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. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 15, 2026, has been entered.
Claim Disposition
3. Claim 62 has been added. Claims 2-4, 9-11, 24, 38, 41-43, 50-52 and 57 have been cancelled. Claims 1, 5-8, 12-23, 25-37, 39-40, 44-49, 53-56, 58-62 are pending. Claims 1, 5-8, 12-23, 25-27 and 61-62 are under examination. Claims 28-37, 39-40, 44-49, 53-56 and 58-60 are withdrawn from further consideration pursuant to 37 CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.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 Statements filed on May 15, 2026 and August 4, 2026, have 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.
Claim objection
5. Claims 1, 5-8, 12-23, 25-27 and 61-62 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to read, “A recombinant….( ADAMTS13) variant comprising a single amino acid substitution [[as compared to a human wildtype ADAMTS13, wherein the amino acid substitution is an]] of an R at [[amino acid position corresponding to ]] Q97 of SEQ ID NO: 1 (human wildtype ADAMTS13) . The dependent claims hereto are also included.
For clarity it is suggested that claim 13 is amended to read, “non-variant human”. The dependent claims hereto are also included.
For clarity it is suggested that claim 14 is amended to read, “…at least [[85%]] 90% sequence identity [[thereof]] to SEQ ID NO:1”. The dependent claims hereto are also included.
For clarity it is suggested that claim 62 is amended to read, “….at position 97 of SEQ ID NO: 2.
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.
6. Claims 1, 5-8, 12-23, 25-27 and 61-62 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 comprising a single amino acid substitution as compared to a human wildtype ADAMTS13, wherein the amino acid substitution is an R at amino acid position corresponding to Q97 of SEQ ID NO: 1. The claimed invention is devoid of any functional limitation. The art generally recognizes that a single amino acid change can be detrimental to the structure-function relationship and there is no indication in the claim as to retention of the native function or an assertion of a different function (other than controlling blood thickness and random clumping in blood). The claim language “is comprising a single amino acid substitution”, however, dependent claims recite additional modifications. The claimed invention is also directed to a pharmaceutical composition comprising the aforementioned variant and said composition has a non-variant human ADAMTS13 with a sequence that is at least 85% to residues 75-1427 of SEQ ID NO:1, which encompasses a large variable genus. 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. Mahurkar, 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.
7. Claims 8, 12-23, 25-27 and 61 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 8 lacks clear antecedent basis for the recitation of ..wherein the ADAMTS13 variant lacks the signal peptide and propeptide and claim 1 from which depends recites that the ADAMTS13 variant has a single amino acid substitution and does not mention lacking signal peptide and propeptide (suggest ‘further comprise”). The dependent claims hereto are also included.
Claim 12 and the dependent claims hereto are indefinite for the recitation of “…..at least one ADAMTS13 variant….”, because it lacks clear antecedent basis with the recitation of ‘a variant with a single amino acid substitution’ in claim 1. The dependent claims hereto are also included.
Claim 61 lacks clear antecedent basis for the recitation of the human ADAMTS13 comprises amino acids 75-1427 of the amino acid sequence of SEQ ID NO:1 which this means the sequence is varied because its missing the signal peptide, and claim 13 from which it depends recites ‘a nonvariant human ADAMTS13.
Response to Arguments
8. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that new rejections have been instituted under 112 first and second paragraphs for the reasons stated above.
Conclusion
9. No claims are presently allowable.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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