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 .
The examiner acknowledges receipt of amendment and remarks filed 04/16/2026 in response to the office action mailed 01/16/2026.
No claim is amended.
New claims 17-18 are added.
Claims 1-18 are pending.
Priority
This application is 371 of PCT/EP2022/068831 filed 07/07/2022 and which claims benefit of EPO application 21184702.5 filed 07/09/2021.
Information Disclosure Statement
The IDS filed 02/29/2024 and 01/08/2024 was considered by the examiner.
Response to Arguments
Applicant argues: A) Claim 1 is a specific combination of components: a) (meth)acrylate copolymer; b) an alkali or ammonium salt of a saturated aliphatic monocarboxylic acid having 10 to 30 carbon atoms; and c) at least one specific compound such as glyceryl tristearate or d) a specific amount (35-90% by weight based on component a) of a compound such as talc. Applicant thus argues that Baron does not disclose such a combination; that Baron cannot be routinely optimized because paragraph 202 of Baron teaches the use of combination of enteric polymers to release the active agent at a desired pH such that the skilled artisan wishing to achieve release at a pH of 6.8 would have been motivated to use enteric polymers and not the specific combination of components and weight percentages including non-polymer component in the claimed composition. Further also, applicant argues that there is a demonstration in the as filed specification in Examples 4-9 in Table 3, that the inventive composition when compared with comparable examples provide advantageous release profiles over the comparable examples.
Response: A) The examiner agrees that Boron does not teach the amount of the stearate. While, Baron in paragraph [0202] teaches using combination of enteric coatings to effect desired release at desired pH as mentioned by applicant in the remarks. However, while teaching combination of enteric coatings, Baron specifically teaches in the same paragraph cited by applicant combination of enteric coatings with other release systems (paragraph [0202]). Thus, it is not just the enteric coatings but combination of enteric coating and release systems. The demonstration in applicant’s specification uses one specific polymer, EUDRAGUARD biotic, which is the same as EUDRAGIT FS 30 D (see at least page 5, lines 35-36). The data is only to one polymer while the claimed polymer is to more than the exemplified polymer. Baron discloses coating composition comprising EUDRAGIT FS 30 D, glyceryl distearate and sodium stearate or talc (paragraph [0260]).
B). Applicant argues that the claimed composition is non obvious because it provides unexpectedly superior results citing examples 4-9 in Table 3 where the compositions with sodium stearate releases at least 90% active component, while comparative Examples 4 and 5 using triethyl citrate and EUDRAGIT FS 30 D only achieved 40% and 80% release. That the sentence bridging pages 22 and 23 of the instant specification clearly notes that the composition using triethyl citrate does not provide sufficient release at pH = 6.8.
Response: The data referenced by applicant uses one polymer EUDRAGAURD biotic while the claims are directed polymers other that EUDRAGUARD biotic. Therefore, the unexpectedly superior results opined by the applicant is not persuasive because EUDRAGUARD biotic does not represent the full scope of (meth)acrylate copolymer and methyl methacrylate: methyl acrylate: methacrylic acid is just one; methyl methacrylate: methacrylic acid is another one. Baron is not limited to example in paragraph [0536] but Baron is considered for all that it teaches. Baron teaches sodium stearate as a release excipient (paragraphs [0197], [0260], [0261]),
For the teaching or non-teaching of glyceryl tristearate, the examiner notes that claims 17 and 18 are new claims and will be addressed in the rejections below.
Therefore, the rejection is maintained below there being no amendment to the rejected claims.
Maintained Rejections
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.
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.
Claim(s) 1-2 and 4-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baron et al., (US 20150150894 A1) as evidenced by ASSMUS et al., (WO 2020114714 A1) for reasons of record and reiterated herein below.
Baron et al., (US 20150150894 A1) teaches compositions having at least one chemosensory ligand (see the whole document with emphasis on the title and the abstract). In one embodiment, the composition is in liquid form including solutions, suspension, dispersions and colloid (paragraphs [0183], [0254]). In an embodiment the chemosensory receptor ligands are coated to modify delivery to the intestine and colon (paragraph [0183]). The coating is accomplished with enteric coatings and pH dependent systems enteric polymers namely copolymers derived from acrylic and/or methacrylic acid ester (paragraphs [0200]-[0203]) and EUDRAGIT FS 30D is used in the example in paragraph [0526]). The composition also contains release excipients including sodium stearate, microcrystalline cellulose, glyceryl behenate and Baron contemplates that varying amounts of these excipients may be used to achieve designated release time (paragraph [0197]). Stearic acid, sodium stearates, magnesium stearates, glycerol, talc, glyceryl distearate, polyethylene glycol, corn starch are further acknowledged as excipients for the composition (paragraph [0260]). In paragraph [0262] Baron teaches that talc, corn starch, sodium stearate, magnesium stearate are flow aids or glidants that improve the flow characteristic of powder mixture. The composition of Baron further comprises plasticizer (paragraphs [0240], [0262]).
EUDRAGIT FS 30D is 10% methacrylic acid, 65% methyl acrylate and 25% methyl methacrylate (see page 2, lines 28-32 of ASSMUS) such that EUDRAGIT FS 30D meets the limitation of claim 1 a) and 12 a).
Thus for claims 1, 2, 4, 8, 9, 10, 12 and 14, the composition of Baron as described above teaches the elements of these claims. Baron differs from claims 1 and 12 by not teaching the amount of the sodium stearate, which is a sodium salt of C18 saturated aliphatic monocarboxylic acid . However, Baron specifically notes that flow aid/glidant such as sodium stearate improve the flow characteristics. Therefore, before the effective date of the invention, the artisan having the desire to improve the coating composition of Baron would be motivated to use amount of the stearate that would be improve the flow characteristic of the compositions in claims 1 and 12 by routine optimization. Further also, with regards to claims 1 and 12 c) or 1 and 12 d), the artisan would use amounts that would be effective for composition that would be effectively released at the desired site such as the intestine/colon.
It was settled in In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) that generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature 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.” See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382.
For claim 5 and 7, the composition of Baron comprises additional excipients and plasticizers; the amount of the further excipient and plasticizer could be used in amounts that would reasonably optimize the composition for release at the desired site, intestine/colon.
For claim 6, the flow aid of Baron meets the requirement for flow aid in claim 6.
For claim 11, Baron teaches that active agent can be in the form of powder or dispersed (paragraphs [0094], [0238]).
For claim 13, Baron teaches that the composition can be in liquid form as dispersion and the liquid forms are shakes or juices (paragraph [0183]) and juice is aqueous.
For claim 15, Barron administers the composition (see at least paragraphs [0008] and [0012]) meeting the method of using of claim 15.
Therefore, Baron as evidenced by ASSMUS renders claims 1-2 and 4-15 prima facie obvious.
Claim(s) 1, 2, 3 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baron et al., (US 20150150894 A1) as evidenced by ASSMUS et al., (WO 2020114714 A1). As applied to claim 1, and in view of TSENG et al. (US 20150342998 A1) and Iwasaki et al. (US 12091555 B1).
Claims 2 and 3 depend on claim 1. Claim 16 depends on claim 2.
Claims 1 and 2 have been described above to be rendered prima facies obvious over Baron as evidenced by ASSMUS. Baron teaches its composition to contain sodium stearate, a sodium salt of stearic acid fatty acid. Baron differs from claims 3 and 16 because Baron does not teach ammonium salt of aliphatic saturated monocarboxylic acid. However, it is known that sodium stearate is an anionic surfactant (see paragraph [0059] of TSENG) and ammonium decanoate, an ammonium salt of decanoic acid, is anionic surfactant (column 7, lines 26-28 of Iwasaki). Therefore, ammonium decanoate and sodium stearate are functionally equivalent such that functionally equivalent ammonium decanoate can be used in place of functionally equivalent sodium stearate with the expectation of having the same effect in the composition of Baron.
Therefore, Baron as evidenced by ASSMUS and in combination with the teachings of TSENG and Iwasaki renders claims 3 and 16 prima facie obvious.
New Rejection
Necessitated by Amendment
Claim Rejections - 35 USC § 103
Claim(s) 1, 12, 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baron et al., (US 20150150894 A1) as evidenced by ASSMUS et al., (WO 2020114714 A1), as applied to claims 1 and 12, in view of Sawhney (US 6632457 B1).
Claim 12 depends on claim 1, Claims 17 and 18 depend on claim 12.
Baron as evidenced by ASSMUS have been described above to render claims 1 and 12 prima facie obvious.
For claim 17, Baron teaches the composition to comprise excipients such as glyceryl distearate, talc and talc (paragraph {0260], [0262]). Baron differs from claim 17 by not teaching glyceryl tristearate. However, glyceryl distearate and glyceryl tristearate are excipients and Sawhney teaches that glyceryl distearate and glyceryl tristearate are rate modifying agents (column 15, lines 46-50). Thus glyceryl distearate and glyceryl tristearate are functionally equivalent. One functional equivalent rate modifying agent can be used in place of the other.
Therefore, before the effective date of the in invention, one having ordinary skill in the art would reasonably expect that using glyceryl tristearate in place of glyceryl distearate would predictably effectively modify the release rate of the composition.
For claim 18, Baron discloses coating composition comprising EUDRAGIT FS 30 D, glyceryl distearate and sodium stearate or talc (paragraph [0260]).
Therefore, Baron as evidenced by ASSMUS in view of Sawhney renders claims 17 and 18 prima facie obvious.
No claim is allowed.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
Prosecution Insights