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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/19/2025, has been entered.
Withdrawn Rejections:
The rejection of claims 1-4 and 6:
1) under 35 U.S.C. 103 as being unpatentable over Bharadwaj of record (Oncotarget, 2016) in view of: 1) Minus of record (Org. & Biomol Chem., 2020, 18, 3288-3296); 2) Tweardy of record (WO2019204427A1); and 3) Basak of record (Advanced Drug Delivery Reviews, 2007, 59, 64-72); and
2) on the ground of nonstatutory double patenting as being unpatentable over claims of: a) U.S. Patent Nos: 1) 11,547.683; 2) 11,077,077; 3) 11,547,683; 4) 11,161,831; 5) 12,053,444; and 6) 12,043,640; and b) U.S. Patent Application Nos: 1) 17/781,349; 2) 18/842,626; and 3) 18/842,628, in view of: 1) Minus of record (Org. & Biomol Chem); and 2) Basak of record (Advanced Drug Delivery Reviews, 2007),
is overcome by the Applicants’ amendments and is hereby withdrawn. Specifically, Applicants amended claim 1 to newly introduced the limitation of a composition comprising a compound of formula (I), a compound of formula (II) and a compound of formula (IV).
Status of the Claims
Claims 1-4 and 6-19 are pending.
Applicants’ arguments filed on 09/19/2025, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicants’ amendments, filed on 09/19/2025, have each been entered into the record. Applicants have amended claims 1-4. Claims 7-19 remain withdrawn from further consideration by the Examiner, pursuant to 37 CFR 1.142(b), as being drawn to non-elected invention. Therefore, claims 1-4 and 6 are the subject of the Office action below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/19/2025, were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS documents were considered. A signed copy of Form PTO-1449 is enclosed herewith.
Claim Rejections - 35 USC § 112-2nd Paragraph
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 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. Claims 2-4 and 6 depend from the rejected claim 1 and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth below.
Claim 1 recites “less than about 1%”, which is indefinite and contradictory because the limitation of “about 1%” normally means for example, 1% ± 0.2, etc. (see, e.g., ¶ 00035 of the specification). The limitation of “less than” removes any lower limit below 1%. Appropriate correction is required.
Each of claims 2-4 recites: “less than about 0.5%” (claim 2); “less than about 0.1%”, (claim 3); and “less than about 0.05%” (claim 4). Claims 2-4 are similarly rejected as in claim 1 above. Appropriate correction is required.
Claim Rejections - 35 USC § 103
New Grounds of Rejection, Necessitated by Applicant’s Amendments
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 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Bharadwaj of record (Oncotarget, 2016) in view of: 1) Minus of record (Org. & Biomol Chem., 2020, 18, 3288-3296); 2) Fu et al (hereinafter “Fu”, Org. Biomol. Chem., 2019, 17, 9994-9998); 3) Tweardy of record (WO2019204427A1); and 4) Basak of record (Advanced Drug Delivery Reviews, 2007).
Independent claim 1 directed to a composition comprising a compound of formula (I):
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(also known as TTI-101, see ¶ 000150 of the specification), a compound of formula (II):
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and a compound of formula (IV):
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, wherein a compound of formula (II) and a compound of formula (IV) are present in an amount of greater than and equal to or less than about 1% area by HPLC.
Claim 6 is drawn to a pharmaceutical composition comprising a composition of claim 1 and a pharmaceutically acceptable carrier.
Claim 6 does not specify a particular carrier, but it does reads on a carrier. Accordingly, for the purpose of examination, any carrier that is employed in the formulation of a pharmaceutical composition comprising a composition of claim 1, is included in the interpretation of “a pharmaceutically acceptable carrier”.
By way of a background, Applicants’ invention (see, e.g., ¶s 00033-00043 of the specification), is drawn to a composition comprising TTI-101 and substantially free of an impurity (see ¶ 00042), selected from the group that include a compound of formula (II) and a compound of formula (IV), or a combination thereof. The specification discloses working examples showing:
a) presence of impurity compound 6 (a compound of formula (II)), during: i) synthesis of compound TTI-101 (see ¶s 000150-000155 of the specification); or ii) recrystallization of compound TTI-101 (see ¶s 000156-000166 of the specification).
b) depending on the storage condition, presence of impurity compound 6 (a compound of formula (II)), or presence of impurity compound 6 (a compound of formula (II)) and impurity compound of formula (IV), during storage of compound TTI-101 (see ¶s 000167-000171 of the specification).
Regarding claims 1-4 and 6, Bharadwaj teaches a pharmaceutical composition comprising TTI-101 (C188-9, see, e.g., Table 1) and a pharmaceutically acceptable carrier. TTI-101 is a STAT3 inhibitor, which was found to inhibit the growth of radioresistant head and neck squamous cell carcinoma (HNSCC) in mice HNSCC xenograft. Please see abstract, Figures 1-5, Tables 1-3 and “Materials AND METODS” section.
Although Bharadwaj is not explicit in disclosing a trace amount of an impurity, in the composition, a person skilled in the art would have reasonably expected that a pharmaceutical composition comprising TTI-101, would comprise a trace amount of an impurity (e.g., greater than zero and up to about 1%), in the composition. This is because at the time of the instant invention:
TTI-101 was known to be susceptible to oxidative degradation.
stability of compound TTI-101 can be enhanced under certain conditions.
3) FDA allow for certain trace levels of impurities in drugs, and determination of the limits for the trace levels of impurities is a routine activity in the pharmaceutical art.
For example:
1a) Minus teaches that significant oxidative decomposition of TTI-101 (C188-9) to iminoquinone compound (which is identical to Applicants’ impurity compound of formula (II), see discussions above), was observed within 4 hours in aqueous buffer (a pharmaceutically acceptable carrier). Please see Minus at ¶ on left column of page 3292, Figure S1 and Scheme 1 illustration below for illustration:
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Minus discloses that the 1,4-substitution pattern of hydroxyl-naphthalene sulfonamides renders the core structure susceptible to oxidation. Some synthetic intermediates indeed proved quite prone to air oxidation and subsequent decomposition. Please see ¶ on left column of page 3292. Minus (see page 3288), also discloses TTI-101 as STAT3 inhibitor with a known utility as an anticancer agent.
1b) Furthermore, N-arylsulfonamide compounds are also susceptible to oxidation at the N-aryl bond to generate corresponding quinone compounds similar to compound (IV). For example, similar to Minus (see discussions above), Fu (see page 9996, Scheme 2), also teaches oxidation of arylsulfonamide compound 1a:
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.
Accordingly, at the time of the instant invention, one skilled in the art would have envisaged the susceptibility of an N-arylsulfonamide compound (e.g., TTI-101) to oxidation at the OH-aryl bond and N-aryl bond, in order to generate a quinone compound of formula (II) and a quinone compound of formula (IV), from the Minus and Fu disclosures.
2) Tweardy at ¶ 00276, states:
“A batch of compound of Formula IIIx was stored in Teflon Bags (5 mil PFA; 5" x 4"; Welch Fluorocarbon, Inc., Part Number (PN) P-00014-1), using plastic tie strips under two conditions: 25 °C/65% RH and 40 °C/75% RH. The results show that under both conditions, compound of Formula IIIx maintained white powder appearance after three months. Additionally, after three months, the purity of compound of Formula IIIx by HPLC remained at 100% AUC under both conditions.” Emphasis added.
Similar to the Minus (see discussions above), Tweardy (see page 77), also teaches a working example of obtaining compound III (i.e., Applicants’ claimed compound of formula (II)), from the oxidation of compound IIIx (i.e., TTI-101), which confirms the prior art knowledge that TTI-101, is susceptible to oxidation (see discussions above).
3) Basak discloses that FDA allow for certain trace levels of impurities in both drug substance and product. Please see abstract and §s 1-8. Drug substance impurities threshold could be up to 1%, depending on the maximum daily dose and the type of impurity. Please see Tables 1-2. The nature and the quantity of these impurities is governed by a number of different factors, including synthetic route of the drug substance, reaction conditions, quality of the starting material of the drug substance, reagents, solvents, purification steps, excipients, drug product manufacturing processes, packaging, and storage of the end product. Emphasis added, please see § 3.
The separation methods include thin layer chromatography (TLC), high performance liquid chromatography (HPLC), gas chromatography (GC), and capillary electrophoresis (CE). HPLC is the most commonly used method for impurity monitoring in an inexpensive way. Please see § 4.
Therefore, at the time of the instant invention, it would have been obvious to one skilled in the art to employ conditions that would, for example, reduce oxidation of TTI-101 at the OH-aryl bond and N-aryl bond, in order to generate a quinone compound of formula (II) and a quinone compound of formula (IV), with a reasonable expectation of limiting the level of impurities to within the threshold of greater than and equal to or less than about 1% area by HPLC. Please see discussions above.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
The threshold of greater than and equal to or less than about 1% area by HPLC, for the claimed impurity compound of formula (II) and impurity compound of formula (IV), is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art (see discussions above).
Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.” It is noted that no criticality (emphasis added) has been demonstrated in the specification with regard to the claimed the threshold of greater than and equal to or less than about 1% area by HPLC, for the claimed compound of formula (II) and compound of formula (IV).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited reference. Therefore, the invention as a whole was prima facie obvious at the time it was made.
Response to Applicants’ Arguments
Applicants raised several arguments (see pages 6-14 of Remarks), alleging that instant claims are non-obvious over the cited prior art on the grounds that:
1) certain synthetic methods of instant application produce highly pure TTI-101 with low to non-detectable amount of an impurity compound of formula (II). Please see page 7 of Remarks.
Response:
Applicants’ arguments have been fully considered but they are found to be persuasive. This is because, the instant invention (e.g., claim 1), is directed to a composition comprising TTI-101, a compound of formula (II) and a compound of formula (IV), wherein a compound of formula (II) and a compound of formula (IV) are present in an amount of greater than and equal to or less than about 1% area by HPLC. However, Applicants are arguing about certain synthetic methods of instant application producing highly pure TTI-101 with low to non-detectable amount of an impurity compound of formula (II). Therefore, Applicants’ arguments are not commensurate in scope with the instant claims (e.g., amended claim 1).
2) long-term stability studies of pure TTI-101 showed from non-quantifiable levels of impurity compound (IV) and non-detectable amounts of impurity compound of formula (III). Please see pages 7-8 of Remarks.
Response:
Applicants’ arguments have been fully considered but they are found to be persuasive. This is because, the instant invention (e.g., claim 1), is directed to a composition comprising TTI-101, a compound of formula (II) and a compound of formula (IV), wherein a compound of formula (II) and a compound of formula (IV) are present in an amount of greater than and equal to or less than about 1% area by HPLC. However, Applicants are arguing about long-term stability studies of pure TTI-101 showing from non-quantifiable levels of impurity compound (IV) and non-detectable amounts of impurity compound of formula (III). Therefore, Applicants’ arguments are not commensurate in scope with the instant claims (e.g., amended claim 1).
Furthermore, the property exhibited by TTI-101, when subjected to long-term stability studies is a property of TTI-101. Since TTI-101 was known in the art at the time of the instant invention (see discussions above), the TTI-101 of the prior art must necessarily exhibit disclosed properties, when subjected to long-term stability studies.
An inherent characteristic may “be part of the prior art in an obviousness analysis even if the inherent characteristic was unrecognized or unappreciated by a skilled artisan.” Endo Pharm. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374, 1381 (Fed. Cir. 2018).
3) the cited prior arts fail to address the limitation of to a composition comprising TTI-101, a compound of formula (II) and a compound of formula (IV), wherein a compound of formula (II) and a compound of formula (IV) are present in an amount of greater than and equal to or less than about 1% area by HPLC, recited in amended claim 1 (see page 8 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are found to be persuasive. This is because, all the claim elements recited the amended claim 1 have been addressed in the new grounds of rejection set forth in the discussions above. The Examiner, therefore, applies the same reasons hereto.
4) the cited prior arts fail to address all the claim elements recited the amended claim 1 (see page 8 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are found to be persuasive. This is because, all the claim elements recited the amended claim 1 have been addressed in the new grounds of rejection set forth in the discussions above. The Examiner, therefore, applies the same reasons hereto.
5) Bharadwaj fails to disclose or suggest any impurity amounts for TTI-101 (see page 9 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are found to be persuasive. This is because, Bharadwaj was cited for teaching a pharmaceutical composition comprising TTI-101 (see discussions above). The Office did not take a position that Bharadwaj teaches any impurity amounts for TTI-101.
6) Although Minus teaches a compound of formula (II) as an impurity for TTI-101, Minus fails to disclose or suggest a compound of formula (IV) as an impurity for TTI-101 (see page 9 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are found to be persuasive. This is because, the Office did not take a position that Minus teaches a compound of formula (IV) as an impurity for TTI-101.
7) Tweardy fails to disclose or suggest an impurity compound of formula (II) or an impurity compound of formula (IV) for TTI-101 (see page 9 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are found to be persuasive. This is because, the reasons for the Office’s reliance on the Tweardy reference, in order to reject the instant claims are set forth in the discussions above. The Examiner, therefore, applies the same reasons hereto. It is also noted that Tweardy (see page 77), also teaches a working example of obtaining compound III (i.e., impurity compound of formula (II)), from the oxidation of compound IIIx (i.e., TTI-101), which confirms the prior art knowledge that TTI-101, is susceptible to oxidation (see discussions above).
8) Basak fails to disclose or suggest TTI-101 or an impurity compound for TTI-101 (see pages 9-10 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are found to be persuasive. This is because, Basak was cited for disclosing that FDA allow for certain trace levels of impurities in both drug substance and product. Drug substance impurities threshold could be up to 1%, depending on the maximum daily dose and the type of impurity. The nature and the quantity of these impurities is governed by a number of different factors, including synthetic route of the drug substance, reaction conditions, quality of the starting material of the drug substance, reagents, solvents, purification steps, excipients, drug product manufacturing processes, packaging, and storage of the end product. Emphasis added, please see discussions above.
9) One skilled in the art would not have had a reasonable expectation of success in combining the cited references because the cited references individually or in combination fails to disclose or suggest how to arrive at a composition comprising TTI-101, a compound of formula (II) and a compound of formula (IV), wherein a compound of formula (II) and a compound of formula (IV) are present in an amount of greater than and equal to or less than about 1% area by HPLC (see pages 10-14 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are found to be persuasive. This is because, the cited references combine to disclose that:
i) TTI-101 is susceptible to oxidation (see discussions above).
i i) oxidation of an N-arylsulfonamide compound (e.g., TTI-101) occurs at the OH-aryl bond and N-aryl bond, in order to generate impurity quinone compound of formula (II) and impurity quinone compound of formula (IV). Please see discussions above.
iii) FDA allow for certain trace levels of impurities in both drug substance and product. Drug substance impurities threshold could be up to 1%, depending on the maximum daily dose and the type of impurity. The nature and the quantity of these impurities is governed by a number of different factors, including synthetic route of the drug substance, reaction conditions, quality of the starting material of the drug substance, reagents, solvents, purification steps, excipients, drug product manufacturing processes, packaging, and storage of the end product. Emphasis added, please see discussions above.
Therefore, at the time of the instant invention, it would have been obvious to one skilled in the art to employ conditions that would, for example, reduce oxidation of TTI-101 at the OH-aryl bond and N-aryl bond, in order to generate a quinone compound of formula (II) and a quinone compound of formula (IV), with a reasonable expectation of limiting the level of impurities to within the threshold of greater than and equal to or less than about 1% area by HPLC. Please see discussions above.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
The threshold of greater than and equal to or less than about 1% area by HPLC, for the claimed impurity compound of formula (II) and impurity compound of formula (IV), is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art (see discussions above).
Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.” It is noted that no criticality (emphasis added) has been demonstrated in the specification with regard to the claimed the threshold of greater than and equal to or less than about 1% area by HPLC, for the claimed compound of formula (II) and compound of formula (IV).
Furthermore, in response to the Applicants’ arguments against the references individually (e.g., Bharadwaj fails to disclose or suggest any impurity amounts for TTI-101, see page 9 of Remarks), one cannot show nonobviousness by attacking references individually where the rejections are based on combination of references. In obviousness rejection a combination of references is used, and the references are relied upon in combination and are not meant to be considered separately as in a vacuum. It is the combination of all of the cited and relied upon references that make up the state of the art with regard to the claimed invention. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co.; 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claims 1-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Alibhai of record (U.S. Pub. No. 20210228512, effective filing date 01/248/2020), in view of: 1) Minus of record (Org. & Biomol Chem., 2020, 18, 3288-3296); 2) Fu (Org. Biomol. Chem., 2019); and 3) Basak of record (Advanced Drug Delivery Reviews, 2007)).
The corresponding teachings of Minus, Fu and Basak, are discussed above and hereby incorporated into the instant rejection.
Regarding claims 1-4 and 6, Alibhai (see Example 5 and Table 6), discloses that the compound of formula (I) is susceptible to oxidation and also discloses a composition comprising compound of formula (I) and having a purity of 99.05% by HLPLC. Please see Example 5 and Table 6.
Accordingly, a composition comprising compound of formula (I), an impurity compound of formula (II) and an impurity compound of formula (IV), from the Alibhai’s disclosures, would have been obvious in view of Minus, Fu and Basak.
MPEP 2143(e) states: The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited reference. Therefore, the invention as a whole was prima facie obvious at the time it was made.
Response to Applicants’ Arguments
Applicants raised several arguments (see pages 14-15 of Remarks), alleging that instant claims are non-obvious over the cited prior art on the grounds that Alibhai fails to disclose or suggest an impurity compound of formula (II) or an impurity compound of formula (IV) for TTI-101 (see page 15 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are found to be persuasive. This is because, Alibhai was cited for disclosing that TTI-101 is susceptible to oxidation and also discloses a composition comprising TTI-101 and having a purity of 99.05% by HLPLC (see discussions above). Minus, Fu and Basak combine to disclose that:
i) oxidation of an N-arylsulfonamide compound (e.g., TTI-101) occurs at the OH-aryl bond and N-aryl bond, in order to generate impurity quinone compound of formula (II) and impurity quinone compound of formula (IV). Please see discussions above.
ii) FDA allow for certain trace levels of impurities in both drug substance and product. Drug substance impurities threshold could be up to 1%, depending on the maximum daily dose and the type of impurity. The nature and the quantity of these impurities is governed by a number of different factors, including synthetic route of the drug substance, reaction conditions, quality of the starting material of the drug substance, reagents, solvents, purification steps, excipients, drug product manufacturing processes, packaging, and storage of the end product. Emphasis added, please see discussions above.
Accordingly, a composition comprising compound of formula (I), an impurity compound of formula (II) and an impurity compound of formula (IV), from the Alibhai’s disclosures, would have been obvious in view of Minus, Fu and Basak.
The threshold of greater than and equal to or less than about 1% area by HPLC, for the claimed impurity compound of formula (II) and impurity compound of formula (IV), is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art (see discussions above).
Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.” It is noted that no criticality (emphasis added) has been demonstrated in the specification with regard to the claimed the threshold of greater than and equal to or less than about 1% area by HPLC, for the claimed compound of formula (II) and compound of formula (IV).
Non-Statutory Obviousness-Type Double Patenting
New Grounds of Rejections Necessitated by Applicants’ Claim Amendments
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-4 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. patent Nos:
11,547.683 (claims 1-19);
11,077,077 (claims 1-19);
11,547,683 (claims 1-19);
11,161,831 (claims 1-15); and
12,053,444 (claims 1-20); and
12,043,640 (claims 1-114),
in view of: 1) Minus of record (Org. & Biomol Chem., 2020, 18, 3288-3296); 2) Fu (Org. Biomol. Chem., 2019); and 3) Basak of record (Advanced Drug Delivery Reviews, 2007).
The corresponding teachings of Minus, Fu and Basak, are discussed above and hereby incorporated into the instant rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application and the reference patents are similarly drawn to a compound of formula (I).
For example, the claims of the instant application are drawn to a composition comprising compound of formula (I) and an impurity, whereas, the claims of the U.S. patent No. 11,547,683 (‘683 patent) are directed to a composition comprising compound of formula (I) and a method of using a composition comprising compound of formula (I).
Although the 683 patent is not explicit in claiming an impurity in the composition, the 683 patent discloses that the compound of formula (I) is susceptible to oxidation and also discloses a composition comprising compound of formula (I) and having a purity of 99.6% by HLPLC. Please see Example 5 and Table 7.
Accordingly, a composition comprising compound of formula (I) and an impurity, from the ‘683 patent embodiment, would have been obvious in view of Minus, Fu and Basak.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
Claims 1-4 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. patent application Nos:
17/781,349 (claims 1-15, 19 and 23);
18/842,626 (claims 1-87); and
18/842,628 (claims 1-42),
in view of: 1) Minus of record (Org. & Biomol Chem., 2020, 18, 3288-3296); 2) Fu (Org. Biomol. Chem., 2019); and 3) Basak of record (Advanced Drug Delivery Reviews, 2007).
The corresponding teachings of Minus, Fu and Basak, are discussed above and hereby incorporated into the instant rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the above cited patent applications are similarly drawn to a composition comprising compound of formula (I).
For example, the claims of the instant application are drawn to a composition comprising compound of formula (I) and an impurity, whereas, the claims of the U.S. patent application No. 17/781,349 (‘349 application), are directed to a composition comprising compound of formula (I).
Although the ‘349 application is not explicit in claiming an impurity in the composition, the ‘349 application discloses that: i) compound of formula (I) can have a purity of greater than 99% (see ¶ 00071) in a composition according to general safety and purity standard as required by FDA (see ¶ 000181); and ii) compositions comprising compound of formula (I) can also comprise antioxidants to retard oxidation (see ¶ 000167).
Accordingly, a composition comprising compound of formula (I) and an impurity, from the ‘349 application embodiment, would have been obvious in view of Minus, Fu and Basak.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicants’ Arguments
Applicants argue alleging that the claimed invention would not have been obvious to a person skilled in the art over the above cited patent applications and above cited patents, for the same reasons argue previously (see pages 15-16 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are found to be persuasive. This is because, the Applicants are reiterating the same arguments which have been addressed (see discussions above). The Examiner, therefore, applies the same response hereto.
Conclusion
No claim is allowable.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629