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 12/4/2023 and 6/4/2026 election
Claims pending 1-22
Claims withdrawn 1-8,21-22 and 9-13
Claims currently under consideration 14-20
Priority
This application has a filing date of Filed: 06/12/2023 and has
PRO 63/350,939 06/10/2022
Election/Restrictions
Applicant’s election without traverse of group II in the reply filed on 6/4/2026 is acknowledged.
Claims 1-8,21-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/4/2026.
Applicant’s election without traverse of including isolating B cells as species of screening technique in the reply filed on 6/4/2026 is acknowledged.
Claims 9-13 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/4/2026.
The requirement is still deemed proper and is therefore made FINAL.
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 14,16-18 are rejected under 35 U.S.C. 102(a)(1 & 2) as being anticipated by Borras et al (US AppPub 20110117091).
Borras et al teach throughout the document and especially paragraphs 0090-0094,0096,0100 and 0020+ selecting antibodies against target IMPs (integral membrane proteins) including steps of: isolating B cells from an animal immunized with such target antigen; sorting the B cells to isolate B cells that express antigen-specific IgGs by FACS and/or CELISA (cell ELISA) “detectable” plate; and using RT-PCR for sequencing and cloning the isolated B cells (performing single cell analysis to identify immunoglobulin variable genes expressed by the sorted B cells). The foregoing reads on claims 14,16,17 & 18.
Claim Rejections - 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 14,16-18 and 15,19, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Borras et al (US AppPub 20110117091) in view of Smith et al (US AppPub 20190276556 – IDS entry 2/26/2024).
Borras et al is relied on as above plus regarding claim 15 lines 2-3. In addition, Borras et al suggest in paragraph 0164 & 0193 and figure 2 respectively, mammalian expression vectors that maintain VH (variable heavy chain) and VL (variable light chain) pairing as minibodies as in claim 20 lines 2-4; and finally fluorescent beads like claim 19.
Borras et al do not explicitly teach a phage Fab display library panned to eliminate anti-poxvirus and enrich for IMP binding molecules per claim 15 lines 1,3-4 & claim 20 lines 1-2; nor streptavidin of claim 19.
Smith et al teach throughout the document and especially the abstract, title and paragraph 0012, displaying target IMP antigens on poxvirus extracellular enveloped vaccinia virons (EEVs) that are preferably biotinylated. More particularly and like present claims 15 lines 1,3-4; 20 lines 1-2; and 19, in document claims 24,26,28, figure 5 and paragraph 0075 if necessary, Smith et al suggest panning a phage Fab display library necessarily generated from VH and VL genes with streptavidin coated surface to eliminate anti-poxvirus while enriching for binding molecules (anti-target IMP binding antibodies).
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 utilized Smith’s biotinylated EEVs in developing or refining IMP antibodies of Borras et al.
One of ordinary skill in the art would have been motivated t have utilized Smith’s biotinylated EEVs in developing or refining IMP antibodies of Borras et al for the advantages of higher antigen density and offering convenience in screening, selecting and indentifying such very antibodies, as described by Smith et al in paragraph 0127.
One of ordinary skill in the art would have had a reasonable expectation of success in applying the EEV technique of Smith et al toward antibody screening selection and/or identification in Borras et al in light of the considerable technological overlap between each reference, each directly concerning antibodies against the same IMP antigens as well as streptavidin-biotin being robust chemistry, recognized the art for decades.
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 14-20 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 14c recites the limitation "the Immunoglobulin variable region genes" in line 1. Claim 16 recites the limitation "the variable heavy chain genes and/or variable light chain genes " in lines 1-2. Claim 20 recites the limitation "the VH and VL genes (V genes)" in line 1. There is insufficient antecedent basis for these limitations in the claims, 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 14 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.
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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