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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-12 in the reply filed on 1/14/2026 is acknowledged. Claims 13-24 have been withdrawn.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Status of Claims
Claims 1-24 are pending. Claims 13-24 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1/14/2026. Claims 1-12 will be examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent 10,130,691 B2, 2018, hereinafter Ibrahim.
Claims 1-12 are drawn to a method of ameliorating and/or preventing an intestinal disease in a mammal. Claim 1 discloses the initial step of administering an immunogenic amount of a vaccine comprising a Candida adhesin polypeptide. Claim 2 specifies the polypeptide comprises an Als protein, and claim 3 specifies the polypeptide is selected from a group of Als1, Als3, HYR1, and HWP1. Claims 4 and 5 modify claim 2, specifying the Als protein is selected from Candida albicans Als3 and Als1, or the N-terminal domain of Candida albicans Als3, respectively. Claim 6 discloses the polypeptide of claim 1 is derived from one of a group of Candida strains, and claim 7 discloses the mammal of claim 1 is human. Claim 8 specifies the intestinal disease as IBD, and claim 9 specifies the intestinal disease as Crohn’s or colitis. Claim 10 specifies the vaccine administration by various routes, and claim 12 discloses the vaccine also comprises an adjuvant. Claim 11 provides a second step of administering a booster dose.
Ibrahim discloses a method of inducing an immune response in a mammal in claim 4 and column 15, line 24. This method comprises administering fragments of the Candida cell surface proteins Als3 and Hyr1 and combinations thereof (col 2, ln 29-30). As these fragments are capable of inducing an immune response, an immunogenic amount of the vaccine would be administered, meeting the limitations of the method of claim 1. Instant claim 1 and all dependent claims are drawn to “a method of ameliorating and/or preventing an intestinal disease in a mammal”. Ibrahim discloses, in Examples, columns 40-44, the administration of the method of inducing an immune response to mice, which are mammals, and the mice do not develop intestinal disease. Therefore, as the mice experienced an immune response and did not develop intestinal disease, the intestinal disease was prevented by the immune response. Thus, Ibrahim teaches a method of ameliorating and/or preventing an intestinal disease in a mammal comprising administering an immunogenic amount of a vaccine comprising a Candida adhesin polypeptide.
Ibrahim recites peptides from C. albicans Als3 and Hyr1 in columns 2-8, meeting the limitations of instant claims 2-6. Ibrahim recites administering this method to a human (see claim 7) via intramuscular, subcutaneous, or intradermal administration (see claim 8), meeting the limitations of claims 7 and 10. The mammals in the examples (col 40-44) did not develop IBD or colitis, thus preventing the diseases specified by instant claims 8 and 9. Ibrahim discloses a booster dose in claim 9, meeting the limitation of instant claim 11. Ibrahim claim 2 recites an adjuvant, meeting the limitation of instant claim 12.
Therefore, Ibrahim anticipates the invention of claims 1-12 as claimed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,364,539. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of using the same vaccine, which accomplishes the same purpose.
Instant claims 1-12 are drawn to a method of ameliorating and/or preventing an intestinal disease in a mammal. Claim 1 discloses the initial step of administering an immunogenic amount of a vaccine comprising a Candida adhesin polypeptide. Claim 2 specifies the polypeptide comprises an Als protein, and claim 3 specifies the polypeptide is selected from a group of Als1, Als3, HYR1, and HWP1. Claims 4 and 5 modify claim 2, specifying the Als protein is selected from Candida albicans Als3 and Als1, or the N-terminal domain of Candida albicans Als3, respectively. Claim 6 discloses the polypeptide of claim 1 is derived from one of a group of Candida strains, and claim 7 discloses the mammal of claim 1 is human. Claim 8 specifies the intestinal disease as IBD, and claim 9 specifies the intestinal disease as Crohn’s or colitis. Claim 10 specifies the vaccine administration by various routes, and claim 12 discloses the vaccine also comprises an adjuvant. Claim 11 provides a second step of administering a booster dose.
‘539 claim 1 is drawn to a method of vaccinating a mammalian host against Candida albicans comprising administering an isolated polypeptide consisting of the N-terminal domain of the Candida albicans agglutinin like sequence (ALS) polypeptide, Als3p, in a pharmacologically acceptable excipient. The method of administering this peptide meets the limitations of instant claims 1-6, as the vaccine is immunogenic, comprises a Candida albicans adhesin polypeptide (instant claim 6), specifically, Als3 (instant claims 2-5). Performing this method of vaccinating a mammal against C. albicans will also prevent intestinal disease, meeting all limitations of instant claims 1, 8 and 9. ‘539 claim 2 further specifies the administration is subcutaneous, meeting the limitations of instant claim 10. ‘539 claim 4 specifies that the composition comprises an immunostimulating adjuvant, meeting the limitations of instant claim 12. ‘539 claim 6 specifies a booster dose, meeting the limitations of instant claim 11. Finally, meeting the limitations of instant claim 7, ‘539 claim 8 states that the mammalian host is human.
Therefore, ‘539 anticipates the claimed invention of claims 1-12.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,653,757. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of using the same vaccine, which accomplishes the same purpose.
Instant claims 1-12 are drawn to a method of ameliorating and/or preventing an intestinal disease in a mammal. Claim 1 discloses the initial step of administering an immunogenic amount of a vaccine comprising a Candida adhesin polypeptide. Claim 2 specifies the polypeptide comprises an Als protein, and claim 3 specifies the polypeptide is selected from a group of Als1, Als3, HYR1, and HWP1. Claims 4 and 5 modify claim 2, specifying the Als protein is selected from Candida albicans Als3 and Als1, or the N-terminal domain of Candida albicans Als3, respectively. Claim 6 discloses the polypeptide of claim 1 is derived from one of a group of Candida strains, and claim 7 discloses the mammal of claim 1 is human. Claim 8 specifies the intestinal disease as IBD, and claim 9 specifies the intestinal disease as Crohn’s or colitis. Claim 10 specifies the vaccine administration by various routes, and claim 12 discloses the vaccine also comprises an adjuvant. Claim 11 provides a second step of administering a booster dose.
‘757 claim 1 recites a method of treating a skin abscess in a human comprising administering an isolated polypeptide consisting of the N-terminal domain of Candida albicans agglutinin-like sequence 3 protein (Als3p) in a pharmaceutically acceptable medium, meeting the limitations of instant claims 1-9. The method of administering this peptide meets the limitations of instant claims 1-6, as the vaccine is immunogenic, comprises a Candida albicans adhesin polypeptide (instant claim 6), specifically, Als3 (instant claims 2-5). Performing this method of vaccinating a human (instant claim 7) will also prevent intestinal disease, meeting all limitations of instant claims 1, 8 and 9. ‘757 claim 9 recites the administration of the composition by intramuscular, subcutaneous, intradermal, or sublingual administration, meeting the limitations of instant claim 10. ‘757 claim 10 discloses a booster dose, meeting the limitations of instant claim 11. ‘757 claim 11 discloses the composition comprises an immunostimulating adjuvant, meeting the limitations of instant claim 12.
Therefore, ‘757 anticipates the claimed invention of claims 1-12.
Claims 1-4 and 6-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 8,541,008. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of using the same vaccine, which accomplishes the same purpose.
Instant claims 1-12 are drawn to a method of ameliorating and/or preventing an intestinal disease in a mammal. Claim 1 discloses the initial step of administering an immunogenic amount of a vaccine comprising a Candida adhesin polypeptide. Claim 2 specifies the polypeptide comprises an Als protein, and claim 3 specifies the polypeptide is selected from a group of Als1, Als3, HYR1, and HWP1. Claim 4 modifies claim 2, specifying the Als protein is selected from Candida albicans Als3 and Als1. Claim 6 discloses the polypeptide of claim 1 is derived from one of a group of Candida strains, and claim 7 discloses the mammal of claim 1 is human. Claim 8 specifies the intestinal disease as IBD, and claim 9 specifies the intestinal disease as Crohn’s or colitis. Claim 10 specifies the vaccine administration by various routes, and claim 12 discloses the vaccine also comprises an adjuvant. Claim 11 provides a second step of administering a booster dose.
‘008 claim 1 discloses a method of vaccinating a mammalian host comprising administering a vaccine comprising an isolated polypeptide consisting of the N-terminal domain of the Candida albicans agglutinin like sequence (ALS) polypeptide, Als1p, in a pharmaceutically acceptable excipient. This method of administering this peptide meets the limitations of instant claims 1-4 and 6, as the vaccine is immunogenic, comprises a Candida albicans adhesin polypeptide (instant claim 6), specifically, Als1 (instant claims 2-4). Performing this method of vaccinating a mammal will also prevent intestinal disease, meeting all limitations of instant claims 1, 8 and 9. ‘008 claim 2 discloses subcutaneous administration, meeting the limitations of instant claim 10. ‘008 claim 4 discloses the composition contains an immunostimulating adjuvant, meeting the limitations of instant claim 12. '008 claim 6 discloses administration of a booster dose, meeting the limitations of instant claim 11. Finally, ‘008 claim 8 discloses the host is a human, meeting the limitations of instant claim 7.
Therefore, ‘008 anticipates the claimed invention of claims 1-4 and 6-12.
Claims 1-10 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,300,120. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of using the same vaccine, which accomplishes the same purpose.
Instant claims 1-12 are drawn to a method of ameliorating and/or preventing an intestinal disease in a mammal. Claim 1 discloses the initial step of administering an immunogenic amount of a vaccine comprising a Candida adhesin polypeptide. Claim 2 specifies the polypeptide comprises an Als protein, and claim 3 specifies the polypeptide is selected from a group of Als1, Als3, HYR1, and HWP1. Claims 4 and 5 modify claim 2, specifying the Als protein is selected from Candida albicans Als3 and Als1, or the N-terminal domain of Candida albicans Als3, respectively. Claim 6 discloses the polypeptide of claim 1 is derived from one of a group of Candida strains, and claim 7 discloses the mammal of claim 1 is human. Claim 8 specifies the intestinal disease as IBD, and claim 9 specifies the intestinal disease as Crohn’s or colitis. Claim 10 specifies the vaccine administration by various routes, and claim 12 discloses the vaccine also comprises an adjuvant.
‘120 claim 1 discloses a method of treating a human comprising administering to the human an immunogenic composition comprising an isolated polypeptide consisting of an N-terminal domain of Candida albicans agglutinin-like sequence 3 protein (Als3p) in a pharmaceutically acceptable medium. This method of administering this peptide meets the limitations of instant claims 1-9, as the vaccine is immunogenic, comprises a Candida albicans adhesin polypeptide (instant claim 6), specifically, Als3 (instant claims 2-5). Performing this method of vaccinating a human (instant claim 7) will also prevent intestinal disease, meeting all limitations of instant claims 1, 8 and 9. ‘120 claim 2 states the composition is administered via intravenous, intramuscular, intraperitoneal, or subcutaneous injection, and ‘120 claim 3 specifies subcutaneous administration, which meets the limitations of instant claim 10. ‘120 claim 4 states the composition further comprises an adjuvant, meeting the limitations of instant claim 12.
Therefore, ‘120 claims 1-4 anticipate the claimed invention of instant claims 1-10 and 12.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,300,120 in view of C.S. Schmidt et al. / Vaccine 30 (2012) 7594-7600. Claims 1-10 and 12 are taught by '120 as explained above, under paragraph 14. '120 does not teach administration of a booster dose as recited in instant claim 11. Schmidt discloses the vaccine of ‘120 and the instant claims, and recites administration of a second, or booster, dose. Schmidt also states “the second dose resulted in a significant boost of IgG and IgA1 titers in >70% of subjects…” in the abstract. Therefore, it would have been obvious to one of ordinary skill in the art of vaccination before the effective filing date of the claimed invention to provide a booster dose in concert with the method of ‘120 in order to induce a significant improvement in immune response. One would have reasonable expectation of success because the vaccines of Schmidt and ‘120 are the same, with both containing the N-terminal portion of the Candida albicans agglutinin-like sequence 3 protein (Als3p). Therefore, it would have been obvious, before the effective filing date of the claimed invention, to provide a booster dose of the method of ‘120 in order to improve immune responses, thereby arriving at the claimed invention of instant claims 1-12.
Claims 1, 3, and 6-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. US 10,130,691 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of using the same vaccine, which accomplishes the same purpose.
Instant claims 1-12 are drawn to a method of ameliorating and/or preventing an intestinal disease in a mammal. Claim 1 discloses the initial step of administering an immunogenic amount of a vaccine comprising a Candida adhesin polypeptide. Claim 3 specifies the polypeptide is selected from a group of Als1, Als3, HYR1, and HWP1. Claim 6 discloses the polypeptide of claim 1 is derived from one of a group of Candida strains, and claim 7 discloses the mammal of claim 1 is human. Claim 8 specifies the intestinal disease as IBD, and claim 9 specifies the intestinal disease as Crohn’s or colitis. Claim 10 specifies the vaccine administration by various routes, and claim 12 discloses the vaccine also comprises an adjuvant. Claim 11 provides a second step of administering a booster dose.
‘691 discloses a method of inducing an immune response in a mammal in claim 4. This method comprises administering a composition comprising an isolated polypeptide consisting of an amino acid sequence with 95% similarity to SEQ ID NO: 6 and a pharmaceutically acceptable carrier. SEQ ID NO: 6 is a fragment of Hyr1, which is a Candida adhesin poly peptide. Inducing an immune response can result in prevention of an intestinal disease. Therefore, ‘691 claim 4 anticipates instant claim 1, 8 and 9. ‘691 claim 1 additionally anticipates instant claims 3 and 6, as SEQ ID NO: 6 is present in the group listed in claim 3 and is derived from C. albicans. Claim 7 of ‘691 recites administering this method to a human, anticipating instant claim 7. ‘691 claim 8 recites that the composition is administered via intramuscular, subcutaneous, or intradermal administration, anticipating claim 10. ‘691 discloses a booster dose in claim 9, meeting the limitation of instant claim 11. ‘691 claim 2 recites an adjuvant, meeting the limitation of instant claim 12.
Therefore, ‘691 anticipates the invention of claims 1, 3, and 6-12.
Claims 1, 3, 6-9, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,160,790. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of using the same vaccine, which accomplishes the same purpose.
Instant claims 1-12 are drawn to a method of ameliorating and/or preventing an intestinal disease in a mammal. Claim 1 discloses the initial step of administering an immunogenic amount of a vaccine comprising a Candida adhesin polypeptide. Claim 3 specifies the polypeptide is selected from a group of Als1, Als3, HYR1, and HWP1. Claim 6 discloses the polypeptide of claim 1 is derived from one of a group of Candida strains, and claim 7 discloses the mammal of claim 1 is human. Claim 8 specifies the intestinal disease as IBD, and claim 9 specifies the intestinal disease as Crohn’s or colitis. Claim 12 discloses the vaccine also comprises an adjuvant.
‘790 discloses in claim 7 a method of inducing an immune response in a mammal comprising administering an isolated polypeptide comprising the amino acid sequence of SEQ ID NO:7 and an immuno-effective amount of an adjuvant. SEQ ID NO: 7 is the sequence of C. albicans HYR1, and so the method meets the limitations of instant claims 1, 3, 6 and 12. Moreover, inducing an immune response can result in prevention of an intestinal disease; therefore, ‘691 claim 4 anticipates instant claim 1, 8 and 9. ‘790 claims 13-16 specify the mammal is human, meeting the limitations of instant claim 7.
Thus, ‘790 anticipates the claimed invention of claims 1, 3, 6-9, and 12.
Claims 1, 3, and 6-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,160,790 in view of U.S. Patent No. 10,130,691. Claims 1, 3, 6-9, and 12 are taught by ‘790, as explained above under paragraph 17. ‘790 does not teach the administration routes of claim 10, and does not teach administration of a booster dose, as in claim 11. However, ‘691 discloses the same vaccine as ‘790 – a method of inducing an immune response in a mammal via administration of a fragment of Hyr1, as in ‘790 claim 7, and discloses both administration via intramuscular, subcutaneous, or intradermal administration in ‘691 claim 8 and administration of a booster dose in ‘691 claim 9. As both ‘790 and ‘691 disclose the same method of inducing an immune response, and that ‘691 discloses the use of the method in a human, via intramuscular, subcutaneous, or intradermal administration, and the administration of a booster dose, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the applications of ‘691 for the method of immunizing recited by ‘790 to arrive at the claimed invention. One would have reasonable expectations of success, as the methods are identical and would thus have the same results. Therefore, ‘446 in view of ‘691 renders the instant claims 1, 3, and 6-12 obvious.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that if a technique has been used to improve one method, and a person of ordinary skill would recognize that it would be used in similar methods in the same way, using the technique is obvious unless its application is beyond that person’s skill. It would be obvious to apply a known technique to a known product to be used in a known method that is ready for improvement to yield predictable results. Thus, the combination of prior art references as combined provided a prima facie case of obviousness, absent convincing evidence to the contrary.
Claims 1, 3, 6, 8, 9, and 12 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 8,709,446. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of using the same vaccine, which accomplishes the same purpose.
Instant claims 1-12 are drawn to a method of ameliorating and/or preventing an intestinal disease in a mammal. Claim 1 discloses the initial step of administering an immunogenic amount of a vaccine comprising a Candida adhesin polypeptide. Claim 3 specifies the polypeptide is selected from a group of Als1, Als3, HYR1, and HWP1. Claim 6 discloses the polypeptide of claim 1 is derived from one of a group of Candida strains. Claim 8 specifies the intestinal disease as IBD, and claim 9 specifies the intestinal disease as Crohn’s or colitis. Claim 12 discloses the vaccine also comprises an adjuvant.
‘446 claim 9 recites a method of immunizing a mammalian host against Candida albicans comprising administering to said host an immunogenically effective amount of a polypeptide consists of the amino acid sequence of SEQ ID NO: 2 and a pharmaceutically acceptable carrier. ‘446 SEQ ID NO: 2 is the amino acid sequence of C. albicans HYR1, and so this method meets the limitations of instant claims 1, 3, and 6. Performing this method of immunizing a mammal against C. albicans will also prevent intestinal disease, meeting all limitations of instant claims 1, 8 and 9. ‘446 claim 10 recites that the vaccine composition further comprises an adjuvant, meeting the limitations of instant claim 12.
Therefore, ‘446 anticipates the invention of instant claims 1, 3, 6, 8, 9, and 12.
Claims 1, 3, and 6-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 8,709,446 in view of US Patent Number 10,130,691. Claims 1, 3, 6, 8, 9, and 12 are taught by ‘446, as explained above under paragraph 19. ‘446 does not teach the administration of the method of claim 9 to a human, nor the administration routes of claim 10, and does not teach administration of a booster dose, as in claim 11. However, ‘691 discloses the same method of immunizing a mammal using a fragment of Hyr1, and does disclose administration to a human (in claim 7), via intramuscular, subcutaneous, or intradermal administration (in claim 8), with a booster dose (in claim 9). As both ‘446 and ‘691 disclose the same method of immunization, and that ‘691 discloses the use of the method in a human, via intramuscular, subcutaneous, or intradermal administration, and the administration of a booster dose, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the applications of ‘691 for the method of immunizing recited by ‘446 to arrive at the claimed invention. One would have reasonable expectations of success, as the methods are identical and would thus have the same results. Therefore, ‘446 in view of ‘691 renders the instant claims 1, 3, and 6-12 obvious.
Furthermore, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that if a technique has been used to improve one method, and a person of ordinary skill would recognize that it would be used in similar methods in the same way, using the technique is obvious unless its application is beyond that person’s skill. It would be obvious to apply a known technique to a known product to be used in a known method that is ready for improvement to yield predictable results. Thus, the combination of prior art references as combined provided a prima facie case of obviousness, absent convincing evidence to the contrary.
Claims 1-3, 6, 8, 9, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 11-14 of U.S. Patent No. 12,324,830. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of using the same vaccine, which accomplishes the same purpose.
Instant claims 1-12 are drawn to a method of ameliorating and/or preventing an intestinal disease in a mammal. Claim 1 discloses the initial step of administering an immunogenic amount of a vaccine comprising a Candida adhesin polypeptide. Claim 2 specifies the polypeptide comprises an Als protein, and claim 3 specifies the polypeptide is selected from a group of Als1, Als3, HYR1, and HWP1. Claim 6 discloses the polypeptide of claim 1 is derived from one of a group of Candida strains, which includes C. auris. Claim 8 specifies the intestinal disease as IBD, and claim 9 specifies the intestinal disease as Crohn’s or colitis. Claim 12 discloses the vaccine also comprises an adjuvant.
‘830 claim 1 discloses a method of treating a subject for, immunizing a subject against, preventing in a subject, or inducing production of antibodies in a subject against, a Candida auris infection by administering to the subject an immunogenic amount of a C. auris Als3 polypeptide. This method of administering this polypeptide meets the limitations of instant claims 1-3 and 6, as the vaccine is immunogenic, comprises a Candida auris adhesin polypeptide (instant claim 6), specifically, Als3 (instant claims 2 and 3). Performing this method against C. auris will also prevent intestinal disease, meeting all limitations of instant claims 1, 8 and 9. Claim 11 of ‘830 discloses that the polypeptide is formulated with an adjuvant, meeting the limitations of instant claim 8.
Therefore, ‘830 claims 1 and 11 anticipate instant claims 1-3, 6, 8, 9, and 12.
Claims 1, 3, and 6-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 11-14 of U.S. Patent No. 12,324,830 in view of US PGPUB 2021/0030852 A1. Claims 1, 3, 6, 8, 9, and 12 are taught by ‘830, as explained above under paragraph 21. ‘830 does not teach the administration of the method of claim 9 to a human, nor the administration routes of claim 10, and does not teach administration of a booster dose, as in claim 11. However, US PGPUB ‘852 discloses the same method of treating a subject for, immunizing a subject against, preventing in a subject, or inducing production of antibodies in a subject against, wherein the subject is human (see paragraph [0003]) and the method is administered subcutaneously, intramuscularly, intradermally, transdermally, intranasally, orally, or via an infusion (paragraph [0010]), as well as booster doses in paragraph [0096]. Given that both ‘830 and ‘852 disclose the same method, and that ‘852 discloses the use of the method in a human, via intramuscular, subcutaneous, intradermal, oral, or intranasal administration, and the administration of a booster dose, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the applications of ‘852 for the methods recited by the claims of ‘830 to arrive at the claimed invention. One would have reasonable expectations of success, as the methods are identical and would thus have the same results. Therefore, ‘830 in view of ‘852 renders the instant claims 1, 3, and 6-12 obvious.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that if a technique has been used to improve one method, and a person of ordinary skill would recognize that it would be used in similar methods in the same way, using the technique is obvious unless its application is beyond that person’s skill. It would be obvious to apply a known technique to a known product to be used in a known method that is ready for improvement to yield predictable results. Thus, the combination of prior art references as combined provided a prima facie case of obviousness, absent convincing evidence to the contrary.
Claims 1, 3, and 6-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 97, 102, 105, 106, and 108 of copending Application No. 19/204,363 in view of US PGPUB 2021/0030852 A1. ‘363 claim 97 recites a composition comprising an Als3 polypeptide derived from C. auris, administration of which meets the limitations of instant claims 1, 3, and 6. ‘363 claim 106 recites the addition of an adjuvant to the composition of claim 97, meeting the limitation of instant claim 12. ‘363 claim 108 recites the formulation of the composition for administration subcutaneously, intramuscularly, intradermally, transdermally, intranasally, orally, or via an infusion, meeting the limitations of instant claim 10. ‘363 does not teach a method of administering this compound, nor does it teach administration to a human as in instant claim 7, for amelioration and/or prevention of IBD or Crohn’s disease, as in instant claims 8 and 9, or administration of a booster dose, as in instant claim 11.
However, PGPUB ‘852 does teach a method of administering a compound identical to that of ‘363, wherein the subject is human (see paragraph [0003]) , as well as booster doses in paragraph [0096], teaching the limitations of instant claims 7 and 11. Additionally, performing this method of ‘852 against C. auris will also prevent intestinal disease, meeting all limitations of instant claims 1, 8 and 9. As both ‘363 and ‘852 disclose the same compound, and ‘852 discloses the use of the method for prevention in a human and the administration of a booster dose, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the composition of ‘363 for the methods recited by ‘852 to arrive at the claimed invention. One would have reasonable expectations of success, as the compounds are identical and would thus have the same results upon administration. Therefore, ‘363 in view of ‘852 renders the instant claims 1, 3, and 6-12 obvious.
Furthermore, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that if a technique has been used to improve one composition, and a person of ordinary skill would recognize that it would be used in similar compositions in the same way, using the technique is obvious unless its application is beyond that person’s skill. It would be obvious to apply a known technique to a known product to be used in a known method that is ready for improvement to yield predictable results. Thus, the combination of prior art references as combined provided a prima facie case of obviousness, absent convincing evidence to the contrary.
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Edwards et al., 2018: Clinical trial results of NDV-3a, a Candida adhesin vaccine, in humans
Casadevall et al., 2018: Commentary on the Edwards article, discloses “NDV-3A may be a landmark human vaccine that mediates protection by altering the immune response at a mucosal body site without affecting the microbial burden.”
Uppuluri et al., 2018: Discloses the importance of anti-Als3p Antibodies for NDV-3A vaccine efficacy. Indicates booster dosing as important for maintaining antibodies.
Gerard et al., 2013: Discloses C. albicans as a possible initiator of the inflammatory processes that contribute to Crohn’s disease.
Leonardi et al., 2018: Discloses the finding that absence of anti-fungal immunity results in colitis in mice; states “antifungal therapy could hold promise for treating intestinal inflammation.”
Gu et al., 2020: Reviews the state of the art surrounding Candida species, in both pathogenic and commensal states, and their relation to intestinal inflammation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amelia C Stephens whose telephone number is (571)272-1006. The examiner can normally be reached M-F 8-5 EST.
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, Daniel E Kolker can be reached at (571) 272-3181. 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.
/AMELIA STEPHENS/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645