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 1/6/2026
Claims pending 1-22
Claims currently under consideration 1-22
Priority
This application has a filing date of 09/19/2022 and has PRO
63/247,160 filed 09/22/2021.
Withdrawn Objection(s) and/or Rejection(s)
The rejection of claim 22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is hereby withdrawn in light of Applicant’s amendments.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)(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 1-15,18-21 stand rejected under 35 U.S.C. 102(a)(1 & 2) as being anticipated by Bergo et al (US AppPub 20120077688).
Throughout the document and especially the title and paragraphs 0002-0004,0006-0007,0027+ Bergo et al is drawn to global proteomic interaction screening with and without beads in, for instance, a microtiter plate (a kind of array with interstitial spaces between small wells) applied toward diagnosing autoimmune diseases. More particularly, such as applied toward in figures 12-15 and at paragraphs 0242-0245, 0007-0024, 0293, 0263 and/or 0012, Bergo et al teach:
providing a 96 well array comprising a plurality of analyte binding sites (e.g. various polyclonal or monoclonal antibody gamma globulins (aka immunoglobulins -- inherently polypeptide molecules that include linkers and comprise small molecule metabolites such as l-alanine bearing a methyl group), such that each analyte binding site of the plurality of analyte binding sites binds a single analyte (e.g. a HSV tagged protein) and is optically resolvable at single-analyte resolution in, for example, the experiment described in paragraphs 0242 and 0245, and further such that, each analyte binding site comprises one and only one binding ligand of a plurality of binding ligands, that is like any antibody or else in each well; contacting such single-analyte array with a plurality of polypeptides in sera, wherein the plurality of polypeptides may be cross-linked and/or constitute an entire human proteome; binding polypeptide molecules of the plurality of polypeptides to a binding ligand of an analyte binding site of the plurality of analyte binding sites; detecting at single-analyte resolution those molecules so bound; and finally determining an identity of such molecules, for example, with a labeled reporter antibody based upon array location or else mass spectrometry. The foregoing reads on claims 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,18,19,20 and 21.
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Please note that the above rejection has been updated from the original version to more clearly address applicants’ new claim amendments 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.
Initially, the penultimate paragraph at p 6 of the current remarks alleges the examiner only relied upon Bergo paragraphs 0002-0004 and 0006-0007, contends Bergo et al only teaches bead arrays and nowhere does Bergo et al teach an analyte binding site that binds only a single analyte with single-analyte resolution.
In this vein, first of all, it is noted the previous action relied upon more than just the paragraphs alleged by the remarks, but also figures 12-15, paragraphs 0242-0245, 0008-0024, 0293, 0263 and/or 0012. Indeed, in paragraph 0242,0245 with results illustrated in figure 12C, Bergo, beyond bead embodiments, for example: provides a 96 well plate (an array) with wells coated with an antibody ligand of a plurality of binding ligands that specifically binds a HSV-tagged proteins; contacts the plate with VSV-GST-HSV or else VSV-SLE (systemic lupus erythematosus autoantigen)-HSV analytes in serum (inherently with well over 1000 different primary sequences) plus negative controls in separate coated wells; detects such bound analytes in each well (single-analyte resolution) with anti-human or VSV specific antibodies; and finally based on the well coordinates (among other approaches) determines the identity which peptide(s) form a sandwiches comprising such anti-HSV ligands like illustrated in figure 12A. In other words, the experimental conditions necessarily have “analyte-specific resolution”, an interpretation consistent the with the definition set forth in paragraphs 0164, 0063,0117 and/or 0051 of the present published application.
Maintained & New Claim Rejection(s) – 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-15,18-21 and 16-17 remain rejected under 35 U.S.C. 103 as being unpatentable over Bergo et al (US AppPub 20120077688) in view of Lorre et al (US AppPub 20230059548).
Bergo et al is relied on as above and the linker recited in claim 17 inter alia.
Bergo et al do not explicitly teach a ligand cross-linking a polypeptide per claims 16-17.
Like claims 16-17, Lorre et al teach throughout the document and especially document claim 1, figure 14, p 76 & p 8 lines 18-26, diabody bispecific tetravalent antibodies which act as a cross-linker between antigens B7.1 and B7.2, which Lorre envisions as the ideal drug to prevent transplant rejection.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have evaluated anti B7.1 + B7.2 diabodies of Lorre et al for evaluating proteome interaction therewith like Bergo et al.
One of ordinary skill in the art would have been motivated to have evaluated anti B7.1 + B7.2 diabodies of Lorre et al for evaluating proteome interaction therewith like Bergo et al in an effort to select variants with minimal side reactions: as interpreted in MPEP 2141 section III (C) the Supreme Court held under KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385, 1396 (2007) the use of a known technique to improve similar devices methods in the same way is obvious.
One of ordinary skill in the art would have had a reasonable expectation of success in analyzing Lorre’s bispecific diabodies with the global proteomic interaction screening approach of Bergo et al, since swapping one antibody for another entails minimal changes.
Response to Arguments
Applicant does not offer further arguments regarding the above obviousness rejection(s) beyond what was set forth with regard to the 35 U.S.C. § 102 rejection, above. To the extent that Applicant is merely repeating their previous argument, the examiner respectfully submits that those issues were adequately addressed supra, which is/are incorporated in their entireties herein by reference.
Claims 1-15,18-21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Bergo et al (US AppPub 20120077688; of record) in view of Sgourakis et al (US AppPub 20230059548). Bergo et al is relied on as in the above 35 USC 102 rejection above regarding claims 1-15,18-21.
Bergo et al do not explicitly teach using a machine learning process of claim 22.
Sgourakis et al teach throughout the document and especially paragraphs 0004-0005 and/or 0105, using machine learning to identify peptides that bind particular MHC alleles.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have employed machine learning as in Sgourakis et al in order to identify autoantigenic sequences in peptide libraries of interest to Bergo et al (cf paragraphs 0027,0048).
One of ordinary skill in the art would have been motivated to have employed machine learning as in Sgourakis et al in order to identify autoantigenic sequences in peptide libraries of interest to Bergo et al because determining which MHC alleles that cause a T cell response in autoimmune diseases is useful according to Sgourakis et al in paragraph 0082, whereas indeed Bergo notes in paragraph 0028 the root causes of the immune dysfunction underpinning autoimmune disease are still not well understood.
One of ordinary skill in the art would have had a reasonable expectation of success in applying the machine learning Sgourakis et al toward identifying autoantigen epitopes in Bergo’s libraries, since Sgourakis et al expressly specify suitability therefor in paragraph 0083.
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 1-22 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 1b recites the limitation "the single-analyte array" in line 1. There is insufficient antecedent basis for this limitation in the claim, rendering the metes and bounds uncertain.
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.
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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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