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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/24/2026 has been entered.
Claim Status
The amendment of 04/24/2026 has been entered. Claims 1, 3-17, and 30-32 are pending (claim set as filed on 04/24/2026). Claims 4-11 and 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant previously elected without traverse invention Group I, drawn to a method of extracting protein from a protein source, ‘egg white material’ as species of protein source material, ‘extraction’ as species of treatment of protein source material, and with traverse ‘ovotransferrin’ as protein species and ‘crosslinked calcium alginate having carboxylate functional groups’ as crosslinked alginate-based carrier in the reply filed on 12/17/2024.
Claims 1, 3, 12-13, 16-17, and 30-32 are currently under examination and were examined on their merits.
Claim Rejections - 35 USC § 112 (b)
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.
Claim 31 is 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.
Claim 31 recites ‘the dilution’ which is indefinite for lacking antecedent basis because ‘dilution’ is not recited within the claim or in claims 1 and 3 from which claim 31 depends. One of ordinary skill in the art would not be able to determine the metes and bounds of the claim, and thus, could not clearly determine how to avoid infringement of claim 31.
In the interest of compact prosecution, claim 31 is interpreted to the broadest embodiment claimed.
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.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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, 12-13, 16-17, and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Omana et al. ("Co-extraction of egg white proteins using ion exchange chromatography from ovomucin-removed egg whites", published on 04/29/2010, Journal of Chromatography B, Vol. 878, pages 1771-1776), hereinafter ‘Omana’, in view of Jain et al. ("Applications of Alginate in Bioseparation of Proteins", published 2006, Artificial Cells, Blood Substitutes, and Biotechnology, Vol. 34, pages 127-144), hereinafter ‘Jain’, and in view of Su et al. ("Encapsulation and release of egg white protein in alginate microgels: Impact of pH and thermal treatment", published on 02/27/2019, Food Research International, Vol. 120, pages 305-311), hereinafter ‘Su’, as evidenced by Pawar et al. ("Alginate derivatization: A review of chemistry, properties and applications", published on 01/26/2012, Biomaterials, Vol. 33, pages 3279-3305), hereinafter ‘Pawar’.
Omana's general disclosure relates to co-extraction of valuable egg white components in a continuous process (see entire document, including abstract).
Regarding claim 1, pertaining to a method of extracting protein, Omana teaches a method of extracting a protein from a protein source material (see abstract), wherein the method comprises:
contacting a carrier with the protein source material and allowing the protein to bind to the carrier, so as to form a protein-loaded carrier product (page 1772, left column, paragraphs 4-5; see Figures 1 and 3); and
separating the protein-loaded carrier product from the remaining protein source material (page 1772, left column, paragraph 5; see Figures 1 and 3; noted, Omana’s flow-through fraction corresponds to the remaining protein source material);
wherein the protein source material is egg white material (page 1172, left column, paragraph 3; see abstract).
Regarding claim 3, please note the elected species ‘extraction’ under Claim Status above.
Regarding claim 31, please note the 112b rejection of claim 31.
Regarding claims 3 and 31, pertaining to treatment of egg white material, Omana teaches wherein the protein source material has undergone extraction ("ovomucin was first prepared using isoelectric precipitation of egg white in the presence of 100mM NaCl solution”; page 1772, left column, paragraph 3; see abstract and Fig. 1) (instant claim 3), wherein the extraction is of one or more protein (“the resultant supernatant obtained after ovomucin isolation was used as the starting material for ion-exchange chromatography. Anion-exchange chromatography of 100mM supernatant yielded a flow-through fraction and three other fractions representing ovotransferrin, ovalbumin and flavoproteins"; see abstract) (instant claim 31).
Regarding claim 12, pertaining to the egg white material, Omana teaches wherein the protein source material is egg white that has been diluted with aqueous medium ("isoelectric precipitation of egg white in the presence of 100mM NaCl solution"; page 1172, left column, paragraphs 1 and 3; see Fig. 1).
Regarding claims 13 and 32, pertaining to the aqueous medium, Omana teaches wherein the aqueous medium contains the water-soluble salt sodium chloride (“100mM NaCl solution”, page 1172, left column, paragraph 3; see Fig. 1). Pertaining to the protein, Omana teaches wherein the protein is ovotransferrin (“The loosely bound second fraction (F2) was eluted during the isocratic elution with 0.14M NaCl solution. The molecular weight of F2 fraction was found to be 77.3 kDa with a purity of 47.7% of ovotransferrin”; page 1773, right column, paragraph 2, see Figures 1-3).
Regarding claim 30, pertaining to the protein, Omana teaches wherein the method provides protein in unbound form (“The loosely bound second fraction (F2) was eluted during the isocratic elution with 0.14M NaCl solution. The molecular weight of F2 fraction was found to be 77.3 kDa with a purity of 47.7% of ovotransferrin”; “Further elution with a gradient from 0.14M NaCl to 0.50M NaCl solution yielded 2 fractions (F3 and F4). The third fraction (F3) was predominantly ovalbumin”, “The last fraction (F4) was found to be 100% pure flavoprotein”; page 1773, right column, paragraph 2; page 1774, left column, paragraph 1; page 1774 right column, paragraph 1; see Fig. 3), and wherein the method further comprises
removing protein from the carrier so as to provide protein in unbound form (page 1773, right column, paragraph 2; page 1774, left column, paragraph 1; page 1774, right column, paragraph 1).
Omana does not teach wherein the carrier is a crosslinked alginate-based carrier (instant claim 1), wherein the crosslinked alginate-based carrier is ionically cross-linked calcium alginate having carboxylate functional groups (instant claims 13 and 32), wherein the crosslinked alginate-based carrier is calcium alginate (instant claim 16), wherein the crosslinked alginate-based carrier is in the form of beads (instant claim 17).
Jain's general disclosure teaches the use of alginate in bioseparation of
proteins (see entire document, including title and abstract).
Regarding claim 1, pertaining to a crosslinked alginate-based carrier, Jain teaches a crosslinked alginate-based carrier (page 128, paragraph 5 - page 129, paragraph 1), wherein crosslinked alginate-based carriers are used for purification of enzymes (see abstract).
In addition, Jain discloses elution of an enzyme off alginate beads by a moderate concentration of NaCl (page 131, paragraph 1).
Regarding claims 13, 16, and 32, pertaining to the crosslinked alginate-based carrier, Jain teaches wherein the crosslinked alginate-based carrier is ionically crosslinked calcium alginate ( page 128, paragraph 5 - page 129, paragraph 1). The Examiner further notes that ionically crosslinked calcium alginate intrinsically comprises carboxylate groups, as evidenced by Pawar (page 3285, left column, paragraph 2 - right column, paragraph 1).
Regarding claim 17, pertaining to the crosslinked alginate-based carrier, Jain teaches wherein the alginate-based carrier is in form of beads (page 131, paragraph 1; see Table 1). Jain further discloses that alginate beads show good fluidization behavior (see Table 1), and that an enzyme could be eluted off alginate beads by a moderate concentration of NaCl (page 131, paragraph 1).
In addition, Jain teaches that “the cost of affinity material has been a major factor that has held back cost-cutting in protein production”, and that “alginate, a cheap and easily available material, in this respect constitutes a unique opportunity” (page 139, paragraph 3). Jain further discloses that “alginate is used widely in processed foods”, and therefore, “as such (in unconjugated form) in bioseparation, makes it an ideal choice for protein purification in the commercial sector where acceptability by regulatory agency is a major issue.” (page 139, paragraph 3).
Su’s general disclosure relates to egg white protein-loaded alginate microgels (see entire document, including abstract).
Su teaches electrostatic interaction between egg white protein and calcium alginate (page 306, left column, paragraphs 2-3; page 306, right column, paragraph 4; see abstract), and discloses wherein colloidal delivery systems have the ability to release active agents in response to specific environmental triggers including pH and ionic strength ( page 305, left column, paragraph 1).
While Omana does not teach wherein the carrier is a crosslinked alginate-based carrier (instant claim 1), wherein the crosslinked alginate-based carrier is ionically cross-linked calcium alginate having carboxylate functional groups (instant claims 13 and 32), wherein the crosslinked alginate-based carrier is calcium alginate (instant claim 16), wherein the crosslinked alginate-based carrier is in the form of beads (instant claim 17), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined Omana's egg white protein extraction method with Jain's teachings on crosslinked alginate based carriers for protein separation and inexpensiveness of alginate, and with Su's teachings on electrostatic interaction between egg white protein and calcium alginate, in order to have created an egg white protein extraction method using a crosslinked alginate-based carrier, wherein the carrier is ionically crosslinked calcium alginate having carboxylate functional groups, wherein the crosslinked alginate-based carrier is calcium alginate, and wherein the crosslinked alginate-based carrier is in the form of beads. One would have been motivated to do so in order to improve extraction of a specific egg white protein, such as ovotransferrin taught by Omana (see abstract), and/or to reduce protein extraction costs since alginate is a cheap and easily available material (Jain, page 139, paragraph 3). A skilled artisan would have reasonably expected success in the combination of Omana’s, Jain's, and Su's teachings, since all references are directed to protein carrier interactions and subsequent release of the protein.
Response to Arguments
Applicant has traversed the previous rejections of claims 1, 3, 12-13, 16-17, and 30-32 under 35 U.S.C. 103 in the reply filed on 04/24/2026 (remarks, pages 5-8). Omana, Jain, and Su are still relied upon in the above rejection. Applicant's arguments have been fully considered but they are not persuasive.
In Applicant’s reply Applicant states that “claim 1 is non-obvious over the cited prior art
Omana et al., in view of Jain et al., in view of Su et al., as evidenced by Pawar et al.” (remarks, page 7), and describes that “the method of Omana is based on adsorption”, that Su’s method “is governed by diffusion-limited entrapment”, and that a person of ordinary skill in the art would not consider substituting a surface adsorption mechanism with a carrier used in a diffusion-limited entrapment mechanism” (remarks, page 6).
In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Omana teaches a method of extracting protein from egg white material using ion exchange chromatography, which is based on electrostatic interaction between protein and carrier, Jain teaches calcium alginate for separating proteins and cost effectiveness of alginate, and Su teaches electrostatic interaction between egg white protein and calcium alginate, as discussed above. It would have been obvious to a skilled artisan to combine Omana’s, Jain’s and Su’s teachings to establish a cost-effective method to extract protein from egg white material.
Applicant states that “Omana explicitly requires high concentrations of monovalent salts (up to 500 mM NaCl) to achieve protein fractionation”, and that “high concentrations of Na+ ions will undergo ion exchange with Ca2+ ions, causing the alginate beads to swell excessively or completely disintegrate” (remarks, page 7).
The Examiner responds that it is within the realm of routine experimentation to determine optimal experimental conditions including salt concentrations for protein extraction using a given carrier material. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[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 (CCPA1955). See MPEP § 2144.05 part II A. It is noted that the specification discloses the use of 0.68M NaCl to release protein from the alginate beads (page 30, lines 10-14).
Applicant describes that “Omana is directed to a pre-processed, partially purified supernatant (post-ovomucin isolation). The claimed invention, however, is directed to a much broader and more complex protein source material, egg white material”, and that “the Examiner fails to distinguish the scope of the claimed invention from the highly specific limitations of Omana” (remarks, page 7).
In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “complex egg white material”) are not recited in the rejected claims. It is noted that the specification describes wherein “the egg white material used in the present invention may be egg white that has undergone one or more treatment prior to being used” (page 10, lines 8-14), and that “the egg white material may be egg white that has had one or more proteins extracted from it” (page 10, lines 20-21).
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANDRA ZINGARELLI whose telephone number is (703)756-1799. The examiner can normally be reached M-F 9-5.
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/SANDRA ZINGARELLI/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653
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