Prosecution Insights
Last updated: August 06, 2026
Application No. 17/908,524

COMPOUNDS FOR USE IN THE TREATMENT OF CORONAVIRUS INFECTION

Final Rejection §112§DOUBLEPATENT
Filed
Aug 31, 2022
Priority
Mar 02, 2020 — EU 20382152.5 +6 more
Examiner
HELLMAN, KRISTINA M
Art Unit
1654
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Pharma Mar S.A.
OA Round
2 (Final)
66%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 66% — above average
66%
Career Allowance Rate
467 granted / 712 resolved
+5.6% vs TC avg
Strong +55% interview lift
Without
With
+55.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 6m
Avg Prosecution
45 currently pending
Career history
752
Total Applications
across all art units

Statute-Specific Performance

§101
5.7%
-34.3% vs TC avg
§103
25.1%
-14.9% vs TC avg
§102
12.7%
-27.3% vs TC avg
§112
37.3%
-2.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 712 resolved cases

Office Action

§112 §DOUBLEPATENT
DETAILED ACTION Examiner acknowledges receipt of the reply filed 5/26/2026, in response to the non-final office action mailed 2/24/2026. Claims 71, 73-76, and 78-97 are pending. Claim 77 has been cancelled. Claims 71, 73-76, and 78-97 are being examined on the merits in this 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 . Terminal Disclaimer The terminal disclaimer filed on 5/26/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Application Nos. 17/908531 and 17/908526 has been reviewed and is accepted. The terminal disclaimer has been approved and recorded. See file wrapper. Drawings- withdrawn The objection to the drawings is withdrawn in view of the amendment to the specification filed 5/26/2026. Claim Objections- withdrawn The objection of claims 71, 74, 75, 77, 78, 83, 80, 84, and 88-94 is withdrawn in view of the amendment filed 5/26/2026. Claim Rejections - 35 USC § 112- withdrawn, in part The rejection of claims 71 and 73-77, 81-94, and 96 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment filed 5/26/2026. Double Patenting- withdrawn The rejection of claims 71, 73-77, 81-88, 93-85, and 97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 130-150 of copending Application No. 17/908526 (hereinafter referred to as “the ‘526 application”), is withdrawn in view of the terminal disclaimer (TD) filed 5/26/2026. The TD was approved and recorded 5/29/2026. See file wrapper. The rejection of claims 71, 73-82, 87, 89, and 93-97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30-55 of copending Application No. 17/908531 (hereinafter referred to as “the ‘531 application”), is withdrawn in view of the terminal disclaimer (TD) filed 5/26/2026. The TD was approved and recorded 5/29/2026. See file wrapper. Response to Arguments Applicant’s arguments and amendment filed 5/26/2026 with respect to the above objections and rejections have been fully considered and are persuasive. The objections and rejections have been withdrawn. Applicant's arguments filed 5/26/2026 have been fully considered but they are not persuasive with respect to the maintained rejections. Upon further consideration, a new ground(s) of objection is made in view of the amendment filed 5/26/2026. New Objection Claim Objections- New objection Claims 75, 83, and 89 are objected to because of the following informalities: Claim 75 should be amended to recite “is a mild infection”, for consistency with the amendment filed 5/26/2026. Claim 83 should be amended to recite “3 days, or 2 days”. Claims 89 should be amended to recite: ondansetron 8 mg intravenous (IV); diphenhydramine hydrochloride 25 mg IV; and ranitidine 50 mg IV. Appropriate correction is required. Maintained Objections/ Rejections Specification- maintained Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See p. 55, l. 33 of specification filed 5/26/2026. Applicant did not traverse this objection in the reply filed 5/26/2026. Claim Rejections - 35 USC § 112- maintained 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 78-80 and 95 remain/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. The rejection is maintained from the office action mailed 2/24/2026, but has been amended to reflect claims filed 5/26/2026. Claim 78 recites the limitation “the treatment”. There is insufficient antecedent basis for the limitation in the claim. Independent claim 71 recites treating, not treatment. Claim 79 recites the limitations "the prophylaxis" and “the treatment”. There is insufficient antecedent basis for the limitations in the claim. Claim 80 recites the limitations "the infectivity” and “the treatment”. There is insufficient antecedent basis for the limitations in the claim. Claim 95 recites the limitations “the likelihood”. There is insufficient antecedent basis for the limitation in the claim. Response to Argument Applicant traversed the rejection at p. 10 of the rely filed 5/26/2026. Applicant asserts the claims have been amended to “refer back to clearly established antecedent terms in the parent claims”. Examiner has reviewed and considered applicants arguments but is not persuaded. Independent claims 71 and 93, respectively, do not provide support for dependent claims reciting the denoted indefinite claim terms. The rejection is maintained for at least these reasons and those made of record. 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. Claims 71, 73-76, and 78-97 remain/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for attenuating or alleviating the progress of a coronavirus infection, does not reasonably provide enablement for prophylaxis, preventing or reversing a coronavirus infection. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. The rejection is maintained from the office action mailed 2/24/2026, but has been amended to reflect claims filed 5/26/2026. Examiner expressly notes that the definition of treatment within the specification (further discussed below) encompasses prevention and prophylaxis. The specification is not enabled for treatment by definition of “treatment” per the specification. The specification is limited to enablement for attenuating, alleviating or inhibiting the progress of a coronavirus infection plitidepsin, but not prevention, prophylaxis, or reversing of a coronavirus infection. Pharmaceutical therapies in the absence of in vivo clinical data are unpredictable for the following reasons; (1) the protein may be inactivated before producing an effect, i.e. such as proteolytic degradation, immunological inactivation or due to an inherently short half-life of the protein; (2) the protein may not reach the target area because, i.e. the protein may not be able to cross the mucosa or the protein may be adsorbed by fluids, cells and tissues where the protein has no effect; and (3) other functional properties, known or unknown, may make the protein unsuitable for in vivo therapeutic use, i.e. such as adverse side effects prohibitive to the use of such treatment. See page 1338, footnote 7 of Ex parte Aggarwal, 23 USPQ2d 1334 (PTO Bd. Pat App. & Inter. 1992). As stated in MPEP 2164.01(a), “there are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” The factors to be considered when determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, were described in In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) as: 1. the nature of the invention; 2. the breadth of the claims; 3. the state of the prior art; 4. the relative skill of those in the art; 5. the predictability or unpredictability of the art; 6. the amount of direction or guidance presented [by the inventor]; 7. the presence or absence of working examples; and 8. the quantity of experimentation necessary [to make and/or use the invention. (1) The Nature of the Invention and (2) The Breadth of the claims Claims 71, 73-76, and 78--92 are drawn to a method of treating coronavirus (CoV) infection, wherein the method comprises administering to an individual in need thereof a therapeutically effective amount of plitidepsin, a stereoisomer of plitidepsin, or a pharmaceutically acceptable salt of any one of the foregoing. Claims 93-96 are drawn to a method of prophylaxis, reduction, or treatment of CoV persistent, long CoV, or post-CoV syndrome, wherein the method comprises administering to an individual in need thereof, a therapeutically effective amount of plitidepsin, a stereoisomer of plitidepsin, a pharmaceutically acceptable salt of any one of the foregoing. Claim 97 is drawn to a method of treatment of CoV infection, the method comprising administering a combination therapy of plitidepsin or a pharmaceutically acceptable salt thereof and a corticosteroid to an individual in need thereof, thereby treating the CoV infection. Claim 73 and 94 recite that the CoV is SARS-COV-2. Claims 79 further recite prophylaxis. The specification defines: The term “treating”, as used herein, unless otherwise indicated, means reversing, attenuating, alleviating or inhibiting the progress of the disease or condition to which such term applies, or one or more symptoms of such disorder or condition. The term treating as used herein may also include prophylactic treatment, that is treatment designed to prevent a disease from occurring or minimize the likelihood of a disease occurring. “Treat”, “treating”, and “treatment” in the context of a viral infection may refer to one or more of the following: 1) reduction in the number of infected cells; 2) reduction in the number of virions present in the serum, including reduction in viral titre (which can be measured by qPCR); 3) inhibition (i.e., slowing to some extent, preferably stopping) the rate of viral replication; 4) reduction in the viral RNA load; 5) reduction in the viral infectivity titre (the number of virus particles capable of invading a host cell); and 6) relieving or reducing to some extent one or more of the symptoms associated with the viral infection. This may include inflammation associated with viral infection. As-filed specification at p. 12, ll. 10-22. Emphasis added. Thus, the instant claim scope encompasses both treating and preventing/prophylaxis, regressing a coronavirus infection comprising administering plitidepsin, a pharmaceutically acceptable salt, or a stereoisomer thereof. (3) The state of the art and (5) The predictability or unpredictability of the art Rangel et al (Curr Prot Pept Sci 18: 72-91 (2017)- previously cited) is a review article discussing marine depsipeptides. Didemnins showed great efficacy against a variety of virus at low doses: herpes simplex virus type 1 and 2, vaccinia virus, coxsackie virus A-21 and equine rhinovirus. Didemnins were also able to significantly reduce herpes virus lesions in rats when used as topical treatment, be sides presenting antitumor activity (p. 80). Aplidine Depsipeptide dehydrodidemnin B (aplidine, plitidepsin, Aplidin®) was isolated from the Mediterranean tunicate Aplidium albicans. Aplidine has a chemical structure very similar to didemnin B 2, a depsipeptide described in the 1980’s and also found in tunicates. Didemnin B has antiviral activity (p. 74). Alonso-Álvarez et al (Drug Design Dev Thera 11: 253–264 (2017)- previously cited) is a review article discussing plitidepsin. Plitidepsin is a cyclic depsipeptide that was first isolated from a Mediterranean marine tunicate (Aplidium albicans) and, at present, is manufactured by total synthesis and commercialized as Aplidin® (abstract). Its antitumor activity, observed in preclinical in vitro and in vivo studies has prompted numerous clinical trials to be conducted over the last 17 years, alone or in combination with other anticancer agents. Single-agent plitidepsin has shown limited antitumor activity and a tolerable safety profile in several malignancies, such as noncutaneous peripheral T-cell lymphoma, melanoma, and multiple myeloma. Id. In patients with relapsed or refractory multiple myeloma, plitidepsin activity seems to be enhanced after addition of dexamethasone while remaining well tolerated, and a Phase III trial comparing plitidepsin plus dexamethasone vs dexamethasone alone is underway. Id. Hu et al. (Nature Rev Microbiol. 19:141-154 (2021) -previously cited) is a review article discussing characteristics of SARS-CoV-2 and COVID-19. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a highly transmissible and pathogenic coronavirus that emerged in late 2019 and has caused a pandemic of acute respiratory disease, named ‘coronavirus disease 2019’ (COVID-19) (abstract). As a novel betacoronavirus, SARS-CoV-2 shares 79% genome sequence identity with SARS-CoV and 50% with MERS-CoV24. Its genome organization is shared with other betacoronaviruses. The six functional open reading frames (ORFs) are arranged in order from 5′ to 3′: replicase (ORF1a/ORF1b), spike (S), envelope (E), membrane (M) and nucleocapsid (N) (p. 142). SARS-CoV-2 uses the same receptor as SARS-CoV, angiotensin-converting enzyme 2 (ACE2)11,47. Besides human ACE2 (hACE2), SARS-CoV-2 also recognizes ACE2 from pig, ferret, rhesus monkey, civet, cat, pangolin, rabbit and dog11,43,48,49. The broad receptor usage of SARS-CoV-2 implies that it may have a wide host range, and the varied efficiency of ACE2 usage in different animals may indicate their different susceptibilities to SARS-CoV-2 infection *p. 146). Similarly to other coronaviruses, SARS-CoV-2 needs proteolytic processing of the S protein to activate the endocytic route. It has been shown that host proteases participate in the cleavage of the S protein and activate the entry of SARS-CoV-2, including transmembrane protease serine protease 2 (TMPRSS2), cathepsin L and furin. Id. To date, there are no generally proven effective therapies for COVID-19 or antivirals against SARS-CoV-2, although some treatments have shown some benefits in certain subpopulations of patients or for certain end points (see later). Researchers and manufacturers are conducting large-scale clinical trials to evaluate various therapies for COVID-19 (p. 149). Fig. 5 indicates SARS-CoV-2 replication and potential therapeutic targets. Yuki et al (Clin Immunol 215:108427 (2020)- previously cited) teach SARS-coV-2 (a coronavirus) caused an acute atypical respiratory disease. The virus primarily affects the respiratory system, although other organ systems are also involved. Lower respiratory tract infection related symptoms include fever, dry cough and dyspnea (p. 1). It is noted that pharmaceutical and biological art is generally unpredictable, requiring each embodiment to be individually assessed for physiological activity. Given this fact, historically the development of new drugs has been difficult and time-consuming. Adding to the unpredictability is that many treatment options may show promise in animal models, but may fail to show therapeutic improvement in clinical trials. There is no absolute predictability, even in view of the high level of skill in the art. The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). Examiner notes that in order to prevent an infection, the skilled artisan must be apprised of patients that are at risk of developing a coronavirus infection. In contrast, the examples relate to treatment following infection. There are no examples of prophylaxis/prevention of infection. (4) The relative skill of those in the art MPEP 2141.03 states (in part)” A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At 1396, 82 USPQ2d at 1396. The “hypothetical person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988) (disagreeing with the examiner’s definition of one of ordinary skill in the art (i.e. a doctorate level engineer or scientist working at least 40 hours per week in semiconductor research or development), and finding that the hypothetical person is not definable by way of credentials, and that the evidence in the application did not support the conclusion that such a person would require a doctorate or equivalent knowledge in science or engineering). In the instant case, the skill in the art high with respect to physicians and scientists. The level of skill in the art (physicians and scientists) would be high. (6) The amount of direction or guidance presented (by the inventor) and (7) The presence or absence of working examples Example 1 is in an in vitro assay indicating a reduction in HIV replication (antiviral activity) in the presence of plitidepsin. Example 2 assessed antiviral activity of plitidepsin in Huh-7 cells (human hepatoma cell line) infected with HCoV-229E. Example 2 states: HCoV-229E has a multiplication and propagation mechanism very similar to SARS-COV-2. The N protein of HCoV-229E has a protein homology greater than 90% with the homologous N protein in SARS-CoV-2. It is believed that all coronaviruses need their N (nucleocapsid) protein to bind to EF1A in order to replicate effectively and synthesize viral proteins. Reducing or abolishing the binding of N to EF1A reduces the viability for the spread of the virus (as-filed specification at p. 49). Example 3 discloses a clinical trial in which COVID-19 patients were administered plitidepsin. Patients exhibited a reduction in viral replication. Examples 4 and 5 disclose antiviral activity of plitidepsin against SARS-CoV-2 was in an in vitro assay using vero cells. Examples 6 and 7 are prophetic examples of a clinical trial of patients with COVID-19. Examiner expressly notes there are no examples of prophylaxis/prevention of a coronavirus infection set forth in the specification. Examiner further notes that in order to prevent an infection, the skilled artisan must first be able to identify and predict patients at risk for developing a coronavirus infection, as well as effective amounts, routes of administration, and dosing regimen sufficient for prophylaxis/preventing a coronavirus infection. There is no evidence that the specification offers a solution to the problem set forth in the specification of providing alternative therapies for prophylaxis/preventing a coronavirus infection. Though not controlling, the lack of working examples, is, nevertheless, a factor to be considered in a case involving both physiological activity and an undeveloped art. When a patent applicant chooses to forego exemplification and bases utility on broad terminology and general allegations, he runs the risk that unless one with ordinary skill in the art would accept the allegations as obviously valid and correct, the PTO may, properly, ask for evidence to substantiate them. Ex parte Sudilovsky, 21 USPQ2d 1702, 1705 (BPAI 1991); In re Novak, 134 USPA 335 (CCPA 1962); In re Fouche, 169 USPQ 429 (CCPA 1971). In essence, the specification merely presents an idea of, and leaves it entirely up to the practitioner to determine whether the method would produce a therapeutically relevant effect, and if so, how to carry out the claimed method. It has been established by legal decision that a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion. Tossing out the germ of an idea does not constitute an enabling disclosure. While every aspect of a generic claim need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable the skilled artisan to understand and carry out the invention. It is true that a specification need not disclose what is well known in the art. However, that general, oft-repeated statement is merely a rule of supplementation, not a substitute for a basic enabling disclosure. It means that the omission of minor details does not cause a specification to fail to meet the enablement requirement under 35 USC 112, first paragraph. When there is no disclosure of the specific starting materials or conditions under which the process can be carried out, there is a failure to meet the enablement requirement. See Genentech Inc. v. Novo Nordisk A/S, 42 USPQ2d 1001, 1005 (Fed. Cir. 1997). (8) The quantity of experimentation necessary (to make and/or use the invention) Owing to the factors listed above, especially in points 1-7, the amount of experimentation needed will be extensive in view of the lack of guidance by the inventor. MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here. Response to Argument Applicant traversed the rejection at pp. 11-12 of the rely filed 5/26/2026. Applicant asserts that human stem cells were prophylactically exposed to plitidepsin and then infected with SARS-CoV-2 virus. The specification states: Results showed that plitidepsin completely eliminated replication of SARS-CoV-2 with no observable cytotoxicity against the pneumocyte like cells (reply at p. 11, as-filed specification at p. 28). Applicant refers to Example 3 and asserts as evidence demonstrating reversal of a CoV infection. Patients with an existing CoV infection were treated with plitidepsin and had a reduction in virus. Some patients had complete viral clearance. Applicant asserts that removal of viral burden maps to the definition of treating at page 12, e.g. a reduction in the viral RNA load and reduction in the number of virions present in the serum (reply at p. 11). Applicant states in the reply at pp.11-12: Achieving a state of zero viral load and resolving the associated respiratory distress is the very definition of reversing a viral infection. Applicant asserts that the specification establishes that plitidepsin operates via a host directed mechanism e.g. binding to the human translation elongation factor eEF1A, and that the interaction prevents the viral nucleocapsid protein from binding to eEF1A, thus halting viral replication (reply at p. 12). Applicant further states at p.12: By relying on these highly conserved, well-characterized host cellular pathways rather than targeting rapidly mutating viral enzymes, the invention overcomes the traditional unpredictability of antiviral development. Because the biological target is a constant human host protein rather than a highly mutable viral target, the therapeutic and prophylactic effects are enabled across the entire scope of the claims. Applicant asserts the specification provides ample guidance, explicit working examples, and a predictable mechanism of action to enable a skilled person in the art to practice the full scope of the invention. Id. Examiner has reviewed and considered applicants arguments, but is not persuaded. The examples reduced to practice an in vitro assay of showing a reduction in viral replication in infected cells. Example 3 indicates treatment of patients with an existing CoV-2 infection. Examiner notes that in order to prevent an infection, the skilled artisan must be apprised of patients that are at risk of developing a coronavirus infection. In contrast, the examples relate to treatment following infection. Examiner reiterates that there are no examples indicating prevention/prophylaxis of a coronavirus infection. The specification does not provide sufficient information as to dosage amounts, routes of administration, dosing regimen for preventing prophylaxis of a coronavirus infection. Contrary to applicant’s assertion, preventing/prophylaxis of a coronavirus infection is not merely halting viral replication but preventing infection in the first instance. In order to prevent a coronavirus infection in the first instance, the skilled artisan must be able to identify patients at risk for developing a coronavirus infection and preemptively administer effective amounts of the claimed plitidepsin. Example 3 treated patients with an existing coronavirus infection. As indicated by applicant data and the cellular mechanism set forth in the specification and arguments, plitidepsin is effective at blocking viral replication. In this instance, the virus is already in the cell in order for replication to occur, e.g., the coronavirus has already infected a cell; an individual is already infected with the coronavirus. Thus, a coronavirus infection is not prevented in the first instance. The rejection is maintained for at least these reasons and those previously made of record. Relevant Art not Relied Upon Rinehart et al (WO 1991/004985 – previously cited) teach dehydrodidemnin B (plitidepsin) in its biological activity. The peptide was found to have activity against herpes simplex virus type 1 (HSV-1) (p. 6, Ex 2). Herpes simplex virus is a double stranded DNA virus. However, the reference does not teach or suggest treatment of a coronavirus (positive-sense, single-stranded RNA). Accordingly, the instant claims are free of the prior art. Conclusion No claims are allowed. Claims 71, 73-76, and 78-97 are pending and rejected. 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 KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm. 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, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KRISTINA M HELLMAN/ Examiner, Art Unit 1654 /JULIE HA/ Primary Examiner, Art Unit 1654
Read full office action

Prosecution Timeline

Aug 31, 2022
Application Filed
Feb 24, 2026
Non-Final Rejection mailed — §112, §DOUBLEPATENT
May 26, 2026
Response Filed
Jun 09, 2026
Final Rejection mailed — §112, §DOUBLEPATENT (current)

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Prosecution Projections

3-4
Expected OA Rounds
66%
Grant Probability
99%
With Interview (+55.0%)
2y 6m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 712 resolved cases by this examiner. Grant probability derived from career allowance rate.

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