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 28 is objected to because of the following informalities: Claim 28 recites “The processing” in the preamble and should recite “The process”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 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.
Claims 25-27 and 29 are rejected under 35 U.S.C. 102a1 as being anticipated by Gautam et al. (USPN 7,220,442), made of record in the parent application.
Regarding Claims 25-27 and 29, Gautam teaches a process for preparing an edible foodstuff from a protein concentrate, comprising the steps of: providing, in an extruder, an extrusion formulation comprising a protein concentrate in either a liquid or powder form, extruding the protein concentrate from the extruder in the form of an expanded extrudate using supercritical carbon dioxide under supercritical fluid extrusion conditions, there by yielding a foodstuff comprising the comprising the expanded extrudate of the protein concentrate, as Gautam teaches preparing a nutrition bar which comprises nuggets, where the nuggets have high levels of selected proteins, particularly whey protein concentrate (Column 3, lines 60-65 and Column 4, lines 50-60, which also meets the limitations of milk protein concentrate, as claimed. Gautam teaches the nuggets can also include dietary fiber (Column 6, lines 20-30), and teaches that the formulation for the nuggets, which includes the non-soy protein, rice flour, additional carbohydrate, plus water is fed into the extruder and is extruded using supercritical carbon dioxide under supercritical fluid extrusion, whereby the supercritical fluid expands, thereby imparting to the product a desirable expanded texture (Column 7, lines 55-65 and Column 8, lines 1-5 and Example 3). It is understood that the protein concentrate is in powder form in light of the disclosure and examples. The expanded nuggets containing the protein concentrate are seen as the edible foodstuff made by the claimed method, but the expanded nuggets are also added to a nutrition bar, which can also meet the limitation of the edible foodstuff comprising the expanded extrudate of the protein concentrate. Gautam also teaches the nuggets can include yogurt powder (Column 5, lines 55-60), which meets the limitation of yogurt protein concentrate as the yogurt powder would be a concentrated form of the yogurt which is known to contain milk protein.
Claim Rejections - 35 USC § 102/103
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 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 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.
Claim 29 is rejected under 35 U.S.C. 102(a1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Onwulata (2005/0084579), previously made of record in the parent application.
Onwulata teaches an edible foodstuff as Onwulata teaches an expanded and extruded milk containing product comprising a milk product such as milk protein concentrate, whey, whey concentrate, or whey protein isolate (abstract). Applicants' Claim 29 is written in a product-by-process format and as such, it is the novelty of the instantly claimed product that needs to be established and not that of the recited process steps. In re Brown, 173 USPQ 685 (CCPA 1972); In re Wertheim, 191 USPQ (CCPA 1976). Regarding Claim 29, since the product shown by this reference is an expanded and extruded foodstuff comprising a protein concentrate, the product is met, or rendered obvious by the teaching of Onwulata.
Claim Rejections - 35 USC § 103
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 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 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.
Claims 1-26, 28, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Ganjyal (US 2013/0136830) in view of Onwulata (US 2005/0084579), both previously made of record.
Regarding Claims 1, 3, 4, 7-15, Ganjyal teaches a process for preparing an edible foodstuff from food industry waste stream byproducts, said process comprising the steps of (Paragraphs 17-20, 53):
Combining, in an extruder, an extrusion formulation comprising a first food byproduct such as whey protein and at least one second food byproduct such as fruit or vegetable pomace, as Ganjyal teaches an exemplary embodiment comprising cranberry pomace in an amount of 20% by weight and where the extrusion formulation comprises one or more of starch as well (Paragraph 53);
Introducing supercritical carbon dioxide into the extruder to mix with the first food byproduct and the at least one additional ingredient; and
Producing an edible foodstuff containing the first byproduct and the at least one additional ingredient, wherein the edible foodstuff comprises an extrudate prepared under supercritical fluid extrusion conditions.
Cranberries meet the limitation of berries and a fruit with skin and seeds as claimed. Since Claims 1 and 10 do not require vegetable pomace and where either fruit or vegetable pomace is used, Ganjyal is deemed to meet the claim limitations. Similarly, since Claims 12 and 13 do not require a protein concentrate, Ganjyal’s teaching of starch is deemed to meet the claimed limitation. Therefore, the use of both whey protein and fruit pomace would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, in light of the teachings of Ganjyal.
Regarding the limitation in Claims 1 of where the first food byproduct is a non-reconstituted liquid food byproduct, and Claims 3, 4, 14 and 15, in particular, Ganjyal teaches adding a certain amount of water along with the other ingredients and discusses an ideal amount of moisture or water added to attain a desired extrudate product (Paragraphs 20, 44 and 45). Therefore, Ganjyal teaches or renders obvious the use of water, whey protein and fruit powder or pomace combined and extruded. However, Ganjyal does not specifically teach using liquid whey as recited, or where the liquid whey is one of the claimed types of whey, and does not teach where the at least one additional ingredient further comprises milk protein concentrate.
However, Onwulata teaches a method of preparing an expanded milk containing product comprising a milk product such as milk protein concentrate, whey, whey concentrate, or whey protein isolate (abstract). The whey taught by Onwulata is understood to mean “sweet whey” as claimed. Therefore, it would appear that the disclosed milk containing products could be substituted for one another in an expanded product. While Onwulata does not specifically teach “liquid whey”, the combination of whey and water, as taught by Ganjyal would result in a liquid whey when mixed in the extruder along with a fruit pomace. Therefore, it would have been obvious to use a similar milk protein such as milk protein concentrate or more than one milk protein component in the expanded product of Ganjyal since Onwulata teaches that whey or whey protein concentrate or milk protein concentrate can be used to form an acceptable, expanded milk protein-containing product.
Regarding Claim 2 limitation of the process not requiring a separate hydration step to yield the extrudate, firstly, it is submitted by the Examiner that combining water, whey or whey protein, and fruit pomace in an extruder is a combined step and the water addition within the extruder is not seen as a “separate hydration step” as claimed. Secondly, Applicant’s claims use “comprising” language, therefore not precluding the use of additional method steps to arrive at the claimed extrudate. Lastly, it is not clear how using liquid whey or a combination of water and whey would result in materially different extruded and expanded food products, and it is not clear what is unexpected about using liquid whey as compared to the combination of whey and water as taught by the combination of cited prior art. As seen in the rejection of Claim 24 and the discussion of the shelf-stability of the product, both Applicant’s product and the product taught by Ganjyal have comparable water activities. Lastly, since no moisture content is recited in the claims in terms of the composition of the liquid whey, water added during the extrusion process along with “whey” as taught by Onwulata is seen to render obvious the limitation of the “liquid whey”.
Regarding Claims 5 and 6, Ganjyal is silent as to the amount of liquid whey present in the extrusion formulation. However, Applicant’s claims provide for a very small amount of liquid whey added, at about 2% by weight and it is understood from the disclosure of Ganjyal that whey protein would be added in a nominal amount as well. In addition, since the whey component provides a source of protein, it would have been obvious to adjust the amount of liquid whey depending on the amount of protein desired in the final product and the nutritional needs of the intended consumer. One of ordinary skill in the art would understand that increasing the amount of whey would increase the amount of milk protein in the resulting extrudate.
Regarding Claim 16, Ganjyal in view of Onwulata teaches that the extrusion formulation is maintained at a temperature of not greater than 90°C (Ganjyal, Paragraph 18).
Regarding Claim 17, Ganjyal in view of Onwulata does not specifically teach that the SC-CO2 is introduced at a constant flow rate. However, the purpose of the SC-CO2 is to expand the extrudate and provide uniform air cells through the food product (Paragraph 21). Therefore, it would have been obvious to introduce the SC-CO2 at a constant flow rate in order to ensure a uniform distribution of air cells.
Regarding Claim 18, Ganjyal in view of Onwulata teaches that the Sc-CO2 is introduced under a high pressure of 1087 psi (7.49MPa) which is “about 7.6 MPa” as claimed (Ganjyal, Paragraph 20).
Regarding Claims 19, 22, and 23, Ganjyal in view of Onwulata teaches forming a puffed, ready-to-eat food product with the method of Claim 1 (Ganjyal, Paragraph 9). The product can be in the form of a breakfast cereal or a bar (Ganjyal, Paragraph 60).
Regarding Claim 20, Ganjyal in view of Onwulata teaches that the edible foodstuff has uniformly distributed air cells throughout the product. The air cells are also uniform in size and density (Ganjyal, Paragraphs 21 and 22).
Regarding Claim 21, Ganjyal in view of Onwulata does not specifically teach that the edible foodstuff retains at least 50 percent of antioxidant and/or phenolic content as compared to that present in the at least one additional ingredient. However, Ganjyal in view of Onwulata renders obvious the method of Claim 1 and the subsequent product of Claim 19 as well as the type of fruit pomace used. Therefore, any properties associated with the claimed method and resulting product would be expected to flow from the prior art.
Regarding Claim 24, Ganjyal in view of Onwulata teaches the extrudates having water activities in the range of 0.2-0.4 (Ganjyal, Paragraph 56). Applicant discloses in Paragraph 144 of the PG Publication that the extrudates having a water activity of between 0.49-0.59 are shelf stable. Therefore, one of ordinary skill in the art that the extrudates of the prior art, having similar or lower water activities would also be shelf-stable.
Regarding Claims 25, 26, 28, 29, Ganjyal teaches a process for preparing an edible foodstuff and the edible foodstuff made by the claimed method, from a protein concentrate, said process comprising the steps of (Paragraphs 17-20, 53): providing in an extruder, an extrusion formulation comprising a whey protein or fruit or vegetable pomace, as Ganjyal teaches an exemplary embodiment comprising cranberry pomace in an amount of 20% by weight (Paragraph 53); introducing supercritical carbon dioxide into the extrude, preparing the edible foodstuff comprising an expanded extrudate using supercritical fluid extrusion conditions and super critical carbon dioxide (Paragraphs 20-22).
Therefore, the use of both whey protein and fruit pomace would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, in light of the teachings of Ganjyal. Ganjyal teaches adding a certain amount of water along with the other ingredients and discusses an ideal amount of moisture or water added to attain a desired extrudate product (Paragraphs 20, 44 and 45). Therefore, Ganjyal teaches or renders obvious the use of water, whey protein and fruit powder or pomace combined and extruded. The whey protein is understood to be in powder form in light of the disclosure. However, Ganjyal does not specifically teach using a protein concentrate per se, or a milk protein concentrate.
Onwulata teaches an expanded and extruded milk containing product comprising a milk product such as milk protein concentrate, whey, whey concentrate, or whey protein isolate (Paragraphs 5-11). Therefore, it would appear that the disclosed milk containing products could be substituted for one another in an expanded and extruded product. Therefore, it would have been obvious to use a similar milk protein such as milk protein concentrate or more than one milk protein component in the expanded product of Ganjyal since Onwulata teaches that whey or whey protein concentrate or milk protein concentrate can be used to form an acceptable, expanded and extruded milk protein containing product.
Regarding Claim 29, Ganjyal in view of Onwulata teaches forming a puffed, ready-to-eat food product with the method of Claim 1 (Ganjyal, Paragraph 9). The product can be in the form of a breakfast cereal or a bar (Ganjyal, Paragraph 60).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Ganjyal (US 2013/0136830) in view of Onwulata (US 2005/0084579), and further in view of Gautam et al. (USPN 7,220,442), all previously made of record in the parent application.
Ganjyal in view of Onwulata are relied upon as above but do not specifically teach a yogurt protein concentrate.
Gautam teaches a process for preparing an edible foodstuff from a protein concentrate, comprising the steps of: providing, in an extruder, an extrusion formulation comprising a protein concentrate in either a liquid or powder form, extruding the protein concentrate from the extruder in the form of an expanded extrudate using supercritical carbon dioxide under supercritical fluid extrusion conditions, there by yielding a foodstuff comprising the comprising the expanded extrudate of the protein concentrate, as Gautam teaches preparing a nutrition bar which comprises nuggets, where the nuggets have high levels of selected proteins, particularly whey protein concentrate (Column 3, lines 60-65 and Column 4, lines 50-60, which also meets the limitations of milk protein concentrate, as claimed. Gautam teaches the nuggets can also include dietary fiber (Column 6, lines 20-30), and teaches that the formulation for the nuggets, which includes the non-soy protein, rice flour, additional carbohydrate, plus water is fed into the extruder and is extruded using supercritical carbon dioxide under supercritical fluid extrusion, whereby the supercritical fluid expands, thereby imparting to the product a desirable expanded texture (Column 7, lines 55-65 and Column 8, lines 1-5 and Example 3). It is understood that the protein concentrate is in powder form in light of the disclosure and examples. The expanded nuggets containing the protein concentrate are seen as the edible foodstuff made by the claimed method, but the expanded nuggets are also added to a nutrition bar, which can also meet the limitation of the edible foodstuff comprising the expanded extrudate of the protein concentrate. Gautam also teaches the nuggets can include flavorings such as yogurt powder (Column 5, lines 55-60), which meets the limitation of yogurt protein concentrate as the yogurt powder would be a concentrated form of the yogurt which is known to contain milk protein.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have included yogurt protein concentrate as an additional protein source in the expanded extrudate of Ganjyal in view of Onwulata in order to provide additional flavorings for the extrudates.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Gautam et al. (USPN 7,220,442), in view of Bhushan et al. (2008), both previously made of record in the parent application.
Gautam is relied upon as above in the rejection of Claim 25 and teaches the extrudate nugget formulation can include fiber such as cellulose and thickeners such as pectin (Column 6, lines 20-35), but does not specifically teach where the extrusion formulation further comprises fruit or vegetable pomace.
Bhushan teaches of the increasing research and development efforts associated with the use of value-added residues such as apple pomace in food processing (Page 285, Column 1), and teaches that apple pomace is a left-over solid residue obtained after extraction of apple juice and that apple pomace includes numerous phytochemicals in the form of simple sugars, pectin, dietary fibers (35-60% by weight of the apple pomace) mainly as cellulose, hemicellulose, pectin substances and lignins, and natural antioxidants (Page 285, Column 2 and Page 288, Column 1, “Dietary Fibre”). Bhushan teaches of a variety of nutritional benefits associated with apple pomace (Page 287, Column 2), including the benefits associated with high fiber diets and the risks associated with low fiber diets (Page 288, Column 2).
Therefore, the use of apple pomace as a high dietary fiber source in the expanded extrudate of Ganjyal in view of Onwulata would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, in light of the known dietary and nutritional benefits associated with apple pomace and the increasing desire of using residue by-products such as apple pomace in nutritionally enhanced value-added products.
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 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-13 of U.S. Patent No. 10,524,497.
Although the claims at issue are not identical, they are not patentably distinct from each other because Claims 1-13 of the patent recite the same process as recited in the claims of the instant application, with more specificity. Therefore, Applicant’s instant Claims 1-25 to one of ordinary skill in the art in light of Claims 1-13 of the prior granted patent.
Claims 26-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-13 of U.S. Patent No. 10,524,497, in view of Gautam et al. (USPN 7,220,442).
Although the claims at issue are not identical, they are not patentably distinct from each other because Claims 1-13 of the patent recite many of the same process steps as recited in the claims of the instant application, with the exception of the extrusion formulation comprising a protein concentrate and where the extrudate is an expanded extrudate.
Gautam teaches a process for preparing an edible foodstuff from a protein concentrate, comprising the steps of: providing, in an extruder, an extrusion formulation comprising a protein concentrate in either a liquid or powder form, extruding the protein concentrate from the extruder in the form of an expanded extrudate using supercritical carbon dioxide under supercritical fluid extrusion conditions, there by yielding a foodstuff comprising the comprising the expanded extrudate of the protein concentrate, as Gautam teaches preparing a nutrition bar which comprises nuggets, where the nuggets have high levels of selected proteins, particularly whey protein concentrate (Column 3, lines 60-65 and Column 4, lines 50-60, which also meets the limitations of milk protein concentrate, as claimed. Gautam teaches the nuggets can also include dietary fiber (Column 6, lines 20-30), and teaches that the formulation for the nuggets, which includes the non-soy protein, rice flour, additional carbohydrate, plus water is fed into the extruder and is extruded using supercritical carbon dioxide under supercritical fluid extrusion, whereby the supercritical fluid expands, thereby imparting to the product a desirable expanded texture (Column 7, lines 55-65 and Column 8, lines 1-5 and Example 3). It is understood that the protein concentrate is in powder form in light of the disclosure and examples. The expanded nuggets containing the protein concentrate are seen as the edible foodstuff made by the claimed method, but the expanded nuggets are also added to a nutrition bar, which can also meet the limitation of the edible foodstuff comprising the expanded extrudate of the protein concentrate. Gautam also teaches the nuggets can include flavorings such as yogurt powder (Column 5, lines 55-60), which meets the limitation of yogurt protein concentrate as the yogurt powder would be a concentrated form of the yogurt which is known to contain milk protein.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for Claims 1-13 to have recited the additional limitations as recited in the instant claims in light of the Gautam and the similarity of the processes of Gautam and the previously granted claims.
Claims 1-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-8 of U.S. Patent No. 12,201,136.
Although the claims at issue are not identical, they are not patentably distinct from each other because Claims 1-8 of the patent recite the same process as recited in the claims of the instant application, with more specificity. Therefore, Applicant’s instant Claims 1-29 to one of ordinary skill in the art in light of Claims 1-8 of the prior granted patent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNA A WATTS whose telephone number is (571)270-7368. The examiner can normally be reached on Monday-Friday. 9am-4:30pm.
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JENNA A. WATTS
Primary Examiner
Art Unit 1791
/JENNA A WATTS/Primary Examiner, Art Unit 1791 6/8/2026
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