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.
Information Disclosure Statement
The information disclosure statement (IDS) filed 12/13/2023 is considered, initialed and is attached hereto.
Status of the Claims
Claims 1-3, 5, 7, 9, 11, 13, 15, 17-18, 20-22, 24, 26-27 and 29-31 are pending; claims 4, 6, 8, 10, 12, 16, 19, 23, 25 and 28 are canceled; and claims 3, 5, 7, 9, 11, 13, 15, 17-18, 20, 22, 24, 26, 27 and 29 are amended. Claims 1-3, 5, 7, 9, 11, 13, 15, 17-18, 20-22, 24, 26-27 and 29-31 are examined below.
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: “detection unit is configured to detect said signal” in claim 18. The generic placeholder is “detection unit”, the functional language “configured to detect said signal”.
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.
In the present case, the originally filed specification at para [0206] recites “detection unit” refers to an instrument capable of detection and/or quantitating data. Although the originally filed specification at para [0212] indicates in some embodiments, a detection unit is a human, the present claimed limitations do not appear to encompass such an embodiment because the claim recites “device, further comprising a detection unit in operable communication with said device”. As such, the claim is not interpreted as encompassing a detection unit structure that is a human, rather the claims are interpreted to a encompass a structure that is “an instrument capable of detection and/or quantitating data”. However, Applicant should confirm or clarify in their response.
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
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, 20-22, 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 the language “comprising a section 1, at least one section 2, at least one section 3 and a section 4”. The claim describes the sections individually numerically, and as such, the language “at least one section 2, at least one section 3” is indefinite because it is confusing as to how there can be more than one section 2 if the section 2 is described as the second section. For example, it is not clear if this language is suggesting that there could be more than one duplicates of this particular section, or if it is implying additional structure to the section referred to as “section 2” (i.e., separating the section 2 into distinct structures/sections, not necessarily duplicates of either other). The language is indefinite because it is confusing and one cannot readily determine the boundaries of what is encompassed by the claim (i.e., if there was more than one section 2, then arguably that additional section would no longer be a “section 2”, but another subsequent section). This reasoning similarly applies to the language “said section 3”.
Claim 1 is further indefinite at line 3, the claim recites “said section 3 is coupled to said section 2”, however section 2 is recited as “at least one section 2”. As a result, the language referring to “said section 2” is indefinite because it is confusing as it appears to reference one singular section, however, the claim recites that there may be more than one section 2. It is not clear what “section 2” section 3 is coupled to, and as a result the boundaries of the claim are unclear.
Claim 2 recites “at least one section 2, comprises a surface comprising said agent and an agent probing molecule having specific binding affinity to said agent”. The claim recites “said agent”, which is indefinite claim language because it is not readily clear if “said agent” is intended as referring to the “agent having a specific binding affinity to said target molecule”, which is recited at section 3 of the claimed device, or if the claim is referencing another previously recited reagent as “said agent”.
Claim 11 recites the limitation "said section 3" in line 1. There is insufficient antecedent basis for this limitation in the claim. See rather, the claim previously refer to section 3 as “at least one section 3”. As a result, “said section 3” is not consistent with this earlier language, and the claim language is considered indefinite (as it does not clearly refer back to the previously recited structure/language as recited).
Claim 15 recites “agent is a drug affecting said target molecule”, the claim language is indefinite because it is unclear what is meant by “affecting”. Although Applicant provide an example of what can be meant by “affecting” at para [0157] (i.e., modulating), this example is not a limiting definition and the terminology “affecting” is extremely broad and variable in scope. As a result, the claim is indefinite because the boundaries regarding what is and is not encompassed are unclear.
Claim 17 recites “wherein said coupled”, the claim language appears to be missing a word/limitation, and as such the language is indefinite because it is not readily clear if “said coupled is in reference to the different sections or any one particular section that is coupled to another section, as recited at claim 1.
Claim 21 recites “comparing it to a calibration curve or indicative value”, it is suggested that “it” be amended to recite “comparing the amount of the signal” in place of “it” to improve clarity. However, the claim also recites “indicative value”, the terminology “indicative” is indefinite because it is not clear what the value is “indicative” of, for example “indicative” is describing the value, but it is not clear what boundaries this limitation is placing on the “value” being used for the comparison such to result in quantification of the amount of sample. As a result, the recited language is indefinite because one cannot clearly determine the boundaries of what is from what is not claimed.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 21 is rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
Claim 21, which depends from and includes all the limitations of claim 20, recites “determining the amount of said signal, and comparing it to a calibration curve or an indicative value”.
The claimed step of “comparing” signal to a “calibration curve or indicative value” is categorized as an abstract idea, namely mental process/concept performed in the human mind (for example, a practitioner simply thinking about the measured signal in relation to a calibration curve or value and making an evaluation, judgment or opinion). The claims, under broadest reasonable interpretation, cover performance of identifying risk solely within the human mind or by a human using pen and paper.
Further, see the groupings of abstract ideas as identified in the MPEP, comparing information regarding a sample to a control or target data represents abstract ideas.
Similar concepts involving comparing information regarding a sample or test subject to a control or target data have been held to be an "abstract mental process", as in University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 113 USPQ2d 1241 (Fed. Cir. 2014) which involved "comparing BRCA sequences and determining the existence of alterations", the collecting and comparing of known information in Classen, the comparing information regarding a sample or test subject to a control or target data in Ambry and Myriad CAFC, as well as Mayo (which also involved specific numerical cutoff levels).
Step 2A, Prong 2
The above indicated step of “comparing” is insufficient to integrate into a practical application because steps corresponding to the judicial exception themself are insufficient to constitute a practical application (is the judicial exception, not a practical application thereof).
In addition to the limitations directed to the judicial exception itself, the claim further recites a step a. “contacting section 1 of the device of claim 1 with a sample” and b. “detecting the presence of a signal” (see claim 20, claim 21 depending from claim 20). Although application of a judicial exception by or with a particular machine can integrate a judicial exception into a practical application (see MPEP 2106.05(b)), it is necessary to determine the particularity or generality of the elements of the machine or apparatus (i.e., the degree to which the machine in the claim can be specifically identified). In the present case, the claims are directed to the use of the device of claim 1.
Further, it is necessary to assess whether the machine’s involvement is extra-solution activity or a field of use, i.e., the extend to which or how the machine imposes meaningful limit (also MPEP 2106.05(b)). Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method would not integrate the judicial exception or provide significantly more. In the present case, the device of claim 1 is merely described to obtain the data. See 2106.05(b), this determination precludes the device of claim 1 from being considered to be “a particular machine”, because its involvement in the claim is only as insignificant extra-solution activity (Step 2A, prong One does not take into consideration whether or not the limitation is well-known).
The claimed device is not sufficient to integrate the judicial exception into a practical application, the combination of the additional elements is not sufficient to integrate into judicial exception (for example, there are no further steps/elements or other limitations that further apply, rely on or use the comparison step such to integrate into a practical application thereof).
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
It is also the case that the combination of the additionally recited elements (recited in addition to the judicial exception itself) does not amount to more than that which was well-known, routine and conventional in the art. As noted, the claims additionally encompass the contacting step of claim 20 step a, contacting with section 1 of the device of claim 1.
However, see further use of such a device, and further a device as claimed, was well known, routine and conventional prior to Applicant’s invention. See for example, see as cited below in more detail (under 35 U.S.C. 102), Georgevich, CA 2009111A1. Georgevich was known to those of ordinary skill in the art well before Applicant’s claimed invention (see published 1990). Georgevich is an example in the prior art teaching 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.
Further, see as discussed in detail previously above, the use of the device of claim 1 in the present claims is directed toward data gathering (insignificant pre-solution activity). See MPEP 2106.05 (b), use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.
For all of these reasons, the claimed invention is not patent eligible under 35 U.S.C. 101.
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 –
Claim(s) 1, 7, 17, 20-22, 24, 26 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Georgevich, CA 2009111A1.
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.
Regarding claim 7, see Figure 3, Georgevich’s device shows additional sections, thereby addressing the claimed “further comprising section 5”. Claim 5 does further recite “optionally wherein said section 5 comprises a surface in contact with a substrate molecule generating a signal in response to said trigger”, however, see MPEP 2143.03, Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. In addition, when a claim requires selection of an element from a list of alternatives, the prior art teaches the element if one of the alternatives is taught by the prior art. See, e.g., Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298, 92 USPQ2d 1163, 1171 (Fed. Cir. 2009). The limitations recited presently as “optional” are not required by the claimed invention. As a result, Georgevich anticipates the claim.
Regarding claim 17, see the rejection under 35 U.S.C. 112(b), the claim appears to be missing language. Although the claim does not clearly refer to what is specifically coupled in contact or overlapping, it appears that this claim limitation is intended in order to reference the sections 1-4, which see as cited above, the reference teaches the sections are in contact. As such, Georgevich anticipates the claim.
Regarding claim 20, see further Georgevich teach contacting section 1 with sample and detecting signal (see page 3, paragraphs 3 and 4).
Regarding claim 21, see further page 10, paragraph 4, comparing to a predetermined scale having gradations (see shown between Figures 2A and 2B). When the claims are given broadest reasonable interpretation, this amounts to “comparing” determined signal to “an indicative value”.
Regarding claims 22, 24 and 26, see Georgevich does teach targeted analytes including, for example antibodies (see page 15, second paragraph). As noted previously above, “optionally” recited limitations are not limiting to the claimed invention (claim 26 further limits an “optional” limitation, see claim 22 does not require or limit claim 22 to an antibody that is a drug).
Regarding claim 27, see Georgevich teach samples that are biological fluids (obtained from a subject as claimed), see page 5, para 3.
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.
Claim(s) 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Georgevich in view of Braasch et al., CA3027972A1.
Georgevich teach a device substantially as claimed (see as cited above).
Regarding Georgevich’s conjugate, although Georgevich does describe an enzyme labeled conjugate, the conjugate provided at the section which reads on the “section 2” as claimed (see page 13, paragraph 1), Georgevich fails to teach at section 2 the surface “comprising said agent” and an agent probing molecule having specific binding affinity to said agent”.
It appears “said agent” of Georgevich may be referring to the “agent having specific binding affinity to said target molecule” as recited at claim 1 at section 3 of the device. As discussed, Georgevich is teaching, in addition to said agent provided at section 3, conjugate specific for target as well (reagent that reads on “said agent”, at claim 2; notably see also rejections over claim 2 set forth above, under 35 U.S.C. 112(b)).
Regarding detection reagent/conjugate, see Braasch et al. teach biotinylated detection antibody bound to streptavidin labeled enzyme label (see for example Figure 2, described at page 14). Biotinylated antibody reads on agent (agent with specific binding affinity for target), and streptavidin labeled enzyme, when given broadest reasonable interpretation reads on “agent probing molecule having specific binding affinity to said agent”, referring to said agent provided at section 2 (the agent of section 2). Similarly to Georgevich, Braasch et al. is describing immunoassays performed, for example, by lateral flow assay (devices that are test strip devices) (see page 4, paragraph 3, page 8, second to last paragraph, page 9, paragraphs 2-3).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the conjugate as taught by Georgevich for the enzyme labeled conjugate of Braasch as a simple substitution of one known enzyme labeled conjugate for another, both known and usable for immunoassay including test strip immunoassays. Georgevich differs from the claimed invention at section 2, namely fails to teach, in addition to agent (specific for target), a probing molecule specific for the agent. Both enzyme conjugate species (that of Georgevich as well as that of Braasch) are art recognized immunoassay conjugate species for detection. Further both references teach the conjugate useable in immunoassay that is a test strip immunoassay device. As a result, one having ordinary skill would have found it obvious to use one in place of the other and the results of the substitution would have predictably yielded a detectable signal. Also, notably, the claimed language is extremely broad at claim 2, and is not particularly limited at claim 2 to any specific species of agent or agent probing molecule, to any particular arrangement (for example, such as related to whether the components are separable, or together), or to how these reagents are provided at the surface at section 2 (regarding whether one or both are immobilized, or mobilizable, for example).
Regarding claim 11, see the combination of the cited art above, section 4 is devoid of said probing molecule and reporter (reagents at section 2).
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Georgevich in view of Babu et al., US PG Pub No. 2009/0289201A1.
Regarding claim 5, see as cited in detail above Georgevich does teach providing at section 3 two components, namely target and anti-target antibody.
However, Georgevich fails to teach section 3 comprises two separate sections 3, the first comprising target, the second comprising agent having the specific binding affinity to the target.
However, see for example Babu et al. at para [0030], as an example of a test strip device comprising a detection zone with multiple detection reagents immobilized thereon, each of the different detection reagents provided in the form of multiple test line (separate test line for each).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the components immobilized at the detection area (that reads on section 3) as two distinctly, separate sections (i.e., a line for each) as an obvious matter of a known technique for a known device. In particular, it was known in the test strip assay device prior art to provide each immobilized capture reagent as a separate line (separate section), one would be motivated to adopt this configuration to make the two components distinguishable. Further, one having ordinary skill in the art would have a reasonable expectation of success because like Georgevich’s embodiment comprising the additional reagent at the capture region of a test strip device, Babu also similarly is providing a technique for providing multiple reagents at a capture region of a test stirp device.
Claim(s) 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Georgevich et al., in view of Barbosa et al., US PG Pub No. 2018/0031547A1.
Although Georgevich teach a device substantially as claimed, for example see as cited above the reference teaching immobilized protein (analyte/analog) at section 3, the reference fails to teach the target analyte (section 3) is a peptide (claim 13); fails to teach agent is a drug affecting said target (claim 15, see further wherein the agent comprises an antibody is recited as an optional limitation, optional limitations are not specifically limiting, see as discussed previously above).
See Barbosa teaching an examples 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.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Georgevich to provide peptides immobilized as the agent at the section 3, for example peptides that are drugs specific for analyte that is an anti-drug antibody, in order to modify the device to make it useful for detection of ADAs, one motivated to detect ADAs because of the many possible applications as taught by Barbosa (selection of therapeutics, evaluation of a need to change therapeutics or to apply tolerance regimens, evaluate patient immune status prior to vaccination, etc.).
Furthermore, the modification to use peptides would have been an obvious matter of a simple substitution of one known immobilized reagent for another, Georgevich already teaching immobilization of proteins at the capture region (the reference silent as to whether said proteins are full length or peptide fragments of the full length proteins), particularly because peptides are merely fragmented pieces of proteins, one further motivated to use peptides for the purpose of epitope mapping for targets comprising antibodies (as in Barbosa).
One having ordinary skill in the art would have a reasonable expectation of success providing peptides at the capture region in place of other protein such as full length protein because Barbosa is the same type of assay device (test strip device) as Georgevich, and because Barbosa teach immobilization of either (see as cited above).
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Georgevich in view of Ghaffari et al., US PG Pub No. 2015/0260713A1.
Georgevich teach a device substantially as claimed (see as cited above), however fails to teach the device further comprising a detection unit in operable communication with said device, the detection unit configured to detect said signal (claim 18).
Ghaffari et al. teach a portable measurement device for performing measurements and transmitting data externally for analysis and displaying of results (abstract, para [0008]), see the measurement device comprising a substrate (test strip, see as shown in Figure 1B), see as described the measurement device (detection unit) is in communication with the device (substrate, i.e., test strip), and detects the signal (para [0009], [0029], para [0069], detector such as an APS). Para [0069], Ghaffari teaching such systems/methods provide for improved signal at the detector with reduced noise. See at para [0119], Ghaffari teach their systems for obtaining accurate reading by controlling the duration of a measurement via automated monitoring of start/stop times, see further para [0120], benefits include reduced chance of error and/or making the device easier to use.
It would have been further prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified the device of Georgevich such that the device further comprises (is included within) a detection unit (for example, as in Ghaffari) in operable communication with the device (in communication with the test device) in order to detect the signal (see the device of Ghaffari comprising a detector, such an APS), one having ordinary skill motivated to make the modification to improve signal, reduce noise, and further because such automated systems allow for more accurate reading, reduce chance of error and/or make the device easier to use. One having ordinary skill would have a reasonable expectation of success because the detection unit of Ghaffari is intended for use with devices such as that of Georgevich (Ghaffari’s system inclusive of a substrate that is a test strip device), and further because it would be expected that the benefits as taught by Ghaffari would be applicable to such a device as that of Georgevich (since both are the same type of assay device).
Claim(s) 22, 24, 26, 27 and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Georgevich in view of Pluim et al., Enzyme linked immunosorbent assay for the quantification of nivolumab and pembrolizumab in human serum and cerebrospinal fluid, Journal of Pharmaceutical and Biomedical Analysis, 164, (2019), p. 128-134 and Messmer et al., US PG Pub No. 2015/0293086A1.
Georgevich teach a device substantially as claimed (see as cited above), see teaching their device is applicable for detection of analytes such as drugs, antibodies, etc. (page 15, second paragraph); however fails teach an analyte that is an antibody, such as an antibody drug (claim 22, see optional limitation), further drug comprising an immune checkpoint inhibitor (claim 24), determining amount of analyte in a sample that is a drug (claims 26, see 27 optionally antibody drug).
Pluim et al. teach immunotherapy with monoclonal antibodies targeted PD-1 receptor has become standard of care for an increasing number of tumor types (abstract). Pluim teach the accurate and sensitive determination of antibody concentrations is essential and may help optimize anti-PD-1 therapy for patients (see also abstract, see also page 133, starting at col. 1 discussion to col. 2). Pluim teach immunoassay to measure nivolumab (an example of an immune checkpoint inhibitor that is an antibody drug) and pembrolizumab.
Messmer et al. teach immunochromatographic test strip assay device for the determination of presence or integrity of a biologic, such as a biologic antibody drug (see e.g., abstract and claims, particularly claims 1-7, Figure 1). See specifically, paras [0006] and [0037]-[0038], Messmer is teaching such tests strip assay devices as an inexpensive solution to a need for simple, rapid assays that verify presence and integrity, amenable for use at any point, including bedside (point of care device).
It would have been further prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the test device (and as such the method of detection) Georgevich in order to target and quantitatively detect a drug that is an antibody biologic, such as nivolumab (an anti-PD-1 antibody biologic drug, and immune checkpoint inhibitor). One having ordinary skill would have been motivated to modify in order to detect nivolumab because this is an example of a drug that has become standard of care for an increasing number of tumor types (so is a drug relevant and applicable to many patients and their treatment), and because the rapid and easy detection of this drug may help patient care optimization (see Pluim, determination of its concentration is essential and may help optimize therapy with this drug). Furthermore, one having ordinary skill would be motivated to detect this target with a test strip device such as that taught by Georgevich because immunochromatographic test strip assay devices for detection of biologic drugs (such as antibody biologics) was recognized in the prior art as an inexpensive, simple and rapid way to perform assay at point of care (Messmer et al.).
One having ordinary skill would have a reasonable expectation of success because it was known in the art to use these types of devices for detection of antibody biologic drugs (Messmer), and further because Georgevich specifically disclose their analytes may include antibodies and drugs.
Regarding claims 29 and 30, the combination of the art, detecting the concentration of nivolumab in a patient amounts to detecting in a patient receiving treatment for tumor (cancer, i.e., a cell proliferation related disease, thereby addressing claims 29 and 30).
Regarding claims 29 and 31, Messmer et al. also detecting therapeutic antibodies to other diagnoses other than cancer, for example autoimmunity (see para [0065]). It would have been further prima facie obvious to one having ordinary skill in the art to have modified methods from detecting a biologic in subjects with cancer (tumor) to instead detect in subjects with autoimmune disease (detecting/quantitating biologic drugs for treating autoimmune disease) as a simple substitution of one known target/subject population for another, both recognized as important for monitoring biologic drug levels (see e.g., Messmer). One having ordinary skill in the art would have a reasonable expectation of success because Messmer supports those receiving drugs for autoimmune disease would benefit from detection similarly as those receiving drugs for cancer.
Correspondence
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/ELLEN J MARCSISIN/ Primary Examiner, Art Unit 1677
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