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 1-4, 7-13, and 16-26 are pending and a preliminary amendment to the claims filed on 08/11/2023 is acknowledged.
Election/Restriction
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-4 and 7-12, drawn to a hydrogel material.
Group II, claims 13 and 16-26, drawn to a method of transport using a hydrogel material.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: the special technical feature appears to be a hydrogel material recited in instant claims 1 and 13. However, Juan et al. (US2014/0031769A1, IDS of 08/11/2023) discloses a hydrogel material comprising a polymer scaffold comprising pores and a stabilizer having an affinity to an active component comprising a biological agent (see entire document, including abstract, [0012], [0013], [0056], etc.).
As a result, the teachings of Juan read on instant claims 1 and 13 and remaining claims having such common features lack the same or corresponding special technical feature and as such, lack unity of the invention. Accordingly, the technical feature linking the invention of Groups I-II does not constitute a special technical feature as defined by PCT Rule 13.2, as it does not define a contribution over prior art for the reasons set forth above. The expression “special technical features” means those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. The requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. Thus, Groups I-II are not linked by the same or corresponding special technical feature so as to form a single general inventive concept and restriction is deemed proper.
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
WHEN CLAIMS ARE DIRECTED TO MULTIPLE CATEGORIES OF INVENTIONS
As provided in 37 CFR 1.475(b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475(c).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of invention may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction/species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other invention.
Inventorship
Applicant is reminded that upon the cancellation of claims to a non-elected invention and/or non-elected species, the inventorship must be amended in compliance with 37 CFR § 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR § 1.48(b) and by the fee required under 37 CFR § 1.17(i).
During a telephone conversation with attorney Ryan A. Schneider on 01/21/2026 a provisional election was made to prosecute the invention of Group II, drawn to claims 13 and 16-26 without traverse. Affirmation of this election must be made by applicant in replying to this Office action.
In light of the foregoing, Group I, drawn to claims 1-4 and 7-12 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being to a nonelected Group, there being no allowable generic or linking claim. Accordingly, claims 13 and 16-26 are being examined and the following rejections are applicable.
Please note that the applicant elected Group II, and claim 13 recites the subject matter of claim 1, and thus, please put all the limitations of claim 1 into claim 13 in the upcoming response.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/11/2023 was filed before the mailing date of the instant first action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith.
Claim Objections
Claim 16 is objected to because of the following informalities:
Claim 16 recites “wherein binding the active component to the stabilizer of the hydrogel material …”, but which would be better to recite “, wherein the binding step includes binding the active component to the stabilizer of the hydrogel material …” Appropriate correction is required.
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, and 21-24 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 Juan et al. (US2014/0031769A1, IDS of 08/11/2023).
Applicant claims the below claim 1 filed on 08/11/2023:
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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 pore size configured to allow the active component to pass therethrough 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 (instant claim 13, in part and instant claim 24); the drug includes corticosteroids ([0026]-[0027]), anti-angiogenesis compound, etc. ([0030]) which reads on the claimed biological agent (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 (instant claim 21), and although Schulz does not expressly pore size definition of instant claim 22, 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 22).
However, Schulz does not expressly teach hydrogel material having 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 - additive).
It would have been obvious to modify hydrogel of Schultz 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, and 21-24 are obvious over Schultz in view of Juan.
Claims 18-20 and 25-26 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 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).
However, Schultz/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. 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, 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 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.
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.
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