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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 request for continued examination filed on 04/20/2026 has been entered.
Response to Amendment
Acknowledgment is made of the receipt of the amendment filed on 06/09/2026 in response to Notice of Non-Compliant amendment mailed on 05/21/2026. Claim 1 is amended to remove the limitation “wherein the buffering agent comprises sodium citrate dihydrate, citric acid, or a combination thereof”, the pH value is amended to 5.0 to 7.0 which is broader than “5.3-6.0”. The scope of claim 1 without recitation of any buffering agent is broadened.
It’s noted the claim amendment filed on 06/09/2026 is still considered non- compliant with amendment requirement. The claim amendment filed on 03/23/2026 and 05/18/2026 after final rejection are not entered. Thus, the claim amendment filed on 06/09/2026 should be based on claim set dated 09/23/2025. For example, claims 6, 7 and 12 are identified as “Previously Presented”. However, claims 6 and 7 have been amended by replacing “excipients” with buffering agent, the sweetener, and the preservative”, which is not properly identified and marked. Claims 12 is amended to recite the preservative "further comprises one or more compounds selected from...” which is not properly identified and marked. Claims 14 is amended to recite the buffering agent comprises one or more compounds selected from...” which is not properly marked.
Election/Restrictions
Applicant elected without traverse of invention Group I: claims 1-16 drawn to a kit, filed on 06/02/2025.
Status of Claims
Claims 1, 4-10, 12 and 14-24 are pending in the instant application.
Claims 17-20 remain withdrawn.
Claims 1, 4-10, 12, 14-16 and 21-24 are currently under examination.
Priority
The instant application 19/033, 064 filed on 01/21/2025 , claims NO priority benefit.
Claim Interpretation
As evidenced by PubChem and FDA database, Vigabatrin is also known as other tradename, SABRIL® Vigadrone® Vigafyde® Vigpoder®, etc., available as solid form (e.g. powder) that could be reconstituted into oral solution and initially approved in 2009, for example, SABRIL® vigabatrin powder for solution label manufactured by Lundbeck Pharm. VIGAFYDE™ (Pyros Pharmaceuticals, Inc.) approved by FDA in 2024, is a ready-to-use 100 mg/mL vigabatrin oral solution which requires no reconstitution.
Instant claims are directed to vigabatrin formulation in a kit, comprising solid form of vigabatrin in the first container and a vehicle comprising buffering agent, preservative and other excipients for reconstituting the solid form of vigabatrin in the second container. It’s noted all limitation of active ingredient (vigabatrin) and inactive ingredients (e.g. buffering agent, preservative), pH value and stability profile (impurity, microbial test, etc.) are directed to the reconstituted solution after the components of two containers are combined/mixed. As such, instant claims are construed as product-by-process type claims and the patentability of instant invention is considered based on the final reconstituted vigabatrin product, wherein the limitation of components stored in separate containers in a kit before reconstitution are considered as limitation of intermediate before the process of reconstitution that do not necessary add patentability weight to the final product. Instant claim 1 recites the limitation wherein the first container is free from buffering agent and the preservative, and the second container contains water, buffering agent, preservative and a sweetener . The property (e.g. stability) of reconstituted oral solution is the result of mixing components of both first and second containers. As such, whether the buffering agent and the preservative is in the first container or in the second container do not necessarily contribute to difference of property of final reconstituted oral solution in absence of evidence to the contrary. It’s noted in product-by-process type claims, the process of producing the product is given no patentable weight since it does not impart novelty to a product when the product is taught by the prior art. See MPEP 2113, In re Thorpe, 227 USPQ 964 (CAFC 1985); In re Marosi, 218 USPQ 289, 292-293 (CAFC 1983) and In re Brown, 173 USPQ 685 (CCPA 1972). Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established.
Regarding the “kit” limitation, assembling / combination of ingredients (active and inactive) in a kit is well-understood, routine, conventional activities known to the industry, as a skilled artisan in the industry would have known to select active and inactive ingredients and mix with other components in a kit. As evidenced in SABRIL® vigabatrin powder for solution label Instruction for Use(page 42), SABRIL® for oral solution comes in a packet wherein SABRIL® packet contains 500 mg of powder that can be reconstituted into oral solution. The container for storing and reconstituting the oral solution and oral syringe, etc. could be easily assembled as a kit that read on instant claimed kit.
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Claim 1 recites limitation “wherein after reconstitution total impurity in the solution is below 0.05% for 3 months at room temperature”, “wherein, according to Antimicrobial Effectiveness Test (AET) under USP <51>, S. aureus, E.coli, P. aeruginosa and/or B. cepacia in the reconstituted solution at day 14 shows not less than 1.0 log10 unit reduction from day 0, and/or no increase in log10 unit at day 28 from day 14, and/or wherein C. albicans and A.brasiliensis show no increase in log 10 unit at day 28 from day 0” . Claim 6 recites limitation “S. aureus… at day 14 shows not less than 1.0 log10 unit reduction from day 0… C. albicans and A. brasiliensis show no increase in log 10 unit at day 28 from day 0”. Claim 7 recites “after reconstitution, B. cepacia in the solution at day 14 shows not less than 1.0 log 10 unit reduction from day 0, and no increase in log 10 unit at day 28 from day 14”. Claims 15 and 16 recite wherein after reconstitution, impurity A or the total impurity in the solution is below 0.1% for 6 months at room temperature. These limitations are construed as property of final vigabatrin formulation once the components and amount/concentration thereof are determined before reconstitution and/or intended result of reconstituting process that do not necessarily contribute to the structural limitation of vigabatrin formulation. Please note compliance with standard/criteria of Antimicrobial Effectiveness Test (AET) under USP <51> as recited in instant claims are considered as general knowledge and common practice of a skilled artisan in the art of pharmaceutical industry that do not necessarily distinguish instantly claimed vigabatrin product patentably from the prior art.
Applicant argues in Remarks dated 03/23/2026: “ present claims are not product-by-process claims at least because they are directed to a kit, which is an article of manufacture, comprising two separate containers with defined contents, not to a reconstituted solution” .
RESPNSE: Applicant’s argument is not persuasive. Claim 1 recites limitation after reconstitution, wherein after reconstitution total impurity in the solution is no more than 0.04% within 2 months at room temperature, wherein the solution has a pH ranging from 5.0 to 7.0 and Antimicrobial Effectiveness Test (AET) of reconstituted solution. Dependent claims also recite limitation after reconstitution. Since the limitation of active ingredient (vigabatrin) and inactive ingredients (e.g. buffering agent, preservative), pH value and stability profile (impurity, microbial test, etc.) are directed to the reconstituted solution after the components of two containers are combined/mixed , instant claims are construed as product-by-process type claims and the patentability of instant invention is considered based on the final reconstituted vigabatrin product, wherein the limitation of components stored in separate containers in a kit before reconstitution are considered as limitation of intermediate before the process of reconstitution that do not necessary add patentability weight to the final product.
Response to Declaration
As indicated in the Advisory Action mailed on 03/31/2026, the Declaration under 37 CFR 1.132 by Zhongqin Wang filed 03/23/2026 is fully considered, but NOT persuasive to overcome the rejection over Wang’s 507 in view of Patel under 35 USC §103.
Wang Declaration argues dual-container kit configurations with different component combinations in each bottle produced markedly different and unpredictable results with respect to the physical appearance, solubility, impurity formation, and stability of the reconstituted vigabatrin solution (See Table 1-4 in ANNEX A ). The relationship between kit configuration and resulting properties is complex and depends on multiple interacting factors, including the solubility behavior of preservatives in
the presence of dissolved vigabatrin, and the interaction between preservatives, buffers, and vigabatrin during reconstitution (See para 9-14).
The examiner agrees that properties of reconstituted vigabatrin depend on multiple factors including vigabatrin, preservatives, buffers, and their interaction. The examiner does not dispute different configurations might have different properties. However, Wang’507 and SABRIL® vigabatrin powder for solution explicitly teach solid form of vigabatrin free of buffering agent and preservative and reconstitution with water in separate container. Assembling / combination of ingredients (active and inactive) in a kit is routine, conventional activities known to the industry. Rearranging known components into separate containers and exploring different kit configuration is considered as experimentation/optimization that’s within the general knowledge/skills of a POSA. As explained in Claim Interpretation, the patentability of instant invention is considered based on the final reconstituted vigabatrin product, wherein the limitation of components stored in separate containers in a kit before reconstitution are considered as limitation of intermediate before the process of reconstitution that do not necessary add patentability weight to the final product.
It’s noted the buffering agent in Wang Declaration is limited to sodium citrate dihydrate and/or citric acid (which is taught by Wang ‘507) and the preservative is limited to sodium methylparaben and/or sodium propylparaben (which is taught by Patel). The alleged unexpected improved property is only based on one specific combination consisting of 25mg vigabatrin in Bottle A, sodium citrate dihydrate, citric acid, sodium methylparaben, sodium propylparaben and water at specific amount in Bottle B. Instant claim 1 is drawn to a kit without recitation of any buffering agent and amount thereof. Instant claim 1 does not recite the amount of vigabatrin and water. The first container containing the solid form of vigabatrin free from a liquid vehicle, a buffering agent and a preservative, does not exclude other pharmaceutical excipients. Thus, the scope of instant claim 1 is extremely broad compared with the specific example disclosed in instant specification and in the comparative study in Wang Declaration. Dependent claims 12 and 14 further reciting variety of buffering agent and preservatives are also broad. As such, the alleged improved property based on specific combination of vigabatrin with specific preservative and buffer at specific amount/range does NOT commensurate with instantly claimed scope. “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support". In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980),See MPEP 716.02(d).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 6 and 7 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Instant claim 6 and 7 recite “wherein the buffering agent, the sweetener, and the preservative, and their respective amounts in the kit are selected so that, after reconstitution, S. aureus, E.coli, and P.aeruginosa … C.albicans and A.brasiliensis in the solution show no increase in log10 unit at day 28 from day 0” or “B. cepacia in the solution…no increase in log 10 unit at day 28 from day 14”. Instant claim 1 does NOT define any buffering agent and amount thereof . It’s not clear what combination of preservative and/or buffering agent at what amount could achieve the alleged antimicrobial property. The lack of clarity and uncertainty of components in the composition contributing to instantly claimed antimicrobial property renders the claims indefinite since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
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 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 non-obviousness.
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 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, 4-10, 12, 14-16 and 21- 24 are rejected under 35 U.S.C. 103 as being unpatentable over WANG et al. ( WO/2020/155507, hereafter “Wang’507”, machine translated copy by WIPO ), in view of Patel et al. (US 2024/0358664A1, hereafter Patel ’664) and SABRIL® vigabatrin powder for solution label (revised in 2021, approved in 2009)
Regarding vigabatrin product in a kit, Wang’507 disclosed a ready-to-use drug delivery system comprising vigabatrin in a solid form which can be reconstituted into an oral solution in a device/kit (e.g. bottle) for drug delivery and multi-dose treatment (See abstract, [0001], [0005]-[0007], [0033], claims 1-18). Wang ‘507 teaches the solid composition are stored in a suitable container prior to reconstitution with a solute (e.g. water) (See [0033]). The suitable container comprising the solid dosage form of vigabatrin is considered as first container and device/ kits/apparatus (e.g. bottle, etc.) for preparing/reconstituting the solid form of vigabatrin into oral solution (See [0008], [0031], [0033]) is considered as second container.
Regarding component of vigabatrin solid form, Wang’507 teaches embodiments comprising vigabatrin with at least one sugar and/or sugar alcohol and other pharmaceutically acceptable excipient, e.g. sweeteners (e.g. sucrose, glucose, sorbitol, sucralose, aspartame, saccharin sodium, etc.) and flavors (e.g. mint, menthol), etc. wherein a single excipient may have a variety of functions (See [0025]-[0030], claims 2-3 and 7-8).
Regarding the second container for preparing a vehicle for reconstituting recited in claim 1, Wang ‘507 teaches a bottle wherein water was added to the solid powder to make a 250mL solution(See [0033], [0044]).
Regarding preservative, Wang ‘507 teaches common preservative for pharmaceutical product, e.g. bacteriostatic agent and a chelating agent. Examples of preservatives include, but are not limited to, benzalkonium chloride, cetylammonium chloride, benzoate (e.g. sodium benzoate), benzyl alcohol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, alkyl acid ester, hydroxybenzoate, and salts thereof (e.g. methyl paraben or propyl ester or salt thereof), methyl mercury salts (e.g. borate or nitrate), sodium hypochlorite, p-hydroxybenzoate, potassium sorbate, etc. (See [0019]). Wang ‘507 teaches embodiments of solid dosage form of vigabatrin substantially free of preservative before reconstitution into solution (See [0006], [0012], claims1-9). Wang’507 teaches the solid dosage form is tablet, powder, pill, etc.(See claim 9).
Regarding the buffering agent and pH limitation recited in instant claims 1, 4, 14 and 22-24, Wang’507 teaches examples of suitable buffers (e.g. sodium citrate, citric acid, etc.) with concentration ranging from about 10 mM to 200 mM, preferably from 10 mM to 50 mM, and sufficient buffering capacity to ensure the reconstituted solution is within the expected pH range of about 5.0 to about 8.0, preferably about 6.0 to about 7.0 (See [0027], [0036], claim 6, 18).
Regarding limitation of Antimicrobial Effectiveness Test (AET) under USP <51> recited in claims 1 and 6-7, Wang’507 teaches the oral solution reconstituted from the solid form of vigabatrin comprising sucrose complies with Antimicrobial Effectiveness Test (AET) under USP <51> when tested at various time period after reconstitution, e.g. day 14, 20, 30, 60, up to 90 days, and the reconstituted oral solution of vigabatrin are stable for up to 90 days for multiple uses(See [0038], [0051]- [0054], Table 2 and 3; claims 14-15 ). Please note Table 3 of Wang’507 is the same as instant Table 4 disclosed by instant specification ([0068]). For example, Bacteria (Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Burkholderia onion): The count from the initial meter on day 14 is reduced by no less than 1.0 log, and the count from day 14 to 28 days is not increased. Yeast and Mold (Candida albicans and Aspergillus niger): No count was increased from the initial calculation at 14 days and 28 days. No increase is defined to be no more than 0.5 log 10 units higher than previously measured values.
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Regarding two separable administration limitation recited in claim 8, Wang’507 explicitly teaches the reconstituted solution of vigabatrin is stable with no over-limit degradation and microbial growth or contamination over a long period of time, and can be used multiple times at least 30 days (See [0005]- [0006],[0018], [0038]-[0039], claim 16).
Regarding the concentration of vigabatrin recited in instant claim 9, Wang’507 teaches embodiments wherein the concentration of the drug(i.e. vigabatrin) is from about 40 to about 60 mg/ml(See [0035], claim 17).
Regarding the syringe limitation of instant claim 10, Wang’507 teaches oral administration syringe may give the patient a suitable amount of liquid medicine based on the prescription (See [0033]).
Regarding the sucrose limitation of instant claim 21, Wang’ 507 teaches powder comprising active ingredient vigabatrin in combination with sucrose (See [0043], Table 1).
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Please note the solid form of vigabatrin comprising vigabatrin (i.e. aminocaproic acid) and sucrose as filler/sweetener read on instantly claimed first container that is free from buffering agent and a preservative.
As elaborated above, Wang’507 collectively teaches a ready-to-use vigabatrin delivery system comprising solid form of vigabatrin and tools/kits for reconstituting into oral solution wherein the reconstituted vigabatrin solution with appropriate pH range (e.g. 5.0-8.0) and desired concentration range is stable for up to 90 days/three month with no over-limit degradation and microbial growth according to AET test under USP<51>. Please note instant claims are construed as product-by-process type claims, wherein the limitation of components stored in separate containers in a kit before reconstitution are considered as limitation of intermediate before reconstitution process that do not necessary add patentability weight to the final product as long as the vigabatrin final product taught by prior art meet the limitation of instantly claimed final product. Please also note instantly claimed stability profile (impurity, microbial/AET, etc.) is the property of final vigabatrin solution or intended result of reconstitution process, which does not necessarily contribute to the structural limitation of final product.
Regarding total impurity, Wang ‘507 teaches embodiments stable up to 90 days with no over-limit degradation. Wang ‘507 is silent about concentration of preservative recited in claim 5 and the impurity A recited in claim 15.
Patel ’664 teaches a stable, read-to-use vigabatrin pharmaceutical compositions comprising excipients (e.g. buffering agents, preservatives, antioxidants, and solubilizers, sweetening agents, flavoring agents, etc.) with improved stability (stable up to at least six or twelve months at room temperature) and better patient compliance (e.g. pediatric patients)(See abstract, [0009]- [0014], [0176]-[0191], claims 1-32). Patel ’664 teaches commercial vigabatrin powder for oral solution kit including syringe, for example, SABRIL®, VIGADRONE® or generics, (See [0019]-[0085], [0132]-[0159], Figs 2-13) and teaches the advantage/superiority of ready-to-use vigabatrin liquid formulation, e.g. improved stability, elimination of potential reconstitution error, etc.(See [0161]-[0165]). It’s noted applicant of Patel’ 664, Pyros Pharmaceuticals, is the manufacture of VIGAFYDE™ approved by FDA in 2024.
Regarding claim 5, Patel ’664 teaches embodiments comprising 0.1125-0.1375 wt% methylparaben, 0.01125-0.01375 wt % propylparaben, 0.225-0.275 wt % sucralose, 0.0027-0.0033 wt % peppermint flavor, that is stable up to at least twelve months at room temperature wherein the total impurities due to degradation are not more than 0.04% (See Table 3, claim 7, 10)(which read on instant claims 5 and 13).
Regarding claim 15, Patel ’664 teaches vigabatrin-related compound A having following structure (See Fig. 1B), and explicitly teaches vigabatrin liquid pharmaceutical composition is stable six months or longer at room temperature and has levels of total impurities and vigabatrin-related compound A that are both not more than 0.04% at, or prior to, six months (See abstract, [0010], [0190]-0191], Table 4, claims 1,3, 10, 24-25).
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Regarding the kit limitation, Patel ’664 teaches suitable containers to maintain the stability of the formulation that can be provided in the form of kit wherein the kit can additionally comprise other dosage form (See [0190]-[0191]).
SABRIL® for oral solution is approved in 2009 for refractory complex partial seizures as adjunctive therapy in patients 2 years of age and monotherapy for infantile spasms. The inactive ingredient in SABRIL® powder for solution is povidone (See Ingredients on page 42), which is free of liquid vehicle, buffering agent and presentive , thus reads on instant first container. SABRIL® vigabatrin powder comes in a packet wherein containing 500 mg of powder that can be reconstituted into oral solution (See Instruction for Use, page 42),. The container for storing and reconstituting the oral solution and oral syringe, etc. could be easily assembled as a kit that read on instant claimed kit.
It would have been obvious to one of the ordinary skilled in the art before the effective filing date of instantly claimed invention to combine the teachings of ready-to-use vigabatrin delivery system comprising solid form of vigabatrin and device/kits for reconstitution by Wang ‘507 with ready-to-use vigabatrin liquid formulation comprising preservatives and other excipients with improved stability (including impurity A) taught by Patel’664, together with experimentation and optimization based on general knowledge of vigabatrin formulation (e.g. SABRIL® powder for oral solution) , and arrive at instantly claimed invention with reasonable expectation of success. At the time the instant invention was filed, it was already known that ready-to-use vigabatrin delivery system comprising solid form of vigabatrin and excipients (e.g. buffer, sweeteners/sucrose) can be reconstituted and provided in a suitable device/kit as taught by Wang’507. It was also known that ready-to-use formulation comprising vigabatrin and excipients (e.g. preservative, buffers, etc.) can be prepared and packaged in suitable containers/kits as taught by Patel’ 664. Assembling / combining ingredients (active and inactive) in a kit is well-understood, routine, conventional activities known to the pharmaceutical industry. A skilled artisan in the pharmaceutical industry would have known to select active ingredients and mix with other components in different container within a kit. 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. MPEP 2144.05.
Wang’507 teaches ready-to-use reconstituted vigabatrin oral solution reduces the risk of administering dose errors, and stable for multiple use with no over-limit degradation and microbial growth according to AET test under USP<51>. Patel ’664 also teaches the advantage/superiority of ready-to-use vigabatrin liquid formulation with improved stability at room temperature (both impurity A and total impurity) and elimination of potential reconstitution error, etc. A skilled artisan would be motivated to combine Wang’507 and Patel’ 664 based on their beneficial teachings because both are directed to vigabatrin formulation for pediatric use with improved patient compliance and reduced reconstitution/ preparation error. The combined teachings of prior art, together with experiment/optimization based on general knowledge of vigabatrin formulation including inactive ingredients (buffering agent, preservative, etc.) would provide a ready-to-use vigabatrin delivery system that can be prepared/ packaged as a kit with enhanced stability/longer shelf life that is convenient and safe with less administration error for multiple use to pediatric patients.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art, together with experiment/ optimization based on general knowledge of vigabatrin formulation. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s Remarks filed on 03/23/2026 and 06/09/2026 are fully considered, but NOT persuasive.
In Remarks dated 03/23/2026, Applicant argues numerous possible configurations exist for dual-container kits that result in different stability profiles that’s similar to Wang Declaration. Please see Response to Declaration.
Applicant argues Wang does not teach or suggest the claimed configuration... There
is no teaching or suggestion in Wang of a second container containing an aqueous solution with
pre-dissolved buffer and preservative for reconstituting solid vigabatrin to arrive at the instant kit (Remarks dated 03/23/2026, page 17).
RESPONSE: As elaborated above, Wang ‘507 teaches devices or kits containing the solid dosage form in a suitable container and means for preparing a solution from the solid dosage form. Wang’507 explicitly teaches the solid composition are stored in a suitable container prior to reconstitution with a solute. The suitable container comprising the solid dosage form of vigabatrin prior to reconstitution is considered as first container and device/ kits/apparatus (e.g. bottle, etc.) for preparing/reconstituting the solid form of vigabatrin into oral solution is considered as second container. Please note water is only one exemplary solute which does not exclude other inactive ingredients be added in the reconstitution vehicle/device (second container). Adding a preservative and a buffering agent in the reconstitution container would have been within the knowledge of a skilled artisan since preservative and buffering agent are conventionally included in aqueous formulations. Please note a skilled artisan would not have to place the buffering agent together with vigabatrin as Applicant argues. The function of buffering agent is to adjust/maintain pH of the reconstituted solution. Accordingly, it would be an obvious alternative to place the buffering agent in the second container containing the reconstituting solution where the buffering agent would perform its intended function.
Applicant argues Patel is directed to a fundamentally different approach compared to the formulation of Wang, i.e., a ready-to-use liquid vigabatrin formulation that does not require reconstitution.
RESPONSE: Please note Patel is a teaching reference that teaches preservative in stable ready-to-use vigabatrin formulation. Instant claims recite limitation of final vigabatrin formulation comprising preservative. As such, Patel is not “teaching away” from instant claimed invention. Rather, Patel provides motivation to improve Wang’507 reconstitution formulation by preparing reconstitution solution comprising preservative which would provide stable ready-to-use solution upon mixing with active ingredient. A skilled artisan would be motivated to combine Wang’507 and Patel’ 664 based on their beneficial teachings for ready-to-use with improved patient compliance and reduced reconstitution/ preparation error.
Applicant’s argument about formulation F7 which is allegedly representative of Patel’s formulation, is NOT persuasive. The obviousness objection is based on combined teachings of Wang ‘507 and Patel. Wang ‘507 already teaches suitable buffers (e.g. sodium citrate, citric acid, etc.) with concentration ranging preferably from 10 mM to 50 mM. Thus, F7 is not representative of combined teachings of Wang ‘507 and Patel.
In Remarks dated 06/09/2026, Applicant argues liquid formulations (F3 to F5, F7 to F9, Fl 1, and F13) were included in the comparative study to demonstrate the breadth of possible configurations between different components...the data for F6 and F10 (solid forms without water) directly refute obviousness.
RESPONSE: The examiner does not dispute different configurations might have different properties. However, Wang’507 and SABRIL® vigabatrin powder for solution explicitly teach solid form of vigabatrin free of buffering agent and preservative and reconstitution with water in separate container. Thus, F2-F10 are not considered as closest first container to the teachings of Wang’507 and SABRIL®. Again, the property of specific exemplary formulation in Wang Declaration dose not commensurate with the scope of instant claims.
Applicant further argues against SABRIL® general knowledge not applicable to the claimed invention... the inquiry is not whether a skilled artisan would have been aware of a vigabatrin powder packet that is free of preservatives, but rather how the excipients are arranged across the two containers of the kit. The claimed subject matter is thus directed to the combined configuration of the two containers and the distribution of components between them.
RESPONSE: SABRIL® is commercially available as solid form (e.g. powder) in a container that could be reconstituted into oral solution. A skilled artisan would have known that vigabatrin powder is stored in a first container (e.g. in packet) separately before reconstitution in a second container. The container for storing water and other excipients and/or reconstituting the powder into oral solution would be considered as the second container that could be easily assembled as a kit that read on instant claimed dual-container kit. A skilled artisan would have also known vigabatrin powder packet contains povidone as inactive ingredient that is free of preservative and buffering agent which read on instantly claimed first container. As such, instantly claimed first container(packet) comprising vigabatrin powder free of preservative and buffering agent before reconstitution that could be reconstituted in the second container is considered as general knowledge of vigabatrin formulation to a skilled artisan. Reconstituting API and inactive ingredients stored in separate containers into a solution is routine practice in the art and not inventive. As for the component in the second container, buffering agent and preservatives are commonly used excipients as taught by Wang’ 507 and Patel ’664 as elaborated above.
Please note instant claimed dual container kit is considered as optimization based on combined teachings of Wang’ 507, Patel ’664, SABRIL® and general knowledge of pharmaceutical formulation including inactive ingredients (buffering agent, preservative, etc.). Both Wang’ 507 and Patel ’664 teach the benefit of vigabatrin formulation for pediatric use with improved patient compliance and reduced reconstitution/ preparation error. Both Wang’507 and Patel ’664 teach improved antimicrobial property for vigabatrin formulation. Applicant’s alleged improved property based on specified distribution of components across two containers does not align with instant claims and disclosure.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
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/LIYUAN MOU/Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
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