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
2. The amendment filed 10/31/2025 is acknowledged and has been entered.
Claims 1 and 8 have been amended. Claims 2-7 have been cancelled.
Claims 1 and 8-20 are pending in the application. Claims 9-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 05/13/2025.
4. Claims 1 and 8 have been examined.
Grounds of Objection and Rejection Withdrawn
5. Unless specifically reiterated below, Applicant’s amendment and/or arguments have obviated or rendered moot the grounds of objection and rejection set forth in the previous Office action mailed 06/04/2025.
New Grounds of Rejection
Claim Rejections - 35 USC § 103
6. 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 of this title, 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.
7. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
8. Claims 1 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Ponnapakkam et al. (US 20190249163, published on 08/15/2019, IDS) in view of Lahoutte et al. (US 20180036442, published on 02/08/2018, IDS), and further in view of Wong et al. (US 20160115468, published on 04/28/2016, IDS).
Claims 1 and 8 are herein drawn to a fusion protein comprising a collagenase and a single domain antibody (sdAb) which is specific for HER2, wherein the sdAb comprises the sequence of SEQ ID NO:3 and the collagenase comprises the sequence of SEQ ID NO:5, the fusion protein further comprising an albumin binding domain.
Ponnapakkam et al. teach a fusion protein comprising a collagen-binding polypeptide segment and a therapeutic agent (e.g., polypeptide), wherein the collagen-binding polypeptide segment is a collagenase (SEQ ID NO: 6); see entire document, e.g., [0041], [0043], [0045].
The collagenase (SEQ ID NO: 6) of Ponnapakkam et al. is 100% identical with the instant claimed SEQ ID NO: 5; see sequence alignment 1 in the previous Office action mailed 06/04/2025.
Ponnapakkam et al. teach the two polypeptide segments of the fusion protein can be linked by peptide linkers; see [0041].
Ponnapakkam et al. teach a pharmaceutical composition comprising the fusion protein (the instant claim 8); see [0047], [0058].
Ponnapakkam et al. do not teach the polypeptide therapeutic agent is a single domain antibody (sdAb) which is specific for HER2.
However, this deficiency is remedied by Lahoutte et al.
Lahoutte et al. teach a sdAb (SEQ ID NO: 4) specific for HER2; see entire document, e.g., Tables 1-2, [0131-0132].
SEQ ID NO: 4 of Lahoutte et al. is 100% identical with the instant claimed SEQ ID NO: 3; see below sequence alignment 3 in the previous Office action mailed 06/04/2025.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the references so as to have a composition comprising a fusion protein comprising a collagenase and a single domain antibody (sdAb) which is specific for HER2. One would have been motivated to do so because Ponnapakkam et al. teach a fusion protein comprising a collagenase and a polypeptide therapeutic agent; Lahoutte et al. teach a sdAb (SEQ ID NO: 4) specific for HER2. Thus, one of ordinary skill in the art would have a reasonable expectation of success that by combining the teachings of the references so as to substitute the polypeptide therapeutic agent of Ponnapakkam et al. for another polypeptide (e.g., sdAb) of Lahoutte et al., because simple substitution of the polypeptide of Ponnapakkam et al. for another polypeptide (e.g., sdAb) of Lahoutte et al. would obtain predictable results.
Given the examination guidelines for determining obviousness under 35 U.S.C. 103 in view of the Supreme Court decision in KSR International Co. V. Teleflex Inc. 82 USPQ2d 1385 (2007) and the Examination Guidelines set forth in the Federal Register (Vol. 72, No. 195, October 10, 2007) and incorporated recently into the MPEP (Revision 9, March 2014), the following rationales to support rejection under 35 U.S.C. 103(a) are noted:
A) Combining prior art elements according known methods to yield predictable results.
B) Simple substitution of one known element for another to obtain predictable results.
C) Use of known technique to improve similar devices (methods, or products) in the same way.
D) Applying known technique to a known device (method, or product) ready for improvement to yield predictable results.
E) “Obvious to try” --- choosing form a finite number of identified, predictable solutions, with a reasonable expectation of success.
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art.
G) Some teachings, suggestion, or motivation in the prior art that would lead to one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
In this case, simple substitution of the polypeptide of Ponnapakkam et al. for another polypeptide (e.g., sdAb) of Lahoutte et al. would obtain predictable results.
Obviousness is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR International Co. V. Teleflex Inc. 82 USPQ2d 1385 (2007). From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Ponnapakkam et al. in view of Lahoutte et al. do not teach the fusion protein comprising an albumin binding domain.
However, this deficiency is remedied by Wong et al.
Wong et al. teach a fusion protein comprising an albumin binding domain, and the albumin binding domain modified fusion protein having high activity, more stable and long in vivo half-life; see entire document, e.g., [0003], [0008-0009], [0011], Example 1, claims 1 and 19-23.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the references so as to modify the fusion protein of Ponnapakkam et al. in view of Lahoutte et al. to include an albumin binding domain for the purpose of developing various fusion proteins including a fusion protein with an increased half-life, high activity and more stable, because a fusion protein comprising an albumin binding domain would have high activity, more stable and long in vivo half-life as taught by Wong et al.
Conclusion
9. No claim is allowed.
10. Applicant's amendment necessitated the new ground(s) of objection/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 extension fee 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 date of this final action.
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/YAN XIAO/Primary Examiner, Art Unit 1642