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, claims 1-7, in reply filed on 10/21/2025 is acknowledged.
Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/21/2025.
The examiner notes that while applicant has indicated claims 8-10 to be withdrawn, they are presented as if they are cancelled. The claims, as currently filed, list claim numbers 8-10 but do not recite anything for those claims.
Claim Interpretation
Claims 1-6 recite the phrase “can be” (e.g., “the natural bio-based polymer can be…”; claim 1., line 4). While “can be” is exemplary language, the metes and bounds of the claim are nevertheless clearly set forth in view of the disclosure as a whole (see, for example, paragraphs 6-9 of the specification and embodiments 1-4 on pages 5-8 of the specification). To wit, the examiner is interpreting the phrase “can be” as comprising language, i.e., “is selected from a group comprising” and prior art will be applied accordingly. See MPEP 2173.05(d).
Claim Rejections - 35 USC § 112
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 1-7 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the they hydrogel matrix" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the supramolecular filler" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
1) Claims 1, 2, 4 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sichuan University (CN 112316204 A, publication date 02/05/2021; cited in IDS; citing English Machine translation).
Sichuan University discloses “a metal polyphenol collagen membrane material which is a hydrogel material and comprises collagen and a nano complex loaded on a collagen porous structure, wherein the nano complex is obtained by chelating metal ions and polyphenol” [p. 7, para. 1]. In one example, nano-complexes are first prepared with epigallocatechin gallate and magnesium ions [p. 9, para. 2, “Example 1”]. Then epigallocatechin gallate and magnesium ion complexes are incorporated into a collagen hydrogel at a weight ratio of 85 parts collagen hydrogel to 15 parts nano-complex [p. 10, para. 2, “Example 3”].
The prior art is anticipatory insofar as it discloses a composition comprising a epigallocatechin gallate and magnesium ion complex in collagen hydrogel at a weight ratio of 15:85, or 1:5.6 (complex to hydrogel). Because the prior art contains substantially the same components as instantly claimed, it would have been expected to possess the same properties and be capable of satisfying the same applications, i.e. sustained release drug delivery system.
2) Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhong et al. (US 2016/0022707 A1, publication date 01/28/2016).
Zhong relates to a drug delivery system [title] and discloses “[a]n injectable hydrogel system comprising agarose, and particles comprised of DS/Mg2+/MH complexes” (see last sentence of [0192]). Zhong defines such particle complexes as “a complex coacervation composed of MH, divalent metal ions (Ca2+ and Mg2+) and dextran sulfate (DS), a biocompatible natural polysaccharide” [0164].
The prior art anticipates instant claim 1 and 2 because it discloses a drug delivery system comprising an agarose hydrogel carrying a complex of a natural biological polymer and a metal ion (i.e., magnesium ion), wherein the natural biological polymer is a polysaccharide biomass (i.e., dextran sulfate).
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1) Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sichuan University (CN 112316204 A, publication date 02/05/2021; cited in IDS; citing English Machine translation) as applied to claims 1, 2, 4 and 7 above.
Sichuan University does not anticipate instant claim 3 because it does not disclose a complex comprising an instantly claimed metal ion, wherein the complex is incorporated into a hydrogel matrix, in one example or embodiment.
However, Sichuan University does discloses that “the metal ion is a water-soluble and antibacterial metal ion, specifically a mixture of one or more of magnesium ion, copper ion, and iron ion” [p. 7, para. 3].
It would have been obvious to one of ordinary skill in the art, at the time of filing, to have simply substituted the magnesium ion of the exemplary composition discussed above for the iron ion because Sichuan University discloses both ions a suitable for the polyphenol complex. The simple substitution of one known element (e.g., the iron ion of Sichuan University) in place of another (e.g., the magnesium ion of Example 1 disclosed by Sichuan University) in order to achieve predictable results (polyphenol metal ion complex) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition comprising a epigallocatechin gallate and iron ion complex in collagen hydrogel.
2) Claims 3, 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (US 2016/0022707 A1, publication date 01/28/2016), as applied to instant claims 1 and 2 above.
Zhong does not discloses the elements of instant claims 3-7 in a single example or embodiment. Accordingly, Zhong does not anticipated claims 3-7. Furthermore, while claims 1 and 2 are anticipated by Zhong, claims 1 and 2 would have been obvious over Zhong as well.
Regarding instant claims 1-3 and 5, Zhong does disclose “drug delivery compositions that allow for immediate and/or sustained release of a therapeutic agent contained within the system” [abstract], “comprising a therapeutic agent or a salt thereof, a polyelectrolyte and a polyvalent metal ion” [0012]. Zhong discloses that in some embodiments “the polyelectrolyte comprises a polyanion. Examples of polyanions include, but are not limited to, dextran sulfate, heparin, chondroitin sulfate, hyaluronic acid, … carboxymethyl cellulose (CMC), or any combinations thereof” [0127]. “In some embodiments, the metal ion comprises a divalent metal ion, such as but not limited to beryllium, magnesium, zinc, cadmium, mercury, lead, calcium, copper (II), barium, iron (II), nickel, and tin” [0129]. Additionally, Zhong discloses that “hydrogel scaffolds are used to encapsulate particles comprised of therapeutic agent/poly electrolyte/metal ion complexes of the present invention in order to immobilize the particles at the target site and to prevent the nanoparticles from being washed away by body fluid” (see sentence spanning columns in [0137]). “Examples of the hydrogels formed from physical or chemical crosslinking of hydrophilic biopolymers include but are not limited to, hyaluronans, chitosans, alginates (including alginate sulfate), collagen, dextran, pectin, carrageenan, polylysine, gelatins or agarose” [0138].
Given the disclosure of each component individually, it would have been prima facie obvious for a person having ordinary skill in the art at, at the time of filling, to have selected and combined known components for their established functions with predictable results by following the teachings of Zhong. MPEP 2143 and 2144.06(I).
Furthermore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to have formulated a composition comprising the hydrogel and the complexed particle within the instantly claimed weight ratio through routine optimization. It has been held that it is not inventive to discover the optimum workable ranges by routine experimentation where, as is here, the general conditions of the claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One of ordinary skill in the art would have been motivated to optimize the amount of the complexed particles present in composition, and therefore the ratio of complexed particle to hydrogel, to affect the dosage of the compositions. One would have had an expectation of success because the complexed particle comprises the therapeutic agent.
Therefore it, would have been obvious for one of ordinary skill in the art, at the time of filling, to have formulated a sustained release composition comprising an agarose hydrogel and a complex of carboxymethyl cellulose (i.e., a natural biological polymer) and a zinc metal ion. Wherein the weight ratio of the complex of a natural biological polymer and a metal ion to the hydrogel is within the instantly claimed amounts.
3) Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (US 2016/0022707 A1, publication date 01/28/2016), as applied to instant claims 1-3, 5 and 7 above, and further in view of Sichuan University (CN 112316204 A, publication date 02/05/2021; cited in IDS; citing English Machine translation).
Zhong, which is discussed above, differs from instant claim 4 insofar as it does not disclose a polyphenol complex.
Zhong does discloses the composition may be employed with a device selected from a group consisting of “tissues replacing a lost or damaged function of human body” (i.e., tissue engineering; see p. 3, [0029], line 12). Zhong also discloses the therapeutic agent may provide anti-biotic and anti-inflammatory action [0022]. Finally, Zhong desires a controlled release: “The drug delivery system of the present invention facilitates the sustained and controlled release of a therapeutic agent from a therapeutic agent/polyelectrolyte/metal ion complex” [0153].
Sichuan University discloses an “porous structure of collagen to load a large amount of metal polyphenol nano particles, and forms a novel hybridization responsive film through the actions of hydrogen bonds and the like. The polyphenol chelates metal ions, so that the collagen membrane material can release and combine the metal ions under the condition of acid-base response” [p. 6, last paragraph]. According to Sichuan University the “material can release polyphenol and metal ions under the PH response, and the polyphenol can absorb excessive active oxygen, eliminate inflammation, inhibit bacterial growth and promote wound healing” [p. 6, para. 1]. Specific polyphenols include epigallocatechin gallate [p. 7, para. 5].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have simply substituted the therapeutic agent/polyelectrolyte/metal ion complex of Zhong for the polyphenol metal ion complexes of Sichuan University. One would have been motivated to make this substitution to gain the pH responsive release described in Sichuan University because Zhong desires a controlled release. One would have had an expectation of success because Sichuan University discloses the polyphenol metal ion complexes may be loaded into a hydrogel to delivery anti-bacterial and anti-inflammation to promote wound healing (i.e., tissue engineering), as desired by Zhong. The skilled artisan would have been motivated to have substituted the polyphenol metal ion complexes of Sichuan University in place of the therapeutic agent / polyelectrolyte / metal ion complex of Zhong to provide anti-bacterial and anti-inflammatory action with a reasonable expectation of success. The simple substitution of one known element (e.g., the polyphenol metal ion complexes of Sichuan University) in place of another (e.g., the therapeutic agent / polyelectrolyte / metal ion complex of Zhong) in order to achieve predictable results (controlled release of anti-bacterial and anti-inflammation) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to formulated a drug delivery system as discussed above comprising a hydrogel loaded with epigallocatechin gallate (i.e., polyphenol) and metal ion complexes.
3) Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (US 2016/0022707 A1, publication date 01/28/2016), as applied to instant claims 1-3, 5 and 7 above, and further in view of Yu et al. (US 2006/0019362 A1, publication date 01/26/2006) and Rosa et al. (Biomaterials, 2003, vol. 24, p. 207–212).
Zhong, which is discussed above, differs from instant claim 4 insofar as it does not disclose a gelatin or collagen complex with a metal ion.
Zhong does discloses the composition may be employed with a device selected from a group consisting of an orthopedic implant, a bone plate or “tissues replacing a lost or damaged function of human body” (i.e., tissue engineering; see p. 3, [0029], line 12). Additionally, Zhong discloses that “[a]ny polyelectrolyte is contemplated for use in the present invention, as would be understood by one skilled in the art” [0126], and provides the example of polyanionic alginate (see [0127], lines 4 and 6).
Yu discloses a biological scaffold comprising a complex of oppositely charged polymers [abstract]. According to Yu, suitable polymers include polyanionic alginate and negatively charged collagen [0044].
Rosa discloses polyanionic collagen “showed low inflammatory reaction associated with bone formation, partially or completely integrated to the cranial bone” [abstract]. Rosa further discloses that collagen has been widely used because it has a low immune response, low toxicity and promotes cellular growth and attachment [p. 207, col. 2, para. 1, lines 4-8].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have simply substituted the negatively charged collagen (i.e., polyanionic collagen) of Yu with polyanionic alginate of Zhong to have formulated a complex comprising collagen and a metal ion. One would have been motivated to substitute these elements because Rosa discloses polyanionic collagen has the desirable properties of low immune response and low toxicity. One would have had an expectation of success because Yu discloses polyanionic alginate and negatively charged collagen are suitable to form complexes in compositions for tissue engineering. Additionally, Zhong desires any polyelectrolyte as would be understood by one skilled in the art. The skilled artisan would have been motivated to have substituted the polyanionic collagen of Yu in place of the polyanionic alginate of Zhong to form a complex with a reasonable expectation of success. The simple substitution of one known element (e.g., the polyanionic collagen of Yu) in place of another (e.g., the polyanionic alginate of Zhong) in order to achieve predictable results (form a complex) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,878,082 B2 in view of Garcia-Brand et al. (Fermentation, 03/08/2022, vol. 8, no. 117) and Sichuan University (CN 112316204 A, publication date 02/05/2021; cited in IDS; citing English Machine translation).
The claims of ‘082 disclose a probiotics solution comprising biomass-based encapsulating material for the probiotic that comprises macromolecules and metal ions [claim 1]. The metal ions are selected from the group consisting of cations of Al, Fe, Zn, Mn, Ni, Co and V while the biological macromolecules are selected from the group consisting of polyphenol, dopamine, dopamine derivatives, polysaccharide biomass, and combinations thereof [claim 1].
The claims of ‘082 does not disclose a hydrogel, specific polyphenols, specific polysaccharides or a protein biomass.
Garcia-Brand discloses that “the inertness of hydrogels in environments with high water activity makes them suitable to entrap molecules and microorganisms, and ensure their integrity and viability in physiological environments” [p. 8, para. 1, lines 4-6] and that “[a]lginate, gelatin, and chitosan are the three main polymers of choice for hydrogel synthesis” [p. 8, para. 1, last 3 lines]. Garcia-Brand also discloses that, with respect to probiotics, “[m]icroparticles, microcapsules, and microspheres usually made of food-grade polymers, such as alginate, chitosan, carboxymethyl cellulose, cellulose acetate phthalate, xanthan gum, starch, carrageenan, gelatin, and pectin [59,110], have demonstrated to be protective barriers of high performance against the GIT’s environmental conditions” [p. 9, para. 1, lines 1-4].
Garcia-Brand does not disclose a polyphenol.
Sichuan University discloses a nanocomplex comprising a metal ion and a polyphenol [p. 6, last paragraph]. The metal ion may be iron and the polyphenol may be dopamine or epigallocatechin gallate [p. 7, para. 3-4].
With respect to instant claims 1 and 2, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the hydrogels (e.g., chitosan hydrogel) of Garcia-Brand as the carrier for the solution of the ‘082 claims. One would have been motivated to, and had an expectation of success in combing these elements because Garcia-Brand discloses hydrogels ensure integrity of molecules and microorganisms in physiological environments. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
With respect to instant claim 4, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have simply substituted the dopamine of the ‘082 claims for the epigallocatechin gallate of Sichuan University. One would have had an expectation of success because Sichuan University discloses they are both suitable for complexing and the claims of ‘082 desire a polyphenol. See MPEP 2143, Exemplary Rationale B.
With respect to instant claims 5 and 6, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected chitosan, carboxymethylcellulose, cellulose or gelatin to as the macromolecule encapsulating the probiotic because Garcia-Brand discloses they are suitable for the purpose. Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
With respect to instant claim 7, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition comprising the hydrogel and the complexed particle within the instantly claimed weight ratio through routine optimization. It has been held that it is not inventive to discover the optimum workable ranges by routine experimentation where, as is here, the general conditions of the claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One of ordinary skill in the art would have been motivated to optimize the amount of the complexed particles present in composition, and therefore the ratio of complexed particle to hydrogel, to affect dose of the probiotics. One would have had an expectation of success because the complexed particle comprises the probiotics.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLMAN WELLES whose telephone number is (571)272-3843. The examiner can normally be reached Monday - Friday, 8:30am - 5:00pm ET.
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, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.T.W./Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights