DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of SEQ ID# 1 and 177R (claims from restriction group 2) in the reply filed on 3/6/26 is acknowledged.
Claim Rejections - 35 USC § 112
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 15-17 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. The claims refer to mutation positions but provide no standard point of reference. The claims should reference a full RSV G sequence by SEQ ID# to fix this.
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 11-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for SEQ ID# 1 with mutation S177R, and single chain Fv 3D3 and 2D10 does not reasonably provide enablement for all other mutations and other forms of 3D3 and 2D10 or any antibody of 3G12. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The specification teaches single chain FV 3D3 and 2D10 (SEQ ID# 12 and 13) but does not teach sequences for the other forms and the specification provides no sequence for 3G12.
The specification provides no showing that mutations can have the prophylactic or therapeutic effect.
The post filing art Bergeron, et al.
“Interestingly, only … 177R immunogen[s] induced a significant (177Q; p = 0.004; 177R p = 0.001) anti-RSV response. (Section 3.2). and
“Ab responses to … 177R showed retention of immunogenicity while having the ability to reduce CX3C-CX3CR1 interaction while G protein vaccination had lower responses.” (Section 4). However, the reference is silent on if the 177R binds mAbs 3d3, 2D10, or 3G12. Those antibodies are known to bind RSV G (Figure 1).
As to the state of the art- Nuñez Castrejon et al. teach “development of an RSV G vaccine antigen has been hindered by its low immunogenicity and safety concerns.” (abstract).
Thus, the difficulties in using RSV G as a vaccine antigen, the lack of working examples/teaching in the specification, and the lack of teaching in the specification of the full structure of antibodies required, it would require undo experimentation to practice the full scope of the invention as claimed.
Claims 11-27 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 guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Fri. January 5, 2001, see especially page 1106 column 3).
The specification does not provide adequate written description of the claimed invention. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention of the claimed invention, the genus of peptides or peptidomimetics that have a mutation in SEQ ID# 1-6 that have 1) diminished activation of the chemokine receptor, 2) elicits Abs that are immunoreactive with RSV G, and 3) immune reactive with mAbs 3d3, 2D10, or 3G12.
The genus of peptides or peptidomimetics are claimed by function, 1) diminished activation of the chemokine receptor, 2) elicits Abs that are immunoreactive with RSV G, and 3) immune reactive with mAbs 3d3, 2D10, or 3G12. The specification does not disclose any peptides or peptidomimetics that are capable of these functions. The Federal Circuit addressed the application of the written description requirement to DNA-related inventions in University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). The court stated that “[a] written description of an invention involving a chemical genus, like a description of a chemical species, requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials.” Id. At 1567, 43 USPQ2d at 1405. The court concluded that “naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” Id.
The Federal Circuit clarified that a molecule can be adequately described without disclosing its complete structure. See Enzo Biochem, Inc. V. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo court adopted the standard that the written description requirement can be met by “show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ....i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “ Id. At 1324, 63 USPQ2d at 1613 (emphasis omitted, bracketed material in original).
Furthermore The Board in Ex Parte Kubin found that the written description of 35 USC 112 was not met, stating that
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
The Board in Ex Parte Kubin further stated on page 16 that
Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
The court in In re Alonso (Fed. Cir. 2008) citing In re Enzo, Enzo, 323 F.3d at 969 stated that
[F]or purposes of satisfying the written description requirement, it is not enough merely to disclose a method of making and identifying compounds capable of being used to practice the claimed invention.
In this case, the specification does not appear to describe any peptides or peptidomimetics that have a mutation in SEQ ID# 1-6 that have 1) diminished activation of the chemokine receptor, 2) elicits Abs that are immunoreactive with RSV G, and 3) immune reactive with mAbs 3d3, 2D10, or 3G12 and thus does not satisfy either the Lilly nor Enzo standards. Thus, the specification does not appear to describe any species within the genus of peptides or peptidomimetics that have a mutation in SEQ ID# 1-6 that have 1) diminished activation of the chemokine receptor, 2) elicits Abs that are immunoreactive with RSV G, and 3) immune reactive with mAbs 3d3, 2D10, or 3G12. There are insufficient structural features common to all members of the genus of peptides or peptidomimetics that have a mutation in SEQ ID# 1-6 that have 1) diminished activation of the chemokine receptor, 2) elicits Abs that are immunoreactive with RSV G, and 3) immune reactive with mAbs 3d3, 2D10, or 3G12. The Board in Kubin indicated that possession may not be shown by merely describing how to obtain possession of members of the claimed genus. The peptides or peptidomimetics that have a mutation in SEQ ID# 1-6 are claimed by function, the ability to have 1) diminished activation of the chemokine receptor, 2) elicits Abs that are immunoreactive with RSV G, and 3) immune reactive with mAbs 3d3, 2D10, or 3G12. However, the specification does not disclose sufficient information on the structural function relationship to identify the claimed genus of autoantibodies. One of ordinary skill in the art would not be able to identify the broad claimed genus of peptides or peptidomimetics that have a mutation in SEQ ID# 1-6 that have 1) diminished activation of the chemokine receptor, 2) elicits Abs that are immunoreactive with RSV G, and 3) immune reactive with mAbs 3d3, 2D10, or 3G12.
Thus, the specification does not provide an adequate written description of the genus of peptides or peptidomimetics that have a mutation in SEQ ID# 1-6 that have 1) diminished activation of the chemokine receptor, 2) elicits Abs that are immunoreactive with RSV G, and 3) immune reactive with mAbs 3d3, 2D10, or 3G12 that is required to practice the claimed invention. Applicants have not described the genus sufficiently to show they had possession of the claimed genus. Since the disclosure fails to provide sufficient relevant identifying characteristics, and because the genus is highly variant, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
Conclusion
Citation of closest prior art-
Boyogluu-Barnum et al. (J of Virology Vol 91, No. 10, year 2017) teach that altering the C3XC motif to a C4XC motif may improve the safety and efficacy of an RSV vaccine (abstract). The reference does not teach or sugest mutations near the motif.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYRON G HILL whose telephone number is (571)272-0901. The examiner can normally be reached Mon-Fri.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671