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 .
Status of the Claims
Amendments to the Specification, Amendments to the Claims and Remarks filed on 12 September 2025, in response to the Office Correspondence dated 12 March 2025, are acknowledged.
The listing of Claims filed 12 September 2025, have been examined. Claims 1-3, 7-13, 15-16, 47, 49, and 55 are pending. Claims 1, 7, 8, 15, and 55 are amended and are supported by the originally-filed disclosure. Claims 4-6, 14, 17-46, 48, 50-54 and 56 are canceled and no new claims have been added.
Response to Amendment
The Specification has been amended to correct the objection defects and therefore the rejection is withdrawn.
The Applicant’s amendment to claim 15 has been reviewed. The previous objection to claim 15 as informal has been overcome by the amendment, which now provides proper antecedent basis and aligns the terminology with that used in claim 1. Accordingly, the objection to claim 15 is withdrawn.
Regarding the 35 USC § 112(b) indefiniteness rejections 4-8, 14-16 and 36, claims 4-6, 14, and 36 have been cancelled, thus the rejection is moot as they are no longer pending. Claims 7, 8, 15 and 16 have been amended to no longer depend on claim 6 accordingly, rejection of claims depending from the rejected claims are withdrawn because the indefiniteness concerns outlined above for the limitations of the claims from which they depend have been resolved.
Regarding the 35 USC § 112(b) and the inadvertent omission of the listing of claim 49, discussed in the prior Office Action dated 12 March 2025, but not formally listed in the rejection heading, The Applicant is correct that the listing of rejected claims on page 3 of the prior Office Action was incomplete. This was a clerical oversight. Upon further review, the rejection of claim 49 under 35 U.S.C. § 112(b) is withdrawn. The Applicant’s reference to pages 24–25 of the specification and citation to MPEP § 2164.04, In re Marzocchi, are noted. However, the rejection under §112(b) is not based on enablement or lack of supporting disclosure but rather on indefiniteness. However given the rejection is withdrawn, the point is immaterial.
The rejection of claim 36 under 35 U.S.C. § 102(a)(1) as being anticipated by Lee (Lee, et al., Fabrication of Hydrogels with a Stiffness Gradient Using Limited Mixing in the Hele-Shaw Geometry. Exp Mech 59, 1249–1259) is considered moot, as the claim has been canceled.
Regarding the 35 U.S.C. § 102(a)(1) rejection of claims 1-16, 47, 49 and 55 as being anticipated by Martin (US10471181B2), claims 4-6, 14, and 47 have been cancelled, therefore the rejection is moot. Claims 1 and 55 have been amended to include the limitation of canceled claim 36, and claims 7, 8 and 15 and been amended to depend from claim 1 therefore claims 2, 3, 7-13, 15-16, 47, and 49 all ultimately depend from the amended claim 1. As such, the Applicant’s arguments, filed 12 September 2025, with respect to the rejections of the claims, as amended, under 35 U.S.C. § 102(a)(1) have been fully considered and are withdrawn. However, upon further consideration, new grounds of rejection are made in view of the amendment to claims 1 and 55, as outlined below.
New Rejections
The following new grounds of rejections are made, as necessitated by the Applicant's amendment to remove the improper multiple dependency, based on the amended/newly cited limitations.
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.
Claim 15 is 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, regards as the invention.
Amended claim 15 recites, “the hydrogel material comprises reactive groups distinct from one or more polar moieties,” but fails to define what is meant by “distinct.” It is unclear whether the distinction refers to chemical type, reactivity, or functionality. Applicant is advised to revise the claim to provide a narrower and define scope that is supported by the specification of the invention.
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-AlIA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AlA) 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.
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 1-3, 7-13, 15-16, 47, 49 and 55 are rejected under 35 U.S.C. § 103 as being unpatentable over Martin (US10471181B2; published 12 November 2019) in view of Lee (Lee, et al., Fabrication of Hydrogels with a Stiffness Gradient Using Limited Mixing in the Hele-Shaw Geometry. Exp Mech 59, 1249–1259; published 10 July 2018).
Regarding instant claim 1, Martin discloses a composite composition comprising polymeric fiber material covalently linked [bonded] to a crosslinked hydrogel material with a plurality of macropores (claim 1).
The technical features of the composition disclosed by Martin are tantamount to that of the instant invention and would therefore also intrinsically be suitable for the intended use of embolization as per the claimed invention of instant claim 1. Further, Martin discloses compositions that may include known embolic agents such as polyvinyl alcohol as, “Synthetic thickeners such as polyvinyl alcohol, vinylpyrrolidone-vinylacetate-copolymers, polyethylene glycols, and polypropylene glycols may also be used.” (page 44, column 21, paragraph 2), where polyvinyl alcohol particles known and commonly used as an agent to occlude precapillary arterioles or small arteries by causing an inflammatory reaction. Martin also discloses compositions that may include common sclerosing embolic agents that serve to harden the endothelial lining of vessels by denaturing proteins of the endothelium and activating the coagulation system to cause a blood clot, such as ethanol and ethanolamine as, “For topical and transdermal administration of some active agents, and in wound dressings, it may be necessary or desirable to incorporate a permeation enhancer into the hydrogel composition in order to enhance the rate of penetration of the agent into or through the skin. Suitable enhancers include, for example, the following: … alcohols such as ethanol; amides and other nitrogenous compounds such as…ethanolamine…” (page 43, columns 19 and 20, last and first paragraphs, respectively). While non-uniform crosslinking density would result in regions of differing stiffness, Martin does not explicitly teach regions of different stiffness.
Lee clearly teaches composition and methods of making a polyacrylamide (PAAM) hydrogel substrate comprising regions of different stiffness. The varied stiffness distribution gradient was quantified as, “The measured Young’s moduli using the Sneddon model were 2.0–2.3 kPa and 34.0–35.3 kPa for the soft and stiff side of one of the fabricated gels, respectively.” (page 6, Stiffness Distribution of PAAM Gels section, right column, last paragraph).
While Lee does not explicitly disclose use as an embolization composition or covalent bonding between the hydrogel and fiber material, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to add use the gradient gel described by Lee in the invention of Martin with a reasonable expectation of success in making the change as both inventions are aimed at the same purpose of providing a hydrogel substrate that mimics the stiffness of the extracellular matrix to facilitate cellular interactions. One would be motivated to make the change to optimize the invention of Martin and use modified hydrogel substrates with a concentration gradient of more distinctly varied degrees of elasticity or stiffness because the extracellular environment is physiologically and mechanically inhomogeneous, hydrogel substrates of stiffness variation or gradient can better mimic the extracellular matrix (see Lee Introduction, paragraph 2). Therefore, it would have been obvious to a person of ordinary skill in the art, seeking to optimize the hydrogel to more closely recapitulate the physiological conditions of the extracellular matrix, while maintaining the mechanical strength for a demanding application like embolization using a fiber material covalently bonded to hydrogel matrix, to incorporate the stiffness-gradient hydrogel described by Lee to the invention of Martin and thereby arrive at the claimed invention without an inventive step. Thus, instant claim 1 obvious over Martin in view of Lee.
Regarding instant claims 2 and 3, instant claim 1 is obvious as described above. In addition, Martin explicitly details a pore size range of 1-100 microns in the specification as, “Pore size can be from below about 1 micron to up to 100 microns, including 1, 2, 3, 4 5, 10, 15, 20, 30, 40, 50, 60 70, 80, 90 or 100 microns, and the size thereof may be narrowly tailored…” (page 40, column 14, lines 9-12), encompassing the instant claims range of at least 10 microns or 50 microns, respectively. Given the claimed range lies within the range disclosed in the prior art, instant claims 2 and 3 are obvious.
Regarding instant claim 7, instant claim 1 is obvious as described above. Martin discloses “The polymers and/or nanostructures may also be crosslinked prior to admixture with the complementary oligomer. In such a case, it may be preferred to synthesize the polymer in crosslinked form, by admixing a monomeric precursor to the polymer with multifunctional comonomer and copolymerizing. Examples of monomeric precursors and corresponding polymeric products are as follows: … The multifunctional comonomer include, for example, bisacrylamide, acrylic or methacrylic esters of diols such as butanediol and hexanediol (1,6-hexane diol diacrylate is preferred), other acrylates such as pentaerythritol tetraacrylate, and 1,2-ethylene glycol diacrylate, and 1,12-dodecanediol diacrylate. Other useful multifunctional crosslinking monomers include oligomeric and polymeric multifunctional (meth)acrylates, e.g., poly(ethylene oxide) diacrylate or poly(ethylene oxide) dimethacrylate; polyvinylic crosslinking agents such as substituted and unsubstituted divinylbenzene; and difunctional urethane acrylates such as EBECRYL 270 and EBECRYL 230 (1500 weight average molecular weight and 5000 weight average molecular weight acrylated urethanes, respectively—both available from UCB of Smyrna, Ga.), and combinations thereof.” (page 47, column 27, paragraph 1). Thus, crosslinking moieties comprising acrylate group (CH2=CHCOOR) reacted with functional groups via Michael addition, free radical polymerization, thiol-ene reactions or other mechanisms (“reacted acrylates”) forming covalent linkage (e.g., for the disclosed diacrylates the acrylate group would primarily react with the vinyl functional group (CH2=CH-), encouraged by the ester group (-COO-), linking two polymer chains covalently) are disclosed by Martin. Therefore, instant claim 7 is obvious.
Regarding instant claim 8, instant claim 1 is obvious as described above. Martin discloses “The polymers and/or nanostructures may also be crosslinked prior to admixture with the complementary oligomer. In such a case, it may be preferred to synthesize the polymer in crosslinked form, by admixing a monomeric precursor to the polymer with multifunctional comonomer and copolymerizing. Examples of monomeric precursors and corresponding polymeric products are as follows: N-vinyl amide precursors for a poly(N-vinyl amide) product; N-alkylacrylamides for a poly(N-alkylacrylamide) product; acrylic acid for a polyacrylic acid product; methacrylic acid for a polymethacrylic acid product; acrylonitrile for a poly(acrylonitrile) product; and N-vinyl pyrrolidone (NVP) for a poly(vinylpyrrolidone) (PVP) product. Polymerization may be carried out in bulk, in suspension, in solution, or in an emulsion. Solution polymerization is preferred, and polar organic solvents such as ethyl acetate and lower alkanols (e.g., ethanol, isopropyl alcohol, etc.) are particularly preferred. For preparation of hydrophilic vinyl polymers, synthesis will typically take place via a free radical polymerization process in the presence of a free radical initiator as described above. The multifunctional comonomer include, for example, bisacrylamide, acrylic or methacrylic esters of diols such as butanediol and hexanediol (1,6-hexane diol diacrylate is preferred), other acrylates such as pentaerythritol tetraacrylate, and 1,2-ethylene glycol diacrylate, and 1,12-dodecanediol diacrylate. Other useful multifunctional crosslinking monomers include oligomeric and polymeric multifunctional (meth)acrylates, e.g., poly(ethylene oxide) diacrylate or poly(ethylene oxide) dimethacrylate; polyvinylic crosslinking agents such as substituted and unsubstituted divinylbenzene; and difunctional urethane acrylates such as EBECRYL 270 and EBECRYL 230 (1500 weight average molecular weight and 5000 weight average molecular weight acrylated urethanes, respectively—both available from UCB of Smyrna, Ga.), and combinations thereof.” (page 47, column 27, paragraph 1) and “The surgical device of claim 1, wherein the reacted crosslinking moiety comprises a reacted maleimide group.” (claim 5).
In summary, Martin discloses covalent linkages formed by crosslinking moieties comprising reacted acrylamides (CH2=CHCONH2, forming a covalent bond by free radical polymerization in the presence of a free radical initiator or by Michael addition when reacted with thiols or amines; i.e., N-alkylacrylamides, bisacrylamide), reacted vinyl ether moieties (CH2=CHOR, forming covalent bonds by reaction with thiols to form thioether linkages, or reactive monomers by undergoing cationic polymerization in the presence of cationic initiators; i.e., N-vinyl pyrrolidone), and reacted maleimides (H2C2(CO)2NH; forming covalent bonds by reaction with nucleophilic thiols via Michael addition or alternatively by thermal polymerization; i.e., reacted maleimide group). Thus, instant claim 8 is obvious.
Regarding instant claims 9 and 10, instant claim 1 is obvious as described above. Martin discloses a composition comprising a polymeric fiber material covalently linked to a hydrogel material, wherein: “b) the scaffold complex comprises a reacted crosslinking moiety…” (claim 1), where Martin defines crosslinking as, “The term “crosslinked” herein refers to a composition containing intramolecular and/or intermolecular crosslinks, whether arising through covalent or noncovalent bonding, and may be direct or include a cross-linker. “Noncovalent” bonding includes both hydrogen bonding and electrostatic (ionic) bonding.” (page 39, column 11, paragraph 4). Further, Martin outlines “The gel/hydrogel polymers may be covalently crosslinked to other polymers or to the nanostructures, either intramolecularly or intermolecularly or through covalent bonds.” (page 46, column 25, paragraph 2). Thus, Martin discloses embodiments of the invention wherein the hydrogel material and the fiber material are associated by ionic bond interactions, therefore instant claim 9 is obvious.
As such, to form crosslinking by ionic bonding, charged functional groups on polymer chains and counterions are required for electrostatic interactions. Therefore, crosslinking via noncovalent electrostatic (ionic) bonding, as described by Martin, necessitates functional groups that can form ionic bonds (e.g., carboxylate groups (-COO-) found in alginate and poly(acrylic acid); sulfonate groups (-SO3-) found in sulfonated polymers or carrageenan; ammonium groups (-NH3+) found in chitosan or poly(allylamine hydrochloride); phosphate groups (-PO43-) found in phosphorylated polymers or DNA and RNA; quaternary ammonium groups (-NR4+) found in poly(diallyldimethylammonium chloride) or cationic cellulose derivatives; imidazole groups ((CH)3(NH)N+) found in synthetic polymers with the group or histidine-containing materials; or sulfate groups (-OSO3-) found in sulfated glycosaminoglycans or heparin-containing materials), which are included as various embodiments of the invention detailed in the specifications. Thus, instant claim 10 is obvious.
Regarding instant claim 11, instant claim 1 is obvious as described above claims. Hydrogel materials containing polar moieties are disclosed by Martin including poly(acrylic acid) containing polar carboxylate (-COO-) functional groups, poly(vinyl alcohol) containing polar hydroxyl (-OH) functional groups, poly(ethylene glycol) containing polar hydroxyl (-OH) and ether (-O-) functional groups, alginate containing polar carboxylate (-COO-) and hydroxyl (-OH) functional groups, chitosan containing polar hydroxyl (-OH) and amino (-NH2) functional groups, hyaluronic acid containing polar carboxylate (-COO-) and hydroxyl (-OH) functional groups, polyacrylamide containing polar amide (-CONH2) functional groups, various cellulose derivatives containing polar hydroxyl (-OH) and ether (-O-) functional groups, poly(vinylpyrrolidone) (PVP) containing polar carbonyl (C=O) and amide-like functional groups and others are referenced throughout the specification, in particular the “Gel/Hydrogel Component” section (page 41, column 16, starting at line 37). Specifically, claim 16 discloses “The surgical device of claim 14, wherein the hydrogel material comprises a poly(ethylene glycol), a collagen, a dextran, an elastin, an alginate, a hyaluronic acid, a poly(vinyl alcohol), or a combination thereof.”, therefore instant claim 11 is obvious.
Regarding instant claim 12, instant claim 11 is obvious as described above. "Hydroxy" refers to the prefix used to indicate the presence of a hydroxyl group (-OH), whereas "hydroxyl" specifically refers to the functional group itself, therefore as described for claim 12, Martin discloses the use of poly(vinyl alcohol), poly(ethylene glycol), alginate, chitosan, hyaluronic acid and various cellulose derivatives containing polar hydroxy moieties. Specifically, claim 16 discloses “The surgical device of claim 14, wherein the hydrogel material comprises a poly(ethylene glycol)… an alginate, a hyaluronic acid, a poly(vinyl alcohol), or a combination thereof.”, therefore instant claim 12 is obvious.
Regarding instant claims 13 and 55, instant claim 1 is obvious as described above, including the covalent bonding and differing stiffness limitations of instant claim 55. Martin further teaches “During the conversion of the liquid into fibers, the fibers harden and/or dry. This hardening and/or drying may be caused by cooling of the liquid, i.e., where the liquid is normally a solid at room temperature; …” (page 47, column 28, lines 45-48), thus the cryogel composite composition of instant claim 13 and a method of making the composition of instant claim 55 is obvious.
Regarding instant claim 15, instant claim 1 is obvious as described above. Hydrogel materials with reactive groups that are not polar would include vinyl groups (C=C), such as N-vinyl pyrrolidone (NVP), thiol groups (-SH) such as thiolated hyaluronic acid, maleimide groups (H2C2(CO)2NH) and alkene groups (C=C) such as PEGDA (polyethylene glycol diacrylate) which are all disclosed by Martin as, “Examples of monomeric precursors and corresponding polymeric products are as follows: N-vinyl amide precursors for a poly(N-vinyl amide) product; N-alkylacrylamides for a poly(N-alkylacrylamide) product; acrylic acid for a polyacrylic acid product; methacrylic acid for a polymethacrylic acid product; acrylonitrile for a poly(acrylonitrile) product; and N-vinyl pyrrolidone (NVP) for a poly(vinylpyrrolidone) (PVP) product.” (page 47, column 27, paragraph 1), thiolated hyaluronic acid (Example 1, 2, 5, 9, 11, and 13), “The surgical device of claim 1, wherein the reacted crosslinking moiety comprises a reacted maleimide group.” (claim 5), and PEGDA (Example 1, 5, 15; Figures 7B, 15A, 19A-C). Therefore, assuming the composition of claim 1 wherein the hydrogel material comprises reactive groups distinct from one or more polar moieties, the prior art renders the invention obvious.
Regarding instant claim 16, instant claim 15 is obvious as described above. Hydrogel materials with reactive groups that are not polar would include PEGDA containing a reactive acrylate group (CH2=CH-COO-) which participated in free radical polymerization or Michael addition to form covalent crosslinks. Martin discloses the use of PEGDA (Example 1, 5, 15; Figures 7B, 15A, 19A-C) and therefore the invention of instant claim 16 is obvious.
Regarding instant claim 47, instant claim 1 is obvious as detailed above. Martin discloses “The hydrogel/nanostructure composites also can be used for coating non-biologic cardiovascular devices such as catheters, stents and vascular grafts. These would include devices made from materials conventionally not used because of their biological incompatibility, but which have superior design characteristics to those devices currently in use. Bioactive factors could be incorporated into the hydrogels to promote endothelization or epithelization of the hydrogel, and thus of the implanted device.” (page 51-52, column 36-37, line 66-67 and 1-7, respectively) and “The gel/hydrogel/nanostructure compositions of the invention can be used advantageously in numerous tissue repair situations, as well as in other applications, such as providing coatings on catheters and other surgical devices and implants. The gel/hydrogel/nanostructure compositions of the invention can also be used to deliver active agents described herein, such as antibiotics, growth factors, and immunosuppressive agents.” (page 49, column 32, line 2-9).
Further, Martin discloses compositions that may include known embolic agents such as polyvinyl alcohol as, “Synthetic thickeners such as polyvinyl alcohol, vinylpyrrolidone-vinylacetate-copolymers, polyethylene glycols, and polypropylene glycols may also be used.” (page 44, column 21, paragraph 2), where polyvinyl alcohol particles known and commonly used as an agent to occlude precapillary arterioles or small arteries by causing an inflammatory reaction. Therefore, Martin discloses delivering the composition 1 by catheter, where the composition would necessarily penetrate blood vessels and function to embolizing the blood vessel.
Regarding instant claim 49, instant claim 1 is obvious as described above. Martin discloses “Hydrogel/nanostructure compositions as herein described also can be used to provide cricoid ring replacements to protect the carotid artery following neck resection for cancer…” (page 50, column 34, lines 11-15), For cosmetic and reconstructive purposes in sites other than the head and neck, for example use as breast implants for breast augmentation, as a wound sealant, for example to fill the void left after removal of lymph nodes (i.e. due to cancer) in the breast or neck…” (page 50, column 34, lines 30-35), and “The compositions of the invention may also be used for treatment of radiation-induced intestinal strictures. Radiation therapy for cancer is associated with numerous morbidities, important among which is intestinal stricture formation. The present hydrogel composites may be used to treat or prevent radiation-induced intestinal strictures.” (page 51, column 36, lines 9-14). Therefore, treating a subject suffering from cancer by administration of the composition disclosed in instant claim 1 as in instant claim 49 is obvious.
Response to Arguments
Applicant Arguments/Remarks of the reply, filed 12 September 2025 have been fully considered.
Regarding the 35 USC § 112(b) and the inadvertent omission of the listing of claim 49, discussed in the prior Office Action dated 12 March 2025, but not formally listed in the rejection heading, The Applicant is correct that the listing of rejected claims on page 3 of the prior Office Action was incomplete. This was a clerical oversight. Claim 49 has been reconsidered and is no longer rejected under 35 U.S.C. § 112(b). The Applicant’s reference to pages 24–25 of the specification and citation to MPEP § 2164.04, In re Marzocchi, are noted. However, the rejection under §112(b) is not based on enablement or lack of supporting disclosure but rather on indefiniteness—the inability of one skilled in the art to ascertain the metes and bounds of the claimed subject matter with reasonable certainty. In re Marzocchi precedent primarily concerns rejections for lack of enablement under 35 U.S.C. § 112(a), not indefiniteness under § 112(b). A rejection for indefiniteness does not require the Office to "doubt the truth or accuracy" of the disclosure. Rather, the burden is on the Applicant to provide claims that distinctly point out and circumscribe the invention. However, the rejection has been withdrawn, therefore this point is moot.
Applicant argues that the rejection of the claims 1-3, 7-13, 15-16, 47, 49 and 55 under 35 U.S.C. §102(a)(1) over Martin are obviated by the amendment to claims 1 and 55. The Examiner has withdrawn the rejection and has issued new 35 U.S.C. §103 rejections over Martin in view of Lee. Martin discloses embolization compositions comprising polymeric hydrogel matrices having fibrous reinforcement and macroporous structures, and further teaches covalent bonding between polymer and crosslinker species to form a stable hydrogel composite (claim 1). The claimed "regions of differing stiffness" is an inherent property of any non-homogeneous composite material- the distribution of fibers within a hydrogel matrix naturally creates regions of varying density and, consequently, varying stiffness; however, Martin does not explicitly teach regions of differing stiffness.
In light of the amendments to claims 1 and 55, a new ground of rejection under 35 U.S.C. §103 is advanced. Lee renders the claims obvious by explicitly teaching compositions of hydrogel substrate comprising regions of varying degrees of stiffness. KSR Intl Co. v. Teleflex Inc., 550 U.S. 398 (2007) teaches, “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.” Adjusting the ratios of hydrogel crosslinking or hydrogel thickness are conventional modifications to the invention of Martin and use of concentration gradients of polymer in the hydrogel composition or micropatterning as disclosed by Lee (see Lee Introduction) are obvious modifications to the invention of Martin to those of ordinary skill in the art. Support for a prima facie case of obviousness, based on facts gleaned from the combination of the prior art, including all of the limitations of newly amended claim 1 and 55, has been established.
Applicant has withdrawn claim 36 and therefore the argument as to the rejection of claim 36 under §102(a)(1) over Lee is considered moot.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new grounds 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 (87 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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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615