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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Species A in the reply filed on March 24, 2026, is acknowledged.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 24, 2026.
Accordingly, claims 1-19 are being examined.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the hydroxyl-containing polymer, primary and secondary crosslinker, and water, as claimed, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-5, 7, 15 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carlson et al., (hereinafter ‘Carlson,’ U.S. PGPub. No. 2013/0142763).
Regarding claim 1, Carlson discloses a miniaturized hydrogel (see [0004], for hydrogel; also see [0031]-[0035]) comprising a reaction product of a hydroxyl-containing polymer (see [0017], for reactable functional groups containing a hydroxyl), a primary crosslinker, and a secondary crosslinker (see abstract for, “one or more crosslinkers that crosslinks the one or more cellulosic polymers together”; [0017]; [0033]-[0034]; [0041]; [0059]); and water (see [0042], for hydrogel containing water); wherein each of the primary crosslinker and the secondary crosslinker are reactive towards the hydroxyl-containing polymer ([0059], “the cellulosic polymers disclosed herein include a number of hydroxyl groups that can be reacted with the various crosslinking agents disclosed herein to form the crosslinkers and therefore provide crosslinked cellulosic polymer.”); and wherein the hydrogel is made by a method comprising: contacting the hydroxyl-containing polymer ([0017]; [0059]), the primary crosslinker, and the secondary crosslinker under conditions effective to provide a crosslinked hydrogel (abstract; [0017]; [0059], “the cellulosic polymers disclosed herein include a number of hydroxyl groups that can be reacted with the various crosslinking agents disclosed herein to form the crosslinkers and therefore provide crosslinked cellulosic polymer.”); acidifying the crosslinked hydrogel ([0017]); drying the crosslinked hydrogel under tension (see [0113], for drying); and rehydrating the dried hydrogel to provide the miniaturized hydrogel ([0017]; [0033]-[0034]; [0041]; [0059]; see claim 145 for ‘rehydrating’).
Regarding claim 3, Carlson discloses wherein the hydroxyl-containing polymer comprises polyvinyl alcohol ([0081]), poly(hydroxypropyl methacrylate) ([0069]), or a copolymer thereof.
Regarding claim 4, Carlson discloses wherein the primary crosslinker comprises silicon ([0054]).
Regarding claim 5, Carlson discloses wherein the primary crosslinker comprises a tetra(C1-6 alkyl)orthosilicate ([0054]).
Regarding claim 7, Carlson discloses wherein the secondary crosslinker comprises a (C3-18 alkylene) dialdehyde, a dicarboxylic acid, or a combination thereof ([0017]; [0002], “the crosslinker is the product of a reaction between the one or more cellulosic polymers and a crosslinking agent selected from the group consisting of a dithio diacid, a dicarboxylic acid . . .”).
Regarding claim 15, Carlson discloses all of the limitations of the miniaturized hydrogel according to claim 1. Therefore, it naturally follows that Carlson discloses wherein the miniaturized hydrogel has a refractive index of 1.35 to 1.45 at 480 nanometers.
Regarding claim 19, Carlson discloses an implantable medical device comprising the miniaturized hydrogel of claim 1 (see abstract for, “Crosslinked cellulosic polymers are well adapted for use in cell and tissue growth in vivo and in vitro. The crosslinked cellulose polymers may also be used as wound care devices.” Also see [0081] for various medical devices).
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.
Claims 2, 10, 11, 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Carlson in view of Carlson.
Regarding claim 2, Carlson discloses wherein the thickness of the hydrogel decreases when dried under tension (as broadly claimed, it naturally follows that the hydrogel decreases when dried under tension). Carlson further discloses rehydrating the dried hydrogel ([0017]; [0033]-[0034]; [0041]; [0059]; see claim 145 for ‘rehydrating’), but is silent regarding the hydrogel does not swell by more than 10% in any direction when rehydrated, and the thickness of the hydrogel is reduced by at least 70% when rehydrated compared to the initial hydrogel.
However, it would have been obvious to one having ordinary skill in the art to have modified the hydrogel, as taught by Carlson, to provide the hydrogel does not swell by more than 10% in any direction when rehydrated, and the thickness of the hydrogel is reduced by at least 70% when rehydrated compared to the initial hydrogel, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 10, Carlson discloses wherein the hydrogel is in the form of a fiber (as broadly claimed, the hydrogel is a ‘fiber’) (also see [0017]; [0033]-[0034]; [0041]; [0059]), but is silent regarding having an average diameter of 50 to 500 micrometers.
However, it would have been obvious to one having ordinary skill in the art to have modified the hydrogel, as taught by Carlson, to provide having an average diameter of 50 to 500 micrometers, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 11, Carlson discloses all of the limitations of the miniaturized hydrogel of claim 10, further comprising an outer layer on the surface of the hydrogel fiber (as broadly claimed, the hydrogel necessarily has an outer layer), wherein the outer layer comprises a crosslinked hydroxyl-containing polymer and a filler (see abstract for, “one or more crosslinkers that crosslinks the one or more cellulosic polymers together”; [0017]; [0033]-[0034]; [0041]; [0059]).
Regarding claim 13, Carlson discloses all of the limitations of the miniaturized hydrogel of claim 1. Carlson further discloses the crosslinked cellulosic polymer :can have a molecular weight in a range from about 2000 daltons to about 500,000 daltons” ([0002]; [0063]), but is silent regarding wherein the primary crosslinker is present in an amount of greater than 0 to 5 weight percent, based on the total weight of the miniaturized hydrogel.
However, it would have been obvious to one having ordinary skill in the art to have modified the hydrogel, as taught by Carlson, to provide wherein the primary crosslinker is present in an amount of greater than 0 to 5 weight percent, based on the total weight of the miniaturized hydrogel, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 16, Carlson discloses all of the limitations of the miniaturized hydrogel of claim 1, but is silent regarding miniaturized hydrogel exhibits a light transmission of greater than 95%.
However, it would have been obvious to one having ordinary skill in the art to have modified the hydrogel, as taught by Carlson, to provide exhibiting a light transmission of greater than 95%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Carlson in view of Slager et al., (hereinafter ‘Slager,’ U.S. PGPub. No. 2023/0338623).
Regarding claim 6, although Carlson discloses one or more crosslinkers (see abstract; [0017]; [0033]-[0034]; [0041]; [0059]), Carlson is silent regarding wherein the secondary crosslinker comprises a dialdehyde.
However, in the same field of endeavor, Slager teaches “[t]he crosslinker can comprise a bio-degradable crosslinker such as, but not limited to degradable dialdehydes, carboxylic acid, or combinations thereof.” ([0161]). Therefore, it would have been obvious to one having ordinary skill in the art to have modified the miniaturized hydrogel, as taught by Carlson, to include wherein the secondary crosslinker comprises a dialdehyde, as taught by Slager, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Carlson in view of Bhaduri et al., (hereinafter ‘Bhaduri,’ U.S. PGPub. No. 2014/0308334).
Regarding claim 8, Carlson discloses all of the limitations of the miniaturized hydrogel of claim 1, but is silent regarding wherein the hydrogel comprises a plurality of nanocrystalline domains, wherein the nanocrystalline domains are present in an amount effective to provide the hydrogel with a total crystallinity of 5 to 20%.
However, in the same field of endeavor, Bhaduri teaches a similar system comprising hydrogel and including a plurality of nanocrystalline domains in order to “enhance both bioactivity and adherence to the substrate.” ([0031]), thereby improving safety and effectiveness. Therefore, it would have been obvious to one having ordinary skill in the art to have modified the miniaturized hydrogel, as taught by Carlson, to include a plurality of nanocrystalline domains, as taught by Bhaduri, in order to “enhance both bioactivity and adherence to the substrate” ([0031]), thereby improving safety and effectiveness.
Carlson in view of Bhaduri are silent regarding wherein the nanocrystalline domains are present in an amount effective to provide the hydrogel with a total crystallinity of 5 to 20%. However, it would have been obvious to one having ordinary skill in the art to have modified the present effective amount, as taught by Carlson in view of Bhaduri, to provide the hydrogel with a total crystallinity of 5 to 20%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Carlson in view of Gong et al., (hereinafter ‘Gong,’ U.S. PGPub. No. 2012/0238644).
Regarding claim 9, Carlson discloses all of the limitations of the miniaturized hydrogel of claim 1, but is silent regarding further comprising a conductive filler.
However, in the same field of endeavor, Gong (Fig. 1) teaches a similar hydrogel comprising a conductive filler ([0055], “Additional additives may be present in the formulation to modify the mechanical properties of the composition. Some additives include, for example, fillers, softening agents and stabilizers. Examples of fillers include, but are not limited to, carbon black, metal oxides, silicates, acrylic resin powder, and various ceramic powders.”). Fillers may be utilized to reinforce the composition, thereby improving strength and durability ([0058]). Therefore, it would have been obvious to one having ordinary skill in the art to have modified the miniaturized hydrogel, as taught by Carlson, to include a conductive filler, as taught by Gong, in order to reinforce the composition, thereby improving strength and durability.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Carlson in view of Sun et al., (hereinafter ‘Sun,’ U.S. PGPub. No. 2021/0353830).
Regarding claim 14, Carlson discloses all of the limitations of the miniaturized hydrogel of claim 1, but is silent regarding wherein the miniaturized hydrogel exhibits: a stretchability of greater than 100%; or an elastic modulus of less than 35 MPa; or both.
However, in the same field of endeavor, Sun teaches a similar hydrogel exhibiting a stretchability of greater than 100% ([0015], “the network hydrogel comprises a rupture stretch that is about 19.2 times higher compared to a hydrogel consisting of alginate alone, e.g., about 10, about 15, about 20, about 25, or about 30 times higher compared to a hydrogel consisting of alginate alone.”). Sun teaches “ [s]ome synthetic elastic hydrogels have achieved stretches in the range 10-20, but these values are markedly reduced in samples containing notches. Described herein is the synthesis of hydrogels from polymers forming ionically and covalently crosslinked networks. Although such gels contain ˜90% water, they can be stretched beyond 20 times their initial length, have fracture energies of ˜9,000 J m2, and are characterized by Young's modulus values in the megaPascal range. Even for samples containing notches, a stretch of 17 is demonstrated.” ([0067]). Therefore, it is desirable to provide a stretchability of greater than 100% (as can be seen in Sun) because “strong gels are needed in drug delivery to change the design and use of capsules and patches [and] [i]mplantable long-term drug delivery devices also need gels with enhanced mechanical properties.” It would have been obvious to one having ordinary skill in the art to have modified the hydrogel, as taught by Carlson, to include wherein the miniaturized hydrogel exhibits a stretchability of greater than 100%, as taught by Sun, in order to provide increased strength and enhanced mechanical properties to existing drug delivery and implantable long-term drug delivery devices, thereby improving safety and efficacy.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Carlson in view of Cui et al., (hereinafter ‘Cui,’ U.S. PGPub. No. 2017/0050996).
Regarding claim 18, Carlson discloses all of the limitations of the miniaturized hydrogel according to claim 1. Although Carlson discloses the hydrogel used with various medical devices (abstract; [0081]), Carlson is silent regarding a neural probe or a microelectrode.
However, in the same field of endeavor, Cui teaches a similar system comprising a neural probe wherein hydrogel is provided on the neural probe ([0026]-[0027]). It is well known in the art (as can be seen in Cui) to provide a hydrogel coating, including “an iSODm coating applied to a neural probe [to] increase[] neural cell density around the probe following chronic implantation in an animal model.” ([0037]; [0040]), thereby improving biocompatibility and overall safety. Therefore, it would have been obvious to one having ordinary skill in the art to have modified the hydrogel, as taught by Carlson, to include a neural probe, as taught by Cui, in order to increase neural cell density (around the probe following chronic implantation in an animal model) ([0037]; [0040]), thereby improving biocompatibility and overall safety. Further, this modification would have merely comprised a simple substitution of one well known medical device for another in order to produce a predictable result. MPEP 2143(I)(B).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: the most pertinent piece of prior art is Carlson (U.S. PGPub. No. 2013/0142763). Carlson teaches a similar miniaturized hydrogel (see [0004], for hydrogel; also see [0031]-[0035]) comprising a reaction product of a hydroxyl-containing polymer (see [0017], for reactable functional groups containing a hydroxyl), a primary crosslinker, and a secondary crosslinker (see abstract for, “one or more crosslinkers that crosslinks the one or more cellulosic polymers together”; [0017]; [0033]-[0034]; [0041]; [0059]); and water (see [0042], for hydrogel containing water).
Regarding claim 17, although the prior art teaches a similar miniaturized hydrogel, the prior art fails to specifically teach comprising, “45 to 65 weight percent of a reaction product of a hydroxyl-containing polymer, a primary crosslinker, and a secondary crosslinker; and 35 to 55 weight percent water; wherein weight percent is based on the total weight of the miniaturized hydrogel; wherein the hydrogel comprises a plurality of nanocrystalline domains, wherein the nanocrystalline domains are present in an amount effective to provide the hydrogel with a total crystallinity of 5 to 20%; wherein the miniaturized hydrogel exhibits one or more of: a stretchability of greater than 100%; an elastic modulus of less than 35 MPa; a refractive index of 1.35 to 1.45 at 480 nanometers; and a light transmission of greater than 95%” as recited in independent claim 17.
Claim 12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
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/C.A.D./Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
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