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 .
Status of Application
The instant application was appealed to the Patent Trial and Appeal Board and a decision was rendered and mailed on 15 May 2026. A summary of the decision is provided below (reproduced from the decision at page 15).
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Response to Amendment
In response to the Decision by the Board, including the new ground of rejection which was added by the Board, Applicant has filed an amendment and response (12 June 2026).
Claims 15 and 43-44 have been amended and claims 1-14, 16-27, 29-36, 38-42 and 45 have been canceled. Claims 15, 28, 37 and 43-44 are currently pending and under consideration in the instant Office action.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any objection or rejection of record which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
Applicant’s arguments filed 12 June 2026 have been fully considered but are not found to be persuasive.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO’s electronic filing system (see Section I.1 of the Legal Framework for EFS-Web or Patent Center (https://www.uspto.gov/patents-application- process/filing-online/legal-framework-efs-web), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via EFS-Web or Patent Center as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via EFS-Web or Patent Center as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is defective. See item 1) a) or 1) b) above.
The file name in the incorporation statement in the substitute specification filed 29 July 2024 does not match the file name for the Sequence Listing which was submitted according to the filing receipt of 01 February 2021. Note the leading “5” and the underscore in the file name.
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Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
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.
Claim 15 and dependent claims 28, 37 and 43-44 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. This is a new matter rejection.
Claim 15 has been amended to include the following process limitations:
“immunizing a mammal with an antigen selected from ADM-NH₂ according to SEQ ID No: 4 or a fragment of mature ADM-NH₂ according to SEQ ID Nos: 21-23,
fusing splenocytes obtained from the immunized mammal with myeloma or hybridoma cells
culturing the resulting cells,
screening for cells expressing antibodies binding specifically to the antigen, propagating cells expressing said antibody and
isolating the antibody from the propagated cells”.
The instant specification does not provide support for the limitation “fusing splenocytes obtained from the immunized mammal with myeloma or hybridoma cells”. The new matter issue is that the specification does not contemplate fusing splenocytes from an immunized mammal with hybridoma cells as currently claimed. The specification (see version of specification filed 29 July 2024 for proper page reference) at page 37 and 51 discusses immunizing a mouse and then recites “Splenocytes from the immunized mouse and cells of the myeloma cell line SP2/0 were fused…”. At no point does the specification contemplate fusing splenocytes from an immunized mouse with hybridoma cells.
The specification discloses methodology for generating a human antibody which includes immortalization which “can be accomplished, for example, by EBV infection or by fusing a human B cell with a myeloma or hybridoma cell to produce a trioma cell” (see page 32 of the specification, lines 24-26). However, this disclosure does not support the current claim limitation with regard to fusing splenocytes with hybridoma cells. Therefore, this is new matter. Claims 28, 37 and 43-44 depend from claim 15 and therefore, also include the new matter via dependency.
Claim 15 has also been amended to include a recitation of propagating cells expressing said antibody and isolating the antibody from the propagated cells. These limitations are also considered new matter because such process steps are not found in the instant specification as originally filed. While Example 1 of the specification mentions propagating microcultures, this was only done after the microcultures were tested and were positive for antigen specific IgG antibodies 3 weeks after fusion. Therefore, these limitations are also new matter. Claims 28, 37 and 43-44 depend from claim 15 and therefore, also include the new matter via dependency.
Claims 15, 28, 37 and 43-44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn a sample which comprises bodily fluid of a subject and an antibody to mature ADM-NH2 “or an antibody to fragments of mature ADM-NH2 according to SEQ ID Nos: 21-23” and wherein the amount of mature ADM-NH2 or fragment is below 10 pg/ml. Claim 37 recites that the level in the sample is below 5 pg/ml. Claim 43 requires that the antibody have a binding affinity of at least 107M-1 and claim 44 requires that the binding affinity be determined by label-free surface plasmon resonance.
In order for one to determine that the amount of ADM-NH2 (or fragment) in the sample of the claim is below 10 pg/ml (or 5 pg/ml), the antibody must have sufficient specificity for the measurement at this low concentration (see specification at page 62). The only antibody which is disclosed in the instant specification which provides for this specificity is one that comprises the following CDRs:
heavy chain CDRs:
SEQ ID NO: 7 GYTFSRYW,
SEQ ID NO: 8 ILPGSGST,
SEQ ID NO: 9 TEGYEYDGFDY;
and light chain CDRs:
SEQ ID NO: 10 QSIVYSNGNTY,
SEQ ID NO: 11 RVS,
SEQ ID NO: 12 FQGSHIPYT.
Claim 15 does not provide any structure for the recited antibody in the claimed sample but recites a process for producing an antibody. Claim 43 requires that the antibody have a binding affinity of at least 107M-1 and claim 44 requires that the binding affinity be determined by label-free surface plasmon resonance.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, states 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, for purposes of the written description inquiry, is whatever is now claimed (see page 1117). A review of the language of the claims indicates that these claims are drawn compounds only defined by function or by processed of potentially obtaining undefined compounds.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing characteristics of the genus. The factors to be considered include 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.
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 of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B(1), the court states, “An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention.”
The only antibody disclosed in the specification is a monoclonal antibody defined by 6 CDRs (beginning at page 38 of the specification). The specification discloses the reduction to practice of antibodies which comprise the following CDRs:
heavy chain CDRs:
SEQ ID NO: 7 GYTFSRYW,
SEQ ID NO: 8 ILPGSGST,
SEQ ID NO: 9 TEGYEYDGFDY;
and light chain CDRs:
SEQ ID NO: 10 QSIVYSNGNTY,
SEQ ID NO: 11 RVS,
SEQ ID NO: 12 FQGSHIPYT.
The disclosed antibody comprises a heavy chain selected from the group consisting of SEQ ID NOs:13-17 and a light chain selected from the group consisting of SEQ ID NOs:19-20. However, the claims encompass any antibody with no recitation of structure which bind to mature ADM-NH2 of SEQ ID NO:4 or to SEQ ID NO:21-23. The specification fails to teach any other antibody other than the above identified monoclonal antibody.
Given the level of skill and knowledge and predictability in the art, those of skill in the art would not conclude that the applicant was in possession of the claimed genera of binders based on disclosures set forth above. The specification and the claims do not provide any guidance on the structure of the antibodies that must be present for binding AMD-NH2 (or fragments) or would permit the determination of an amount of mature adrenomedullin below 10 pg/ml.
"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).
For inventions 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. See, e.g., Eli Lilly.
Further, it is not sufficient to define the genus solely by its principal biological property, because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property. Per the Enzo court's example, (Enzo Biochem, Inc. v. Gen-Probe Inc., 63 USPQ2d 1609 (CA FC 2002) at 1616) of a description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) couched "in terms of its function of lessening inflammation of tissues" which, the court stated, "fails to distinguish any steroid from others having the same activity or function" and the expression "an antibiotic penicillin" fails to distinguish a particular penicillin molecule from others possessing the same activity and which therefore, fails to satisfy the written description requirement. Similarly, the function of the variant as claimed does not distinguish a particular variant from others having the same activity or function and as such, fails to satisfy the written-description requirement. Applicant has not disclosed any relevant, identifying characteristics, such as structure or other physical and/or chemical properties, sufficient to show possession of the claimed genus. Mere idea or function is insufficient for written description; isolation and characterization at a minimum are required. A description of what a material does, rather than what it is, usually does not suffice. (Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406).
In the absence of sufficient recitation of distinguishing characteristics, the specification does not provide adequate written description of the claimed genus of antibodies which is recited in the claims. Further, the specification does not provide an adequate written description of antibodies which could be produced from the recited methodology in claim 15 or with the recited binding affinity of claims 43-44. One of skill in the art would not recognize from the disclosure that the applicant was in possession of the claimed genus. 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).
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Response to Arguments
Applicant argues at page 4 of the response that the claims are now directed to an antibody produced by a product by process exemplified in the specification in Example 1 and “request reconsideration of the Board’s affirmance of the written description rejection to claim 10 (now a part of claim 15)”.
Applicant’s argument has been fully considered, but is not found persuasive. The Board clearly stated “the Specification does not describe sufficient representative species encompassing the breadth of the genus” (see decision, mailed 14 May 2026, at page 8).
Applicant asserts at page 5 of the response that “the product by process step meaningfully limit the scope of the antibody claimed and should be considered when assessing written description of the claim as a whole”. The limitation has been considered however it has not been found to provide an adequate written description for the claimed subject matter for the reasons provided above.
Applicant argues at page 5 various case law relied upon by the Board. Applicant also urges that the antibodies of the claims are defined by a product by process and asserts that the Appeal Decision “demand” that antibody product claims be supported by structural disclosure in the specification is “antithetical to over 100 years of caselaw concerning product by process claims which none of the cited caselaw from the Appeal Decision overrule or are relevant too [sic]”.
Applicant’s argument has been fully considered, but is not found persuasive. The element in the claims that Applicant is relying upon for the “product by process” limitation does not result in a singular product, but rather, a genus of compounds which then need to be screened and evaluated for function. This is not the same thing as producing a “product”. The process which is recited in the claims will not result in a singular product, nor will it necessarily result in a product with the binding specificities recited in claims 43 and 44.
Product-by-process claims are not limited to the manipulations of the recited steps, “only the structure implied by the steps” (see MPEP 2113). However, the manipulations of the recited steps to not imply any structure beyond that of an antibody which is not enough structure to perform the task of binding mature ADM-NH2 of SEQ ID NO:4 or SEQ ID NO: 21-23 nor are the process steps sufficient to produce the antibody of the claim as the processes result in a host of molecules which then must be screened for their ability to bind the specified target as well as be tested for their binding affinity.
Applicant asserts “In this case, the claim tells one skilled in the art to perform the claimed process and whatever antibody product results from that process, use it in the claimed sample.” Applicant’s argument has been fully considered, but is not found persuasive. The claimed process does not produce a “product” but rather a genus of molecules, which may or may not result in an antibody which binds mature ADM-NH2 of SEQ ID NO:4 or SEQ ID NO: 21-23 or which has the specificity required to detect the protein target below the required threshold level of 10 pg/ml.
Applicant asserts at page 6 of the response that product-by-process claims were created as an alternative to structural claiming and that a position that a written description of such subject matter requires the claimed subject matter to have a structural definition is not consistent with the foundational purpose of product-by-process claiming.
Applicant’s argument has been fully considered, but is not found persuasive. The issue is that that process limitations that are recited in the instant claim do not result in a specific product. Rather, the process results in a host of molecules which then need to be screened to identify the actual product; the process results in a genus of molecules which then require additional screening to identify those products which meet the limitations of the claims (binding and affinity).
Applicant argues that MPEP § 2163(II)(A)(3)(a)(i) addresses this situation and states that applicants have satisfied written description (see response at bottom of page 6).
Applicant’s argument has been fully considered, but is not found persuasive. MPEP § 2163(II)(A)(3)(a)(i) is directed to “claim drawn to a single embodiment or species”. The instant claims encompass a genus of antibodiess. Furthermore, the methods which are recited do not result in the specified antibody as the processes result in a host of antibodies which then must be screened for their ability to bind the specified target as well as be tested for their binding affinity. Therefore, the recitation of the process in the instant claim does not actually appear to produce a specific species/product but rather a genus of compounds which then would require further screening and selection to arrive at a potential compound which could be used in the claimed sample. The MPEP at the section cited by Applicant goes on to state that “the requirement may not be satisfied where it is not clear that the acts set forth in the specification can be performed, or that the product is produced by that process”.
Applicant again refers to case law regarding product-by-process claims at the top of page 7 of the response. Applicant’s argument is again not persuasive because the recited process of claim 15 does not produce a “product”, but rather it produces a genus of molecules which must be further screened to identify a product and therefore, it lacks written description.
Applicant asserts in the middle of page 7 of the response that MPEP § 2163(II)(A)(3)(a)(i) states "Where the process has actually been used to produce the product, the written description requirement for a product-by-process claim is clearly satisfied…". Applicant’s argument has been fully considered, but is not found persuasive. A review of Example 1 (page 51 of the specification) reveals that the limitations in claim 15 are not the only steps in the process for generating an antibody as the method clearly requires screening for antigen specific IgG antibodies as well as testing and cloning and recloning.
Applicant argues at page 8 of the response that the rejection should be withdrawn in light of the decision in GMBH v. Eli Lilly and Company, No. 2024-1094 (Fed. Cir. 16 April 2026). Applicant asserts that the context of the current case is the same and that the claims are not directed to the antibodies themselves, “the antibodies are simply binding agents to mature ADM-NH2 or fragments there of [sic] as defined in the claim in the preparation of a sample”.
Applicant’s arguments have been fully considered and are not found persuasive. The instant claims are directed to a “sample” which is a composition of matter that comprises two components; one is an antibody that binds to mature ADM-NH2 or fragments thereof and the other is a bodily fluid of a subject which has an amount of adrenomedullin which is below a stated concentration. Therefore, the claims are clearly directed to a composition of matter comprising two components, one of which is an antibody so the claims are most definitely directed to a combination which includes the antibody.
Applicant asserts that the product by process includes a step of screening and therefore a skilled artisan would understand that all antibodies that result from the claimed product by process bind to the antigen. Applicant’s argument has been fully considered, but is not found persuasive. The process of making the antibody (immunizing a mammal with the target protein) makes a host of antibodies. The screening step is not part of the process of making the antibody but rather it is a step that identifies which of the antibodies that are made will work.
Applicant’s attempt to compare the instant application to the fact pattern of Teva is noted but is unpersuasive. In Teva, the claims were directed to methods of treatment and the instant claims are directed to compositions of matter. Applicant appears to be attempting to claim any composition of matter which can be made by combining a bodily fluid with any antibody to adrenomedullin wherein the bodily fluid has an amount of adrenomedullin that is below a stated concentration. Applicant has not provided an adequate written description of this subject matter.
Claims 15, 28, 37 and 43-44 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The instant claims are directed to a sample which comprises bodily fluid of a subject and an antibody to mature ADM-NH2 “or an antibody to fragments of mature ADM-NH2 according to SEQ ID Nos: 21-23” and wherein the amount of mature ADM-NH2 or fragment is below 10 pg/ml. In order to make the claimed “sample”, one must be able to quantitate the amount of mature ADM-NH2 or fragment below 10 pg/ml. The instant specification discloses at page 61 that the bio-ADM assay which was used to measure mature ADM-NH2 was the assay from Weber et al. (2017, JALM, 2(2): 222-233). Therefore, the “sample” of the claims includes the antibody from Weber et al. (which is the same antibody of the instant application with the CDR structures disclosed at page 41 of the specification). The instant specification states that the assay sensitivity (limit of detection) was 3 pg/ml. However, the limit of detection does not provide for quantitating the amount of protein to the detection limit. Weber et al. states that the assay has a limit of detection of 3 pg/mL and a limit of quantification of 11 pg/ml (see Results summary on page 222). Therefore, the antibody in the “sample” of the claims cannot be used to quantitate a level of adrenomedullin below 10 pg/ml because the sensitivity of the assay (based on the antibody) is not capable of measuring accurately below 11 pg/ml. At most, one would know that there is at least 3 pg/ml and less than 11 pg/ml but there would be no way of assessing if the level was below 10 pg/ml (or 5 pg/ml as required in claim 37). The instant specification does not identify any other antibodies which would provide the ability to determine the amount of adrenomedullin in the sample wherein the amount is below 10 pg/ml and therefore, the claims are not enabled because one of ordinary skill in the art could not make the claimed invention.
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.
Claim 15 and 43-44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims recite “or a binder to fragments of mature ADM-NH2 according to SEQ ID Nos: 21-23”. Mature ADM-NH2 has the amino acid sequence of SEQ ID NO:4. However, SEQ ID NO:23 is not identical to SEQ ID NO:4 and therefore, is not a fragment of mature ADM-NH2 . SEQ ID NO:23 comprises amino acids 42-52 of SEQ ID NO:4 but it has an additional N-terminal cysteine which is not present in SEQ ID NO:4.
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The claims are indefinite because SEQ ID NO:23 is not a fragment of mature ADM-NH2 as stated in the claim.
Claim Rejections - 35 USC § 102
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.
Claim 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nomura et al. (Reg. Pep. 158: 127-131, 2009) as evidenced by Behara et al. (Alzheimer’s Dementia, 21(7): 1-14, 2025; cited in the Patent Board Decision, mailed 14 May 2026).
Nomura et al. discloses measurement of adrenomedullin (AM-NH2) in subjects (with no overt cardiovascular diseases, see section 2.1) who were obese and non-obese. The subjects had not been diagnosed with dementia as there is no disclosure of such a diagnosis. In order to measure adrenomedullin, a sample is required which comprises a bodily fluid from the subject (plasma) and an antibody to mature ADM-NH2 (see section 2.2 at page 128). While Nomura et al. do not indicate how the antibody was produced, determination of patentability is based on the product itself. Therefore, the antibody of Nomura et al. meets the limitations of the claim.
Figure 1 shows an average level of ADM-NH2 of about 2 fmol/ml which is approximately 12 pg/ml (based on a molecular weight of about 6029 for mature adrenomedullin). Figure 2 shows individual data points for measured ADM-NH2.
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It is clear that there are several data points which are at or below 1 fml/ml. These samples would meet the limitation of an amount of ADM-NH2 which is below 10 pg/ml as the sample comprises both the antibody as well as ADM-NH2 in an amount below 10 pg/ml. Therefore, Nomura et al. anticipates the instant claim.
Nomura et al. does not state anything regarding dementia and there is no evidence that the subjects of Nomura had been diagnosed with dementia. However, it is statistically very likely that at least one subject in Nomura's study had not been diagnosed with dementia. Nomura's subjects' ages range from 51-70.6 years (60.8 ± 9.8 years). Nomura 127. "All subjects examined gave their written informed consent before participating in [Nomura's] study." Id. at 128. Behera reports that the prevalence of dementia in Japanese people aged 50-69 was 795.371/100,000 (about 0.8%), and was 7970.49/100,000 (about 8%) in Japanese people aged 70+ in 1990. Behera Table 1. Behera reports these numbers increased in 2021 to 913.386/100,000 (about 0.9%) and 10,573.29/100,000 (about 10.6%), respectively. Id. Given these data, and the fact that all of Nomura's subjects gave their written informed consent before participating, the likelihood that at least one subject in Nomura's study was not diagnosed with dementia was very high. Therefore, Nomura anticipates the claim.
Response to Arguments
Applicant urges at page 4 of the response that “[t]he subject matter of claim 45 was not rejected under 35 USC 102 and thus the inclusion of the subject matter of this claim renders the rejection under 35 USC 102 moot. As such, the rejections to the claims are moot and appellants respectfully request that they be reversed/withdrawn”.
Applicant’s assertion is incorrect as the subject matter of claim 45 has not been incorporated into claim 15. Claim 45 (now canceled) included CDR amino acid sequences – none of the pending claims include any amino acid sequence structure for CDRs. Applicant’s statement regarding the 102 rejection in relation to canceled claim 45 is confusing.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christine J Saoud whose telephone number is (571)272-0891. The examiner can normally be reached M-F, 6am-2:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Z Wu can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christine J Saoud/Primary Examiner, Art Unit 1645
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