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 .
Claim Objections
Claim 1 is objected to because of the following informalities: in line 4, “biding” is mispelled. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, and 4-7 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 present claims require the function of:
-Antibodies to RSV N that bind the 12 recited peptides in claim 1.
The Court has indicated in Amgen Inc vs Sanofi ( 2017-1480, Fed Cir, 2017) that the disclosure of a well characterized antigen (here, the scanning peptides of RSV N) is insufficient for an adequate written description of the antibody that binds the antigen.
The Court stated that “an adequate written description must contain enough information about the actual makeup of the claim products – a precise definition such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other material,” which may be present in “function “terminology “when the art has established a correlation between structure and function” (page 17, 1st paragraph). The Court went on to indicate that knowledge of the chemical structure of an antigen does not tell you anything about the structure of the antibody (Id).
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 antibodies claimed by function as described at the start of the rejection.
The specification appears only discloses one antibody that binds the 12 peptides (page 8).
There is no teaching of the structure required (CDRs or VH or VH) for the functions as claimed of binding to 12 peptides of RSV N.
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 by structure or other means any antibodies that bind the 12 peptides recited in claim 1 and thus does not satisfy either the Lilly nor Enzo standards.
There are insufficient structural features common to all members of the genus of antibodies. 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 antibodies are claimed by function, as discussed above. However, the specification does not disclose sufficient information on the structural function relationship to identify the claimed genus of antibodies. One of ordinary skill in the art would not be able to identify the broad claimed genus of antibodies.
Thus, the specification does not provide an adequate written description of the genus of antibodies that is required to practice the claimed invention. Applicants have not described the genus of antibodies claimed by function 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.
Applicant argues that the specification shows that antibodies can be made, there is no per se rule that biological macromolecules contain structure, and that the claims only require binding and no additional function, so Amgen and Centocor are not applicable.
Also, the claims are to a reagent and method, not product as in Amgen and Centocor. And that applicant meets the clarity required in MPEP 2163.
Applicant’s arguments have been fully considered and not found persuasive.
First, the detection reagent is a product.
As to the cited case, Amgen, “The Court has indicated in Amgen Inc vs Sanofi ( 2017-1480, Fed Cir, 2017) that the disclosure of a well characterized antigen (here, the scanning peptides of RSV N) is insufficient for an adequate written description of the antibody that binds the antigen.”
As pointed out in the rejection, knowing how to make something does not show possession. Describing the antigens that are bound do not describe the antibody. Applicant has not shown how to identify the antibodies without having to screen each one and that does not show possession.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, and 4-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, and 7--8 of copending Application No. 17776204 (reference application, allowance mailed 9/16/25)) in view of Ziemann (20140272931). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference is to a single antibody defined by sequence that appears to be the same as the instantly claimed antibody genus. The antibodies have the same binding properties as shown in Tables 1 and 2 (1 and 3 in reference).
Where, as here, the Patent Office lacks the facilities to perform comparisons between the claimed material and prior art materials that reasonably appear to meet the claim limitations, the burden is properly shifted to applicant to distinguish the claimed product from the prior art product. See In re Best, Bolton, and Shaw, 195 USPQ 430 (CCPA 1977); Ex Parte Gray, 10 USPQ2nd 1922 (BPAI 1989).
The reference is drawn to a species and thus anticipates the genus. The antibody is claimed in claim 1 and in claim 1 in the reference application.
Claims 2, and 4-7 correspond to the same limitations in claims 4, 5, and 7--8 of the reference that have limitations of type of antibody, intended use and a method.
The use of labels and binding to solid phase is routine in the art, see Ziemann claims 1, 7, and 8.
One of ordinary skill in the art before the effective filing date would be motivated to use solid support and label because it makes the antibody easier to use and see the results.
Thus, it would be prima facie obvious before the effective time of filing to modify the antibodies to include solid support and label and have the expectation of success knowing they are used in the art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented (allowance mailed).
Applicant argues that the claims have been amended to include the limitations of bound to solid phase and labeled and requests the rejection be withdrawn.
Applicant’s arguments have been fully considered and not found persuasive.
The use of solid support and label are known in the art of antibodies and obvious.
Conclusion
Citation of closest prior art.
Murray et al. (2001 Virology 289, pages 252-261. From IDS) teach antibodies to RSV N but do not teach one that binds to at least a region corresponding to SEQ ID# 30 (Figure 1 maps locations binding location to peptides of RSV N).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 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.
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.
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671