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 .
The amendment filed 24 March 2026 has been received, entered and considered. The following information has been made of record in the instant amendment:
1. Claim 18 has been canceled.
2. New Claim 33 has been added.
3. Claims 1, 4-8, 11-12 and 17 have been amended.
4. Remarks drawn to claim objections and rejections under 35 USC 101, 112, 102 and 103.
The following objection(s)/rejection(s) has/have been overcome:
5. The objection to Claims 6 and 7 has been overcome by amendment.
6. The rejection of Claim 18 under 35 U.S.C. 101 for being not a proper process claim under 35 U.S.C. 101 has been rendered moot by cancelation.
7. The rejection of Claim 17 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 has been overcome by amendment. The rejection of claim 18 has been rendered moot by cancelation.
8. The rejection of Claim(s) 1-2, 14-17, 19 and 26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Winget (WO 94/24984: cited in IDS filed 10/14/2022) has been withdrawn in view of the amendment to claim 1. In claim 1 the recitation ‘and eicosapentaenoic acid (EPA)’ has been deleted. Winget does not disclose a composition comprising the claimed components in amended claim 1. Therefore, Winget does not anticipate instant claims 1-2, 14-17, 19 and 26.
Claims 1-17, 19, 26 and 33 are pending in the case. Claims 20-25 and 27-32 have been withdrawn as being drawn to non-elected invention. Claims 1-17, 19, 26, and 33 are under prosecution in this Action.
The following rejections are necessitated by Applicant's amendment filed 24 March 2026 wherein the limitations in pending claims 1, 4-8, 11-12 and 17 have been amended.
In view of the amendments, the rejection under 35 USC 103 of record in the previous action is being replaced by the rejection as set forth below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-17, 19, 26 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Winget (WO 94/24984: cited in IDS filed 10/14/2022; of record) in view of Dror et al (US 2008/0085319 A1; cited in IDS filed 10/14/2022; of record).
Winget teaches a lipid composition wherein eicosapentaenoic acid is attached to the sn-1 and sn-2 position of MGDG (page 2, lines 1-21; page 5, formula IV; MGDG as in claim 1). In structure I at page 2, R1 and R2 can be a hydrocarbon chain of a fatty acid containing 10 to 25 carbons and from 0 to 6 carbon-carbon double bonds. This means that the invention of Winget also includes MGDG conjugated to a-linolenic, stearidonic and arachidonic acids as in claim 1. Another embodiment is DGDG which is conjugated to hydrocarbon chain of a fatty acid containing 10 to 25 carbons and from 0 to 6 carbon-carbon double bonds (page 2, line 22 through page 3, line 9). This reads on DGDG conjugated to a-linolenic, stearidonic and arachidonic acids as in claim 1. The composition can further contain phosphatidyl choline (page 3, lines 9-11; limitation of claim 2). The teaching of Winget also reads on claims 14-16. Claims 14-16 recite how the composition is produced which is not given patentable weight. Winget teaches formulations in the form of tablets, capsules, lotions, enteric coated pills etc. (page 7, line 23 through page 9, line 4). This reads on claim 17 (pharmaceutical formulation, a dietary supplement, medical food and functional food) and claims 19 and 26. Claim 19 is drawn to a food or drink additive comprising the composition of claim 1. Since Winget teaches the composition of claim 1 in the form of syrup or oil (page 21, claim 12 of Winget) this can serve as an additive to a food or drink as in claim 19. In view of this teaching, it would be obvious to the artisan to make an animal feed comprising the lipid composition of claim 1 as in claim 33.
Winget does not teach sulfoquinvosyldiacylglycerol as in claim 1 and the limitations of claims 3-13.
Dror teaches phospholipids enriched with omega-3 and omega-6 fatty acids covalently attached to the lipid backbone (para 0003). The invention also includes several phospholipids covalently bonded to linolenic acid to either or both the sn-1 or sn-2 positions of the glycerol moiety of the phospholipid. The phospholipid can also be enriched with omega-3 fatty acids (para 0111; part of the limitations of claims 3). The compositions can be in the form of tablets, syrups dietary supplements. It can be incorporated into a variety of foods, drinks, infant formulas, pharmaceutical formulations (para 0128-0134).
In view of the combined teachings of Winget and Dror it would be obvious to make the compositions as in instant claims 3-7, make the compositions in claims 8-13 having the percentages claimed, and the various forms of the compositions as in claim 17.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings compositions comprising glycolipid head groups conjugated to the claimed fatty acids and phospholipids conjugated to the claimed acids are known in the art. Thus, it is obvious to arrive at the claimed compositions with a reasonable expectation of success.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. One of ordinary skill in the art would be motivated to make the claimed compositions since the compositions comprising DGDG which is conjugated to hydrocarbon chain of a fatty acid containing 10 to 25 carbons and from 0 to 6 carbon-carbon double bonds, and to MGDG are known to be anti-inflammatory (Winget-abstract) and the compositions comprising the phospholipids conjugated to polyunsaturated fatty acids can be used for improvement of health disorders such as inflammatory disorders (Dror-para 0060) because lipids based on a glycerol backbone and containing a phosphate head group are the main building blocks of cell membranes (Dror-para 0006). Use of phospholipids as carriers of polyunsaturated fatty acids may result in enhanced stability due to antioxidative properties of phospholipids (Dror-para 0039). For these reasons one of ordinary skill in the art will be motivated to make the claimed compositions including those glycolipid head group is sulfoquinovosyldiacylglycerol. The artisan would make the compositions with glycolipid head group is sulfoquinovosyldiacylglycerol, and the ones as in claims 5-13 having the fatty acids at both positions and having the claimed percentages of the fatty acids in order to look for compositions that provide optimal beneficial effects for the uses taught in the prior art.
Response to Applicant’s Remarks
Applicant has traversed the rejection of claims under 35 USC 103 arguing that claim 1 has been amended to remove eicosapentaenoic acid. Winget is silent with respect to ALA, SDA and omega-3 ETA as in amended claim 1. Dror does not disclose the glycolipids MGDG, DGDG or SQDG, nor does it teach conjugating ALA, SDA or omega-3 ETA to glycolipid head groups. One of ordinary skill in the art would not have had the motivation to combine Winget and Dror to arrive at the claimed lipid composition, nor would there have been a reasonable expectation of success in doing so (pages 8-9 of Remarks).
Applicant’s arguments are not found to be persuasive. In view of the amendment the rejection under 35 USC 103 as above is made of record.
One of the embodiments of Winget’s invention is MGDG wherein the fatty acid chain can be one that has 10 to 25 carbon atoms or from 0 to 6 carbon-carbon double bonds. The fatty acids are conjugated to the sn-1 and sn-2 positions. Another embodiment is compositions comprising DGDG (pages 2-3). This means that compositions comprising ALA, SDA and omega-3 ETA conjugated to the sn-1 and sn-3 positions of MGDG and DGDG are also embodiments of the invention of Winget, even though these are not exemplified. Winget also teaches that its compositions further comprise phosphatidyl choline. Therefore, there is a suggestion to make the compositions as in amended claim 1.
Dror need not necessarily disclose the glycolipids MGDG, DGDG or SQDG, nor does it teach conjugating ALA, SDA or omega-3 ETA to glycolipid head groups since Winget suggests these. Dror is cited to show that phospholipids can be enriched with omega-3 and omega-6 fatty acids covalently attached to the lipid backbone (para 0003). The invention also includes several phospholipids covalently bonded to linolenic acid to either or both the sn-1 or sn-2 positions of the glycerol moiety of the phospholipid. Thus, Dror teaches what is not taught by Winget.
The combined teachings of Winget and Dror do render the instant claims obvious. The rejection is maintained.
Conclusion
1. Elected claims 1-17, 19, 26, and 33 (Group I) are rejected.
2. Groups II-V Claims 20-25, and 27-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
3. Claim 18 has been canceled.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693
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