Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
FINAL REJECTION
Priority
Instant application 17/512,451 filed on 10/27/2021 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 169-176 are pending.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/24/2026, 07/18/2025, 02/04/2025, 01/08/2025, 09/27/2024, 04/16/2024, 01/26/2024, 01/09/2024, 10/11/2022, 11/07/2022, 07/19/2022, 05/04/2022 and 02/10/2022 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments/Amendments
The amendment filled on 03/24/2026 has been entered.
It should be noted that applicant amended instant claims to recite a biosynthesized benzylisoquinoline alkaloid active pharmaceutical ingredient, comprising: a codeine, wherein the benzylisoquinoline alkaloid active pharmaceutical ingredient does not contain a compound selected from the group consisting of morphine, oripavine, and morphinone.
Regarding the 102 rejection of record, Applicant's arguments filed 03/24/2026 have been fully considered but they are not persuasive.
Applicant submitted “that Trost teaches production of chemical synthesis of codeine via chemical transformations performed using reagents, catalysts, and synthetic reaction steps and contains no disclosure or suggestion of biosynthetic production, pathway engineering, or microbial fermentation”.
Applicant's arguments have been fully considered but they are not persuasive because the amended claims are interpreted as product-by process claims.
The term biosynthesized is not given patentable weight because the patentability of a product does not depend on its method of production.
MPEP 2113 states: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.
Therefore the 102 rejection is maintained.
Regarding double patenting rejections, Applicant submitted that Applicant will address the double patenting rejections upon an indication that the claims are otherwise in condition for allowance. Since no arguments are present, the double patenting rejections are maintained below.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 169-176 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Trost (Barry M. Trost and Weiping Tang Journal of the American Chemical Society 2002 124 (49), 14542-14543) evidenced by Bhandari (Bhandari M, Bhandari A, Bhandari A. Recent updates on codeine. Pharm Methods. 2011 Jan;2(1):3-8. doi: 10.4103/2229-4708.81082. PMID: 23781422; PMCID: PMC3658028).
Claim Interpretation:
The amended claims recite a biosynthesized benzylisoquinoline alkaloid active pharmaceutical ingredient, comprising: a codeine, wherein the benzylisoquinoline alkaloid active pharmaceutical ingredient does not contain a compound selected from the group consisting of morphine, oripavine, and morphinone.
The term biosynthesized is not given patentable weight because the patentability of a product does not depend on its method of production.
MPEP 2113 states: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.
Trost teaches synthesis of codeine (compound 2) (see title and Figure 1).
Trost teaches bromovanillin (compound 11) and the allylic ester (compound 12) as starting materials in the synthesis of codeine (see page 14541, Scheme 1):
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Trost teaches (see Scheme 2):
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It is noted that codeine (compound 2) is separated and characterized (see supporting information page S6). Since neither morphine, oripavine nor morphinone is present during any step preceding the separation of codeine (compound 2), thus, the produced codeine (compound 2) must be free from morphine, oripavine and morphinone.
Please also note that codeine may be converted (demethylated using boron tribromide) to morphine in a separate/following reaction (see Scheme 2) but morphine is not an intermediate in the synthesis disclosed by Trost.
MPEP 2131.02 states “A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962))”.
In the instant case, a skilled artisan would at once envisioned codeine as a pharmaceutical product, because codeine is a common pharmaceutical ingredient, for example, as evidenced by Bhandari, codeine is frequently combined with acetaminophen (Tylenol) or aspirin for more effective pain relief.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 169-176 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9534241 (application 14/211,611).
Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of Patent No. 9534241 recite a method of preparing and recovering benzylisoquinoline alkaloid products, including codeine:
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The recitation of claims of the 9534241 patent meet all the limitations of instant claims, thus, the instant claims are anticipated.
Claims 169-176 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 8 of U.S. Patent Number 10017799 (Application 15/360,763).
Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of Patent No. 10017799 recite a method of preparing and recovering benzylisoquinoline alkaloid products, including codeine.
Claims 1 and 8 of the 10017799 patent recite:
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The recitation of claims of the 10017799 patent meet all the limitations of instant claims, thus the instant claims are anticipated.
Claims 169-176 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 9 of U.S. Patent Number 10858681 (application 15/978,005).
The claims of the 10858681 patent recite a medicinal product that comprises the benzylisoquinoline alkaloid product produced, codeine, from a engineered microbial cell.
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The recitation of claims of the 10858681 patent meet all the limitations of instant claims, thus the instant claims are anticipated.
Claims 169-176 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent Number 11884949 (Application 16/984,900).
The claims of Patent Number 11884949 recite alkaloid product codeine:
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The recitation of claims of the 11884949 patent meet all the limitations of instant claims, thus the instant claims are anticipated.
Claim 169-176 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 19 of copending Application No. 18/511,394. Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of copending Application No. 18/511,394 recite an engineered non-plant cell wherein the engineered non-plant cell converts a precursor of a promorphinan molecule to an alkaloid product (claim 1).
The claims of copending Application No. 18/511,394 recite codeine (claim 19):
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The recitation of claims of 18/511,394 meet all the limitations of instant claims, thus, the instant claims are anticipated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim allowed.
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 IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached on (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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/I.S./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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