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
This office action is a response to Applicant’s amendments/remarks after non-final rejection filed 3/10/2026.
As filed, claims 1-28 are pending.
Drawings
The objection to the drawings of Figs. 27, 30, 31, 37, 61, 64, 67, and 70 is maintained because the Applicant’s remarks regarding the drawings are not persuasive. The texts and numbering of the abovementioned Figs. remained blurry and/or illegible.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/3/2025 has been considered by the Examiner.
Response to Amendments/Remarks
Applicant’s amendments/remarks, filed 3/10/2026, with respect to claims 1-28, have been fully considered and are entered. The status for each rejection in the previous Office Action is set out below.
The § 112(b) indefinite rejection of claims 1-27 is withdrawn per amendments/remarks.
The § 112(b) indefinite rejection of claim 28 is maintained because the phrase, “the sequestered anions(s)”, still lack antecedent basis.
Claim Rejections - 35 USC § 112(a)
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 5 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant’s amendment with respect to amended claims 5 and 8 herein has been fully considered but is deemed to insert new matter into the claim since the specification as originally filed does not provide support for the newly added limitations of “-CH2O(CH2)7CH3”; “ -CH2OR’’’ ”; and “ -CH2OR’ ”, for instant variable R, as instantly claimed.
The instant specification and the originally filed claim (i.e. filed 3/10/2023) only provide support for the following:
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100
626
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(paragraph 0008)
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226
670
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(paragraph 0138)
Accordingly, “-CH2O(CH2)7CH3”; “ -CH2OR’’’ ”; and “ -CH2OR’ ”, for instant variable R are considered new matter.
Adequate written description means that, in the specification, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 [19 USPQ2d 1111] (Fed. Cir. 1991).
See MPEP 2163 regarding the guidelines for the written description requirement: "The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981).
See MPEP § 2163.06 through § 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The claims as filed in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).”
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 1-5 and 10-28 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 claims 1 and 2, the claims recite the phrase, “the linked benzamide groups define a backbone”, wherein the word, “the”, requires antecedent basis, and it is unclear where structure I, when n=0, has “a” linked benzamide group. Without antecedent basis, the claims are rendered indefinite.
Regarding claims 3-5 and 10-28, the claims are directly or indirectly dependent of claim 1, and they failed to correct the indefiniteness issue of claim 1, which rendered these claims indefinite.
Regarding claim 28, the claim is dependent of claim 23, and recites the phrase, “the sequestered anions(s)”, wherein the word, “the”, requires antecedent basis, and it is unclear where applicant has defined “a” sequestered anions. Without antecedent basis, the claim is rendered indefinite.
Claim Objections
Claims 1 and 23 are objected to because of the following informalities:
Regarding claim 1, the claim recites the following structure I:
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194
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The R’, as shown in the box above, needs to be further away from the bond. At this time, it can look like variable R.
Regarding claim 23, the claim recites the phrase, “affecting a physiological gradient comprising”.
Such expression can be clarified by reciting -- affecting a physiological gradient of anion concentration comprising --.
Appropriate correction is required.
Allowable Subject Matter
Claims 6, 7, and 9 are objected to as being dependent upon a rejected and objected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, as well as the objection of the base claim is corrected.
Conclusion
Claims 1-5, 8, and 10-28 are rejected.
Claims 1, 6, 7, 9, and 23 are objected.
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.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
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