DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission, filed 08/22/2026, has been entered.
Status of Application
Receipt of the amendments to the specification, drawings and claims as well as applicant arguments/remarks, filed 08/22/2026, is acknowledged. Amendments to the specification and drawings have been entered.
Claims 1-8 and 11-18 are pending in this action. Claims 1-8, 11-18 have been amended. Claims 9-10 and 19-20 have been cancelled. Claims 21-40 have been cancelled previously. Further, it is noted that claims 3 and 13 have been cancelled previously, as filed 03/31/2026. To this point, it is noted that the claim canceled by amendment may be reinstated only by a subsequent amendment presenting the claim as a new claim with a new claim number. MPEP 608.01(s). Therefore, claims 3 and 13 are cancelled. Claims 1-2, 4-8, 11-12, 14-18 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Priority
This application, filed February 20, 2025, claims benefit of provisional U.S. Application No. 63/556,256, filed February 21, 2024.
Information Disclosure Statement
The information disclosure statement, filed 08/22/2026, is acknowledged and has been considered. Please see the attached initialed PTO-1449.
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.
Claims 4 and 14 are 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 pre-AIA the applicant regards as the invention.
Newly amended claim 4 (dependent on claims 1, 2) recites the limitation “wherein the at least one non-alginate polymer is selected from the group consisting of non-alginate polysaccharide, collagen, gelatin, polyethylene glycol, chitosan, agarose, and combinations thereof” that is unclear, because the claim recites a broad limitation (i.e., non-alginate polysaccharide) together with a narrow limitation (e.g., chitosan, agarose) that falls within the broad limitation in the same claim. Therefore, the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. MPEP § 2173.05(c). Similar is applied to claim 14. Clarification is required.
Claim Rejections - 35 USC § 103-MAINTAINED
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.
Claims 1-2, 4-8, 11-12, 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ramachandran et al., US 2015/0352056 A1 (hereinafter referred to as Ramachandran), in view of Ott et al., US 2022/0233454 A1 (hereinafter referred to as Ott), and further in view of Grover et al., US 2022/0175672 (cited in IDS; hereinafter referred to as Glover).
Ramachandran teaches method of encapsulating biological material in a 3-dimensional hydrogel matrix, wherein said method comprises (Claim 1; Title; Abstract; Para. 0003, 0007, 0018-0020, 0025 as applied to claims 1, 11):
(i) providing a hydrogel precursor solution that comprises a hydrogel precursor compound, a biological material, and a divalent cation selected from the group consisting of calcium, barium, strontium, and combinations thereof, dispersed or dissolved in a solvent system;
(ii) combining said hydrogel precursor solution with alginate to yield core/shell microparticles comprising an alginate shell and a liquid core comprising the hydrogel precursor solution and the biological material;
(iii) crosslinking the hydrogel precursor compound in the liquid core to yield core/shell crosslinked microparticles, wherein each of the core/shell crosslinked microparticles comprises the alginate shell and a core comprising a 3-dimensional hydrogel matrix and the biological material suspended, encapsulated/entrapped in the hydrogel matrix;
(iv) removing the temporary alginate shell to yield self-sustaining hydrogel microbeads, each comprising the 3-dimensional hydrogel matrix and biological material entrapped therein.
Ramachandran teaches the use of such crosslinkable hydrogel precursor compounds as non-alginate copolymers, e.g., modified hyaluronic acid, collagen, gelatin, polyethylene glycol, chitosan, agarose (Para. 0019 as applied to claims 1, 2, 4, 11, 14).
Ramachandran teaches that the hydrogel precursor may also include additional ingredients such as fibronectin, laminin, collagen, other components of the extracellular matrix, and the like, including synthetic versions thereof (Claim 4; Para. 0015 as applied to claims 5, 15); photo-initiated crosslinkers, thermal-initiated crosslinkers, chemical crosslinkers (Para. 0027, 0028 as applied to claims 1, 11, 12).
Ramachandran teaches the use of sodium alginate bath (Claim 9; Para. 0024 as applied to claims 1, 6, 11, 16).
Ramachandran teaches that the alginate shell is removed by using a chelating agent, e.g., citrate, ethylene diamine tetraacetic acid (EDTA), ethylene glycol tetraacetic acid (EGTA), phosphates (Claim 17; Para. 0031 as applied to claims 7, 8, 17, 18).
Ramachandran teaches that said method provides resulting hydrogel microbeads/microparticles having an average (mean) maximum surface-to-surface dimension of less than 2 mm, e.g., ranging from 50 μm to 750 μm (Para. 0032).
Ramachandran does not specifically teach the use of methacrylated hyaluronic acid, and/or sodium hyaluronate (claims 1, 11), and also does not teach the use of such biological material as hormones (claims 1, 11).
Ott teaches preparation of non-alginate hydrogel microparticles for encapsulating biologics (Abstract; Para. 0002), wherein said hydrogel microparticles are fabricated, e.g., by using methacrylated hyaluronic acid, e.g., crosslinked by UV exposure (Abstract; Para. 0004-0008, 0054-0057, 0085, 0096), and wherein said microparticles may include hormones (Claim 21; Para. 0065). Ott further teaches that said microparticles can also include polyethylene glycol, hyaluronan/hyaluronic acid, fibrin, chitosan, collagen, fibronectin, laminin, and such media components as sodium (Para. 0004, 0059, 0065).
Grover teaches compositions and methods for sustained drug release from an injectable hydrogel (Title), wherein upon injection the drug, e.g., hormone/testosterone, is encapsulated within the hydrogel (Para. 0038), and wherein said hydrogels may be used to deliver small molecules such as steroids, e.g., to be used for testosterone replacement therapy (Para. 0015).
It would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to use/try methacrylated hyaluronic acid as taught by Ott preparing hydrogel microparticles comprising a biological agent as taught by Ramachandran. One would do so with expectation of beneficial results, because Ott teaches that said microparticles can be used for providing controlled/sustained release of biological agents, e.g., hormones, incorporated therein. It also would be obvious to use/try such active agent as steroid hormones, e.g., testosterone, as taught by Grover to be included into hydrogel microparticles as taught by Ramachandran and Ott. One would do so with expectation of beneficial results, because the cited prior art teaches that said approach will provide hydrogel microparticles without alginate and providing controlled/sustained release of incorporated biological agents.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Salamone et al., US 20160303281A1 (cited in IDS) - teaches crosslinked microgel particles (e.g., spheres, ellipses, etc.) that can be coated, injected, sprayed, or implanted in tissues, organs, and may include such hormones as estradiol, testosterone and combinations thereof (Claim 14; Para. 0043, 0062, 0097)
US 2022/0143270 A1 – teaches core/shell microparticles (e.g., spheres, ellipses, etc.) that may include such active agent as androgen/testosterone, estrogen, etc. (Para. 0121-0122, 0155-0157)
Response to Arguments
Applicant's arguments, filed 08/22/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and/or rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Additional examiner comments are set forth next.
In response to applicant's arguments against the references individually, it should be noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggests the combination to achieve the same advantage or result discovered by applicant. Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). Further, it has been held that a prior art reference must either be in the field of applicant’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the applicant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In the present case,
All cited references are reasonably drawn to the same field of endeavor that is hydrogel microparticles and/or hydrogel systems for localized delivery and sustained release of incorporated active agents.
Ramachandran teaches method of encapsulating biological material in a 3D hydrogel matrix, wherein said method provides resulting non-alginate hydrogel microbeads/microparticles comprising biologics.
Ott teaches preparation of non-alginate hydrogel microparticles for encapsulating biologics/hormones, wherein said hydrogel microparticles are fabricated by using methacrylated hyaluronic acid and are crosslinked by UV exposure.
Grover teaches compositions and methods for sustained drug release from an injectable hydrogel, wherein said drug (e.g., hormone/testosterone/steroids) is encapsulated within the hydrogel and can be used for testosterone replacement therapy.
Therefore, the examiner maintains the position that it would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to use/try methacrylated hyaluronic acid and/or such biological material as hormones as taught by Ott and Glover preparing hydrogel microparticles comprising a biological agent as taught by Ramachandran, because it is prima facie obvious to combine compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a new composition to be used for the very same purpose. MPEP 2144.06.
To this point, it should be noted that the Supreme Court decided (KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)) that:
the obviousness analysis needs not seek out precise teachings directed to the subject matter of the challenged claim and can take into account the inferences and creative steps that one of ordinary skill in the art would employ.
the obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents.
it is error to look only the problem the patentee was trying to solve. Any need or problem known in the field of endeavor at the time of invention and addressed by the prior art can provide a reason for combining the elements in the manner claimed.
it is error to assume that one of ordinary skill in the art in attempting to solve a problem will be led only to those elements of prior art designed to solve the same problem. Common sense teaches that familiar items may have obvious uses beyond their primary purposes, and in many cases one of ordinary skill in the art will be able to fit the teachings of multiple patents together like pieces of a puzzle (one of ordinary skill in the art is not automaton).
it is error to assume that a patent claim cannot be proved obvious merely by showing that the combination of elements was “obvious to try”.
Therefore, it is the examiner’s position that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made/filed, because every element of the invention has been collectively taught by the combined teachings of the references. Applicant is advised to clarify the scope of the claims, the compounds to be used in the claimed method and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance,
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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