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 .
Status of the Claims
Claims 1-6, 9-12, 14 and 16-19 are pending in the instant application and subject to examination herein.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. PCT/EP2021/054941, filed on 02/26/2021.
Claim Interpretation
The scope of systemic and ocular diseases intended for treatment with preparation(s) disclosed in claim 1 and its dependent claims is understood to be defined by the Specification, which provides the following diseases:
• Systemic: diabetes mellitus (page 1), Flammer syndrome (pages 5-6) and small vessels disease (microvascular disease or microangiopathy - page 6).
• Ocular: diabetic retinopathy, macular degeneration (MD), glaucoma such as primary open angle glaucoma (POAG), primary angle closure glaucoma (PACG) and normal tension glaucoma (NTG) (page 9).
Claim Rejections - 35 USC § 112(b) - Withdrawn
The prior rejection of claims 4 and 7 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or a joint inventor(or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in response to Applicant’s amendment of claim 4 and cancellation of claim 7.
Claim Rejections - 35 USC § 112(a) - Withdrawn
The prior rejection of claim 8 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for lack of enablement by the specification for safe and efficacious administration of acetylcholine, is withdrawn in response to Applicant’s cancellation of claim 8.
Claim Rejections - 35 USC § 102 – Maintained
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.
The prior rejection of claims 1-6, 14 and 17-19 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Richardson (US Patent No. 6,207,190 B1)1 is maintained. Applicant has traversed the rejection on the grounds that Richardson cannot anticipate the form of currently amended claims 1 and 17 that require that the treatment of systemic and ocular diseases is accomplished by the mechanism of reduction of an elevated retinal venous pressure, a functional attribute that is not disclosed by Richardson.
Applicant’s argument has been considered but is not found persuasive, for the following reasons: the structure of the treatment of systemic and ocular diseases in claims 1 and 17 is not fundamentally altered by the amendments requiring that the mechanism of the therapeutic benefit of the treatment must be a reduction of an elevated retinal venous pressure, because this attribute does not limit in any way how a person would make and/or use the claimed invention. The structure of the composition in claim 1 remains as a composition (“preparation”) comprising at least one folate, with the intended use for treatment of systemic and ocular diseases. The structure of the method of claim 17 remains as a method for treating systemic and ocular diseases comprising administering a composition (“preparation”) to the individual comprising at least one folate. The mechanism of reduction of an elevated retinal venous pressure does not result in any alteration of the composition comprising at least one folate, nor in any alteration of the method of administering such a composition to an individual.
Apparently, Applicant has discovered a new property or advantage of the composition(s) and/or method(s) that were already anticipated by the disclosure of Richardson. MPEP 2112 I. states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Reiterated Rejection:
Claim 1 is drawn to a composition (“preparation”) comprising at least one folate, with an intended use of treating systemic and ocular diseases wherein the treatment accomplishes a reduction of an elevated retinal venous pressure.
Richardson discloses an invention of pharmaceutical preparations that prevent optic nerve damage and visual loss (Col. 6, lines 20-39), directed specifically to treatment of chronic glaucomas of the eye (Col. 1, lines 14-17), comprising folic acid, L-arginine, N-acetyl-cysteine, alpha-lipoic acid, and B-complex vitamins including riboflavin (B2) pyridoxine (B6), and cyanocobalamin (B12) (Col. 7, lines 30-67 to Col. 8, lines 1-46). For example, see Table II (Cols. 22-23), that discloses all of these compounds “in a bilayer tablet” (Col. 22, lines 54-58).
Thus, claim 1 is anticipated by the disclosure of Richardson.
Claim 2 further limits claim 1 to wherein the ocular disease is selected from a Markush group that includes glaucoma. Claim 3 further limits claim 2 to wherein the glaucoma is selected from a Markush group that includes primary angle open glaucoma. Richardson discloses that primary open angle glaucoma (POAG) is the most common form of glaucoma (Col. 2, lines 37-46), glaucoma patients would benefit from treatment with the preparations disclosed therein due to positive influences in both risk factors of glaucoma: elevated intraocular pressure and compromised optic nerve vascularity (Col. 7, lines 3-11).
Claims 4-6 and 14 further limit claim 1 with respect to additional components of the preparation, and all are met by the disclosure of Richardson described above.
Claim 17 is drawn to a method of treating systemic and ocular disease wherein the disease is linked to elevated retinal venous pressure in an individual, comprising administering a preparation comprising at least one folate, and is met by the disclosure of Richardson described above.
Claim 18 further limits claim 17 to wherein the ocular disease is selected from a Markush group that includes glaucoma. Claim 19 further limits claim 18 to wherein the glaucoma is selected from a Markush group that includes primary open angle glaucoma. These claims are met by the disclosure of Richardson described above.
Thus, claims 2-6, 14 and 17-19 are anticipated by the disclosure of Richardson.
The prior rejection of claims 1-2, 4-5, 9, 11-12, 14 and 17-18 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Dattilo (US PG Pub 2020/0237701 A1) is maintained. Applicant has traversed the rejection on the grounds that Dattilo cannot anticipate the form of currently amended claims 1 and 17 that require that the treatment of systemic and ocular diseases is accomplished by the mechanism of reduction of an elevated retinal venous pressure, a functional attribute that is not disclosed by Dattilo.
Applicant’s argument has been considered but is not found persuasive, for the following reasons: the structure of the treatment of systemic and ocular diseases in claims 1 and 17 is not fundamentally altered by the amendments requiring that the mechanism of the therapeutic benefit of the treatment must be a reduction of an elevated retinal venous pressure, because this attribute does not limit in any way the how a person would make and/or use the claimed invention. The structure of the composition in claim 1 remains as a composition (“preparation”) comprising at least one folate, with the intended use for treatment of systemic and ocular diseases. The structure of the method of claim 17 remains as a method for treating systemic and ocular diseases comprising administering a composition (“preparation”) to the individual comprising at least one folate. The mechanism of reduction of an elevated retinal venous pressure does not result in any alteration of the composition comprising at least one folate, nor in any alteration of the method of administering such a composition to an individual.
Apparently, Applicant has discovered a new property or advantage of the composition(s) and/or method(s) that were already anticipated the disclosure of Dattilo. MPEP 2112 I. states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Reiterated Rejection:
The limitations of claims 1-2, 4-5, 14 and 17-18 are discussed in the rejection above and hereby incorporated into the instant rejection.
Dattilo discloses pharmaceutical, dietary and/or food compositions, preferably dietary supplements, that exert indirect antioxidant effects (paragraph [0036]). Dattilo additionally discloses that compositions disclosed therein can improve the energy production from mitochondria so that energy substrates become processable, which results in the removal of insulin resistance (paragraph [0106]), and that such positive effect on removing insulin resistance can benefit patients with type 2 diabetes mellitus (paragraph [0108]), a systemic disease that, per the instant Specification is linked to elevated retinal venous pressure (Specification, page 1). Dattilo further discloses that patients with diabetes mellitus who are treated with oral drugs, mainly metformin, are known to suffer from a direct negative effect of metformin that increase circulating homocysteine. Metformin associates/causes folate shortage and inhibits the activity of vitamin B12. The increased homocysteine causes a faster progression of diabetic peripheral neuropathy. It is also known that diabetic patients carrying a C677T mutation of the MTHFR gene are at higher risk to develop diabetic peripheral neuropathy, including retinopathy (paragraph [0109]).
Dattilo discloses “Example 1”, a tablet for oral administration comprising (6S)-5-methyltetrahydrofolic acid as the glucosamine salt, betaine, L-cysteine, niacin (vitamin B3) and cyanocobalamin (vitamin B12) (paragraph [0129]).
Thus, claim 1 is anticipated by the disclosures of Dattilo.
Claim 2 further limits claim 1 to wherein the ocular disease is selected from a Markush group that includes diabetic retinopathy, and is met by the disclosure of Dattilo.
Claims 5, 9, 11-12 and 14 further limit claim 1 to including additional compounds and are met by the disclosure of Dattilo described above.
Claim 4 further limits claim 1 to wherein the composition further includes a sulfur donor compound that is N-acetylcysteine. Dattilo discloses that the supplementation of bioavailable SH groups, i.e., cysteines, can be accomplished with N-acetylcysteine, a good source of bioavailable cysteine after oral administration (paragraph [0042] and Dattilo’s claim 8).
Regarding claims 17 and 18, Dattilo specifically discloses that the compositions according to the invention can be used in the treatment of type 2 diabetes mellitus with the aim to improve the glucose metabolism, to decrease or avoid the need for antidiabetic drugs and to reduce or delay the occurrence of diabetic peripheral neuropathy by means of an improved oxy-redox status, of an improved energy metabolism removing insulin resistance and of a decreased burden of circulating homocysteine (paragraph [0111]) and claims methods of decreasing circulating homocysteine (claim 14) and of treating diabetes mellitus (claim 20) comprising administering a composition of the invention disclosed therein.
Thus, claims 2, 4-5, 9, 11-12, 14 and 17-18 are anticipated by the disclosures of Dattilo.
The prior rejection of claims 1-2, 4-5, 10, 12, 14 and 16-18 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Wang (Wang, et al.; Eye and Vision, v6, Article 21, pp.1-11; 2019)2 is maintained. Applicant has traversed the rejection on the grounds that Wang cannot anticipate the form of currently amended claims 1 and 17 that require that the treatment of systemic and ocular diseases is accomplished by the mechanism of reduction of an elevated retinal venous pressure, a functional attribute that is not taught by Wang.
Applicant’s argument has been considered but is not found persuasive, for the following reasons: the structure of the treatment of systemic and ocular diseases in claims 1 and 17 is not fundamentally altered by the amendments requiring that the mechanism of the therapeutic benefit of the treatment must be a reduction of an elevated retinal venous pressure, because this attribute does not limit in any way the how a person would make and/or use the claimed invention. The structure of the composition in claim 1 remains as a composition (“preparation”) comprising at least one folate, with the intended use for treatment of systemic and ocular diseases. The structure of the method of claim 17 remains as a method for treating systemic and ocular diseases comprising administering a composition (“preparation”) to the individual comprising at least one folate. The mechanism of reduction of an elevated retinal venous pressure does not result in any alteration of the composition comprising at least one folate, nor in any alteration of the method of administering such a composition to an individual.
Apparently, Applicant has discovered a new property or advantage of the composition(s) and/or method(s) that were already anticipated the teaching of Wang. MPEP 2112 I. states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Reiterated Rejection:
The limitations of claims 1-2, 4-5, 12, 14 and 16-18 are discussed in the rejections above and hereby incorporated into the instant rejection.
Wang teaches the effects on retinal microvasculature in patients with diabetic and/or hypertensive retinopathy of administering the medical food Ocufolin™ (Abstract, page 1) which comprises L-methylfolate3, vitamin D, vitamins B1-B3 and B6-B7 and B12, alpha-lipoic acid and N-acetylcysteine (Table 2, page 3). Wang teaches that the use of a carefully formulated medical food which includes L-methylfolate and vitamin D may be effective in facilitating the improvement of diabetic retinopathy (page 9).
Thus, claim 1 is anticipated by the teaching of Wang.
Regarding claim 2, Wang teaches the treatment of diabetic retinopathy with a composition compriging L-methylfolate.
The limitations of claims 4-5, 12 and 14, requiring additional component(s) in the folate composition are met by the teaching of Wang discussed above.
Claim 10 further limits claim 1 to including vitamin D in the folate composition, and is met by the teaching of Wang discussed above.
Regarding claims 17-18, Wang teaches the treatment of diabetic retinopathy with a medical food comprising L-methylfolate.
Thus, claims 2, 4-5, 10, 12, 14 and 17-18 are anticipated by the teaching of Wang.
Double Patenting – Withdrawn
The prior rejection of claim 4 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 16 of U.S. Patent No. 9,642,853 B2 (hereafter named as “Ulmann”) is withdrawn in response to Applicant’s amendment of claim 4.
Double Patenting – Maintained
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.
The prior rejection of claims 1 and 12 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 16 of U.S. Patent No. 9,642,853 B2 (hereafter named as “Ulmann”) is maintained. Applicant has traversed the rejection on the grounds that Ulmann cannot anticipate the form of currently amended claim 1 that requires that the treatment of systemic and ocular diseases is accomplished by the mechanism of reduction of an elevated retinal venous pressure, a functional attribute that is not claimed by Ulmann.
Applicant’s argument has been considered but is not found persuasive, for the following reasons: the structure of the treatment of systemic and ocular diseases in claim 1 is not fundamentally altered by the amendments requiring that the mechanism of the therapeutic benefit of the treatment must be a reduction of an elevated retinal venous pressure, because this attribute does not limit in any way the how a person would make and/or use the claimed invention. The structure of the composition in claim 1 remains as a composition (“preparation”) comprising at least one folate, with the intended use for treatment of systemic and ocular diseases. The mechanism of reduction of an elevated retinal venous pressure does not result in any alteration of the composition comprising at least one folate.
Apparently, Applicant has discovered a new property or advantage of the composition(s) already claimed by Ulmann. MPEP 2112 I. states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Reiterated Rejection:
The limitations of instant claims 1 and 12 are discussed in the rejections above and hereby incorporated into the instant rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because Ulmann’s claim 1 discloses a pharmaceutical aqueous composition containing folates, whereas the instant claim 1 discloses a preparation comprising at least one folate. The intended use of instant claim 1 does not further limit the structure of the claimed invention, and therefore Ulmann’s claim 1 anticipates the instant claim 1. Instant claim 12 is anticipated as the folates listed in Ulmann’s claim 1 include those claimed in instant claim 12.
The prior rejection of claims 1 and 11-12 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-5 of U.S. Patent No. 11,787,808 B2 (hereafter named as “Wiesler”) is maintained. Applicant has traversed the rejection on the grounds that Wiesler cannot anticipate the form of currently amended claim 1 that requires that the treatment of systemic and ocular diseases is accomplished by the mechanism of reduction of an elevated retinal venous pressure, a functional attribute that is not claimed by Wiesler.
Applicant’s argument has been considered but is not found persuasive, for the following reasons: the structure of the treatment of systemic and ocular diseases in claim 1 is not fundamentally altered by the amendments requiring that the mechanism of the therapeutic benefit of the treatment must be a reduction of an elevated retinal venous pressure, because this attribute does not limit in any way the how a person would make and/or use the claimed invention. The structure of the composition in claim 1 remains as a composition (“preparation”) comprising at least one folate, with the intended use for treatment of systemic and ocular diseases. The mechanism of reduction of an elevated retinal venous pressure does not result in any alteration of the composition comprising at least one folate.
Apparently, Applicant has discovered a new property or advantage of the composition(s) already claimed by Wiesler. MPEP 2112 I. states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Reiterated Rejection:
The limitations of claims 1 and 11-12 are discussed in the rejections above and hereby incorporated into the instant rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because Wiesler’s claims 1 and 3-5 disclose a crystalline folate salt-comprising composition wherein the counterion to 5-methyl-(6S)-tetrahydrofolic acid is choline. The intended use of instant claim 1 does not further limit the structure of the claimed invention, and therefore Wiesler’s claims anticipate the instant claims.
The prior rejection of claims 1 and 11-12 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,690,846 B2 (hereafter named as “Bodenmuller”). Applicant has traversed the rejection on the grounds that Bodenmuller cannot anticipate the form of currently amended claim 1 that requires that the treatment of systemic and ocular diseases is accomplished by the mechanism of reduction of an elevated retinal venous pressure, a functional attribute that is not claimed by Bodenmuller.
Applicant’s argument has been considered but is not found persuasive, for the following reasons: the structure of the treatment of systemic and ocular diseases in claim 1 is not fundamentally altered by the amendments requiring that the mechanism of the therapeutic benefit of the treatment must be a reduction of an elevated retinal venous pressure, because this attribute does not limit in any way the how a person would make and/or use the claimed invention. The structure of the composition in claim 1 remains as a composition (“preparation”) comprising at least one folate, with the intended use for treatment of systemic and ocular diseases. The mechanism of reduction of an elevated retinal venous pressure does not result in any alteration of the composition comprising at least one folate.
Apparently, Applicant has discovered a new property or advantage of the composition(s) already claimed by Bodenmuller. MPEP 2112 I. states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Reiterated Rejection:
The limitations of claims 1 and 11-12 are discussed in the rejections above and hereby incorporated into the instant rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because Bodenmuller’s claims 1 discloses a folate salt-comprising composition wherein the anion is 5-formyl-(6S)-tetrahydrofolic acid and the cation is an organic compound selected from a Markush group that closely overlaps with the Markush group of cations in instant claim 11. Bodenmuller’s claims 2-4 further limit the amorphous folate salt to a cation of arginine, that is included in instant claim 11. Bodenmuller’s claim 5 further elaborates the folate salt into a pharmaceutical composition. The intended use of instant claim 1 does not further limit the structure of the claimed invention, and therefore Bodenmuller’s claims anticipate the instant claims.
The prior rejection of claims 1, 5-6 and 9-12 on the ground of nonstatutory double patenting as being unpatentable over claims 7-16 of U.S. Patent No. 12,138,266 B2 (hereafter named as “Dutler”) is maintained. Applicant has traversed the rejection on the grounds that Dutler cannot anticipate the form of currently amended claim 1 that requires that the treatment of systemic and ocular diseases is accomplished by the mechanism of reduction of an elevated retinal venous pressure, a functional attribute that is not claimed by Dutler.
Applicant’s argument has been considered but is not found persuasive, for the following reasons: the structure of the treatment of systemic and ocular diseases in claim 1 is not fundamentally altered by the amendments requiring that the mechanism of the therapeutic benefit of the treatment must be a reduction of an elevated retinal venous pressure, because this attribute does not limit in any way the how a person would make and/or use the claimed invention. The structure of the composition in claim 1 remains as a composition (“preparation”) comprising at least one folate, with the intended use for treatment of systemic and ocular diseases. The mechanism of reduction of an elevated retinal venous pressure does not result in any alteration of the composition comprising at least one folate.
Apparently, Applicant has discovered a new property or advantage of the composition(s) already claimed by Dutler. MPEP 2112 I. states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Reiterated Rejection:
The limitations of claims 1, 5-6 and 9-12 are discussed in the rejections above and hereby incorporated into the instant rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because Dutler’s claim 7 discloses a folate-comprising preparation wherein the folate is a salt with anion selected from a Markush group of Dutler’s parent claim 1 that overlaps with instant claim 12 and the cation is selected from a Markush group that overlaps with instant claim 11. Dutler’s claims 8-9 and 11-16 further elaborate the preparation with regard to weight percents of the composition and additional excipient(s), while Dutler’s claim 10 further elaborates the preparation to include additional compounds selected from a Markush group that includes vitamins of B complex (instant claim 5) and D complex (instant claim 10), arginine (instant claim 6), and glucosamine (instant claim 9). The intended use of instant claim 1 does not further limit the structure of the claimed invention, and therefore Dutler’s claims anticipate the instant claims.
The prior rejection of claims 1-2, 4-6, 10-12, 14 and 16-19 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6-22 of U.S. Patent No. 12,048,702 B2 (hereafter named as “Flammer”) is maintained. Applicant has traversed the rejection on the grounds that Flammer cannot anticipate the form of currently amended claims 1 and 17 that require that the treatment of systemic and ocular diseases is accomplished by the mechanism of reduction of an elevated retinal venous pressure, a functional attribute that is not disclosed by Flammer.
Applicant’s argument has been considered but is not found persuasive, for the following reasons: the structure of the treatment of systemic and ocular diseases in claims 1 and 17 is not fundamentally altered by the amendments requiring that the mechanism of the therapeutic benefit of the treatment must be a reduction of an elevated retinal venous pressure, because this attribute does not limit in any way the how a person would make and/or use the claimed invention. The structure of the composition in claim 1 remains as a composition (“preparation”) comprising at least one folate, with the intended use for treatment of systemic and ocular diseases. The structure of the method of claim 17 remains as a method for treating systemic and ocular diseases comprising administering a composition (“preparation”) to the individual comprising at least one folate. The mechanism of reduction of an elevated retinal venous pressure does not result in any alteration of the composition comprising at least one folate, nor in any alteration of the method of administering such a composition to an individual.
Apparently, Applicant has discovered a new property or advantage of the composition(s) and/or method(s) that were already anticipated the disclosure of Flammer. MPEP 2112 I. states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Reiterated Rejection:
The limitations of claims of claims 1-2, 4-6, 10-12, 14 and 16-19 are discussed in the rejections above and hereby incorporated into the instant rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because Flammer’s claim 1 discloses a folate salt-comprising preparation wherein the folate anion is selected from a Markush group that closely overlaps with the Markush group of instant claim 12 and the folate cation is selected from a Markush group that closely overlaps with the Markush group of instant claim 11. The intended use of instant claim 1 does not further limit the structure of the claimed invention, just as the intended use of Flammer’s claim 1 does not limit the structure of that invention, and therefore Flammer’s claims anticipate the instant claims. Flammer’s claims 2-3, 6-11 and 22 further elaborate the preparation to include additional compounds including N-acetylcysteine (instant claim 4), B vitamins (instant claims 5 and 14) and vitamin D (instant claim 10). Flammer’s claims 12-14 further elaborate the preparation into compositions for oral and topical administration and a kit containing the preparation. Flammer’s claims 15-21 disclose a method of reducing intraocular pressure in a patient having an eye disease comprising administering a folate salt-comprising preparation, with such eye diseases including diabetic retinopathy and glaucoma.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
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/W.J.Y./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 Cited in Applicant’s Information Disclosure Sheet dated 04/02/2024.
2 Cited in Applicant’s Information Disclosure Sheet dated 04/02/2024.
3 5-methyltetrahydrofolate – see Wang’s page 2, bottom left paragraph.