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 3JUL2026
Claims Pending 1,3-15,17,18,20-24
Claims Under Consideration 1,3-15,17,18,20-24
Priority
This application has a filing date of 07/15/2023 and has
PRO 63/389,883 filed 07/16/2022
Withdrawn Objection(s) and/or Rejection(s)
The rejection of claims 1,4,5,7-11 under 35 U.S.C. 102(a)(1 & 2) as being anticipated by Lai et al (WO 2006/110918 aka PCT/0S2006/014353) is hereby withdrawn in light of Applicant’s amendments.
The rejection of claim 19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is hereby withdrawn in view of cancellation thereof the claim.
Maintained Claim Rejection(s) - 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1,3-15,17,18,20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Lai et al (WO 2006/110918 aka PCT/0S2006/014353) in view of Gay et al (1999 Int J Cancer 83:235-41) as evidenced by Lockhart et al (US AppPub 20030186221) if necessary.
Lai et al teach throughout the document and especially the abstract and example 17, using a phage display affinity technique featuring specificity filters and forward screening of Lockhart et al that includes: contacting a reference ligand immobilized on solid support beads, with a phage-displayed protein domain of interest in the presence and absence of the test compound*, such as a small molecule pharmaceutical candidate molecules; incubating the immobilized reference ligand and the phage-displayed protein domain of interest under conditions allowing binding between the immobilized reference ligand and the phage-displayed protein domain of interest in the presence and absence of the test compound, wherein the phage-displayed protein domain of interest binds a specific peptide the immobilized reference ligand; removing the unbound phage-displayed protein domain of interest and detecting the phage-displayed protein domain of interest bound to the immobilized reference ligand by qPCR (quantitative polymerase chain reaction; that is detecting a DNA amplicon located within a phage genome associated with the phage-displayed protein domain of interest), whereby a decrease in the binding of the phage-displayed protein domain of interest to the immobilized reference ligand in the presence of the test compound as compared to the absence of the test compound indicates that the test compound binds to the protein domain of interest. The foregoing reads on claims 1 (in part),4,5,7,8,9,10,11,12 (in part), 14,17 and 18 (in part).
At p 63 lines 28-37 and as in claims 21 and 23, Lai et al further teach using qPCR in determining a dissociation constant for binding between the test compound and the phage-displayed protein domain of interest based on the detected amount of the phage-displayed protein domain of interest bound to the immobilized reference ligand at one or more concentrations of the test compound, wherein a decrease in binding of the phage-displayed protein domain of interest to the immobilized reference ligand is detected at a low concentration of the test compound, thereby necessarily identifying the test compound as a high affinity binder of the phage-displayed protein domain of interest.
Lai et al do not explicitly teach: human SH2 domains that bind a specific phosphopeptide sequence in a known ligand as in claims: 1;3;6;12;13,15,18, 20, 22 & 24 inter alia. However, Gay et al disclose throughout the document and especially the first paragraph of the text Grb2 human SH2 domains that bind SHC bearing a specific phosphopeptide endogenous ligand sequence that is inhibited by small molecule drug candidates like claims 1;3;6;12;13,15,18, 20, 22 & 24 inter alia as well as further reading on claims 4,5 and 14.
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 the phage display affinity technique featuring specificity filters and forward screening utilized by Lai et al detailed in Lockhart et al for assaying Grb2 binders as disclosed in Gay et al.
One of ordinary skill in the art would have been motivated to have employed the phage display technique utilized by Lai et al for assaying Grb2 binders as disclosed in Gay et al for the benefits of: obviating the problem of false positives, permitting discovery of interactions of only moderate affinity, as well as providing a method to screen for a multiplicity of alternative compounds which could substitute for compounds that have been found to bind to a particular phage-displayed protein, all as further described in Lockhart et al paragraph 0009.
One of ordinary skill in the art would have had a reasonable expectation of success in applying the phage display affinity technique featuring specificity filters and forward screening utilized by Lai et al toward Grb2 ligand discovery as in Gay et al since substituting the DNA encoding one protein for another and is well within reach of a competent molecular biologist.
* For additional experimental details concerning such phage display affinity technique with specificity filters and forward screening, in paragraph 0039, Lai et al incorporate by reference the entirety of Lockhart et al: see paragraph 0045+.
***
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.
More particularly, starting with the paragraph spanning pp 7 to 8, the current remarks urge Lai does not disclose a phage-displayed SH2 domain that binds to a specific phosphopeptide sequence that is detected with a DNA amplicon associated with such phage genome. In the following paragraph, the remarks contend that Gay teaches SH2-phosphopeptide competition assays but asserts Gay utilizes GST fusion protein immunoassays rather than qPCR of phage displaying SH2s and only reports IC50 values.
In response, regarding detection with a DNA amplicon associated with such phage genome, applicant’s attention is respectfully invited p 63 lines 28-37 of example 17 cited in the previous action, which plainly discloses performing qPCR of the phage genome to determine KD.
Whereas in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Here, a SH2 domain that binds a specific phosphopeptide sequence (and small molecule competitive inhibitors thereof) is provided in Gay as admitted by applicant. Gay’s GST fusion protein immunoassays is immaterial, since it is the combination of Lai and Gay that would have suggested to the skilled artisan a phage-displayed SH2 domain that binds to a specific immobilized phosphopeptide sequence quantitated with a DNA amplicon associated with such phage genome in an effort to measure dissociation constants (KDs) of potent competitors.
Finally, as applicant notes, the fact that Gay et al only report IC50 values - which are simpler to determine experimentally than KD - only serves to provide even more motivation to combine with Lai et al.
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 3 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 3 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 or alternatively, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted structural cooperative relationships or omitted steps which render the metes and bounds uncertain are as follows.
Claim 3 depends from claim 2, which is now cancelled.
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 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTOPHER M GROSS/
Primary Examiner, Art Unit 1684
