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 .
Response to Amendment
Applicant’s amendment and response filed 30 June 2025 has been received and entered. Claims 1, 8-10, 14 and 17-19 have been amended and claims 3-5, 13, 21-22 and 24-35 have been canceled. Claims 1-2, 6-12, 14-20 and 23 are currently pending.
Claims 14-16, 20 and 23 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04 October 2024. Applicant’s election of AgG2-17 and the combination of AgG2-17 and AgG6-11 as the elected species of 04 October 2024 is noted. Claims 1, 8 and 9 are examined in so far as they read on the elected invention/species.
The antibody of AgG2-17 comprises CDRs with the amino acid sequences of SEQ ID NO:6, KAS and SEQ ID NO:7-10 and light/heavy chains of SEQ ID NO:127 and 135.
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or rejection of record which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.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 30 June 2025 have been fully considered but are not found to be persuasive.
Drawings
The drawings are objected to for the following reasons:
Figure 1 contains an amino acid sequence for which there is no sequence identifier. While the “Description of the Figures” at pages 4-5 has been amended to recite sequence identifiers for the glycosylated peptides which are identified in the figure, the complete amino acid sequence which is depicted in the figure does not have the necessary corresponding sequence identifier. Correction is required.
Figure 2 contains text which is cut off and therefore, it is not clear what is being referenced. See screenshot below.
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Figure 3 contains 10 panels (A-J). However, Figure 3 is labeled as “Fig. 3” and “Fig. 3(cont)”. 37 CFR 1.84(u)(1) states that “partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter”, therefore the recitations of “Fig. 3” and “Fig. 3(cont)” are not compliant with 37 CFR 1.84(u)(1). The first page of the drawing would be Fig. 3A-3F and the second page would be Fig. 3G-3J in order to be compliant with 37 CFR 1.84(u)(1).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), 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 the USPTO patent electronic filing system 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 the USPTO patent electronic filing system 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 – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Specifically, Figure 1 still contains an amino acid sequence which is not identified by a sequence identifier either in the Figure itself or in the Brief Description of the Drawings. While sequence identifiers have been provided for the 7 short peptides which are identified, a sequence identifier for the full-length amino acid sequence of Figure 1 is not provided in either the Figure itself or in the description of the figures in the specification.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. “APOJ” should be spelled out. Additionally, the elected invention does not include “uses thereof” nor would “uses thereof” be descriptive.
Applicant asserts at page 25 of the response that clarification on the objection is requested. In response, clarification is provided above.
The disclosure is objected to because of the following informalities:
The specification fails to comply with 37 CFR 1.52 which requires at (a)(1)(iv-v) that all papers be plainly and legibly written either by a typewriter or machine printer in permanent dark ink or its equivalent and be presented in a form having sufficient clarity and contrast between the paper and writing thereon to permit the direct reproduction of readily legible copies in any number by use of photographic, electrostatic, photo-offset, and microfilming processes and electronic capture by use of digital imaging and optical character recognition. The specification at page 60 contains text which is not legible or is not presented in a form having sufficient clarity to meet the requirements of 37 CFR 1.52 (a)(1)(v). See example below.
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The text is not clear and the lines are not defined which results in errors when OCR attempts are made. Correction is required.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see page 8, line 21). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Objections
Claims 1, 9 and 17 are objected to because of the following informalities:
Claims 1 and 17 are directed to an antibody which specifically binds glycosylated ApoJ selected from an “antibody specifically binding an epitope”. The language of “specifically binding an epitope” is active language and would imply that what is being claimed is an antibody that is bound to the epitope recited in the claims. It is believed that it is not the intent of the claim to be limited to an antibody which is bound to the epitope to which it was generated, but that is how the claim is currently worded. Amendment of the claims to recite “an antibody which binds an epitope” would be remedial.
Claim 9 is objected to because of the recitation “VL-CDR1 FWR1 corresponds to SEQ ID NO:1” in line 2 of part (i) of the claim. This nomenclature is found in all parts of claim 9, including part (ii) which reads on the elected antibody. The specification (see at least Table 1) indicates that SEQ ID NO:1 is the amino acid sequence for the VL CDR1 and not a framework region. The inclusion of “FWR1” appears to be a typographical error.
Appropriate correction is required.
Improper Markush
Claims 1, 8-9 and 17 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of antibodies recited in claim 1 ((i)-(ix)) is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the structure of each peptide is unique and therefore does not provide a single structural similarity.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Dependent claims 2, 6, 7, 10-12, 19 are also rejected for depending on a rejected claim.
Response to Arguments
Applicant argues at page 29 of the response that claim 1 as amended meets the requirement that the members of the Markush group all be members of the same art recognized class and that they all have a common use of specifically binding to glycosylated ApoJ and not binding to non-glycosylated ApoJ.
Applicant’s argument has been fully considered, but is not found persuasive. While the members of the recited Markush group are all antibodies, the various members do not share a single structural similarity which provides for their common use. The requirement for a proper Markush is not only that the members belong to the same recognized physical or chemical class or the same art-recognized class, but then it must be disclosed in the specification or known in the art that the members be functionally equivalent and have a common use. While the members of the group are all antibodies, the members do not have a common use based on that basis. Not all antibodies are useful for binding glycosylated ApoJ and there is no art-recognized class of antibodies which bind glycosylated ApoJ. Next, the specification does not disclose that the members are functionally equivalent and have a common use because the specification clearly discloses that the antibodies bind to one of seven different peptides which contains an Asn residue and which can be glycosylated. The antibodies are not functionally equivalent because an antibody which binds to a peptide that has been glycosylated at position 86 will not bind to any of the other glycosylated positions. If position 86 is not glycosylated, for example, the antibody which binds the position when glycosylated would not be useful for identifying ApoJ which IS glycosylated, but glycosylated at another position. Therefore, the antibodies are not functionally equivalent.
Since the members of the Markush group do not belong to an art-recognized class and a disclosure that they are functionally equivalent or have a common use, the next criteria to consider is if the members of the Markush grouping share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. In the instant case, the members of the Markush grouping do not share a substantial structure feature and a common use that flows from that substantial structural feature because the structural feature which provides for their use is the CDR structure, which is not shared by the members of the Markush grouping.
Claim Rejections - 35 USC § 112
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.
Claims 9-10 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.
Claim 9 recites the limitation "(i) when the antibody corresponds to claim 1(i):” however, the CDR sequences which are recited in (i) of claim 9 do not match with those in claim 1(i); rather, they match with claim 1(ii). Claim 9 reverses the antibodies of claim 1(i) and (ii). Therefore, claim 9 lacks antecedent basis for the elements which are recited as they are not found in claim 1(i) and they clearly do not correspond to claim 1(i).
Claim 9 recites the limitation "(ii) when the antibody corresponds to claim 1(ii): VL-FWR1 corresponds to SEQ ID NO: 54”, etc.". There is insufficient antecedent basis in claim 9 for the framework regions which are recited.
Claim 9 recites that particular regions of the antibody “corresponds” to a particular amino acid sequence or that the antibody “corresponds” to a portion of claim 1. The claim is indefinite because the metes and bounds of “corresponds” cannot be determined. It is not clear if the antibody must comprise the amino acid sequences which are recited or if the antibody and its segments only “correspond” to those sequences recited. Additionally, the claim in part (ii) then states that “and the antibody is referred to as Ag2G-17”. The intent of this recitation is not clear. As the antibody which is being claimed is not definitively a singular molecule (as the “corresponds to” language may mean that the antibody and its segments do not actually possess the amino acid sequence which is recited), it is not clear if the claim intends the antibody actually be “Ag2G-17” or if it is merely to be referred to as “Ag2G-17”. It is noted that Ag2G-17 is the name designed for an intact antibody in the instant specification as originally filed and that “Ag2G17” is not a molecule that consists of 3 CDRs and 4 framework regions from the light and heavy chains excluding constant domains.
Claim 10 is indefinite for reciting “derived from a human antibody framework region, which is humanized”. The claim is indefinite because one cannot humanize a human antibody framework. Humanization is a process that is applied to antibodies from other species. Therefore, the metes and bounds of what is intended by “humanized” in the context of framework which is already of human origin is unclear.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8, 9 and 11 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8(i) recites a light chain domain and a heavy chain domain comprising the amino acid sequences of SEQ ID NO:125 and 134, respectively. However, the CDRs of the antibody of claim 1(i) are not found in the sequences of SEQ ID NO:125 and 134. Therefore, the claim does not include all the limitations of the claim from which it depends. NOTE: it appears that the elements in (i) and (ii) are reversed with respect to claim 1. As claims 8 and 9 seem to recite the antibodies in numerical order (Ag1G-11, Ag2G-17, etc.), it might be easier to correct the order in claim 1 as (i) recites the CDRs of Ag2G-17 and (ii) recites the CDRs of Ag1G-11).
Claim 9(ii) recites that the antibody corresponds to claim 1(ii) and recites amino acid sequences for the 6 CDRs. However, the CDRs of claim 1(ii) are not found in the amino acid sequence recited in claim 9(ii), therefore, claim 9 does not include all the limitations of the claim from which it depends. See NOTE above for claim 8.
In so far as claim 9 recites “when the antibody corresponds to claim 1(ii)” and that particular CDRs correspond to a particular amino acid sequence, claim 9 does not further limit the subject matter of the claim from which it depends (claim 1(ii)) because an amino acid sequence that “corresponds” to a given sequence does not necessarily possess the same sequence to the one it “corresponds to”. Therefore, claim 9 broadens the scope of what is being claimed as the antibody does not seem to require the amino acid sequences of the CDRs recited in claim 1.
Claim 11 recites that the antibody is “a single-domain antibody” or “a nanobody”. However, these embodiments would not include all the limitations of claim 1, from which it depends as a single-domain antibody or a nanobody do not include light chain elements.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 11 is 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 11 is directed to an antibody of claim 1 which is an Fab, an F(ab)2, a single-domain antibody, a single chain variable fragment (scFv) or a nanobody. Claim 11 encompasses antibody forms which are single domain and do not require both heavy and light chain CDRs.
The elected species of antibody, AgG2-17, has light/heavy chain CDRs with the amino acid sequences of SEQ ID NO: 6-10 and KAS (L-CDR2) and light/heavy chain variable regions with the amino acid sequences of SEQ ID NO: 126 and 135. An antibody with these structures (all 6 recited CDRs or both heavy/light chains) of CDRs has written description. However, the instant specification does not describe antibodies which lack a full complement of CDRs which also have the ability to bind their respective target. The instant specification does not teach antibodies with less than a complete complement of CDRs from the same antibody as having the ability to bind their stated target.
The specification fails to provide a written description of the genus of antibodies which bind glycosylated ApoJ and do not bind non-glycosylated ApoJ which lack the recited 6 CDRs identified above in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. While the specification contemplates single domain antibodies, the specification does not make such antibodies or demonstrate that such constructs would bind their respective target and have the required functional activities of the claims. The instant specification may contemplate such antibodies but the specification fails to provide an adequate written description for such as no antibodies meeting these structural criteria have been provided or described.
The structures of the antibodies claimed are not adequately described. In AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., Ill USPQ2d 1780 (Fed. Cir. 2014) AbbVie had claims to functionally claimed antibodies and Centocor presented evidence that the antibodies described in AbbVie's patents were not representative of other members of the functionally claimed genus. The decision states, “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.’ Id. at 1349. We have held that '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.’ Id. at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). Here, the claimed invention is a class of fully human antibodies that are defined by their high affinity and neutralizing activity to human IL-12, a known antigen. AbbVie's expert conceded that the '128 and '485 patents do not disclose structural features common to the members of the claimed genus.”
The AbbVie decision considers how large of a genus is involved and what species of the genus are described in the patent. With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that “merely recite a description of the problem to be solved while claiming all solutions to it and ... cover any compound later actually invented and determined to fall within the claim's functional boundaries.”).
In the instant application, the specification and claims draw a fence around a perceived genus but the genus is not adequately described. The specification exemplifies an antibody comprising 6 CDRs with a heavy chain amino acid sequence of SEQ ID NO:135 and a light chain amino acid sequence of SEQ ID NO:126 and 6 CDRs of SEQ ID NO: 6-10 (with KAS as the light chain CDR2); however, claim 11 encompasses single domain antibodies and therefore, does not possess the light chain CDRs. No reasonable structure-function correlation has been established that is commensurate in scope with the claims. The specification does not describe representative examples to support the full scope of the claims.
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 claim indicates that these claims are drawn to antibodies which have specific functional characteristics.
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.”
Thus, 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 single domain antibodies which bind glycosylated ApoJ but not non-glycosylated ApoJ based on disclosures set forth above. "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, which are single domain antibodies that specifically bind glycosylated ApoJ and not non-glycosylated ApoJ and which vary from the disclosed antibody AgG2-17 with the recited structures identified above. One of skill in the art would not recognize from the disclosure that the applicant was in possession of the 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).
Claim 17-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a composition which comprises an antibody wherein said antibody comprises 6 CDRs which have the amino acid sequences of SEQ ID NO:6, KAS, SEQ ID NO:7-10 and a second antibody does not reasonably provide enablement for an antibody that “specifically binds an epitope which comprises an N-glycosylation site within ApoJ and wherein said glycosylation site comprises an Asn residue 86 with respect to the ApoJ precursor sequence as defined in NCBI database entry with accession number 001822.3”. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The drafting of the instant claims reads on antibodies which bind to ApoJ in the absence of glycosylation. The claim recitation that the antibody “specifically binds an epitope which comprises an N-glycosylation site within ApoJ” encompasses both glycosylated and non-glycosylated ApoJ. The instant specification discloses that the antibody which comprises 6 CDRs which have the amino acid sequences of SEQ ID NO:6, KAS, SEQ ID NO:7-10 binds to ApoJ which is glycosylated at position 86 relative to full-length ApoJ and wherein the glycosylation is N-glycosylation. The specification teaches that the elected antibody binds Apo J-GlcNAc at position 86 and not non-glycosylated ApoJ (see page 6 of the specification). Therefore, the claims are not enabled for an antibody which binds non-glycosylated ApoJ.
The claims could be simplified by merely reciting the amino acid sequence structure for the antibody which is being claimed. The additional verbiage regarding what structure the antibody is binding is not necessary as the ability to bind a specific target is inherent to the antibody having the specific amino acid sequence structure of the 6 CDRs of the antibody. However, when the claim recites particular functionality, the claims then need to provide sufficient structure to provide for the recited functionality. In the instant claims, the functionality that is recited encompasses glycosylated and non-glycosylated ApoJ which is broader than the enabling disclosure.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/Christine J Saoud/Primary Examiner, Art Unit 1645