DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicants’ Amendment
1) Acknowledgment is made of Applicants’ amendment filed filed 09/21/26 in response to the non-final Office Action mailed 07/01/26.
Status of Claims
2) Claims 26, 28 and 40 have been amended via the amendment filed 09/21/26.
Claims 29-38 have been canceled via the amendment filed 09/21/26.
New claims 47 and 48 have been added via the amendment filed 09/21/26.
Claims 26-28 and 39-48 are pending.
Claims 26-28, 39, 40, 45, 47 and 48 are under examination.
Attempts at Facilitating an Examiner’s Amendment
3) Two attempts were made by the Office to advance prosecution of this application towards a potential Examiner’s amendment and allowance. Two voice mail messages were left to Applicants’ representative Ms. Erin M. Dunston at the telephone number provided, (215) 965-1291, requesting her to contact the Examiner of record. See Interview Summary. The Examiner has not heard from Applicants’ representative within the indicated deadline and as of the issuance of this Office Action.
Prior Citation of Title 35 Sections
4) The text of those sections of Title 35 U.S. Code not included in this action can be found in a prior Office Action.
Prior Citation of References
5) The references cited or used as prior art in support of one or more rejections in the instant Office Action and not included on an attached form PTO-892 or form PTO-1449 have been previously cited and made of record.
Objection(s) Withdrawn
6) The objection to the specification set forth in paragraph 9(b) of the Office Action mailed 07/01/26 is withdrawn in light of Applicants’ amendment to the specification.
7) The objection to claim 40 set forth in paragraph 9(c) of the Office Action mailed 07/01/26 is withdrawn in light of Applicants’ amendment to the claim.
Objection(s) Maintained
8) The objection to the specification set forth in paragraph 9(a) of the Office Action mailed 07/01/26 is maintained.
Although Applicants have amended page 28 of the specification referring to the panels of Figures 1 and 3, the references to these Figures in the two full paragraphs under the section “EXAMPLE” on page 29 of the as-filed specification remain unamended.
Objection(s) to Specification
9) Claim 26, as amended, and the specification are objected to for the following reason(s):
35 U.S.C § 132 states that no amendment shall introduce new matter into the disclosure of the invention. 37 CFR 1.75(d)(1) provides, in part, that ‘the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description.’
Claim 26, as amended, includes the limitations: a VS4 polypeptide having at least “95%” identity with the amino acid sequence that ranges from ........ SEQ ID NO: 1. Applicants refer to lines 31-33 of page 10 and lines 19-30 of page 15 as well as claims 1, 8 and 9 for support. However, there is no antecedent basis and descriptive support in the as-filed specification for said limitation(s) that includes “95%” identity as claimed.
Rejection(s) Moot
10) The rejection of claims 29-35 set forth in paragraph 11 of the Office Action mailed 07/01/26 under 35 U.S.C § 112(a) or 35 U.S.C § 112(pre-AIA ), first paragraph with regard to the written description issue is moot in light of Applicants’ cancellation of the claims.
11) The rejection of claim 35 set forth in paragraph 13 of the Office Action mailed 07/01/26 under 35 U.S.C § 112(b) or 35 U.S.C § 112(pre-AIA ), second paragraph as being indefinite is moot in light of Applicants’ cancellation of the claim.
12) The rejection of claims 29-35 set forth in paragraph 15 of the Office Action mailed 07/01/26 on the ground of nonstatutory double patenting as being unpatentable over claims 42, 39, 40-44, 46, 47 and 52 of the co-pending application 18274848 is moot in light of Applicants’ cancellation of the claims.
Rejection(s) Withdrawn
13) The rejection of claims 26-28, 39, 40 and 45 set forth in paragraph 11 of the Office Action mailed 07/01/26 under 35 U.S.C § 112(a) or 35 U.S.C § 112(pre-AIA ), first paragraph with regard to the written description issue is withdrawn in light of Applicants’ claim amendments. A new rejection is set forth in this Office Action to address the claims as amended.
14) The rejection of claim 28 set forth in paragraph 13(a) of the Office Action mailed 07/01/26 under 35 U.S.C § 112(b) or 35 U.S.C § 112(pre-AIA ), second paragraph as being indefinite is withdrawn in light of Applicants’ claim amendment.
15) The rejections of claim 40 set forth in paragraphs 13(h), 34(i) and 34(j) of the Office Action mailed 07/01/26 under 35 U.S.C § 112(b) or 35 U.S.C § 112(pre-AIA ), second paragraph as being indefinite are withdrawn in light of Applicants’ claim amendments.
16) The rejection of claims 39, 40 and 45 set forth in paragraph 15 of the Office Action mailed 07/01/26 on the ground of nonstatutory double patenting as being unpatentable over claims 42, 39, 40-44, 46, 47 and 52 of the co-pending application 18274848 is withdrawn in light of Applicants’ claim amendments in this application and the claim amendments in the co-pending application.
Rejection(s) under 35 U.S.C § 112(a) or (Pre-AIA ), First Paragraph
17) The following is a quotation 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 35 U.S.C. § 112 (pre-AIA ), first paragraph:
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 the invention.
18) Claim 26, as amended, and the dependent claims 27, 28, 39, 40, 45, 47 and 48 are rejected under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, as containing 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 26, as amended, includes the limitations: a VS4 polypeptide having at least “95%” identity with the amino acid sequence that ranges from ........ SEQ ID NO: 1. Applicants refer to lines 31-33 of page 10 and lines 19-30 of page 15 as well as claims 1, 8 and 9 for support. However, there is no descriptive support in the as-filed specification for said limitations that includes “95%” identity as claimed. However, there is no descriptive support for said limitations that include “95%” identity as claimed. Therefore, the above-identified limitation(s) in the claim(s) and/or the current scope of the claim(s) constitute new matter. See M.P.E.P 608.04 to 608.04(c).
Applicants are invited to point to the descriptive support in specific pages and lines of the disclosure, as originally filed, for the limitation identified above, or alternatively, remove the new matter from the claim(s). Applicants should specifically point out the support for any amendments made to the disclosure. See MPEP 714.02 and 2163.06.
19) Claims 45 and 26 are rejected under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, as containing 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The purpose of the written description requirement is “to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.” In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). The analysis of whether the as-filed specification complies with the written description requirements calls for the Office to compare the scope of the claims with the scope of the description to determine whether Applicant has demonstrated possession of the full scope of the claimed invention at the time of the invention. In the instant application, an analysis of the scope of the claims and of the antibody genus and the genus of VS4 polypeptide variants having at least 95% identity with the amino acid sequence that ranges from the amino acid residue at position 282 to the amino acid residue at position 358 in SEQ ID NO: 1 indicates the following.
Claim 26, as amended, is representative of the claimed invention. The amended claim 26 is drawn to an antibody that is specific for CD40, wherein the heavy chain, the elected species, is conjugated to or fused to a VS4 polypeptide having at least 95% identity with the amino acid sequence that ranges from the amino acid residue at position 282 to the amino acid residue at position 358 in SEQ ID NO: 1. The recited “a VS4 polypeptide ......” as claimed is a genus encompassing a variety of structurally divergent VS4 polypeptide variant species having up to 5% non-identity with the amino acid sequence that ranges from the amino acid residue at position 282 to the amino acid residue at position 358 in SEQ ID NO: 1. This VS4 polypeptide variant genus is an essential component of the claimed product. The composition in the dependent claim 45 comprising the antibody wherein the heavy chain is conjugated or fused to the claimed VS4 polypeptide genus encompassing up to 5% non-identical variants is required to be a “vaccine” composition. As is evident from claim 46, the claimed vaccine is for vaccinating a subject in need against Chlamydia trachomatis. The ‘vaccine’ ‘must by definition trigger an immunoprotective response in the host vaccinated; a mere antigenic response is not enough’. In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). However, at the time of the invention, Applicants were not in possession of the full breadth of the variable genus identified supra and the full scope of the claimed invention.
Whether or not one of skill in the art would recognize that Applicant was in possession of the claimed invention as a whole at the time of invention is to be determined upon considering the actual reduction to practice, sufficient relevant identifying characteristics, disclosure of drawings or structural chemical formulas, method of making the claimed invention, level of skill and knowledge in the art, and predictability in the art. Under the written description provision of the 35 U.S.C § 112(a) or pre-AIA , first paragraph, the structure of a representative number and variety of the encompassed structurally variable VS4 polypeptide variant species, the fusion or the conjugate of which species, is required to be correlated with the requisite vaccine function(s). The written description requirement can be met by describing the claimed subject matter to a person skilled in the art using sufficiently detailed, relevant identifying characteristics such as functional characteristics and correlating those functional characteristics with a disclosed structure. See Enzo Biochem v. Gen-Probe, 323 F.3d 956, 964, 967, 968 (Fed. Cir. 2002). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the 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); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; 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"). In the instant application, the structure of a sufficient number and variety of species encompassed within the variable and structurally divergent genus has not been correlated with the requisite vaccine functions.
In the instant application, the specification does not disclose distinguishing and identifying features of a representative number and variety of members of the genus of the structurally variable VS4 polypeptide variant species to which the heavy chain of the claimed antibody specific for CD40 is conjugated or fused, wherein the structure of the resultant product is correlated with the requisite vaccine function(s) such that a skilled artisan could immediately envision or recognize at least a substantial number and variety of members of the claimed genus of the VS4 polypeptide. The as-filed specification fails to disclose which specific regions of the amino acid sequence ranging from the amino acid residue position 282 to the amino acid residue position 358 in SEQ ID NO: 1 are critical for the requisite vaccine function(s) such that one could produce at least 95% identical variant species of the VS4 polypeptide genus that retain the requisite vaccine function(s). Which amino acid residues within the amino acid residue position 282 to the amino acid residue position 358 in SEQ ID NO: 1 might be substituted, inserted, deleted, added, or modified while retaining the required vaccine function(s) are not disclosed. Clearly, there is lack of adequate description and lack of structure-vaccine function correlation within the as-filed specification. This is important because ‘[f]or 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’. A ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within each genus as in the instant case, one must describe a sufficient variety of species to reflect the variation within the genus along with a concrete structure-function correlation. The Court in Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) stated that “[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated”). The written description inquiry is case-specific and context-specific. It “depend[s] on the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed.” Ariad, 560 at 1372. A number of factors guide the inquiry, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, and the predictability of the aspect at issue.” Ariad, 560 at 1372 [Emphasis added]. MPEP 2163 states [Emphasis added]:
The description needed to satisfy the requirements of (pre-AIA ) 35 U.S.C § 112 “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084. Patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art.
Evidence required to demonstrate possession of the invention is fact-specific and varies inversely with the maturity and predictability of the technology area. Inventions in “unpredictable” arts are subject to greater scrutiny under the written description requirement, and require a greater showing of possession than more predictable arts. The state of the art at the time of the invention documents unpredictability associated with amino acid modifications within a protein or polypeptide sequence. For example, Mikayama et al. Proc. NatI. Acad. Sci. USA, 90: 10056-10060, 1993 (of record) taught that the three-dimensional structure of molecules is important for their biological function and even a single amino acid difference may account for markedly different biological activities. See page 10060. Skolnick et al. Trends in Biotechnology, 18: 34-39, 2000 (of record) teach that the skilled artisan is well aware that assigning functional activities for any particular protein or protein family based on sequence homology is inaccurate, in part because of the multifunctional nature of proteins. See abstract and ‘Sequence-based approaches to function prediction’ on page 34. Skolnick et al. further teach that 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 function of the structurally related protein. See in particular abstract and Box 2. With regard to the structure-function relationship of an encoded amino acid sequence in general, Rudinger J. In: Peptide Hormones. (Ed) JA Parsons, University Park Press, pages 1-7, 1976 (of record) taught that ‘the significance of particular amino acid sequences for different aspects of biological activity cannot be predicted a priori but must be determined from case to case by painstaking experimental study’. See page 6 of Rudinger J. Rudinger J. further taught that ‘it is impossible to attach a unique significance to any residue in a sequence’ and that a ‘given amino acid will not by any means have the same significance in different peptide sequences, or even in different positions of the same sequence. See page 3 of Rudinger J. Furthermore, the art recognizes that defining epitopes is not easy and there is a confusing divergence between the textbook definition of epitope and the definition that is in use in published descriptions of experimental investigations and that epitopes must be empirically determined. See Greenspan et al. Nature Biotechnology 17: 936-937, 1999 (of record). Even with regard to conservative amino acid substitutions, Lazar et al. Mol. Cellular Biol. 8: 1247-1252, 1988 (of record) demonstrated that a substitution of the Leucine residue with a conservative amino acid residue such as, Isoleucine or Histidine, in the transforming growth factor (TGF) alpha led to a mutant protein with dramatically altered biological activities. Lazar et al. expressly stated that they ‘did not expect that a mutation of Leu to Ile (which have similar sizes and polarities) would cause such a strong effect’. See the paragraph bridging left and right columns on page 1251; and third full paragraph on page 1251. In the instant application, with up to 5% sequence non-identity permitted within the recited VS4 polypeptide variant genus comprised in the claimed vaccine composition, there is no predictability that the VS4 amino acid sequence variant species in the vaccine would retain the conformational integrity and the native VS4 polypeptide immunospecificity such that the encompassed various variant species in the vaccine composition would retain the requisite protective vaccine functions against Chlamydia trachomatis.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California V. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California V. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while Applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B(1), the court states, "An adequate written description of a DNA requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention." Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, states that 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, for purposes of the written description inquiry, is whatever is now claimed (see page 1117). The decision in AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., III USPQ2d 1780 (Fed. Cir. 2014) stated: “When a patent claims a genus using the functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus”. Id. at 1349. We have held that “a sufficient description of a genus ....... requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus.” Id. at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). 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."). In the instant application, the as-filed specification and the claims draw a fence around a perceived genus but the genus is not adequately described. The claims are not limited to the particular elements described in the specification and variability for the genus encompassed by the claims is large. The specification does not describe representative examples to support the full scope of the claims.
MPEP § 2163.02 states: ‘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’. The courts have decided that 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). Applicants should note that written description provision of 35 U.S.C § 112(a) or pre-AIA , first paragraph is severable from its enablement provision, and written description requires more than a mere statement that something is part of the invention and a 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. A mere idea or unsubstantiated function is insufficient for written description; characterization of a representative number of species within the huge variable genus as claimed, with their precise structure correlated with the requisite or intended functions is required. In the absence of sufficient recitation of distinguishing characteristics, the specification does not provide adequate written description of the claimed genus. In the instant case, one of skill in the art would not recognize from the disclosure that the Applicants were in possession of the variable genus. The specification does not clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed. See Vas-Cath at page 1116. Applicants’ specification does not contain a written description sufficient to show that they had possession of the full breadth of the varied genus and the full scope of the claimed invention at the time the application was filed. Instant claims do not meet the written description provision of 35 U.S.C § 112(a) or pre-AIA , first paragraph. Applicants are reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C § 112 is severable from its enablement provision (see page 1115).
Conclusion
20) No claims are allowed.
21) Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. THIS ACTION IS MADE FINAL. Applicants are reminded of the extension of time policy as set forth in 37 C.F.R 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 C.F.R 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
22) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Jeffrey Stucker, can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
23) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
October, 2026
