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 .
Abstract
The abstract of the disclosure is objected to because it does not appear on a separate page. Correction is required. See MPEP § 608.01(b).
The abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b) because it shares a page with the title. A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text.
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 1-2 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Wieckhusen et al. (previously cited) as evidenced by in view of Persson (US PGPub No. 2018/0021894) and Horiba Scientific: A guidebook to particle size analysis (2010 – henceforth Horiba reference).
Wieckhusen et al. teach crystalline iloperidone in an injectable depot that is a suspension formulated for intramuscular injection (see abstract and column 1 lines 23-27 and lines 59-64 and column 5 lines 6-14). The drug is an anti-psychotic compound that is released over 2 to 8 weeks (see column 5 lines 6-14 and 36-38). Wieckhusen et al. teach the combination of particles in a vial with a liquid suspension vehicle, followed by shaking or swirling to yield a homogenous suspension, withdrawal by a syringe, and injection (see column 5 lines 31-33 and examples 2-3; instant claims 1 and 7). Various doses are generated where 120 mg/ml and 425 mg/ml are employed in 1 ml or 2 ml volumes that yield a range of consistencies from a homogeneous liquid suspension to a homogeneous suspension paste that are separately injected into a subject (see examples 1-3). Wieckhusen et al. also teach a dosing range of 100 to 750 mg per injection (see column 5 lines 19-21; instant claims 22, 36, 42, 47, and 61-62). Average particle sizes, X50, are taught to range from 1 to 200 micron, where examples provide averages of 32 and 15 microns and preferred ranges narrow to 10 to 170 microns and 15 to 70 microns (see column 2 lines 25-30 and column 4 lines 1-9; instant claims 67-68). These exemplary sizes are less than 120 microns. Persson details that the mean particle diameter can be expressed as X50 which is the median particle diameter and is understood as a volume based measurement (e.g., Dv50) (see paragraph 28 and Horiba reference page 4). Wieckhusen et al. teach that the particle size can be adjusted as desired by producing larger particles than needed then milling and sieving them to the desired size (see column 4 lines 10-21). While Wieckhusen et al. do not exemplify a composition of iloperidone with a concentration as instantly claimed, their teachings provide a range of concentrations that span from 120 to 425 mg/ml which embrace the claimed range and provide a variation in consistency that increases in viscosity with concentration. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to choose a concentration within the claimed range, including those instantly claimed, as a matter of routine optimization because the concentration is a result effective variable. In addition, the claimed range is embraced by that of Wieckhusen et al. which renders the claimed range obvious. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). The recitation of iloperidone at about 600 mg in about 3 to 3.6 ml yields a total amount of iloperidone that falls within the range of 120 mg to 850 mg that were reconstituted in the examples and is near the upper end of the preferred range that is also taught. Given that the range implied by “about 600 mg” is embraced by both ranges it is obvious (see MPEP 2144.05). Further, exemplified average (median) particle sizes of 32 and 15 microns taught by Wieckhusen et al. fall within the instantly claimed range of Dv50 up to 120 microns. The particle size is additionally obvious to optimize within the taught range as a matter of routine experimentation. Therefore claims 1-2 and 7 are obvious over Wieckhusen et al. as evidenced by Persson and the Horiba reference.
Claims 1-2, 7-8, 13, 15, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wieckhusen et al. as evidenced by Persson and the Horiba reference as applied to claims 1-2 and 7 above, and further in view of in view of Lesch (US PGPub No. 2008/0154200), Bokelman et al. (US PGPub No. 2015/0174326), and Wolfgang et al. (US PGPub No. 2009/0306137).
Wieckhusen et al. as evidenced by Persson and the Horiba reference render obvious the limitations of the injectable suspension depot of instant claims 1-2 and 7 and provide a size that meets the limitation of Dv50 up to 120 microns, the concentration of instant claims 13 and 15 and dosing of claims 18 and 19 due to the overlap in the recited ranges of drug mass and suspension volume. Single injections of 100 to about 750 mg are detailed (see page 6 sixth full paragraph). Wieckhusen et al. do not detail the time for injection.
Lesch teach a device for the administration of a fluid medicament via a needle assisted autoinjector syringe (see abstract and paragraph 7). The envisioned drugs include antidepressants (see paragraph 28). They go on to teach the device for intramuscular injection as well as the administration of 0.02 to about 3 ml and preferably about 1 ml in an injection (se paragraphs 12 and 45). Lesch teach the injection of the entire amount of medicament in less than about 4 seconds and a rate of preferably about 0.5 ml/sec (steady speed; single push) (see paragraph 46; instant claims 8 and 13).
Bokelman et al. note the benefit of autoinjectors for medication administration by untrained users as well as convenience and increased patient compliance (see abstract and paragraph 5). They also discuss their suitability for injecting liquid drug suspensions (see paragraphs 21 and 56).
Wolfgang et al. teach iloperidone as an antidepressant (see abstract and paragraph 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide and administer the compositions rendered obvious by Wieckhusen et al. as evidenced by Persson and the Horiba reference via the needle assisted autoinjector of Lesch. The modification is obvious because autoinjectors provide a broadly applicable clinical and user benefit for injectable medicaments, as noted by Bokelman et al. Further, Lesch teach a particular variety of autoinjector that envisions the administration of anti-depressants, a category to which the iloperidone of Wieckhusen et al. as evidenced by Persson and the Horiba reference belongs, in light of Wolfgang. Additionally, the modification has a reasonable expectation of success, given the recognized suitability of autoinjectors for injecting drug suspensions, as indicated by Bockelman et al. The modification would also have been obvious as the application of the same technique to a similar product in order to yield the same improvement. This would then yield an injection of the volumes of Lesch of a composition of Wieckhusen et al. within less than 4 seconds at a rate as detailed by Lesch. These volumes meet or overlap the instantly claimed volumes explicitly or due to the approximate nature of the claim limitations. The corresponding range of dosing concentrations that span from 120 to 425 mg/ml in these volumes embrace those instantly claimed, thereby rendering the claimed ranges obvious (see MPEP 2144.05; instant claims 2, 13, 15, and 18-19). Therefore claims 1-2, 7-8, 13, 15, and 18-19 are obvious over Wieckhusen et al. in view of in view of Lesch, Bokelman et al., and Wolfgang et al. as evidenced by Persson and the Horiba reference.
Claims 1-2, 7-11, 13-15, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wieckhusen et al. in view of in view of Lesch, Bokelman et al., and Wolfgang et al. as evidenced by Persson and the Horiba reference as applied to claims 1-2, 7-8, 13, 15, and 18-19 above, and further in view of Lambert et al. (previously cited) as evidenced by Zhang et al. (previously cited).
Wieckhusen et al. in view of in view of Lesch, Bokelman et al., and Wolfgang et al. as evidenced by Persson and the Horiba reference render obvious the limitations of instant claims 1-2, 7-8, 13, 15, and 18-19. Their teachings render obvious the injection of about 1.25 ml to about 1.5 ml and about 2.5 to 3 ml as well as a dosing levels of about 166.67 to about 200 mg, about 500 mg, and about 250 mg. The exemplified and taught average size of the crystalline iloperidone particles of Wieckhusen et al., include 1 to 200 microns, 10 to 170 microns, 15 to 70 microns, 15 microns and 32 microns. Wieckhusen et al. teach the suspension of the iloperidone in water as well as in a solution of mannitol, poloxamer 188 (called Pluronic® F68), and carboxymethyl cellulose sodium in a vial (see column 5 lines 31-33 and examples 2-3; Zhang et al. page 376 first column last partial paragraph; instant claims 9 and 14). The proportions of the excipients in the suspension vehicle are not detailed by Wieckhusen et al.
Lambert et al. teach a suspension vehicle for an injectable particulate drug depot (see abstract, page 11 fifth paragraph, and page 14 third paragraph following section “e”). They further teach 1 to 5 ml as well as 2 mL volumes injection volumes (see page 12 eighth paragraph). The suspension is prepared in an aqueous vehicle that includes water, mannitol, poloxamer 188 (called Pluronic® F68), and carboxymethyl cellulose sodium (see page 11 sixth paragraph and example 2). When included in a vial, the preferred vehicle contains 14 mg carboxymethyl cellulose sodium, 90 mg mannitol, and 4 mg poloxamer 188 in 2 ml (see example 2; instant claims 9 and 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the suspension vehicle excipient proportions taught by Lambert et al. in the suspensions of Wieckhusen et al. that are administering in view of Lesch, Bokelman et al., and Wolfgang et al. This choice would have been obvious because they were known for suspending medium components that are also contemplated by Wieckhusen et al. Additionally, they are preferred for single chambered vessel (e.g., syringe or vial) preparations of injectable depots, as is employed in Wieckhusen et al. and envisioned by Lesch as noted in their paragraph 7. This then implicitly meets the limitations for the process steps where the excipients are added and the volume brought to 2 ml, as volume exemplified by Wieckhusen et al. (see instant claims 9 and 14). The other volumes rendered obvious by Wieckhusen et al. in view of in view of Lesch, Bokelman et al., and Wolfgang et al. as evidenced by Persson and the Horiba reference are still obvious as well (see instant claims 10-11). The particle sizes of Wieckhusen et al. meet or yield an overlapping or embracing range of Dv50 values relative to those instantly claimed and renders them obvious (see instant claims 3 and 14; MPEP 2144.05). There is no evidence of the criticality of the claimed particles sizes and Wieckhusen et al. indicate that the size and distribution can be selected within their taught ranges as desired, suggesting routine optimization. Therefore claims 1-2, 7-11, 13-15, and 18-19 are obvious over Wieckhusen et al. in view of Lesch, Bokelman et al., Wolfgang et al., and Lambert et al. as evidenced by Persson, the Horiba reference, and Zhang et al.
Claims 1-2, 7-8, 12-13, 15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wieckhusen et al. as evidenced by Persson and the Horiba reference as applied to claims 1-2 and 7 above, and further in view of in view of Bokelman et al., Lesch, and Wolfgang et al.
Wieckhusen et al. as evidenced by Persson and the Horiba reference render obvious the limitations of the injectable suspension depot of instant claims 1-2 and 7 and provide a size that meets the limitation of Dv50 up to 120 microns. Single injections of 100 to about 750 mg are detailed (see page6sixth full paragraph). Wieckhusen et al. also teach combining the crystalline iloperidone with a suspension vehicle in a vial, shaking to form a homogeneous suspension, then withdrawing the suspension into a syringe, and then injecting into a subject (see page 6 seventh full paragraph and example 2; instant claim s12 and 20). No waiting/holding period is detailed between steps suspension (e.g. injection within less than 48 from suspension n vehicle). Wieckhusen et al. do not detail the time for injection.
Bokelman et al. note the benefit of autoinjectors for medication administration by untrained users as well as convenience and increased patient compliance (see abstract and paragraph 5). They also discuss their suitability for injecting liquid drug suspensions (see paragraphs 21 and 56). Bokelman et al. go on to discuss autoinjectors that employ pre-filled syringes as well as the benefits of automatic injectors that accommodate single use syringes and safety syringes (see paragraph 58). They further teach prefilled or at-time-of-use filled (e.g., within 48 hours of suspension) safety syringes in the autoinjector (see paragraphs 8 and 58).
Lesch teach a device for the administration of a fluid medicament via a needle assisted autoinjector syringe (see abstract and paragraph 7). The envisioned drugs include antidepressants (see paragraph 28). They go on to teach the device for intramuscular injection as well as the administration of 0.02 to about 3 ml and preferably 1 ml in an injection (se paragraphs 12 and 45). Lesch teach the injection of the entire amount of medicament in less than about 4 seconds and rate of preferably 0.5 ml/sec (steady speed; single push) (see paragraph 46; instant claims 8, 12-13, and 20).
Wolfgang et al. teach iloperidone as an antidepressant (see abstract and paragraph 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide and administer the compositions rendered obvious by Wieckhusen et al. as evidenced by Persson and the Horiba reference via a syringe containing autoinjector of Bokelman et al. The modification is obvious because autoinjectors provide a broadly applicable clinical and user benefit for injectable medicaments. Further, Lesch teach envisioned rates of injection, times of injection, and volumes of injection that are desirable for such devices as well as their use for the administration of anti-depressants, a category to which the iloperidone of Wieckhusen et al. as evidenced by Persson and the Horiba reference belongs, in light of Wolfgang. Thus the application of these use parameters in the autoinjector devices of Bockelman et al. would have been obvious as would the administration of an iloperidone suspension. Since Bockelman et al. specifically tout the utility of time-of-use filled safety syringes, the in-vial reconstitution and syringe filling of Wieckhusen et al. would have been obvious to perform as part of providing time-of-use filled safety syringes for the autoinjector. Administration, following reconstitution, syringe filling, and syringe loading would then follow (e.g., within 48 hours of suspension). Additionally, the modification has a reasonable expectation of success, given the recognized suitability of autoinjectors for injecting drugs suspensions as indicated by Bockelman et al. The modification would also have been obvious as the application of the same technique to a similar product in order to yield the same improvement. This would then yield an injection of volumes of a composition of Wieckhusen et al. between about 1 and about 3 mL, per the teachings of Wieckhusen et al. and Lesch, as well as within less than 4 seconds and at a rate as detailed by Lesch. These prior art volumes meet the instantly claimed volumes explicitly or due to the approximate nature of the claim limitations and he result overlap (see MPEP 2144.05; instant claims 13, 15, and 18-19). The corresponding range of dosing concentrations that span from 120 to 425 mg/ml in these volumes embrace those instantly claimed, thereby rendering the claimed ranges obvious (see MPEP 2144.05; instant claims 2, 15, and 18-19). Therefore claims 1-2, 7-8, 12-13, 15, and 18-20 are obvious over Wieckhusen et al. in view of in view of Bokelman et al., Lesch, and Wolfgang et al. as evidenced by Persson and the Horiba reference.
Claims 1-2, 4-8, 12-13, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wieckhusen et al. in view of in view of Bokelman et al., Lesch, and Wolfgang et al. as evidenced by Persson and the Horiba reference as applied to claims 1-2, 7-8, 12-13, 15, and 18-20 above, and further in view of in view of Shah et al. (US PGPub No. 2004/0146562) as evidenced by Mandpe et al. (Pharmaceutical Development and Technology 2015 20(3): 320–329).
Wieckhusen et al. in view of in view of Bokelman et al., Lesch, and Wolfgang et al. as evidenced by Persson and the Horiba reference render obvious the limitations of the injectable suspension depot method of production of instant claims 1-2, 7-8, 12-13, 15, and 18-20. They render obvious injection volumes and dose amounts in accordance with instant claims 5 and 6. The modified teachings of Wieckhusen et al. do not discuss all the instantly recited reconstitution details for the time-of-use loading of the syringe for the autoinjector.
Shah et al. teach the reconstitution of a poorly water soluble psychotherapeutic drug, like that of Wieckhusen et al., into an injectable depot (see paragraphs 3 and 5; Mandpe et al. abstract page 321 first column first full paragraph). Here a dry drug powder is made into a suspension where a liquid medium is added to the drug particles in a vial and agitated to fully resuspend them (see paragraph 54). The suspension is left to equilibrate prior to administration to permit stabilization of the amount of dissolved drug in the suspending medium (see paragraph 41). A liquid suspending medium is added to the vial followed by agitation to disperse the particles (see paragraph 54). Subsequently, the vial is left undisturbed for 30 minutes ± 15 minutes, then agitated again to redisperse the particles immediately prior to dosing (see paragraph 54; instant claims 4 and 16). A dosing syringe then withdraws a desired volume from the vial, and both trapped air bubbles and any excess volume are removed, such that the desired volume of suspension is left in the syringe (see paragraph 54; instant claims 5-6 and 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to reconstitute the suspension and then load the time-of-use syringe of Wieckhusen et al. in light of the known procedure for reconstituting injectable depots as detailed by Shah et al. The range of times for sitting after the initial resuspension as well as that after the second resuspension before loading the syringe overlap with those instantly claimed, thereby rendering the claimed ranges obvious (see MPEP 2144.05). Therefore claims 1-2, 4-8, 12-13, and 15-20 are obvious over Wieckhusen et al. in view of Bokelman et al., Lesch, Wolfgang et al., and Shah et al. as evidenced by Persson, the Horiba reference, and Mandpe et al..
Claims 1-2, 4, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Wieckhusen et al. as evidenced by Persson and the Horiba reference as applied to claims 1-2 and 7 above, and further in view of Andreef et al. (previously cited) and Fuchs et al. (previously cited).
Wieckhusen et al. as evidenced by Persson and the Horiba reference render obvious the limitations of the injectable suspension depot method of production of instant claims 1-2 and 7. Wieckhusen et al. do not discuss all the instantly recited reconstitution details.
Andreef et al. also teach reconstitution of a dry drug powder into a suspension where a liquid medium is added to the drug particles in a vial and agitated to fully resuspend them (see paragraph 42-43 and 46). If foam occurs, they detail letting the vial stand (undisturbed) for a few minutes until the foam subsides (see paragraph 46). They then teach gently inverting the vial to redisperse any settled material and loading the suspension into a desired administration dispensing apparatus (see paragraph 46).
Fuchs et al. teach a particulate injectable drug depot that is reconstituted prior to injection (see abstract and paragraph 99). Here they detail mixing the particles well in the vehicle, drawing the suspension into a syringe, and injecting into the desired location within 10 to 30 seconds of syringe loading to avoid settling and potential clogging of the syringe (see paragraph 99).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to permit a shaken and reconstituted version of the composition of Wieckhusen et al. to sit undisturbed so that foam can dissipate in view of Andreef et al. The duration of this time period is a result effective and thus obvious to optimize as a matter of routine work which renders the instant duration obvious (see instant claim 4). It additionally would have been obvious to gently re-disperse any settled material in the container via inverting, loading a syringe and injecting within 10 to 30 seconds to avoid additional settling in the vial or syringe as Fuchs et al. teach can occur. The range of time between gentle redispersion and syringe loading overlaps with that instantly claimed, thereby rendering the claimed range obvious (see MPEP 2144.05). Therefore claims 1-2, 4, and 7 are obvious over Wieckhusen et al. in view of Andreef et al. and Fuchs et al. as evidenced by Persson and the Horiba reference.
Response to Arguments
Applicant's arguments filed July 16, 2026 have been fully considered. In light of the amendment to the claims, the rejection under 35 USC 112(b) is hereby withdrawn. New grounds of rejection are detailed to address the new combinations of limitations. Some previous rejections under 35 USC 103 are modified in light of the amendment others are withdrawn. Those reliant upon Hickey et al. are withdrawn due to their statement of their expectation of the their viscosity modification approach at reducing needle clogs. While they do not elaborate on the reason for the position it is enough to make the expectation of success for its application elsewhere less tenable, absent further connection. The rejections detailed above represent the full set of rejections currently pending. The arguments directed toward the objection and the remaining rejections are not persuasive and are addressed below.
Regarding the objection to the abstract:
The abstract shares a page with the title and therefore does not appear on a separate sheet apart from any other text as required.
Regarding the rejection under 35 USC 103 over Wieckhusen et al.:
The applicant argues that Wieckhusen et al. exemplifies DV50 values in the claimed range of up to 120 microns, but the presence of examples outside the range makes the claimed range non-obvious. This argument is unpersuasive because the presence of an example outside the instantly claimed range does not negate the presence of another example inside the claimed range. A stated higher preference for a narrow region of a taught range is not a teaching away from other values in the taught range (see MPEP 2123). The application of an exemplified particles size to the range of iloperidone concentrations that they disclose also would have been obvious because it is suggested for all the particle sizes they envision. There is no evidence of record of the criticality of the claimed range of crystalline iloperidone size. Thus the application of the teachings of Wieckhusen et al. as set forth in the rejection remains obvious.
The applicant further agues about pharmacokinetic parameters’ relationship to particle size, none of which are claimed or discussed in the instant disclosure,. Therefore these arguments are not relevant to the claims under examination or the rejections.
Regarding the rejection under 35 USC 103 over Wieckhusen et al. in view of Andreef and Fuchs:
The applicant argues that there are no commonalities between the drugs of Andreef and Fuchs and the instant drug. As reconstituted injectable drug suspensions, they share common issues such as the need to be homogenously redispersed, avoidance of excessive settling that can interfere with injection, and introduction of gas during resuspension that is unwanted in the injected material. There is nothing unique about any of these physics based concerns that Andreef and Fuchs ameliorate that is limited to a particular drug. Gravity acting on particles in a suspension and causing them to settle is inherent as is the risk of temporary gas entrapment in a shaken liquid that includes cellulose and a surfactant and negative outcomes from including excess gas bubbles in a liquid injection. Thus the teachings of Andreef and Fuchs are applicable to the injectable depot suspensions of Wieckhusen et al.
The applicant comments on the propriety of including claims in multiple rejections in which that can be rejected. The instant claims layer a suspension, methods of preparing the suspension, methods of preparing the suspension in a syringe, and methods of administering the syringe loaded suspension with various different combinations of details about each. Claims drawn to the broad suspension found to be obvious over one set of art will also be obvious when that set of art is relied upon in rejections of claims to methods of making and methods of administration of the suspension. While implicit to some, these broader claims are included in the subsequent rejections to make clear they are also obvious over the base prior art when additional references are relied upon to address added limitations. This particularly can occur in situations, as instantly presented, when the added limitations concern details of methods of making and methods of use that are at times layered into single claims and other times separately recited. The rejections are not merely cumulative, as the applicant argues, due to a finding of non-obviousness of the product being able to overcome the rejection of its method of making and method of use. Instead the address the various combinations of limitations in the claims as they arise in overlapping sets of combinations.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
