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
Applicant’s election without traverse of Group I, claims 1-3, in the reply filed on 2/25/26 is acknowledged.
Claims 4-10 are canceled.
Specification
The disclosure is objected to because of the following informalities:
On paragraphs [0005] and [0008], the term “acidation” should read “acidification”.
Appropriate correction is required.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 recites the term “and/or” several times throughout the body of the claim to separate three sets of conditions (i.e., 1) pectin, first and second protein component concentrations; 2) glutamine transaminase concentration, and 3) mass ratio of the functional dietary fiber to the pectin). The claim should be amended to specify these three conditions separately for better claim construction.
Appropriate correction is required.
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 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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fan et al. [CN 114711326 A], hereinafter Fan, in view of Scionti [US 20210345643 A1], Matsumoto et al. [US 20120021063 A1], hereinafter Matsumoto, and Bishop et al. [US 5834232 A], hereinafter Bishop, evidenced by Guo [Effect of Glutamine Transaminase on the Gel Properties of Mutton, 2020], hereinafter Guo.
Regarding claim 1, Fan teaches a bioink (edible muscle ink) [Fan, abstract], wherein raw materials for preparing the bioink comprise pectin [Fan, 0098], glutamine transaminase (also known as transglutaminase, see Guo, p.1, Introduction) [Fan, claim 3, claim 7, 0104, Espacenet Translation; p.47, par.2, PE2E Translation], a first protein component and a second protein component (more than one of various protein components, i.e., potato protein, soy protein isolate) [Fan, claim 2 element 4, 0021-0024, 0091, 0093].
Fan does not teach the first protein component is gelatin and/or collagen.
Scionti teaches an edible micro-extruded product that can be carried out by 3D printing, using a viscoelastic composition comprising proteins and pseudoplastic polymers as injectable ink (bioinks [Scionti, 0256, 0259, 0262]) for 3D printing from which the micro-extruded elements are made [Scionti, 0029, 0194]. The edible micro-extruded product comprises proteins and pseudoplastic polymers including pseudoplastic proteins such as gelatin and/or collagen. Scionti further disclose pseudoplastic proteins also include proteins already disclosed by Fan such as pea protein, mung bean protein, peanut protein, rice protein and other plant proteins [Scionti, 0112, 0114; Fan, 0022].
It would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the first protein component of gelatin and/or collagen as taught by Scionti, in the bioink of Fan, because both are in the same field of endeavor of 3D printing for production of edible food, and also because Scionti teaches that gelatin/collagen can be used in a similar manner as plant proteins as taught by Fan. Furthermore, it would have obvious to one of ordinary skill in the art to include the first protein component of gelatin and/or collagen as taught by Scionti, because Scionti teaches that the use of these proteins (pseudoplastic proteins polymers, i.e., gelatin and collagen [Scionti, 0110, 0112, 0114]) and mixtures of these pseudoplastic proteins with pseudoplastic polysaccharide polymers (i.e., polysaccharide such as pectin [Scionti, 0110-0111, 0113]) would make possible to produce micro-extrudable homogeneous pastes, of variable viscosity [Scionti, 0205] due to the rheological properties of said viscoelastic composition comprising these pseudoplastic proteins/polysaccharide polymers [Scionti, 0029].
Fan does not teach the second protein component is protamine.
Matsumoto teaches a crosslinked material suitable for various uses such as biomedical applications such as scaffold materials [Matsumoto, abstract]. The crosslinked material comprising proteins (collagen/elastin) may additionally comprise protamine [Matsumoto, 0119]. It is also noted that protamine is a fish derived protein [Matsumoto, 0119], and Scionti discloses including fish protein [Scionti, 0106], and that animal proteins and plant proteins can be used in a similar manner [Scionti, 0112].
It would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the second protein component of protamine as taught by Matsumoto, in the bioink of Fan, because both are in the same field of endeavor of crosslinked materials (polymers such as proteins and polysaccharides) [Fan, 0091; Matsumoto, abstract], (“cross-linking of proteins polypeptides/polysaccharides”, as disclosed in par.[0014-0015] of the instant Specification), for the production of protein containing compositions including foods and/or medical (biomedicine) applications [Matsumoto, abstract], (“biomedicine”, as disclosed in par.[0046] of the instant Specification), and because Matsumoto teaches that the addition of protamine to the crosslinked material would provide beneficial effects such as antibacterial effect [Matsumoto, 0121], and the combination of protamine with other proteins (collagen/elastin) may be blended in such a blending amount that the objective physical properties, properties or functions can be provided in a crosslinked material [Matsumoto, 0123].
Fan does not teach the pectin has a molecular weight of 250-350 kDa, an esterification degree of greater than 75%, and a mass ratio of neutral sugar to acidic sugar of 1:(2-3); and/or, the gelatin is type A gelatin and/or type A+B gelatin.
Bishop teaches a crosslinked protein gel materials [Bishop, abstract] such as gelatin and collagen [Bishop, col.3, l.67; col.4, l.1-2, col.5, l.55-56], and the gelatin may be a type A gelatin [Bishop, Example 1, col.10, l.66] and/or type A+B gelatin [Bishop, col.9, l.46-47].
It would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a type A gelatin and/or type A+B gelatin as taught by Bishop, in the bioink of Fan, because both are in the same field of endeavor of crosslinked polymeric materials (polypeptides) [Fan, 0091; Bishop, abstract], (“cross-linking of proteins polypeptides/polysaccharides under the action of glutamine transaminase also known as transglutaminase”, as disclosed in par.[0014-0015] of the instant Specification), for the production of protein containing compositions including foods [Bishop, col.9, l.23-30] and/or medical (biomedicine) applications [Bishop, abstract, col.8, l.66-67], (“biomedicine”, as disclosed in par.[0046] of the instant Specification), and because Bishop teaches that the crosslinked gel materials of the invention comprising type A gelatin and/or type A+B gelatin provide the advantages of uniformity and specific cross-linking in combination with high thermal stability, which permit use of the gels within new and expanded applications including medical and food applications [Bishop, col.9, l.1-8], and wherein the foodstuffs prepared with the crosslinked gel materials and methods of the invention would allow for the preparation of protein-containing food products, with improved functional properties of said proteinaceous foods [Bishop, col.9, l.23-26].
Regarding claim 2, Fan teaches the bioink comprising the first protein component (potato protein), and the second protein component (soy protein isolate) [Fan, 0093], Scionti teaches the edible viscoelastic composition comprising proteins and pseudoplastic polymers as bioink [Scionti, 0256, 0259, 0262], where the proteins are pseudoplastic proteins such as gelatin and/or collagen [Scionti, 0112, 0114], and Matsumoto teaches the crosslinked material comprising proteins (collagen/elastin) and additionally comprise protamine [Matsumoto, 0119] as discussed above in claim 1; and Fan further teaches the mass ratio of the first protein component (potato protein) to the second protein component (soy protein isolate) is 4.2:8.4 [Fan, 0093], which is equivalent to a ratio of 1:2, and falls within the claimed range mass ratio of the first protein component to the second protein component of 1:(1.6-3).
Therefore, because Fan teaches the first protein component and the second protein component, wherein the mass ratio of the first protein component (potato protein) to the second protein component (soy protein isolate) is 4.2:8.4 (1:2), Scionti teaches the proteins (pseudoplastic proteins) such as gelatin and/or collagen (which are the instantly claimed first protein component), and Matsumoto teaches the crosslinked material comprising proteins such as collagen (which is also the instantly claimed first protein component already taught by Scionti) in combination with protamine (which is the instantly claimed second protein component), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the gelatin and/or collagen (as taught by Scionti) as the first protein component, and the protamine (as taught by Matsumoto) as the second protein component, into the bioink having a mass ratio of the first protein component to the second protein component of 1:2 of Fan, because simple substitution of one known element (i.e., potato protein “first protein component” and soy protein isolate “second protein component” of Fan) for another (i.e., gelatin and/or collagen “first protein component” of Scionti, and protamine “second protein component” of Matsumoto) would have yielded predictable results to one of ordinary skill in the art, particularly because as explained above, Scionti disclose pseudoplastic proteins also include proteins already disclosed by Fan such as pea protein, mung bean protein, peanut protein, rice protein and other plant proteins [Scionti, 0112, 0114; Fan, 0022] and that gelatin/collagen can be used in a similar manner as plant proteins as taught by Fan [Scionti, 0112]. Moreover, additionally to Scionti already teaching gelatin and/or collagen, Matsumoto also teach using collagen (first protein component) further combined with protamine (second protein component), wherein the blending amount (ratio) of the collagen component to protamine component is not limited, and may be blended in such a blending amount that the objective physical properties, properties or functions can be provided in a crosslinked material [Matsumoto, 0117, 0123]. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the claimed mass ratio of the first protein component to the second protein component during the course of normal experimentation and optimization in the method of Fan in view of Scionti, Matsumoto and Bishop, due to factors such as the individual rheological properties of proteins and pseudoplastic proteins/polymers of said viscoelastic compositions comprising these, the type and quantities of the various ingredients, and/or the desired final viscosity of the final product as taught by Scionti [Scionti, 0029, 0205].
Regarding claim 3, modified Fan teaches the bioink comprising pectin [Fan, 0098], glutamine transaminase (transglutaminase which is the cross-linking agent) [Fan, 0052, claim 3], the first protein component (gelatin and/or collagen [Scionti, 0112, 0114]), and the second protein component (protamine [Matsumoto, 0119]) [Fan, 0091] as discussed above in claim 1, and further teaches the bioink comprises water [Fan, 0110], and mixing the above mentioned materials (pectin, glutamine transaminase, the first protein component, the second protein component, and water) [Fan, 0112], thus, forming a solution wherein the components are cross-linked under the action of a cross-linking agent (glutamine transaminase) [Fan, 0044], (where the pectin, the first protein component, and the second protein component are cross-linked under the action of the glutamine transaminase (transglutaminase) which is the cross-linking agent as explained above, and as disclosed by Applicant on par.[0015] of the instant Specification).
Fan does not explicitly teach the concentration of the glutamine transaminase is 0.5%-1.5% in the raw material mixed aqueous solution discussed above.
However;
Fan teaches that the bioink comprise crosslinking agents including glutamine transaminase (transglutaminase) and calcium chloride [Fan, 0052, claim 3], and teach the crosslinking agent of calcium chloride being used in an amount of 0.89% as crosslinking agent [Fan, 0141]. Therefore, one of ordinary skill in the art would recognize the use of the glutamine transaminase as crosslinking agent in the same amount of the crosslinking agent of calcium chloride being used by Fan at 0.89%, which is an amount that falls within the claimed range of 0.5%-1.5% for the concentration of the crosslinking agent glutamine transaminase.
Because Fan teaches that calcium chloride can be similarly used as glutamine transaminase for crosslinking components [Fan, 0052], it would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a concentration of 0.89% of the crosslinking agent glutamine transaminase in the raw material mixed aqueous solution taught by Fan above, because Fan teaches that these crosslinking agents would enable the bioink (muscle printing ink) to quickly gel [Fan, 0052] (crosslinking of polypeptide/polysaccharide components in the solution, such as pectin, gelatin/collagen, and protamine in the bioink of modified Fan) and solidify by the action of said crosslinking agents [Fan, 0044]. Additionally, it would have obvious to one of ordinary skill in the art to have used glutamine transaminase concentrations that falls within or encompass the claimed range during the course of normal experimentation and optimization in the method of modified Fan, due to factors such as the type and quantities of the various polypeptide/polysaccharide ingredients, the desired final texture and solidity of the final product, and/or the desired crosslinking effect (quickly cross-linkage of proteins with good printing performance) [Fan, 0091, 0104].
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969), MPEP 2144.05, II. A.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUIS EUGENIO DIOU BERDECIA whose telephone number is (571)270-0963. The examiner can normally be reached Monday-Friday 7:30-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at (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 published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.E.D./Examiner, Art Unit 1792
/VIREN A THAKUR/Primary Examiner, Art Unit 1792