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 .
Response to Amendment
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejections and/or objections made in the previous Office action and not repeated below are hereby withdrawn.
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).
Claim Rejections - 35 USC § 112
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, 2, 4, and 8 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 1 has been amended to recite a cellulose-based polymer having at least one hydroxyl group or acetyl group at the 2-, 3-, or 6-position being “directly” replaced with a positively charged compound. The generic language “directly replaced” is not found within the specification as originally filed. While the examples appear to illustrate certain positively charged compounds directly replacing hydroxyl moieties, the breadth encompassed by the claim is not seen to be supported. For instance, no instance is described where acetyl groups of cellulose polymers are “directly replaced” with a positively charged compound is described. Therefore, it is concluded claim 1 fails to comply with the written description requirement.
As claims 2, 4, and 8 depend from claim 1, they are rejected for the same issue discussed above.
Claim 2 has been amended to recite “the positively charged compound… which has a positive charge in a sample liquid containing exosomes”. The limitation at issue is not found within the specification as originally filed. Therefore, claim 2 fails to comply with the written description requirement.
Claim 2 is 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 2 indicates the positively charged compound can be a tertiary amine. However, a tertiary amine is not positively charged. The specification gives examples such as compounds of Formula (I) at ¶ 17, but the compounds therein are not positively charged. In view of the discrepancy between the express language of the claims and what is indicated by the specification, it is generally unclear what is meant or implied by replacing various groups of cellulose with a “positively charged tertiary amine compound”.
Claim 2 requires the compound have “a positive charge in a sample liquid containing exosomes”. The scope of the claim is indefinite as the particulars of the sample liquid are not defined. For instance, a tertiary amine may or may not exhibit a positive charge depending on the pH of the aqueous medium.
Response to Arguments
Applicant's arguments filed 1/28/2026 have been fully considered but they are only partially persuasive.
With respect to the 112(b) rejection pertaining to positively charged compounds, Applicant essentially argues the positively charged groups of the membranes interact with negatively charged exosomes. This is not found persuasive. The relevance of Applicant’s arguments is unclear. Claim 1 requires the membranes be a cellulose-based polymer being replaced with a positively charged compound. Thus, the positively charged compound is not a moiety/group on the membranes; it is a reactant used to create the membrane. See for instance ¶ 17 of the specification: “it is preferable to use a tertiary amine represented by the following formula (I) or a quaternary ammonium compound represented by the following formula (II) as the positively charged compound”. See also ¶ 35: “the cellulose-based porous substrate membrane is immersed in a non-dissolving solvent in the presence of an alkali, and a solution of a positively charged compound is added dropwise, followed by a reaction with heating and then quenching with alcohol”.
Applicant’s arguments with respect to Hummersone have been considered and are found persuasive. Specifically, the membranes of Hummersone are different in structure insofar as they are produced via electrospinning cellulose fibers whereas the membranes described are produced via phase separation. Therefore, the claimed specific surface areas are not seen to necessarily be present.
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 STEPHEN E RIETH whose telephone number is (571)272-6274. The examiner can normally be reached Monday - Friday, 8AM-4PM Mountain Standard Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Duane Smith can be reached at (571)272-1166. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHEN E RIETH/Primary Examiner, Art Unit 1759
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