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 .
Election/Restrictions
Applicant's election with traverse of Group II (claim 9 and newly added claims 10-16) in the reply filed on 8/5/2026 is acknowledged. The traversal is on the ground(s) that the composition does not lack a special technical feature because “Kalhapure does not teach or suggest a method that specifically controls and maintains a strict post-sterilization viscosity window of 10 to 30 cps coupled with an osmolality of 270 to 370 mOsm/kg under controlled room temperature stability conditions.” This is not persuasive because this is not the shared technical feature between two groups (see claims 1 and 9). The shared technical feature of the claims, in view of amendment, is a stable injectable composition comprising triamcinolone acetonide and pharmaceutical excipients. Kalhapure makes obvious the shared technical feature, thus it does not constitute a special technical feature as it does not make a contribution over the prior art. See Restriction Requirement dated 5/6/2026.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-8 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/5/2026.
Specification
The use of the term Kenalog 40, which is a trade name or a mark 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.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Examiner Comment
The Examiner has cited particular columns and line numbers, paragraphs, or figures in the references as applied to the claims for the convenience of the Applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the Applicant, in preparing the responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
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 9 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kalhapure et al. (US2021/0251903 A1, published 8/19/2021, cited on the 9/12/2024 IDS).
Regarding claims 9 and 14-15, Kalhapure teaches a method for preparing a stable [0036], sterilized injectable composition comprising triamcinolone acetonide and one or more pharmaceutically acceptable excipients [0032]. The method of Kalhapure comprises the steps of [0032]:
(a) in one container, dissolving sodium chloride (reads on tonicity adjusting agent of instant claim 9; see para. 0049) and sodium carboxymethylcellulose (reads on suspending or viscosity modifying agent of instant claims 9 and 15; see para. 0048) in water for injection, and transferring to a second container of step (b);
(b) in the second container, adding triamcinolone acetonide to form a slurry, and filtering and sterilizing at 122° C for about 15 to about 90 minutes under nitrogen atmosphere (reads on moist heat sterilization of instant claim 14, see para. 0063); and
(c) in a third container, dissolving polysorbate 80 (reads on wetting agent of instant claims 9 and 15, see para. 0046) in water for injection, and filtering and transferring aseptically to the suspension of step (b) [0032]. See also Kalhapure claims 13-15 and 18.
Kalhapure further teaches that pharmaceutically acceptable excipients include buffering agents (reads on buffering system of instant claim 9) [0045; 0050]. Kalhapure does not explicitly disclose the step wherein the buffering system is added, however, the selection of any order of mixing ingredients is prima facie obvious. MPEP 2144.04. Additionally, the order of method steps explicitly taught by Kalhapure differs slightly from that of the instantly claimed method, for example, with regard to where the sterilization step occurs. The selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. MPEP 2144.04. Here, Kalhapure teaches a sterilization step after the first solution and triamcinolone are combined, in addition to a filtration step and aseptic transfer when the wetting agent is added. The end result of both the disclosed method and instantly claimed method is a sterile, injectable composition. Thus, the method taught by Kalhapure makes obvious the instantly claimed method steps.
The instant claim also recites resultant properties of performing the claimed method, such as viscosity, osmolality, and physical and chemical stability. The composition of Kalhapure may have a viscosity of about 8 to about 50 cPs [claim 12] and is stable at room temperature [0061]. Kalhapure does not explicitly disclose the osmolality of the injectable triamcinolone composition nor teach that the composition is stored in a glass container, however, the prior art teaches the claimed method, thus, the properties that result as a consequence of performing the claimed method would be expected absence evidence to the contrary. Additionally, a chemical composition and its properties are inseparable. The instant claim limitations are drawn to the properties of a claimed composition formed as a result of performing the claimed method. Furthermore, claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed. The instant recitation of “wherein the composition remains chemically and physically stable when stored in a glass container” does not further limit the manipulative steps of the claimed method and does not recite an active step. The language “when stored” is therefore being interpreted as optional. MPEP 2114.04.Since Kalhapure makes obvious the same composition made by the claimed method, and a composition and its properties are inseparable, the claimed properties are presumed to be inherent. MPEP 2111.01.
Regarding claim 11, Kalhapure teaches that the injectable triamcinolone composition made by the disclosed method may have a pH of 4 to 8 [0050]. This range overlaps with and makes obvious the instantly claimed range. MPEP 2144.05.
Regarding claim 12, Kalhapure teaches that the injectable triamcinolone composition prepared by the disclosed process can easily flow through a syringe needle [0035]. Kalhapure further teaches that intra-articular administration of triamcinolone acetonide suspension for injection is well known in the art [0003]. The injectable triamcinolone composition made by the disclosed method is capable of intra-articular injection, thus the method of Kalhapure reads on the instant claim limitation.
Regarding claim 13, Kalhapure teaches that the injectable triamcinolone composition prepared by the disclosed process may have a total impurity percentage of 0.113% when stored at 25°C for 2 months. Kalhapure does not explicitly disclose data for the impurity content at 12 months, however, the instant claim recites resultant properties of performing the claimed method. The prior art teaches the claimed method, thus, the properties that result as a consequence of performing the claimed method would be expected absence evidence to the contrary. Additionally, a chemical composition and its properties are inseparable. The instant claim limitations are drawn to the properties of a claimed composition formed as a result of performing the claimed method. Since Kalhapure makes obvious the same composition made by the claimed method, and a composition and its properties are inseparable, the claimed properties are presumed to be inherent. MPEP 2111.01.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kalhapure et al. (US2021/0251903 A1, published 8/19/2021, cited on the 9/12/2024 IDS) as applied to claim 9 above, and further in view of Alam et al. (US2004/0186084 A1, published 9/23/2004, cited on the 9/12/2024 IDS).
Regarding claim 16, this claim recites the limitation wherein the prepared vehicle phase and resulting composition are free of benzyl alcohol and other preservatives. Kalhapure does not explicitly disclose a method wherein the prepared vehicle phase and the resultant composition are free of benzyl alcohol and other preservatives. Alam teaches a sterile, injectable triamcinolone formulation comprising triamcinolone acetonide, a tonicity adjusting agent, a pH adjusting agent [0007], and low amounts of excipients such as suspending agents and thickening agents [0022], see also claim 50. Alam further teaches that the injectable triamcinolone formulation is preferably free of alcohol and preservatives [0028; claims 14-17]. It would be obvious to one of ordinary skill, before the effective filing date of the claimed invention, to modify the teachings of Kalhapure with that of Alam, to modify the method of Kalhapure and remove benzyl alcohol and other preservatives as ingredients that are added to the injectable composition. A skilled artisan would be motivated to make this modification due to the reduction in side effects associated with such ingredients [0016].
Claims 9, 11-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US2022/0211618 A1, effectively filed 4/19/2019, WO publication cited on the 9/12/2024 IDS), as evidenced by Bajaj et al. (2012).
Regarding claim 9, Nguyen teaches a method of preparing a stable, injectable pharmaceutical composition comprising triamcinolone acetonide [Abstract; 0092]. The steps for preparing the composition comprise preparing a first solution comprising one of more one of more tonicity adjusting agents, one or more viscosity agents, and one or more pH buffering agents; preparing a second solution comprising one or more wetting agents; adding triamcinolone acetonide to the second solution [0024]; and the combining the first solution and the second solution comprising triamcinolone to form a suspension [0013-0017; claim 16]. The method may further comprise the step of sterilizing the suspension [0269]. See also Figure 5 for a schematic representation of the disclosed method.
The order of method steps explicitly taught by Nguyen differs slightly from that of the instantly claimed method, however, the selection of any order of mixing ingredients is prima facie obvious. MPEP 2144.04. Additionally, Nguyen does not explicitly teach a sterilization step of the vehicle phase before addition of triamcinolone. Instead, Nguyen teaches the sterilization step at the end of the process [Figure 5; 0269]. The selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. MPEP 2144.04. The end result of both the disclosed method and instantly claimed method is a sterile, injectable composition. Thus, the method taught by Nguyen makes obvious the instantly claimed method steps.
Regarding the instant claim limitations reciting the resultant properties of the composition prepared with the disclosed method, Nguyen teaches that the composition made by the disclosed process may have a viscosity of about 10 cPs [claim 37]. Nguyen further teaches that the composition may have an osmolality of 270-330 mOsm/kg [Table 3]. These ranges overlap with and make obvious the instantly claimed ranges. MPEP 2144.05. The composition of Nguyen was stable for at least three months under accelerated stability conditions at 40°C [0364]. As evidenced by Bajaj [pg. 131 - Accelerated stability testing], the higher temperature accelerated stability testing conditions provide more stress to the drug product to accelerate degradation compared to lower temperature conditions. Thus, the stability of the composition at the claimed conditions (controlled room temperature of 20°C to 25°C) is expected based on teachings of Nguyen. Nguyen does not explicitly disclose that the stability testing was conducted in a glass container, however, claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed. The instant recitation of “wherein the composition remains chemically and physically stable when stored in a glass container” does not further limit the manipulative steps of the claimed method and does not recite an active step. The language “when stored” is therefore being interpreted as optional. MPEP 2114.04. Additionally, the prior art teaches the claimed method, thus, the properties that result as a consequence of performing the claimed method would be expected absence evidence to the contrary. A chemical composition and its properties are inseparable. The instant claim limitations are drawn to the properties of a claimed composition formed as a result of performing the claimed method. Since Nguyen makes obvious the same composition made by the claimed method, and a composition and its properties are inseparable, the claimed properties are presumed to be inherent. MPEP 2111.01.
Regarding claim 11, Nguyen teaches that the pH of the composition may be in the range of 6 to 7. This range overlaps with and makes obvious the instantly claimed range. MPEP 2144.05.
Regarding claim 12, Nguyen does not explicitly that the injectable triamcinolone composition is formulated for intra-articular injection. However, the composition of Nguyen is capable of being suprachoroidal injection through a microneedle [Abstract], thus it is capable of being administered intra-articularly and reads on the instant claim limitation.
Regarding claim 13, the instant claim recites resultant properties of performing the claimed method. The prior art teaches the claimed method, thus, the properties that result as a consequence of performing the claimed method would be expected absence evidence to the contrary. Additionally, a chemical composition and its properties are inseparable. The instant claim limitations are drawn to the properties of a claimed composition formed as a result of performing the claimed method. Since Nguyen makes obvious the same composition made by the claimed method, and a composition and its properties are inseparable, the claimed properties are presumed to be inherent. MPEP 2111.01.
Regarding claim 15, Nguyen teaches that the viscosity agent may comprise of sodium carboxymethylcellulose [0127] and the wetting agent may comprise polysorbate 80 [0128].
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US2022/0211618 A1, effectively filed 4/19/2019, WO publication cited on the 9/12/2024 IDS), as evidenced by Bajaj et al. (2012), as applied to claim 9 above, and further in view of Arnold et al. (EP1537876 A1, published 6/8/2005).
Regarding claim 10, Nguyen teaches that the triamcinolone composition made by the disclosed process may be packaged as a product in a suitable container such as a glass vial (reads on stored in a glass container) [0212]. Nguyen does not explicitly teach that the glass container is a Type I glass vial as instantly claimed. Arnold teaches that pharmaceutical compositions may be stored in Type I glass vials [0126]. The selection of a known material based on its suitability for its intended use is prima obvious. MPEP 2144.07. Thus, it would be obvious to one of ordinary skill to apply the teachings of Arnold to that of Nguyen and select a Type I glass vial for use with the method of Nguyen.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US2022/0211618 A1, effectively filed 4/19/2019, WO publication cited on the 9/12/2024 IDS), as evidenced by Bajaj et al. (2012)., as applied to claim 9 above, and further in view of Alam et al. (US2004/0186084 A1, published 9/23/2004, cited on the 9/12/2024 IDS).
Regarding claim 16, this claim recites the limitation wherein the prepared vehicle phase and resulting composition are free of benzyl alcohol and other preservatives. Nguyen does not explicitly disclose a method wherein the prepared vehicle phase and the resultant composition are free of benzyl alcohol and other preservatives. Alam teaches a sterile, injectable triamcinolone formulation comprising triamcinolone acetonide, a tonicity adjusting agent, a pH adjusting agent [0007], and low amounts of excipients such as suspending agents and thickening agents [0022], see also claim 50. Alam further teaches that the injectable triamcinolone formulation is preferably free of alcohol and preservatives [0028; claims 14-17]. It would be obvious to one of ordinary skill, before the effective filing date of the claimed invention, to modify the teachings of Nguyen with that of Alam, to modify the method of Nguyen and remove benzyl alcohol and other preservatives as ingredients that are added to the injectable composition. A skilled artisan would be motivated to make this modification due to the reduction in side effects associated with such ingredients [0016].
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA LYNN CHI whose telephone number is (571)272-0026. The examiner can normally be reached Monday - Friday 9 am-5pm ET.
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/AMANDA LYNN CHI/Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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