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 .
CONTINUING DATA
This application is a 371 of PCT/US21/48581 09/01/2021
PCT/US21/48581 has PRO 63/226,357 07/28/2021
PCT/US21/48581 has PRO 63/073,073 09/01/2020
Applicant’s election without traverse of Group I in the reply filed on September 19, 2025 is acknowledged.
Claims 12-13 and 24-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 19, 2025.
Claim Rejections - 35 USC § 112
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 14 and 22 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 8 depends from claim 1 and recites that the bait is refreshed at least biweekly. Claim 1 does not recite an extended period of treatment or a refreshment of bait, so it is unclear what is required in claim 8. Likewise, claim 22 depends from claim 14 and recites that the bait is refreshed at least biweekly. Claim 14 does not recite an extended period of treatment or a refreshment of bait, so it is unclear what is required in claim 22.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 1-2, 4, 11-12, 14, 16, 18, , and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lewis (WO 2020041179A1, February 27, 2020).
Lewis teaches treatment of a disease associated with a spirochete in an animal, comprising administering Hygromycin A, wherein the disease associated with a spirochete includes Lyme disease, and wherein the spirochete is of the Borrelia species. See claims. The spirochete is Borrelia burgdorferi, Borrelia mayonii, Borrelia afzelii, or Borrelia garinii (claim 10). In Example 3, C3H mice were infected with Borrelia burgdorferi and treated with Hygromycin A. Tested doses included 25-250 mg/kg by oral gavage [0123]. The concentration of Hygromycin A solution was 50 mg/ml (250 mg/kg), 15 mg/ml, 14 mg/ml, 10 mg/ml, and 5 mg/ml (25 mg/kg) [0122]. An aqueous solution at 50 mg/ml is approximately 50 mg/g because the density of water is 1 g/ml. After treatment, skin tissue was obtained from the mouse and a level of Borrelia burgdorferi was measured and found to be less than the amount present in the control. Paragraphs [0123]-[0124]. Lewis’s treatment involved administration of a saline solution of Hygromycin A.
The current specification paragraph [0037] does not provide a limiting definition of “bait,” but says that a bait may refer to a composition containing an active compound and a carrier that may be at least partially edible to a target animal. A water solution is at least partially edible to a mouse.
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 (i.e., changing from AIA to pre-AIA ) 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, 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.
Claim(s) 1-2, 4, 11, 14, 16, 18, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis (WO 2020041179A1, February 27, 2020).
Lewis teaches treatment of a disease associated with a spirochete in an animal, comprising administering Hygromycin A, wherein the disease associated with a spirochete includes Lyme disease, and wherein the spirochete is of the Borrelia species. See claims. The spirochete is Borrelia burgdorferi, Borrelia mayonii, Borrelia afzelii, or Borrelia garinii (claim 10). After treatment, skin tissue was obtained from a mouse and a level of Borrelia burgdorferi was measured. Paragraphs [0123]-[0124]. The Hygromycin A is incorporated in environmental mouse baits including bait formula and peanut butter. Paragraphs [0059], [0111], and [0112]. Tested doses include 25-250 mg/kg by oral gavage [0123]. The concentration of Hygromycin A solution was 50 mg/ml (250 mg/kg), 15 mg/ml, 14 mg/ml, 10 mg/ml, and 5 mg/ml (25 mg/kg), and all doses were effective [0122]. An aqueous solution at 50 mg/ml is approximately 50 mg/g because the density of water is 1 g/ml. Lewis teaches that dose levels from about 5 mg/kg to about 250 mg/kg are useful [0106]. The compound is present in the formulation in an amount of between 0.0001-60%, or 0.1-10%, or 0.5-5% [0091]. The claimed 0.001 mg/g to about 5 mg/g corresponds to 0.0001% to 0.5%.
Lewis teaches that the composition may be administered in the form of a bait, but Lewis’s working example included administration of a Hygromycin A saline solution.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to administer Hygromycin A to a subject infected with Borreliella wherein the Hygromycin A is contained in a bait composition because Lewis teaches that the Hygromycin A may be administered as a bait composition. The skilled artisan would have administered the Hygromycin A in an amount of 5 mg/kg to 250 mg/kg because Lewis teaches that those amounts are useful. The skilled artisan would have administered the Hygromycin A in a composition at a concentration of 0.0001-60%, or 0.1-10%, or 0.5-5% because Lewis teaches that those concentrations are useful. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEP 2144.05. In this instance, the claimed range 0.001 mg/g to about 5 mg/g lies inside the prior art range 0.0001-60% and overlaps with the prior art ranges 0.1-10%, or 0.5-5%. In this instance, the claimed 100 mg/kg to 1000 mg/kg overlaps with the prior art range 5 mg/kg to 250 mg/kg.
Claim(s) 3, 6, 8-10, 17, 20, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis (WO 2020041179A1, February 27, 2020, cited on IDS) in view of Dolan (Ann. J. Trop. Med. Hyg. 85(6); 2011, pp. 1114-1120, cited on IDS).
Lewis teaches as set forth above, but does not teach administration to a tick or to a rodent which is Peromyscus spp., or contact for a duration of 3 months to 3 years, or wherein the bait is refreshed at least biweekly.
Dolan teaches the use of doxycycline bait to reduce Borrelia in rodents and Ixodes scapularis ticks. See abstract. The rodents were white-footed mice (Peromyscus leucopus). Page 1117, Small-mammal tick burdens. The bait was highly effective in providing prophylaxis against tick-transmitted B. burdorferi, curing infected small mammals and reducing infection rates in questing ticks. See page 1119, last paragraph. Bait stations were maintained after 19 consecutive weeks of deployment and rebaited as necessary. The bait contained 500 mg/kg doxycycline (corresponding to 0.5 mg/g or 0.05%). Page 1114, Deployment and maintenance of bait stations.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to administer Hygromycin A to ticks and rodents in order to lower infection rates in these reservoirs so that they would be less likely to pass infection on to humans. The skilled artisan would have employed this strategy because a similar strategy has been successfully tried using a different agent, doxycycline. The skilled artisan would have maintained the Hygromycin A bait for as long as desired, and would have refreshed the bait as needed to keep it active.
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 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6, 8-11, 14, 16, 18, 20, and 22-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12233081 in view of Dolan (Ann. J. Trop. Med. Hyg. 85(6); 2011, pp. 1114-1120, cited on IDS).
The ‘081 patent claims a method of treating Lyme disease caused by Borrelia burgdorferi in an animal using Hygromycin A (claims 1-2). Administration is oral (claim 4) in an amount of 5 mg to 250 mg/kg body weight (claim 7).
The ‘081 patent does not claim treatment of mice or ticks, does not teach a Hygromycin A bait, and does not teach the concentration of Hygromycin A in the bait.
Dolan teaches the use of doxycycline bait to reduce Borrelia in rodents and Ixodes scapularis ticks. See abstract. The rodents were white-footed mice (Peromyscus leucopus). Page 1117, Small-mammal tick burdens. The bait was highly effective in providing prophylaxis against tick-transmitted B. burdorferi, curing infected small mammals and reducing infection rates in questing ticks. See page 1119, last paragraph. Bait stations were maintained after 19 consecutive weeks of deployment and rebaited as necessary. The bait contained 500 mg/kg doxycycline (corresponding to 0.5 mg/g or 0.05%). Page 1114, Deployment and maintenance of bait stations.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to administer the ‘081 composition in the form of a bait to ticks and rodents in order to lower infection rates in these reservoirs so that they would be less likely to pass infection on to humans. The skilled artisan would have employed this strategy because a similar strategy has been successfully tried using a different agent, doxycycline. The skilled artisan would have maintained the Hygromycin A bait for as long as desired, and would have refreshed the bait as needed to keep it active. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEP 2144.05. The ‘081 patent teaches a dose (5-250 mg/kg) which overlaps with the claimed dose of 100 mg/kg to 1000 mg/kg. The skilled artisan would have used Dolan’s guidance for concentration of active agent in the bait (0.5 mg/g or 0.05%, which anticipates the claimed agent) combined with the total dose recited in the ‘081 patent to arrive at an appropriate concentration of Hygromycin A in the bait.
Conclusion
No claims are allowed.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693