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 .
Election/Restrictions
Applicant’s election of Group II, corresponding to claims 11, 12, and 14-31, as amended, in the reply filed on 04/24/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-10 and 13 have been cancelled.
Claims 11, 12, and 14 – 31 are under examination.
Priority
This is a National Stage Entry under 35 U.S.C. 371 of International Patent Application
No. PCT/KR2022/000683, filed January 13, 2022. This application also claims priority to KR Provisional Application No. 1020210004780, filed on January 13, 2021.
Claim Rejections - 35 USC § 112- Indefiniteness
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.
Claim 27 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 21 and 27 recite the phrase “wherein the self-replication infection indicates that the coronavirus replicates in the respiratory cells of the subject and infects surrounding cells.” The term “indicates” 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 term “indicated” means to convey information. Furthermore, as evidenced by V’kovski et al (Nat Rev Microbiol, 2020, hereinafter “V’kovski”), replicating in respiratory cells is a natural property of SARS-CoV-2. As written, the metes and bounds of the claim are not defined in the claim.
For the purpose of examination, claims 21 and 27 is interpreted as “wherein the coronavirus replicates in the respiratory cells of the subject and infects surrounding cells.”
Claim Rejections - 35 USC § 112 - 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 11, 12 and 14 –31 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 protecting and/or restraining infection from SARS-CoV-2 and H1N1 does not reasonably provide enablement for protecting or restraining any self-replication infection caused by respiratory viruses. 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.
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.” These factors include, but are not limited to:
• (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.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Here, the instant claims are broadly drawn to a method for protecting or restraining self-replication infection of respiratory viruses in a subject. The level of skill in the art is high and would include, e.g., Ph.D. level scientists
Sperber et al. (J Infectious Diseases, 1989, hereinafter, “Sperber”) teaches that the restraining of post exposure interferon treatment can be effective in some cases of rhinoviral infections but not all (Abstract). Sperber teaches the use of recombinant IFN-B to treat rhinoviral infections in patients (Material and Methods). Sperber teaches that particularly pathogenic viruses are not restrained by IFN treatment while some strains are affected by IFN (Figure 1). Similarly, Dolin et al. (Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases (Eighth Edition), 1025, hereinafter, “Dolin”) also teaches that while there are many viral infections that can be treated with IFN, IFN is ineffective in preventing or treating CMV infection (Section: Herpesviruses). As such, the art offers no predictability for the protection and restraining from any self-replication infection of respiratory viruses.
The Specification only exemplifies and reduces to practice the protection and restraining from SARS-CoV-2 Wuhan and Delta strains as well as H1N1. However, the Specification offers no reasonable direction or working example for the protection and restraining from any self-replication infection of respiratory viruses, especially from all Adenovirus, Avian Influenza Virus, Bocavirus, Coronavirus, Cytomegalovirus, Hantavirus, Herpes Simplex Virus, Influenza Virus, Measles, Metapneumovirus, Parainfluenza Virus, Respiratory Syncytial Virus, Rhinovirus, and Varicella-zoster Virus or the particular strains 229E, NL63, OC43, HKU1, SARS-CoV, MERS-CoV, porcine epidemic diarrhea virus (PEDV), (porcine) transmissible gastroenteritis virus (TGEV), canine coronavirus (CCoV), feline coronavirus (FCoV), Miniopterus bat coronavirus 1, Miniopterus bat coronavirus HKU8, Rhinolophus bat coronavirus HKU2, Scotophilus bat coronavirus 512, porcine hemagglutinating encephalomyelitis virus (PHEV), bovine coronavirus (BCoV), equine coronavirus (EqCoV), murine coronavirus (MuCoV), Tylonycteris bat coronavirus HKU4, Pipistrellus bat coronavirus HKU5, Rousettus bat coronavirus HKU9, Avian coronavirus, Beluga whale-coronavirus SW1, Bulbul-coronavirus HKU11, Thrush-coronavirus HKU12, and Munia-coronavirus HKU13.
In view of the foregoing, a vast quantity of experimentation, including expansive clinical trials, would be needed to use the invention based on the content of the disclosure. Taken together, 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.
Claim Rejections - 35 USC § 103
The following is a quotation of 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.
Claim(s) 11, 12, and 14 – 31 are rejected under 35 U.S.C. 103 as being unpatentable over Marsden et al (US20230338475A1, hereinafter, “Marsden”) in view of Shin et al (US application No. US20180236092A1, hereinafter, “Shin”) and as evidenced by Groneberg et al (Respiratory medicine, 2003, hereinafter “Groneberg”) and V’kovski et al (Nat Rev Microbiol, 2020, hereinafter “V’kovski”).
Marsden teaches the method for preventing or reducing the severity of lower respiratory tract illness in patients infected with coronavirus by administering interferon-beta (IFN-B) by inhalation (Claim 1). Marsden teaches IFN-B can be used to treat SARS-CoV-2 infections by delivering IFN-B to the airways of the infected individual (Claim 7).
Marsden does not teach the sequence of SEQ ID NO: 1.
However, Shin teaches the exact sequence of SEQ ID NO: 1 (Reproduced below, “Qy”, is SEQ ID NO: 1, Shin is “Db”). Shin teaches the composition and production of IFN-B with the exact sequence of SEQ ID NO: 1 (Claim 1, Claim 9).
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Regarding claims 11 and 14, Marsden teaches a post-exposure prophylaxis method of preventing increased severity of infections by SARS-CoV-2 after exposure to SARS-CoV-2 with IFN-B (Claim 1, ¶0029).
Regarding claim 12, Marsden teaches administering IFN-B to prevent severity of infections by SARS-CoV-2 (Claim 1).
Regarding claims 15, 22, and 28, Marsden teaches IFN-B can be used to treat SARS-CoV-2 infections by delivering IFN-B to the airways of the infected individual (Claim 7).
Regarding claims 16, 17, 21, 23, 24, 29, and 30, Marsden teaches a nebulized formulation of IFN-B for treatment of respiratory virus infection and that IFN-B has been administered to the lungs (¶0001, 0002, 0064). Groneberg evidences the fundamentals of pulmonary drug delivery. As evidenced by Groneberg, the lungs are comprised of respiratory cells (Introduction).
Regarding claim 18, 20, 25, 26, and 31, Marsden teaches administering IFN-B through inhalation can be used to treat SARS-CoV-2 infection (Claim 1, Claim 4).
Regarding claim 19, Marsden teaches individuals infected with SARS-CoV-2 can be asymptomatic (¶0052).
Regarding claim 27, Marsden teaches SARS-CoV-2 replicates within susceptible cells (¶0051). V’kovski evidences the general coronavirus biology and replication with a focus on SARS-CoV-2. As evidenced by V’kovski, SARS-CoV-2 “replicates abundantly in upper respiratory epithelia”.
Marsden and Shin are considered to be analogous to the claim invention because they both aim use IFN-B as treatments. Marsden teaches a method of using IFN-B to treat SARS-CoV-2 through nebulization and inhalation (Claim 1, ¶0001). Shin teaches a composition and production of the exact sequence of SEQ ID NO:1 which encodes IFN-B (Claim 1, Claim 9, Sequence 2).
Together, the prior art teaches that IFN-B comprising the exact sequence of SEQ ID NO: 1 can be used to prevent, lessen, or treat a SARS-CoV-2 infection. Therefore, it would have been prima facie obvious before the to administer IFN-B comprising the exact sequence of SEQ ID NO: 1 before or after exposure to SARS-CoV-2 because doing so would advantageously permit the treatment or prevention of an infection with a composition that is known to be effective. One of ordinary skill in the art would have had a reasonable expectation of success in using IFN-B comprising the exact sequence of SEQ ID NO: 1 to prevent or treat SARS-COV-2 infection given that the method and composition is well known, has been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
Prior art not discussed but pertinent to the application:
Sallard et al (Antiviral research, June 2020)
Pfieffer-Smadja et al (Lancet Respir Med, Nov 2020)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danyal H Alam whose telephone number is (571)272-1102. The examiner can normally be reached M - F 9am - 5pm.
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/DANYAL HASSAN ALAM/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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