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 .
Status of the Claims
Claims 1, 2, 9, 11, 13, 14, 17, 18, 119-120, 123, 132, 136-138, 163, 164 and 166 are pending in a Response of 05/16/2026. Claims 119-120, 123, 132, 136-138, 163, 164 and 166 have been withdrawn. Accordingly, claims 1, 2, 9, 11, 13, 14, 17 and 18 are being examined.
Withdrawn rejections:
Applicant's amendments and arguments along with a Rule 1.132 Declaration filed 05/16/2026 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 Any rejection and/or objection not specifically addressed below are herein withdrawn.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/Rejection --- as necessitated by amendment
Claim Objection
Claim 13 is objected to a minor informality.
Claim 13 recites chemical names of the compound. However, the Examiner respectfully requests inserting e.g., “alginate-dopamine” besides chemical name for the first compound in claim 13. The remaining compounds can be added in a similar manner.
Further, the specification should have same amendments as in instant claim 13.
Appropriate correction is respectfully requested.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 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 1, 2, 9, 11, 13, 14, 17 and 18 remain rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. (WO2018/081757, IDS of 12/14/2022) in view of Forooshani et al., “Recent approaches in designing bio-adhesive materials inspired by mussel adhesive protein” (IDS of 12/14/2022).
Claims 1, 2, 9, 11, 14, 17 and 18 are rejected by Gao; and
Claim 13 (elected species of macromer) is rejected by Gao in view of Forooshani.
Applicant claims the below claim 1 filed on 05/16/2026:
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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/cosmetic 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, cosmetics 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)
Gao teaches rapid polymerization of polyphenols (title) and a method for polymerizing polyphenols to provide polyphenol polymers using peroxidase and similar catalysis and a method for depositing a polyphenol polymer including providing, at a target site, an enzyme having peroxidase-like activity immobilized at the surface, and polymerizing, at the target site, a polyphenol in the presence of an oxidant and the enzyme to provide the polyphenol polymer, deposited on the surface (abstract and [0089]) wherein the polyphenol can be dopamine (elected species) or its derivative (abstract) which reads on the claimed single species of monomer, and its derivatives may read on the claimed dopamine derivatives including levodopa, methyldopa, levodopa methyl ester, levodopa ethyl ester; the oxidant is hydrogen peroxide ([0102]) which reads on the claimed oxygen source; the enzyme peroxidase includes horseradish peroxidase (HRP) (e.g., [0089]) and endogenous peroxidase ([0118], [0146], and [0152]). That is, Gao teaches a method for polymerization in-situ of a polyphenol (e.g., dopamine or its derivatives) in the presence of oxygen source such as hydrogen peroxide, the method comprising contacting the dopamine or its derivatives and hydrogen peroxide with the enzyme having peroxidase-like activity (e.g.,. HRP) in order to form in situ a coating film on a surface such as a cell surface or a microsphere, suitable for capturing an analyte e.g., antigen (e.g., [0102]-[0103] and [0138], Example 7, [0144] and [0155]).
Gao does not expressly teach the oxygen source contacts an endogenous catalyst in a tissue of the subject, and however, when the composition is applied, the oxygen source contacts the exogenous catalyst, but also any catalyst in the tissue as well. In this respect, Gao discloses “quenching endogenous peroxidase” at [0118], [0146], and [0152], and here, Gao recognizes endogenous peroxidase present in biological tissues can participate in or influence the polymerization of monomer, and accordingly, the ordinary artisan would have understood that endogenous peroxidase activity could catalyze polymerization of suitable monomers, and endogenous peroxidase is considered a potential interfering or contributing catalytic activity in the reaction environment. That is, the ordinary artisan would have expected endogenous tissue catalyst to provide the same catalytic function.
Although Gao does not expressly teach administering to a subject of subject, the skilled artisan would reasonably expect that such administration or contacting would result in formation of the polymer on the tissue of the subject. This is because Gao teaches providing a polyphenol, providing an enzyme having peroxidase-like activity; contacting the polyphenol and an oxidant with the enzyme having peroxidase-like activity, under conditions sufficient to polymerize the polyphenol to form a polyphenol polymer, resultingly in forming the polyphenol polymer forms a surface coating on a surface (claims 1 and 4 of prior art), and thus, when the prior art method applies to certain surface such as organs, tissues, cells, the method provides a polymer coating on e.g., the tissue surface by implicitly and necessarily releasing oxygen from hydroxide peroxide oxygen source (instant claims 1, 2, 9, 11 and 14); the polyphenol used in the method can further contain polyethylene glycol (PEG) ([0084]) (instant claim 12); the preparation in the method further contains detection reagent, antibodies, imaging agents, etc. ([0007], [0088] and the Examples including [0144] and [0155]) (instant claim 17); and the polymerization is in a buffer solution ([00104]) (instant claim 18).
However, Gao does not expressly teach hyaluronic acid (elected species of macromolecule) of claim 11. The deficiency is cured by Forooshani.
Forooshani discloses a method for the polymerization in-situ of dopamine in the presence of H2O2, the method comprising the steps of contacting the dopamine, H2O2 with peroxidase or a catalase, and the composition may further comprise a macromolecule such as hyaluronic acid (HA), PEG, alginate, chitosan, etc. which is used for forming in situ curable bio-adhesive hydrogels (pages 14-20 and 25-28) (instant claim 13), and the bio-adhesives are well suited for tissue engineering and drug-delivery applications and hydrogels are highly hydrated three dimensional polymer networks and can be used in various biomedical applications, including drug-delivery vehicles, actuators, and tissue adhesives (page 19, right column); HA grafted with dopamine demonstrated excellent biocompatibility with enhanced wet adhesive properties, and the HA-based bioadhesive successfully encapsulated two types of cells (i.e., human adipose-derived stem cells and hepatocytes) and demonstrated the potential for minimally invasive cell transplantation, and encapsulated cell demonstrated increased viability and functionality when compared to those encapsulated in conventional hydrogels crosslinked through photopolymerization (page 25, right column).
It would have been obvious to modify monomer of Gao such as dopamine derivatives with hyaluronic acid, alginate, chitosan or its combination of Forooshani as a matter of choice or design because such compounds of the applied art are used for the same purpose of biomedical applications.
The claimed monomers and macromolecule species other than those of Gao and/or Forooshani would also have equivalent function/properties for the same purpose, and thus selecting one of such monomers/macromolecules would be obvious in the biomedical application field.
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(a).
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.
Response to Arguments
Applicant’s arguments based on the Declaration have been fully considered, but are not persuasive.
Applicant argues that Gao fails to disclose using endogenous catalyst of catalase or peroxidase in a tissue of the subject in vivo; Gao’s HRP is exogenous catalyst from plant which is not the claimed subject; as demonstrated in the instant specification and Declaration, the claimed method provides unexpected results in polymerization compared to control without catalase (see Example 1 and Figs. 1C-1D, 2C, 3, 5A-5F, 11N, 11D, 19, 20A-20B, 23C-23F); and the Gao references discloses only the formation of polymer ex vivo/in vitro and relies on that the addition of an exogenous catalyst, i.e., horseradish peroxidase, which is endogenous only to a horseradish plant, not a subject as claimed, while quenching endogenous catalyst; and Forooshani also fails to disclose the claimed polymerization as claimed.
The Examiner responds that as noted in the body of action, Gao recognizes endogenous catalyst contributes polymerization of monomers (e.g., [0118], etc.), and thus, the ordinary artisan would have understood that the endogenous catalyst can be a candidate of catalyzing polymerization in tissue engineering, and the instant specification also admits exogenous catalyst can be used (see, [0075] and Example 2 of instant publication), and the ordinary artisan would have expected endogenous tissue catalyst of Gao to provide a catalytic function the same as or equivalent to exogenous catalyst. It is well-established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches, when viewed in light of the submitted knowledge in the art, to a person of ordinary skill in the art. Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (“the fact that a specific [embodiment] is taught to be preferred is not controlling, since all disclosures of the prior art, including unpreferred embodiments, must be considered”) (quoting In re Lamberti, 545 F.2d 747, 750 (C.C.P.A. 1976)). Concerning alleged unexpected results, such results would be expected due to the teachings/suggestions of Gao (e.g., [0118], [0142], and [0152]), and the applicant showed a comparison between the claimed method (with catalase) and control (without catalase): see instant Figs. 1C-1D. However, this is not a fair comparison. Applicant should have shown a comparison between the claimed method and the closet art Gao method wherein the claimed method using endogenous catalase would much have yield significant degree of polymerization of e.g., dopamine compared with the same amount of exogenous catalyst HRP in addition to certain advantages (e.g., superior safety and selectivity, natural efficiency and compatibility, environment harmony, etc. – ordinary artisan already recognizes those advantages). Further, it appears that the 100-200 times increase of polymerization (instant Example 2) relate to in-vitro test for TPA assemblies using exogenous catalase 10 µL which is outside scope of the claimed invention; even further the tested data in the Examples of the instant application is not commensurate with the scope of instant claim 1 because the data requires e.g., specific oxygen source, and used amounts of monomer, catalase, and oxygen sources. And the claimed “subject” can be anything including plant because the claimed subject is not limited to human and/or animal; and what the Examiner relied on Forooshani for disclosing hyaluronic acid, alginate, chitosan, etc. recited in instant claim 11. Forooshani discloses a method for the polymerization of dopamine in the presence of H2O2 and catalase. Thus, Forooshani is relevant and combinable to the primary reference. It is noted 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.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2, 9, 11, 13, 14, 17 and 18 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 6, 8 and 11-15 of patent no. 12,016,901.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require a method of forming a polymer comprising administering to the subject a composition comprising contacting monomer such as dopamine and oxygen source such as H2O2 in the presence of catalase. The difference between them is that patent ‘901 requires a plurality of dopamine and the claimed invention recites monomer. However, the claimed monomer recites the combination of the monomers and/or macromolecule (instant claims 9, 11 and 13) and thus a plurality of dopamine would be obvious. Further, the claimed invention does not recite forming a polymer on a surface of tissue, and however it would be implicit from the claimed method using forming a polymer in situ in a subject in vivo.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
Claims 1, 2, 9, 11, 13, 14, 17 and 18 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 166-189 of copending application no. 18/596376.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require a composition comprising contacting monomer such as dopamine and oxygen source such as H2O2 in the presence of catalase. The difference between them is that copending ‘376 requires macromer and the claimed invention recites monomer. However, the claimed monomer recites the combination of the monomers and/or macromolecule (instant claims 9, 11 and 13 and copending claims 166, 176 and 177). Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter ‘376.
Claims 1, 2, 9, 11, 13, 14, 17 and 18 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 113, 116, 117, 122, 125-131, 149-153, 155-158 of copending application no. 18/660924.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require a composition comprising contacting dopamine and oxygen source such as H2O2 in the presence of catalase. The difference between them is that instant invention requires monomer including dopamine and release oxygen source on the tissue while copending ‘924 refers to dopamine only and release oxygen source on the lumen of the small intestine. However, such difference is not makes the instant invention non-obvious over copending ‘924 because the instant invention encompasses such specific monomer and tissue of copending ‘924. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter ‘924.
Response to Arguments
For the reasons set forth above, this double patenting rejections have maintained as Applicant has deferred to rebut the rejection under Rejection, Obviousness Type Double Patenting.
Conclusion
All examined claims are rejected.
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.
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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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