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 . Claims 1-4 and 6-10 filed February 04, 2025 are currently pending.
Priority
Acknowledgment is made of the national stage entry of PCT/US2023/010727 filed 01/13/2023 which claims priority to U.S. Provisional Application 63299610 filed 01/14/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/10/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112-Paragraph B
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 1-4 and 6-10 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 1 recites the broad recitation D-alpha tocopherol and at least one or more of D-beta tocopherol, D-gamma tocopherol and D-delta tocopherol. Given the broadest reasonable interpretation, said phrase encompasses a combination of D-alpha tocopherol and D-beta tocopherol, or alternatively D-alpha tocopherol and D-gamma tocopherol, or in the third alternative D-alpha tocopherol and D-delta tocopherol, or in the fourth alternative D-alpha tocopherol, D-beta tocopherol and D-gamma tocopherol, or in the fifth alternative, D-alpha tocopherol, D-gamma tocopherol and D-delta tocopherol and so on.
Additionally, the claim also recites “the combined D-alpha tocopherol, D-beta tocopherol, D-gamma tocopherol and D-delta tocopherol” which is the narrower statement of the range/limitation as it requires all four tocopherols. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Accordingly, one of ordinary skill in the art prior to the time of the invention would not have been reasonably apprised of the metes and bounds of the subject matter for which Applicant is presently seeking protection. To overcome the rejection, Applicant is invited to amend the phrase “the combined D-alpha tocopherol, D-beta tocopherol, D-gamma tocopherol and D-delta tocopherol” to “the tocopherol blend comprising D-alpha tocopherol and one or more of D-beta tocopherol, D-gamma tocopherol and D-delta tocopherol”. This language is also found in claims 8-9.
Claims 2-4 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.
Claim 2 recites the limitation "“the glycol is 80.00-99.999% of the total weight of the glycol composition ". There is insufficient antecedent basis for the phrase “the glycol” as the claim from which it depends (claim 1) recites a specific glycol “a polyethylene glycol” as well as the phrase “a glycol composition”. The claim is unclear as to the meets and bounds of which glycol the phrase “the glycol” is referring to.
Accordingly, one of ordinary skill in the art prior to the time of the invention would not have been reasonably apprised of the metes and bounds of the subject matter for which Applicant is presently seeking protection. To overcome the rejection, Applicant is invited to amend the phrase “the glycol” to “the polyethylene glycol”.
Claim Rejections - 35 USC § 112-Paragraph D
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3-4 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 is directed to a glycol composition, comprising: a polyethylene glycol; and a tocopherol blend comprising D-alpha tocopherol and one or more of D-beta tocopherol, D-gamma tocopherol and D-delta tocopherol, wherein the D-alpha tocopherol is less than 50 %wt. of the combined D-alpha tocopherol, D-beta tocopherol, D-gamma tocopherol and D-delta tocopherol.
Claims 3-4 broaden the scope of the glycol of claim 1 from a distinct alkylene oxide glycol “a polyethylene glycol” to any polyalkylene oxide having a molecular weight of 400 g/mol to 10,000,000 g/mol, or 2000 g/mol to 5000 g/mol as measured according to gel permeation chromatography. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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) 1, 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bhagwat (US2003/0165577 published 09/04/2003).
Claim interpretation is as follows: Claim 1 is directed to a glycol composition, comprising: a polyethylene glycol; and a tocopherol blend comprising D-alpha tocopherol and one or more of D-beta tocopherol, D-gamma tocopherol and D-delta tocopherol, wherein the D-alpha tocopherol is less than 50 %wt. of the combined D-alpha tocopherol, D-beta tocopherol, D-gamma tocopherol and D-delta tocopherol.
As recited in MPEP 2111.03, the transitional term “comprising” is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). In the present case, claim 1 does not exclude additional unrecited elements, including additional pharmaceutical excipients.
Bhagwat teaches pharmaceutical compositions comprising 3% wt. gamma tocopherol, 1% wt. alpha tocopherol and 2.80 %wt. PEG-100 ([0107], [0118])]. Bhagwat teaches employing Cov-ox T70 which comprises 70% mixed tocopherols which about 60% are D-gamma-tocopherol and 14% are D-alpha tocopherol ([0038]-[0046]). Bhagwat teaches formulating said gamma-tocopherol with alpha-tocopherol and PEG-100 into a tank and mixing until homogenous ([0107], [0118]).
Regarding claims 8-9, the D-alpha tocopherol component of the glycol composition is 25% wt. of the combined D-alpha tocopherol and one or more of D-beta tocopherol, D-gamma tocopherol and D-delta tocopherol (1%wt:3%wt. ratio of D-alpha tocopherol to D-gamma tocopherol).
Regarding claim 10, Bhagwat teaches combining the composition containing PEG-100, D-alpha tocopherol and D-gamma tocopherol to a tank containing water ([0118]-[0119]). The resulting combination of PEG-100, D-alpha tocopherol and D-gamma tocopherol to the tank comprising water results in a composition comprising water and 0.1-99% wt. of the aforementioned glycol composition, which reads on the presently claimed formulation.
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 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.
Claim(s) 1-4 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Haupts (U.S. Patent 9,579,285 published 02/28/2017) and Gupta (U.S. Patent 5,695,689 published 12/09/1997).
Haupts teaches formulating a composition comprising polyethylene glycol and D-alpha tocopherol. Haupt teaches it is suitable to incorporate an additional pharmaceutically acceptable excipient into the PEG and D-alpha tocopherol composition, including antioxidants and preservatives (col. 4 lines 55 to col. 5 line 5; col. 5 lines 30-45).
Regarding claims 2-3, PEG 6000 (98.8%) was melted in a beaker at 70°C and D-alpha tocopherol (1.2% wt.) was added to the melt and mixed until a homogenous melt was formed (col. 20 lines 20-45). Said composition was allowed to congeal in an extruder and exit the extruder in the form of a powder (col. 3 lines 50-65; col. 20 lines 20-45). Regarding claims 6-7, Haupts teaches that the polyalkylene glycol: alpha tocopherol range may be adjusted up to 1000:1 (co. 17 lines 50-60).
The difference between the presently claimed glycol composition and the glycol composition of Haupts is that Haupts does not specifically teach wherein the composition further contains one or more of D-beta tocopherol, D-gamma tocopherol and D-delta tocopherol, wherein the D-alpha tocopherol is less than 50% wt. of the combined D-alpha tocopherol, D-beta tocopherol, D-gamma tocopherol and D-delta tocopherol.
Gupta (U.S. Patent 5,695,689 published 12/09/1997) teaches alpha and beta-tocopherol are used to stabilize polyether polyols comprising a molecular weight of 300-10,000 (abstract, col. 1 lines 5-10, col. 1 lines 60 to col. 2 line 20). Gupta teaches suitable polyether polyols that are stabilized with tocopherol include di-functional polyols and that the tocopherol is present in 0.01 % wt. to 1% wt. of the composition (col. 2 lines 1-30; Example 1).
Therefore, one of ordinary skill in the art of preparing glycol compositions comprising the polyethylene glycol PEG 6000 and D-alpha tocopherol, wherein PEG 6000 is present in 98.8 %wt. of the composition and D-alpha tocopherol is present in 1.2 %wt. of the composition as taught by Haupts, said artisan would have found it prima facie obvious to reduce the amount of D-alpha tocopherol in the composition and incorporate the stabilizer D-beta tocopherol to the tocopherol stabilizing component of the composition in view of Gupta, arriving at the presently claimed composition.
MPEP 2143 provides rationale for a conclusion of obvious including (A): Combining prior art elements according to known methods to obtain predictable results;
In the present case, Gupta teaches that beta-tocopherol and alpha tocopherol are each suitable preservatives to stabilize polyether polyols comprising a molecular weight of 300-10,000. Accordingly, said artisan would have readily predicted that the addition of D-beta-tocopherol to the glycol composition of Haupts would have stabilized the polyether polyol polyethylene glycol in the composition.
Regarding the limitation wherein the D-alpha tocopherol is less than 50 %wt. of the combined D-alpha tocopherol, D-beta tocopherol, D-gamma tocopherol and D-delta tocopherol, or wherein the D-alpha tocopherol is 0-40% wt. of the combined D-alpha tocopherol, D-beta tocopherol, D-gamma tocopherol and D-delta tocopherol component of the glycol composition, it is considered well within the capabilities of one of ordinary skill in the art to optimize the amounts of D-alpha tocopherol and D-beta tocopherol in the glycol composition to provide optimal stability of the polyol.. The amounts of D-alpha tocopherol and D-beta tocopherol in the glycol composition are each a result effective parameter that will affect the physical properties of the final composition. Said amounts of D-alpha tocopherol and D-beta tocopherol in the glycol composition are clearly a results effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the combination of Haupt and Gupta provide a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the amounts of D-alpha tocopherol and D-beta tocopherol in the glycol composition to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Secondly, regarding the limitation of claim 4, wherein the glycol is a polyalkylene oxide having a weight average molecular weight of 2,000 g/mol to 5,000 g/mol, said artisan would have found it prima facie obvious to substitute the polyethylene glycol PEG-6000 in the glycol composition of Haupt and Gupta, for a polyethylene glycol with an average molecular weight of 2,000 g/mol to 5,000 g/mol.
MPEP 2143 provides rationale for a conclusion of obviousness including (B): Simple substitution of one known element for another to obtain predictable results;
In the present case, Gupta teaches alpha and beta-tocopherol are used to stabilize polyether polyols comprising a molecular weight of 300-10,000. As such, said artisan would have readily predicted that the D-alpha tocopherol and D-beta tocopherol in the glycol composition would have stabilized a polyethylene glycol with an average molecular weight of 2,000 g/mol to 5,000 g/mol.
Thirdly, regarding the limitation of claim 6, the combination of Haupt and Gupta teach that tocopherol is present in 0.01 % wt. of the composition is sufficient to stabilize the polyether polyols comprising a molecular weight of 300-10,000. (Gupta: col. 2 lines 1-30). Applicant is further reminded of MPEP 2144.05 wherein “[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. Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. 2004). The patent claim at issue was directed to a weight plate having 3 elongated openings that served as handles for transporting the weight plate. Multiple prior art patents each disclosed weight plates having 1, 2 or 4 elongated openings. 392 F.3d at 1319, 73 USPQ2d at 1226. The court stated that the claimed weight plate having 3 elongated openings fell within the "range" of the prior art and was thus presumed obvious. 392 F.3d at 1322, 73 USPQ2d at 1228. The court stated that the "range" disclosed in multiple prior art patents is "a distinction without a difference" from previous range cases which involved a range disclosed in a single patent since the "prior art suggested that a larger number of elongated grips in the weight plates was beneficial... thus plainly suggesting that one skilled in the art look to the range appearing in the prior art." The court further stated that “[Nonetheless, where there is a range disclosed in the prior art, and the claimed invention falls within that range, there is a presumption of obviousness. But the presumption will be rebutted if it can be shown: (1) That the prior art taught away from the claimed invention, In re Geisler, 116 F.3d 1465, 1471 [43 USPQ2d 13621 (Fed. Cir. 1997); or (2) that there are new and unexpected results relative to the prior art, In re Woodruff, 919 F.2d 1575, 1578 M6 USPQ2d 19341 (Fed. Cir. 1990).
In the instant case, there is no teaching away of incorporating 0.01% wt. or less of tocopherol blend based on the total weight of the glycol composition. Rather, as disclosed by the combination Haupt and Gupta, tocopherol is present in 0.01 % wt. of polyol the composition is sufficient to stabilize the polyether polyols comprising a molecular weight of 300-10,000. (Gupta: col. 2 lines 1-30). Secondly, there are no unexpected results demonstrating the criticality of the claimed percent weights of tocopherol blend in the glycol composition.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Haupts (U.S. Patent 9,579,285 published 02/28/2017) and Gupta (U.S. Patent 5,695,689 published 12/09/1997) as applied to claims 1-4 and 6-9 above in view of Bhagwat (US2003/0165577 published 09/04/2003).
As disclosed above, the combination of Haupts and Gupta render obvious a composition comprising the polyethylene glycol PEG 6000 in 98.8 %wt. and a combination of D-alpha tocopherol and D-beta tocopherol in 1.2% wt. of the composition, as it was known in the prior art that beta-tocopherol and alpha tocopherol are each suitable preservatives to stabilize polyether polyols comprising a molecular weight of 300-10,000.
The difference between the polyethylene glycol composition of Haupt and Gupta and that of the present claims is that the combined teachings of Haupt and Gupta do not specifically teach wherein said glycol composition is added to water to make a formulation comprising water and 0.1-99% of the glycol composition.
Bhagwat (US2003/0165577 published 09/04/2003) teaches pharmaceutical compositions comprising mixed tocopherols, PEG and water. Bhagwat teaches said pharmaceutical composition comprising 3% wt. gamma tocopherol, 1% wt. alpha tocopherol and 2.80 %wt. PEG (PEG-100) ([0038]-[0046], [0107], [0118])]. Bhagwat teaches formulating said gamma-tocopherol with alpha-tocopherol and PEG-100 into a tank and mixing until homogenous ([0107], [0118]). Bhagwat teaches combining the composition containing PEG-100, D-alpha tocopherol and D-gamma tocopherol to a tank containing water ([0118]-[0119]).
Therefore, one of ordinary skill in the art prior to the time of the invention would have found it prima facie obvious to incorporate the composition comprising the polyethylene glycol PEG 6000 in 98.8 %wt. and a combination of D-alpha tocopherol and D-beta tocopherol in 1.2% wt. of the composition to water to arrive at the presently claimed formulation in view of Bhagwat.
MPEP 2143 provides rationale for a conclusion of obviousness including (A): Combining prior art elements according to known methods to obtain predictable results;
In the present case, it was known in the prior art of Bhagwat to formulate compositions comprising mixed tocopherols and polyethylene glycol with water in order to arrive at a pharmaceutically acceptable carrier. Consistent with this reasoning, it would have been obvious to have selected the formulating of mixed tocopherols and polyethylene glycol with water techniques from within the prior art Bhagwat above and apply it to the mixed tocopherol and polyethylene glycol composition of Haupt and Gupta, arriving at the claimed composition “yielding no more than one would expect from such an arrangement”.
Regarding the limitation wherein the composition comprising polyethylene glycol and mixed D-alpha tocopherol and D-beta tocopherol is present in 0.1-99% wt. of the formulation, it is considered well within the capabilities of one of ordinary skill in the art to optimize the amounts of PEG 6000, D-alpha tocopherol and D-beta tocopherol in formulation to provide optimal stabilizing properties. The amounts of PEG 6000, D-alpha tocopherol and D-beta tocopherol in the formulation is a result effective parameter that will affect the physical properties of the final composition. Said amounts of PEG 6000, D-alpha tocopherol and D-beta tocopherol in the formulation are clearly a results effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the combination of Haupt, Gupta and Bhagwat provide a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the amounts of PEG 6000, D-alpha tocopherol and D-beta tocopherol in the formulation to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Conclusion
In view of the rejections set forth above, no claim is allowed.
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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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