DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372. This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1. In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-9, drawn to a composition.
Group II, claims 10-16, drawn to a composition.
Group III, claims 17-20, drawn to a method of making.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: the Groups lack unity of invention because even though the inventions of the Groups require the common technical features of a biodegradable bead comprising a mixed cellulose ester (“MCE”), having an oil absorption property of ≥30 mL per 100 g as measured according to ASTM D281, wherein the MCE comprises i) a DSAc in the range of 0.9-2.3, ii) a DSBu in the range of 0.1-1.1, and iii) a DSOH in the range of 0.7-1.4, these common technical features do not make for a special technical feature as they do not make a contribution over the prior art in view of Tamagawa, US 9,256,016 (2016). Tamagawa teaches a MCE having a preferred overall acyl (defined as having between 2 C atoms, i.e. acetyl, and 4 C atoms, i.e. propionyl or butyryl) degree of substitution of 1.1-1.9, and, within said overall acyl range, a preferred C3-4 acyl degree of substitution of 1.0-1.9, indicating that its desired C2 acyl degree of substitution is 0.1-0.9; Tamagawa specifically teaches that its MCE can have C2 acyl groups as well as C3-4 acyl groups. See id. at, e.g., col. 4, ln. 34-67. The foregoing range teachings and their overlap of the common technical features’ ranges render employing a MCE having a DSAc of 0.9, a DSBu of 1.0, and (therefore) a DSOH of 1.0 (obtained by subtracting the foregoing values from the overall maximum value of 3) prima facie obvious1. While Tamagawa is silent as to said oil absorption property, given that Tamagawa renders prima facie obvious the structural/compositional limitations of the common technical features, said property is reasonably considered to be met/present and/or at least would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention2. The “biodegradable” feature/property is likewise reasonably considered to be met/present and/or prima facie obvious for the same reasons. As to the “bead” shape, Tamagawa’s silence thereon is not regarded as rendering said shape non-obvious; it is noted that changes in size and shape are not patently distinct over the prior art absent persuasive evidence that the particular configuration of the claimed invention is significant. See MPEP 2144.04 IVA-B, citing In re Rose, 220 F.2d 459 (CCPA 1955), In re Rinehart, 531 F.2d 1048 (CCPA 1976), Gardner v. TEC Syst., Inc., 725 F.2d 1338 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984), and In re Dailey, 357 F.2d 669 (CCPA 1966). As such, the requisite unity of invention is thus lacking a posteriori.
During a 10/13/26 phone conversation with agent Kendrick Vidale, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-9. This election must be affirmed by applicant in replying to this Office action. Claims 10-20 are withdrawn from further consideration by the examiner per 37 CFR 1.142(b) as drawn to non-elected Groups.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
This Restriction Requirement (“R/R”) is between product claims and process claims. Where applicant elects claims directed to the product, and all product claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product claim for that process invention to be rejoined. In the event of rejoinder, the R/R between the product claims and the rejoined process claims will be withdrawn; rejoined process claims will be fully examined for patentability per 37 CFR 1.104. To be allowable, the rejoined claims must meet all criteria for patentability including those of 35 U.S.C. 101-103 & 112. Until all claims to the elected product are found allowable, an otherwise proper R/R between product claims and process claims may be maintained. Withdrawn process claims not commensurate in scope with an allowable product claim will not be rejoined. See MPEP § 821.04. Also, for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the R/R is withdrawn by the examiner before the/any patent issues. See MPEP § 804.01.
Double Patenting
The nonstatutory double patenting (“NSDP”) 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 NSDP 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 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046 (Fed. Cir. 1993); In re Longi, 759 F.2d 887 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937 (CCPA 1982); In re Vogel, 422 F.2d 438 (CCPA 1970); In re Thorington, 418 F.2d 528 (CCPA 1969).
A timely filed Terminal Disclaimer (“TD”) in compliance with 37 CFR 1.321(c) or (d) may be used to overcome an actual or provisional NSDP rejection 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 TD must be signed in compliance with 37 CFR 1.321(b). The filing of a TD by itself is not a complete reply to a NSDP rejection. A complete reply requires that the TD 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 TD forms that may be used. See 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 (“eTD”) may be filled out completely online using web-screens. An eTD that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTDs, see www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Instant claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Appl’n 19/167,555 (published 9/17/26 as US 2026/0272810) (9/22/25 claim set, herein “’555”). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope and do not manifest any non-obvious differences, as detailed below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not yet in fact been patented.
Regarding instant claims 1-5, ’555 claims biodegradable microparticles comprising an MCE, wherein the MCE has a DSAc in the range of 0.1-2.3, a DSPr or DSBu in the range of 0.1-1.5, and a DSOH in the range of 0.6-2.8; the microparticles have an oil absorption property as claimed. See ‘555 at clms. 1 & 25. As to the “bead” shape, ‘555’s silence thereon is not regarded as rendering said shape non-obvious; it is noted that changes in size and shape are not patently distinct over the prior art absent persuasive evidence that the particular configuration of the claimed invention is significant. See MPEP 2144.04 IVA-B, citing In re Rose, In re Rinehart, Gardner v. TEC Syst., Inc., and In re Dailey. While ‘555 also claims additional features for its microparticles, this is not a patentable distinction; the omission of an element or limitation with a corresponding loss of function has been held to be an obvious variation. See In re Kuhle, 188 USPQ 7, 9 (CCPA 1975); Ex parte Wu, 10 USPQ 2031 (BPAI 1989); MPEP 2144.04 II. A.
Regarding instant claims 6-8, ‘555 so claims. See ‘555 at, respectively, clms. 9-10 & 18.
Regarding instant claim 9, ‘555’s microparticles have a ≥10% sphericity. See id. at clm. 24. ‘555’s silence as to its microparticles’ diameter and density values is not regarded as rendering said size and configuration non-obvious; it is noted that changes in size and shape (and, as here, compaction/density) are not patently distinct over the prior art absent persuasive evidence that the particular configuration of the claimed invention is significant. See MPEP 2144.04 IVA-B, citing In re Rose, In re Rinehart, Gardner v. TEC Syst., Inc., and In re Dailey.
Instant claims 1-7 & 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, 9-10, 12, 14, 16, 18, 20, 22-24, and 26-29 of copending Appl’n 19/163,870 (published 9/3/26 as US 2026/0256673) (9/10/25 claim set, herein “’870”). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope and do not manifest any non-obvious differences, as detailed below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not yet in fact been patented.
Regarding instant claims 1-5, ’870 claims biodegradable microparticles comprising an MCE, wherein the MCE has a DSAc in the range of 0.1-2.3, a DSPr or DSBu in the range of 0.1-0.5, and a DSOH in the range of 0.6-2.8; the microparticles have an oil absorption property as claimed. See ‘870 at clms. 1, 10, 12, 14, 16, & 22. As to the “bead” shape, ‘870’s silence thereon is not regarded as rendering said shape non-obvious; it is noted that changes in size and shape are not patently distinct over the prior art absent persuasive evidence that the particular configuration of the claimed invention is significant. See MPEP 2144.04 IVA-B, citing In re Rose, In re Rinehart, Gardner v. TEC Syst., Inc., and In re Dailey. While ‘870 also claims additional features for its microparticles, this is not a patentable distinction; the omission of an element or limitation with a corresponding loss of function has been held to be an obvious variation. See In re Kuhle; Ex parte Wu; MPEP 2144.04 II. A.
Regarding instant claims 6-7, ‘870 so claims. See ‘870 at, e.g., clms. 1 and 9.
Regarding instant claim 9, ‘870’s microparticles have 1-50 µm diameter and a <50% average sphericity. See id. at, e.g., clm. 3. The term “average” immediately preceding “sphericity” is considered to connote that some microparticles have a ≥50% sphericity (i.e. within the claimed range). MPEP 2144.01 & 2144.05. Additionally and/or alternatively, the <50% sphericity range (which includes, e.g., 49.99999% sphericity) is considered sufficiently close to 50% sphericity to render the latter prima facie obvious- a prima facie case of obviousness exists where the claimed and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties (or results). See MPEP 2144.05 I; Titanium Metals Co. of Am. v. Banner, 778 F.2d 775 (Fed. Cir. 1985); Accord, In re Kirsch, Barnby, and Potts, 182 USPQ 286, 290 (CCPA 1974) (finding that prior art teachings lying slightly outside of a claimed range nevertheless negate non-obviousness, especially in the absence of any criticality statements regarding the claimed range). ‘870’s silence as to its microparticles’ density value is not regarded as rendering said configuration non-obvious; it is noted that changes in size and shape (and, as here, compaction/density) are not patently distinct over the prior art absent persuasive evidence that the particular configuration of the claimed invention is significant. See MPEP 2144.04 IVA-B, citing In re Rose, In re Rinehart, Gardner v. TEC Syst., Inc., and In re Dailey.
Instant claims 1-7 & 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Appl’n 18/998,908 (published 1/29/26 as US 2026/0027018) (1/27/25 claim set, herein “’908”). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope and do not manifest any non-obvious differences, as detailed below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not yet in fact been patented.
Regarding instant claims 1-5, ’908 claims biodegradable microparticles comprising an MCE, wherein the MCE has a DSAc in the range of 0.1-2.3, a DSPr or DSBu in the range of 0.1-1.5, and a DSOH in the range of 0.6-2.8; the microparticles have an oil absorption property as claimed. See ‘908 at clms. 1, 6-11, & 17. As to the “bead” shape, ‘908’s silence thereon is not regarded as rendering said shape non-obvious; it is noted that changes in size and shape are not patently distinct over the prior art absent persuasive evidence that the particular configuration of the claimed invention is significant. See MPEP 2144.04 IVA-B, citing In re Rose, In re Rinehart, Gardner v. TEC Syst., Inc., and In re Dailey. While ‘908 also claims additional features for its microparticles, this is not a patentable distinction; the omission of an element or limitation with a corresponding loss of function has been held to be an obvious variation. See In re Kuhle; Ex parte Wu; MPEP 2144.04 II. A.
Regarding instant claims 6-7, ‘908 so claims. See ‘908 at, e.g., clms. 1 and 5.
Regarding instant claim 9, ‘908’s microparticles have 5-20 µm diameter and a ≥10% sphericity. See id. at clms. 4 & 16. ‘908’s silence as to its microparticles’ density value is not regarded as rendering said configuration non-obvious; it is noted that changes in size and shape (and, as here, compaction/density) are not patently distinct over the prior art absent persuasive evidence that the particular configuration of the claimed invention is significant. See MPEP 2144.04 IVA-B, citing In re Rose, In re Rinehart, Gardner v. TEC Syst., Inc., and In re Dailey.
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.
In considering the obviousness rejections below, the applicant should note that the person having ordinary skill in the art at the time of the effective filing date of the claimed invention has the capability of understanding the scientific and engineering principles applicable to the claimed invention. The references of record in the application reasonably reflect this level of skill.
Claims 1-9 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Tamagawa, US 9,256,016 (2016). Regarding claims 1-3 and 5, Tamagawa teaches a MCE having a preferred overall acyl (defined as having between 2 C atoms, i.e. acetyl, and 4 C atoms, i.e. propionyl or butyryl) degree of substitution of 1.1-1.9, and, within said overall acyl range, a preferred C3-4 acyl degree of substitution of 1.0-1.9, indicating that its desired C2 acyl degree of substitution is 0.1-0.9; Tamagawa specifically teaches that its MCE can have C2 acyl groups as well as C3-4 acyl groups. See id. at, e.g., col. 4, ln. 34-67. The foregoing range teachings and their overlap of those claimed render employing a mixed cellulose ester having a DSAc of 0.9, a DSPr or DSBu of 1.0, and (therefore) a DSOH of 1.0 (obtained by subtracting the foregoing values from the overall maximum value of 3) prima facie obvious3. While Tamagawa is silent as to said oil absorption property, as Tamagawa renders the claimed structural/compositional limitations prima facie obvious, said property is reasonably considered to be met/present and/or at least would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention4. The “biodegradable” feature/property is likewise reasonably considered to be met/present and/or prima facie obvious for the same reasons. As to the “bead” shape, Tamagawa’s silence thereon is not regarded as rendering said shape non-obvious; it is noted that changes in size and shape are not patently distinct over the prior art absent persuasive evidence that the particular configuration of the claimed invention is significant. See MPEP 2144.04 IVA-B, citing In re Rose, In re Rinehart, Gardner v. TEC Syst., Inc., and In re Dailey.
Regarding claim 4, Tamagawa teaches that a DSPr or DSBu of 0.9 ≤ [DSPr or DSBu] < 2.0 is preferred to achieve a desirable retardation feature/property, rendering a DSPr of 0.9 prima facie obvious. MPEP 2144.05. See Tamagawa at, e.g., col. 4, ln. 43-46. Additionally and/or alternatively, Tamagawa renders employing a DSPr of 1.0 prima facie obvious as detailed above vis-à-vis, e.g., claim 1. While this value lies slightly above the claimed 0.9 maximum, Tamagawa’s 1.0 value is considered sufficiently close to 0.9 to render the latter prima facie obvious- a prima facie case of obviousness exists where the claimed and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties (or results). See MPEP 2144.05 I; Titanium Metals Co. of Am. v. Banner; Accord, In re Kirsch, Barnby, and Potts.
Regarding claims 6-7, as Tamagawa renders claim 1’s structural/compositional limitations prima facie obvious, said properties are reasonably considered to be met/present and/or at least would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention5.
Regarding claim 8, Tamagawa’s MCE has a weight average MW of ≤ 150,000 (Da), with 50-100 kDa being preferred. See Tamagawa at, e.g., col. 4, ln. 34-42 and col. 5, ln. 42-44.
Regarding claim 9, Tamagawa teaches that its MCE is formed into shapes (the shaping thereof into beads being prima facie obvious as detailed above vis-à-vis claim 1) having a thickness -which is considered equivalent to diameter on converting the shape to beads as claimed- of 10-35 µm. See id. at, e.g., col. 2, ln. 32-33 and col. 3, ln. 41-42. Tamagawa’s silence as to the sphericity and density is not regarded as rendering said shape and configuration non-obvious; it is noted that changes in size and shape (and, as here, compaction/density) are not patently distinct over the prior art absent persuasive evidence that the particular configuration of the claimed invention is significant. See MPEP 2144.04 IVA-B, citing In re Rose, In re Rinehart, Gardner v. TEC Syst., Inc., and In re Dailey.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL BERNS whose telephone number is (469)295-9161. The examiner can normally be reached M-F 8:30-5:00 (Central). 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, Anthony Zimmer can be reached at (571) 270-3591. 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.
/DANIEL BERNS/ October 14, 2026
Primary Examiner
Art Unit 1736
1 Given Tamagawa’s cited teachings, it would have been obvious to one of ordinary skill in the art to ascertain and employ desired/optimal DSAc, DSBu, and (therefore) DSOH ranges, such as those within the Groups’ common technical features, via routine experimentation, as it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP 2144.05, citing In re Aller, 220 F.2d 454, 456 (CCPA 1955).
2 The conclusion of obviousness is buttressed by the Federal Circuit’s holding that “[w]hen a chemical composition is claimed, a prima facie case of obviousness under Section 103 may be established by [the prior art’s teaching of] a
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similar composition, the presumption being that similar compositions have similar properties.” See, e.g., In re Soni, 54 F.3d 746 (Fed. Cir. 1995) (internal citations omitted); Titanium Metals Corp. v. Banner, 778 F.2d 775 (Fed. Cir. 1985); MPEP 2112.01 I-II; MPEP 2144.09 I, citing In re Payne, 606 F.2d 303, 313 (CCPA 1979).
3 See fn. 1, above.
4 See fn. 2, above.
5 See fn. 2, above.
Prosecution Insights