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.
Priority
Acknowledgment is made of the present application as a proper National Stage (371) entry of PCT Application No. PCT/IL2021/050779, filed 06/24/2021 which claims benefit under 35 U.S.C. 119(e) to provisional application No. 63/043,830, filed 06/25/2020.
Status of the Claims
Claims 1, 3, 5, 7, 9, 11, 13, 15, 17, 18, 20, 21, 24, 26-27 and 29-31 are pending; claims 1, 3, 4, 11, 15, 17-18, 20-21, 24, 26-27 are amended; claims 2, 4, 6, 8, 10, 12, 14, 16, 19, 22, 23, 25 and 28 are cancelled. Claims 1, 3, 5, 7, 9, 11, 13, 15, 17, 18, 20, 21, 24, 26-27 and 29-31 are examined below.
Information Disclosure Statement
The information disclosure statement (IDS) filed 02/23/2026 is considered, initialed and is attached hereto.
Withdrawn Objections/Rejections
The previous rejections of claims under 35 U.S.C. 112(b) are withdrawn in response to Applicant’s amendments to the claims.
The previous rejection of claim 21 is withdrawn in response to Applicant’s amendments to the claims (specifically referring to the device of claim 1).
The previous rejection of claims under 35 U.S.C. 102 and 103 are withdrawn in response to Applicant’s amendments to the claims (see referring to amendments to independent claim 1).
Claim Objections
Claim 20 is objected to because of the following informalities:
Claim 20 is a method claim for determining the presence of analyte, the claimed method comprising “contacting section 1 of the device of claim 1 with a sample”, as a result, it is understood that the method of claim 20 is limited to being performed using the device of claim 1, however it is suggested that Applicant amend the claim language in the interest of improving clarity to further recite something such as, “A method for determining the presence of analyte in a sample using the device of claim 1, wherein said analyte is an antibody drug, a neutralizing antibody of said antibody drug, or both, the method comprising the steps of: a) contacting section 1 of the device of claim 1 with a sample…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 7 is 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 7 depends from claim 1, and as such, includes all the limitations recited at claim 1. As a result, claim 7 encompasses a device having two sections with substrate molecule generating a signal response to said trigger, namely section 4 as recited at claim 1 and section 5 recited at claim 7 (see claim 7, “optionally wherein said section 5 comprises a surface in contact with a substrate molecule generating a signal in response to said trigger”). There does not appear to be support in the originally filed specification for a device comprising substrate present at a section 4 and a section 5. As a result, the recited language is considered to be new matter.
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, 3, 5, 7, 9, 11, 13, 15, 17, 18, 20, 21, 24, 26-27 and 29-31 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 “probing molecule linked to a reporter molecule that generates a trigger whether bound to said antibody drug or not”, the claim further reciting “section 4 comprises a surface in contact with a substrate molecule generating a signal in response to said probing molecule”. The recited language is confusing, for example, the specification suggests that the reporter (e.g., an enzyme) generates a trigger (such as hydrogen peroxide), which reacts with the substrate to release a signal (see for example the originally filed specification at para [0165], the specification indicating the trigger (such as hydrogen peroxide) oxidizes the substrate molecule, signal generated by the oxidized substrate (see para [0266]). However, the amended claim suggests that the signal is in response to said probing molecule, and the claim fails to relate the trigger to signal, so it’s not readily clear what structural feature “trigger” is in reference to with respect to the claimed device (for example, the claims don’t indicate it is the trigger generated by the enzyme reporter, which interacts with the substrate to generate the signal). As such, the boundaries are unclear regarding what is and is not encompassed by the claims in terms of trigger and how the trigger is related to the reporter. It is suggested that Applicant amend the claim accordingly (e.g., amend to recite the reporter is an enzyme, that the enzyme produces a trigger, and that the trigger interacts with the substrate to generate a signal, consistent with language as supported by the originally filed specification ).
Claim 7 recites “a section 5”, section 5 is recited as “optionally” comprising “a surface in contact with a substrate molecule generating a signal in response to said trigger”, however, see as noted previously above, claim 1, from which 7 depends, recites this same limitation as present at a “section 4”. It is unclear then if claim 7 is intended as further limiting the device to having two sections, sections 4 and 5, each with the same (or different) substrate molecule, or rather if claim 7 is intended to recite the only substrate present at section 5 and not at section 4 (which conflicts with those limitations at claim 1). The recited language raises confusion as to what is and is not encompassed by the recited language.
Claim 9 is indefinite because the claim recites reporter molecules such as an enzyme, but also that the reporter may be labels that are not consistent with an enzyme, and that which would not be consistent with species of reporter molecules which generate signal in response to said probing molecule comprising the reporter molecule. It is suggested that Applicant amend the claims in order to recite at claim 1, limitations that limit the reporter to an enzyme and cancel claim 9, specifically because the claims as amended are directed to embodiments comprising substrate at the recited section 4 (embodiments directed to the use of an enzyme/substrate reporting system).
Claim 15 recites “wherein said antibody drug reduces or inhibits the activity of said target molecule or signaling thereof”, the recited language indicating that the antibody drug reduces or inhibits signaling of activity of the target molecule raises confusion as to what is encompassed by the recited claim language. The drug itself would not be considered as having the functional ability of reducing activating of the “signaling” itself, but merely of the activity, which would be considered to affect the signaling during the use of the device. It is suggested that Applicant omit the newly recited language “or signaling thereof”.
Claim 18 as amended by Applicant recites “thereby detecting said signal”, which reads as or is suggestive of a performed method steps encompassed by the claim. However, the claim is directed to a product, namely a device. As a result, the claim is indefinite because it is not clear if the claim is attempting to recite a method step as part of a claimed device. It is suggested that Applicant amend the claim in order to omit the language “, thereby detecting said signal”.
Claim 20 recites at b) “detecting the presence of a signal”, the claim reciting the use of the device of claim 1 (and, as such encompassing all the limitations of the device of claim 1), and claim 1 previously recites “a substrate molecule generating a signal in response to said probing molecule”. It is not readily clear from the language “a signal” at claim 20 whether the claim is in reference to the signal referred to in claim 1 or if the claim encompasses additional signal. It is suggested that Applicant amend the language at claim 20, in the interest of proper antecedent basis, to recite at step (b) “detecting presence of signal at section 5 produced in response to the probing molecule”.
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.
Claims 24 and 26 are 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.
Specifically, each of claims 24 and 26 depend from a canceled claim (namely claim 22, canceled by the amended claims failed 02/23/2026).
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.
Closest Prior Art:
Georgevich, CA 2009111A1 (cited previously).
Georgevich teach a test strip device (see for example, shown at Figure 3) comprising a section for addition of sample (a proximal end, reading on “section 1” as claimed, see e.g., page 5, first paragraph and Figure 3, labeled (12)), a section containing indicator reagent, conjugate (reads on “at least one section 2 coupled to section 1”, as claimed, see e.g., page 13, paragraph 2, Figure 3, labeled section (32)), see further a capture region coupled to the conjugate region, see this region having a surface functionalized with reagent (see page 14, first paragraph, page 15, first paragraph, immobilized reagent such as immobilized analyte or analyte analog) (reads on at least one section 3 comprises a surface functionalized with a target molecule). See further page 15, paragraph 3, Georgevich further teach immobilizing in capture zone 34 a second distinct ligand capable of binding analyte (thereby addressing section 3 also functionalized with an agent having specific binding affinity to said target molecule). Georgevich’s device has a section 4 (see Figure 3, labeled (18), substrate zone). As shown in Figure 3, each of 1-4 are arranged along a horizontal axis, in liquid communication such that liquid is able to flow through the sections sequentially.
Regarding the language “lateral flow” recited at the claims, this limitation describes the flow of sample through the device when held laterally/horizontally. Although Georgevich fails to specifically use the language “lateral” or “lateral flow” in describing their device or the use of their device, see at page 18, the reference does teach pipetting, spotting, wicking, exposing fluid stream OR dipping (recited in alternative form) the proximal end of the test strip into test sample. See further page 6 Georgevich describe sample moving across the length of test strip by capillary action. As such, Georgevich is considered to anticipate the claimed invention because the structure of Georgevich is indistinct from that presently claimed, and based on these citations of Georgevich, the structure of the cited art similarly would allow/is usable for lateral flow of liquid sequentially from sections 1 to 4, as claimed.
However, Georgevich et al. differs from that which is claimed in that Georgevich fails to teach their device for detecting antibody drug, a neutralizing antibody of said antibody drug, or both, the device comprising at section 2 both antibody drug having a specific binding affinity to a target molecule and a probing molecule having specific binding affinity to said antibody drug (the probing molecule comprising reporter molecule as claimed), and fails to teach at section 3, surface functionalized with said target molecule and the same antibody drug as recited at section 2.
The prior art does include references directed to immunochromatographic test strip or lateral flow devices for the purpose of detecting antibody drug, neutralizing antibody of said antibody drug, or both (see for Example Barbosa et al., US PG Pub No. 2018/0031547A1). Barbosa does teach an example of a lateral flow device, Barbosa’s device as a portable device for anti-drug antibody testing, teaching testing for ADAs can be applied for selection of therapeutics, evaluation of a need to change therapeutics or to apply tolerance regimens, evaluate patient immune status prior to vaccination, etc. (see abstract regarding various applications for a device testing for ADAs). At para [0023], Barbosa teach for detection of ADA, the capture region comprising a test protein immobilized on the membrane (referring to Figure 5 test strip device). See further para [0085], such devices comprising immobilized distinct regents of therapeutic proteins and/or peptides, to allow for epitope mapping.
However, Barbosa et al. fails to teach the combination of binding agents recited at section 2 of the instant claims, and the combination of immobilized reagents at section 3 as in the instant claims.
Response to Arguments
Applicant's arguments filed 02/23/2026 have been fully considered.
Regarding remarks at page 7-8, see as indicated in detail above, the previous rejections of claims under 35 U.S.C. 112(b) are withdrawn in response to Applicant’s amendments to the claims.
Regarding the rejection of claim 21 under 35 U.S.C. 101, see as indicated in detail above, the previous rejection is withdrawn in response to Applicant’s amendments to the claims.
Regarding remarks at pages 9-11, as indicated above the previous prior art rejections (under 35 U.S.C. 102 and 35 U.S.C. 103) are withdrawn in response to Applicant’s amendments to the claims.
See new grounds set forth in detail above in response to amendments to the claims.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN J MARCSISIN whose telephone number is (571)272-6001. The examiner can normally be reached M-F 8:00am-4:30pm.
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/ELLEN J MARCSISIN/ Primary Examiner, Art Unit 1677
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