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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/30/2026 has been entered.
Applicant' s amendment and response filed on 01/30/2026 has been received and entered into the case.
Amendments
In the reply filed 01/30/2026, Applicant has amended claims 1, 8, 9, 15 and 23, newly canceled claims 4-7 and 11, and added new claim 29.
Claim Status
Claims 1-2, 8-9, 12, 15, 17, 21-24, 26 and 29 are pending.
Claims 24 and 26 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/15/2025.
Claims 1-2, 8-9, 12, 15, 17, 21-23 and 29 are considered on the merits.
Claim Objections
Claims 8 and 22 are objected to because of the following informalities:
Claim 8 recites the phrase “the least one” at the end of line 2, which contains a typographical error. It should be changed to “the at least one”.
Claim 22 recites the phrase “a plurality of bioactive peptide amphiphiles”. Since claim 1 has recited the phrase, this phrase in claim 22 is recommended to change to “the plurality of bioactive peptide amphiphiles”.
Appropriate correction is required.
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, 8-9, 12, 15, 17, 21-22 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Mousa et al., (Chem. Mater. 2022, 34, 2752-2763. IDS 05/05/2025) in view of Yu et al., (Acta Biomaterialia. 2022; 139: 4-21), Álvarez et al., (Science. 2021; 374: 848-856 and supplemental p. 1-3. Cited in IDS 05/05/2025), and Ahmed et al., (Adv. Sustainable Syst. 2022, 6, 2100316, p. 1-8).
With respect to claim 1, Mousa teaches generation of a copolymer P(EDOT-S/EDOT-OH) (named “A5”) and teaches injecting A5 copolymer into the agarose gel cast with a physiological buffer generates a stable and highly conductive hydrogel (e.g., abstract). Thus, Mousa teaches a composition comprising (a) a copolymer comprising (i) a sulfonatoalkoxy EDOT monomer (i.e., EDOT-S) and (ii) an EDOT monomer functionalized with a hydroxyl group (i.e., EDOT-OH), and (b) a hydrogel material (i.e., an agarose gel). Mousa teaches this water-processable, syringe-injectable, and self-doped PEDOT-S polymer capable of forming a conductive hydrogel in tissue mimics is suitable for future applications within in vivo electronics, in treating Parkinson’s disease, epilepsy, vagus nerve stimulation, and pain (abstract and p. 2752, left col).
However, Mousa is silent on a plurality of bioactive peptide amphiphiles in claim 1 (b), nor teach the sequences in claims 15, 17 and 21-22.
Yu summarizes the use of injectable conducting polymer-based hydrogels for tissue engineering and for promoting the repair of damaged tissues such as neurological treatment (e.g., abstract). Yu teaches that hydrogels can be intrathecally implanted into localized impaired areas to efficaciously treat CNS diseases, including spinal cord injury (SCI), and soft matrix cues and electrical signal transmission in hydrogels have been demonstrated to be two key factors for improving the survival, differentiation, and functional expression of neural progenitor cells (NPCs) (e.g., p. 15, para. 4.1 “Neurological treatment”).
Álvarez teaches a plurality of bioactive peptide amphiphile (PA) that promotes recovery from spinal cord injury (e.g., abstract, related to claim 1 (b)). Alvarez teaches the IKVAV-PA2 comprises a sequence of C16AAGGEEEEGIKVAV (supplemental p. 2, para 1), which comprises a hydrophobic tail comprising a 8-24 carbon alkyl chain (i.e., C16), the structure peptide segment having a total propensity for forming β-sheet conformations of 4 or less comprising A2G2 (SEQ ID NO: 2) (i.e., AAGG), the charged peptide segment comprising EEEE (SEQ ID NO: 3) (see EEEE in the above sequence), the bioactive moiety comprising IKVAV (SEQ ID NO: 1) (see IKVAV in the above sequence), and the bioactive moiety is attached to the charged peptide segment by a linker that is a single glycine residue (see a single G between the bioactive moiety IKVAV and the charged peptide segment EEEE in the above sequence). The sequence of IKVAV-PA2 (C16AAGGEEEEGIKVAV) is 100% identical to the claimed sequence of SEQ ID NO: 11 (C8-24-A2G2E4GIKVAV). Thus, Alvarez teaches claims 15, 17 and 21-22. Álvarez teaches the bioactive PA mimics the natural ECM fibrils and incorporates bioactive signals to promote vascular growth, axonal regeneration, myelination, survival of motor neurons, reduced gliosis, and functional recovery in a model of spinal cord injury (abstract and p. 1, left col and middle col).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition comprising an EDOT-S/EDOT-OH copolymer and a hydrogel material suggested by Mousa, by combining a plurality of bioactive peptide amphiphiles with claimed sequence taught by Álvarez and using the composition in the repair of spinal cord injury as suggested by Yu with a reasonable expectation of success. Since Mousa teaches this water-processable, syringe-injectable, and self-doped copolymer forms a conductive hydrogel that is suitable for use in treating Parkinson’s disease, epilepsy, vagus nerve stimulation, and pain (abstract and p. 2752, left col), since Yu suggests the use of injectable conducting polymer-based hydrogels for promoting the repair of damaged tissues such as spinal cord injury (e.g., abstract and p. 15, para. 4.1), and since Álvarez teaches the bioactive PA mimics the natural ECM fibrils and incorporates bioactive signals to promote functional recovery in a model of spinal cord injury (abstract and p. 1, left col and middle col), one of ordinary skill in the art would have had a reason to combine a plurality of bioactive peptide amphiphiles of Álvarez in the injectable conductive hydrogel of Mousa in order to use the composition to promote functional recovery in damaged tissue such as spinal cord injury (see Yu, p. 15, para. 4.1 and Álvarez, p. 1, middle col, last para).
In regard to i) the copolymer being retained within the hydrogel material, Mousa teaches injecting A5 copolymer into the agarose gel cast with a physiological buffer generates a stable hydrogel (e.g., abstract and Fig 1b-1d for “limited diffusion” after 2 hours or 15 days), thus teaches the copolymer is retained within the hydrogel material.
In regard to i) hydrogen bonding between the copolymer and the hydrogel material, Mousa teaches that in the copolymer, there are =O atoms (i.e., hydrogen acceptors) and -OH (i.e., either hydrogen donor or acceptor) in both EDOT-S and EDOT-OH (see Mousa Scheme 2 in p. 2758). Mousa teaches the hydrogel material being agarose (e.g., abstract), which comprises -OH groups (i.e., either hydrogen donors or acceptors). Accordingly, one of ordinary skill in the art would have immediately understood that there would be hydrogen bonding between hydrogen donors (-OH groups) in the copolymer and hydrogen acceptors (-OH groups) in the agarose, or between hydrogen acceptors (-OH or =O groups) in the copolymer and hydrogen donors (-OH groups) in the agarose. Furthermore, since Mousa teaches the copolymer is retained within the agarose (see above), one of ordinary skill in the art would have appreciated that the hydrogen bonding between the copolymer and the agarose would contribute to the retention of the copolymer within the hydrogel material.
In regard to ii) the copolymer forming particles having an average diameter of at least 2000 nm, it is noted that this limitation is directed to the natural property of the claimed copolymer. MPEP 2112.01(II) recites that "products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable." Since Mousa teaches a copolymer that is identical to that in claim 1 (a) (see above), the property of Mousa’s copolymer would be the same as claimed, i.e., forming particles having an average diameter of at least 2000 nm.
Nevertheless, Mousa teaches A5 (the EDOT-S/EDOT-OH copolymer) has a large polymer dispersion index (Mw being 174,000 Da) indicating that A5 forms aggregates in solution (p. 2757, last para – p. 2758, para 1. It is noted that these aggregates are equivalent to the claimed particles formed by the copolymer). To analyze the nanoparticles of the A5, Mousa teaches the Dynamic Light Scattering measurement (Supporting Information, p. 12) that “A5 was dissolved in prefiltered 1 mM NaCl solution and ultrasonicated. The solution was then filtered (0.2 μm PVDF) before analysis.” Thus, Mousa teaches the aggregates formed by A5 have a diameter of at least 0.2 μm evidenced by the necessity of ultrasonication (to break down the aggregates/particles) and filtration through a 0.2 μm filter. Furthermore, prior art Ahmed aims to produce thick films of PEDOT:PSS conducting polymers (e.g., abstract) and teaches PEDOT colloidal particles undergo a fast flocculation leading to an increase of particle size by about 100 times, the flocculation leads to particles of the order of 100 microns in size (p. 2, end of left col. – right col. See Fig 1C the particles being about 500 microns). Thus, Ahmed indicates that the starting PEDOT colloidal particles before the flocculation have a size in the order of several microns (i.e., the order of 100 microns after flocculation / about 100 times increase).
Accordingly, one of ordinary skill in the art would have immediately expected that the EDOT-S/EDOT-OH copolymer of Mousa would form aggregates/particles having an average diameter of at least 2000 nm (i.e., 2 microns) since Ahmed indicates that the PEDOT colloidal particles have a size in the order of several microns (see above).
In regard to iii) leakage of the copolymer from the hydrogel being less than 10% over the course of 7 days in claim 1 and less than 5% in claim 12, as stated supra, Mousa teaches the EDOT-S/EDOT-OH copolymer (“A5”) can be injected into an agarose gel cast with a physiological buffer to generate a stable hydrogel and the ion-treated A5 hydrogel remains stable and maintains initial conductivities for 7 months in pure water (see e.g., abstract). Mousa also teaches in a diffusion assay that A5 in agarose gel prepared with Ringer buffer has “limited diffusion” after 15 days (p. 2755, left col, last para – right col, para 1, see Fig 1d the 4th bar showing the A5 diffusion being non-detectable, and see p. 2753, right col, para 3 “Characterization of PEDOT-S Diffusion” for method of assay). Thus, Mousa suggests that leakage of the copolymer from the hydrogel is likely to be less than 10%, or less than 5%, over the course of 7 days. Accordingly, one of ordinary skill in the art would have appreciated that Mousa’s composition comprising an EDOT-S/EDOT-OH copolymer and a hydrogel material (A5 in an agarose gel cast with a physiological buffer) would have had leakage of the copolymer from the hydrogel be less than 10% or less than 5% over the course of 7 days as suggested by Mousa.
In regard to iv) the copolymer enhancing bioactivity of the bioactive PA in the hydrogel material compared to the bioactivity of PA not contained in the hydrogel material in claim 1 and the enhanced bioactivity comprising enhanced neural maturation in claim 29, it is noted that this limitation is directed to the property of the claimed composition such that the composition, comprising the copolymer in the hydrogel material and the bioactive PA, has enhanced bioactivity compared to the PA alone. Since Mousa, in view of Yu and Álvarez, suggests a composition that is identical to that in claim 1 (see above), the property of the composition in prior art would be the same as claimed, i.e., having enhanced bioactivity, e.g., enhanced neural maturation, compared to the PA alone. See MPEP 2112.01(II).
Nevertheless, as stated supra, Yu teaches injectable conducting polymer-based hydrogels can efficaciously treat CNS diseases, including spinal cord injury (SCI), because soft matrix cues and electrical signal transmission in hydrogels have been demonstrated to be two key factors for improving the survival, differentiation, and functional expression of neural progenitor cells (NPCs) (e.g., p. 15, para. 4.1 “Neurological treatment”, related to enhanced neural maturation in claim 29).
Accordingly, one of ordinary skill in the art would have immediately expected that the copolymer in the hydrogel material of Mousa (i.e., an injectable conducting polymer-based hydrogel providing soft matrix cues and electrical signal transmission) would improve the survival, differentiation, and functional expression of neural progenitor cells (i.e., enhance neural maturation) to efficaciously treat CNS diseases including spinal cord injury as indicated by Yu. Since Álvarez teaches the bioactive PA is used to promote functional recovery in spinal cord injury (see above), one of ordinary skill in the art would have expected that the copolymer in the hydrogel material of Mousa would enhance the bioactivity of the bioactive PA of Álvarez, e.g., enhance neural maturation, in treating spinal cord injury, as compared to the PA alone.
With respect to claim 2 directed to the sulfonatoalkoxy EDOT monomer comprising EDOT-S, as stated supra, Mousa teaches a copolymer P(EDOT-S/EDOT-OH) (named “A5”, see e.g., abstract), comprising an EDOT-S monomer.
With respect to claim 8 directed to the sulfonatoalkoxy EDOT monomer and the EDOT-OH monomer at a ratio of 1:10 to 10:1, Mousa teaches the ratio of EDOT-S/EDOT-OH in A5 being 85/15 (i.e., about 6:1) (see Table 1 in p. 2756).
With respect to claim 9 directed to the sulfonatoalkoxy EDOT monomer and the EDOT-OH monomer at a ratio of 4:1, Mousa teaches the ratio of EDOT-S/EDOT-OH being 85/15 in A5 (i.e., about 6:1), and 75/25 (i.e., about 3:1) in A5 synthesized with addition of 10% EDOT-OH (see Table 1, row 1 and row 3, in p. 2756). Mousa also teaches an A5 synthesized with addition of 5% EDOT-OH (see Fig 3b-3f), which would be expected to have a ratio of EDOT-S/EDOT-OH being between 6:1 and 3:1.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Mousa in view of Yu, Álvarez and Ahmed, by adjusting the addition of EDOT-OH as suggested by Mousa to arrive at the claimed ratio of EDOT-S/EDOT-OH being 4:1 with a reasonable expectation of success. Since Mousa aims to generate copolymers of EDOT-S/EDOT-OH with different ratios of the monomers to evaluate the dispersion and conductivity of the copolymers (see e.g., p. 2761, right col, last three sentences), one of ordinary skill in the art would have had a reason to adjust the additional amount of EDOT-OH to EDOT-S in order to optimize the copolymers for applications. Notably, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. It is a routine procedure to optimize component amounts to arrive at an optimal product that is superior for its intended use. See M.P.E.P. §2144.05.
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Response to Traversal:
Applicant’s arguments filed on 01/30/2026 are acknowledged.
Applicant firstly argues that the goal of Mousa is to develop bioelectronic devices, and Mousa is exclusively focused on the formation of an injectable conductive material. Mousa does not disclose or suggest introduction of any bioactive moiety into the conductive hydrogel. Alvarez discloses bioactive PA for treating spinal cord injury. Alvarez does not disclose or suggest that bioactivity of a PA would be improved by formulating the PA into a hydrogel comprising a copolymer. (Remarks, p. 7, para 2-3).
Applicant’s arguments have been fully considered but they are not persuasive. Mousa teaches “Moving beyond the current stimulation techniques used, for example, in Parkinson’s disease, epilepsy, vagus nerve stimulation, and pain, there is a need to develop minimally invasive implantable bioelectronic devices without foreign body responses” (p. 2752, left col), and teaches the water-processable, syringe-injectable, and self-doped PEDOT-S polymer capable of forming a conductive hydrogel in tissue mimics paves a way for future applications within in vivo electronics (abstract). Thus, Mousa suggests that the injectable conductive hydrogel would be suitable for treating diseases such as Parkinson’s disease, epilepsy, vagus nerve stimulation, and pain as a minimally invasive implantable bioelectronic device. This is also evidenced by prior art Yu who summarizes the use of injectable conducting polymer-based hydrogels for tissue engineering and for promoting the repair of damaged tissues such as spinal cord injury (e.g., abstract). Yu teaches that the features of soft matrix cues and electrical signal transmission in the conductive hydrogels have been demonstrated to be two key factors for improving the survival, differentiation, and functional expression of neural progenitor cells (NPCs) (e.g., p. 15, para. 4.1 “Neurological treatment”). Accordingly, one of ordinary skill in the art would have appreciated that Mousa’s conductive hydrogel would be suitable for treating diseases such as spinal cord injury suggested by Yu. Since Alvarez discloses bioactive PA for treating spinal cord injury, one of ordinary skill in the art would have had a reason to incorporate the bioactive PA of Alvarez in the conductive hydrogel of Mousa in order to improve the therapeutic efficacy on spinal cord injury. In other words, the bioactivity of a PA alone in treating spinal cord injury would be improved by formulating the PA into a conductive hydrogel since the conductive hydrogel may provide features of soft matrix cues and electrical signal transmission, that have been demonstrated to be two key factors for improving the survival, differentiation, and functional expression of neural progenitor cells (NPCs) (Yu, e.g., p. 15, para. 4.1 “Neurological treatment”).
Applicant further argues that Alvarez discloses that the addition of CaCl2 (the same cross-linking agent used in forming the hydrogel of Mousa) decreases the supramolecular motion and reduces bioactivity of the PA (p. 3, columns 1-2). Therefore, a skilled artisan is expressly discouraged from combining the PA into the composition of Mousa (p. 7, last para).
Applicant’s arguments have been fully considered but they are not persuasive. Both Alvarez and Mousa teach use of the compositions in the context of physiological buffers that contain CaCl2. Specifically, Alvarez tests the bioactivity of PA in hNPCs cultured in DMEM/F12 medium (see Fig 2C for DMEM/F12 medium for hNPC culture and Fig 2J for results in hNPCs treated with PA in the absence or presence of extra Ca2+, also see p. 3, left column for teaching of PA mixed with 5 mM CaCl2 also cited in Applicant’s argument). The DMEM/F12 medium comprises 1 mM CaCl2. Thus, Alvarez discloses that PA is bioactive in a physiological medium containing 1 mM CaCl2. Similarly, Mousa teaches the conductive hydrogel (i.e., copolymer in agarose gel) cast with a physiological buffer Ringer buffer (see e.g., abstract and Fig 1). The Ringer buffer contains 1.4-2.2 mM CaCl2 depending on modifications. It is noted that most of classic media, such as DMEM, contain 1.8 mM CaCl2. Therefore, one of ordinary skill in the art would have expected that the bioactive PA of Alvarez would be active in the conductive hydrogel of Mousa since both of them have use the physiological buffers that contain physiological molarity of CaCl2. The finding that the PA being less active when mixed with non-physiological molarity of CaCl2 would not discourage a skilled artisan from combining Alvarez’s PA into Mousa’s conductive hydrogel.
Applicant finally argues that the instant application demonstrates that hydrogel containing the exemplary copolymer PEDOT-S/OH (PS2) improved bioactivity compared to that of the bioactive PA alone, and in some experiments demonstrating a “synergistic” effect between PS2 and the bioactive PA. The significant improvement in bioactivity achieved using the composition of claim 1 would simply not be expected in view of cited references (Remarks, page 8, specification p. 50-54 and Figures 6-11).
Applicant’s arguments have been fully considered but they are not persuasive. As a first matter, MPEP 716.02(d), states that unexpected results must be commensurate in scope with the claimed invention. In the instant case, the purported unexpected results presented by Applicant (e.g., “synergistic” effect between PS2 and the bioactive PA in page 51 of specification and Figure 8) were studies performed with the copolymer PS2 (PEDOT-S/OH) combined with the bioactive PA (PA+PS2), which is not commensurate in scope with the composition of claim 1 comprising (a) a copolymer comprising (i) at least one sulfonatoalkoxy EDOT monomer or at least one cationic EDOT monomer, and (ii) at least one EDOT functionalized with a hydroxyl group, and (b) a hydrogel comprising a plurality of PA, wherein i) the copolymer is retained within the hydrogel material by hydrogen bonding between the copolymer and the hydrogel material, ii) the copolymer forms particles having an average diameter of at least 2000 nm, iii) leakage of the copolymer from the hydrogel is less than 10% over the course of 7 days, and iv) the copolymer enhances bioactivity of the bioactive PA in the hydrogel material compared to the bioactivity of PA not contained in the hydrogel material. In other words, if Applicant interprets the PA as a form of hydrogel so that the composition of PA+PS2 reads on claim 1 (a) and (b), this interpretation would not satisfy the wherein clause in claim 1 (e.g., limitation (i) the copolymer is retained within the hydrogel material by hydrogen bonding between the copolymer and the hydrogel material), as argued by Applicant in the Remarks filed 09/10/2025 regarding Tovar’s PA+EDOT that “hydrogen bonding between the EDOT monomer and peptide amphiphiles would not occur” (see p. 8, para 2, of Remarks filed 09/10/2025).
Furthermore, as stated supra, prior art Yu teaches injectable conducting polymer-based hydrogels can efficaciously treat CNS diseases, including spinal cord injury (SCI), because soft matrix cues and electrical signal transmission in hydrogels have been demonstrated to be two key factors for improving the survival, differentiation, and functional expression of neural progenitor cells (NPCs) (e.g., p. 15, para. 4.1 “Neurological treatment”). Accordingly, one of ordinary skill in the art would have expected that the copolymer in the hydrogel material of Mousa (i.e., an injectable conducting polymer-based hydrogel providing soft matrix cues and electrical signal transmission) would improve the survival, differentiation, and functional expression of neural progenitor cells (i.e., enhance neural maturation) to efficaciously treat CNS diseases including spinal cord injury as indicated by Yu. Since Álvarez teaches the bioactive PA is used to promote functional recovery in spinal cord injury (see above), one of ordinary skill in the art would have expected that the copolymer in the hydrogel material of Mousa would enhance the bioactivity of the bioactive PA of Álvarez, e.g., enhance neural maturation, in treating spinal cord injury, as compared to the PA alone.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Mousa et al., (Chem. Mater. 2022, 34, 2752-2763. IDS 05/05/2025) in view of Yu et al., (Acta Biomaterialia. 2022; 139: 4-21), Álvarez et al., (Science. 2021; 374: 848-856 and supplemental p. 1-3. Cited in IDS 05/05/2025), and Ahmed et al., (Adv. Sustainable Syst. 2022, 6, 2100316, p. 1-8), as applied to claim 1 above, and further in view of Stupp et al., (US 2012/0294902, prior art of record).
Claim 23 is directed to the hydrogel material further comprising a filler PA which does not comprise a bioactive moiety.
However, Mousa, Yu, Álvarez and Ahmed are silent on a filler PA that does not comprise a bioactive moiety in claim 23.
Stupp teaches a peptide amphiphile (PA) and method of electrostatically control bioactivity of the IKVAV peptide epitope (see e.g., abstract). Stupp teaches a composition comprising (a) a first PA comprising (1) a hydrophobic segment, (2) a β-sheet-forming structural peptide segment; (3) a charged peptide segment, and (4) a signaling epitope (i.e., a bioactive moiety); and (b) a second peptide amphiphile comprising the peptide sequence (V)x(A)y(E)z-NH, wherein x=y=z=2 (see e.g. [0021] and reference claim 10). It is noted that this second peptide amphiphile also comprises a hydrophobic segment in addition to the peptide sequence to make it a peptide amphiphile. Thus, Stupp teaches a composition comprising, in addition to the first PA having a bioactive moiety, a second PA (i.e., a filler PA) comprising a hydrophobic segment comprising an acyl group of six or more carbons (i.e., a hydrophobic non-peptide tail), a peptide sequence of V2A2 (i.e., a structural peptide segment, see e.g., [0055]), a peptide sequence of E2 (i.e., a charged peptide segment, see e.g., [0056]), without a bioactive moiety, thus teaches claim 23.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition comprising a copolymer and a hydrogel material comprising a plurality of bioactive peptide amphiphiles as suggested by Mousa in view of Yu, Álvarez and Ahmed, by combining a second filler PA without a bioactive moiety as taught by Stupp with a reasonable expectation of success. Since Álvarez teaches it would be advantageous to have easy tunability of signal density (Álvarez, p. 1, middle col, para 1), and since Stupp teaches a composition comprising a first bioactive PA and a second filler PA without a bioactive moiety (see e.g. [0021] and reference claim 10), one of ordinary skill in the art would have had a reason to combine a second filler PA without a bioactive moiety as taught by Stupp into the hydrogel material comprising a bioactive PA in order to tune the signal density of the bioactive moiety by adjusting the ratio of the bioactive PA versus the filler PA without a bioactive moiety.
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Response to Traversal:
Applicant’s arguments filed on 01/30/2026 are acknowledged and have been discussed above.
Conclusion
No claims are allowed.
Examiner Contact Information
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/JIANJIAN ZHU/Examiner, Art Unit 1631