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.
Specification
The disclosure is objected to because of the following informalities: there are sequences disclosed without their SEQ ID number, note p6 for example. The MPEP states that "37 CFR 1.821(d) requires the use of the assigned sequence identifier in all instances where the description or claims of a patent application discuss sequences regardless of whether a given sequence is also embedded in the text of the description or claims of an application” (MPEP 2422.03).
Appropriate correction is required.
Drawings
The drawings are objected to because some figures are illegible without color, and some figures have sequences. Figs 7B and 16 both have too many different samples to tell one sample from another in greyscale. Applicants are required to either delete these drawings or redraw them so color is not needed. If that is not possible without losing information applicants believe is important, they can petition for color drawings. In addition, fig 10 lists sequences without the appropriate SEQ ID number. The MPEP states that "It should be noted that when a sequence is presented in a drawing, regardless of the format or the manner of presentation of that sequence in the drawing, the sequence must still be included in the sequence listing and the sequence identifier ("SEQ ID NO:X") must be used, either in the drawing or the brief description of the drawings” (MPEP 2422.02). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Election/Restrictions
Applicant’s election without traverse of PEG, PVA, or copolymers physically crosslinked with SEQ ID 2 in the reply filed on 5 Aug, 2026 is acknowledged.
The requirement is deemed proper and is therefore made FINAL.
Applicants elected SEQ ID 2 bound to PVA, PEG, or a copolymer of the two. A search was conducted for this invention, and references rendering it obvious were found. As a result, claims 123 and 128 were examined, and claims 1-5, 8, 10, 15, 21, 22, 37, 58-61, 63, 65, 66, 70, 76, 78, 79, 81, 82, 98, 99, and 120 were withdrawn from consideration. Applicants state that they believe many of the withdrawn claims read on their elected species, but these are all dependent on claims 1 or 2, which require a precursor formulation, with the polymer and the peptide not yet reacted. As applicants elected that the polypeptide be physically crosslinked, these claims are properly withdrawn.
During examination, a reference was found that anticipated at least one claim. This reference is discussed below.
Claims Status
Claims 1-5, 8, 10, 15, 21, 22, 37, 58-61, 63, 65, 66, 70, 76, 78, 79, 81, 82, 98, 99, 120, 123, and 128 are pending.
Claims 1-5, 8, 10, 15, 21, 22, 37, 58-61, 63, 65, 66, 70, 76, 78, 79, 81, 82, 98, 99, and 120 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. Applicant timely traversed the restriction (election) requirement in the reply filed on 5 Aug, 2026.
Claim Rejections - 35 USC § 112(b)
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 123 and 128 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Unfortunately, the peptide of claim 123 is not as well defined as could be desired. There are a number of issues. First, it is not clear if the limitation “folding group” is a functional limitation requiring that this group induce some structure to the peptide, or if the “plurality of charged amino acid residues and hydrophobic residues arranged in a substantially alternating pattern” is all that is required. Note that applicants have not defined this term, and “plurality” is defined as two or more items (p98, line 15), so the only structural information is one charged and one hydrophobic residue. The next issue is the limitation “amphiphilic.” It is not clear what this means, and the term is not defined by applicants. Typically, this means a compound with hydrophobic and hydrophilic sections, note Dehsorkhi et al (cited by applicants)(2nd page, 2nd column, 3d paragraph), but the examples of applicants do not have this feature. The next issue is the term hydrophobic. Applicants have defined hydrophobic amino acid residues as those that tend to repel water (p23, 2nd paragraph). That does not provide a clean test for any given residue. Note that the cutoff between hydrophobic and non-hydrophobic is not established in the art; for example, Zhang et al (US 5,670,483) describes both Ser and Thr as hydrophobic (see claim 7), while the Boc sales literature (downloaded 26 Aug, 2026) lists both residues as hydrophilic (p7-8). Next, it is not clear what a “substantially alternating pattern” limits the claims. It is clear that a pattern of alternating hydrophobic and charged residues will meet the limitation, and “substantially” allows for some disruption of this pattern, but it is not clear how much variation it allows. Finally, it is not clear what is meant by a “turn sequence,” a term not defined by applicants. Note that peptides are typically unstructured (Merritt et al, Pept. Sci. (Hoboken) (2020) 112(1), 1st page, 2nd paragraph). Helices have turns; for an α-helix it’s one turn every 3.5 amino acid residues. Beta sheets have turns at either end of the sheet. Proline will induce a kink into a structure, while Gly will allow a bend at that site. This leads to multiple reasonable interpretations of this claim language.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 128 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 123, from which claim 128 depends, requires crosslinking. Claim 128 required covalent, ionic, or physically crosslinking the compound. This is every way it can be done, so the claim is not further limiting. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 123 and 128 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kudva et al (J. Biomed. Matter. Res. part A (2018) 106A p33-42).
Kudva et al describe a reaction between 20 kDa 4-arm PEG-vinyl sulfone with the sequence GCGYGRGDSPG (p34, 2nd column, 4th paragraph). Note that this sequence has CGYGRGD (charged and hydrophobic residues in a substantially alternating pattern) and a Pro residue (turn sequence, note p23, last paragraph of spec). Thus, the reference anticipates claims 123 and 128.
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) 123 and 128 are rejected under 35 U.S.C. 103 as being unpatentable over Piluso et al (cited by applicants) in view of Veiga et al (Biomater. (2012) 33 p8907-8916).
Piluso et al discuss hydrogels with RADA16 peptides (title). This allows for modulation of hydrogel properties by chemical crosslinking (introduction). RADA16 sequences with Cys residues were bound to a vinyl sulfone 4 arm PEG (materials and methods). These compounds supported cell adhesion (results and discussion) and mention 2D and 3D structures (conclusion). Note that 2D is reasonably interpreted as a film, and 3D requires a porous material, or the cells will not be able to enter the structure.
The difference between this reference and applicant’s elected species is that this reference does not discuss SEQ ID 2.
Veiga et al discuss self assembling peptides as antibacterial gels (title). A number of sequences were tested, including PEP6R, identical with SEQ ID 2 of the examined claims and applicant’s elected peptide. These sequences rapidly form a beta sheet fibrillar network that forms a hydrogel (p8909, 2nd column, 2nd paragraph), similar to the RADA16 of Piluso et al. These sequences are also antibacterial (p8911, 1st column, 2nd paragraph), and the PEP6R showed low hemolytic activity (p8912, 1st column, 1st paragraph). The authors state that this sequence has the optimal biological and material properties (p8913, 2nd column, 3d paragraph, continues to p8915, 1st column, 2nd paragraph). This reference discusses a peptide sequence similar to RADA16 in many ways.
Therefore, it would be obvious to use the sequence of Veiga et al in the formulation of Piluso et al, to add antimicrobial properties to the compounds. As both sequences form fibrilliar networks, and the peptide of Veiga et al has low hemolytic activity, an artisan in this field would attempt this substitution with a reasonable expectation of success.
Conclusion
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.
Examiner interviews are available via telephone 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, 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.
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.
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
Prosecution Insights