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 Application
The Amendments and Remarks filed on 09/19/25 are acknowledged.
Claims 1-4, 7-14, 17, 19, and 21-23 were cancelled.
Claims 5-6, 15-16, 18, 20, and 24-25 were amended.
New claims 26-37 were added.
Claims 5-6, 15-16, 18, 20, and 24-37 are pending and are included in the prosecution.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 07/17/25 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement.
Please see the attached copy of PTO-1449.
Response to Amendments/Arguments
Claim Objections
In light of the amendment of claims 20 and 24, the objections to these claims are withdrawn.
Rejection of claims under 35 USC § 112(b)
In light of the amendment of claim 24 to delete “encapsulated gel,” the rejection of this claim under 35 U.S.C. 112(b) is withdrawn.
However, since new claim 27 is dependent on itself, a new ground of rejection is made below.
Rejection of claims under 35 USC § 112(d)
In light of the amendment of claim 25 to recite “A method of treating or preventing cardiovascular disease,” the rejection of this claim under 35 U.S.C. 112(d) is withdrawn.
Rejection of claims under 35 USC § 102(a)(1)
In light of the cancellation of claims 1, 3, and 7-9, the rejection of these claims under 35 U.S.C. 102(a)(1) as being anticipated by Petrie is rendered moot.
Applicant amended claim 5 to recite that the composition comprises 28% -50% DPAn-3, which narrows the previously recited range of 20%-50% DPAn-3. In light of this amendment, Applicants’ arguments (Pages 5-8, filed 09/19/25) regarding the rejection of claims 1, 3-9, 15-16, 18, and 24-25 under 35 U.S.C. 102(a)(1) as being anticipated by Petrie et al. (WO 2015/196250 A1 – “Petrie” hereafter) have been fully considered and are persuasive. Previously, claim 5 was anticipated by Petrie since this reference teaches 25.8% DPA (22:5 n-3) (Page 141, Table 21, Seed 19); 16-28.2% OA (18:1 n-9) (Page 139, Table 19), 2.3-7.8% ETA (20:4n-3) (Page 137, Table 17).
However, since the new range is not taught in the same composition of Petrie, a new ground of rejection under 35 U.S.C. 103 based on Petrie is made below.
Since the new grounds of rejection were necessitated by Applicants’ amendment, this action is made FINAL.
Rejection of claims under 35 USC § 103
In light of the cancellation of claims 13 and 14, the rejection of these claims under 35 U.S.C. 103 as being unpatentable over Petrie in view of Remmereit et al. (US 10,154,979 B2) is rendered moot.
Applicant’s arguments (Pages 8-9) regarding the rejection of claims 10, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Petrie are addressed in detail below.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112(b)
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.
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.
Claim 27 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 27 recites “The lipid composition of claim 27 …” and is therefore dependent on itself. The dependency of claim 27 is unclear and it does not refer to a preceding claim. For examination purposes, claim 27 is construed to be dependent on claim 26. Clarification and/or amendment are required.
Notice for all US Patent Applications filed on or after March 16, 2013
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 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.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 103
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 5-6, 15-16, 18, 20, and 24-37 are rejected under 35 U.S.C. 103 as being unpatentable over Petrie et al. (WO 2015/196250 A1 – “Petrie”).
Instant claim 5 is drawn to a lipid composition comprising an enriched seed oil-derived omega-3 docosapentaenoic acid n-3 (DPAn-3), wherein the composition comprises 28%-50% DPAn-3, 10-30% oleic acid (OA), and 2%-20% omega-3 eicosatetraenoic acid (ETA).
Petrie discloses extracted plant lipid comprising DPA (Abstract), particularly the production of long chain polyunsaturated fatty acids (LC-PUFA) from transgenic Brassica juncea seeds (Example 8 - Page 134, line 9 to Page 141). The B. juncea seed oil comprises 9.4-25.8% DPA (22:5 n-3) (Page 137, Table 17, Seed JT1-4-A-2; and Page 141, Table 21, Seed 19); 1.2-4.3% ETA (20:4n-3), 0.4-2.0% ETrA (20:3n-3), 1.0-2.2% DTA (22:4 n-3), 25-43.3% OA (18:1 n-9), 16.1-24% ALA (18:3n-3) and 4.5-10% LA (18:2n-6) based on the total fatty acid content (Page 137, Table 17, JT1 -4-A-2, JT1 -4-A-6, JT1 -4-A-11, JT1 -4-A-15, JT1 -4-B-5, and Page 140, Table 20 all seeds except 3, 8 and 10, Page 141, Table 21 all seeds). The progeny seeds with up to 35% DPA in the total fatty acid content of the seed lipid are produced (Page 136, lines 32-33). Petrie discloses treating the lipid from the seed oil to increase the level of DPA as a percentage of the total fatty acid content, and certain embodiments where the fatty acid composition of the lipid after such treatment comprises at least 60%, at least 70%, at least 80% or at least 90% DPA (Page 26, lines 21-28). For example, the lipid such as canola oil may be treated to convert the fatty acids in the oil to alkyl esters such as methyl or ethyl esters, which may then be fractionated to enrich the lipid or oil for the DPA (Page 26, lines 24-26). Pharmaceutical compositions may comprise one or more of the fatty acids and/or oils, in combination with a standard, well-known, non-toxic pharmaceutically acceptable carrier, including a tablet, capsule, ingestible liquid or powder, injectable, or topical ointment or cream (Page 92, lines 29-35). Petrie also teaches examples of conditions which would benefit from a PUFA including elevated serum triglyceride levels, elevated serum cholesterol levels such as elevated LDL cholesterol levels, cardiac arrhythmias, inflammation, coronary heart disease, hypertension, high blood pressure, etc. (Page 35, lines 26-36).
Petrie does not expressly teach an example where the composition comprises 28%-50% DPAn-3, 10-30% OA, and 2%-20% ETA.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the composition comprising LC-PUFA extracted from transgenic B juncea seeds, wherein progeny seeds with up to 35% DPA in the total fatty acid content of the seed lipid are produced, wherein the B. juncea seed oil comprises 9.4-25.8% DPA (22:5 n-3); 1.2-4.3% ETA (20:4n-3), and 25-43.3% OA (18:1 n-9), based on the total fatty acid content, as taught by Petrie, modify the proportion of the lipids and based on the desired stability and therapeutic effects on conditions which would benefit from a PUFA, which are also taught by Petrie, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because the concentration of the fatty acids is a modifiable parameter. One of ordinary skill in the art would have found it obvious to adjust the concentration of the various fatty acids in the composition in order to achieve the desired stability and therapeutic effects on conditions which would benefit from a PUFA, which are also taught by Petrie (Page 35, lines 26-36).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 5, the limitation of a lipid composition comprising an enriched seed oil-derived DPAn-3, wherein the composition comprises 28%-50% DPAn-3, 10-30% OA, and 2%-20% ETA would have been obvious over the LC-PUFA extracted from transgenic B juncea seeds (Example 8 - Page 134, line 9 to Page 141 – Table 20), wherein the progeny seeds contain up to 35% DPA in the total fatty acid content of the seed lipid (Page 136, lines 32-33); wherein the B. juncea seed oil comprises 9.4-25.8% DPA (22:5 n-3) (Page 137, Table 17, Seed JT1-4-A-2; and Page 141, Table 21, Seed 19); 1.2-4.3% ETA (20:4n-3), and 25-43.3% OA (18:1 n-9), based on the total fatty acid content (Page 137, Table 17, JT1 -4-A-2, JT1 -4-A-6, JT1 -4-A-11, JT1 -4-A-15, JT1 -4-B-5, and Page 140, Table 20 all seeds except 3, 8 and 10, Page 141, Table 21 all seeds); the pharmaceutical compositions comprising one or more of the fatty acids and/or oils, in combination with a standard, well-known, non-toxic pharmaceutically acceptable carrier, including a tablet, capsule, ingestible liquid or powder, injectable, or topical ointment or cream (Page 92, lines 29-35); and the enrichment of the seed oil to increase the DPA level (Page 26, lines 21-26), as taught by Petrie. The ranges of up to 35% DPA (Page 136, lines 32-33); 25-43.3% OA (18:1 n-9); and 1.2-4.3% ETA (20:4n-3), as taught by Petrie overlap the claimed ranges of 28%-50% DPAn-3, 10-30% OA, and 2%-20% ETA, respectively. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claim 6, the limitation of the lipid composition comprising about 36% DPAn-3, about 22% OA, and about 6% ETA would have been obvious over the progeny seeds which have up to 35% DPA (Page 136, lines 31-33), 22.3% OA (18:1 n-9) (Page 139, Table 19, JT1-4-A-10), and 5.6% ETA (20:4n-3) (Page 139, Table 19, JT-4-B-12), respectively, as taught by Petrie. The instant specification discloses that the term “about” refers generally to ±1% of the designated value, but may allow for ±5% or ±10% of the designated value as accepted in the relevant context by one of skill in the art (Page 5, [0021]). Based on this definition of the term “about” the teaching of 35% DPA (Page 136, lines 31-33) by Petrie is -2.77% of 36% DPAn-3; 22.3% OA (18:1 n-9) (Page 139, Table 19, JT1-4-A-10) by Petrie is +1.36% of 22% OA; and 5.6% ETA (20:4n-3) (Page 139, Table 19, JT-4-B-12) by Petrie is -6.67% of 6% ETA, and therefore, are rendered obvious.
Regarding instant claims 15-16, 27-28, and 34-35, the limitations of Brassicacea and B. juncea would have been obvious over the production of LC-PUFA from transgenic Brassica juncea seeds (Example 8 - Page 134, line 9 to Page 141), as taught by Petrie.
Regarding instant claim 18, the limitation of a lipid composition that inhibits inflammatory cytokine production would have been obvious over the composition containing LC-PUFA extracted from transgenic B juncea seeds (Example 8 - Page 134, line 9 to Page 141, and the progeny seeds which have up to 35% DPA (Page 136, lines 31-33), 22.3% OA (18:1 n-9) (Page 139, Table 19, JT1-4-A-10), and 5.6% ETA (20:4n-3) (Page 139, Table 19, JT-4-B-12), and the conditions which would benefit from a PUFA including inflammation (Page 35, lines 26-36), as taught by Petrie.
Regarding instant claim 20, the limitation of about 5% omega-3 docosatetraenoic acid (DTAn-3) would have been obvious over the DTA (22:4 n-3) (Page 95, line 21), which was extracted from freeze-dried developing seeds (Page 94, lines 27-29), where multiple reaction monitoring (MRM) lists were based on a group of fatty acids, including 22:4 (Page 94, line 36 to Page 95, line 3), and where neutral lipids were targeted on major fatty acids including DTA or 22:4 (Page 95, lines 19-23), as taught by Petrie. One of ordinary skill in the art would have found it obvious that the fatty acids extracted from the developing seeds included DTA or 22:4ω3. One of ordinary skill in the art would have found it obvious to adjust the amount of DTA in the composition based on the desired stability and therapeutic effect, unless there is evidence of criticality or unexpected results.
Regarding instant claim 20, the limitation of about 14% α-linolenic acid (ALA) would have been obvious over the overlapping range of 12.7%-19.9% ALA (18:3n-3) based on the total fatty acid content (Page 137, Table 17, JT1-4-A-6 and JT1-4-A-8), as taught by Petrie.
Regarding instant claim 20, the limitation of about 6% linoleic acid (LA) would have been obvious over the overlapping range of 4-9% LA (18:2ω-6) in the transgenic seeds (Page 129, lines 8-10), as taught by Petrie.
Regarding instant claims 24, 29, and 36, the limitations of the composition provided in the form of a tablet capsule, ingestible liquid or powder, or a topical ointment or cream would have been obvious over the tablet, capsule, ingestible liquid or powder, injectable, or topical ointment or cream (Page 92, lines 29-35), as taught by Petrie.
Regarding instant claims 25, 31, and 37, the limitations of a method of treating or preventing cardiovascular disease, reducing overall serum cholesterol levels, reducing triglycerides, or reducing high blood pressure in a patient in need thereof would have been obvious over the conditions which would benefit from a PUFA including elevated serum triglyceride levels, elevated serum cholesterol levels such as elevated LDL cholesterol levels, and hypertension (Page 35, lines 26-36), as taught by Petrie.
Regarding instant claim 26, the limitation of 60-70% DPAn-3 would have been obvious over the fatty acid composition of the lipid after the enriching treatment which comprises at least 60% and at least 70% DPA (Page 26, lines 21-28), as taught by Petrie. The limitation of 5-20% ETA would have been obvious over the 5.6% ETA (20:4n-3) (Page 139, Table 19, JT-4-B-12), as taught by Petrie.
Regarding instant claim 30, the limitation of a lipid composition that inhibits inflammatory cytokine production denotes future-intended uses and thus, does not accord patentable weight to the claims. The recited intended use does not alter the structure of the claimed lipid composition. Moreover, because the prior art has the same components and arrangement of components, and teaches the same application of the composition it must intrinsically possess the same properties. In the instant case, the prior art lipid composition taught by Petrie (Example 8 - Page 134, line 9 to Page 141) is the same as the instant lipid composition, and as a result, is capable of performing the claimed intended uses (see MPEP § 2112.01).
Regarding instant claim 32, the limitation of 90%-99% DPAn-3 and 0.1%-5% OA would have been obvious over the level of ethyl esters of DPA in the medicament of at least about 95% (Page 36, lines 15-18) and the level of OA of between about 1% and about 30% (Page 6, lines 14-15), as taught by Petrie. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claim 33, the limitation of about 96% DPAn-3 and about 1% OA would have been obvious over the level of ethyl esters of DPA in the medicament of at least about 95% (Page 36, lines 15-18) and the level of OA of between about 1% and about 30% (Page 6, lines 14-15), as taught by Petrie. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Response to Arguments
Applicant’s arguments (see Pages 5-9, filed 09/19/25) with respect to the rejection of claims under 35 USC § 103(a) as being unpatentable over Petrie have been fully considered but are not persuasive.
Applicant argues that claim 5 “provides a lipid composition comprising 28%-50% DPAn-3, 10%-30% QA, and 2% to 20% ETA The Examiner has referred to a recitation of a seed with 25.8% DPA, which is below the claimed DPA range. More importantly, the Examiner has not provided a single example where Petrie describes the claimed composition, arranged as required by the claim (i.e., in a lipid composition). Instead, the Examiner refers to various texts and different seeds with different fatty acid contents, none of which provide the identical invention - a lipid composition – as arranged in the present claims. For example, Seed 19 of Table 21 may contain 25.8% DPA, but it contained only 1.3% ETA, well below the claimed 2%-20% ETA, and contained 39.2% OA, well above the claimed 10%-30% OA.” Applicant argues that “Indeed, none of the compositions described in Petrie contain the recited DP An-3 range and the recited amount of ETA and the recited about of QA as required by claim 5.”
This is not persuasive because previously claim 5 recited 20%-50% DPAn-3, and the teaching of 25.8% DPA (22:5 n-3) (Page 141, Table 21, Seed 19) by Petrie anticipated this limitation. The limitations of 10-30% OA and 2%-20% ETA were also anticipated by 16-28.2% OA (18:1 n-9) (Page 139, Table 19), 2.3-7.8% ETA (20:4n-3) (Page 137, Table 17), as taught by Petrie.
Claim 5 was amended to recited 28%-50% DPAn-3. Therefore, the anticipation rejection has been withdrawn and amended claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Petrie since this reference teaches that the progeny seeds contain up to 35% DPA in the total fatty acid content of the seed lipid (Page 136, lines 32-33); the B. juncea seed oil comprises 1.2-4.3% ETA (20:4n-3), and 25-43.3% OA (18:1 n-9), based on the total fatty acid content (Page 137, Table 17, JT1 -4-A-2, JT1 -4-A-6, JT1 -4-A-11, JT1 -4-A-15, JT1 -4-B-5, and Page 140, Table 20 all seeds except 3, 8 and 10, Page 141, Table 21 all seeds). The ranges of up to 35% DPA (Page 136, lines 32-33); 25-43.3% OA (18:1 n-9); and 1.2-4.3% ETA (20:4n-3), as taught by Petrie overlap the claimed ranges of 28%-50% DPAn-3, 10-30% OA, and 2%-20% ETA, respectively. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Applicant argues that “Indeed, none of the compositions described in Petrie contain the recited DPAn-3 range and the recited amount of ETA and the recited about of QA as required by claim 5.”
This is not persuasive because even though the obviousness rejection relies on different pages and tables, MPEP 2141.03(I) discloses that “Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” One of ordinary skill in the art would have found it obvious to combine the disclosures of the progeny seeds containing up to 35% DPA in the total fatty acid content of the seed lipid (Page 136, lines 32-33) and the B. juncea seed oil comprising 1.2-4.3% ETA (20:4n-3), and 25-43.3% OA (18:1 n-9), based on the total fatty acid content (Page 137, Table 17, JT1-4-A-2, JT1-4-A-6, JT1-4-A-11, JT1-4-A-15, JT1-4-B-5, and Page 140, Table 20 all seeds except 3, 8 and 10, Page 141, Table 21 all seeds) by Petrie since all the fatty acids are produced by the same B. juncea seeds.
Applicant argues that Petrie provides no enablement on how any of the various seeds cited by the Examiner would be enriched to provide for the claimed lipid composition.
This is not persuasive because Petrie teaches the enrichment of the seed oil for the desired fatty acids. For example, Petrie teaches that the lipid such as canola oil may be treated to convert the fatty acids in the oil to alkyl esters such as methyl or ethyl esters, which may then be fractionated to enrich the lipid or oil for the DPA (Page 26, lines 24-26). Furthermore, Petrie also teaches that the fatty acid may be in a mixture of fatty acids having a fatty acid composition as described herein, or may be enriched so that the fatty acid, preferably DPA, comprises at least 40% or at least 90% of the fatty acid content of the mixture (Page 34, lines 13-15). Also, Petrie teaches that further treatment such as fractionation or distillation may be applied to enrich the lipid or oil for the DPA (Page 36, lines 13-14).
Applicant argues that the Examiner’s assertion that Page 136, lines 31-33 of Petrie “refers to progeny seeds with up to 35% DPA, the actual reference is to "F1 plants ... which are homozygous for both of the T-DNA insertions are expected to produce up to 35% DHA and DPA." This recitation (a) refers to a cumulative amount of DHA and DPA, not DPA, (b) is completely silent regarding the amount of ETA and QA in such seeds.”
This is not persuasive because the Examiner refers to Page 136, lines 31-33 which clearly discloses that the progeny seeds have up to 35% DPA. Applicant’s argument regarding F1 plants and up to 35% DHA and DPA is not the citation provided by the Examiner since this is on Page 135, lines 31-33.
Applicant argues that claim 8 was canceled and similar subject matter was reintroduced in new claim 26, and that the cited language of the Petrie reference on page 26, lines 21-28 is completely silent regarding ETA and does not anticipate new claim 26.
Claim 8 was previously rejected as being anticipated by Petrie because claim 8 recited that ETA was optional, and therefore not required. Since claim 8 was canceled the anticipation rejection for this claim is rendered moot. Regarding new claim 26, the limitation of 60-70% DPAn-3 would have been obvious over the fatty acid composition of the lipid after the enriching treatment which comprises at least 60% and at least 70% DPA (Page 26, lines 21-28), as taught by Petrie. The limitation of 5-20% ETA would have been obvious over the 5.6% ETA (20:4n-3) (Page 139, Table 19, JT-4-B-12), as taught by Petrie.
Applicant argues that claim 9 has been canceled rendering the rejection moot, and the Examiner agrees.
Applicant argues that, with respect to new claim 32, regardless of the references in Petrie to medicaments comprising at least 90% or at least 95% DPA, there is no lipid composition disclosed in Petrie comprising 90%-99% DPAn-3 and 0.1 %-5% OA. Applicant argues that none of the various seeds or compositions referred to in Petrie simultaneously fulfil all of the requirements of the independent claims as required by extant law and patent practice, and Petrie does not, anticipate the independent and dependent claims.
Please note that in light of the amendments and addition of new claims the previous anticipation rejection has been withdrawn.
Applicant’s argument, as it now applies to the obviousness rejection of new claim 32, is not persuasive because the limitation of 90%-99% DPAn-3 and 0.1%-5% OA would have been obvious over the level of ethyl esters of DPA in the medicament of at least about 95% (Page 36, lines 15-18) and the level of OA of between about 1% and about 30% (Page 6, lines 14-15), as taught by Petrie. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.” Also, MPEP 2141.03(I) discloses that “Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” One of ordinary skill in the art would have found it obvious to combine the disclosures of the progeny seeds containing up to 35% DPA in the total fatty acid content of the seed lipid (Page 136, lines 32-33) and the B. juncea seed oil comprising 25-43.3% OA (18:1 n-9), based on the total fatty acid content (Page 137, Table 17, JT1-4-A-2, JT1-4-A-6, JT1-4-A-11, JT1-4-A-15, JT1-4-B-5, and Page 140, Table 20 all seeds except 3, 8 and 10, Page 141, Table 21 all seeds) by Petrie since all the fatty acids are produced by the same B. juncea seeds.
Applicant argues that with reference to claim 10, the Examiner cited Petrie page 95, line 21, as teaching a composition comprising DTAn-3, but this portion of Petrie does not refer to a lipid composition at all and instead refers to methods of lipid profiling using LC-MS technology.
This is not persuasive because the limitation of about 5% omega-3 docosatetraenoic acid (DTAn-3) in claim 20 would have been obvious over the DTA (22:4 n-3) (Page 95, line 21), which was extracted from freeze-dried developing seeds (Page 94, lines 27-29), where multiple reaction monitoring (MRM) lists were based on a group of fatty acids, including 22:4 (Page 94, line 36 to Page 95, line 3), and where neutral lipids were targeted on major fatty acids including DTA or 22:4 (Page 95, lines 19-23), as taught by Petrie. One of ordinary skill in the art would have found it obvious that the fatty acids extracted from the developing seeds included DTA or 22:4ω3. One of ordinary skill in the art would have found it obvious to adjust the amount of DTA in the composition based on the desired stability and therapeutic effect, unless there is evidence of criticality or unexpected results.
Applicant argues that to the extent Petrie refers to processes to increase the DPA content in any composition, there is no motivation to simultaneously adjust all the fatty acid components of any seed to provide the fatty acid components and amounts of these as in the claimed composition.
This is not persuasive because one of ordinary skill in the art would have found it obvious to modify or adjust the fatty acid composition based on the teaching by Petrie that “… the lipid or oil may subsequently be treated by fractionation or other procedures to alter the fatty acid composition” (Page 14, lines 7-9). Petrie also teaches that “When combined with a fractionation process, transesterification can be used to modify the fatty acid composition of lipids” (Page 86, liens 15-16).
Applicant argues that regarding claims 5 and 20 they found that combinations of DPAn-3 and ETA were effective inhibitors of inflammatory cytokines ([0149]), and that this effect is not suggested by Petrie, and there is no suggestion in Petrie to simultaneously increase the levels of DPAn-3 and ETA to the levels required by claim 5 and claim 20.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., inhibition of inflammatory cytokines) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Instant claims 5 and 20 are drawn to lipid compositions and not to methods of inhibiting inflammatory cytokines. Instant claim 30 recites “A lipid composition that inhibits inflammatory cytokine production …” but this claim is also a composition claim and not a method of inhibiting inflammatory cytokine production. The feature upon which applicant relies is a future intended use of the composition and is not given patentable weight. The recited intended use does not alter the structure of the claimed lipid composition. Moreover, because the prior art has the same components and arrangement of components, and teaches the same application of the composition it must intrinsically possess the same properties. In the instant case, the prior art lipid composition taught by Petrie (Example 8 - Page 134, line 9 to Page 141) renders obvious the instant lipid composition, and as a result, is capable of performing the claimed intended uses (see MPEP § 2112.01).
The Examiner agrees with Applicant’s argument that claims 13 and 14 were canceled and the rejection over Petrie in view of Remmereit (US 10,154,979 B2) was moot.
Conclusion
No claims are 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615