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 .
DETAILED ACTION
Responsive to communications entered 10JUL2025
Claims Pending 1-6,8-13,15-19
Claims Withdrawn 15-19
Claims Under Consideration 1-6,8-13
Elections/Restrictions
Newly submitted claim 19 is directed to an invention that is independent or distinct from the invention under examination for the following reasons:
The originally elected invention (group I) and that set forth in claim 19 are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the product(s) may be used for structural studies or else as protease substrates, etc.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 19 stands withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Further the last paragraph at p 11 of the remarks requests rejoinder of groups II-IV however it is noted the 12/27/2024 election was made without traverse and the restriction mailed 10/30/2024 is still deemed proper and is therefore made FINAL. Consequently, Applicant’s request is denied.
Priority
This application has a filing date of 04/21/2021.
This application is a 371 of PCT/EP2019/078568 10/21/2019
PCT/EP2019/078568 has PRO 62/887,483 08/15/2019
PCT/EP2019/078568 has PRO 62/796,711 01/25/2019 PCT/EP2019/078568 has PRO 62/748,523 10/22/2018
Withdrawn Objection(s) and/or Rejection(s)
The following rejection(s) are hereby withdrawn in view of applicant's amendments:
claims 13 and 14 under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism;
claims 7, 13 and 14 under 35 U.S.C. 101 because the claimed invention is directed to natural product(s) without significantly more;
claims 12 and 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph for the reasons raised in the previous action; and
claims 7 and 13 under 35 U.S.C. 102(a)(1 and 2) as being anticipated by Clark et al (US PG-Pub 20060263774; PTO 892 entered 10/30/2024).
The rejection of claims 1-7,9-13 and 14 under 35 U.S.C. 103 as being unpatentable over Clark et al (US PG-Pub 20060263774; PTO 892 10/30/2024) in view of Quarnstrom (WO 2006/048655 a.k.a. PCT/GB2005/004255, sic Qwarnstrom) is hereby withdrawn as being cumulative.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6,9-13 are rejected under 35 U.S.C. 102(a)(1 and 2) as being anticipated by Clark et al (US PG-Pub 20060263774; PTO 892 entered 10/30/2024).
Clark et al teach throughout the document and especially paragraphs 0012-0015,0284,0302-0303 & document claim 20, diagnosing and prognosing immune related diseases such as rheumatoid arthritis and others with protein molecules including SEQ ID 2115 (aka human NENF, STN registry no. 694555-78-7) therein that comprise both present SEQ ID 2 with arginine at position 16 and present SEQ ID 3 with arginine at positions 13-14. In paragraph 0194, Clark et al teach such proteins may be immobilized on a solid support for quantitation by ELISA. The foregoing reads on claims 1,9,13; and necessarily on 2,3,4,5,6,10,11,12.
***
Please note that the above rejection has been updated from the original version to more clearly address applicants’ newly amended and/or added claims and/or arguments.
Response to Arguments
The remarks accompanying the present response argue not all elements are taught.
Applicant’s arguments have been fully considered but they are not deemed persuasive for the following reasons.
In the last paragraph at p 8, the remarks assert Clark does not teach citrulline or homocitrulline.
In response to applicant's argument that the references fail to show certain features of applicant’s invention, it is noted that the limitations upon which applicant relies (i.e., citrulline or homocitrulline containing peptides) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). See also indefiniteness rejection under 35 USC 112 second paragraph below.
Maintained 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 1-6,8-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural product(s), a judicial exception to patent eligible subject matter without significantly more. Taken individually or in combination as a whole, said claims recite(s) a composition(s) comprising "synthetic classifier" peptides with no differences from NENF and FRAS1 proteins present in humans as evidenced by at least the Clark and Quarnstrom references and detailed in the prior art rejections above and/or in the previous action. Regarding claim 8, as reviewed by Nijenhuis et al (2004 Clinica Chimica Acta 350:17–34; of record), autoantibodies are elicited to citrullinated proteins in rheumatoid arthritis patients occur naturally as well. As such, this judicial exception is not integrated into a practical application because the natural sequences do not differ from the subject matter presently claimed, indeed claims 1 and 9 do not have any additional elements whatsoever.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Moreover, claims 1 & 9 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Humans comprise FRAS1 and NENF bearing at least present SEQ IDs 2,3 and 7 as detailed in the previous action and above.
Response to Arguments
The remarks accompanying the present response argue the claimed composition as currently presented is markedly different from proteins that occur in humans.
Applicant’s arguments have been fully considered but they are not deemed persuasive for the following reasons.
The claimed composition, for instance, may be drawn to peptide molecules comprising KGVVFDVTSGKEFYGRGAPYNALTGKDS (from present SEQ ID 2) or YKAKYPIVGYTARRILNEDGSPNLDFKP (from present SEQ ID 3), both of which are present in human NENF protein molecules, as detailed in the last two actions.
New 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 1-6,8-13 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 pre-AIA the applicant regards as the invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships which render the metes and bounds uncertain are as follows.
Claim 1 includes the ambiguous limitation “at least one Cit/R in SEQ ID NOS: 1,2,3,4,6 and 8 represents an arginine to citrulline substitution”. Unlike, the legend to table 1 of the present published application, the claim term represents makes it unclear if the claimed peptides require citrulline or alternatively either citrulline or arginine at the Cit/R positions. Further, whether claim 1 intends to encompass lysine or homocitrulline at the hc/K position in SEQ IDs 5 & 7 is similarly ambiguous.
The present sequence listing is not enlightening stating in the comment field “Variant residues given in the sequence have no preference with respect to those in the annotations for variant positions”
In accordance with MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. See Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
In so far as the metes and bounds of the offending claim(s) may not be interpreted properly for the reasons above, all dependent claims therefrom claim 1 are rejected as being indefinite as well.
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 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.
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 CHRISTOPHER M GROSS whose telephone number is (571)272-4446. The examiner can normally be reached M-F 10-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on (571)272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER M GROSS/
Primary Examiner, Art Unit 1684