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 .
Priority
The instant application, filed 01/12/2024, claims foreign priority to CN202310064585.2, filed 01/16/2023, and CN202311661466.1, filed 12/06/2023. It is noted however, that Applicant has not filed certified copies of the foreign applications as required by 37 CFR § 1.55. Therefore, Applicant is not entitled to the effective filing date of 01/16/2023 associated with the foreign priority document CN202310064585.2, or the effective filing date of 12/06/2023 associated with the foreign priority document CN202311661466.1.
Status of Claims
Claims 1-20 are pending in the instant application. Claims 8-16 are withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 1-7 and 17-20 read on an elected invention and species and are therefore under consideration in the instant application.
Information Disclosure Statement
The Information Disclosure Statement filed on 08/30/2026 is acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the information disclosure statement is considered.
Restriction/Election
Applicant’s election with traverse of Group I in the reply filed on 05/07/2026 is acknowledged. Furthermore, the election of the following species is also acknowledged:
Species A: A viral infection caused by SARS-CoV-2 (paragraph [0057])
However, an error was made in the requirement for restriction/election filed 03/11/2026. The requirements for Species B-F were intended to be a requirement solely for Group II, i.e., the claims which are drawn to the buccal tablet. The claims of Group I do not recite any specific coloring agents, adhesives, etc. Therefore, the election of species B-F are not applicable to the election of Group I.
The traversal by Applicant is on the grounds that the search and examination of all the claims in the application can be made without serious burden.
Applicant’s argument is found not persuasive because a method of treating an infection and the buccal tablet composition instantly claimed are classified in different fields of search, and require different search strategies and search tools for examination. A method of treatment claim requires searching for the disclosed pharmacological activity and dosing regimen, while a composition claim requires searching for the disclosed excipient composition and formulation. The prior art relevant to one group is not likely to be relevant to the other. Furthermore, given the differing forms the claimed species could take, an entirely different set of species must be searched for each group, and the search for one group would not encompass the search required for the other. Accordingly, a serious search and/or examination burden exists, and the requirement for restriction is deemed proper.
Applicant further states that “should the examiner make the restriction requirement final, Applicant asserts the right for rejoinder of the withdrawn product claims upon finding the method claims allowable.”
Applicant’s assertion is incorrect because, pursuant to MPEP § 821.04, in order to be eligible for rejoinder, a claim to a nonelected invention must depend from, or otherwise require all the limitations of an allowable claim. Applicant is further advised that rejoinder under MPEP § 821.04 (b) operates only in one direction: it permits withdrawn process claims to be rejoined once an elected product claim is found allowable. It does not provide a basis for rejoining withdrawn product claims where, as in the instant case, when the process is the elected invention. Accordingly, if the elected process claims are ultimately found allowable, the withdrawn product claims will not become eligible for rejoinder.
The requirement is deemed proper and is therefore made FINAL.
In accordance with the MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant claims based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP § 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species does not make a contribution over the prior art of record.
The Specification
The disclosure is objected to because of the following informalities:
The attempt to incorporate subject matter into this application by reference to the determination method of disintegration time of the Chinese Pharmacopoeia, 2020 Edition is ineffective because the determination method has not been described or provided to a person seeking to practice the method.
Appropriate correction is required.
Drawings
The drawings filed on 01/12/2024 objected to under 37 CFR § 1.83(a) for the following reasons:
The different data types are indistinguishable in Figures 1 and 3A. The original figures rely on color-coding of the data, a feature not available in the black and white drawings. The figures must be remade with shapes or line-types used to describe the different data points.
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.
Claim Objections
Claims 5-7 and 18-20 are objected to for the following informalities:
The claims recite “virus infection,” however, the proper grammatical designation to be used would be “viral infection” in every case recited in claims 5-7.
Further regarding claims 6 and 19, the claim should be amended to recite “and” before “the bacterial infection,” in order to have a proper listing of the species.
Appropriate correction is required.
Claim interpretation
The instant claims are subject to the following interpretation:
The instant claims recite, “buccal cavity.” According to the broadest reasonable interpretation set forth by MPEP § 2111, “buccal cavity” is determined to be synonymous with “the oral cavity.” This is evidenced by the NCBI Bookshelf, which states, “The oral cavity, or more commonly known as the mouth or buccal cavity, serves as the first portion of the digestive system” (StatPearlsPublishing, Anatomy Head and Neck, Updated August 14, 2023). Therefore, the instant claims drawn to a “buccal cavity” are interpreted to be synonymous with “oral cavity.”
Claim Rejections - 35 U.S.C. § 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 2, 6, and 19 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.
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 2 recites the broad recitation “1 to 20 minutes,” and the claim also recites “preferably 1 to 5 minutes” which is the narrower statement of the range/limitation.
Furthermore, claim 6 recites the broad recitation “influenza A virus, influenza B virus, rhinovirus (HRV), adenovirus (AdV), coronavirus,” and the claim also recites “(including but not limited to SARS virus, SARS-CoV-2), vesicular stomatitis virus (VSV), human immunodeficiency virus (HIV), enterovirus 71 (EV71), hepatitis B virus (HBV), herpes simplex virus type 1 and 2 (HSV-1 and HSV-2), hepatitis C virus (HCV), coxsackievirus, and novel enterovirus D68 (EV-D68), the bacterium infection is an infection caused by a Helicobacter pylori” which is the narrower statement of the range/limitation.
Finally, claim 19 recites the broad recitation “influenza A virus, influenza B virus, rhinovirus (HRV), adenovirus (AdV), coronavirus”, and the claim also recites “including but not limited to SARS virus, SARS-CoV-2), vesicular stomatitis virus (VSV), human immunodeficiency virus (HIV), enterovirus 71 (EV71), hepatitis B virus (HBV), herpes simplex virus type 1 and 2 (HSV-1 and HSV-2), hepatitis C virus (HCV), coxsackievirus, and novel enterovirus D68 (EV-D68), the bacterium infection is an infection caused by a Helicobacter pylori.“ which is the narrower statement of the range/limitation.
The claims 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.
Claim Rejections – 35 U.S.C. § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 and 5-7 are rejected under 35 U.S.C. § 102 (1) as being anticipated by Zhang et al. (Trends Food Sci Tech, Volume 132, pages 40-53 published December 28, 2022), hereinafter Zhang.
The instant claims are drawn to a method for preventing and/or treating a viral infection—elected to be caused by SARS-CoV-2— comprising the administration of a buccally effective amount of epigallotechin gallate (EGCG).
Zhang teaches a method of using EGCG to prevent and treat coronavirus infection (Abstract, see instant claim 1). Zhang discloses specific buccal-activity residence times of EGCG and concentration data supporting the use of treating COVID-19 (Table 2, see instant claim 1). Specifically, Zhang teaches that EGCG is retained in the buccal cavity well beyond one minute—a 2-minute oral hold produces saliva EGCG of 120-200 mM (i.e. 0.120- 0.2 mM, Table 2 see instant claims 1-3). Zhang further teaches that saliva concentrations were recorded at 220 mM (i.e. 0.22 mM) at 10 minutes after drinking a beverage containing 28mg ECGC (Table 2, see instant claim 3). The entire disclosure by Zhang focuses on proposed methodology of preventing and treating the respiratory virus, SARS-CoV-2 using EGCG. Zhang explicitly states “Given that SARS-CoV-2 Omicron variant has a greater tropism toward the upper respiratory tract and that EGCG can be massively retained in the upper respiratory tract following its contact with the oral cavity (Yang et al., 1999), EGCG clearly has potential as a preventive and therapeutic agent against Omicron” (page 42) and extensively reviews the application of EGCG on SARS-CoV-2 replication (page 42, see instant claims 5-7).
Regarding claim 3, the prior art teaches that the average concentration of EGCG in the buccal cavity was recorded to be 0.2 mM and 0.22 mM, which overlap with the range instantly claimed. The instantly claimed ranges merely lie inside within the concentration ranges found in the prior art teachings. It is noted that the courts have stated
where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also found that,
“where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.
Therefore, the claimed ranges merely represent an obvious variant and routine optimization of already disclosed within the prior art prior art.
Claim Rejections - 35 U.S.C. § 103
The following is a quotation of pre-AIA 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4 and 17-20 is rejected under 35 U.S.C. § 103 as being unpatentable over Zhang et al. (Trends Food Sci Tech, Volume 132, pages 40-53 published December 28, 2022), hereinafter Zhang (as applied to claims 1-3 and 5-7 above) in view of Reddy (Daru, Volume 1, Issue 6, pages 385-403, published October 22, 2011), hereinafter Reddy.
The instant claims are further drawn to EGCG in the form of a buccal tablet.
The teachings of Zhang are as set forth above. Zhang further teaches that EGCG has low bioavailability, and that concentrations of EGCG reject most low mM concentrations after pharmacological intervention (Abstract).
Zhang fails to teach or suggest EGCG in the form of a tablet.
The teachings of Zhang are remedied by Reddy, who teaches mucoadhesive buccal tablets as a conventional dosage form, used specifically to prolong residence time and local concentration in the oral mucosa (pages 389 and 391).
Regarding claims 17-20, the teachings of Zhang outline a method for treating and/or preventing a viral infection by SARS-CoV-2 through buccal administration (Abstract, Table 2).
Prior to the filing of the instant claims, a person having ordinary skill in the art would have been motivated to formulate a buccal tablet by modifying the teachings of Zhang in using EGCG to treat SARS-CoV-2, in order to further increase the bioavailability of EGCG in an effort to make a more effective treatment.
Correspondence
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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