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
Continued Examination under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/30/2026 has been entered.
Status of the application
3. Claims 1-3, 5-7, 9-15 are pending in this office action.
Independent claims 1, 6 are amended.
Claims 4,8 are cancelled.
Claims 1-3, 5-7, 9-15 are rejected.
Claim Rejections - 35 USC § 103
4. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
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-AlA) 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.
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. 4a. The factual enquiries set forth in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S. C. 103(a) are summarized as follows:
a. Determining the scope and contents of the prior art.
b. Ascertaining the differences between the prior art and the claims at issue.
c. Resolving the level of ordinary skill in the pertinent art.
d. Considering objective evidence present in the application indicating obviousness or non-obviousness.
5. Claims 1-3, 5-7 are rejected under 35 U.S.C. 103(a) as being unpatentable over Brody et al. USPN 3,113, 030 in view of Yang et al. (TW 94105228 A) in view of Donaldson et al. WO 2007086762 A1 (Please consider Donaldson posted by examiner on 4/22/2025 as FOR Ref and not the prior one on 2/29/2024 ,23 pages which is incomplete) in view of Hundscheid et al. US 2009/0068315 and as evidenced by NPL pressure Cooker.
6. Regarding claims 1-3, 5-7, Brody et al. discloses a method of making a soluble protein composition comprising soluble proteins with additional ingredients, as desired (at least col 1 lines 5-10, 15-20; col 2 lines 22-25). Brody et al. also discloses that animal meat is hydrolyzed using proteolytic enzyme derived from many sources including Aspergillus orzyae and also it can be any type of protease including e.g. trypsin, papain, bromelin , ficin or Rhozyme P11 (at least in col 2 lines 22-25).
It is to be noted that the claimed invention claims enzyme: starting material ratio. However, Brody discloses that “animal meat is hydrolyzed by the enzyme. In specification, it is evidenced by applicant’s specification (in paragraph [0048]) that protease enzyme added to chicken solids. Therefore, the disclosed ‘animal protein’ can read on “ starting material” which contains protein. Therefore, protein as starting material source serves as the substrate for the enzyme protease.
Therefore, it meets enzyme of claims 1(a), 6 (a) and ‘protease’ of claim 3. Brody et al. also discloses the method of making the soluble protein is performed using an amount of 0.01 to 1.0% (col 2 lines 27-28) or 0.4 % of the proteolytic enzyme on the basis of the protein content of the meat (col 4 Ex 3) and under 50-55 degree C for 1-2 hours incubation (col 2 lines 35-40) to obtain a mixture having fine suspension and the balance of a solution (at least in col 2 lines 45- 50, col 4 under Example 3) which meets claim limitation of enzyme : Starting material (substrate) ratio of claims 1, 6 and also it meets enzyme concentration of claim 5. It is to be noted that this enzyme substrate ratio is also optimizable and discussed below. 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).
Brody et al. is silent about the (i) sequential steps of claims 1, 6 including further (ii) treatment step at the claimed temperature range under pressure condition prior to the step of centrifugal separation and after enzymatic treatment step as claimed in claim 1 (c) and claim 6 (c).
With respect to (i) and (ii), Yang et al. also discloses a method of making chicken essence by heating at 40-60 degree C (i.e. 104 degree F-140 degree F) and adding protease enzyme(s) e.g. enzyme Bacillus metallo- endopeptidase (E.C. 3.4.24.28) and 0.01 to 0.1% Aspergillus serine carboxypeptidase (E.C. 3.4.16.1) (i.e. protease) of the weight of chicken meat and bone mixture, add water for a time period of 30-120 minutes followed by elevating the temperature to 100-121 degree C (121 degree C=250 degree F) at 1 to 1.5 atm pressure (atmospheric pressure is about 15 psig.) and extracting for 0.5 to 8 hours (at least in Abstract; page 3 , Under “Invention Content”). It is evidenced by NPL pressure cooker that the claimed temperature and pressure is the conventional pressure cooker (See page 1, e.g. 121 degree C=250 -degree F and also page 2 under Quora , e.g. 8-12 psi) and atmospheric pressure is about 15 psig). Therefore, it meets claimed temperature, pressure and time of treatment as claimed in independent claims 1 and 6. 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). This sequential step of enzymatic treatment followed by pressure cooking meets sequential steps of claims 1, 6 and it successfully eliminates the bitterness value of the final product when compared to previous enzyme treated product (at least in Abstract, and page 3, Under “Invention Content”). It is to be noted that the disclosed steps are similar and identical to the treatment conditions as claimed in claims 1 and 6, therefore, will have identical claimed property of the claimed product.
Therefore, the disclosed processed product will contain chicken essence as a mixture of fully cooked slurry at the end of the claimed steps of claim 1 (a), (b) and claim 6 (a) and (b). Therefore, one of ordinary skill in the art would have been motivated to further purify to make chicken essence as a soluble broth to be used in other food products after performing the necessary steps of further separation.
It is understood that the disclosed method to make chicken essence as disclosed by Yang et al. contains “soluble protein from a starting material derived from animal source” as claimed in claims 1, 6.
Yang et al. also discloses that after the steps of enzymatic hydrolysis followed by high pressure extraction, the mixture is separated from oil (i.e. aqueous containing soluble protein) (at least in Abstract and under “Implementation method”, on page 4, mid-section).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Brody et al. with the teaching of Yang et al. to perform additional heat treatment under pressure after enzymatic treatment which successfully eliminates the bitterness value of the final product when compared to previous enzyme treated product (Yang et al., Abstract and page 3, Under “Invention Content”).
Body et al. in view of Yang et al. are specifically silent about the further separation at the steps of claim 1(c)-(d) and claim 6 (c)- (d) and separation step (c ) is carried out by centrifugation as claimed by claim 2 in order to obtain “a soluble protein composition”.
Yang et al. discloses that the mixture is left to stand until the oil is separated (page 3 Under Implementation method, last five lines).
Donaldson et al. discloses specifically the method of separation of such hydrolyzed animal protein to separate into three distinct fractions using centrifugation method in order to make pure soluble protein composition free of fat/oil and to separate residual solid fraction (meat fiber containing layer fraction) (page 6, last two paragraphs). Donaldson et al. discloses that high speed centrifugation of such a similar hydrolyzed product will cause it to separate into three distinct fractions, being the fats, a clear liquid containing over 99% of the protein content, and the meat fiber (at least on page 6, last two paragraphs and page 7, first two lines) in order to use them separately in the market as per demand (at least on page 6, last two paragraphs, and page 7 lines 1-2).
Therefore, it is also to be noted that the disclosed “a clear liquid containing the soluble protein content” fraction reads on first protein composition of claim 6 ( e) and which recites the collection of liquid fraction to obtain first protein composition (i.e. Broth) to obtain said protein fraction with minimal /no fat containing “broth” of claim 1 (e) and “first protein fraction” of claim 6 (e) and claim 7 and “the meat fiber” fraction reads on second protein composition as it is Known and is evidenced in “background section” that undigested solid portion includes undigested meat portions e.g. as meat fiber which relates to the residual “protein tissue fiber’ can remain as undigested solid portion (at least on page 3, of Donaldson et al., the evidence is from cited prior art USPN 6319527 by Donaldson et al. ) after extraction and separation step. One of ordinary skill in the art would have been motivated to separate undigested portion of the protein which relates to the residual ‘protein tissue fiber’ etc. (at least on page 6, of Donaldson et al. last two paragraphs and page 7 first two lines) with a reasonable expectation of success for its further desired use with or without further processing.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Body et al. in view of Yang et al. with the teaching of Donaldson et al. to separate fat from aqueous liquid which (fat) is present in the protein source (at least in page 6 last two paragraphs and page 7, first two lines) in order to obtain said protein fraction with minimal /no fat containing “broth” of claim 1 (e) and “meaty layer” of claim 1 and “ at least a solid fraction” of claim 6 (e) which provides benefits of having pure soluble protein composition in combination with separated fractions with the removal of fat and residual ‘solid fraction’ for the further desired use of individual components with or without further processing step (at least on page 6, of Donaldson et al. last two paragraphs and page 7 first two lines).
7. For claims 1, 5, 6, it is known and Brody et al. discloses that the concentration of enzyme depends upon the purity of the enzyme used the time allowed for the enzymatic reaction and the nature of the substrate ( col 2 lines 28-34).
Donaldson et al. also discloses that the amount of enzyme required to achieve complete hydrolysis varies depending on the composition of the protein source being treated (page 9 lines 22-26 of Donaldson) and numerous variations and modifications may be made to these embodiments without departing from the scope of the invention (page 17, Under Variations, paragraph 1 of Donaldson et al.). Therefore, it is optimizable.
Absent showing of unexpected results, the specific amount of enzyme is not considered to confer patentability to the claims. As the amount of protein to be digested is variable that can be modified, among others, by adjusting the number of enzymes, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of enzyme in Yang et al. in view of Donaldson et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired complete hydrolysis of the protein (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art ( In re Aller, 105 USPQ 223).
It is to be noted that and as discussed above that Donaldson et al. discloses that high speed centrifugation of such a similar hydrolyzed product will cause it to separate into three distinct fractions, being the fats, a clear liquid containing over 99% of the protein content, (at least on page 6, last two paragraphs and page 7, first two lines) in order to use them separately in the market as per demand (at least on page 6, last two paragraphs, and page 7 lines 1-2).
8. Regarding the claim limitation of “PDCAAS of at least 90”, Brody et al. in view of Yang et al. in view of Donaldson et al. are specifically silent about the claim limitation of “PDCAAS of at least 90” as claimed in claims 1, 6.
Hundscheid et al. discloses that PDCAAS score 0.9 or greater ([0085]) is a measure of good quality protein which is fully understood by those skilled in the art ([0085]).
Therefore, one of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Brody et al. to include the teaching of Hundscheid et al. to evaluate the quality of the soluble proteins with respect to its PDCAAS value greater than 0.9 in order to have good quality protein for the use as food or to add in other food composition.
However, it is understood that the combinations of prior art discloses the same method steps from the same starting material derived from animal source using same enzyme and performing same enzymatic hydrolysis followed by cooking with pressure under identical conditions of claimed condition as claimed in claims 1, 6. Therefore, as the disclosed method steps with identical condition using identical components meet the claimed condition of claims 1, 6, therefore, the product will have identical claimed property including the property of having “ wherein said soluble protein composition has a PDCAAS of at least 90” as claimed in claims 1, 6.
It is also to be noted that regarding the PDCAAS value, and the “protein digestibility score” and ‘amino acid score” as claimed in claims 1,6, the Office is not equipped to manufacture prior art products and compare them for patentability. Applicant is reminded that 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 USPQ430, 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, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
9. Regarding claim 7, in addition to the discussion above, it is also to be noted that it would have been obvious that the fat and soluble protein containing liquid are considered as liquid fraction which is not solid fraction (protein fiber fraction) (at least in page 6 last two paragraphs and page 7, first two lines of Donaldson et al.) which meets the claim limitation “liquid fraction comprises a fat layer” as claimed in claim 7. It is to be noted that the liquid fraction comprising fat layer can further be separated from fat if the residual fat remains by using the same disclosed method of Donaldson et al. to separate fat from aqueous liquid when fat is more in the protein source.
10. Claims 9, 10 are rejected under 35 U.S.C. 103(a) as being unpatentable over Brody et al. USPN 3,113,030 in view of Yang et al. (TW 94105228 A) in view of Donaldson et al. WO 2007086762 as applied to claim 1 and further in view of D1 et al. KR 100512705 B1 (As inventor’s name is in KR language, therefore, examiner wrote D1 inventor).
11. Regarding claim 9, and 10, Brody et al. in view of Yang et al. in view of Donaldson et al. are silent about the acidification step using carbonated water. It is also to be noted that an acidic environment serves as preservative because it does not allow unwanted microbes to grow during storage (Common knowledge).
D1 discloses that the use of carbonated water as acidifying agent provides the benefit of removing chicken smell (at least under TECH-SOLUTION, paragraph 3, page 3).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Brody et al. to include the teaching of D1 et al. to consider introduction of carbonated water as acidic agent to broth layer in order to reduce pH and also this has an effect to remove chicken smell (at least under TECH-SOLUTION, paragraph 3, page 3) and serves as carbonated liquid food having specific known taste and texture of carbonated liquid food.
12. Claim 11 is rejected under 35 U.S.C. 103(a) as being unpatentable over Brody et al. USPN 3,113,030 in view of Yang et al. (TW 94105228 A) in view of Donaldson et al. WO 2007086762 in view of Hundscheid et al. US 2009/0068315 as applied to claim 1 and further in view of Raghavan et al. US 2005/0170060.
13. Regarding claim 11, Brody et al. silent about microfiltration step.
Raghavan et al. discloses that microfiltration step removes off-flavor from chicken broth ([0020], Fig 5) and also it effectively removes fat ([0022]), and this method develops concentrated chicken broth ([0029]) which means microfiltration method enrich certain proteins or certain amino acids obtained from step (e).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Brody et al. to include the teaching of Raghavan et al. to perform the microfiltration step after step (e ) of claim 1 in order to develop concentrated chicken broth ([0029]) , therefore, it makes an enriched chicken broth with certain proteins or certain amino acids and also microfiltration step removes off-flavor from chicken broth ([0020], Fig 5) and it effectively removes (residual) fat ([0022]).
14. Claims 12, 13 are rejected under 35 U.S.C. 103(a) as being unpatentable over Brody et al. USPN 3,113, 030 in view of Yang et al. (TW 94105228 A) in view of Donaldson et al. WO 2007086762 in view of Hundscheid et al. US 2009/0068315 as applied to claim 1 and further as evidenced by Salemme Francis US 2006/0286276 Al.
15. Regarding claims 12, 13, Brody et al. in view of Yang et al. in view of Donaldson et al. disclose “protein rich liquid extract” (at least in claim 1) to make protein rich liquid broth (at least in claim 4 (d) of Donaldson et al.) which is from animal source including any animal including chicken (page 7 lines 15-22) to make broth. Therefore, it is Known that this animal broth is a food or beverage. However, more specifically, Salemme Franchise discloses the method of making low sodium containing beverage by reducing sodium chloride and considering potassium chloride and Taurine in chicken broth that can be used as food or beverage as disclosed by Salemme Franchise ([0002] and claims 1, 17 of Salemme Francis). It is to be noted that this food or beverage of Salemme Franchise can read on “soluble protein” is an ingredient of this chicken broth beverage as claimed in claim 12.
One of ordinary skill in the art before the effective filling date of claimed invention would have been motivated to modify the animal source of Brody et al. in view of Yang et al. in view of Donaldson et al. from chicken (page 7 lines 15-25 of Donaldson et al.) to include the teaching of Salemme Franchise to consider using chicken broth as food or beverage which is source of protein and the chicken broth beverage of Salemme Franchise is salt substituted chicken broth beverage for known health benefit.
16. Claims 12, 13, 14 are rejected under 35 U.S.C. 103(a) as being unpatentable over Brody et al. USPN 3,113, 030 in view of Yang et al. (TW 94105228 A) in view of Donaldson et al. WO 2007086762 in view of Hundscheid et al. US 2009/0068315 as applied to claim 1 and further in view of Sorensen et al. (WO 2004049818).
17. Regarding claims 12-14, Brody et al. in view of Yang et al. in view of Donaldson et al. “protein rich liquid extract” which is from animal source including any animal including chicken as discussed above to make soluble protein composition as discussed above. Therefore, it is Known that this animal broth is a food or beverage.
However, more specifically, Sorensen et al. discloses that hydrolyzed product from raw material e.g., including waste product from animal (at least under Detailed Description on page 4, Under A. ‘Raw material ‘, paragraphs 2-3), can have hydrolysate comprising water soluble high protein fraction can be used as food additive, nutritional supplement, broth etc. (at least on page 13, Under H, paragraph 4).
One of ordinary skill in the art before the effective filling date of claimed invention would have been motivated to modify Brody et al. in view of Yang et al. in view of Donaldson et al. to include the teaching of Sorensen et al., hydrolyzed product from raw material e.g., including waste product from animal (at least under Detailed Description on page 4, Under A. ‘Raw material ‘, paragraphs 2-3), can have hydrolysate comprising water soluble high protein fraction can be used as food additive, nutritional supplement, broth etc. (at least on page 13, Under H, paragraph 4).
18. Claim 15 rejected under 35 U.S.C. 103(a) as being unpatentable over Brody et al. USPN 3,113030 in view of Yang et al. (TW 94105228 A) in view of Donaldson et al. WO 2007086762 in view of Hundscheid et al. US 2009/0068315 and further in view of Sorensen et al. (WO 2004049818) as applied to claim 14 and as evidenced by Lynch et al. EP 3047853.
19. Regarding claim 15, it is to be noted that the combinations of prior arts disclose the method steps of the claimed invention of claim 1. Donaldson et al. discloses that the method can include connective tissue also which provides an improved nutritional composition (page 16 line 19).
It is known and as evidence by applicants’ specification that supplement has various functionality including promoting growth of certain bacteria ([0021] in PGPUB) and soluble collagen fiber is a prebiotic as is evidenced by Lynch et al. (at least in Under Summary, paragraph 6).
Pertinent prior art
20. Cruz Serna et al. US 2012/0258236 : Discloses PER, PDCAAS to evaluate protein quality ([0005]-[0007]).
Response to arguments
21. Applicant’s arguments and amendment have been considered and they overcome 112 (a), 112 (b) and 112 (d) rejections and obviousness rejections of record.
Regarding obviousness rejection, Examiner has considered a new secondary prior art by Hundscheid et al. US 2009/0068315 to address the amended claim limitation of “ wherein said soluble protein composition has a PDCAAS of at least 90” as claimed in claims 1, 6 and discussed in detail in this office action.
Examiner’s arguments related to D1 secondary prior art by D1 and Raghavan et al.is addressed below.
Argument’s argued on fifth page in remarks that D1 is improper because D1 is from disparate technical fields with different objectives. Examiner is responding considering the complete arguments made for D1.
In response, it is to be noted that even if D1 is directed to a method of cooking, however, D1 is used as secondary prior art to address the acidification step with motivation. However, D1 is related to chicken food preparation. Therefore, analogous art. In this instance, motivations are (i) to acidify in order to inhibit the growth of unwanted microorganisms and (ii) it removes chicken smell (at least under TECH-SOLUTION In addition, “Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis)”., paragraph 3, page 3) as discussed in detail in the office action above.
However, note that while D1 does not disclose all the features of the present claimed invention, D1 is used as teaching reference, and therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981). Rather this reference teaches a certain concept, namely acidification step to acidify chicken protein product with motivation, and in combination with the primary reference, discloses the presently claimed invention.
22. Applicant’s arguments made for Raghavan is also considered. It is to be noted that Raghavan is used as secondary prior art and not primary prior art. It is to be noted that Raghavan et al. discloses off-flavor removal by microfiltration method. Claim 11 does not claim the higher temperature at the step of microfiltration (MF). Raghavan’s MF is considered as an additional step in order to remove off-flavor from chicken, therefore, analogous art and proper to modify Brody et al. to meet further step (f) of claim 1 as claimed in claim 11.
In addition, according to MPEP 2143.01, “Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis)”.
Therefore, examiner has considered a specific teaching from Raghavan et al. to modify Brody et al. with motivation, and discussed in detail in the office action above.
However, note that while Raghavan et al. does not disclose all the features of the present claimed invention, Raghavan et al. is used as teaching reference, and therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981). Rather this reference teaches a certain concept, namely acidification step to acidify chicken protein product with motivation, and in combination with the primary reference, discloses the presently claimed invention.
There are no further arguments.
The rejection is made as non-final.
Conclusion
23. 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