Detailed Action
The present office action is in response to the remarks filed on 30 Mar 2026.
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 .
Status
Claims 1, 3, 6-7, and 11 of the pending application have been examined on the merits. Claims 12-13, 15-17, 21, and 23-26 are withdrawn (see “Response to Applicant Election” below). Acknowledgement is made of the amendments filed 30 Mar 2026. Acknowledgement is made of the cancellation of claims 2, 4-5, 8-10, 14, 18-20, and 22.
Priority
Applicants identify the instant application, Serial #: 18/569,813, filed 13 Dec 2023, as a National Stage Entry of International Patent Application #: PCT/EP2022/066235, filed 14 Jun 2022, which claims foreign priority from Foreign Application #s: EP21179336.9, filed 14 Jun 2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 13 Dec 2023 and 19 Sep 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Response to Applicant Election
Applicant’s election without traverse of Group I in the reply filed on 30 Mar 2026 is acknowledged. The restriction requirement mailed 10 Feb 2026 required the election of a first local anesthetic. However, the claim amendments filed 30 Mar 2026 have narrowed the first local anesthetic to lidocaine and so the election requirement is withdrawn.
Claims 12-13, 15-17, 21, and 23-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 30 Mar 2026.
Claim Interpretation
Instant claim 1 recites the following, “A pharmaceutical composition for use in the treatment of pain or prophylaxis of algophobia or odontophobia in a patient…” The phrase, “for use in the treatment of pain or prophylaxis of algophobia or odontophobia in a patient” is an intended use. MPEP § 2111.02(II) says that if the “preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” Because the above phrase of the preamble of claim 1 is an intended use, it has no significance to claim construction and is not considered a limitation to the claims.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”. Currently, the instant specification provides nucleotide sequences without proper sequence listing on pg. 12, lines 28-29.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Currently there is browser executable code on pg. 2, line 36 of the specification.
Claim Objections
Claims 1 and 7 are objected to because of the following informalities: The provided amendments of claims 1 and 7 are of low-resolution verging on illegible. Applicant is respectfully asked to submit a corrected copy of the claim amendments in black and white to ensure the claims are legible. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1, 3, 6-7, and 11 is/are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Cook et al. (J Endod, 2018, 44:683-688; provided in IDS 12/13/23), hereinafter Cook.
The elected claims are directed to a pharmaceutical composition comprising a combination of a first and second local anesthetic and optionally pharmaceutically acceptable excipients, where the first local anesthetic is lidocaine and the second local anesthetic is prilocaine (claim 1). The instant claims further narrow the composition to be for an injection (claim 3) and further include a vasoconstrictor (claim 6) selected from epinephrine and felypressin (claim 7). The claims include the limitation where the local anesthetics are comprised in separate containers (claim 11).
Cook teaches a combination of 4% prilocaine and 2% lidocaine with 1:100,000 epinephrine (Abstract). These formulations were administered as injections and provided in separate containers to decrease pain in a subject (pg. 683, column 2). By teaching a method of administering a combination of prilocaine and lidocaine with epinephrine, Cook necessarily shows possession of a composition of a first and second local anesthetic of prilocaine and lidocaine with epinephrine for injection in separate containers.
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 6-7, and 11 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Meechan et al. (Anesth Prog, 1992, 39:9-12).
Meechan teaches treating ten patients with a 2% lidocaine with 1:80,000 epinephrine injection and treating ten patients with a 3% prilocaine with 0.03 IU/mL felypressin injection as a local anesthetic for those undergoing oral surgery under midazolam sedation (pg. 9, column 1). Meechan teaches that both injections are known anesthetics used in oral surgery (pg. 9, column 2 to pg. 10, column 1). However, Meechan does not teach a combination of the local anesthetics as a pharmaceutical composition.
Based on the teachings of Meechan, it would be prima facie obvious to one having ordinary skill in the art to combine the composition of 2% lidocaine with 1:80,000 epinephrine injection with the composition of 3% prilocaine with 0.03 IU/mL felypressin injection to create a third composition as a local anesthetic for oral surgery with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gazal (Saudi Med J, 2019, 40:97-100) is considered pertinent for teaching a clinical study comparing the anesthetic effect of 2% lidocaine with 1:100,000 adrenaline with 3% prilocaine and felypressin 0.03 IU/mL for upper teeth extractions. Yamashita et al. (J Oral Maxillofac Surg, 2019, 78:215.e1-215.e8) is considered pertinent for teaching local anesthetic preparations of lidocaine-epinephrine and prilocaine-felypressin.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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