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 .
Claim Status
Claims 9, 13-17, 22, 25-28 and 30-34 are pending.
Claims 1-8, 10-12, 18-21, 23-24 and 29 have been canceled.
Claims 30-34 have been added.
Claim 9 is currently amended.
Claims 9, 13-17, 22, 25-28 and 30-34 are currently under consideration.
Claims 9, 13-17, 22, 25-28 and 30-34 are rejected.
Acknowledgement of Receipt
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 and declaration under 37 CFR § 1.132 filed on 09/24/2025 has been entered. This Office Action is in response to Applicants' amendments and remarks filed 09/24/2025.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 02/27/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this IDS has been considered by the Examiner.
Applicant Claims
The instant claims are directed to a method of treating a Parvoviridae infection in a canine subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising an iron containing compound and an excipient, wherein the iron containing compound is ferric citrate (claim 9); the canine is a young puppy and/or weighs less than 5 lbs. (claim 13); the method shortens the course of the disease (claim 14); the method ameliorates at least one symptom of Canine parvovirus infection selected from the group consisting of fever, dehydration, vomiting, diarrhea, lethargy, and loss of appetite (claim 15); the canine further has a hookworm infection (claim 16); wherein the administering is performed orally (claim 17); wherein the pharmaceutical composition further comprises glucose (claim 22); further comprising a salt solution (claim 25); wherein the pharmaceutical composition is a liquid (claim 28); wherein the ferric citrate is administered at a dose of 2.2 mg/kg bodyweight (claim 30); wherein the ferric citrate is administered twice daily (claim 31).
Applicants claim the method further comprising a salt solution (i.e., claim 25), wherein the salt solution comprises one or more of sodium chloride, potassium chloride, potassium phosphate monobasic, sodium phosphate dibasic, magnesium sulfate, calcium chloride, and sodium bicarbonate (claim 26).
Applicants claim the method’s pharmaceutical composition further comprising glucose (i.e., claim 22), wherein the pharmaceutical composition comprises ferric citrate, sodium chloride, potassium chloride, potassium phosphate monobasic, sodium phosphate dibasic, magnesium sulfate, calcium chloride, sodium bicarbonate, and D- glucose (claim 27).
Applicants claim the method’s ferric citrate administered at a dose of 2.2 mg/kg bodyweight (i.e., claim 30), wherein the ferric citrate is administered twice daily (claim 32).
Applicants claim the method of claim 17 (i.e., orally), wherein the ferric citrate is administered at a dose of 2.2 mg/kg bodyweight (claim 33).
Applicants claim the method’s oral administering (i.e., claim 17) of ferric citrate at 2.2 mg/kg bodyweight (i.e., claim 33), wherein the ferric citrate is administered twice daily (claim 34).
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.
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.
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) 9, 13-15, 17 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (CN 109394788 A, pub. 03/01/2019) evidenced by Khare et al. (Journal of Pharmacognosy and Phytochemistry 2020; 9(4): 1601-1604) herein referenced Chen and Khare. Citations are from the translation document previously provided.
Chen discloses a pet oral liquid solution and a preparation method thereof, comprising iron (ferric) ammonium citrate as iron fortifier and blood supplement to treat iron deficiency anemia in dogs (abstract, pg. 3, para. 1, 3-4, 6; pg. 4, examples 1-3, claims 1, 2, 3.b.). Chen discloses ferric (ammonium) citrate as the iron containing compound (pg. 3, see detailed ways, element b.; pg. 4, examples 1-3, claims 1, 2, and 3.b.).
Regarding claim 13, Chen teaches that puppies are affected by anemia (pg. 1, see no. 2). Chen teaches that anemia is a common condition in dogs and refers to abnormal symptoms in which the total amount of red blood cells in the circulating blood of the system is reduced below normal (pg. 1, para. 3). Chen teaches that Parvovirus causes anemia in dogs (pg. 1, no. 1). Chen provides embodiments in which the solution is administered to dogs (pgs. 4-5, examples 1-3; pg. 5, Cases 1-2).
Regarding claims 14-15, Chen teaches that the objective of the oral liquid and preparation method thereof replenishes energy (i.e., ameliorate lethargy) (pg. 2, para. 2). Chen exemplifies this with a dog that was exhibiting weakness recovered after a week (pg. 5, see Case 1-2).
Regarding claim 17, Chen teaches that the oral solution is administered orally explicitly teaching the liquid as being administered directly on the tongue of the subject (pg. 5, see Case 1).
Regarding claim 28, Chen teaches a liquid (pg. 1, para. 1; pg. 5, cases 1-2; claims 1-3).
While Chen does not appear to reduce to practice treatment of a subject that has a Parvoviridae infection by administering a composition comprising an iron containing compound and an excipient, based on the foregoing, it would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to utilize the method taught by Chen to arrive at the claimed invention. Chen provides a composition that includes an iron based compound and appropriate excipients to ameliorate anemia caused by parvovirus. As evidenced by Khare, in dogs, in particular puppies, Parvoviridae infections result in anemia (see Introduction, Results, pg. 1601, last para.; see Conclusion, pg. 1603). Moreover, the solution in liquid form taught by Chen offers three taste options, is fast absorbing, and minimizes gastrointestinal irritations to facilitate ease of use (pg. 3, para. 1; claim 2).
Claims 16, 22 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Chen evidenced by Khare, as applied to claims 9, 13-15, 17 and 28 above, in view of Bortz (US 2014/0364491 A1, pub. 12/11/2014) evidenced by PubChem (https://pubchem.ncbi.nlm.nih.gov/compound/Sucrose), herein referenced Bortz and PubChem.
The teachings of Chen above are incorporated herein.
Chen does not teach hookworm, glucose and salt solution.
Bortz teaches an orally deliverable dosage system comprising iron in a form of one or more physiologically acceptable iron grades, compounds and/or complexes including ferrous citrate (abstract, [0041]). Bortz teaches that compounds and complexes in the iron (II) or ferrous (Fe++) oxidation state are generally preferred but in some instances, compounds and complexes in the iron (III) or ferric (Fe+++) form could be preferred ([0041]). Bortz teaches that examples of ferric forms of iron that may be used include ferric citrate and ferric ammonium citrate ([0041]). Bortz teaches that the dosage system can be in the form of a solution or suspension and can also be referred to as an oral supplement ([0033]). Bortz teaches that the dosage system can be orally administered to a subject in need to increase the level of hemoglobin in the subject's blood, for example therapy for conditions of iron deficiency anemia and can be orally administer to a subject in need thereof therapy for iron deficiencies and associated complications arising from parasites including hookworm ([0075]).
Bortz teaches sodium chloride and sucrose and sucrose-based diluents such as compressible sugar as a suitable diluents as well as glucose as a binding agent ([0058-0059]). As evidenced by PubChem, sucrose is a sugar molecule that is made up of one glucose and one fructose unit (pg. 1, see highlighted).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to combine the sodium chloride and glucose to treat hookworm taught by Bortz with Chen evidenced by Khare. One would be motivated to do so because Bortz provides, in part, a combination of components, namely iron and an ion-chelating compound, that has hitherto been contrary to established thinking in the art, but that, when administered in a way that segregates their locus of release in the gastrointestinal tract, more particularly by formulating the ion-chelating compound for release distal to the primary site of iron absorption in the duodenum, gives rise to benefits ([0097]) of which include the suggestion of deterring clinical symptoms of iron-related gastrointestinal adverse effects for example constipation, diarrhea and abdominal cramps ([0098]).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Chen evidenced by Khare, in view of Bortz evidenced by PubChem as applied to claims 9, 13-17, 22-26 and 28 above, further in view of AAT Bioquest (https://www.aatbio.com/resources/buffer-preparations-and-recipes/hbss-hanks-balanced-salt-solution, 2019), Tanaka et al. (US 2018/0125805, pub. 05/10/2018) and Spitler et al. (US 2003/0017976, pub. 01/23/2003) herein referenced AAT Bioquest, Tanaka, and Spitler.
The teachings of Chen, Khare, Bortz, and PubChem above are incorporated herein.
Chen does not teach any of the species of instant claim 27.
The Examiner notes that those skilled in the art would immediately recognize that claim 27 discloses all of the components that make up the well-known buffer solution, Hank’s Balanced Salt Solution (AKA Hank’s Buffered Salt Solution, HBSS), which is commonly used in the art. As shown by AAT Bioquest, Hank’s Balanced Salt Solution (HBSS) is composed of sodium chloride (NaCl), potassium chloride (KCl), KH2PO4 (potassium phosphate monobasic), Na2HPO4 (sodium phosphate dibasic), MgSO4 (magnesium sulfate), CaCl2 (calcium chloride), and NaHCO3 (sodium bicarbonate).
Tanaka discloses compositions that can be used as a prophylactic and/or a therapeutic agent for virus infections to prevent proliferation of viruses and said compositions comprise an iron compound e.g., iron sodium citrate, iron ammonium citrate (abstract, [0019-0020], [0067], claims 20-21). Tanaka teaches a solution, and a liquor dissolved, e.g., in a syrup ([0071]). Examples of the acid addition salt include an inorganic acid salt such as a hydrochloride, a phosphate, a sulfate, and an organic aid addition salt such as a citrate ([0064]). Tanaka teaches the metal salt to include a sodium salt, a potassium salt, a magnesium salt and a calcium salt (i.e., calcium chloride) ([0064]). Tanaka adds that these salts can be used by dissolving it before use which suggests the administering of the composition in liquid form ([0064]).
Spitler is provides to further teach the above mentioned HBSS.
Spitler peptide compositions that may be administered in liposomes (title; abstract). Spitler cites that activation of macrophages by oral administration enhances hosts defenses against infections e.g., canine osteosarcoma ([0004]). Spitler teaches the concept of using HBSS to orally administer therapeutic compositions in which a suspension with HBSS is prepared for oral feedings ([0007], [0193]).
In light of these teachings, it would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to combine the teachings of Chen evidenced by Khare in view of Bortz evidenced by PubChem, further in view of AAT Bioquest, Tanaka, and Spitler with expected results. One would be motivated to do so with a reasonable expectation of success because Tanaka teaches that administration of an ALA (5-aminolevulinic acid) compound and an iron compound preferably exhibits a synergistic effect ([0069]). Further, an artisan would understand Spitler’s teaching of a suspension in HBSS (Hank’s Balanced Salt Solution) to indicate a liquid composition with appropriate dilution (e.g., of a stock solution) ([0193]) to improve handleability while orally administering a pharmaceutically effective amount in liquid form. Moreover, the current record does not support a finding that the specific salt combination recited in claim 27 is critical. Applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range. See MPEP § 716.02. In the instant case, there is no showing that the specific salt combination recited in claim 27 results in any unexpected or improved properties.
Claim(s) 30-34 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Chen, evidenced by Khare, in view of Bortz, evidenced by PubChem, further in view of AAT Bioquest, Tanaka, and Spitler as applied to claims 9, 13-17, 22, 25-28 above, further in view of Hi-Vite Drops (Web.archive.org, VetRxDirect, Wholesalepet document, 07/19/2017).
The teachings of Chen, Khare, Bortz, PubChem, AAT Bioquest, Tanaka, and Spitler above are incorporated herein.
Chen discloses Pet Hi-Vite Drops oral solution and preparation method thereof (see title). Looking to the Hi-Vite document, the Hi-Vite Drops are a liquid vitamin supplement for dogs, cats, puppies and kittens to supplement pets with vitamin deficiencies or as an addition to daily nutrition (see description). The feeding instructions include orally administering twice daily (see feeding instructions). The ingredients include Ferric Ammonium Citrate (source of Iron) and per dropperful (1 ml) iron is shown as 11.60 mg (see guaranteed analysis).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to apply the teachings of administering twice daily Hi-Vite containing 11.60 mg (1 ml) modified by Chen, Khare, Bortz, AAT Bioquest, Tanaka, and Spitler and employ optimization and routine experimentation to achieve the desired dosage, e.g., 2.2 mg/kg bodyweight. The adjustment of particular conventional working conditions (e.g., determining effective amounts of ingredients beneficially taught by the cited references) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
For the foregoing reasons the instant claims are rendered obvious by the teachings of the prior art.
Response to Arguments
Applicant's declaration and arguments filed 09/24/2025 have been fully considered but they are not persuasive.
35 U.S.C. § 103
Applicants argue that anemia is not an initial nor primary symptom of canine parvovirus infection whereas death is the primary symptom of concern when treating canine parvovirus infected dogs and cites Otto, Greene, Sykes and Myloankis (Remarks, bridging pages 4-5).
The Examiner, in response, respectfully maintains that the cited prior art of record’s teachings treating secondary or tertiary symptoms of the infection meets the claims as written. Applicants admit that anemia is a symptom of parvovirus referencing Greene wherein dogs and puppies are routinely examined for anemia as part of a normal veterinary exam for parvovirus infections (see Remarks, pg. 5, para. 1). Regarding “therapeutically effective,” Applicants’ specification describes this as being a measurable change that reduces the frequency or severity of the signs or symptoms which would meet the criteria of treatment (see Spec., [0057-0058] shown below). Here the prior art of record meets the criteria of therapeutically effective.
[0057] "Treatment" or "treating" includes (1) inhibiting a disease in a subject or patient experiencing or displaying the pathology or symptomatology of the disease (e.g., arresting further development of the pathology and/or symptomatology), (2) ameliorating a disease in a subject or patient that is experiencing or displaying the pathology or symptomatology of the disease (e.g., reversing the pathology and/or symptomatology), and/or (3) effecting [sic] (Examiner’s indication) any measurable decrease in a disease or symptom thereof in a subject or patient that is experiencing or displaying the pathology or symptomatology of the disease.
[0058] The term "therapeutic benefit" or "therapeutically effective" as used throughout this application refers to anything that promotes or enhances the well-being of the subject with respect to the medical treatment of this condition. This includes, but is not limited to, a reduction in the frequency or severity of the signs or symptoms of a disease.
Applicants argue that Chhabra along with Otto teach away from using iron (Remarks, pg. 5, para. 4).
Chhabra is no longer used and Otto is not of prior record.
Applicants argue that the data from Exhibit B in which canine cells are inoculated with canine parvovirus isolate demonstrate that maximal protection is observed with ferric citrate and that this protective effect is unique to ferric citrate. (Remarks, pg. 6, para. 4).
Inoculated canine cells are not in scope with the rejected claims.
Declaration
Experimental data demonstrates the importance of iron availability for cell survival during CPV infection to include puppies supplemented with 0.22, 1.1, or 2.2 mg/kg ferric citrate solution orally, twice daily for up to five days, and monitored for 14 days (Declaration, pgs. 3-4, item no. 4). The highest concentration tested, 2.2 mg/kg, showed 100% survival of all puppies to show that iron, as ferric citrate, is important for protection from virus mediated death (Declaration, pg. 4, item no. 6).
In response the Examiner respectfully submits that inoculated canine cells are not in scope with the rejected claims and that the claims as written do not recite the number of days of treatment, survival rates, etc. Therefore, the claims are not in scope with the instant disclosure.
For these reasons, Applicants’ arguments are found unpersuasive.
Conclusion
Claims 9, 13-17, 22, 25-28 and 30-34 are rejected; no claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Karen Ketcham whose telephone number is (571)270-5896. The examiner can normally be reached 900-500 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Karen Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
