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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 11/25/2024 is acknowledged. Furthermore, with regards to the species restriction requirement, applicant elects unsubstituted dialcohol cellulose without traverse.
Claims 4-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/25/2024.
Additionally, claims 9-16 are withdrawn from further consideration as be drawn to nonelected species. Thus, claims 1-3 are pending the current application.
Drawings
The drawings filed 7/23/2021 are accepted.
Specification
The abstract filed 7/23/2021 as part of the substitute specification is sufficient to address the objection to the specification noted in the previous Office Action.
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.
Claim(s) 1-3 and 17-20 (all pending claims) is/are rejected under 35 U.S.C. 103 as being unpatentable over “Hollow cellulose capsules from CO2 saturated cellulose solutions-their preparation and characterization” (RSC Advances, 2013, 2, 2462; Christopher Carrick-herein referred to as “Carrick”) in view of WO 2018/135984 (herein referred to as “Larson”) and Sheiko (US 2018/0045843).
Carrick teaches hollow spherical cellulose capsules (see all; including abstract). Said capsules have use in biomedical applications (abstract). Carrick does not teach that the cellulose should comprise dialcohol cellulose. However, Larson teaches a method of modifying cellulose to dialcohol cellulose (abstract). Larson teaches the dialcohol cellulose has improved gas and liquid barrier properties and decrease sensitivity to degradation from moisture (page 8). Thus, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the cellulose disclosed in Carrick to be a dialcohol cellulose. The motivation for doing so would have been the skilled artisan would expect the resulting hollow spherical particles to exhibit improved barrier properties and reduced sensitivity to degradation by water.
Neither reference teaches that the hollow spherical cellulose capsule should further comprise a blowing agent. However, Shieko teaches that blowing agents such as volatile hydrocarbons, halogenated hydrocarbons, organic silanes, or mixtures thereof. Suitable volatile hydrocarbons include ethane, ethylene, propane, propene, butane, isobutene, neopentane, acetylene, isopentane, decane, hexane, heptane, and the like. Suitable halogenated hydrocarbons include chlorofluorocarbons, such as trichlorofluoromethane, dichlorofluoromethane, chlorotrifluoromethane, and the like, and perfluorocarbons, such as perfluorohexane, perfluoropentane, perfluorooctane, and the like. The blowing agent may be added to pharmaceutical microcapsules (0057 to allow for ultrasound-triggered pharmaceutical drug release while also enhancing acoustic imaging contrast. The expandable microcapsules of the present disclosure may be used to enhance the contrast of soft and hard tissues and allow for targeted pharmaceutical drug release (0083). Thus, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to add a blowing agent to the capsules disclosed in Carrick. The motivation for doing so would have been such blowing agent allows for ultrasound-triggered pharmaceutical drug release while also enhancing acoustic imaging contrast and allow for targeted pharmaceutical drug release.
With regards to claim 3, the particles of the prior art are understood to meet said limitations as Carrick teaches pressure will affect the volume/expansion of the particle (see Figure 6). Alternatively, the particle disclosed in Carrick is understood to inherently meet said condition as the volume of a solid is known to vary based upon temperature and pressure.
With regards to claim 18, the examiner notes that the claim does not require dialkyl ethers to be selected as the blowing agent, it merely further limits the dialkyl ether blowing agent if said blowing agent is present.
With regards to claim 19, Sheiko teaches the blowing agent may be a C3-C12alkane.
With regards to claim 20, Sheiko teaches the blowing agent may be a haloalkane which is a C1-C10 haloalkane.
Claim(s) 1-3 and 17-20 (all pending claims) is/are rejected under 35 U.S.C. 103 as being unpatentable over “Hollow cellulose capsules from CO2 saturated cellulose solutions-their preparation and characterization” (RSC Advances, 2013, 2, 2462; Christopher Carrick-herein referred to as “Carrick”) in view of “Chemical Modification of Cellulose Fibres and Fibrils for Design of New Materials” (Veronica Lopez Duran; KTH Royal Institute of Technology; School of Engineering Sciences in Chemistry, Biotechnology and health; Department of Fiber and Polymer Technology; Stockholm, 2018-herein referred to as “Duran”) and Sheiko (US 2018/0045843).
Carrick teaches hollow spherical cellulose capsules (see all; including abstract). Said capsules have use in biomedical applications (abstract).Carrick does not teach that the cellulose should comprise dialcohol cellulose. However, Duran teaches that the modification of cellulose to dialcohol cellulose results in an increase in Tensile strength and modulus (page 25). Thus, it would have been obvious to one of ordinary skill in the art at the time the invention was filed the cellulose disclosed in Carrick to be a dialcohol cellulose. The motivation for doing so would have been the skilled artisan would expect an increase in the tensile strength and modulus.
With regards to claim 3, the particles of the prior art are understood to meet said limitations as Carrick teaches pressure will affect the volume/expansion of the particle (see Figure 6). Alternatively, the particle disclosed in Carrick is understood to inherently meet said condition as the volume of a solid is known to vary based upon temperature and pressure.
Neither reference teaches that the hollow spherical cellulose capsule should further comprise a blowing agent. However, Shieko teaches that blowing agents such as volatile hydrocarbons, halogenated hydrocarbons, organic silanes, or mixtures thereof. Suitable volatile hydrocarbons include ethane, ethylene, propane, propene, butane, isobutene, neopentane, acetylene, isopentane, decane, hexane, heptane, and the like. Suitable halogenated hydrocarbons include chlorofluorocarbons, such as trichlorofluoromethane, dichlorofluoromethane, chlorotrifluoromethane, and the like, and perfluorocarbons, such as perfluorohexane, perfluoropentane, perfluorooctane, and the like. The blowing agent may be added to pharmaceutical microcapsules (0057 to allow for ultrasound-triggered pharmaceutical drug release while also enhancing acoustic imaging contrast. The expandable microcapsules of the present disclosure may be used to enhance the contrast of soft and hard tissues and allow for targeted pharmaceutical drug release (0083). Thus, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to add a blowing agent to the capsules disclosed in Carrick. The motivation for doing so would have been such blowing agent allows for ultrasound-triggered pharmaceutical drug release while also enhancing acoustic imaging contrast and allow for targeted pharmaceutical drug release.
With regards to claim 18, the examiner notes that the claim does not require dialkyl ethers to be selected as the blowing agent, it merely further limits the dialkyl ether blowing agent if said blowing agent is present.
With regards to claim 19, Sheiko teaches the blowing agent may be a C3-C12alkane.
With regards to claim 20, Sheiko teaches the blowing agent may be a haloalkane which is a C1-C10 haloalkane.
Response to Arguments
Applicant’s arguments filed 8/15/2025 have been fully considered but are not persuasive.
Rejections Under 35 USC 103
With regards to claim(s) 1-3 and 17 under 35 U.S.C. 103 as being unpatentable over "Hollow cellulose capsules from CO2 saturated cellulose solutions-their preparation and characterization" (RSC Advances, 2013, 2, 2462; Christopher Carrick-herein referred to as "Carrick") in view of WO 2018/135994 (herein referred to as "Larson"), applicant argues the Office has not established prima facie obviousness such that the rejections fail and should be withdrawn. Specifically, applicant argues
the skilled person would appreciate that Carrick describes that he is only using unmodified cellulose; thus, making it exceedingly clear that he is only using unmodified cellulose. Said argument is noted but is not persuasive as Carrick was never relied upon to teach modified cellulose. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
To the contrary, the Office proposes that one of skill in the art would modify Carrick using secondary references to change Carrick’s unmodified cellulose to dialcohol cellulose. Applicant argues said modification “expressly contradict(s) what Carrick himself has stated” in that Carrick “clearly and unequivocally discourages the use of modified cellulose.” However, it is not clear to which portion of Carrick applicant is referring; the examiner cannot find any unequivocal discouragement against the use of modified cellulose or a teaching which is expressly contradicted by the proposed modification. It is also unclear how the proposed modification “violates the clear text of Carrick.” While applicant argues the proposed modification would “form an entirely different molecular and an entirely different hollow capsule” than what is taught in Carrick, the examiner notes that there is no basis in the law for applicant’s “entirely different” standard for establishing when a modification is obvious.
Furthermore, as applicant notes, Carrick is also using carboxymethylated cellulose; carboxymethylation is a type of “modification” such that Carrick is not actually using “only” unmodified cellulose as argued by applicant. Applicant argue Carrick’s use of “only” one time in the Conclusion section of the reference is an indication the teachings of Carrick are limited to unmodified cellulose and explicitly excludes the modification proposed by the examiner. The examiner respectfully disagrees with applicant’s reading of the reference. Rather, the use of the word “only” in the conclusion section is a recap of the preparation technique disclosed in the reference, and indicates the simplicity of precipitation method, requires “only” three components: native cellulose fibers, a cellulose solvent, and an inert gas to saturate the cellulose solution.
Applicant further argues Carrick speaks of using unmodified cellulose in direct comparison to carboxymethylated cellulose and that the carboxymethylation of cellulose is used as comparative examples to evaluate swelling and shrinkage in varying pH environments (see Column 1, Page 2463). Said argument is noted but is not persuasive as said argument fails to establish that the unmodified cellulose is critical to Carrick’s invention or that a skilled artisan making the proposed modification would not have had a reasonable expectation of success.
Applicant argues Carrick explains that his technology is superior because he can achieve his goals by using unmodified cellulose, but does not provide a citation or further explanation of the teachings of Carrick. Thus, the examiner is not able to fully address applicant’s argument. Furthermore, while applicant argues the skilled person would not attempt to utilize a lesser performing comparative example in Carrick as a starting point in attempting to form the claimed invention, the proposed combination of art does not suggest using the comparative example as a starting point. Thus, applicant’s argument does not seem germane to the present rejection.
Applicant further argues unmodified cellulose is very different from modified cellulose
such that these molecules cannot simply be substituted for one another or assumed to function in
the same way; arguing they are quite different in form and function. Said argument is noted but is not persuasive as counsel’s argument cannot take the place of evidence. Applicant does not provide evidence supporting the conclusion that unmodified cellulose is very different from modified cellulose
such that these molecules cannot simply be substituted for one another or assumed to function in
the same way. To the contrary, applicant discuses cellulose spheres in the “background” section of the specification and applicant’s original claims encompassed both species; seemingly acknowledging that cellulose and dialcohol cellulose are analogous. Applicant also has not present any evidence suggesting that the proposed modification would either not have a reasonable expectation of success.
Applicant argues the proposed modification would Impermissibly change the principle of operation of Carrick. Specifically, applicant argues if the hollow capsules of unmodified cellulose of Carrick were modified as suggested by the Office, it “would impermissibly change numerous chemical and physical properties of Carrick’s technology and thus change the heart of Carrick’s technology itself.” Applicant further argues that Carrick’s unmodified cellulose technology “does not operate using the same principle of operation as modified cellulose” relative to at least chemical structure, functional groups, degree of substitution/modification, chemical properties, pH sensitivity, physical appearance, water interaction, crystallinity, and thermal stability. Applicant argues if even one of those were to change, the principle of operation of Carrick would impermissibly change. Said argument is noted but is not persuasive as counsel’s arguments cannot take the place of evidence. Applicant provides no evidence with regards to the “principle of operation” of Carrick’s invention and why it would be impermissibility changed by the proposed modification. Any modification will change the chemical/physical properties to some extent, but that is not the legal standard for determining obviousness. Applicant has failed to provide evidence supporting the conclusion the proposed modification would change the principle of operation of Carrick. Thus, applicant’s argument is not persuasive.
Applicant further argues the proposed modification would render Carrick unsatisfactory for Its intended purpose. Specifically, applicant argues the purpose of Carrick is “to use unmodified cellulose for various applications.” Applicant argues the chemical and physical differences between native cellulose, and dialcohol cellulose are such that Carrick’s evaluations could not occur if his native cellulose was changed and his intended purpose would be destroyed. Just as above, it is very clear that changing the native cellulose of Carrick into a dialcohol cellulose would change to some extent the chemical and physical properties of those molecules. But applicant has failed to provide evidence or persuasive argument suggesting the modification would render Carrick unsatisfactory for its intended purpose. Furthermore, the examiner disagrees (for the reasons noted above) with applicant that Carrick’s expressly stated goal is using “only” modified cellulose and that said goal would be destroyed,
Lead Compound Analysis
Applicant argues the Office still has to perform a lead compound analysis to show why and how the skilled person would select unmodified cellulose — expressly against the stated goals of Carrick — as a starting point for modification to form the claimed invention. Said argument is noted but is not persuasive as the proposed analysis is not germane to the present applicant. As noted by applicant, a “lead compound” analysis may be required to determine when a new chemical compound would have been prima facie obvious over particular prior art compounds. The present applicant is not analogous to the cited case law; the claimed dialcohol cellulose is a known compound. The examiner is not suggesting modifying a prior art compound to make a “new chemical compound.” Rather, the Office action proposed making a known modification to the cellulose of Carrick resulting in a known modified product.
Additional Differences Between Amended Claims and Modified Carrick
Applicant further argues no reference cited by the Office teach the newly added limitation that the spherical capsules be expandable by heating and/or by reducing the external pressure and that the hollow core includes a particular blowing agent chosen from dialkyl ethers, alkanes, halocarbons and combinations thereof. Said argument is noted but is not persuasive in view of the new grounds of rejection (necessitated by amendment).
For the reasons noted above, applicant’s arguments are not persuasive and the claims are rejected for the reasons set forth herein.
Conclusion
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 KEVIN R KRUER whose telephone number is (571)272-1510. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Callie Shosho can be reached on (571) 272-1123. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEVIN R KRUER/Primary Examiner, Art Unit 1787