DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claim 36 is pending and examined on the merits.
Claim Rejections - 35 USC § 112
Indefiniteness
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.
Claim 36 is 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 pre-AIA the applicant regards as the invention.
Claim 36 recites “characterised by one or more or all of the following properties…” It is unclear how interpret this phrase. What is “characterised by” intended to mean? Is this a characteristic of the claimed cell? If so, is it an always required characteristic? It is suggested that the claim be amended to use firmer language such that these questions are unnecessary.
Claim 36 “preferably characterised…” It is unclear how to weigh whatever follows the word “preferably.” It is unclear if the following recitations are required or optional. As such, the metes and bounds of the claim cannot be determined.
Lack of Written Description
The following is a quotation 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.
Claim 36 is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 36 is broadly drawn to recombinant cells of any species that comprise the recited fatty acid metabolic genes and have at least one of the conversion efficiencies recited.
Applicants describe in the prosecution of “great-grand parent application” 14/332202 in the declaration filed on May 30, 2017 that the claimed lipid composition can be achieved Brassica napus. Note that the Examiner allowed these data to be entered in support of the requirements of 35 USC 112(a), because the disclosure had stated that Brassica napus plants had been transformed with the constructs in question to alter seed oil composition. The data presented were only the result of analysis of the working example plants of the original disclosure. Also note that there are also some working examples in N. benthamiana and A. thaliana.
These descriptions are insufficient, because they fail to provide description of means to engineer any species of recombinant cell to have the claimed conversion ratios. Dubois et al 2007 (Eur. J Sci Technol. 109: p. 710-732) describe the fatty acid profiles of eighty different vegetable oils. Some species are biased toward producing large amounts of saturated or monounsaturated fats and some species do not produce any ALA at all (such as palm or pistachio oils). The instant specification provides no description of how engineer such cells to produce VLCPUFAs. Note that this is just the assessment of description for plant species, yet the claim is not even limited to plants, which makes the lack of written description even greater (For example, most bacteria do not produce VLCPUFAs).
Given the broad scope of the claimed genus, the lack of working examples and the failure to describe the structures required to confer the claimed function, one of skill in the art would not have recognized that Applicant was in possession of the claimed genus at the time of filing.
Claim Rejections - 35 USC § 102
(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.
Claim(s) 36 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Kinney (WO2004071467A2).
Kinney discloses soybean comprising both the pKR365 (Figure 6) and pKR357 (Figure 8) constructs. These constructs collectively comprise a delta 4 desaturase, a delta 5 desaturase, a delta 6 desaturase, a delta 5 elongase, and a delta 6 elongase and at least one of the fatty acid traits recited in the claim (Table 10). For example, line 1142-10-8-1 has ALA (18:3) percentage of 11.1% and a DHA level of 2.6% and an EPA level of 0.5%. This means that all items a) – d) are met. Accordingly, claim 36 is rejected as being anticipated by Kinney.
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.
The instant claims are drawn to recombinant cells engineered to produce VLC-PUFAs that comprises a delta 6 desaturase, a delta 6 elongase, and a delta 5 desaturase, a delta 5 elongase, and a delta 4 desaturase. Claims of copending/patented claims are all within the same plant family as instantly claimed. Moreover, the copending claims are all directed cells/plants and associated methods of producing VLC-PUFAs using a specific combination of fatty acid metabolic enzymes, most notably a delta 6 desaturase having greater activity toward Acyl-CoA vs acyl-ACP substrates which leads to greater production of VLC-PUFAs. By this basis, the instant claims and copending/patented claims are all of the same invention and terminal disclaimers are required to allow the instant claims.
Note: According to SUN PHARMACEUTICAL vs ELI LILLY Sun Pharma vs. Eli Lilly 611 F.3d 1381 (Fed. Cir. 2010) (pages 7-8), it was found that an ODP rejection would have been proper when one case in its specification suggests using a compound to treat cancer without claiming said method of treatment and the copending case claims a method of treating cancer. This fact pattern is analogous to the instant case as the specification informs a specific embodiment which is claimed in the copending case.
Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804.
Claim 36 is rejected on the ground of nonstatutory double patenting over claims 1-9 of U.S. Patent No. 8809559 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent.
Claim 36 is are rejected on the ground of nonstatutory double patenting over claims 1-6 of U.S. Patent No. 9938486 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent.
Claim 36 is rejected on the ground of nonstatutory double patenting over claims 1-15 of U.S. Patent No. 9976107 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent.
Claim 36 is rejected on the ground of nonstatutory double patenting over claims 1-12 of U.S. Patent No. 9994792 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent.
Claim 36 is rejected on the ground of nonstatutory double patenting over claims 1-24 of U.S. Patent No. 10648046 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent.
Claim 36 is rejected on the ground of nonstatutory double patenting over claims 1-20 of U.S. Patent No. 11976287 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent.
Claim 36 is rejected on the ground of nonstatutory double patenting over claims 1-17 of U.S. Patent No. 12195739 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent.
Claim 36 is rejected on the ground of nonstatutory double patenting over claims 1-14 of U.S. Patent No. 12203087 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R KEOGH whose telephone number is (571)272-2960. The examiner can normally be reached M-Th 7-4:30, half day on Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663