DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-4, 10-11, and 13-18 are pending and presently considered.
Election/Restrictions
An election/restriction requirement has not been set forth on record at this time. However, Applicant is directed to MPEP §§ 818, 818.02(a), 819, and 821. SEQ ID NOs: 1-10 define sequences that have been deemed free of the prior art. Remaining issues are discussed below.
Priority
The priority claim to KR10-2020-0157143, KR10-2020-0157148, KR10-2020-0157147, and KR10-2020-0157149, each filed 11/20/2020 is acknowledged. Certified copies of each were placed on record on 5/17/2023.
Examiner notes that no certified translation of the Foreign Applications KR10-2020-0157143, KR10-2020-0157148, KR10-2020-0157147, or KR10-2020-0157149 have been placed on record. If applicant wants the application to be accorded benefit of the non-English language application, a certified translation is required (see 35 U.S.C. 119(b)(3), 37 CFR 1.55(g)(1)-(4)). Applicant is advised that any showing of priority that relies on a non-English language application is prima facie insufficient if no certified translation of the application is on file. See 37 CFR 41.154(b).
The priority claim to PCT/KR2021/005678, filed 5/06/2021 is acknowledged.
Information Disclosure Statement
The IDS filed 5/17/2023 and 12/09/2024 are each acknowledged and presently considered.
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
Claim 1 is representative of the pending claim scope. Claim 1 recites and requires a protein comprising “an amino acid sequence selected from the amino acid sequences of SEQ ID NO: 1 to SEQ ID NO: 10 which specifically binds to a receptor binding domain (RBD) of corona virus”. The phrase “which specifically binds to a receptor binding domain (RBD) of corona virus” does not correspond to a structure/function relationship of record, and therefore is not a functional limitation, but merely a recitation of intended and expected results fully satisfied by any protein comprising “an amino acid sequence selected from the amino acid sequences of SEQ ID NO: 1 to SEQ ID NO: 10”. Accordingly, the phrase “which specifically binds…” is superfluous (see objection below; see also MPEP § 2111.04(I), noting that “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”).
Additional claim interpretations are discussed below.
Objections to the Specification
The disclosure is objected to because of the following informalities:
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, e.g., Spec. filed 5/17/2023 at ¶¶[120], [139], [154], [223], [241], [256], [325], [343], [358], [427], [443], [458]).
Paragraph [94] is blank.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Appropriate correction is required.
Sequence Listing
The instant disclosure is objected to for not complying with 37 C.F.R. 1.821 as detailed in MPEP §§ 2421–2424. Specifically, the instant application does not comply with 37 C.F.R. 1.821(b)-(e). The instant claims and/or disclosure contain references or disclosures of amino acid sequences that should be accompanied by a sequence listing and identified using "SEQ ID NOs” as prescribed (see, MPEP §§ 2421–2424). Specifically, the instant application discloses sequences that are not accompanied with a SEQ ID NO: or otherwise do not appear in the sequence listing at paragraphs [154], [256], [358], [458], and Figures 8-10, 23-25, 38-40, 49 (e.g., the paragraphs disclose nucleotide sequences and the Figures disclose peptide sequences with a polyhistidine tails, N-terminal sequences, C-terminal sequences, etc. that do not correspond to instant SEQ ID NOs: 1-10 and do not appear with a sequence identifier).
Appropriate correction is required.
Objection to Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show details as described in the specification. Specifically, the Specification identifies that Figures 1, 16, 31, and 46 show the color “pink” (see, e.g., Spec. filed 5/17/2023 at ¶¶[14], [29], [44], [59]), but all figures are in grayscale, and furthermore the relevant details of the disclosed figures cannot be distinguished in grayscale at the low resolution presently provided. In addition, Figures 2-15, 17-30, 32- 45, 47-51 contain one or more instances of illegible text and details (i.e., terms, labels, axis, title, sequences, etc).
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 is objected to because it contains redundant and superfluous language that fails to meaningfully limit the pending claim scope. Specifically, claim 1 recites that phrase “which specifically binds to a receptor binding domain (RBD) of corona virus”, which does not appear to correspond to a specific structure/function relationship of record that further limits the scope of claim 1. If the phrase is merely a recitation of intended and expected results fully satisfied by any and all proteins comprising “an amino acid sequence selected from the amino acid sequences of SEQ ID NO: 1 to SEQ ID NO: 10”, then the phrase is superfluous and non-limiting, and should be deleted to reduce claim clarity and prevent confusion (see also MPEP § 2111.04(I), noting that “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”). Redundant and superfluous language should be removed to enhance claim clarity and to minimize potential confusion.
This objection could be overcome by simply deleting the phrase “which specifically binds to a receptor binding domain (RBD) of coronavirus” from claim 1.
Claim Rejections
Claim Rejections - 35 USC § 112(b)
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 1-4, 10-11, and 13-18 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.
Claim 1 recites the phrase “which specifically binds to a receptor binding domain (RBD) of coronavirus”, which renders the claim scope indefinite. This is understood to be a functional limitation, but fails to correspond to a structure/function relationship commensurate in scope with the pending claims. Per MPEP § 2173.05(g),
[T]he use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008)
Here, instant SEQ ID NOs: 1-10 are understood to specifically bind to the RBD of SARS-CoV2, which is not representative of all possible coronaviruses (see, e.g., Spec. filed 5/17/2023 at [2]-[4], explaining that the sequences block binding between RBD and ACE2 to treat COVID-19). This is relevant because “coronavirus” reads upon numerous types of coronaviruses, including MERS. This is pertinent because Mou et al1 teaches that not all coronavirus RBD bind to the same target; for example the RBD of the MERS coronavirus binds to DPP4, not ACE2 (see, e.g., Mou at title, abs, 9381 at col I at 1st to 2nd full ¶¶), and therefore each of SEQ ID NOs: 1-10 function by attempting to block RBD interaction with ACE2, and therefore would not be necessarily expected to successfully block any and all coronavirus infections, such as MERS infections mediated via different binding partners such as DPP4 (see id; compare id. with instant Spec. at [2]-[4]). Accordingly, the functional limitation recited in the phrase “which specifically binds to a receptor binding domain (RBD) of coronavirus” renders the claim scope indefinite because it is unclear which sequences actually satisfy such limitation since each coronavirus RBD is different, and no single, common required structural motif satisfying the functional limitation for all possible coronaviruses has actually been identified on record.Accordingly, the Specification does not reasonably inform an artisan how to distinguish between infringing and non-infringing compounds, because an artisan would not be aware of what structures did or did not possess the requisite functionality presently claimed. The Courts have stated that
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
Accordingly, claim 1 is rejected as indefinite in view of the recitation of the functional limitation, which lacks clear metes and bounds sufficient to apprise an artisan of infringing and non-infringing compounds. For purposes of consideration in view of the prior art, the phrase “which specifically binds to a receptor binding domain (RBD) of coronavirus” has been treated as non-limiting, superfluous language (see objection above). Applicant may overcome this rejection by deleting the phrase from claim 1 reciting “which specifically binds to a receptor binding domain (RBD) of coronavirus” or replacing it with “which specifically binds to a receptor binding domain (RBD) of SARS-CoV2”
Claim 2 is directed to a product, but recites a method step (“inhibits binding”). Per MPEP § 2173.05(p)(II), a single claim reciting both a product and a method step is indefinite because it is unclear when infringement occurs (i.e., before, during, or after the completion of the step). Accordingly, claim 2 is rejected as indefinite. For purposes of examination in view of the prior art, the active method step has been interpreted as a description of expected activity attributable to the product (i.e., “wherein the product is capable of inhibiting binding…”).
Claim 4 is directed to a product, but recites a method step (“binds to”). Per MPEP § 2173.05(p)(II), a single claim reciting both a product and a method step is indefinite because it is unclear when infringement occurs (i.e., before, during, or after the completion of the step). Accordingly, claim 2 is rejected as indefinite. For purposes of examination in view of the prior art, the active method step has been interpreted as a description of expected activity attributable to the product (i.e., “wherein the product is capable of binding to…”).
Claim 13 is directed to an incomplete method, which lacks a clear preamble and lacks cognizable steps of achieving the preamble; therefore, the claim scope is indefinite. As an initial matter, the preamble phrase “of delivering” is unclear because “delivering” can be used as a transitive or intransitive verb, and here it is unclear what the direct object of “delivering” might be (i.e., “delivering a package to a person by truck”, “delivering an injection to a patient”, “delivering a completed formulation of a compound”, etc.), which materially impacts the pending claim scope. In addition, claim 13 is indefinite because it lacks any active method steps for actually achieving “delivery”, and therefore the claim scope is indefinite. For purposes of examination in view of the prior art, claim 13 is understood to have the scope of claim 10, but limited to prophylactic delivery (i.e., vaccination).
Claims 14 depends from claim 13, but refers to “the drug”. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 depends from claim 13, but refers to “the antiviral agent”. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 is directed to an incomplete method, which recites preamble that requires “diagnosing coronavirus infection”, but fails to recite a cognizable step wherein such diagnosis is achieved as required by the preamble; therefore, the claim scope is indefinite for omission of essential steps; instant claim 17 recites a method wherein a protein of claim 1 is administered to “a sample from a subject” (i.e., blood, spit, urine, feces, plasma, tears, biopsy, etc.), but no means of detection of a particular outcome is required or recited (i.e., no fluorescence, binding, precipitation event, PCR step, etc.), and no step wherein a diagnosis is either confirmed or rejected in view of a particular result is required or recited (compare with Spec. at [92]-[95]). Accordingly, as written, claim 17 recites an ex vivo method of administering a protein of claim 1 to a subject “suspected of having coronavirus infection”, but provides no step confirming or rejecting any diagnosis as recited and required by the preamble; accordingly, the preamble reciting a diagnosis does not reflect the single ex vivo step presently required. This raises substantial and significant concerns regarding the pending claim scope and completeness of the claim, which is therefore rejected as indefinite. For purposes of examination in view of the prior art, claim 13 is understood to have the scope of claim 10, but limited to prophylactic delivery (i.e., vaccination).
Claim 17 recites the patient population consisting of “a subject suspected of having a coronavirus infection”. The phrase “suspected of having a coronavirus infection” in claim 17 is a relative phrase which renders the claim indefinite. The phrase “suspected of having a coronavirus infection” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The “suspicion” of one artisan would not necessarily be identical to another artisan’s “suspicion”, which means that the meaning of the phrase would differ from artisan to artisan. Furthermore, the phrase “suspected of having a coronavirus infection” fails to correspond to any specific objective, diagnostic criteria set forth in the originally filed disclosure (e.g., initial screening results, recent travel history, recent exposure to confirmed cases, cough, fever, etc.), and therefore an artisan would not be reasonably apprised of the scope of the invention.
Claim 18 depends from claim 17, but refers to “wherein the coronavirus is SARS-CoV2”. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this refers to the diagnosed coronavirus in the diagnosis recited in the preamble (i.e., limiting the claim scope to methods wherein patients are actually diagnosed with SARS-CoV2), or to the initial patient population “suspected of having coronavirus infection (i.e., limiting the initially tested population to patients specifically “suspected of having” only SARS-CoV2 rather than another coronavirus).
Claims 2-4, 10-11, and 13-18 depend, directly or indirectly from an indefinite claim, but fail to correct the indefiniteness of the base claim. Accordingly, claims 14-16 are rejected as indefinite as depending upon an indefinite base claim.
Accordingly, claims 1-4, 10-11, and 13-18 are rejected.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-4 and 14-16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 2-3 depend from claim 1. Claim 1 defines a product comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-10. For purposes of this rejection, the phrase “which specifically binds to a receptor binding domain (RBD) of coronavirus” has been treated as non-limiting language, which is reasonable in the absence of any structure/function relationship (see, e.g., MPEP § 2111.04(I), noting that claim scope is not limited by claim language that does not limit a claim to a particular structure). Claims 2-3 fail to further limit the structure of the claimed products of claim 1. The phrases at claims 2-3 do not correspond to functional limitations corresponding to any disclosed structure/function relationship of record, and therefore claims 2-3 appear fully satisfied by any and all products within the scope of claim 1. Accordingly, claims 2-3 are rejected for failing to further limit the subject matter of the claim upon which it depends.
Claim 4 depends from claim 1. Claim 1 defines a product comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-10. For purposes of this rejection, the phrase “which specifically binds to a receptor binding domain (RBD) of coronavirus” has been treated as non-limiting language, which is reasonable in the absence of any structure/function relationship (see, e.g., MPEP § 2111.04(I), noting that claim scope is not limited by claim language that does not limit a claim to a particular structure). Claim 4 fails to further limit the structure of the claimed products of claim 1. The phrases at claim 4 do not correspond to functional limitations corresponding to any disclosed structure/function relationship of record, and therefore claim 4 appears to be fully satisfied by any and all products within the scope of claim 1 because claim 4 appears to merely provide a description of the compounds of claim 1 but in the absence of any additional structural limitations. Accordingly, the scope of claim 1 and 4 appear to be identical, and therefore claim 4 is rejected for failing to further limit the subject matter of the claim upon which it depends.
Claims 13-16 have been rejected as indefinite under 35 USC 112(b), above, and those discussions are incorporated herein. For purposes of the instant rejection, the terms “the drug” and “the antiviral agent” at claims 14-16 are understood to refer to a “pharmaceutical composition comprising the protein of claim 1 as an active ingredient” as recited at claim 13. If correct, claims 14-16 fail to further limit the scope of claim 13, because claim 13 already recites “a pharmaceutical composition comprising the protein of claim 1 as an active ingredient”, wherein the protein of claim 1 is any product comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-10. Upon review of the original disclosure, claims 14-16 do not reasonably appear to correspond to some functional limitation that defines a subgenus of such compounds; rather, the recitations of claims 14-16 are reasonably understood to merely restate the same exact scope as claim 13 by merely referring to the same identical set of compounds by different phrases (i.e., “antiviral agent” and “antiviral agent against coronavirus” refer to any and all pharmaceutical compositions within the scope of claim 13, and therefore claims 14-16 have the same scope as claim 13). Accordingly, the scope of claims 14-16 appear to be identical to the scope of claim 13, and therefore claims 14-16 are rejected for failing to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Accordingly, claims 2-4 and 14-16 are rejected.
Claim Rejections - 35 USC § 112(a), Scope of Enablement
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 10-11 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 treatment of SARS-CoV2, does not reasonably provide enablement for preventing all possible coronavirus infectious diseases as presently claimed, or treating coronaviruses that infect via pathways not involving ACE2 binding. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The applicable legal standards for enablement are discussed at MPEP § 2164 and the specific legal standards relevant to determinations regarding the scope of enablement are set forth at MPEP § 2164.08. MPEP § 2164 identifies the following relevant factors for determining “undue” experimentation: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.” The factors which have led the Examiner to conclude that the specification fails to teach how to make and/or use the claimed invention without undue experimentation, are addressed in detail below.
The breadth of the claims and nature of the invention: Claims 10-11 are directed to broad methods of “treating and preventing” all types of coronavirus infectious diseases, in any patient population, by administering any amount of peptides of claim 1, via any route of administration2. The term “coronavirus infectious diseases” is understood to include all strains and variants of coronavirus, including those yet to be discovered. Accordingly, the claim scope is vast and highly varied, and raises concerns regarding credibility as discussed below.
Brief introduction of the issue: The enablement provided is not commensurate in scope with the claims because the claims read upon prevention of all strains and variants of “coronavirus infectious diseases”, including those yet to be discovered. This is not credible in the absence of any clinical verification as it is well-understood that viral sequences mutate substantially and rapidly, as discussed below.
The amount of direction or guidance presented and the existence of working examples: Zero working examples showing prevention of any strain of any coronavirus infectious disease was shown. Zero clinical data was shown. Zero experimental validation of any “prevention” of any infection of any strain of coronavirus was actually provided. Accordingly, the ability to “prevent” diseases is at best, a hoped for and desired outcome that the inventors wish to achieve, but which is unsupported by any objective evidence in a clinical setting.
State of the art: Dinata3 is a review that explains that a drug capable of “preventing” all coronaviruses (e.g., SARS-CoV-2) still did not exist even in 2025 due to antiviral drug resistance (see, e.g., Dinata passim). Dinata explains that even if “Drug repurposing and drug discovery may lead to a successful SARS-CoV2 antiviral [circa 2025]”, that “rapid drug use may cause unexpected mutations and antiviral drug resistance”, and that “novel variants of the SARS-CoV-2 can diminish the neutralizing efficacy of vaccines, thereby “enhancing viral fitness and increasing the likelihood of drug resistance emergence” (see, e.g., Dinata at title, abs). Dinata explains that, circa 2025, previously approved treatments authorized in 2020 were not sufficient because of the “rapid emergence of new mutants”, which “has always remained a challenge” (see, e.g., Dinata at 1 at Intro). Accordingly, per Dinata, an artisan would not reasonably conclude that Applicant was enabled for the prevention of all possible strains and mutants of coronavirus, because artisans understood that Coronavirus rapidly mutated and that novel strains would exhibit drug resistance.
State of the prior art: Naqvi et al.4, published June 2020, published prior to filing of the instant Application, further explains that during that time period, scientists appreciated that even a “minimal variation in the genome of SARS-CoV-2” were understood to be capable of “mak[ing] available drugs ineffective” (see, e.g., Naqvi at title, abs). Artisans understood that “[p]otential adaptive mutations in the SARS-CoV-2 genome possibly made it highly pathogenic and difficult for drug and vaccine development” (see Naqvi at 2 at col II at final ¶). Accordingly, an artisan aware of the difficulty of drug development and adaptive mutations characterizing coronaviruses, such as SARS-CoV-2, would not reasonably conclude that an untested, unverified drug could “prevent” all possible strains and variants of all possible coronaviruses, including those yet to be discovered, in the absence of credible evidence.
In addition, Mou et al5 teaches that not all coronavirus RBD bind to the same target; for example the RBD of the MERS coronavirus binds to DPP4, not ACE2 (see, e.g., Mou at title, abs, 9381 at col I at 1st to 2nd full ¶¶), and therefore proteins that function by attempting to block RBD interaction with ACE2 would not be necessarily expected to successfully block coronavirus infections mediated via different binding partners (see id; compare id. with instant Spec. at [2]-[4]). Accordingly, an artisan would not reasonably expect or conclude that a compound capable of blocking interaction with ACE2 would necessarily “prevent or treat” all possible coronaviruses as presently claimed, because not all coronaviruses have infection pathways involving ACE2 binding.
Relative skill of those in the art, and the predictability or unpredictability of the art: Although the relative skill in the art is high, the general predictability of the art regarding the complete prevention of all strains and variants of all coronaviruses is very low because coronaviruses rapidly mutate and develop drug resistance (see, e.g., discussions regarding Dinata and Naqvi, above). Accordingly, an artisan would readily appreciate that, circa 2020, that complete prevention of coronavirus infection was not known, understood, or expected by artisans aware of the rapid rise of drug-resistant strains.
The quantity of experimentation required to practice the claimed invention based on the teachings of the specification. While methods of treating coronavirus infection were known at the time of the invention, prevention of all strains and variants of all types of coronavirus infections were not routine or otherwise known in the art. Accordingly, in the absence of experimental validation for all strains and variants of all types of coronavirus infections, an artisan would be unduly forced to actually test and validate the claimed invention for each protein claimed in each patient population. Furthermore, in the absence of any evidence, an artisan would not reasonably or credibly expect a static compound to “prevent” infection of a constantly evolving coronavirus known for developing drug resistance. In addition, in view of Mou, an artisan would readily appreciate that different coronaviruses infect via different molecular pathways, including pathways that are not dependent upon ACE2, and would therefore not reasonably expect that a drug designed to treat SARS-CoV2 by blocking RBD and ACE2 interactions would prevent (or treat) all other coronaviruses in the absence of evidence; in the absence of such evidence, preventing or treating coronaviruses by blocking an interaction that is unnecessarily for infection would not reasonably be inferred or expected to work. Accordingly, an artisan would be unduly burdened to utilize the claimed invention to treat and prevent all possible coronaviruses as presently claimed.
Therefore, at the time of filing, an artisan would reasonably doubt that such activity was possible to achieve in the absence of credible and substantial guidance. No such credible and substantial guidance has been set forth on record. Accordingly, to practice the full scope of the instant invention including 100% prevention of all types, variants, and strains of coronaviruses, including those yet to be discovered, an artisan would be unduly burdened to actually identify an “effective” doses and effective administration routes for all patient populations (age, gender, weight, etc.), for all different strains and variants of all types of coronaviruses in all possible subjects (e.g., human and non-human), as encompassed by instant claims 10-11, which the prior art teaches is likely impossible due to rapid mutations accumulated by coronaviruses leading to drug resistance. Furthermore, a review published circa 2025 supports a determination that no enabling disclosure for prevention of all possible coronaviruses actually existed or was discovered prior to 2025.
Conclusion: Therefore, in view of the lack of guidance and working examples, high degree of unpredictability, and failure to address the concerns present in the art, an artisan would be unduly burdened with experimentation in order to practice the full scope of the instantly claimed invention.
Accordingly, claims 10-11 are rejected.
Applicant is advised that this rejection could be resolved by amending claim 10 to remove the phrase “preventing or” from the preamble of claim 10, and to incorporate the limitation of claim 11 into claim 10 to limit treatment to SARS-CoV2.
Claim Rejections - 35 USC § 112(a), New Matter
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 17-18 are 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.
Applicable Case Law
The MPEP states that "[w]hile there is no in haec verba requirment, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP 2163.
Claims 17-18 were added in the amendments filed 5/22/2023 and therefore do not constitute a portion of the originally filed disclosure as filed 5/17/2023.
Lack of literal Support
The MPEP states that "[w]hile there is no in haec verba requirment, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP 2163.
Claims 17-18 do not appear in the originally filed disclosure. For example, the phrase defining a patient population reciting a “subject suspected of having coronavirus infection” is not literally found in the originally filed disclosure.
Accordingly, claims 17-18 lack literal support in the originally filed disclosure.
Lack of Implicit or Inherent Support
The MPEP states that "[w]hile there is no in haec verba requirment, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP 2163. As noted above, the claims are not literally or inherently supported by the originally filed disclosure. Accordingly, the relevant issue is whether or not the new amendments and resulting claim scope is implicitly or inherently supported by the originally filed disclosure.
Per MPEP § 2163(I)(B), “[a]n amendment to correct an obvious error does not constitute new matter where the ordinary artisan would not only recognize the existence of the error in the specification, but also recognize the appropriate correction. In re Oda, 443 F.2d 1200, 170 USPQ 268 (CCPA 1971)”. Here, no allegation that the amendments correct an obvious error has been made. Furthermore, upon inspection, Examiner is unable to identify any single “obvious error” that would lead to instantly amended claim 1 and the scope thereof.
Zero examples of a method of diagnosing were reduced to practice, and therefore no inherent support exists for the newly added claims.
No definition of the phrase a “subject suspected of having coronavirus infection” is provided on record identifying that the term is synonymous or equivalent in scope with another term of art in the record.
Conclusion
Per MPEP § 2163, new or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement (see, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971)). Here, the newly added claim limitations result in a narrower claim genus which defines a novel subgenus of species that was not inherently, implicitly, or literally supported by the originally filed disclosure.
Although the originally-filed disclosure may render the instant claims obvious, “a description which renders obvious a claimed invention is not sufficient to satisfy the written description requirement of that invention” (see, Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1567 (Fed. Cir. 1997)) because “[o]ne shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious” (Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1571-72 (Fed. Cir. 1997) at 1572).
Accordingly, claims 17-18 are rejected.
Claim Rejections - 35 USC § 112(a), Written Description
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 1-2, 4, 10-11, 13-15, and 17-18 are 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.
Claim 1 is representative of the pending claim scope.
The relevant issue is that claim 1 presently recites a functional limitation (i.e., “which specifically binds to a receptor binding domain (RBD) of coronavirus”) which fails to correspond to a structure/function relationship of record commensurate in scope with the pending claims. As noted above, per MPEP § 2173.05(g),
[T]he use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008)
The issue of indefiniteness is related to the instant rejection because Applicant cannot evidence “possession” of the full scope of an invention which is not defined sufficiently to permit an artisan to distinguish infringing from non-infringing embodiments:
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
Here, zero examples of the claimed invention were reduced to practice and shown to be capable of binding to all possible coronaviruses or otherwise capable of binding to any coronavirus other than SARS-CoV2. Specifically, instant SEQ ID NOs: 1-10 are understood to specifically bind to the RBD of SARS-CoV2 (see, e.g., Spec. filed 5/17/2023 at [2]-[4], explaining that the sequences block binding between RBD and ACE2 to treat COVID-19), SARS-CoV2 is not representative of all possible coronaviruses as explained below.
This is relevant because “coronavirus” as recited in the functional limitation reads upon numerous types of coronaviruses, including MERS. This is pertinent because Mou et al6 teaches that not all coronavirus RBD bind to the same target; for example the RBD of the MERS coronavirus binds to DPP4, not ACE2 (see, e.g., Mou at title, abs, 9381 at col I at 1st to 2nd full ¶¶), and therefore each of SEQ ID NOs: 1-10 function by attempting to block RBD interaction with ACE2, and therefore would not be necessarily expected to successfully block any and all coronavirus infections, such as MERS infections mediated via different binding partners such as DPP4 (see id; compare id. with instant Spec. at [2]-[4]). Accordingly, one of ordinary skill in the art would not reasonably expect for instant SEQ ID NOs: 1-10 to “specifically binds to a receptor binding domain (RBD) of” non-SARS-CoV2 coronaviruses, such as MERS in the absence of objective supporting evidence.
In view of Mou, the claimed structures (i.e., SEQ ID NOs: 1-10) would not reasonably be inferred to be sufficient to bind to the RBD of all possible coronaviruses on record, including MERS. The instant disclosure fails to address this shortcoming by defining the functional limitation with respect to a common structural motif capable of binding to all possible RBD of any possible coronavirus. Therefore, the functional limitation presumably requires some unknown, undisclosed additional structure that would render the functional limitation satisfied. However, it is unknown in view of the record and prior art exactly what structure would be sufficient to satisfy such a function.
Accordingly, in view of the art, an artisan would appreciate that each coronavirus RBD is different, and would reasonably conclude, in the absence of objective evidence to the contrary, that no single, common required structural motif satisfying the functional limitation for all possible coronaviruses was identified on record or otherwise known in the prior art. Furthermore, no such common structural motif is known in the prior art. No evidence that such a common structural motif is possible has been placed on record.
Conclusion
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). The courts have stated that “merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus” (see, e.g., AbbVie v. Janssen, 111 USPQ2d 1780 (Fed. Cir. 2014) at 1789). In addition, the Courts have stated
“[r]egardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
This is pertinent because, in the instant case, Applicants have claimed a broad and highly varied genus comprising an unknown number of species defined by reference to one or more functional limitations; however, the originally filed disclosure has failed to identify any common structure/function relationship sufficient to permit an artisan to identify what structures are included or excluded by the claim scope. This also means that it is prima facie unclear what structures are infringe or do not infringe upon the pending claim scope.
In conclusion, for the reasons discussed above, the skilled artisan would not reasonably conclude that the inventor(s), at the time the application was filed, had possession of the full scope of the claimed invention.
For purposes of consideration in view of the prior art, the phrase “which specifically binds to a receptor binding domain (RBD) of coronavirus” has been treated as non-limiting, superfluous language (see objection and 112(b) rejections, above).
Applicant may overcome this rejection by deleting the phrase from claim 1 reciting “which specifically binds to a receptor binding domain (RBD) of coronavirus” or replacing it with “which specifically binds to a receptor binding domain (RBD) of SARS-CoV2”.
Allowable Subject Matter
Although SEQ ID NOs: 1-10 are understood to be based upon sequences derived from hACE2-peptidase domain (PB) that are capable of blocking binding between ACE2 and SARS-CoV-2 RBD as previously disclosed in the prior art (see, e.g., Sitthiyotha et al., passim, as cited in IDS filed 12/09/2024 as cite No. 1), however, the closest prior art of record (id.) does not anticipate nor render obvious the specific sequences corresponding to instant SEQ ID NOs: 1-10. Accordingly, such sequences are a point of novelty.
Examiner suggests amending claim 1 to remove “which specifically binds to a receptor binding domain (RBD) of coronavirus”; canceling claims 2-4, 11, 13-16, and 18; amending claim 10 to replace the preamble of instant claim 10 with “A method for treating SARS-CoV2 in a patient in need thereof”; and amending claim 17 to be limited to SARS-CoV2, to remove the phrase “suspected of having coronavirus infection”, and to include a diagnostic step of “detecting binding thereof”, “wherein detection of binding is indicative of SARS-Cov2 infection” or similar language as supported by the original disclosure at [93]-[96].
If Applicant would like to discuss any proposed amendments further, Applicant is invited to contact the Examiner directly to schedule an interview.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Examiner notes US Application Number 18/018,364, which shares at least once common named inventor, is directed to similar, but not overlapping subject matter. A notice of Allowance was mailed in App’364 on 12/15/2025 and the Issue Fee was paid on 1/09/2026. SEQ ID NO: 1 as referenced in the allowed claims is non-identical to instant SEQ ID NOs: 1-10, and differs in a manner from instant SEQ ID NO: 1-10 that cannot be said to be obvious in view of the art of record.
Conclusion
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
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/RANDALL L BEANE/ Primary Examiner, Art Unit 1654
1 Mou et al., The receptor binding domain of the new Middle East respiratory syndrome coronavirus maps to a 231-residue region in the spike protein that efficiently elicits neutralizing antibodies. J Virol. 2013 Aug;87(16):9379-83. doi: 10.1128/JVI.01277-13. Epub 2013 Jun 19. PMID: 23785207; PMCID: PMC3754068; hereafter “Mou”.
2 Routes of administration include at least enteral, oral, sublingual, buccal, rectal, parenteral, intravenous, intramuscular, subcutaneous, intraarterial, transnasal, inhalation, vaginal, transdermal, intraosseous, etc., etc.
3 Dinata et al., Evolution of Antiviral Drug Resistance in SARS-CoV-2. Viruses. 2025 May 18;17(5):722. doi: 10.3390/v17050722. PMID: 40431733; PMCID: PMC12115881; hereafter “Dinata”
4 Naqvi et al., Insights into SARS-CoV-2 genome, structure, evolution, pathogenesis and therapies: Structural genomics approach. Biochim Biophys Acta Mol Basis Dis. 2020 Oct 1;1866(10):165878. doi: 10.1016/j.bbadis.2020.165878. Epub 2020 Jun 13. PMID: 32544429; PMCID: PMC7293463; hereafter “Naqvi”.
5 Mou et al., The receptor binding domain of the new Middle East respiratory syndrome coronavirus maps to a 231-residue region in the spike protein that efficiently elicits neutralizing antibodies. J Virol. 2013 Aug;87(16):9379-83. doi: 10.1128/JVI.01277-13. Epub 2013 Jun 19. PMID: 23785207; PMCID: PMC3754068; hereafter “Mou”.
6 Mou et al., The receptor binding domain of the new Middle East respiratory syndrome coronavirus maps to a 231-residue region in the spike protein that efficiently elicits neutralizing antibodies. J Virol. 2013 Aug;87(16):9379-83. doi: 10.1128/JVI.01277-13. Epub 2013 Jun 19. PMID: 23785207; PMCID: PMC3754068; hereafter “Mou”.