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/EP2022/071875 08/03/2022
FOREIGN APPLICATIONS
EP 21189392.0 08/03/2021
Claims 16-35 are pending.
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 22, 26, 29, and 33-34 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 22 recites the broad recitation (ESA), and the claim also recites “optionally selected from,” etc. which is the narrower statement of the range/limitation. Claim 22 recites the broad recitation “hepcidin modulators,” and the claim also recites “optionally,” etc. which is the narrower statement of the range/limitation. Claim 22 recites the broad recitation “antiparasitic drugs,” and the claim also recites “optionally,” etc. which is the narrower statement of the range/limitation. Claim 26 recites the broad recitation “1,200 to 1,400 Da,” and the claim also recites “preferably,” etc. which is the narrower statement of the range. Claim 29 recites the broad recitation “non-human subject,” and the claim also recites “optionally a dog or cat,” which is the narrower statement of the limitation. Claim 30 recites the broad recitation “non-human subject,” and the claim also recites “optionally a dog or cat,” which is the narrower statement of the limitation. Claim 34 recites the broad recitation (ESA), and the claim also recites “optionally selected from,” etc. which is the narrower statement of the range/limitation. Claim 34 recites the broad recitation “hepcidin modulators,” and the claim also recites “optionally,” etc. which is the narrower statement of the range/limitation. Claim 34 recites the broad recitation “antiparasitic drugs,” and the claim also recites “optionally,” etc. which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 33 is drawn to the method of claim 16 and recites “the erythropoiesis-stimulating agent.” Claim 16 does not recite an erythropoiesis-stimulating agent, so there is insufficient antecedent basis for this limitation.
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.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Svoboda (cited on IDS).
Svoboda teaches subcutaneous injection of iron dextran to iron-deficient piglets. The treatment prevented development of anemia and there was not a significant difference between the subjects treated by intramuscular injection compared to subcutaneous injection. See abstract.
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) 16-18, 22-30, and 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andreasen (WO 2010/108493 A1, cited on IDS) in view of Naigamwalla (Can Vet J 2012; 53:250-256, cited on IDS).
Andreasen teaches treatment of iron deficiency anaemia using an iron oligosaccharide compound having a dimer content of 2.9% by weight or less. See abstract. The fraction with more than 9 saccharide units is less than 20% (page 4). The weight average molecular weight is 500-3000 Daltons (page 5, line 23) or 1600 Daltons or less (claim 5). The apparent molecular weight is 120 to 180 kDa (page 6, second paragraph). The composition is formulated for parenteral administration (page 7, second paragraph), and parenteral administration includes subcutaneous (page 1, lines 18-21). The composition may include antibiotics (page 7, line 21). The composition is used for treating iron deficiency anaemia in animals or humans (claim 28). The oligosaccharide is an oligoisomaltose (page 5, second paragraph). 90% of the dextran has molecular weights less than 3500 Daltons. Page 5. The reducing capability of the dextrin is less than 3.0%. Page 10. An exemplary oligosaccharide has a molecular weight of 850 to 1150 Daltons (page 4).
Andreasen’s oligosaccharide molecular weight range overlaps with the claimed molecular weight range (850-1150 versus 1150-1350) and Andreasen is silent about the dispersity of the complex and the proportion of molecules having 6-10 monosaccharide units. Andreasen teaches treatment of animals, but not companion animals specifically.
Naigamwalla teaches that iron deficiency occurs in dogs and cats. See abstract. Treatment includes iron supplementation. Page 254, Therapeutic approach to iron deficiency anemia.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to carry out Andreasen’s method of treatment wherein the subject was a companion animal because companion animals suffer from iron deficiency and require supplementation. Andreasen teaches treatment of animals generally, so the skilled artisan would have expected that companion animals could have been treated. The skilled artisan would have arrived at a dose using routine experimentation.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare Andreasen’s compound using a dextrin having a molecular weight of 1150-1350 Da. The claimed molecular weight range over laps with the prior art molecular weight range. MPEP 2144.05 states that where claimed ranges overlap with the disclosed by the prior art, a prima facie case of obviousness exists. It would have been further obvious to prepare a composition with low dispersity and wherein the majority of molecules have 6-10 monosaccharide units because Andreasen teaches that fractions having lower or high molecular weights have non-desired side effects. Page 5, starting at line 21.
Claim(s) 16-22 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chalhoub (Journal of Feline Medicine and Surgery (2011) 13, 629-640) in view of Svoboda (cited on IDS).
Chalhoub teaches that CKD is a common disorder of domestic cats and many cats with CKD develop anemia. The main cause is reduced production of erythropoietin. ESAs can be used as treatment. See page 629. If the anemia is unlikely to resolve on its own and the cat is symptomatic, Darbepoetin or epoetin should be used along with iron supplementation with iron dextran IM monthly. Page 633, Guidelines for using ESAs.
Chalhoub does not teach that the administration of iron dextran is subcutaneous.
Svoboda teaches subcutaneous injection of iron dextran to iron-deficient piglets. The treatment prevented development of anemia and there was not a significant difference between the subjects treated by intramuscular injection compared to subcutaneous injection. See abstract. Subcutaneous administration of iron dextran prevents complications such as myopathy, polymyositis, and rhabdomyolysis, and nerve damage. Page S11.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to administer iron dextran subcutaneously for cats having anemia related to CKD because IM supplementation is known for treating these subjects, and Svoboda teaches that subcutaneous administration is as effective as IM and avoids complications. It would have been further obvious to include an addition drug such as an ESA because Chalhoub teaches that ESAs should be used along with iron supplementation.
Claim(s) 19-22 and 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andreasen (WO 2010/108493 A1, cited on IDS) in view of Naigamwalla (Can Vet J 2012; 53:250-256, cited on IDS) as applied to claims 16-18, 22-30, and 34-35 above, and further in view of Chalhoub (Journal of Feline Medicine and Surgery (2011) 13, 629-640).
Andreasen and Naigamwalla teach as set forth above. Andreasen and Naigamwalla suggest treatment of companion animals with the claimed iron octasaccharide complex, but not cats with CKD specifically.
Chalhoub teaches that CKD is a common disorder of domestic cats and many cats with CKD develop anemia. If the anemia is unlikely to resolve on its own and the cat is symptomatic, Darbepoetin or epoetin should be used along with iron supplementation. Page 633, Guidelines for using ESAs.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to administer the composition suggested by Andreasen to a cat having CKD because Andreasen teaches that the composition is for treatment of iron deficiency in animals, and cats with CKD are an example of animals which require iron supplementation.
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 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11040059B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘059 patent claims a method of increasing blood haemoglobin concentration by parenterally administering an iron carbohydrate complex (claim 1). The subject is a pig (claim 4). The dose is 20 mg/kg BW (claim 6). Administration is subcutaneous (claim 11).
The current specification states that “companion animal” refers to an animal suitable to be a companion for humans. Pigs are commonly kept as pets, so pigs meet the limitation “companion animal.”
Claims 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 6291440 in view of Naigamwalla (Can Vet J 2012; 53:250-256).
The ‘440 patent claims parenteral administration of iron-dextran to an animal for treatment of iron deficiency. See claims 1-5. The ‘440 patent defines “parenteral” as subcutaneous, intramuscular, or intravenous administration. MPEP 804 states that the specification can be used as a dictionary to learn the meaning of a term in the claim.
The ‘440 patent does not claim treatment of a companion animal.
Naigamwalla teaches that iron deficiency occurs in dogs and cats. See abstract. Treatment includes iron supplementation. Page 254, Therapeutic approach to iron deficiency anemia.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to carry out the ‘440 method wherein the subject was a companion animal because companion animals suffer from iron deficiency and require supplementation. The ‘440 patent claims treatment of animals generally, so the skilled artisan would have expected that companion animals could have been treated. The skilled artisan would have arrived at a dose using routine experimentation.
Claims 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 6977249 in view of Naigamwalla (Can Vet J 2012; 53:250-256).
The ‘249 patent claims a pharmaceutical composition for treatment of iron deficiency, comprising iron dextran complex, by parenteral administration. See claims 1-13. The ‘249 patent defines “parenteral” as subcutaneous, intramuscular, or intravenous administration. MPEP 804 states that the specification can be used as a dictionary to learn the meaning of a term in the claim.
The ‘249 patent does not claim treatment of a companion animal.
Naigamwalla teaches that iron deficiency occurs in dogs and cats. See abstract. Treatment includes iron supplementation. Page 254, Therapeutic approach to iron deficiency anemia.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to carry out the ‘249 method wherein the subject was a companion animal because companion animals suffer from iron deficiency and require supplementation. The ‘249 patent claims treatment of iron deficiency generally, so the skilled artisan would have expected that companion animals could have been treated. The skilled artisan would have arrived at a dose using routine experimentation.
Claims 16-18 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11111261 in view of Naigamwalla (Can Vet J 2012; 53:250-256).
The ‘261 patent claims an iron carbohydrate complex formulated for administration to a non-human animal. The formulation is for subcutaneous administration. The iron carbohydrate complex is hydrogenated oligoisomaltose. Claims 1-11.
The ‘261 patent does not claim treatment of a companion animal.
Naigamwalla teaches that iron deficiency occurs in dogs and cats. See abstract. Treatment includes iron supplementation. Page 254, Therapeutic approach to iron deficiency anemia.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to administer the ‘261 formulation to a companion animal because companion animals suffer from iron deficiency and require supplementation. The ‘261 patent claims treatment of animals generally, so the skilled artisan would have expected that companion animals could have been treated. The skilled artisan would have arrived at a dose using routine experimentation.
Claims 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 8815301 in view of Naigamwalla (Can Vet J 2012; 53:250-256).
The ‘301 patent claims a method of treatment of iron deficiency in an animal, comprising iron oligosaccharide complex, by parenteral administration. See claims 1-19. The ‘301 patent defines “parenteral” as subcutaneous, intramuscular, or intravenous administration. MPEP 804 states that the specification can be used as a dictionary to learn the meaning of a term in the claim.
The ‘301 patent does not claim treatment of a companion animal.
Naigamwalla teaches that iron deficiency occurs in dogs and cats. See abstract. Treatment includes iron supplementation. Page 254, Therapeutic approach to iron deficiency anemia.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to carry out the ‘301 method wherein the subject was a companion animal because companion animals suffer from iron deficiency and require supplementation. The ‘301 patent claims treatment of iron deficiency generally, so the skilled artisan would have expected that companion animals could have been treated. The skilled artisan would have arrived at a dose using routine experimentation.
Conclusion
No claims are allowed.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693
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