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 .
Priority
This application claims benefit of priority to Provisional Application 63/276,943 filed 11/08/2021.
Drawings
The drawings were received on 06/30/2026. These drawings are not acceptable. The New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the newly filed drawing are marked up, a clean copy of the drawings is required. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Amendment and Claim Status
In the reply filed 06/30/2026, Applicant amended claims 1 and 6-8.
Claims 1-20 are currently pending.
Claims 11-20 are withdrawn by the Examiner as they are not encompassed by the elected group.
Claims 1-10 are under examination.
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.
Claims 9-10 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.
Claims 9 and 10 recite “a first peptide fusion protein” and “a second peptide fusion protein” in line 2 of each claim, respectively. A ‘peptide fusion protein’ is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what a “peptide fusion protein” is. It is unclear whether a peptide fusion protein is the fusion of a peptide and a protein, the fusion of two peptides creating a protein or something else. If a peptide fusion protein is the fusion of a peptide and a protein, the claim is further unclear because a protein is not claimed, a repeating peptide unit having a C-terminus and N-terminus is claimed. A ‘peptide unit’ is not necessarily a protein. Overall, claims 9 and 10 are unclear.
35 USC § 112 - Response to Arguments
Applicant's arguments filed 06/30/2026 have been fully considered but they are not persuasive.
Applicant argued the phrase “peptide fusion protein” is described in the instant Specification as being used to form the junction of the hydrophobic and hydrophilic arms and can comprise SpyTag and SpyCatcher. Applicant further states SpyTag/SpyCatcher has been used in the field for over a decade via the term “fusion protein” and argues the term would be instantly recognizable to those of skill in the art.
The Examiner respectfully disagrees. A description of what a ‘peptide fusion protein’ does or an example of what a peptide fusion protein can be does not make it clear exactly what a peptide fusion protein is. Additionally, the Examiner agrees that the term ‘fusion protein’ is recognizable to one of ordinary skill in the art. However, a ‘fusion protein’ is not claimed, a ‘peptide fusion protein’ is claimed and it remains the Examiner’s position that it is unclear what a ‘peptide fusion protein.’ It is unclear how the term ‘peptide’ is intended to limit the fusion protein. Thus, the 112b rejection over claims 9-10 is maintained.
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.
Claims 1-2 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hossainy et al. (US 20070286885 A1, 12/13/2007) (Of Record) in view of Chilkoti et al. (US 20190328662 A1, 10/31/2019) (Of Record) as evidenced by Lotocki et al. (Pharmaceutics, 08/30/2020) (Of Record).
Regarding claims 1 and 7-8, Hossainy et al. disclose a copolymer comprising a block of an elastin pentapeptide and a method of making and using the copolymer (See entire document, Abstract). The elastin-based copolymers are useful for coating an implantable device such as a drug delivery stent or for forming a composition such as a cell therapy carrier (Paragraph [0002]). Specifically, the elastin-based polymer is an ABA triblock copolymer, where A is a block comprising the VGVPG sequence and B is a block derived from a peptide or monomer, or B can be a hydrophilic variant of the VGVPG peptide wherein variant refers to any form of VGVPG modification (Paragraph [0015]). For example, an amino acid in the peptide can be replaced with another amino acid or the sequence of VGVPG can be varied so as to form a variant of the VGVPG peptide (Paragraph [0015]). In some embodiments, the polymer can be a branched polymer such as a star polymer (Paragraph [0023]). Thus, Hossainy et al. disclose an ABA triblock copolymer wherein the two A portions are the amino acid sequence VGVPG, reading on a first and second hydrophobic arm, and the B portion is a hydrophilic variant of the amino acid sequence VGVPG, reading on a first hydrophilic arm, making the copolymer amphiphilic. Additionally, the peptide sequences disclosed by Hossainy et al. necessarily each have a C-terminus and an N-terminus.
Hossainy et al. do not explicitly disclose the first hydrophilic arm is bound to the first hydrophobic arm at a junction formed by the second N-terminus and the first C-terminus or the second hydrophobic arm is bound by the third C-terminus to the junction of the first hydrophilic arm and the first hydrophobic arm. Additionally, Hossainy et al. do not explicitly disclose the arms are comprised of repeating peptide units.
However, it appears, absent evidence to the contrary, the ABA triblock copolymer as a branched star polymer disclosed by Hossainy et al. would necessarily have this conformation as evidenced by Lotocki et al. Lotocki et al. disclose:
miktoarm polymers (sometimes known as heteroarm star polymers) are a class of star polymers with asymmetric branching in which at least three branching strands originate from a shared core. Their compositions differ from slight variations in molecular weight, to having completely different repeating units and chemical configurations. Due to their asymmetry, miktoarm variants are categorized in the form: AXBYCZ, where A, B and C are examples of polymeric chains, and the subscript denotes their number (Page 2, Paragraph 2).
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(Figure 1 of Lotocki et al.)
Thus, it appears, absent evidence to the contrary, the ABA triblock copolymer in a branched star configuration disclosed by Hossainy et al. would necessarily have all of the arms, including both hydrophobic arms and the one hydrophilic arm, bound at a central junction as that is the general configuration of star polymers. Additionally, the peptide units would necessarily be repeating as that is what a polymer is, a molecule composed of multiple monomers, with the monomers in this case being the peptide units. This is evidenced by Lotocki et al., as discussed above, who state the composition of miktoarm stars differ based on different repeating units (Page 2, Paragraph 2).
Regarding the newly added limitation to instant claim 1, Hossainy et al. do not disclose a lipid bound to an end the first hydrophobic arm. Similarly, Hossainy et al. do not disclose the lipid bound to the first arm is myristic acid or a second lipid bound to the second hydrophobic arm.
However, Chilkoti et al. disclose conjugates of lipids and polypeptides, such as fatty acid-modified elastin-like polypeptides that are thermally responsive and can form aggregates (Paragraph [0004]) which are useful for applications such as tissue engineering, regenerative medicine and drug-delivery (Paragraph [0006]). The conjugates are thermally responsive and exhibit temperature-triggered hierarchical self-assembly into aggregates which make the conjugates useful for a range of applications, including injectable biomaterials, and provides the ability to trigger the self-assembly of the conjugates on demand (Paragraph [0058]). Chilkoti et al. disclose creating a recombinant lipid-modified polypetide called Fatty Acid-Modified Elastin-like polypeptide (FAME) (Paragraph [0211]). FAME includes three components: myristic acid which can be incorporated at the N-terminus of protein in a single reaction, a short structure-directing peptide and an elastin-like polypeptide (Paragraphs [0211]-[0212]). Chilkoti et al. specifically disclose myristoylation of the ELP (elastin-like peptide) GVGVP (Paragraph [0144]). Myristoylation is the process of adding myristic acid to a peptide/protein. Chilkoti et al. further disclose myristoylation reduced the transition temperature of ELPs by about 15°C (Paragraph [0144]).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a lipid, specifically myristic acid, to the first and/or second hydrophobic arm in the ABA triblock copolymer of Hossainy et al. because myristoylation, or adding myristic acid, is a known means of reducing the transition temperature as taught by Chilkoti et al. motivated by the desire to create an effective ABA triblock copolymer for drug delivery to a broader range of locations due to the lowered transition temperature. It would have further been obvious to specifically modify GVGVP with a reasonable expectation of success as that is the specific ELP sequence myristoylated by Chilkoti et al.
Regarding claim 2, as discussed above, Hossainy et al. disclose an ABA triblock copolymer, where A is a block comprising the amino acid sequence VGVPG (Paragraph [0015]).
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hossainy et al. (US 20070286885 A1, 12/13/2007) and Chilkoti et al. (US 20190328662 A1, 10/31/2019) (Of Record) and further in view of Pattanaik (US 20120301518 A1, 11/29/2012) (Of Record) as evidenced by Lotocki et al. (Pharmaceutics, 08/30/2020) (Of Record).
The teachings of Hossainy et al. and Chilkoti et al. are discussed above.
Regarding claim 3, as discussed above, Hossainy et al. disclose the first and third peptide unit comprise the amino acid sequence VGVPG (Paragraph [0015]).
Hossainy et al. do not disclose the first and third repeating peptide unit comprise GVGVP.
However, Pattanaik discloses biocompatible and biodegradable polymers comprising one or more ECM (extracellular matrix)-mimetic peptides and methods of using the biocompatible polymers (Paragraph [0002]). Pattanaik further discloses the repeating pentapeptide sequence of Val-Pro-Gly-Val-Gly in elastin, which is the second most common ECM, contributes to the elasticity of the protein (Paragraph [0003]). There are multiple peptide sequences that can be used as the elastin ECM-mimetic peptide sequence without losing the ECM-mimetic character, including GVGVP and GxGVP where x can be multiple different amino acids, including serine (Paragraph [0058]). Substitutions that would be expected to produce the greatest changes in the protein properties are substituting a hydrophilic residue, such as seryl or threonyl, with a hydrophobic residue, such as leucyl, isoleucyl, phenylalanyl, valyl or alanyl (Paragraph [0030]).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized GVGVP as the A portion of the ABA triblock copolymer of Hossainy et al. as it was a known hydrophobic elastin-based peptide sequence that retains the ECM-mimetic character as taught by Pattanaik as it amounts to simple substitution of one known element for another. Examples of rationales that may support a conclusion of obviousness include simple substitution of one known element for another to obtain predictable results. See MPEP 2143(I)(B).
Regarding claim 4, Hossainy et al. do not disclose the second repeating unit comprises GSGVP.
However, as discussed above regarding claim 3, Pattanaik discloses there are multiple peptides sequences that can be used as the elastin ECM-mimetic peptide sequence without losing the ECM-mimetic character, including GVGVP and GxGVP where x can be multiple different amino acids, including serine (Paragraph [0058]). Substitutions that would be expected to produce the greatest changes in the protein properties are substituting a hydrophilic residue, such as seryl or threonyl, with a hydrophobic residue, such as leucyl, isoleucyl, phenylalanyl, valyl or alanyl (Paragraph [0030]).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the peptide sequence GxGVP where x is a seryl residue, reading on serine, as the B portion of the ABA triblock copolymer of Hossainy et al. because Hossainy et al. specifically state the B portion is a hydrophilic variant of the amino acid sequence VGVPG, and GSGVP, under the broadest reasonable interpretation, is a hydrophobic variant of VGVPG disclosed by Pattanaik as being useful in elastin ECM-mimetic peptides. Therefore, it would have been obvious to use GSGVP as the B portion of the ABA triblock copolymer of Hossainy et al. motivated by the desire to create a polymer that retains the ECM-mimetic character with a reasonable expectation of success as taught by Pattanaik.
Regarding claim 5, Hossainy et al. do not disclose the first and third repeating peptide unit comprise 40 repeats.
However, Pattanaik discloses a method of preparing a biocompatible polymer where the first step is providing an ECM-mimetic peptide reagent with the formula HN-(Xaa-Xbb-Xcc-Xdd-Xee)x-OH wherein Xaa, Xbb, Xcc, Xdd, Xee are each independently an amino acid residue and x is an integer from 1 to 100 (Paragraph [0185]). More specifically, the ECM-mimetic peptide reagent can be SEQ ID NO: 29, which is Gly-Val-Gly-Val-Pro (GVGVP) (Paragraph [0187]).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to repeat the first and third repeating peptide unit, being portion A of the ABA triblock copolymer, of Hossainy et al. any number of times from 1 to 100, including 40, as this was a known and effective number of repeats of elastin-based polymers as taught by Pattanaik. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 6, Hossainy et al. do not disclose the second repeating peptide unit comprises 60 repeats.
However, Pattanaik discloses a method of preparing a biocompatible polymer where the first step is providing an ECM-mimetic peptide reagent with the formula HN-(Xaa-Xbb-Xcc-Xdd-Xee)x-OH wherein Xaa, Xbb, Xcc, Xdd, Xee are each independently an amino acid residue and x is an integer from 1 to 100 (Paragraph [0185]).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to repeat the second repeating unit, being portion B of the ABA triblock copolymer, of Hossainy et al. any number of times from 1 to 100, including 60, as this was a known and effective number of repeats of elastin-based polymers as taught by Pattanaik. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 9, see 112b rejection above. As discussed above regarding claim 1, the arms of the ABA triblock polymer in a branched star conformation of Hossainy et al. would necessarily be bound at a central junction as that is the general conformation of star polymers. As it is unclear exactly what a ‘peptide fusion protein’ is, the peptides making up the arms being bound, or fused, reads on a peptide fusion protein.
Regarding claim 10, as discussed above regarding claim 1, the arms of the ABA triblock polymer in a branched star conformation of Hossainy et al. would necessarily be bound at a central junction as that is the general conformation of star polymers. The peptides being bound at the central junction reads on being irreversibly conjugated as it would be expected that the peptides would remain bound.
35 USC § 102 & 103 - Response to Arguments
Applicant's arguments filed 06/30/2026 have been fully considered but they are not persuasive.
Applicant argued Hossainy discloses a co-polymer formed from two different blocks in ABA format as a chain polymer and states Hossainy completely lacks any disclosure that the ABA polymer comprises anything other than a linear polymer (Page 7, Paragraph 2).
The Examiner respectfully disagrees. As restated above on Page 4, Hossainy disclose the polymer can be a branched polymer such as a star polymer (Paragraph [0023]). A branched polymer is not a linear polymer. Additionally, Hossainy specifically state the polymer can be a star polymer. Thus, Applicant’s argument is not persuasive as Hossainy explicitly disclose a star polymer which is not a linear polymer, but is the exact structure claimed.
Applicant further argued the secondary reference, Lotocki, proves the composition of Hossainy cannot form the claimed arrangement because Hossainy lacks the special processes, procedures and chemistry needed to form the claimed structure. Applicant goes on to state Hossainy does not disclose forming different hydrophobic and hydrophilic arms nor does Hossainy disclose binding those arms together to form a star miktoarm polymer (Page 8).
The Examiner respectfully disagrees. It remains the Examiner’s position that Hossainy does teach the claimed structure. It is noted the claims being examined are directed to a product, not a method of making a product. Thus, the reference must only disclose the product as-claimed, the reference does not have to disclose a specific method of making said product. As stated above, Hossainy discloses an ABA triblock copolymer wherein the two A portions are the amino acid sequence VGVPG, reading on a first and second hydrophobic arm, and the B portion is a hydrophilic variant of the amino acid sequence VGVPG, reading on a first hydrophilic arm, making the copolymer amphiphilic. Hossainy additionally discloses the polymer can be a branched polymer such as a star polymer. Thus, the ABA triblock copolymer in a star configuration of Hossainy reads on a star miktoarm amphiphile. A miktoarm star is simply a star polymer with different arms, that is, all of the arms of the star are not the same. The difference between a miktoarm star polymer and a regular star polymer is simply the composition of the arms, with the arms of a regular star polymer being the exact same while the arms of a miktoarm star polymer are not all the same. However, all star polymers comprise arms that radiate from a central core. Thus, the disclosure of Hossainy of an ABA triblock copolymer wherein the A portions are VGVPG (hydrophobic arms) and the B portion is a hydrophilic variant of VGVPG in a star configuration reads on the product of claim 1 as originally presented. An amended rejection has been set forth above to address the newly added limitation of a lipid being bound to an end of the first hydrophobic arm.
Conclusion
Claims 1-10 are rejected.
No claims are allowed.
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.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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