5/25DETAILED 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 .
Status of the claims
The amendment filed 12/05/25 is acknowledged and has been entered. Claims 1, 6, 13 and 20 have been amended. Claims 3, 5, 7-10, 12, 14-16, 18, 21-24, 26 and 28 have been canceled. Claim 2 was previously canceled. Claims 6, 11, 13, 17, 19-20, 25 and 27 remain withdrawn as being directed to non-elected inventions for reasons of record. Accordingly, claims 1 and 4 are under examination.
Withdrawn Rejections
All rejections of claims not reiterated herein, have been withdrawn.
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.
Written Description
Claims 1 and 4 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Possession may be shown, for example for the claimed method, by describing an actual reduction to practice of the claimed invention by showing that the inventor constructed an embodiment or performed a process that met all the limitations of the claim and determined that the invention would work for its intended purpose. For claimed product the specification must provide sufficient distinguishing identifying characteristics of the genus, including disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
The claims are broadly drawn, such that they apply to a genus of specific binding partners which have the unique capability of specifically binding to a portion of a hapten. The limitation “binding partner” represent a genus and encompasses proteins, peptides, drugs, nucleic acids, aptamers and synthetic binding agents to name a few.
The specification on pages 13-15 discloses antibodies and fragments thereof used to specifically bind to a hapten such as tacrolimus. The specification in paragraph 0009 makes reference to US Patent 6,635,745 for assays. US Patent 6,636,745 provides for monoclonal antibodies specific for rapamycin. The specification in paragraph 0011 discloses immunoassays (assay using an antibody to detect) for detecting therapeutic drugs and makes reference to US Patent 7,223,553. The only example in the specification on pages 21-22 is limited to the use of antibodies for specifically binding to two different portions of a happen. Further, the preamble of the claim reciters that the reagent is an immunoassay reagent and thus implies that the specific binding partner is an antibody.
However, the specification does not teach any other binding partners other than an antibody and does not provide any teaching of the production of any and all possible partners and does not disclose a single example of a nucleotide encoding a hapten. There are no tables, data or evidence to provide that any other binding partner other than antibodies are known in the art which possess this unique characteristic or capabilities. For example, the specification does not disclose a single drug which is capable of binding to another drug such as a hapten or provide any literature or examples showing any other specific binding partner other than that of an antibody.
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 by describing structural features common the genus that “constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997): “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNA, defined by nucleotide sequence, 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.” The Federal Circuit has recently clarified that a DNA 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 characteristic, 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”.
The court has since clarified that this standard applies to compounds other than cDNAs. See University of Rochester v. G.D. Searle & Co., Inc., F.3d ,2004 WL 260813, at *9 (Fed.Cir.Feb. 13, 2004). The instant specification fails to provide sufficient descriptive information in the claimed method of any other binding agent for the measurement of CILP other than that of known and conventional antibodies. Thus, one of skill in the art would reasonably conclude that the inventor(s), at the time the application was filed, did not have possession of the broadly claimed invention.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “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 page 1117.) 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). As discussed above, the skilled artisan cannot envision the detailed chemical structure(s) and functional attribute(s) of the encompassed genus of variants or derivatives used in the method, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Considering the potentially large numbers of binding partners encompassed by these claims, the disclosure is not sufficient to show that a skilled artisan would recognize that the applicant was in possession of the claimed invention (genus) commensurate to its scope at the time the application was filed.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sigler et al (US 2008/0081379).
Sigler et al discloses a particle having two monoclonal antibodies for an immunosuppressant drug (hapten) wherein each antibody has specificity for a different site on the immunosuppressant drug (e.g. para 0057). Sigler et al discloses that the immunosuppressant drug can be tacrolimus (e.g. para 0056). Sigler et al discloses that the particles can be a latex particle (e.g. para 0030, 0058).
With respect to the recitations “for detection of a hapten released from its endogenous binding protein/immunophilin complex” and “whereby binding of hapten to the diagnostic immunoassay reagent results in particle enhanced agglutination for signal detection” as recited in claim 1. These limitations are intended use of the reagent. Applicant is reminded that a recitation of the intended use of the claimed invention, i.e. use of the reagent for binding of hapten, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Sigler et al discloses the same particle and binding partner as recited in the instant claims and therefore the reagent is capable of binding to a hapten released from it endogenous binding protein/immunophilin complex and would result in particle enhanced agglutination for signal detection.
Response to Arguments
Applicant's arguments filed 12/05/25 have been fully considered but they are not persuasive.
102 Rejections:
Applicant argues that while the antibodies in Sigler et al may recognize two different sites on the immunosuppressant drug, those two sites on the drug are not the entire epitopes for binding.
This argument is not found persuasive because the current claims do not recite any specific epitopes of the hapten but merely recite “binds to a portion”. The claim does not recite any specific structures of the binding partner but merely requires the binding partner binds a portion of the hapten. Applicant’s statement “that while the antibodies may recognize two different sites” appears to provide further evidence that the antibodies of Sigler read on the claim because the antibodies of Sigler et al would bind to different portions (i.e. different sites). There is nothing in the claims limiting a specific epitope of the hapten.
Applicant argues that Sigler et al does not explicitly disclose a diagnostic immunoassay reagent that comprises a particle having two antibodies bound thereto, wherein the two antibodies are capable of detecting a hapten released from its endogenous binding protein/immunophilin complex.
This argument is not found persuasive because as stated supra this is intended use of the immunoassay reagent. Applicant is reminded that a recitation of the intended use of the claimed invention, i.e. use of the reagent for binding of hapten, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Sigler et al discloses the same particle and binding partner as recited in the instant claims and therefore the reagent is capable of binding to a hapten released from it endogenous binding protein/immunophilin complex and would result in particle enhanced agglutination for signal detection.
Conclusion
No claims are allowed.
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.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678