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 .
Status of the Claims
Claims 1-20 are pending in the application.
Claims 2-10, 14-17, and 19-20 are withdrawn.
Claims 1, 11-13, and 18 are the subject of this office action.
Election/Restrictions
Applicant’s election of Group I and the species MMP7 and THBS2 in the reply filed on 27 July 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 2-10, 14-17, and 19-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 27 July 2026.
Priority
The instant application is a 371 National Stage of PCT/EP2022/060631, filed 21 April 2022, which claims benefit of provisional application 63/201,281, filed 21 April 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 20 October 2023, 18 January 2024, 5 January 2026, and 16 March 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
In claim 1: “the antibodies are configured to selectively bind to two or more of the target proteins”
This limitation is interpreted under 112(f) because it links a generic structure (antibody) to a particular binding function, wherein the generic recitation of structure does not comprise sufficient detail to support the recited function (i.e. not every generic antibody is capable of performing the recited binding function). Further interpretation is discussed in the 112(b) section below.
in claim 13: “wherein the indicating comprises visually indicating binding to a user”
this limitations are interpreted under 112(f) because they link a generic structure (solid surface) to a particular function (visually indicating binding), wherein the generic recitation of structure does not comprise sufficient detail to support the recited function. Further interpretation is discussed in the 112(b) section below.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(a)
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 11-13 and 18 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include: (1) Actual reduction to practice (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. complete structure, ii. Partial structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed structure, and correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art. See MPEP 2163.
Claim 1 recites a device comprising a plurality of antibodies “wherein the antibodies are configured to selectively bind to two or more of the target proteins”. As discussed further in the 112(b) section below, it appears that this limitation could encompass embodiments wherein the device comprises multiple species of antibodies which each bind to a different target protein and/or an embodiment wherein the device comprises a single species of antibody provided in plurality, wherein that single species of antibody is configured to selectively bind to multiple target proteins.
The specification does not explicitly disclose or discuss any particular species of antibodies which fulfill the recited function under either interpretation. The specification does provide some discussion of an exemplary lateral flow device which comprises multiple different test lines for the detection of a different target analyte at each respective test line, wherein each test line consists of an antibody match to the respective target analyte (Par. 34). This appears to provide support for an embodiment wherein the device comprises multiple different species of antibody which each bind to a different target protein, though it is noted that no particular species of antibodies are recited or disclosed. There is no indication of how any particular species of antibody is specifically modified or “configured to” perform the recited binding function.
There is no explicit support or reduction to practice for an embodiment wherein a single species of antibody provided in plurality is configured to selectively bind to multiple target proteins. Further, the predictability of the art regarding such an embodiment is low because the art does not provide particular or known examples of a single species of antibody which is known to be capable of specifically selectively binding to both MMP7 and TBSH2.
As such, given the breadth of the claims and the lack of disclosed or art-recognized examples of antibodies which are capable of performing the recited binding function, one of ordinary skill in the art would not have envision possession of the claimed invention comprising antibodies configured to selectively bind to two or more of the target proteins.
Dependent claims 11-13 and 18 are rejected because they fail to remedy the deficiencies of written description presented by the independent claim.
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.
Claims 1, 11-13, and 18 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 is rejected as indefinite over the limitation “wherein the antibodies are configured to selectively bind to two or more of the target proteins…” wherein it is not clear from the recitation if this means that the plurality of antibodies contains multiple different species of antibody which each bind to one species of target protein, or whether this means that each individual antibody within the plurality of antibodies is “configured to” selectively bind to two or more target proteins. Additionally, it is not clear in what particular way the antibodies are “configured to” perform this function, wherein the language “configured to” implies some particular arrangement or modification of the antibodies, and it is not clear what this arrangement or modification is, or whether the recited binding function is simply an inherent property of a particular species of antibody used.
Claim 1 is rejected because the claim recites abbreviation which are not spelled-out on their first use in the claims. This renders the scope of the claim unclear because it is not clear exactly what each abbreviation is referring to.
Claim 11 is vague regarding “the lateral flow detection surface”. There is no prior introduction of a lateral flow detection surface in claim 11 or in claim 1 from which it depends, therefore there is insufficient antecedent basis for this limitation in the claim. Additionally, it is not clear how the lateral flow detection surface is related to the rest of the recited elements in the claimed detection device. For example, is the lateral flow detection surface a limitation on the “solid surface” introduced in claim 1, such that the plurality of antibodies are bound to the lateral flow detection surface? or is the lateral flow detection surface an additional and distinct surface which does not then require a plurality of antibodies bound to its surface? Clarification is required.
Claim limitation “the antibodies are configured to selectively bind…” in claim 1 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. As discussed in the rejection above, the recitation is unclear because it is not clear from the recitation if this means that the plurality of antibodies contains multiple different species of antibody which each bind to one species of target protein, or whether this means that each individual antibody within the plurality of antibodies is “configured to” selectively bind to two or more target proteins. Additionally, it is not clear in what particular way the antibodies are “configured to” perform this function. The specification provides generic repetition/discussion of this limitation, but does not explicitly clarify this ambiguity, and does not provide any particular examples of antibody species that fulfill the recited function. See, for example, Par. 7, 34. The best description appears to be provided in Par. 36: “the test lines 5a-e each consist of an antibody match to the respective target analyte and, if present in the sample, will form a complex resulting in a visible test line”. Which appears to suggest that a lateral flow assay may comprise multiple different species of antibodies which may each be capable of specifically binding a particular target analyte. However, this structure does not fully support all broadest reasonable interpretations of the claim, which seem to include the possibility that a single species of antibody could be configured to specifically bind to multiple species of target analyte. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claim limitation “wherein indicating comprises visually indicating binding to a user” in claim 13 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification provides description of a lateral flow device as shown in Fig. 2 and as described in Par. 35, wherein visual indication of binding is provided by a gold-colloid conjugated antibody. However the gold colloid conjugated antibody is disposed in a separate conjugate pad 2 which is distinct from the nitrocellulose membrane 4 (i.e. the solid surface on which a plurality of antibodies are bound. It is therefore not clear exactly how the recited solid surface itself is “configured to” visually indicate binding between each antibody and a corresponding target protein. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Dependent claims 11-13 and 18 are rejected as indefinite because they depend from an indefinite claim and fail to remedy its deficiencies.
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 1, 13, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gill et al (US 2020/0166523 A1).
Regarding claims 1, 13, and 18, Gill teaches:
a detection device comprising:
a solid surface comprising a plurality of antibodies bound to the solid surface and configured to visually indicate selective binding between each antibody and a corresponding target protein, wherein the antibodies are configured to selectively bind MMP7 and THBS2 (Abstract: disclosure includes devices for the detection of biomarkers; Par. 39: biomarker values can be detected by performing an in vitro assay which may involve at least one capture agent corresponding to each of the biomarkers, wherein the capture agent may be an antibody; Par. 129: a biomarker value can be detected using any of a variety of known analytical methods including use of a capture reagent which may be immobilized on a solid support, wherein the capture reagent may be an antibody; Par. 162-165: immunoassay methods used to detect the biomarkers may include a variety of immunoassays known in the art which comprise an antibody immobilized on a solid surface, and may include the use of visual labels and detection; Par. 31, 56-57, Tables 1-3: the invention comprises measuring N biomarkers from those presented in Table 3, wherein N=2-10 biomarkers, and wherein Table 3 contains 10 biomarkers total, 2 of which are MMP7 and THBS2).
Regarding the preamble of the claim which recites “a pancreatic cancer detection device”: the normal purpose of a claim preamble is to recite the purpose or intended use of the claimed invention. Such statements merely define the context in which the invention operates and usually will not limit the scope of the claim or distinguish it over the prior art (MPEP 2111.02). When the body of the claim fully and intrinsically sets forth the complete invention, and the preamble offers no distinct definition of any of the claimed inventions limitations, but rather merely states, for example, the purpose or intended use of the invention, then the preamble is of no significance to claim construction because it cannot be said to constitute or explain a claim limitation. In the instant case, the statement of the preamble merely expresses the purpose and intended use of the claimed product, and does not result in a structural difference. As such, prior art such as Gill which teaches all claimed structural features of the claims is understood to read on the claims, regardless of whether it teaches the same intended use.
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.
Claims 1, 11-13, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gill et al (US 2020/0166523 A1) in view of Irudayaraj et al (US 2020/0124595 A1).
Regarding claims 1, 11-13, and 18, Gill discloses immunoassays for the detection of biomarkers including MMP7 and THBS2 comprising a plurality of anti-biomarker antibodies attached to a solid support (Abstract; Par. 31, 39, 56-57, 129, 162-165; Tables 1-3).
Gill further teaches that the solid support to which the anti-analyte antibodies are bound may be a membrane (Par. 122).
Gill does not teach the device comprising a lateral flow detection test strip or comprising a control line.
Irudayaraj discloses a lateral flow device for sensitive and quantitative detection of multiple protein analytes in a sample (Abstract; Par. 10, 12, 22, 121; Fig. 4A, 9).
Irudayaraj teaches the device comprising a lateral flow detection test strip as a solid surface to which a plurality of anti-analyte antibodies are immobilized at test lines for each respective analyte, wherein binding of the analyte to the antibody is visually indicated to the user (Par. 22: immobilized capture ligands of the assay device may comprise antibodies which are specific for each target analyte such that they bind the complex of labeled conjugate-target analyte to produce a visible signal at the respective test line for that analyte; Par. 28, 80).
Irudayaraj further teaches the lateral flow test strip comprising a control line (Par. 105, Fig. 4A: control zone 408b that captures any particle and thereby shows that reaction conditions are appropriate).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gill such that the solid surface comprises a lateral flow detection test strip comprising anti-MMP7 and anti-THBS2 antibodies bound to the lateral flow test strip surface, and such that binding of the target protein to the antibodies on the lateral flow test strip is visually indicated to a user, as taught by Irudayaraj. One would be motivated to make this modification because a lateral flow device such as the one taught by Irudayaraj is advantageous in providing rapid, visual results in a simple and easy to use assay format (Irudayaraj, Par. 82-83).
Additionally, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the lateral flow device of Gill in view of Irudayaraj to further comprise a control line, as taught by Irudayaraj. One would be motivated to make this modification because a control line provides indication and confirmation of the proper functioning of the lateral flow device and its reagents.
One of ordinary skill in the art would have a reasonable expectation of success in making this these modifications because Gill discloses that the analytes of Table 3 (including MMP7 and THBS2) may be detected via various different immunoassay formats which may comprise anti-analyte antibodies attached to a solid support such as a membrane, while Irudayaraj discloses an immunoassay format comprising anti-analyte antibodies attached to a membranous solid support and explicitly teaches that this format may be used for the detection of multiple protein analytes in a sample.
Claims 1, 11-13, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Irudayaraj et al (US 2020/0124595 A1) in view of Gill et al (US 2020/0166523 A1).
Regarding claims 1, 11-13, and 18:
Irudayaraj discloses a lateral flow device for sensitive and quantitative detection of multiple protein analytes in a sample (Abstract; Par. 10, 12, 22, 121; Fig. 4A, 9).
Irudayaraj teaches the device comprising a lateral flow detection test strip as a solid surface to which a plurality of anti-analyte antibodies are immobilized at test lines for each respective analyte, wherein binding of the analyte to the antibody is visually indicated to the user (Par. 22: immobilized capture ligands of the assay device may comprise antibodies which are specific for each target analyte such that they bind the complex of labeled conjugate-target analyte to produce a visible signal at the respective test line for that analyte; Par. 28, 80).
Irudayaraj further teaches the lateral flow test strip comprising a control line (Par. 105, Fig. 4A: control zone 408b that captures any particle and thereby shows that reaction conditions are appropriate).
Irudayaraj differs from the instant claim in that it does not explicitly teach the device configured for detection of MMP7 and TBSH2. Irudayaraj teaches generally that the target analyte may comprise a protein (Par. 12).
Gill discloses immunoassays for the detection of biomarkers including MMP7 and THBS2 comprising a plurality of anti-biomarker antibodies attached to a solid support (Abstract; Par. 31, 39, 56-57, 129, 162-165; Tables 1-3).
Gill further teaches that the solid support to which the anti-analyte antibodies are bound may be a membrane (Par. 122).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Irudayaraj to specifically comprise anti-MMP7 and anti-TBSH2 antibodies for the detection of MMP7 and TBSH2 on the lateral flow device. One would be motivated to modify the device for the detection of MMP7 and TBSH2 as markers which are useful for the evaluation of risk of a cardiovascular event, as taught by Gill. One would have a reasonable expectation of success in making this modification because both Irudayaraj and Gill disclose immunoassays for the detection of multiple target proteins comprising anti-analyte antibodies immobilized on a solid phase.
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, 11, 13, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-22, 29 and 34 of copending Application No. 17/770,025 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
All limitations of instant claim 1 are taught by reference claim 29.
All limitations of instant claim 11 are taught by reference claims 21-22.
All limitations of instant claim 13 are taught by reference claim 24.
All limitations of instant claim 18 are taught by reference claims 29 and 34
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 12 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21-22 and 29 of copending Application No. 17/770,025 in view of Irudayaraj et al (US 2020/0124595 A1).
All limitations of instant claims 1 and 11 are taught by reference claims 21-22 and 29, as discussed in the rejection above. The reference claims differ from instant claim 12 in that they do not teach the lateral flow test strip comprising a control line.
Irudayaraj discloses a lateral flow test strip for the detection of multiple analytes in a sample comprising a plurality of anti-analyte antibodies immobilized to the surface of the lateral flow test strip (Abstract; Par. 10, 12, 22, 28, 80, 121).
Irudayaraj further teaches the lateral flow test strip comprising a control line (Par. 105, Fig. 4A: control zone 408b that captures any particle and thereby shows that reaction conditions are appropriate).
It would have been obvious to one of ordinary skill in the art to modify the device of the reference claims such that the lateral flow test strip comprises a control line, as taught by Irudayaraj. One of ordinary skill in the art would be motivated to make this modification because Irudayaraj teaches that a control line is useful for confirming the proper functioning of the assay. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both the reference claims and Irudayaraj are directed to lateral flow devices for the detection of multiple analytes in a sample.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/ELLIS FOLLETT LUSI/Examiner, Art Unit 1677
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
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