DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submission filed on 01/13/2026 has been entered.
Status of Claims
Receipt of Remarks/Amendments filed on 01/13/2026 is acknowledged. Claims 1-3 and 9-10 are amended. Claims 1-15 are currently pending and are examined on the merits herein.
Priority
Acknowledgment is made of applicant’s claim for foreign priority based on an application filed in Republic of India on 02/04/2022. It is noted, however, that applicant has not filed a certified copy of the IN202241006098 application as required by 37 CFR 1.55.
Information Disclosure Statement
No information disclosure statement has been received as of the date of this action.
Non-Compliant Amendments
Claims 2-3 and 10 contain amendments to the text but do not report the correct claim status. Any claims which have been amended should recite “(Currently Amended)”. See MPEP Patent Rules 1.121.
Withdrawn Objections and Rejections
Claims 2-3 and 10 were objected to for informalities. Applicant’s amendments to these claims have overcome the objections and the objections are withdrawn.
Claims 1-14 were rejected under 35 U.S.C. 103 as being unpatentable over Azpitarte in view of Wang. Upon further consideration this rejection is withdrawn.
Claims 1-15 were rejected under 35 U.S.C. 103 as being unpatentable over Azpitarte, Wang, and Fan. Upon further consideration this rejection is withdrawn.
Claim Objections
Claims 9 and 10 are objected to because of the following informalities: Sebacate appears to be misspelled as “sebecate”. 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.
1. Claim 10 is 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. Claim 10 defines wherein the amount of hydroxypropylmethyl cellulose in the core is 40% to 60% (inclusive of 40%), while its parent claim 9 defines hydroxypropylmethyl cellulose as present in an amount of more than 40% (exclusive of 40%). As such, an amount of 40% in claim 10 lacks antecedent basis and it is unclear whether an amount of 40% is included or excluded from the claims.
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 (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.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Gilis et al. (US 5681582 A, 10/28/1997, PTO-892), hereinafter Gilis, in view of Padhi et al. (US 20100172984 A1, 07/08/2010, PTO-892), hereinafter Padhi, and Chen et al. (CN 111249244 A, 06/09/2020, PE2E translation used, PTO-892), hereinafter Chen, as evidenced by Colorcon. (2016). Opadry® AMB II Product Brochure. (PTO-892), hereinafter Colorcon.
Gilis teaches an extended release, film coated tablet comprising as active ingredients astemizole and pseudoephedrine hydrochloride (abstract).
Regarding claim 1: The tablet comprise an extended release matrix core, reading on I, comprising pseudoephedrine hydrochloride, reading on a), a highly viscous hydrophilic polymer, reading on b), a solid diluent and optionally other formulating agents, reading on c) (col. 1, lines 44-50; claim 1). For the active ingredient pseudoephedrine hydrochloride, the highly viscous hydrophilic polymer in the core should be hydroxypropyl methylcellulose (col 2, lines 11-22; claims 1 and 4), further reading on the hydroxypropylmethyl cellulose (HPMC) of b). The tablets comprise about 75% (i.e., 60 to 90%) of the available pseudoephedrine hydrochloride in the core and the remaining 25% (i.e., 10 to 40%) in the drug coating (col. 1, lines 59-64; claim 2), reading on the amounts of pseudoephedrine in I and V. The tablet also comprises an extended release coating comprising ethylcellulose, HPMC, and PEG (col. 1, lines 51; col. 2, lines 58-67; claims 5 and 9), which reads partially on the extended release coating of III. The tablet comprises a drug coating containing pseudoephedrine hydrochloride, astemizole, and a hydrophilic polymer, reading on V; and a seal coating (col. 1, lines 51-58; claim 1). The seal coating comprises a hydrophilic polymer such hydroxypropyl methylcellulose, (col. 3, lines 35-37; claim 9), reading on the sub coat of IV.
Regarding claim 2: As discussed above, the tablet comprises 75% of the pseudoephedrine in the core and the remaining 25% in the immediate release coating (col. 1, lines 59-64; claim 2).
Regarding claim 3: Tablets for adult humans comprise about 180 mg pseudoephedrine hydrochloride in the core, about 60 mg pseudoephedrine hydrochloride in the drug coating (col. 2, lines 1-4; claim 9).
Regarding claim 9: The tablet comprise an extended release matrix core, reading on I, comprising pseudoephedrine hydrochloride, reading on a), a highly viscous hydrophilic polymer, reading on b), a solid diluent and optionally other formulating agents, reading on c) (col. 1, lines 44-50; claim 1). For the active ingredient pseudoephedrine hydrochloride, the highly viscous hydrophilic polymer in the core should be hydroxypropyl methylcellulose (col 2, lines 11-22; claims 1 and 4), further reading on the hydroxypropylmethyl cellulose (HPMC) of b). Tablets for adult humans comprise about 180 mg pseudoephedrine hydrochloride in the core, about 60 mg pseudoephedrine hydrochloride in the drug coating (col. 2, lines 1-4; claim 9), reading on the amounts of pseudoephedrine in I and V. The tablet also comprises an extended release coating comprising ethylcellulose, HPMC, and PEG (col. 2, lines 58-67; claims 5 and 9), which reads partially on the extended release coating of III. The tablet comprises a drug coating comprising pseudoephedrine hydrochloride, astemizole, and a hydrophilic polymer, reading on V; and a seal coating (col. 1, lines 51-58; claim 1). The seal coating comprises a hydrophilic polymer such hydroxypropyl methylcellulose, (col. 3, lines 35-37; claim 9), reading on the sub coat of IV, and the hydrophilic polymer in the drug coating is hydroxypropyl methyl cellulose (col. 3, lines 11-16; claim 9), further reading on V.
Regarding claim 12: The tablet core is prepared by mixing the various components and compressing the mixture into tablets (col. 3-4, lines 66-12; col. 5, lines 2-4).
The quantity of hydrophilic polymer necessary in the core depends on both the amount of pseudoephedrine hydrochloride therein and the viscosity of the polymer. More polymer is needed as the amount of pseudoephedrine hydrochloride increases and/or the viscosity is reduced. The quantity of hydroxypropyl methylcellulose (15.000 mPa*s) used can range from about 50% to about 90% by weight of the amount of pseudoephedrine hydrochloride (col. 2, lines 24-32).
The teachings of Gilis differ from that of the instant invention in that Gilis does not explicitly teach more than 40% of hydroxypropyl methyl cellulose in the core, the polyvinyl alcohol seal coat, or the cellulose acetate extended-release coating of claims 1 and 9, and further defined in claims 4-8 and 10-11, nor wherein the immediate release coating further comprises cetirizine as defined in claim 15.
Padhi discloses a tablet dosage form comprising a) an extended release core tablet comprising pseudoephedrine and b) an immediate release layer comprising cetirizine over the core tablet ([0022]-[0024]). The extended release component further comprises an extended release polymer such as hydroxypropylmethyl cellulose ([0051]). A formulation example comprises a pseudoephedrine HPMC matrix ER core (extended-release), wherein Hypromellose (i.e., HPMC) is present in the core at 43% by total weight of the core (i.e., 102 mg/235 mg*100) (Example 1, [0065]), which falls within the range taught by claims 1 and 9-10. The same example teaches cetirizine HCl in the immediate release coating along with Hypromellose (HPMC) (Example 1, [0065]). The dosage form may optionally be coated with non-functional layers comprising film-forming polymers, if desired. There may be an intermediate seal coat present between pseudoephedrine core and cetirizine coating ([0060]; claim 7). Coating may be performed by applying one or more film forming polymers, with or without other pharmaceutically inert excipients, as a solution/suspension using any conventional coating technique known in the art, such as spray coating in a conventional coating pan or fluidized bed processor; or dip coating ([0062]). The coating may be selected from amongst one or more of those suitable coating materials known in the art. For example, the coating material can be Opadry or Opadry AMB (aqueous moisture barrier) ([0062]). Opadry coatings are typically HPMC or polyvinyl alcohol (PVA) coatings, with Opadry AMB specifically being a PVA-based coating as evidenced by Colorcon (p. 2, para. 2). A non-functional seal coat comprising Opadry AMB therefore reads on the PVA seal coat of II in claims 1 and 9.
Chen discloses a sustained-release formulation of gliclazide (abstract). A control-released tablet is prepared by pressing a tablet comprising the active and then spray coating a coating liquid onto the tablet (p. 3, (1)-(6); claim 1). The coating liquid is composed of polymer base material, releasing speed regulator and a plasticizer (p. 3, 2nd to last paragraph; claim 3). The base material of the coating may be cellulose acetate (p. 4, para. 13; claims 4 and 7-8), such a coating reading on the extended release coating of II in claim 1. The plasticizer compound may be diethyl phthalate, dibutyl sebacate, triacetin, or triethyl citrate (p. 4, para. 13; claims 4 and 7-8), all of which read on the plasticizer of claims 5, with dibutyl sebacate reading on that of claim 6. The releasing speed regulator, also known as a pore-forming agent, may be PEG, PVP, HPMC, or HPC (p. 3, final paragraph; p. 4, para. 13-14; claims 4 and 7-8), all of which read on the pore former of claim 7, with PEG reading on that of claim 8. The coating weight is 2% to 5, based on the parts by weight, and the weight ratio of the polymer base material: plasticizer: releasing speed regulator is 1: 0.2~0.4: 0.2~0.5 (p. 4, para. 7; p. 6, para. 1; claims 3, 6, and 10), which falls within the ratio range of claim 4, overlaps with the ratio range of claim 9, and is very close to the ratio of claim 11.
First, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to optimize the amount of HPMC in the tablet core of Gilis to be above 40% as claimed, since the amount of HPMC is a results-effective parameter as taught by Gilis and 43% is a known and effective amount at which to incorporate HPMC in an extended release matrix core comprising pseudoephedrine, as taught by Padhi. Gilis teaches that the quantity of hydrophilic polymer in the core (i.e., HPMC) depends on the amount of pseudoephedrine and the polymer’s viscosity. Thus, the amount of HPMC in the core is a results effective parameter that one of ordinary skill in the art would be more than capable of optimizing depending on the active amount, polymer viscosity, and desired release profile. As such, one of ordinary skill in the art would have arrived at the instantly claimed range of the extended release polymer in claims 1 and 9-10 through no more than routine experimentation. The optimization of a result effective parameter is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B). It would have also been obvious to adopt the amount of HPMC in the core taught by Padhi (i.e., 43%) since such an amount is known and effective in an extended release core comprising pseudoephedrine and HPMC. One of ordinary skill in the art would have had a reasonable expectation of success in making the above modifications since both Gilis and Padhi teach extended release pseudoephedrine cores with immediate release coatings. Gilis also teaches a broad range of the hydrophilic polymer in the core, ranging from 50% to 90% based on the amount of pseudoephedrine, which would reasonably allow one to optimize the amount of HPMC to above 40% based on the total weight of the core.
It would have been further prima facie obvious to one of ordinary skill in the art, to incorporate a seal coat comprising PVA as a film former since such coatings are known and routine in the art as taught by Padhi. As discussed above, Padhi teaches Opadry AMB (i.e., PVA-based) as a known and routine coating material in the art which can be applied via conventional coating techniques. Thus, one of ordinary skill in the art could have applied the PVA seal coat of Padhi to the tablet of Gilis via known techniques to predictably yield the instant seal coat of II in claims 1 and 9. One of ordinary skill in the art would have had a reasonable expectation of success in adding such a seal coat since these coatings are taught by Padhi as non-functional and would not result in a drastic change from the tablets of Gilis.
It would have also been prima facie obvious to one of ordinary skill in the art to replace the extended release coating of Gilis with the coating of Chen since such a coating is a known and routine controlled release coating in the art as taught by Chen. One of ordinary skill in the art could have performed simple substitution to switch out the known extended release coating of Gilis for the known controlled (i.e., extended) release coating of Chen to predictably yield the instant invention. One of ordinary skill in the art would have had a reasonable expectation of success in making such a substitution since the extended release coating of Gilis comprises ethylcellulose, HPMC, and PEG, each of which are taught by Chen as known and acceptable polymer base material, releasing speed regulator, and plasticizer, respectively. Thus, one of ordinary skill in the art would have a reasonable expectation of success in substituting a coating with each of these elements with another coating also comprising each of these elements. Regarding the specific combination of cellulose acetate as the polymer base material, dibutyl sebacate as the plasticizer, and PEG as the releasing speed regulator (i.e., pore former), which are individually taught by Chen, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. The selection of each of these components would have been “obvious to try” given that it entails no more than choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. Such a combination reads on a formulation comprising the extended release coating of claims 1 and 5-8.
Regarding the weight ratio of the cellulose acetate (i.e., base material), dibutyl sebacate (i.e., plasticizer), and PEG (i.e., pore former/releasing speed regulator) in the above coating, Chen teaches a ratio range of the polymer base material: plasticizer: releasing speed regulator of 1: 0.2~0.4: 0.2~0.5, which falls within the range of claim 4, as discussed above. Such a range also overlaps the ratio range of claim 9. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. While weight percent is not explicitly taught by Chen, the ratio lends itself to the following calculation: Based on the lower end of the ranges, the coating solution has a total of 1.4 parts (i.e., 1+0.2+0.2). In this embodiment the polymer base material, defined as cellulose acetate above, makes up 71% of the total coating (i.e., 1/1.4*100), while the plasticizer and pore former make up 28% of the total coating (i.e., 0.4/1.4*100). Based on the higher end of the ranges, the coating solution has a total of 1.9 parts. In this embodiment the polymer base material, defined as cellulose acetate above, makes up 52% of the total coating (i.e., 1/1.9*100), while the plasticizer and pore former make up 47% of the total coating (i.e., 0.9/1.9*100). In both cases, the weight percent amounts fall within the ranges of claim 9. While the ratio range of Chen does not read on the ratio of claim 11, specifically in regards to the plasticizer (i.e., dibutyl sebacate), 0.15 part of plasticizer, as claimed, is very close to 0.2 parts of plasticizer, as taught by Chen. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art by are merely close. See MPEP 2144.05. Furthermore, it is well within the abilities of an ordinary artisan to optimize the amount of plasticizer in the coating depending on the desired flexibility and performance of the final coating, as taught by Chen. As such, one of ordinary skill in the art would have arrived at the instantly claimed ratio of claim 11 through no more than routine experimentation. Generally, differences in concentration will 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).
Regarding the release profile of the instantly claimed formulation, as recited in claims 1 and 13, because the composition made obvious by the prior art is identical to the composition of claims 1 and 9, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Regarding claim 14, the combined tablet of Gilis, Padhi, and Chen comprises a decongestant, which would reasonably be used for the relief of symptoms associated with nasal congestion. However, claim 14 simply recites the intended use of the extended release formulation of claim 1 without reciting any additional structural limitations. Thus, claim 14 is treated as substantially the same as claim 1 and is rejected for the same reasons as claim 1, set forth above.
Regarding claim 15, it would have been prima facie obvious to one of ordinary skill in the art to replace the astemizole in the immediate release layer of Gilis with the cetirizine of Padhi since cetirizine is a known and routine antihistamine in the art as taught by Padhi. One of ordinary skill in the art could have replaced the known astemizole antihistamine of Gilis with the known cetirizine antihistamine of Padhi via simple substitution to predictably yield the instant invention. One of ordinary skill in the art would have had a reasonable expectation of success in doing so since astemizole and cetirizine are both taught by their respective references in immediate release coatings also comprising HPMC, for the coating of extended release pseudoephedrine cores.
Response to Arguments
Applicant’s arguments with respect to the rejections of claims 1-15 under 35 USC 103, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex).
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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