DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on October 16, 2025, has been received and entered.
Claim Disposition
3. Claims 2-4, 9-11, 24, 38, 41-43, 50-52 and 57 have been cancelled. Claim 61 has been added. Claims 1, 5-8, 12-23, 25-37, 39-40, 44-49, 53-56, 58-61 are pending. Claims 1, 5-8, 12-23, 25-27 and 61 are under examination. are withdrawn from further consideration pursuant to 37 CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
4. The Information Disclosure Statement filed on October 16, 2025, has been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action.
Specification objection
5. The specification filed on 10/16/25 has been received and entered.
Claim objection
6. Claims 1, 5-8, 12-23, 25-27 and 61 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to read, “….wherein the ADAMTS13 variant consists of a single amino acid substitution at amino acid Q97 [[as denoted in]] corresponding to the sequence set forth in SEQ ID NO: 1 that is a wildtype ADAMTS13 protein, or an equivalent amino acid position in [[a wild type ADAMTS13 protein]] the amino acid sequence of SEQ ID NO: 2, and wherein the single amino acid change is from a Q to an R”. The specification at paragraph [0009] discloses hADAMTS13 as the wildtype which is SEQ ID NO:1”, thus the equivalent language is redundant. The dependent claims hereto are also included.
For clarity it is suggested that claim 12 is amended to read, “…..comprising [[at least one]] the ADAMTS13 variant of claim 1……”.
Claim 13 is objected to under 37 CFR 1.75(c), as being of improper dependent form for failing to further limit the subject matter of a previous claim. Applicant is required to cancel the claim(s), or amend the claim(s) to place the claim(s) in proper dependent form, or rewrite the claim(s) in independent form. Note that claim 1 from which it depends recites ADAMTS13 protein. The dependent claims hereto are also included.
For clarity it is suggested that claims 14 and 15 are amended to recite, “SEQ ID NO: 2”, see claim 5 for example identifying those amino acids as SEQ ID NO:2.
For clarity it is suggested that claim 17 is amended to read, “obtained from plasma”, in lieu of ‘plasma derived’.
For clarity it is suggested that claim 20 is amended to read, “…..by a peptide mapping method”.
For clarity it is suggested that the acronym in claim 21 is spelled out.
Appropriate correction is required.
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.
7. Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention. The claims recite added material, which is not supported by the original disclosure. Claim 14 recite " 85% sequence identity to amino acids 75-1427 of SEQ ID NO: 1” and the specification does not support this language.
The specification discloses :
[00061] As used in herein, the terms "identical" or percent "identity," in the context of
describing two or more polynucleotide or amino acid sequences, refer to two or more sequences or subsequences that are the same or have a specified percentage of amino acid residues or nucleotides that are the same (for example at least 80% identity, preferably 85%, 90%, 91%, 92%, 93, 94%, 95%, 96%, 97%, 98%, 99%, or 100% identity, to a reference sequence, e.g., SEQ ID NO:1), when compared and aligned for maximum correspondence over a comparison window, or designated region as measured using one of the following sequence comparison algorithms or by manual alignment and visual inspection. Such sequences are then said to be "substantially identical." With regard to polynucleotide sequences, this definition also refers to the complement of a test sequence. Preferably, the identity exists over a region that is at least about 50 amino acids or nucleotides in length, or more preferably over a region that is 75-100 amino acids or nucleotides in length.
It is noted that the language in claim 14 is not supported by the instant specification. Therefore, the specification lacks adequate written description.
8. Claims 1, 5-8, 12-23, 25-27 and 61 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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 claimed invention is directed to a recombinant ADAMTS13 variant with a single substitution of Q97R pertaining to SEQ ID NO:1 or an equivalent amino acid position, and the claimed invention is not adequately described because it is devoid of an activity for the mutated structure. No correlation is made between structure and function. In addition, there is no source. It is noted that dependent claim 8 indicates that the protein is human, however, claim 1 needs to stand on its own and claim 8 does not rectify all the missing information in claim 1. The claimed invention encompasses a broad genus with the recited 85% (see claim 14). Thus the claimed invention is not adequately described.
The specification fails to provide a representative number of species for the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described, are representative of the entire genus.
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 applicant was in possession of the claimed genus. Vas-Cath Inc. v. Madhukar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), 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 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 genus, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
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.
9. Claims 12-23 and 25-27 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 12 and the dependent claims hereto are indefinite for the recitation of “…..at least one ADAMTS13 variant….”, because it lacks clear antecedent basis.
Clarification is required.
Response to Arguments
10. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that the rejections under 112 first and second paragraphs remains for the reasons stated above and herein. Applicant traverses the rejections and state that the claims have been amended to expedite the claimed invention, however, the amendments did not obviate all grounds of rejection and also required raised new issues that required additional rejections. The claimed invention is not adequately described and encompasses a large variable genus. Applicant argues that the human and a comparison with gorilla is provided, however, the claimed invention as recited in claim 1 for example, is not limited. The art recognizes that the metalloprotease breaks down extracellular matrix, zinc dependent, however, there is no indicia as to whether the activity is retained with the variant. Moreover, the wildtype is not provided for a comparison structurally and there needs to be a clear recitation of where the mutation can be found. Thus for all these reasons the rejection remains. The examiner would welcome an opportunity to discuss the remaining issues to place the application in better form.
Conclusion
11. No claims are presently allowable.
12. Applicant’s amendment necessitated the new/modified 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652