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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
DETAILED ACTION
This action is in response to claim amendments filed 6/18/26. Claims 1-11, 13-14, and 16-17 are pending and under examination.
Drawings
A color drawing petition has been submitted. The drawings remain objected to as no decision has been rendered on the petition. However, it is confirmed that should the petition be accepted then the objection will be withdrawn.
Withdrawn Rejections
The claim objections are withdrawn in light of the amendments.
The §112b rejections are withdrawn in light of the amendments. Note the new rejection under this statute necessitated by amendment.
The §112a rejection is withdrawn in light of the amendments.
The §101 rejection is withdrawn. While claims 13 and 16 still recite a judicial exception (naturally occurring fragment), this is combined with a non-naturally occurring antibody. Thus, claims 13 and 16 are eligible because the claims contain an element beyond the judicial exception that practically integrates the exception.
The §102 rejection is withdrawn. All claims now require at least the antibody which is allowable over the prior art for the reasons of record.
Maintained Rejections and New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
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 13 and 16 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 13 and 16 recite a fragment that “consists of” an amino acid sequence “comprised between” certain residues. Using closed language (consists of) followed by open language (comprised) leads to indefiniteness of the claim scope. The closed language of “consists of” excludes any additional elements; however, “comprising” or “comprised” is open language that allows for the addition of any non-recited elements.
The claim also recites “an amino acid sequence”, which refers to any subsequence of the recited residues, e.g., AR is “an amino acid sequence” in residues A1-L48. However, the claims also recite “or a segment thereof”. It is unclear if this limitation means that a single amino acid is encompassed by the claims, e.g., “A” is a segment of the sequence AR.
Therefore, claims 13 and 16 are indefinite.
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.
Claims 14 and 17 are 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 14 is directed to a kit that comprises the limitations of claim 13. Claim 17 is directed to a kit that comprises the limitations of claim 16. There is no special definition of “kit” and so the preamble of the claim does not impart any limitations on the claim. Further, the only potential additional limitation is the list of what the autoimmune disease is. However, this is a limitation related to the “for assessing disease” phrase in claim 13/16 and the limitation of those diseases is related to an intended use. This use also is recited in the preamble and does not impart any specific limitations. When considering the claim as a whole, there are no additional limitations in claim 14 compared to claim 13 and no additional limitations in claim 17 compared to claim 16 and so fails to further limit the claim.
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.
Response to Arguments
Applicant's arguments filed 6/18/26 have been fully considered but they are not persuasive.
Regarding the §112b rejection over combining “consists of” and “comprised” as well as reciting “an amino acid sequence”, Applicant does not argue the merits of the rejection but rather solely argues that claim 12 was canceled. Applicant amended claims 13 and 16 to contain the exact language which was rejected. As Applicant has not argued the merits of the rejection, Applicant’s arguments are not persuasive.
Regarding the §112d rejection, Applicant argues that claim 14 includes a listing of specific autoimmune diseases. While true, this does not point to any specific deficiency in the rejection, which is that narrowing the intended use does not place any structural limitation on the kit. The specification does not suggest that a kit “for” assessing these autoimmune diseases is necessarily different than the kit “for” assessing the other diseases in claim 13. The previous rejection articulated why the “wherein the disease” clause is not limiting and Applicant has not argued any deficiency in this reasoning and so the arguments are not persuasive.
Conclusion
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 ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-T 9-18; W-R 9-15.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Weidner/Primary Examiner, Art Unit 1675
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