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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 25, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Copies of non-patent literature documents NPL5, NPL12, NPL15, NPL18, NPL20, NPL40, NPL43, NPL51, NPL57, NPL58, NPL76, NPL78, NPL86, NPL93, NPL177, NPL182, NPL184, NPL207 were not attached, and therefore have not been considered at the present time (MPEP 609.01(B)(2)(b)).
Claim Status
Claims 1 – 47 are examined here-in.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 – 40, 42, and 44 – 47 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Prussin (US 2022/0040154 A1).
Prussin teaches methods of treating moderate to severe asthma of eosinophilic phenotype in a human subject in need thereof with a daily dose of about 75 to 300 mg (or more specifically 150 to 300 mg) dexpramipexole or pharmaceutically acceptable salt thereof (abstract, paragraphs 0018, 0204 – 0206). Prussin teaches the asthma in the human subject is already being treated by two asthma medications, such as an inhaled corticosteroid and a long-acting beta agonist (paragraphs 0204 – 0206).
Prussin’s teaching for a method of treating moderate to severe asthma of eosinophilic phenotype in a human subject in need thereof with a daily dose of about 150 to 300 mg dexpramipexole or pharmaceutically acceptable salt thereof, wherein the asthma in the human subject is already being treated by two asthma medications, such as an inhaled corticosteroid and a long-acting beta agonist (abstract, paragraphs 0018, 0204 – 0206) anticipates instant claims 1, 21, and 45.
Prussin teaches the administration of a daily dose of 150 mg dexpramipexole (paragraphs 0073, 0249), anticipating instant claims 2 and 22.
Prussin teaches the administration of dexpramipexole administration at a dose of 75 mg twice per day (paragraph 0252), anticipating instant claims 3 and 23.
Prussin teaches the administration of a daily dose of 300 mg dexpramipexole (paragraph 0250), anticipating instant claims 4 and 24.
Prussin teaches the administration of dexpramipexole administration at a dose of 150 mg twice per day (paragraph 0265), anticipating instant claims 5 and 25.
Prussin teaches the administration of dexpramipexole daily for 52 weeks (paragraph 0393), anticipating instant claim 6.
Prussin teaches the subject has been diagnosed with asthma severity of GINA 4-5 (paragraphs 0055, 0161), anticipating instant claims 7 and 27.
Prussin teaches the subject has an elevated AEC of 0.30x109 cells/L (paragraph 0161), anticipating instant claims 8 and 28.
Prussin teaches that treatment with dexpramipexole shows improvement in reduction in frequency of asthma exacerbations (paragraphs 0123, 0167, 0228), anticipating instant claim 9.
Prussin teaches administration of dexpramipexole leads to reduction in frequency of exacerbations, measured as a rate of exacerbation over 24 or 52 weeks (paragraph 0229), anticipating instant claims 10, 33, and 46.
Prussin teaches administration of dexpramipexole leads to reduction in frequency of exacerbations, measured as an extension in the time between exacerbations (paragraph 0229), anticipating instant claims 11 and 47.
Prussin teaches that treatment with dexpramipexole shows reduction in the use of oral corticosteroids, reduction in use of inhaled corticosteroids, reduction in use of long-acting beta agonist, improvement in the mean forced expiratory volume in 1 second (FEV1), improvement in forced vital capacity (FVC), improvement in score on asthma control questionnaire (ACQ), improvement in score on asthma control test (ACT), improvement in score of asthma quality of life questionnaire (AQLQ), or a combination thereof (paragraphs 0094, 0124, 0140, 0184b 0228), anticipating instant claims 12, 13, and 30 – 32.
Prussin teaches that treatment with dexpramipexole shows reduction in level of blood eosinophils (paragraphs 0125 – 0126), anticipating instant claims 14 and 34.
Prussin teaches that treatment with dexpramipexole shows reduction in level of blood eosinophils by at least 50% (paragraph 0132), anticipating instant claims 15 and 35.
Prussin teaches the subject is between 12 to 75 years old, 12 to 17 years old, or 18 years old and older (paragraph 0164), anticipating instant claims 16 – 18 and 36 – 38.
Prussin teaches the inhaled corticosteroid is selected from the group consisting of beclomethasone, fluticasone, ciclesonide, mometasone, budesonide, flunisolide, and combinations thereof (paragraph 0206), anticipating instant claims 19 and 39.
Prussin teaches the long-acting beta agonist is selected from the group of albuterol sulfate, formoterol fumarate, salmeterol, salmeterol xinafoate, arformoterol tartrate, olodaterol, vilanterol, indacaterol, and combinations thereof (paragraph 0206), anticipating instant claims 20 and 40.
Prussin teaches dexpramipexole is administered once daily for 24 weeks (paragraph 0254), anticipating instant claim 26.
Prussin teaches administration of dexpramipexole leads to improved pulmonary function (paragraph 0094), anticipating instant claim 29.
Prussin teaches that the subject has been treated with a long-acting beta agonist for at least 3 months (paragraphs 0205 – 0206, Table 15), anticipating instant claims 42 and 44.
However, in the event that the previous does not have sufficient specificity to rise to anticipation, claims 1 – 40, 42, and 44 – 47 are also rejected under 35 U.S.C. 103 below.
Claim Rejections - 35 USC § 103
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 non-obviousness.
Claims 1 – 47 are rejected under 35 U.S.C. 103 as being unpatentable over Prussin (as cited above).
For the purposes of this ground of rejection only, and purely arguendo, the examiner will take the position that Prussin does not teach a specific embodiment (i.e., preferred embodiment, working example, etc.) having all of the claimed elements arranged as required by claims 1 – 40, 42, and 44 – 47 without resorting to some “picking and choosing” within the prior art disclosure. That being said, although Prussin thus would not be anticipatory by this interpretation of the facts, it nevertheless does fairly suggest the claimed invention, as shown below.
Prussin teaches methods of treating moderate to severe asthma of eosinophilic phenotype in a human subject in need thereof with a daily dose of about 75 to 300 mg (or more specifically 150 to 300 mg) dexpramipexole or pharmaceutically acceptable salt thereof (abstract, paragraphs 0018, 0204 – 0206). Prussin teaches the asthma in the human subject is already being treated by two asthma medications, such as an inhaled corticosteroid and a long-acting beta agonist (paragraphs 0204 – 0206). Prussin teaches the inhaled corticosteroid is selected from the group consisting of beclomethasone, fluticasone, ciclesonide, mometasone, budesonide, flunisolide, and combinations thereof; and the long-acting beta agonist is selected from the group of albuterol sulfate, formoterol fumarate, salmeterol, salmeterol xinafoate, arformoterol tartrate, olodaterol, vilanterol, indacaterol, and combinations thereof (paragraph 0206). Prussin teaches the subject has been treated with a medium dose inhaled corticosteroid for at least 3 months and on a stable dose for at least one month (paragraph 0205, Table 15). Prussin teaches that the subject has been treated with a long-acting beta agonist for at least 3 months (paragraphs 0205 – 0206, Table 15)
Prussin teaches the administration of a daily dose of 150 mg dexpramipexole (paragraphs 0073, 0249), which can be administered as 75 mg twice per day (paragraph 0252).
Prussin teaches the administration of a daily dose of 300 mg dexpramipexole (paragraph 0250), which can be administered as 150 mg twice per day (paragraph 0265).
Prussin teaches the administration of dexpramipexole daily for 24 or 52 weeks (paragraphs 0254, 0393).
Prussin teaches the subject has been diagnosed with asthma severity of GINA 4-5 (paragraphs 0055, 0161). Prussin teaches the subject has an elevated AEC of 0.30x109 cells/L (paragraph 0161). Prussin teaches the subject is between 12 to 75 years old, 12 to 17 years old, or 18 years old and older (paragraph 0164).
Prussin teaches that treatment with dexpramipexole leads to improved pulmonary function (paragraph 0094), reduction in frequency of exacerbations, measured as a rate of exacerbation over 24 or 52 weeks or measured as an extension in the time between exacerbations (paragraphs 0123, 0167, 0228 - 0229). Prussin teaches that treatment with dexpramipexole shows reduction in the use of oral corticosteroids, reduction in use of inhaled corticosteroids, reduction in use of long-acting beta agonist, improvement in the mean forced expiratory volume in 1 second (FEV1), improvement in forced vital capacity (FVC), improvement in score on asthma control questionnaire (ACQ), improvement in score on asthma control test (ACT), improvement in score of asthma quality of life questionnaire (AQLQ), or a combination thereof (paragraphs 0094, 0124, 0140, 0184b 0228). Prussin teaches that treatment with dexpramipexole shows reduction in level of blood eosinophils by at least 50% (paragraphs 0125 – 0126, 0132).
As discussed above, for the purposes of this rejection, and purely arguendo, Prussin does not teach a specific embodiment having each of the claimed elements, however, claims 1 – 47 are rendered prima facie obvious over the teachings of Prussin, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results (MPEP 2143(i)(a)). In the instant case, all the claimed elements (e.g., dexpramipexole, dosage regimens) were known in the prior art (e.g., asthma and respiratory conditions) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (e.g., a method for administering dexpramipexole to a human subject) to one of ordinary skill in the art.
Prussin’s teaching for a method of treating moderate to severe asthma of eosinophilic phenotype in a human subject in need thereof with a daily dose of about 150 to 300 mg dexpramipexole or pharmaceutically acceptable salt thereof, wherein the asthma in the human subject is already being treated by two asthma medications, such as an inhaled corticosteroid and a long-acting beta agonist (abstract, paragraphs 0018, 0204 – 0206) reads on instant claims 1, 21, and 45.
Prussin’s teaching for the administration of a daily dose of 150 mg dexpramipexole (paragraphs 0073, 0249), reads on instant claims 2 and 22.
Prussin’s teaching for the administration of dexpramipexole administration at a dose of 75 mg twice per day (paragraph 0252), reads on instant claims 3 and 23.
Prussin’s teaching for the administration of a daily dose of 300 mg dexpramipexole (paragraph 0250), reads on instant claims 4 and 24.
Prussin’s teaching for the administration of dexpramipexole administration at a dose of 150 mg twice per day (paragraph 0265), reads on instant claims 5 and 25.
Prussin’s teaching for the administration of dexpramipexole daily for 52 weeks (paragraph 0393), reads on instant claim 6.
Prussin’s teaching that the subject has been diagnosed with asthma severity of GINA 4-5 (paragraphs 0055, 0161), reads on instant claims 7 and 27.
Prussin’s teaching that the subject has an elevated AEC of 0.30x109 cells/L (paragraph 0161), reads on instant claims 8 and 28.
Prussin’s teaching that treatment with dexpramipexole shows improvement in reduction in frequency of asthma exacerbations (paragraphs 0123, 0167, 0228), reads on instant claim 9.
Prussin’s teaching that the administration of dexpramipexole leads to reduction in frequency of exacerbations, measured as a rate of exacerbation over 24 or 52 weeks (paragraph 0229), reads on instant claims 10, 33, and 46.
Prussin’s teaching that the administration of dexpramipexole leads to reduction in frequency of exacerbations, measured as an extension in the time between exacerbations (paragraph 0229), reads on instant claims 11 and 47.
Prussin’s teaching that treatment with dexpramipexole shows reduction in the use of oral corticosteroids, reduction in use of inhaled corticosteroids, reduction in use of long-acting beta agonist, improvement in the mean forced expiratory volume in 1 second (FEV1), improvement in forced vital capacity (FVC), improvement in score on asthma control questionnaire (ACQ), improvement in score on asthma control test (ACT), improvement in score of asthma quality of life questionnaire (AQLQ), or a combination thereof (paragraphs 0094, 0124, 0140, 0184b 0228), reads on instant claims 12, 13, and 30 – 32.
Prussin’s teaching that treatment with dexpramipexole shows reduction in level of blood eosinophils (paragraphs 0125 – 0126), reads on instant claims 14 and 34.
Prussin’s teaching that treatment with dexpramipexole shows reduction in level of blood eosinophils by at least 50% (paragraph 0132), reads on instant claims 15 and 35.
Prussin’s teaching the subject is between 12 to 75 years old, 12 to 17 years old, or 18 years old and older (paragraph 0164), reads on instant claims 16 – 18 and 36 – 38.
Prussin’s teaching that the inhaled corticosteroid is selected from the group consisting of beclomethasone, fluticasone, ciclesonide, mometasone, budesonide, flunisolide, and combinations thereof (paragraph 0206), reads on instant claims 19 and 39.
Prussin’s teaching that the long-acting beta agonist is selected from the group of albuterol sulfate, formoterol fumarate, salmeterol, salmeterol xinafoate, arformoterol tartrate, olodaterol, vilanterol, indacaterol, and combinations thereof (paragraph 0206), reads on instant claims 20 and 40.
Prussin’s teaching that dexpramipexole is administered once daily for 24 weeks (paragraph 0254), reads on instant claim 26.
Prussin’s teaching that the administration of dexpramipexole leads to improved pulmonary function (paragraph 0094), reads on instant claim 29.
Prussin’s teaching that the subject has been treated with a medium dose inhaled corticosteroid for at least 3 months and on a stable dose for at least one month (paragraph 0205, Table 15) overlaps on the instantly claimed amounts of at least 12 months and at least 3 months, as recited in claims 41 and 43. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Prussin’s teaching that the subject has been treated with a long-acting beta agonist for at least 3 months (paragraphs 0205 – 0206, Table 15) reads on instant claims 42 and 44.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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.
Double Patenting over U.S. Patent No. 11,612,589
Claims 1 – 47 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1 - 128 of U.S. Patent No. 11,612,589.
Although the claims at issue are not identical, they are not patentably distinct from each other because: instant claims 1, 21, and 45 are drawn to a method of treating inadequately controlled moderate to severe asthma of the eosinophilic phenotype in a human subject in need thereof, comprising orally administering to the subject a daily dose of about 150 mg to about 300 mg of dexpramipexole, or a pharmaceutically acceptable salt thereof, wherein the subject is already receiving at least two asthma medications.
Conflicting claims 1 and 17 are drawn to a method of treating moderate to severe eosinophilic asthma in a human in need thereof comprising orally administering to the human a therapeutically effective amount of dexpramipexole, or a pharmaceutically acceptable salt thereof, wherein the therapeutically effective amount of dexpramipexole, or a pharmaceutically acceptable salt thereof, is about 50 milligrams to about 600 milligrams per day and wherein eosinophilic asthma is characterized by 150 eosinophil cells or more per microliter in peripheral blood prior to administering dexpramipexole.
The instant and conflicting claims differ because conflicting claim 1 recites the eosinophilic asthma is characterized by 150 eosinophil cells or more per microliter. Instant claims 8 and 28 recite the overlapping amount of 0.30x109 cells/L, which is equal to 300 cells per microliter. The recitation for 50 to 600 milligrams dexpramipexole per day in conflicting claims 1 and 17 overlaps on the claimed range of 150 to 300 mg dexpramipexole per day recited in instant claims 1, 21, and 45. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Conflicting claim 2 recites the asthma is moderate, reading on instant claim 21.
Conflicting claim 3 recites the asthma is severe, reading on instant claims 1, 21, and 45.
Conflicting claims 6, 20, 41, and 58 recite the daily dose of dexpramipexole is 150 mg per day, overlapping on the claimed range of 150 to 300 mg recited in instant claims 1, 21, and 45, and 150 mg per day as recited in instant claims 2, 3, 22, and 23.
Conflicting claims 7, 21, 42, and 59 recite the daily dose of dexpramipexole is 300 mg per day, overlapping on the claimed range of 150 to 300 mg recited in instant claims 1, 21, and 45, and 300 mg per day as recited in instant claims 4, 5, 24, and 25.
Conflicting claims 117 – 120 and 123 – 125 recite dexpramipexole is administered in ranges of 50 to 300 mg per day, 100 to 600 mg per day, 150 to 300 mg per day, and 150 to 600 mg per day, overlapping on the claimed range of 150 to 300 mg recited in instant claims 1, 21, and 45, on the amounts of 150 mg recited in claims 2, 3, 22, and 23, and on the amount of 300 mg recited in claims 4, 5, 24, and 25.
Conflicting claims 31 – 38, 52 – 55, and 69 – 72 recite the daily dose is administered once per day, which appears to overlap on instant claims 2, 4, 22, and 24, which suggest the daily dose is administered as a whole once per day.
Conflicting claims 9 – 12, 23 – 26, 44 – 47, and 61 – 64 recite the daily dose is administered in two parts, as half the daily dose, twice per day, which appears to overlap on instant claims 3, 5, 23, and 25 which suggest the daily dose is administered as a half dose twice per day.
Conflicting claims 12, 14, 27, 28, 48, and 49 recite the administration of a second therapeutic agent which is a corticosteroid, reading on instant claims 1, 19, 21, and 39.
Conflicting claims 73 and 78 recite the eosinophilic asthma is characterized by about 300 eosinophil cells or more per microliter in the peripheral blood prior to the administration of dexpramipexole, which overlaps on the range of greater than 0.30x109 cells/L, which is equal to 300 cells per microliter recited in instant claims 8 and 28.
Conflicting claims 83 and 88 recite the eosinophil cells in the subject’s blood are reduced by at least 50% compared to prior to the administration of dexpramipexole, reading on instant claims 14, 15,34, and 35.
Each of the conflicting dependent claims not explicitly addressed above are also rejected due to their dependence on a rejected independent claim.
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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