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
The amendment filed on 8-29-2025 is acknowledged. Claims 1, 9-10 and 13-14 have been amended. Claims 7, 12. 15 and 18 have been canceled. Claim 19 has been added. Claims 1, 8-10, 13-14, 16-17 and 19 are pending. Claims 8 and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1, 9-10, 14, 16-7 and 19 are currently under examination.
Objections Withdrawn
The objection to claim 1 for reciting claim language drawn to non-elected inventions is withdrawn.
Claim Rejections Withdrawn
The new matter rejection of claims 1, 9-10 and 14-18 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of the amendment thereto.
Claim Rejections Maintained
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.
The rejection of claims 1, 9-10, 14, 16-7 and 19 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 is maintained for reasons set forth in the previous Office action in the rejection of claims 1, 9-10 and 14-18. 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.
Applicant argues:
1. Applicant has amended independent claim 1 to recite i) a method of inducing an immune response to Streptococcus pneumoniae, ii) a peptide that has at least 90% amino acid sequence identity with a peptide found within SEQ ID NO: 4, and iii) an amino acid sequence with at least 90% identity to any one of SEQ ID NOs: 34-41.
2. Amended claim 1 recites a particular sepsis-inducing bacterial species and peptides that have at least 90% identity to the GAPDH protein from S. pneumoniae (i.e., SEQ ID NO: 4), and that include particular regions of the peptide that are immunogenic. A skilled artisan would recognize that the claimed peptides are capable of inducing an immune response to S. pneumoniae.
Applicant’s arguments have been fully considered and deemed non-persuasive.
With regard to Points 1 and 2, the amendment is insufficient to overcome the rejection as there is still no correlation between structure (sequence) and function (i.e. to elicit a directed immune response against S. pneumoniae. Contrary to Applicant’s assertion the skilled artisan would not recognize that the claimed peptides would elicit a directed immune response against S. pneumoniae as the specification are limited to the use of the “Neonatal Vaccine” (which consist of the peptides consisting of SEQ ID NO:9-12 conjugated to a KLH or OVA carrier protein) and antibodies raised against said vaccine. Peptides 1 and 2 (SEQ ID NO:9 and SEQ ID NO:10) are native sequences from GBS, S. aureus and S. pneumoniae while Peptides 3 and 4 (SEQ ID NO:11 and SEQ ID NO:12) are native sequences form E. coli, K. pneumoniae and/or P. aeruginosa. While the specification states:
“These peptides are illustrative of many more GAPDH peptides that may be found amongst the surface peptides of the bacteria, and used to create a vaccine of the
invention. Any peptide sequence within the native sequence may be used, but the sequence must not be substantively shared by GAPDH in humans.”
it is silent with regard to the efficacy of any other peptides derived from GAPDH that has efficacy in eliciting a directed immune response against any bacterial species. The specification is equally silent with regard to the efficacy of any variant of Peptides 1-4 in eliciting a directed immune response against S. pneumoniae. Moreover, the specification is limited to the “passive immunization” against S. pneumoniae strain Tigr4, E. coli strain IHE3034, S. aureus strain NEWMAN and GBS NEM316. It should be noted that passive immunity, by definition, only lasts until the administered antibodies are cleared by the subject’s immune system and is vastly different from protective immunity wherein the protective immune response is long term. Such a limited disclosure cannot be extrapolated to the use of any and all peptides and their variants encompassed by the claim for the prevention of infections by any and all sepsis-inducing bacteria.
The instant claims are drawn to methods of inducing a directed immune response to Streptococcus pneumoniae utilizing a peptide with at least 90% amino acid sequence identity with a peptide found within SEQ ID NO:4 wherein said peptide is between 8 and 49 amino acids in length and has at least 90% sequence identity to SEQ ID NO:34-41. The specification provides insufficient written description to support the genus encompassed by the claim since, as evidenced by the specification, there is variability between the sequences of various SEQ ID NO:4 or SEQ ID NO:34-41 based peptides, 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 peptides, Applicant must adequately describe which peptides (if any) have efficacy in eliciting a directed immune response against S. pneumoniae. The specification, however, does not disclose distinguishing and identifying features of a representative number of members of the genus of antibodies to which the claims are drawn, such as a correlation between the structure of the peptide and its recited function (inducing a directed immune response against S. pneumoniae), so that the skilled artisan could immediately envision, or recognize at least a substantial number of members of the claimed genus of peptides. The specification fails to disclose what peptide sequences are essential for the induction of a given directed immune response, or which amino acids might be added, replaced or deleted so that the resultant domain peptide retains the binding specificity of its parent, or by which other amino acids the essential amino acids might be replaced so that the resultant peptide retains the binding specificity of its parent. Therefore, the specification fails to adequately describe at least a substantial number of members of the genus of peptides to which the claims refer.
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 (undefined) against S. pneumoniae. 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 peptides 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 peptides. The specification does not provide substantive evidence that the claimed vaccines are capable of inducing any type of directed immune response against S. pneumoniae. This demonstration is required for the skilled artisan to be able to use the claimed peptides for their intended purpose of preventing/preventing S. pneumoniae infections. 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. The specification is limited to characterizing the immunological characteristics of their “Neonatal Vaccine” (which consist of the peptides consisting of SEQ ID NO:9-12 conjugated to a KLH or OVA carrier protein) and the use of antibodies raised against said vaccine in animal studies. Peptides 1 and 2 (SEQ ID NO:9 and SEQ ID NO:10) are native sequences from GBS, S. aureus and S. pneumoniae while Peptides 3 and 4 (SEQ ID NO:11 and SEQ ID NO:12) are native sequences form E. coli, K. pneumoniae and/or P. aeruginosa. While the specification states:
“These peptides are illustrative of many more GAPDH peptides that may be found amongst the surface peptides of the bacteria, and used to create a vaccine of the
invention. Any peptide sequence within the native sequence may be used, but the sequence must not be substantively shared by GAPDH in humans.”
it is silent with regard to the efficacy of any other peptides derived from GAPDH or any variants thereof that have efficacy in preventing an infection by any sepsis-inducing bacterial species or inducing any type of directed immune response against S. pneumoniae. The specification is equally silent with regard to the efficacy of any variant of Peptides 1-4 in preventing an infection by any sepsis-inducing bacterial species or inducing any type of directed immune response against S. pneumoniae. Finally, the specification is limited to the “passive immunization” against S. pneumoniae strain Tigr4, E. coli strain IHE3034, S. aureus strain NEWMAN and GBS NEM316. It should be noted that passive immunity, by definition, only lasts until the administered antibodies are cleared by the subject’s immune system and is vastly different from protective immunity wherein the protective immune response is long term. Such a limited disclosure cannot be extrapolated to the use of any and all peptides and their variants encompassed by the claim for the prevention of infections by any and all sepsis-inducing bacteria.
This disclosure cannot be extrapolated to the claimed genus of peptides as the ability to reasonably predict the capacity of a single bacterial immunogen to induce a given immune response from in vitro 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 successfully use a given therapeutic/vaccine without the prior demonstration of its immunological efficacy.
Moreover, as evidenced by the teachings of Skolnick et al. (Trends in Biotechnology 18: 34-39, 2000), the art is unpredictable. Skolnick et al. discloses the skilled artisan is well aware that assigning functional activities for any particular protein or protein family based upon sequence homology is inaccurate, in part because of the multifunctional nature of proteins (see, e.g., the abstract; and page 34, Sequence-based approaches to function prediction). Even in situations where there is some confidence of a similar overall structure between two proteins, only experimental research can confirm the artisan's best guess as to the function of the structurally related protein (see, in particular, the abstract and Box 2). Thus, one skilled in the art would not accept the assertion, which is based only upon an observed similarity in amino acid sequence that a variant of a given peptide would necessarily have a given immunological property. The instant specification has failed to teach or disclose compositions comprising the claimed SEQ ID NO:4 and 34-41-based peptides that are capable of eliciting any type of directed immune response against S. pneumoniae. There is no disclosure of subjects that have been administered any of the claimed peptides who have developed any type of directed immune response against S. pneumoniae. Consequently, there is no correlation between structure and function as required by the Written Description requirement.
Therefore, because the art is unpredictable, in accordance with the MPEP and current case law, the description of claimed peptides is not deemed representative of the genus of peptides to which the claims refer.
New Grounds of Rejection
35 USC § 112
New Matter
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 1, 9-10 and 14-18 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. This is a new matter rejection.
Applicant has amended claim 1 to recite “… within SEQ ID NO:4 is at least 8 amino acids and less than 50 amino acids in length, and comprises an amino acid sequence with at least 90% identity to any one of SEQ ID NOs: 34-41…” This phrase does not appear in the specification, or original claims as filed. Applicant does not point out specific basis for this limitation in the application, and none is apparent. While the SEQ ID NO:s per se are recited in the claims are disclosed in the specification, they are not disclosed not disclosed in conjunction with the claimed peptide length or percent identity. Therefore this limitation is new matter.
Conclusion
No claim is allowed.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 October 16, 2025