DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/28/25 has been entered.
3. Claims 27-41 and 45-51 are pending upon entry of amendment filed on 1/28/25.
Claims 27-41 and 45-51 are under consideration in the instant application.
4. Applicant’s submission of IDS filed on 6/13/24 has been acknowledged.
5. The following rejections remain.
6. 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.
7. Claim 29 is rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for method of treating SAR2-CoV-2 infection comprising a therapeutic rIn . r(C12U)n.forth in claim 27, does not reasonably provide enablement for more.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use of the invention commensurate in scope with these claims.
The specification does not enable one of skill in the art to practice the invention as claimed without undue experimentation. Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.Cir.1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of the skilled in the art to practice the claimed invention.
There is insufficient guidance in the specification as filed as to how the skilled artisan would make and use tdsRNA other than the formula 1 that is beneficial in treatment of viral infections.
Examples 1-9 disclose treatment plans for SARS-cov-2 with Rintatolimod. No examples show treatment of viral infections encompassed by the claimed invention with tdsRNA encompassed by the claimed invention. As evidenced by Table 3, polyICLC readable upon tdsRNA other than Rintatolimod does not provide treatment for SARS-Cov-2. Further, Table 5 of the instant application (p. 95-96) lists sequence homologies among various coronavirus variants. The table indicates there are 49-81% of homology even between the same virus group. Therefore, other than Rintatolimod readable upon formula 1, it is unpredictable to develop a universal treatment plan with tdsRNA.
Claim 27 of the instant application reads on treatment of any viral infection with any tdsRNA encompassed by vast genus. The specification described the key input in terms of use or function in limited example of Rintatolimod rather than its physical characteristics or chemical properties of tdsRNA. As such, even allowing a reasonable degree of experimentation, the results of Rintatolimod in SARS-cov-2 cannot be extrapolated to any other embodiments encompassed by the claimed invention.
The specification fails to provide sufficient guidance to direct a person of skilled in the art to make and achieve the intended use of the claimed invention without undue experimentation. The specification discloses one exemplary method of treatment (see p. 88-95) with Rintatolimod species but the methods encompassed by the claims have not been tested for other virus sources.
To summarize, reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view or the quantity of experimentation necessary, the limited working example, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breath of the claims, it would take undue trials and errors to practice the claimed invention.
Applicant’s response filed on 1/28/25 has been fully considered but they were not persuasive.
Applicant has asserted that the currently amended claim obviates the rejection.
However, although rIn . r(C12U)n treats SARS-CoV-2 infection, claim 29 recites prevention of the infection. The prevention reads on prevention of entry of viral particle to subject and the specification does not disclose prevention. Appropriate correction is required.
8. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
9. 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
10. Claim(s) 27-41 and 45-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Pub. 2012/0009206 (IDS reference, of record) in view of U.S. Pub. 2007/0141080 (of record) for the reasons set forth in the office action mailed on 12/28/23.
The ‘206 publication teaches methods of treating viral infections comprising administering therapeutic double stranded RNA (claims 27-42) where the dsRNA reads formula 1 of the claimed invention. Note therapeutic RNA includes Ampligen (Examples) readable upon Rintatolimod of the instant application the administration routes include intravenous, mucosal, inhaled, intranasal and oral ([0078]) readable upon claim 45. IN lack of determining the first and the second compound in claims 31-32, the ‘206 publication recites administration of dsRNA as vaccine and adjuvant and may be administered concurrently or subsequently, it meets limitations of claims 31-32.
Further, nebulizer, syringes or other delivery device are included ([0078]) and meets limitations of claims 45 and 48. Claims 46-47 indicating tissues or cells where the dsRNA exerted are inherent targets and included in this rejection. Given that the both prior art and the instant application administer identical substance to treat viral infection, it is expected to reduct nasal virus titer and claim 49 is included in this rejection.
Moreover, the ‘206 publication teaches use of dsRNA as vaccine for viral antigens ([0072]) for viral infections, concurrent, sequential administrations readable upon claims 29-33 are included in this rejection. The immune response includes antibody production and dosage between 1-600mg ([0080-0083]) and meets limitations of claims 29-34 of the instant application.
The disclosure of the ‘206 publication differs from the claimed invention in that it does not teach the use of SARS-Cov as in claims 35, 40-43 or exposure less than 2 weeks as in claim 28 of the instant application. Or the ‘080 publication differs from the claimed invention in that it does not teach the delivery methods as in claims 45-49 of the instant application.
The ‘080 publication teaches methods of treating severe acute respiratory syndrome (SARS_ comprising administering to an infected subject dsRNA using oral, IV, IM or SQ (claims 1-5) and the SARS caused by SARS-Cov including OC43 ([0020-0023]). Further, the ‘06 publication teaches administration of ampligen that reads on formula 1 of the instant application ([0022]). IN addition, the ampligen is being administered within 24 hours of exposure, repeated administrations ([0023-26]) and dosage of 400mg ([0027]) twice weekly.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize viral antigens that is taught by the ‘080 publication into the methods taught by the ‘206 publication or known regimen or obvious administration routes that are known for treatment of viral infections as taught by the ‘206 publication into the SARS treatment methods taught by the ‘080 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the therapeutic double strand RNA taught by the ‘206 and the ‘080 publication is comparable to treat viral infections and the regimens are similar enough to treat the viral infection where the treatment for species disease may be applicable to treatment of broader disease genus.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Applicant’s response filed on 1/28/25 has been fully considered but they were not persuasive.
Applicant has asserted the SARS-Cov-2 and SARS-COV are genetically different from each other and the treatment method for SARS-CoV cannot be used to treat SARS-CoV-2. The combination of the references is not obvious and there is no reasonable expectation of success in combining the references.
IN addition, Applicant has asserted that the rejection is based on hindsight reasoning. Although the SARS-CoV is similar to SARS-CoV-2, the differences in genetic makeup result in significant behavior and change transmissibility and fatality.
However, Applicant is reminded that the prior art of record shares the Ampligen or Rintatolimod is well recognized for viral treatment including SARS-CoV and such regimen is also effective for high fever and acute respiratory infection (note ‘080 publication) caused also by SARS-CoV from China (e.g. shares origin from SARS-CoV-2, ‘080 pub [003]). As such, given that the identical symptoms are treatable with the same treatment methods, it is obvious to expand to different virus sources. Unlike Applicant’s assertion that the treatment of SARS-CoV is obvious or regiment of SARS-CoV for SARS-CoV-2 is obvious. Note low dose of Ampligen is effective for other structurally unrelated virus such as AIDS ([026]).
As in claim 41 of the instant application, the same composition comprising rIn . r(C12U)n is used to treat any additional viral infections (e.g. readable upon second different virus from) listed in table 2 (note p.75-85) of the instant specification. The Table 2 of the instant specification comprises 10 pages and is deemed to list any viruses from A-Z. Given that the administering rIn . r(C12U)n may treat any additional viruses listed in Table 2, administering rIn . r(C12U)n expects to treat SARS-CoV or SARS-Cov-2. Therefore, the combination of the references remains obvious and the rejection is maintained.
11. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
12. Claims 27-41 and 45-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Application No. 17/745723.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘723 application recites treatment methods of viral infection caused by viral antigen including SARS-Cov comprising tdsRNA set forth in claim 27 (or 1 ) of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s response filed on 1/28/25 has been fully considered but they were not persuasive.
Applicant has asserted that the treatment of the ‘723 application relates viral fatigue symptoms and the claims of the instant application drawn to viral infection. Applicant has asserted that the ‘723 application has later effective filing date.
Unlike Applicant’s assertion, improvement of the symptoms of viral infection is considered as treatment of viral infection in lack of further discussion of the symptoms encompassed by the viral infection caused by SARS-CoV-2.
The ‘538 application has a later effective filing date and the rejection is be held in abeyance until the prosecution of any one of application is closed.
13. No claims are allowable.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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, Misook Yu can be reached on 571-272-0839. 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.
Yunsoo Kim
Patent Examiner
Technology Center 1600
February 11, 2025
/YUNSOO KIM/Primary Examiner, Art Unit 1641
