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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/17/26 has been entered.
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.
The factual inquiries 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.
Claim(s) 15, 18-28 and 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Ron et al (US 2003/0092776 A1 hereafter Ron) in view of Appel et al (WO 2016/049360 A1 hereafter Appel) in view of USGC-NWHC Environmental Assessment: Field and Captive Studies to Assess the Safety and Efficacy of Treatment Delivery Methods in Bats. Published November 2019. https://www.usgs.gov/media/files/environmemtal-assessment-field-studies-wns-vaccine-nov-2019).
Ron discloses a pharmaceutical composition comprising viscosifying polymers and methods for their application, and in particular, topical and/or musical applications [0002]. The hydrogels comprising polymers in an aqueous medium are well known in the art wherein the polymer networks are formed and stabilized by covalent bonding or physical bonding such as hydrogen, ionic, hydrophobic or van de Waals forces [0007. The formulation can be used to delivery active agents, including vaccines [0018, 0111-0113]. The active agents can specifically be useful in veterinary applications including topical applications of antibacterials, antifungals [0092, 0126]. The treatments can be used to treat and prevents disease in animals, including mammals such as cats, dogs, livestock [0109]. The active agents can be vaccines, including sub and full length antigen [0111-0113]. The formulation comprises a 2% wt poloxamer polyacrylic acid (1:1) aqueous composition [0047]. This ratio is the ratio of the aqueous carrier formulation to the particles, which is within the claims below 5%. The pH of the gel formulation is 3-9 [0049]. The formulation has viscosity between 10-100 pa*s at low shear [Figure 6].
While the formulation comprises a low viscosity gel material comprising particles bound together in a carrier where a vaccine is delivered topically, the viscosity at zero shear is not expressly disclose. Figure 6 shows a shear thinning effect with the viscosity dropping the higher the shear rate. However a low viscosity formulation for drug delivery at zero shear is known in the art as seen in the Appel patent.
Appel discloses a method comprising providing a viscosifying construct and a medicament and an aqueous carrier fluid, where the construct comprises a plurality of particles bonded through hydrogen or ionic bonds with a polymer [abstract, pg. 14, lin.3-10; pg. 22, lin. 14-25; pg. 25, lin. 20-25]. The viscofluid has a viscosity of about 10-100 pa*s at zero shear [Fig.2A, pg. 16, lin. 28-25]. The gel is formed by shear thinning the composition decrease the viscosity [pg. 8, lin. 14-16]. The formulation is useful for delivery of active agent such as vaccine [pg. 25, lin. 20-25]. The gel comprises cellulose polymers comprising amine containing carbohydrates such as chitosan [pg. 15, lin. 1-20; pg. 18, lin. 5]. The formulation further comprises an aqueous carrier [pg. 14, lin. 3-10]. It would have been obvious to include the gel components of Appel into the method of treatment and formulation of Ron as they have similar components, and deliver low viscosity dosage form.
While the combination would provide a low viscosity, vaccine formulation useful in topical vaccine delivery, it does not provide a specific application to bats. The use of topical aqueous carrier formulation for the delivery of vaccine is known for the treatment of bats as seen in the USGC study.
The USGS document teaches treatment delivery methods in wild bats against white-nose syndrome (pg. 5, para. 1), a fungal disease caused by the fungus Pseudogymnoascus destructans (Pd) (pg. 8, para. 1). The USGS specifically teaches an oral vaccine for bats against Pd comprising a viral vector based on a raccoon poxvirus that is modified to express highly-conserved fungal and Pd specific antigens (pg. 9, para. 3). In order to control the delivery of this vaccine for Pd, the USGS methods rely on viscous mediums through a high-quality spray via filament extension atomization (FEA) which generates narrowly-dispersed micron-sized droplets from fluids with this range of viscosities (from 1mPa-s to 600 Pa-s) (pg. 10, para. 2). USGS teaches that the small aerosol droplets can then be inhaled or ingested by the bats (mucosal uptake in the mouth or nose) as well as absorbed through their skin (transdermal uptake) with the viscosity contributing significantly to bioretention in both cases (pg. 10, para. 2). The USGS teaches a variety of mass scalable delivery methods, including spray devices being mounted at cave entrances to allow for delivery as bats fly through (pg. 11, para. 1; see also Fig. 6). In summation, the USGS-NWHC teaches methods for treating white-nose syndrome in a population of bats relying on the topical administration of a vaccine vector in a viscous medium applied through a high-quality spray (pg. 10, para. 12), wherein the small aerosol droplets can then be inhaled or ingested by the bats (i.e., during social grooming) (pg. 9, para. 4).
With these aspects in mind, it would have been obvious to combine the prior art to combine the prior art in order to form a stable method for treating animals topically. It would have been obvious to combine the components of Appel into the treatment method of Ron to produce a low viscosity, topical vaccine as they comprise the same components and solve similar problems. It would have been obvious to apply the low viscosity gel formulation to bats as seen in the USGS study. RON et al., USGS-NWHC and APPEL et al. are all directed to pharmaceutical compositions and methods comprising gel polymer viscosifying constructs. Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was filed, to modify the methods of RON and USGS-NWHC with the specific polymer nano-particle gel (PNP) networks to achieve the predictable result of obtaining a viscous pharmaceutical composition suitable for topical application to multiply animals by spraying via the formation of a shear-thinned fluid. One of ordinary skill in the art would have been motivated to do so because APPEL teaches that the shear-thinning and self-healing gel is an advantageous and cost effective method for the controlled application and release of bioactive or therapeutic agents (1007-0012), owing to characteristics such as a biodegradable polymer and the ability to form homogenous size distribution for a controlled application (10045-0048). Therefore claims 15 and 22-26 are obvious over RON et al., USGS-NWHC and APPEL et al.
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.
Claim 15, 18-21, 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7, 13-16, 18 and 19 of copending Application No. 17/819,152 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method comprising topically applying a viscofluid comprising a medicament onto at least animal using a delivery device. The instant claims are silent to a specific delivery device for the formulation, however delivered the same formulation. The formulations both comprise a viscosity construct with low viscosity at zero shear as determined though steady shear rheometry. The instant claims are a species of the genus method of claims 7 and would act as obviating art over each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments, see Remarks, filed 12/23/25, with respect to the rejection(s) of claim(s) 15, 18-28, 31-34 under 35 USC 103(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the above recited rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618