DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 54-65 are withdrawn.
Claims 46-53 are pending and represent all claims currently under consideration.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claims 46-53 are considered to have an effective filing date of 09/20/2021.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 04/13/2026 is acknowledged. The traversal is on the ground(s) that the groups have unity of invention, because Crater does not disclose, describe, or exemplify any particle size for desidustat. This is not found persuasive because Crater teaches the claimed particle as described in the rejection below.
The requirement is still deemed proper and is therefore made FINAL.
Claims 54-65 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/13/2026.
Information Disclosure Statement
The information disclosure statements filed 03/01/2024 and 08/07/2024 have been considered.
Specification
The use of the terms Malvern and Mastersizer, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 nonobviousness.
Claims 46, 48, 50 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Crater (US 20210346357 A1). Crater was cited previously by the Examiner.
Regarding claim 46, Crater teaches a composition which can comprise desidustat (Crater, page 21, paragraph 0273), and teaches an example wherein the composition has a mean particle diameter of less than about 1.5 micrometers (Crater, page 18, paragraph 0240). Therefore, it would be prima facie obvious to one of ordinary skill in the art to utilize a particle comprising desidustat in the same size. While Crater does not specifically state 90% of the particles are less than about 250 micrometers, it would be reasonable to expect particles with a diameter of less than about 1.5 micrometers to meet this limitation. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Crater is considered to be analogous to the claimed invention, because both Crater and the instant invention are in the same field of therapeutic particles. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the claimed invention based on the teachings of Crater under the meaning of 35 U.S.C. 103.
Regarding claim 48, Crater teaches all the elements of the current invention as applied to claim 46. As above, Crater teaches an example of a suitable particle for the composition to have a mean diameter of less than about 1.5 micrometers (Crater, page 18, paragraph 0240). Therefore, it would be prima facie obvious to one of ordinary skill in the art to utilize a particle comprising desidustat in the same size. While Crater does not specifically state 90% of the particles are less than about 200 micrometers, it would be reasonable to expect particles with a diameter of less than about 1.5 micrometers to meet this limitation absent evidence to the contrary.
Regarding claim 50, Crater teaches all the elements of the current invention as applied to claim 46. As above, Crater teaches an example of a suitable particle for the composition to have a mean diameter of less than about 1.5 micrometers (Crater, page 18, paragraph 0240). Therefore, it would be prima facie obvious to one of ordinary skill in the art to utilize a particle comprising desidustat in the same size. While Crater does not specifically state at least 10% of the particles are less than about 30 micrometers, it would be reasonable to expect particles with a diameter of less than about 1.5 micrometers to meet this limitation absent evidence to the contrary.
Regarding claim 52, Crater teaches a composition comprising particles which can comprise desidustat (Crater, page 21, paragraph 0273), and teaches an example of a suitable particle for the composition to have a mean diameter of less than about 1.5 micrometers (Crater, page 18, paragraph 0240). Therefore, it would be prima facie obvious to one of ordinary skill in the art to utilize a particle comprising desidustat in the same size. While Crater does not specifically state a percentage of the particles which are less than each claimed size, it would be reasonable to expect particles with a diameter of less than about 1.5 micrometers to meet each limitation absent evidence to the contrary.
Claims 47, 49, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Crater (US 20210346357 A1) as applied to claims 46, 48, 50 and 52, further in view of Shekunov (Pharmaceutical Research, 2007).
Regarding claim 47, Crater teaches all the elements of the current invention as applied to claim 46. Crater teaches the composition is administered by inhalation (Crater, claim 4), but does not measure a value of particle size at which 50% of the particles are greater than about 5 micrometers. Shekunov, however, teaches an optimum range of acceptable drug particle sizes in pharmaceuticals (Shekunov, page 224, 2nd paragraph), and teaches particle size ranges from about 1 to about 125 micrometers for aerosols and nasal sprays (Shekunov, Fig 1; pages 204-205, “Respiratory Drug Delivery”).
Crater and Shekunov are considered to be analogous to the claimed invention, because Crater, Shekunov, and the instant invention are in the same field of particulate therapeutic treatments. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the particle size of Crater within the range known to be effective in the field, as shown by Shekunov, because Crater teaches that it will be understood by those of ordinary skill in the art that various changes can be made (Crater, page 31, paragraph 0386) and Shekunov teaches this range to be optimal for delivery (Shekunov, Fig 1; pages 204-205, “Respiratory Drug Delivery”).
Regarding claim 49, Crater and Shekunov together teach all the elements of the current invention as applied to claim 47. As above, Crater teaches an example of a suitable particle for the composition to have a mean diameter of less than about 1.5 micrometers (Crater, page 18, paragraph 0240). Therefore, it would be prima facie obvious to one of ordinary skill in the art to utilize a particle comprising desidustat in the same size. While Crater does not specifically state 50% of the particles are less than about 150 micrometers, it would be reasonable to expect particles with a diameter of less than about 1.5 micrometers to meet this limitation absent evidence to the contrary.
Regarding claim 53, Crater teaches a composition comprising particles which can comprise desidustat (Crater, page 21, paragraph 0273). Crater does not teach a specific surface area value of the particles. However, Shekunov, however, teaches there is an optimum range of acceptable drug particle sizes in pharmaceuticals which are dependent on factors such as the surface and shape of the particle (i.e., surface area; Shekunov, page 224, 2nd paragraph). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the particle size, surface, and shape of Crater as suggested by Shekunov, because Crater teaches that it will be understood by those of ordinary skill in the art that various changes can be made (Crater, page 31, paragraph 0386) and Shekunov teaches optimization of these parameters are critical in the manufacturing process (Shekunov, pages 224, 1st-2nd paragraphs).
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Crater (US 20210346357 A1) as applied to claims 46, 48, 50 and 52, further in view of Desai (US 20190359574 A1; IDS reference, 03/01/2024).
Regarding claim 51, Crater teaches all the elements of the current invention as applied to claim 46. As above, Crater teaches desidustat, but Crater does not specify the desidustat particles are crystalline. Desai, however, teaches a compound of formula I-a (i.e., desidustat) is known to be a crystalline compound (Desai, claim 48) and has characteristic powder X-ray diffraction pattern peaks expressed at about 8.0, 8.9, 10.6, 11.3, 16.1, 25.5, and 26.2±0.2 degree 2 theta (Desai, claim 50).
Crater and Desai are considered to be analogous to the claimed invention, because Crater, Desai, and the instant invention are in the same field of desidustat treatments. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the crystalline desidustat taught to have the claimed X-ray diffraction pattern in the particles of Crater, because Crater teaches the use of desidustat, and Desai teaches desidustat characterized as claimed to be known in the field.
Conclusion
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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