FINAL 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 .
Status of the Claims
This action is in response to papers filed 01/28/2026 in which claims 7-13 and 18-20 were withdrawn; and claims 1, 14 and 15 were amended. All the amendments have been thoroughly reviewed and entered.
Claims 1-6 and 14-17 are under examination.
Withdrawn Objections/Rejections
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
New Rejections
Necessitated by Applicant’s Claim Amendments
Claim Rejections - 35 USC § 112 – NEW MATTER
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 and 14-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 3 introduces new matter as the claim recites the limitation: “derived from a natural biopolymer” There is no support in the specification for the regenerated biopolymer to be “derived from a natural biopolymer.”
Applicant asserted for the amendment in claim 1 can be found at paragraph [0033] of the US Application Publication No. 2024/0076583 A1. (Remarks filed 01/28/2026, page 6, 2nd paragraph).
However, after a thorough review of paragraph [0033] of the published application, as well as, throughout the published application, there appeared to be no support or disclosure for the regenerated biopolymer to “derived from a natural biopolymer.”
Below is a snapshot of paragraph [0033] of the published application:
PNG
media_image1.png
154
298
media_image1.png
Greyscale
.
As disclosed above in paragraph [0033], Applicant only has support for the regenerated polymer to be “made from a natural biopolymer” and said regenerated biopolymer is obtained by dissolving, precipitation and re-dispersion treatment process, which are physical modification of the natural biopolymer. Applicant does not have support for “derived from a natural biopolymer,” as the “derived” encompassed a natural biopolymer that has undergone chemical modification, which is not supported by paragraph [0033] or anywhere in the specification (published application). Thus, Applicant only has possession of “the regenerated polymer is made from a natural biopolymer,” but does not have possession of the claimed “the regenerated polymer is derived from a natural biopolymer.”
Therefore, it is the Examiner’s position that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendments at the time of filing of the instant application.
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 1-6 and 14-17 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.
Regarding claim 1, the limitation of “the regenerated biopolymer …is in a regenerated state resulting from dissolving precipitating, and re-dispersing” renders the claim indefinite because it is not clear the metes and bounds of the “is in a regenerated state resulting from dissolving, precipitating, and re-dispersing,” as this limitation appeared to be an incomplete process. It is not clear what is being dissolved, precipitated and redispersed to provide the result of the regenerated state or in other words, the regenerated biopolymer. The recitation of “resulting from dissolving, precipitating, and re-dispersing” is an incomplete process as it does not identify what is being dissolve, precipitate, and re-disperse. It is noted that paragraph [0033] of the published application (US Application Publication No. 2024/0076583 A1) disclosed that the regenerated biopolymer is “obtained by dissolving, precipitation and re-dispersion treatment process.” This disclosure makes clear that the regenerated biopolymer is obtained by dissolving, precipitation and re-dispersion treatment process, yet this is not adequately captured in claim 1. Thus, to obviate this indefinite rejection, it is suggested that Applicant amend “is in a regenerated state resulting from dissolving, precipitating, and redispersing” as recited in claim 1 to “is obtained by dissolving, precipitation and re-dispersion treatment process.”
Claims 2-6 and 14-17 are also rejected as they depend directly or indirectly from indefinite claim 1.
As a result, claims 1-6 and 14-17 do not clearly set forth the metes and bounds of patent protection desired.
Claim Interpretation
Claim 1 is structured as a product-by-process with regards to the limitation “the regenerated biopolymer …is in a regenerated state resulting from dissolving precipitating, and re-dispersing.” Thus, claim 1 will be interpreted and examined for art rejections purposes (102 and 103 rejections) as product-by-process type claim. MPEP §2113 (I) states “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Thus, while the structure implied by the process steps should be consider when assessing patentability of product-by-process claims over the prior art; however, burden of proof is placed upon Applicant to show that the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). Also see MPEP § 2113.
Maintained-Modified Rejections
Claim Rejections - 35 USC § 102
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.
Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rein et al (US 2018/0019036 A1).
The product-by-process claim interpretation applies here.
Regarding claims 1 and 4, Rein teaches a microcapsule comprising a core containing a hydrophobic material, and a shell containing a regenerated cellulose (Abstract; [0016]-[0121]; Examples 1-2), thereby the claimed structures of “a regenerated biopolymer” and “the regenerated biopolymer is derived from a natural biopolymer” as recited in claim 1.
As a result, the aforementioned teaching from Rein is anticipatory to claims 1 and 4 of the instant invention.
Claim(s) 1, 4, 6, 14 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Budijono et al (US 2014/0023688 A1).
The product-by-process claim interpretation applies here.
Regarding claims 1 and 4, Budijono teaches a microcapsule comprising a core containing an oil, and a shell containing a regenerated silk fibroin (Abstract; [0004]-[0211]; Example 3; claims 1-31, 110-116, and 195), thereby the claimed structures of “a regenerated biopolymer” and “the regenerated biopolymer is derived from a natural biopolymer” as recited in claim 1.
Regarding claim 6, Budijono teaches the oil is perfume oil ([0004]-[0005], [0017], [0044]-[0045], [0064], [0084], [0101], [0113], [0120], [0171]-[0198]; claim 4).
Regarding claim 14, Budijono teaches a consumer product comprising vitamins and a plurality of the microcapsule (Abstract; [0004]-[0211]; Example 3; claims 1-31, 110-116, and 195).
Regarding claim 16, as discussed above, Budijono teaches a microcapsule comprising a core containing a perfume oil and a shell containing a regenerated silk fibroin.
As a result, the aforementioned teachings from Budijono are anticipatory to claims 1, 4, 6, 14 and 16 of the instant invention.
Claim(s) 1, 4, 6, and 14-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaplan et al (US 2015/0164117 A1).
The product-by-process claim interpretation applies here.
Regarding claims 1 and 4, Kaplan teaches a microcapsule comprising a core containing an oil, and a shell containing a regenerated silk fibroin (Abstract; [0006]-[0101], [0560]-[0566]; claims 1-172), thereby the claimed structures of “a regenerated biopolymer” and “the regenerated biopolymer is derived from a natural biopolymer” as recited in claim 1.
Regarding claim 6, Kaplan teaches the oil is a perfume or fragrance oil (Abstract; [0006]-[0101], [0560]-[0566]; claims 1-172).
Regarding claim 14, Kaplan teaches a consumer product containing soap or bath salts, and a plurality of the microcapsule ([0025], [0029], [0169]-[0186]; clams 44, 61, and 172).
Regarding claim 15, Kaplan teaches a consumer product containing a detergent or bleaching agent, and a plurality of the microcapsule ([0029], [0169], [0210], [0489]; clams 44, 61, and 172).
Regarding claim 16, as discussed above, teaches a microcapsule comprising a core containing a perfume oil or fragrance oil, and a shell containing a regenerated silk fibroin.
As a result, the aforementioned teachings from Kaplan are anticipatory to claims 1, 4, 6, and 14-16 of the instant invention.
Response to Arguments
Applicant's arguments filed 01/28/2026 have been fully considered but they are not persuasive.
Applicant argues:
“[a]s amended, claim 1 requires a regenerated biopolymer that is structurally and physically distinct from non-regenerated biopolymers. Such regeneration typically results in reduced crystallinity, yielding a more random and amorphous arrangement of polymer chains, a lower degree of polymerization with shorter repeating units, and differences in degree of substitution and chemical modification. These structural differences impart different physical properties, such as altered solubility and interaction behavior, compared to non-regenerated counterparts.
None of Rein, Budijono, or Kaplan discloses a regenerated biopolymer having these characteristics. Rein discloses cellulose shells formed directly from dissolved cellulose during capsule formation, but does not disclose or recognize a regenerated biopolymer in a regenerated state as required by amended claim 1. Budijono and Kaplan similarly disclose silk fibroin materials that are dissolved and re-formed into shells or matrices through self-assembly or physical cross-linking, without disclosure or recognition of regenerated biopolymers possessing the claimed regenerated-state structural and physical properties.
Because anticipation requires that each and every limitation of a claim be disclosed in a single reference, either expressly or inherently, and none of the cited references discloses the regenerated biopolymer in the regenerated state now recited in claim 1, none of Rein, Budijono, or Kaplan anticipates amended claim 1.” (Remarks, pages 7-8).
In response, the Examiner disagrees. First, as discussed in the Claim Interpretation section, Claim 1 is structured as a product-by-process with regards to the limitation “the regenerated biopolymer …is in a regenerated state resulting from dissolving precipitating, and re-dispersing.” Thus, claim1 will be interpreted and examined for art rejections purposes (102 and 103 rejections) as product-by-process type claim. MPEP §2113 (I) states “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, while the structure implied by the process steps should be consider when assessing patentability of product-by-process claims over the prior art; however, burden of proof is placed upon Applicant to show that the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). Also see MPEP § 2113.
As discussed in the pending 102 rejections, Rein teaches regenerated cellulose; and Budijono and Kaplan teach regenerated silk fibroin. Both regenerated cellulose and regenerated silk fibroin meet the broadly claimed structures of “a regenerated biopolymer” and “the regenerated biopolymer is derived from a natural biopolymer” as recited in claim 1. Thus, there is no structure difference between the regenerated cellulose or regenerated silk of Rein, Budijono and Kaplan, respectively, to that the claimed regenerated biopolymer. This is supported by dependent claim 4, which recites that the regenerated biopolymer is regenerated cellulose or regenerated silk fibroin.
As a result, the 102 rejections over Rein, Budijono and Kaplan, respectively, are maintained the reason of record.
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, 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.
Claim(s) 1-6 and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan et al (US 2015/0164117 A1), and further in view of Sasaki et al (US 2017/0189283 A1).
The product-by-process claim interpretation applies here.
The microcapsule and consumer product of claims 1, 4, 6, and 14-16, respectively, are discussed above from Kaplan, said discussion being incorporated herein in its entirety.
Regarding claims 2-3, 5, and 17, Kaplan teaches the silk fibroin material can be mixed or blended with a biocompatible polymer such as polyaspartic acid (a polyamide), wherein the biocompatible polymer is present in a concentration of about 0.1 wt% to about 70 wt% ([0102]).
It would have been obvious to one of ordinary skill in the art to select a polyamide such as polyaspartic acid as the biocompatible polymer blended with the silk fibroin material of Kaplan so as to form the shell, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Sasaki established that biocompatible polymers including silk fibroin material, polyamide, polyurethane, polysiloxanes, polyurea, polyimide, polyvinyl alcohol, polyanhydride, polysaccharide, protein, polylactide (PLA), polyglycolide (PGA), polyorthoester, polyphosphazene, silicone, lipid, modified cellulose, gelatin, gum Arabic, polyesters or combinations of these materials are known to be suitable as wall-forming polymers for use in preparing microcapsules (Sasaki: Abstract; [0006]-[0010], [0039]-[0097] [0151], [0163], and [0207]). Thus, it is noted that [t]he selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.).
It would also have been obvious to one of ordinary skill in the art to optimize the amount of biocompatible polymer such as polyaspartic acid (a polyamide) in the shell of Kaplan to an amount less than 20% by weight, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Kaplan teaches that the biocompatible polymer can be used at a concentration of about 0.1 wt% to about 70 wt%, which is a range that overlap the claimed range of less than 20% by weight as recited in claims 5 and 17. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the weight amount of the polymeric material based on the total weight of the microcapsule would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
From the 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 in art the before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 01/28/2026 have been fully considered but they are not persuasive.
Applicant argues:
“As amended, independent claim 1 requires a polymeric shell comprising a regenerated biopolymer derived from a natural biopolymer and present in a regenerated state. As indicated above, regenerated biopolymers are materially distinct from their non-regenerated counterparts. In particular, regeneration results in reduced crystallinity, yielding a more random and amorphous arrangement of biopolymer chains, a lower degree of polymerization with shorter repeating units, and differences in degree of substitution and chemical modifications. These structural differences impart different physical properties comparted to the non-regenerated biopolymer counterparts such as for example their solubility.
Neither Kaplan nor Sasaki discloses or suggests microcapsules employing regenerated biopolymers having these characteristics. Kaplan relies on silk fibroin materials formed into shells or matrices through self-assembly or physical cross-linking, and does not disclose or recognize the use of regenerated biopolymers having reduced crystallinity, altered polymer chain structure, or modified substitution profiles as required by amended claim 1. Sasaki likewise merely provides a broad listing of classes of polymers that may be used as wall-forming materials, without addressing regenerated biopolymers in a regenerated state or the structural and physical distinctions arising therefrom.” (Remarks, page 9, 1st and 2nd paragraphs).
In response, the Examiner disagrees. As discussed above, Claim 1 is structured as a product-by-process with regards to the limitation “the regenerated biopolymer …is in a regenerated state resulting from dissolving precipitating, and re-dispersing.” Thus, claim 1 will be interpreted and examined for art rejections purposes (102 and 103 rejections) as product-by-process type claim. MPEP §2113 (I) states “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, while the structure implied by the process steps should be consider when assessing patentability of product-by-process claims over the prior art; however, burden of proof is placed upon Applicant to show that the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). Also see MPEP § 2113.
As discussed above, the claimed regenerated biopolymer as recited in claim 1 has been anticipated by the teaching from Kaplan. Kaplan teaches regenerated silk fibroin, which meets the broadly claimed structures of “a regenerated biopolymer” and “the regenerated biopolymer is derived from a natural biopolymer” as recited in claim 1. Thus, there is no structure difference between the regenerated silk fibroin of Kaplan to that the claimed regenerated biopolymer. This is supported by dependent claim 4, which recites regenerated silk fibroin as the regenerated biopolymer.
Applicant argues:
“the claimed regenerated biopolymers provide technical advantages not
suggested by the cited references. The benefits are demonstrated in the present application. For instance, Example 2 impressively demonstrates the formation of various microcapsules using regenerated biopolymers, such as regenerated chitin, regenerated silk fibroin or regenerated bagasse. Example 3 impressively demonstrates that the microcapsules show extremely low fragrance leakage under TGA test conditions of minimum 1.80%. Thereby, the claimed microcapsules enable the use of more eco-friendly materials, while not compromising on the performance of the microcapsules that can be provided.”(Remarks, page 9, last paragraph to page 10).
In response, the Examiner disagrees. As discussed above, the claimed regenerated biopolymer as recited in claim 1 has been anticipated by the teaching from Kaplan. Kaplan teaches regenerated silk fibroin, which meets the broadly claimed structures of “a regenerated biopolymer” and “the regenerated biopolymer is derived from a natural biopolymer” as recited in claim 1. Thus, there is no structure difference between the regenerated silk fibroin of Kaplan to that the claimed regenerated biopolymer. This is supported by dependent claim 4, which recites regenerated silk fibroin as the regenerated biopolymer, as well as, Example 2 particularly used the structurally same regenerated silk fibroin of Kaplan. It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
As a result, for at least the reason discussed above, claims 2-3, 5, and 17 remain rejected as obvious and unpatentable over the combined teachings of Kaplan and Sasaki in the standing 103 rejection as set forth in this office action.
Conclusion
No claim is allowed.
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 DOAN THI-THUC PHAN whose telephone number is (571)270-3288. The examiner can normally be reached 8-5 EST Monday-Friday.
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, Brian 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.
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.
/DOAN T PHAN/ Primary Examiner, Art Unit 1613
Prosecution Insights