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
Claims 1-3, 7, 8, 12-14, 16-21 and 23-31 are pending; and amendments to the claims filed on 05/10/2026 are acknowledged. By way of applicant’s election of 01/21/2026, claims 1-3, 7, 8 and 12 have been withdrawn. Accordingly, claims 13, 14, 16-21 and 23-31 are being examined at this time.
Withdrawn rejections:
Applicant's amendments and arguments filed 05/10/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
New Grounds of objection and rejections --- as necessitated by amendment
Specification
The disclosure is objected to because of the following informalities: the specification discloses abbreviations such as SAP, PSAP, AM, SA, MBA, DI, APS ([0052], [0077], [0079], etc. of instant publication), which should be spelled out at the first encounter in the specification. Appropriate correction is required.
Claim Objections
Claim 24 is objected to because of the following informalities:
Claim 24 recites “at least one of the stimuli”, but which would be better to recite either “the one or more stimuli” or “the at least one of stimuli”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13, 14, 16-21 and 23-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163.II.A.3.(b) states, “when filing an amendment an applicant should show support in the original disclosure for new or amended claims” and “[i]f the originally filed disclosure does not provide support for each claim limitation, or if an element which applicant describes as essential or critical is not claimed, a new or amended claim must be rejected under 35 U.S.C. 112( or pre-AIA 35 USC 112, para. 1, as lacking adequate written description”. According to MPEP § 2163.I.B, “While there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure” and “The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117”.
Here, claim 13 recites the below new limitations:
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Claim 28 recites similar features of claim 13 and but adds “more than 1 to less than 1000 times the pre-swell volume” in lines 14-15.
However, it appears the originally filed specification does not expressly support the underlined limitations of instant claims 13 and 28. In particular, the limitations “… an active component having a component size larger than pre-swell pore size, … to a post-swell pore size larger than the component size…” do not find support.
Further, claim 30 recites “approximately 70C”, and but the term “approximately” is not supported by the specification.
If applicant disagrees, please provide relevant location and explanation.
The remaining claims are also rejected due to the rejection of base claims 13 and 28.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 30 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 30 recites “a reaction mixture”, but claim 28 does not require that recite reaction mixture. It is not clear what the reaction mixture means. Does applicant intend to mean “a reaction mixture of hydrogel material and liquid”?
Appropriate correction/clarification are requested.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 13, 14, 16, 17, 21, 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Schultz et al. (US2016/0158320A1, IDS of 08/11/2023) in view of D’Agostino et al., “Swelling-induced structural changes and microparticle uptake of gelatin gels probed by NMR and CLSM”, Royal society of chemistry, 2017, 13, pp. 2952-2961; and Juan et al. (US2014/0031769A1, IDS of 08/11/2023).
Applicant claims the below claim 13 filed on 05/10/2026:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical hydrogel research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so. In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01);
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02); and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
Schultz discloses a method for the delivery of drugs for the treatment of posterior segment disease (title) and the method refers to passive transference of the drug from a dilute solution into the hydrogel produces the delivery system and that is, the hydrogel, when placed in contact with the eye, deliver the drug ([0020]) and the hydrogel has consistent pore size which makes a variety of compounds delivered with consistency ([0063]), and that is, the hydrogel has consistent pore size that reads on the claimed hydrogel material having larger pore size configured to allow the active component to pass therethrough and into the polymer scaffold and the hydrogel is mixed with the dilute solution which reads on the claimed liquid, allowing pass therethrough of the drug, which reads on the claimed mixing step; then the drug is passively transferred into the hydrogel ([0024]) which reads on the claimed binding step of the active component with the hydrogel material; then when the hydrogel is placed in contact with the eye, it releases the drug, and which means the hydrogel is placed in the body temperature and the drugs can be released as the hydrogel dissolves ([0020] and [0023]) wherein the temperature reads on the claimed exposing step to temperature stimuli; Shultz teaches “fully hydrated hydrogel is placed in the soaking solution to produce the medicated hydrogel ([0024]). In this respect, please note that hydrogel itself has properties that swells when it contacts water or liquid as defined in the instant publication ([0050]) and evidenced by US publication 2015/0274805A1 that “Hydrogels are used as scaffolds for tissue engineering applications because of their biocompatibility and high water content’ ([0068] of ‘805) and “the sizes of the pores size can change depending on the water content in the hydrogel” ([0188] of ‘805) and thus the claimed swelling step of the hydrogel with liquid is implicit (instant claim 13, in part and instant claim 24); the drug includes corticosteroids ([0026]-[0027]), anti-angiogenesis compound, etc. ([0030]) and the drug may be provided as a suspension or solution, e.g., water for injection or saline for injection ([0064]) which reads on the claimed biological or pharmaceutical liquid (instant claim 14); the hydrogel can be admininstered via injection ([0021] and [0064]-[0065]) (instant claim 17); the hydrogel polymers include a tetrapolymer of hydroxymethylmethacrylate, ethylene glycol, dimethylmethacrylate, and methacrylic acid ([0006]) that reads on the claimed polymer having crosslinked side chains, and although Schulz does not expressly pore size definition/dimension of instant claim 21, since Schulz teaches that the said tetrapolymer having crosslinked side chains, the pore size can be an average mesh size or distance between crosslinkers in the hydrogel network as evidenced by Zarzycki et al., “Drug Release From hydrogel matrices,” Ecological chemistry and engineering S vol. 17, no. 2, 2010, page 117, para. 2, (IDS of 0/11/2023) that “the solid phase of a hydrogel includes a network of cross-linked polymeric chains which create a three-dimensional matrix with interstitial space filled up with water and often biological fluids” (instant claim 21). The drug may be admixed with a pharmaceutically acceptable carrier including various ingredients ([0037]) which reads on the claimed additives (instant claim 23).
Although Schulz’s hydrogel itself is capable of swelling upon contacting liquid, Schulz does not expressly teach pre-swell size and post-swell size of the polymer scaffold in the hydrogel of instant claim 13. The deficiency is cured by D’Agostino.
D’Agostino discloses swelling induced structural changes of gelatin gel which is hydrogel and as one parameter, this prior art teaches pore size of gelatin gel increase during swelling (abstract); and further teaches the penetration of tracers provides evidence of the heterogeneity of the gel structure and shows that single microcarriers can be loaded in gelatin gels upon swelling (abstract) for pharmaceutical field (page 2952, right column).
Such teaching of pore size change during swelling is long standing old concept as taught by D’Agostino. That is, this reference evidences pre-swelling of hydrogel has smaller pore size, and during swelling, its pore size increases, and therefore, larger particles can enter the gel upon swelling. Accordingly it would have been obvious to further define pore-sizes before and after swelling of hydrogel so that the active agent having larger particles can center the hydrogel upon swelling as taught by D’Agostino.
However, Schulz/D’Agostino do not expressly teach hydrogel material further comprising stabilizer of instant claim 13; binding the active component to the stabilizer of the hydrogel material renders the active component inert of instant claim 16; and additive of instant claim 23. The deficiencies are cured by Juan.
Juan discloses a device for treating an eye comprising a reservoir chamber having a volume sized to receive an injection of an amount of a formulation of a therapeutic agent, a porous structure (e.g., hydrogel) to release therapeutic amounts of the therapeutic agent for an extended time, and a stabilizer is configured to maintain stability of the therapeutic agent in the reservoir chamber (abstract, [0012], [0013], [0056], etc.) wherein the therapeutic agent can form a complex with the stabilizer, and the stabilizer comprises a molecular weight of at least about 5 k Daltons such that a portion of the stabilizer remains in the reservoir chamber for the extended time ([0056]), and although Juan does not expressly teach stabilizer renders the active component inert of instant claim 16, it would be implicit because the stabilizer is complexed with therapeutic agent to maintain the therapeutic agent in the reservoir chamber for certain time (instant claims 13 and 16 - stabilizer); further, Juan teaches that the therapeutic agent bound reversibly to the binding agent, the therapeutic agent complexed with the stabilizer and therapeutic agent in solution can be in substantial equilibrium within the chamber of the device so as to modulate release of the therapeutic agent when the therapeutic agent is stabilized ([0014]), and therefore the binding agent protects the therapeutic agent to modulate release of the agent from the binding agent, and the binding agent reads on the claimed additive (instant claim 23 - additives).
It would have been obvious to modify hydrogel of Schultz/D’Agostino with addition of stabilizer/additive of Juan in order to maintain the stability of therapeutic agent and control its release from the binding agent as taught by Juan.
In light of the foregoing, instant claims 13, 14, 16, 17, 21, and 23-24 are obvious over Schultz in view of D’Agostino and Juan.
Response to Arguments
Applicant’s arguments have been fully considered, but are moot in view of new reference of D’Agostino. Further, Juan discloses hydrogel and relied on to disclose stabilizer to protect active therapeutic agent, and Juan teaches the therapeutic agent is released in therapeutic amounts through a porous structure ([0013]) and hydrogel ([0279]-[0280]), and thus Juan is relevant art. Even please note that [O]ne cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In reKeller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In reMerck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). MPEP 2145.
In light of the foregoing, applicant’s arguments are not persuasive.
Claims 18-20 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Schultz et al. (US2016/0158320A1, IDS of 08/11/2023) in view of D’Agostino et al., “Swelling-induced structural changes and microparticle uptake of gelatin gels probed by NMR and CLSM”, Royal society of chemistry, 2017, 13, pp. 2952-2961; Juan et al. (US2014/0031769A1, IDS of 08/11/2023) and further in view of Goneçalves et al., “Synthesis and characterization of high performance superabsorbent hydrogels using bis[2-(methacryloyloxy)ethyl] phosphate as crosslinker.”, Polymer Letters Vol. 10., No. 3 (2016, pp. 248-258, of record).
However, Schultz/D’Agostino/Juan do not expressly disclose pore size of instant claims 18-20; superabsorbent polymer material of instant claim 25; and volume increase capability of instant claim 26; and swelling ratio of instant claim 27. The deficiencies are cured by Goneçalves.
Goneçalves discloses various superabsorbent polymers (SAPs) are a class of hydrogel like materials wherein the hydrogel is used in a wide range of products and areas (e.g., pharmaceutical, biomedical, etc.); SAPs include SAP 1-5 (Fig. 2), and for example, SAP 5 has high porosity with pore sizes between 6 and 21 microns and with a predominance of large pores allows an easy access of water, which contributes to the good swelling properties of the hydrogel (Fig. 2) in which the pore size of 6-21 microns overlaps the ranges of instant claims 18-19, MPEP 2144. 05: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976),” and although this prior art does not expressly teach the claimed pore size of approximately 10 nm to approximately 1 microns of instant claim 20, it would be optimized with the claimed range depending on the intended purpose (e.g., for denser network that absorbs less water), in the absence of criticality evidence (instant claim 20); and the SAP hydrogel has three-dimensional structure which can absorb large amount of water or aqueous fluids in relatively short periods of time which reads on the claimed superabsorbent polymer and generally absorb an amount of water that can reach 1000 times (or more) which overlaps the instant range of approximately 1000 times due to their unique properties such as hydrophilicity (See I. Introduction on page 248, left column). MPEP 2144.05 (instant claims 25-26).
It would have been obvious to further define or modify the hydrogel material of Schultz/D’Agostino/Juan with SAPS hydrogel having hydrophilicity of Goneçalves in order to absorb large amount of water or aqueous fluid and increase volume by 1000 times or more as taught by Goneçalves.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Schultz et al. (US2016/0158320A1, IDS of 08/11/2023) in view of D’Agostino et al., “Swelling-induced structural changes and microparticle uptake of gelatin gels probed by NMR and CLSM”, Royal society of chemistry, 2017, 13, pp. 2952-2961; Juan et al. (US2014/0031769A1, IDS of 08/11/2023) and further in view of Goneçalves et al., “Synthesis and characterization of high performance superabsorbent hydrogels using bis[2-(methacryloyloxy)ethyl] phosphate as crosslinker.”, Polymer Letters Vol. 10., No. 3 (2016, pp. 248-258); and Park et al. (US6271278B1).
The applied references Schultz, D’Agostino, June and Goneçalves were discussed above.
Park discloses super-porous hydrogel composite, and swelling ratio is greater than 300 (Table 2: Samples 2-8) which overlaps the instant range of at least of 150g/g in deionized water (instant claim 27); the hydrogel composite is formed from a crosslinking agent such as functionalized peptides and proteins (e.g., albumin); superporous hydrogel composite has an average pore size in the range of 10 microns to 3,000 microns and porous hydrogels with pore sizes above 40-50 microns are too weak to maintain the intact structure … (col. 36, lines 9-12 and claim 21); and the composite is useful in making devices in tissue engineering, artificial cornea, etc. (col. 32, last para.). The superporous hydrogels and superporous hydrogel composite having high swelling ratio provides improvement of mechanical properties, excellent water absorption and controlled drug delivery (e.g., col. 28: IV and col 32: VI).
It would have been obvious the teachings of the applied art with high swelling ratio of Park in order to enhance superior/fast absorption properties, mechanical properties, and better drug delivery as taught by Park.
Claims 28 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Schultz et al. (US2016/0158320A1, IDS of 08/11/2023) in view of D’Agostino et al., “Swelling-induced structural changes and microparticle uptake of gelatin gels probed by NMR and CLSM”, Royal society of chemistry, 2017, 13, pp. 2952-2961; Juan et al. (US2014/0031769A1, IDS of 08/11/2023) and further in view of Goneçalves et al., “Synthesis and characterization of high performance superabsorbent hydrogels using bis[2-(methacryloyloxy)ethyl] phosphate as crosslinker.”, Polymer Letters Vol. 10., No. 3 (2016, pp. 248-258, of record).
Applicant claims the below claim 28 filed on 05/10/2026:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical hydrogel research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so. In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01);
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02); and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
Schultz discloses a method for the delivery of drugs for the treatment of posterior segment disease (title) and the method refers passive transference of the drug from a dilute solution into the hydrogel produces the delivery system and that is, the hydrogel, when placed in contact with the eye, deliver the drug ([0020]) and the hydrogel has consistent pore size which makes a variety of compounds delivered with consistency ([0063]), and that is, the hydrogel has consistent pore size that reads on the claimed hydrogel material having larger pore size configured to allow the active component to pass therethrough and into the polymer scaffold and the hydrogel is mixed with the dilute solution which reads on the claimed liquid, allowing pass therethrough of the drug; then the drug is passively transferred into the hydrogel ([0024]) which reads on the claimed binding step of the active component with the hydrogel material; then when the hydrogel is placed in contact with the eye, it releases the drug, and which means the hydrogel is placed in the body temperature and the drugs can be released as the hydrogel dissolves ([0020] and [0023]) wherein the temperature reads on the claimed exposing step to temperature stimuli; Shultz teaches “fully hydrated hydrogel is placed in the soaking solution to produce the medicated hydrogel” ([0024]). In this respect, please note that hydrogel itself has properties that swells when it contacts water or liquid as defined in the instant publication ([0050]) and evidenced by US publication 2015/0274805A1 that “Hydrogels are used as scaffolds for tissue engineering applications because of their biocompatibility and high water content” ([0068] of ‘805) and “the sizes of the pores size can change depending on the water content in the hydrogel” ([0188] of ‘805) and thus the claimed swelling step of the hydrogel with liquid is implicit (instant claim 28, in part); the drug includes corticosteroids ([0026]-[0027]), anti-angiogenesis compound, etc. ([0030]) and the drug may be provided as a suspension or solution, e.g., water for injection or saline for injection ([0064]); the hydrogel can be admininstered via injection ([0021] and [0064]-[0065]); the hydrogel polymers include a tetrapolymer of hydroxymethylmethacrylate, ethylene glycol, dimethylmethacrylate, and methacrylic acid ([0006]), and although Schulz does not expressly pore size definition/dimension of instant claim 21, since Schulz teaches that the said tetrapolymer having crosslinked side chains, the pore size can be an average mesh size or distance between crosslinkers in the hydrogel network as evidenced by Zarzycki et al., “Drug Release From hydrogel matrices,” Ecological chemistry and engineering S vol. 17, no. 2, 2010, page 117, para. 2, (IDS of 0/11/2023) that “the solid phase of a hydrogel includes a network of cross-linked polymeric chains which create a three-dimensional matrix with interstitial space filled up with water and often biological fluids”. The drug may be admixed with a pharmaceutically acceptable carrier including various ingredients ([0037]).
Although Schulz’s hydrogel itself is capable of swelling upon contacting liquid, Schulz does not expressly teach pre-swell size and post-swell size of the polymer scaffold in the hydrogel of instant claim 28. The deficiency is cured by D’Agostino.
D’Agostino discloses swelling induced structural changes of gelatin gel which is hydrogel and as one parameter, this prior art teaches pore size of gelatin gel increase during swelling (abstract); and further teaches the penetration of tracers provides evidence of the heterogeneity of the gel structure and shows that single microcarriers can be loaded in gelatin gels upon swelling (abstract) for pharmaceutical field (page 2952, right column).
Such teaching of pore size change during swelling is long standing old concept as taught by D’Agostino. That is, this reference evidences pre-swelling of hydrogel has smaller pore size, and during swelling, its pore size increases, and therefore, larger particles can enter the gel upon swelling. Accordingly it would have been obvious to further define pore-sizes before and after swelling of hydrogel so that the active agent having larger particles can center the hydrogel upon swelling as taught by D’Agostino.
However, Schulz/D’Agostino do not expressly teach hydrogel material further comprising stabilizer of instant claim 28; and binding the active component to the stabilizer of the hydrogel material renders the active component inert and excluding harmful microorganism/enzyme of instant claim 31. The deficiencies are cured by Juan.
Juan discloses a device for treating an eye comprising a reservoir chamber having a volume sized to receive an injection of an amount of a formulation of a therapeutic agent, a porous structure (e.g., hydrogel) to release therapeutic amounts of the therapeutic agent for an extended time, and a stabilizer is configured to maintain stability of the therapeutic agent in the reservoir chamber (abstract, [0012], [0013], [0056], etc.) wherein the therapeutic agent can form a complex with the stabilizer, and the stabilizer comprises a molecular weight of at least about 5 k Daltons such that a portion of the stabilizer remains in the reservoir chamber for the extended time ([0056])(instant claim 28 - stabilizer); Juan further teaches that the therapeutic agent bound reversibly to the binding agent, the therapeutic agent complexed with the stabilizer and therapeutic agent in solution can be in substantial equilibrium within the chamber of the device so as to modulate release of the therapeutic agent when the therapeutic agent is stabilized ([0014]); and although Juan does not expressly teach stabilizer renders the active component inert of instant claim 31, it would be implicit because the stabilizer is complexed with therapeutic agent to maintain the therapeutic agent in the reservoir chamber for certain time. Although the applied art alone or in combination does not expressly teach impurities of hydrogel materials, it would be obvious to remove or exclude harmful microorganism/enzymes in the hydrogel material from the standpoint of an ordinary artisan (instant claim 31).
It would have been obvious to modify hydrogel of Schultz/D’Agostino with addition of stabilizer/additive of Juan in order to maintain the stability of therapeutic agent and control its release from the binding agent as taught by Juan.
However, Schultz/D’Agostino/Juan do not expressly disclose volume increase capability of instant claim 28. The deficiency is cured by Goneçalves.
Goneçalves discloses various superabsorbent polymers (SAPs) are a class of hydrogel like materials wherein the hydrogel is used in a wide range of products and areas (e.g., pharmaceutical, biomedical, etc.); SAPs include SAP 1-5 (Fig. 2), and for example, SAP 5 has high porosity with pore sizes between 6 and 21 microns and with a predominance of large pores allows an easy access of water, which contributes to the good swelling properties of the hydrogel (Fig. 2); and the SAP hydrogel has three-dimensional structure which can absorb large amount of water or aqueous fluids in relatively short periods of time which reads on the claimed superabsorbent polymer and generally absorb an amount of water that can reach 1000 times (or more) which overlaps the instant range of approximately 1000 times due to their unique properties such as hydrophilicity (See I. Introduction on page 248, left column). MPEP 2144.05 (instant claim 28 – volume increase).
It would have been obvious to further define or modify the hydrogel material of Schultz/D’Agostino/Juan with SAPS hydrogel having hydrophilicity of Goneçalves in order to absorb large amount of water or aqueous fluid and increase volume by 1000 times or more as taught by Goneçalves.
Claims 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Schultz et al. (US2016/0158320A1, IDS of 08/11/2023) in view of D’Agostino et al., “Swelling-induced structural changes and microparticle uptake of gelatin gels probed by NMR and CLSM”, Royal society of chemistry, 2017, 13, pp. 2952-2961; Juan et al. (US2014/0031769A1, IDS of 08/11/2023) and further in view of Goneçalves et al., “Synthesis and characterization of high performance superabsorbent hydrogels using bis[2-(methacryloyloxy)ethyl] phosphate as crosslinker.”, Polymer Letters Vol. 10., No. 3 (2016, pp. 248-258, of record); and Park et al. (US6,271,278B1).
The applied art was discussed above.
Park discloses superporous hydrogel composite, and swelling ratio is greater than 300 (Table 2: Samples 2-8); the hydrogel composite is formed from a crosslinking agent such as functionalized peptides and proteins (e.g., albumin)(claim 17 of prior art) (instant claim 29); superporous hydrogel composite has an average pore size in the range of 10 microns to 3,000 microns and porous hydrogels with pore sizes above 40-50 microns are too weak to maintain the intact structure … (col. 36, lines 9-12 and claim 21); and the composite is useful in making devices in tissue engineering, artificial cornea, etc. (col. 32, last para.); and the polymerization condition includes a temperature in the range of 5-90C (col. 7, lines 26-29) which overlaps the instant range of 70C (instant claim 30).
It would have been obvious to modify the teachings of the applied art with albumin and temperature of Park in order to enhance the properties of the hydrogel.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613
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