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 .
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-3, 5, 14, 16 and 25-26, drawn to an industrial scale high volume method of manufacturing a texture modified food product for consumption by a dysphagic consumer.
Group II, claim 28, drawn to a texture modified food product.
Group III, claim 29, drawn to a packaged texture modified food product for industrial scale high volume manufacture and consumption by a dysphagic consumer.
Group IV, claims 36-40 drawn to a method of dressing the texture modified food product.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-IV lack unity of invention because even though the inventions of these groups require the technical feature of the limitations recited by claim 1, this technical feature is not a special technical feature as it does not make a contribution over the prior art combination applied to claim 1 in the rejection below.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Newly submitted claims 36-40 are directed to an invention that is independent or distinct from the invention originally claimed for the reasons stated above.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 36-40 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claims 1 and 16 are objected to because of the following informalities:
Regarding claim 1, in line 1 before “texture” insert “moulded” for consistency with the language of the amended limitations.
In step c) after “particles of the” insert “partially” for consistency with the language of step b).
In step e) delete “prior to introducing the paste therein and vacuum drawing the first layer of packaging material into the mould prior to receiving the paste”, and amend to instead recite “and vacuum drawing the first layer of packaging material into the mould prior to introducing the paste therein”. While the limitation as currently drafted is clear i.e., the mould is lined with the first packaging material, and the material is vacuum drawn in to the mould before receiving the paste of step d), the limitation should be amended as proposed above in order to remove redundant phrases and to better reflect the language of the specification (page 18 line 33 to column 19 line 2).
Regarding claim 16, in line 2 after “impart” delete “a” and amend to instead recite “the” to place the claim in better form.
In line 3 after “vegetable” insert “used” in order to place the claim in better form.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5, 14, 16 and 25-26 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.
Regarding claim 1, the limitation “industrial scale high volume” is directed to a relative feature. Neither “industrial scale” nor “high volume” is defined by the claim, and the specification does not provide a standard for ascertaining the requisite degree. Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the limitation suggests an increased scale/volume, the indefiniteness rises from the fact that one of ordinary skill in the art would not be able to determine, in view of the disclosure, exactly what scale/volume is considered to be “industrial scale” and “high volume”. For example, an individual may consider an “industrial scale high volume method” to require at least a 10,000 sq ft production plant outputting 1,000 tons of product per year, whereas another individual may consider the same “industrial scale high volume method” to require at least 20,000 sq ft outputting 2,000 tons per year. Since the boundary of the limitation cannot be ascertained, it is unclear at which scale/volume infringement occurs, and unclear how to interpret the limitation regarding application of the prior art.
In step d) limitation i., the limitation “a xanthan gum having a content of between 0.1-0.5% by weight” renders the claim indefinite since it is unclear what the range is relative to. The limitation previously recited simply “a xanthan gum content of between…”, which one of ordinary skill understands to mean the xanthan gum is added into the paste such that the content of the xanthan gum in the paste is 0.1-0.5 % by weight. See also specification page 23 lines 4-13. However, the current amendment including the phrase “having a” confounds the meaning of limitation i.; it is now unclear if the limitation recites a xanthan gum itself having a content of some unrecited substance between 0.1-0.5% by weight, the additive has a xanthan gum content between 0.1-0.5% by weight, or the content of the xanthan gum in the paste is 0.1-0.5% by weight. The rejection can be overcome by removing “having a” from the limitation.
Claims 2-3, 5, 14, 16 and 25-26 are rejected by virtue of their dependence on a rejected base claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5, 14, 16 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Jaeger et al. (WO 2016150960 A1) in view of Wiebe (US 5,928,690), Cassel et al. (US 2009/0047390 A1), McLenithan et al. (US 2017/0088298 A1), Adam (US 2017/0107048 A1), Schoenfellinger et al. (US 2018/0086535 A1), Nutricia Nutilis “Tasty food. Safer food. Delicious recipes for people with swallowing difficulties” (made of record in the IDS filed 11/17/2020), hereon referred to as Nutricia NPL, and Villota et al. (US 2004/0156960 A1). Blixer NPL is relied on as evidence for claim 5.
Citations to Jaeger et al. are taken from the EPO machine translation provided with the Office Action mailed 2/2/2023.
Regarding claim 1, Jaeger et al. teaches a method for producing food compositions with a defined external shape (paragraph 2) comprising commencing cooking of a raw fruit or vegetable such as peas (paragraph 151), arresting the cooking to provide a partially cooked (blanched) vegetable (paragraph 152), comminuting the partially cooked vegetable to form a paste, the comminuted composition having a particle size to facilitate consumption by individuals with dysphagia (paragraphs 37 and 153), adding a texturizing agent such as xanthan gum (paragraphs 31 and 155-156), and setting the paste in a mold to form the texture modified food product (paragraphs 48, 54 and 157).
The xanthan gum absorbs a significant amount of water to form a “stable gel” (paragraphs 31 and 52). The gum is used as the third texturizing agent in combination with guar gum (paragraph 31), where the xanthan gum can comprise at least 0.1% by weight of the composition (paragraph 33). It is noted that the reference states the composition is in a “still liquid or free-flowing” state when introduced into molds (paragraph 48), and therefore the comminuted partially cooked vegetable is construed to be a type of paste. The composition further includes dietary fiber such as pectin, hemicellulose, beta-glucan, psyllium husk, inulin, arabinoxylans or polydextrose (paragraph 30). The fibers are all understood to be sourced from vegetables. The reference also teaches directly including vegetables (paragraph 36), which one of ordinary skill in the art would have reasonably expected to include fiber.
Jaeger et al. does not teach an “industrial scale high volume” method.
However, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process to be an “industrial scale high volume” manufacturing method since large scale processes are well understood and commonly practiced, since there is no evidence that the process of Jaeger et al. cannot be made continuous, automated, and scaled, and therefore as a matter of achieving a desired manufacturing capacity and/or to meet demand. See also MPEP 2144.04 III., 2144.04 IV.A., and 2144.04 V.E.
Jaeger et al. does not explicitly recite 5-40 microns with respect to the comminuted particle size.
However, the reference teaches the comminuting is continued until the paste comprises particles having a size of less than 1 mm (paragraph 37), which encompasses the claimed range. Reducing the particle size facilitates consumption for individuals with special requirements e.g., dysphagia.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process to comminute the fruit or vegetable to the claimed particle size since the prior art already acknowledges a range encompassing the claimed values, particularly to facilitate feeding people with special requirements in terms of the texture of the food, since there is no record of criticality or unexpected results associated with the claimed range, and since the values would have been used during routine experimentation and optimization procedures due to factors such as desired texture, intended consumer, and ease of consumption. See also 2144.05 I-II.
Jaeger et al. does not teach an agglomerated modified potato starch content of between 1-3 wt%.
However, the reference teaches additional starch can be added as needed to obtain a desired starch content (paragraph 30). The composition can include a plurality of texturizing agents including xanthan and guar gum as stated above, where the agents are provided in amounts of e.g., at least 0.1% by weight (paragraph 33).
Weibe teaches a method for production of pureed meat products that resemble their non-pureed counterparts (column 1 lines 4-6), the pureed products suitable for patients with dysphagia (column 1 lines 7-9), where the food includes modified food starch to bind added water and moisture released from the meat or poultry during cooking and prevent moisture loss during freeze/thaw cycles, as well as obtain a desired texture (column 2 lines 63-67). The modified starch can be sourced from potatoes, and can be used in ranges of 0.5-3% based on the level of added water in the formulation (column 3 lines 3-7).
Cassel et al. teaches a snack food incorporating various ingredients of chicken noodle soup (abstract), where the ingredients are ground and blended with modified food starch and other additives to form an extrudable mixture (paragraph 24). Agglomerated modified food starch is added to provide a desired viscosity and mouthfeel, while xanthan gum is added to provide a unique [rheological] property (paragraph 33).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Jaeger et al. to include the claimed amount of agglomerated modified potato starch and xanthan gum since the prior art acknowledges the combination can be used in reformed food products, recognizes modified potato starches for use in foods intended for dysphagic individuals, and therefore to combine prior art elements according to known methods to yield predictable results and/or since it would have been “obvious to try” a known substance recognized to modify rheological properties, see MPEP 2143 I.(A) and (E), for the advantages taught by Weibe, since there is no evidence of criticality or unexpected results associated with the claimed feature, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as desired text/mouthfeel, rheological properties, palatability, and resistance to the rigors of extrusion, cooking, freezing, freeze/thaw cycles, and blowout during microwave reheating.
Jaeger et al. does not teach lining the mold with a first layer of packaging material and vacuum drawing the first layer of material into the mold prior to introducing the paste, setting the paste in the mold to form a molded texture modified food product, at least a portion of the mold being shaped and textured to impart a shape and texture resembling the generic shape of the selected fruit or vegetable onto the paste, disposing a second layer of packaging material over the mold, fusing the second layer with the first layer to form a pouch, evacuating air around the molded texture modified food product, back-flushing the pouch with carbon dioxide and nitrogen to remove suspended oxygen, and sealing the pouch. It is noted that the limitation “generic shape” is given its broadest reasonable interpretation to mean that the shape and texture are such that an individual can easily recognize the selected fruit or vegetable that the food product is made from.
McLenithan et al. teaches a pouch manufacturing machine used to wrap food products in food safe film (paragraph 53), the machine comprising platen 106 having molds 108 with apertures 107 formed in the bottom (figures 5-6). Base film 110 is passed through heated roller 142 then laid over the platen to cover the molds, and a vacuum is pulled in the molds through apertures 107 to draw the film 110 therein (figure 1; paragraph 59). Thus, the machine of McLenithan et al. is construed to be a type of thermoforming machine since heat is used to facilitate plastic formation of the package. The platen 106 moves to position under one or more fill heads that fill the molds with the food (paragraph 60), then moves to the next stage that applies a lid film 124 over the filled molds and bonds the films together around the perimeter of the molds (paragraph 62). The system allows pouches to be formed, filled and discharged from the platens that are moved by independently controlled motors, thus decreasing cycle time and providing improved flexibility for the type of product made (abstract; paragraphs 10-11).
Adam teaches a method of preserving fruits and vegetables (abstract) comprising a film 102 comprising cavities 101 for receiving the food 202 (figures 1-2A; paragraph 66), applying a top film 203 and fusing the films to form a pouch while retaining ports 301 and 303 (figure 2B-3), and flowing preservation gas through the ports before final sealing (paragraph 69).
Schoenfellinger et al. teaches a perishable food product packaging system (abstract) comprising a packaging in the form of a plastic bag, where the first wall 26 and second wall 28 (first and second packaging materials) are joined along three edges to form a pouch into which food product 16 is placed (figures 5-7; paragraph 26). The pouch includes closure 30 which remains unsealed until the pouch enters a modified atmospheric packaging sealer that removes atmospheric air from the pouch interior and then flushes the pouch with inert gas comprising carbon dioxide and nitrogen prior to sealing, with or without vacuum packaging (paragraph 32). Absent evidence to the contrary, one of ordinary skill would have expected flushing with inert gas to remove at least some suspended oxygen from the molded texture modified food product. This is particularly since the reference teaches wanting to minimize oxygen in the sealed package (paragraph 32). The process is recognized to prolong shelf life and postpone spoilage, where the packages are formed in a known manner and then sealed using a commonly known method (paragraph 33).
Thus, the prior art suggests a thermoforming device that shapes and seals food within a package according to the shape of a mold, where the initial seal (fusing) is incomplete in order to allow removal of atmospheric air and introduction/flushing of preservation-related gases prior to final and complete sealing. It is noted that removing air is understood to facilitate preservation by minimizing or eliminating oxygen available in the package such that oxidative reactions are similarly prevented.
Nutricia NPL teaches texture modified fruits and vegetables for consumption by a dysphagic consumer and a method for making them (pages 8-9). The vegetables are cooked and blended with milk and butter (pages 36-37). The vegetable is mixed with Nutilis powder for thickening and further blended. The thickened vegetable is placed into molds (pages 36-37 and 48) suitable to shape the composition into their original shape [as observed prior to cooking] (page 9).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Jaeger et al. to treat and package the food product in the manner recited by steps e)-l) since the prior art recognizes the features for packaging foods and extending shelf life thereof, acknowledges vegetable pastes can be molded to mimic their original forms, particularly for foods intended for dysphagic consumers, where Jaeger et al. already contemplates the food being molded and suitable for such consumers, and therefore to provide a similar shape for design and/or visual appeal purposes, to allow the consumer to visually determine what the product is made from, to allow the food product to be simultaneously molded and packaged, thereby decreasing cycle time and increasing flexibility, and since there is no evidence of record that the particular shape/texture of the food product and the packaging method was significant. See also In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding setting the paste in the mold, Jaeger et al. teaches setting the paste in the mold as stated above, where the paste is introduced into the mold and cooled therein (paragraph 54). The prior art combination above renders obvious introducing the food into the mold having the first packaging material thereon and covering with a second material prior to evacuating, flushing, and sealing.
It would have been further obvious to set the paste in the mold prior to disposing the second layer of packaging material in order to ensure the paste is sufficiently solidified such that risk of deformation during packaging and subsequent handling/storage is minimized, and to prevent the paste from leaking out of the package prior to final sealing.
Jaeger get al. does not teach pasteurizing the molded texture modified food product with the sealed pouch to increase shelf life.
Villota et al. teaches a method for preserving food (abstract), comprising sealing cut vegetables in a pouch and heating the sealed pouch at 160oF for 1 minute for pasteurization (paragraph 33). The process allows for a shelf life of at least 90 days under refrigerated conditions without the use of preservatives and/or extensive thermal processing (paragraph 1).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process to pasteurize the product after sealing in order to similarly prolong shelf life without the need for preservatives or extensive thermal processing, for consumer safety, and since hot pasteurization is a well-known process, and therefore to use a known technique to improve similar methods in the same way, see MPEP 2143 I.(C).
Jaeger et al. does not specify freezing the sealed pouch for distribution.
However, the reference teaches freezing the molded product (paragraph 157), and the prior art teaches packaging the molded product in a sealed pouch as stated above.
It would have been obvious to one of ordinary skill in the art at the time of the invention to freeze the sealed pouch for distribution since the process is commonly practiced and well known in the art, since freezing is understood to further prolong shelf life, and to minimize risk of spoilage during storage and/or transport.
Regarding the xanthan gum content minimizing bleeding of liquids from the molded food product and the agglomerated modified potato starch content increasing the viscosity of the paste to retain the shape of the molded food product through a heating process, the combination above teaches and renders obvious the claimed amounts of said substances.
Further, Jaeger et al. teaches xanthan gum as a texturizing agent which has a water-binding effect (paragraph 66). Wiebe teaches modified starch is used to bind added water and released moisture in order to prevent moisture loss during freeze/thaw cycles (column 2 lines 63-66). Cassel et al. teaches agglomerated modified food starch is added to provide a desired viscosity and mouthfeel, while xanthan gum is added to provide a unique [rheological] property (paragraph 33).
Absent persuasive evidence to the contrary, one of ordinary skill in the art would have reasonably expected the molded food product of the prior art combination to exhibit the same features claimed by Applicant, particularly since a compound and its properties are inseparable In re Papesch, 137 USPQ 43 (CCPA 1963).
Regarding claim 2, Jaeger et al. teaches the vegetable is heated in boiling salted water for 5 minutes (paragraph 151). It is noted that blanching processes are generally understood to include immersing (plunging) the product to be blanched into the water. Therefore Jaeger et al. is construed to include “plunging” as claimed.
Regarding claim 3, Jaeger et al. teaches the heated vegetable is cooled with ice water (paragraph 152). It is noted that ice water cooling processes are generally understood to include immersion (plunging) the product to be cooled into the water. Therefore Jaeger et al. is construed to include “plunging” as claimed.
Regarding claim 5, Jaeger et al. teaches the vegetable is comminuted using a Blixer (paragraph 153). Blixer NPL shows that the device includes shearing blades which can comminute vegetables into paste (timestamp 0:34 to 1:00). Therefore, the Blixer taught by Jaeger et al. is construed to be a type of “shear-blade” cutter.
Regarding claim 14, the combination of Jaeger et al. with McLenithan et al. applied to claim 1 teaches methods of packaging using thermoforming machines. Such machines are known to be capable of fusing portions of packaging together by means including adhesive and heat bonding. Further, Adams teaches partial bonding can be performed by adhesive, welding, or applying pressure and heat to the polymer films (paragraph 17).
It would have been obvious to perform step h) of claim 1 using a thermoforming machine for the same reasons stated for the combination of Jaeger et al. with McLenithan et al. for said claim, since thermoforming machines are recognized to be capable of performing said fusing process, where partial fusing allows for gas evacuation/flushing to enhance shelf life, and therefore to combine prior art elements according to known methods to yield predictable results in prolonging shelf life.
Regarding claim 16, the combination applied to claim 1 teaches molding to the shape and texture of the vegetable. While convex molds are known, the mold of the combination applied to claim 1 would have necessarily required a recess having the corresponding shape and texture as shown by Nutricia NPL (pages 37 and 48 figures).
Regarding claim 25, Jaeger et al. does not teach hot pasteurizing the sealed pouch. It is noted that “hot” pasteurization is construed to be thermal inactivation of pathogens as is known in the art. The combination of Jaeger et al. with Villota et al. applied to claim 1 teaches and renders obvious hot pasteurization for preservation.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Jaeger et al. in view of Weibe, Cassel et al., McLenithan et al., Adam, Schoenfellinger et al., Nutricia NPL, and Villota et al. as applied to claim 1 above, and further in view of Sepehr (US 2013/0142917 A1).
Regarding claim 26, Jaeger et al. does not teach cold pasteurizing the sealed pouch as claimed. The limitation is interpreted to include HPP as disclosed in the specification (page 21 line 1), and as is known in the art.
Sepehr teaches a method of processing and packaging fruit with extended shelf life (abstract), where the fruit is treated using cold pasteurization (paragraph 15). The pasteurization process avoids heating the fruit, thereby having negligible adverse effect on freshness, texture or taste while extending shelf life (paragraph 14).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process to include cold pasteurization as claimed in order to provide the appropriate treatment without degrading the quality of the product and to eliminate the need for syrups and preservatives which can compromise the quality and taste as taught by Sepehr (paragraph 8), for consumer safety, or as a substitution of art recognized equivalents suitable for the same purpose of pasteurization, see MPEP 2143 I.(B) and 2183.
Response to Arguments
The amendment to claim 1 now requires the step of “evacuating air…” to be performed after “fusing the second layer…” Jones et al. requires evacuation to be performed prior to fusing/sealing as explained in item 28 of the previous Office Action. Therefore, the amendment necessitated new grounds of rejection and Jones is no longer relied upon. The instant rejection relies on McLenithan, Adams and Schoenfellinger et al. to show that pouches can be formed by partially fusing the package while maintaining at least one opening to allow for subsequent evacuation of air and flushing with inert gas prior to final sealing.
Applicant's arguments filed 9/10/2025 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant argues on page 7 that the limitation “industrial scale high volume” would be understood by a skilled person to mean a continuous production line process rather than batch process, and imposes a limitation on the claim that would be clearly understood to be exclusive of batch processes.
This is not persuasive since the issue of indefiniteness is not limited only to whether the method is continuous or batch-wise. Rather, the limitation is indefinite since the scope of the claim cannot be determined for other features, such as overall capacity as explained in the rejection above. There is no indication in Applicant’s disclosure that “industrial scale high volume” is intended to be defined only by continuous/batch operation, and Applicant has not shown evidence that the phrase has an art-recognized definition commensurate with the alleged definition. Since the scope of the claim cannot be determined, one of ordinary skill in the art would not be able to determine at which point infringement occurs, and how the limitation should be interpreted with respect to parameters such as production rates when applying the prior art.
Applicant argues on page 9 that the inventive solution is the claimed additive of xanthan gum and agglomerated modified potato starch in the claimed amounts, which minimizes liquid bleeding during defrosting and helps the texture modified food product retain its shape and texture during reheating.
This is not persuasive since the claimed substances are known in the art to be thickening and water-binding agents that prevent moisture loss during freeze/thaw cycles as taught by Weibe and Cassel et al. Thickening agents are known to increase viscosity, facilitate gel stability, and provide a texture suitable for dysphagic individuals. Therefore, the prior art suggests to one of ordinary skill that a composition having the claimed additives in the claimed amounts would be expected to exhibit the argued properties. Applicant has not shown evidence that the claimed substances and values are critical or yield results other than those expected by the prior art.
Applicant argues the claimed invention addresses a long-felt need of the industry to supply dysphagic consumers with safe, nutritious and appetizing meals in a dignified manner, where only Jaeger and Nutricia NPL relate to preparation of dysphagic consumers and neither relate to problems of (i)-(iii) as stated.
This is not persuasive since Applicant has not provided any factual evidence to support the argument. See MPEP 716.01(c) II. and 716.04. Regardless, Jaeger already recognizes that xanthan gum and other starches can be used to adjust texture and viscosity of a food product intended for dysphagic consumers. Weibe and Cassel show that food products include agglomerated modified food starch (e.g., from potatoes) in order to obtain desired viscosity, mouthfeel, texture and rheological property. Applicant has not shown evidence that the argued features are critical or yield unexpected results as stated above.
Furthermore, adjusting the respective characteristics of the product to be compliant with IDDSI standards for dysphagic consumer safety and providing a food that is stimulating would have been readily obvious since Jaeger is already directed to facilitating consumption for dysphagic individuals (paragraph 37), and the prior art recognizes that foods can be molded to obtain a shape that represents the original fruit/vegetable from which the food is made as taught by Nutricia.
Applicant argues on page 10 that Jaeger does not disclose an industrial scale high volume method as claimed, and it would not have been obvious to one of ordinary skill in the art to make the process of Jaeger continuous, automate and scaled due to safety requirements. Applicant argues the 3D printing taught by Jaeger can cause issues at the industrial scale and is not suitable for industrial scale food preparation.
This is not persuasive since automating, scaling, and making continuous the process of the prior art is prima facie obvious absent evidence to the contrary. See also MPEP 2144.04 III., 2144.04 IV.A., and 2144.04 V.E. Applicant has not shown evidence to support the argument that the process of Jaeger cannot be scaled. Further, the 3D printing of Jaeger is a preferred embodiment (i.e. “If the shaping is done by means of 3D printing”); the reference explicitly states the food product can be formed by molding (paragraphs 3, 54, 148, and 157). See also MPEP 2123.
Regardless, McLenithan teaches the packaging machine, comprising a plurality of molds on platens which are carried by independently actuated means, allows for the stages of the process to move at different speeds, thereby decreasing overall cycle (manufacture) time (abstract). The machine runs continuously (paragraphs 79 and 81). Large scale molding techniques (e.g., parallel processing, molding conveyors, and surging means) are recognized for food packaging, and modification would have been obvious for the reasons taught by McLenithan and stated for claim 1.
Applicant argues on page 10-11 that Jaeger does not clearly name the range of 5-40 microns, provides no clear direction toward the claimed range, Examiner’s argument would lead to the illogical conclusion that any broad disclosure would also be considered a disclosure of the claimed range, the claimed range allows the chopped fruit or vegetable to be approximately equal to the air bubbles introduced into the paste for a mousse-like texture that obtains soft peaks and retains liquid for compliance with IDDSI levels 3 and 4, and Jaeger provides no motivation to adjust the particle size to the claimed range.
This is not persuasive since the particle size taught by Jaeger encompasses that of the claimed range. The comminution is performed such that “at least 90% by weight” has a “maximum particle size of… preferably <1 mm” and complies with a known standard, where “setting the maximum particle size can be advantageous if food compositions are to be provided which are intended for…people suffering from dysphagia because it makes consumption easier for these people” (paragraph 37). While the range of 5-40 microns is not explicitly taught, the reference nonetheless suggests to one of ordinary skill in the art that particle sizes encompassing the claimed range are advantageous for facilitating consumption by dysphagic individuals. Applicant has not shown evidence that the claimed range is critical or yields unexpected results, and therefore modification of Jaeger to comminute the food to the claimed range of particle sizes would have been prima facie obvious for reasons such as ease of consumption by dysphagic individuals and desired texture/mouthfeel. See also MPEP 2144.05 I.-II. The rejection is not based on a genus-species relationship as argued, but rather routine experimentation and optimization of an encompassing particle size range taught by the prior art.
Regarding the argument of air bubbles introduced for compliance with IDDSI, the argument is not persuasive for the same reasons stated above. Applicant has not shown evidence that the argued feature actually occurs over the claimed range, nor that the comminuted product of Jaeger does not obtain said features. See also MPEP 716.01(c) “Arguments presented by the applicant cannot take the place of evidence in the record.” In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Whipping to obtain a desired texture by incorporating air is well-known in the art, and producing such a texture would have been prima facie obvious for a desired mouthfeel, intended user, and type of food product. Further, Jaeger teaches using a blixer for comminution (paragraph 153), which appears to be the same method by which Applicant obtains the claimed texture i.e., chopping by fast-moving blades (page 16 lines 1-5). Jaeger also teaches including known texturing/rheology modifying agents such as gums and starch as stated for claim 1. Regardless, the claims do not positively recite that the comminuted material is actually required to obtain a “mousse-like” texture as argued.
Applicant argues on page 11 that neither Jaeger nor Cassel provide teaching regarding the amount of xanthan gum required to minimize bleeding of liquid from the food product, which allows the product to retain liquid through defrosting, heating, and consumption.
This is not persuasive since Jaeger et al. teaches at least 0.1 wt% of the third texturing agent comprising xanthan gum, where the third agent has a water-binding effect (paragraphs 31 and 33). A compound and its properties are inseparable. In re Papesch, 137 USPQ 43 (CCPA 1963). Further, Weibe teaches modified food starch binds water and moisture released from the food during cooking and prevents moisture loss during freeze/thaw cycles as stated for claim 1. Absent persuasive evidence to the contrary, one of ordinary skill would have reasonably expected the molded product of Jaeger, containing the same amount of xanthan gum, to exhibit the same property as that of the claimed molded product.
Applicant argues on pages 11-12 that Jaeger and Wiebe do not teach the claimed range of agglomerated modified potato starch increases the viscosity of the paste, Wiebe’s disclosed range is directed to a broader range of concentration and provides no direction to the claimed range, and the feature assists in retaining the food’s shape after heating.
This is not persuasive since Wiebe teaches the percentage of starch is on weight basis (claim 18), and since the claimed range would have been subjected to routine optimization as stated for claim 1. Wiebe teaches adjusting the amount of agglomerated modified potato starch to control moisture loss during freeze/thaw cycles and obtain a desired texture (column 2 lines 63-67), and Cassel teaches providing desired viscosity and mouthfeel (paragraph 24). Additionally, maintaining the food’s shape after heating would have been prima facie obvious in order to maintain the decorative features imparted by the mold and/or prevent unintentional egress before the package is fully sealed.
Applicant argues on pages 12-13 that it would not have been obvious to modify the process of Jaeger to include the step of setting the paste in the mold to form the molded texture modified food product, the mold shaped and textured to impart a shape and texture resembling that of a generic shape of the selected fruit or vegetable onto the paste, where Jaeger teaches 3D printing for shaping as opposed to molds, and Nutricial NPL teaches molds in a domestic kitchen in batches. Applicant argues the significance of the shape and texture of the food product on the dysphagic consumer’s appetite, citing various references in support.
This is not persuasive for the same reasons stated above. Jaeger teaches shaping can be performed using molds, and scaling to an “industrial scale high volume” is prima facie obvious. Continuously operating food packaging devices are recognized by the prior art as shown by McLenithan. Nutricia is not relied on to teach the process, nor its process modified in any way. The reference is cited only to show that food for dysphagic consumers can “be shaped using special food moulds so that it more closely resembles the original ingredient” (page 9). Further, Nutricia acknowledges the importance of achieving consistency of texture for safety (page 3 sixth paragraph). While the references cited by Applicant have been considered, the prior art still teaches a method for molding food paste into shapes that resemble the original food. One of ordinary skill would have expected the molded food to have a similar effect on a dysphagic consumer’s appetite.
Applicant argues on page 14 Jaeger is incompatible with Jones and therefore it would not have been obvious to combine, and Jaeger teaches way from mold-in-place packaging by teaching 3D printing, where xanthan gum is included for its properties for 3D printing.
This is not persuasive since Jaeger teaches shaping can be performed by molding as stated above, where 3D printing is a preferred embodiment that is not relied upon. Further, Jaeger states the xanthan gum is preferable for 3D printing, but does not exclude the use thereof for molding. The composition of the texturing agents can also be selected based on desired firmness (paragraph 32).
Additionally, Applicant’s amendments necessitated new grounds of rejection. Jones is no longer relied upon in the instant rejection. McLenithan is relied on to teach thermoforming machines used to package foods, where such machines include vacuum thermoforming to shape the package as desired.
Applicant argues on page 15 that it would not have been obvious to combine the back-flushing of Bender and the pasteurization and freezing of Villota with Jaeger since there is no motivation to do so, Villota presents a self-contained preservation process, Bender solves a different problem related to modified atmosphere packaging, and a skilled person would not make the combination since adding the protective gas of Bender to the process of Villota would be redundant and add complexity. Applicant argues that the claimed invention uses a combination of back-flushing, pasteurization and freezing to meet safety, quality and longevity needs for texture modified foods.
As an initial matter, the arguments against the combination have been fully considered but the amendments necessitated new grounds of rejection. Bender is no longer relied upon. Examiner also notes that the process of Villota is not modified in any way. Rather, the reference is relied on to show that hot pasteurization is recognized to facilitate prolonged shelf life of packaged food.
As stated for claim 1, McLenithan teaches a thermoforming device that uses vacuum drawing to mold a first packaging material into a desired shape, followed by placing food product within the molded packaging and sealing with a second packaging material. Adams teaches sealing partially first packaging and second packaging materials such that gas flow conduits are retained prior to final sealing. Schoenfellinger teaches a “pouch” type package can be formed with three fused sides, placing the food in the pouch, removing air and flushing with inert gas, then sealing, thus extending shelf life. Jaeger teaches freezing the molded product, where the prior art combination would freeze the molded and packaged product.
The cited prior art teaches packaging by removing and replacing air with inert gas, followed by pasteurization and freezing. Each feature is known in the art to facilitate preservation, and commonly practiced in food packaging. Jaeger does not teach or otherwise indicate that the process cannot be modified to include the argued features, nor that any of the proposed modifications would yield a process unsuitable for its intended purpose. Thus, modification of Jaeger to include all the argued features would have been obvious for enhancing preservation, as well as the reasons stated for claim 1.
Applicant argues on page 16 that the claimed invention addresses the issue of freezer burn by evacuating air from the pouch and the xanthan gum helping to retain moisture, preventing or slowing the speed at which the paste begins to dry out.
This is not persuasive since the prior art combination teaches a process of forming a food product comprising the claimed amount of xanthan gum, forming a pouch that is not completely sealed and placing the food product therein, evacuating air and flushing the pouch with inert gas such as nitrogen and carbon dioxide, and final sealing. The process of the prior art combination appears to be the same as that of Applicant’s claimed process. Absent persuasive evidence to the contrary, one of ordinary skill would have reasonably expected the prior art combination to exhibit a similar property of preventing freezer burn. Further, freezer burn is generally understood in the art to be undesirable due to texture and flavor changes, regardless of whether said changes affect dysphagic individuals. It would have been within the capability of one of ordinary skill to adjust the above features to minimize undesired freezer burn.
Applicant’s arguments on pages 16-17 summarizing the already presented arguments and against the dependent claims are not persuasive for all the same reasons stated in this section.
Regarding new claims 36-40, Examiner acknowledges Applicant’s argument that said claims are an extension of the process of claim 1. However, the claims are subjected to restriction since they are directed to a separate method requiring the technical feature of claim 1. The technical feature does not make a contribution over the prior art combination applied to said claim. Thus, claims 36-40 are withdrawn in view of election by original presentation. Examiner notes claim 1 recites a method, whereas the preamble of claim 36 suggests claim 1 is a product. Examiner is willing to consider rejoinder, but the language of the preamble recited by claim 36 must be amended to be consistent with that of claim 1. It is noted that any amendments to claim 36 and its dependents require further consideration before rejoinder.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BRYAN KIM/Examiner, Art Unit 1792