DETAILED ACTION
Request for reconsideration of the application filed on 03/02/2026, is acknowledged. No amendment was made to the claims. Claims 1-4, 6-7, 18 and 24-29 are pending in the application and are considered on merits.
In response to reconsideration, the examiner maintains all rejections established in the previous 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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1-4, 6-7, 18 and 24-29 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101.
In the present case, the claims recite a method of “self-treating a human patient” and require multiple steps that are:
performed on and within the human patient, and
inseparably tied to the physiological state and treatment of that human individual.
The claimed method, when considered as a whole, effectively encompasses the human patient as an integral component of the claimed invention, rather than merely using a human as an external subject. The human patient is not incidental but is central to every step of the claimed method (diagnosis, treatment, and response).
Accordingly, the claims are not merely directed to a process applied to a human, but rather to a comprehensive treatment paradigm that encompasses the human organism itself.
Here, the claims:
require administering a diagnostic test to a human patient,
determining a disease state in that human patient, and
administering and controlling drug treatment within that human patient.
Because the claimed steps are inseparable from the human body and its physiological processes, the claimed invention necessarily encompasses the human organism.
The present claims are distinguishable from typical treatment claims because they:
define a complete, self-contained treatment system centered on the human patient, and
integrate diagnosis, treatment eligibility, drug administration, and ongoing monitoring in a manner that effectively claims control over the treatment of the human organism itself.
Thus, the claims go beyond merely reciting the administration of a drug and instead encompass the human organism as part of the claimed system, which falls within the scope of AIA §33(a).
When evaluated as a whole, the claims:
require a specific human patient,
define diagnostic and therapeutic steps performed directly on that patient, and
condition continued treatment on the patient’s physiological responses.
Such claims effectively define a state-dependent method governing the condition and treatment of a human body, thereby encompassing the human organism.
The prohibition of AIA §33(a) is intended to prevent claims that, in substance, cover a human organism or its condition as a whole. The present claims, by tying all limitations to the human patient’s condition and treatment, fall within that scope.
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 18 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.
In claim 18, the steps of " determining only by a trained retail pharmacist at the retail point-of-sale location, in the untreated human patient the presence of the chronic condition comprising elevated cholesterol, based on the test results of the patient from the specific CLIA-waived diagnostic test used for diagnosing the chronic condition, without any physician diagnosis of elevated cholesterol, thereby indicating that the patient would benefit from an initial treatment with OTC atorvastatin” lack adequate written description in the Specification.
Careful review of the Specification as originally filed reveals that only paragraphs 21, 35, 40, and 50 touch on the subject of making a diagnosis.
In paragraph 21, Applicant discloses that "trained healthcare personnel" located "at the point of sale" make a determination "that the patients are in need of treatment with the drug based on the results of the diagnostic test" (Spec. par 21). Although the "trained healthcare personnel" could be a pharmacist or retail pharmacist as recited in claims 18, paragraph 21 merely discloses that such a person determines treatment is needed, not that the person determines a diagnosis without the assessment and decision of a doctor.
In paragraph 35, Applicant discloses that "[a] retail healthcare person must analyze the results of the diagnostic test consistent with the requirements of the retail location's CLIA certificate of waiver" (Spec. par 35). However, this simply discloses that the retail healthcare person, even if it were a retail pharmacist or pharmacist as recited in claim 18, analyzes the diagnostic test results, not that the pharmacist determines "a presence of the chronic condition" (claim 18).
In paragraph 40, Applicant discloses one embodiment "in which the physician examines the patient and makes a diagnosis for a disease state" (Spec. par 40). That is, Applicant only discloses that the physician or doctor determines a diagnosis, not a pharmacist or retail pharmacist as recited in claims 18.
Finally, although paragraph 50 does not use the word "diagnosis," this paragraph discloses that a retail healthcare person may encompass a pharmacist that has the ability to understand diagnostic test results and "make a determination as to whether or not to offer the patient a drug regimen for the condition or disease state that the patient has been tested for" (Spec. par 50). However, paragraph 50 is simply defining what a "retail healthcare person" can encompass, it does not positively support that a pharmacist determines a disease diagnosis without an assessment and a decision of a doctor, as set forth in claim 18.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1, 7, 18, 24-25 and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Hammond et al. (Pharmacotherapy, 2003, IDS) (Hammond) in view of Applicant admitted prior art and NIH Elevated Cholesterol Guidance (National Cholesterol Education Program, 2001).
Regarding claim 1, Hammond teaches a method of self-treating a human patient for a chronic disease (page 1220, par 0), consisting of:
administering, by a pharmacy technician at a retail pharmacy point-of-sale location, an initial, test to a human patient currently untreated and not under any physician care for a chronic disease comprising elevated cholesterol, wherein the specific test is administered for diagnosing the chronic disease prior to any medication use for treating elevated cholesterol, and is required as a condition of safe use for ensuring no unsupervised, unlabeled, non-prescription medication use by the patient, the non-prescription medication being over-the-counter (OTC) drug, by obtaining a fluid sample from the human patient (pharmacist …ordering drug therapy-related laboratory tests) at the retail pharmacy point-of-sale location (pharmacy store) (page 1210, par 3);
testing, by the pharmacy technician, the fluid sample in a diagnostic machine wherein the diagnostic machine analyzes the retail pharmacy fluid sample (page 1210, par 3);
identifying, only by a trained retail pharmacist at the retail pharmacy point of-sale location, the untreated human patient as a disease-appropriate patient suffering from the chronic disease comprising elevated cholesterol, having determined the presence of the chronic disease in the patient based on the results of the specific diagnostic test used for diagnosing the chronic disease, without any physician diagnosis of elevated cholesterol, indicating that the patient would benefit from an initial treatment with OTC drug (pharmacist … performing patient assessments; ordering drug therapy related laboratory tests; administering drugs; and selecting, initiating, monitoring, continuing, and adjusting drug regiments ) (page 1210, par 3);
based on the identification, approving by the retail pharmacist, without any prescription or OTC drug regimen approved by any physician for the chronic disease comprising elevated cholesterol levels, for the human patient to receive, without the human patient seeing a doctor, a plurality of unit doses of OTC drug in sufficient amount to treat the chronic disease of the patient such that the patient can self-administer a unit dose and the chronic disease state is treated (pharmacist … performing patient assessments; ordering drug therapy related laboratory tests; administering drugs; and selecting, initiating, monitoring, continuing, and adjusting drug regiments) (page 1210, par 3);
dispensing, by the retail pharmacist, the plurality of unit doses of OTC drug to the human patient with access to the medication allowed without the human patient seeing any physician (pharmacist … performing patient assessments; ordering drug therapy related laboratory tests; administering drugs; and selecting, initiating, monitoring, continuing, and adjusting drug regiments) (page 1210, par 3); and
self-administering, by the human patient, the unit dose of OTC drug in the sufficient amount to treat a chronic disease comprising elevated cholesterol, without the patient being treated by any physician for the chronic disease (inherently done by the patient).
CDTM establishes that pharmacists, under collaborative practice agreements with physicians, are permitted to:
Perform patient assessments;
Order and interpret drug-therapy related laboratory tests;
Initiate, monitor, continue, or adjust drug regimens.
Thus, it would have been obvious to one of ordinary skill in the art (POSITA, e.g., a clinical pharmacist) that these activities encompass reviewing laboratory results (such as lipid panels) to determine disease control status.
The NIH Elevated Cholesterol Guidelines clearly define at which cholesterol level as a chronic condition diagnosed through lipid panel testing (e.g., LDL ≥ 190 mg/dL) (Step 1, Table).
Based on NIH’s guidelines, A POSITA would understand that diagnosis of high cholesterol is objective, laboratory-based, and routinely performed in primary care.
It would have been obvious to combine CDTM practice with the NIH established guidelines for elevated cholesterol diagnosis because:
CDTM expressly allows pharmacists to interpret lab results for chronic disease management.
Lipid panels are a standard, objective test, requiring no complex differential diagnosis.
A POSITA would reasonably expect success in applying CDTM to elevated cholesterol management by allowing pharmacists to identify and act upon high cholesterol test results.
Dr. Blazing’s declaration states that “The standard of care requires that a diagnosis of elevated cholesterol be confirmed by measured values that exceed defined clinical thresholds. When such a test is performed using a CLIA-waived lipid panel and appropriately placed in context based on where the values fall into guideline recommendations by a trained pharmacist, the diagnostic conclusion reached is functionally equivalent to that which would be made by a physician under similar circumstances.” (Declaration, par 8). Dr. Blazing’s declaration confirms that applying CDTM to elevated cholesterol management by allowing pharmacists to identify and act upon high cholesterol test results, the trained pharmacist is able to make the diagnostic conclusion functionally equivalent to that which would be made by a physician under the same circumstances (under the NIH Elevated Cholesterol Guidance).
Hammond does not specifically teach that the drug is atorvastatin. However, atorvastatin, brand names Lipitor, is a well-known drug for treating elevated cholesterol level as evidenced by The Free Dictionary. The Free Dictionary recites that “atorvastatin- an oral drug (trade name Lipitor) that is effective in lowering triglycerides; potent in reducing LDL cholesterol because higher doses can be given”.
Hammond does not specifically teach a specific “Clinical Laboratories Improvement Act” (CLIA) -waived diagnostic machine at the point-of-sale location. However, As defined by CLIA, waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” The Food and Drug Administration (FDA) determines which tests meet these criteria when it reviews manufacturer’s applications for test system waiver. Thus, this feature is well known in the art, as admitted by the Applicant. In particular, applicant admits that "CLIA-waived diagnostic test", "CLIA-waived diagnostic machine at the point- of-sale location, wherein the CLIA-waived diagnostic machine analyzes the fluid sample and delivers results in less than 30 minutes" are well-known in the art. For instance, par. 58 recites: "CLIA-waived diagnostic machine, Abaxis Piccolo Xpress" and par. 59 recites: "Diagnostic Test Equipment: Recently, new table-top diagnostic test equipment (the Piccolo Xpress) has been developed by Abaxis, Inc. of Union City, CA, for use at the Point of Sale or Service (POS) with physicians. The results from this machine can be delivered in under 15 minutes making its use practical for the first time in determining if a patient meets the requirements for receiving a drug under the proposed, Rx-to-OTC switch treatment method patent.". Thus, it would have been obvious to one of ordinary skill in the art to perform CLIA-waived diagnostic test at the point-of-sale location as cited by Applicant, because CLIA-waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result”, suitable for on-site test.
OTC stands for "over-the-counter", which means the medication can be purchased without a doctor’s prescription. These drugs are generally considered safe and effective for use without a healthcare provider’s supervision, as long as the instructions on the label are followed.
Some medications exist in both OTC and prescription versions because of differences in dosage strength, intended use, or how much medical supervision is needed.
Here’s a clear breakdown:
OTC Version
Prescription Version
Lower dose
Higher dose
For mild, common conditions
For more severe or chronic conditions
Meant for short-term, self-treatment
Meant for longer-term use or complex cases
Fewer risks of side effects at OTC strength
Higher risk of side effects or interactions, needs doctor monitoring
Example 1: Ibuprofen– OTC = 200 mg tablets for headaches or minor pain– Prescription = 400 mg, 600 mg, or 800 mg tablets for arthritis or serious inflammation
Example 2: Omeprazole (Prilosec)– OTC = 20 mg for short-term heartburn relief– Prescription = higher doses or longer courses to treat ulcers or GERD under doctor care
The claimed term “OTC atorvastatin” by definition is an OTC version of atorvastatin. Therefore, OTC atorvastatin can be purchased without a doctor’s prescription.
By definition, an OTC atorvastatin is a drug that is provided without a prescription, and under a CDTM agreement, a qualified pharmacist sells a drug to a patient without a prescription from a doctor. This is in agreement with Applicant's definition of OTC drugs in the Specification:
As used herein, the terms "over-the-counter" or "OTC" or "non-prescription medicine" refer to drugs that may be purchased (e.g., by a patient) without a prescription from a retail outlet such as a Food, Drug, or Mass Merchandiser retail store. All these terms are used synonymously herein. (Spec par 47).
As a result, the addition of negative limitations such as “without any prescription or OTC drug regimen approved by any physician for the chronic disease comprising elevated cholesterol levels" (claims 1) does not differentiate from the well-known method of dispensing over the counter drugs or the CDTM agreement in Hammond.
Regarding claim 18, Hammond teaches a method of self-treating a human patient for a chronic disease (page 1220, par 0) consisting of:
administering, by a pharmacy technician at a retail pharmacy point-of-sale location, an initial specific diagnostic test to an untreated human patient with the patient requesting the diagnostic test to determine whether the human patient, who is not currently under any physician care for a chronic disease comprising elevated cholesterol has elevated cholesterol, by obtaining a fluid sample from the patient at the retail pharmacy point-of-sale location, wherein the administration of the specific diagnostic test is administered prior to any medication use for treating high cholesterol, and is required as a condition of safe use for ensuring no unsupervised unlabeled, non-prescription medication use by the patient, the nonprescription medication being OTC drug (pharmacist …ordering drug therapy-related laboratory tests) (page 1210, par 3);
determining, only by a trained retail pharmacist at the retail point-of-sale location, in the untreated human patient the presence of the chronic condition comprising elevated cholesterol, based on the test results of the patient from the specific diagnostic test used for diagnosing the chronic condition, without any physician diagnosis of elevated cholesterol, thereby indicating that the patient would benefit from an initial treatment with OTC drug (pharmacist … performing patient assessments; ordering drug therapy related laboratory tests; administering drugs; and selecting, initiating, monitoring, continuing, and adjusting drug regiments) (page 1210, par 3);
based on the determining, providing approval, by the retail pharmacist, without any prescription or OTC drug regimen approved by any physician for the chronic disease comprising elevated cholesterol, for the human patient to self-treat the chronic disease using a plurality of unit doses of OTC drug comprising a sufficient amount, as determined to treat the chronic disease (pharmacist … performing patient assessments; ordering drug therapy related laboratory tests; administering drugs; and selecting, initiating, monitoring, continuing, and adjusting drug regiments) (page 1210, par 3);
dispensing, by the retail pharmacist, the plurality of unit doses of OTC drug to the human patient with access to the medication allowed without seeing any physician, (pharmacist … performing patient assessments; ordering drug therapy related laboratory tests; administering drugs; and selecting, initiating, monitoring, continuing, and adjusting drug regiments) (page 1210, par 3); and
self-administering, by the human patient, the plurality of unit doses of OTC drug such that the chronic disease comprising elevated cholesterol is treated without the patient being treated by any physician (inherently done by the patient).
CDTM establishes that pharmacists, under collaborative practice agreements with physicians, are permitted to:
Perform patient assessments;
Order and interpret drug-therapy related laboratory tests;
Initiate, monitor, continue, or adjust drug regimens.
Thus, it would have been obvious to one of ordinary skill in the art (POSITA, e.g., a clinical pharmacist) that these activities encompass reviewing laboratory results (such as lipid panels) to determine disease control status.
The NIH Elevated Cholesterol Guidelines clearly define at which cholesterol level as a chronic condition diagnosed through lipid panel testing (e.g., LDL ≥ 190 mg/dL) (Step 1, Table).
Based on NIH’s guidelines, A POSITA would understand that diagnosis of high cholesterol is objective, laboratory-based, and routinely performed in primary care.
It would have been obvious to combine CDTM practice with the NIH established guidelines for elevated cholesterol diagnosis because:
CDTM expressly allows pharmacists to interpret lab results for chronic disease management.
Lipid panels are a standard, objective test, requiring no complex differential diagnosis.
A POSITA would reasonably expect success in applying CDTM to elevated cholesterol management by allowing pharmacists to identify and act upon high cholesterol test results.
Dr. Blazing’s declaration states that “The standard of care requires that a diagnosis of elevated cholesterol be confirmed by measured values that exceed defined clinical thresholds. When such a test is performed using a CLIA-waived lipid panel and appropriately placed in context based on where the values fall into guideline recommendations by a trained pharmacist, the diagnostic conclusion reached is functionally equivalent to that which would be made by a physician under similar circumstances.” (Declaration, par 8). Dr. Blazing’s declaration confirms that applying CDTM to elevated cholesterol management by allowing pharmacists to identify and act upon high cholesterol test results, the trained pharmacist is able to make the diagnostic conclusion functionally equivalent to that which would be made by a physician under the same circumstances (under the NIH Elevated Cholesterol Guidance).
Hammond does not specifically teach that the drug is atorvastatin. However, atorvastatin, brand names Lipitor, is a well-known drug for treating elevated cholesterol level as evidenced by The Free Dictionary. The Free Dictionary recites that “atorvastatin- an oral drug (trade name Lipitor) that is effective in lowering triglycerides; potent in reducing LDL cholesterol because higher doses can be given”.
Hammond does not specifically teach a specific CLIA-waived diagnostic machine at the point-of-sale location, testing, by a pharmacy technician, the fluid sample in a specific diagnostic machine at the retail point-of-sale location, wherein the specific diagnostic machine analyzes the fluid sample. However, As defined by CLIA, waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” The Food and Drug Administration (FDA) determines which tests meet these criteria when it reviews manufacturer’s applications for test system waiver. Thus, this feature is well known in the art, as admitted by the Applicant. In particular, applicant admits that "CLIA-waived diagnostic test", "CLIA-waived diagnostic machine at the point- of-sale location, wherein the CLIA-waived diagnostic machine analyzes the fluid sample and delivers results in less than 30 minutes" are well-known in the art. For instance, par. 58 recites: "CLIA-waived diagnostic machine, Abaxis Piccolo Xpress" and par. 59 recites: "Diagnostic Test Equipment: Recently, new table-top diagnostic test equipment (the Piccolo Xpress) has been developed by Abaxis, Inc. of Union City, CA, for use at the Point of Sale or Service (POS) with physicians. The results from this machine can be delivered in under 15 minutes making its use practical for the first time in determining if a patient meets the requirements for receiving a drug under the proposed, Rx-to-OTC switch treatment method patent.". Thus, it would have been obvious to one of ordinary skill in the art to perform CLIA-waived diagnostic test at the point-of-sale location, testing, by a pharmacy technician, as cited by Applicant, because CLIA-waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result”, suitable for on-site test.
OTC stands for "over-the-counter", which means the medication can be purchased without a doctor’s prescription. These drugs are generally considered safe and effective for use without a healthcare provider’s supervision, as long as the instructions on the label are followed.
Some medications exist in both OTC and prescription versions because of differences in dosage strength, intended use, or how much medical supervision is needed.
Here’s a clear breakdown:
OTC Version
Prescription Version
Lower dose
Higher dose
For mild, common conditions
For more severe or chronic conditions
Meant for short-term, self-treatment
Meant for longer-term use or complex cases
Fewer risks of side effects at OTC strength
Higher risk of side effects or interactions, needs doctor monitoring
Example 1: Ibuprofen– OTC = 200 mg tablets for headaches or minor pain– Prescription = 400 mg, 600 mg, or 800 mg tablets for arthritis or serious inflammation
Example 2: Omeprazole (Prilosec)– OTC = 20 mg for short-term heartburn relief– Prescription = higher doses or longer courses to treat ulcers or GERD under doctor care
The claimed term “OTC atorvastatin” by definition is an OTC version of atorvastatin. Therefore, OTC atorvastatin can be purchased without a doctor’s prescription.
By definition, an OTC atorvastatin is a drug that is provided without a prescription, and under a CDTM agreement, a qualified pharmacist sells a drug to a patient without a prescription from a doctor. This is in agreement with Applicant's definition of OTC drugs in the Specification:
As used herein, the terms "over-the-counter" or "OTC" or "non-prescription medicine" refer to drugs that may be purchased (e.g., by a patient) without a prescription from a retail outlet such as a Food, Drug, or Mass Merchandiser retail store. All these terms are used synonymously herein. (Spec par 47).
As a result, the addition of negative limitations such as "without any drug regimen approved by any physician" and “without any disease diagnosis made by any physician”, does not differentiate from the well-known method of dispensing over the counter drugs or the CDTM agreement in Hammond.
Regarding claim 30, Hammond teaches a method of self-treating a human patient for a chronic disease (page 1220, par 0) comprising:
administering, by a retail pharmacy technician, a specific diagnostic test to a human patient without the patient seeing a doctor, by obtaining a fluid sample from the human patient at a retail point-of-sale location, wherein the administration of the specific diagnostic test is required by a retail pharmacist (pharmacist …ordering drug therapy-related laboratory tests) (page 1210, par 3);
determining, by a retail pharmacist without an assessment and a decision of a doctor, a diagnosis by analyzing results of the specific diagnostic test at the point-of-sale location to certify a positive result of the diagnostic test indicating that the patient would benefit from treatment with OTC drug (pharmacist … performing patient assessments; ordering drug therapy related laboratory tests; administering drugs; and selecting, initiating, monitoring, continuing, and adjusting drug regiments) (page 1210, par 3);
based on the determining, providing approval, by a retail pharmacist, for the human patient to self-treat the chronic disease using a plurality of unit doses of OTC drug comprising a sufficient amount, as determined by the pharmacist without a prescription from a doctor, to treat a chronic disease of the human patient, the chronic disease comprising elevated cholesterol levels (pharmacist … performing patient assessments; ordering drug therapy related laboratory tests; administering drugs; and selecting, initiating, monitoring, continuing, and adjusting drug regiments) (page 1210, par 3);
dispensing, by a retail pharmacist, the plurality of unit doses of OTC drug such that the chronic disease of elevated cholesterol is treated without the human patient seeing a doctor (pharmacist … performing patient assessments; ordering drug therapy related laboratory tests; administering drugs; and selecting, initiating, monitoring, continuing, and adjusting drug regiments) (page 1210, par 3); and
self-administering, by the human patient, the plurality of unit doses of OTC atorvastatin such that the chronic disease of elevated cholesterol is treated without the human patient seeing a doctor (inherently done by the patient).
CDTM establishes that pharmacists, under collaborative practice agreements with physicians, are permitted to:
Perform patient assessments;
Order and interpret drug-therapy related laboratory tests;
Initiate, monitor, continue, or adjust drug regimens.
Thus, it would have been obvious to one of ordinary skill in the art (POSITA, e.g., a clinical pharmacist) that these activities encompass reviewing laboratory results (such as lipid panels) to determine disease control status.
The NIH Elevated Cholesterol Guidelines clearly define at which cholesterol level as a chronic condition diagnosed through lipid panel testing (e.g., LDL ≥ 190 mg/dL) (Step 1, Table).
Based on NIH’s guidelines, A POSITA would understand that diagnosis of high cholesterol is objective, laboratory-based, and routinely performed in primary care.
It would have been obvious to combine CDTM practice with the NIH established guidelines for elevated cholesterol diagnosis because:
CDTM expressly allows pharmacists to interpret lab results for chronic disease management.
Lipid panels are a standard, objective test, requiring no complex differential diagnosis.
A POSITA would reasonably expect success in applying CDTM to elevated cholesterol management by allowing pharmacists to identify and act upon high cholesterol test results.
Dr. Blazing’s declaration states that “The standard of care requires that a diagnosis of elevated cholesterol be confirmed by measured values that exceed defined clinical thresholds. When such a test is performed using a CLIA-waived lipid panel and appropriately placed in context based on where the values fall into guideline recommendations by a trained pharmacist, the diagnostic conclusion reached is functionally equivalent to that which would be made by a physician under similar circumstances.” (Declaration, par 8). Dr. Blazing’s declaration confirms that applying CDTM to elevated cholesterol management by allowing pharmacists to identify and act upon high cholesterol test results, the trained pharmacist is able to make the diagnostic conclusion functionally equivalent to that which would be made by a physician under the same circumstances (under the NIH Elevated Cholesterol Guidance).
Hammond does not specifically teach that the drug is atorvastatin. However, atorvastatin, brand names Lipitor, is a well-known drug for treating elevated cholesterol level as evidenced by The Free Dictionary. The Free Dictionary recites that “atorvastatin- an oral drug (trade name Lipitor) that is effective in lowering triglycerides; potent in reducing LDL cholesterol because higher doses can be given”.
Hammond does not specifically teach a specific CLIA-waived diagnostic machine at the point-of-sale location, testing, by a pharmacy technician, the fluid sample in a specific diagnostic machine at the retail point-of-sale location, wherein the specific diagnostic machine analyzes the fluid sample. However, as defined by CLIA, waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” The Food and Drug Administration (FDA) determines which tests meet these criteria when it reviews manufacturer’s applications for test system waiver. Thus, this feature is well known in the art, as admitted by the Applicant. In particular, applicant admits that "CLIA-waived diagnostic test", "CLIA-waived diagnostic machine at the point- of-sale location, wherein the CLIA-waived diagnostic machine analyzes the fluid sample and delivers results in less than 30 minutes" are well-known in the art. For instance, par. 58 recites: "CLIA-waived diagnostic machine, Abaxis Piccolo Xpress" and par. 59 recites: "Diagnostic Test Equipment: Recently, new table-top diagnostic test equipment (the Piccolo Xpress) has been developed by Abaxis, Inc. of Union City, CA, for use at the Point of Sale or Service (POS) with physicians. The results from this machine can be delivered in under 15 minutes making its use practical for the first time in determining if a patient meets the requirements for receiving a drug under the proposed, Rx-to-OTC switch treatment method patent.". Thus, it would have been obvious to one of ordinary skill in the art to perform CLIA-waived diagnostic test at the point-of-sale location, testing, by a pharmacy technician, as cited by Applicant, because CLIA-waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result”, suitable for on-site test.
OTC stands for "over-the-counter", which means the medication can be purchased without a doctor’s prescription. These drugs are generally considered safe and effective for use without a healthcare provider’s supervision, as long as the instructions on the label are followed.
Some medications exist in both OTC and prescription versions because of differences in dosage strength, intended use, or how much medical supervision is needed.
Here’s a clear breakdown:
OTC Version
Prescription Version
Lower dose
Higher dose
For mild, common conditions
For more severe or chronic conditions
Meant for short-term, self-treatment
Meant for longer-term use or complex cases
Fewer risks of side effects at OTC strength
Higher risk of side effects or interactions, needs doctor monitoring
Example 1: Ibuprofen– OTC = 200 mg tablets for headaches or minor pain– Prescription = 400 mg, 600 mg, or 800 mg tablets for arthritis or serious inflammation
Example 2: Omeprazole (Prilosec)– OTC = 20 mg for short-term heartburn relief– Prescription = higher doses or longer courses to treat ulcers or GERD under doctor care
The claimed term “OTC atorvastatin” by definition is an OTC version of atorvastatin. Therefore, OTC atorvastatin can be purchased without a doctor’s prescription.
By definition, an OTC atorvastatin is a drug that is provided without a prescription, and under a CDTM agreement, a qualified pharmacist sells a drug to a patient without a prescription from a doctor. This is in agreement with Applicant's definition of OTC drugs in the Specification:
As used herein, the terms "over-the-counter" or "OTC" or "non-prescription medicine" refer to drugs that may be purchased (e.g., by a patient) without a prescription from a retail outlet such as a Food, Drug, or Mass Merchandiser retail store. All these terms are used synonymously herein. (Spec par 47).
As a result, the addition of negative limitations such as "without prescription from a doctor" and “without the human patient seeing a doctor”, does not differentiate from the well-known method of dispensing over the counter drugs or the CDTM agreement in Hammond.
Regarding claim 7, applicant admits that "wherein the specific CLIA-waived diagnostic machine delivers results in less than 30 minutes" are well-known in the art. For instance, par. 58 recites: "CLIA-waived diagnostic machine, Abaxis Piccolo Xpress" and par. 59 recites: "Diagnostic Test Equipment: Recently, new table-top diagnostic test equipment (the Piccolo Xpress) has been developed by Abaxis, Inc. of Union City, CA, for use at the Point of Sale or Service (POS) with physicians. The results from this machine can be delivered in under 15 minutes making its use practical for the first time in determining if a patient meets the requirements for receiving a drug under the proposed, Rx-to-OTC switch treatment method patent." Thus, applicant admitted that it is well-known that wherein the specific CLIA-waived diagnostic machine delivers results to the healthcare person at the point-of-sale location in less than 30 minutes.
Regarding claim 24 and 28, Hammond fairly suggests that retail point-of-sale pharmacy personnel entering the results of the initial diagnostic test before medication use for determining the presence of the chronic disease comprising elevated cholesterol into a patient registry, which can be accessed by appropriate health care persons at the original retail point-of-sale location or a second retail pharmacy point-of-sale location that has access to the patient registry, so that the individual human patient who would benefit from treatment with OTC atorvastatin can receive a plurality of unit doses of the medication at the original or a different retail pharmacy point-of-sale location (The pharmacist must have access to medical records that include the patient’s medical history, problem lists, progress notes, laboratory and procedure results, and drug history….This is one area where pharmacy organizations can facilitate CDTM by promoting and assisting with the sharing of medical information through support of new technologies.) (page 1222, par 5-6).
Hammond (2003) explicitly teaches that, under collaborative drug therapy management (CDTM), pharmacists must have access to medical records that include the patient’s medical history, laboratory results, and drug history, and that sharing of medical information through support of new technologies is encouraged to facilitate pharmacist drug therapy management (page 1222, par 5-6). Hammond further teaches that pharmacy organizations should support the sharing of medical information across practice settings to ensure effective management of patient therapy (page 1222, par 6).
Thus, Hammond reasonably suggests that pharmacists would document and enter diagnostic test results into a record accessible to other health care personnel. At the time of the invention, patient registry and electronic medical record systems were well known and widely implemented to enable continuity of care across multiple sites. See, e.g., Hammond, p. 1222 (discussing computerized medical records and the need for information-sharing to overcome obstacles to access).
It would have been obvious to a POSITA to adapt Hammond’s teaching of shared access to patient medical records to a retail pharmacy point-of-sale environment, motivated by the need to allow patients to refill or obtain medications at different retail pharmacy locations while ensuring continuity of care. The claimed step of “entering results into a patient registry accessible at multiple pharmacy locations” is therefore a routine implementation of Hammond’s disclosure of shared medical records using computerized systems.
Regarding claim 25, 27 and 29, Hammond fairly suggests that a patient registry accepting the initial and any subsequent CLIA-waived test results from the retail pharmacy point-of-sale location exclusively for the chronic disease comprising elevated cholesterol;
wherein the specific CLIA-waived diagnostic test approved for use with atorvastatin only measures the biomarkers associated with the chronic disease comprising elevated cholesterol;
wherein the patient registry shows proof that the individual human patient has taken all the mandatory tests and is eligible to continue to receive pluralities of unit doses of OTC atorvastatin to treat the chronic disease comprising elevated cholesterol; and
wherein pharmacy personnel at any location having access to the national patient registry are allowed to dispense OTC atorvastatin only to individual patients with confirmed elevated cholesterol biomarkers, thereby ensuring only a labeled use, and not an unsupervised use for any other chronic disease (The pharmacist must have access to medical records that include the patient’s medical history, problem lists, progress notes, laboratory and procedure results, and drug history….This is one area where pharmacy organizations can facilitate CDTM by promoting and assisting with the sharing of medical information through support of new technologies.) (page 1222, par 5-6).
Hammond teaches pharmacist access to medical records including lab results and drug histories, and encourages sharing of medical information through support of new technologies (page 1222, par 5-6).
While Hammond does not explicitly limit the registry to cholesterol, it does contemplate disease-specific recordkeeping as part of chronic disease management programs (e.g., dyslipidemia). NIH guidelines provide thresholds for cholesterol biomarkers. A POSITA would have found it obvious to implement a disease-specific registry focused on elevated cholesterol to streamline atorvastatin use.
Hammond expressly requires documentation of pharmacist activities and patient records to ensure quality assurance and monitoring (page 1222, par 5-6)
Requiring the registry to confirm mandatory testing before continued access to atorvastatin is an obvious extension of Hammond’s teaching that pharmacists should monitor therapy through documented lab values and ongoing follow-up.
Hammond and NIH guidelines collectively stress appropriate use of statins based on confirmed lab values. Limiting dispensing to patients whose registry data confirms elevated cholesterol is an implementation detail consistent with best practices already promoted by CDTM. It would have been obvious to a POSITA to enforce appropriate labeled use by requiring confirmation of lab results in a shared registry before refills are provided.
Claim 2-4, 6 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hammond in view of Applicant admitted prior art and NIH Elevated Cholesterol Guidance (National Cholesterol Education Program, 2001) as applied to claims 1, 7, 18, 24-25 and 27-30 above, and further in view of Safeer et al. (Choosing Drug Therapy for Patients with Hyperlipidemia, 2000) (Safeer).
Regarding claim 2, Hammond teaches that the OTC medicine is provided approval by a pharmacist to receive, without the human patient seeing a doctor (pharmacist … perform patient assessments; administering drugs; and selecting, initiating, monitoring, continuing, and adjusting drug regiments) (page 1210, par 3).
Hammond does not specifically teach that after all of the received unit doses have been self-administered, the patient undergoes a second required CLIA-waived drug effectiveness and safety test to determine whether the patient is either: (i) expressing a biomarker that indicates that the patient's condition is being treated by OTC atorvastatin or (ii) expressing a biomarker that indicates that the patient is experiencing an asymptomatic and problematic side effect of OTC atorvastatin; wherein the patient that expresses biomarkers that confirm that the patient is being treated by OTC atorvastatin and is not expressing the biomarker that indicates the problematic side effect, qualifies for and receives a second plurality of unit doses of OTC atorvastatin in sufficient amount to treat the chronic disease comprising elevated cholesterol.
However, Safeer teaches that after all of the received unit doses have been self-administered, the patient undergoes a second required CLIA-waived drug effectiveness and safety test (Obtain lipid profiles for response at 4 weeks) to determine whether the patient is either: (i) expressing a biomarker that indicates that the patient's condition is being treated by OTC atorvastatin or (ii) expressing a biomarker that indicates that the patient is experiencing an asymptomatic and problematic side effect of OTC atorvastatin; wherein the patient that expresses biomarkers that confirm that the patient is being treated by OTC atorvastatin and is not expressing the biomarker that indicates the problematic side effect, qualifies for and receives a second plurality of unit doses of OTC atorvastatin in sufficient amount to treat the chronic disease comprising elevated cholesterol (Table 4). Thus, It would have been obvious to one of ordinary skill in the art to let the patient undergoes a second required CLIA-waived diagnostic test OTC to determine whether the patient is either: (i) expressing a biomarker that indicates that the patient's condition is being treated by OTC atorvastatin or (ii) expressing a biomarker that indicates that the patient is experiencing an asymptomatic and problematic side effect of OTC atorvastatin; wherein the patient that expresses biomarkers that confirm that the patient is being treated by OTC atorvastatin and is not expressing the biomarker that indicates the problematic side effect, qualifies for and receives a second plurality of unit doses of OTC atorvastatin in sufficient amount to treat the chronic disease comprising elevated cholesterol, in order to monitor the treatment.
Regarding claim 3, Safeer teaches that wherein the patient self-administers a unit dose of OTC atorvastatin from the second plurality of unit doses (Table 4).
Regarding claim 4, Safeer teaches that wherein the patient continues to undergo CLIA-waived diagnostics to determine that the patient is being treated by OTC atorvastatin and is not expressing the biomarker that indicates the problematic side effect and the patient continues to self-administer atorvastatin for treatment of the chronic disease only after CLIA-waived diagnostic confirms that the patient is being treated by OTC atorvastatin and is not expressing a biomarker that indicates the problematic side effect (Table 4).
Regarding claim 6, Safeer teaches that wherein the chronic disease is an asymptomatic chronic disease (Table 4).
Regarding claim 26, Hammond fairly suggests that retail point-of-sale pharmacy personnel entering into the patient registry the safety and effectiveness results of the second required CLIA-waived diagnostic test after medication use, wherein the registry will contain the safety and effectiveness results of the medication in the individual human patient who is suffering from the chronic disease comprising elevated cholesterol, both positive and negative, in order to either allow the individual human patient to continue to receive pluralities of unit doses of the medication or to prevent the patient, who would not benefit from OTC atorvastatin, from receiving additional pluralities of unit doses of the medication (The pharmacist must have access to medical records that include the patient’s medical history, problem lists, progress notes, laboratory and procedure results, and drug history….This is one area where pharmacy organizations can facilitate CDTM by promoting and assisting with the sharing of medical information through support of new technologies.) (page 1222, par 5-6).
Hammond teaches that pharmacists under CDTM are responsible for monitoring drug therapy outcomes, including effectiveness and adverse drug effects, and for documenting these results in patient records (page 1210, par 3, page 1219, par 1, page 1223, par 1). Monitoring is a core element of CDTM, and documentation of outcomes is considered necessary for safe chronic disease management.
Safeer teaches that statin therapy should be monitored over time by repeat lipid testing to assess efficacy and safety. Follow-up lipid panels after therapy initiation are required to determine whether LDL levels reach target values and to identify adverse outcomes (Table 4).
Requiring the patient registry to capture post-treatment test results (both positive and negative) is an administrative detail of the already-known requirement that pharmacists (or other providers) record patient lab results and outcomes. Hammond at p. 1222 specifically discusses computerized medical records including progress notes, laboratory results, and drug history, and encourages sharing of such information across practice settings.
It would have been obvious to a POSITA to restrict continuation of atorvastatin therapy based on objective monitoring results, as Safeer requires discontinuation or adjustment if cholesterol does not respond or if safety issues arise. Incorporating this into a registry that informs dispensing decisions across retail locations is a routine extension of the combined teachings.
Response to Arguments
Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive.
101 Rejection
1. Claims “Directed to a Process” vs. “Encompassing a Human Organism”
Applicant argues that the claims are directed to a statutory “process” and not to a human organism, asserting that the recitation of a “human patient” does not render the claims ineligible.
While it is acknowledged that method claims are generally categorized as processes under §101, the form of the claim is not determinative. The proper inquiry under AIA §33(a) is whether the claims are directed to or encompass a human organism, regardless of claim format.
In the present case, the claims recite a method of “self-treating a human patient” and require multiple steps that are:
performed on and within the human patient, and
inseparably tied to the physiological state and treatment of that human individual.
The claimed method, when considered as a whole, effectively encompasses the human patient as an integral component of the claimed invention, rather than merely using a human as an external subject. The human patient is not incidental but is central to every step of the claimed method (diagnosis, treatment, and response).
Accordingly, the claims are not merely directed to a process applied to a human, but rather to a comprehensive treatment paradigm that encompasses the human organism itself.
2. Applicant’s Argument that No Claim Element “Is” a Human Organism
Applicant argues that the Office has not identified any specific claim element that “is” or “encompasses” a human organism.
This argument is not persuasive.
AIA §33(a) does not require that a claim explicitly recite a human organism as a standalone element. Rather, the statute applies when the claimed invention as a whole encompasses a human organism.
Here, the claims:
require administering a diagnostic test to a human patient,
determining a disease state in that human patient, and
administering and controlling drug treatment within that human patient.
Because the claimed steps are inseparable from the human body and its physiological processes, the claimed invention necessarily encompasses the human organism.
3. Applicability of AIA §33(a) to Method-of-Treatment Claims
Applicant argues that AIA §33(a) does not bar method-of-treatment claims and that such claims have historically been considered patent-eligible .
This argument is not persuasive.
While it is true that many method-of-treatment claims are patent-eligible under §101, AIA §33(a) imposes an additional statutory limitation that must be evaluated independently.
The present claims are distinguishable from typical treatment claims because they:
define a complete, self-contained treatment system centered on the human patient, and
integrate diagnosis, treatment eligibility, drug administration, and ongoing monitoring in a manner that effectively claims control over the treatment of the human organism itself.
Thus, the claims go beyond merely reciting the administration of a drug and instead encompass the human organism as part of the claimed system, which falls within the scope of AIA §33(a).
4. Scope of the Claims as a Whole
When evaluated as a whole, the claims:
require a specific human patient,
define diagnostic and therapeutic steps performed directly on that patient, and
condition continued treatment on the patient’s physiological responses.
Such claims effectively define a state-dependent method governing the condition and treatment of a human body, thereby encompassing the human organism.
The prohibition of AIA §33(a) is intended to prevent claims that, in substance, cover a human organism or its condition as a whole. The present claims, by tying all limitations to the human patient’s condition and treatment, fall within that scope.
Conclusion
Applicant has not persuasively demonstrated that the claims avoid encompassing a human organism under AIA §33(a). The claims, when considered as a whole, recite a method that is inseparably tied to and encompasses the human organism.
Accordingly, the rejection of claims 1–4, 6–7, 18, and 24–29 under 35 U.S.C. §101 and AIA §33(a) is maintained.
112(a) Rejection
1. Alleged Support for “Pharmacist-Only Diagnosis”
Applicant argues that the Specification, when read by a POSITA, supports the limitation of:
“determining, only by a trained retail pharmacist … the presence of the chronic condition comprising elevated cholesterol … without any physician diagnosis …”
and relies on paragraphs [0021], [0035], and [0050], as well as Dr. Blazing’s declaration, to assert that a pharmacist’s interpretation of lipid panel results is the “functional equivalent” of a diagnosis.
This argument is not persuasive.
The cited portions of the Specification describe that a “retail healthcare person” may:
analyze diagnostic test results, and
determine whether to offer a drug regimen.
However, these disclosures do not reasonably convey possession of the specific claimed limitation requiring that:
the determination is made only by a trained retail pharmacist, and
the determination constitutes a diagnosis of the disease in the absence of any physician involvement.
The Specification broadly refers to “healthcare personnel” and decision-making regarding treatment, but does not explicitly or inherently disclose that a pharmacist independently determines the presence of the disease itself (i.e., performs a diagnosis), particularly without any physician diagnosis.
A determination that a patient “may benefit from treatment” is not equivalent to a definitive diagnosis of a disease, as now recited in the claims.
2. Functional Equivalence vs. Written Description
Applicant relies on Dr. Blazing’s declaration to assert that a pharmacist’s interpretation of lipid panel results is “functionally equivalent” to a physician diagnosis.
This argument is not persuasive.
Written description requires that the Specification reasonably convey to a POSITA that the inventor had possession of the claimed subject matter at the time of filing (see MPEP §2163).
The issue is not whether a pharmacist could perform a diagnosis or whether such activity is functionally similar to a physician’s diagnosis. Rather, the issue is whether the Specification describes the claimed invention, namely:
a pharmacist making a diagnosis of the disease, and
doing so without any physician diagnosis.
The Specification does not describe this exclusionary and role-specific limitation. The reliance on “functional equivalence” improperly attempts to expand the disclosure beyond what is expressly or inherently described.
3. Use of the Blazing Declaration
Applicant argues that the Office cannot rely on Dr. Blazing’s declaration for §103 while rejecting written description under §112(a).
This argument is not persuasive.
The declaration is used in different contexts for different legal purposes:
Under §103, the declaration is considered as evidence of what a POSITA would understand regarding diagnosis of elevated cholesterol, including the objective nature of lipid panel thresholds.
Under §112(a), the inquiry is whether the Specification itself conveys possession of the claimed invention.
These are distinct legal standards. Evidence of what is known in the art cannot substitute for a lack of disclosure in the Specification. See MPEP §2163.06.
Accordingly, even if a POSITA would understand that pharmacists could interpret lipid panels, this does not establish that the inventor possessed the specific claimed embodiment of pharmacist-only diagnosis without physician involvement.
4. Absence of Support for Negative Limitation
The claim further requires that the diagnosis occurs “without any physician diagnosis.”
The Specification does not provide:
an express description of excluding physician involvement in diagnosis, nor
a clear indication that the invention is limited to pharmacist-only diagnosis.
Negative limitations must be supported by the Specification, either explicitly or inherently. See MPEP §2173.05(i).
Here, the Specification does not describe the absence of physician diagnosis or a system that excludes physician involvement. At most, it describes that pharmacists may participate in care, which is insufficient to support the claimed exclusion.
5. Conclusion
The Specification fails to reasonably convey to a POSITA that the inventor had possession of:
a pharmacist-only diagnosis of elevated cholesterol, and
such diagnosis occurring without any physician involvement,
as now required by claim 18.
Accordingly, the rejection of claim 18 under 35 U.S.C. §112(a) for lack of written description is maintained.
103 Rejection
1. Board Decision Regarding Hammond and “Diagnosis”
Applicant argues that the Board previously found that Hammond does not teach pharmacist diagnosis and asserts that the present rejection improperly relitigates that issue.
However, the present rejection does not rely on Hammond alone to teach pharmacist diagnosis. Rather, the rejection relies on Hammond in view of NIH guidelines and Applicant Admitted Prior Art (AAPA) to establish that:
Diagnosis of elevated cholesterol is objective and laboratory-based, based on lipid panel thresholds; and
A pharmacist interpreting such results under CDTM authority inherently performs the functional equivalent of identifying the disease condition for treatment purposes.
The Board’s prior finding was limited to Hammond in isolation. The present rejection is based on a combination of references, which is proper under §103. See MPEP §2143. The combination supplies what Hammond alone may not explicitly disclose.
2. Use of the Blazing Declaration
Applicant argues that the Examiner improperly relies on Dr. Blazing’s declaration as prior art or to “supply missing claim limitations” .
This argument is not persuasive.
The declaration is not relied upon as prior art, but rather as evidence of the level of ordinary skill in the art and the understanding of a POSITA, which is expressly permitted. See MPEP §2141 and §716.01(c).
Specifically, the declaration confirms that:
Elevated cholesterol diagnosis is based on objective lipid thresholds, and
A trained pharmacist interpreting such results reaches a conclusion functionally equivalent to a physician diagnosis.
This evidence is used to interpret the teachings of the prior art (Hammond + NIH) and to demonstrate what would have been obvious to a POSITA—not to modify Hammond’s disclosure. Accordingly, no improper hindsight reconstruction has occurred.
3. Alleged Lack of Motivation to Combine / Eliminate Physicians
Applicant asserts that NIH teaches continued physician involvement and therefore does not motivate removal of physicians from the diagnostic process .
This argument is not persuasive.
The rejection does not require complete elimination of physicians, but rather shows that:
CDTM (Hammond) explicitly allows pharmacists to:
interpret lab results,
monitor therapy, and
adjust drug regimens under protocol; and
NIH guidelines provide clear, objective thresholds for identifying elevated cholesterol.
A POSITA would have recognized that, for objective, lab-defined conditions such as elevated cholesterol, pharmacist interpretation of lipid panels under CDTM inherently enables identification of patients requiring treatment.
Further, extending such known pharmacist-managed care to retail settings and OTC contexts represents a predictable use of prior art elements according to their established functions (KSR).
NIH’s recommendation for physician involvement does not teach away from pharmacist participation; rather, it reflects a conservative clinical context. It does not preclude or discourage implementation of pharmacist-led screening and treatment in appropriate settings.
4. OTC Atorvastatin and Alleged “Physician-Free Paradigm”
Applicant argues that the cited references do not teach converting atorvastatin into an OTC drug or implementing a pharmacist-only treatment paradigm.
This argument is not persuasive.
Atorvastatin (e.g., Lipitor) is a well-known statin used to treat elevated cholesterol.
The distinction between prescription and OTC status is a matter of regulatory classification, not a structural or functional difference in the drug itself.
As acknowledged in the Specification, OTC drugs are defined as those that can be dispensed without a prescription.
It would have been obvious to a POSITA to apply known statin therapy (atorvastatin) in a setting where:
diagnosis is based on objective test results, and
pharmacists are already authorized to manage therapy under CDTM.
Thus, the claimed “OTC atorvastatin” does not impart patentable distinction over the prior art use of atorvastatin for treating elevated cholesterol.
5. Registry and Gating Limitations (Claims 24–29)
Applicant argues that the claimed registry is a novel “national, disease-specific, biomarker-gated” system that is not taught or suggested by the prior art .
This argument is not persuasive.
Hammond explicitly teaches that pharmacists must have access to medical records including laboratory results and drug history, and that such information may be shared across systems and locations. This encompasses:
storage of patient test results,
access by multiple healthcare providers, and
use of such data to guide therapy decisions.
The claimed registry limitations—such as:
storing test results,
verifying eligibility for treatment, and
allowing access across multiple pharmacy locations—
represent routine data management and information-sharing practices in healthcare systems.
Restricting the registry to a specific disease (elevated cholesterol), or using it to guide dispensing decisions, is merely an intended use or data organization choice that would have been obvious to optimize the known system for its clinical purpose.
Further, using test results to determine whether to continue or discontinue therapy is explicitly taught by NIH and Safeer, which require ongoing monitoring of lipid levels and treatment effectiveness.
6. Registry-Based Control of Continued Dispensing (Claim 26)
With respect to claim 26, the additional limitation of entering post-treatment safety and effectiveness results into the registry and using such results to allow or prevent further dispensing is also obvious.
Hammond teaches monitoring patient outcomes and documenting them in medical records.
NIH and Safeer teach retesting lipid levels and adjusting or discontinuing therapy based on results.
Incorporating these known monitoring and documentation practices into a shared registry that informs dispensing decisions represents a predictable and routine implementation of known clinical workflows.
Conclusion
Applicant’s arguments improperly attack the references individually and fail to address the combined teachings of Hammond, NIH, AAPA, and Safeer.
The prior art, when considered as a whole, teaches or renders obvious all claimed limitations, including:
pharmacist interpretation of objective diagnostic tests,
treatment of elevated cholesterol using atorvastatin, and
recording and using patient test results to guide therapy decisions across locations.
Accordingly, the rejection under 35 U.S.C. §103 is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/XIAOYUN R XU, Ph.D./ Primary Examiner, Art Unit 1797