The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10-30-2025 has been entered.
The amendment filed on 10-30-2025 is acknowledged. Claims 1, 3-4, 11, 31, 55-56, 58 and 60 have been amended. Claims 2, 9, 12, 15, 19, 35, 39, 57, 29 and 61 have been canceled. Claims 56-61 have been added. Claims 1, 3-5 11, 13, 21, 31, 33, 41, 47, 55-56, 58 and 60 are pending.
Election/Restrictions
Claims 1, 3-5 and 56 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 11, 13, 21, 31, 33, 41, 47, 55, 58 and 60, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 6-11-2024 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01. Consequently, claims 1, 3-5 11, 13, 21, 31, 33, 41, 47, 55-56, 58 and 60 are currently under examination.
Claim Rejections Withdrawn
The rejection of claims 1-3, 5, 9 and 56-57 under 35 U.S.C. 103 as being unpatentable over Pillich et al. (U.S. Patent Application Publication US 2003/0152594) and Clements et al. (mSphere Vol. 3, No 4, pages 1-17) is withdrawn in light of the amendment thereto.
The rejection of claims 1-5, 9 and 56-57 under 35 U.S.C. 103 as being unpatentable over Pillich et al. (U.S. Patent Application Publication US 2003/0152594), Clements et al. (mSphere Vol. 3, No 4, pages 1-17) and Kandil et al. (U.S. Patent 5,837,250) is withdrawn in light of the amendment thereto.
New Grounds of Rejection
35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 his invention.
Claims 11, 13, 21, 31, 33, 41, 47, 55, 58 and 60 are 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. The claim(s) 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are drawn to methods of inducing a directed immune response to bacteria generally (claims 11, 13 and 58) and E. coli, Enterobacter cloacae or a species of Klebsiella specifically (claim 21); treating or prevention a bacterial infection generally (claims 31, 33, 47 and 60); and E. coli, Enterobacter cloacae or a species of Klebsiella specifically (claim 41); and methods of treating or prevention a Gram-negative bacterial infection generally (claims 55-56), 33 and 47) wherein said methods utilize the OmpC, OmpW and Omplolb (and optionally OmpX) from a Klebsiella species. Consequently, the instant claims encompass the treatment and prevention of any and all bacterial infections utilizing the recited Omps derived from any and all Klebsiella species. The specification is limited to the use of OmpX or a combination of OmpC, OmpW, Omplolb and Omp36K derived from Klebsiella pneumoniae K2 strain to prevent infection by Klebsiella pneumoniae K1 and K2 strains. This limited disclosure cannot be extrapolated to the treatment or prevention of all of the recited bacteria and thus, the specification does not support the genus (peptides with the recited sequence homologies) encompassed by the rejected claims.
To fulfill the written description requirements set forth under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. To adequately describe the genus of therapeutics/vaccines, Applicant must adequately describe which Omps (i.e. type and bacterial source) (if any) have efficacy in eliciting a directed immune response against a given bacterial species. The specification, however, does not disclose distinguishing and identifying features of a representative number of members of the genus of therapeutics/vaccines to which the claims are drawn, such as a correlation between the structure of the Omps and its recited function (inducing a directed immune response against a given bacterial species), so that the skilled artisan could immediately envision, or recognize at least a substantial number of members of the claimed genus of therapeutics/vaccines. The specification fails to disclose what which bacterial Omps (i.e. bacterial source etc.) are essential for the induction of a given directed immune response therefore, the specification fails to adequately describe at least a substantial number of members of the genus of therapeutics/vaccines to which the claims refer.
Moreover, claims 31, 33, 41, 47, 55-56 and 60 are drawn to vaccines. The term “vaccinate” is defined as the use of a specific antigen to induce protective immunity to infection or disease induction. The specification does not provide substantive evidence that the claimed vaccines are capable of inducing protective immunity. This demonstration is required for the skilled artisan to be able to use the claimed vaccines for their intended purpose of preventing infections. Without this demonstration, the skilled artisan would not be able to reasonably predict the outcome of the administration of the claimed vaccines, i.e. would not be able to accurately predict if protective immunity has been induced. The ability to reasonably predict the capacity of a single bacterial immunogen to induce protective immunity from in vitro antibody reactivity studies is problematic. Ellis (Vaccines, W.B. Saunders Company, Chapter 29, 1988, pages 568-574) exemplifies this problem in the recitation that "the key to the problem (of vaccine development) is the identification of the protein component of a virus or microbial pathogen that itself can elicit the production of protective antibodies"(page 572, second full paragraph). Unfortunately, the art is replete with instances where even well characterized antigens that induce an in vitro neutralizing antibody response fail to elicit in vivo protective immunity. See Boslego et al (Vaccines and Immunotherapy, 1991, Chapter 17), wherein a single gonococcal pillin protein fails to elicit protective immunity even though a high level of serum antibody response is induced (page 212, bottom of column 2). Accordingly, the art indicates that it would require empirical testing to formulate and use a successful vaccine without the prior demonstration of vaccine efficacy.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed' ”. The courts have decided:
The purpose of the “written description” requirement is broader than to merely explain how to “make and use”; the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the “written description” inquiry, whatever is now claimed.
See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 USC § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
MPEP 2163.02 further states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention” See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Additionally, MPEP 2163 states:
"A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)”
And:
For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
Additionally, the rejected claims require that the recited peptides have efficacy in eliciting a directed immune response (i.e. therapeutic or protective immune response against a given bacterial strain). To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. As set forth supra, the specification fails to adequately describe at least a substantial number of members of the genus of Omps to which the claims refer; and accordingly the specification fails to adequately describe at least a substantial number of members of the claimed genus of therapeutics/vaccines. The specification does not provide substantive evidence that the claimed Omps are capable of inducing any type of directed immune response against a given bacterial strain. This demonstration is required for the skilled artisan to be able to use the claimed Omps for their intended purpose of treating/preventing a given bacterial infection. Without this demonstration, the skilled artisan would not be able to reasonably predict the outcome of the administration of the claimed peptides, i.e. would not be able to accurately predict if a given directed immune response has been induced.
Therefore, because the art is unpredictable, in accordance with the MPEP and current case law, the description of claimed Omp based therapeutics/vaccines is not deemed representative of the claimed genus.
Conclusion
No claim is allowed.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 July 9, 2026
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