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
Claims 1-20 are pending in the application. Claims 1, 4, 6, 7 and 10 are rejected. Claims 2-5, 8 and 9 are objected to. Claims 11-20 are withdrawn.
Restriction/Election of Species
Applicant's election with traverse of Group I, claims 1-10, and further elected species of “anti-inflammatory agent” in the reply filed on June 4, 2026 is acknowledged. The traversal is on the ground(s) that “the Examiner’s distribution in separate groupings is not based upon any undue searching burden, since the subject matter of the other groups must be reviewed in order to determine whether the claims are patentable...[and] searching of the additional symptoms would not impose a serious burden upon the Office...because all the claims of the groups are directed to triazelaine or its use.” See pages 2-3 of Applicant’s Remarks dated June 4, 2026. This is not found persuasive because claim 1, from which claims 2-10 are dependent therefrom, has been found to be anticipated by the prior art. See 35 U.S.C. § 102(a)(1) and 102(a)(2) rejection below. Therefore, the “subject matter of the other group[]” (i.e., Group II drawn to methods of treating an inflammatory condition of the skin) does not have to be reviewed “in order to determine whether the claims are patentable.” See page 2 of Applicant’s Remarks dated June 4, 2026. Furthermore, Applicant’s position appears to be that any search conducted by the Examiner for the Group I invention (as indicated in the Restriction Requirement mailed March 2, 2026) would necessarily require consideration of the Group II invention (also as indicated in the Restriction Requirement mailed March 2, 2026). For instance, Applicant asserts that a “search of triazelaine would necessitate a search of uses of triazelaine, including treating inflammatory conditions of the skin.” See page 2 of Applicant’s Remarks dated June 4, 2026. Applicant’s position, therefore, appears to be that the prior art is limited with respect to triazelaine to the claimed utility of Group II (i.e., methods of treating an inflammatory condition of the skin). This, however, is also not necessarily true. For example, U.S. PGPub. No. 2010/0210873 A1 (August 19, 2010) teach triazelains “as starting materials for polyester-based plasticizers, nylons, polyester starting materials, lubricating oil, and the like” (see e.g., paragraphs [0039] and [0041]– which is a distinct use from the claimed Group II invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-20 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. Applicant timely traversed the restriction (election) requirement in the reply filed on June 4, 2026.
Priority
This application is a continuation-in-part of U.S. Application No. PCT/IL2022/050777, filed on July 19, 2022, which claims benefit of Provisional Application No. 63/265,310, filed on December 13, 2021, which claims benefit of Provisional Application No. 63/223,322, filed on July 19, 2021.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on April 5, 2024 and July 7, 2025 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Specification
The substitute specification filed on April 5, 2024 is objected to.
A replacement substitute specification excluding the claims is required pursuant to 37 CFR 1.125(a) because the substitute specification, filed on April 5, 2024, does not include the following cross-reference to related applications statement included in the earlier-filed specification dated January 19, 2024:
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Applicant must file a replacement substitute specification to avoid the mailing of a PTOL-324 Notice of Non-Compliant Amendment form. See 37 CFR 1.121.
A substitute specification must not contain new matter. When appropriate, the substitute specification must be submitted with markings showing all the changes relative to the immediate prior version of the specification of record. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. An accompanying clean version (without markings) and a statement that the substitute specification contains no new matter must also be supplied. Numbering the paragraphs of the specification of record is not considered a change that must be shown.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 should be amended to replace “an antibiotics” with -an antibiotic- for sake of clarity and consistency.
Claim 3 should be amended to include the word -and- before “a sample of non-lipase probiotic microorganism” for proper Markush language.
Appropriate correction is required.
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 10 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 “wherein the biomolecule is...protein complexes” and is rejected as indefinite. It is unclear how a “biomolecule” (i.e., a singular entity) can be “protein complexes” (i.e., plural entity) at a given instant. It is suggested Applicant replace “protein complexes” with -protein complex- to overcome this issue of indefiniteness.
Claim 10 recites the limitation “range of 1% to 100%” and is rejected as indefinite. It is unclear what unit of measurement Applicant intended the claimed percentage range to be in reference to.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(1 of 2) Claims 1, 6, 7 and 10 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by CAS Registry No. 20473-92-1 (entered STN on November 16, 1984).
The prior art teaches triazelain in unbuffered water with a molar solubility of 0.000058 mol/L which reads on the limitations of instant claims 1, 6, 7 and 10. See e.g., page 3.
(2 of 2) Claims 1 and 10 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Kon et al. (U.S. PGPub. No. 2010/0210873 A1).
Kon et al. teach triazelains “as starting materials for polyester-based plasticizers, nylons, polyester starting materials, lubricating oil, and the like.” See e.g., paragraphs [0039] and [0041].
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Allowable Subject Matter
Claims 2-5, 8 and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and/or amended to overcome claim objections/35 USC 112(b) rejections as discussed above.
Conclusion
Claims 1, 4, 6, 7 and 10 are rejected. Claims 2-5, 8 and 9 are objected to. Claims 11-20 are withdrawn.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
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