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 .
In the event the determination of the status of the application as subject to AIA 35
U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any
correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will
not be considered a new ground of rejection if the prior art relied upon, and the rationale
supporting the rejection, would be the same under either status.
Claim Status
Applicant’s preliminary amendment of 01/25/2023 is acknowledged. Claims 8-10 are amended. Claims 1-10 are currently pending.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-7, and election of species in the reply filed on 07/16/2025 is acknowledged. The traversal is on the grounds that Groups I and II fall within a single inventive concept of a novel glycopyrronium salts oral film composition and its process for preparation and that the assertion of lack of unity of invention is improper. Applicant further argues that Dillaha and Irfan fail to disclose a glycopyrronium salts oral film composition comprising all components and concentrations recited in instant claim 1 and that the basis for the election of species is without merit. However, Applicant does not specifically point out how the combination of Dillaha and Irfan fail to disclose the instantly claimed composition.
Neither argument is found persuasive because PCT Rule 13.2 requires that in order to relate to a single general inventive concept under PCT Rule 13.1, the inventive groups must share a special technical feature. As discussed in detail in the Requirement for Restriction/Election filed 05/20/2025 and further demonstrated in the prior art rejections below in view of Merello et al. (US20080102102A1; published: 05/01/2008; effectively filed: 01/19/2006; PTO-892 of instant action) in view of Irfan et al. (Saudi Pharmaceutical Journal, vol. 24, p. 537-546; published: 03/10/2015; PTO-892 of 05/20/2025), the technical feature of a glycopyrronium salts oral composition comprising 0.05% to 5% (w/w) of glycopyrronium salts, 0.1% to 10% (w/w) of saliva stimulating agents, 0.5% to 60% (w/w) of film-forming agents, 0.05% to 10% (w/w) of buffering agents, 0.1% to 25% (w/w) of plasticizers, and 0.5% to 90% (w/w) of other pharmaceutically acceptable excipients is obvious in view of the prior art. Because the technical feature of a glycopyrronium salts oral film composition as set forth in instant claim 1 does not make a contribution over the prior art, it is not a special technical feature. Thus, Groups I and II lack unity of invention, and the various claimed species of glycopyrronium salts oral film composition also lack unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Claims 1-7 are being examined on the merits herein.
It is noted that Applicant’s election of “polyethylene” for the plasticizers is interpreted by the Examiner to mean any plasticizer comprising polyethylene. Further, it is noted that the Examiner has extended the search beyond Applicant’s species election to demonstrate that other species of Applicant’s glycopyrronium salts oral film composition are also obvious over the prior art.
Priority
The instant application is a 371 of PCT/IB2021/056855 filed on 07/28/2021 and claims foreign priority to IN202041032260 filed on 07/28/2020 as reflected in the filing receipt dated on 05/25/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/25/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claims 1-7 are objected to because of the following informalities:
Claims 1-7 recite at least nine instances wherein the term “Glycopyrronium” is inappropriately capitalized and should be “glycopyrronium”.
In claim 5, the term “Sodiumcarboxy” in line 3 and the terms “Starch”, “Pectin” and “Sodium” in line 5 are inappropriately capitalized. Further, a space is missing between the terms “sodium” and “carboxy” in the term “Sodiumcarboxy” recited in line 3. The terms should read: “sodium carboxy”, “starch”, “pectin”, and “sodium”.
Claim 5, line 7, recites an extraneous hyphen within the term “co-polymers”. The term should read “copolymers”.
Claim 5, line 9, recites the limitation “a polyalkenylpolyethers”, wherein “a” is a singular article and “polyalkenylpolyethers” is a plural term. The limitation should read either “a polyalkenylpolyether” or “polyalkenylethers”.
Appropriate correction is required.
Title
The title of the invention is objected to because of the following informalities:
In the Application Data Sheet dated 01/25/2023 and in the Filing Receipt dated 05/25/2023, the term “IT’S” contains an extraneous apostrophe in the application title and should read “ITS” to reflect the possessive form of the term, indicating association with the subsequent term “PROCESS”, rather than the contraction form, which is equivalent to the recitation “IT IS”.
Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities:
Page 4, line 30, recites a typographical error wherein the term “saltss” has an extra “s”, and should be “salts”.
Appropriate correction is required.
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 5 and 6 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 5, the phrase "such as" recited in lines 8 and 9 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term “lightly crosslinked” in claim 5, line 9, is a relative term which renders the claim indefinite. The term “lightly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear the minimum and maximum amount of crosslinking required to fall within the scope of being “lightly” crosslinked versus, for example, heavily crosslinked. Therefore, the metes and bounds of the claim are indefinite.
In claim 6, lines 3-4, the limitation “glycerol monoacetate, diacetate or triacetate” falls within a Markush grouping. While it appears the terms “diacetate” and “triacetate” should also modify the term “glycerol”, it is unclear whether the terms “glycerol monoacetate”, “diacetate”, and “triacetate” are separate plasticizers as in listed within the Markush grouping. Therefore, the scope of the claim is indefinite. The Examiner recommends amending the claims to recite “glycerol monoacetate, glycerol diacetate, glycerol triacetate” to provide clarity if they are meant to be interpreted as such.
Claim Interpretation
The limitation “novel” recited in the instant claims is interpreted by the Examiner as carrying no patentable weight because the term does not appear to impart a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Further, because the components of the claimed composition are recited in the plural form, the Examiner is interpreting the claims to mean that more than species within each genus of component is permitted, so long as the total concentration of species within each genus of component is present within the claimed range.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Merello et al. (US20080102102A1; published: 05/01/2008; effectively filed: 01/19/2006; PTO-892 of instant action) in view of Irfan et al. (Saudi Pharmaceutical Journal, vol. 24, p. 537-546; published: 03/10/2015; PTO-892 of 05/20/2025).
Merello discloses methods and compositions comprising an anti-cholinergic agent for decreasing saliva production and treating sialorrhea, wherein such compositions are applied intra-orally to an individual (Abstract and Paragraph 0023).
In an exemplary embodiment (Paragraph 0113, Example 6), slow dissolving films comprising glycopyrrolate contain: 36 g polyvinyl alcohol, 1 g glycopyrrolate, 1.4 g citric acid, 1.7 g polyoxyethylene hydrogenated castor oil, and 36 g propylene glycol, among other ingredients to a total weight of 100.01 g. While the ingredients are initially dissolved in an unspecified amount of water to form a wet film, Merello notes that the film is dried to form a final product, indicating that water does not contribute to the final weight of the slow dissolving films (Paragraph 0113).
Glycopyrrolate is also referred to as glycopyrronium bromide (Paragraph 0059) and, thus, reads on the glycopyrronium salts component of instant claims 1-7. The amount of glycopyrronium salts, 1% w/w, lies within and thus renders obvious the range recited in instant claim 1. The glycopyrrolate film composition as a whole reads on the instantly claimed glycopyrronium salts oral film composition, as well as Applicant’s elected species of bromide for the glycopyrronium salts oral film composition.
Regarding the film-forming agents recited in instant claims 1 and 5, Merello discloses that preferable nonionic polymers include polyvinyl alcohol, gelatin, hydroxypropyl methylcellulose, or a combination thereof (Paragraph 0091). Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention could at once envisage an embodiment wherein hydroxypropyl methylcellulose, which reads on Applicant’s elected species of film-forming agents, is used as the nonionic polymer rather than polyvinyl alcohol. The amount of film-forming agents, 36% w/w, lies within and thus renders obvious the range recited in instant claim 1.
Citric acid reads on Applicant’s elected species of buffering agents recited in instant claims 1 and 4. The amount of buffering agents, 1.4% w/w, lies within and thus anticipates the range recited in instant claim 1. Because Merello does not specify that the citric acid is hydrated, one of ordinary skill in the art would conclude that the ingredient is present in its pure, anhydrous form. Therefore, the citric acid of Merello also reads on Applicant’s elected species of saliva stimulating agents recited in instant claims 1 and 3, and the amount of saliva stimulating agents, 1.4% w/w, lies within and thus renders obvious the range recited in instant claim 1.
Propylene glycol reads on Applicant’s elected species of permeation enhancers for the other pharmaceutically acceptable as recited in instant claims 1 and 7 as evidenced by Applicant’s instant specification, which states propylene glycol is a permeation enhancer (Instant Specification, Page 15, lines 25-27). The amount of propylene glycol, 36% w/w, lies within and thus anticipates the range recited in instant claim 1.
To the extent that other ingredients, i.e. besides glycopyrrolate, hydroxypropyl methylcellulose, citric acid, and propylene glycol, also read on non-elected species of the instantly claimed other pharmaceutically acceptable excipients recited in instant claim 1, the remainder of ingredients comprise 25.61% w/w of the composition, which when combined with propylene glycol account for 61.61% w/w of the composition, which lies within and thus renders obvious the instantly claimed range.
While propylene glycol reads on a non-elected species of the instantly claimed plasticizers as evidenced by instant claim 6 and by Merello, which lists propylene glycol, polyethylene glycol, triethyl citrate, and other citrate esters, as suitable plasticizing agents (Paragraph 0082), Merello does not expressly teach that the oral film composition comprises 0.1% to 25% w/w of plasticizers as recited in instant claim 1, or Applicant’s elected species of plasticizers, polyethylene.
Irfan teaches that oral disintegrating films incorporate plasticizers at concentrations of 0% to 20% w/w to improve the mechanical properties, such as tensile strength and percent elongation, of formulations (Page 540, 2.3 Plasticizers). Common examples of plasticizers include PEG—also known as polyethylene glycol—glycerol, diethyl phthalate, triethyl citrate, tributyl citrate, etc. (Page 540, 2.3 Plasticizers). Polyethylene glycol reads on Applicant’s elected species of instantly claimed plasticizers, and triethyl citrate and tributyl citrate read on non-elected species, as evidenced by instant claim 6.
Regarding the plasticizers recited in instant claims 1 and 6, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the oral film composition of Merello by further including one or more of polyethylene glycol, triethyl citrate, or tributyl citrate, as taught by Irfan. One of ordinary skill in the art would have been motivated to include other plasticizers and to adjust the total amount of plasticizers within the range taught by Irfan, which substantially overlaps the instantly claimed range, in order to manipulate the mechanical properties of the film to achieve a desired strength or flexibility, as taught by Irfan. 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). Note MPEP 2144.05.
It is generally noted that differences in concentrations do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Given that applicant did not point out the criticality of the concentration of plasticizers in the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine where in a disclosed set of ranges is the optimum concentration. NOTE: MPEP 2144.05.
One of ordinary skill in the art would reasonably expect success in modifying the oral film composition of Merello with the teachings of Irfan as proposed because Merello teaches that propylene glycol, polyethylene glycol, triethyl citrate, and other citrate esters are suitable plasticizing agents for use in its oral film compositions, and the concentration of plasticizers is known in the art to be useful in formulating disintegrating oral films.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 4:00 PM ET, Friday 8:00 AM - 12:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH C WISTNER/ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616