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 reply filed on September 1, 2026.
Status of Claims
Amendment of claims 16, 19-20 and 28; and addition of claim 31 is acknowledged
Claims 16-30 are currently pending and are the subject of this office action.
Claims 22-30 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on March 3, 2026.
Claims 16-21 and 31 are presently under examination.
Priority
The present application is a 371 of PCT/EP2023/237484 filed on 06/05/2023 and claims priority to foreign application EPO EP22177932.5 filed on 06/08/2022.
Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 102 (Modified rejection not Necessitated by Amendment).
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 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) 16-19 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moser et. al. (US 10,570,134).
NOTE: for this rejection it is assumed that:
the process of lyophilization removes most of the water present in the original solution is removed, leaving only traces of water.
that the sodium citrate tri-hydrate of Moser is actually sodium citrate tri-hydrate
For claim 16, Moser teaches a water solution consisting of (see column 25, Example 1-5 (a) Lyophilizate for reconstitution to be used for intravenous application):
18,480 g water
1,386 g sodium hydroxide 2M
968.9 g sodium citrate tri-hydrate
473.9 g 5,10-methylene (6R)-tetrahydrofolic acid hemisulfate
210 g water
121.8 g sodium hydroxide 2M, and
203.6 g water
The following molecular weights (MW) are being used for the calculations below:
MW 5,10-methylene (6R)-tetrahydrofolic acid disodium salt = 501.22 g/mol
MW 5,10-methylene (6R)-tetrahydrofolic acid = 457.44 g/mol
MW 5,10-methylene (6R)-tetrahydrofolic acid hemisulfate =1,012.95 g/mol
MW sulfuric acid = 98.07 g/mol
MW sodium sulfate = 142.04 g/mol
MW sodium hydroxide = 40.00 g/mol
MW sodium citrate tri-hydrate = 312.10 g/mol
MW sodium citrate = 258.06 g/mol
After mixing all these components, sodium hydroxide will react with the 5,10-methylene (6R)-tetrahydrofolic acid hemisulfate to form 5,10-methylene (6R)-tetrahydrofolic acid disodium salt and sodium sulfate with following stoichiometry:
1- Total amount of sodium hydroxide 2M
1,386 g + 121.8 g = 1,507.8 g of sodium hydroxide 2M
The density of a 2M sodium hydroxide is about 1.07 g/ml
So, 1,507.8 g /1.07 g/ml = 1,409.16 ml of 2M sodium hydroxide
1.40916 L x 2 mol/L = 2.818 mol sodium hydroxide
2- total amount of sulfuric acid and 5,10-methylene (6R)-tetrahydrofolic acid
473.9 g 5,10-methylene (6R)-tetrahydrofolic acid hemisulfate / 1,012.95 g/mol = 0.468 mol of 5,10-methylene (6R)-tetrahydrofolic acid hemisulfate, which is equivalent to:
0.468 mol of sulfuric acid, and
0.936 mol of 5,10-methylene (6R)-tetrahydrofolic acid
3- the 0.468 mol of sulfuric acid will react with 0.936 mol of sodium hydroxide to afford 0.468 mol of sodium sulfate
0.468 mol sodium sulfate x 142.04 g/mol = 66.47 g sodium sulfate
4- the 0.936 mol of 5,10-methylene (6R)-tetrahydrofolic acid will react with 1.872 mol of sodium hydroxide to afford 0.936 mol of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt
0.936 mol of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt x 501.22 g/mol = 469.14 g of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt
5- amount of sodium hydroxide left
+ 2.818 mol (original amount)
– 0.936 mol (reacted with sulfuric acid)
– 1.872 mol (reacted with 5,10-methylene (6R)-tetrahydrofolic acid)
= 0.01 mol of sodium hydroxide left
0.01 mol of sodium hydroxide x 40 g/mol = 0.40 g of sodium hydroxide
6- total amount of sodium citrate
968.9 g sodium citrate tri-hydrate / 312.10 g/mol = 3.10 mol of sodium citrate tri-hydrate, which is equivalent to:
3.10 mol of sodium citrate
3.10 mol of sodium citrate x 258.06 g/mol = 799.99 g of sodium citrate
In summary, the solution disclosed by Moser will contain:
Approximately 18,894 g of water (18, 480 g + 210 g + 204 g)
799.99 g sodium citrate
66.47 g sodium sulfate
469.14 g of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt, and
0.40 g of sodium hydroxide
If one assumes that most of the water is removed by lyophilization, then the lyophilized composition will consist of:
799.99 g sodium citrate
66.47 g sodium sulfate
469.14 g of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt, and
0.40 g of sodium hydroxide, and
Water (traces)
TOTAL = 1336.00 g of lyophilized composition
469.14 g of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt / 1336.00 g) x 100 = 35.11 % w/w of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt, which anticipates the weight percentage of claim 16.
For claim 17, Moser teaches that the composition does not contain any further reducing agents or antioxidants. Moser further states that the stabilization of these compositions can be achieved without additional reducing agents (antioxidants) and without the exclusion of atmospheric oxygen (see column 1, lines 27-30).
For claim 18, the molar ratio
5,10-methylene (6R)-tetrahydrofolic acid disodium salt / sodium sulfate is:
(0.936 / 0.468) x 100 = 200 mol %
Which anticipates the instantly claimed range (40 mol % to 200 mol %).
For claim 19, the molar ratio
Sodium citrate / 5,10-methylene (6R)-tetrahydrofolic acid disodium salt is:
(3.10 / 0.936) x 100 = 331 mol %
Which anticipates the instantly claimed range (200 mol % to 400 mol %)
For claim 21, Moser teaches that when it comes to the stability of the original 5,10-methylene (6R)-tetrahydrofolic acid hemisulfate salt, the highest purity is preferable including 100% or greater than 99.5% pure (see column 3, line39 through column 5, line 21; see also column 36, lines 36-39), all this will result in the disodium salt of 5,10-methylene (6R)-tetrahydrofolic acid being 100% pure or at least 99.5% pure.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 20 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moser et. al. (US 10,570,134).
Moser teaches all the limitations of claim 20 (see 102(a)(1) rejection above), except for the concentration of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt of 40% w/w. However, as discussed in the above 102 rejection, Moser teaches a concentration of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt of 35.11 % w/w, which is very close to the percentage of claim 20 (40 % w/w.)
MPEP 2144.05 states: “A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).”
All this will result in the practice of claim 20 with a reasonable expectation of success.
Moser teaches all the limitations of claim 31 (see 102(a)(1) rejection above), except for the concentration of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt of 40% w/w. However, as discussed in the above 102 rejection, Moser teaches a concentration of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt of 35.11 % w/w, which is very close to the percentage of claim 20 (40 % w/w.)
MPEP 2144.05 states: “A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).”
The statement “which is a stable lyophilizate….”seems to describe a property of the obvious compositions. Moser teaches that: “the disclosed formulations are also particularly suitable for producing lyophilization solutions and lyophilizates or dry powders and dry mixtures, since the stable solutions of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt can be used in high concentrations for filing corresponding vessels. The lyophilizates can be stored well, and are stable” (see column 28, last paragraph, right column)
All this will result in the practice of claim 31 with a reasonable expectation of success.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16-21 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moser et. al. (US 10,570,134).
NOTE: for this rejection it is assumed:
that the process of lyophilization removes most of the water present in the original solution is removed, leaving only traces of water, and
that the sodium citrate tri-hydrate of Moser is a sodium citrate di-hydrate.
For claim 16, Moser teaches a water solution consisting of (see column 25, Example 1-5 (a) Lyophilizate for reconstitution to be used for intravenous application):
18,480 g water
1,386 g sodium hydroxide 2M
968.9 g sodium citrate di-hydrate
473.9 g 5,10-methylene (6R)-tetrahydrofolic acid hemisulfate
210 g water
121.8 g sodium hydroxide 2M, and
203.6 g water
The following molecular weights (MW) are being used for the calculations below:
MW 5,10-methylene (6R)-tetrahydrofolic acid disodium salt = 501.22 g/mol
MW 5,10-methylene (6R)-tetrahydrofolic acid = 457.44 g/mol
MW 5,10-methylene (6R)-tetrahydrofolic acid hemisulfate =1,012.95 g/mol
MW sulfuric acid = 98.07 g/mol
MW sodium sulfate = 142.04 g/mol
MW sodium hydroxide = 40.00 g/mol
MW sodium citrate di-hydrate = 294.09 g/mol
MW sodium citrate = 258.06 g/mol
After mixing all these components, sodium hydroxide will react with the 5,10-methylene (6R)-tetrahydrofolic acid hemisulfate to form 5,10-methylene (6R)-tetrahydrofolic acid disodium salt and sodium sulfate with following stoichiometry:
1- Total amount of sodium hydroxide 2M
1,386 g + 121.8 g = 1,507.8 g of sodium hydroxide 2M
The density of a 2M sodium hydroxide is about 1.07 g/ml
So, 1,507.8 g /1.07 g/ml = 1,409.16 ml of 2M sodium hydroxide
1.40916 L x 2 mol/L = 2.818 mol sodium hydroxide
2- total amount of sulfuric acid and 5,10-methylene (6R)-tetrahydrofolic acid
473.9 g 5,10-methylene (6R)-tetrahydrofolic acid hemisulfate / 1,012.95 g/mol = 0.468 mol of 5,10-methylene (6R)-tetrahydrofolic acid hemisulfate, which is equivalent to:
0.468 mol of sulfuric acid, and
0.936 mol of 5,10-methylene (6R)-tetrahydrofolic acid
3- the 0.468 mol of sulfuric acid will react with 0.936 mol of sodium hydroxide to afford 0.468 mol of sodium sulfate
0.468 mol sodium sulfate x 142.04 g/mol = 66.47 g sodium sulfate
4- the 0.936 mol of 5,10-methylene (6R)-tetrahydrofolic acid will react with 1.872 mol of sodium hydroxide to afford 0.936 mol of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt
0.936 mol of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt x 501.22 g/mol = 469.14 g of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt
5- amount of sodium hydroxide left
+ 2.818 mol (original amount)
– 0.936 mol (reacted with sulfuric acid)
– 1.872 mol (reacted with 5,10-methylene (6R)-tetrahydrofolic acid)
= 0.01 mol of sodium hydroxide left
0.01 mol of sodium hydroxide x 40 g/mol = 0.40 g of sodium hydroxide
6- total amount of sodium citrate
968.9 g sodium citrate di-hydrate / 294.09 g/mol = 3.29 mol of sodium citrate di-hydrate, which is equivalent to:
3.29 mol of sodium citrate
3.29 mol of sodium citrate x 258.06 g/mol = 849.01 g of sodium citrate
In summary, the solution disclosed by Moser will contain:
Approximately 18,894 g of water (18, 480 g + 210 g + 204 g)
849.01 g sodium citrate
66.47 g sodium sulfate
469.14 g of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt, and
0.40 g of sodium hydroxide
If one assumes that most of the water is removed by lyophilization, then the lyophilized composition will consist of:
849.01 g sodium citrate
66.47 g sodium sulfate
469.14 g of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt, and
0.40 g of sodium hydroxide, and
Water (traces)
TOTAL = 1385.02 g of lyophilized composition
469.14 g of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt / 1385.02 g) x 100 = 33.87 % w/w of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt, which is very close to the concentration of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt of claim 16 (35%).
MPEP 2144.05 states: “A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).”
All this will result in the practice of claim 16 with a reasonable expectation of success.
For claim 17, Moser teaches that the composition does not contain any further reducing agents or antioxidants. Moser further states that the stabilization of these compositions can be achieved without additional reducing agents (antioxidants) and without the exclusion of atmospheric oxygen (see column 1, lines 27-30).
All this will result in the practice of claim 17 with a reasonable expectation of success.
For claim 18, the molar ratio
5,10-methylene (6R)-tetrahydrofolic acid disodium salt / sodium sulfate is:
(0.936 / 0.468) x 100 = 200 %
Which anticipates the instantly claimed range (40 mol % to 200 mol %).
All this will result in the practice of claim 18 with a reasonable expectation of success.
For claim 19, the molar ratio
Sodium citrate / 5,10-methylene (6R)-tetrahydrofolic acid disodium salt is:
(3.29 / 0.936) x 100 = 351 %
Which anticipates the instantly claimed range (200 mol % to mol 400 %).
For claim 20, as discussed above, Moser teaches a concentration of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt of 33.87 % w/w, which is very close to the concentration of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt of claim 20 (40 % w/w.)
MPEP 2144.05 states: “A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).”
All this will result in the practice of claim 20 with a reasonable expectation of success.
For claim 21, Moser teaches that when it comes to the stability of the original 5,10-methylene (6R)-tetrahydrofolic acid hemisulfate salt, the highest purity is preferable including 100% or greater than 99.5% pure (see column 3, line39 through column 5, line 21; see also column 36, lines 36-39), all this will result in the disodium salt of 5,10-methylene (6R)-tetrahydrofolic acid being 100% pure or at least 99.5% pure.
Moser teaches all the limitations of claim 31, except for the concentration of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt of 40% w/w. However, as discussed above, Moser teaches a concentration of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt of 33.87 % w/w, which is very close to the percentage of claim 20 (40 % w/w.)
MPEP 2144.05 states: “A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).”
The statement “which is a stable lyophilizate….”seems to describe a property of the obvious compositions. Moser teaches that: “the disclosed formulations are also particularly suitable for producing lyophilization solutions and lyophilizates or dry powders and dry mixtures, since the stable solutions of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt can be used in high concentrations for filing corresponding vessels. The lyophilizates can be stored well, and are stable” (see column 28, last paragraph, right column)
All this will result in the practice of claim 31 with a reasonable expectation of success.
Response to Applicant’s arguments related to the above rejections
Examiner’s response:
First, Moser explicitly teaches that the reagent is sodium citrate tri-hydrate, not di-hydrate as Applicant argues.
Second, even assuming arguendo that the correct structure is sodium citrate di-hydrate, the concentration of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt is 33.87 % w/w (see above 103 rejection), which is very close to the instantly claimed 35 % w/w. As such, due to the close proximity it will be expected to have the same or similar properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).”
Third, Applicant argues that the claimed composition shows unexpected properties when the concentration of concentration of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt is above 35 % w/w. However, the specification and the original claims state that “lyophilizates of the present invention contain more than 20% w/w of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt, such as more than 25% w/w, such as more than 30 % w/w, such as more than 35 % w/w or such as about 40 % w/w of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt” (see for example instant specification, page 8, lines 12-15)., which clearly indicates that at all these concentrations the properties are the same or very similar, as such the Moser concentration of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt estimated when the citrate sodium is a di-hydrate (33.87 % w/w) should have the same or similar properties as the instant composition comprising 5,10-methylene (6R)-tetrahydrofolic acid disodium salt at a concentration of 20 % w/w or 25 % w/w or 30 % w/w/ or 35 % w/w or 40 % w/w.
Fourth, the title of Moser reference is: “Stable formulations of 5,10-methylene (6R)-tetrahydrofolic acid”, and the entire reference emphasizes about the stability of the formulations, clearly indicating that the formulations disclosed by Moser are as stable as the instant ones. For example: Moser teaches that: “the disclosed formulations are also particularly suitable for producing lyophilization solutions and lyophilizates or dry powders and dry mixtures, since the stable solutions of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt can be used in high concentrations for filing corresponding vessels. The lyophilizates can be stored well, and are stable” (see column 28, last paragraph, right column)
Fifth if Applicant still believes that there is something unexpected when the concentration of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt is above 35 % w/w, that does not occur at the concentration disclosed by Moser (33.87 % w/w), then Applicant should provide experimental data showing side by side the properties of the instant composition (concentration of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt more than 35 % w/w) vs. the prior art (concentration of 5,10-methylene (6R)-tetrahydrofolic acid disodium salt 33.87 % w/w) and show the observed differences.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached on Flexing M-F 7 AM-7 PM.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
September 2, 2026.
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