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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/2/25 has been entered.
Claim Status
The amendments and arguments filed 9/2/25 are acknowledged. Claims 1-27 and 31-32 are cancelled. Claims 28 and 33-34 are amended. Claims 28-30 and 33-34 are pending.
Claims 28-30 and 33-34 are currently under consideration for patentability under 37 CFR 1.104.
Claim Rejections Withdrawn
The rejection of claims 31-32 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 due to incorporation of new matter, is rendered moot by cancellation of the claims.
The rejection of claims 31 and 32 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 is rendered moot by cancellation of the claims.
The rejection of claim(s) 28-30 and 33-34 under 35 U.S.C. 103 as being unpatentable over Bergmann et al (WO 2014/053501 A1; filed 10/1/13; published 4/10/14) in view of Chan et al (European Journal of Heart Failure, 16 (Suppl. 2), page 342, Abstract P1711; Poster presented Tues. May 20, 2014), and as evidenced by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) fact sheet “How well are your kidneys working”, last revised February 2012; downloaded from https://www.niddk.nih.gov/health-information/professionals/advanced-search/explain-kidney-test-results on 6/12/23) is withdrawn in light of Applicant’s amendments and arguments thereto. The rejection of claims 31-32 is rendered moot by cancellation of the claims.
The rejection of claim(s) 28-30 and 33-34 on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 9,664,695 (hereinafter “Bergmann”) in view of Chan et al (European Journal of Heart Failure, 16 (Suppl. 2), page 342, Abstract P1711; Poster presented Tues. May 20, 2014) and as evidenced by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) fact sheet “How well are your kidneys working”, last revised February 2012; downloaded from https://www.niddk.nih.gov/health-information/professionals/advanced-search/explain-kidney-test-results on 6/12/23) is withdrawn in light of Applicant’s amendments and arguments thereto. The rejection of claims 31-32 is rendered moot by cancellation of the claims.
The rejection of claim(s) 28-30 and 33-34 on the ground of nonstatutory double patenting as being unpatentable over claims 1-49 of U.S. Patent No. 10,114,029 in view of Chan et al (European Journal of Heart Failure, 16 (Suppl. 2), page 342, Abstract P1711; Poster presented Tues. May 20, 2014) and as evidenced by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) fact sheet “How well are your kidneys working”, last revised February 2012; downloaded from https://www.niddk.nih.gov/health-information/professionals/advanced-search/explain-kidney-test-results on 6/12/23) is withdrawn in light of Applicant’s amendments and arguments thereto. The rejection of claims 31-32 is rendered moot by cancellation of the claims.
The rejection of claim(s) 28-30 and 33-34 on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,016,107 and as evidenced by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) fact sheet “How well are your kidneys working”, last revised February 2012; downloaded from https://www.niddk.nih.gov/health-information/professionals/advanced-search/explain-kidney-test-results on 6/12/23) is withdrawn in light of Applicant’s amendments and arguments thereto. The rejection of claims 31-32 is rendered moot by cancellation of the claims.
The provisional rejection of claims 28-30 and 33-34 on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 17/635,265 (reference application) and as evidenced by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) fact sheet “How well are your kidneys working”, last revised February 2012; downloaded from https://www.niddk.nih.gov/health-information/professionals/advanced-search/explain-kidney-test-results on 6/12/23) is withdrawn in light of Applicant’s amendments and arguments thereto. The rejection of claims 31-32 is rendered moot by cancellation of the claims.
The provisional rejection of claim(s) 28-30 and 33-34 on the ground of nonstatutory double patenting as being unpatentable over claims 20, 23-24, 26-28, 32-36, 38-101 of copending Application No. 17/328,100 (reference application) and as evidenced by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) fact sheet “How well are your kidneys working”, last revised February 2012; downloaded from https://www.niddk.nih.gov/health-information/professionals/advanced-search/explain-kidney-test-results on 6/12/23) is withdrawn in light of Applicant’s amendments and arguments thereto. The rejection of claims 31-32 is rendered moot by cancellation of the claims.
Rejections withdrawn in favor of newly amended rejections below
The rejection of claims 28-29 and 33-34 on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 9,664,695 (hereinafter “Bergmann”) and as evidenced by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) fact sheet “How well are your kidneys working”, last revised February 2012; downloaded from https://www.niddk.nih.gov/health-information/professionals/advanced-search/explain-kidney-test-results on 6/12/23) is withdrawn in favor of the newly amended rejection below. The rejection of claims 31-32 is rendered moot by cancellation of the claims.
The rejection of claims 28-29 and 33-34 on the ground of nonstatutory double patenting as being unpatentable over claims 1-49 of U.S. Patent No. 10,114,029 and as evidenced by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) fact sheet “How well are your kidneys working”, last revised February 2012; downloaded from https://www.niddk.nih.gov/health-information/professionals/advanced-search/explain-kidney-test-results on 6/12/23) is withdrawn in favor of the newly amended rejection below.
Claim Rejections Maintained
Claim Rejections - 35 USC § 112(a)
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
The rejection of claim 33 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 is maintained. The rejection of claims 28-29 and 34 is withdrawn in light of Applicant’s amendments thereto to recite a product-by-process. The rejection of claims 31-32 is rendered moot by cancellation of the claims. The rejection has been updated to reflect current claim amendments. 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 MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention.”
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, 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 Applicants were in possession of the claimed genus.
The instant claims are directed to a point of care device comprising an antibody that binds to Pro-Enkephalin or fragments thereof, which comprise SEQ ID NO:1-2, 5-6, 8-11. The specification does not specifically identify any antibodies that can bind any of the named fragments, and only defines said antibodies according to their binding and specificity functions.
There are a large number of possible antibodies encompassed by the claims. These antibodies have no correlation between their structure and function, and the specification provides no guidance regarding which antibodies are capable of the required function. Therefore, the specification provides insufficient written description to support the genus encompassed by the claim. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear 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 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.)
The skilled artisan cannot envision the detailed chemical structure of the encompassed polypeptides, 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 for isolating it. The nucleic acid and/or protein itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2datl966.
Regarding the encompassed antibodies and fragments thereof, the functional characteristics of antibodies (including binding specificity and affinity are dictated on their structure. 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. For example, Vajdos et al. (J Mol Biol. 2002 Jul 5;320(2):415-28 at 416) teaches that, “ … Even within the Fv, antigen binding is primarily mediated by the complementarity determining regions (CDRs), six hypervariable loops (three each in the heavy and light chains) which together present a large contiguous surface for potential antigen binding. 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. As an important step to understanding how a particular antibody functions, it would be very useful to assess the contributions of each CDR side-chain to antigen binding, and in so doing, to produce a functional map of the antigen-binding site." The art shows an unpredictable effect when making single versus multiple changes to any given CDR. For example, Brown et al. (J Immunol. 1996 May;156(9):3285-91 at 3290 and Tables 1 and 2), describes how the VH CDR2 of a particular antibody was generally tolerant of single amino acid changes, however the antibody lost binding upon introduction of two amino changes in the same region.
The claims encompass an extremely large genus of antibodies or antigen binding fragments thereof that have required functions. Recently, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) decided Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), which concerned adequate written description for claims drawn to antibodies. 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 even when preparation of such an antibody would be routine and conventional. Amgen, 872 F.3d at 1378-79. A key role played by the written description requirement is to prevent “attempt[s] to preempt the future before it has arrived.” Ariad at 1353, (quoting Fiers v. Revel, 984 F.2d at 1171). Upholding a patent drawn to a genus of antibodies that includes members not previously characterized or described could negatively impact the future development of species within the claimed genus of antibodies. In the instant application, neither the art nor the specification provide a sufficient representative number of antibodies or a sufficient structure-function correlation to meet the written description requirements.
The prior art recognizes that the antigen binding by antibodies requires precise orientation of the complementarity determining region (CDR) loops in the variable domain to establish the correct contact surface. For example, Vattekatte, (PeerJ. 2020 Mar 6:8:e8408. doi: 10.7717/peerj.8408. eCollection 2020.) teach that antigen binding in heavy chain only antibodies, (HCAbs) is mediated by only three CDR loops from the single variable domain (VHH) at the N-terminus of each heavy chain, (see abstract). The Vattekatte et al further teach that the amino acid length distribution in different regions of VHH (see Fig. S7) shows diversity in CDR lengths, and that most diversity in CDR3, (see page 7 and 19). However, the prior art also recognizes that a single protein can be bound by a very large and structurally diverse genus of antibodies (i.e., there is no common structural relationship even for antibodies that bind to the same protein, epitope, or overlapping epitopes). For example, Edwards et al. (Mol Biol. 2003 Nov 14;334(1):103-18) teach that over 1,000 different antibodies to a single protein can be generated, all with different sequences, and representative of almost the entire extensive heavy and light chain germline repertoire (42/49 functional heavy chain germlines and 33 of 70 V-lambda and V-kappa light chain germlines), and with extensive diversity in the HCDR3 region sequences (that are generated by VDJ germline segment recombination) as well (see table 2, figure 2).
Lloyd et al. (Protein Eng Des Sel. 2009 Mar;22(3):159-68. Epub 2008 Oct 29.) teach that a large majority of VH/VL germline gene segments are used in the antibody response to an antigen, even when the antibodies were selected by antigen binding, (abstract). The Lloyd et al reference further teaches that in their studies, of the 841 unselected and 5,044 selected antibodies sequenced, all but one of the 49 functional VH gene segments was observed, and that there are on average about 120 different antibodies generated per antigen (page 167, column 1). Said reference also teaches that a wide variety of VH and VL pairings further increase diversity. (page 159, column 2).
Goel et al. (J Immunol. 2004 Dec 15;173(12):7358-67) teach that three mAbs that bind to the same short (12-mer) peptide, exhibit diverse V gene usage, indicating their independent germline origin. Said reference further teaches that two of these mAbs recognize the same set of amino acid residues defining the epitope (alternate amino acid residues spread over the entire sequence), however, the relative contribution of each set of residues in the peptide showed significant variation. The reference notes that all of the mAbs do not show any kind of V gene restriction among themselves, implying variable paratope structure, despite that two of these mAbs bind to the peptide through a common set of residues. (See entire reference).
Khan et al. (J Immunol (2014) 192 (11): 5398–5405) teach that two structurally diverse germline mAbs recognizing overlapping epitopes of the same short peptide do so in different topologies, the antibodies possessing entirely different CDR sequences. Said reference teaches that unrelated mAbs structurally adjust to recognize an antigen, indicating that the primary B cell response is composed of BCRs having a high degree of structural adaptability. Said reference also teaches that the common epitope(s) also adopt distinct conformations when bound to different mAbs, with the higher degree of structural plasticity inherent to the mAbs. Said reference further teaches “It has been shown that both the framework region and the CDRs have a considerable amount of inherent conformational plasticity...Therefore, it is not surprising that distinct germline Abs recognize the same epitope by rearranging the CDR conformations. This may well have implications of Ag specificity beyond the naive BCR repertoire, because Kaji et al... .have shown in a recent report that the B cell memory can contain both germline-encoded and somatically mutated BCRs.” (See entire reference).
Poosarla et al. (Biotechnol Bioeng. 2017 June ; 114(6): 1331–1342) teach substantial diversity in designed mAbs (sharing less than 75% sequence similarity to all existing natural antibody sequences) that bind to the same 12-mer peptide, binding to different epitopes on the same peptide. Said reference further teaches “most B-cell epitopes... in nature consist of residues from different regions of the sequence and are discontinuous...de novo antibody designs against discontinuous epitopes present additional challenges...". (See entire reference.)
Rabia, et al. (Biochem Eng J. 2018 Sep 15:137:365-374. Epub 2018 Jun 5) teach what effects mutations can have on an antibody's stability, solubility, binding affinity and binding specificity. Rabia et al. report that an increase in antibody affinity can be associated with a decrease in stability (p. 366, col. 2 last paragraph; Fig. 2). Rabia et al. thus teach that affinity and specificity are not necessarily correlated and that an increase in affinity does not indicate an increase in specificity (Fig. 3; p. 368, col. 1, section 3,1st full paragraph to col. 2, 2nd full paragraph).
Therefore, neither the art nor the specification provide a sufficient representative number of antibodies or a sufficient structure-function correlation to meet the written description requirements.
Applicant is reminded that generally, 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 (Enzo Biochem, Inc. v. Gen- Probe Inc., 323 F.3d 956 (Fed. Cir. 2002); Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004); Regents of the University of California v. Eli Lilly Co., 119 F.3d 1559 (Fed. Cir. 1997)). 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 Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017) at page 1358). An adequate written description must contain enough information about the actual makeup of the claimed products — “a precise definition, such as structure, formula, chemical 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” (Amgen page 1361).
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow person of ordinary skill in the art to recognize that he or she invented what is claimed’”. The courts have decided: 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).
Furthermore, the written description provision of 35 USC §112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993). And Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Moreover, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has the Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Therefore for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that Applicant had possession of the claimed invention at the time the instant application was filed.
Applicant’s Arguments
Applicant argues:
1. The claims now recite a product-by-process method, and the specification sets forth WO 2014/053501 as describing the hybridoma method, therefore the claimed invention is described.
Applicant’s arguments have been fully considered and are not persuasive for the following reasons:
While claims 29, 30, and 34 have been amended to recite a product by process composition, the rejected claim 33 still recites “wherein said antibody has an amino acid sequence which is identical to an antibody produced by a process comprising…” Therefore the claim does not recite a product by process, and the antibody is therefore not adequately described.
Claim Rejections - 35 USC § 112(b)
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.
The rejection of claim 33 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 is maintained. The rejection of claims 28, 29, and 34 is withdrawn in light of Applicant’s amendments thereto. The rejection of claims 31-32 is rendered moot by cancellation of the claims.
Claims 33 recites “wherein said antibody has an amino acid sequence which is identical to an antibody produced by a process…” However the sequence of the antibodies produced by the process are not identified in the specification, therefore it is impossible to know which antibodies are encompassed by the claim. The scope of the encompassed antibodies is therefore indefinite.
Applicant’s Arguments
Applicant argues:
1. The claims now recite a product-by-process method, and the specification sets forth WO 2014/053501 as describing the hybridoma method, therefore the claimed invention is described.
Applicant’s arguments have been fully considered and are not persuasive for the following reasons:
While claims 29, 30, and 34 have been amended to recite a product by process composition, the rejected claim 33 still recites “wherein said antibody has an amino acid sequence which is identical to an antibody produced by a process comprising…” Therefore the claim does not recite a product by process, and the antibody is therefore not adequately described.
New Claim Rejections
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 33 and 34 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Bergmann et al (WO 2014/053501 A1; filed 10/1/13; published 4/10/14).
The instant claims are drawn to a point of care device adapted for measuring the level of Pro-enkephalin of SEQ sample SEQ ID NO:1, 2, 5-6, or 8-11 in a sample of a body fluid. The antibody has an amino acid sequence that is identical to an antibody produced by a process of creating a hybridoma with an antibody expressing an antibody that binds to the same sequences of pro-enkephalin. The claims are further drawn to a kit comprising the point of care device, wherein the antibody binds SEQ ID NO:13 and/or SEQ ID NO:14.
Regarding the limitation of claims 33-34, Bergmann teaches an assay for determining pro-enkephalin or fragments thereof (see e.g. page 18, third paragraph). Bergmann specifically teach the use of an assay to diagnose or monitor kidney function in a subject, or predicting or monitoring risk of adverse events in a diseased subject, comprising determining the level of pro-enkephalin or fragments thereof in a bodily fluid obtained from the subject, and correlating the measurement with kidney dysfunction above a certain threshold that is predictive or diagnostic for kidney dysfunction (see e.g. page 39, claim 1). The level of pro-enkephalin or fragments thereof is determined by using a binder to the pro-enkephalin or fragments (see e.g. claim 2). Applying the binder to the sample would generate the sample of the instant claims. The assay can be used for samples from healthy or diseased subjects (see e.g. page 2, second paragraph). The diseased individual includes individuals that do not have chronic kidney failure, such as those with acute kidney failure or other diseases such as sepsis, stroke, etc. (see e.g. page 6, first and third paragraph). The binder can bind sequences selected from reference SEQ ID NO:1-10, which have identical sequences to instant SEQ ID NO:1-11 (see e.g. page 9, last paragraph, through page 10, last paragraph).
Regarding the limitations of instant claim 33, the level of Proenkephalin can be determined by using a binder to Proenkephalin (see e.g. claim 2-3), in a point of care device (see e.g. page 17, fourth paragraph, page 20, fifth paragraph, and page 21, second paragraph). wherein the binder can be an antibody, antibody fragment, or non-Ig-Scaffold (see e.g. claim 3). The binder can be a binder that is directed to pro-enkephalin amino acid 133-140 (LELLETG, SEQ ID NO. 13) and amino acid 152-159 (SDNEEEVS, SEQ ID No. 14) wherein each of said regions comprises at least 4 or 5 amino acids. (see e.g. page 21, second and third paragraphs). The binder can bind to a region that can be SEQ ID NO:6, which is MR-PENK, which identical to instant SEQ ID NO:6 (see e.g. claim 6). The antibodies can be produced by immunizing a mouse with a conjugate comprising the pro-enkephalin peptide, then the immunized mouse cells can be fused to a myeloma cell line (see e.g. Example 1, pages 22-23). The cells are then cultured, then the cell culture supernatants can be tested for antigen specific IgG antibodies. The antibody-producing clones then can be selected and recloned to produce monoclonal antibodies (see e.g. Example 1, pages 22-23). Applicant is advised that the measuring the level of pro-enkephalin is interpreted as an intended use of the point of care device. Because the product of Bergmann is structurally identical to the instant claimed invention, Bergmann’s point of care device would be capable of performing the intended use recited in the claim. See MPEP 2111.02.
Regarding the limitations of instant claim 34, the point of care device can be present in a kit (see e.g. page 21, first, fourth, and fifth paragraphs).
Applicant’s Arguments
Applicant argues:
1. The claims as amended are not obvious over Bergmann. Applicant specifically argues the threshold of pro-enkephalin that must be present.
Applicant’s arguments have been fully considered and are not persuasive for the following reasons:
1. The obviousness rejection has been withdrawn, and a new anticipation rejection is provided that is directed to only claims 33 and 34. The Office Action is non-final to allow Applicant an opportunity to address the new grounds of rejection.
Double Patenting
Statutory
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 33 and 34 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 14 and 15 of prior U.S. Patent No. 9,664,695. This is a statutory double patenting rejection.
The instant claims are drawn to a point of care device adapted for measuring the level of Pro-enkephalin of SEQ sample SEQ ID NO:1, 2, 5-6, or 8-11 in a sample of a body fluid. The antibody has an amino acid sequence that is identical to an antibody produced by a process of creating a hybridoma with an antibody expressing an antibody that binds to the same sequences of pro-enkephalin. The claims are further drawn to a kit comprising the point of care device, wherein the antibody binds SEQ ID NO:13 and/or SEQ ID NO:14.
Regarding the limitation of claims 33-34, the reference patent teaches a point of care device comprising an antibody that binds to SEQ ID NO:13 or 14 (see e.g. reference claims 14 and 15, which have identical sequences to instant SEQ ID NO:13 and 14. Regarding the limitations of adaptation for use in a method, these are limitations that are an intended use for the point of care device. A prior art structure which is capable of performing the intended use meets the claim limitations. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); MPEP 2111.02(II) and MPEP 2144.07.
Non-Statutory
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
The rejection of claims 33-34 on the ground of nonstatutory double patenting as being unpatentable over claims 27-28 of U.S. Patent No. 9,664,695 (hereinafter “Bergmann”) is maintained. Although the claims at issue are not identical, they are not patentably distinct from each other. The rejection of claims 28-29 is withdrawn in light of Applicant’s amendments and arguments thereto.
The instant claims are drawn to a point of care device adapted for measuring the level of Pro-enkephalin of SEQ sample SEQ ID NO:1, 2, 5-6, or 8-11 in a sample of a body fluid. The antibody has an amino acid sequence that is identical to an antibody produced by a process of creating a hybridoma with an antibody expressing an antibody that binds to the same sequences of pro-enkephalin. The claims are further drawn to a kit comprising the point of care device, wherein the antibody binds SEQ ID NO:13 and/or SEQ ID NO:14.
Regarding the limitation of claims 33-34, the reference patent claims 27 and 28 teaches a point of care device and kit comprising the point of care device comprising an antibody that binds to SEQ ID NO:13 or 14 (see e.g. reference claims 27 or 28), which have identical sequences to instant SEQ ID NO:13 and 14. Regarding the instant limitations of adaptation for use in a method, these are limitations that are an intended use for the point of care device. A prior art structure which is capable of performing the intended use meets the claim limitations. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); MPEP 2111.02(II) and MPEP 2144.07.
The reference claims differ in scope from the instant claims by requiring that the antibody does not bind to enkephalin peptides of SEQ ID NO:3 (see e.g. reference claim 27-28), which is not required by the instant claims. Therefore, the reference claims 27-28 are species encompassed by the genus of the instant claims.
The rejection of claims 33-34 on the ground of nonstatutory double patenting as being unpatentable over claims 25-26 and 39-40 of U.S. Patent No. 10,114,029 is maintained. Although the claims at issue are not identical, they are not patentably distinct from each other The rejection of claims 28-29 is withdrawn in light of Applicant’s amendments and arguments thereto.
The instant claims are drawn to a point of care device adapted for measuring the level of Pro-enkephalin of SEQ sample SEQ ID NO:1, 2, 5-6, or 8-11 in a sample of a body fluid. The antibody has an amino acid sequence that is identical to an antibody produced by a process of creating a hybridoma with an antibody expressing an antibody that binds to the same sequences of pro-enkephalin. The claims are further drawn to a kit comprising the point of care device, wherein the antibody binds SEQ ID NO:13 and/or SEQ ID NO:14.
Regarding the limitation of claims 33-34, the reference patent claims 25-26 and 39-40 teaches a point of care device and kit comprising the point of care device comprising an antibody that can be used in a method for diagnosing or monitoring kidney dysfunction or adverse events by determining Pro-enkephalin levels in a body fluid, wherein the Pro-enkephalin has SEQ ID NO:1, 2, 5-6, or 8-11 (see e.g. reference claims 25-26 and 39-40), which have identical sequences to SEQ ID NO: of the instant claims. Regarding the instant limitations of adaptation for use in a method, these are limitations that are an intended use for the point of care device. A prior art structure which is capable of performing the intended use meets the claim limitations. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); MPEP 2111.02(II) and MPEP 2144.07.
The reference claims differ in scope from the instant claims by requiring that the antibody does not bind to enkephalin peptides of SEQ ID NO:3 (see e.g. reference claim 27-28), which is not required by the instant claims. Therefore, the reference claims 27-28 are species encompassed by the genus of the instant claims.
Applicant’s Arguments
Applicant argues:
1. The claims as amended are not obvious over the copending applications. Applicant specifically argues the threshold of pro-enkephalin that must be present.
Applicant’s arguments have been fully considered and are not persuasive for the following reasons:
1. The rejections have been amended to reflect the new grounds of rejection that have been applied to the newly amended claims, and a new statutory double patenting rejection is presented for only claims 33 and 34. The Office Action is non-final to allow Applicant an opportunity to address the new grounds of rejection.
Conclusion
Claims 28-30 are allowed.
Claims 33-34 are not allowed.
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/ANDREA K MCCOLLUM/Examiner, Art Unit 1674