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 claim set of 25NOV2025
Claims pending:
1-3,6-8,14,15,18,21,36,39,42,45,48,49,54,55,58-60,66,67,70,73,88,91,94,97,100,104
Claims currently under consideration:
1-3,6-8,14,15,18,21,36,39,42,45,48,49,54,55,58-60,66,67,70,73,88,91,94,97,100,104
Priority
This application has a filing date of 11/29/2021 and is a CON of
PCT/US2020/032715 filed 05/13/2020
This application has PRO 62/855,767 filed 05/31/2019
Withdrawn Objection(s) and/or Rejection(s)
The rejection of claims 1-3,8,42,48,54,55,58,60,94,97 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 4-8,8,10-13 of copending Application No. 17/320118 is hereby withdrawn with applicant’s filing of an approved terminal disclaimer.
The rejection of claims 7,8,49,54-55,59,60,70,104 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph for the reasons raised in the last action is hereby withdrawn in light of Applicant’s amendments.
Maintained 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)(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 1-3,6-8,14,15,18,21,36,39,42,45,48,49,54,55,58-60,66,67,70,73, 88,91,94,97,100,104 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Greving et al (US AppPub 20230016112; aka application 17/320118; of record).
Greving et al teach throughout the document and especially the abstract, engineered polypeptides that comprise a combination of spatially-associated topological constraints and methods of selecting said engineered polypeptides for use.
More particularly in figures 1,5 and/or document claims 1,10,11,12; and/or paragraphs 0090,0110,0078,0081,0084,0085,0106,0103,0104,0129,0138 at least, Greving et al teaches steps to: identify one or more topological characteristics (e.g. amino acid adjacency) of a reference target associated with a biological response mediated at a peptide-protein interface; design spatially-associated constraints for each topological characteristic to produce a combination of spatially-associated topological constraints derived from the reference target (e.g. from a polymorphic region); compare spatially-associated topological characteristics of candidate peptides with the combination of spatially-associated topological constraints derived from the reference target; and select a candidate peptide with spatially-associated topological characteristics that overlap with the combination of spatially-associated topological constraints derived from the reference target to produce the engineered peptide.
Greving et al thereby engineer a peptide with a molecular mass of between 1 kDa and 10 kDa and comprises up to 50 amino acids that includes a combination of spatially-associated topological constraints, such that: one or more of the spatially-associated topological constraints is a reference target-derived constraint; between 10% to 98% of the amino acids of such engineered peptide meet the one or more reference target-derived constraints (e.g. atomic fluctuations and/or amino acid adjacency); and the amino acids that meet the one or more reference target-derived constraints with less than 8.0 Angstrom backbone RMSD structural homology with the reference target; and wherein: the amino acids that meet the one or more reference target-derived constraints have between 10% and 90% sequence homology and target-derived topological constraints; a van der Waals surface area overlap with the reference target of between 30-3000 square Angstroms; the combination comprises one or more non-reference target-derived constraints that are not derived from the reference target.
Said passages read on claims 1,2,3,6,7,8,14,15,49, 55,59,60,70,104; at least inherently on claims49 18,21;36,39,42,45 and 48,58,66,67,100; at least inherently on claims 73,88,91,94,97; and appears to read on claim 54 as well (see indefiniteness rejection below).
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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 fifth paragraph at p 12 of the remarks accompanying the present response argue by stating Greving is an exception to prior art since the present application and Greving are each assigned to iBio, Inc. and that the present application has a priority date of 5/31/2019, which is less than one year from earliest the priority date of Greving being 11/14/2018. Moreover, in said section the remarks contend the present invention was conceived and reduced to practice before the filing date of Greving.
Applicant’s arguments have been fully considered but they are not deemed persuasive for the following reasons.
First, it is not clear if such statement is attempting to invoke an exception under 35 USC 102(b)(1) or 35 USC 102(b)(2). The one year grace period alluded to in the remarks concerns 35 USC 102(b)(1) exceptions to 35 USC 102(a)(1) prior art, whereas the instant rejection over Greving is under 35 USC 102(a)(2). On the other hand, assuming arguendo the remarks are attempting to invoke 35 USC 102(b)(2) which does concerns exceptions to 35 USC 102(a)(2) prior art, it is noted in accordance with the last paragraph of MPEP 2154.02(c) that 35 USC 102(b)(2)(C), requires the subject matter disclosed and presently claimed be commonly assigned not later than the effective filing date of the invention under examination. Here, on 5/31/2019 (the present effective filing date), Greving (application 17/320118) was assigned to Rubryc Therapeutics, Inc., whereas the present application was assigned to Ibio, Inc. It appears it was only in September 2022, well AFTER 5/31/2019 - and even the present application’s actual filing date - that both Greving and the instant were assigned to Ibio, Inc.
Regarding conception and reduction to practice, it is noted the present application is filed under the first inventor to file (FITF) provisions of the AIA , that is NOT pre-AIA practice based on date of invention. See MPEP 2138.04-2139.05.
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.
Claim 18 is 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 18 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 18 depends from claim 0, which does not exist.
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).
Claim Objections
Claim 104 is objected to because of the following informalities: The struck through material previously presented referred to claim 99, not claim 100. To clarify the record, applicant may cancel claim 104 and add a new claim with precisely the same subject matter as currently presented.
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
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