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 the application
2. Claims 1-15 are pending in this application.
Claims 1-15 have been rejected.
Claim Rejections - 35 USC § 112
3. 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.
4. Claims 2, 3, 8, 9, 11 and 15 are 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.
5. (a) Claim 2 claims “ two different alternatives of pre-treatment(i) the hydrolyzed material or (ii) the fat reduced material and the final claim limitation of claim 2 refers only to a “pre-dried hydrolyzed material” and not to an alternative option of a pre-dried fat -reduced material” which renders claim 2 indefinite. Claim 3 depends on claim 2 and claim 3 is also indefinite.
(b) Claim 8 depends on independent claim 1. Claim 8 recites the limitation “wherein the pre-treatment of the hydrolyzed material”. Independent claim 1 does not recite any “pre-treatment step. There is insufficient antecedent basis for this limitation in the claim. Accordingly, claims 9, 11 which depend on claim 8 are indefinite. In addition, the phrase “may be” in claim 9, and “may have’ in claim 11 can be interpreted as optional. Therefore, claims 9, 11 do not meet the requirement of claim 8.
(c ) At least claims 11, 15 recite the phrase ‘such as’. Regarding claims 11, 15, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
(d) Regarding claim 11, it is also to be noted that “A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c)”.
In the present instance, claim 11 recites the broad recitation of moisture content 20-45% (w/w) and the claim also recites moisture content 25-43 % (w/w), 30-40% (w/w), 32-38% (w/w) and also 35% 9w/w) respectively which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
6. 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.
7. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
8. Claim(s) 1, 2, 6-10, 12 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Fillieres et al. (USPN 10154678 B2).
9. Regarding claims 1, 7, 12, Fillieres et al. discloses a method of making digestible keratinaceous material comprising the steps of hydrolyzing keratinaceous material in the presence of water in a hydrolyzer (at least in Abstract and claim 1 of Fillieres et al.) which anticipates first step of hydrolysis as claimed in claims 1, 12 and also anticipates claim 7. It is to be noted that claim 12 is product-by -process claim and addressed below.
Fillieres et al. also discloses that the method further comprises the next step of reducing fat from the hydrolyzed product by performing further separation of hydrolyzed keratinaceous material by separating a liquid phase from solid material in a press, wherein after said pressing, the water content of the material is reduced to about 45 wt.% or lower (col 5 lines 10-15). (at least in col 5 lines 13-40, col 5 line 62 to col 6 line 23) which anticipates the second step of subjecting the hydrolyzed material to a fat removal step of independent claim 1.
Fillieres et al. also discloses that the method further comprises the next step of drying using air dryer (at least in col 3 lines 36-38) and using disc dryer, fluidized bed dryer etc. ( col 6 lines 20, 23-26) after the step of fat removal (at least in col 6 lines 1-5) which anticipates the third step of drying of fat-reduced material of independent claim 1.
10. Regarding claim 2, Claim 2 claims alternative limitation of “hydrolyzed material or the fat-reduced material”. Fillieres et al. discloses that the drying is generally done by bringing the mixture leaving the hydrolyzer to atmospheric pressure, while evaporating part of the water which is pre-treatment to vaporize water (at least col 5 lines 6-10). Therefore, it is pre-treatment to vaporize (i.e. evaporate) water which anticipates claim 2.
11. Regarding claim 6, Fillieres et al. also discloses that the drying process is performed using rotating flash dryer (i.e. spin flash dryer ) (at least in claim 14 of Fillieres et al.). Therefore, it anticipates claim 6.
12. Regarding claim 8, Fillieres et al. discloses that the drying is generally done by bringing the mixture leaving the hydrolyzer to atmospheric pressure, while evaporating part of the water to bring down the water content in the hydrolyzed material (at least col 5 lines 6-11, 12-15). Therefore, the ‘evaporation’ is pre-treatment of the hydrolyzed material. This anticipates “wherein the pre-treatment of the hydrolyzed material is a pre-drying of the hydrolyzed material of claim 8.
13. Regarding claims 9, 10, Fillieres et al. also discloses that the drying process is performed using disc dryer which is contact dryer (Col 6 lines 25-27) and anticipates claims 9, 10.
14. Regarding claim 12, the examiner also notes that claim 12 is product-by-process claims.
Therefore, it is to be noted that, in this case, the courts have held that when the
prior art factor appears to differ from the claimed factor only in the method of obtaining the factor, the burden of persuasion was on applicant to show that the claimed product exhibited unexpected properties compared with that of the prior art. The courts further noted that “no objective evidence has been provided establishing that no method was known to those skilled in this field whereby the claimed material might have been synthesized.” 10 USPQ2d at 1926.
The courts also held that “even though product-by-process claims are limited by
and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Furthermore, "[b]ecause validity is determined based on the requirements of
patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). See MPEP §2113.
Lastly the courts have held that when the prior art discloses a product which
reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). The examiner further notes that “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). See MPEP §2113.
Claim Rejections - 35 USC § 103
15. 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.
16. 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.
17. 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.
18. Claim(s) 3, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Fillieres et al. (USPN 10154678 B2).
Claims 2 and 8 are relied upon as above.
19. Regarding claims 3, 11, Fillieres et al. discloses the step of further separation of hydrolyzed keratinaceous material by separating a liquid phase from solid material in a press, wherein after said pressing, the water content of the material is reduced to about 45 wt.% or lower (col 5 lines 10-15). This meets claim limitation of claims 3, 11. It shows prima facie case of obviousness 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. 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).
20. Claim(s) 4, 5, 13, 14 are rejected under 35 U.S.C. 103 as being unpatentable over Fillieres et al. (USPN 10154678 B2).
21. Regarding claim 4, Fillieres et al. discloses a method of making digestible keratinaceous material comprising the steps of hydrolyzing keratinaceous material in the presence of water in a hydrolyzer (at least in Abstract and claim 1 of Fillieres et al.) to meet first step of hydrolysis as claimed in claim 4.
Fillieres et al. discloses that the drying is generally done by bringing the mixture leaving the hydrolyzer to atmospheric pressure, while evaporating part of the water to bring down the water content in the hydrolyzed material (at least col 5 lines 6-11, 12-15). Therefore, the ‘evaporation’ (i.e. vaporization) step is pre-treatment step to pre-treat the hydrolyzed material to make partially dried hydrolyzed material prior to fat removal ( (at least col 5 lines 6-11, 12-15). For example, Fillieres et al. also discloses the step of further separation of hydrolyzed keratinaceous material by separating a liquid phase from solid material in a press, wherein after said pressing, the water content of the material is reduced to about 45 wt.% or lower (col 5 lines 10-15). This meets claim limitation of claim 4. It is to be noted that claim 4 claims fat removal step after pre-drying step.
It is to be noted that claim 4 claims the fourth step of “and/or wherein the pre-dried hydrolyzed material is subjected to a fat removal step”. Accordingly, Fillieres et al. discloses that the method further comprises the next step of reducing fat from the pre-dried hydrolyzed product followed by next step of drying (at least in col 5 lines 5-40, col 5 line 62 to col 6 line 23). For example, Fillieres et al. also discloses the step of further separation of hydrolyzed keratinaceous material by separating a liquid phase from solid material in a press, wherein after said pressing, the water content of the material is reduced to about 45 wt.% or lower (col 5 lines 10-15). This meets claim limitation of claim 4. It is to be noted that claim 4 claims fat removal step after pre-drying step.
Fillieres et al. also discloses that the flash drying or hot air -drying results in better digestibility of the product ( at least in col 6 lines 20-25). Therefore, one of ordinary skill in the art would have been motivated to perform the step of subjecting the pre-dried hydrolyzed material to a drying process using the flash drying or hot air drying with a reasonable expectation of success to achieve better digestibility of the product ( at least in col 6 lines 20-25).
Regarding the fat removal step, it is to be noted that claim 4 can be interpreted as hydrolyzed material is subjected to fat-removal step followed by drying to make highly digestible fat reduced final product. Fillieres et al. also discloses that the disclosed pressing is followed by centrifuging the liquid phase to separate an aqueous phase containing solubilized proteins, a fat phase and residual solids, and reincorporating the defatted aqueous phase and the residual solids into the keratinaceous material (at least in col 5 lines 13-40, col 5 line 62 to col 6 lines 1- 23 and claim 1 of Fillieres et al.). It would also have been obvious that one of ordinary skill in the art may perform the drying method to make dried water solubilized protein keratinaceous material which is separated from fat to make highly digestible fat reduced final product.
23. Regarding claim 5, Fillieres et al. also discloses that the disclosed drying process can use air dryer (at least in col 3 lines 36-38), air dryer can be using disc dryer, fluidized bed dryer etc. ( col 6 lines 20, 23-26) after the step of fat removal (at least in col 6 lines 1-5) which meets claim 5.
24. Regarding claim 13, Fillieres et al. also discloses that the dried product contains 8 wt.% or less or 4-8 wt.% moisture content ( col 6 lines 10-15) and, in combination, the disclosure that “ reincorporating the defatted aqueous phase (i.e. with soluble proteins), and the residual solids” ( col 6 lines 4-8) can be interpreted as less/minimal fat in the final product. Therefore, it would have been obvious that the rest is protein in the final product. Therefore, the range amount of these three components overlap the claimed range amount as claimed in claim 13. It shows prima facie case of obviousness 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. 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).
25. Regarding claim 14, Fillieres et al. also discloses the higher digestibility of the hydrolyzed keratinaceous material (at least col 6 lines 28-32) including ‘pepsin digestibility about 70% to about 80% (at least col 6 lines 20-24). Regarding particle size, Fillieres et al. also discloses that D50 between about 50 microns to about 2 mm ( at least in col 5 lines 46-49).
26. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Fillieres et al. (USPN 10154678 B2) in view of NPL Boushy et al. (in Biological Wastes 32: 39-74, 1990).
27. Regarding claim 15, Fillieres et al. discloses a method of making digestible keratinaceous material comprising the steps of hydrolyzing keratinaceous material in the presence of water in a hydrolyzer (at least in Abstract and claim 1 of Fillieres et al.) to meet first step of hydrolysis as claimed in claim 1.Fillieres et al. also discloses that the method further comprises the next step of reducing fat from the hydrolyzed product (at least in col 5 lines 13-40, col 5 line 62 to col 6 line 23). Fillieres et al. discloses the step of further separation of hydrolyzed keratinaceous material by separating a liquid phase from solid material in a press, wherein after said pressing, the water content of the material is reduced to about 45 wt.% or lower (col 5 lines 10-15). Fillieres et al. also discloses that the flash drier can be rotating (i.e. spin) flash dryer (i.e. spin flash dryer).
Fillieres et al. is silent about a claimed system to perform the method as claimed in claim 15.
NPL Boushy et al. discloses a continuous processing method which provides the benefit of having shorter processing time ( e.g. 6-15 minutes, page 42, “continuous processing”) compared to longer processing time in Batch process ( e.g. 4-7 hrs. see Batch process, page 41). NPL Boushy et al. also discloses the arrangement and interconnection between hydrolyzer (For hydrolyzation), drying apparatus and also pressed liquid is returned to continuous drying which is considered and would have obvious be in liquid connection to the individual devices dedicated for specific purpose.
Fillieres et al. discloses that the pressed keratinaceous material is centrifuged, to separate residual solids with aqueous phase containing solubilized protein which is eventually reincorporated to the defatted aqueous phase ( col 6 lines 1-6). If we consider Fig 2 of NPL Boushy et al.(page 43), one of ordinary skill in the art can consider the guideline teachings to introduce the apparatus design of NPL Boushy et al. to make and use for the implementation of the method to make high digestible protein from keratinaceous material. In this instance, for example, apparatus of NPL Boushy et al. with the device at the pressing step can be connected to the decanter centrifuge which will generate waste fat (discard) and the defatted aqueous solubilized protein fraction will combine after “waste heat evaporation” and “before continuous drying” of the apparatus of NPL Boushy et al. (Fig 2) which will have obvious the fluid connection between oil and fat removing device, and also fat removing device is also in fluid connection to a contact dryer for continuous drying to meet claimed invention of claim 15.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Fillieres et al. with the teaching of NPL Boushy et al. by introducing an apparatus system having fluid connection between oil and fat removing device, and also fat removing device is also in fluid connection to a contact dryer for continuous drying to perform as continuous processing device because the continuous processing method with the such an apparatus provides the benefit of having shorter processing time ( in NPL Boushy et al. e.g. 6-15 minutes, page 42, “continuous processing”) compared to longer processing time in Batch process ( in NPL Boushy et al. e.g. 4-7 hrs. see Batch process, page 41).
Conclusion
28. One pertinent prior art by Fillieres et al. (US 2016/0157511 A1) is closest prior art. However, even if Fillieres ‘511 discloses many types of dryers like hot-air drying, spray drying etc. ( at least in [0035]) e.g. disc dryer ([0060]), but it does not teach all the claimed dryers including rotating (i.e. spin) flash dryer etc. Therefore, Fillieres et al. (USPN 10154678 B2) is considered as primary prior art in this office action.
29. Any inquiry concerning the communication or earlier communications from the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139.
If attempts to reach the examiner by telephone are unsuccessful, examiner’s supervisor Erik Kashnikow, can be reached on 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BHASKAR MUKHOPADHYAY/Examiner, Art Unit 1792
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