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 .
DETAILED ACTION
This office action is in response to Applicant’s Amendment and Response to Restriction/Election Requirement filed on 6/18/2026, where claims 1-16, 18 and 19 and canceled, claim 17 is amended and claims 20-34 are newly added.
Claims 17 and 20-34 are pending in the instant application.
Election/Restrictions
Applicants’ election, without traverse, for the invention of Group II drawn to a product of manufacture, encompassing claim 17, in the reply filed on 6/18/2026 is acknowledged. Applicants’ election, without traverse, for the species of the combination of ivermectin, an antibiotic or antiviral and zinc, encompassing claim 17, in the reply filed on 6/18/2026 is acknowledged. Claims 1-16 directed to the invention of Group I are canceled. Claim 17 has been amended to narrow the scope to recite the elected species of a combination of ivermectin, an antibiotic or antiviral and zinc. New claims 20-34 depend from claim 17. Considering these amendments the restriction requirement of 12/18/2025 is withdrawn.
Claims 17 and 20-34 will be examined on the merits herein.
Priority
The application is a National Stage entry of PCT/AU2021/051526 filed on 12/20/2021, which claims priority to the following provisional applications:
Application #
Filing date
63/257192
10/19/2021
63/241498
9/7/2021
63/223432
7/19/2021
63/215041
6/25/2021
63/178671
4/23/2021
63/128152
12/20/2020
Information Disclosure Statement
The information disclosure statements (IDS) dated 6/20/2023 and 11/24/2024 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 17, 20 and 23-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cadegiani et al. (medRxiv, November 2020, PTO-892).
Cadegiani et al. discloses a composition for treating COVID-19 comprising 500 mg azithromycin, ivermectin (0.2 mg/kg/day), vitamin C, vitamin D and zinc. (p. 9, 2nd¶)
Accordingly, the instant claims are anticipated by the prior art.
Claims 17, 20, 22-25, 28, 30 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abreu (Inter. J. Good Con., September 2020, PTO-892).
Abreu discloses a composition for treating COVID-19 comprising hydroxychloroquine sulfate tablet 400 mg, ivermectin tablet 12 mg, zinc sulfate tablet 80 mg and vitamin C 500 mg. (p. 18-19)
Accordingly, the instant claims are anticipated by the prior art.
Claim Rejections - 35 USC § 103
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.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 21 and 26-34 are rejected under 35 U.S.C. 103 as being unpatentable over Cadegiani et al. (medRxiv, November 2020, PTO-892), in view of Hazan et al. (US 2021/0290649A1, filed Sept 18, 2020, PTO-892).
The disclosure of Cadegiani is referenced as discussed above. Cadegiani does not teach doxycycline as an antibiotic, does not teach amounts of vitamins or zinc and does not teach routes of administration.
Hasan discloses a composition for treating COVID-19 comprising 250-500 mg azithromycin, 200 mg hydroxychloroquine, 3000 mg vitamin C, 3000 mg vitamin D and 50 mg zinc. (Example 3, Tables 11-13, see also ¶0007, 0008, 0013 and 0014 for dose ranges and dose schedules) Hasan discloses that the composition may be administered as an aerosol, a pill, liquid solution, lozenges, topical treatment such as a cream or oil, or any other means of delivery. (¶0015, 0047-0048) Hasan also discloses that azithromycin may be substituted with doxycycline at a daily dosage range of 25 mg to 800 mg, for those unable to take azithromycin. (¶0054)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Cadegiani to incorporate the dosages of various components, various routes of administration and substitution of azithromycin with doxycycline, as taught by Hasan, thereby arriving at the instant invention. One would be motivated to modify Cadegiani in this manner because both Cadegiani and Hasan are directed to composition for treating the same condition, COVID-19, using similar composition components. Moreover, one would be motivated to substitute azithromycin with doxycycline for subjects who cannot take azithromycin, because Hasan teaches just such a substitution.
The claimed concentration ranges for components overlap those of the prior art. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. 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). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here 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). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 21, 26, 27, 29, 31, 32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Abreu (Inter. J. Good Con., September 2020, PTO-892), in view of Hazan et al. (US 2021/0290649A1, filed Sept 18, 2020, PTO-892).
The disclosure of Abreu is referenced as discussed above. Abreu does not teach doxycycline as an antibiotic, does not teach the addition of vitamin D and does not teach routes of administration.
Hasan discloses a composition for treating COVID-19 comprising 250-500 mg azithromycin, 200 mg hydroxychloroquine, 3000 mg vitamin C, 3000 mg vitamin D and 50 mg zinc. (Example 3, Tables 11-13, see also ¶0007, 0008, 0013 and 0014 for dose ranges and dose schedules) Hasan discloses that the composition may be administered as an aerosol, a pill, liquid solution, lozenges, topical treatment such as a cream or oil, or any other means of delivery. (¶0015, 0047-0048) Hasan also discloses that azithromycin may be substituted with doxycycline at a daily dosage range of 25 mg to 800 mg, for those unable to take azithromycin. (¶0054)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Abreu to incorporate the dosages of various components, various routes of administration and addition of azithromycin, as taught by Hasan, thereby arriving at the instant invention. One would be motivated to modify Abreu in this manner because both Abreu and Hasan are directed to composition for treating the same condition, COVID-19, using similar composition components. Moreover, one would be motivated to substitute azithromycin with doxycycline for subjects who cannot take azithromycin, because Hasan teaches just such a substitution.
The claimed concentration ranges for components overlap those of the prior art. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. 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). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here 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). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 17, 22-25, 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Hu et al. (CN 104286467A, 2015, PTO-892), in view of Wang et al. (Vet. Record, 2010, PTO-892).
Hu discloses a feed for egg-laying hens comprising 5-7 parts antibiotic, 1-3 parts abamectin, 2-5 parts vitamin D, 9-11 parts zinc sulfate. (Abstract)
Hu does not teach a composition comprising ivermectin.
Wang et al. discloses that for controlling ectoparasites in egg-laying hens either abamectin or ivermectin may be used. (p. 3, Col. 2)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Hu to substitute abamectin with ivermectin, thereby arriving at the instant invention. One would be motivated to modify Hu in this manner because Wang teaches that ivermectin and abamectin are functionally equivalent antiparasitics for egg-laying hens. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
The claimed concentration ranges for components overlap those of the prior art. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. 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). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here 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). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Double Patenting
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 17 and 20-34 of the instant application are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3, 13 and 14 of US 11,857,617. Although the conflicting claims are not identical, they are not patentably distinct from each other because: The claims of ‘617 are drawn to a method with administers a composition that anticipates the instant claimed composition. It order to practice the method of ‘721, one must be in possession of the administered composition. Thus, claims to a composition which are anticipated by the administered composition of ‘721 are an obvious variant of ‘721.
Claims 17 and 20-34 of the instant application are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 and 20 of copending application 19/431721. Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘721 anticipate the instant claims.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DALE R MILLER/Primary Examiner, Art Unit 1693
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