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 .
DETAILED ACTION
Status of Claims
Claims 1-18 are currently pending. Claims 1-18 have been subject to election/restriction requirement mailed 05/14/2025. Claims 1-14 are withdrawn from further consideration. See the office action of 08/27/2025 for the withdrawal of claims 1-14 as being directed non-elected invention Therefore, claims 15-18 are examined.
Claim Rejections - 35 USC § 112
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 112 that form the basis for the rejections under this section made in this Office action.
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 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 15-18 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.
Claim 15 is directed to a method comprising adding an antibody specific for Formula I to the sample. The antibody is essential and a critical component to practice the invention.
It is the Examiner’s position that the instant specification fails to provide adequate written description for the genus of antibodies in the method directed to various epitopes on Formula I as claimed for the process. The Examiner’s position is based on the following facts and considerations.
MPEP § 2163 states that to satisfy the written description requirement, 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:
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. 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 reGosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), 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. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter.” Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In reKaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).” Emphasis added.
MPEP § 2163 further states that disclosure of an antigen fully characterized by its structure does not provide an adequate written description of an antibody claimed by its binding affinity to that antigen, even when preparation of such an antibody is routine and conventional:
“…disclosure of an antigen fully characterized by its structure, formula, chemical name, physical properties, or deposit in a public depository does not, without more, provide an adequate written description of an antibody claimed by its binding affinity to that antigen, even when preparation of such an antibody is routine and conventional. See Amgen Inc. v. Sanofi, 872 F.3d 1367, 1378, 124 USPQ2d 1354, 1361 (Fed. Cir. 2017)(“knowledge of the chemical structure of an antigen [does not give] the required kind of structure-identifying information about the corresponding antibodies”); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1351-52, 97 USPQ2d 1870, 1877 (Fed. Cir. 2011) (patent disclosed the antigen the claimed antibody was supposed to bind, but did not disclose any antibodies with the specific claimed properties).” Emphasis added.
See also a memorandum “Clarification of Written Description Guidance For Claims
Drawn to Antibodies and Status of 2008 Training Materials”, https://www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf, in which the USPTO adopts the Federal Circuit’s decision Amgen Inc. v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). The USPTO explains in the memorandum, the Federal Circuit’s decision in Amgen clarifies “the law of written description as it applies to antibodies.” In particular, as the USPTO points out, the “Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. § 112(a) requires adequate written description of the antibody itself.” The USPTO also emphasizes that “the in Amgen court expressly stated that the so-called ‘newly characterized antigen’ test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. § 112(a) for a claim drawn to an antibody.” The newly characterized antigen test allowed the description of a new antigen or target combined with routine and conventional methods of making antibodies to substitute for written description of the antibodies themselves, i.e., antibodies that may bind and inhibit that target. As the USPTO explains, the Federal Circuit rejected such an approach as contrary to the quid pro quo of the patent system: “Citing its decision in Ariad Pharm., Inc. v. Eli Lilly & Co., the court also stressed that the ‘newly characterized antigen’ test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent.” In the case of claims that are drawn to antibodies, “35 U.S.C. § 112(a) requires adequate written description of the antibody itself.”
Further, to provide evidence of possession of a claimed genus, the specification
must provide sufficient distinguishing identifying characteristics of the genus. For a claimed genus, the written description requirement may be satisfied through sufficient description of a representative number of species by actual reduction to practice, 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 Applicant was in possession of the claimed 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 the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that “only describe[d] one type of structurally similar antibodies” that “are not representative of the full variety or scope of the genus.”). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (“[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.”). “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). Emphasis added.
In Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017), relying upon Ariad Pharms., Inc. v. Eli Lily & Co., 94 USPQ2d 1161 (Fed Cir. 2010), the following is noted:
To show invention, a patentee must convey in its disclosure that is “had possession of the claimed subject matter as of the filing date. Demonstrating possession “requires a precise definition” of the invention. To provide this precise definition” for a claim to a genus, a patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen at page 1358). Emphasis added.
An adequate written description must contain enough information about the actual makeup of the claimed products – “a precise definition, such as structure, formula, chemic name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials”, which may be present in “functional terminology when the art has established a correlation between structure and function” (see Amgen at page 1361). Emphasis added.
In Ariad, the court further noted that the written description plays a particularly important role in the biological arts, where patentees might otherwise be tempted to claim a genus of compounds by its function or result:
“The written description requirement also ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function—a problem that is particularly acute in the biological arts. 5 See Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, 1, “Written Description” Requirement, 66 Fed. Reg. 1099, 1105-1106 (Jan. 5, 2001). This situation arose not only in Eli Lilly but again in University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916 [69 USPQ2d 1886] (Fed. Cir. 2004). In Rochester, we held invalid claims directed to a method of selectively inhibiting the COX-2 enzyme by administering a non-steroidal compound that selectively inhibits the COX-2 enzyme. Id. at 918. We reasoned that because the specification did not describe any specific compound capable of performing the claimed method and the skilled artisan would not be able to identify any such compound based on the specification's function description, the specification did not provide an adequate written description of the claimed invention. Id. at 927-28. Such claims merely recite a description of the problem to be solved while claiming all solutions to it and, as in Eli Lilly and Ariad's claims, cover any compound later actually invented and determined to fall within the claim's functional boundaries—leaving it to the pharmaceutical industry to complete an unfinished invention.” Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc). Emphasis added.
Notably, the same standard applies with regard to the written description requirement for “method claims”. See University of Rochester v. G.D. Searle & Co., 358 F.3d 916,926 (Fed. Cir. 2004):
“Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.”
In University of Rochester, the "claimed method depend[ ed] upon finding a compound that selectively inhibits PGHS-2 activity. Without such a compound, it is impossible to practice the claimed method of treatment." Id. (citation omitted).
Similarly, here, the claimed method cannot be practiced without an antibody that specifically binds to a compound of Formula I.
It is the Examiner’s position that the instant specification fails to provide adequate written description and clear guidance for the methods as claimed, which methods employ a genus of antibodies that specifically bind to a compound of Formula I, which genus of antibodies produced against a genus of the structurally unidentified immunogens of Formula I.
The Examiner’s position is based on the following facts and considerations.
First, the instant claims cover the use of an enormous genus of antibodies, which specifically bind the compounds of generic Formula I, which formula covers a practically unlimited set of the C5 biotin derivatives and C5 biotin conjugates with haptens and polypeptides.
Second, the instant specification is limited to the functional characterization of the produced monoclonal antibodies as follows:
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However, these antibodies represent an undecipherable “black box” beyond understanding to one of skill in the art because neither structural characterization by sequencing of heavy (VH) and light (VL) chain variable regions and/or the corresponding complementarity determining regions (6 CDRs), nor information regarding biological deposits of cell lines producing those monoclonal antibodies are provided.
Third, the instant specification is limited to the use of the only two species of KLH conjugates of formula [22] and [28] for production of monoclonal antibodies (see Example 1.19-1.21, pages 77-80; and Example 5, page 86):
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Emphasis added.
Fourth, although methods of making an antibody against an immunogen of the identified chemical structure meet the written description requirement because making antibodies were routine in the art at the time the application was filed, the claims are not drawn to a process of making the product but to the use of the product itself.
Fifth, recent court cases have indicated that recitation of an antibody which has specific functional properties in the absence of knowledge of the antibody sequences that give rise to said functional properties do not satisfy the requirements for written description. See for example AbbVie Deutschland GmbH v. Janssen Biotech. Inc. 759 F.3d 1285 (Fed. Cir. 2014) as well as Amgen v. Sanofi, (Fed Cir, 2017-1480, 10/5/2017). In Amgen, the court indicates that that it is improper to allow patentees to claim antibodies by describing something that is not the invention, i.e., the antigen, as knowledge of the chemical structure of an antigen does not give the required kind of structure-identifying information about the corresponding antibodies, with the antibody-antigen relationship be analogized as a search for a key on a ring with a million keys on it. Office guidance has been updated to reflect that adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional. See the Memorandum dated February 22, 2018 entitled “Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials” available at https://www.uspto.gov/sites/default/files/documents/ amgen22feb2018.pdf. “When a patent claims a genus using 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 invented species sufficient to support a claim to the functionally-defined genus" (Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005)) (emphasis added). “[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” (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69) (emphasis added). It is true that functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date” (AbbVie, 759 F.3d at 1298, reiterating Enzo Biochem, Inc., 323 F.3d at 964) (emphasis added). In the present case, there is insufficient evidence of an established structure-function correlation for an affinity reagent having the function of binding to a compound of Formula I, because, even for the disclosed antibodies, no data regarding any structural characteristics, such as, for example, 6 CDRs sequences, are provided in the application as filed. Therefore, the specification fails to disclose 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.” Ariad, 598 F.3d at 1350.
Sixth, the art is highly unpredictable at least because correlation between structure and function is less likely for antibodies than for other molecules. Antibody structure cannot be easily predicted. Antibody structure is highly variable. The complementary determining regions (CDRs) of antibodies are generally considered to be the region of contact between the antibody and the antigen. See Almagro et al., “Humanization of Antibodies”, Frontiers in Bioscience, 2008, vol. 13, pp. 1619-1633, at Introduction and Section 4. While antibody CDRs are necessary for binding, they are highly diverse in structure, and their sequence does not correlate to binding in a predictable fashion. For example, Goel et al., “Plasticity within the Antigen Combining Site May Manifest as Molecular Mimicry in the Humoral Immune Response”, J. Immunol., 2004, vol. 173, No 12, pp. 7358-7367, made three antibodies that bind to the same 12-mer but have very different CDRs (see Figures 2-3 in particular). See also Edwards et al., "The remarkable flexibility of the human antibody repertoire; isolation of over one thousand different antibodies to a single protein, BLyS," J. Mol. Biol., 2003, vol. 334, pp. 103–118, which shows the immense combinatorial flexibility and capacity of the human antibody repertoire to generate binding sites to an individual protein antigen, the B-lymphocyte growth factor known as “BLyS” (see entire document). Edwards et al. describes in detail how the breadth of antibody structures against a given immunogen can be influenced by the immunization and/or selection methods (see Discussion Section). Edwards et al. found that a library contained over 1000 antibodies that bound to a single 51 kDa protein, including 1098 unique VH and 705 VL sequences. There were 568 different CDR3 regions, indicating high diversity. Like Edwards et al., Lloyd et al., "Modelling the human immune response: performance of a 10e11 human antibody repertoire against a broad panel of therapeutically relevant antigens," Protein Engineering, Design and Selection, 2009, vol. 22, issue 3, pp. 159–168, shows a repertoire of 1x1011 human antibody variable regions can generate large numbers of unique, biologically active scFvs against a variety of polypeptide targets (see e.g., at page 161-62 bridging paragraph and in Table 1, cited herewith). Lloyd et al. found that on average, about 120 different antibodies in a library can bind to a given antigen. As further illustration of the unpredictability in the art, Brown et al., “Tolerance of single, but not multiple, amino acid replacements in antibody VH CDR 2: a means of minimizing B cell wastage from somatic hypermutation?”, J. Immunol., 1996 vol. 156, No 9, pp. 3285-3291, describes how a one amino acid change in the VH CDR2 of a particular antibody was tolerated whereas, the antibody lost binding upon introduction of two amino changes in the same region (at 3290 and Tables 1 and 2). Vajdos et al., “Comprehensive functional maps of the antigen-binding site of an anti-ErbB2 antibody obtained with shotgun scanning mutagenesis,” J. Mol. Biol., 2002, vol. 320, No 2, pp. 415-428, teach that amino acid sequence and conformation of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin (see especially at 416). Aside from the CDRs, the Fv also contains more highly conserved framework segments which connect the CDRs and are mainly involved in supporting the CDR loop conformations, although in some cases, framework residues also contact antigen. In view of the above, given the highly diverse nature of antibodies, and particularly the highly variable structure of antibodies in their CDR regions which are responsible for antigen binding, one cannot envision the structure of an antibody merely by knowing its binding characteristics. In this case, one cannot visualize or recognize the identities of the members of the genus of antibodies that exhibit the claimed functional properties.
Therefore, Claims 15-18 do not meet the written description provision of 35 U.S.C. §112(a) or 35 U.S.C. §112 (pre-AIA ), first paragraph.
Claim Rejections - 35 USC § 103
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 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.
Claims 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Dakshinamurti et al (Niochem. J. 1986; cited in IDS of 5/21/2024 of 13 pages, cite # 8).
Claim 1 is detected to a method of measurement of analyte in a sample, wherein the method comprises the steps of adding an antibody to the sample wherein the antibody specifically binds to a compound of Formula I. As claimed, the method steps only comprise adding the antibody specific to Formula I to the sample. The recitation “method of scavenging free biotin potentially interfering with measurement of analyte in a sample, said measurement using a method which makes use of (strept)avidin/biotin binding pair”, it is the examiner’s position that this is an intended use language as the method steps only comprise adding the antibody specific to Formula I to the sample. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone.
Dakshinamurti discloses monoclonal antibody the specifically binds to biotin and biotin conjugates (e.g. biotin-bovine serum albumin, biotin-KHL) (abstract). Dakshinamurti discloses that monoclonal antibodies to biotin have been prepared by using biotin linked to keyhole limpet haemocyanine (KLH) as the antigen (Abstract). Dakshinamurti discloses that biotin was activated to NSH to provide N-hydroxysuccinimidobiotin, which is covalently attached to KLH that were used as an antigen for immunization and production of monoclonal antibody to biotin (pages 477-479). Dakshimamurti discloses detection of biotin-BSA, biotin-KLH, biotin and biocytin in a sample by adding monoclonal antibody to the sample (page 478, second para of second col. and page 479, 1st para of 2nd col,).
Dakshinamurti does not expressly teach cross-reactivity of the antibody with the compound of Formula I recited in claim 15.
However, since the antibody of Dakshinamurti have the similar property of binding specifically to biotin, in the absence of evidence to the contrary, it is reasonable to assume that the monoclonal antibody taught by Dakshinamurti may recognize the common epitopes present in the biotin of Formula I. Under MPEP § 2112 a rejection under 35 U.S.C. 102/103 is appropriate when the prior art product or process seems to be identical with the claimed product or process except that the prior art is silent as to an inherent characteristic. The Examiner cannot determine whether or not the monoclonal antibodies of the reference implicitly or inherently possess properties which anticipate or render obvious the claimed antibodies. Further, the Patent and Trademark Office does not have the facilities and resources to provide the factual evidence needed in order to establish that there is a difference, in the first place, between the monoclonal antibodies of the prior art and those instantly disclosed and, that if there is such a difference, that such a difference would have been considered unexpected, i.e. unobvious, by one of ordinary skill in the art. The burden is upon Applicant to present such factual evidence. See e.g. In re Best (195 USPQ 430 (CCPA 1977)) or Ex parte Phillips (28 USPQ2d 1302 (BPAI 1993)).
In regards to claims 16-18, claim 16 is directed to the product (i.e. the antibody) utilized in the process of claim 15, wherein the antibody is obtained by the processes as claimed in claims 16-18. However, the produced antibody that is utilized in the process of claim 15, as described above, have similar property and as described above, in the absence of evidence to the contrary, may recognize the common epitopes present in the biotin of Formula I. Under MPEP 2113, "If the product in a product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (In re Thorpe, 227 USPQ 964 Fed. Cir.1985). Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself." (In re Brown, 173 USPQ 685 (CCPA 1972 ); In re Pilkington, 162 USPQ 145 (CCPA 1969); Buono v. Yankee Maid Dress Corp., 26 USPQ 57 (2d Cir. 1935).
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 15-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 5-7of copending Application No. 19/233,088 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of copending application discloses a monoclonal antibody wherein the monoclonal antibody specifically binding the compound of Formula I
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and the antibody appears to having same specificity to the antibody of claim 15 directed to a compound of Formula I
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. Claims 5-7 of the copending application also teaches measuring an analyte in a sample by contacting the sample with the antibody wherein a (strept)avidin/biotin binding pair is used to bind a biotinylated analyte specific binding agent to (strept)avidin. Thus the method processes as claimed in claims 15-18 are obvious and broadly encompassed by the disclosed claims of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to argument
Applicant's arguments and amendments filed 02/25/2026 have been fully considered and are persuasive to overcome the enablement rejections under 35 USC 112 (a) and the rejection under 35 USC 112 (b) in view of the amendments.
However, Applicant’s arguments have been rendered moot in view of the modified 35 USC 112(a) rejection and a new ground of rejections under 35 USC 103 and obviousness double patenting, as described in this office action necessitated upon a further review of the claims.
However, an Applicant’s argument has been addressed below.
Applicant argued that this application as filed described several different monoclonal antibodies having the desired properties. Applicant argued that it is described that it is not even necessary to obtain a monoclonal antibody since examples 5 and 6 describe that it is possible to obtain polyclonal antisera having the described properties by immunizing animals with the immunogen of the invention. Applicant argued that it is important to note that property of scavenging free biotin is not restricted to monoclonal antibodies.
The above arguments have fully been considered but are not found persuasive because claims 16-18 are directed to monoclonal antibody and claim 15 encompasses genus of polyclonal antibodies and genus of monoclonal antibodies specifically binding to compound of Formula I wherein the genus encompasses specificity to different epitopes on the compound of Formula I. Regarding monoclonal antibody, few of the monoclonal antibodies are disclosed but structurally functional correlation of the monoclonal antibodies (CDR sequence and binding epitopes) have not been disclosed providing representation of genus of antibodies as encompassed by monoclonal antibody. Regarding polyclonal antisera, contrary to Applicant’s assertion of using polyclonal antibody, specification teaches monoclonal antibody and criticality of antibody which specifically binds to free biotin, but not to the conjugated biotin on a biotinylated target molecule wherein such antibody would bind the biotin primarily from its “tail”, i.e. would importantly interact with the valeric acid moiety of biotin. Specification teaches that in line with the above reasoning, a desired antibody of the invention is a monoclonal antibody which specifically binds biotin, wherein the biotin is in dissociated form in aqueous solution (page 4 of the specification). Polyclonal antibody having specificity to only free biotin and only to epitope covering its tail has not been characterized and contrary to that, polyclonal antibody encompasses plurality of antibodies directed against different determinants (epitopes). Moreover, disclosure of one or two polyclonal antibody is not representative of the genus of polyclonal antibodies.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GALINA M YAKOVLEVA whose telephone number is (571)270-3282. The examiner can normally be reached on M-F 8:30 AM-5:00 PM.
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/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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