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 .
Claims 1-16 are pending. Claims 9-16 are withdrawn. Claims 1-8 are under examination.
Election/Restrictions
Applicant’s election without traverse of Group I claims 1-8 in the reply filed on 01/30/2026 is acknowledged.
Claims 9-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/30/2026.
Information Disclosure Statement
The information disclosure statements filed 7/3/2024 and 3/11/2025 have been considered and initialed copies are enclosed.
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 1-8 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.
The metes and bounds of “at least a portion of an antigen-antibody reaction between an antigen derived from the target bacterium and the labeling antibody in the sample liquid to form a first complex” is not clear because the specification does not define what “at least a portion of an antigen-antibody reaction” is. What is a portion of an antigen-antibody reaction?
In claim 8, how does the labeling antibody and bacteriolysis agent dissolve in the sample liquid if they are respectively attached to the labeling antibody-attached member and the bacteriolysis agent-attached member?
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-3 and 5-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maehana et al. US 2015/0160212 06/11/2015 cited in IDS.
Claim 1: Maehana et al disclose a method for detecting a target bacterium in a sample of milk using an antibody antigen reaction using an immunochromatographic device, comprising the steps of:
Immersing in a large volume of milk (paragraph 43) at least a portion of a test strip i.e. “a labeling antibody-attached member” to which a labeled first antibody directed to said bacteria (see paragraph 40) is attached, in the milk to thereby cause at least a portion of an antigen-antibody reaction between an antigen derived from the target bacterium and the first labelled antibody in the milk to form a first complex. See paragraphs 30-33 and paragraph 46.
In paragraph 37-38, Maehana et al disclose the first complex can be detected by using a second capture antibody immobilized on the immunochromatographic device wherein the capture antibody is also directed to the antigen derived from bacteria in a sandwich format such that said second capture antibody also binds to the antigen derived from the bacteria thus forming a second complex, thereby detecting the bacterium based on the label of the labeling (see paragraph 39 for labels) antibody. See paragraph 46, and paragraphs 56-95.
Claim 2: Maehana et al disclose that the test strip part comprising the labeled antibody (labeling antibody attached member), the bacteriolysis agent attached member to which a bacteriolysis agent is attached (i.e. a lytic enzyme immobilized on the test strip) is immersed in the milk. See paragraph 44, 46, 47 and 48.
Claim 3: Maehana et al disclose at least a portion of the labeling antibody-attached member (the test strip comprising the labeled antibody) and the bacteriolysis agent attached member (same test strip also comprising the lytic enzyme) are immersed in the milk at the same time such that the lytic enzyme acts on the milk and the antigen is released from the bacteria cells. See paragraph 44, 46, 47 and 48-50.
Claim 5-7: Maehana et al disclose that the antigen released from the bacteria is ribosomal L7/L12 intracellular protein. See paragraph 52.
Claim 8: The labeling antibody attached to the test strip and the bacteriolysis agent attached to the test strip will necessarily also dissolve in the sample liquid.
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.
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.
Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maehana et al. US 2015/0160212 06/11/2015.
Claim 1: Maehana et al disclose a method for detecting a target bacterium in a sample of milk using an antibody antigen reaction using an immunochromatographic device, comprising the steps of:
Immersing in a large volume of milk (paragraph 43) at least a portion of a test strip i.e. “a labeling antibody-attached member” to which a labeled first antibody directed to said bacteria (see paragraph 40) is attached, in the milk to thereby cause at least a portion of an antigen-antibody reaction between an antigen derived from the target bacterium and the first labelled antibody in the milk to form a first complex. See paragraphs 30-33 and paragraph 46.
In paragraph 37-38, Maehana et al disclose the first complex can be detected by using a second capture antibody immobilized on the immunochromatographic device wherein the capture antibody is also directed to the antigen derived from bacteria in a sandwich format such that said second capture antibody also binds to the antigen derived from the bacteria thus forming a second complex, thereby detecting the bacterium based on the label of the labeling (see paragraph 39 for labels) antibody. See paragraph 46, and paragraphs 56-95.
Maehana et al does not disclose agitating the sample liquid after the immersion and before the detection.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date to have agitated the milk after the immersion of the labeling antibody-attached member (test strip) d before detection, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is to make sure that the labeling antibody attached member (test strip) is wetted with the milk sample and thus the labeling antibody comes in contact with sufficient amounts of the antigen in the sample.
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 1-5 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10048262. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘262 claims disclose
Claim 1: detecting a bacterium in milk using an immunochromatographic device comprising the steps of immersing at least a portion of the test strip labeling antibody-attached member (contacting the milk at the third part or further upstream part… flowing the milk up to the second part or a further downstream part) to which a labeled first antibody is attached to cause a an antigen-antibody reaction between the antigen in the milk derived from bacteria and the labeled antibody to form a first complex[ and causing a reaction between a second antibody immobilized on the test strip and the first complex to form a second complex, thereby detecting the bacteria based on the label of the labeled antibody.
Claim 2-3: the ‘262 claims disclose the test strip (labeling antibody attached member), a lytic enzyme attached member (the same test strip) to which a lytic enzyme is attached is immersed in the milk at the same time (contacting the milk at the third part or further upstream part… flowing the milk up to the second part or a further downstream part).
Claim 4: the ‘262 claims do not disclose agitating the sample liquid after the immersion and before the detection. However, it would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date to have agitated the milk after the immersion of the labeling antibody-attached member (test strip) so that the milk and before detection, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is to make sure that the labeling antibody attached member (test strip) is wetted with the milk sample and thus the labeling antibody comes in contact with sufficient amounts of the antigen in the sample.
Claims 5: the ‘262 claims disclose the antigen is a component exposed out from a cell of a staphylococcus, thus is intracellular and the lytic enzyme is lysostaphin.
Claim 8: The labeling antibody attached to the test strip and the bacteriolysis agent attached to the test strip will necessarily also dissolve in the sample liquid.
Claims 1 and 5-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10048262 in view of Maehana et al. US 2015/0160212 06/11/2015 cited in IDS. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘262 claims is disclosed above but does not disclose that the intracellular antigen is a ribosome protein, wherein the ribosome protein is L7/L12 protein.
Maehana et al disclose an immunochromatographic device comprising a lytic enzyme lysostaphin and that when the presence of Staphylococcus aureus is especially suspected as an etiologic bacterium of mastitis, it may be preferable to use lysostaphin that specifically exhibits a bacteriolytic action against Staphylococcus aureus. See claims and paragraph 51. Maehana et al disclose when a lysostaphin is used as the lytic enzyme, for example, an antigen consisting of the ribosomal L7/L12 protein of Staphylococcus aureus can be detected by the immunochromatographic method. See paragraph 52.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention that in the “262 claims Staphylococcus aureus L7/L12 ribosome protein can be detected in the sample due to the lysostaphin lysis as taught by Maehana et al, thus resulting in the instant invention with a reasonable expectation of success. The teaching to do so is that Maehana et al disclose when a lysostaphin is used as the lytic enzyme, for example, an antigen consisting of the ribosomal L7/L12 protein of Staphylococcus aureus can be detected by the immunochromatographic method.
Status of Claims
Claims 1-8 are rejected. Claims 9-16 are withdrawn.
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/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645
