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 .
DETAILED ACTION
Status of Claims
Note: The amendment of May 19th 2025 has been considered.
Claims 1-14, 16-17 and 25 are cancelled.
Claim 26 was added.
Claims 15, 18-24 and 26 are pending and examined in the current application.
Any rejections not recited below have been withdrawn.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35 of the U.S. Code not included in this action can be found in a prior Office action.
Claim 26 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 enablement requirement. The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
the quantity of experimentation necessary,
the amount of direction or guidance provided,
the presence or absence of working examples,
the nature of the invention,
the state of the prior art,
the relative skill of those in the art,
the predictability of the art, and
the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108,427 F.2d 833,839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, state and predictability of the art, and relative skill level:
The invention relates to crude fat fractionation and separation of the fractions by using centrifuge filtration. The relative skill of those in the art is above average.
The breadth of the claims:
Since the instant specification provides no limiting definition or description of the radius of the centrifuge’s rotor, the rotation per minute (‘rpm’) recited in claim 26 encompasses a very broad relative centrifugal force (‘RCF’) or g-force.
The amount of direction or guidance provided and the presence or absence of working examples:
The specification provides no direction or guidance for practicing the claimed invention in its “full scope”. NO reasonably specific guidance is provided concerning the pressure/force to be applied in order to filter the fractioned crude poultry oil.
The quantity of experimentation necessary:
Since the quality and quantity of the oil produced depends on the rate it is filtered, and since the rate of filtration through centrifuge filtration depends on the g-force applied, which depends on the rotation rate and the radius of the rotor. The absence of experimental evidence, or disclosure of the radius of the rotor, renders the current process non-enabling to a skilled artisan as it fails to comply with the enablement requirement of 35 USC §112(a).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35 of the U.S. Code not included in this action can be found in a prior Office action.
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 15, 18, 21, 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over NPL Arnaud et al., “Chicken fat dry fractionation: Effects of temperature and time on crystallization, filtration and fraction properties” (‘Arnaud1’), NPL Arnaud et al., “Suitable cooling program for chicken fat dry fractionation” (‘Arnaud2’) (from Eur. J. Lipid Sci. Technol. 109 (2007) 127-133), NPL Arnaud et al., “Thermal characterization of chicken fat dry fractionation process” (‘Arnaud3’) (from Journal of Food Engineering 72(2006) 390-397) and NPL Timms., “Fractional Crystallisation – The Fat Modification Process for The 21st Century” (from Malaysian Oil Science and Technology 2005, Vol. 14, No. 1).
Regarding claims 15, 18, 21 and 23: Arnaud1, Arnaud2 and Arnaud3 disclose dry fractionating crude chicken fat, where the fat is heated up above the melting point of the fat to form chicken oil, and then slowly cooled down to a desired temperature and the formed solid fat crystals (i.e., stearin) are removed from the fat via filtration or centrifugation leaving the liquid oil (i.e., olein) behind (see Arnaud1 pages 239-241; Arnaud2 page 127-129 and Arnaud3 390-394) and Timms discloses that crystallizing fat during fat fractionation, by standing at a predetermined temperature is well known and conventional in the art (see Timms abstract; sections 2.1-2.3 and page 5, right column). Moreover, Arnaud1 specifically discloses an example where the solid fat crystals were collected at 14.3 ºC (see Arnaud1 page 243).
As to frying or boiling fatty tissues of poultry and removing impurities of dregs or water to obtain crude poultry oil recited in claim 15: Arnaud1, Arnaud2 and Arnaud3 disclose obtaining the crude chicken fat by melting the fat and eliminating the collagenic by-products by filtration and liquid fractionation by decantation (see Arnaud1, section 2.1; Arnaud2, section 2.1; Arnaud3, section 2.2), which reads on the claimed limitations.
As to standing the crude poultry oil recited in claim 15 and 18: Arnaud1, Arnaud2 and Arnaud3 disclose of continuous gentle stirring; However, Timms discloses that a gentle stirring followed by no agitation provides for better nucleation and large crystal growth (see Timms section 2.2-2.3). Therefore, it would have been obvious to a skilled artisan to have cooled the crude chicken oil while gently stirring followed by no agitation, in order to provide better nucleation and large crystal growth, and thus arrive at the claimed limitations.
As to the temperatures, durations and stirring rates recited in claims 15-18: Arnaud1, Arnaud2 and Arnaud3 disclose dry fractionating crude chicken fat, where the fat is heated up above the melting point of the fat to form chicken oil, and then slowly cooled down to a desired temperature and the formed solid fat crystals (i.e., stearin) are removed from the fat via filtration or centrifugation leaving the liquid oil (i.e., olein) behind (see Arnaud1 pages 239-241; Arnaud2 page 127-129 and Arnaud3 390-394), but fail to disclose the temperatures and durations recited; However, Arnaud1, Arnaud2, Arnaud3 and Timms disclose the physical/textural properties of the fractions depend on the temperature and duration of crystallization (see Arnaud1 whole document, Arnaud2 whole document, Arnaud3 whole document and Timms pages 3-5) and the rate of stirring (gentle agitation and/or no agitation) to encourage development of large crystals is well known (see Timms page 3, left column). Therefore, it would have been obvious to a skilled artisan to have modified Arnaud1, Arnaud2 and Arnaud3 and to have adjusted the fractionation temperature, duration and stirring rates in order to attain fat with desired physical/textural properties and thus arrive at the claimed limitations. As set forth in MPEP §2144.05 discovering an optimum value of a result effective variable, involves only routine skill in the art.
Moreover regarding the agitation rates recited in claim 15: Arnaud3 discloses agitating the fat during crystallization was well known and conventional (see Arnaud3 page 391; figure 1). Moreover, Arnaud1, Arnaud2 and Arnaud3 disclose of using variable-speed agitator during crystallization (see Arnaud1 page 240, left column; Arnaud2 page 128, left column; and Arnaud3 page 391). Arnaud1, Arnaud2 and Arnaud3 disclose of using agitation rates that are higher than the rate recited in claim 15, Arnaud3 discloses that using slow agitation rate allows for a homogenous temperature without breaking crystals being formed (see Arnaud3 page 391) and Timms discloses the rate of stirring (gentle agitation and/or no agitation) to encourage development of large crystals is well known (see Timms page 3, left column). Therefore, it would have been obvious to a skilled artisan at the time the application was filed to have modified Arnaud1, Arnaud2 and Arnaud3 and to have adjusted the agitation rate and standing time in order to encourage the development of large crystals and to maintain homogenous temperature without breaking crystals being formed, and thus arrive at the claimed limitations. As set forth in MPEP §2144.05 discovering an optimum value of a result effective variable, involves only routine skill in the art.
Regarding claim 24: Given the fact that dry fractionation is known to provide stearin fractions with a higher saturated fatty acid content and olein fractions with higher unsaturated fatty acid content (see Arnaud3 introduction on page 390) and since the crude oil is a mixture of the olein and stearin fractions, the harvested poultry oil (i.e., olein fraction) clearly has higher monounsaturated fatty acid content than the crude oil.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being obvious over NPL Arnaud1, Arnaud2, Arnaud3 and Timms as applied to claims 15, 18, 21, 23 and 24 above, and further in view of Kaas (USPat.Pub 2006/0268659 A1).
Regarding claims 19 and 20: Arnaud3 discloses agitating the fat during crystallization was well known and conventional (see Arnaud3 page 391; figure 1). Moreover, Arnaud1, Arnaud2 and Arnaud3 disclose of using variable-speed agitator during crystallization (see Arnaud1 page 240, left column; Arnaud2 page 128, left column; and Arnaud3 page 391). Arnaud1, Arnaud2 and Arnaud3 disclose of using agitation rates that are higher than the rate recited in claim 9, Arnaud3 discloses that using slow agitation rate allows for a homogenous temperature without breaking crystals being formed (see Arnaud3 page 391) and Timms discloses the rate of stirring (gentle agitation and/or no agitation) to encourage development of large crystals is well known (see Timms page 3, left column), but Arnaud1, Arnaud2, Arnaud3 and Timms fail to disclose using a mixer paddle with silicone pads attached wherein the silicone pads are configured to scrape the an inner wall of the mixing bowl; However, Kaas discloses using a mixer paddle with silicone pads attached wherein the silicone pads are configured to scrap the inner wall of the mixing bowl to provide better mixing (see Kaas abstract; paragraphs [0006]-[0008]; figures 1-5). Therefore, it would have been obvious to a skilled artisan at the time the application was filed to have modified Arnaud1, Arnaud2, Arnaud3 and Timms and to have used a mixer paddle with silicone pads attached wherein the silicone pads are configured to scrap the inner wall of the mixing bowl to provide better mixing, and thus arrive at the claimed limitations.
Claims 22 and 26 are rejected under 35 U.S.C. 103 as being obvious over NPL Arnaud1, Arnaud2, Arnaud3 and Timms as applied to claims 15, 18, 21, 23 and 24 above, and further in view of Seynaeve et al (EP 0651046 A1) and Boroughs et al. (US 3,670,888).
Regarding claims 22 and 26: Arnaud1, Arnaud2 and Arnaud3 disclose dry fractionating crude chicken fat, where the fat is heated up above the melting point of the fat and slowly cooled down to a desired temperature and the formed solid fat crystals (i.e., stearin) are removed from the fat via filtration leaving the liquid oil (i.e., olein) behind (see Arnaud1 pages 239-241; Arnaud2 page 127-129 and Arnaud3 390-394). While Arnaud1, Arnaud2 and Arnaud3 disclose examples where the stearin was filtered out of the olein for 20 minutes using pressure (see Arnaud1 page 240, left column; Arnaud2 page 128, left column and Arnaud3 page 390, left column), Arnaud1, Arnaud2 and Arnaud3 fail to disclose using centrifuge to provide the pressure/force to push the filtrate through the filter; However, Seynaeve discloses in example 2 on page 5, that centrifuge filtering (i.e., filtration over a laboratory basket centrifuge, where filtration bags are used) of stearin fraction out of olein fraction, is well known and conventional, and Boroughs claims that separating solid fat fraction (i.e., crystalized solid fat (e.g., wax)) from hot liquid oil by basket centrifuge is superior to other separation means, and that rotating the centrifuge at 50-1,000 RPM and using nylon filter bag as the filtration medium provides solid fat crystals larger than 50µm (see Boroughs abstract; column 1, lines 26-33 and 50-75; Examples 1 and 2), which encompasses the rotation speed recited in claim 26, and also reads on nylon filter bag with pore size of 50µm, as a nylon filter bag with pore size of 50µm will clearly separate solid fat crystals larger than 50µm as disclosed in Boroughs. Accordingly, it would have been an obvious matter of choice to a skilled artisan at the time the application was filed to have modified Arnaud1, Arnaud2 and Arnaud3 and to have used centrifuge filtering using nylon filter bag with a pore size of 50µm at a rate encompassing the rotation speed in claim 26 in order to separate the stearin fraction from the olein fraction, as known and conventional in the art, and thus arrive at the claimed limitations.
Response to Arguments
Applicant's arguments filed on May 19th 2025 have been fully considered but they are not persuasive.
Applicant argues on pages 4-8 of the “Remarks” that the prior art references fail to render the claimed invention obvious, because the statement in the introduction of Arnaud 3 discloses that “fat consists of a mixture of triglycerides with different melting points. The fat dry fractionation process involves selective crystallization of the highest melting point triglycerides followed by filtration. This leads to separation of a solid fraction (stearin) with a higher saturated fatty acid content and a liquid fraction (olein) with a higher unsaturated fatty acid content” lacks evidentiary support, as the document Arnaud3 relies on, “Characterisation of chicken fat dry fractionation at the pilot scale” (‘Arnaud4’) teaches in table 2 that dry fractionation of chicken fat provides a stearin fraction comprising 46.1% saturated fatty acids and 53.9% unsaturated fatty acids (MUFA+PUFA), and an olein fraction comprising only 13.9% saturated fatty acids and 69.7% unsaturated fatty acids, which is within 5% o4f the original fat (i.e., pre-fractioned mixture of triglycerides). The Applicant asserts that further evidence is needed. The examiner respectfully disagrees.
Table 2 in Amaud4 teaches dry fractionation of chicken fat provides a stearin fraction with higher saturated fatty acids content (i.e., 46.1%) versus an olein fraction with lower saturated fatty acids content (i.e., %13.9) and higher unsaturated fatty acids (i.e., 69.7%), whereas the stearin fraction comprises lower unsaturated fatty acids (i.e., 53.9%), which clearly supports the assertion in Amaud3 that dry fractionation separates a mixture of triglycerides into a stearin fraction with higher saturated fatty acids content and an olein fraction with higher unsaturated fatty acids content.
It is noted that Table 1 in Amaud4 where the results of another dry fractionation of chicken fat provides similar results where the stearin fraction comprises 43.5% saturated fatty acids and an olein fraction comprising lower saturated fatty acids content (i.e., 27.4%), and where the olein fraction comprises higher unsaturated fatty acids content (i.e., 72.6%) than the stearin fraction (i.e., 56.5%).
Accordingly, Arnoud4 clearly supports the assertion in Arnoud3 that dry fractionation separates a mixture of triglycerides into a stearin fraction with higher saturated fatty acids content and an olein fraction with higher unsaturated fatty acids content.
In arguendo, even if Arnaud1 is misinterpreted to compare the saturated and unsaturated fatty acids in stearin and olein fractions to the original unfractionated fat, the data provided in Arnaud4 clearly supports that interpretation in table 2: pre-fractionated chicken fat comprises 33.3% saturated fatty acids and 66.7% unsaturated fatty acids and dry fractionation provided a stearin fraction comprising 46.1% saturated fatty acids and 53.9% unsaturated fatty acids (MUFA+PUFA), and an olein fraction comprising only 13.9% saturated fatty acids and 69.7% unsaturated fatty acids. Arnaud4 also supports that interpretation in table 1: pre-fractionated chicken fat comprises 30.3% saturated fatty acids and 69.7% unsaturated fatty acids and dry fractionation provided a stearin fraction comprising 43.5% saturated fatty acids and 56.5% unsaturated fatty acids (MUFA+PUFA), and an olein fraction comprising only 27.4% saturated fatty acids and 72.6% unsaturated fatty acids.
Lastly, it is unclear where Applicant had attained the 5% margin of error assumption.
Applicant argues on pages 8-17 of the “Remarks” that the prior art references fail to render the claimed invention obvious, because Arnaud4 and Arnaud3 are aware that dry fractionation provides stearin and olein fractions with fatty acid profiles and melting points that are similar to the original triglyceride mixtures, which contradicts the disclosure in Arnaud1 that “fat consists of a mixture of triglycerides with different melting points. The fat dry fractionation process involves selective crystallization of the highest melting point triglycerides followed by filtration. This leads to separation of a solid fraction (stearin) with a higher saturated fatty acid content and a liquid fraction (olein) with a higher unsaturated fatty acid content”. The examiner respectfully disagrees.
As discussed above, the statement in Arnaud1 that “fat consists of a mixture of triglycerides with different melting points. The fat dry fractionation process involves selective crystallization of the highest melting point triglycerides followed by filtration. This leads to separation of a solid fraction (stearin) with a higher saturated fatty acid content and a liquid fraction (olein) with a higher unsaturated fatty acid content” is clearly supported in Tables 1 and 2 in Arnaud4. Where Table 1 discloses dry fractionated chicken fat with a stearin fraction comprising 43.5% saturated fatty acids and 56.5% unsaturated fatty acids (MUFA+PUFA), and an olein fraction comprising only 27.4% saturated fatty acids and 72.6% unsaturated fatty acids, from pre-fractionated chicken fat comprising 30.3% saturated fatty acids and 69.7% unsaturated fatty acids; and Table 2 discloses dry fractionated chicken fat with a stearin fraction comprising 46.1% saturated fatty acids and 53.9% unsaturated fatty acids (MUFA+PUFA), and an olein fraction comprising only 13.9% saturated fatty acids and 69.7% unsaturated fatty acids, from pre-fractionated chicken fat comprising 33.3% saturated fatty acids and 66.7% unsaturated fatty acids.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASSAF ZILBERING whose telephone number is (571)270-3029. The examiner can normally be reached M-F 8:30-5:00.
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/ASSAF ZILBERING/Examiner, Art Unit 1792