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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election, without traverse, of Group I, claims 1-2, 5-6, 12, 14-17, 30, 32-35, 39, 99-100 and 131, in the reply filed on 08/07/2026, is acknowledged.
Claims 4, 18, 29, 101, 126-130, 132 and 135-136 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 08/07/2026.
Applicant elected the following species, without traverse:
1. Polypeptide: semaglutide.
2. Monomer: dopamine.
3. Oxygen source: urea hydrogen peroxide.
4. Permeation enhancer: bile salt, further limited to sodium glycocholate.
Claim Rejections - 35 USC § 112 –
Indefiniteness, Broad Limitation followed by
Narrow Limitation, Trademarks in the Claims and Indefinite Language
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 5-6 and 39 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 broad to narrow limitations, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claims 5-6 recite the broad recitation of the polymer precursor or the oxygen source, and the claims also recite “(polymer precursor, oxygen source, and permeation enhancer)” which are the narrower statements of the range/limitations.
The Applicant is encouraged to remove the parentheses from the claims. Recommended language (claim 5): The composition of claim 1, wherein the composition comprises an amount of polymer precursor to the composition of 40 % to 90 %. The Applicant is encouraged to apply similar language to claim 6.
In the present instance, claim 39 recites several broad to narrow limitations. For example, “palmitoyl carnitine chloride” and “(PCC)”. Please remove all parentheses from claim 39.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 39 contains the trademark/trades name Brij® and Triton. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe emulsifying, dispersing, solubilizing, detergents, dispersants and wetting agents and, accordingly, the identification/description is indefinite.
The Applicant is encouraged to remove the trademark/trades from the claim.
Regarding indefinite language, and further regarding claim 39, the phrase "etc." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The Applicant is encouraged to remove the indefinite language.
Claim Rejections - 35 USC § 103 - Obviousness
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) 1-2, 12-17, 30, 32, 33-35, 39 and 99 are rejected under 35 U.S.C. 103 as being unpatentable over Langer et al (US 2021/0177938 A1), in view of Zizzari et al (Drug Discovery Today, 26(4), 2021).
Langer taught a method of forming a polymer in situ in a subject, the method comprising administering to a subject a composition comprising a monomer and an oxygen source, wherein the monomer and the oxygen source contacted a catalyst endogenous to the subject, and the catalyst polymerized the monomer, and wherein the monomer was dopamine (e.g., about 0.001 to about 1000 mg/mL at [0086]), and the oxygen source (e.g., about 0.01 to about 100 mM at [0087]) was urea hydrogen peroxide [claim 1].
The composition, which was administered orally [claim 9, ¶s 0091, 0226-0227], further comprised an active pharmaceutical ingredient [claim 8] (e.g., synthetic polypeptides, in general, at [0151]), for treating type 2 diabetes mellitus [0141], or obesity [claim 48]. One or more additional pharmaceutical agents was also taught [0229].
Although Langer generally taught polypeptides, Langer did not specifically teach semaglutide, as instantly elected. Additionally, Langer did not teach bile salts, as instantly elected.
Zizzari taught semaglutide as an FDA approved oral peptide against type 2 diabetes mellitus [page 1097, left column, 2nd paragraph], where bile salts, as permeation enhancers, are successfully used for the oral delivery of peptides [Figure 2, schematic and legend].
Since Langer generally taught polypeptides as actives, as well as the treatment of type 2 diabetes mellitus, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Langer, semaglutide, as taught by Zizzari. The ordinarily skilled artisan would have been motivated to include an FDA approved oral peptide against type 2 diabetes mellitus, as taught by Zizzari [page 1097, left column, 2nd paragraph]. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, it is prima facie obvious to select semaglutide for incorporation into a composition, based on its recognized suitability for its intended use as an oral peptide for treating diabetes, as taught by Zizzari et al.
Furthermore, the ordinarily skilled artisan would have been motivated to include Zizzari’s bile salts within Langer, because bile salts, as permeation enhancers, are successfully used for the oral delivery of peptides, as taught by Zizzari [Figure 2, schematic and legend].
Langer, in view of Zizzari, reads on claims 1-2, 12-17, 30, 32, 33-35, 39 and 99.
Claims 5-6 are rendered prima facie obvious because Langer taught administering to a subject, an effective amount of a composition comprising a monomer and an oxygen source [0219], wherein an “effective amount” referred to an amount, disclosed as variable, and sufficient to elicit the desired biological response [0061].
Given that Langer taught about 0.001 to about 1000 mg/mL of the monomer (e.g., polymer precursor) and about 0.01 to about 100 mM of the oxygen source, it would be prima facie obvious to one of ordinary skill in the art to mathematically determine a range of the polymer precursor and oxygen source, that falls within the claimed range. The ordinarily skilled artisan would be motivated to design an optimal experiment, guided by Langer’s disclosure that amounts of the composition are variable, up to an effective amount, where an effective amount, of each of the monomer and the oxygen source, is sufficient to elicit the desired biological response.
Claim 100 is rejected under 35 U.S.C. 103 as being unpatentable over Langer et al (US 2021/0177938 A1), in view of Zizzari et al (Drug Discovery Today, 26(4), 2021) and further in view of Moghimipour et al (Molecules, 20(8), 2015, 14451-14473).
The 35 U.S.C. 103 rejection over Langer, in view of Zizzari, was previously discussed.
Additionally, Zizzari taught bile salts, as permeation enhancers, as previously discussed.
The combined teachings of Langer and Zizzari did not teach sodium glycocholate, as instantly elected, and as further recited in claim 100.
Moghimipour taught sodium glycocholate as a bile salt [Table 3].
It is prima facie obvious to select sodium glycocholate for incorporation into a composition, based on its recognized suitability for its intended use as a bile salt, as taught by Moghimipour.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612
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