DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicants’ amendment and response of 10/2/2025 are acknowledged. Claims 301, 302, 317-322 and 326-327 have been amended. Claim 306 has been canceled.
Status of Claims
3. Claims 296-305, 307-310 and 316-327 are pending. Claims 301, 302, 308 and 310 have been amended. New claims 323-327 have been added. Claims 301, 302, 317-322 and 326-327 have been amended. Claim 306 has been canceled.
Claims 1-295 and 311-315 have canceled by previous amended. Claim 310 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 20, 2024. Claims 296-305, 307-309 and 316-327 are currently under examination.
Rejections Moot
Claim Rejections - 35 USC § 102 Moot
4. Rejection of claim 306 under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Porro et al., (WO 2014/118201 A1), priority to 1/31/2013, is moot in view of cancelation of said claim.
Claim Rejections - 35 USC § 103 Moot
5. Rejection of claim 306 rejected under 35 U.S.C. 103 as being unpatentable over Caufield et al. WO 2011/100151 A1, art of record applicants’ search report, in view of Porro et al., (WO 2014/118201 A1), priority to 1/31/2013, in view of John J. Mekalanos US 9533032 B and further in view of del Amo et al. (Clinical Microbiology and Infection vol. 20, pp. 684-689, 8 November 2013), is moot in view of cancelation of said claim.
Claim Rejections - 35 USC § 102 Withdrawn
6. Rejection of claims 296, 298, 299, 301, 302, 303, 304, 305, 307, 308 and 309 under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Porro et al., (WO 2014/118201 A1), priority to 1/31/2013, is withdrawn in view of application’s amendment and response of 10/2/2025.
Claim Rejections - 35 USC § 103 Maintained
7. Rejection of claims 296-305, 307-309, 316-327 claims under 35 U.S.C. 103 as being unpatentable over Caufield et al. WO 2011/100151 A1, art of record applicants’ search report, in view of Porro et al., (WO 2014/118201 A1), priority to 1/31/2013, in view of John J. Mekalanos US 9533032 B and further in view of del Amo et al. (Clinical Microbiology and Infection vol. 20, pp. 684-689, 8 November 2013), is maintained.
Claim 296 is drawn to a pharmaceutical composition comprising at least 2 immunogenic saccharide- polypeptide conjugates each comprising individually a capsular polysaccharide, fragment thereof, or combination thereof, conjugated to a polypeptide, wherein the capsular polysaccharide, fragment thereof, or combination thereof is from a unique Streptococcus pneumoniae serotype, wherein a first serotype comprises 16, 20A, 20B, 24F or 31 and at least one additional serotype is selected from the group consisting of 1, 2, 3, 4,5, 6A, 6B, 6C, 7F, OV, 14, 18C, 19A, 19F, 23F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 20A, 22F, 23A, 23B, 24F, 31, 33F, 34, 35B, and 38, wherein the at least one additional serotype is not the first serotype; and wherein the fragment of the capsular polysaccharide is a monosaccharide, a disaccharide, a trisaccharide, a tetrasaccharide, a pentasaccharide, a hexasaccharide or an oligosaccharide.
Porro et al. disclose limitations of claims 296, 298, 299 a pharmaceutical or antigenic multivalent molecular construct consisting of a basic unit comprising a helper-T dependent carrier protein covalently bound to a minimum of three carbohydrate structures of different serological specificity, wherein each carbohydrate structure are at least three capsular polysaccharides selected among type 1, 2, 3, 4, 5, 6A, 6B, 6C, 6D, 7F, 8. 9N, 9V,10A, 11A, 11B, 11C, 11F, 12F, 14, 15A, 15B, 15C, 17F, 18C, 19F, 20, 22F, 23A, 23F, 33F and 35B of Streptococcus pneumoniae ( see abs, claims specially claims 1, 2, 4, 5, 8, 9, 11. As to amended claim 296, Porro et al. teach serotype 20 which inherently include serotypes 20A and 20 B ( see claim 6, pages 3, 20, 81). Porro et al. teach monosaccharide and oligosaccharide (see pages 5, 6, 8, 9, 12, 48, 80). Porro et al. disclose conjugated polypeptides to capsular polysaccharides (see claims). The invention contains each S. pneumonia capsular saccharide (see page 8, 12, 68 and claim 5). Porro et al. disclose that examples of carrier proteins which may be used in the present invention are diphtheria toxoid, tetanus toxoid, CRM197, pneumococcal surface protein, PspA and protein D from H. influenzae (see claims 4, 7, 8 and pages 8, 14). meeting the limitation of claims 301, 302, 307). Porro et al. disclose cross-linked polysaccharide to poly peptide limitations of claim 307 see pages 43, 45 and 47. Porro et al. disclose the immunogenic composition may be adjuvanted (pages 26,31, 60, 63 and tables 5,6 and claims 13-14), and may further comprise a buffering agent (pages 36, 38, 43, 47, 52 and fig 4) and a salt (page 38 (meeting the limitation of claim 303). Moreover, the vaccine preparation (claim 11-12; meeting the limitation of claim 304) containing immunogenic compositions may be administered via the intramuscular, intradermal or subcutaneous routes (see page 31,61 and claim 14). As to limitation of claim 305, Porro et al. teach opsonophagocytic response (see pages 20, 61). As to limitation of claims 306 and 309. Porro et al. teach 0.1 to 1.0 microgram saccharide-polypeptide conjugate amount by weight (see claim 12, page 62). As it pertains to claim 308, the Office takes the position that the prior art meets this limitation, particularly, the polypeptide that is a toxoid based upon Applicant’s definition: paragraph 035- The term "partly mitigated" in reference to the toxin activity of a polypeptide can refer to a decreased toxicity of the polypeptide as compared to a wild type version of the polypeptide. A CRM197 protein or toxoid is inherently, based upon Applicant’s definition, ‘partly mitigated’.
Caulfield et al. teach an immunogenic composition comprising: a multivalent polysaccharide-protein conjugate mixture consisting of capsular polysaccharides from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F of Streptococcus pneumoniae conjugated to a carrier protein; and a pharmaceutically acceptable carrier and further comprise a carrier protein CRM197 and a adjuvant. ( see claims and abstract).
Caulfield et al. page 5 recites “The present invention provides a multivalent immunogenic composition comprising, consisting essentially of, or alternatively, consisting of 15 distinct polysaccharide- protein conjugates, wherein each of the conjugates contains a different capsular polysaccharide conjugated to a carrier protein, and wherein the capsular polysaccharides are prepared from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F of S. pneumoniae, together with a pharmaceutically acceptable carrier. In certain embodiments, the carrier protein is CRM197. “ Caulfield et al. teach composition comprising a plurality of at least two immunogenic polysaccharide-protein conjugates containing serotypes 22F and 33F provides robust antibody responses ( see page 6). Caulfield et al. do not teach all the serotypes recited in claim 296 and new claims 323-327.
Porro et al. disclose limitations of claims 296, 298, 299 and new claims 323-327 a pharmaceutical or antigenic multivalent molecular construct consisting of a basic unit comprising a helper-T dependent carrier protein covalently bound to a minimum of three carbohydrate structures of different serological specificity, wherein each carbohydrate structure are at least three capsular polysaccharides selected among type 1, 2, 3, 4, 5, 6A, 6B, 6C, 6D, 7F, 8. 9N, 9V,10A, 11A, 11B, 11C, 11F, 12F, 14, 15A, 15B, 15C, 17F, 18C, 19F, 20, 22F, 23A, 23F, 33F and 35B of Streptococcus pneumoniae ( see abs, claims specially claims 1, 2, 4, 5, 8, 9, 11. As to amended claim 296, Porro et al. teach serotype 20 which inherently include serotypes 20A and 20 B ( see claim 6, pages 3, 20, 81). Porro et al. teach monosaccharide and oligosaccharide ( see pages 5, 6, 8, 9, 12, 48, 80). Porro et al. disclose conjugated polypeptides to capsular polysaccharides ( see claims). The invention contains each S. pneumonia capsular saccharide (see page 8, 12, 68 and claim 5 ). Porro et al. disclose that examples of carrier proteins which may be used in the present invention are diphtheria toxoid, tetanus toxoid, CRM197, pneumococcal surface protein (see claims 4, 7 8). meeting the limitation of claims 301, 302, 307). Porro et al. disclose cross-linked polysaccharide to poly peptide limitations of claim 307 see pages 43, 45 and 47. Porro et al. disclose the immunogenic composition may be adjuvanted (pages 26,31, 60, 63 and tables 5,6 and claims 13-14), and may further comprise a buffering agent (pages 36, 38, 43, 47, 52 and fig 4) and a salt (page 38 (meeting the limitation of claim 303). Moreover, the vaccine preparation (claim 11-12; meeting the limitation of claim 304) containing immunogenic compositions may be administered via the intramuscular, intradermal or subcutaneous routes (see page 31,61 and claim 14). As to limitation of claim 305, Porro et al. teach opsonophagocytic response (see pages 20, 61). As to limitation of claims 306 and 309. Porro et al. teach 0.1 to 1.0 microgram saccharide-polypeptide conjugate amount by weight ( see claim 12 , page 62). As it pertains to claim 308, the Office takes the position that the prior art meets this limitation, particularly, the polypeptide that is a toxoid based upon Applicant’s definition: paragraph 035- The term "partly mitigated" in reference to the toxin activity of a polypeptide can refer to a decreased toxicity of the polypeptide as compared to a wild type version of the polypeptide. A CRM197 protein or toxoid is inherently, based upon Applicant’s definition, ‘partly mitigated’.
Porro et al. do not teach serotypes 16F, 19A, 23B. 24F or 31.
Mekalanos teaches a vaccine composition comprising at least 2 immunogenic saccharide- polypeptide conjugates each comprising individually a capsular polysaccharide ( see claims, abstract and columns 17-18). Mekalanos claim 15 teaches
Streptococcus pneumoniae polysaccharide is capsular type 1, 2, 3, 4, 5, 6A, 6B, 7A, 7B, 7C, 7F, 8, 9A, 9L, 9N, 9V, 10A, 10B, 10F, 11A, 11B, 11C, 11D, 11F, 12A, 12B, 12F, 13, 14, 15A, 15B, 15C, 15F, 16A, 16F, 17A, 17F, 18A, 18B, 18C, 18F, 19A, 19B, 19C, 19F, 20, 21, 22F, 23B, 23F, 24A, 24B, 24F, 25A, 25F, 27, 28A, 28F, 29, 31, 32A, 32F, 33A, 33B, 33D, 33F, 34, 35A, 35B, 35F, 36, 37, 38, 39, 40, 41A, 41F, 42, 43, 44, 45, 46, 47A, 47F, or 48. The above serotypes include serotypes 16F, 20, 24F and 31. As to newly added claims 316, 317, 319, 320, 321, 322 the added serotype have been taught by Mekalanos including 19A, 23B and others recited in those claims.
Additionally, del Amo et al. teach plurality of Streptococcal pneumoniae serotypes included in the new generations of conjugate vaccines or pharmaceutical compositions (see title, abstract page 685 and tables 1 and 2). del Amo et al. teach 40 serotypes/serogroups (1, 2, 3, 4, 5, 6A/6B, 6C, 7C/(7B/ 40), 7F/7A, 8, 9N/9L, 9V/9A, 10A, 10F/(10C/33C), 11A/11D, 12F/(12A/44/46), 13, 14, 15A/15F, 15B/15C, 16F, 17F, 18/(18A/ 18B/18C/18F), 19A, 19F, 20, 21, 22F/22A, 23A, 23B, 23F, 24/ (24A/24B/24F), 31, 33F/(33A/37), 34, 35A/(35C/42), 35B, 35F/ 47F, 38/25F, 39) see page 685.
It would have been obvious to combine the teaching of references to obtain the claimed invention. Because, Caulfield et al. teach an immunogenic composition comprising: a multivalent polysaccharide-protein conjugate mixture consisting of capsular polysaccharides from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F of Streptococcus pneumoniae conjugated to a carrier protein; and a pharmaceutically acceptable carrier and further comprise a carrier protein CRM197 and a adjuvant. ( see claims and abstract). Porro et al. disclose limitations of claims 296, 298, 299 and new claims 323-327 a pharmaceutical or antigenic multivalent molecular construct consisting of a basic unit comprising a helper-T dependent carrier protein covalently bound to a minimum of three carbohydrate structures of different serological specificity, wherein each carbohydrate structure are at least three capsular polysaccharides selected among type 1, 2, 3, 4, 5, 6A, 6B, 6C, 6D, 7F, 8. 9N, 9V,10A, 11A, 11B, 11C, 11F, 12F, 14, 15A, 15B, 15C, 17F, 18C, 19F, 20, 22F, 23A, 23F, 33F and 35B of Streptococcus pneumoniae ( see abs, claims specially claims 1, 2, 4, 5, 8, 9, 11).
It would have been obvious before the effective filing date of the presently claimed invention to employ serotypes 16F,19A, 23B, 24F, 31 taught by del Amo et al. and Mekalanos together with the claimed serotypes recited by Porro et al. to obtain the claimed invention. Because the extra serotypes further cover infections associated with that serotype with a reasonable expectation of success. One of skill in the art would be motivated because one can prevent those infections also. There is an expectation of success because Porro et al. specifically teach that you can mix any of the ones listed and the conjugates have been made with various mixtures for a long time. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & lnterf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396). Accordingly, the subject matter of claims would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to combine known serotypes recited by the claims in a conjugate which function in a predictable manner to yield a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Thus, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Applicants’ Arguments
8. Applicant's arguments filed 10/2/2025 have been fully considered but they are not persuasive. Applicants argue:
As noted above, the claims have been amended and are directed to a pharmaceutical composition comprising a plurality of at least two immunogenic saccharide-polypeptide conjugates, each immunogenic saccharide-polypeptide conjugate consisting of a capsular polysaccharide, fragment thereof, or combination thereof, conjugated to a polypeptide, wherein the capsular polysaccharide, fragment thereof, or combination thereof is from a unique Streptococcus pneumoniae serotype, wherein a first serotype comprises 16F, 20A, 20B, 24F, or 31, and at least one additional serotype comprises 1, 2, 3, 4, 5, 6A, 6B, 6C, 7F, 8, 9N, 9V, lOA, l lA, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19A, 19F, 20A, 20B, 22F, 23A, 23B, 23F, 24F, 31, 33F, 34, 35B, or 38, wherein the at least one additional serotype is not the first serotype; and wherein the fragment of the capsular polysaccharide is a monosaccharide, a disaccharide, a trisaccharide, a tetrasaccharide, a pentasaccharide, a hexasaccharide, or an oligosaccharide.
None of the cited references, alone or in combination, teach the composition of the amended claims. Caufield, cited for its purported disclosure of a multivalent polysaccharide-protein conjugate mixture consisting of capsular polysaccharides from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F of Streptococcus pneumoniae conjugated to a carrier protein (e.g., CRM197), does not describe the combination of serotypes recited in claim 296, nor does it remedy the deficiencies of Porro discussed above. Mekalanos, cited for its purported disclosure of serotypes 16F, 19A, 23B, 24F, and 31, describes vaccine compositions comprising an antigen entrapped within a cross-linked carrier protein matrix, and does not remedy the deficiencies of Porro and Caufield. Similarly, the Examiner cited del Amo for its purported disclosure of numerous serotypes (e.g., 1, 2, 3, 4, 5, 6A/6B, 6C, 7C/(7B/40), 7F/7A, 8, 9N/9L, 9V/9A, lOA, 10F/(10C/33C), l lA/11D, 12F/(12A/44/46), 13, 14, 15A/15F, 15B/15C, 16F, l 7F, 18/(18A/18B/18C/18F), 19A, 19F, 20, 21, 22F/22A, 23A, 23B, 23F, 24/(24A/24B/24F), 31, 33F/(33A/37), 34, 35A/(35C/42), 35B, 35F/47F, 38/25F, and 39); however, the list of serotypes in del Amo includes those that may be detected using an in vitro assay, not for conjugation, let alone for inclusion in a composition comprising immunogenic saccharide-polypeptide conjugates as claimed. Moreover, using the assays described in del Amo, the authors found that serotypes 1, 3, 5, 7F, and 19A are the most invasive serotypes and serotypes 6A, 6C, 19A, 19F, and 23B are the most common serotypes in carriage (Abstract). The most common serotypes, 1, 3, 5, 6A, 6C, 7F, 19A, 19F, and 23B, are not those required by the claim. In addition, del Amo suggests that the other serotypes should not be included in a vaccine, concluding that "all serotypes with high attack rate are included in PCV13 and that the remaining serotypes circulating in our regions have a low invasive disease potential" (p. 687).
Therefore, as none of the cited references, alone or in combination, teaches or suggests the claimed composition comprising immunogenic saccharide-polypeptide conjugates, withdrawal of the rejection is respectfully requested.
General Comments on Dependent Claims Each of the dependent claims depends from a base claim that is believed to be in condition for allowance, and Applicant therefore believes that it is unnecessary at this time to argue the allowability of each of the dependent claims individually. Applicant does not, however, necessarily concur with the interpretation of the dependent claims as set forth in the Office Action, nor does Applicant concur that the basis for the rejection of any of the dependent claims is proper. Therefore, Applicant reserves the right to specifically address the patentability of the dependent claims in the future.
Office Response
9. Applicant's arguments filed 10/2//2025 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show non-obviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicants’ arguments, it is the examiner’s position that Porro teach immune saccharide- polypeptide conjugates of the claims. In particular, Porro does not disclose immunogenic saccharide-polypeptide conjugates, each comprising a capsular polysaccharide, fragment thereof, or combination thereof, conjugated to a polypeptide (see pages 3, 4, 5, 6, 7, 8, 10, 11 and claims 4, 7, 8, 18, 26). Porro teach glycoconjugates (see pages 7, 10, 11).
Page 10 of Porro recites that “:the present invention summarizes the concepts and the technical procedures above referenced 10 for conjugate antigens composed of protein carrier and a maximum of two different carbohydrate structures. In developing the above state of the art, the preferred (not limitative) embodiment of the basic molecular construct subject of the present invention is composed 15 by a multivalent, preferably a tetra-valent semi- synthetic glycoprotein which features built-in multiple epitopes and expresses its helper I-dependent immunogenic specificity "in vivo" to the protein CRM197, as well as to three carried type-specific Ps, 20 for example Ps of S. pneumoniae. As an example, any triad of the Ps type 1, 2, 3, 4, 5, 6A, 6B, 6C, 7F, 8, 9N, 9V, 10A,11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F of S. pneumoniae such as the triad consisting of the Ps type 3,6A,7F.”
In response to applicants’ arguments, it is the examiner’s position that Porro teach the limitations of amended claim 296. Porro et al. disclose limitations of claims 296, a pharmaceutical or antigenic multivalent molecular construct consisting of a basic unit comprising a helper-T dependent carrier protein covalently bound to a minimum of three carbohydrate structures of different serological specificity, wherein each carbohydrate structure are at least three capsular polysaccharides selected among type 1, 2, 3, 4, 5, 6A, 6B, 6C, 6D, 7F, 8. 9N, 9V,10A, 11A, 11B, 11C, 11F, 12F, 14, 15A, 15B, 15C, 17F, 18C, 19F, 20, 22F, 23A, 23F, 33F and 35B of Streptococcus pneumoniae ( see abs, claims specially claims 1, 2, 4, 5, 8, 9, 11. As to amended claim 296, Porro et al. teach serotype 20 which inherently include serotypes 20A and/or 20 B ( see claim 6, pages 3, 20, 81). Porro et al. teach monosaccharide and oligosaccharide ( see pages 5, 6, 8, 9, 12, 48, 80). Porro et al. disclose conjugated polypeptides to capsular polysaccharides ( see claims). The invention contains each S. pneumonia capsular saccharide (see page 8, 12, 68 and claim 5 ).
Additionally, Mekalanos column 11 teach a conjugate vaccine for a conjugate made
between a PS and the carrier protein tetanus toxoid. In this model, only B-cells that display antibody receptors that recognize the PS bind the PS-protein conjugate.
Mekalanos column 23 teach various carrier proteins of the invention include, e.g.,
toxins and toxoids diphtheria toxoid or CRM 197, tetanus toxin, tetanus toxoid.
Caulfield et al. teach an immunogenic composition comprising: a multivalent polysaccharide-protein conjugate mixture consisting of capsular polysaccharides from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F of Streptococcus pneumoniae conjugated to a carrier protein; and a pharmaceutically acceptable carrier and further comprise a carrier protein CRM197 and a adjuvant. ( see claims and abstract).
Caulfield et al. page 5 recites “The present invention provides a multivalent immunogenic composition comprising, consisting essentially of, or alternatively, consisting of 15 distinct polysaccharide- protein conjugates, wherein each of the conjugates contains a different capsular polysaccharide conjugated to a carrier protein, and wherein the capsular polysaccharides are prepared from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F of S. pneumoniae, together with a pharmaceutically acceptable carrier. In certain embodiments, the carrier protein is CRM197. “ Caulfield et al. teach composition comprising a plurality of at least two immunogenic polysaccharide-protein conjugates containing serotypes 22F and 33F provides robust antibody responses ( see page 6).
The combination of references make the claims obvious.
Conclusion
10. No claims are allowed.
11. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHATOL S SHAHNAN SHAH whose telephone number is (571)272-0863. The examiner can normally be reached on Mon-Tue, Thurs-Fri 12pm-8pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel Kolker can be reached on 571-272-3181 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Khatol S Shahnan-Shah/
Examiner, Art Unit 1645
January 13, 2026
/JANA A HINES/Primary Examiner, Art Unit 1645
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