DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicants’ Amendment
1) Applicants’ amendment filed 02/02/2026 in response to the non-final Office Action mailed 10/02/25 is acknowledged.
Status of Claims
2) Claims 40-42, 44, 50 and 57 have been amended via the amendment filed 02/02/2026.
Claims 40-59 are pending.
Claims 40-45, 48, 50 and 53-57 are under examination.
Substitute Specification
3) Applicants’ substitute specification filed 02/02/2026 is acknowledged.
Replacement Drawings
4) Applicants’ replacement drawings filed 02/02/2026 is acknowledged.
Prior Citation of Title 35 Sections
5) The text of those sections of Title 35 U.S. Code not included in this action can be found in a prior Office Action References.
Prior Citation of References
6) The references cited or used as prior art in support of one or more rejections in the instant Office Action and not included on an attached form PTO-892 or form PTO-1449 have been previously cited and made of record.
Objection(s) Withdrawn
7) The objections to the specification set forth in paragraphs 9(a) and 9(b) of the Office Action mailed 10/02/25 are withdrawn.
Objection(s) to Claim(s) & Specification
8) 37 C.F.R 1.75(d)(1) provides, in part, that ‘the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description’. The terms or limitations identified below lack antecedent basis in the as-filed specification. Furthermore, 35 U.S.C § 132 states that no amendment shall introduce new matter into the disclosure of the invention.
Claim 4, as currently amended, includes the limitations: a ratio of maltodextrin to sucrose is “from” 4:1 (w/w) “to” 9:1 (w/w). This amendment replaces the previously recited individual ratio of 4:1 (w/w) and 9:1 (w/w) with the currently recited ratio range, which ratio range lacks antecedent basis and descriptive support in the as-filed specification.
Rejection(s) Withdrawn
9) The rejection of claim 40 set forth in paragraph 11(a) of the Office Action mailed 10/02/25 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in light of Applicants’ amendments to the claim.
10) The rejections of claim 57 set forth in paragraphs 11(b), 11(c) and 11(e) of the Office Action mailed 10/02/25 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite are withdrawn in light of Applicants’ amendments to the claim.
11) The rejection of claims 43, 45 and 56 set forth in paragraph 11(d) of the Office Action mailed 10/02/25 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn. Applicants refer to MPEP 2173.05(b) and present the following arguments:
"Terms of degree are not necessarily indefinite. 'Claim language employing terms of degree has long been found definite where it provided enough certainty to one of skill in the art when read in the context of the invention.' Interval Licensing LLC V. AOL, Inc., 766 F.3d 1364, 1370, 112 USPQ2d 1188, 1192-93 (Fed. Cir. 2014) (citing Eibel Process Co. v. Minnesota & Ontario Paper Co., 261 U.S. 45, 65-66 (1923).
Proper claim interpretation regarding a term of degree requires determining whether its usage within the context of the claim(s) and specification is clear. The identification of a claim term as one of degree alone is not enough to conclude a claim is indefinite. Clearone, Inc. V. Shure Acquisition Holdings, Inc., 35 F.4th 1345, 1349, 1351, 2022 USPQ2d 509 (Fed. Cir. 2022).
Applicants assert that the term "about" is used in the context of values of mg/mL (claims 43 and 45) or temperature (claim 56) and a skilled person is provided enough certainty when read in the context of the invention and its usage within the context of the claim(s) and specification is clear. The term “about ....” in these claims is given the broadest reasonable interpretation (BRI) as set forth below in this Office Action.
12) The rejection of claim 50 set forth in paragraph 11(f) of the Office Action mailed 10/02/25 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in light of Applicants’ amendments to the claim.
13) The rejection of claims 40-42 and 54 set forth in paragraph 13 of the Office Action mailed 10/02/25 under 35 U.S.C § 102(a)(1) as being anticipated by US 20050175630 A1 (of record) is withdrawn in light of Applicants’ claim amendments. Applicants’ arguments set forth on pages 11 and 12 of REMARKS are moot in light of the withdrawal of the rejection and some are addressed to the extent still applicable in a new rejection set forth below in this Office Action to address the claims as amended. See also the ‘Claim(s) Interpretation’ section set forth in this Office Action below.
14) The rejection of claims 43-45 set forth in paragraph 15 of the Office Action mailed 10/02/25 under 35 U.S.C § 103 as being unpatentable over US 20050175630 A1 (of record) as applied to claim 40 above and further in view of Gancz et al. (Appl Environ Microbiol. 71:4850-4855, 2005, of record) is withdrawn in light of Applicants’ claim amendments.
15) The rejection of claim 53 set forth in paragraph 16 of the Office Action mailed 10/02/25 under 35 U.S.C § 103 as being unpatentable over US 20050175630 A1 (of record) as applied to claim 40 above and further in view of Ano et al. (Vaccine 29: 5758-5764, 2011, of record) is withdrawn in light of Applicants’ amendments to the base claim.
16) The rejection of claims 40, 55 and 56 set forth in paragraph 17 of the Office Action mailed 10/02/25 under 35 U.S.C § 103 as being unpatentable over Ahuja et al. (Vaccine 5: 184-186, 1987, of record) in view of Gancz et al. (Appl Environ Microbiol. 71:4850-4855, 2005, of record) is withdrawn in light of Applicants’ amendments to the base claim.
17) The rejection of claims 40, 50 and 53 set forth in paragraph 18 of the Office Action mailed 10/02/25 under 35 U.S.C § 103 as being unpatentable over Borde et al. (Eur. J. Pharm. Biopharm. 79: 508-518, 2011, of record) as evidenced by European Medicines Agency: “ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS”, pages 1-27, 20 May 2019 (of record) in view of US 20190223448 A1 (of record) and Ano et al. (Vaccine 29: 5758-5764, 2011, of record) (not Gancz et al. (Appl Environ Microbiol. 71:4850-4855, 2005, of record as mistyped inadvertently) is withdrawn in light of Applicants’ amendments to the base claim. Applicants’ arguments are considered, but are moot in light of the withdrawal of the rejection.
Rejection(s) under 35 U.S.C § 112(a) or (Pre-AIA ), First Paragraph
18) 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 the invention.
19) Claim 44 is rejected under 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. Claim 44 as amended 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 the (pre-AIA ), the Applicant. This is a new matter rejection.
Claim 4, as currently amended, includes the limitations: a ratio of maltodextrin to sucrose is “from” 4:1 (w/w) “to” 9:1 (w/w)”. This amendment replaces the previously recited individual ratio of 4:1 (w/w) and 9:1 (w/w) with the currently recited ratio range, which ratio range lacks descriptive support in the as-filed specification. While there is descriptive support in the as-filed specification for individual maltodextrin to sucrose ratio of 4:1 (w/w) or 9:1 (w/w), there is no descriptive support for the above-identified ratio range. Therefore, the above-identified limitations in the claim(s) and/or the current scope of the claim(s) constitute new matter. See M.P.E.P 608.04 to 608.04(c).
Applicants are invited to point to the descriptive support in specific pages and lines of the disclosure, as originally filed, for the limitation identified above, or alternatively, remove the new matter from the claim(s). Applicants should specifically point out the support for any amendments made to the disclosure. See MPEP 714.02 and 2163.06.
Claim(s) Interpretation
20) The pharmaceutical composition comprising inactivated Vibrio cholerae bacteria as claimed is not limited to the art-known oral vaccine composition, DUKORAL, the only composition tested in the instant application to show that it has certain specific features only when comprised in specific mg/mL and in a specific ratio. The inactivated Vibrio cholerae bacteria comprised in the claimed composition encompass, within their broad scope, Vibrio cholerae inactivated or killed by any means including lethal irradiation. A pharmaceutical composition comprising said inactivated Vibrio cholerae bacteria as claimed is not required to be an oral pharmaceutical composition.
The limitation “at least one year” in claims 55 and 57 and the limitation “at least two years” in claim 56 are interpreted as encompassing any number of years beyond one year and beyond two years since the limitation “at least” has no upper limit.
In the absence of a definition in the as-filed specification defining what precisely is encompassed in the relative claim limitation “about”, the limitations in claims 43, 45 and 56 “about .... mg/mL”, “about .... mg/mL”, and “about .... oC” respectively, are given the broadest reasonable interpretation (BRI) to encompass the recited number + 10%.
Freeze-drying (lyophilization) or spray drying is a process used in the instant application for obtaining the composition of the claimed or asserted features. For example, see the bottom of pages 4 and 7 of the as-filed specification. Thus, freeze-drying (lyophilization) and spray drying of inactivated Vibrio cholerae bacteria are expected to necessarily result in the recited water activity level, the recited residual moisture (water) content, the recited potency, and the claimed or asserted features of the composition claimed.
The limitation composition “comprising” in claim 40 represents open-ended claim language and therefore, does not exclude additional, unrecited elements. See MPEP 2111.03 [R-1]. See Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 ‘ (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”). Accordingly, any ingredient(s) comprised in a prior art composition such as ‘630’s composition in addition to the sucrose disaccharide species and the maltodextrin carbohydrate species are not excluded from the scope of instant claims.
Rejection(s) under 35 U.S.C § 102
21) The following is a quotation of the appropriate paragraphs of 35 U.S.C § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
22) Claims 40-42 and 54-57 are rejected under 35 U.S.C § 102(a)(1) as being anticipated by US 20050175630 A1 (‘630, of record).
US 20050175630 A1 disclosed a pharmaceutical composition or an immunogenic composition comprising inactivated i.e., lethally irradiated, whole Vibrio cholerae bacteria and one or more components including suitable stabilizers, disaccharides, and carbohydrates. The composition comprised less than about 5% water, i.e., inclusive of 3% or less. The composition is in the form of a tablet. See claims 11, 5, 6 and 1; sections [0052], [0137], [0140] and [0141]; lines 1-18 of section [0057]; sections [0146], [0273], [0274], and [0292]; and the last sentence of section [0290]. Contrary to Applicants’ assertion, even the neutraceutical composition of the ‘630 art is included in the definition therein of the pharmaceutical composition (see 4th full sentence in section [0270]) and therefore the prior art neutraceutical composition also qualifies as a pharmaceutical composition. The prior art pharmaceutical composition comprised the solid-based dry materials, the sucrose disaccharide species and the maltodextrin carbohydrate species. See the last sentence of sections [0273], [0274] and [0272]; and claims 5, 4, 2, 1 and 11. Along with the disclosure that the ’630 prior art’s lethally irradiated bacterial compositions are lyophilized, i.e., freeze-dried, and are storage stable, the ’630 prior art expressly taught that such storage stability reduces costs associated with transportation and storage, which feature makes the subject immunogenic compositions ideal for developing countries. The ’630 prior art further taught that this lyophilization feature allows stockpiling of vaccines. See section [0052]. The ’630 prior art further expressly taught that lyophilization provides long-term stability allowing the vaccine preparations to be conveniently and practically stored over long periods. See the last full sentence of the paragraph bridging the two columns of page 27. The prior art composition meets the structural requirements of the instantly claimed composition. Given that the prior art’s lethally irradiated Vibrio cholerae bacterial composition is lyophilized, i.e., freeze-dried, it is expected to necessarily have the recited water activity level, the recited residual moisture (water) content, the recited storage life and potency, and the claimed or asserted features. Furthermore, the claim limitations “measured at ......” in claims 40 and 41 and the limitation “measured by ....” in claim 57 are process limitations in product claims.
The patentability of a product does not depend on its method of preparation. If the product in the product-by-process claim is the same as or obvious over a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Since the Office does not have the facilities for examining and comparing the prior art composition and the claimed composition, the burden is on the Applicants to show a novel or an unobvious difference between the instantly claimed product and the prior art product. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzerald et al., 05 USPQ 594. The ’630 prior art taught having the sucrose disaccharide species and the maltodextrin carbohydrate species as additional components in the composition disclosed therein. The limitation composition “comprising” represents open-ended claim language and therefore, does not exclude additional, unrecited elements. See MPEP 2111.03 [R-1]. See Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 ‘ (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”). Accordingly, any ingredient(s) comprised in a prior art ‘630’s composition in addition to the sucrose disaccharide species and the maltodextrin carbohydrate species are not excluded from the scope of instant claims. Note that when the antibodies to the specific polypeptide species are taught, the claims are anticipated no matter how many other antibody species are additionally named. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that ‘the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is described’ as that term is used in 35 U.S.C. § 102(a), in that publication.’). Id. at 1718.
Claims 40-42 and 54-57 are anticipated by US 20050175630 A1 (‘630).
Rejection(s) under 35 U.S.C § 103
23) 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 claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 148 USPQ 459, 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 unobviousness.
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 at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicants are 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 at the time a later invention was effectively filed 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.
24) Claim 53 is rejected under 35 U.S.C § 102(a)(1) as being anticipated by US 20050175630 A1 (‘630, of record) as applied to claim 40 above and further in view of Pastor et al. (J. Drug Target. 2014;22: 478–487, 2014).
The teachings of US 20050175630 A1 are set forth supra, which are silent on the composition being spray-dried.
However, spray-drying of inactivated V. cholerae was known in the art at the time of the invention. For instance, Pastor et al. taught spray-drying an inactivated V. cholerae O1 Ogawa El Tor biotype at different temperatures and concluded that the spray-dried V. cholerae seem to be a promising step toward a powder-form cholera vaccination. See Abstract. Pastor et al. further taught that killed Vibrio cholerae was found to be an interesting active pharmaceutical ingredient for spray drying. See last sentence of 1st full paragraph on page 479. See section ‘Bacterial strain’ under ‘Materials and Methods’ on page 479. Pastor et al. expressly taught the different advantages of developing an inactivated vaccine in powder form such as allowing the possibility of decreasing the burden of handling, storage and transport and allowing the possibility of preparing different solid pharmaceutical dosage forms such as tablets, capsules or granules. See first two sentences in right column of page 478.
Given the teachings and showing of Pastor et al., it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of instant application to have the 630’s inactivated Vibrio cholerae composition spray-dried to produce the instant invention. One of ordinary skill in the art would have been motivated to produce the instant invention for the expected benefit of advantageously providing the 630’s inactivated Vibrio cholerae composition in a dry powder form allowing the possibility of decreasing the art-recognized burden of handling, storage and transport and allowing the possibility of preparing different solid pharmaceutical dosage forms such as tablets, capsules or granules.
Claim 53 is prima facie obvious over the prior art of record.
25) Claims 40, 42, 48 and 50 are rejected 35 U.S.C § 103 as being unpatentable over Borde et al. (Eur. J. Pharm. Biopharm. 79: 508-518, 2011, of record) as evidenced by European Medicines Agency: “ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS”, pages 1-27, 20 May 2019 (of record) further in view of US 20050175630 A1 (of record).
Along with the teaching that freeze-drying is a low-temperature process where water or solvent is removed by direct sublimation leading to a dry and porous matrix that is often sufficiently stable for storage and easy distribution, and the teaching that stabilizing excipients including sucrose that hinder aggregation and replace hydrogen-bonded water are usually required in the formulation to be freeze-dried, Borde et al. taught the internationally widely licensed oral cholera vaccine composition Dukoral™ from Sweden, which comprises a cocktail of whole inactivated Vibrio cholerae together with cholera toxin B-subunit (CTB) along with sucrose stabilizer. Dukoral™ is also the composition that is used by Applicants in the instant application and therefore the prior art Dukoral™ composition has all the features and ingredients of the composition claimed in instant claims 50 and 48. The freeze-dried formulations had a residual moisture content of 2-4%, i.e., encompassing equal to or less than 3%. The composition comprising whole inactivated cells were reconstituted in PBS for immunization. Borde’s composition showed a LPS antigen recovery of 89%. See Abstract; the sentence bridging pages 508 and 509; sections 2.3 and 2.4.2 on page 510; the paragraph bridging pages 510 and 511; right column of page 512; first full paragraph in right column of page 513; the first full sentence under section 3.2.2 on page 515; and the last full sentence of the last full paragraph of page 517; first paragraph under ‘4. Discussion’; and page 516. The Dukoral™ vaccine was subjected to freeze-drying with the stabilizer and was found to remain active and stable. The prior art Dukoral™ is a mixture of formalin-killed and heat-inactivated V. cholerae of both Inaba and Ogawa serotypes in combination with CTB protein. See section 3.2 on page 515 and the last two full sentences in left column of page 517. Applicants acknowledge that Borde teaches freeze-drying a sucrose-stabilized vaccine. See line 3 on page 16 of Applicants’ REMARKS filed 02/02/26. That the SBL Dukoral vaccine comprises approximately 1.25x1011 of the inactivated O1 Inaba and Ogawa, classic and El Tor strains with 1 mg of cholera toxin B subunit per one dose is implied in the teachings of Borde et al. in light of what was well in the art. For instance, see page 2 of the reference of European Medicines Agency: “ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS”, 20 May 2019.
Borde et al. are silent on the presence of maltodextrin together with the sucrose-containing inactivated Vibrio cholerae in the composition.
However, having maltodextrin carbohydrate species as an additional component with sucrose disaccharide species in a pharmaceutical composition or an immunogenic composition comprising inactivated Vibrio cholerae bacteria was known or routine in the art at the time of the invention. For instance, see the disclosure of US 20050175630 A1 (‘630) set forth supra.
Given the teachings of the ‘630 reference of having maltodextrin as an additional component with sucrose in an inactivated V. cholerae composition, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of instant application to have the Applicant-acknowledged Borde’s sucrose-stabilized inactivated whole Vibrio cholerae composition with an art-known maltodextrin to produce the instant invention.
Doing so would have been well within the realm of routine experimentation. As set forth in KSR Int'l Co. v. Teleflex Inc., 27 S. Ct. 1727, 1741-42, 82 USPQ2d 1385, 1397 (2007), [i]n determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103". KSA International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the use of known techniques to improve similar devices, methods or products in the same way is obvious because enhancing a particular class of devices, methods, or products has been made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement in other situations. Absent evidence of unexpected effects resulting from having maltodextrin and sucrose at any unspecified ratio and amounts and at any unspecified temperature in a composition comprising V. cholerae inactivated by any generic means, instant claims are prima facie obvious.
Claims 40, 42, 48 and 50 are prima facie obvious over the prior art of record.
Claim(s) Objection
26) Claim 57, as amended, is objected to for the confusing and/or the unnecessary notation “-“ within the limitation “as-a”.
Relevant Art
27) The art made of record and not relied upon in any of the rejections is considered pertinent to Applicants’ disclosure:
t Kanojia et al. (Eur. J. Pharmaceutics & Biopharmaceutics 129: 21-29, 2018) taught the use of maltodextrin polysaccharide in combination with a disaccharide in the spray drying of a microbial vaccine. Kanojia et al. taught that the trehalose disaccharide and maltodextrin are believed to exert their protective mechanism by immobilization of vaccine. Kanojia et al. taught that maltodextrin has also been previously used to stabilize Salk IPV vaccine in a formulation used for vacuum drying. Kanojia et al. See entire reference including 1st three sentences on page 25.
Conclusion
28) No claims are allowed.
The use of trademark recitation “Dukoral” in Figures 1-4 and 7-9 of the instant application is objected to. All trademark recitations should be CAPITALIZED wherever they appear, or where appropriate, should include a proper symbol indicating use in commerce such as TM, SM, or ® following the term. See M.P.E.P 608.01(v) and Appendix l. Although the use of trademarks is permissible in patent applications, the propriety nature of the marks should be respected and every effort made to prevent their use in any manner, which might adversely affect their validity as trademarks.
For proper antecedence and clarity, in claim 44, it is suggested that Applicants insert the limitation --the-- prior to “maltodextrin” and “sucrose”.
For proper antecedence and clarity, in claims 43 and 45, it is suggested that Applicants insert the limitation --of the-- prior to “maltodextrin” and “sucrose”.
29) Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 C.F.R 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 C.F.R 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.
Correspondence
30) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's Supervisor, Jeffrey Stucker, can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
31) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
June, 2026
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