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
Status of claims
The amendment filed on Jan, 12, 2026 is acknowledged. Claims 1-10 are under examination in the instant office action.
Applicants' arguments, filed on Jan, 12, 2026, have been fully considered but they are not deemed to be persuasive or moot in view of a new ground of rejection necessitated by the amendments (newly added limitations in claim 1). Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Rejections - 35 USC § 112 (a)
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention
New matter Rejection
Claims 1-10 are rejected 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. All dependent claims are included.
Claim 1 is amended to recite “further comprises an acrylic polymer selected from Carbomer or Acrylates C10-30 Alkyl Acrylate Crosspolymer.” According to the specification the acrylic polymers are disclosed as a filler (see [0049]). Claim 1 already recites the controlling layer contains a second filler. Thus, claim 1 as amended now require including the acrylic polymers in addition to a second filler. Thus, it appears the controlling layer requires two fillers. However, the combination of the second filler selected from the group consisting of colloidal silicon dioxide, acrylic acid polymers, polyvinyl pyrrolidone K90, and Acrylates/C10-30 Alkyl Acrylate Crosspolymer with an additional filler such as Carbomer or Acrylates C10-30 Alkyl Acrylate Crosspolymer is not supported by the original disclosure. Therefore, it is considered as new matter.
New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See MPEP § 608.04 (a) to § 608.04(c).
Due to lack of sufficient disclosure for the claimed specific embodiment, the specification does not allow persons of ordinary skill in the art to recognize that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of claimed embodiment.
Claim Rejections - 35 USC § 112 (b)
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. All the dependent claims are included.
Claim 1 as amended contain the following trade name: Carbomer. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112, second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982).
In the present case, the trademark/trade name is used to identify/describe acrylic polymer material.
The claim scope is uncertain since the trademark or trade name cannot be used properly to describe any particular material or product. In fact, the value of a trademark would be lost to the extent that it became the generic name of a product, rather than used as an identification of a source or origin of a product. Thus, the use of a trademark or trade name in a claim to describe a material or product would not only render a claim indefinite, but would also constitute an improper use of the trademark or trade name. See MPEP 2173.05 (u).
Applicants are advised to recite what the name of the goods is instead of the trade name.
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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0225103 (hereafter, THEOBALD) in view of US 2015/0258037 (hereafter, SIVARAMAN).
THEOBALD teaches a transdermal therapeutic system (TTS) releasing an active pramipexol agent during a time ranging from 4 to 7 days (abstract).
THEOBALD further teaches TTS is a pharmaceutical dosage form which has a layered structure and consists of at least one active ingredient-containing polymer layer (reservoir layer) and one backing layer which is ordinarily impermeable for the active ingredient and may also optionally comprise further layers, frequently a membrane which controls the rate of release of the active ingredient, a pressure-sensitive adhesive layer which ensures adhesion of the TTS to the patient's skin, a barrier layer, and a protective layer which covers the active ingredient-delivering side of the TTS until use (release liner) ([0003], [0018], and claim 2).
THEOBALD teaches that the active ingredient-containing layer further comprises a pressure-sensitive adhesive polymer which includes polyisobutylenes ([0019] and [0020]).
THEOBALD teaches that the approved maximum daily dose of pramipexol, based on pramipexol base, in the therapy of Parkinson's disease is 3.2 mg per day and based on a transdermal therapeutic system which is to have an area of 20 cm2 for delivering the active ingredient pramipexol to the skin, the necessary flux rate resulting therefrom is 6.25 μg/ cm2 per hour ([0034]). The rate falls within the range recited in claim 8.
THEOBALD teaches the pramipexol-containing TTS is particularly preferably employed for restless leg syndrome and for Parkinson's disease ([0036]).
THEOBALD does not specifically teach that the active ingredient-containing polymer layer (reservoir layer) further comprises a filler such as silicon dioxide, plasticizer such as mineral oil, and a tackifier such as colloidal silicon dioxide with an adhesive polymer such as polyisobutylene. Also, THEOBALD does not specifically teach a controlling layer comprising a filler such as colloidal silicon dioxide, plasticizer such as mineral oil, and a tackifier such as colloidal silicon dioxide with an adhesive polymer such as polyisobutylene.
However, it was known in the art that the adhesive polymer such as polyisobutylene is used in combination with mineral oil and colloidal silicon dioxide for drug-containing matrix layer in a transdermal patch as evidenced by SIVARAMAN ([0011]). SIVARAMAN teaches that the interaction of the polyisobutylene and the hydrophobic colloidal silica with the mineral oil was considered very significant in influencing the physical properties of the whole transdermal system and the silica materials can provide a physically acceptable transdermal system for an active ingredient which is in the oil state with the combination of polyisobutylene and mineral oil ([0066]). Especially, the hydrophobic silica material can provide an acceptable transdermal system both physically and chemically ([0066]).
SIVARAMAN teaches that the hydrophobic reservoir layer contains a drug and a hydrophobic matrix, where the hydrophobic matrix contains hydrophobic colloidal silicon dioxide (filler and tackifier) in an amount effective to adsorb said drug; and a mixture of polyisobutylene and mineral oil (plasticizer) ([0018], [0028], and [0059]).
Also, SIVARAMAN discloses a patch for transdermal drug administration comprising a polymer matrix layer containing laminated hydrophobic reservoir matrix layer containing the drug (the drug reservoir layer) and release-controlling hydrophobic polymeric material layer (controlling layer), wherein the resulting laminate is deposited on a drug-impermeable backing layer so that an exposed surface of the reservoir matrix layer contacts the backing layer, and a release liner may then be applied to an exposed surface of the release-controlling hydrophobic polymeric material layer ([0018], [0055], [0056] and [0072]). The resulting transdermal system allows the rate of drug delivery to be controlled and lamination of an adhesive layer with varied thickness to a drug reservoir layer can improve the physical performance of the transdermal system ([0022]).
SIVARAMAN further teaches that the layer of the release-controlling hydrophobic polymeric material acts to control release of the drug from the reservoir layer both during storage and during use and the release-controlling hydrophobic polymeric material provides an additional layer of polymeric material through which the drug must diffuse to reach the release liner during storage, or to reach a skin surface during use of the transdermal system ([0071]) and the release-controlling layer comprises hydrophobic colloidal silica (filler and tackifier); and a mixture of polyisobutylene and mineral oil (plasticizer) ([0020] and [0054]). In addition, SIVARAMAN teaches that the release-controlling hydrophobic polymeric material layer acts as a skin-contacting adhesive layer and contains hydrophobic colloidal silica, which acts to adsorb the drug as it diffuses through the release-controlling hydrophobic polymeric layer, thereby slowing diffusion of the drug through the release-controlling hydrophobic polymeric layer (([0069] and [0071]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the adhesive polymer matrix comprising polyisobutylene, mineral oil and colloidal silicon dioxide taught by SIVARAMAN for the drug-containing matrix layer of THEOBALD because THEOBALD already teaches the use of polyisobutylene as adhesive polymer material and mineral oil and colloidal silicon dioxide were taught to be used with polyisobutylene adhesive for improving physical properties and performance of the transdermal system as evidenced by THEOBALD. Also, it would have been prima facie obvious to use the release-controlling hydrophobic polymeric material layer (controlling layer) comprising polyisobutylene, mineral oil and colloidal silicon dioxide taught by SIVARAMAN for the transdermal system of THEOBALD because THEOBALD already teaches and suggest adding a membrane controlling the rate of release of the active ingredient and a pressure-sensitive adhesive layer. The skilled artisan would have been motivated to do so for obtaining desired release profile via the release-controlling layer and would have reasonably expected that the release-controlling hydrophobic polymeric material layer comprising polyisobutylene, mineral oil and colloidal silicon dioxide taught by SIVARAMAN would act as a skin-contacting adhesive layer as well as release-controlling layer as evidenced by SIVARAMAN.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the known adhesive matrix composition for the drug-reservoir layer and the release-controlling layer for improving physical properties and performance (e.g., controlled release of pramipexole) of the transdermal patch comprising pramipexole of THEOBALD.
As to the new limitation “the controlling layer further comprising an acrylic polymer selected from Carbomer or Acrylates C10-30 Alkyl Acrylate Crosspolymer, “Carbomer” is a trade name of “polyacrylates”. SIVARAMAN teaches that the release controlling layer comprises a release-controlling hydrophobic polymeric material and the layer of the release-controlling hydrophobic polymeric material acts to control release of the drug from the reservoir layer both during storage and during use. ([0069] and [0071]). Suitable adhesive polymers may include hydrophobic polymers, such as polyisobutylenes or (meth)acrylate ester polymers (polyacrylate) ([0005]) and the adhesive polymers, together with fillers, plasticizers, and other pharmacologically inactive ingredients, make up an adhesive hydrophobic matrix ([0005]). Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add additional release controlling polymeric material such as Carbomer to the release-controlling layer taught by SIVARAMAN for the transdermal system of THEOBALD because THEOBALD already teaches and suggest adding a membrane controlling the rate of release of the active ingredient and a pressure-sensitive adhesive layer and the carbomer is well-known polymer for such use. The skilled artisan would have been motivated to do so for obtaining desired release profile via the release-controlling layer and would have reasonably expected that the combination of Carbomer would provide suitable release-controlling hydrophobic polymeric material for the release-controlling layer. According to M.P.E.P. § 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In this case, one would be motivated to combine two polymeric materials such as polyisobutylenes and acrylic polymer such as carbomer based on their independent activities in controlling the release of the drug from the reservoir layer both during storage and during use. One would have a reasonable expectation of success, as noted above, that they would be similarly useful for controlling the release when combined.
Claims 1-7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0072884 (hereafter, HAMLIN) in view of US 2015/0258037 (hereafter, SIVARAMAN).
HAMLIN teaches transdermal compositions that are configured to transdermally deliver an active agent such as rasagiline to a subject wherein the compositions include two or more layers, where the two or more layers include at least an active agent layer and a conversion layer, and wherein the two or more layers are configured to provide for multi-day delivery of a therapeutically effective amount of an active agent to a subject when the composition is topically applied to said subject (abstract, [0017], [0025], and [0026]).
HAMLIN disclose a transdermal patch comprises active agent layer (reservoir layer), a converting layer, a support layer/rate controlling membrane, a backing layer and release liner, wherein the active agent layer (reservoir layer) and a support layer/rate controlling membrane are disposed between the backing layer and the release liner ([0024] and figure 1A and 1B).
HAMLIN teaches that the active agent layer includes an amount of the active agent in a matrix wherein the matrix includes adhesive polymeric material such as polyisobutylenes ([0029]).
HAMLIN also discloses that the compositions provide delivery of a target dosage of active agent that is 0.5 mg/day or greater over a one-week period (i.e., 7 days or 168 hours), including 1.0 mg/day or greater over a one-week period, such as 10 mg/day or greater over one week ([0018]). HAMLIN further discloses that while the actual flux may vary, in some instances (e.g., as determined using the skin permeation assay reported in the Experimental Section, below) skin permeation rates of 1 μg/ cm2/hr or greater, including 10 μg/ cm2/hr or greater are provided by the compositions ([0019]). The rate falls within the range recited in claim 8.
HAMLIN teaches the transdermal compositions comprising rasagiline in use for treating Parkinson's disease ([0067] and [0069]). In addition, HAMLIN teaches there is a constant need to administrate physiologically active agents, such as anti-Parkinson agents, into human body and administration through human skin (transdermal drug delivery) is an alternative route to oral administration and can provide some advantages such as the avoidance of first pass metabolism, controlled delivery, more simple dosing regime, and better patient compliance ([0002] and [0003]).
HAMLIN does not specifically teach that the active ingredient-containing polymer layer (reservoir layer) further comprises a filler such as silicon dioxide, plasticizer such as mineral oil, and a tackifier such as colloidal silicon dioxide with an adhesive polymer such as polyisobutylene. Also, HAMLIN does not specifically teach a controlling layer comprising a filler such as colloidal silicon dioxide, plasticizer such as mineral oil, and a tackifier such as colloidal silicon dioxide with an adhesive polymer such as polyisobutylene.
However, it was known in the art that the adhesive polymer such as polyisobutylene is used in combination with mineral oil and colloidal silicon dioxide for drug-containing matrix layer in a transdermal patch as evidenced by SIVARAMAN ([0011]). SIVARAMAN teaches that the interaction of the polyisobutylene and the hydrophobic colloidal silica with the mineral oil was considered very significant in influencing the physical properties of the whole transdermal system and the silica materials can provide a physically acceptable transdermal system for an active ingredient which is in the oil state with the combination of polyisobutylene and mineral oil ([0066]). Especially, the hydrophobic silica material can provide an acceptable transdermal system both physically and chemically ([0066]).
SIVARAMAN teaches that the hydrophobic reservoir layer contains a drug and a hydrophobic matrix, where the hydrophobic matrix contains hydrophobic colloidal silicon dioxide (filler and tackifier) in an amount effective to adsorb said drug; and a mixture of polyisobutylene and mineral oil (plasticizer) ([0018], [0028], and [0059]).
Also, SIVARAMAN discloses a patch for transdermal drug administration comprising a polymer matrix layer containing laminated hydrophobic reservoir matrix layer containing the drug (the drug reservoir layer) and release-controlling hydrophobic polymeric material layer (controlling layer), wherein the resulting laminate is deposited on a drug-impermeable backing layer so that an exposed surface of the reservoir matrix layer contacts the backing layer, and a release liner may then be applied to an exposed surface of the release-controlling hydrophobic polymeric material layer ([0018], [0055], [0056] and [0072]). The resulting transdermal system allows the rate of drug delivery to be controlled and lamination of an adhesive layer with varied thickness to a drug reservoir layer can improve the physical performance of the transdermal system ([0022]).
SIVARAMAN further teaches that the layer of the release-controlling hydrophobic polymeric material acts to control release of the drug from the reservoir layer both during storage and during use and the release-controlling hydrophobic polymeric material provides an additional layer of polymeric material through which the drug must diffuse to reach the release liner during storage, or to reach a skin surface during use of the transdermal system ([0071]) and the release-controlling layer comprises hydrophobic colloidal silica (filler and tackifier); and a mixture of polyisobutylene and mineral oil (plasticizer) ([0020] and [0054]). In addition, SIVARAMAN teaches that the release-controlling hydrophobic polymeric material layer acts as a skin-contacting adhesive layer and contains hydrophobic colloidal silica, which acts to adsorb the drug as it diffuses through the release-controlling hydrophobic polymeric layer, thereby slowing diffusion of the drug through the release-controlling hydrophobic polymeric layer (([0069] and [0071]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the adhesive polymer matrix comprising polyisobutylene, mineral oil and colloidal silicon dioxide taught by SIVARAMAN for the drug-containing matrix layer of HAMLIN because HAMLIN already teaches the use of polyisobutylene as adhesive polymer material and mineral oil and colloidal silicon dioxide were taught to be used with polyisobutylene adhesive for improving physical properties and performance of the transdermal system as evidenced by HAMLIN. Also, it would have been prima facie obvious to use the release-controlling hydrophobic polymeric material layer (controlling layer) comprising polyisobutylene, mineral oil and colloidal silicon dioxide taught by SIVARAMAN for the transdermal system of HAMLIN because HAMLIN already teaches and suggest adding a support layer/rate controlling membrane. The skilled artisan would have been motivated to do so for obtaining desired release profile via the release-controlling layer and would have reasonably expected that the release-controlling hydrophobic polymeric material layer comprising polyisobutylene, mineral oil and colloidal silicon dioxide taught by SIVARAMAN would act as a supporting adhesive layer as well as release-controlling layer as evidenced by SIVARAMAN.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the known adhesive matrix composition for the drug-reservoir layer and the release-controlling layer for improving physical properties and performance (e.g., controlled release of rasagiline) of the transdermal patch comprising rasgiline of HAMLIN.
As to the new limitation “the controlling layer further comprising an acrylic polymer selected from Carbomer or Acrylates C10-30 Alkyl Acrylate Crosspolymer, “Carbomer” is a trade name of “polyacrylates”. SIVARAMAN teaches that the release controlling layer comprises a release-controlling hydrophobic polymeric material and the layer of the release-controlling hydrophobic polymeric material acts to control release of the drug from the reservoir layer both during storage and during use. ([0069] and [0071]). Suitable adhesive polymers may include hydrophobic polymers, such as polyisobutylenes or (meth)acrylate ester polymers (polyacrylate) ([0005]) and the adhesive polymers, together with fillers, plasticizers, and other pharmacologically inactive ingredients, make up an adhesive hydrophobic matrix ([0005]). Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add additional release controlling polymeric material such as Carbomer to the release-controlling layer taught by SIVARAMAN for the transdermal system of THEOBALD because THEOBALD already teaches and suggest adding a membrane controlling the rate of release of the active ingredient and a pressure-sensitive adhesive layer and the carbomer is well-known polymer for such use. The skilled artisan would have been motivated to do so for obtaining desired release profile via the release-controlling layer and would have reasonably expected that the combination of Carbomer would provide suitable release-controlling hydrophobic polymeric material for the release-controlling layer. According to M.P.E.P. § 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In this case, one would be motivated to combine two polymeric materials such as polyisobutylenes and acrylic polymer such as carbomer based on their independent activities in controlling the release of the drug from the reservoir layer both during storage and during use. One would have a reasonable expectation of success, as noted above, that they would be similarly useful for controlling the release when combined.
Response to Applicant’s arguments:
Responses are limited to Applicants' arguments relevant to either reiterated or newly applied rejections.
Applicant argued that the cited references fail to disclose or suggest co-formulating pramipexole and rasagiline together in a single transdermal therapeutic system and coordinating their release profile over 7 days.
On the contrary to Applicant’s assertion, it is noted that a dual-API transdermal delivery system and their release profile over 7 days are not recited in rejected claims. Instead, the claim 1 recites “the reservoir layer contains a pharmaceutically active ingredient” and then recites “the pharmaceutically active ingredient is selected from the group consisting of pramipexole and rasagiline”. Thus, the claim 1 encompasses a transdermal patch containing either pramipexole or rasagiline only as a pharmaceutically active ingredient, not together. This is further evidenced by dependent claims 8-9, which recites either pramipexole or rasagiline only. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
As to the argument regarding the new limitation, they have been addressed in the above rejections.
As to the alleged unexpected 7-day stable release of both APIs, it is noted that it is applicant's burden to demonstrate unexpected results over the prior art. See MPEP 716.02, also 716.02 (a) - (g). Furthermore, the unexpected results should be demonstrated with evidence that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Moreover, evidence as to any unexpected benefits must be "clear and convincing" In re Lohr, 137 USPQ 548 (CCPA 1963), and be of a scope reasonably commensurate with the scope of the subject matter claimed, In re Linder, 173 USPQ 356 (CCPA 1972).
In the instant case, the alleged unexpected result of the claimed composition is not commensurate in scope with the claims. As stated above, claim 1 encompasses transdermal patch compositions containing only pramipexole or rasagiline as a pharmaceutically active ingredient in combination with various first and second fillers, plasticizers, and tackifiers, but the test result for 7-day release in the specification is limited to a specific formulation comprising both drugs with a specific first and second filler, plasticizer, and tackifier (see Example 14 and Tables 5-6). In addition, Applicant did not provide any evidence that the alleged 7-day stable release is in fact unexpected and unobvious over the prior art.
Accordingly, Applicant’s arguments have not been found to be persuasive.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611