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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/12/2026 has been entered.
Status of the application
3. Claims 6-12, 14 are pending in this office action.
Claims 1-5, 13 have been cancelled.
Claim 14 is new.
Claims 6-12, 14 have been rejected.
Claim Rejections - 35 USC § 103
4. 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.
5. 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:
(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.
6. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ459 (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.
7. Claim(s) 6-11, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lerer et al. (WO 2020/102673 A1) in view of Nikolaevna et al. RU 2548111 C1 in view of Swaminathan US 2014/0079864 A1.
8. Regarding claims 6, 8, 10 -11, Lerer et al. discloses that phycobiliprotein are water soluble proteins which play a key role in photosynthesis. Lerer et al. also discloses that the major phycobiliproteins (PBP) include R-phycoerythrin, B-phycoerythrin from algae including Porphyridium cruentum (red algae) (page 1 lines 31-33 and page 2 lines 1-6) which meets Phycoerythrin of claim 6 and also meet claim limitation of “R-Phycoerythrin” of claim 8 and “red algae” of claim 10.
Lerer also teaches the coloring component phycobiliproteins (PBP) can be used in an amount of ‘at least 0.1% by weight of the PBP’ (i.e. pigment) composition (at least on page 30 which is non meat protein (page 30 lines 5-6). Phycoerythrin is used as natural colorant in food to replace artificial color (page 1, lines 31-page 2 lines 1-11) which is produced from Porphyridium cruentum (page 2 line 4, page 18, line 25; page 43, lines 12-15) to meet claim 8. Lerer et al. discloses that phycoerythrin , a red-colored PBP is extracted from Porphyridium cruentum (at least in page 18 lines 23-25) to meet claims 8, 11.
Lerer et al. also discloses that Porphyridium cruentum is a source of the red pigment phycoerythrin which is used to provide color to food; foods in which the PBP may be used include meat products and food ingredients such as wheat flour (page 42, lines 13-17; page 37, line 29 e.g. ‘meat product”, lines 21-30) to provide a red color to the meat substitute” as claimed in amended claim 6. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to provide the non-meat protein includes soy, pea, wheat flour (page 11, lines 25-30) to color appropriately in order to have meat analogue product made from above non-meat protein source.
As discussed above, Lerer teaches Phycoerythrin is used as natural colorant in food to replace artificial color (page 1, lines 31-page 2 lines 1-11). Lerer also teaches that the coloring component phycobiliproteins (PBP) can be used in an amount of ‘at least 0.1% by weight of the PBP’ (i.e. pigment) composition (at least on page 30) which is non meat protein (page 30 lines 5-6).
However, Lerer et al. does not explicitly address “meat substitute composition”. Lerer et al. is specifically also silent about the claim limitation of “ wherein the meat substitute composition contains 0.001 to 2.0% by wet (total) weight basis of the pigment composition” as claimed in claim 6.
It is to be noted that the above claim limitation can be interpreted as the pigment composition comprising phycoerythrin is in wet weight basis i.e. pigment composition can be liquid composition and when added to “meat substitute composition” it is wet, and , therefore, it is the claimed 0.001 to 2.0% by wet (total) weight basis of the pigment composition.
Lerer et al. discloses that the composition may be in liquid form with preservative also (page 29, lines 15-21).
Nikolaevna et al. discloses an aqueous extract solution having phycoerythrin content 0.4 mg/ml (page 4 paragraphs 3,6) can provide coloring in food product (at least Title, and page 2 third paragraph).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Lerer et al. (page 29, lines 12-20) to include the teaching of Nikolaevna et al. to consider phycoerythrin as an aqueous composition having phycoerythrin content 0.4 mg/ml (page 4 paragraphs 3,6) suitable for coloring food product (at least Title, and page 2 third paragraph, page 4 paragraphs 3,6) and the preparation is suitable for food coloring purposes (page 4, paragraph above claims of Nikolaevna et al. ).
As discussed above, Nikolaevna et al. discloses an aqueous extract solution having phycoerythrin content 0.4 mg/ml (page 4 paragraphs 3,6) can provide coloring in food product (at least Title, and page 2 third paragraph). Therefore, this aqueous composition having 0.4mg/ml phycoerythrin can be used to color meat substitute composition.
It is to be noted that Lerer et al. discloses that red algae is Porphyridium cruentum (red algae) (page 1 lines 31-33 and page 2 lines 1-6). Nikolaevna et al. discloses that red algae is Porphyridium purpurewn (at least page 2 paragraph 4).
However, when the teachings of the references are combined, an ordinary skilled artisan can use the method of Nikolaevna et al. to make a liquid ‘pigment composition’ made from Porphyridium cruentum comprising phycoerythrin which can be in the form of liquid extract using the method of Nikolaevna et al.
It is known and is evidenced by NPL Phycoerythrin that phycoerythrin color changes to red brown upon heating (page 1, Mid-section).
As discussed above, it is interpreted that the disclosed phycoerythrin is identical to the claimed phycoerythrin and, therefore, will have identical claimed property including the property of “ wherein the pigment composition provides a red color to the meat substitute prior to cooking that is decreased after cooking” as claimed in claim 6.
However, Lerer et al. in view of Nikolaevna et al. are specifically silent about the amount of pigment composition present in the specific food composition which is meat substitute composition product.
Swaminathan discloses that meat substitute product composition and it comprises wheat protein, nutritional yeast, seasonings and water (at least in [0030]).The meat substitute may include the aforementioned constituents in the following ranges: wheat protein from about 10 to about 45%; barley flour may range from about 1 to about 15%; nutritional yeast from about 0.1 to about 3%; water may range from about 15 to about 90%; and seasonings may be added as necessary depending on the desired flavor ([0030]).
Therefore, if we consider the range amount of 15-90% water, for 15% water, phycoerythrin content 0.4 mg/ml (Nikolaevna et al. page 4 paragraphs 3,6) will be 0.6mg which will be present in 100 gm final product i.e. 0.006 % by weight and for 90% water, it will be 0.036gm per 100 gm final meat substitute composition (i.e. 0.036% by weight). It meets claimed range amount of 0.001 to 2% by wet of the final meat substitute composition. 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).
Therefore, one of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Lerer et al. in view of Nikolaevna et al. (e.g. water in meat substitute composition [0030] of Swaminathan) with the teaching of aqueous extract solution having phycoerythrin content 0.4 mg/ml (in Nikolaevna et al. page 4 paragraphs 3,6) in order to provide red color to the meat substitute product.
It meets claim limitation of “ 0.001 to 2% by wt. of the pigment composition to meet amended claim 6.
It is to be noted that Lehrer et al. discloses that PBP are used in an effective amount (page 37 lines 22-26) to provide color to food; foods in which the PBP may be used include meat products and food ingredients such as wheat flour (page 42, lines 13-17; page 37, lines 21-32).
Therefore, “the meat substitute composition contains 0.001 to 2%, by weight (dry basis) of a non-meat protein” as claimed in amended claim 6 is also optimizable.
Absent showing of unexpected results, the specific amount pigment composition in meat substitute composition is not considered to confer patentability to the claims. As the amount of red color in raw meat and substitute and the turning to brown color /loss of red color after cooking meat substitute is variable that can be modified, among others, by adjusting the amount of phycoerythrin (PBP) as the source of pigment composition (phycoerythrin), 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 phycoerythrin as non-meat protein in “pigment composition and finally in the “meat substitute composition” in a way so that the desired red color in raw meat and substitute and the turning to brown color /loss of red color after cooking meat substitute is achieved (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).
9. Regarding claims 7, 14, for example, for claim 7, that Lerer et al. is specifically silent about the claim limitations of amended claim 7 as discussed above. However, it is interpreted that the disclosed phycoerythrin is identical to the claimed phycoerythrin and therefore, will have identical property as claimed in claim 7.
Regarding claim 14, claim 14 recites “wherein at least 50% of the phycoerythrin degrades when the meat substitute composition is heated to a temperature of 80 degree C for at least 4 minutes”. It is to be noted that the disclosed phycoerythrin is identical to the claimed phycoerythrin. Therefore, the disclosed meat substitute product with the disclosed phycoerythrin will have identical property including the claimed property of wherein at least 50% of the phycoerythrin degrades when the meat substitute composition is heated to a temperature of 80 degree C for at least 4 minutes”. This is considered as inherent property of phycoerythrin.
Therefore, it would have been obvious that it is within the skill one of ordinary skill in the art to provide the non-meat protein includes soy, pea etc. plant-based protein (page 11, lines 25-30) to color appropriately in order to have meat analogue product because when it is cooked, it is considered as the inherent property of red colored phycoerythrin ingredient to be degraded after heating with the less intense red color, however, desired color attribute by consumers expecting a meat-like product will be. Therefore, it would have been obvious and it is within the skill of one of ordinary skill in the art to optimize the heat treatment condition in order to degrade phycoerythrin to a certain extend to color change to red to brown upon heating which is its inherent property as evidenced by applicants’ specification and also as evidenced by NPL phycoerythrin (page 1, Mid-section).
It is also to be noted that the disclosed phycoerythrin is identical to the claimed phycoerythrin, therefore, the phycoerythrin present in the disclosed meat substitute composition will have identical property of degradation of phycoerythrin as claimed in claim 7 and it can be “at least 50% phycoerythrin degradation when heated to a temperature of 80 degree C for at least 4 minutes” as claimed in claim 14. One of ordinary skill in the art would consider this heat treatment condition with a reasonable expectation of success to achieve desired attribute by consumers expecting a meat-like product as discussed above. It is known and as evidenced by applicant’s own specification that the color intensity is determined by L*, a*, b* parameters and decrease of red color corresponding to a decrease in the a* value of L*a*b* colorimetry of at least 5% as claimed in claim 7 and “degradation of at least 50% of the phycoerythrin” which is time, temperature dependent and are optimizable.
Absent showing of unexpected results, the specific amount of heating condition to degrade phycoerythrin is not considered to confer patentability to the claims. As the degradation of phycoerythrin are variables that can be modified, among others, by adjusting the heating condition (e.g. at least 4-minute time), 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 heating condition in Lerer et al., to amounts, including that presently claimed, in order to obtain the desired degradation of phycoerythrin to a certain extend to change in color with the color transformation from red to brown including a decrease of a* value in L*a*b* by at least 5% in order to achieve desired attribute of a meat-like color product (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).
10. Regarding claim 9, as discussed for claim 6 above, Lehrer et al. discloses that PBP is used to provide color to food; foods in which the PBP may be used include meat products and food ingredients such as wheat flour etc. (at least in page 11, lines 25-30 and page 42, lines 13-17; page 37, line 29 e.g. ‘meat product”, lines 21-30). It is known that wheat flour contains wheat protein. Also, Swaminathan discloses that meat substitute product comprises wheat protein, nutritional yeast, seasonings and water (at least in [0030]).
11. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lerer et al. (WO 2020/102673 A1 in view of Nikolaevna et al. RU 2548111 C1 in view of Swaminathan US 2014/0079864 A1 as applied to claim 6 and further in view of Palomares et al. US 2010/0178674 A1
12. Regarding claim 12, As discussed above, Lerer et al. broadly discloses that the major phycobiliproteins (PBP) include R-phycoerythrin, B-phycoerythrin from algae including Porphyridium cruentum (red algae) which is a source of the red pigment phycoerythrin (page 1 lines 31-33 and page 2 lines 1-6). Lerer teaches Phycoerythrin is used as natural colorant in food to replace artificial color (page 1, lines 31-page 2 lines 1,3-11). Lerer et al. also discloses that PBP can be in the form of dried powder (page 5 lines 22-25).
However, Lerer et al. does not explicitly disclose the pigment composition comprises at least 50% phycoerythrin as claimed in claim 12.
Palomares et al. discloses that B-phycoerythrin (BFE) (BFE) is an intense red colored phycobiliprotein protein dye which can be used as proteinaceous dye for food coloring purpose also ([0003]). Palomares et al. also discloses it can be isolated in pure form from porphyridium cruentum by isoelectric precipitation (Abstract) yielding a highly purified form (Abstract) [0005]) to be used for various applications which reads on “at least 50% phycoerythrin on a dry weight basis” as claimed in claim 12.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Lerer et al. to include the teaching of Palomares et al. discloses that B-phycoerythrin (BFE) is an intense red colored phycobiliprotein protein dye which can be used as proteinaceous dye for food coloring purpose (Abstract, [0003]).
Response to arguments
13. Applicant’s arguments and amendments of independent claim 6 overcome the 112 second paragraph rejection of record.
However, applicant’s arguments and amendment of independent claim 6 overcome the rejections of record. Examiner has considered few secondary prior arts in combination with Lerer et al. as primary prior art to address the amended claim limitation of independent claim 6. made for Lehrer et al. does overcome 103 (a) obviousness rejections of record. Examiner is responding the arguments made for Lehrer et al.
14. Applicants argued that Lerer et al. does not establish a weight basis for including PBP in a meat substitution composition as claimed”.
In response, applicant’s arguments and amendment of independent claim 6 overcome the rejections of record. Examiner has considered few secondary prior arts in combination with Lerer et al. as primary prior art to address the amended claim limitation of independent claim 6. made for Lehrer et al. does overcome 103 (a) obviousness rejections of record.
However, examiner has considered Lerer et al. as primary prior art because Lerer et al. is considered as broad disclosure of phycobiliprotein are water soluble proteins which play a key role in photosynthesis. Lerer et al. also discloses that the major phycobiliproteins (PBP) include R-phycoerythrin, B-phycoerythrin from algae including Porphyridium cruentum (red algae) (page 1 lines 31-33 and page 2 lines 1-6) which meets Phycoerythrin of claim 6 and also meet claim limitation of “R-Phycoerythrin” of claim 8 and “red algae” of claim 10.
Lerer also teaches the coloring component phycobiliproteins (PBP) can be used in an amount of ‘at least 0.1% by weight of the PBP’ (i.e. pigment) composition (at least on page 30 which is non meat protein (page 30 lines 5-6). Phycoerythrin is used as natural colorant in food to replace artificial color (page 1, lines 31-page 2 lines 1,3-11) which is produced from Porphyridium cruentum (page 2 line 4, page 18, line 25; page 43, lines 12-15) to meet claim 8. Lerer et al. discloses that phycoerythrin , a red-colored PBP is extracted from Porphyridium cruentum (at least in page 18 lines 23-25) to meet claims 8, 11. Lerer et al. also discloses that Porphyridium cruentum is a source of the red pigment phycoerythrin which is used to provide color to food; foods in which the PBP may be used include meat products and food ingredients such as wheat flour (page 42, lines 13-17; page 37, line 29 e.g. ‘meat product”, lines 21-30). It is known that wheat flour contains wheat protein. However, examiner used another secondary prior art to address that meat analogue product is made using wheat protein and discussed in detail in the office action. Therefore, phcoerythrin provides a red color to the meat substitute” as claimed in amended claim 6.
There is no further arguments. The rejection is made as non- final.
Conclusion
15. 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571 -272-1000.
/BHASKAR MUKHOPADHYAY/
Examiner, Art Unit 1792