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 .
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.
Response to Amendment
The amendment filed March 11, 2026 has been entered. Claims 1-9 have been amended, claims 10-18, 21-24, and 27-35 have been cancelled. Applicant’s amendments to the claims have overcome the 112(b) rejections of claims 2-9 and 102 rejections previously set forth in the Non-Final Office Action mailed September 11, 2025. Applicants cancellation of claims 10-18, 21-24, and 27-35 have rendered the corresponding 112(a), 112(b), 112(d), 102, 103, and double patenting rejections moot. As such, these rejections are hereby withdrawn.
Applicant’s arguments filed March 11, 2026 were fully considered but they were not persuasive. Modified/New rejections necessitated by Applicant’s amendment and response to arguments are addressed below.
Claims 1-9, 19-20, 25-26, and 36 are pending in this application.
Priority
This application is a United States national stage application filed under 35 U.S.C. § 371 of International Application No. PCT/IB2021/052005, filed March 10, 2021, which claims the benefit of priority to U.S. Provisional Application No. 62/988,375, filed March 11, 2020 and U.S. Provisional Application No. 63/045,585, filed June 29, 2020.
Claim Interpretation
With respect to instant claim 1, which is directed to a pharmaceutical composition and recites the phrase ““for visual health”. The Examiner notes that it is well settled that “intended use” of a composition or product, e.g., “for visual health”, will not further limit claims drawn to a composition, so long as the prior art discloses the same composition comprising the same ingredients in an effective amount, as the instantly claimed (See MPEP 2111.02 (II)).
Modified/New Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9, 19-20, 25-26, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Rafanelli (US 2011/0142766, IDS filed September 8, 2022) in view of Christen (Arch Intern Med., 2009), and Leonard (WO 2006/055526, IDS filed September 8, 2022).
Regarding claims 1-9, 19-20, 25-26, and 36: Rafanelli teaches an effervescent dietary supplement formulation that may be beneficial to the management of symptoms related to ocular diseases (abstract). Also provided are methods of treating an ocular disease, such as macular degeneration, by administering the dietary supplement to a subject in need thereof (abstract). Rafanelli teaches the supplements slow the progression of various ocular diseases (pg. 1, para. 0012). In a specific embodiment Rafanelli teaches a supplement wherein a packet is added to water (i.e. liquid formulation, immediate release) comprising 10 mg thiamin HCL (vitamin B1), 10 mg riboflavin (vitamin B2), 20 mg niacinamide (vitamin B3), 3 mg pyridoxine (vitamin B6), 0.8 mg folic acid (vitamin B9), 0.1 mg cyanocobalamin (vitamin B12), 0.03 mg biotin (vitamin B7), 500 mg calcium pantothenate (vitamin B5) (pg. 7, paras. 0059-0072). The dietary supplement can be administered daily and/or once per day (pg. 1, paras. 0010-0011, pg. 6, para. 0056). The dietary supplements can be prepared into orally dispersible pills or tablets (pg. 4, paras. 0039-0040). Rafanelli teaches in other embodiments pantothenic acid is present in an amount of about 50 mg (pg. 2, para. 0021). Rafanelli further teaches the following concentration ranges of vitamins: thiamin (vitamin B1) is 10-12 mg, riboflavin (vitamin B2) is 8-12 mg, niacin (vitamin B3) is 2- 10 mg, pantothenic acid (vitamin B5) is 10-50mg, pyridoxine (vitamin B6) is 10-20 mg, biotin (vitamin B7) is 0.006-0.03mg, folate (vitamin B9) is 0.4-0.8 mg, cyanocobalamin is (vitamin B12) is 0.08-0.12mg (pg. 2, para. 0021). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. (See MPEP 2144.05 (I)).
Rafanelli does not teach wherein vitamin B1 thiamin is about 3.4 to about 4.6 mg, vitamin B2 riboflavin is about 3.4 mg to about 5.6 mg, vitamin B3 niacinamide is about 25 mg to about 60 mg, vitamin B6 pyridoxine is about 45 to about 60 mg, vitamin B7 biotin is 0.05 mg to about 0.75 mg, or vitamin B12 cyanocobalamin is about 0.5 mg to 1.5 mg.
However, Christen teaches the administration of a combination of 2.5 mg folic acid, 50 mg pyridoxine HCl, and 1 mg cyanocobalamin for the reduction of risk of developing age-related macular degeneration (abstract). Leonard teaches a method of treating macular degeneration in a human comprising administering to a human in need of such treatment an effective amount a composition comprising B vitamins (abstract, pg. 6, lines 28-30, pg. 7, whole page, pg. 8, lines 1-20, pg. 85, example 6). Leonard teaches compositions comprising 1.5 mg or 4.5 mg thiamin (pg. 83, line 29, pg. 85, line 17). Leonard teaches thiamin can be present in up to about 9 or 3 mg (pg. 7, lines 4-8). Leonard teaches compositions comprising 1.7 mg or 5.1 mg riboflavin (pg. 79, line 5, pg. 80, line 27). Leonard teaches riboflavin can be present in up to about 30 or 10 mg (pg. 7, lines 9-13). Leonard teaches compositions comprising 20 mg or 5.1 mg niacin (pg. 79, line 6, pg. 85, line 19). Leonard teaches niacin can be present in up to about 60 mg (pg. 7, lines 14-21). Leonard teaches compositions comprising 0.045 mg or 5.1 mg biotin (pg. 77, line 33). Leonard teaches niacin can be present in up to about 0.9 mg (pg. 8, lines 10-14).
Taken together, it would have been prima facie obvious to a person of ordinary skill in the art to further optimize the formulation of Rafanelli with values suggested by Christen and Leonard and arrive at the claimed formulations. A person of ordinary skill would have had the motivation to do so with a reasonable expectation of success given that the art establishes compositions comprising B vitamins are useful for the treatment of ocular degenerative disorders and a wide range of concentrations are viable options in formulations. Wherein the art establishes a wide range of concentrations are viable options and wherein the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (See MPEP 2144.05 (II)).
Maintained/Modified 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 1-9, 19-20, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/905,924 (US 2023/0165895, cited in previous action). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 1-9, 19-20, and 25: The copending claims teach a method for treating and or preventing at least one disease, disorder, and/or condition associated with a loss of visual acuity the method comprising administering to a subject a composition comprising B vitamins (copending claims 1). The copending claims teach the composition can be used to delay the progression or onset of macular degeneration (claim 70). The copending claims teach the composition is on a daily dosage basis (claim 69). The copending claims teach a composition for visual health consisting of each B that overlap/encompass the claimed formulations (claim 73). The copending claims teach the composition can be in the form of tablets (claim 59). The copending claims teach the composition can be in the form of immediate release or modified release formulation (claim 60).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 26 and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/905,924 (US 2023/0165895, cited in previous action) as applied to claims 1-9, 19-20, and 25 above in view of Rafanelli (US 2011/0142766, IDS filed September 8, 2022). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 26 and 36: As discussed above the copending claims teach a composition for visual health comprising the claimed B vitamins in comparable concentrations. The copending claims teach the composition is on a daily dosage basis (claim 69). The copending claims teach wherein the composition is formulated into one, two, three, or four dosage units for daily administration (claim 61).
They do not teach wherein the composition is for delaying the onset of macular degeneration as recited by instant claim 26.
However, Rafanelli teaches an effervescent dietary supplement formulation that may be beneficial to the management of symptoms related to ocular diseases (abstract). Also provided are methods of treating an ocular disease, such as macular degeneration, by administering the dietary supplement to a subject in need thereof (abstract). Rafanelli teaches the supplements slow the progression of various ocular diseases (pg. 1, para. 0012). In a specific embodiment Rafanelli teaches a supplement wherein a packet is added to water (i.e. liquid formulation, immediate release) comprising 10 mg thiamin HCL (vitamin B1), 10 mg riboflavin (vitamin B2), 20 mg niacinamide (vitamin B3), 3 mg pyridoxine (vitamin B6), 0.8 mg folic acid (vitamin B9), 0.1 mg cyanocobalamin (vitamin B12), 0.03 mg biotin (vitamin B7), 500 mg calcium pantothenate (vitamin B5) (pg. 7, paras. 0059-0072). The dietary supplement can be administered daily and/or once per day (pg. 1, paras. 0010-0011, pg. 6, para. 0056). The dietary supplements can be prepared into orally dispersible pills or tablets (pg. 4, paras. 0039-0040). Rafanelli teaches in other embodiments pantothenic acid is present in an amount of about 50 mg (pg. 2, para. 0021). Rafanelli further teaches the following concentration ranges of vitamins: thiamin (vitamin B1) is 10-12 mg, riboflavin (vitamin B2) is 8-12 mg, niacin (vitamin B3) is 2- 10 mg, pantothenic acid (vitamin B5) is 10-50mg, pyridoxine (vitamin B6) is 10-20 mg, biotin (vitamin B7) is 0.006-0.03mg, folate (vitamin B9) is 0.4-0.8 mg, cyanocobalamin is (vitamin B12) is 0.08-0.12mg (pg. 2, para. 0021).
Taken together it would have been prima facie obvious to apply the composition for the delaying onset of macular degeneration as taught by Rafanelli. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the art establishes B-vitamin compositions are effective for this purpose. A person of ordinary skill in the art would recognize the composition for visual health as recited by the copending claims being applicable for this purpose.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments filed March 11, 2026 with respect to the claims have been fully considered but they are not persuasive.
On pages 10-11 of Applicant’s response, Applicant argues the Examiner relies on general ranges and exemplary compositions of Leonard and Christen to arrive at the instantly claimed composition (bridging para.). On page 11 of Applicant’s response, Applicant argues the Examiner relies on general ranges and exemplary compositions to modify the composition of Rafanelli, but has not provided requisite motivation to make each individual modifications, let alone each of the individual modifications in combination (para. 2). Applicant argues that based on the teachings of Rafanelli and Leonard, a person of ordinary skill in the art would have to reduce vitamin concentrations in specific amounts to arrive at the claimed ranges (para. 3). On page 12 of Applicant’s response, Applicant argues that based on the teachings of Rafanelli and Leonard, a person of ordinary skill would have to then increase vitamin concentrations in specific amounts to arrive at the claimed range even though some concentrations of Rafanelli are already in the preferred ranges described by Leonard (para. 2). On pages 12-13 of Applicant’s response, Applicant argues that a person of ordinary skill in the art would not have made these modifications in combination to arrive at the claimed composition, but rather that the Examiner cherrypicked concentrations from the art in a manner only supported by impermissible hindsight (bridging para.).
However, wherein the art as a whole establishes B vitamin compositions are beneficial for the treatment of macular degeneration, and these concentrations are known to be effective for the same purpose, arriving at the claimed concentrations would be well within the technical grasp of the skilled artisan through routine optimization. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical (see MPEP 2144.05 (II)). The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages. Additionally, the prior art references establish varying effective ranges for B vitamins to be included in a given composition. A range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case (See MPEP 2144.05 (I)). A person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range given that these compositions are for the same purpose and establish effective amounts of each vitamins (i.e. treating macular degeneration). A person of ordinary skill in the art would look to the ranges appearing in the prior art and arrive at the claimed invention.
On page 13 of Applicant’s response Applicant argues that the present application and the copending application '924 have the same filing date and their patent terms are equal, thus, the granting of one would not create an unjustified extension of the other's term. (Section VII).
In response, applicant's attention is respectfully drawn to MPEP 804 which state: If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application, or includes a compliant terminal disclaimer under 37 CFR 1.321 that obviates the rejection. If the reply is sufficient, the examiner will withdraw the nonstatutory double patenting rejection in the application in which it was submitted.
Applicant’s reply is considered to be a bona fide attempt at a response and is being accepted as a complete response. The 35 USC § 103 and double patenting rejections are maintained for reason of record and foregoing discussion.
Conclusion
No claims are allowed in this action.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SAMUEL L GALSTER whose telephone number is (571)270-0933. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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/S.L.G./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693
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