DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's election with traverse of Group II in the reply filed on February 9, 2026 is acknowledged. Additionally Applicants elected the following species with traverse: (i) Post Infection Protocol 5, (ii) treatment with an ACE inhibitor and beta blocker, (iii) the beta blocker metoprolol; (iv) the ACE inhibitor lisinopril; (v) the single combination of SNPs rs5051, rs699, rs4762, rs7079, rs12750834, rs5186, rs12171234, rs12010448, rs143695310, rs1996225, rs200781818, rs2158082, rs4060, rs4646127, rs4830983, rs5936029, rs66291, rs1801252, rs1801253, and rs1799752.
The traversal of the restriction requirement is on the grounds that restriction is optional and if a search and examination of an entire application can be made with serious burden then the Examiner must examine the entire application. Further Applicants argue that they should not be required to incur the additional costs of filing multiple divisional applications. These arguments have been fully considered but are not persuasive. The instant application was filed under 35 USC 371 and therefore the Unity of Invention standard applies. As discussed in the restriction the common technical feature is treating coronavirus with a compound that modulates the expression of ACE2. However since this was already known (Dobie WO 2005/086804 3/10/2004) in the art, there is no special technical feature and the claims lack unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
The traversal of the election of species requirements is on the grounds that a search of all of the alleged species could be made by the Examiner without an undue burden, and that the results of any such search would likely bear on all of the alleged species. This argument has been fully considered but is not persuasive. Again this is a 371 case and therefore the Unity of Invention standard applies. The recited species lack unity of invention because they do not have a common property or activity and a common structure when the species are chemical compounds and they do not share the same technical features when the species are not chemical compounds. The election of species requirement is still deemed proper and is therefore made FINAL.
It is further noted that the following election of species requirements have been WITHDRAWN: (i) the requirement to elect administration of an antiviral pharmaceutical, quinoline-like pharmaceutical, naphthoquinone-like pharmaceutical, or a combination thereof; (ii) the requirement to elect an antivirial pharmaceutical from AZT, acyclovir also known as abacavir, lamivudine, raltegravir, elvitegravir, dolutegravir, lopinavir, indinavir, nelfinavir, amprenavir, ritonavir, darunavir or atazanavir or any combination thereof; and the requirement to elect a quinoline-like or naphthoquinone-like pharmaceutical from hydroxychloroquine, chloroquine, amodiaquine, mefloquine or atovaquone, or any combination thereof.
3. Claims 1-27 are currently pending.
Claims 1-11, 23, and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected subject matter, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 9, 2026.
Claims 12-22, 24, 25, and 27 have been examined to the extent that the claims read on the elected species (Protocol 5, treatment with an ACE inhibitor and beta blocker, and the single combination of SNPs rs5051, rs699, rs4762, rs7079, rs12750834, rs5186, rs12171234, rs12010448, rs143695310, rs1996225, rs200781818, rs2158082, rs4060, rs4646127, rs4830983, rs5936029, rs66291, rs1801252, rs1801253, and rs1799752). Claim 24 has been examined to the extent that the claims read on the elected species (Metoprolol). Claim 25 has been examined to the extent that the claims read on the elected species (lisinopril). The additionally recited Protocols, treatments, combinations of SNPs, specific beta blockers, and ACE inhibitors have been withdrawn from consideration as being directed to non-elected subject matter. Prior to allowance of the claim, any non-elected subject matter that is not rejoined with any allowed elected subject matter will be required to be removed from the claims.
Claim Rejections - 35 USC § 112
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-22, 24, 25, and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 12-22, 24, 25, and 27 are drawn to a method for treating a patient who is infected with a coronavirus by administering one or more pharmaceutical compounds that increase ACE2 levels according to Post-infection Protocol 5. This protocol recites administering an ACE inhibitor and beta blocker to a person with a genotype score less than 550. The administering step in this protocol is conditionally recited since it only occurs when the genotype score is less than 550. When the genotype score is greater than 500 the ACE inhibitor and beta blocker are not administered. This creates confusion and one of skill in the art would not be able to determine the metes and bounds of the claimed subject matter so as to avoid infringement.
Claims 12-22, 24, 25, and 27 are rejected over the recitation of “patient” and “person” in the claims (see claims 12 and 15-18). The specification (paras 0077-0078) seems to differentiate these two words. A “person” is someone who has been or could have been exposed to COVID-19 but is not yet infected by COVID-19, whereas a “patient” is someone who tests positive for the presence of COVID-19 or other coronavirus and is either asymptomatic or exhibits symptoms of COVID-19 or other coronavirus infection. Since the claims are drawn to a method for treating a patient who is infected with a coronavirus by administering a Post Infection Protocol, it is unclear why the word “person” is being used in these claims. The use of both terms in the claims creates confusion with respect to the scope of these claims. This rejection can be overcome by removing the word “person” from the claims.
Regarding Claims 12-22, 24, 25, and 27 it is noted that a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites a broad limitation “a pharmaceutical compound that increases ACE2 levels”, and the claim also recites “ACE inhibitor” and “beta blocker” which is the narrower statement of the limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 12-22, 24, 25, and 27 are rejected over the recitation of "the person with genotype score less than 550" in claim 12. First it is noted that there is insufficient antecedent basis for this limitation in the claim. Further this recitation is confusing because the claims do not recite an active process step of determining a genotype score for the person. Thus it is unclear how the user of the method obtains the persons genotype score. The breadth of the claims encompass administering the ACE inhibitor and beta blocker to a person known to have a genotype score less than 550 based on the calculation as well as persons who inherently have genotypes scores less than 550 even if this was not known/calculated.
Claims 12-22, 24, 25, and 27 are rejected over the recitation that “the genotype score is determined by obtaining the multiplication product of the weight number of each of the person's individual SNPs weight numbers determined by their positive homozygous fx, heterozygous fx and null fx numbers of Table 2 times the corresponding individual SNP influence numbers of Table 2 and the products are summed together to provide the genotype score”. This recitation is confusing because in order to determine the genotype score for the person, one must have the genotype with respect to the 21 SNP in Table 2. However there are no active process steps of genotyping recited in the claim and it is unclear where the genotypes are being obtained from.
Claims 12-22, 24, 25, and 27 are rejected to for referring to specific figures and/or tables in the specification. In particular the claims refer to Table 2. MPEP 2173.05(s) states that “Where possible claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into a claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.”
Claims 12-22, 24, 25, and 27 are rejected over the recitation of "the weight number of each of the persons individual SNPs". There is insufficient antecedent basis for this limitation in the claim.
Claims 12-22, 24, 25, and 27 are rejected over the recitation of "the corresponding SNP influence numbers". There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites a method wherein “the blood pressure and blood sugar of the patient is evaluated prior to or in conjunction with determining the patient's genotype”. This recitation is confusing because the claims do not require an active process step of determining the patients genotype.
Claim 15 recites a method wherein blood pressure and blood sugar are evaluated prior to determining the person or patient's genotype and if either is above normal values, the genotype is determined. This recitation is confusing because it encompasses not determining the person or patients genotype when the blood pressure and blood sugar are in the normal range and without the genotype information it is unclear how one could perform Post-infection protocol 5 which requires calculating a genotype score based on the patients genotype.
Claim 25 recites the following trademarks: EquatenTM, PrentylTM, and SynecorTM. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademarks are used to identify/describe ACE inhibitors and, accordingly, the identification/description is indefinite.
Claim 25 is rejected over the recitation of "the diuretic". There is insufficient antecedent basis for this limitation in the claim because the claims do not previously refer to a diuretic. Further this is confusing because it’s unclear if a diuretic is required to be administered along with the ACE inhibitor and beta-blocker.
Claim Rejections - 35 USC § 101
5. 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.
Claims 12-22, 24, 25, and 27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims recite a judicial exception that is not integrated into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim analysis is set forth below.
Step 1: The claims are directed to the statutory category of a process.
Step 2A, prong one: Evaluate Whether the Claim Recites a Judicial Exception
The instant claims recite abstract ideas.
The claims recite that a genotype score is determined by “obtaining the multiplication product of the weight number of each of the person's individual SNPs weight numbers determined by their positive homozygous fx, heterozygous fx and null fx numbers of Table 2 times the corresponding individual SNP influence numbers of Table 2 and the products are summed together to provide the genotype score”. Mathematical concepts, such as performing mathematical calculations, are considered to be abstract ideas. Further the genotype score could be determined by a mental process because it could be calculated in one’s head or using a pen and paper. Mental processes, which are concepts performed in the human mind (including observation, evaluation, judgment, opinions) are considered to be abstract ideas.
Step 2A, prong two: Evaluate Whether the Judicial Exception Is Integrated Into a Practical Application
The claims do NOT recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). For example, the claims do not practically apply the judicial exception by including one or more additional elements that the courts have stated integrate the exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
An additional element effects a transformation or reduction of a particular article to a different state or thing; and
An additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological
environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
Claim 12 recites “administering an ACE inhibitor and beta blocker for the person with a genotype score less than 550”. Here the administering step is conditional and only occurs when the genotype score is less than 550. The claim broadly encompasses situations where the genotype score is greater than 550 and in those situations the ACE inhibitor and beta blocker are not administered. Since the administering step need not occur, claim 12 does not recite any steps or elements that integrate the judicial exception so as to practically apply the judicial exception.
In addition to the judicial exceptions, claims 19-22 and 27 further require treating the subject with an antiviral, quinoline like pharmaceutical, napthoquinone like pharmaceutical, or a mineralocorticoid receptor antagonist. These claims do not integrate the judicial exception into a practical application because they are not applying the judicial exceptions in any way. They are merely adding insignificant post-solution activity to the judicial exception.
Step 2B: Evaluate Whether the Claim Provides an Inventive Concept
In addition to the judicial exceptions, claims 19-22 and 27 further require treating the subject with an antiviral, quinoline like pharmaceutical, napthoquinone like pharmaceutical, or a mineralocorticoid receptor antagonist. These steps do not amount to significantly more because they simply append well understood, routine, and conventional activities previously known in the art, specified at a high level of generality, to the judicial exceptions.
The prior art also demonstrates the well understood, routine, conventional nature of additional elements because it teaches that the additional elements are well known or commercially available.
For example the prior art of Yan (International Journal of Environmental Research and Public Health March 30, 2020 17, 2323) is a review article on SARS-CoV-2. The article describes treating the disease with antiviral therapies (pages 13-15).
Additionally the prior art of Guo (Military Medical Research March 13, 2020 7:11) is another article of COVID-19. The article discusses treatment of COVID-19 with antiviral therapies and chloroquine (page 6).
For the reasons set forth above the claims are not directed to patent eligible subject matter.
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA HANEY whose telephone number is (571)272-8668. The examiner can normally be reached Monday-Friday, 8:15am-4:45pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Shen can be reached at 571-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA HANEY/ Primary Examiner, Art Unit 1682