DETAILED CORRESPONDENCE
Status of the Application
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 17, 2026 has been entered.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 69-73, 75-82, and 86-92 are pending in the application.
Applicant’s amendment to the claims, filed July 17, 2026, is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Applicant’s amendment to the specification, filed July 17, 2026, is acknowledged.
Applicant’s remarks filed July 17, 2026 in response to the final rejection filed January 20, 2026 are acknowledged and have been fully considered.
Restriction/Election
In response to a requirement for restriction/election filed December 20, 2024, applicant elected without traverse the invention of Group II, corresponding to pending claims 73 and 88-92, and the species of SEQ ID NO: 18 in the reply filed June 25, 2025. is acknowledged.
Claims 69-72, 75-82, 86, and 87 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 73 and 88-92 are being examined on the merits.
Priority
This application is filed under 35 U.S.C. 121 as a divisional application of non-provisional application no. 16/770,207, filed on June 5, 2020, which issued as U.S. Patent No. 11,560,578, which is filed under 35 U.S.C. 371 as a national stage of international application PCT/CA2018/051520, filed on November 29, 2018, which claims domestic priority under 35 U.S.C. 119(e) to provisional application nos. 62/594,854 and 62/686,337, filed on December 5, 2017 and June 18, 2018, respectively.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/594,854, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) for one or more claims of this application.
Regarding claims 73 and 88-91, the provisional application 62/594,854 fails to provide adequate descriptive support for the limitation “SEQ ID NO: 54.”
Regarding claims 73 and 89, the provisional application 62/594,854 fails to provide adequate descriptive support for the limitations “at least 80% identity” and “at least 90% identity.”
The effective filing date for claims 73 and 88-92 is June 8, 2018.
Specification/Informalities
The objection to the specification is withdrawn in view of applicant’s amendment to disclose the size of the XML file in bytes.
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.
Claims 73 and 88-92 are rejected under 35 U.S.C. 112(a) 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 at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
MPEP § 2163.II.A.3.(b) states, “when filing an amendment an applicant should show support in the original disclosure for new or amended claims”. See also MPEP 714.02. MPEP § 2163.II.A.3.(b) further states, “[i]f the originally filed disclosure does not provide support for each claim limitation, or if an element which applicant describes as essential or critical is not claimed, a new or amended claim must be rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, para. 1, as lacking adequate written description”. According to MPEP § 2163.I.B, “While there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure” and “The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117.”
Claim 73 (claims 88-92 dependent therefrom) recites “an amino acid sequence having at least 80% identity to SEQ ID NO: 54” and claim 89 recites an amino acid sequence having at least 90% identity to SEQ ID NO: 54. Applicant cites to paragraphs [0209] and [0224] of the published application (corresponding to paragraphs [0142] and [0157] of the substitute specification filed July 17, 2026) for descriptive support for the noted limitations. The cited support fails to disclose 80% and 90% identity. Applicant is invited to show support for the limitations at issue. In the absence of descriptive support, the noted limitations in claims 73 and 89 introduce new matter into the claims.
RESPONSE TO REMARKS: Applicant argues that since 80% identity falls within the disclosed range of amino acid identity thresholds, the recitation of “an amino acid sequence having at least 80% identity to SEQ ID NO: 54” is supported by the specification.
Applicant’s arguments are not found persuasive. There appears to be no dispute that the specification fails to explicitly provide descriptive support for “at least 80% identity.” Rather, applicant appears to take the position that in view of the disclosed range of “at least 70% identical,” descriptive support for the range of “at least 80% identity” would have been obvious to one of skill in the art. However, one shows that one is “in possession” of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious. Put another way, obviousness is not the standard for satisfying the written description requirement of 35 U.S.C. 112(a). See Lockwood v. American Airlines Inc., 41 USPQ2d 1961 (Fed. Cir. 1997).
Claim Rejections - 35 USC § 102/103
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claims 73 and 88-92 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Facchini et al. (WO 2018/005553 A1; cited on the IDS filed on December 22, 2022; hereafter “Facchini”).
Applicant’s attention is directed to MPEP 2112.III regarding a rejection under 5 U.S.C. 102/103 when the prior art product seems to be identical except that the prior art is silent as to an inherent characteristic.
As amended, claims 73 and 88-91 are drawn to a recombinant polypeptide consisting of an amino acid sequence having at least 80%, 85%, 90%, 95%, or 100% identity to SEQ ID NO: 54, wherein the polypeptide exhibits neopinone isomerase activity, and wherein the polypeptide does not comprise the full-length amino acid sequence of SEQ ID NO: 2.
Claim 92 is drawn to the polypeptide of claim 73, wherein the polypeptide is an isolated polypeptide.
Regarding claims 73 and 88-91, Facchini teaches a thebaine synthesis polypeptide having the sequence of SEQ ID NO: 5 (paragraph [0226]). SEQ ID NO: 5 of Facchini consists of SEQ ID NO: 54 of this application. Facchini teaches a method for recombinantly preparing the thebaine synthesis polypeptide (paragraphs [0121] to [0124]; sentence bridging pp. 52-53).
Facchini does not teach or suggest the thebaine synthesis polypeptide exhibits neopinone isomerase activity. However, according to MPEP 2112.01.I, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed by be inherent, and according to MPEP 2112.01.II, a chemical composition and its properties are inseparable, therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In accordance with MPEP 2112.01, since the sequence of the thebaine synthesis polypeptide of Facchini consists of SEQ ID NO: 54 of this application, the thebaine synthesis polypeptide of Facchini necessarily exhibits neopinone isomerase activity. Since the Office does not have the facilities for examining and comparing applicants’ recombinant polypeptide with the recombinant polypeptide of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed recombinant polypeptide and the recombinant polypeptide of the prior art (i.e., that the recombinant polypeptide of the prior art does not possess the same material structural and functional characteristics of the claimed recombinant polypeptide). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Regarding claim 92, Facchini teaches the thebaine synthesis polypeptide is isolated (paragraph [0195]).
Therefore, Facchini anticipates or, in the alternative, renders obvious the recombinant polypeptide of claims 73 and 88-92.
Claims 73 and 88-92 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Chen et al. (Nature Chemical Biology 14:738-743, May 2018; cited on Form PTO-892 filed July 9, 2025; hereafter “Chen”) as evidenced by Supplementary Information (May 2018, 46 pages; cited on Form PTO-892 filed July 9, 2025; hereafter “Supplementary Information”).
Applicant’s attention is directed to MPEP 2112.III regarding a rejection under 5 U.S.C. 102/103 when the prior art product seems to be identical except that the prior art is silent as to an inherent characteristic.
Regarding claims 73 and 88-92, Chen teaches a purified polypeptide referred to as “PR10-3” (p. 740, Fig. 3). Evidentiary reference Supplementary Information is cited in accordance with MPEP 21313.01.III to show that the amino acid sequence of PR10-3 (p. 8, Supplementary Figure 6) consists of SEQ ID NO: 54 of this application.
Chen does not teach PR10-3 is “recombinant.” However, the recitation of “recombinant” in claims 73 and 88-92 does not structurally and/or functionally distinguish the claimed polypeptide from PR10-3 of Chen.
Chen does not teach or suggest PR10-3 exhibits neopinone isomerase activity. However, according to MPEP 2112.01.I, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed by be inherent, and according to MPEP 2112.01.II, a chemical composition and its properties are inseparable, therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In accordance with MPEP 2112.01, since the sequence of PR10-3 consists of SEQ ID NO: 54 of this application, PR10-3 of Chen necessarily exhibits neopinone isomerase activity. Since the Office does not have the facilities for examining and comparing applicants’ recombinant polypeptide with the recombinant polypeptide of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed recombinant polypeptide and the recombinant polypeptide of the prior art (i.e., that the recombinant polypeptide of the prior art does not possess the same material structural and functional characteristics of the claimed recombinant polypeptide). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Therefore, Chen anticipates or, in the alternative, renders obvious the recombinant polypeptide of claims 73 and 88-92.
Claims 73 and 88-92 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Enquist-Newman et al. (WO 2019/051046 A1 with priority to September 8, 2017; cited on Form PTO-892 filed July 9, 2025; hereafter “Enquist-Newman”).
Applicant’s attention is directed to MPEP 2112.III regarding a rejection under 5 U.S.C. 102/103 when the prior art product seems to be identical except that the prior art is silent as to an inherent characteristic.
Regarding claims 73 and 88-92, Enquist-Newman teaches a thebaine synthase polypeptide comprising SEQ ID NO: 51 (paragraph [00094]). SEQ ID NO: 51 of Enquist-Newman consists of SEQ ID NO: 54 of this application. Enquist-Newman teaches the enzyme is recombinant to the cell and isolated (paragraph [000168]).
Enquist-Newman does not teach or suggest the thebaine synthase polypeptide exhibits neopinone isomerase activity. However, according to MPEP 2112.01.I, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed by be inherent, and according to MPEP 2112.01.II, a chemical composition and its properties are inseparable, therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In accordance with MPEP 2112.01, since the sequence of the thebaine synthase polypeptide of Enquist-Newman consists of SEQ ID NO: 54 of this application, the thebaine synthase polypeptide of Enquist-Newman necessarily exhibits neopinone isomerase activity. Since the Office does not have the facilities for examining and comparing applicants’ recombinant polypeptide with the recombinant polypeptide of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed recombinant polypeptide and the recombinant polypeptide of the prior art (i.e., that the recombinant polypeptide of the prior art does not possess the same material structural and functional characteristics of the claimed recombinant polypeptide). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Therefore, Enquist-Newman anticipates or, in the alternative, renders obvious the recombinant polypeptide of claims 73 and 88-92.
RESPONSE TO REMARKS: Applicant argues neopinone isomerase activity is not necessarily an inherent characteristic and the presumption that the prior art polypeptides exhibit neopinone isomerase activity is rebutted by the failure of the prior art to observe this activity.
Applicant’s arguments are not found persuasive. Regarding applicant’s argument that neopinone isomerase activity is not necessarily an inherent characteristic, as previously stated, according to MPEP 2112.01.I, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed by be inherent, and according to MPEP 2112.01.II, a chemical composition and its properties are inseparable, therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In accordance with MPEP 2112.01, since the sequences of the polypeptides of the cited prior art each consists of SEQ ID NO: 54 of this application, each the polypeptides of the cited prior art necessarily exhibits neopinone isomerase activity. Since the Office does not have the facilities for examining and comparing applicants’ recombinant polypeptide with the recombinant polypeptide of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed recombinant polypeptide and the recombinant polypeptide of the prior art (i.e., that the recombinant polypeptide of the prior art does not possess the same material structural and functional characteristics of the claimed recombinant polypeptide). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Regarding applicant’s argument that the presumption that the prior art polypeptides exhibit neopinone isomerase activity is rebutted by the failure of the prior art to observe this activity, according to MPEP 2112.II, there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference and in view of the preponderance of the evidence, each the polypeptides of the cited prior art necessarily exhibits neopinone isomerase activity.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 73 and 88-92 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Applicant’s attention is directed to the "Guidance for Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products”, released on December 16, 2014. This rejection has been modified from its previous version to address applicant’s claim amendment.
Claim Interpretation: As amended, claims 73 and 88-91 are drawn to a recombinant polypeptide consisting of an amino acid sequence having at least 80%, 85%, 90%, 95%, or 100% identity to SEQ ID NO: 54, wherein the polypeptide exhibits neopinone isomerase activity, and wherein the polypeptide does not comprise the full-length amino acid sequence of SEQ ID NO: 2.
Claim 92 is drawn to the polypeptide of claim 73, wherein the polypeptide is an isolated polypeptide.
For reasons set forth above in the rejections under 35 U.S.C. 102/103, each of Facchini, Chen, and Enquist-Newman teaches a naturally-occurring polypeptide consisting of the amino acid sequence of instant SEQ ID NO: 54.
Patent Eligibility Analysis Step 1: The claims are drawn to a polypeptide, which is a composition of matter and is one of the statutory categories of invention.
Patent Eligibility Analysis Step 2A Prong 1: Claims 73 and 88-92 recite “recombinant” and claim 92 recites “isolated.” However, there is no evidence of record that polypeptides encompassed by claims 73 and 88-92 have markedly different characteristics from their naturally-occurring counterparts.
Patent Eligibility Analysis Step 2A Prong 2: There are no additional elements recited in the claims beyond the judicial exception.
Patent Eligibility Analysis Step 2B: The claims only recite a law of nature and do not include any additional elements that could add significantly more to the judicial exception.
As such, the claims do not qualify as eligible subject matter. For these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter.
RESPONSE TO REMARKS: Applicant argues the rejection is obviated by amendment to recite “recombinant” in claims 73 and 88-92 and to exclude the full-length sequence of SEQ ID NO: 2. According to applicant, since recombinant polypeptides are man-made and not naturally-occurring, the rejection should be withdrawn.
Applicant’s arguments are not found persuasive. As previously stated, there is no evidence of record that polypeptides encompassed by claims 73 and 88-92 have markedly different characteristics from their naturally-occurring counterparts and for the reasons set forth above, the claims do not qualify as eligible subject matter.
Claim Rejections - 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 73 and 88-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 11,142,780 B2 (cited on the IDS filed December 22, 2022).
Claim 7 of the patent recites a heterologous comprising an amino acid sequence that is at least 95% sequence identical to any one of SEQ ID NO: 5.
Claim 7 of the patent does not recite the thebaine synthesis polypeptide is “recombinant.” However, the recitation of “recombinant” in claims 73 and 88-92 of this application does not structurally and/or functionally distinguish the claimed polypeptide from the thebaine synthesis polypeptide recited in claim 7 of the patent.
Claim 7 of the patent does not recite the thebaine synthesis polypeptide exhibits neopinone isomerase activity. However, according to MPEP 2112.01.I, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed by be inherent, and according to MPEP 2112.01.II, a chemical composition and its properties are inseparable, therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In accordance with MPEP 2112.01, since the sequence of the thebaine synthase polypeptide of the patent encompasses a polypeptide that consists of SEQ ID NO: 54 of this application, the thebaine synthase polypeptide of the patent necessarily exhibits neopinone isomerase activity. Since the Office does not have the facilities for examining and comparing applicants’ recombinant polypeptide with the polypeptide of the patent, the burden is on the applicant to show a novel or unobvious difference between the claimed recombinant polypeptide and the polypeptide of the patent (i.e., that the polypeptide of the patent does not possess the same material structural and functional characteristics of the claimed recombinant polypeptide). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Claims 73 and 88-92 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 42 of co-pending application no. 19/186,191 (reference application).
Claim 42 of the reference application recites a method of making a BIA outside of a cell comprising,
contacting a substrate that is capable of being converted by one or more enzymes, wherein the one or more enzymes comprise a tyrosine hydroxylase (TYR); DOPA decarboxylase (DODC); norcoclaurine synthase (NCS); 6-O-Methyltransferase (6OMT); coclaurine N-methyltransferase (CNMT), cytochrome P450 N- methylcoclaurine hydroxylase (NMCH), and 4-O-methyltransferase (4OMT); cytochrome P450 reductase (CPR), salutaridine synthase (SAS); salutaridine reductase (SalR ); salutaridinol-7-O-acetyltransferase (SalAT); purine permease (PUP); or any combination thereof;
contacting the product of a) with one or more of a thebaine synthesis polypeptide; a codeine O-demethylase (CODM); a thebaine 6-O-demethylase (T6ODM); a codeinone reductase (COR); or any combination thereof.
According to MPEP 804.II.B.1, the portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim and in view of the specification at paragraph [000226] of the reference application, SEQ ID NO: 5 of the reference application is within the scope of the recited thebaine synthesis polypeptide of claim 42. SEQ ID NO: 5 of the reference application consists of SEQ ID NO: 54 of this application.
Claim 42 of the reference application does not recite the thebaine synthesis polypeptide is “recombinant.” However, the recitation of “recombinant” in claims 73 and 88-92 does not structurally and/or functionally distinguish the claimed polypeptide from the thebaine synthesis polypeptide recited in claim 42 of the reference application.
Claim 42 of the reference application does not recite the thebaine synthesis polypeptide exhibits neopinone isomerase activity. However, according to MPEP 2112.01.I, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed by be inherent, and according to MPEP 2112.01.II, a chemical composition and its properties are inseparable, therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In accordance with MPEP 2112.01, since the sequence of the thebaine synthase polypeptide of the reference application consists of SEQ ID NO: 54 of this application, the thebaine synthase polypeptide of the reference application necessarily exhibits neopinone isomerase activity. Since the Office does not have the facilities for examining and comparing applicants’ recombinant polypeptide with the polypeptide of the reference application, the burden is on the applicant to show a novel or unobvious difference between the claimed recombinant polypeptide and the polypeptide of the reference application (i.e., that the polypeptide of the reference application does not possess the same material structural and functional characteristics of the claimed recombinant polypeptide). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Therefore, claims 73 and 88-92 of this application are unpatentable over claim 42 of the reference application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
RESPONSE TO REMARKS: Applicant will address the obviousness double patenting rejection, to the extent necessary, upon an indication that the claims are otherwise in condition for allowance. Applicant’s remarks regarding the obviousness-type double patenting rejection are acknowledged.
Conclusion
Status of the claims:
Claims 69-73, 75-82, and 86-92 are pending.
Claims 69-72, 75-82, 86, and 87 are withdrawn.
Claims 73 and 88-92 are rejected.
No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID J STEADMAN whose telephone number is (571)272-0942. The examiner can normally be reached Monday to Friday, 7:30 AM to 4:00 PM.
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/David Steadman/Primary Examiner, Art Unit 1656
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