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 . 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 (i.e., changing from AIA to pre-AIA ) 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 16 June, 2025 has been entered.
Election/Restrictions
Applicants elected a composition comprising biopolymer with segments B, C, X, Y, and D without traverse in the reply filed on 31 July, 2024.
Claims Status
Claims 1, 2, 4-11, 16-20, 28, and 30-32 are pending.
Claims 1, 2, 7, and 9 have been amended.
Claims 2, 4-10, 18-20, 28, and 30-32 have been withdrawn due to an election/restriction requirement.
Claim 2 was previously examined, however, applicants have amended this claim so it no longer reads on applicant’s elected species.
Withdrawn Rejections
The rejection of claim 2 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or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is hereby withdrawn due to amendment.
The rejection of claims 1, 2, 11, 16, and 17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to inconsistency with a limit on the number of repeats and the open claim language is hereby withdrawn due to amendment.
The rejection of claim 16 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to uncertainty as to what constitutes a bioink is hereby withdrawn due to amendment.
Maintained/Modified Rejections
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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 11, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez-Colino et al (Biomacromolecules (2015) 16(10) p3389-3398, cited by applicants) in view of Fernandez-Colino et al (Biomacromolecules (2014) 15 p3781-3793, called Fernandez-Colino1 in this office action).
Fernandez-Colino et al discuss a polypeptide with both an elastin like block and a leucine zipper block to generate stable hydrogels (title). The idea is to combine the dimerization ability of the leucine zipper with the thermal responsiveness of the elastin like polypeptide (p3390, 1st column, 2nd paragraph). Three sequences were made, all have an MESLLP N-terminal sequence, followed by an elastin like polypeptide sequence (VPGVG)2-(VPGEG)-(VPGVG)2-(VGIPG)60, with the other two having an leucine zipper sequence, one with VGGGGGKENQJAIRASFLEKENSALRQEVADLRKELGKCKNILAKYEAGGGGG, the other with the Cys residue mutated to a Leu (table 1, p3391, top of page). Note that the elastin like polypeptide sequence comprises repeats of SEQ ID 7 and SEQ ID 3 (monomers B and C of claim 1), and the Cys bearing leucine zipper matches SEQ ID 4 of the application, monomer X. Upon heating to 37°C, all three materials at 15 wt% in solution formed hydrogels, but were liquids at 5°C (p3392, 1st column, 3d paragraph and fig 3, p3392, 1st column, bottom of page). When excess medium was added, the elastin like polypeptide gel dissolved, while the other two were much more stable, with the Cys leucine zipper variant more stable than the Leu mutated version (p3392, 2nd column, 4th paragraph). In other words, the leucine zipper improves the stability of the hydrogels (p3392, 2nd column, 5th paragraph).
The difference between this reference and the examined claims is that this reference does not have a segment Y (SEQ ID 8).
Fernandez-Colino1 discusses silk-elastin block polymer to form hydrogels (title). These experiments used two sequences; one identical to the elastin like polypeptide control of Fernandez-Colino et al, the other with an additional segment V(GAGAGS)5G (comprising SEQ ID 5 of the examined application) attached to the C-terminal end of the elastin like polypeptide sequences. Both sequences dissolved at 15% in water formed hydrogels upon heating (p3784, 2nd column, 2nd paragraph). Similarly, to Fernandez-Colino et al, the hydrogel formed by the control sequence dissolved upon dilution, while the silk polypeptide sequence addition conferred stability to the hydrogel under the same conditions (p3785, 1st column, 1st paragraph). The authors mention the ability to add such features as cell adhesion sequences (p3791, 2nd column, 2d paragraph).
Therefore, it would be obvious to add the silk polypeptide sequence from Fernandez-Colino1 to the polypeptide of Fernandez-Colino et al to increase the stability of the sequence as a hydrogel. As this addition showed this effect for the elastin like polypeptides of Fernandez-Colino1, and the sequences of Fernandez-Colino et al comprise the same sequence, an artisan in this field would attempt this modification with a reasonable expectation of success.
The combination of references generates a polypeptide with segments B, C, X, and Y, rendering obvious claim 1.
Both references discuss hydrogel formation by heating in aqueous solution, rendering obvious claim 11.
There is no mention of properties that would preclude printing with these materials, rendering obvious claim 16.
The hydrogels are 3D structures, and there is nothing described in either reference that would preclude using them internally. Note that Fernandez-Colino et al (title) and Fernandez-Colino1 (abstract) both describe their materials as injectable, suggesting internal intended use. Thus, the combination of references renders obvious claim 17.
response to applicant’s arguments
Applicants argue a number of improved properties, which they say are an unexpected result.
Applicant's arguments filed 16 June, 2025 have been fully considered but they are not persuasive.
Applicants have argued that the material with both binding segments has improved print fidelity, enhanced shape retention, and accelerated crosslinking, which they argue are unexpected results. It is applicant’s responsibility to demonstrate that the results are unexpected (MPEP 716.02(b)(1)); this burden has not been met. The first two results that applicants are arguing is essentially improved cohesion, but Fernandez-Colino1 explicitly states that the portion that corresponds to SEQ ID 5 self assembles (p3782, 1st column, 3d paragraph, continues to 2nd column, 1st paragraph). This indicates attractive forces, i.e. cohesion. The reference also mentions that these domains crosslink themselves (p3782, 2nd column, 1st paragraph); an additional crosslinking domain would reasonably lead to more crosslinks in the same amount of time compared to a species without the additional crosslinking domain. In other words, the results that applicants are claiming are unexpected would reasonably be expected to flow from the known properties of the polypeptide corresponding to SEQ ID 5.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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