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 Status
The amendment of 06/30/2025 has been entered. Claims 1, 3-17, and 30-32, are pending (claim set as filed on 06/30/2025). Claims 4-11 and 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 3, 12-13, 16-17, 30-32 are currently under examination and were examined on their merits.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 06/30/2025 has been received and considered.
Withdrawn Objections/Rejections
The rejections of claims 2-3 and 13 under 35 U.S.C. 112(b) as being indefinite
as set forth in the previous Office action are withdrawn in light of the amendment filed on 06/30/2025.
The previous prior art rejections of claims 1, 3, 16, 17, and 30 under 35 U.S.C. 102(a) set forth in the previous Office action are withdrawn in light of the amendment filed on 06/30/2025, which narrowed the scope of base claim 1.
The previous prior art rejections of claims 1, 3, 12-13, 16-17, and 30, under 35 U.S.C. 103 are maintained, and rejections of new claims 31-32 under 35 U.S.C. 103 have been added, as discussed below.
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 “and/or ore more acid”, which renders the claim indefinite since it is unclear what the phrase “ore more acid” means. 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. The Examiner further suggests the use of Markush language to clearly define the agent alternatives as water-soluble salt, surfactant, or acid (see MPEP 2117 and 2173.05(h)).
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 newly rejected as necessitated by amendment 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) 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), 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), 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).
Omana et al.'s general disclosure relates to isolation of egg white components
using a continuous process (see entire document, including abstract).
Regarding claim 1, pertaining to a method of extracting protein, Omana et al. teaches a method of extracting a protein from a protein source material (“Efficient isolation of egg white components is desired due to its potential uses. Existing methods mainly targeted on one specific protein; an attempt has been made in the study to co-extract all the valuable egg white components in a continuous process.”; 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 (“Proteins from 100mM supernatant were separated by two-step chromatographic methods. Initially the supernatant was allowed to pass through an anion exchange chromatographic column to separate different fractions.”, “After sample injection (10 mL), flow-through fraction (4 column volume [CV]) was collected using water as the eluent, followed by isocratic elution (4 CV) of the sample using 0.14M NaCl. Finally the bound fraction was eluted (5 CV) using gradient elution (0.14–0.5M) of NaCl.”; page 1772, left column, paragraphs 4-5); and
separating the protein-loaded carrier product from the remaining protein source material (“After sample injection (10 mL), flow-through fraction (4 column volume [CV]) was collected using water as the eluent, followed by isocratic elution (4 CV) of the sample using 0.14M NaCl.; page 1772, left column, paragraph 5);
wherein the protein source material is egg white material (“Briefly, ovomucin was first prepared using isoelectric precipitation of egg white in the presence of 100mM NaCl solution.”, “The supernatants obtained during the first step (with 100mM NaCl solution) and the second step (…) were further used for ion-exchange chromatography to separate other egg white proteins.; page 1172, left column, paragraph 3).
Regarding claims 3 and 31, pertaining to treatment of egg white material, Omana et al. teaches wherein the protein source material has undergone extraction ("Ovomucin was first isolated by our newly developed two-step method; the resultant supernatant obtained after ovomucin isolation was used as the starting material for ion-exchange chromatography."; see abstract) (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 claims 3, 12 and 31, pertaining to the egg white material, Omana et al. teaches wherein the protein source material is egg white that has been diluted with aqueous medium ("As a protein responsible for the viscous nature of egg white, ovomucin used to be isolated by dilution with three volumes of water at pH 6 [19,20]. However, ovomucin prepared by this method was contaminated with lysozyme and ovalbumin ... However, in this method mucin-free egg white was prepared by precipitation using water while the present work involved usage of 100mM NaCl solution for ovomucin separation. It is well established that precipitation of ovomucin using water causes huge loss of other proteins especially ovalbumin and lysozyme. Precipitation with 100mM NaCl helps to precipitate mainly ovomucin while leaving most of the other proteins in the supernatant.", "Briefly, ovomucin was first prepared using isoelectric precipitation of egg white in the presence of 100mM NaCl solution."; page 1171, right column, paragraph 2 - page 1172, left column, paragraph 1; page 1172, left column, paragraph 3).
Regarding claims 13 and 32, pertaining to the water-soluble salt and to the protein, Omana et al. teaches a water-soluble salt (““Briefly, ovomucin was first prepared using isoelectric precipitation of egg white in the presence of 100mM NaCl solution.”, “SDS-PAGE pattern of fractions obtained by anion-exchange chromatography of supernatant after treatment of egg white with 100mM NaCl solution”; page 1172, left column, paragraph 3; see Fig. 3), and further teaches wherein the protein is ovotransferrin (“OVT: 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 (Table 1)”. “SDS-PAGE pattern of fractions obtained by anion-exchange chromatography of supernatant after treatment of egg white with 100mM NaCl solution”; page 1773, right column, paragraph 3, see Figures 1-3).
Regarding claim 30, pertaining to the unbound protein, Omana et al. 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”; page 1773, right column, paragraph 3), and wherein the method further comprises
removing protein from the carrier so as to provide 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”; page 1773, right column, paragraph 3).
Omana et al. does not teach
- wherein the carrier is a crosslinked alginate-based carrier (instant claim 1)
- wherein the aqueous medium contains one or more water soluble salts
(instant claim 13),
- wherein the aqueous medium contains sodium chloride (instant claim 32),
- 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 et al.'s general disclosure teaches the use of alginate in bioseparation of
proteins ("Alginate is a polysaccharide that is a block polymer ... Thus, this versatile
marine resource has tremendous potential in bioseparation of proteins."; see entire
document, including abstract).
Regarding claim 1, pertaining to a crosslinked alginate-based carrier, Jain et al.
teaches a crosslinked alginate-based carrier ("Alginate forms gels with most di- and
multivalent cations. Alginate gel formation with calcium ions has been of interest in most
applications."; page 128, paragraph 5), and wherein a crosslinked alginate-based
carriers are used for purification of enzymes ("Alginate is a polysaccharide that is a
block polymer consisting of block units of guluronic acid and mannuronic acid. It shows
inherent biological affinity for a variety of enzymes such as pectinase, lipase,
phospholipase D, a and b amylases and glucoamylase. Taking advantage of its
precipitation with Ca2+ and the above-mentioned property, alginate has been used for
purification of these enzymes"; see abstract).
Regarding claims 13, 16, and 32, pertaining to the crosslinked alginate-based carrier, Jain et al. teaches wherein the crosslinked alginate-based carrier is ionically crosslinked calcium alginate (“Alginate forms gels with most di- and multivalent cations. Alginate gel formation with calcium ions has been of interest in most applications. Monovalent cations and Mg2+ ions do not induce gelation, while ions like Ba2+ and Sr2+ will produce stronger alginate gels than Ca2+. The gel strength will depend upon the guluronic content and also on the average number of G-units in the G-blocks. Gelling of alginate occurs when divalent cations take part in the interchain binding between G-blocks giving rise to a three-dimensional network in the form of a gel.”; 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 et al. (“The partially and fully acetylated alginates were used as tools to enhance understanding of the chelate structure formed in ionically crosslinked alginate gels [47] …Therefore, based on the data acquired a chelate structure was proposed wherein a single Ca2+ ion coordinated with two carboxylate groups and two vicinal hydroxyl groups belonging to the same sugar to form a gel.”; page 3285, left column, paragraph 2 - right column, paragraph 1).
Regarding claim 17, pertaining to the crosslinked alginate based carrier, Jain et al. teaches wherein the crosslinked alginate carrier is in form of beads (“Table 1. Bioseparation strategies based on properties of alginate … Can be converted into
alginate beads, which shows good fluidization behavior”, “observation that alginate beads bind pectinase”; page 131, paragraph 1; see Table 1).
Additionally, Jain et al. 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 et al. 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 et al.’s general disclosure relates to egg white protein-loaded alginate microgels (“Egg white protein-loaded alginate microgels”; see entire document, including abstract).
Su et al. teaches electrostatic interaction between egg white protein and calcium alginate (“Protein encapsulation efficiency and retention was highest at the lowest pH, which was attributed to the strong electrostatic attraction between the cationic egg white proteins and anionic alginate.”; “egg white protein (EWP)”; “EWP-loaded alginate microgels were produced using a hand-held syringe (…). 10 mL of EWP-alginate solution was injected into 100 mL of 10% calcium chloride solution with continuous stirring; page 306, left column, paragraph 2; page 306, right column, paragraph 4; see abstract), and teaches wherein colloidal delivery systems have the ability to release active agents in response to specific environmental triggers including pH and ionic strength (“Colloidal delivery systems (CDS)”, “CDS can be designed to increase the stability of bioactive agents … They also have the ability to control the release profile of encapsulated active agents or to release active agents in response to specific environmental triggers, such as pH, ionic strength,” (page 305, left column, paragraph 1).
While Omana et al. does not teach wherein the protein carrier is a crosslinked
alginate-based carrier (instant claim 1), further wherein the crosslinked alginate based
carrier is ionically cross-linked calcium alginate having carboxylate functional groups
(instant claims 13, 16, and 32), 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 et al.'s protein extraction method with Jain's et al. teachings on crosslinked alginate based carriers for protein separation, and with Su et al.'s teachings on interactions between egg white protein and ionically crosslinked calcium alginate, in order to have created a protein extraction method comprising a crosslinked alginate-based carrier, wherein the carrier is ionically crosslinked calcium alginate, and wherein the carrier is in form of beads. One would have been motivated to do so in order to improve extraction of a specific protein, such as ovotransferrin (see Omana et al. above), and to reduce protein extraction costs since alginate is a cheap and easily available material (see Jain et al. above). One would have reasonably expected success in the combination of Omana et al.'s, Jain et al.'s, and Su et al.'s teachings, since all references are directed to protein carrier interactions and subsequent release of the protein (see above).
While Omana et al. does not expressly teach wherein the egg white material is
diluted with aqueous medium containing a water-soluble salt (instant claim 13), and wherein the aqueous medium contains sodium chloride (instant claim 32), 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 et al.'s teachings on water diluted
egg white material with Omana et al.'s teachings on a 100 mM NaCl solution, in order to
create a method wherein the egg white material is diluted with water containing NaCl.
One would have been motivated in order to avoid the loss of egg white proteins other
than ovomucin from the liquid phase (see Omana et al. above). A skilled artisan would
have reasonably expected success since Omana et al.'s teachings are directed to
separating and isolating proteins.
Response to Arguments
Applicant has traversed the previous prior art claim rejections under 35 U.S.C. 102(a) and under 35 U.S.C.103 (remarks, page 7). As discussed above, the previous rejections under 102(a) are withdrawn in light of Applicant’s amendment filed on 06/30/2025. The previous rejections under 35 U.S.C. 103 are maintained, and rejections for new claims 31-32 have been added, as discussed above. Omana et al., Jain et al., and Su et al. are still relied upon in the above rejections. Applicant’s arguments filed on 06/30/2025 have been fully considered but they are not persuasive.
In Applicant’s reply, Applicant states that “a person of ordinary skill in the art would not expect to combine Omana, Jain, and Su to successfully reach the claimed invention” (remarks, page 10).
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 et al.’s teachings provide binding of egg white proteins, i.e. ovotransferrin, to a matrix, and release therefrom (see above). Jain et al.’s teachings provide purification of proteins using crosslinked alginate (see above), and Su et al. teaches wherein “strong electrostatic attraction between the cationic egg white proteins and anionic alginate” leads to retention of egg white proteins in crosslinked alginate gels, and further discloses the use of pH or ionic strength to release proteins (see above). As such, it would have been obvious to one of ordinary skill to have combined Omana et al.’s, Jain et al.’s, and Su et al.’s teachings to have created a method using cross-linked alginate to extract egg white proteins from egg white.
Applicant states that “protein extraction is an unpredictable art” (remarks, page 10).
The Examiner responds that based on the teachings of the above cited references, the extraction of egg white proteins using cross-linked alginate is considered predictable. One of ordinary skill would have expected binding of egg white proteins, i.e. ovotransferrin, to a crosslinked alginate matrix and release therefrom based on the above teachings, especially the teachings on electrostatic interactions between egg white proteins and crosslinked alginate.
Applicant describes that “even if the skilled person was to combine Omana, Jain, and Su, they would not have expected to successfully purify ovotransferrin from egg
white material using an alginate-based carrier without the benefit of hindsight.”, and that “the skilled person must use substantial amounts of hindsight to choose to explore the particular modifications that would have been required to arrive at the claimed method” (remarks, page 10).
In response to Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
No claims are allowed.
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.
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