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 4 is objected to because of the following informalities:
In line 1, insert “the” before “hydrated poultry fat product” to place the claim in better form.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 3 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The antecedent basis of the claim as a whole is unclear since claim 2 is now canceled.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 3, the claim depends from now canceled claim 2.
Regarding claim 16, the claim is no longer further limiting since claim 15 as currently amended does not recite alternatives “introducing water or injecting stem”, and now requires injecting steam.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 3-6, 8-11, and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Slade et al. (US 11,118,133 B2) in view of Hicks et al. (US 2019/0249110 A1) and Reformation NPL.
Regarding claim 1, the limitation “a rendered poultry fat product” is interpreted in as defined the specification to contain a maximum MIU of 2% (paragraph 57).
Slade et al. teaches a method of treating a composition including animal fats (abstract), the animal fats including tallow and poultry fat (column 4 line 65 to column 5 line 1), the composition comprising free fatty acids (FFA) (column 6 line 59), comprising an alkalinity reduction process of injecting steam into the fat to form a hydrated poultry fat at a temperature of about 150-200oF (column 10 lines 9-10; column 18 lines 64-67), agitating the hydrated poultry fat to obtain a mixture including homogeneously dispersed droplets (column 10 lines 9-15 and 19-20), and separating a sludge phase, an aqueous phase, and an oil phase in a three-phase centrifuge to obtain an oil phase (refined fat product) having reduced metal ions (column 10 lines 15-19 and 30-35). The same process is disclosed to separate impurities as sludge (understood to include at least some water), remove solids and precipitates, and remove water-soluble impurities as part of the aqueous phase (column 19 lines 7-17). The process is therefore construed to teach “droplets of water are dispersed throughout and coalesce with water-soluble impurities and particulate impurities…to form a plurality of water-laden particles” which are then removed from the poultry fat to obtain the refined poultry fat product. The process allows for the reduction of impurities while maintaining the weight percent of FFA in the composition (column 4 lines 5-13; column 15 table 2; column 18 lines 12-14)
Slade et al. does not teach the poultry fat being a rendered poultry fat product comprising a maximum MIU of 2% as interpreted above and said agitation performed with heating the hydrated poultry fat product to a temperature of less than about 150oC.
Hicks et al. teaches a method of purifying a rendered fat (abstract), where the rendered fat source includes poultry (paragraph 9). The fat is heated in a water bath with agitation to a temperature of 60-70oC (paragraphs 47-58).
Reformation NPL teaches a method of rendering suet i.e., beef fat (timestamp 0:09) comprising introducing water into the beef fat to form a hydrated fat (timestamp 0:23-0:30), agitating and heating the hydrated fat under “low heat” (timestamp 0:35-0:45), and filtering the rendered beef fat from the solids to obtain a rendered beef fat (timestamp 0:48-1:24). The process is performed in a slow cooker, which one of ordinary skill understands to operate at temperatures below 150oC, particularly at the “low heat” setting. The rendered fat is then solidified (timestamp 1:25-1:30) and separated from the water, where the water includes water-soluble and particulate impurities (timestamp 1:32-2:00). After separation, the rendered fat is broken into chunks and the above process is repeated “1-2 more times until the water (or gel) on the bottom is clear” (timestamp 2:10-2:27). The final product is a rendered fat product that has been refined multiple times to remove impurities (timestamp 2:33).
The prior art recognizes performing multiple purification steps on rendered fat in order to gradually isolate and remove impurities using water and heated agitation, and further recognizes steam injection can be used to heat the fat without loss or change of FFA content to the refining process. Slade et al. further teaches the purification process yields a fat product having a MIU of less than 2 wt% (column 16 table 5 “moisture” “insoluble impurities” “unsaponifiables”). One of ordinary skill would have reasonably expected performing multiple refining processes to yield at least one cycle which both begins and ends with a fat product having less than 2% MIU. Thus, the issue to be addressed is a matter of repeating the refining processes after reduction of MIU to 2% or lower. One of ordinary skill would have recognized that the relative content of water soluble and particle impurities to MIU can vary based on source e.g., initial contamination level and/or introduction during transport, storage, and handling.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Slade et al. to use a rendered poultry fat product having no more than 2% MIU and heat the hydrated fat product while agitating since the reference teaches the animal fat to be treated includes RBD (already refined) grade tallow (column 4 lines 62 and 67), since the rendered poultry fat product is commercially available as recognized by Applicant (paragraph 61) thus as a matter of preference and/or availability of the fat source, to ensure the fat remains in a liquid state during processing and facilitate uniform dispersion of the clarifying water throughout the fat during agitation, to provide a known and commonly used technique (steam injection) to rapidly heat the fat to a working temperature while simultaneously introducing purifying water, and to obtain a refined poultry fat product having a desired level of water soluble and particulate impurity reduction, where the process would have been performed multiple times based on the relative contents of water soluble and particle impurities to MIU e.g., a significantly higher content of the prior relative to the latter would require additional refining after the MIU content is reduced to below 2% in order to reduce the water soluble and particulate impurities to a desired level.
Regarding claim 3, in view of the rejections under 35 USC 112(b) and 112(d) above, the claim is interpreted to refer to the temperature of the rendered fat product after steam injection.
Slade et al. teaches the fat is heated via steam injection to a temperature of 150-200oF as stated for claim 1, and provides an example of 80oC (column 18 lines 64-66).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Slade et al. to heat the fat with steam to a temperature in the claimed range since the prior art recognizes temperatures both overlapping and within the range, since there is no evidence of criticality with respect to the temperature, and since the values would have been used during the course of routine experimentation and optimization procedures due to factors such as fat composition and melting temperature thereof, temperature and amount of injected steam, and desired working temperature.
Regarding claim 4, Slade et al. does not specify the hydrated poultry fat has a water content of about 2-5 wt%.
However, the reference teaches the amount of water combined with the composition can be from about 0.2-10% based on composition mass (column 10 lines 24-26) and steam can be mixed at a rate of 5% by mass of the composition (column 18 lines 64-66).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Slade et al. such that the hydrated fat has a water content in the claimed range since the reference recognizes a similar range of added water, since there is no evidence of criticality with respect to the claimed range, and since the values would have been used during the course of routine experimentation and optimization procedures due to factors such as fat composition and melting temperature thereof, temperature and amount of injected steam, desired working temperature, and to provide sufficient water for removal of impurities.
Regarding claim 5, Slade et al. teaches the separation method can include settling tanks known to skilled artisans (column 11 lines 6-8; column 16 lines 37-39), where settling tanks are known to employ gravity.
Reformation NPL teaches refrigeration of the heated fat thereby allowing the plurality of water-laden particles to settle by gravity (timestamp 1:26-1:50).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Slade et al. to allow the plurality of water-laden particles to settle by gravity since the reference states embodiments can be practiced together (column 1 lines 59-62), since the process is recognized by the prior art as a means to separate water soluble and particulate impurities from rendered fat, and to ensure stratification of the different phases to facilitate separation by the three-phase centrifuge.
Regarding claim 6, Slade et al. teaches a centrifugation step as stated for claim 1, and the modification to claim 5 renders obvious settling by gravity.
Regarding claim 8, the specification does not explicitly define “fatty acid profile”, and therefore the limitation is construed to refer to the profile of any type of fatty acid within the composition e.g., free fatty acid profile.
Slade et al. teaches the refining process maintains the FFA content of the composition as stated for claim 1, and the combination applied to said claim renders obvious the claimed process. One of ordinary skill in the art would have understood that a FFA profile is therefore not altered by the process.
Regarding claim 9, the combination applied to claim 1 renders obvious the rendered poultry fat product having a MIU of less than 2%.
Regarding claim 10, Slade et al. teaches the steam heated composition at a temperature of 150-200oF, including an example of about 80oC as stated for claim 1. The temperature would have necessarily passed through the range of 40-60oC. Since the claim does not recite or otherwise require the temperature to be maintained at said range, the steam heating of Slade et al. is construed to read on the claim.
Regarding claim 11, Slade et al. teaches the steam heated composition at a temperature of 150-200oF, including an example of about 80oC, and Reformation NPL teaches heating and agitation at a “low temperature” before separation as stated for claim 1. The separation step of Reformation NPL is also shown to be performed at room temperature (timestamp 0:42-1:25). Neither reference requires additional heating during settling and separation.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Slade et al. to perform the separation of step (c) at a temperature of less than about 80oC since the prior art recognizes the range for working temperatures, since the evidence of record does not indicate criticality or unexpected results associated with the range, and since the values would have been used during the course of routine experimentation and optimization procedures due to factors such as fat composition and melting temperature thereof, temperature and amount of injected steam, desired working temperature, and minimizing energy usage while ensuring the fat composition remains liquid during phase separation.
Regarding claims 13-14, the combination applied to claim 1 teaches heating and agitating fat with added water, where the working temperature can be 150-200oF as taught by Slade et al., and therefore reads on claim 13.
Slade et al. does not explicitly teach about 90-100oC as stated for claim 14.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Slade et al. to heat the hydrated poultry fat product to a temperature of about 90-100oC for the same reasons stated for claim 3, particularly since the evidence of record does not indicate criticality or unexpected results associated with the range, and since the values would have been used during the course of routine experimentation and optimization procedures due to factors such as fat composition and melting temperature thereof, temperature and amount of injected steam, desired working temperature, and minimizing energy usage while ensuring the fat composition remains liquid during phase separation.
Regarding claim 15, the combination applied to claim 1 is applied to claim 15 and would have been obvious for the same reasons. Claim 15 recites the same limitations as claim 1, except step (b) is performed at a temperature of less than about 100oC.
Slade et al. teaches 150-200oC as stated for claim 1, and therefore reads on the claimed temperature range.
Regarding claim 16, Slade et al. teaches injecting steam as stated for claim 1.
Regarding claim 17, Slade et al. does not specify the hydrated poultry fat has a water content of about 2-5 wt%.
However, modification would have been obvious for the same reasons stated for claim 4.
Regarding claim 18, the modification applied to claim 5 renders obvious the claimed features. The same modification is applied to claim 18 and would have been obvious for the same reasons.
Regarding claim 19, Slade et al. teaches a centrifugation step as stated for claim 1.
Regarding claim 20, Slade et al. does not explicitly teach 90oC for step (b).
However, modification would have been obvious for the same reasons stated for claim 14.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Slade et al. in view of Hicks et al. and Reformation NPL as applied to claim 1 above, and further in view of Bexar NPL and Gruver Jr. (US 3,261,546).
Regarding claim 12, Slade et al. does not teach measuring the turbidity of the refined fat product.
Bexar NPL teaches a method for purifying rendered beef fat comprising rendering beef fat with water, settling, and separating the impurities (timestamp 1:50-4:16), where the process is repeated four times, and fat purified twice has a different color i.e., more impurities, than that of four-time purified fat (timestamp 4:23-4:43).
Gruver Jr. teaches a method of purifying rendered fats to produce clarified, solid free material (column 1 lines 9-13), where the turbidity of the clarified fat is measured (column 2 lines 20-21).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Slade et al. to measure the turbidity of the refined fat product since means for measuring turbidity are well known and commonly available, where it is desirable to reduce turbidity to determine if the clarity of the product is acceptable, and therefore as a selection of known means and methods to determine degree of clarity and/or effectiveness of the clarifying process, see also MPEP 2143 I.(A) and (D).
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.
Claims 1, 3-6, and 8-20 (particularly claims 1 and 15) are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-17 (particularly claim 13) of U.S. Patent No. 12,357,008 B2 in view of Slade et al.
The ‘008 patent does not recite the rendered poultry fat product comprising FFA, and the FFA content is not altered or increases as a result of the process.
Slade et al. teaches a process of removing impurities from a fat composition containing FFA by injecting steam to a temperature below 150oC, agitating, and removing water-laden particles, where the process does not affect the FFA content as stated in the prior art rejection above. The reference further teaches lipid feeds are used for production of renewable diesel, where the feeds containing FFA are converted to isoparaffinic hydrocarbons (column 3 lines 29-31).
It would have been obvious to modify the ‘008 patent such that the process is carried out on a fat containing FFA and such that the FFA content is not altered in order to provide lipid feeds having sufficient FFA for production of renewable diesel, and since the prior art recognizes the purification process to maintain FFA content.
Response to Arguments
Applicant's arguments filed 2/10/2016 have been fully considered but the amendments to claims 1 and 15 necessitated new grounds of rejection. Specifically, the claim now explicitly requires steam injection, FFA present in the rendered fat, and no alteration or increase in FFA content after processing. The presence of FFA together with the unaltered or increased FFA content was not previously recited nor considered. Therefore, Reformation NPL is no longer relied on as the primary reference. Lin and Cheftalk NPL are no longer relied upon in the prior art rejection. Slade et al. is now relied on as the primary reference, and teaches steam injection with agitation and separation, where the process does not alter FFA content.
Applicant argues Lin teaches steam injection for neutralization and reduction of unwanted FFA due to unpalatability.
While the reference is no longer relied upon, Examiner notes that Lin discloses the steam injection process requires vacuum to evaporate and remove FFA (paragraph 3). Slade et al. as relied upon above does not require vacuum evaporation, and teaches unaltered FFA content. Further, the claimed process does not require the refined fat product to be used as a food, nor does the process require palatability of the product.
Applicant argues on page 7 that repetition of the process is not required in the scope of claim 1, and performing the claimed process only once converts the rendered poultry fat into a refined poultry fat, so the following process would not begin with a rendered poultry fat as claimed.
This is not persuasive since the claim does not exclude repetitions, particularly due to the transitional phrase “comprising” in line 2. Further, the specification does not exclude previously refined fat from the “rendered poultry fat product”, nor is there any indication that the refined poultry fat cannot be subjected to further refining. One of ordinary skill would have considered a rendered poultry fat that has been refined to still be a type of rendered fat.
Additionally, the rejection does not rely on purifying repetitions per se. Rather, the teaching is cited to show that rendered fat can be refined multiple times, where the input fat would have been expected to eventually comprise a MIU content below a certain value e.g., 2%. Based on the open-ended transitional phrase, the particular cycle in which the above occurs would then read on the claimed process and the “rendered poultry fat product” as defined in the specification.
Applicant’s argument against Bexar NPL and Gruver Jr. has been considered, but the amendments applied to claims 1 and 15 necessitated new grounds of rejection as stated above. The prior art combination applied to said claims renders obvious the claimed process. Bexar NPL and Gruver Jr. are relied on to show that turbidity measurements can be performed on the refined product in order to determine the degree of purification.
Applicant’s argument against the dependent claims has been fully considered but are not persuasive for the same reasons stated above.
Applicant’s argument against the statutory double patenting rejection have been considered, and the rejection is withdrawn in view of the amendments to claims 1 and 15. However, the claims (and their dependents) are now rejected under non-statutory double patenting to U.S. Patent No. 12,357,008 B2 in view of Slade et al.
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 BRYAN KIM whose telephone number is (571)270-0338. The examiner can normally be reached 9:30-6.
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/BRYAN KIM/Examiner, Art Unit 1792