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
The text of those sections of Title 35, U.S. Code not included in this action can be found in a
prior Office action.
This action is in response to papers filed on March 17, 2026. Pursuant to the amendments filed on March 17, 2026, claims 1-13, 15-16, 18 and 20 are currently pending. Claims 1-3, 15-16 and 18 have been amdned and claim 14 has been canceled by Applicants’ amendment filed on 3/17/2026.
Claims 23 and 25 were previously withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to non-elected invention, there being no allowable generic or linking claim. Claims 5 and 6 were previously withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to non-elected species, there being no allowable generic or linking claim. Claims 7-12 were previously withdrawn from further consideration as they are dependent on claim 6. Claim 13 was previously withdrawn from consideration as it is dependent on claim 5. The restriction requirement was previously made FINAL.
Therefore, claims 1-4, 15-16, 18 and 20 are under examination to which the following grounds of rejection are applicable.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. PCT/US21/19922 , filed on 02/26/2021 . This application has claims priority to PRO 62/983,056 filed 02/28/2020.
Thus, the earliest possible priority for the instant application is February 28, 2020.
Claim Objections
The claims filed on 03/17/2026 does not comply with the requirements of 37 CFR 1.121(c) because changes in claim 16 are not identified with the proper status of the claim. Amendments to the claims filed on or after 08/19/2025 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
Any further claim amendments must comply with 37 CFR 1.121(c) or they may not be entered.
Response to Arguments
Withdrawn Objections/Rejections in Response to Applicants’ arguments or amendments
Specification Objection
In view of Applicants’ amendments to the Specification filed March 17, 2026, wherein the terms Thermofisher and Sigma Aldreich is marked in the Specification with the appropriate symbol of commerce, the objection to the Specification is withdrawn.
Claim Rejections - 35 USC § 112 (a)
In view of Applicants’ amendments filed on March 17, 2026, the rejection of claims 1-4, 15-16, 18 and 20 under USC 112(a) as failing to comply with the enablement and written description requirement has been withdrawn.
Claim Rejections - 35 USC § 112 (b)
In view of Applicants’ amendments filed on March 17, 2026, the rejection of claims 1-4, 15-16, 18 and 20 under USC 112(b) has been withdrawn. Applicants’ recite pp. 4-5, which provide definitions for what is considered “substantially spherical”. Upon reconsideration, the specification provides sufficient guidance to inform a person with ordinary skill in the art the scope of the claimed subject matter.
Claim Rejections - 35 USC § 103
In view of Applicants’ amendment filed on March 17, 2026, the rejection of claims 1-3 and 18 under USC § 103 as being obvious over O’Bryan (Published 26 February 2019, ACS Appl. Bio Mater, IDS filed on 8/28/2022 ) are withdrawn.
Applicants have amended claim 1 to introduce the limitations of claim 14 which was not rejected under USC § 103 as being obvious over O’Bryan.
In view of Applicants’ amendment filed on March 17, 2026, the rejection of claims 1, 4, 16 and 20 under USC § 103 as being obvious over O’Bryan (Published 26 February 2019, ACS Appl. Bio Mater, IDS filed on 8/28/2022) and Weaver et al. (US 20190321797 A1, IDS filed on 08/26/2022) are withdrawn.
In view of Applicants’ amendment filed on March 17, 2026, the rejection of claims 14 and 15 under USC § 103 as being obvious over O’Bryan (Published 26 February 2019, ACS Appl. Bio Mater, IDS filed on 8/28/2022) and Canning et al. (Published on March 9 2016, Macromolecules 2016, 49, 6, 1985–2001). are withdrawn as the prior art is drawn to a canceled claim.
A response to Applicant’s arguments with regard to a withdrawn rejection is moot. A response to any argument pertaining to a new or maintained rejection can be found below.
New Grounds of Objection/ Rejection:
Claim Rejections - 35 USC § 103
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.
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
Claims 1-4, 16, 18 and 20 are newly rejected under 35 U.S.C. 103 as being unpatentable over O’Bryan (Published 26 February 2019, ACS Appl. Bio Mater, IDS filed on 8/28/2022 ), in view of Canning et al. (Published on March 9 2016, Macromolecules 2016, 49, 6, 1985–2001) es evidenced by Lin et al. (Published: 2006. Journal of Membrane Science, vol. 276, no. 1-2, 1 May 2006, pp. 145–161).
This is a new rejection necessitated by Applicants’ amendments to the claims in the response filed on March 17, 2026.
Regarding claim 1, O'Bryan teaches a three-dimensional (3D) cell culture medium (abstract, "We explore the potential application of these microgels as biomaterials for 3D cell culture") comprising: a plurality of microgel particles (pg 1511 col 2 para 3, "Each microgel system is prepared with a charged species at varying polymer charge density; here, we use ... carboxybetaine methacrylate (CBMA) for zwitterionic microgels"); and a liquid cell culture medium (pg 1511 col 1 para 1-2, "Microgels for cell culturing are swollen in MEGM cell growth media to a final polymer concentration of 4 wt %. After passaging, the cells are pelleted and resuspended at a high density in liquid growth media before subsequently being pipetted into the microgel growth media"), wherein the microgel particles have a radius of from 0.5 um to 100 um (pg 1511 col 2 para 3, ''We measure the average size of each microgel in the dilute state and find the mean particle diameters to be ... 5.21 +/- 2.14 um for the CBMA microgels"). Further, O’Bryan teaches a percentage of polymer network (pp. S-4, “Small amplitude oscillatory frequency sweeps of polyelectrolyte microgels swollen in MEGM cell growth media at 4 wt % polymer”).
O'Bryan does not explicitly teach the microgel particles as charge-neutral or substantially spherical or within the same embodiment.
However, O’Bryan further discusses the modification of the hydrogel composition to be charge neutral to reduce deformities within the microgel particles (pp. 1512 col 2 para 2, "Neutral hydrogels swell to an equilibrium concentration in which the driving osmotic pressure (pi) generated from the random motion of the polymer chains is balanced" ; pp. 1516 col 1 para 1, "In contrast, simple polyelectrolyte scaling laws do not capture the rheological behavior of zwitterionic microgels. Instead, zwitterionic microgels exhibit a plateau in rheological properties in the high-salt limit. This unique behavior may be advantageous when swelling microgels in salt-rich solvents, such as cell growth media. However, interactions between the zwitterionic microgels and biological zwitterionic molecules, including amino acids and proteins, may result in unforeseen changes in rheological properties beyond the scope of this work. Further development of charge-neutral microgels may circumvent these interactions, providing opportunities for further biomaterial applications using microgels").
A skilled artisan would have been motivated to utilize charge-neutral microgels to circumvent altered rheological properties of microgel particles. Therefore, it would be obvious for one skilled in the art to incorporate charge-neutral microgels to prevent unwarranted changes in rheological properties as contemplated by O’Bryan with a reasonable expectation of success.
However, O’Bryan does not explicitly teach that the charge-neutral microgel particles comprise a crosslinked polymer network comprises poly(ethylene qlycol) methyl ether acrylate (PEGa) and poly(ethylene qlycol) diacrylate (PEGda), wherein a ratio of PEGa to PEGda is about 80:20, and wherein the 3D cell culture medium comprises about 10 wt% to about 25 wt% crosslinked polymer network.
Canning et al. teaches non-ionic microgels particles comprise a crosslinked polymer network of poly(ethylene glycol) methyl ether acrylate and poly(ethylene glycol) diacrylate, (pp. 1989, “Similarly, RAFT aqueous emulsion polymerization has been used to produce non-ionic, anionic, or cationic spheres.”; pp. 1991, “RAFT CTA can be used to confer pH-responsive behavior on ostensibly non-ionic diblock copolymers while requiring minimal amounts of added base or acid.”; page 1989, col 2 para 3 bridging into page 1990 col 1 para 1, “Chain extension of a poly(ethylene glycol) (PEG)-based macro-CTA with 2-methoxyethyl acrylate (MEA), PEG methyl ether acrylate, and a small amount of PEG diacrylate (PEGDA) cross-linker produced spherical nanogels, whose dimensions decreased almost linearly as the solution temperature was increased from 20 to 60 °C”).
It would be obvious to substitute the charged-microgels of O’Bryan with the charge-neutral microgels of Canning, because PEG-based acrylates are well known in the art to be neutral and hydrophilic monomers. The incorporation of PEGa and PEGda would result in a chemically inert gel that would not respond to any charged stimuli, representing a predictable design choice that a skilled artisan would to produce a neutral microgel. Furthermore, O’Bryan mentions the use of charge-neutral microgels to overcome the unforeseen changes in rheological properties (pg 1516 col 1 para 1,”Further development of charge-neutral microgels may circumvent these interactions, providing opportunities for further biomaterial applications using microgels.”). So, a skilled artisan in the art would have been motivated to utilize PEGa and PEGda as they are known to produce charge neutral microgels and prevent any change in rheological characteristics of the gel. Further, it would have been obvious to optimize aspects of the charge-neutral microgel based on influential considerations of the design, such as modifying ratios of PEGa and PEGda, processing conditions, pH of culture medium, to achieve the claimed range of 10% to 25% wt polymer network within a 3D culture medium.
However, neither Canning or O’Bryan teach a ratio of PEGa to PEGda, or a culture medium comprising a percentage of the crosslinked polymer network.
Lin et al. teaches a ratio of PEG methyl ethyl acrylate and PEG diacrylate (Table 3, Table 4, see attached). Moreover, Lin teaches that ratios of PEG methyl ethyl acrylate and PEG diacrylate improved permeability. (pp. 159, “Three series of crosslinked polymers containing ethylene oxide were prepared based on poly(ethylene glycol) diacrylate (PEGDA)… Increasing PEGMEA content decreased polymer density, glass transition temperature, and activation energy of permeation and diffusion, and increased free volume, gas permeability and diffusivity.”)
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It would have been obvious to modify the charge-neutral microgel of the combined teachings of Canning and O’Bryan, to use the ratio of PEG methyl ethyl acrylate and PEG diacrylate taught by Lin, as it was found to influence permeability and diffusivity of PEGa/PEGda materials. Further, a skilled artisan would have optimized certain ratios of PEGa to PEGda as Lin discusses that characteristics such as permeability, diffusivity and density are known to be dependent on varying concentrations of PEGa and PEGda.
The Court has stated that generally such differences amount to mere optimization and will not support patentability unless there is evidence indicating the claimed feature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). In KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421.
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MPEP § 2144 sets forth Applicant' s burden for rebuttal of a prima facie case of obviousness based upon routine optimization. Applicant must provide either a showing that the particular amount or range recited within the claims is critical; and/or a showing that the prior art reference teaches away from the claimed amount.
Regarding claim 2, the combined teachings of Lin, O’Bryan and Canning render obvious the claimed methodology of claim 1. Moreover, O’Bryan teaches microgels with a surface roughness, relative to a perfect spherical surface (Figure 1A, See attached; pp. 1514 col 1, “As the polymer concentration of the microgels increases above the jamming concentration, individual microgel particles will deform without osmotically driven deswelling, resulting in volume fractions in excess of the random close packing limit of hard spheres”).
Regarding claim 3, the combined teachings of Lin, O’Bryan and Canning render obvious the claimed methodology of claim 1. Moreover , O'Bryan teaches the microgels to have a polymer concertation of 4 wt% (pg 1511 col 1 para 1-2, "Microgels for cell culturing are swollen in MEGM cell growth media to a final polymer concentration of 4 wt% ... ").
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Regarding claim 15, the combined teachings of Lin, O’Bryan and Canning render obvious the claimed methodology of claim 1. Moreover, Lin teaches that permeability is influenced by PEGda content (Fig. 7 See attached).
It would have been obvious for a skilled artisan to optimize aspects of the microgel, such as polymer identity, concentration, processing conditions, etc. to achieve a permeability within the claimed range of the instant application. As permeability is known to depend on the composition and structure of the polymer network, as taught by Lin, a skilled artisan would have recognized that permeability is a result effective variable that would have constituted routine optimization. Applicant must provide evidence demonstrating that the claimed permeability range is critical or yields unexpected results (See MPEP 2144.05).
Regarding claim 16, the combined teachings of Lin, O’Bryan and Canning render obvious the claimed methodology of claim 1. Further, O’Bryan discloses that yield stress of microgels is influenced by the environment in which the microgels are cultivated in (pp. 1513, “Similar to the yield stress of microgels, the elastic shear modulus decreases with increasing concentrations of calcium chloride.”).
It would have been obvious for a skilled artisan to optimize aspects of the microgel, such as polymer identity, concentration, processing conditions, etc. to achieve a yield stress within the claimed range of the instant application. As yield stress is known to depend on the composition, structure of the polymer network, and the environment in which it is suspended in as taught by O’Bryan, a skilled artisan would have recognized that yield stress is a result effective variable that would have constituted routine optimization. Applicant must provide evidence demonstrating that the claimed yield stress range is critical or yields unexpected results (See MPEP 2144.05).
Regarding claim 18, O’Bryan renders obvious the 3D cell culture medium according to claim 1, wherein the concentration of the microgel particles is from 0.05% to 1.0% by weight (Results and Discussion, pg 1511 col 2 para 7 bridging into pg 1512 col 1 para 1, “We find the jamming concentrations of the microgels to be 0.3, 0.45, and 0.9 wt % for microgel particles containing 17 mol % of MAA, qDMAEMA, and CBMA, respectively"), falling within the scope of concentration of microgel particles is from 0.05% to 1.0% by weight.
***
Claims 1, 4 and 20 are newly rejected under 35 U.S.C. 103 as being unpatentable over O’Bryan (Published 26 February 2019, ACS Appl. Bio Mater, IDS filed on 8/28/2022 ), in view of Canning et al. (Published on March 9 2016, Macromolecules 2016, 49, 6, 1985–2001) Lin et al. (Published: 2006. Journal of Membrane Science, vol. 276, no. 1-2, 1 May 2006, pp. 145–161) and Weaver et al. (US 20190321797 A1, IDS filed on 08/26/2022).
With regard to instant claim 1, the combined teachings the 3D cell culture medium in O’Bryan, Canning and Lin render obvious the claimed product, as iterated above in the 103 rejection the content of which is incorporated herein, in its entirety.
However, the combined teachings fail to teach teaches a pore space formed between adjacent charge-neutral microgel particles is from 50 nm to 10 um as recited in claim 4.
Weaver teaches a pore space formed between adjacent charge-neutral microgel particles is from 50 nm to 10 um (Claim 10, “ the stabilized scaffold comprising pores having a median diameter of about 10 μm to about 35 μm). Further, Weaver teaches that microporous gel systems provide prevention and treatment for infections (para 0005, “In some instances, microporous gel systems disclosed herein provide for prevention and treatment of infections via antimicrobial activity.”).
It would have been obvious to modify the charge-neutral microgels of O’Bryan, Canning and Lin, to have a porous structure as the system can aid in treating infections. Further, it would have been obvious to optimize aspects of the 3D cell culture medium based on influential considerations in the design of the charged-neutral microgels such as adjusting the ratio of PEGa:PEGda or processing conditions, to achieve a pore diameter of 50nm to 10 um.
The Court has stated that generally such differences amount to mere optimization and will not support patentability unless there is evidence indicating the claimed feature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). In KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421.
MPEP § 2144 sets forth Applicant' s burden for rebuttal of a prima facie case of obviousness based upon routine optimization. Applicant must provide either a showing that the particular amount or range recited within the claims is critical; and/or a showing that the prior art reference teaches away from the claimed amount.
Regarding claim 20, the combined teachings of Lin, O’Bryan and Canning render obvious the claimed methodology of claim 1. Moreover, Weaver teaches a similar microgel 3D culture medium that further comprises antibiotics (Abstract, “The microgel scaffolds are fluidic during application and annealed or crosslinked after application to the implant site in the subject. The microgel scaffolds may contain various therapeutic agents, including antibiotics and analgesics, throughout the gel.”).
Therefore, it would have been obvious to one of ordinary skill in the art to incorporate antibiotics into the 3D cell culture as routine experimentation to prevent unwanted microbial growth in O’Bryan’s 3D cell culture.
Response to Applicant Arguments as they apply to the rejection of claims 1-4, 15-16, 18 and 20
under 35 USC § 103 in view of O’Bryan and Canning
Beginning on page 6 of the Remarks filed on March 17, 2025, Applicants’ essentially argue the following:
O’Bryan does not teach charge-neutral microgels and the Office heavily relies on a statement of future projects taught by O’Bryan, and that suggestions of future-direction hold no weight.
Neither Canning or O’Bryan teach the claims PEDa/PEGda composition and polymer concentration %wt and the Office failed to establish a clear motivation for routine optimization.
The roughness of the particle and the physical characteristic of the surface (roughness) are not the same and argue that deformation are sphericity are two distinct properties.
Claim 15 is allowable because the cited references do not teach the claimed range of permeability
In response to the argument, it has been fully considered but is not persuasive due to the following reasons:
Regarding 1) O’Bryan identifies specific limitations of zwitterionic microgels to have unforeseen changes in rheological properties, and further teaches that “charge-neutral microgels may circumvent these interactions.” Thus, O’Bryan identifies a recognized problem within microgels that carry a charge (zwitterionic) and proposes a solution thereto. A skilled artisan would have understood this statement as providing a motivation to employ known charge-neutral microgel systems in order to avoid the undesirable interactions recognized by O’Bryan. Further, Canning is relied upon as it teaches PEG-based non-ionic nanogels as well as thermo-responsive nanogels comprising polyethylene glycol methyl ether acrylate and PEGda. Accordingly, a person with ordinary skill in the art would have been motivated to substitute the zwitterionic microgels of O’Bryan with the known non-ionic PEG-based polymer composition of Canning in order to avoid the limitations of zwitterionic, cationic and anionic microgels.
Regarding 2), it is noted that neither O’Bryan or Canning expressly teach the claimed ratio of PEGa:PEGda, or that the 3D cell culture medium comprises 10 wt% to 25 wt% of polymer network. However, obviousness does not require that the prior art must teach within the claimed ratio. See MPEP 2144.05 “Applicants can rebut a prima facie case of obviousness by showing the criticality of the range. "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range”. Canning teaches PEGa and PEGda-based microgels systems, and a person with ordinary skill in the art would have optimized such ratios and concentrations of PEGa and PEGda based on influential considerations of the design, such as yield stress, sphericity, and surface roughness. Applicant has not provided evidence demonstrating criticality or unexpected results associated with the claimed ratio.
Regarding 3) the rejection relies upon the fact that properties such as surface roughness and yield stress are properties that can be influenced by the ratio of PEGa:PEGda and polymer concentration, as they present-result effective variables that a skilled artisan would routinely optimize. Further, O’Bryan discloses that yield stress of microgels is influenced by the environment in which the microgels are cultivated in (pp. 1513, “Similar to the yield stress of microgels, the elastic shear modulus decreases with increasing concentrations of calcium chloride.”). Thus, the prior art demonstrates that yield stress is a result-effective parameter that a skilled artisan would optimize and give predictable results.
Regarding 4), the rejection relies on that the permeability is an inherent property of the hydrogel network that is influenced by polymer concentration. Further, Canning teaches that polymer vesicles through which small molecules are likely to permeate through the membranes (pp. 1992, “In this context, it is worth emphasizing that small molecules are likely to permeate through such vesicle membranes rather quickly, but soluble macromolecules or nanoparticles should be retained much more efficiently.”). A person of ordinary skill in the art would have recognized that permeability is related to the structure and identity of the PEGa/PEGda polymer network, and would be an aspect to be routinely optimized. Applicant has not provided evidence demonstrating criticality or unexpected results associated with the claimed ratio.
Conclusion
No claims 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Katriel B Kasayan whose telephone number is (571)272-1402. The examiner can normally be reached 10-4p.
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/KATRIEL BARCELLANO KASAYAN/ Examiner, Art Unit 1634
/MARIA G LEAVITT/ Supervisory Patent Examiner, Art Unit 1634
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