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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/04/2026 has been entered.
Applicants' arguments, filed 05/04/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 presently being applied to the instant application.
Claim Status
Claims 1-9, 12, and 13, are pending and under examination.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Ticehurst et al (US 20140141247 A1), in view of Helliwell (WO 2017075232) and Helliwell et al (US 20170246117 A1, hereinafter “Helliwell ‘117”), as evidenced by Wilson et al (Powder Tech, 2018, 339, pp 641-650) and Octagonchem (Fluticasone Propionate: Your ultimate Guide).
Ticehurst et al teach it was known to recrystallize fluticasone propionate with controlled particle size suitable for micronization (abs). In one embodiment, the D(0.9) of the particles was 135.9 microns, the D(0.5) was 55.1 microns, and the D(0.1) was 15.4 microns (table 2 ex 4). The process yields particles that are 5-200 microns in length, with a width of 3-30 microns (¶ 17).
Ticehurst et al do not teach the specific milling process, a methanol solution, and resulting particle size structure instantly claimed.
Helliwell teaches that recrystallization produces large crystal dimensions, which make it possible to resize (by milling) drug crystals into substantially uniform dimensions (p.7). As evidenced by Wilson, resizing crystal particles via milling breaks particles along the shortest axis, reducing needle length, whilst preserving needle width (into 3rd ¶, graphical abs). Large crystals up to 2000 microns were obtained, and the large crystals were then resized (ex. 1). The particle size distribution of the resized crystals are disclosed (see fig 1b, 1c). Crystals of ropivacaine (crystalline active) can be shortened and sieved before coating (pg. 7). The recrystallized, resized and sieved drug crystals may have at least two dimensions that are substantially the same, providing an aspect ratio of 1:1 (pp. 7-8). The crystals have at least one dimension ranging from 35-500 microns, more typically in the range of 50-200 microns (pg. 8 lines 4-7, figs 1b, 1c). The solvent for recrystallization was methanol, and the drug recrystallized with methanol did not exhibit burst release (pg. 20 ln 20-23, pg. 22 ln 24-26).
Helliwell, while teaching recrystallization in a methanol solution, does not specifically teach fluticasone propionate recrystallized from a methanol solution.
Helliwell ‘117 teaches methanol solutions were known to recrystallize fluticasone propionate powder, where crystal growth occurred (¶¶ 188, 189). As evidenced by Octagonchem, fluticasone propionate powder is crystalline.
With regards to claim 1, where Ticehurst et al and Helliwell are directed to crystalline actives with similar crystal sizes that are suitable for size reduction techniques, it would have been obvious to use the milling method of Helliwell in the process of Ticehurst et al, where they are reasonably expected to result in the desired crystal sizes.
Regarding the methanol solution of claim 1, it would have been obvious to use known solvents suitable for recrystallization of drugs that produce large crystal dimensions, such as methanol, which was known to make it possible to resize the drug crystals into substantially uniform dimensions, as taught by Helliwell. The skilled artisan would have had a reasonable expectation of success in using methanol where Helliwell ‘117 teaches it was known that methanol solutions were suitable for recrystallizing fluticasone propionate crystals into larger crystalline structures, and where both are directed to resizing crystalline drugs for desired uses.
Regarding wherein at least 90% by mass of the recrystallized crystals have the shortest dimensions in the range of 50-250 microns of claim 1, where Ticehurst et al and Helliwell are both directed a method of producing larger crystalline active agents that are resized to desired sizes, it would have been obvious for the skilled artisan to adjust the crystal sizes to other sizes that were known to be suitable for resizing, such as up to 2000 microns, as taught by Halliwell, as a matter of routine optimization to achieve desired particle sizes for desired dosage forms, etc. See MPEP 2144.05(II)(A). While Halliwell does not explicitly disclose that 90% by mass have the shortest dimension in the range of 50-250 microns, recrystallized drugs for resizing were known to be up to 2000 microns, which appears to overlap the range instantly claimed. See MPEP 2144.05(I). Further, where an aspect ratio of 1 was known with particle sizes ranging from 35-500 microns, and were resized by shortening (i.e., only segmenting along the lengthwise axis while retaining the transverse plane dimensions), it appears the shortest dimensions of the particle would fall within the particle size ranges made obvious above.
Regarding wherein no more than 10% of the sized crystals are less than 30 microns of claim 1, it would have been obvious to modify the process of Ticehurst et al, by adjusting the size of the sized crystals to other sizes that were known to be suitable for sized crystalline drug forms, such no more than 10% of the sized crystals having a particle size less than 30 microns, as shown in Fig. 1C of Helliwell, in order to optimize the particle size distribution for desired dosage forms, etc. See MPEP 2144.05(II)(A).
Regarding claims 2-5, it is noted that the crystal sizes instantly claimed overlap with those taught by the Helliwell. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). While the specific percentages by weight are not specifically disclosed, it is reasonably expected that the limitations are met where the disclosed sizes are within the range and the disclosed sizes are expected to be the majority of the crystal sizes.
Response to Arguments
First, Applicants assert Ticehurst does not teach the claimed dimensions of recrystallized fluticasone propionate. Applicants assert Ticehurst employs a solvent/antisolvent system to create drug crystals and then subjects them to further micronization. Applicants assert Ticehurst begins with much smaller crystals than the claimed crystals, which are smaller than the shortest dimensions instantly claimed.
Second, Applicants assert crystal growth and sizing are unpredictable for different chemical compounds, and where Helliwell is directed to a different API, there is no way of knowing or predicting which API might be able to have controlled crystal growth and sizing by segmentation. Applicants assert they have discovered that, from the claimed methanol solution, the fluticasone propionate crystals can grow thicker even after the c-axis growth slows down. Applicants assert this is in contrast to conventional recrystallization. Applicants assert the fluticasone propionate can be preferentially segmented along the lengthwise axis while maintaining the shortest dimensions and asserts these traits are specific to the compound and its crystal structure. Applicants assert Wilson does not provide guidance to utilize the knowledge of Ticehurst and Helliwell in order to arrive at the claimed process, where Applicants assert Wilson teaches breaking particles along the shortest axis, which is the exact opposite of the claimed process.
First, respectfully, this argument is not persuasive. While it does appear that the particle sizes from the working embodiments of Ticehurst et al are smaller than those instantly claimed, Ticehurst et al more broadly teaches a process of resizing recrystallized fluticasone propionate with a controlled particle size to achieve sizing for desired dosage forms. Helliwell teaches a similar process where particle sizes overlapping those instantly claimed were known, and even teaches the recrystallized larger crystals had a particle size of up to 2000 microns with the resized particles ranging from 35-500 microns with an aspect ratio of 1. Helliwell also teaches a D10 particle size distribution falling within the claimed ranges were known to be produced by this process, as discussed above. As such, it would have been obvious for the skilled artisan to optimize the process of Ticehurst et al for desired administration forms, for the same reasons discussed above. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions. See MPEP 2144(II)(A).
Second, respectfully, this argument is not persuasive. Applicants assert that crystal growth and sizing are unpredictable with different chemical compounds, but do not appear to have provided evidence to support this assertion. Where Ticehurst et al and Helliwell are both directed to crystallizing active agents and subjecting the crystallized active agent to resizing steps to achieve desired crystal sizes, it would be reasonably expected that the use of a known technique, with a known solvent suitable for recrystallization that was also known to be suitable for recrystallizing fluticasone propionate specifically, would result in crystals that can be segmented to achieve desired crystal size for desired uses. Applicants assert the methanol solution was able to grow thicker crystals even after the c-axis growth slows down compared to “conventional recrystallization,” but it does not appear that Applicants have provided any comparative data to support these assertions. Likewise, Applicants assert that fluticasone propionate can be preferentially segmented along the claimed axis and assert these traits are specific to fluticasone propionate, but again, there appears to be no evidence or a showing to support this assertion. Arguments presented by the applicant cannot take the place of evidence in the record. See MPEP 716.01(c). From the prior art, Wilson evidences resizing crystal particles via milling breaks particles along the shortest axis, reducing needle length, whilst preserving needle width, thereby providing a reasonable expectation that resizing the crystals made obvious above via milling would break the particles along the shortest axis, reducing needle length, whilst preserving needle width (emphasis added). Applicants assert this is the opposite of what is claimed where the claim recites retaining the shortest axis, but it appears both are reducing the length while preserving the width. The claim appears to describe the process relative to the lengthwise axis, while Wilson describes the orientation of the break plane, where both result in shorter length with no change to the shortest dimension.
Claims 6-8, 12, and 13, are rejected under 35 U.S.C. 103 as being unpatentable over Ticehurst et al (US 20140141247 A1), Helliwell (WO 2017075232), and Helliwell et al (US 20170246117 A1, hereinafter “Helliwell ‘117”), in view of Malamatari (Pharmaceutical nanocrystals: production by wet milling and applications, Drug Discovery Today, Volume 23, Issue 3, March 2018, pp. 534-547), as evidenced by Turk et al (Pharmaceutics, 2021, 13, 746, pp 1-11).
Helliwell is discussed above and further teaches the particles were resized by milling (example 1). The recrystallized particles may have smaller/finer crystals attached to the surface; to remove these finer crystals, the particles were suspended in a polyvinyl alcohol (PVA) solution and washed with methanol and water (p.21), sieved (p.21), and individually coated with PVA (p.9). The degree of the crystallinity of the PVA coating may be controlled by thermal curing at a certain temperature for a certain period of time (p.10). Halliwell teaches methods of forming polymeric coatings on particles are well known in the art, and include spray coating, air suspension techniques, etc. (pg 12 last ¶ - pg 13 1st ¶).
Ticehurst et al, Helliwell, and Helliwell ‘117, are discussed above but do not specifically teach using a rotor/stator homogenizer to provide shorter crystals, nor the use of fluid bed coating equipment to coat the polymer membrane on the sized crystals.
Malamatari teaches it was known to resize crystalline actives with rotor-stator mills (i.e., homogenizer) (abs, pg 539 2nd col 3rd ¶ and “Rotor-stator mixers/wet mills”). Rotor-stator mills lead to size reduction (“Rotor-stator mixers/wet mills”). Fluticasone propionate is taught as a suitable drug (pg 543 1st col last ¶). Fluidized-bed coating was known technique to be used with crystalline drugs (pg 541 2nd col 2nd ¶). As evidenced by Turk et al, fluidized bed coating is a process used in the pharmaceutical industry to coat drugs with a polymer film (intro 1st ¶).
Regarding claim 6, it would have been obvious to use a known milling method for reducing the particle size of crystalline drugs, such as by using rotor/stator homogenizers, where Helliwell and Malamatari both teach milling as a method for shortening crystalline actives.
Regarding claim 7, a person having ordinary skill in the art following the teachings of Helliwell would have been motivated to use sieving to provide the desired sized particles having substantially uniform dimensions as taught by Helliwell.
Regarding claim 8, it would have been obvious to suspend the particles in PVA and wash with methanol and water, in order to remove finer crystals from the resized crystals, as taught by Helliwell. Further, it appears polyvinyl alcohol reads on a surfactant, therefore, the limitation of the rinsing liquid comprising a surfactant and one or more solvents is met.
Regarding claim 12, it would have been obvious to use known techniques to coat the sized fluticasone propionate crystals made obvious by Helliwell and Ticehurst et al above, such as by using fluid bed coating equipment, as taught by Malamatari.
Regarding claim 13, it would have been obvious to coat the crystals with a polyvinyl alcohol, as taught by Helliwell.
Response to Arguments
Applicants again assert Turk et al are relied upon to show the milling step, however, the claimed process requires a “sizing” step that is “segmenting the supersized crystals along the respective lengthwise axes while retaining the dimensions of the transverse plane perpendicular to the lengthwise axis.” Applicants assert this is different from “milling” in micronization, which does not have preferential segmentation.
Respectfully, this argument is not persuasive. Applicants assert that Turk et al was recited for teaching the milling step, however, as previously discussed Turk et al was only cited as an evidentiary reference that defines the process of fluidized bed coating, which is taught by Malamatari. The examiner notes that Malamatari was cited for teaching rotor-stator milling was a known method for resizing crystalline drugs, as discussed above, which appears to be the same resizing method instantly claimed, which recites rotor-stator milling. Segmenting the crystals along the respective lengthwise axes while retaining the dimensions of the transverse plane perpendicular to the lengthwise axis is taught by Helliwell and evidenced by Wilson et al, as discussed above.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ticehurst et al (US 20140141247 A1), Helliwell (WO 2017075232), Helliwell et al (US 20170246117 A1, hereinafter “Helliwell ‘117”), and Malamatari (Pharmaceutical nanocrystals: production by wet milling and applications, Drug Discovery Today, Volume 23, Issue 3, March 2018, pp. 534-547), and further in view of Chen (CN 101757634 A).
Ticehurst et al, Helliwell, Helliwell ‘117, and Malamatari, are discussed above but do not specifically teach polysorbate 80 as the surfactant (description, ¶¶ 2, 33).
Chen discloses a pharmaceutical composition comprising fluticasone propionate, where TWEEN 80 (i.e., polysorbate 80) was known to be used as a surfactant.
It would have been obvious to substitute polysorbate 80 for the PVA used as the rinse of Helliwell, where polysorbate 80 is a surfactant that is known to be suitable for use with fluticasone propionate. See MPEP 2143(I)(B).
Regarding the amounts, a skilled artisan would reasonable be expected to determine the working range of polysorbate 80 to use in the rinsing liquid, such as 0.05-1 wt%. MPEP 2144.05(II).
Response to Arguments
Applicants assert Malamatari and Chen et al do not cure the deficiency of Ticehurst as they are limited to conventional milling processes.
Respectfully, this argument is not persuasive. Regarding claim 9, Malamatari is discussed above, and Chen et al was cited for simply teaching known surfactants used pharmaceutical compositions of fluticasone propionate.
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 1-9, 12, and 13, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/753,995 (reference application), hereinafter referred to as ‘995, in view of Ticehurst et al (US 20140141247 A1), Helliwell (WO 2017075232), Helliwell et al (US 20170246117 A1, hereinafter “Helliwell ‘117”), Malamatari (Pharmaceutical nanocrystals: production by wet milling and applications, Drug Discovery Today, Volume 23, Issue 3, March 2018, pp. 534-547), and Chen (CN 101757634 A). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘995 discloses a dosage form comprising fluticasone propionate crystals coated with a polyvinyl alcohol membrane (claim 1). 90% of the total mass of the particles are no larger than 250 microns, 50% have a mean size in the range of 120-160 microns, 10% are less than 65 microns (claim 7).
‘995 does not disclose a process for providing crystals of fluticasone propionate of desired size and morphology as instantly claimed.
Where the polyvinyl alcohol coated crystal fluticasone propionate particles comprise the same coating as instantly claimed and have overlapping particle size distributions, it would have been obvious to modify the particles of ‘995 by formulating the fluticasone propionate crystals with the method made obvious by Ticehurst et al, Helliwell, Helliwell ‘117, Malamatari, and Chen, for the same reasons discussed above as applied to each of the instant claim limitations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The following are also rejected for the same reasons:
Copending Application No. 17/735,915, while disclosing a composition comprising a crystalline drug coated with a PVA membrane, the claims do not disclose a process for providing crystals of fluticasone propionate of desired size and morphology as instantly claimed. It would have been obvious to modify the claims of ‘915 by substituting fluticasone propionate crystals of Helliwell for the active agent, where both are directed to coated crystalline drugs, depending on desired use. It would have been obvious to modify the claims of ‘915 by formulating the fluticasone propionate crystals with the method made obvious by Ticehurst et al, Helliwell, Helliwell ‘117, Malamatari, and Chen, for the same reasons discussed above as applied to each of the instant claim limitations.
Copending Application No. 17/457,248, while disclosing a composition comprising a crystalline drug selected from fluticasone propionate coated with a PVA membrane, the claims do not disclose a process for providing crystals of fluticasone propionate of desired size and morphology as instantly claimed. It would have been obvious to modify the claims of ‘248 by formulating the fluticasone propionate crystals with the method made obvious by Ticehurst et al, Helliwell, Helliwell ‘117, Malamatari, and Chen, for the same reasons discussed above as applied to each of the instant claim limitations.
Copending Application No. 18/964,311, while disclosing method of treating inflammation or pain in a subject with a crystalline drug coated with a polymeric shell, and wherein the active is fluticasone propionate, the claims do not disclose a process for providing crystals of fluticasone propionate of desired size and morphology as instantly claimed. It would have been obvious to modify the claims of ‘311 by formulating the fluticasone propionate crystals with the method made obvious by Ticehurst et al, Helliwell, Helliwell ‘117, Malamatari, and Chen, for the same reasons discussed above as applied to each of the instant claim limitations.
Response to Arguments
Applicants assert claims 1-9, 12 and 13 are patentably distinct from the reference application because Ticehurst et al do not render the claims obvious, as set forth above.
Respectfully, this argument is not persuasive. Examiner disagrees for the same reasons above and of record. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. 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 1-9, 12, and 13, are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,351,124 B2, hereinafter referred to as ‘124, in view of Ticehurst et al (US 20140141247 A1), Helliwell (WO 2017075232), Helliwell et al (US 20170246117 A1, hereinafter “Helliwell ‘117”), Malamatari (Pharmaceutical nanocrystals: production by wet milling and applications, Drug Discovery Today, Volume 23, Issue 3, March 2018, pp. 534-547), and Chen (CN 101757634 A). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘124 discloses a pharmaceutical composition comprising one or more crystals of local anesthetic agent (crystalline active), and a polyvinyl alcohol coating, wherein each microparticle has at least one dimension in the range of 35-500 microns (claim 1). The local anesthetic agent is ropivacaine (claim 14).
‘124 does not disclose a process for providing crystals of fluticasone propionate of desired size and morphology as instantly claimed.
It would have been obvious to modify ‘124 by formulation the crystals with the method made obvious above by Ticehurst et al, Helliwell, Helliwell ‘117, Malamatari, and Chen, for the same reasons discussed above as applied to each of the instant claim limitations.
It would have been obvious to substitute fluticasone propionate for the active of ‘124, for the same reasons discussed above by Halliwell and Ticehurst et al, where both are drawn to crystal drugs that are coated and have an overlapping size range.
The following are also rejected for the same reasons:
U.S. Patent No. 9,987,233 B2, while disclosing a composition comprising a crystalline drug comprising fluticasone propionate coated with a PVA membrane, the claims do not disclose a process for providing crystals of fluticasone propionate of desired size and morphology as instantly claimed. It would have been obvious to modify the claims of ‘233 by formulating the fluticasone propionate crystals with the method made obvious by Ticehurst et al, Helliwell, Helliwell ‘117, Malamatari, and Chen, for the same reasons discussed above as applied to each of the instant claim limitations.
U.S. Patent No. 11,219,604 B2, while disclosing a method for making PVA coated microparticles comprising crystalline drug cores of fluticasone propionate, and comprises the step of sizing a plurality of recrystallized particles of fluticasone propionate, the claims do not disclose a process for providing crystals of fluticasone propionate of desired size and morphology as instantly claimed. It would have been obvious to modify the claims of ‘604 by formulating the fluticasone propionate crystals with the method made obvious by Ticehurst et al, Helliwell, Helliwell ‘117, Malamatari, and Chen, for the same reasons discussed above as applied to each of the instant claim limitations.
Response to Arguments
Applicants assert claims 1-9, 12 and 13 are patentably distinct from the reference application because Ticehurst et al do not render the claims obvious, as set forth above.
Respectfully, this argument is not persuasive. Examiner disagrees for the same reasons above and of record. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. 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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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