DETAILED ACTION
Election/Restrictions
Applicant’s election of Group I, claims 1-5, 10, 11(a) and 12-15 in the reply filed on 12/2/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 6-9 and 11(b)-(d) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Information Disclosure Statement
The Information Disclosure Statements filed on 9/29/23 and 2/19/26 have been considered. An initialed copy is attached hereto.
It should be noted that 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 § 112-2nd paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 10, 11 and 12-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is vague and indefinite due to the “optionally” in part iii because it leaves ambiguity in the claim, e.g., it’s unclear what is a required feature. Accordingly, the metes and bounds of the claim are unclear. See MPEP 2173.05(h).
Claims 1, 2, 3 and 12 recite the term “preferably” and claim 12 recites “preferably consisting of, alternatively comprising” this is vague and confusing because these terms leave it unclear what is intended to be in the claim. The term “preferably” expresses an optional or preferred embodiment rather than a required feature leaving the metes and bounds of the invention as unclear. The claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "optionally"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim 11 is vague and indefinite due to the phrase “such as” because it leaves ambiguity in the claim. The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 11 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of protein vaccines and nucleic acid/vector vaccines in claim 11 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
The polypeptides of part a) and the polynucleotides/vectors/host cells of part b)-d) represent different special technical features for the following reasons. Polypeptides, which are composed of amino acids, and polynucleotides, which are composed of purine and pyrimidine units, are structurally distinct molecules. Searching, therefore is not coextensive. These are different products which generate different immune profiles in a subject.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
NOTE: Applicants should remove parts b)- d) from claim 11.
Claim Rejections - 35 USC § 112-Written Description
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 1-5, 10, 11(a) and 12-15 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 claimed invention is directed to immunogenic fusion proteins comprising a polypeptide with at least 90% sequence identity to SEQ ID NO: 7 (and with preferably 170-178 amino acids, preferably 174 to 175 amino acids) and a polypeptide with at least 90% sequence identity to SEQ ID NO:14 (and with preferably 165-164 amino acids, 169-170 amino acids) and methods of vaccination against group B streptococcus infection, or treating a group B Streptococcus infection comprising administering the immunogenic fusion protein comprising said immunogenic fusion proteins in a human or animal. Claims 11 and 12 recite further comprising an immunogenic fusion protein 90-99% identical to SEQ ID NO: 42.
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 number 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 vaccines, Applicant must adequately describe the immunoepitopes within the polypeptide of SEQ ID NO: 7 and the polypeptide of SEQ ID NO:14 that induce a protective immune response against group B Streptococcus when part of a fusion protein. The specification, however, does not disclose distinguishing and identifying features of a representative number of members of the genus of vaccines (fusion proteins) to which the claims are drawn, such as a correlation between the structure of the fusion protein and its recited function (inducing a protective immune response against a given pathogen), so that the skilled artisan could immediately envision, or recognize at least a substantial number of members of the claimed genus of vaccines. Moreover, the specification fails to disclose which amino acid residues in the component proteins are essential for eliciting the claimed immune response, or which amino acids might be added, replaced or deleted so that the resultant component protein retains the immunological characteristics of its parent, or by which other amino acids the essential amino acids might be replaced so that the resultant component protein retains the immunological characteristics of its parent. Therefore, the specification fails to adequately describe at least a substantial number of members of the genus of fusion proteins 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 vaccines. The term “vaccine” 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 fusion proteins 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 fusion proteins, 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.).
As evidenced by the teachings of Skolnick et al., the art is unpredictable. Skolnick et al. (Trends in Biotechnology 18: 34-39, 2000) 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 polypeptide would necessarily have a given immunological property. The instant specification has failed to teach or disclose vaccine compositions comprising the claimed fusion proteins that are protective against infections caused by group B Streptococcus. The specification fails to teach or disclose data that demonstrates that the claimed vaccines can provide protection against infections caused by group B Streptococcus. There is no disclosure of subjects that have been immunized with the claimed fusion proteins nor is there a disclosure of challenge studies that have been conducted to establish the claimed fusion protein’s ability to provide protection against a given pathogen. The specification merely refers to the use of the claimed fusion proteins in a general or prophetic sense but provides no real data. Consequently, there is no correlation between structure and function as required by the Written Description requirement. Moreover, the specification clearly demonstrates that the efficacy of all potential “vaccines” must be tested empirically when it states: “To determine whether protective immunity is induced by a fusion protein or vaccine, techniques well known for a person skilled in the art can be used. For example, to determine whether immunization with a given fusion protein induces protective immunity against a given pathogen (e.g., group B Streptococcus infection), immunized test animals can be challenged with a said pathogen and growth and spread of the group B Streptococcus is measured.” (see paragraph [0061] of the published specification).
With respect to 90% variants, 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. Applicants have not described the genus of claimed variants such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed.
With the written description of a genus, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that "merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim's functional boundaries."). Abbvie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 U.S.P.Q.2d 1780, 1790, 2014 BL 183329, 12 (Fed. Cir. 2014).
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.
The purpose of the "written description" requirement is broader than tomerely explain how to "make and use"; the applicant must convey with reasonableclarity to those skilled in the art that, as of the filing date sought, he or she was inpossession of the invention. The invention is, for purposes of the "writtendescription" 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 fromits enablement provision; and adequate written description requires more than amere statement that it is part of the invention and reference to a potential methodfor isolating it. The nucleic acid [product] itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Possession 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" (Id. at 1104). 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. An 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." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). To satisfy the written description requirement, an 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, and that the invention, in that context, is whatever is now claimed. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991) and MPEP 2163.02.
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. 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'" (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. The scope of the claim includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between genus members is permitted.
There are no drawings or structural formulas disclosed of any of thesefragments or variants of the claimed fusion polypeptides There is no teaching in thespecification regarding which 10% of the structure can be varied and still produce a polypeptide which has the recited immunogenic properties. Although the disclosure of SEQ ID NOs: 7, 14 and 42 combined with the knowledge in the art, may put one in possession of peptides that are at least 90% identical to SEQ ID NO: 7, 14 and 42, the level of skill and knowledge in the art is such that one of ordinary skill would not be able to identify without further testing which of those peptides having at least 90% identity to SEQ ID No: 7 and 14 and produce a fusion polypeptide which has the ability to treat or prevent group B Streptococcus infection in a human or animal.
Based on the lack of knowledge and predictability in the art, those of ordinaryskill in the art would not conclude that the applicant was in possession of theclaimed genus of fusion polypeptides.
One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described.
Therefore, because the art is unpredictable, in accordance with the MPEP, the description of claimed fusion proteins is not deemed representative of the genus of fusion proteins to which the claims refer.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4, 10, 11(a) and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lindahl, G (US Patent No. 8,313,748; WO 2008/127179, 10/23/2008; US-20100062015A1), Pederson et al (WO 2017/068112; April 27, 2017; provided by Applicants) and Pederson et al (WO 2017/114655, July 6, 2017; provided by Applicants)
Notes: Instant claim 1 uses the open language “comprising” and recites:
An immunogenic fusion protein comprising or consisting of an amino acid sequence consisting of: i) a first amino acid sequence part consisting of 170-175 amino acids, and having at least 90% sequence identity with the amino acid sequence shown in SEQ ID NO: 7;
ii. a second amino acid sequence part consisting of 165-170 amino acids, and having at least 90% sequence identity with the amino acid sequence shown in SEQ ID NO: 14; and optionally: iii. a linker amino acid sequence part consisting of 1 to 20 amino acids and separating the first amino acid sequence part from the second amino acid part, and wherein the immunogenic fusion protein preferably consists of 335 to 372 amino acids, preferably 343 to 353 amino acids, more preferably 343 to 347 amino acids.
Instant claim 4 recites: the immunogenic fusion protein according to claim 1, wherein the immunogenic fusion protein has at least 90% sequence identity to SEQ ID NO: 21.
Lindahl, G (US Patent No. 8,313,748), Lindahl, G (WO 2008/127179; 10/23/2008) and Lindahl G. (US20100062015A1) all teach:
Lindahl teaches a S. agalactiae group B Rib-AlphaC fusion protein, shown in SEQ ID 6, which is 99.7% identical to Applicant’s SEQ ID NO: 21. Amino acids 33-378 from SEQ ID NO: 6 of Lindahl, match Applicant’s 2-347 of Applicant’s SEQ ID NO: 21.
Lindahl also teaches a first amino acid (SEQ ID NO: 2) which is 179 amino acids in total length and 99.4% identical to Applicant’s SEQ ID NO: 7 (zero mismatches/substitutions). Claim 1 allows for the peptide to be from 170-178 amino acids in length, but includes variants.
Lindahl also teaches a second amino acid (SEQ ID NO: 4) which is 175 acids in total length and 100% identical to the full-length of Applicant’s SEQ ID NO: 14 (amino acids 1-170). Claim 1 allows for the polypeptide to be from 165-170 amino acids in length, but includes variants.
The Lindahl references teach methods of vaccinating vertebrates to treat and/or prevent Group B streptococcus infections. It is taught the fusion protein vaccines may be administered to humans or animals, including mammals and birds, such as rodents (mouse, rat, guinea pig, or rabbit); birds (turkey, hen or chicken); other farm animals (cow, horse, pig or piglet); pets (dog, cat and other pets); and humans. While many animals may be treated with the preparation of the invention, a preferred individual for treatment is a human or commercially valuable animal and livestock. See paragraphs 76-87. Vaccination of females, e.g., mothers is specifically taught.
Pederson et al (WO 2017/068112; 4/27/17; provided by Applicants) discloses an immunogenic fusion protein (SEQ ID NO:6) comprising the N- terminal domains of two Streptococcal proteins (Rib and AlpC). Pederson teaches SEQ ID NO: 12 which is 100% identical to Applicant’s SEQ ID NO: 42. Pederson discloses an first amino acid sequence having at least 80% identity with the N-terminal region of a Rib protein and a second sequence at least 80% identical to an AplC protein. See claims, for example.
Pederson et al (WO 2017/114655, 7/6/17; provided by Applicants) discloses an immunogenic fusion protein (SEQ ID NO:6) comprising the N- terminal domains of two Streptococcal proteins (Rib and AlpC) for use in combination with a bacterial polysaccharide. Pederson teaches SEQ ID NO: 12 which is 100% identical to Applicant’s SEQ ID NO: 42. Pederson discloses an first amino acid sequence having at least 80% identity with the N-terminal region of a Rib protein and a second sequence at least 80% identical to an AplC protein. See claims for example.
Accordingly, Lindahl’s Rib first portion is 179 amino acids in length (not 170-178) and Lindahl’s second AlpC portion is 175 amino acids in length (not 165-174), yet the fusion of these portions in Lindahl is 354 total amino acids in length, e.g., within the range of 335-372. Lindhal’s SEQ ID NO: 6 fusion protein in 378 amino acids in length. All references teach the use of an adjuvant with the fusion protein. Claims 16 and 17 of Pederson ‘112 and claims 19 and 20 of Pederson ‘655 specifically teach the use of aluminum hydroxide.
Accordingly, Lindahl does not explicitly recite a Rib-AlpC fusion protein comprising a Rib and AlpC sequences of the recited length, the ambiguity of the claim languages makes it obvious in view of the teachings of Lindahl that a very significant portion and variants of those portion, e.g., up to 90% are acceptable, and just 1 amino acid longer than Applicant’s SEQ ID NO: 7 and just 5 amino acids longer than Applicant’s SEQ ID NO: 14. Pederson et al teach fusions between the N-terminal region of Rib and AlpC with variations of up to 80%.
It would have been prima facie obvious to one of ordinary skill in the art to provide an immunogenic fusion protein comprising N-terminal sequences from the two streptococcal proteins, Rib and AlpC. Instant Claim 1 does not state which sequences from SEQ ID NO:7 and 14 are to be used, and they are only 90% identical, so no effects can be assumed. The linker sequence in the claims is optional. However, the features a linker to connect two polypeptides in a fusion protein is routine in the art. The differences are considered mere arbitrary variations that the skilled person could select; the linker is in any case known from Pederson in SEQ ID NO:6 . Lindahl teaches a S. agalactiae group B Rib-AlphaC fusion protein, shown in SEQ ID 6, which is 99.7% identical to Applicant’s SEQ ID NO: 21. Amino acids 33-378 from SEQ ID NO: 6 of Lindahl, match Applicant’s 2-347 of Applicant’s SEQ ID NO: 21. Pederson et al teach fusions between the N-terminal region of Rib and AlpC with variations of up to 80%. One additional amino acid from Rib and up to 5 from AlpC would have been obvious variations according the prior art teachings in the art. No unexpected results have been shown and the instant claim does not even recite which particular amino acids are to be included in the claimed fusion proteins.
Status of Claims:
No claim is presently allowed.
An immunogenic fusion polypeptide consisting of the amino acid sequence of SEQ ID NO: 21 is free of the prior art. Claim 5 would be allowable if rewritten in independent form and if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Amino acids 33-378 from SEQ ID NO: 6 of Lindahl, match Applicant’s 2-347 of Applicant’s SEQ ID NO: 21. The instant claims do not require the leading sequence (SEQ ID NO: 43) to be removed as shown in Applicant’s SEQ ID NO: 21. The instant claims allow for any amino acids, e.g., in any position, from SEQ ID NO: 7 and 14, as well as variants of up to 90%; however, the working examples in the specification utilize SEQ ID NO: 21.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel E. Kolker, can be reached on (571) 272-3181.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/ Primary Examiner, Art Unit 1645 2/27/26