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 .
Claim Status
Claim 4 has been cancelled.
Claims 1-3 and 5-24 are currently pending.
Claims 7-24 have been withdrawn.
Claims 1-3 and 5-6 are currently being examined.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) of Provision application 63/289,749 as follows:
Claim 1 has been amended to recite “citrullinated or homocitrullinated peptide” with amino acid sequence of SEQ ID NO:24, where X1 is K or J, and X2 is R or B. The Claim 1 has been further amended to recite “there in J is homocitrulline and B is citrulline.” However, the provisional application 63/289,749 does not provide support for the claimed peptide sequence. In particular, the provisional application does not disclose that the residue J is homocitrulline, and B is citrulline, which specific amino acid residue are also not listed in the Sequence listing.
Thus, the instant claims 1-3 and 5-6 do not obtain the benefit of the provisional application. The effective filing date for the instant claims 1-3 and 5-6 is 12/12/2022.
Claim Objection(s) / Rejection(s) Withdrawn
All previous claim Objection(s) / Rejection(s) as set forth in the previous Office action (mailed 1/6/26) that are not repeated and/or maintained in the instant Office action are withdrawn.
New and Maintained Claim Objection(s) / Rejection(s)
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.
New Matter Rejection
Claims 1-3 and 5-6 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite “citrullinated or homocitrullinated peptide” with amino acid sequence of SEQ ID NO:24, where X1 is K or J, and X2 is R or B. The Claim 1 has been further amended to recite “there in J is homocitrulline and B is citrulline.” However, the instant specification and claims as originally filed do not provide support for the claimed peptide sequence. In particular, the instant specification and claims as originally filed do not disclose that the residue J is homocitrulline, and B is citrulline, which specific amino acid residue are also not listed in the Sequence listing. Neither the originally filed specification nor the claims provide definitions for J and B, which are not claimed to represent amino acids that are contrary to the usage of these symbols in the art. See MPEP 2412.03(a) for WIPO ST.26 amino acid residue symbols. The symbol J is known in the art to refer to Leucine or Isoleucine, and B is for Aspartic acid or Asparagine. Applicant’s usage of these symbols are contrary to the conventional meaning in the art. Thus, these claim amendments represent new matter as there are not disclosure of these symbols meaning in the originally filed specification and claims, as well as any indication that these symbols are routinely used as instant claimed usage in the art.
Applicants have pointed to paragraphs [030], [044], [075] and Example 1. However, none of these disclosure recites “J is homocitrulline”, and “B is citrulline.”
If Applicant believes this rejection is in error, applicant must disclose where in the specification support for the entire scope of the amendment(s) and/or new claims can be found. As a result, Claims 1-3 and 5-6 represent new matter.
112 (b) Rejection
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 and 5-6 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 1 recites “each X1 is…” and “each X2 is…” for SEQ ID NO:24, which has the following sequence as listed in the Sequence Listing:
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410
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First, the sequence listing does not specifically label each of the three “X” as X1, X2 and X3. Assuming that the first occurring, X is X1, and the next X is X2. Then there is only one X1. But the recitation of “each X1” or “each X2” implies that there are multiple X1s or X2s, or each of X can be either X1, or X2. In addition, the Sequence Listing provides that the first occurring X is K or J, the second occurring X is also K or J, and the third occurring X is R or B, which is in direct conflict with the instant claim 1 stating X2 (assuming the seconding occurring X) is R or B. This causes confusing and unclarity of the sequence that is being claimed.
Second, the usage of J for homocitrulline and B for citrulline are not specifically defined in the instant specification (see discussion above), and it is in contrary to the use of these symbols in the art. See MPEP 2412.03(a) for WIPO ST.26 amino acid residue symbols. The symbol J is known in the art to refer to Leucine or Isoleucine, and B is for Aspartic acid or Asparagine. Applicants usage of these symbols are contrary to the conventional usage in the art, and thus cause confusing and unclarity to the claimed sequence.
Further, claim 1 also recites “wherein least one X1 is J or at least X2 is B” in the last line of the claim, which recitation is also confusing. It appears the term “at” is missing in front of “least one X1”. The recitation is confusing and unclear as to what is the required for X1 or X2.
Claims 2-3 and 5-6 depend on claim 1 and do not clarify the issues, and thus are also rejected.
112 (d) Rejection
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.
Claim 2 is 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 2 recites peptide of SEQ ID NO:21, which sequence has X2 position as “K”. However, Claim 1 to which claim 2 depends on recite peptide of SEQ ID NO:24, which recites X2 is R or B. Thus, Claim 2 recited SEQ ID NO:21 expands the scope of claim 1.
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.
Answer to Arguments
In light of Applicants arguments and amendments to the claims, the previous art rejections have been withdrawn. However, applicants amendments to the claims have necessitated new grounds of rejection as stated above.
Conclusion
No claims are 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 SUE LIU whose telephone number is (571)272-5539. The examiner can normally be reached M-F 9-5.
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/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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