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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks November 1st, 2025. Claims 1-14 are pending.
Priority
The present Application, which is a CIP Application of 15/430,698, does not receive the priority date of 15/430,698, as the disclosure of 15/430,698 does not provide basis for the claimed subject matter of the “at least one encryption processing component that encrypts the at least one result, shares the at least one result, or a combination thereof” as in cls. 1 and 10, and dependents thereof that constitute the full claim set 1-14.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “at least one encryption processing component that encrypts…” as in claims 1 and 10 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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:
At least one encryption processing component that encrypts the at least one result, shares the at least one result, or a combination thereof as in cls. 1 and 10.
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.
Unclear from the disclosure. *See further discussion under 35 USC 112 b/2nd paragraph below.*
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 1-14 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.
As discussed above “at least one encryption processing component that encrypts…” as in both of independent claims 1 and 10 is indefinitely disclosed in its corresponding structural metes and bounds.
It is unclear from Applicant’s disclosure what structure(s) constitute the at least one encryption component for its recited functionalities.
Applicant’s disclosure in par. [0047] in US 2022/0170914 provides that “…the digital camera component or camera system can also comprise at least one encryption processing component that encrypts…” However, this disclosure merely generally speaks to exemplary discussion of inclusion to such an “…encryption component that encrypts…” to a “digital camera component” or “camera system.”
This disclosure and the remaining portions thereof are absent discussion as to the particular structure(s) that defines such “at least one encryption component that encrypts…”
Clarification is required as to the constituent structural element(s) that constitute the “at least one encryption processing component that encrypts…” as in both of independent claims 1 and 10.
Additionally, the claims recite that “the at least one multi-layer coating that at least partially covers the assay membrane, the secure device or a combination thereof” is indefinitely understood.
The choosing of assay membrane as to the element covered by the multi-layer coating is indefinitely provided for as this presupposes the choosing of assay membrane, wherein the claim previously recites “an assay membrane or a test device” in which the choosing of an assay membrane is not necessitated.
By this, Examiner asserts that Applicant should recite “at least partially covers the assay membrane or the test device” and provide language that correlates the choosing of an assay membrane/test device in the first instance to also coincide with the placement of the at least one multilayer coating to the respectively chosen membrane/test device (i.e. precluding the further indefinite recitation in which one may choose, for example, the assay membrane in the first instance, and the test device in the second with respect to the multi-layer coating).
Further, with respect to the multi-layer coating at least partially covering the secure assay device, this option is indefinitely understood as the secure assay device refers to the totality of the claim as the claim itself is drawn to a secure assay device. And it does not appear from the disclosure that there is an intent to at least partially cover the entirety of the device and its constituent parts in some manner with at least one multi-layer coating.
Further, the choice of “a combination thereof” is indefinitely defined as the claim sets forth a choosing of 1) assay membrane (“assay [device]” as in cl. 10) or 2) a test device, in which the claim does not provide a provision to some sort of hybrid conglomerate of a 1) assay membrane AND a 2) test device.
Further, as in claims 10-14, the metes and bounds of the structural/functional relationship between the recited elements so as to form the sought operative embodiment of the “secure reader” are indefinitely defined.
Claim 10 provides a general parts listing to a set of electronics, a digital camera component, an illumination component, a housing component, an assay or a test device, at least one multi-layer coating, and at least one encryption element.
Aside from the multi-layer coating being related with respect to the assay membrane, the remainder of the elements are without any structural and/or functional interrelationship(s) so as to provide for the sought operative embodiment of the secure reader.
It is also noted that the set of electronics, a digital camera component, an illumination component, a housing component are all provided in name only and absent any functionalities in which it is unclear their purpose in providing the sought secure reader.
With regard to claim 3, the recitation “the test device is a lateral flow and/or vertical flow immunoassay” is indefinitely understood as the provision of the claim is drawn to a device wherein Applicant has recited an immunoassay that is a procedure/methodology and is not a more particular device. For example, does Applicant intend to recite that the substrate/surface is a lateral flow/vertical flow immunochromatographic test strip?
Further, provision of “and” is indefinitely provided for and understood herein as the provision of a lateral flow and vertical flow assay/device is not possible and otherwise renders the relative orientation of “lateral” and “vertical” without meaning.
Lastly, claim 3 presupposes the choosing of “assay device” which is indefinitely provided for as base claim 1 provides for a choosing of an assay membrane or a test device. It appears that Applicant intends to recite “wherein the assay membrane or test device.”
Similarly, as in claim 4, the recitation that the test device comprises a fluorescence assay is indefinitely understood as the claim sets forth a provision to the test device. For example, does Applicant intend to claim particular fluorescence element (i.e. fluorophore, fluorescent label to the assay membrane/test device), or an added particularly arranged fluorometer, photodetector, etc.?
With regard to claim 6, it is unclear what is meant by the multi-layer coating comprises an adjustable transmission. Applicant’s disclosure does not remedy this is discussing the material of construction or further, appended external element(s) thereto the multi-layer coating that imparts such a functionality of “an adjustable transmission.” This appears to speak to an ability of the multi-layer coating to be dynamically more or less transmissive to light, however, the specification does not particularly define or discuss a multi-layer coating and its structure(s) that affords such adjusting to this static element. Examiner notes pars.[0039-0042] of Applicant’s pre-grant publication US 2022/0170914 generally discuss this element, but are absent particular discussion as to both what is meant by “comprises an adjustable transmission” and the corresponding structure of the multi-layer coating that affords such.
The claim does not further delineate its structure or material of construction coinciding therewith that provides for this “adjustable transmission,” which speaks to a dynamic functionality imparted to the physical structure of the at least one multilayer coating and not to the mere capability that one multilayer coating may be replaced for another depending on the assay at-hand (and noting the claims herein are drawn to a device and not a method).
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 3-5 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. Claims 3-5 provide recitations to the test device, however, its choosing is not necessitated as independent claim recites “an assay membrane or a test device”. 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.
Herein, in each of claims 3-5, Applicant may recite-
The secure assay device of claim 1, wherein the secure assay device comprises the test device and wherein the test device comprises…
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4 and 6-14, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Karlovac et al. (WO 2015/004555), hereafter Karlovac, in view of Xiang et al. (US 2012/0123686), hereafter Xiang.
With regard to claim 1, Karlovac discloses a secure assay device comprising an assay membrane or a test device that provides at least one result (abstract, page 5, rapid diagnostic test, (RDT) in a position relative to a digital camera component), wherein the assay membrane or test device comprises at least one surface which exhibits a change in response to at least one target particle (page 14, test pads, nitrocellulose membrane, page 20, blank and test bands that change color, at least one marker or a combination thereof, wherein the change is illuminated or digitally visible and is recordable by a camera system, abstract, page 5, 14, 21, digital camera component, recorded via cell-phone camera); and at least one multi-layer coating that at least partially covers the assay membrane, page 20, light reaching the camera is diffused either through two layers of plastic with and without the strip or one layer plus the strip, figure 8, the secure assay device or a combination thereof, wherein the multi-layer coating blocks or impairs a user visualization of the change, the at least one result or a combination thereof (page 20, layers of plastic with and without the strip or one layer plus the strip).
Examiner asserts that diffusing layers (i.e. interacting with the intensity of the incoming light) of plastic arranged at least partially covering the assay membrane or secure assay/test device provides to block or impair in as much as recited and required herein, and further noting that the recited “blocks or impairs user visualization” is recited at a high level of breadth given that the multi-layer coating is both generally recited in its structural constitution (i.e. requiring only partial covering of the assay membrane, and without any particular material of construction/optical property thereto).
With regard to claim 2, the recitation to the at least one target particle/at least one marker/combination is drawn to an intended use recitation not afforded patentable weight wherein the at least one target particle/at least one marker/combination are not positively claimed elements of the device and are drawn to intended workpieces therewith. Further, it is noted that Karlovac teaches such elements comprises an analyte, an antibody, a molecule, a virus, bacteria, a cell, or a combination thereof, page 14 antigen, analyte, antibody, protein.
With regard to claim 3, the recitation is drawn to a process recitation not afforded patentable weight in a device claim. Additionally, and noting the above-discussed rejection under 35 USC 112 b/2nd, Karlovac disclose that the assay device is a lateral flow and/or vertical flow immunoassay device, Figures 1 and 3, cassette tray is lateral flow. With regard to claim 4, the recitation is drawn to a process recitation not afforded patentable weight; in addition, Karlovac discloses application with a fluorescence assay, page 13, page 18, page 21, claim 17. With regard to claim 6, as best understood, Karlovac discloses that the multi-layer coating comprises an adjustable transmission, page 13-15.; With regard to claim 7, Karlovac discloses wherein the multi-layer coating is partially reflective (and noting that the claim is broad in its recitation to reflection as it is without respect to a particular wavelength/range thereof), page 13-15. With regard to claim 8, Karlovac discloses wherein the multi-layer coating is partially transparent given the layers of plastic providing a light diffusion functionality in which such provides that the plastic is at least partially transparent to the incoming light (and further noting that the claim is broad in its recitation to partial transparency as it is without particular wavelength/range thereof. With regard to claim 9, Karlovac discloses wherein the multi-layer coating further comprises layer or layers that are sensitive to light polarization, wavelength, or intensity, page 14, page 23, claim 17 (i.e. plastic providing a light diffusion of the incoming intensity).
With regard to claim 10, similar discussion to that of claim 1 is included herein to those overlapping elements as provided by Karlovac. Additionally, Karlovac discloses a set of control electronics, a digital camera component, 5, an illumination component, and a housing component, (abstract, page 5, figs. 8, 14, 15, for example).
With regard to claim 11, Karlovac discloses that the illumination component which illuminates the secure assay device from the opposite side than the digital camera component, Figure 8, page 18-19. With regard to claim 12, Karlovac discloses wherein illumination component which illuminates the assay device from the same side as the digital camera component, Figure 14, page 21. With regard to claim 13, Karlovac discloses the illumination component which illuminates the secure assay device with a wavelength matched to the multi-layer coating in the secure assay device, page 14. With regard to claim 14, Karlovac discloses the illumination component which illuminates the secure assay device from the same side as the digital camera component in order to excite a fluorophore and up-converting phosphor in a fluorescent and up-converting phosphor based assay, page 13, page 18, fluorescent tests, claim 17. Further, as in claims 11-14, the recitations are provided as process recitations not afforded patentable weight in a device claim wherein, as discussed above, the illumination component of Karlovac is fully capable of providing for such process steps in as much as claimed and required herein.
With regards to claims 1 and 10, Karlovac does not specifically disclose at least one encryption processing component that encrypts the at least one result, shares the at least one result with at least one entity or individual or a combination thereof.
Xiang discloses a handheld diagnostic test device and method for use with an electronic device and a test cartridge in a rapid diagnostic test (abstract). Xiang discloses that the test device comprises on-board memory that enables the electronic device’s processor to encrypt patient identification data and/or the networking electronic device to transmit, without the patient identification data, at least a portion of the presentation data, the test data, and the encrypted data for recording in one or more remote and/or distributed databases (pars.[0038-0039,0143,0147], for example).
It would have been obvious to one of ordinary skill in the art to modify Karlovac to utilize at least one encryption processing component that is functional for encrypting as claimed such as suggested in the analogous art of rapid diagnostic test devices as in Xiang in order to provide a diagnostic test device with on-board means of recording, securing, privatizing, and transmitting patient data to a remote location without comprising personal and confidential medical information.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karlovac in view of Xiang as applied to claims 1-4 and 6-14 above, and further in view of Davis et al. (US 2007/0031283), hereafter Davis.
Karlovac/Xiang does not specifically disclose that the assay device[membrane] or test device is a microfluidic device.
Davis discloses assay cartridges and methods for point of care instruments (abstract). Davis discloses that in addition to lateral flow devices, microfluidic channels for transport may be utilized in the cartridge point of care instrument (par.[0157], for example).
It would have been obvious to modify Karlovac/Xiang to provide the assay device[membrane]/test device as a microfluidic device such as taught by Davis in order to provide another, obvious alternative and suitable fluid handling format for a POC assay device.
Response to Arguments
Applicant's arguments filed November 1st, 2025 have been fully considered but they are not persuasive.
With regards to the present Application, which is a CIP Application of 15/430,698, does not receive the priority date of 15/430,698, as the disclosure of 15/430,698 does not provide basis for the claimed subject matter of the “at least one encryption processing component that encrypts the at least one result, shares the at least one result, or a combination thereof” as in cls. 1 and 10, and dependents thereof that constitute the full claim set 1-14, Applicant traverses.
Applicant sets forth showings from the original disclosure and that of the present disclosure.
Applicant asserts that while the exact wording of “an encryption processing component” isn’t specifically provided in the original application, all of the components are specifically called out in the original application.
Examiner asserts that such arguments are not persuasive as the original disclosure, including those portions provided herein by Applicant, do not provide basis for “at least one processing component that encrypts the at least one result, shares the at least one result, or a combination thereof” as in cls. 1 and 10.
Applicant remarks acknowledge this as the disclosure is absent discussion to “at least one encryption component…” as recited herein.
The general, prophetic discussion to “all of the components are specifically called out…” is both unsubstantiated and fails to provide a showing of “at least one encryption component…” for the recited functionalities claimed herein.
Further to this, Applicant’s assertion to “all of the components are specifically called out” is without discussion as to these supposed components that are specifically called out, and wherein, Examiner asserts the claim recitation at-issue is drawn to at least one encryption component for the functionalities recited herein, which further confounds Applicant’s general, prophetic offering of support.
The claims are drawn to a device, wherein at least one encryption component for the functionalities recited herein is a structural element to the device and wherein such element/component does not have basis in the present disclosure, and thus does not receive the priority date of 15/430,698.
With regard to the objection of the drawings, Applicant asserts that Figures 3 and 4 show the digital camera component or system can also comprise at least one encryption processing component as claimed.
Examiner asserts that this does not provide a showing of such a structure of at least one encryption processing component as claimed.
Assertion that “figures 3 and 4 show the digital camera component or system can also comprise at least one encryption processing component as claimed” does not provide a showing of such element within the drawings, and is instead drawn to a proffered, potential or prophetic implementation that does not suffice to provide an actual showing of the claimed element.
With regard to claims 1-14 rejected under 35 USC 112 b/2nd paragraph, Applicant traverses the rejection.
Applicant asserts that pages 10 and 11 of the original specification discloses the encryption process.
Applicant remarks are not persuasive as it is not a question of processing/method steps, but of the structural constituency and equivalents thereof being construed to the recitation “at least one encryption processing component that encrypts…” as in both of independent claims 1 and 10.
Further, the discussion on pages 10 and 11 does not even meet the proffered attestation that “pages 10 and 11 of the original specification discloses the encryption process.”
These pages discuss general infrastructure of the device as well as general discussion to “not providing the results to the end user” and “[t]he integrated read-out instrument can encrypt the test result…” as well as discussion to “[a] contemplated secure assay device which provides confidentiality and security of test results can be referred to by [tradename SECASSAY].”
The discussion in pages 10 and 11 cited herein to does not suffice to satisfy the definiteness requirement under 35 USC 112 b/2nd paragraph as providing the corresponding structure to the “at least one encryption component that encrypts…” as recited herein.
It is unclear from Applicant’s disclosure what structure(s) constitute the at least one encryption component for its recited functionalities.
Such recitation is properly treated under 35 USC 112F/6th as it provides a generic placeholder of “component” followed by functional language without sufficient structure recited therein the claims so as to provide for the recited functions.
See also MPEP 2181, II, A.
Further, and within the above section - Biomedino, LLC v. Waters Technology Corp., 490 F.3d 946, 952, 83 USPQ2d 1118, 1123 (Fed. Cir. 2007) (Disclosure that an invention “may be controlled by known differential pressure, valving and control equipment” was not a disclosure of any structure corresponding to the claimed “control means for operating [a] valving” and the claim was held indefinite).
Further, with regards to claims 1 and 10 and rejection under 35 USC 112 b/2nd with respect to the multi-layer coating, Applicant asserts that Examiner is conflating the secure assay device and the test device, wherein they are different components.
Examiner asserts that this is not the case. The claim language provided herein is indefinite.
The claim, which is to a secure device as a whole as seen in the preamble, first recites “an assay membrane or a test device…” that provides an alternative choosing of an assay membrane or a test device.
Thus, within the recitation to the at least one multi-layer coating, the recitation “…that at least partially covers the assay membrane, the secure assay device, or a combination thereof” is indefinitely provided for several reasons.
First, the choosing of assay membrane as to the element covered by the multi-layer coating is indefinitely provided for as this presupposes the choosing of assay membrane, wherein the claim previously recites “an assay membrane or a test device” in which the choosing of an assay membrane is not necessitated.
By this, and as similarly discussed in the prior Office Action, Examiner asserts that Applicant should recite “at least partially covers the assay membrane or test device” and provide language that correlates the choosing of an assay membrane/test device in the first instance to also coincide with the placement of the at least one multilayer coating to the respectively chosen membrane/test device (i.e. precluding the further indefinite recitation in which one may choose, for example, assay membrane, in the first instance, and test device in the second with respect to the multi-layer coating).
Further, with respect to the multi-layer coating at least partially covering the secure assay device, this option is indefinitely understood as the secure assay device refers to the totality of the claim as the claim itself is drawn to a secure assay device.
With respect to the recitation “combination thereof,” and as similarly, previously discussed, the recitation is indefinitely defined as the claim sets forth a choosing of 1) assay membrane or a test device, in which the claim does not provide a provision to some sort of hybrid conglomerate of a 1) assay membrane AND a 2) test device.
Further, with regards to the rejection of claims 10-14 under 35 USC 112 b/2nd, Applicant asserts that the claims have been amended to obviate the rejection.
Examiner notes that the claims are amended to clarify the prior antecedent basis issue and utilize “assay membrane” in all instances, however, this amendment alone does not account for the remaining issues previously provided in the rejection.
Claim 10 provides a general parts listing to a set of electronics, a digital camera component, an illumination component, a housing component, an assay or a test device, at least one multi-layer coating, and at least one encryption element.
Aside from the multi-layer coating being related with respect to the assay membrane, the remainder of the elements are without any structural and/or functional interrelationship(s) so as to provide for the sought operative embodiment of the secure reader.
It is also noted that the set of electronics, a digital camera component, an illumination component, a housing component are all provided in name only and absent any functionalities in which it is unclear their purpose in providing the sought secure reader.
With regards to claims 3-5, Examiner acknowledges the amendment to recite “test device” in lieu of the previous recitation to “the assay device” that lacked antecedent basis.
However, in view of the amendments thereto, claims 3-5 are rejected under 35 USC 112 d/4th paragraph as discussed above.
Further, the claims were further rejected under 35 USC 112 b/2nd as previously discussed in the prior Office Action and this amendment does not address or obviate these additional issues of clarity.
As previously discussed with regard to claim 3, the recitation “the test device is a lateral flow and/or vertical flow immunoassay” is indefinitely understood as the provision of the claim is drawn to a device wherein Applicant has recited an immunoassay that is a procedure/methodology and is not a more particular device.
For example, does Applicant intend to recite that the substrate/surface is a lateral flow/vertical flow immunochromatographic test strip?
Further, provision of “and” is indefinitely provided for and understood herein as the provision of a lateral flow and vertical flow assay/device is not possible and otherwise renders the relative orientation of “lateral” and “vertical” without meaning.
Similarly, as in claim 4, the recitation that the test device comprises a fluorescence assay is indefinitely understood as the claim sets forth a provision to the test device. For example, does Applicant intend to claim particular fluorescence element (i.e. fluorophore, fluorescent label to the assay membrane/test device) or an added particularly arranged fluorometer, photodetector, etc.?
With regard to claim 6 rejected under 35 USC 112 b/2nd, Applicant asserts that Page 13 of the original specification provides basis for the recitation to “…comprises an adjustable transmission.
Examiner asserts that discussion to the optical properties being adjusted by altering the material thickness, or the individual layers of materials, or composition or density does not suffice to provide clear metes and bounds as to the structure(s) of the at least one multi-layer coating that affords such functionality to “comprising an adjustable transmission.”
These discussions are predicated on processes not required herein (i.e. there are no steps of compressing and/or expanding the multi-layer coating, nor an active structure as some sort of compression device to effect a thickness), nor does the general discussion of “individual layers of materials or composition or density” coincide with the presently-claimed structural element of “at least one multi-layer coating.” The claim does not further delineate its structure or material of construction coinciding therewith that provides for this “adjustable transmission” which speaks to a dynamic functionality imparted to the physical structure of the at least one multilayer coating and not to the mere capability that one multilayer coating may be replaced for another depending on the assay at-hand.
With regards to claims 1-4 and 6-14 rejected under 35 USC 103 as being unpatentable over Karlovac in view of Xiang, Applicant traverses the rejection.
Applicant asserts that neither Karlovoc nor Xiang discloses “at least one multi-layer coating that at least partially covers…blocks or impairs a user visualization of the change, the at least one result or a combination thereof.”
Examiner asserts that Applicant has failed to structurally distinguish the claimed device and its above-discussed “at least one multi-layer coating that partially covers…blocks or impairs…”
As discussed above, Karlovac discloses a commensurately arranged and structured multi-layer coating, and in which such multi-layer coating is fully capable of blocking or impairing a user visualization of the change, the at least one result, or a combination thereof.
Examiner asserts that diffusing layers of plastic (which interact and effect the intensity of the incoming light) arranged as at least partially covering the assay membrane or secure assay/test device provide to block or impair a user visualization of the change, the at least one result or a combination thereof in as much as recited and required herein.
It is further noted that the recitation “blocks or impairs user visualization” is recited at a high level of breadth/scope given that the multi-layer coating is both generally recited in its structural constitution (i.e. requiring only partial covering of the assay membrane, and without any particular material of construction/optical property thereto).
It is further noted that Applicant’s specification does not define the at least one multi-layer coating with respect to its “blocks or impairs a user visualization of the change, the at least one result, or a combination thereof” so as to preclude the multi-layers of diffusing plastic as in Karlovac from reading on this claimed element for its recited functionality.
Examiner invites Applicant to further define the at least one multi-layer coating such as by its material of construction or particular optical properties that particularly provide for the sought “blocks or impairs a user visualization of the change, the at least one result or a combination thereof.”
With regard to claim 5 rejected under 35 USC 103 as being unpatentable over Karlovac in view of Xiang and in further view of Davis, Applicant traverses the rejection.
Applicant provides likewise arguments as those discussed above in relation to independent claims 1 and 10.
As discussed above, there are no such deficiencies with respect to Karlovac in view of Xiang, and combination with Davis is maintained for the above discussed reasons provided in the body of the action.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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/NEIL N TURK/Primary Examiner, Art Unit 1798