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
Applicant’s Request for Reconsideration dated October 14, 2025 is acknowledged.
Claims 1-5, 7 and 10-16 are pending.
Claims 6, 8 and 9 are cancelled.
Claims 4 and 5 are currently amended.
Claims 10-16 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claims 1-5 and 7 as filed on October 14, 2025 are pending and under consideration to the extent of the elected species, e.g., the species of biodegradable polymer is cellulose acylate having an acyl group having 2 or more and 10 or less carbons, and the cellulose acylate has a total degree of substitution of more than 0 and less than 0.7.
This action is made FINAL.
Patent Prosecution Highway
The Patent Prosecution Highway (PPH) is a framework in which an application whose claims have been determined to be patentable by an Office of Earlier Examination (OEE) is eligible to go through an expedited examination of corresponding claims in a corresponding patent application pending in a second patent office. The response filed October 14, 2025 does not contain a statement certifying that the amended claims sufficiently correspond to the claims in the OEE application as required by the program. Applicant must certify sufficient correspondence every time the claims are amended. If the certification statement is omitted, the amendment will not be entered and will be treated as a non-responsive reply. In the interest of compact prosecution, the response as filed October 14, 2025 has been entered because the amendments to dependent claims 4 and 5 are editorial in nature and because claim 1 has not been amended and necessarily corresponds.
Withdrawn Objections / Rejections
In view of the amendment of the specification and Applicant’s remarks, all previous objections to the specification are withdrawn.
In view of the amendment of the claims, some of the previous claim objections are withdrawn and all of the previous claim rejections under 35 USC 112(d) are withdrawn.
Applicant’s arguments have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 15, 2025 was considered.
Claim Objections
Claims 1-5 are objected to because of the following informalities:
Claim 1: “a main component” is properly “the main component” in view of the definition in paragraph [0016] of the specification as encompassing at least 50 wt%.
Claim 2: “a ratio” is properly “the ratio” because antecedent basis is implicit.
Claims 2, 3: “a biodegradation degree” is properly “the biodegradation degree”.
Claim 4: “the micron-sized recess” is properly “a micron-sized recess”.
Claim 5: “the micron-sized protrusion” is properly “a micron-sized protrusion”.
Appropriate correction is required.
New Grounds of Rejection Necessitated by Amendment
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 and 5 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 4 recites the limitation "the micron-sized recess". There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the micron-sized protrusion". There is insufficient antecedent basis for this limitation in the claim.
Maintained Grounds of Rejection: 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.
Claims 1-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable Abe (WO 2022/050004 A, published March 10, 2022, as evidenced by English equivalent US 2023/0303782, of record) as evidenced by Kazuhiro et al. (GB 2,152,936 A, of record) and as evidenced by Nakata et al. (US 2002/0094444, of record).
Abe teaches resin beads that have excellent biodegradability formed of a resin containing cellulose (polysaccharide) as the main component, having a median particle size of 50 microns or less, having a sphericity of 0.7 to 1.0 (spherical), having a 5 day biodegradability of 20% or greater according to a circumscribed process (title; abstract; claims, in particular claim 1; paragraphs [0037], [0039], [0047]-[0060]; Figure 1), as required by instant claims 4, 5, 7:
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In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. 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). See MPEP 2144.05.
The CV of the particle size is 10 to 90% (claim 4).
The cellulose may comprise a cellulose derivative, such as a cellulose ester in which the content of the acyl group, such as an acetyl group, is 60 mass% or less (esterification degree of 2.8 or less as evidenced by Kazuhiro (e.g., abstract)) (paragraphs [0061], [0068], [0070], [0083]).
Regarding instant claims 2 and 3 which recite different ranges for the ratio of the biodegradation on day 5 to day 28 (e.g., the equation of claim 3 can be re-arranged to recite a value for BD5/BD28), because Abe renders obvious biodegradable spherical particles as instantly claimed, comprising the same polysaccharide core and having the same size and same biodegradability on day 5, it is presumed that the particles of Abe are also characterized by the same biodegradability on day 28 such that the particles of Abe are also characterized by the same BD ratio as instantly claimed. In further support of this presumption, Nakata evidences biodegradation curves to be sigmoidal (Figure 1; paragraphs [0023], [0119], [0634], [0752]):
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Furthermore, one skilled in the art would be imbued with the reasonable expectation that the ratio falls within the range of (10% or more)/(100% or less - 10% or more).
Claims 1-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Abe ‘293 (JP 6921293 B1, published August 18, 2021, as evidenced by the Google translation, of record) as evidenced by Kazuhiro et al. (GB 2,152,936 A, of record) and as evidenced by Nakata et al. (US 2002/0094444, of record).
Abe ‘293 teaches cellulose resin beads having good biodegradability, having an average particle size of 50 microns or less, a sphericity of 0.7 to 1.0, and a surface smoothness of 70 to 100% (title; abstract; claims, in particular 1; Figure), as required by instant claims 4, 5, 7:
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In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. 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). See MPEP 2144.05. The CV (coefficient of variation) value of the particle size is 10 to 90% (claim 9; page 3, 8th full paragraph).
The biodegradation rate for 5 days is 10% or more (claim 6).
The cellulose resin beads are obtained from a cellulose ester selected from the group inclusive of cellulose acetate (claim 12). It is preferable to use cellulose esters having an acyl group content of 60% by mass or less (esterification degree of 2.8 or less as evidenced by Kazuhiro (e.g., abstract)) (page 5, 3rd full paragraph).
Regarding instant claims 2 and 3 which recite different ranges for the ratio of the biodegradation on day 5 to day 28 (e.g., the equation of claim 3 can be re-arranged to recite a value for BD5/BD28), because Abe ‘293 renders obvious biodegradable spherical particles as instantly claimed, comprising the same polysaccharide core and having the same size and same biodegradability on day 5, it is presumed that the particles of Abe ‘293 are also characterized by the same biodegradability on day 28 such that the particles of Abe ‘293 are also characterized by the same BD ratio as instantly claimed. In further support of this presumption, Nakata evidences biodegradation curves to be sigmoidal (Figure 1; paragraphs [0023], [0119], [0634], [0752]):
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Furthermore, one skilled in the art would be imbued with the reasonable expectation that the ratio falls within the range of (10% or more)/(100% or less - 10% or more).
Response to Arguments: Claim Rejections - 35 USC § 103
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant states at page 10 of the Remarks that the cited references fail to disclose or suggest the claimed biodegradability. This is not found persuasive because the Abe documents collectively disclose cellulose acetylate particles as instantly claimed and as elected having a 5 day biodegradability of 20% or greater, of 10% or greater and it is presumed that biodegradation kinetics are inherent to the particles per se. Once a reference teaching a product appearing to be substantially identical is applied and the evidence or reasoning is presented to show inherency, the burden of production shifts to Applicant. See MPEP 2112 V.
Therefore, the rejections are properly maintained.
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 1-5 and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable (A) over claims 1-14 of U.S. Patent No. 11,434,348 and (B) over claims 1-13 of U.S. Patent No. 11,628,134 in view of Abe (WO 2022/050004 A, published March 10, 2022, as evidenced by English equivalent US 2023/0303782, of record) or/and Abe ‘293 (JP 6921293 B1, published August 18, 2021, as evidenced by the Google translation, of record), and as evidenced by Nakata et al. (US 2002/0094444, of record).
The instant claims are drawn to biodegradable spherical particles comprising a biodegradable polymer inclusive of a polysaccharide or a polysaccharide ester having a total degree of substitution less than 0.7, the particles have a size variation CV of 40% or less, an average size of 0.08 to 100 microns, and a day five biodegradation degree (BD) of 40% or less as calculated by a circumscribed protocol. The ratio BD5/BD28 may be 0.60 or less. There are substantially no particles (as defined in paragraph [0034] of the instant specification) having a micron-sized recess or protrusion.
The ‘348 Patent claims are drawn to cellulose derivative particles comprising an acyl group having 3 or more carbons having a total degree of substitution of 0.7 to 3, an average size of 80 nm to 100 microns, a sphericity of 90 to 100%, and a surface smoothness of 80 to 100% (implies no recesses or protrusions).
The ‘134 Patent claims are drawn to cellulose acetate particles having a total degree of substitution of 0.7 to 2.9, an average size of 80 nm to 80 microns, and a sphericity of 0.7 to 1.0. The particles may have a size variation of 0 to 60%. The particles may have a surface smoothness of 85 to 100% (implies no recesses or protrusions).
The cellulose acylate (polysaccharide ester) spherical particles of conflicting, patented claims differ with respect to the size variation CV, with respect to the BD5, and with respect to the BD28. However, these differences are bridged in view of the prior art to Abe as elaborated supra. Abe discloses cellulose acylate spherical particles having a CV of 10 to 90% and favorable biodegradability, meaning 20% or more at day 5 (e.g., abstract; paragraphs [0047]), and Abe ‘293 discloses good biodegradability as 10% or more for particles having a CV of 10 to 90% (e.g., abstract; page 4, 3rd full paragraph). Therefore, it would have been obvious to one of ordinary skill in the art to modify the cellulose acylate spherical particles of the conflicting, patented claims to have a CV of 10 to 90% and to have a biodegradability at day 5 of 10% or more as taught by Abe in order to have a more uniform collection of particles with qualitatively good biodegradability. Regarding the ratio of the biodegradation on day 5 to day 28 (e.g., the equation of claim 3 can be re-arranged to recite a value for BD5/BD28), because the conflicting, patented claims in view of Abe or/and Abe ‘293 render obvious biodegradable spherical particles as instantly claimed, it is presumed that these particles are also characterized by the same biodegradability on day 28 such that these particles are also characterized by the same BD ratio as instantly claimed. In further support of this presumption, Nakata evidences biodegradation curves to be sigmoidal (Figure 1; paragraphs [0023], [0119], [0634], [0752]):
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Furthermore, one skilled in the art would be imbued with the reasonable expectation that the ratio falls within the range of (10% or more)/(100% or less - 10% or more).
Claims 1-5 and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable (1) over claims 1-8 of copending Application No. 18/010,591; (2) over claims 1-9 of copending Application No. 18/115,215; and (3) over claims 1-7 of copending Application No. 18/718,131 in view Abe (WO 2022/050004 A, published March 10, 2022, as evidenced by English equivalent US 2023/0303782, of record) or/and Abe ‘293 (JP 6921293 B1, published August 18, 2021, as evidenced by the Google translation, of record), and as evidenced by Nakata et al. (US 2002/0094444, of record).
The instant claims have been described supra.
The copending ‘591 claims are drawn to cellulose acetate particles having an average size of 80 nm to 100 microns, a sphericity of 0.7 to 1, and a total degree of acetyl substitution of 0.7 to 3.0. The particles may have a degree of surface smoothness of 10 to 95% (implies no recesses or protrusions).
The copending ‘215 claims are drawn to cellulose acetate particles having an average size of 80 nm to 100 microns, a sphericity of 0.7 to 1, and a surface smoothness of 80 to 100% (implies no recesses or protrusions). The particles may have a size variation of 0 to 60%.
The copending ‘131 claims are drawn to particles comprising a biodegradable polysaccharide ester having a degree of substitution of 0.7 to 3.0, an average size of 80 nm to 100 microns, and a sphericity of 0.7 to 1. The particles may have a degree of surface smoothness of 10 to 95% (implies no recesses or protrusions). The ester may be a cellulose acylate having an acyl group having 3 or more carbons.
The cellulose acylate (polysaccharide ester) spherical particles of conflicting, copending claims differ with respect to the size variation CV, with respect to the BD5, and with respect to the BD28. However, these differences are bridged in view of the prior art to Abe as elaborated supra. Abe discloses cellulose acylate spherical particles having a CV of 10 to 90% and favorable biodegradability, meaning 20% or more at day 5 (e.g., abstract; paragraphs [0047]), and Abe ‘293 discloses good biodegradability as 10% or more for particles having a CV of 10 to 90% (e.g., abstract; page 4, 3rd full paragraph). Therefore, it would have been obvious to one of ordinary skill in the art to modify the cellulose acylate spherical particles of the conflicting, copending claims to have a CV of 10 to 90% and a biodegradability at day 5 of 10% or more as taught by Abe in order to have a more uniform collection of particles with qualitatively good biodegradability. Regarding the ratio of the biodegradation on day 5 to day 28 (e.g., the equation of claim 3 can be re-arranged to recite a value for BD5/BD28), because the conflicting, copending claims in view of Abe or/and Abe ‘293 render obvious biodegradable spherical particles as instantly claimed, it is presumed that these particles are also characterized by the same biodegradability on day 28 such that these particles are also characterized by the same BD ratio as instantly claimed. In further support of this presumption, Nakata evidences biodegradation curves to be sigmoidal (Figure 1; paragraphs [0023], [0119], [0634], [0752]):
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Furthermore, one skilled in the art would be imbued with the reasonable expectation that the ratio falls within the range of (10% or more)/(100% or less - 10% or more).
This is a provisional nonstatutory double patenting rejection.
Claims 1-5 and 7 are directed to an invention not patentably distinct from claim 1-8 of commonly assigned Application No. 18/010,591, from claims 1-9 of commonly assigned Application No. 18/115,215 and from claims 1-7 of commonly assigned Application No. 18/718,131. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned Application Nos. 18/010,591, 18/115,215 and 18/718,131, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Arguments: Double Patenting
Applicant states at page 11 of the Remarks that the cited references fail to disclose or suggest the claimed biodegradability. This is not found persuasive because the Abe documents collectively disclose cellulose acetylate particles as instantly claimed and as claimed in the conflicting Patents and conflicting Applications and it is presumed that biodegradation kinetics are inherent to the particles per se. Once a reference teaching a product appearing to be substantially identical is applied and the evidence or reasoning is presented to show inherency, the burden of production shifts to Applicant. See MPEP 2112 V.
Therefore, the rejections are properly maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cui et al. (CN 111163745 A, as evidenced by English equivalent US 2020/0214954) is the closest prior art as identified by USPTO artificial intelligence and teaches spherical particles comprising a fatty alcohol and a sucrose-based surfactant (title; abstract; claims).
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 ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID BLANCHARD can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISSA PROSSER/
Examiner, Art Unit 1619
/MARIANNE C SEIDEL/Primary Examiner, Art Unit 1600