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 .
DETAILED ACTION
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 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.
Status of the claims
Claims 1-9 are examined on merits in this office action to the extant it encompasses the elected species.
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 1-9 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.
Claim 1 recites “by adding dropwise the neutralized antigen-concentrated solution onto a gold holding pad, which is a pad that holds modified gold particles for labeling, which are gold particles for labeling modified with first binding substance capable of binding to the antigen, of an insoluble carrier having the gold colloid holding pad……..has been immobilized”. It is unclear what applicant is intended to claim in the recitation. “by adding dropwise” is not a positive recitation and “pad that holds modified gold particles for labeling” is also not a positive recitation. “that holds” does not positively indicate that the pad has/contains the modified gold particles and thus it is unclear what is actually achieved by the indirect recitation process step. The insoluble carrier has not been clearly described as having the holding pad at an upstream site and the reaction site at a downstream site for spreading the complex formed from the modified gold particles with the antigen in the neutralized antigen-concentrated solution. The claim step(s) should be clear and particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 recites “gold particles for labeling modified with a first binding substance capable of binding to the antigen, of an insoluble carrier having the gold colloid holding pad and a reaction site at which a second binding substance capable of binding to the antigen has been immobilized”. It is unclear as to whether the monoclonal antibody recited in line 6 is different from the first binding substance and the second binding substance? It is unclear as to whether the first binding substance is different from the second binding substance.
The step also recites “spreading particle composite bodies for labeling on the insoluble carrier”. It is unclear how is the spreading step is carried out? Mechanical spreading or allowing to diffuse or spread naturally? The spreading step is not clear in the specification.
Claim 7 recites “dissociation solution contains NaOH or HCl”. Claim 1 recites “dissociation solution that is an alkaline solution”. It is unclear how solution containing HCl can be considered an alkaline solution.
Claim 8 recites “neutralization solution contains HCL and at least one selected from the group consisting of ……. NaOH….vicine”. It is unclear if the dissociation solution is alkaline, how an alkaline dissociation solution is neutralized by a solution having NaOH.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 7 recites “dissociation solution contains NaOH or HCl”. Claim 7 is dependent on Claim 1, which recites “dissociation solution that is an alkaline solution”. Dissociation solution containing HCl is not considered an alkaline solution and thus claim 7 is broader in scope than claim 1 and thus failed to further limit claim 1 limitation of alkaline solution. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is directed to immunochromatography method comprising capturing antigen with particle having monoclonal antibody that specifically binds the antigen to form a particle composite material comprising the particle associated with the antigen, sedimenting the particle composite and dissociating the antigen from the particle composite with an alkaline solution and recovering the antigen in the alkaline solution by sedimenting dissociated particle by centrifugation, neutralizing the recovered antigen and allowing the recovered antigen to bind to gold particle having affinity molecules that binds the antigen for lateral flow immunoassay detection.
As claimed, the antigen encompasses various types of inordinately a large number of antigens, as for example, small molecule antigens, saccharide antigen, LPS, various types of proteins, cell surface proteins, cancer cell antigen, bacteria, virus and various other antigens. As claimed, the process encompasses employing monoclonal antibody against the various antigens, which the specification does not have a clear descriptive support. The specification if very limited to lipoarabinomannan (LAM) antigen and the monoclonal antibody is limited to monoclonal antibody binding to lipoarabinomannan antigen. However, monoclonal antibody against lipoarabimannan encompasses genus of monoclonal antibodies directed to various epitopes of liporabimannan. Specification only discloses monoclonal antibody A194-01 (described in WO2017/139153A) and the disclosure of capturing and elution if strictly based in the above particle immobilized monoclonal antibody binding to the specific antigen LAM, which binding is binding to an specific epitope. The detection sensitivity in Table 1 is strictly limited to dissociation in alkaline solution (50mmol/L NaOH) of specific LAM antigen bound to the designated monoclonal antibody A194-01 bound to a particle. As described above, monoclonal antibody against LAM encompasses genus of monoclonal antibody specific for various epitopes on the LAM (i.e. multiple antibody directed to different epitopes) and each antibody would have different binding specificity/binding strength and would require different elution conditions. Therefore, by disclosing a single species of a monoclonal antibody binding to specific location of LAM, the specification does not have descriptive support for genus of anti-LAM monoclonal antibodies let alone the claimed genus of inordinately large number of monoclonal antibody in a detecting process of the various claimed antigens with the alkaline dissociation process. LAM is not representative of all the structurally divergent antigens and monoclonal antibody A194-01 cannot be considered representative of the genus of anti-LAM monoclonal antibodies or monoclonal antibodies against various antigens as encompassed by claim 1.
Walsh (mAbs 2012, 4:5, 578-585) teaches that all monoclonal antibodies encompass various types of antibodies with distinct properties (acidic, basic species) and have distinct elution and binding properties (the whole document).
A description of a genus of antibodies may be achieved by means of a recitation of a representative number of antibodies, defined by sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. The written description requirement can be met by showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ....i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. The court found that if the disclosed species only abide in a corner of the genus, one has not described the genus sufficiently to show that the inventor invented, or had possession of, the genus. He only described a portion of it. The specifically defined antibody sequences claimed or disclosed in the specification are not representative of nor predictive of any and all other antibody sequences for the broadly claimed genus.
Therefore, by disclosing a single species of a monoclonal antibody binding to specific location of LAM, the specification does not have descriptive support for genus of anti-LAM monoclonal antibodies let alone the claimed genus of inordinately large number of monoclonal antibody in a detecting process of all the monoclonal antibodies with different types of antigens utilizing the assay steps including alkaline dissociation as claimed.
Response to argument
Applicant's arguments and amendments filed 12/19/2025 have been fully considered and are persuasive to overcome the rejection in view of the amendments. However, Applicant’s arguments have been rendered moot in view of the new grounds of rejections as described in this office action.
Conclusion
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.
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/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678