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 .
Status of the Application
1. Claims 1-18 are pending and subject to examination on the merits. Claims 1-2 and 14-18 are withdrawn from consideration as being drawn to non-elected subject matter. Claims 3-13 are currently under examination.
Election/Restrictions
2. Applicant's election with traverse of Group II, claims 3-13, in the reply filed on 07 May 2026 is acknowledged. The traversal is on the ground(s) that “Groups II and II require the yeast cell of claim 3.” This seems to be an apparent typographical error and was meant to be Groups II and III. Nonetheless, this is not found persuasive because although the two groups may utilize the same yeast, the breaking of unity is across all three groups based on the presence of the shared technical feature not making a contribution over the prior art. Specifically, unity was broken based on the shared Z13-fatty-alcohol, where the prior art applied was Borodina et al (Borodina et al., 2020, WO 2020/169389 A1—cited on the IDS dated 06 March 2024), which teaches pheromone production utilizing recombinant yeast expressing a desaturase to introduce at least one double bond, acyl-CoA-reductase to convert fatty acyl CoA to fatty alcohol and the production of ΔZ11, Δ13-16:OH in yeast utilizing the ΔZ11-16 desaturase from A. transitella, ΔZ13-16 desaturase from T. pityocampa, and a fatty acyl-CoA reductase from H. armigera (abstract; p. 135, Example 19).
The requirement is still deemed proper and is therefore made FINAL.
Priority
3. Acknowledgement is made of applicant’s claim for foreign priority based on an application filed in EP (EP21183459.3 and EP22161120.5) on 02 July 2021 and 09 March 2022, respectively. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
4. The information disclosure statements (IDS) submitted on 06 March 2024 have been considered by the examiner. See initialed and signed PTO/SB/08’s.
Drawings
5. The drawings are objected to because Fig. 2A-E are lacking x- and y-axis labels and units, Fig. 3A-C are missing a y-axis labels and units, and 4A-C are missing a y-axis labels and units. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
6. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (p. 11, line 27; p. 132, line 11). 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.
7. The use of the term GeneArt™ (p. 104, line 4), Phusion™ (p. 104, line 6), FastDigest™ (p. 104, line 13; p. 109, line 8), Nucleospin™ (p. 104, line 17), ChemStation™ (p. 114, line 6), MassHunter™ (p. 115, line 3) which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
8. Claims 6 (part iii) and 7 (parts ii and iii) are objected to because of the following informalities: periods in claims “(i.e.)” are not permitted except at the end of the claim and when used for abbreviations (See MPEP 608.01(m)). Thus, it is suggested to replace, for example, “a.” with “(a)” or “a)”, etc. and “i.” with “(i)” or “i)”, etc. It is noted, the preferred format for sequence identifiers is “SEQ ID NO:” – see MPEP 2422.01 and 37 C.F.R. 1821(c) and (d).
Appropriate corrections are required.
FOR SEQ ID NO: - – See MPEP 2422.01 and 37 C.F.R. 1.821(c) and (d)
Claim Interpretation
9. For examination purposes, the phrases following “optionally,” “i.e.,” and “preferably” are not treated as claim limitations. “Optionally,” while is not indefinite, allows the examiner to “opt” not to utilize that limitation in prior art rejections. Additionally, the phrases “i.e.” and “preferably” are indefinite (as explained in the 35 U.S.C. 112(b) rejections below) and will also not be treated as a claim limitation. This is applicable to claims 4, 6-7, and 9-12.
Claim Rejections - 35 USC § 112(a)
10. 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Written Description:
11. Claims 3-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a yeast cell capable of producing a desaturated fatty acyl-coenzyme A (fatty acyl-CoA) having n' double bond(s), wherein at least one of said double bond(s) is at position 13, wherein said yeast cell expresses a heterologous Δ13 fatty acyl-CoA desaturase, said desaturase being capable of introducing a double bond at position 13 in a saturated fatty acyl-CoA or a desaturated fatty acyl-CoA having a carbon chain consisting solely of single and double bonds, preferably a desaturated fatty acyl-CoA, wherein said fatty acyl-CoA has a carbon chain length of at least 15 (claim 6) and has n double bond(s), wherein n and n' are integers, wherein 0 < n < 3 and wherein 2 < n' <4 (claims 7-8), wherein the desaturase may be any functional homolog with 70% or more sequence identity to SEQ ID NOs: 1 or 56 (claims 4-5) or SEQ ID NOs: 3, 5, 7, 9, 11, 31, 33, 29, 51, 59, 61, 63, 65, 67, 69, 71 (claim 10), and wherein the cell may further express a FAR selected from SEQ ID NOs: 13, 15, 19, 21, 45, 35, 37, 41, 39, 43, 73, 75, 77, 79, 81, 83, 85, 87, 89, 91, 93, 95, 97, 99, 101, 103, 107, 109, 111, 113, 115, 117, 119, 121, 123, 125, 127, 129, 131 or a homolog with at least 70% sequence identity thereof (claim 11).
MPEP 2163(1):
35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en bane); Vas-Gath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111, 1114 (Fed. Cir. 1991); see also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing the history and purpose of the written description requirement); In re Curtis, 354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a claim's enablement is not equally conclusive of that claim's satisfactory written description"). The written description requirement has several policy objectives. "[T]he 'essential goal' of the description of the invention requirement is to clearly convey the information that an applicant [inventor] has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). "The 'written description' requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee [inventor] was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent's term.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Gath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings.
12. The claims are drawn to a yeast cell capable of producing a desaturated fatty acyl-coenzyme A (fatty acyl-CoA) having n' double bond(s), wherein at least one of said double bond(s) is at position 13, wherein said yeast cell expresses a heterologous Δ13 fatty acyl-CoA desaturase, said desaturase being capable of introducing a double bond at position 13 in a saturated fatty acyl-CoA or a desaturated fatty acyl-CoA having a carbon chain consisting solely of single and double bonds, preferably a desaturated fatty acyl-CoA, wherein said fatty acyl-CoA has a carbon chain length of at least 15 (claim 6) and has n double bond(s), wherein n and n' are integers, wherein 0 < n < 3 and wherein 2 < n' <4 (claims 7-8), wherein the desaturase may be any functional homolog with 70% or more sequence identity to SEQ ID NOs: 1 or 56 (claims 4-5) or SEQ ID NOs: 3, 5, 7, 9, 11, 31, 33, 29, 51, 59, 61, 63, 65, 67, 69, 71 (claim 10), and wherein the cell may further express a FAR selected from SEQ ID NOs: 13, 15, 19, 21, 45, 35, 37, 41, 39, 43, 73, 75, 77, 79, 81, 83, 85, 87, 89, 91, 93, 95, 97, 99, 101, 103, 107, 109, 111, 113, 115, 117, 119, 121, 123, 125, 127, 129, 131 or a homolog with at least 70% sequence identity thereof (claim 11). The variability in the sequences, host cells, and multiple expression of different polypeptides is enormous. The specification does not describe all of the sequences that could possibly qualify as a homolog of the listed sequences, and so, the sequences listed, although represents a lot of sequences, are a representative number of sequences from specific insect desaturases and later, reductases. The recitation of these sequences is not representative for all other reductases and desaturases that could possibly match the recited low sequence identity. Additionally, how an enzyme works in a different cell system from its natural host is difficult to predict, and again, with the enormous number of sequences that could make up the claimed invention, one skilled in the art would not be able to accurately determine all of the sequences that are inclusive to the invention. Here the specification is incomplete and it mandates that those skilled in the art must then figure out how to use the aimed invention. Thus, the claims do not find adequate support in any place in the specification to show that possession of methods for treating or preventing immune dysregulation diseases with cell envelope proteases (CEP's) lacking PA domains in Groups VII-XIII. The courts have established:
Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir. 2013):
A patent, however, "is not a reward for the search, but compensation for its successful conclusion." Ariad, 598 F.3d at 1353 (quoting University of Rochester, 358 F.3d at 930 n.10). For that reason, the written description requirement prohibits a patentee from "leaving it to the ... industry to complete an ufinished invention.” Id.
Enablement:
13. Claims 3-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for fourteen Z11 desaturases in the production of Z11-13-16:Me co-expressed with one Z13 desaturase, AtrAATO (SEQ ID NO: 1) from Amyelois transitelia, in the yeast, Yarrowia lipolytica (Example 8), and enabling for 38 FAR proteins co-expressed in a Yarrowia lipolytica expressing SEQ ID NOs: 1 and 31 (Example 9). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims without significant undue experimentation.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states:
"Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The claims in their broadest are drawn to a yeast cell capable of producing a desaturated fatty acyl-coenzyme A (fatty acyl-CoA) having n' double bond(s), wherein at least one of said double bond(s) is at position 13, wherein said yeast cell expresses a heterologous Δ13 fatty acyl-CoA desaturase, said desaturase being capable of introducing a double bond at position 13 in a saturated fatty acyl-CoA or a desaturated fatty acyl-CoA having a carbon chain consisting solely of single and double bonds, preferably a desaturated fatty acyl-CoA, wherein said fatty acyl-CoA has a carbon chain length of at least 15 (claim 6) and has n double bond(s), wherein n and n' are integers, wherein 0 < n < 3 and wherein 2 < n' <4 (claims 7-8), wherein the desaturase may be any functional homolog with 70% or more sequence identity to SEQ ID NOs: 1 or 56 (claims 4-5) or SEQ ID NOs: 3, 5, 7, 9, 11, 31, 33, 29, 51, 59, 61, 63, 65, 67, 69, 71 (claim 10), and wherein the cell may further express a FAR selected from SEQ ID NOs: 13, 15, 19, 21, 45, 35, 37, 41, 39, 43, 73, 75, 77, 79, 81, 83, 85, 87, 89, 91, 93, 95, 97, 99, 101, 103, 107, 109, 111, 113, 115, 117, 119, 121, 123, 125, 127, 129, 131 or a homolog with at least 70% sequence identity thereof (claim 11). The direction and guidance coupled with the working examples of the application, however, are drawn only to demonstrating one specific yeast strain, utilizing one Z13 desaturase with 14 Z-11 desaturases and then one specific yeast strain, utilizing one Z11 and Z13 desaturase with 41 FARs; specifically, the specification discloses fourteen Z11 desaturases in the production of Z11-13-16:Me co-expressed with one Z13 desaturase, AtrAATO (SEQ ID NO: 1) from Amyelois transitelia, in the yeast, Yarrowia lipolytica (Example 8), and enabling for 38 FAR proteins co-expressed in a Yarrowia lipolytica expressing SEQ ID NOs: 1 and 31 (Example 9). The quantity experimentation would be considerable because, while the relative skill level in the art is high (PhD or MD), they would be required to ascertain which enzymes or combination of enzymes to use from an enormous amount of enzymes and homologs that encompass the 70% sequence identity requirement to all of the claimed sequences; additionally, they would have to determine which yeast strains would work with which combinations of enzymes. It would be extremely difficult to be able to discern which disclosed combinations would give rise to each of the disclosed fatty acyl-CoA products, resulting in an excessive trial and error to produce the disclosed fatty alcohol pheromone precursors. It would be almost impossible to reliably predict the combination and/or combinations necessary to produce all of the different products claimed in the application.
Claim Rejections - 35 USC § 112(b)
14. 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.
15. Claims 3-13 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.
16. Regarding claim 3, the phrase "preferably" 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). Claims 4-13 are included in the instant rejection, since they do not mitigate the issue.
17. Claim 3 recites the limitations “a saturated fatty acyl-CoA” in line 4, “a desaturated fatty acyl-CoA” in line 6, and "wherein said fatty acyl-CoA" in line 7. There is insufficient antecedent basis for these limitations in the claim because it is unclear if these instances are further limiting on the first instance of “a desaturated fatty acyl-coenzyme A” without the designation of “the” instead of the recited “a.” Additionally, this rejection encompasses both the saturated and unsaturated instances because the number of n bonds in the first recitation may be 0. Claims 4-13 are included in the instant rejection, since they do not mitigate the issue.
18. Claim 4 recites the limitation “70% similarity or identity. It is unclear as to what the similarity is in reference, i.e. functionality, since the claim also recites a “functional homolog.” Additionally, it is unclear what the similarity is in reference, i.e. is this “amino acid sequence identity” or “amino acid sequence similarity,” or again, functionality?
19. Claim 4 recites narrow limitations (SEQ ID NOs) followed by a broad limitations (functional homologs having 70% sequence identity) in the same claim. This is unclear as to what exactly applicants are claiming. To mitigate this issue, the applicant is advised to separate the broad and narrow limitations into different claims.
20. Claim 5 recites the limitation “70% similarity or identity. It is unclear as to what the similarity is in reference, i.e. functionality, since the claim also recites a “functional homolog.” Additionally, it is unclear what the similarity is in reference, i.e. is this “amino acid sequence identity” or “amino acid sequence similarity,” or again, functionality?
21. Claim 5 recites narrow limitations (SEQ ID NOs) followed by a broad limitations (functional homologs having 70% sequence identity) in the same claim. This is unclear as to what exactly applicants are claiming. To mitigate this issue, the applicant is advised to separate the broad and narrow limitations into different claims.
22. Claim 6 recites the limitations “said saturated or desaturated fatty acyl-CoA” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim because it is unclear which instance of saturated or unsaturated fatty acyl-CoA this instance is references in claim 3, since claim 3 has 3 instances of “a saturated fatty acyl-CoA” in line 4, “a desaturated fatty acyl-CoA” in line 6, and "wherein said fatty acyl-CoA" in line 7.
23. Regarding claim 6, the phrase "(i.e. n=1)" 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).
24. Regarding claim 7, the phrases "(i.e. n’=1)" and “(i.e. n’=2)” render 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).
25. Claim 9 recites multiple instances of “optionally,” which appear to be linked to each other, i.e. narrowing or broadening the claim limitations with each additional instance of “optionally.” It is unclear if these optional features are linked as suggested or if they are differing optional features.
26. Claim 10 recites narrow limitations (SEQ ID NOs) followed by a broad limitations (functional variants having 70% sequence identity) in the same claim. This is unclear as to what exactly applicants are claiming. To mitigate this issue, the applicant is advised to separate the broad and narrow limitations into different claims.
27. Claim 10 recites the limitation “70% similarity or identity. It is unclear as to what the similarity is in reference, i.e. functionality, since the claim also recites a “functional homolog.” Additionally, it is unclear what the similarity is in reference, i.e. is this “amino acid sequence identity” or “amino acid sequence similarity,” or again, functionality?
28. Claim 11 recites the limitation “70% similarity or identity. It is unclear as to what the similarity is in reference, i.e. functionality, since the claim also recites a “functional homolog.” Additionally, it is unclear what the similarity is in reference, i.e. is this “amino acid sequence identity” or “amino acid sequence similarity,” or again, functionality?
29. Claim 11 recites narrow limitations (SEQ ID NOs) followed by a broad limitations (functional variants having 70% sequence identity) in the same claim. This is unclear as to what exactly applicants are claiming. To mitigate this issue, the applicant is advised to separate the broad and narrow limitations into different claims.
30. Regarding claim 12, the phrase "preferably" 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).
Claim Rejections - 35 USC § 103
31. 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.
32. 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.
33. Claims 3-4 and 6-12 is rejected under 35 U.S.C. 103 as being unpatentable over Borodina et al (Borodina et al., 2020, WO 2020/169389 A1—cited on the IDS dated 06 March 2024). Regarding claim 3, drawn to a yeast cell capable of producing a desaturated fatty acyl-coenzyme A having n’ double bonds, wherein at least one of the said double bonds is at position 13, wherein said yeast cell expresses a heterologous Δ13 fatty acyl-CoA desaturase, said desaturase being able to introduce a double bond at position 13 in a saturated or desaturated fatty acyl-CoA, wherein said fatty acyl-CoA has a carbon length of at least 14 and has n double bonds, wherein 0 ≤ n ≤ 3 and wherein 1 ≤ n’ ≤ 4, Borodina et al. teaches pheromone production using recombinant yeasts expressing acyl-CoA desaturase to introduce at least one double bond (abstract). Specifically, Borodina et al. teaches a fatty acyl-CoA desaturase capable of introducing at least one double bond in E/Z conformations in fatty acyl-CoA having a carbon length of 8-22 carbon atoms (p. 30, lines 15-21) and that the double bond may be introduced in any position, including position 13 (p. 30, line 34 and p. 31, line 9), and wherein the cell is capable of expressing at least one heterologous Δ13 desaturase (p. 31, line 28). Regarding claims 4 and 10, drawn to the yeast cell expressing a heterologous Δ13 desaturase is native to Amyelois transitella, Borodina et al. teaches that the heterologous desaturase may be derived from Amyelois transitella (p. 32, lines 4-8). Regarding claims 6-9, and 11, drawn to a yeast cell, wherein saturated or desaturated fatty acyl-CoA having a carbon chain of at least 14 and having n double bonds, with a carbon length of at least 15, wherein the cell expresses a further heterologous desaturase that introduces a double bond at a different carbon position (other than 13 and therefore, there would be an n’=2), and wherein, the cell expresses a subsequent fatty acid reductase to produce 11,13-hexadecadien-1-ol, Borodina et al. teaches carbon lengths of 8-22 (p. 30, lines 19-20), and further, Borodina et al. teaches the utilization of a 16:CoA desaturated to a ΔZ11-16:CoA, a subsequent desaturation step to produce ΔZ11 ΔZ13-16:CoA, and a reductase step producing ΔZ11 ΔZ13-16:OH (Fig. 15 and p. 6, lines 26-28). Regarding claim 12, drawn to the yeast belonging to the genus Saccharomyces, Pichia, Yarrowia, Kluyveromyces, Candida, Rhodotorula, Rhodosporidium, Cryptococcus, Trichosproron, and Lipomyces, Borodina et al teaches that the genus of the said yeast is selected from Saccharomyces,Pichia, Yarrowia, Kluyveromyces, Candida, Rhodotorula, Rhodosporidium, Cryptococcus, Trichosporon and Lipomyces.
Borodina et al. does not teach a single working example utilizing a specific desaturase that creates a double bond at position 13 in a saturated and/or unsaturated fatty acyl-CoA.
Nonetheless, it 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 to apply the possible desaturases, specifically the Δ13 fatty acyl-CoA desaturase from a Amyelois transitella, and express said desaturase in a yeast cell to produce pheromone precursors, such as 11, 13-hexadecadien-1-ol, because insect pheromones are used in agriculture and forestry applications for monitoring safety, as taught by Borodina et al (p. 2, lines 7-8). One would be motivated to produce insect pheromone precursors in a yeast cell because chemical synthesis of pheromones is batch limiting and expensive as taught by Borodina et al (p. 2, line 9). There would be reasonable expectation of success, yielding no surprising results to apply the teachings of Borodina et al. to produce insect pheromone precursors by utilizing a yeast cell expressing a heterologous desaturase specific for carbon position 13 because Borodina et al. teaches the general strategy for this specific application, especially at Figure 15. As such, this provides a reasonable expectation of success.
Double Patenting
34. 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.
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35. Claim 3-4, 6-10, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 5 of U.S. Patent No. 11345922. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘922 claims would still anticipate the instant claims.
The instant claims in their broadest are drawn to a yeast cell capable of producing a desaturated fatty acyl-coenzyme A (fatty acyl-CoA) having n' double bond(s), wherein at least one of said double bond(s) is at position 13, wherein said yeast cell expresses a heterologous Δ13 fatty acyl-CoA desaturase, said desaturase being capable of introducing a double bond at position 13 in a saturated fatty acyl-CoA or a desaturated fatty acyl-CoA having a carbon chain consisting solely of single and double bonds, preferably a desaturated fatty acyl-CoA, wherein said fatty acyl-CoA has a carbon chain length of at least 15 (claim 6) and has n double bond(s), wherein n and n' are integers, wherein 0 < n < 3 and wherein 2 < n' <4 (claims 7-8).
The ‘922 claims in the broadest are drawn to Yarrowia lipolytica yeast cell capable of producing a desaturated fatty alcohol with a titer of at least 5 mg/L, said cell: i) expressing at least one heterologous desaturase capable of introducing at least one double bond in a fatty acyl-CoA; and ii) expressing at least one heterologous fatty acyl-CoA reductase (FAR), capable of converting at least part of said desaturated fatty acyl-CoA to a desaturated fatty alcohol; and iii) having- a mutation resulting in reduced activity of fatty alcohol oxidase Fao1 of Yarrowia lipolytica, wherein the at least one desaturase is selected from a group including a Δ13 desaturase and Δ11 desaturase, and wherein the at least one heterologous desaturase is an insect desaturase.
Thus, the only difference between the instant claims and the ‘922 claims is the reduction in activity of the Fao1 in Y. lipolytica. However, the ‘922 claims would still anticipate the instant claims, since the mutated Y. lipolytica is still able to express the at least one heterologous desaturases, including both Δ13 desaturase and Δ11 desaturase.
36. Claims 3, 6-9, and 12 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, and 9 of copending Application No. 18/570,268 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘268 claims would anticipate the instant claims.
The instant claims in their broadest are drawn to a yeast cell capable of producing a desaturated fatty acyl-coenzyme A (fatty acyl-CoA) having n' double bond(s), wherein at least one of said double bond(s) is at position 13, wherein said yeast cell expresses a heterologous Δ13 fatty acyl-CoA desaturase, said desaturase being capable of introducing a double bond at position 13 in a saturated fatty acyl-CoA or a desaturated fatty acyl-CoA having a carbon chain consisting solely of single and double bonds, preferably a desaturated fatty acyl-CoA, wherein said fatty acyl-CoA has a carbon chain length of at least 15 (claim 6) and has n double bond(s), wherein n and n' are integers, wherein 0 < n < 3 and wherein 2 < n' <4 (claims 7-8).
The ‘268 claims in their broadest are drawn to a yeast cell capable of producing a desaturated fatty acyl-coenzyme A (fatty acyl-CoA) having n' double bond(s), wherein at least one of said double bond(s) is at position 12, wherein said yeast cell expresses a heterologous Δ12 fatty acyl-CoA desaturase, said desaturase being capable of introducing a double bond at position 12 in a saturated fatty acyl-CoA or a desaturated fatty acyl-CoA having a carbon chain consisting solely of single and double bonds, preferably a desaturated fatty acyl-CoA, wherein said fatty acyl-CoA has a carbon chain length of at least 15 (claim 4) and has n double bond(s), wherein n and n' are integers, wherein 0 < n < 3 and wherein 2 < n' <4 (claim 5).
Thus the only difference between the ‘268 claims and the instant claims is the requirement of the instant claims to have at least a Δ13 fatty acyl-CoA desaturase, whereas the ‘268 claims require at least a Δ12 fatty acyl-CoA desaturase. The ‘268 claims would still anticipate the instant claims because both claim sets utilize the “at least” language, which leaves the claim language open to express these two desaturases together with any others.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
37. All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIARA A MCKNIGHT whose telephone number is (703)756-4791. The examiner can normally be reached M-F 8:00am-4:30pm.
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/CIARA A MCKNIGHT/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
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