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 .
Claim Status
Claims 9-13 are newly added, and are pending and examined. Claims 1-8 are canceled.
Priority
The instant application is a continuation-in-part of 16/733,328 (filing date 1/3/2020), which is itself a divisional application of 15/570,163 (filing date 10/27/2017). 15/570,163 is a 371 of PCT/IB2016/000658 (filing date 5/2/2016), and PCT/IB2016/000658 claims priority to provisional applications 62/278,814 (filing date 1/14/2016), 62/278,805 (filing date 1/14/2016), 62/156,087 (filing date 5/1/2015), 62/156,093 (filing date 5/1/2015), 62/156,072 (filing date 5/1/2015), and 62/156,079 (filing date 5/1/2015). As the application is a continuation-in-part, the claims are accorded a filing date based on the earliest priority document, if any, that provides support for the claimed subject matter.
Claims 9-10 are supported by at least [0007] and [0016] of the Specification of 62/156,079, and claims 9-11 have therefore been accorded an effective filing date of 5/1/2015.
Claims 9 and 11 are supported by at least [0008] and [0018] of the Specification of 62/156,087, and claim 11 has therefore been accorded an effective filing date of 5/1/2015.
Claims 9 and 12 are supported by at least [0007] and [0016] of the Specification of 62/156,093, and claim 12 has therefore been accorded an effective filing date of 5/1/2015.
Claim 13 finds its earliest support in [0028] and [0074] of the Specification of PCT/IB2016/000658, and claim 13 has therefore been accorded an effective filing date of 5/2/2016.
Information Disclosure Statement
The information disclosure statement (IDS) received on 11/11/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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, a device comprising a plurality of individual pads comprising a first individual reagent pad comprising a reagent specific for human serum albumin, a second individual reagent pad comprising a reagent specific for lysozyme, and a third individual reagent pad comprising a reagent specific for lactoferrin 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 Objections
Claims 10-13 are objected to because of the following informalities:
Regarding claim 10, Ln. 1 recites, “wherein first individual reagent pad comprises…”, which is grammatically incorrect. The above limitation needs to be amended to recite, “wherein the first individual reagent pad comprises…” to be grammatically correct.
Claims 11-12 contain similar issues regarding the recitation of the limitation “wherein first individual reagent pad comprises…”, and are similarly objected to.
Regarding claim 13, Lns. 1-2 recite, “wherein the plurality of individual pads comprises a first individual reagent pad comprising…”. However, claim 13 depends on claim 9, which previously recited a first individual reagent pad. Therefore, the above limitation should read, “wherein the plurality of individual pads comprises the first individual reagent pad comprising…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 9 and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eilat et al. (WO Pub. No. 2013/080196; hereinafter Eilat; already of record on the IDS received 11/11/2022).
Regarding claim 9, Eilat discloses a device (Pg. 6 4th Para., Pg. 8 Last Para.-Pg. 10 1st Para., see Fig. 1). The device comprises:
a test strip configured to receive a tear sample from a patient (Pg. 6 4th Para., Pg. 8 Last Para.-Pg. 10 1st Para., see Fig. 1).
a plurality of individual reagent pads (Pg. 6 4th Para., Pg. 8 Last Para.-Pg. 10 1st Para., see Fig. 1).
The test strip is configured to deliver the tear sample to the plurality of individual reagent pads (Pg. 6 4th Para., Pg. 8 Last Para.-Pg. 10 1st Para., see Fig. 1).
A first individual reagent pad comprises a reagent specific for a protein of the tear sample (Pg. 6 4th Para., in order to detect one of lactoferrin/lysozyme/immunoglobulins/cytokines in the tear sample, a reagent must intrinsically be present that is specific for lactoferrin/lysozyme/immunoglobulins/cytokines, Pg. 8 Last Para.-Pg. 10 1st Para., see Fig. 1).
The reagent is configured to undergo a reaction to produce a color upon contact with the protein of the tear sample (Pg. 6 4th Para., Pg. 8 Last Para.-Pg. 10 1st Para., see Fig. 1).
The reaction results in an intensity of the color that is proportional to the amount of the protein in the tear sample (Pg. 6 4th Para., Pg. 4 2nd to Last Para., Pg. 10 2nd-8th Paras., see Fig. 2).
The intensity of the color indicates that the patient has an ocular surface disorder (Pg. 6 4th Para., Pg. 4 2nd to Last Para., Pg. 10 2nd-8th Paras., see Fig. 2).
Regarding claim 11, Eilat discloses the device of claim 9, wherein the first individual reagent pad comprises a reagent specific for lysozyme (Pg. 6 4th Para.).
Regarding claim 12, Eilat discloses the device of claim 9, wherein the first individual reagent pad comprises a reagent specific for lactoferrin (Pg. 6 4th Para.).
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.
Claims 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Eilat as applied to claims 9 and 11-12 above, and further in view of Versura et al., “Diagnostic performance of a tear protein panel in early dry eye”, 2013, Molecular Vision, Vol. 19, Pgs. 1247-1257 (hereinafter Versura; already of record on the IDS received 11/11/2022).
Regarding claim 10, Eilat discloses the device of claim 9. Eilat further discloses the first individual reagent pad that is specific for a protein (Pg. 6 4th Para., in order to detect one of lactoferrin/lysozyme/immunoglobulins/cytokines in the tear sample, a reagent must intrinsically be present that is specific for lactoferrin/lysozyme/immunoglobulins/cytokines, see Fig. 1 at reagent pads 3a-3n), but fails to explicitly disclose that the protein is human serum albumin.
Versura is in the analogous field of correlating protein levels in tear samples to ocular surface disorders (Versura Pg. 1247 at Abstract). Versura teaches correlating concentrations of human serum albumin, lysozyme, and lactoferrin to the presence of an ocular surface disorder (Versura; Pg. 1247 at Abstract, patients with dry eye have elevated levels of exudated serum albumin, and lower levels of lysozyme-C and lactoferrin compared to control subjects, see Pg. 1249 at Table 3, and Pg. 1251 at Table 5). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Eilat, which teaches a reagent specific for a protein, to be specific for human serum albumin as taught by Versura, as the concentration of human serum albumin in a tear sample is indicative of dry eye disorder in a patient (Versura; Pg. 1247 at Abstract, see Pg. 1249 at Table 3, and Pg. 1251 at Table 5).
Regarding claim 13, Eilat discloses the device of claim 9. Eilat further discloses that the plurality of individual pads comprises a first individual reagent pad specific for a protein, a second individual reagent pad specific for a protein, and a third individual reagent pad specific for a protein (Pg. 6 4th Para., in order to detect one of lactoferrin/lysozyme/immunoglobulins/cytokines in the tear sample, a reagent must intrinsically be present that is specific for lactoferrin/lysozyme/immunoglobulins/cytokines, see Fig. 1 at reagent pads 3a-3n).
Modified Eilat fails to explicitly disclose that the first individual reagent pad comprises a reagent specific for human serum albumin, the second individual reagent pad comprises a reagent specific for lysozyme, and the third individual reagent pad comprises a reagent specific for lactoferrin.
Versura is in the analogous field of correlating protein levels in tear samples to ocular surface disorders (Versura Pg. 1247 at Abstract). Versura teaches correlating concentrations of human serum albumin, lysozyme, and lactoferrin to the presence of an ocular surface disorder (Versura; Pg. 1247 at Abstract, patients with dry eye have elevated levels of exudated serum albumin, and lower levels of lysozyme-C and lactoferrin compared to control subjects, see Pg. 1249 at Table 3, and Pg. 1251 at Table 5). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Eilat, which teaches first, second, and third individual reagent pads having reagents specific for a protein, with the teachings of Versura, so that the reagent of the first individual reagent pad is specific for human serum albumin, the reagent of the second individual reagent pad is specific for lysozyme, and that the reagent of the third individual reagent pad is specific for lactoferrin, as the concentrations of human serum albumin, lysozyme, and lactoferrin in a tear sample are indicative of dry eye disorder in a patient (Versura; Pg. 1247 at Abstract, see Pg. 1249 at Table 3, and Pg. 1251 at Table 5). Further, measuring the concentration of all three proteins in a tear sample would enable a user to more accurately determine that a patient has dry eye disorder, compared to only measuring for one of the proteins.
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wadsworth (US Pat. No. 4,198,389) teaches a reagent specific for human serum albumin, a reagent specific for lysozyme, and a reagent specific for lactoferrin, where the reagent undergoes a reaction to produce a color upon contact with the specific protein of a biological sample, and the reaction results in an intensity of color that is proportional to the amount of the specific protein in the biological sample (Col. 1 Ln. 48-Col. 2 Ln. 2, see Table I at Col. 2 Ln. 5-Col. 5 Ln. 8, particularly Col. 4 Ln. 18 “Albumin” and Col. 4 Lns. 33-34 “Lactoferrin”, “Lysozyme”, see Col. 12 Ln. 59-Col. 13 Ln. 5, which shows that color intensity of a test spot correlates to the amount of specific antigen).
Conclusion
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/JOHN MCGUIRK/Examiner, Art Unit 1798