DETAILED ACTION
This office action is in response to the Applicant’s filing date November 17th, 2022.
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 .
Status of Claims
Claims 1-9, 17-18, 24, 26, 32-33, 39, 41, 43-45, and 53 are pending in the instant application. Acknowledgement is made of Applicant’s remarks and amendments filed on November 17th, 2022. Acknowledgment is made of Applicant’s amendment of claims 1, 9, 18, 24, 26, 32-33, 39, 41, 43-44 and 53; and cancelation of claims 10-16, 19-23, 25, 27-31, 34-38, 40, 42, 46-52 and 54-59.
Priority
This application is a 371 of PCT/US2021/033418 filed on May 20th, 2021; and has a PRO 63/029,375 filed on May 22nd, 2020.
Specification
A substitute specification excluding the claims is required pursuant to 37 CFR 1.125(a) because the drawing of the chemical structure of nintedanib on page 20 of the specification is completely illegible.
A substitute specification must not contain new matter. The substitute specification must be submitted with markings showing all the changes relative to the immediate prior version of the specification of record. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. An accompanying clean version (without markings) and a statement that the substitute specification contains no new matter must also be supplied. Numbering the paragraphs of the specification of record is not considered a change that must be shown.
Claim Objections
Claim 9 is objected to because of the following informalities: There should be a space present between “The method of claim 1” and “wherein the compound capable of inhibiting”. Appropriate correction is required.
Claim 39 is objected to because of the following informalities: There is an improper use of brackets reciting “[or about one month]”. Appropriate correction is required.
Claim 41 is objected to because of the following informalities: There is an improper use of parenthesis reciting “(equivalent to about 132µm)”. Appropriate correction is required
Claim Rejections - 35 USC § 112
Claim 33 rejected on the basis that it contains improper Markush format. See MPEP § 2173.05(h). The Markush language recited “The method of claim 1 wherein the compound is administered from the group consisting of” is improper, and should read “The method of claim 1 wherein the compound is administered in the dosing regimen selected from the group consisting of”.
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.
Claims 1-3, 9, 17-18, 24, 26, 33, 39, 41, 43-44 and 53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al (WO 2018/195084 A1).
Regarding claims 1-3, 9, 17-18 and 24, Wu teaches a method for treating or preventing Acute Lung Injury (ALI), including Acute Respiratory Distress Syndrome and lung fibrosis, in a subject in need thereof; comprising administering to the subject a therapeutically effective amount of pazopanib or a salt thereof, using an administration route selected from the group consisting of oral, parenteral, nasal, inhalational, intratracheal, intrapulmonary, intrabronchial and may be administered with a nebulizer (page 12, lines 6-13; page 44, claims 1-3, 5 and 7). Wu further discloses that the subject can be human (page 4, lines 6-7; page 15, line 12; page 45, claim 14). Moreover, Wu teaches that pazopanib inhibits MAP3K2/3 (page 7, line 12); and can treat, reverse or ameliorate pulmonary edema (page 12, lines 4-5); as seen in Example 5 (pages 40-41).
Regarding claim 26, Wu anticipates the method as described in the above rejection. Wu further teaches that pazopanib inhibits MAP3K2 and MAP3K3, which leads to an increase in ROS production in neutrophils, and attenuates lung injury (page 12, lines 26-31).
Regarding claims 33 and 39, Wu anticipates the method as described in the above rejection. Wu further teaches the pazopanib is administered to the subject at a frequency selected from the group consisting of about three times a day, about twice a day, about once a day, about every other day, about every third day, about every fourth day, about every fifth day about every sixth day and about once a week (page 3, lines 20-23; page 44, claim 8). Wu further states that the treatment period is continued for periods of time effective to treat a disease or disorder (page 22, lines 5-7), thus indicating treatment stops once the disease or disorder has been treated.
Regarding claim 41, Wu anticipates the method as described in the above rejection. The prior art of Wu does not explicitly teach the disclosed composition has “pharmacokinetic parameters achieved in the human subject selected from an AUC of about 1,037 mcg*h/mL or a Cmax of about 58.1 mcg/mL (equivalent to about 132 µM) for the compound capable of inhibiting MAP3K2/MAP3K3”. However, the above pharmacokinetic parameters depend, among other things, from the specific components, relative amounts, type of formulation, and pH of the formulation etc., all of which seem to be the same or very similar to the composition made obvious by the prior art (see above rejections).
However, Wu discloses administration of the same compounds via the same method to the same patient population under the same conditions as those instantly claimed. Since pharmacokinetic parameters such as AUC and Cmax are inherent properties determined by the composition, dosage and route of administration; the pharmacokinetic profile and parameters would be the same.
Regarding claim 43, Wu anticipates the method as described in the above rejection. Wu further teaches that the active agent can be administered in an amount ranging “from about 50 mg to about 800 mg” (page 23, lines 8-15).
MPEP 2131.03 states:
"[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)).
Regarding claim 44, Wu anticipates the method as described in the above rejection. Wu further teaches that the subject can be further administered an additional agent to treat, prevent or reduce the symptoms of Acute Lung Injury or lung fibrosis (page 3, lines 16-17; page 44, claims 6-7)
Regarding claim 53, Wu anticipates the method as described in the above rejection. Wu further teaches a kit comprising pazopanib, or a salt thereof, and an instructional material for use thereof (page 2, lines 30-31; page 45, claim 15).
Thus, the teachings of Wu anticipate the method of instant claims 1-3, 9, 17-18, 24, 26, 33, 39, 41, 43-44 and 53.
Claims 1-2, 6-9, 17-18, 24, 26, 33, 41 and 43-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Surber et al (WO 2020/041631 A1).
Regarding claims 1-2, 6-9, 17-18 and 24, Surber teaches Example 10, wherein therapeutically effective amounts of nintedanib esylate is administered orally, and nintedanib hydrobromide is administered via inhalation, to rats to treat pulmonary fibrosis (pages 147-150). Surber further teaches that the pulmonary fibrosis can be secondary to viral induced Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS) (page 16, paragraph [0058]); and that the nintedanib compound, or salt thereof, can be administered to humans (page 6, paragraphs [0016-0017]).
The prior art of Surber is silent regarding "inhibiting MAP3K2/MAP3K3 and reducing pulmonary edema". However: "inhibiting MAP3K2/MAP3K3 and reducing pulmonary edema" will inevitably flow from the teachings of the prior art (see above), since the same compounds are being administered to the same subjects (humans infected with a viral infection). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding "inhibiting MAP3K2/MAP3K3 and reducing pulmonary edema", by practicing the method taught by the prior art: "Specially Formulated Compositions of Inhaled Nintedanib and Nintedanib Salts", one will also be "inhibiting MAP3K2/MAP3K3 and reducing pulmonary edema”, even though the prior art was not aware of it.
MPEP 2112 (I) states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Regarding claim 26, Surber anticipates the method as described in the above rejection. The wherein limitations of this claim, are considered to simply express the intended result of a process step positively recited, which is not given patentable weight (See MPEP 2111.04: [T]he court noted (quoting Minton v. Nat'lAss'n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQgd 1614, 1690 (Fed. Cir. 2003)) that a "'whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.'" Hoffer v. Microsoft Corp., 405 F.3d 1396, 1399, 74 USPQgd 1481, 1483 (Fed. Cir. 2005).). In the instant case, the wherein clause is directed to the intended result (i.e. reduced time on ventilator, improved blood oxygen levels, reduced recovery time etc.) of the process step positively recited (i.e. administering nintedanib to patients infected with a virus in need of treating or preventing lung injury.).
Regarding claim 33, Surber anticipates the method as described in the above rejection. Surber further teaches that the active agent can be administered “once per day, twice per day, three times a day, four times a day, and may be administered daily, every other day, every third day, every fourth day, every fifth day, every sixth day or weekly” (page 56, paragraph [00165]).
Regarding claim 41, Surber anticipates the method as described in the above rejection. The prior art of Surber does not explicitly teach the disclosed composition has “pharmacokinetic parameters achieved in the human subject selected from an AUC of about 1,037 mcg*h/mL or a Cmax of about 58.1 mcg/mL (equivalent to about 132 µM) for the compound capable of inhibiting MAP3K2/MAP3K3”. However, the above pharmacokinetic parameters depend, among other things, from the specific components, relative amounts, type of formulation, and pH of the formulation etc., all of which seem to be the same or very similar to the composition made obvious by the prior art (see above rejections).
However, Surber discloses administration of the same compounds via the same method to the same patient population under the same conditions as those instantly claimed. Since pharmacokinetic parameters such as AUC and Cmax are inherent properties determined by the composition, dosage and route of administration; the pharmacokinetic profile and parameters would be the same.
Regarding claim 43, Surber anticipates the method as described in the above rejection. Surber further teaches that the nintedanib, or salt thereof, can be administered in a dose of about 100mg (page 59, paragraph [00176]).
MPEP 2131.03 states:
"[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)).
Regarding claim 44, Surber anticipates the method as described in the above rejection. Surber further teaches that pirfidone can be combined as an additional active ingredient with nintedanib, or a salt thereof (page 42, paragraph [00131]).
Thus, the teachings of Surber anticipate the method of instant claims 1-2, 6-9, 17-18, 24, 26, 33, 41 and 43-44.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 9, 17-18, 24, 26, 32-33, 39, 41, 43-44, and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 11-15, and 18-19 of copending Application No. 17/756,212 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because there is significant overlap of the methods claimed in the reference art and the methods claimed in the instant application; including compounds administered, patient population, treatment regimen and intended therapeutic results.
The reference application teaches an overlapping method of treating, ameliorating or preventing lung injury related to a coronavirus infection, acute lung injury, acute respiratory distress syndrome, or lung fibrosis in a human subject comprising administering to the subject a therapeutically effective amount of pazopanib, or a salt or solvate thereof, via overlapping delivery methods and following overlapping dosing regimens as the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 6-9, 18, 24, 26, 32-33, 39, 41, 43-45, and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 11,304,947.
Although the claims at issue are not identical, they are not patentably distinct from each other because there is significant overlap of the methods claimed in the reference art and the methods claimed in the instant application; including compounds administered, patient population, treatment regimen and intended therapeutic results.
The reference patent teaches an overlapping method of treating or reducing the severity of a lung injury associated with a coronavirus infection, specifically SARS-CoV-2; including acute respiratory distress syndrome, or lung fibrosis in a human subject comprising administering to the subject a therapeutically effective amount of nintedanib, or a pharmaceutically acceptable salt or solvate thereof, via overlapping delivery methods and following overlapping dosing regimens as the instant claims.
Claims 1-5, 9, 17-18, 24, 26, 33, 39, and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6-7 and 12-14 of U.S. Patent No. 11,166,953.
Although the claims at issue are not identical, they are not patentably distinct from each other because there is significant overlap of the methods claimed in the reference art and the methods claimed in the instant application; including compounds administered, patient population, treatment regimen and intended therapeutic results.
The reference patent teaches an overlapping method of treating acute lung injury, including acute respiratory distress syndrome, or lung fibrosis in a human subject comprising administering to the subject a therapeutically effective amount of pazopanib, or a salt or solvate thereof, via overlapping delivery methods and following overlapping dosing regimens as the instant claims.
Conclusion
Claims 1-9, 17-18, 24, 26, 32-33, 39, 41, 43-45, and 53 are rejected.
No claim is allowed.
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/C.L.J./Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691