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 .
Election/Restrictions
Applicant's election with traverse of the invention of Group 1 (claims drawn to nucleic acids encoding ADAMTS-7 polypeptide) in the reply filed on 05/19/2025 is acknowledged. The traversal is on the ground(s) that the inventions of Groups 1, 2 and 3 share a special technical feature of the prodomain and catalytic domain of the ADAMTS protein. This is not found persuasive because as set forth in the Requirement of 03/09/2025 the broadly encompassed structural feature is not a special technical feature in view of the prior art (as noted on page 5 of the Requirement).
The requirement is still deemed proper and is therefore made FINAL.
Claims 8, 10-12 and 14-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/19/2025.
Specification
The disclosure is objected to because of the following informalities: the specification recites the term “disintergrin” (p.23, ln.20), where likely the term “disintegrin” is intended.
Appropriate correction is required.
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 specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). See for example the specification at: p.7, ln.16; p.58, ln.17; p.75, ln8.
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 sequence identifiers, 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.
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. See for example Figures 2B and 2C (and the description on pages 5-6 of the Specification); Fig 7; Figures 9B and 9C;
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.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 1, 3-5, 7 and 23 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.
Claims 1, 3-5, 7 and 23 are unclear over recitation of the limitation “a functional segment of a rodent prodomain of ADAMTS-7”, as recited in claim 1, and “a functional segment of an ADAMTS-7 prodomain” as recited in claim 5. The claims are unclear because it is unclear what particular functionalities are intended to be required for the required structures, and what portions for the structures are required for those functionalities. The specification provides that the structures of a “prodomain” broadly include sequences that are N-terminal to the catalytic domain, and are cleaved off prior to generation of a functional enzyme. But the function of any prodomain is unclear, where the specification teaches that a “functional protein” has biological activity, but the activity of the prodomain is not defined in the specification (page 24) which only provides:
… a functional segment of a prodomain has activity in the sense that it facilitates expressing or purifying the biologically active domain it is associated with (e.g., by improving the folding of the CD domain or catalytic domain).
Considering that any sequence may be used as a purification tag, it is unclear what is intended to be required for the claims “functional segment of a rodent prodomain of ADAMTS-7” or “a functional segment of an ADAMTS-7 prodomain”.
Claims 1, 3-5, 7 and 23 are unclear over recitation of the limitation “a functional segment of human catalytic domain (CD) of ADAMTS- 7”. The requirements of the “CD” domain are unclear where the claim appears to only require a “catalytic domain”, but the specification provides (p.23) that:
… the term "CD domain" refers to the catalytic domain plus disintegrin part of the respective protein (e.g., as characterized by UniProt, which might use the alternative term "peptidase" for the catalytic domain)
See also specification at p.6 ln. 4: “CD domains (CD = catalytic + disintegrin)”. Thus it is unclear if the claims intend to require a disintegrin part of the protein.
Claim Rejections - 35 USC § 112 – Written Description
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.
Claims 1, 3, 5, 7 and 23 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 instant rejection is relevant where the claims encompass a wide variety of possible structures of nucleic acids that encode polypeptides. Claims 1, 5 and 23 are generic and encompass any nucleic acid sequences encoding any polypeptide sequences. Claim 3 encompasses any nucleic acid sequences that encode polypeptides that are at least 80% identical (allowing for a plurality of without limitation as to the nature and positions of these changes) to positions 1-217 of SEQ ID NO: 1 or 2, and positions 218-518 of SEQ ID NO: 1. Claim 7 requires only that the first portion of the encoded polypeptide includes RQKR. As such the genus of encompassed structures is very large.
However, the encoded polypeptides require the functional limitations of being composed of a prodomain that is a “rodent prodomain” and a catalytic domain that is a “human catalytic domain”, and that the each portion of the encoded polypeptides include “a functional segment” of ADAMTS-7.
But neither the specification nor the related art provides the skilled artisan with the ability to pick from the broadly encompassed genu of structures those particular species that will satisfy the functional requirements of the claims. The claims encompass any rodent ADAMTS-7 prodomain segments. But the specification teaches only mouse and rat sequences. The disconnect between the generic breadth of the claim and the particular teachings of the specification are relevant where there are more than 2000 species of Rodents (e.g.: Kay et al, 2008) with a wide variety of diversity, and the ADAMTS-7 gene has not been identified in most of the species. The lack of a clear structure:fuction relationship is further relevant where the specification does provide any particular limitations for the function of a prodomain, and teaches (page 24) that the function of the segment of the claims can be that it facilitates expressing or purifying the biologically active domain it is associated with (e.g., by improving the folding of the CD domain or catalytic domain). The specification does not teach what structures (e.g.: sequences of encoded polypeptides) are required for a prodomain to improving the folding of the CD domain or catalytic domain; the specification does not teach any structures that are particularly relevant to any functionality of a prodomain. In this regard (i.e.: where the claims encompass any rodent ADAMTS-7 prodomain with some functionality), it is relevant to point out that information pertaining to a gene product/function in one organism may not be relevant to identification of a gene product/function in another different organism. For example, Juppner (1995) teaches that despite significant structural conservation, rat, opossum, and human PTH/PTHrP receptor homologs display distinct functional characteristics (Abstract; pp.39S-40S).
So, while one can envision the genus of sequences that are, for example, 80% identical to SEQ ID NO: 1 or 2, the specification has not disclosed a representative number of those sequences which will actually provide the function required by the claims, and has not provided any basis for predicting which variants of SEQ ID NO: 1 or 2 will provide the function. Accordingly, one of skill could not conclude that Applicant was in possession of the genus of nucleic acids that are claimed.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 5 and 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nucleic acids that encompass portions of naturally occurring nucleic acids without significantly more.
The claim(s) recite(s) nucleic acids that encode a portion of a rodent ADAMTS-7 polypeptide prodomain and a portion of a human ADAMTS-7 polypeptide catalytic domain. Here it is noted that the rejected claims do not set forth any particular structural limitations (e.g.: polypeptide length or amino acid sequence) of the segment of a rodent ADAMTS-7 polypeptide prodomain; where the specification teaches that the “function” of the segment may be related to the purification of the encoded protein. Where the related art teaches a naturally occurring nucleic acid (i.e.: mRNA that is GenBank locus AF140675) that encodes an ADAMTS-7 polypeptide that includes a polypeptide sequence identical to a portion of a rodent ADAMTS-7 prodomain, and a human catalytic domain, such a teaching is evidence that the claimed nucleic acids encompass naturally occurring nucleic acids.
Because claims recite a nature-based product limitation (the claimed nucleic acid), the “markedly different characteristics analysis” is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). While some of the claims recited additional elements (e.g.: the “kit” of claim 23) the markedly different characteristics analysis is applied only to the nature-based product limitation (i.e.: the claimed nucleic acid). MPEP 2106.04(c)(I)(A). The markedly different characteristics analysis is performed by comparing the nature-based product limitation (in this case the claimed nucleic acid) in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II). Here, the closest natural counterpart is the human mRNA that encodes the ADAMTS7 polypeptide (e.g.: GenBank locus AF140675) that is found in cells. When the claimed nucleic acid is compared to this counterpart, the comparison indicates that there are no differences in structure, hybridization ability, or other characteristics. Therefore, the nucleic acid of the claims is a product of nature exception.
This judicial exception is not integrated into a practical application because the claims do not recite any additional physical elements that clearly integrate the nucleic acids into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements is only the broadly/generically recited kit of claim 23, and such elements are well-known, routine, and conventional with regard to compositions comprising nucleic acids.
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(s) 1, 5, and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hurskainen et al (1999).
Relevant to the instantly rejected claims, Hurskainen et al teaches a collection of reagents, where a collection of reagents in a kit (claim 23) including cDNA molecules that encode polypeptides meeting the broad structural limitations of the claims (i.e.: the cDNA submitted as AF140675 (e.g.: p.25555, left col; p.25558 - Cloning of ADAMTS7; Fig. 2).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN THOMAS KAPUSHOC whose telephone number is (571)272-3312. The examiner can normally be reached M-F, 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571)272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Stephen Kapushoc
Primary Examiner
Art Unit 1684
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683