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 .
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 15-20 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. The term “longitudinal” in claim 15 is a relative term which renders the claim indefinite. The term “longitudinal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In order for the term to be definite, the carrier must be defined to have dimensions that provide for a longitudinal axis, which is absent in the claims. For prosecution, the term will be interpreted as the axis of the elongate barrel that houses the carrier. Support for this interpretation of the “longitudinal axis” is synonymous with the elongate barrel axis, as the Fig. 1 in the instant application appears to show the carrier with an axis “ax2” and supported by Specification p. 17 lines 4-6. The claim requires further amendment of the relative term for the claim 15 (and dependent claims 16-20) to be definite.
Claims 16-20 are rejected for being dependent on claim 15 and failing to remove the ambiguity in the parent claim.
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) 1-3, 5, 7, 9-14, 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slowey et al (US 20080118397, Document AA, p. 4 of 7 in IDS filed on 6/12/2023) in view of Deutsch et al (WO 2019/159167, publication 8/22/2019, Document AH, p. 1 of 7 in IDS filed on 6/12/2023).
Regarding claim 1, Slowey et al teach an apparatus, comprising:
an elongate barrel (Fig. 8: 120 compression tube), shaped to define a channel (para. 0075: dual channel pad compression tube) therethrough, the barrel having:
an opening into the channel at a proximal region of the barrel (Fig. 8: inlet where pad 115 enters), and an outlet from the channel at a distal region of the barrel (Fig. 8: 122 outlet);
a surfactant (Para. 0079: buffer solution in the pad compression tube);
a collection tube, reversibly coupled to the outlet (Fig. 8: collection tube 126);
a plunger, having a distal portion that is introducible into the channel via the opening, and is dimensioned to slide snugly within the channel (Para. 0073; Fig. 8: 114 handle that fits and locked into place); and
a sponge, coupled to the distal portion of the plunger, and configured to hold saliva (Fig. 8: 115 absorbent pad), wherein the plunger is: configured to introduce the sponge holding the saliva into the channel via the opening, and dimensioned such that sliding of the distal portion through the channel compresses the sponge within the channel (Para. 0075), and wherein the apparatus is configured such that, while the sponge holds the saliva, compression of the sponge within the channel drives at least a portion of the saliva (Para. 0075): out of the sponge through the outlet and into the collection tube.
Slowey is silent to a porous carrier, disposed within the channel; and the surfactant held in the carrier; and through the carrier, and from the carrier, together with at least a portion of the surfactant.
Deutsch et al teach system 100 with an elongated barrier including a porous carrier with a surfactant held in the carrier (p. 10 lines: surfactant copolymer held in the carrier). It is advantageous to provide a surfactant in a carrier to ensure the surfactant comes into contact with the sample to increase the flow through the device. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the porous carrier of Deutsch et al to hold the surfactant to provide the above advantage of increasing contact with the sample to increase flow through the device.
Regarding claim 2, Slowey/Deutsch teach a protease inhibitor, held in the carrier, wherein the apparatus is configured such that, while the sponge holds the saliva, compression of the sponge within the channel drives at least a portion of the saliva: out of the sponge and through the carrier, and from the carrier, together with at least a portion of the surfactant and at least a portion of the protease inhibitor, through the outlet and into the collection tube. (Slowey: Para. 0079: EDTA for suitable buffer in pad to preserve the integrity and minimize degradation).
Regarding claim 3, Slowey/Deutsch teach the surfactant comprises polysorbate 20. (para. 0058, 0080: Tween 20)
Regarding claim 5, Slowey/Deutsch teach the surfactant comprises octylphenol ethoxylate (Para. 0080: Triton X-100)
Regarding claim 7, Slowey/Deutsch teach the surfactant comprises sodium dodecyl sulfate. (para. 0080: SDS)
Regarding claim 9, Slowey/Deutsch teach the carrier is sufficiently compressible, and the plunger is dimensioned, such that sliding of the distal portion of the plunger through the channel compresses the carrier within the channel (p. 10 lines 28-30: carrier is sufficiently compressible; sliding the distal portion of the plunger through the channel compresses the carrier).
Regarding claim 10, Slowey/Deutsch teach the collection tube has a capacity that is between 100 and 2000 microliters. (Para. 0091: 0.3ml to 2ml)
Regarding claims 11-12, Slowey/Deutsch teach the carrier 170 within channel to hold surfactants and reagents contained within the elongate barrel 162. It is desirable to provide a carrier with sufficient width to be contained within the elongate barrel and sufficient length to contain sufficient volume to hold surfactants. Slowey/Deutsch are silent to the specific length that is 5-15 mm and width that is 7-12 mm of the carrier. In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a length and width of the carrier is a result effective variable that gives the well known and expected results of providing sufficient width and length to fill the channel and provide sufficient volume to hold the surfactants. In the absence of a showing of unexpected results, the Office maintains the length that is 5-15 mm and width that is 7-12 mm of the carrier would have been within the skill of the art as optimization of a results effective variable.
Regarding claim 13, Slowey/Deutsch teach the sponge is configured to hold a volume of saliva, the volume being between 200 and 800 microliters. (Slowey: Para. 0054: 0.5ml of specimen, Para. 0091: 0.3ml to 2ml)
Regarding claim 14, Slowey/Deutsch teach the sponge comprises an indicator, the indicator configured to indicate that the sponge holds at least the volume of saliva. (Slowey: Para. 0064: sufficiency indicator).
Regarding claim 23, Slowey et al teach a method for determining a condition of a subject, the method comprising: (A) using a sponge, collecting saliva such that the sponge holds the saliva (Fig. 8: 115 absorbent pad); (B) subsequently, while the sponge holds the saliva, compressing the sponge within a channel defined by a receptacle (Para. 0075), the receptacle having: an opening into the channel at an upstream region of the receptacle (Fig. 8: inlet where pad 115 enters), and an outlet from the channel at a downstream region of the receptacle , and an outlet from the channel at a distal region of the barrel (Fig. 8: 122 outlet); wherein compressing the sponge within the channel comprises driving the saliva out of the sponge (Para. 0075) and enters a collection tube through the outlet, the collection tube reversibly coupled to the outlet ; and (C) subsequently, transferring at least part of the saliva to a diagnostic assay. (Para. 0091: supplemental or confirmatory testing). Slowey teach a surfactant for mixing with the saliva (Para. 0079: buffer solution in the pad compression tube)
Slowey is silent to a porous carrier that: is disposed within the channel between the opening and the outlet, and holds the a surfactant such that at least some of the saliva: dissolves the surfactant, and with the dissolved surfactant, enters a collection tube through the outlet, the collection tube reversibly coupled to the outlet.
Deutsch et al teach system 100 with an elongated barrier including a porous carrier with a surfactant held in the carrier (p. 10 lines: surfactant copolymer held in the carrier). The carrier is disposed within the channel between the opening and the outlet, and holds the a surfactant such that at least some of the saliva: dissolves the surfactant, and with the dissolved surfactant, reaches the outlet. It is advantageous to provide a surfactant in a carrier to ensure the surfactant comes into contact with the sample to increase the flow through the device. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the porous carrier of Deutsch et al to hold the surfactant to provide the above advantage of increasing contact with the sample to increase flow through the device.
Regarding claim 24, Slowey/Deutsch teach prior to transferring the saliva, storing the saliva in the collection tube at room temperature for at least 1 hour and for no more than 72 hours. (Para. 0032: Supplementary testing at a later date).
Claim(s) 4, 6, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slowey/Deutsch in view of Jackson et al (US 20190144919).
Regarding claims 4, 6, and 8, Slowey/Deutsch teach surfactants, but are silent to ethyl trimethyl ammonium bromide, polyethylene glycol nonylphenyl ether, and 3-[(3-Cholamidopropyl)dimethylammonio]-1-propanesulfonate.
Jackson teaches a device for storing and stabilizing molecules from saliva (Para. 0003) in a sponge matrix (Para. 0003). The sponge matrix having surfactants (Para. 0314) and detergent reagents to lyse cells (Para. 0108: ethyl trimethyl ammonium bromide, Triton X-100, NP-40 ("polyethylene glycol nonylphenyl ether"), Tween 20, 3-[(3-Cholamidopropyl)dimethylammonio]-1-propanesulfonate (CHAPS)). It is desirable to provide surfactants and detergent reagents to prepare the sample for storage and further processing. Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the surfactant of Slowey/Deutsch for the surfactant/detergents of Jackson to provide the above advantage of preparing the sample for storage and further processing.
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slowey/Deutsch in view of Loudermilk et al (US 2020/0376483, filed 2/14/2020).
Regarding claims 21-22, Slowey/Deutsch teach collection tubes attached to the elongate barrel (Para. 0075: collection tube attached to a compression tube), but are silent to an adapter having adapter-threading, the adapter configured to facilitate reversible coupling of the collection tube to the outlet; and the adapter-threading is shaped to define a vent through the adapter-threading, the vent configured to facilitate air flow from within the collection tube to outside the collection tube, while the adapter couples the collection tube to the outlet.
Loudermilk teach collection vial 32 attached to the elongate barrel with collection sponge 12A using threads 37 having a notch 38 for venting. (Para. 0056). It is desirable to provide an adapter threading with vent for enabling air venting while simultaneously sealing to prevent leaking and facilitate fluid flow into vial 32. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the adapter-threading with a vent to provide the above advantage of enabling air venting while simultaneously sealing to prevent leaking and facilitate fluid flow into vial.
Allowable Subject Matter
Claims 15-20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 15 identifies the uniquely distinct features "plurality of fibers arranged such that: spaces between the fibers define pores of the carrier, and the fibers are generally not arranged along a longitudinal axis of the carrier". As discussed in the 112b rejection supra, the interpretation is that the “longitudinal axis” is synonymous with the elongate barrel axis, as the Fig. 1 in the instant application appears to show the carrier with an axis “ax2” and supported by Specification p. 17 lines 4-6. The closest prior art, Slowey et al (US 20080118397) and Deutsch et al (WO 2019/159167), either singularly or in combination, fail to anticipate or render the above limitations obvious. The fiber arrangement is not disclosed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris R. Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Dennis White/Primary Examiner, Art Unit 1758