DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-14, in the reply filed on 03/29/2024 is acknowledged. The traversal is on the grounds that it should be no undue burden on the Examiner to consider all claims in the single application. This argument is not found to be persuasive because Examiner has required restriction between Groups I and II because they represent a detecting apparatus and a method for detecting an analyte in a liquid sample, which are distinct inventions corresponding to a product (i.e. the detecting apparatus) and a process of using a product (i.e. the method for detecting an analyte with a detecting apparatus) (see MPEP § 806.05(h)), and have acquired a separate status in the art in view of their different classifications (see Restriction Requirement pp 2-3). The product of Group I as claimed can be used in a materially different process, such as collection and storage of a liquid sample without detecting an analyte, and the process of Group II as claimed can be performed using a materially different product, such as a detecting apparatus comprising a covering end that covers the opening of the collecting chamber, but does not seal an opening of the collecting chamber as required by the product of Group I (see Restriction Requirement pp 2-3).
The requirement is still deemed proper and is therefore made FINAL.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/29/2024.
Priority
This application, Serial No. 17/576,183 was filed on 01/14/2022. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to Applications CN 2021100842090, CN 2021201662118, CN 2021201687045, CN 202120168705X, and CN 2021201687064, all filed on 01/21/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Claims
Claims 1-20 are pending. Claims 15-20 are withdrawn as being drawn to a nonelected invention. Claims 1-14 are examined herein.
Information Disclosure Statement
The information disclosure statement filed on 03/24/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “110” has been used to designate both the “collector” (e.g. Fig. 12) and the “hole” (e.g. Figs. 13 and 17). Furthermore, it is unclear what label “110” is indicating in Figs. 14 and 16. 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 102, 108, 201, 202, 210, 212, 213, 228, and 229. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Specification
The disclosure is objected to because of the following informalities:
The specification recites on pp. 19, lines 3-5: “As for the structure shown in FIG. 12 for example, the cover body has a sealing element similar to a plug 200; when the cover body is closed, the plug is inserted into the hole 101, thus achieving sealing” (emphasis added). However, there is no label 200 present in Fig. 12. This is apparently a typographical error and is assumed to refer to Fig. 14, which presents label 200.
The specification refers to label 1112 as a “channel of the pipe 111” (pp. 19, line 6), and elsewhere as the “pipe” (pp. 20, Para. 3, lines 9-10).
Appropriate correction is required.
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.
Claim 1 recites the limitation "the inner part of the collecting chamber and the outside" in lines 3-4, line 5, and lines 6-7. There is insufficient antecedent basis for this limitation in the claim because an “inner part of the collecting chamber” and an “outside” have not been defined in the claim. It is unclear what comprises the inner part of the collecting chamber, and whether “the outside” is part of the claimed detecting apparatus, or not. Therefore, it is unclear whether the hole referenced in claim 1 maintains a balanced air pressure between parts within the claimed detecting apparatus, or whether it maintains a balanced air pressure between the inside of the collecting chamber and the atmosphere outside of the detecting apparatus. Clarification is required to define the metes and bounds of the claim.
Claims 2-14, which depend from claim 1, are similarly rejected.
Claim 6 recites the limitation, “when the collector is inserted, there is a sealing state between the collecting chamber and inner wall of the pipe chamber” (emphasis added). This claim is indefinite because it is unclear how the insertion of the collector could cause a sealing state between the collecting chamber and the inner wall of the pipe chamber. For example, in the embodiment of the invention presented in Fig. 12, the insertion of collector (apparently labeled as 110) would not cause a sealing state between the collecting chamber 109 and the inner wall of the pipe chamber (i.e. label 2091 of Fig. 15, which represents the inner wall of the pipe body represented by label 107 of Fig. 12). This appears to be a typographical error, and the reference to “collecting chamber” should read as “collector”, to maintain logical consistency and as supported by pp. 16, lines 9-10 of the Instant Specification (Similarly, it is desired that the absorbing element 103 of the collector is sealed with the inner wall 2091 of the pipe body 107.). Correction and/or clarification is required, however, for the purpose of compact prosecution the reference to “collecting chamber” in claim 6 has been interpreted as referring to “collector”.
Claim 7 recites the limitation, “wherein, the diameter of the hole is configured in such a way that gas is allowed to pass through, while liquid is not allowed to pass through due to surface tension”. This claim is indefinite because it does not provide sufficient structure to define how the diameter of the hole is limited such that gas is allowed to pass through and not liquid, due to surface tension. It is unclear what limitations this language places on the hole structurally, for example, how the diameter is configured, or for example whether there is any other structure (e.g. a hydrophobic filter) that would ensure that the hole is permeable to gas but not liquid. Clarification is required to define the metes and bounds of the claim.
Claim 9, which depends from claim 7, is similarly rejected.
Claim 8 recites the limitation, “wherein, the channel is configured in such a way that gas is allowed to pass through, while liquid is not allowed to pass through due to surface tension”. This claim is indefinite because it does not provide sufficient structure to define how the channel is limited such that gas is allowed to pass through and not liquid, due to surface tension. It is unclear how the channel is “configured” (in terms of what structure/structural limitations this language places on the claims), and whether there is any other structure (e.g. a hydrophobic filter) that would ensure that the channel is permeable to gas but not liquid. Clarification is required to define the metes and bounds of the claim.
Claim 10, which depends from claim 8, is similarly rejected.
Claim 12 recites the limitation "the sealing element" in line 1. There is insufficient antecedent basis for this limitation in the claim because a “sealing element” has not been defined in the claim. For the purpose of compact prosecution, claim 12 has been interpreted as depending from claim 11, which defines a “sealing element”. Correction or clarification is required to define the metes and bounds of the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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 1-5 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Knight (US 20180290141 A1).
Regarding claim 1, Knight teaches throughout the document a receptacle for minimizing evaporation of a fluid (Abstract and Figs. 1-2; see fluid at Fig. 10 label 600). The receptable is an apparatus that may be used for the purpose of detection (Para. 45: In some embodiments, fluid 600 can be any fluid used by a sample processing instrument. For example, fluid 600 can be any fluid used by an instrument capable of performing an assay on a sample and rendering a result, such as a fluid used by an instrument to determine the presence of an analyte in the sample.). The receptacle comprises a collecting chamber having an opening (Fig. 3 label 202 shows a chamber with an opening 206, formed within a body 200; and Abstract lines 3-4: The body includes a first chamber having a first opening.), a covering end used for sealing the opening of the collecting chamber (Fig. 1 label 400 shows a lid (i.e. covering end) that forms an assembly with a septum 300 and a fluid-tight seal 214 that seal the opening of chamber 202; and Abstract lines 4-5: The fluid-tight seal is affixed to a surface of the body that defines the first opening.), and a collector used for collecting a liquid sample (Para. 73: Septum 300 may be penetrable (i.e., configured to allow a fluid retrieval device 502 (e.g., a removable pipette tip or an integral probe) coupled to or an integral component of a fluid transfer mechanism 500 (e.g., an automated pipettor) to pass there through).), wherein, the apparatus further comprises a hole keeping air circulation between the inner part of the collecting chamber and the outside; wherein, when there is an air pressure difference between the inner part of the collecting chamber and the outside, the hole is configured for maintaining a balanced air pressure between the inner part of the collecting chamber and the outside (Knight teaches a hole (i.e. opening 211 of conduit 210 seen in Figs. 1-2 and 10) that balances air pressure between the inside of chamber 204 and the outside; Para. 107: As fluid 600 is aspirated from first chamber 202, fluid 600 may flow from second chamber 204 into first chamber 202 via fluid conduit 210. Air may simultaneously move between the portion of first chamber 202 above fluid 600 and the portion of second chamber 204 above fluid 600 via conduit 212 as the pressure in the first chamber 202 and the second chamber 204 is equalized, thereby preventing a vacuum from forming in second chamber 204 and retarding the flow of fluid 600 from second chamber 204 into first chamber 202 via fluid conduit 210.).
Regarding claim 2, Knight further teaches:
wherein, when the collecting chamber is sealed by the covering end, air pressure in the collecting chamber is higher than the air pressure of the outside (Fig. 1 and Fig. 2 (as described in Para. 44) show a septum 300 that is coupled (i.e. secured) to the body when the lid is pressed down against it (e.g. by friction fit as described in Para. 12, or by snap-fit closure as described in Para. 93), and this pressure of the lid acting down on the septum and the opening of the collecting chamber inherently increases the air pressure in the collecting chamber relative to outside.).
Regarding claim 3, Knight further teaches:
wherein, when the collector is inserted into the collecting chamber, air pressure in the collecting chamber is higher than the air pressure of the outside (Fig. 10 shows the insertion of a collector 500 in the collecting chamber through a septum 300, which seals the chamber opening and acts as a barrier; Para. 76, lines 4-8: By sealing first chamber opening 206, septum 300 limits the amount of exposure fluid 600 contained within first chamber 202 has with ambient conditions, thereby eliminating or reducing evaporation of fluid 600 from first chamber 202.; Therefore the insertion of the collector presses down on air within the collecting chamber which cannot immediately escape due to the septum, and inherently increases the air pressure in the collecting chamber relative to outside.).
(Examiner Note: Claim 4 recites the limitation, “a flowing pipe; one end of the flowing pipe is in gas communication with the collecting chamber, and another end is connected with the hole.” (emphasis added). The “flowing pipe” recited in claim 4 is not explicitly defined in the text of the instant specification. A “flowing pipe” is only referenced in the instant specification in clause 4 on page 32 and in clause 20 on page 33, which provide the following information to define the structure: “one end of the flowing pipe is in gas communication with the collecting chamber, and another end of the flowing pipe is connected with the hole”. However, Figs. 15 and 17 do depict a channel (label 111) that fulfills the plain meaning of a flowing pipe (i.e. a pipe structure that allows flow), and also has one end in communication with the collecting chamber (i.e. the bottom end in Figs. 15 and 17), and another end that is connected with the hole, as supported by the specification (pp. 20, Para. 2, lines 1-4: To further improve the sealing possibility, a channel 111 is extended under the holes 35, 110; the channel has an equivalent width with the hole, or has a smaller diameter than the opening of the hole. Moreover, the channel 111 also extends into the collecting chamber and is in gas communication with the collecting chamber.). Therefore the “flowing pipe” has been interpreted according to its plain meaning and as structurally recited at the claim.
Regarding claims 4-5, Knight further teaches:
wherein, the collecting chamber further comprises a flowing pipe; one end of the flowing pipe is in gas communication with the collecting chamber, and another end is connected with the hole; and the apparatus includes a channel extending to the inner part of the collecting chamber from the hole (Conduit 210 reads on a channel extending to the inner part of the collecting chamber from the hole, which is in gas communication with the hole (i.e. opening 211 on one end and with the collection chamber 202 on the other, as seen in Fig. 9 and described in Para. 107).
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.
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 6 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Knight (US 20180290141 A1) in view of Gwynn (US 20130132006 A1), as evidenced by Dictionary.com (Dictionary.com, Definition for “Bolt”, Accessed 05/31/2024, Downloaded from: https://www.dictionary.com/browse/bolt, 8 pages).
(Examiner Note: As discussed above, claim 6 has been interpreted as requiring the limitation of “when the collector is inserted, there is a sealing state between the collector and inner wall of the pipe chamber”, to maintain logical consistency and in light of support from the Instant Specification (See Claim Rejections – 35 USC § 112 section)).
Regarding claim 6, Knight teaches the detecting apparatus according to claims 1 and 3, as described in detail above (See Claim Rejections - 35 USC § 102).
Regarding claim 6, Knight further teaches:
wherein, the collecting chamber further comprises a septum used for the insertion of the collector; when the collector is inserted, there is a sealing state between the collector and inner wall of the pipe chamber; the pipe chamber is in gas communication with the collecting chamber.
(Figs. 1 and 2 label 300 shows a septum 300 situated between the opening of the collecting chamber and the lid; and Fig. 10 shows the insertion of a collector 500 in the collecting chamber through a septum 300, which seals the chamber opening and acts as a barrier; The septum has a small opening at the center (located at label 312 in Fig. 1) that receives the collector, once the collector pierces the septum and is inserted into the collecting chamber (as seen in Fig. 10), there is a sealing state between the collector and inner wall of the pipe chamber (i.e. septum opening), while the septum is in gas communication with the collecting chamber as seen in Fig. 10.).
However, Knight does not explicitly teach a pipe chamber used for the insertion of the collector; when the collector is inserted, there is a sealing state between the collector and inner wall of the pipe chamber; the pipe chamber is in gas communication with the collecting chamber.
Gwynn teaches throughout the document systems and apparatus for processing and analyzing (i.e. detecting) samples such as biological fluids (Abstract). Gwynn teaches a device for collecting samples (i.e. a millitip pipettor) that includes a piston 726 that manipulates a pipet tip (i.e. the piston is part of the collector), and a barrel 727 that acts a chamber (i.e. pipe chamber). The piston is inserted through the barrel, and the barrel is configured to allow movement of the piston within the barrel. There is a sealing state between the piston and the inner wall of the barrel. (Gwynn, para. 267: The piston 726 lies partially within a barrel 727 that serves as a pressure chamber. A seal lies between the piston 726 and an inner wall of the barrel 727. The barrel 727 can be cooperatively configured to allow movement of the piston within the barrel.).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the detecting apparatus of Knight by substituting the septum for sealing the collecting chamber upon insertion of the collector with a pipe chamber (i.e. barrel) as taught by Gwynn, because the structure of the barrel can be cooperatively configured to allow movement of the collector within the barrel (Gwynn, Para. 267) (i.e. because the barrel may also move within the collecting chamber to maintain sealing over a greater range of motion, unlike a septum which only contacts the top surface of the collecting chamber).
One having ordinary skill in the art would have had a reasonable expectation of success in combining the prior art references because Knight and Gwynn are similarly drawn to detecting apparatus comprising chambers for holding fluids, and the modification would simply require replacing the septum with a barrel structure using methods already known in the art, as taught by Gwynn.
(Examiner Note: Claim 12 recites the limitation, “wherein, the sealing element is a bolt; and the bolt may be inserted into the hole to achieve the hole sealing.” (emphasis added). The “bolt” recited in claim 12 is not explicitly defined in the text of the instant specification. A “bolt” is only referenced in the instant specification in clause 12 on page 32, which provides the following information to define the structure: “the sealing element is a bolt; and the bolt may be inserted into the hole to achieve the hole sealing”. A “bolt” may be defined as “a movable bar or rod that when slid into a socket fastens a door, gate, etc.” (Dictionary.com, accessed 05/31/2024 from the link: https://www.dictionary.com/browse/bolt). Figs. 13 and 14 depict a rod shaped sealing element that when plugged into the hole seals the hole and fastens the cover (label 200 of Figs. 13 and 14 show a sealing element consisting of an approximately rod shaped structure that plugs into a hole (The plugged state is depicted in Fig. 17); and Specification pp. 19, lines 3-5: “As for the structure shown in FIG. 12 for example, the cover body has a sealing element similar to a plug 200; when the cover body is closed, the plug is inserted into the hole 101, thus achieving sealing.”. It is understood from the Specification that plugging is also used for fastening the cover (Specification, pp. 22, Para. 2, lines 7-12: “Generally, a cover and an end 31 (called as a cover body; the cover body is sealed via way similar to a plug instead of threads, in this way, the collector, the cover and the end are directly inserted into a chamber body 20 to extrude the absorbing element when the collector, the cover and the end are connected into an integral structure) are used to seal the opening of the chamber body 20; after the covering end is covered, the overall chamber body is in a sealing state, as shown in FIG. 6.”)). Therefore the “bolt” has been interpreted as referring to the sealing element 200.).
Regarding claims 11-12, Knight teaches the detecting apparatus according to claim 1, as described in detail above (See Claim Rejections - 35 USC § 102).
Knight does not explicitly teach:
wherein, the apparatus further includes a sealing element for air sealing the hole (according to claim 11); and
wherein, the sealing element is a bolt; and the bolt may be inserted into the hole to achieve the hole sealing (according to claim 12).
Gwynn teaches throughout the document systems and apparatus for processing and analyzing (i.e. detecting) samples such as biological fluids (Abstract). Gwynn teaches the use of a plug 222 (i.e. the plug reads on a bolt, as it is an approximately rod shaped structure that fits into a hole) to seal a hole in a reaction vessel containing a fluid (Fig. 5(a)-(b)). The plug provides the benefit of reducing the risk of contamination of fluid in the reaction chamber during an assay (Para. 337: Once the vessel plug is seated, the vessel plug 222 locks to the vessel base 246 and seals the amplification mixture within the assembled reaction vessel 221. The reaction vessel 221 can remain sealed and locked through completion of the assay to reduce the risk of contamination.). The plug structure further provides the benefit of tight seal that combines a radial seal with a face-to-face seal in a way that would air seal the hole (Para. 356; and Para. 357: The seal made by the plug 222 when it is inserted into the vessel 221 can be characterized as a hybrid seal, having characteristics of both a radial seal (such as an O-ring) and a face-to-face seal (where a seal is simply pressed against a surface).).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the detecting apparatus of Knight by including a plug (i.e. bolt) that may be inserted into the hole for sealing as taught by Gwynn (i.e. in order to air seal the hole through a combination of radial and face-to-face sealing), because this provides the advantage of protecting the fluid in the collecting chamber from contamination during an assay (Gwynn).
One having ordinary skill in the art would have had a reasonable expectation of success in combining the prior art references because Knight and Gwynn are similarly drawn to detecting apparatus comprising chambers for holding fluids, and the modification would simply require providing a plug of appropriate dimensions using methods already known in the art, as taught by Gwynn.
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Knight (US 20180290141 A1) in view of McMillan (US 20040200909 A1).
Regarding claims 7-10, Knight teaches the detecting apparatus according to claims 1 and 5, as described in detail above (See Claim Rejections - 35 USC § 102).
Knight does not specifically teach that the diameter of the conduit (i.e. which corresponds to the diameter of both the hole and the channel) is configured in such a way that gas is allowed to pass through, while liquid is not allowed to pass through due to surface tension (according to claims 7 and 8);
wherein, the conduit (i.e. which corresponds to both the hole and the channel) has a diameter of 0.1-1 mm (according to claims 9 and 10).
McMillan teaches an apparatus for disrupting cells or viruses comprising a chamber for holding cells or viruses (Abstract). The apparatus comprises a sample chamber for holding a fluid sample, as well as chambers for detection assays, including the use of master mix with fluorescent probes (Para. 72).
McMillan further teaches the use of vents with holes (labels 34 and 36 in Fig. 1) that are connected to flow channels, and are on the same order of size as the flow channels (as seen in Fig. 7), and which are preferably configured with hydrophobic membranes that allow the passage of gas but not liquid (Para. 70, lines 17-20: The cartridge 20 further includes vents 34, 36. Each pressure port and vent preferably includes a hydrophobic membrane that allows the passage of gas but not liquid into or out of the vents and pressure ports.; and Para. 121, lines 13-15: The channel 134 leads to the vent 36 which has a hydrophobic membrane to permit the escape of gas but not liquid from the cartridge.).
McMillan further teaches the ideal use of channel diameters of 0.8-1.6 mm because they avoid flow restriction that would occur at smaller diameters, and loss of fluid volumes in the flow path that would occur at larger diameters (Para. 178: The flow channels in the cartridge are generally D-shaped in cross section (with the gasket 63 forming the flat side of the channel) and preferably have a width or diameter in the range of 1/64 to 1/8 of an inch (0.4 to 3.2 mm), and more preferably a width of 1/32 to 1/16 of an inch (0.8 to 1.6 mm). These ranges are presently preferred to avoid having channels to narrow (which creates flow restriction) and to avoid having channels too wide (which yields unused volumes of liquid sitting in the flow path).).
In the case where claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05(I)). It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the detecting apparatus of Knight by using a conduit diameter (i.e. which corresponds to both the hole and the channel diameter) of 0.8 to 1 mm (i.e. the portion of the range that overlaps between the claims and the prior art) and configuring the conduit with a hydrophobic membrane as taught by McMillan (i.e. configuring the diameter of the conduit in such a way that gas is allowed to pass through but not liquid due to surface tension of the liquid, which hinders passage due to the hydrophobic nature of the membrane as well as the small diameter of the conduit, which overlaps with the size range of 0.8-1.6 mm taught by McMillan), because this allows the escape of gas without losing liquid sample from the chamber (McMillan).
In particular, it would have been obvious to have arrived at a range within the claimed range, for example 0.8-1 (which reads on the claimed range), out of routine optimization of the range disclosed by the prior art (0.8-1.6), namely by selecting from the art disclosed values (McMillan). The prior art discloses a range overlapping the claimed range, where the upper limit is slightly larger (the prior art teaching up to 1.6, as compared to the claimed value of 1mm). In the present case, the diameter is a result effective variable, namely a variable that achieves a recognized result (in the present case, the diameter is a parameter that was recognized as effecting flow restriction and loss of fluid). The prior art defines a finite range of suitable diameters for achieving the desired result, and since the diameter is a result-effective variable, it would have been an obvious matter to try the values within the art disclosed range, thereby arriving at a diameter of .8-1 (reading on the claimed range). (MPEP 2144.05).
One having ordinary skill in the art would have had a reasonable expectation of success in combining the prior art references because Knight and McMillan are similarly drawn to detecting apparatus comprising chambers for holding fluids, and Knight already teaches the use of a conduit for pressure equalization, and the modification would simply require the fabrication of a conduit of appropriately small diameter and the application of a hydrophobic membrane using methods already known in the art, as taught by McMillan. One having ordinary skill would have a reasonable expectation of success arriving at the claimed diameter given that the art suggests a range that is substantially similar, and overlaps that which is claimed.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Knight (US 20180290141 A1).
Regarding claim 13, Knight teaches the detecting apparatus according to claim 5, as described in detail above (See Claim Rejections - 35 USC § 102).
While Knight teaches that the conduit (i.e. channel) may have a non-negligible length (Para. 55: In some embodiments, conduit 210 can be a channel, for example, a channel extending between first chamber 202 and second chamber 204 over a non-negligible length. In some embodiments, conduit 210 can be an opening having a negligible length—for example, simply the thickness of a thin wall defining such an opening and separating first chamber 202 from second chamber 204.), the reference does not explicitly teach that the conduit (i.e. channel) has an extending length of 5-10 mm.
Knight further teaches a second conduit 212 that is a channel with an extending length from about 1.5 mm to about 5.0 mm (Para. 57: As shown in FIG. 3, body 200 may also include a second fluid conduit 212 that fluidly connects first chamber 202 and second chamber 204.; and Para. 58: In some embodiments, conduit 212 can be a channel, for example, a channel extending between first chamber 202 and second chamber 204 over an extended length (e.g., a range from about 1.5 mm to about 5.0 mm).). Figs. 13-14 shows embodiments whereby the first and second conduits cross the same surface 244 and are of similar length and width.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use an extending length of about 5.0 mm as the length of the channel of the detecting apparatus of Knight, because Knight teaches that the channel may be any non-negligible length, and further teaches a second conduit with a length of about 5.0 mm, and further teaches embodiment whereby the first and second conduits are of similar length and width. One having ordinary skill in the art would have had a reasonable expectation of success in the modification because Knight teaches that the first conduit may be any non-negligible length, and already teaches a second conduit with an extending length of about 5.0 mm.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Knight (US 20180290141 A1) in view of Fang (US 20180011079 A1).
Regarding claim 14, Knight teaches the detecting apparatus according to claim 1, as described in detail above (See Claim Rejections - 35 USC § 102).
Knight does not explicitly teach:
wherein, the collecting chamber is internally provided with a testing element; and the testing element may detect an analyte in a liquid sample by an immune method.
Fang teaches throughout the document an apparatus for detecting the presence or absence of an analyte in a liquid sample, including a collection chamber which contains a testing element for testing the analyte in liquid sample (Abstract, Para. 74, and Fig. 1). The testing element includes a test strip which can be analyzed using an immunoassay (Para. 59: The testing element includes a test strip, which can be analyzed in various forms such as immunoassay or chemical test to detect such analyte in samples as drugs or relevant metabolites indicating physical conditions.). The testing element may be used to test drugs, such as drugs of abuse, which can be dangerous and lead to physical and mental damage (Para. 68 and 70).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the detecting apparatus of Knight by internally providing a testing element comprising a test strip for immunoassay-based detection of drugs of abuse to the collecting chamber as taught by Fang, because this allows safer detection of drugs that may be dangerous to handle because they can lead to physical and mental damage (Fang), without having to remove them from the collecting chamber.
One having ordinary skill in the art would have had a reasonable expectation of success in combining the prior art references because Knight and Fang are similarly drawn to detecting apparatus comprising chambers for holding fluids, and Knight already teaches a chamber that is compatible with assays such as immunoassays (Knight, Para 42).
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 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,964,268 (hereinafter ‘268) in view of Knight (US 20180290141 A1).
Regarding instant claim 1, claim 1 of ‘268 teaches a detecting apparatus, comprising:
a sample collector for collecting a sample, wherein the sample collector comprises a covering end, and the covering end is used to cover an opening of a collecting chamber.
Claim 1 of ‘268 does not explicitly teach:
that the covering end provides a seal; and
wherein, the apparatus further comprises a hole keeping air circulation between the inner part of the collecting chamber and the outside; wherein, when there is an air pressure difference between the inner part of the collecting chamber and the outside, the hole is configured for maintaining a balanced air pressure between the inner part of the collecting chamber and the outside.
Knight teaches throughout the document a receptacle for minimizing evaporation of a fluid (Abstract and Figs. 1-2; see fluid at Fig. 10 label 600). The receptable is an apparatus that may be used for the purpose of detection (Para. 45: In some embodiments, fluid 600 can be any fluid used by a sample processing instrument. For example, fluid 600 can be any fluid used by an instrument capable of performing an assay on a sample and rendering a result, such as a fluid used by an instrument to determine the presence of an analyte in the sample.). The receptacle comprises a collecting chamber having an opening (Fig. 3 label 202 shows a chamber with an opening 206, formed within a body 200; and Abstract lines 3-4: The body includes a first chamber having a first opening.), a covering end used for sealing the opening of the collecting chamber (Fig. 1 label 400 shows a lid (i.e. covering end) that forms an assembly with a septum 300 and a fluid-tight seal 214 that seal the opening of chamber 202; and Abstract lines 4-5: The fluid-tight seal is affixed to a surface of the body that defines the first opening.), and a collector used for collecting a liquid sample (Para. 73: Septum 300 may be penetrable (i.e., configured to allow a fluid retrieval device 502 (e.g., a removable pipette tip or an integral probe) coupled to or an integral component of a fluid transfer mechanism 500 (e.g., an automated pipettor) to pass there through).), wherein, the apparatus further comprises a hole keeping air circulation between the inner part of the collecting chamber and the outside; wherein, when there is an air pressure difference between the inner part of the collecting chamber and the outside, the hole is configured for maintaining a balanced air pressure between the inner part of the collecting chamber and the outside (Knight teaches a hole (i.e. opening 211 of conduit 210 seen in Figs. 1-2 and 10) that balances air pressure between the inside of chamber 204 and the outside; Para. 107: As fluid 600 is aspirated from first chamber 202, fluid 600 may flow from second chamber 204 into first chamber 202 via fluid conduit 210. Air may simultaneously move between the portion of first chamber 202 above fluid 600 and the portion of second chamber 204 above fluid 600 via conduit 212 as the pressure in the first chamber 202 and the second chamber 204 is equalized, thereby preventing a vacuum from forming in second chamber 204 and retarding the flow of fluid 600 from second chamber 204 into first chamber 202 via fluid conduit 210.).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the detecting apparatus of claim 1 of ‘268 by providing the cover for sealing as taught by Knight (i.e. incorporating an air tight sealing cover comprising a lid, septum, and seal, according to Knight), and by providing a hole keeping air circulation between the inner part of the collecting chamber and the outside; wherein, when there is an air pressure difference between the inner part of the collecting chamber and the outside, the hole is configured for maintaining a balanced air pressure between the inner part of the collecting chamber and the outside as taught by Knight (i.e. incorporating a conduit according to Knight), because the seal prevents contamination, and the hole prevents the formation of a vacuum in the chamber (Knight).
One having ordinary skill in the art would have had a reasonable expectation of success in combining the prior art references because ‘268 and Knight are similarly drawn to detecting apparatus comprising chambers for holding fluids, and the modification simply requires providing an air tight cover and a hole using methods already known in the art, as taught by Knight.
Regarding claim 2, ‘268 in view of Knight further teaches:
wherein, when the collecting chamber is sealed by the covering end, air pressure in the collecting chamber is higher than the air pressure of the outside (Fig. 1 and Fig. 2 (as described in Para. 44) show a septum 300 that is coupled (i.e. secured) to the body when the lid is pressed down against it (e.g. by friction fit as described in Para. 12, or by snap-fit closure as described in Para. 93), and this pressure of the lid acting down on the septum and the opening of the collecting chamber inherently increases the air pressure in the collecting chamber relative to outside.).
Regarding claim 3, ‘268 in view of Knight further teaches:
wherein, when the collector is inserted into the collecting chamber, air pressure in the collecting chamber is higher than the air pressure of the outside (Fig. 10 shows the septum 300, which seals the chamber opening and acts as a barrier when a collector is inserted through it; Para. 76, lines 4-8: By sealing first chamber opening 206, septum 300 limits the amount of exposure fluid 600 contained within first chamber 202 has with ambient conditions, thereby eliminating or reducing evaporation of fluid 600 from first chamber 202.; Therefore the insertion of the collector presses down on air within the collecting chamber which cannot immediately escape due to the septum, and inherently increases the air pressure in the collecting chamber relative to outside.).
(Examiner Note: As discussed above, the “flowing pipe” of claim 4 and the “channel” of claim 5 have been interpreted as the same structure (i.e. the channel structure referenced by label 111 in the specification and depicted in Figs. 15 and 17) (See Claim Rejections – 35 USC § 102 section)).
Regarding claims 4-5, ‘268 in view of Knight further teaches:
wherein, the collecting chamber further comprises a flowing pipe; one end of the flowing pipe is in gas communication with the collecting chamber, and another end is connected with the hole; and the apparatus includes a channel extending to the inner part of the collecting chamber from the hole (Conduit 210 reads on a channel extending to the inner part of the collecting chamber from the hole, which is in gas communication with the hole (i.e. opening 211 on one end and with the collection chamber 202 on the other, as seen in Fig. 9 and described in Para. 107).
Regarding claim 13, while ‘268 in view of Knight teaches that the conduit (i.e. channel) may have a non-negligible length (Para. 55: In some embodiments, conduit 210 can be a channel, for example, a channel extending between first chamber 202 and second chamber 204 over a non-negligible length. In some embodiments, conduit 210 can be an opening having a negligible length—for example, simply the thickness of a thin wall defining such an opening and separating first chamber 202 from second chamber 204.), the combination does not explicitly teach that the conduit (i.e. channel) has an extending length of 5-10 mm.
Knight further teaches a second conduit 212 that is a channel with an extending length from about 1.5 mm to about 5.0 mm (Para. 57: As shown in FIG. 3, body 200 may also include a second fluid conduit 212 that fluidly connects first chamber 202 and second chamber 204.; and Para. 58: In some embodiments, conduit 212 can be a channel, for example, a channel extending between first chamber 202 and second chamber 204 over an extended length (e.g., a range from about 1.5 mm to about 5.0 mm).). Figs. 13-14 shows embodiments whereby the first and second conduits cross the same surface 244 and are of similar length and width.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use an extending length of about 5.0 mm as the length of the channel of the detecting apparatus of ‘268 in view of Knight, because Knight teaches that the channel may be any non-negligible length, and further teaches a second conduit with a length of about 5.0 mm, and further teaches embodiment whereby the first and second conduits are of similar length and width. One having ordinary skill in the art would have had a reasonable expectation of success in the modification because the combination of ‘268 in view of Knight teaches a conduit but does not specify a specific length, and the modification simply requires using an extending length of about 5.0 mm, which was known in the art, as taught by Knight.
Claims 7-10 are rejected on the ground of