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Claims 54-65 are withdrawn.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.
Response to Amendment
The amendment filed 08/04/2026 has been entered.
Claims 48-50 were amended. No new material was added.
Applicant’s amendments have overcome the previous objections to the specification.
Response to Arguments
Applicant's arguments filed 08/04/2026 have been fully considered but they are not persuasive.
Applicant argues that Crater is directed toward a size of a compound that is entirely different from desidustat, and does not teach or suggest desidustat having any particular physical form, particle size, particle size distribution, or other physical property (Remarks, pages 7-8). Applicant further states that there would be no objective reason why one of ordinary skill in the art would take the particle size for compound 1 and apply it to desidustat as there is no physical or chemical similarity between the compounds, and the two compounds are mentioned in entirely different contexts (Remarks, page 9). This argument is not persuasive, because Crater teaches a meter-dose inhaler composition comprising compound 1, which results in particles having a mean diameter of less than about 1.5 micrometers (Crater, page 18, paragraphs 0241-0242). Therefore, the size taught by Crater is not the size of compound 1, but of the particle itself. Desidustat is taught by Crater as an additional therapeutic agent to be used in combination with compound 1 (Crater, claim 24; pages 21-22, paragraph 0273), suggesting the two compounds should be used together in the same composition, which would be reasonably expected to result in particles of similar size.
Applicant argues that the mere inclusion of desidustat in a laundry list of potential combination agents does not constitute a teaching of desidustat particles as claimed, and that there is no preference for desidustat (Remarks, page 8-9). This argument is not persuasive, because desidustat is taught in a finite list of 350 additional therapeutic agents to be used in combination with compound 1 (Crater, claim 24; pages 21-22, paragraph 0273). Therefore, it would have been prima facie obvious to one of ordinary skill in the art to have utilized desidustat in the composition of Crater.
Modified/Maintained 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 as an additional therapeutic (Crater, page 21, paragraph 0273; claim 24), 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). The references were cited previously by the Examiner.
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). The references were cited previously by the Examiner.
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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHASITY P JANOSKO whose telephone number is (703)756-5307. The examiner can normally be reached 7:30-3:30 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
Prosecution Insights