DETAILED ACTION
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 .
Response to Amendment
Applicant’s amendment filed 09/19/2025 is acknowledged. Claims 1, 7, and 9 are amended. Claims 20-21 are new. Claims 10-19 are withdrawn. Claims 1-9 and 20-21 are under examination.
Objection/Rejections Withdrawn
All previous rejections and/or objections to claims 10-19 are hereby withdrawn in response to Applicant’s withdrawal of the claims.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Specification Objections
The objection to the Title of the Specification is withdrawn in response to the Applicant’s correction of the grammatical error.
Claim Rejections - 35 USC § 112(b)
The rejections of claims 1-9 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in response to Applicant’s amendment removing the indefinite language outlined at pages 3-4 of the Office action mailed 03/20/2025.
Claim Rejections - 35 USC § 112(a) – Enablement
The rejection of claims 1-9 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in response to Applicant’s amendment. Applicant has amended claims 1 and 7 to delete reference to conservative variants of SEQ ID NO: 1.
Claim Rejections - 35 USC § 112(a) – Written Description
The rejection of claims 1-9 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in response to Applicant’s amendment. Applicant has amended claims 1 and 7 to delete reference to conservative variants of SEQ ID NO: 1.
Rejections Maintained
Claim Rejections - 35 USC § 103
The rejection of claims 1-7 under 35 U.S.C. 103 as being obvious over Hamzah et al., 2014 in view of Zhang et al., 2004 is maintained for reasons of record and the following.
Response to Arguments
Applicant argues at pages 7-8 that one of ordinary skill in the art at the time of the invention would have (i) lacked motivation to use the CSGRRSSKC peptide of Zhang in place of CSG of Hamzah, and (ii) even if the skilled person had considered modifying the conjugates of Hamzah, they could not have had a reasonable expectation of success in doing so. Applicant argues that Zhang merely makes a passing reference to the identification of the CSGRRSSKC peptide through in vitro biopanning of a CX7C phage library and in vivo selections in tumor-bearing mice. Applicant argues that Zhang does not teach binding of ECM by the CSGRRSSKC peptide. Applicant argues the authors only speculate that the CSGRRSSKC peptide "could be a candidate peptide that targets extracellular matrix of breast tumor" (sentence bridging pages 6-7 of the publication). Applicant argues the authors fail to provide any experiments with the peptide demonstrating it has ECM binding activity. Applicant argues it was not until the work of the present inventors that the ECM-binding activity of the CSGRRSSKC peptide was confirmed. Applicant argues that prior to the work of the present inventors, the skilled person would have lacked motivation to test the use of the CSGRRSSKC peptide in a conjugate with TNFa, based only on the highly speculative teachings of Zhang. Applicant argues that the skilled person could not have had a reasonable expectation of success even if they had prepared and tested the conjugate. Applicant argues that it is only through hindsight analysis that the invention can be said to be obvious in view of Hamzah and Zhang.
This has been fully considered, but is not found to be persuasive. In regards to the Applicant’s argument that there was a lack of motivation to combine Hamzah and Zhang, an ordinary artisan would want to synthesize and use the peptide taught by Hamzah to treat cancer, yet Hamzah is silent on the specific sequence. Since the specific sequence is required to make and use the peptide to treat cancer, an ordinary artisan would be motivated to search the prior art and would find it obvious that Zhang SEQ ID NO: 1 would remedy this deficiency because Zhang teaches the peptide could be useful for binding the ECM and Hamzah teaches the CSG motif in SEQ ID NO: 1 is the structure necessary to perform the function of binding the ECM. In regards to Applicant’s argument a skilled artisan would not have a reasonable expectation of success because Zhang “only speculates” and “does not teach binding of ECM by the CSGRRSSKC peptide,” it is Hamzah in view of Zhang that provides the reasonable expectation of success, not Zhang viewed alone. Hamzah teaches that the conjugate degrades the ECM and teaches the structure of the CSG motif within the peptide binds the ECM. An ordinary artisan would therefore have a reasonable expectation of success. Furthermore, in regards to the Applicant’s argument that Zhang does not provide experiments that demonstrate the peptide has ECM binding activity and the present inventors do provide experimental data demonstrating the binding activity that Zhang suggested, it is not inventive to find the teachings of Zhang to be accurate. Said another way, providing data to support Zhang does not render the limitation non-obvious. In response to Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The rejection of claims 1-9 under 35 U.S.C. 103 as being obvious over Hamzah et al., 2014 and Zhang et al., 2004, as applied to claims 1-7 above, and in further view of Wriggers et al., 2005 is maintained for reasons of record and the following. In addition, new claims 20-21 are hereby included in this rejection. Specifically, Wriggers teaches that the linker can comprise two or more, or three or more, glycine residues (Fig. 3; pg. 739 second column). The rejection of claims 20-21 are necessitated by amendment as limitations of claim 9 have been moved to dependent claims 20-21.
Response to Arguments
Applicant argues at pages 7-8 that the Examiner concedes that Hamzah and Zhang do not disclose glycine-rich linkers but cites Wriggers as teaching that such linkers are commonly used to conjugate two proteins. Applicant argues that reference is made to the arguments presented above regarding the failure of the combination of Hamzah and Zhang to make obvious the invention as recited in the amended claim set. Applicant argues that it is submitted that the additional disclosure of Wriggers does not cure the defects of Hamzah and Zhang. Applicant argues that the combination of Hamzah, Zhang, and Wriggers fails to make obvious the invention as recited in the amended claim set presented herein.
This has been fully considered, but is not found to be persuasive. In response to Applicant’s argument that an ordinary artisan would have no reason to use the Wriggers’ linkers because Wriggers does not cure the defects of Hamzah and Zhang, an ordinary artisan would have both had a motivation to combine and a reasonable expectation of success, as outlined above, and as such, an ordinary artisan would be motivated to use the Wriggers linkers to fuse the conjugate together because Wriggers teaches that linkers offer control of structural flexibility between two conjugated proteins which allows for the proper function of each domain (Wriggers abstract). Said another way, Zhang cures the defects of Hamzah, as outlined above and for reasons of record, and Wriggers provides a useful, and obvious, means to link the domains together. Furthermore, an ordinary artisan would have had a reasonable expectation of success.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH CESARE whose telephone number is (571)272-6908. The examiner can normally be reached Monday - Friday 10am-4pm.
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, Jeffrey Stucker can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH D. CESARE/ Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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