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 .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a liquid pharmaceutical composition, and the following species:
Solvent: citrate buffer;
Preservative: the combination of methyl parahydroxybenzoate and ethyl parahydroxybenzoate;
Solubilizer: super-refined PEG400; and
Flavoring agent: cherry flavor
in the reply filed on July 2, 2026 is acknowledged.
Claims 22, 32, 34-36 and 40-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 2, 2026.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on July 2, 2026, wherein claims 1-4, 7, 11, 18 and 21 are amended; claims 5-6, 8-10, 12-17, 19-20, 23-31 and 33 are canceled; and claims 37-44 are newly added.
Claims 1-4, 7, 11, 18, 21-22, 32 and 34-44 are pending.
Claims 22, 32, 34-36 and 40-44 are withdrawn.
Claims 1-4, 7, 11, 18, 21 and 37-39 are under examination in accordance with the elected species.
Priority
The instant application 18/293,274 filed on January 29, 2024 is a 371 of PCT/US2022/033283 filed on June 13, 2022, which claims priority to, and the benefits of U.S. Provisional Application No. 63/227,778 filed on July 30, 2021.
Response to Amendment
Acknowledgement is made of the receipt and entry of the amendment to the specification filed on July 17, 2024.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/29/2024 and 7/2/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
The use of the terms “super-refined PEG400” (see e.g., [0019]), “PEG 400 Super refined” (see e.g., Table 27), “Kollisolv G 99” (see e.g., Table 27), which are trade names or marks used in commerce, have been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. While the Examiner has made every attempt to check the specification for trade name or mark compliance, Applicant is required to carefully check the entire specification for any and all issues regarding trade name or mark.
Appropriate correction is required.
Claim Objections
Claims 1, 3, 7, 21, and 39 are objected to because of the following informalities:
Regarding claim 1, the recitation of “[a] liquid pharmaceutical composition comprising” is missing a comma between the term “composition” and “comprising”.
Regarding claim 21, “preservative” in the phrase of “in amount of preservative” appears to be missing an definite article -the- proceeding the noun, and should read – the preservative –, such that it is referring back to the very same preservative previously set forth in claim 1.
Regarding claims 1, 3, 7 and 39, the claim repeatedly recites “comprises”, and it is not being consistent throughout the claims, and should read –comprising—for the sake of consistency.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 21 and 39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 21,
the term “substantial” in the phrases of “no substantial increase”, “no substantial change” is a relative term which renders the claim indefinite. The term “substantial” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In the present case, the claim and the specification do not clearly set forth what is considered to be substantial and non-substantial.
the term “related” in the phrase of “related degradation products” is a relative term which renders the claim indefinite. The term “related” and “related degradation products” is not defined by the claim nor the specification. It is not clear what is considered to be a related or unrelated degradation products. The specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claims 7 and 39, the “super-refined PEG400” instantly claimed contains the trademark/trade name “Super Refined”, see American Pharmaceutical Review (“Super Refined™ PEG 400 from Croda” [Online], Published online on August 3, 2020). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe “PEG400” or Polyethylene Glycol 400. The instant specification does not define what makes the PEG 400 “super-refined” nor does it explain what characteristics distinguish it from conventional PEG 400, thus, one cannot determine the scope of “super-refined PEG400” and the identification/description is indefinite. The applicant should recite the actual compositional or purity characteristics, if those characteristics are relied upon, rather than proprietary trade name. In order to advance prosecution, the claimed “super-refined PEG400” is given its broadest reasonable interpretation to refer to PEG 400.
Further regarding claim 39,
the recitation of “the liquid pharmaceutical composition comprises clemizole HCl, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, super-refined PEG400, glycerol, a flavoring agent, sucralose, and pH 4.5 citrate buffer” can lead to various interpretations, because it is not clear if the “clemizole HCl”, “methyl parahydroxybenzoate”, “ethyl parahydroxybenzoate”, “glycerol” and “pH 4.5 citrate buffer” recites therein is (i) referring back to the very same clemizole HCl, preservative (methyl parahydroxybenzoate and ethyl parahydroxybenzoate), glycerol, and solvent (citrate buffer) set forth in claim 1, or is (ii) referring that the liquid pharmaceutical composition further includes another clemizole HCl, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, super-refined PEG400, glycerol, a flavoring agent, sucralose, and pH 4.5 citrate buffer in addition to the ingredient(s) set forth in claim 1, for instance, the liquid pharmaceutical composition now contains methyl parahydroxybenzoate and ethyl parahydroxybenzoate in addition to a preservative comprising at least one of potassium sorbate, sodium methyl parahydroxybenzoate, sodium ethyl parahydroxybenzoate, methyl parahydroxybenzoate, or ethyl parahydroxybenzoate. The metes and bounds of the liquid pharmaceutical composition is indefinite, because one cannot reasonably determine which interpretation applies. In order to advance prosecution, the Examiner is examining the claim in view of the elected species to the extent that the liquid pharmaceutical composition comprising the clemizole HCl, methyl parahydroxybenzoate and ethyl parahydroxybenzoate as the preservative, super-refined PEG400 as a solubilizer, the glycerol, a flavoring agent, sucralose, and pH 4.5 citrate buffer as the solvent.
the recitation of “PH 4.5 citrate buffer” is ambiguous, because it is not clear if applicant is intending to claim (i) a citrate buffer prepared at pH of 4.5 or (ii) a citrate buffer is used to product a liquid pharmaceutical composition having a pH of 4.5. The metes and bounds of the liquid pharmaceutical composition is indefinite, because one cannot reasonably determine which interpretation applies. In order to advance prosecution, the Examiner is examining the claim to the extent that the citrate buffer is prepared at pH 4.5.
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.
Claims 1-4, 7, 11, 18, 21 and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Frodsham et al. (US 2017/0312281 A1), in view of Sawa (), Baraban et al. (US 2020/0323825 A1), Gutsche et al. (Drug Dev Ind Pharm. 2008 Dec;34(12):1277-84) and Cohen et al. (US 10,300,015 B2), as evidenced by Makris et al. (The Evidence So Far. Molecules., 2020. Vol. 25(24): 5842).
Frodsham et al. teaches methotrexate is almost insoluble in water, alcohol, chloroform and ether (see e.g., [0006]); and liquid compositions comprising the free acid of methotrexate and a buffer, wherein the pH is in the range of 6.5 to 8.2, overcomes the solubility and stability issues previously reported for methotrexate liquid formulation, and exemplified four oral liquid formulations shown below:
PNG
media_image1.png
412
529
media_image1.png
Greyscale
(see e.g., [0049]), wherein Formulation 1 uses 0.05 M sodium citrate buffer to give a pH of 6.8 (see e.g., [0051]). Frodsham et al. further teaches sodium citrate buffer is a citrate buffer comprising tri-sodium citrate, citric acid, and purified water; and various buffers may be used to prepare the pharmaceutical composition, including citrate buffers (see e.g., [0028]). Frodsham et al. further teaches it is common practice in drug development, and in the reformulation of known drugs, to use salt versions of a drug; this is because drug salts are known to have preferential properties, including improved stability, solubility and improved processability; and therefore, in the development of stable formulations, salts are generally preferred (see e.g., [0013]). Frodsham et al. further teaches pH and buffer concentration also impact the stability and solubility of pharmaceutically acceptable excipients, such as preservatives, that are present in the final formulation; therefore, the final pH of the final product, as well as being key to the stability and solubility of the active ingredient, must also be carefully chosen so as not to negatively impact the stability and efficacy of the preservatives; parabens have been reported to have an effective pH range of 4 to 8, and have been shown to work more effectively in combinations (see e.g., [0014]). Frodsham et al. further teaches all formulations according to the present invention, following storage at 25 °C and 40 °C for three months, showed no change in appearance or pH (see e.g., [0056]).
Frodsham et al. does not teach clemizole HCl. Frodsham et al. also does not teach the pH ranges from 4 to 5.
Sawa teaches examples of hardly soluble drugs include antiallergics, e.g., clemizole; and antitumor drugs, e.g., methotrexate (see e.g., [0046]).
Baraban et al. teaches a pharmaceutical composition that includes clemizole, a clemizole analog, or a pharmaceutically acceptable salt thereof for use in treating an epilepsy disorder (see e.g., [0006]); and the pharmaceutically acceptable salt of clemizole in the pharmaceutical composition may be clemizole HCI (see e.g., [0074]). Baraban et al. further teaches salts tend to be more soluble in aqueous or other protonic solvents that are the corresponding free base forms (see e.g., [0097]). Baraban et al. further teaches when clemizole or a clemizole analog contain relatively basic functionalities, acid addition salts can be obtained by contacting the neutral form of such compounds with a sufficient amount of the desired acid, either neat or in a suitable inert solvent; and examples of pharmaceutically acceptable acid addition salts includes those derived from inorganic acids like hydrochloric (see e.g., [0020]). Baraben et al. further teaches oral preparations include, inter alia, liquids (see e.g., [0046]).
Gutsche et al. teaches many drugs are weak bases or salts thereof, which demonstrate pH-dependent solubility with good solubility at lower pH but poor solubility at higher pH (see e.g., p. 1277, left column, “Introduction”, line 1-3). Gutsche et al. further teaches weakly basic drugs demonstrate higher solubility at lower pH, thus often leading to faster drug release at lower pH (see e.g., abstract).
Cohen et al. teaches a citrate buffer having a pH comprised between 4 and 7, preferably between 4.5 and 5.5 (see e.g., Col. 3, line 19-20). Cohen et al. further teaches the experimental results show that acetate or citrate buffers, as compared to other buffers (e.g., phosphate) confer high stability and no or low contamination (see e.g., Col. 6, line 41-43).
In the present case, the Formulation 1 of Frodsham et al. is a liquid pharmaceutical composition comprising methyl parahydroxybenzoate, ethyl parahydroxybenzoate, glycerol, citrate buffer, sucralose, and orange flavoring agent. The difference between the Formulation 1 of Frodsham et al. and the claimed invention is that the prior art formulation contains methotrexate free acid rather than clemizole HCI as the poorly soluble active ingredient, and the prior art formulation has a pH value of 6.8 rather than in the pH range of 4 to 5 instantly claimed. Accordingly, both methotrexate and clemizole are merely representative poorly soluble drugs, and that the references collectively teach a formulation strategy applicable to poorly soluble actives generally. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by selecting the Formulation 1 of Frodsham et al., and then modifying said formulation by replacing the free acid of methotrexate with clemizole HCI of Baraban et al. as the poorly soluble active ingredient, and then adjusting the pH of said formulation by optimizing the pH of citrate buffer through routine experimentation. One would have been motivated to do so, because Frodsham et al. teaches the liquid composition comprising a citrate buffer overcomes the solubility and stability issues; Sawa teaches clemizole is hardly soluble, and Baraban et al. teaches clemizole HCI, a salt of clemizole, tend to be more soluble than the free base form; Gutsche et al. teaches weakly basic drug demonstrates higher solubility at lower pH; and Cohen et al. teaches citrate buffer has a pH range between 4 and 7, preferably between 4.5 and 5.5. One of ordinary skill in the art would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the pH of the formulation is a recognized known result-effective variable to improve stability and solubility of the active ingredient; and therefore, one would have reasonably expected that by adjusting the citrate buffer to a lower pH, including 4.5, would successfully improve the solubility of the substituted hardly soluble, basic drug (i.e., clemizole HCl) in the liquid pharmaceutical composition, and that would successfully lower the pH of the formulation, including the claimed pH, and that renders obvious the pH of the liquid pharmaceutical composition (“from 4 to 5”) and the pH of citrate buffer (“pH 4.5 citrate buffer”) as claimed in claims 1 and 38. Furthermore, one of ordinary skill in the art would have recognized clemizole HCl as a suitable substitute for methotrexate in the formulation strategy taught by Frodsham.
Regarding “further comprising a solubilizer, wherein the solubilizer comprises at least one of… super-refined PEG 400” in claim 7, the claimed term “super-refined PEG 400”, given its broadest reasonable interpretation, is direct to PEG 400; therefore, the fact that the Formulation 1 of Frodsham et al. contains PEG 400 as the polyethylene glycol, the PEG 400 within the modified Formula 1 of Frodsham et al. set forth above renders obvious the “super-refined PEG400”.
Regarding the limitation of “wherein the glycerol is at a concentration of 10 - 30% (wt/wt) and the citrate buffer is at a concentration of 90 - 70% (wt/wt)” in claim 2, in the present case, Frodsham et al. expresses the formulation 1 in the unit of mg/ml (w/v), whereas instant claim 2 recites weight-by-weight percentage(s). Although the prior art does not expressly disclose the claimed weight-by-weight percentage(s), converting between concentration format (e.g., w/v and w/w) or determine the corresponding w/w percentage based on the density of the formulation would have been routine mathematical conversion within the ordinary skill of a pharmaceutical formulator. The prior art discloses the identity and relative amounts of the formulation components, and a person of ordinary skill in the art would have routinely determined the corresponding w/w percentages when preparing or optimizing the formulation set forth above. Therefore, expressing the composition in terms of w/w percentages would have been an obvious matter or routine optimization and does not patentably distinguish the claimed composition. For instance, Formulation 1 of Frodsham et al. contains 50-200 mg/mL of glycerol, and said glycerol has a density of 1.261 g/mL as evidenced by Makris et al., which when calculated by:
50
m
g
1
m
L
×
1
g
1000
m
g
×
m
L
1.261
g
×
100
=
3.96
w
/
w
%
200
m
g
1
m
L
×
1
g
1000
m
g
×
m
L
1.261
g
×
100
=
15.86
w
/
w
%
, gives 3.96 – 15.86 % (wt/wt) of glycerol. In addition, Formulation 1 of Frodsham et al. contains sodium citrate buffer that is sufficient to bring the final volume to 1 mL; therefore, the weight-by-weight percentage of sodium citrate buffer can be back-calculated by subtracting the weight-by-weight percentage of each and every ingredient from the total weight-by-weight percentage (i.e., 100 w/w %), for example, subtracting the (w/w) % of glycerol calculated above from the total weight-by-weight percentage shown below:
100
%
t
o
t
a
l
-
3.96
%
g
l
y
c
e
r
o
l
=
96.04
%
100
%
t
o
t
a
l
-
15.86
%
g
l
y
c
e
r
o
l
=
84.14
%
, gives at most 84.14 – 96.04 (wt/wt) % of citrate buffer.
Regarding “wherein the preservative is at a concentration of 0.01-0.5% (w/v)” in claim 4, Frodsham et al. expresses the quantity of methyl parahydroxybenzoate and ethyl parahydroxybenzoate in Formulation 1 in the unit of mg/ml, whereas instant claim 4 recites weight-by-volume percentage(s). Although the prior art does not expressly disclose the claimed weight-by-volume percentage(s), converting between concentration format (e.g., mg/ml and w/v %) would have been routine calculation within the ordinary skill of a pharmaceutical formulator. The prior art discloses the identity and relative amounts of methyl parahydroxybenzoate and ethyl parahydroxybenzoate, and a person of ordinary skill in the art would have routinely determined the corresponding w/v percentages when preparing or optimizing the formulation set forth above. Therefore, expressing the composition in terms of w/v percentages would have been an obvious matter or routine optimization and does not patentably distinguish the claimed composition. For example, 0.1-0.5 mg/mL of methyl parahydroxybenzoate, which when calculated by:
0.1
m
g
1
m
L
×
1
g
1000
m
g
×
100
=
0.01
%
(
w
/
v
)
0.2
m
g
1
m
L
×
1
g
1000
m
g
×
100
=
0.02
%
(
w
/
v
)
, gives 0.01-0.02% (w/v) of methyl parahydroxybenzoate; and 1-5 mg/mL of ethyl parahydroxybenzoate, which when calculated by:
1
m
g
1
m
L
×
1
g
1000
m
g
×
100
=
0.1
%
(
w
/
v
)
5
m
g
1
m
L
×
1
g
1000
m
g
×
100
=
0.5
%
(
w
/
v
)
, gives 0.1-0.5% (w/v) of ethyl parahydroxybenzoate. In other words, methyl parahydroxybenzoate and ethyl parahydroxybenzoate together gives a total of 0.11 to 0.52 % (w/v).
Regarding “wherein the clemizole HCl is at a concentration of 1 mg/ml – 30 mg/mL in the liquid pharmaceutical composition” in claim 18, and “wherein the clemizole HCl is at a concentration of 5 mg/mL” in claim 37, according to MPEP 2144.05, I, “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”. Applying same logic to instant product claim, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to selectively choose to incorporate the clemizole HCl of Baraban et al. at 0.4-20 mg/mL in the modified formulation 1 set forth above, because Frodsham et al. teaches the active ingredient, the free acid of methotrexate, is at a quantity of 0.4-20 mg/mL in Formulation 1 to arrive at a liquid composition. One would have a reasonable expectation of success to arrive at the claimed invention that includes the claimed concentration, because one would have reasonably expected that by incorporating clemizole HCl at the same amount as the free acid of methotrexate taught by Frodsham et al. in the modified formulation set forth above would have successfully arrive at a liquid composition.
Regarding “wherein the liquid pharmaceutical composition is stable over time, as determined by: (i)…., following 36 months of storage at … 25 °C or 40 °C” in claim 21, in the present case, Frodsham demonstrates stability of substantially the same formulation over three months. Extending storage time represents optimization of a known property of an otherwise obvious pharmaceutical composition. In the absence of persuasive evidence demonstrating criticality of the recited thirty-six-months limitation, the claimed stability would have been an inherent or reasonably expected property of the obvious composition, or at least an obvious property to optimize through routine stability testing.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Claims 1-4, 7, 11, 18, 21 and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Frodsham et al. (US 2017/0312281 A1), in view of Frodsham et al. (US 11,129,833 B2), in view of Sawa (US 2003/0195179 A1), Baraban et al. (US 2020/0323825 A1), Gutsche et al. (Drug Dev Ind Pharm. 2008 Dec;34(12):1277-84) and Cohen et al. (US 10,300,015 B2) as applied to claims 1-4, 7, 11, 18, 21 and 37-39 above, and further in view of Dries et al. (US 2006/0270611 A1).
To the extent that the flavoring agent is the elected flavoring agent (i.e., “a cherry flavor”), then the following rejection applies.
The teachings of Frodsham et al., Frodsham et al., Sawa, Baraban et al., Gutsche et al., and Cohen et al. are set forth above and applies as before.
Frodsham et al., Frodsham et al., Sawa, Baraban et al., Gutsche et al., and Cohen et al. does not teach a cherry flavor as claimed in claim 38.
Dries et al. teaches suitable flavors include fruit flavors, such as cherry (see e.g., [0047]). Dries et al. further teaches sweetener(s) and/or flavor(s) may be added to the composition in order to increase the palatability of the liquid composition upon reconstitution with an aqueous medium (see e.g., [0045]).
In the present case, the difference between the modified Formulation 1 set forth above and the claimed invention is that the prior art formulation contains orange flavor rather than the cherry flavor instantly claimed. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to further modify the modified Formulation 1 set forth above by substituting one flavor for another, in this case, substituting the orange flavor with cherry flavor, because Dries et al. teaches cherry is a suitable fruit flavor that can be added to a liquid composition to improve palatability. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the substituted cherry flavor would have successfully add fruit flavor to the liquid composition to improve palatability.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Conclusion
No claims are allowed.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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