DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The instant application is a DIV of 17/841,117, now US PAT 11858976, which is a DIV of 17/748,683, now US PAT 12384827, which is a DIV of 16/458,740 now US PAT 11339199, which is a DIV of 14/600,799, now US PAT 10336804, which is a CON of 12/407,440 03/19/2009 now ABN, which is a CIP of 11/575,878 now US PAT 7994298.
Claims 8-20 are examined in the instant application.
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).
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.
The amended claims set forth on 11/14/2023 recite that the third nucleic acid encoding an immune signaling receptor is “Sequence Ex. A” and that this sequence can be found in the addendum to the application. However, there is no addendum to the specification that would indicate what is Sequence Ex. A. Further the most recent specification filed on 1/26/2024 provides no teaching about any sequence that would encompass Sequence Ex. A. Thus the specification must be amended to comport with the requirements set forth above.
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.
Claims 8-20 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.
New Matter
Applicant filed a preliminary amendment on 11/14/2023, which cancelled claims 1-7 and
set forth new claims 8-20. However, new claim 8 would raise the issue of new matter.
Specifically, claim 8 recites:
“a third nucleic acid encoding an immune signaling receptor containing an immunoreceptor tyrosine-based activation motif of Sequence Ex. A (found in the Addendum to Application)”.
It should be noted that on 11/14/2023 an amendment to the specification was made, but only the title of the invention was amended in the specification, and no amendments regarding any sequence is set forth at this date or in the specification filed on 1/26/2024.
However, a search of the instantly filed specification and the originally filed claims (11/13/2023) provide no support for new claim 8 with respect to an immunoreceptor tyrosine-based activation motif of Sequence Ex. A. Accordingly, the new claims set forth on 11/14/2023 are rejected under new matter. If Applicant believes this rejection is in error, they are invited to cite page and line number where support for new claim 8 is found.
Written Description
When the claims are analyzed in light of the specification, the instant invention encompasses any nucleic acid encoding an immunoreceptor tyrosine-based activation motif of Sequence Ex. A.
Regarding function, the claims recite that the nucleic acid encodes receptor for immune signaling. However, the specification provides no description of any regarding Sequence Ex. A, that would indicate possession at the time of filing for a nucleic acid encoding an immunoreceptor tyrosine-based activation motif that would be based upon Sequence Ex. A.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their structure. In the instant case, there are no description in the specification or any amended specification that would teach possession of a nucleic acid that would contain an immunoreceptor tyrosine-based activation motif of Sequence Ex. A. The specification does not provide any disclosure as to what the complete structure would be of any nucleic acid sequence with respect to Sequence Ex. A. The specification teaches no structural analysis for said nucleic acid sequence or the protein encoded.
As of the filing date, there was no known or disclosed correlation between a structure set forth as Sequence Ex. A and an immunoreceptor tyrosine-based motif. There is no general knowledge in the art about regarding immunoreceptor tyrosine-based motifs to suggest that general similarity of structure confers the activity.
Next, then, it is determined whether a representative number of species have been sufficiently described by other relevant identifying characteristics (i.e. other than nucleotide sequence), specific features and functional attributes that would distinguish different members of the claimed genus. In the instant case, there are no nucleotide sequences disclosed regarding Sequence Ex. A. This is significant since the art teaches that while immunoreceptor tyrosine-based activation motifs (ITAMs) are well-understood in the art, they are each unique to how they mediate cell signal transduction via their ligand (see Isakov N., 1997, J. Leukocyte Biology, Vol. 61, pgs. 6-16). Thus without the teaching of the specific sequence that would encode the motif of claim 8, it cannot be determined which motif Applicant is in possession of.
The skilled artisan could not rely upon the disclosure in the specification such that the specification would sufficiently describe that Applicant was in possession of a nucleotide sequence encoding an immune signaling receptor containing an immunoreceptor tyrosine-based activation motif of Sequence Ex. A at the time of filing.
Applicants' attention is directed to the decision in Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, which clearly 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).
With the exception of the sequences referred to above, the skilled artisan cannot envision the detailed chemical structure of the encompassed polynucleotides, and therefore conception is not achieve 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 nucleic acid itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Therefore, the Sequence Ex. A as it relates to immune signaling receptor containing an immunoreceptor tyrosine-based activation motif does not meet the written description provision of 35 U.S.C. §112, first paragraph. 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).
The claimed invention as a whole is not adequately described if the claims require essential or critical elements that are not adequately described in the specification and that is not conventional in the art as of applicants effective filing date. Possession may be shown by actual reduction to practice, clear depiction of the invention in a detailed drawing, or by describing the invention with sufficient relevant identifying characteristics such that a person skilled in the art would recognize that the inventor had possession of the claimed invention. Pfaff v. Wells Electronics, Inc., 48 USPQ2d 1641,1646 (1998).
In conclusion, this limited information is not deemed sufficient to reasonably convey to one skilled in the art that applicant is in possession of an immune signaling receptor containing an immunoreceptor tyrosine-based activation motif of Sequence Ex. A as embraced by the claims.
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 8-20 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.
New claim 8 is unclear. Claim 8 recites the limitation “immune signaling receptor containing an immunoreceptor tyrosine-based activation motif of Sequence Ex. A”. However, it is not clear what is encompassed by the limitation Sequence Ex. A. The specification does not recite any teachings regarding Sequence Ex. A and it is not clear what type of sequence is encompassed, i.e. nucleic acid or amino acid. Sequence Ex. A does correspond with any sequence on the CRF filed on 11/14/2023, thus it is not clear what is encompassed by the sequence set forth in Sequence Ex. A.
Conclusion
The claims are free of the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632