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 166-189 are currently pending and a preliminary amendment to the claims filed on 03/05/2024 is acknowledged.
Election/Restriction
Applicant's election of Group I, claims 166-177 and 189 in the Reply filed on 03/05/2024 is acknowledged. By way of applicant’s election, claims 178-188 have been withdrawn from further consideration. Therefore, claims 166-177 and 189 are examined on the merits to which the following grounds of rejections are applicable.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). Thus, the requirement is still deemed proper and is therefore made FINAL.
As a result, claims 166-177 and 189 are examined on the merits to which the following grounds of rejections are applicable.
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 four (4) information disclosure statement (IDS) submitted on 06/08/2026; 09/10/2025; 06/05/2024 (2) were filed before the mailing date of the instant first action on the merits. The submissions thereof are 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 statements have been considered by the examiner, and signed and initialed copies are enclosed herewith.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 176 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 176 recites a combination of dopamine or its derivatives with macromolecules.
However, base claim 166 requires “dopamine itself” instead of reciting “dopamine or its derivatives”. In this context, the instant specification distinguishes “dopamine” and “its derivatives” (please see e.g., [0005] of instant publication). Accordingly, it may not be said that dependent claim 176 reciting various dopamine derivatives further limits claim 166 in a proper manner.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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 166-177 and 189 are rejected under 35 U.S.C. 103 as being unpatentable over Guo et al. (WO2018/081757, IDS of 06/08/2026) in view of Forooshani et al., “Recent approaches in designing bio-adhesive materials inspired by mussel adhesive protein” (IDS of 06/08/2026) and further in view of Li et al. (US2017/0246288A1).
Applicant claims the below claim 166 filed on 03/05/2024:
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For examination purpose, “the limitations led by when-clause” of claim 166 are an intended use of product. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use “when-clause” is not limiting. Please see the supportive case law holding that “the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Moreover, the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Thus, "recitation of a new intended use for an old product does not make a claim to that old product patentable." In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1977). Here, the claimed invention is directed to a product not a method of use, and accordingly, the claimed when-clause features do not structurally define the claimed invention. Consequently, if the prior art teaches the claimed composition, such intended use of the composition would be implicit from the prior art composition.
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)
Guo 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 which reads on the claimed monomer, or its derivative (abstract) and its derivatives includes levodopa, methyldopa, levodopa methyl ester, levodopa ethyl ester ([0084]); the oxidant is hydrogen peroxide ([0102]) which reads on the claimed oxygen source; the enzyme peroxidase includes horseradish peroxidase (HRP) (e.g., [0089]). That is, Guo teaches in-situ polymerized polyphenol (e.g., dopamine or its derivatives) in the presence of oxygen source such as hydrogen peroxide, the method comprises contacting the dopamine or its derivatives and hydrogen peroxide with the enzyme having peroxidase-like activity 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]). Although the prior art does not expressly teach instructions for administering the solid dosage form to a subject of instant kit claim 189, such printed instruction matter does not distinguish the claimed product from the prior art. In this context, please see MPEP 2112.02 part III (instant claims 166 and 189 (in part) and instant claims 168-169); and the composition further contains detection reagent, antibodies, imaging agents, etc. (e.g., [0007], [0088] and the Examples including [0144] and [0155]) which may read on the claimed diagnostic agent (instant claim 170).
However, Guo does not expressly teach macromolecule alginate, PEG, chitosan or hyaluronic acid of claims 166-167 and 176-177. The deficiencies are cured by Forooshani.
Forooshani discloses a method for the polymerization in-situ of catecholic amino acid, 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 alginate, hyaluronic acid (HA), PEG, chitosan, etc. which is used for forming in situ curable bio-adhesive hydrogels (pages 14-20 and 25-28) (instant claims 166-167 and 176-177: macromolecules), 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) wherein the drug includes anti-cancer drug such as paclitaxel (pages 26-27); for example, macromolecule 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 Guo such as dopamine or its derivatives by grafting hyaluronic acid, PEG, alginate, chitosan or its combination with dopamine or its derivatives of Forooshani, in order to enhance material properties including desirable swelling properties and excellent biocompatibility, enhanced wet adhesive properties and therapeutic effects of the composition as taught by Forooshani for use in biomedical applications such as bioadhesives. The claimed monomers including macromolecule of Guo and Forooshani would have equivalent function/properties for the same purpose/applications, and thus selecting combination of such monomers, e.g., dopamine grafted with the said macromolecules, would be obvious in the biomedical application field.
It is well-established proposition of patent law that no invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients, In re Sussman, 1943 C.D. 518. From MPEP 2143 A: “…all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).”
However, Guo/Forooshani do not expressly teach various active agents of instant claims 170-174; and solid dosage form of instant claims 166 and 175. The deficiencies are cured by Li.
Li discloses drug delivery system with higher loading capability a capacity to sequester high tumors levels of both hydrophobic and hydrophilic agents simultaneously, and longer release profiles (abstract); the system can be administered by a variety of route and the particular mode selected will depend upon the particular active agent selected, the particular condition being treated and the dosage required for therapeutic efficacy, and the route includes oral form e.g., tablet (instant claim 166 – solid dosage form) as well as parenteral form including injection or infusion, inhalation, transdermal, etc. (e.g., [0270]-[0271] and [0273]), and the system contemplates administering the agents to regions, tissues or cells in vivo or in vitro, and any agent may be delivered using the composition in encapsulated form (e.g., [0152]); and the system comprises anti-viral agent ([0181]), anti-bacterial agent such as antibiotics including amoxicillin ([0227]-[0228]), anticancer agent, dopaminergic agent ([0232]), anti-inflammatory agent ([0234]), anti-diabetic agent, anorexic agent, and antiparkinsonian agent ([0236]), anti-cancer agent ([0246]), etc. (instant claims 170-174: various active agents). The system contains vesicle conjugated to polyethylene glycol ([0039] and claim 83 of prior art) and the system contemplates tissue engineering and kits ([0283]-[0284]).
It would have been obvious to modify the teachings of Guo/Forooshani with various active agents and tablet solid dosage form of Li because Guo/Forooshani teach diagnostic agent, and anti-cancer agents and thus selecting various active agents of Li depending on the intended purpose would be a matter of choice or design. Further as taught by Li, the administration route depends on particular active agent selected, the particular condition being treated, and the dosage required for therapeutic efficacy (e.g., [0270]), and the system contemplates administering the agents to regions, tissues or cells in vivo or in vitro (e.g., [0152]), therefore, it would be obvious to select certain solid dosage form e.g., tablet to the tissue or cells in vivo in order to achieve intended therapeutic effects, as taught by Li.
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.
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 166-177 and 189 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 6, 8 and 11-15 of patent 12,016,901 in view of Forooshani.
Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims are directed to a solid dosage composition and patent ‘901 claims are directed to a method of use, and however both claim sets require monomer such as dopamine or its derivatives, and oxygen source such as H2O2, and administration and its effects. The difference between them is that the claimed invention requires macromolecule species as claimed. The deficiency is cured by Forooshani.
Forooshani discloses a method for the polymerization in-situ of catecholic amino acid, 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 alginate, hyaluronic acid (HA), PEG, chitosan, etc. which is used for forming in situ curable bio-adhesive hydrogels (pages 14-20 and 25-28), 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) wherein the drug includes anti-cancer drug such as paclitaxel (pages 26-27); for example, macromolecule 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 patent ‘901 such as dopamine or its derivatives by grafting hyaluronic acid, PEG, alginate, chitosan or its combination with dopamine or its derivatives of Forooshani, in order to enhance material properties including desirable swelling properties and excellent biocompatibility with enhanced wet adhesive properties as well as therapeutic effects of the composition as taught by Forooshani for use in biomedical applications such as bioadhesives. The claimed monomers including Forooshani would have equivalent function/properties for the same purpose, and thus selecting combination of such monomers, e.g., dopamine grafted with the said macromolecules, would be obvious in the biomedical application field.
Further, the claimed invention does not recite forming a polymer on a surface of tissue, and however it would be implicit from the claimed composition using 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 166-177 and 189 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 9, 11, 13, 14, 17, 119, 123, 132, 136-138, 163, 164 and 166 of copending application no. 17/784598.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require a composition comprising monomer such as dopamine/macromolecule and oxygen source such as H2O2 in the presence of catalase. The difference between them is that copending ‘376 requires that the oxygen source contacts an endogenous catalyst in a tissue of the subject in vivo. However, the claimed monomer recites the combination of the monomers and macromolecule and oxygen source (instant claims 166, 176 and 177 and copending claims 1, 9 and 11-13). When the composition is applied, the oxygen source contacts the exogenous catalyst but also any catalyst in the tissue as well. Although Guo does not expressly teach administering to a subject of subject, the skilled artisan would reasonably expect that such administration would result in formation of the polymer on the tissue of the subject. This is because Guo 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 product 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. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter ‘376.
Claims 166-177 and 189 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 113, 116, 117, 122, 125-131, 149-153 and 155-158 of copending application no. 18/660924 in view of Forooshani.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require a composition comprising dopamine and oxygen source such as H2O2 in the presence of catalyst. The difference between them is that instant invention requires monomer including dopamine and macromolecule 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 does not make the instant invention non-obvious over copending ‘924 because the instant invention encompasses such specific monomer. And, the claimed invention further requires macromolecule while copending ‘924 does not. The deficiency is cured by Forooshani.
Forooshani discloses a method for the polymerization in-situ of catecholic amino acid, 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 alginate, hyaluronic acid (HA), PEG, chitosan, etc. which is used for forming in situ curable bio-adhesive hydrogels (pages 14-20 and 25-28), 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) wherein the drug includes anti-cancer drug such as paclitaxel (pages 26-27); for example, macromolecule 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 copending ‘924 such as dopamine or its derivatives by grafting hyaluronic acid, PEG, alginate, chitosan or its combination with dopamine or its derivatives of Forooshani, in order to enhance material properties including desirable swelling properties and excellent biocompatibility with enhanced wet adhesive properties as well as therapeutic effects of the composition as taught by Forooshani for use in biomedical applications such as bioadhesives. The claimed monomers including Forooshani would have equivalent function/properties for the same purpose, and thus selecting combination of such monomers, e.g., dopamine grafted with the said macromolecules, would be obvious in the biomedical application field.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter ‘924.
Conclusion
All the examined claims are rejected.
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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