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 1-22 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. Claims that depend directly or indirectly from claims 1, 10 and 19 is/are also rejected due to said dependency.
In regard to claims 1, 3, 7, 10, 12, and 16, the recited “allow” is considered as conditional/ optional languages which do not positively claim the limitations (“Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation”, see MPEP 2103 C and 2111.04). The conditional/ optional limitations are not given patentable weight. It is unclear whether the function(s)/ step(s) recited after “allow” is/are performed or not.
In regard to claim 19, the preamble recites “The method”, which lacks of sufficient antecedent basis. It is unclear whether the method depends on a missing method or it is a typo. Clarification is requested by amendments. If the second, it is suggest “A” should be set forth.
In regard to claims 21 and 22, the recited terms of “about” and “around” are considered as relative terms which render the claims indefinite. The term “about” and “around” are 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. It is unclear what degree of variance is considered as “about” or “around” the recited does/ volume.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7, 9-16 and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Slowey et al. (USPGPUB 20160123856 – applicant cited) in view of Fojtik (USPN 8,992,482 – applicant cited). In regard to claim 1, Slowey discloses an oral fluid collection device (Figs. 1-7 and associated descriptions; abstract; [0010]) for drug testing (intended use with insufficient patentable weight; It is noted that the preamble merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02), comprising: a funnel for collecting a specimen of oral fluids (elements 12, 30 ,40, and/or 1166, Fig. 1 and associated descriptions; saliva, [0010-0011] and [0034]) and simultaneously split the specimen into two or more metered doses (simultaneously split the fluid into two receivers 14a and 14b, Figs. 1-2 and associated descriptions; [0034]; it is noted that plungers of syringe devices ultimately meter a dosage by cylinder sample volume and amount of compression on the plunger), the funnel comprising: the specimen to exit the funnel when a plunger is driven into the funnel (elements acting as a plunger, [0031]; [0034]); and the plunger that at least partially nests in the funnel to drive the specimen out of the funnel through the valve in the two or more metered doses (liquid sample is distributed to sample receivers 14a, 14b, through filter discharge ports 1104, 1106, [0034]).
Slowey does not specifically disclose the funnel comprising: a valve that allows the specimen to exit the funnel when a plunger is driven into the funnel; and the plunger that at least partially nests in the funnel to drive the specimen out of the funnel through the valve (intended uses, referring to 35 USC 112(b) rejection above).
Fojtik teaches syringes (abstract; Figs. 1-9 and associated descriptions) comprises a funnel (element 120, Figs. 5-6 and associated descriptions) that allows the specimen to exit the funnel when a plunger is driven into the funnel; and the plunger that at least partially nests in the funnel to drive the specimen out of the funnel through the valve (Figs. 5-6 and associated descriptions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device (Slowey) to incorporate the one or more of valves and associated elements/functions as taught by Fojtik, since both devices are syringe type of fluid collection systems and one of ordinary skill in the art would have recognized that a valve can be utilized to control the liquid flow direction and prevent leakage. The rationale would have been to prevent leakage.
In regard to claim 2, Slowey as modified by Fojtik discloses two or more legs for collecting the two or more metered doses in a single specimen (elements 1110, 1104, 1112, and 1106, Fig. 2 and associated descriptions of Slowey).
In regard to claim 3, Slowey as modified by Fojtik discloses the funnel includes a translucent or transparent material (element 22 is visible through a sidewall if element 30, Fig. 1-7 and associated descriptions of Slowey) to allow a user to verify a volume of the specimen that has been collected in the funnel (intended uses, referring to the 35 USC 112(b) rejection above).
In regard to claim 4, Slowey as modified by Fojtik discloses a fill indicator to verify a volume of the specimen has met a minimum and/or maximum volume (sample sufficiency indicator 22 shows sufficient sample volume has been absorbed, [0034] of Slowey).
In regard to claim 5, Slowey as modified by Fojtik discloses the fill indicator accounts for foaming of the specimen when collected (internal vents 38 to vent air while expressing sample from sample collector, [0034] of Slowey).
In regard to claim 6, Slowey as modified by Fojtik discloses all the claimed limitation except an overflow channel for overflow of the specimen and air to escape from the funnel when driven by the plunger. Fojtik further teaches an overflow channel for overflow of the specimen and air to escape from the funnel when driven by the plunger (communication port 134 allows fluid communication between interior 13 of barrel 120 and a space on proximal side of plunger tip 133, Col 6 lines 41-49; Fig. 5 and associated descriptions). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device to incorporate the overflow channel/ configuration as taught by Fojtik in order to control the pressure inside in funnel and reduce turbulence and increase stability during injecting the samples into the containers.
In regard to claim 7, Slowey as modified by Fojtik discloses all the claimed limitation except a cover to prevent the overflow of the specimen from escaping the plunger and to allow air to escape (intended uses, referring to the 35 USC 112(b) rejection above). Fojtik further teaches a cover to prevent the overflow of the specimen from escaping the plunger and to allow air to escape (tip 133 has communication port 134 with valve 50 and barrel’s orientation and pressure could lead to air escape through valve 50 but not fluid specimen, Fig. 4 and associated descriptions; valve can have a threshold pressure to open, Col 5 lines 44-47). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device to incorporate the cover configuration and associated elements/function as taught by Fojtik in order to maintain the pressure and reduce bubbles of the liquid sample.
In regard to claim 9, Slowey as modified by Fojtik discloses a hard stop for metering the two or more metered doses (element 40 in contact with sample collection pas reaches a hard stop at pad compression tube second end 34, Fig. 7 and associated descriptions of Slowey).
In regard to claim 10, Slowey as modified by Fojtik discloses an oral fluid collection assembly (referring to claim 1 above) for drug testing (intended use with insufficient patentable weight; It is noted that the preamble merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02), comprising: a funnel for collecting a specimen of oral fluids and simultaneously split the specimen into two or more metered doses (referring to claim 1 above), the funnel comprising: a valve that allows the specimen to exit the funnel when a plunger is driven into the funnel (referring to claim 1 above); the plunger that at least partially nests in the funnel to drive the specimen out of the funnel through the valve in the two or more metered doses (referring to claim 1 above); and two or more tubes to collect each of the two or more metered doses from the funnel (elements 14a and 14b, Fig. 1 and associated descriptions of Slowey).
In regard to claim 11, Slowey as modified by Fojtik discloses the funnel includes two or more legs for collecting the two or more metered doses in a single specimen (referring to claim 2 above).
In regard to claim 12, Slowey as modified by Fojtik discloses the funnel includes a translucent or transparent material (referring to claim 3 above) to allow a user to verify a volume of the specimen that has been collected in the funnel (intended uses, referring to the 35 USC 112(b) rejection above).
In regard to claim 13, Slowey as modified by Fojtik discloses the funnel includes a fill indicator to verify a volume of the specimen has met as minimum and/or maximum volume (referring to claim 4 above).
In regard to claim 14, Slowey as modified by Fojtik discloses the fill indicator accounts for foaming of the specimen when collected (referring to claim 5 above).
In regard to claim 15, Slowey as modified by Fojtik discloses an overflow channel for overflow of the specimen and air to escape from the funnel when driven by the plunger (referring to claim 6 above).
In regard to claim 16, Slowey as modified by Fojtik discloses a cover to prevent the overflow of the specimen from escaping the plunger and to allow air to escape (referring to claim 7 above).
In regard to claim 18, Slowey as modified by Fojtik discloses the plunger further comprises: a hard stop for metering the two or more metered doses (referring to claim 9 above).
In regard to claim 19, Slowey as modified by Fojtik discloses the method of collecting a specimen of an oral fluid (referring to claim 1 above) for drug testing (intended use with insufficient patentable weight; It is noted that the preamble merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02), the method comprising: collecting the specimen in a funnel to simultaneously split the specimen into two or more metered doses (referring to claim 1 above); driving the specimen from the funnel with a plunger (referring to claim 1 above); and collecting, via a valve of the funnel (referring to claim 1 above), each of the two or more metered doses in a testing tube (referring to claim 1 above; receivers 14a and 14b, Figs. 1-2 and associated descriptions; [0034] of Slowey).
In regard to claim 20, Slowey as modified by Fojtik discloses adding a buffer solution or preservative to the testing tube; and mixing the buffer solution or preservative and each of the two or more metered doses in the testing tube (stabilizing reagent and liquid sample share the same space and thus mix inside sample receivers 14a and 14b, Fig. 1 and associated descriptions of Slowey).
In regard to claim 21, Slowey as modified by Fojtik discloses all the claimed limitations except each of the two or more metered doses is at least about one milliliter (mL). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try difference ranges of the doses including at least about one mL through routine experiments/ investigation in order to find the optimum/ minimum ranges of the liquid sample for different diagnostic testing and reduce the burden of sample collection. The rationale would have been “obvious to try”, see KSR International Co. v. Teleflex Inc., 550 USPQ2d 398, 421(2007).
In regard to claim 22, Slowey as modified by Fojtik discloses all the claimed limitations except a volume of the mixed buffer solution or preservative is around two mL It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try difference volume of the mixed buffer solution or preservative including around two mL through routine experiments/ investigation in order to find the optimum/ minimum volume(s) of the mixed buffer solution or preservative to match the collected fluid sample and reduce the cost/ volume of the mixed buffer solution or preservative. The rationale would have been “obvious to try”, see KSR International Co. v. Teleflex Inc., 550 USPQ2d 398, 421(2007).
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Slowey and Fojtik as applied to claims 1-7, 9-16 and 19-22 above, and further in view of Liang et al. (USPGPUB 2009/0004058). In regard to claims 8 and 17, Slowey as modified by Fojtik discloses all the claimed limitations except the valve is overmolded to the funnel.
Liang discloses an apparatus for collecting a biological/ liquid sample (Figs. 1-3 and associated descriptions) comprises valve is overmolded onto a device for collection of a biological fluid (a valve overmold may be placed over the valve member face that engages the test assembly, to form a robust seal against the opening 322, [0070]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the coupling configuration of the valve and the funnel (Slowey as modified by Fojtik) with the overmolding attachment method as taught by Liang to yield predictable results, since both ways are alternative equivalent methods for attaching/ coupling a valve to a funnel. The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 8 and 10-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8 and 10-22 of copending Application No. 17/709,638 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-5, 8 and 10-22 of ‘638 anticipate/ recite similar limitations of claims 1-5, 8 and 10-22 of present application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791