non-radioactive isotope labeled endogenous molecule further comprises 5+ adenine (See Para 0162… adenine can be labeled with a radioactive label or a fluorescence label, or any other suitable label that can be detected.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bateman and Jimenez to incorporate that the stable non-radioactive isotope labeled endogenous molecule further comprises adenine, as taught by Grossman for the benefit of facilitating the detection of an antibody-antigen complex (Grossman, Para 0159), allowing to optimize the sensitivity and specificity of protein detection assays while also reducing the time and cost of these assays (Grossman, Para 0013).
The combination of Bateman, Jimenez and Grossman does not explicitly 5+ adenine.
In the analogous art of compounds, compositions, and method useful for treating a viral infection, such as human immunodeficiency virus (HIV) and/or hepatitis B virus (HBV) infection, are disclosed, Byun teaches 5+ adenine (See Para 0827-0828.. [adenine-13C5]).
Under BRI, the mass of adenine is 135.13 Da while the mass of Adenine-13C5 is 140.09, which shows an mass shift of 5+ , thereby teaching “5+ adenine”. The respective masses of both Adenine-13C5 and adenine are evidenced by PubChem in the pertinent art by not cited section of the office action.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination of Bateman, Jimenez and Grossman to incorporate the use of “5+ adenine”, as taught Byun for the benefit of determining the level of TFV-DP loading in PBMCs in the presence of human serum using LC-MS/MS (Byun, Para 0827), allowing for the provision of improved treatments for HIV and other viral infections (Byun, Para 0003).
Regarding Claim 24 (Examiner views claim as claim 25 in light of the objection), the method of Claim 24 is obvious over Bateman, in view of Jimenez, further in view of Grossman and further in view of Byun.
The combination of Bateman, Jimenez and Grossman does not teach that the 5+ adenine includes a non- radioactive isotope of carbon, nitrogen and/or oxygen.
In the analogous art of compounds, compositions, and method useful for treating a viral infection, such as human immunodeficiency virus (HIV) and/or hepatitis B virus (HBV) infection, are disclosed, Byun teaches that the 5+ adenine (See Para 0827-0828.. [adenine-13C5]). Under BRI, the mass of adenine is 135.13 Da while the mass of Adenine-13C5 is 140.09, which shows an mass shift of 5+ , thereby teaching “5+ adenine”. The respective masses of both Adenine-13C5 and adenine are evidenced by PubChem in the pertinent art by not cited section of the office action) includes a non- radioactive isotope of carbon, nitrogen and/or oxygen (See Para 0827-0828…13C5]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination of Bateman, Jimenez and Grossman to incorporate the use of “5+ adenine”, as taught Byun for the benefit of determining the level of TFV-DP loading in PBMCs in the presence of human serum using LC-MS/MS (Byun, Para 0827), allowing for the provision of improved treatments for HIV and other viral infections (Byun, Para 0003).
Response to Arguments
Applicant’s arguments, see Page 8, filed 06/04/2026, with respect to the rejection(s) of claim(s) 1-3 under 35 U.S.C. §102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made for Claim 1 by Bateman et al. (US20130115716A1).
Applicant respectfully submits that the present amendments patentably distinguish over the Dennis reference. It is axiomatic that a proper rejection under § 102 requires that the cited reference must teach every element required by the claim under its broadest reasonable interpretation. MPEP 2131. Well settled case law further expounds on this requirement. "A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference." Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987). "When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art." Brown v. 3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376 (Fed. Cir. 2001) (claim to a system for setting a computer clock to an offset time to address the Year 2000 (Y2K) problem, applicable to records with year date data in "at least one of two-digit, three-digit, or four-digit" representations, was held anticipated by a system that offsets year dates in only two-digit formats). "The identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).As Dennis fails to teach each and every element of Claims 1-3 as currently amended, Applicant respectfully requests favorable reconsideration and withdrawal of the rejection of those claims under § 102.
Applicant’s arguments with respect to amended claim 1 has been considered and Examiner respectfully disagrees.
Examiner submits that the limitations of amended Claim 1 is taught as disclosed in the rejection of Claim 1 (Supra) by Bateman et al. (US20130115716A1).
Applicant’s arguments, see Page 8, filed 06/04/2026, with respect to the rejection(s) of claim(s) 4-12 under 35 U.S.C. §103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made for Claims 4-5 and 7-8 by Bateman et al. (US20130115716A1); Claim 9 by Bateman et al. (US20130115716A1) as applied to claim 1 above, and further in view of Dennis et al. (US20070224128A1); Claims 10-11 by Bateman et al. (US20130115716A1) as applied to claim 1 above, and further in view of Jimenez et al. (US20100196308A1); and Claim 12 by Bateman et al. (US20130115716A1) as applied to claim 1 above, and further in view of Rohan et al. (US20200253885A1).
Accordingly, Applicant respectfully submits that Claims 4 and 5 are patentable distinct from the combination of Dennis and Kell and respectfully requests favorable reconsideration and withdrawal of the rejection under 35 USC § 103.
Turning to the rejection of Claims 6 and 10-11 as being unpatentable over the
combination of Dennis with Jimenez, the Examiner acknowledges that Dennis does not teach that the stable non-radioactive taggant is added to an endogenous molecule.1 Jimenez is cited as teaching the use of vitamin D compounds, such as vitamin D3, or analogs and/or metabolites thereof, to modulate bone marrow progenitors and stromal cells prior administering antineoplastic agents. The Examiner points to Jimenez [0107] as teaching the inclusion of non- radioactive isotopes added to the endogenous molecule, i.e., vitamin D compounds.
This acknowledgement is material to the anticipation rejection and would appear to admit that Claim 1, as amended, is not anticipated by Dennis…
Claim 12 was rejected under 35 USC 103 as being unpatentable over Dennis in view of Rohan. Rohan does teach HTV prophylaxis by administering an antimicrobial, antiviral, or antiretroviral compounds in a film for intravaginal or intra-anal administration. However, to the extent that Claim 1, from which claim 12 depends, is allowable, Claim 12 is necessarily allowable as well.
Applicant’s arguments with respect to claims 4-12 (which are dependent on amended claim 1) has been considered and Examiner respectfully disagrees.
Examiner submits that the limitations of claims 4-12 (which are dependent on amended claim 1) is taught as disclosed in the rejection (Supra) of :
Claims 4-5 and 7-8 by Bateman et al. (US20130115716A1);
Claim 9 by Bateman et al. (US20130115716A1) as applied to claim 1 above, and further in view of Dennis et al. (US20070224128A1);
Claims 10-11 by Bateman et al. (US20130115716A1) as applied to claim 1 above, and further in view of Jimenez et al. (US20100196308A1); and
Claim 12 by Bateman et al. (US20130115716A1) as applied to claim 1 above, and further in view of Rohan et al. (US20200253885A1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
PubChem (https://pubchem.ncbi.nlm.nih.gov/compound/Adenine-13C5 and https://pubchem.ncbi.nlm.nih.gov/compound/190) discloses the molecular weight of Adenine-13C5 (140.09 g/mol ) and Adenine (135.13 g/mol).
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 OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached on (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797
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