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 6/2/2026, where it is noted that no claim amendments accompany the response.
Claims 1, 2, 26, 27, 32, 35, 37, 38, 43, 60, 78-81, 85, 130, 131, 135, 141 and 142 are pending in the instant application.
Election/Restrictions
Applicants’ election, without traverse, for species cyanocobalamin and bone marrow failure, encompassing claims 1, 2, 26, 27, 32, 35, 37, 38, 43, 60, 78-81, 85, 130, 131, 135, 141 and 142, in the reply filed on 6/2/2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 2, 26, 27, 32, 35, 37, 38, 43, 60, 78-81, 85, 130, 131, 135, 141 and 142 will be examined on the merits herein.
Priority
The application is a continuation of application 18/174989, now US 12,026,230, filed on 2/27/2023, which is a continuation of the National Stage entry of PCT/US2021/048012 filed on 8/27/2021, which claims priority to provisional application 63/071825, filed on 8/28/2020.
Information Disclosure Statement
The information disclosure statements (IDS) dated 6/11/2024 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 1, 2, 26, 27 and 142 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stanley et al. (Aust. Vet. J., 2017, PTO-892).
Stanley discloses a method for treating bone marrow failure in cats by parenteral administration of cyanocobalamin. (Abstract)
With respect to claim 142 and the limitation regarding activation of NFkB, this limitation is not accorded patentable weight because of the inseparable connection between an administered composition and the mechanism of action within the subject to which the composition is administered. The active method step in the instant claim is administering the cobalamin to a subject having bone marrow failure, whereas the activation of NFkB is an effect which will necessarily occur and does not delineate a manipulative difference between the instant method and the method of the prior art. Therefore, because the combined prior art teaches the same active step to administer the same composition, the properties applicant discloses and/or claims are necessarily present. Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993). See also MPEP § 2112.02.
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.
Claim 141 is rejected under 35 U.S.C. 103 as being unpatentable over Stanley et al. (Aust. Vet. J., 2017, PTO-892).
Stanley discloses a method for treating bone marrow failure in cats by subcutaneous injection administration of cyanocobalamin. (Abstract; p. 157) Stanley further discloses that Multiple components of this case are consistent with haematological disease resulting from cobalamin deficiency as documented among human and isolated canine patients to date (p. 158, Col. 1)… The most well-recognized manifestation of cobalamin deficiency in humans is megaloblastic anaemia…bone marrow histopathology has revealed hypercellularity of erythroid and myeloid cell lines and, ultimately, complete bone marrow failure and pancytopenia may result. (p. 158, Col. 2)
Stanley does not explicitly teach ameliorating bone marrow failure in humans.
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 method of Stanley to treat a human subject with bone marrow failure by administration of cyanocobalamin. It has been decided that: 1) when there is a reasonable correlation between in vitro or in vivo animal testing and a claimed method invention, a rigorous correlation between said testing and the claimed method is not necessary and 2) that there is no insurmountable difficulty in moving to the next level in the screening chain (i.e. in vitro testing – in vivo animal testing – in vivo human testing) once successful testing has been demonstrated at the previous link in the chain. Cross v. Iizuka, 753 F.2d 1040, 1051, 224 USPQ 739, 747-48 (Fed. Cir. 1985) and (MPEP § 2107.03 and § 2164.02) Stanley provides data demonstrating the efficacy of cyanocobalamin in treating feline bone marrow failure, at the in vivo animal model testing level of the screening chain. Thus, the data of Stanley show that one of ordinary skill in that art would expect a reasonable correlation between testing in animals and a method of treating humans.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 1, 2, 26, 27, 32, 37, 38, 43, 60, 78, 79, 85, 130, 131, 135, 141 and 142 are rejected under 35 U.S.C. 103 as being unpatentable over Niyikiza et al. (WO 2002/02093A2, PTO-892), in view of Leguit et al. (Histopathology, 2010, PTO-892).
Niyikiza discloses a method for treating lymphoma, breast cancer, and head and neck cancer, or ameliorating a toxic event associated with administering an antifolate chemotherapeutic agent, where the toxic event includes neutropenia or anemia, by administering a methylmalonic acid lower agent (MMA) in combination with the antifolate, where the MMA is a cobalamin, including a cyanocobalamin. (Claims 1-7; p. 1, Ln. 11-15; p . 5, Ln. 11-15) Niyikiza also discloses that the cobalamin may be administered, in the form of a tablet of intramuscular injection, simultaneous with or 1-3 weeks prior to administering the antifolate. (p. 7, 10; Claim 20) Niyikiza exemplifies that neutropenia is markedly reduced upon administration of a cobalamin/folic acid/antifolate combination. (Table 1)
Niyikiza does not teach ameliorating bone marrow failure.
Leguit discloses that the causes of bone marrow failure are classified according to the categories anemia, neutropenia, thrombocytopenia or pancytopenia. (p. 3) Leguit further discloses that patients with neutropenia or pancytopenia may develop aplastic anemia or myelodysplastic syndrome. (pp. 11, 18-19)
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 method of Niyikiza to specifically ameliorate blood marrow failure caused by neutropenia, thereby arriving at the instant invention. One would be motivated to modify Niyikiza in this manner because Leguit teaches that it is well-established that bone marrow failure is caused by conditions including neutropenia, thrombocytopenia, pancytopenia, aplastic anemia or myelodysplastic syndrome. Thus, since Niyikiza is directed to amelioration of neutropenia or anemia, one would find is obvious that blood marrow failure would also be ameliorated by the method of Niyikiza because blood marrow failure is caused by neutropenia or anemia.
With respect to claim 142 and the limitation regarding activation of NFkB, this limitation is not accorded patentable weight because of the inseparable connection between an administered composition and the mechanism of action within the subject to which the composition is administered. The active method step in the instant claim is administering the cobalamin to a subject having bone marrow failure, whereas the activation of NFkB is an effect which will necessarily occur and does not delineate a manipulative difference between the instant method and the method of the prior art. Therefore, because the combined prior art teaches the same active step to administer the same composition, the properties applicant discloses and/or claims are necessarily present. Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993). See also MPEP § 2112.02.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 1, 2, 26, 27, 35, 37, 38, 60, 78-81, 130, 131, 135, 141 and 142 are rejected under 35 U.S.C. 103 as being unpatentable over Scott et al. (US 2013/0089623A1, PTO-892), in view of Leguit et al. (Histopathology, 2010, PTO-892).
Scott discloses a method for treating subjects having thyroid conditions including megaloblastic anemia, pancytopenia, aplastic anemia, neutropenia, agranulocytosis, thrombocytopenia, leukopenia, pernicious anemia, or iron deficiency, by administering a capsule composition comprising an anti-thyroid drug, folate and vitamin B12, where the vitamin B12 may be cyanocobalamin. (Claim 30, 45, 52; ¶0025, 0101) Scott further discloses that the subject may have been exposed to radiation therapy on the thyroid gland. (Claim 33; ¶0038) Scott also discloses that the subject being treated may have thyroid cancer. (¶0033)
Scott does not teach ameliorating bone marrow failure.
Leguit discloses that the causes of bone marrow failure are classified according to the categories anemia, neutropenia, thrombocytopenia or pancytopenia. (p. 3) Leguit further discloses that patients with neutropenia or pancytopenia may develop aplastic anemia or myelodysplastic syndrome. (pp. 11, 18-19)
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 method of Scott to specifically ameliorate blood marrow failure caused by megaloblastic anemia, pancytopenia, aplastic anemia, neutropenia, or thrombocytopenia, thereby arriving at the instant invention. One would be motivated to modify Scott in this manner because Leguit teaches that it is well-established that bone marrow failure is caused by conditions including neutropenia, thrombocytopenia, pancytopenia, aplastic anemia or myelodysplastic syndrome. Thus, since Scott is directed to amelioration of megaloblastic anemia, pancytopenia, aplastic anemia, neutropenia, or thrombocytopenia, one would find is obvious that blood marrow failure would also be ameliorated by the method of Scott because blood marrow failure is caused by these conditions.
With respect to claim 142 and the limitation regarding activation of NFkB, this limitation is not accorded patentable weight because of the inseparable connection between an administered composition and the mechanism of action within the subject to which the composition is administered. The active method step in the instant claim is administering the cobalamin to a subject having bone marrow failure, whereas the activation of NFkB is an effect which will necessarily occur and does not delineate a manipulative difference between the instant method and the method of the prior art. Therefore, because the combined prior art teaches the same active step to administer the same composition, the properties applicant discloses and/or claims are necessarily present. Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993). See also MPEP § 2112.02.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 1, 2, 26, 27, 130, 131, 135, 141 and 142 are rejected under 35 U.S.C. 103 as being unpatentable over Koch et al. (WO 2015/077511A1, PTO-892).
Koch discloses a method for increasing bioavailability of vitamin B12 by administering a pharmaceutical composition, in the form of a capsule, a tablet, a softgel, a powder, an effervescent form, or a lozenge, comprising vitamin B12 and a di/tri-terpene glycoside, to a subject in need thereof, where the subject has vitamin B12 deficiency, which can cause megalobastic anemia, bone marrow failure, demyelinating nervous system disease, autoimmune gastritis (pernicious anemia), glossitis, infertility, thrombosis. (¶0002, 0055, 0079-0082; Claims 14, 32)
Koch does not teach ameliorating bone marrow failure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the method of Koch for increasing bioavailability of vitamin B12, to treat a vitamin B12 deficient subject, would be applicable to any condition taught to be caused by a vitamin B12 deficiency , including bone marrow failure, thereby arriving at the instant invention. One would be motivated to ameliorate bone marrow failure by administering the anti-vitamin B12 deficiency composition of Koch because Koch teaches that bone marrow failure is caused by vitamin B12 deficiency.
With respect to claim 142 and the limitation regarding activation of NFkB, this limitation is not accorded patentable weight because of the inseparable connection between an administered composition and the mechanism of action within the subject to which the composition is administered. The active method step in the instant claim is administering the cobalamin to a subject having bone marrow failure, whereas the activation of NFkB is an effect which will necessarily occur and does not delineate a manipulative difference between the instant method and the method of the prior art. Therefore, because the combined prior art teaches the same active step to administer the same composition, the properties applicant discloses and/or claims are necessarily present. Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993). See also MPEP § 2112.02.
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 1, 2, 26, 27, 32, 35, 37, 38, 43, 60, 78-81, 85, 130, 131, 135, 141 and 142 of the instant application are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over US 12036230B2. Although the conflicting claims are not identical, they are not patentably distinct from each other because: The instant method is drawn to treating bone marrow failure by administering cyanocobalamin, compared to the method of ‘230 being directed to a method of treating acute radiation syndrome by administering cyanocobalamin. However, as per Baranowitz et al. (US 2017/0071966A1, PTO-892), it is known that subjects having acute radiation syndrome most often die from bone marrow failure. (¶0003) Thus, the instant claims are an obvious variant of ‘230.
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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/DALE R MILLER/Primary Examiner, Art Unit 1693
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