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 .
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.
Withdrawing/ Vacating Previous Office Action
The previous office action of 02/11/2025 is vacated and replaced with the current office action,
primarily to add rejection of claims 23-35 under 35 U.S.C. 102 for anticipation by Stein et al. (US 2014/0080119 A1), withdraw the previous rejection of claims 23-35 under 35 U.S.C. 103 as being unpatentable over Stein et al. (US 2014/0080119 A1) and King et al. (US 2007 /0059678 A1) and add non statutory double patenting rejection of instant claims 23-35 over claims 23-35 of copending Application No. 16/877,379.
The previous rejection of claims 23-35 under 35 U.S.C. 103 as being unpatentable over Stein et al. (US 2014/0080119 A1) and King et al. (US 2007 /0059678 A1) is withdrawn and replaced with the current rejection of claims 23-35 under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Stein et al. (US 2014/0080119 A1) in light of reasonable claim interpretation.
Priority
This application is a U.S. National Stage (371) application of PCT/US20/33489 filed on 05/18/2020 which claims priority to Provisional Application No. 62/849,032 filed on 05/16/2019.
Claim Status
Claims 1-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention as noted in the Office action of 02/11/2025. Claims 23, 26, 28 and 31 are currently amended and the Applicant notes that no new matter is added. Claims 24-25, 29-30 and 32-35 are original. Claim 27 is previously presented.
Thus, claims 23-35 are pending and are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/26/2025 has been received. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and all references are considered except where they were lined through.
Withdrawn Rejections
The previous rejection of claims 23-35 under 35 U.S.C. 112(b), regarding indefiniteness, is withdrawn in light of Applicant’s amendments of claims.
As noted above, the previous rejection of claims 23-35 under 35 U.S.C. 103 as being unpatentable over Stein et al. (US 2014/0080119 A1) and King et al. (US 2007 /0059678 A1) is withdrawn and replaced with the current rejection of claims 23-35 under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Stein et al. (US 2014/0080119 A1) in light of reassessment of a reasonable claim interpretation.
Claim Interpretation
Claim 23 is an apparatus claim. The functional limitations of the apparatus are examined so that the physical and chemical characteristics are not necessarily directed to the intended use of the apparatus. “Milk” is not a required part of the apparatus, rather the apparatus has probes that detect allergens that may exist in human milk. The reasonable interpretation would be that the apparatus has the minimum physical/chemical attributes to detect an allergen which is met by Reference Stein et al. (US 2014/0080119 A1).
New Rejections
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 23-35 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Stein et al. (US 2014/0080119 A1).
Regarding claim 23, Stein teaches an apparatus to detect presence of one or more allergen molecules in a sample ([0156]; [0338] and [0361]; [419]).
Stein teaches a substrate having a plurality of detection sites [0219].
Stein teaches that each of the plurality of detection sites is configured to detect presence of one or more allergen molecules when exposed to the sample ([0141]; [0334-0335]; [0338] and [0361]).
Stein teaches that at least one detection site has a probe with an active site ([1208]; [1218], “Specific analytes captured by said molecular net 4501 can be detected using specific detection probes having reporter agents against a portion of the captured nucleic acid 4505.”).
Stein teaches that the active site is configured to bind to a fragment of DNA, RNA, or amino acids corresponding to a first allergen molecule ([0163]; page 9, “TABLE 1”, “EXEMPLARY LIGAND
BOUND BY CAPTURE AGENT”; [0180] and [0335]). A skilled artisan would know that an antibody binds to specific amino acids of a polypeptide fragment of an allergen.
Stein teaches detecting the presence of the first allergen molecule in a sample ([0333-0335]; [0338] and [0361]).
Regarding claims 23 and 26, Stein teaches detecting allergens that are not naturally occurring molecules in human milk such as cat allergens or any of the animal products [0338-0344].
Regarding claim 24, Stein teaches that at least one of the detection sites comprises a probe with an active binding site ([1208] and [1218], “Specific analytes captured by said molecular net 4501 can be detected using specific detection probes having reporter agents against a portion of the captured nucleic acid 4505.”).
Regarding claim 25, Stein teaches that the probe with an active binding site is selected to bind to the fragment of the DNA, RNA, or amino acids corresponding to the first allergen molecule ([0180]; [0283], “adding one or more of linking agents under conditions in which a multilayer net forms, and assessing the ability of each multilayer net to bind the first and second analytes” and [0335]).
Regarding claim 27, Stein teaches that the detected fragment defines a selected portion of a DNA, RNA, or amino acid sequence associated with the allergen ([0163]; page 9, “TABLE 1”, “EXEMPLARY LIGAND BOUND BY CAPTURE AGENT”; [0180] and [0334]).
Regarding claim 28, Stein teaches detecting DNA sequences that are not normally present in human milk such as bacterial DNA of infectious species [0469].
Regarding claim 29, Stein teaches that each of the plurality of detection sites is configured to detect presence of a respective allergen molecule ([0141] and [0334-0335]).
Regarding claim 30, Stein teaches that each of the plurality of detection sites is configured to detect presence of a different fragment of the first allergen molecule [0282].
Regarding claim 31, Stein teaches that one of the plurality of active sites is configured to bind to a fragment of DNA, RNA, or amino acids corresponding to a second allergen molecule ([0163]; page 9, “TABLE 1”, “EXEMPLARY LIGAND BOUND BY CAPTURE AGENT”; [0282]; [0384], “wherein all testing areas
can be exposed to said test sample or a separated, semi-purified, or fractionated test sample to enable one or more analyte to be immobilized by multiple capture molecules in one or more molecular net in one or more testing area of said device”; [0385]; [0403], “a plurality of molecular
nets separated into chambers wherein all are exposed to said test sample or a sub-fractionated population of the test sample to enable one or more analyte to be immobilized by
interacting with capture molecules of each molecular net” and page 70, claim 6, “wherein the
plurality of first capture agents is heterogeneous and comprise at least a first species of capture agent and a second species of capture agent that are specific to different targets.”).
Stein teaches to detect the presence of a second allergen molecule in a sample ([0282]; [0283], “adding one or more of linking agents under conditions in which a multilayer net forms, and assessing the ability of each multilayer net to bind the first and second analytes” and [0335]).
Regarding claim 32, Stein teaches that the allergen molecule is selected from the group consisting of egg, fish, crustacean, tree nut, legume, cereals, grains, or other known immune reactive groups ([0116]; [0336] and [0338-0380]).
Regarding claim 33, Stein teaches detecting presence of the first allergen molecule by detecting a plurality of DNA, RNA, or amino acid fragments with each fragment encoding a portion of the first allergen molecule ([0282]; [0018]; [0163]; page 9, “TABLE 1”, “EXEMPLARY LIGAND BOUND BY CAPTURE AGENT” and [0282]).
Regarding claim 34, Stein teaches the redundancy of detection of an analyte with an example due to overlapped portions of the detected analyte [0282].
Regarding claim 35, Stein teaches that at least one of the plurality of DNA, RNA, or amino acid fragments is substantially different from the plurality of DNA, RNA, or amino acid fragments ([0018]; [0163]; page 9, “TABLE 1”, “EXEMPLARY LIGAND BOUND BY CAPTURE AGENT” and [0282]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 23-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-35 of copending Application No. 16/877,379.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 23 pertaining to an apparatus to detect presence of one or more allergen molecules in a composition of human milk. The apparatus of claim 23 comprise a substrate having a plurality of detection sites thereon, each of the plurality of detection sites configured to detect presence of one or more allergen molecules when exposed to a quantity of human milk, at least one detection site having a probe with an active site, the active site configured to bind to a fragment of DNA, RNA, or amino acids corresponding to a first allergen molecule to thereby detect the presence of a first allergen molecule in the quantity of human milk; and wherein the detected fragment does not overlap with naturally occurring molecules present in the composition of human milk, ‘379 teaches an apparatus to detect presence of one or more allergen molecules in a composition of mammalian milk, the apparatus comprising a substrate having a plurality of detection sites thereon, each of the plurality of detection sites configured to detect presence of one or more allergen molecules when exposed to a quantity of mammalian milk, at least one detection site having a probe with an active site, the active site configured to bind to a fragment of DNA, RNA, or amino acids corresponding to a first allergen molecule to thereby detect the presence of a first allergen molecule in the quantity of mammalian milk and wherein the detected fragment excludes naturally occurring molecules present in the composition of mammalian milk (See claim 23 of ‘379).
Regarding claim 24 pertaining to at least one of the detection sites comprises a probe with an active binding site, ‘379 teaches at least one of the detection sites comprises a probe with an active binding site (See claim 24 of ‘379).
Regarding claim 25 pertaining to that the probe with an active binding site is selected to bind to the fragment of the DNA, RNA, or amino acids corresponding to the first allergen molecule, ‘379 teaches that the probe with an active binding site is selected to bind to the fragment of the DNA, RNA, or amino acids corresponding to the first allergen molecule (See claim 25 of ‘379).
Regarding claim 26 pertaining to that the first active binding site does not bind to a naturally occurring fragment of the human milk, ‘379 teaches that the first active binding site does not bind to a naturally occurring fragment of the mammalian milk (See claim 26 of ‘379).
Regarding claim 27 pertaining to that the detected fragment defines a selected portion of a DNA, RNA, or amino acid sequence associated with the allergen, ‘379 teaches that the detected fragment defines a selected portion of a DNA, RNA, or amino acid sequence associated with the allergen (See claim 27 of ‘379).
Regarding claim 28 pertaining to that the composition of human milk does not include the selected portion of DNA, RNA, or amino acid sequence, ‘379 teaches that the composition of mammalian milk excludes the selected portion of DNA, RNA, or amino acid sequence (See claim 28 of ‘379).
Regarding claim 29 pertaining to the that each of the plurality of detection sites is configured to detect presence of a respective allergen molecule, ‘379 teaches that each of the plurality of detection sites is configured to detect presence of a respective allergen molecule (See claim 29 of ‘379).
Regarding claim 30 pertaining to that each of the plurality of detection sites is configured to detect presence of a different fragment of the first allergen molecule, ‘379 teaches that each of the plurality of detection sites is configured to detect presence of a different fragment of the first allergen molecule (See claim 30 of ‘379).
Regarding claim 31 pertaining to that one of the plurality of active sites is configured to bind to a fragment of DNA, RNA, or amino acids corresponding to a second allergen molecule to thereby detect the presence of a second allergen molecule in the quantity of human milk, ‘379 teaches that one of the plurality of active sites is configured to bind to a fragment of DNA, RNA, or amino acids corresponding to a second allergen molecule to thereby detect the presence of a second allergen molecule in the quantity of mammalian milk (See claim 31 of ‘379).
Regarding claim 32 pertaining to that the allergen molecule is selected from the group consisting of cow's milk protein, egg, fish, crustacean, tree nut, legume, cereals, grains, or other known immune reactive groups, ‘379 teaches that the allergen molecule is selected from the group consisting of cow's milk protein, egg, fish, crustacean, tree nut, legume, cereals, grains, or other known immune reactive groups (See claim 32 of ‘379).
Regarding claim 33 pertaining to that detecting presence of the first allergen molecule by detecting a plurality of DNA, RNA, or amino acid fragments with each fragment encoding a portion of the first allergen molecule, ‘379 teaches detecting presence of the first allergen molecule by detecting a plurality of DNA, RNA, or amino acid fragments with each fragment encoding a portion of the first allergen molecule (See claim 33 of ‘379).
Regarding claim 34 pertaining to that the plurality of DNA, RNA, or amino acid fragments comprise overlapping portions, ‘379 teaches that the plurality of DNA, RNA, or amino acid fragments comprise overlapping portions (See claim 34 of ‘379).
Regarding claim 35 pertaining to that at least one of the plurality of DNA, RNA, or amino acid fragments is substantially different from the plurality of DNA, RNA, or amino acid fragments, ‘379 teaches that at least one of the plurality of DNA, RNA, or amino acid fragments is substantially different from the plurality of DNA, RNA, or amino acid fragments (See claim 35 of ‘379).
Response to Arguments
Applicant's arguments filed on 08/11/2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to rejection of claims 23-35 under 35 U.S.C. 103 as being unpatentable over Stein et al. (US 2014/0080119 A1) and King et al. (US 2007 /0059678 A1) have been considered but are moot regarding King et al. because the new ground of rejection of claims 23-35 under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Stein et al. (US 2014/0080119 A1) does not rely on King as applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The Applicant alleged that there has been no reasoning provided in Stein that would have suggested Stein’s disclosure be extended to human milk particularly in view of the long list of samples Stein considers testing that does not include milk.
However, Stein clearly lists milk as one of the allergens to test for [0361]. Stein further teaches an apparatus that have the minimum physical/chemical attributes to detect an allergen as noted above when interpreting claim 23.
The Applicant alleged that it is not known whether Stein's molecular nets are capable of detecting allergens in milk.
However, as noted above, Stein teaches that the allergens that are immobilized and detected by molecular nets include milk ([0338] and [0361]).
The Applicant alleged that Stein appears to teach that the molecular nets are blocked with milk as Stein states ([0830], "45) Blocked nets with 100 µL of 1: 1 ratio of egg white and 100% non-fat milk for 30 minutes at room temperature"). The Applicant further alleged that therefore, Stein seemingly teaches away from testing milk via the molecular nets.
However, Stein is only using non-fat milk in the example that the Applicant brought. Nonfat milk is milk that has been processed to remove most of the fat from it, and thus it will not have all the ingredients of natural milk. Furthermore, the blocking of molecular nets is not only achieved with non-fat milk as noted in the different examples of Stein’s method (Examples 1-2 and 6-8). Thus, Stein is not teaching away from testing milk in the molecular nets.
The Applicant alleged that it has not been shown that Stein's molecular nets are capable of being applied to testing strips.
However, there is no teaching in Stein against using molecular nets onto a strip. Furthermore, Stein teaches using the molecular nets as part of a testing device [0442].
Conclusion
No claims are allowed.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678