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 .
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites the abbreviation AI. The full term describing the abbreviation should be recited first.
Claims 1 and 16-21 are also objected to for not including the term “content” when referencing the AI. As noted in [0020] of the present specification, AI refers to the method of determining the amount of phospholipids. The actual amounts reference the content.
Appropriate correction is required.
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.
Claims 1-10, 12 and 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over EP1624047 (KELLENS) (see IDS of 11/29/2022)
PNG
media_image1.png
420
675
media_image1.png
Greyscale
PNG
media_image2.png
466
647
media_image2.png
Greyscale
As to (a), KELLENS teaches providing an oil-containing phospholipid composition in the form of wet gums [0023]. KELLENS does not provide a range as to how much oil is present relative to the total weight of the oil-containing phospholipid composition. However, in Example 3 [0047], 200 g of wet gums provides 43g of oil [0048] indicating that the oil-containing phospholipid composition can contain 21% of oil (i.e., 43g/200g= 21.5%). It would have been obvious to use an oil-containing phospholipid composition within the claimed range, as KELLENS exemplifies that wet gums with a ratio of oil-containing phospholipid composition within this range can be used to maximize oil yield [0014].
As to (b), KELLENS teaches admixing water with the oil-containing phospholipid composition to obtain an aqueous composition [0027]. KELLENS does not teach the claimed ratio but teaches that the amount of water to be mixed with the wet gums has been found to be hardly critical so long as a good oil recuperation is obtained [0027]. Thus, it would have been obvious to vary the ratio of the oil-containing phospholipid composition to water based on the amount needed to obtain a good oil recuperation.
As to (c), KELLENS teaches separating the aqueous composition into an oil-rich fraction and an oil-depleted fraction, the oil-depleted fraction comprising water and phospholipids [0027];
As to (d), KELLENS removing the separated oil-rich fraction to obtain an aqueous, oil-depleted fraction comprising phospholipids [0027].
Step (e) is optional.
As to AI, the fraction would naturally exhibit the same AI, as composition contains phosphatides from the same sources. Applicant has chosen to use parameters that cannot be measured by the Office, for the purpose of prior art comparison, because the office is not equipped to manufacture prior art products and compare them for patentability. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, as a prima facia case of obviousness has been properly established, the burden is shifted to the applicant to show that the prior art product is different.
As noted above, KELLENS does not teach the claimed ratio but teaches that the amount of water to be mixed with the wet gums has been found to be hardly critical so long as a good oil recuperation is obtained [0027]. Thus, it would have been obvious to vary the ratio of the oil-containing phospholipid composition to water based on the amount needed to obtain a good oil recuperation.
PNG
media_image3.png
94
632
media_image3.png
Greyscale
As noted above, KELLENS does not provide a range as to how much oil is present relative to the total weight of the oil-containing phospholipid composition. However, KELLENS teaches that the process optimizes oil yield [0014]. It would have been obvious to one skilled in the art to use wet gums with high amounts of oil, as KELLENS teaches that the process optimizes oil yield. Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In reKulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
PNG
media_image4.png
252
648
media_image4.png
Greyscale
PNG
media_image5.png
137
579
media_image5.png
Greyscale
As to claims 3 and 4, KELLENS teaches that wet gums from soy and sunflower oils can be used [0023]. The wet gums can be obtained from treating crude/raw oil [0023]. It is also noted that the term “obtained by degumming a raw oil” is interpreted in a manner similar to a product-by-process limitation as the phrase “obtained by” only indicates the source or means by which the oil-containing phospholipid was acquired. The claim does not actively require the process step of degumming.
PNG
media_image6.png
120
658
media_image6.png
Greyscale
KELLENS is silent as to the oil-containing phospholipid composition containing phospholipids in an amount of at least 20% relative to the weight of the composition. However, KELLENS teaches in the Background of the Invention that phospholipid compounds such as lecithin can be isolated, dried [0013] and that wet gums are a source of phospholipids as discussed above [0023]. It would have been obvious to one skilled in the art to use wet gums with at least 20wt% relative to the overall weight of the composition, KELLENS teaches they are a source of phospholipids.
PNG
media_image7.png
64
648
media_image7.png
Greyscale
KELLENS teaches admixing water with the oil-containing phospholipid composition to obtain an aqueous composition [0027]. KELLENS does not teach the claimed range. However, KELLENS explicitly teaches that the amount of water to be mixed with the wet gums has been found to be hardly critical so long as a good oil recuperation is obtained [0027]. Thus, it would have been obvious to vary the ratio of the oil-containing phospholipid composition to water based on the amount needed to obtain a good oil recuperation.
PNG
media_image8.png
175
656
media_image8.png
Greyscale
As to claims 7-8, KELLENS teaches that the water to be mixed into the wet gums is preferably brought to about the same temperature as that of the wet gums before being mixed with these gums but on the other hand, the water temperature can also be used to adjust the temperature of the mixture [0026]. [0026] teaches that temperature ranges 40 to 90oC [0025]. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Moreover, it would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
PNG
media_image9.png
61
651
media_image9.png
Greyscale
KELLENS does not teach a time parameter. However, KELLENS teaches that in Example 2 the separation can occur up to 48 hours [0045], in Example 4 up to 92 hours [0050] and in Example 7 up to 120 hours [0056]. KELLENS teaches in [0045]-[0056] that the separation improves over time. Thus, it would have been obvious to one skilled in the art to separate within the claimed range based on the separation needed.
PNG
media_image10.png
89
626
media_image10.png
Greyscale
KELLENS teaches that the separation is carried out with a centrifuge [0033].
PNG
media_image11.png
65
626
media_image11.png
Greyscale
In [0019], it is taught that the aqueous phase can be recuperated and recycled so that the claimed steps of (c ) and (d) are repeated [0019].
PNG
media_image12.png
64
622
media_image12.png
Greyscale
KELLENS teaches that wet gums from soy and sunflower oils can be used [0023]. These are some of the same oils as claimed (see above). Given the same oils are taught, the oils would naturally contain these compounds.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over KELLENS as applied to claim 1 above, and further in view of United States Patent Application Publication No. 2004/0082536 (COOPER) .
PNG
media_image13.png
87
631
media_image13.png
Greyscale
KELLENS is silent as to adding luteine or zeaxanthine.
However, COOPER teaches that lutein and Zeaxanthine are antioxidants [0042] and have been found to decrease the risk and even reverse the development of macular degeneration
It would have been obvious to add these compounds to KELLENS as antioxidants with the added benefit they are also known to inhibit macular degeneration.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over KELLENS as applied to claim 1 above, and further in view of United States Patent No 8,232,418 (BILBIE).
PNG
media_image14.png
110
578
media_image14.png
Greyscale
KELLENS teaches in the Background of the Invention that phospholipid compounds such as lecithin can be dried [0013] but does not teach how or the resulting moisture content.
BILBIE teaches that a process for making a lecithin that has a moisture content of about 0.01% to 6% (col. 2, lines 42-50 and col. 2, lines 35-40). A lecithin is obtained with desirable color and odor.
Thus, it would have been obvious to dry lecithin with the claimed moisture content as taught by BILBIE, as BIBLIE teaches that a lecithin (i.e. a phospholipid) with good color and odor is obtained.
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered but they are not persuasive.
The applicant argues that KELLENS does not teach the claimed fractions as KELLENS teaches the use of a phospholipidolytic agent.
However, only a partial hydrolysis occurs [0036]. Thus, while it is true the crude oil fraction can be increased by doing so, a fraction of phosphatide still remains. Step e) remains optional. Thus, the claims does not require an actual dried fraction. Moreover, the claims are so broad that any amount of a phospholipid fraction with the claimed AI satisfies the claim. New claims 20 and 21 only discuss the amount of oil and water present. A minimum amount of phospholipid is not needed.
As the alleged unexpected results based on Example 1, these results are not commensurate in scope with the claims. Example 1 is limited to sunflower oil and uses very specific processing parameters (i.e., amounts, temps, ratio of 3:1, etc…) and steps (i.e., centrifugation twice) and a freeze dried fraction. None of which are recited in independent claim 1.
Conclusion
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 PHILIP A DUBOIS whose telephone number is (571)272-6107. The examiner can normally be reached M-F, 9:30-6:00p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki Dees can be reached at 571-270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PHILIP A DUBOIS/ Examiner, Art Unit 1791
/Nikki H. Dees/ Supervisory Patent Examiner, Art Unit 1791