DETAILED ACTION
This action is pursuant to claims filed on 05/24/2022. Claims 1,4-10,12,14-18 and 48-54 are pending. A first action on the merits of claims 1,4-10,12,14-18 and 48-54 is as follows.
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 Objections
Claims 1, 4, and 15 are objected to because of the following informalities:
In claim 1, “wherein first container includes a reagent” should read “wherein the first container includes a reagent”
In claim 4, “the first container includes fluid” should read “the first container includes the fluid”
In claim 15, “comprise a plastic” should read “comprise of a plastic”
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 5, 7, 12, and 52 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.
Regarding claim 5, the claim recites the limitation “the tapered end”. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether this refers to “the tapered upper portion” introduced in claim 4, or a different tapered end. If it is meant to refer to the tapered upper portion from claim 4, it should read “the tapered upper portion”. If it is meant to refer to different tapered end, it should read “a tapered end”. For purposes of examination, it is being interpreted as referring to the tapered upper portion from claim 4.
Regarding claim 7, the claim recites the limitation “about”. This is relative terminology, and it makes it unclear what the specified measurement for the diameter of the first container and the diameter of the second container are, and how far off from the stated value will still teach on this limitation. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite.
Regarding claim 12, the claim recites the limitation “about”. This is relative terminology, and it makes it unclear what the specified measurement for the volume of the first container and the diameter of the second container are, and how far off from the stated value will still teach on this limitation. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite.
Regarding claim 52, the claim recites the limitation “the cap”. There is insufficient antecedent basis for this limitation in the claim. It should read “a cap”, or be dependent on a claim that introduces the cap.
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)(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, 4-6, 8-9, 14-15, 17, and 48-53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhan (US Patent Application Publication No. 20190200966).
Regarding independent claim 1, Zhan teaches a collection device for collection of a fluid, the collection device (Abstract: “The present disclosure relates to the technical field of medical instruments, in particular to a bodily fluid collector and a bodily fluid collection method”) comprising a first container positioned inside a second container (Figs. 1-3; [0066]: “When the collection member 1 is engaged with the storage member 2, a lower end of the collection member 1 is inserted into the storage chamber 21”) wherein an internal space is formed between the first container and the second container ([0066]: “When the collection member 1 is engaged with the storage member 2, a lower end of the collection member 1 is inserted into the storage chamber 21 and divides the storage chamber 21 into a first chamber 211 and a second chamber 212 by fitting with the storage member 2”), the first container having a first container compartment sealed by a plug inside the second container ([0072]: “one of the lower end of the collection member 1 and the storage member 2 may plug the other to partition the storage chamber 21 into a first chamber 211 and a second chamber 212, i.e. the storage chamber 21 is partitioned into the first chamber 211 and the second chamber 212 by plugging fit of the lower end the collection member 1 and the storage member 2”), the first container comprising a sleeve attached to the first container by at least one rib, wherein the first container fits sealably into an opening in the second container (Fig. 3; [0075]: “one of the lower end of the collection member 1 and the storage member 2 is provided with a pre-storage structure 12, and the other of the lower end of the collection member 1 and the storage member 2 is provided with a sealing structure 13, and the pre-storage structure 12 comprises a pre-storage cavity 121 for pre-storing the preservative product and an end opening 122 located at an end of the pre-storage cavity 121 and used for receiving the preservative product into the pre-storage cavity 121. When the collection member 1 is engaged with the storage member 2, the sealing structure 13 cooperates with the pre-storage structure 12 to seal the end opening 122, such that the first chamber 211 is formed by a lateral outer wall of the pre-storage cavity 121 and a lateral inner wall of the storage chamber 21, and such that the second chamber 212 is formed by the pre-storage structure 12 and the sealing structure 13.”) and transmits fluid received into the sleeve through a drain in the sleeve ([0093]: “Since the saliva needs to enter the storage chamber 21 through the collection cavity 1112 in the collection process, the collection cavity 1112 also needs to communicate with the storage chamber 21. Further, in order to achieve the communication between the collection cavity 1112 and the storage chamber 21, in this embodiment, an outflow port is further provided at the connection of the pre-storage tube 12a and the inner wall of the collection cavity 1112. The outflow port communicates with the portion of the collection cavity 1112 located above the pre-storage tube 12a and the portion thereof located below the pre-storage tube 12a, such that the outflow port may communicates with the storage chamber 21 and the collection port 1111 (i.e. the upper end of the collection member 1) so that the saliva may flow into the storage member 2 via the collection member 1, when the collection member 1 is connected onto the storage member 2.”), wherein the fluid flows over the first container and directly into the internal space between the first container and the second container ([0093]-[0095]), and wherein first container includes a reagent disposed in the first container compartment ([0075]: “the pre-storage structure 12 comprises a pre-storage cavity 121 for pre-storing the preservative product and an end opening 122 located at an end of the pre-storage cavity 121 and used for receiving the preservative product into the pre-storage cavity 121.”).
Regarding claim 4, Zhan teaches the collection device of claim 1, wherein the first container has a tapered upper portion wherein the fluid flowing over the first container includes fluid flowing over the tapered upper portion (Fig. 2, [0091]: “the collection body 11 of this embodiment comprises a funnel 111. The funnel 111 has a collection cavity 1112 that is open both at the top and the bottom. The upper end of the collection cavity 1112 is the upper end of the collection member 1, which is open to form a collection port 1111 for receiving the saliva to be detected, so that the collection cavity 1112 can collect the saliva to be detected.”).
Regarding claim 5, Zhan teaches the collection device of claim 4, wherein the sleeve is attached to the tapered end ([0092]: “the pre-storage tube 12a of this embodiment is connected to the lower part of the funnel 111. Specifically, the pre-storage tube 12a is connected to the inner wall of the collection cavity 1112, and the lower end of the pre-storage tube 12a extends to below the lower end of the funnel 111. Therefore, it should be noted that, the lower end of the pre-storage tube 12a is the lower end of the collection member 1.”).
Regarding claim 6, Zhan teaches the collection device of claim 1, wherein the first container and the second container are cylindrical (Figs. 1-3) and the first container has an external diameter less than an internal diameter of the second container ([0096]: “the outer diameter of the pre-storage tube 12a is smaller than the inner diameter of the storage member 2”).
Regarding claim 8, Zhan teaches the collection device of claim 1, wherein the sleeve is configured as a funnel (Figs. 1-3; [0091]: “the collection body 11 of this embodiment comprises a funnel 111.”).
Regarding claim 9, Zhan teaches the collection device of claim 1, wherein the second container comprises threads configured to screw into a top of the first container ([0088]: “the upper portion of the lateral outer wall of the storage chamber 21 is provided with an external thread for effectuating detachably connecting the storage member 2 with the collection member 1”).
Regarding claim 14, Zhan teaches the collection device of claim 1, wherein the second container comprises an open end comprising internal or external threads for sealing with a screw cap when the first container is removed from the second container ([0088]: “the upper portion of the lateral outer wall of the storage chamber 21 is provided with an external thread for effectuating detachably connecting the storage member 2 with the collection member 1 and the blockage 3, so that the engagement of the collection member 1 or the blockage 3 with the storage member 2 may be conveniently realized by tightening the collection member 1 or the blockage 3 onto the storage member 2.”).
Regarding claim 15, Zhan teaches the collection device of claim 1, wherein the first container and the second container comprise a plastic ([0091]: “The funnel 111 is preferably made of an environmentally friendly plastic material for facilitating extrusion and recycling.”).
Regarding claim 17, Zhan teaches the collection device of claim 1, wherein the reagent comprises an RNA preservative ([0008]: “Saliva is a complex mixture that contains not only various proteins but also contains DNA, RNA, fatty acid, various microorganisms and the like”; [0066]: “the second chamber 212 is configured to store a preservative product for preserving the bodily fluid and is sealedly isolated from the first chamber 211 to separate the bodily fluid from the preservative product.”).
Regarding claim 48, Zhan teaches the collection device of claim 1, wherein the reagent is released into the second container when the plug is removed from the first container ([0087]: “the recess 13a serves as a sealing structure 13 for partitioning the storage chamber 21 into two temporary independent cavities internally and externally provided”; Abstract: “the mixing of the bodily fluid with the preservative product is no longer dependent on the damage of the thin film by a blade, but only needs to separate the collection member from the storage member.”).
Regarding claim 49, Zhan teaches the collection device of claim 1, wherein the plug is threaded ([0079]: “the contact of the sealing structure 13 with the lateral outer wall of the pre-storage cavity 121 may be realized by threaded connection between the sealing structure 13 and the lateral outer wall of the pre-storage cavity 121”).
Regarding claim 50, Zhan teaches the collection device of claim 1, wherein the first container is threaded to receive the plug ([0079]: “the contact of the sealing structure 13 with the lateral outer wall of the pre-storage cavity 121 may be realized by threaded connection between the sealing structure 13 and the lateral outer wall of the pre-storage cavity 121”).
Regarding claim 51, Zhan teaches the collection device of claim 1, wherein the plug forms a friction fit with the first container ([0077]: “the fit between the sealing structure 13 and the pre-storage structure 12 may be a plugging fit, i.e. the sealing structure 13 is inserted into the pre-storage cavity 121 through the end opening 122 to contact with the inner wall of the pre-storage cavity 121 so as to seal the end opening 122”).
Regarding claim 52, Zhan teaches a method of collecting a fluid using the collection device of claim 48, wherein:
a user deposits a fluid in the sleeve ([0033]: “collecting a bodily fluid with the collection member engaged to the storage member”);
the fluid flows through the drain into the internal space ([0093]: “Since the saliva needs to enter the storage chamber 21 through the collection cavity 1112 in the collection process, the collection cavity 1112 also needs to communicate with the storage chamber 21. Further, in order to achieve the communication between the collection cavity 1112 and the storage chamber 21, in this embodiment, an outflow port is further provided at the connection of the pre-storage tube 12a and the inner wall of the collection cavity 1112. The outflow port communicates with the portion of the collection cavity 1112 located above the pre-storage tube 12a and the portion thereof located below the pre-storage tube 12a, such that the outflow port may communicates with the storage chamber 21 and the collection port 1111 (i.e. the upper end of the collection member 1) so that the saliva may flow into the storage member 2 via the collection member 1, when the collection member 1 is connected onto the storage member 2.”);
the first container is removed from the plug ([0087]: “the recess 13a serves as a sealing structure 13 for partitioning the storage chamber 21 into two temporary independent cavities internally and externally provided”; Abstract: “the mixing of the bodily fluid with the preservative product is no longer dependent on the damage of the thin film by a blade, but only needs to separate the collection member from the storage member.”);
the reagent flows from the first container and mixes with the fluid ([0087]: “the recess 13a serves as a sealing structure 13 for partitioning the storage chamber 21 into two temporary independent cavities internally and externally provided”; Abstract: “the mixing of the bodily fluid with the preservative product is no longer dependent on the damage of the thin film by a blade, but only needs to separate the collection member from the storage member.”); and
the cap is placed on the second container ([0088]: “the upper portion of the lateral outer wall of the storage chamber 21 is provided with an external thread for effectuating detachably connecting the storage member 2 with the collection member 1 and the blockage 3, so that the engagement of the collection member 1 or the blockage 3 with the storage member 2 may be conveniently realized by tightening the collection member 1 or the blockage 3 onto the storage member 2.”).
Regarding claim 53, Zhan teaches the collection device of claim 1, wherein the reagent comprises of compounds selected from the group consisting of nucleic acid, such as DNA or RNA and a protein ([0010]: “The saliva collector is a bodily fluid collector that achieves saliva DNA collection.”; [0008]: “Saliva is a complex mixture that contains not only various proteins but also contains DNA, RNA, fatty acid, various microorganisms and the like.”).
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.
Claims 7, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Zhan as applied to claim 1 and 6 above.
Regarding claim 7, Zhan teaches the collection device of claim 6. However, Zhan does not explicitly disclose wherein the first container has an external diameter of about 10 mm to 20 mm and the second container has an internal diameter of about 15 mm to 30 mm.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to construct the first container such that it has an external diameter of about 10 mm to 20 mm and the second container such that it has an internal diameter of about 15 mm to 30 mm, since a mere change in size is recognized as being within the level of ordinary skill in the art. The motivation for doing so would be to establish a volume for a proper amount of sample saliva to interact with the preservative product.
Regarding claim 10, Zhan teaches the collection device of claim 1. However, Zhan does not explicitly disclose wherein the second container comprises a screw protruding from a bottom portion of the second container, wherein the screw comprises threads configured to screw into internal threads in a top of the first container.
However, it is noted that Zhan discloses a threaded connection between storage member 2 and collection member 1 ([0079]: “the contact of the sealing structure 13 with the lateral outer wall of the pre-storage cavity 121 may be realized by threaded connection between the sealing structure 13 and the lateral outer wall of the pre-storage cavity 121”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to dispose external threads on the bottom of the second container and internal threads on the top of the first container, since a mere reversal of essential working parts of a device involves only routine skill in the art. The motivation for doing so would be to protect the threads on the collection member when it is not connected to the storage member.
Regarding claim 12, Zhan teaches the collection device of claim 1. However, Zhan does not explicitly disclose wherein the first container has a volume of about 2 ml to about 20 ml and the second container has a volume of about 7 ml to about 45 ml.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to construct the first container such that it has a volume of about 2 ml to about 20 ml and the second container has a volume of about 7 ml to about 45 ml, since a mere change in size of a component is recognized as being within the level of ordinary skill in the art. The motivation for doing so would be to establish relative volumes for a proper amount of sample saliva to interact with the preservative product.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Zhan as applied to claim 15 above, and further in view of Klapproth (US Patent Application Publication No. 20180305740).
Regarding claim 16, Zhan teaches the collection device of claim 15. However, Zhan does not teach wherein the plastic comprises polypropylene or polyethylene.
Klapproth teaches a sample collection tube. Specifically, Klapproth teaches wherein the plastic comprises polypropylene or polyethylene ([0030]: “The sample tube can be made of any biologically inert material (e.g., a plastic or borosilicate), and is preferably made of a plastic (e.g., polypropylene, polypropylene copolymer, or polycarbonate)”). Zhan and Klapproth are analogous arts as they are both sample collection tubes use to collect DNA samples.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use the plastic types from Klapproth into the collection tube from Zhan since using these plastics can make the collection and storage members biologically inert and thereby avoiding sample contamination (Klapproth, [0030]).
Claims 18 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Zhan as applied to claim 17 above, and further in view of Birnboim (US Patent Application Publication No. 20040038269).
Regarding claim 18, Zhan teaches the collection device of claim 17. However, Zhan does not teach wherein the RNA preservative is selected from the group consisting of formalin, sulfate, isothiocyanate and urea.
Birnboim discloses a sample device for saliva. Specifically, Birnboim teaches wherein the RNA preservative is selected from the group consisting of formalin, sulfate, isothiocyanate and urea ([0022]: “The inclusion of an inhibitor of ribonuclease in the composition of the invention is particularly desirable when the nucleic acid to be preserved is RNA, desirably mRNA, or when the nucleic acid to be preserved is from a virus or a bacterium.”; [0068]: “The action of deoxyribonucleases and ribonucleases can also be inhibited by denaturing agents that will destroy the complex structures of these enzymes (proteins). Hence, denaturing agents are included in the nucleic acid preserving composition of the invention. Examples of denaturing agents that may be used (alone or in combination) include, but not limited to, urea, soluble salts of dodecyl sulfate and other strong detergents, guanidinium chloride, guanidinium thiocyanate, soluble salts of perchlorate, alcohols, such as ethanol, above 10%.”). Zhan and Birnboim are analogous arts as they both are used for collecting samples from saliva.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the RNA preservative from Birnboim into the collection tube from Zhan, as Zhan is silent on the type of RNA preservative that is used, and Birnboim teaches a suitable RNA preservative used in an analogous device.
Regarding claim 54, Zhan teaches the collection device of claim 17. However, Zhan does not teach wherein the RNA preservative is selected from the group consisting of formalin, sulfate, isothiocyanate and urea.
Birnboim discloses a sample device for saliva. Specifically, Birnboim teaches wherein the RNA preservative is selected from the group consisting of formalin, sulfate, isothiocyanate and urea ([0022]: “The inclusion of an inhibitor of ribonuclease in the composition of the invention is particularly desirable when the nucleic acid to be preserved is RNA, desirably mRNA, or when the nucleic acid to be preserved is from a virus or a bacterium.”; [0068]: “The action of deoxyribonucleases and ribonucleases can also be inhibited by denaturing agents that will destroy the complex structures of these enzymes (proteins). Hence, denaturing agents are included in the nucleic acid preserving composition of the invention. Examples of denaturing agents that may be used (alone or in combination) include, but not limited to, urea, soluble salts of dodecyl sulfate and other strong detergents, guanidinium chloride, guanidinium thiocyanate, soluble salts of perchlorate, alcohols, such as ethanol, above 10%.”). Zhan and Birnboim are analogous arts as they both are used for collecting samples from saliva.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the RNA preservative from Birnboim into the collection tube from Zhan, as Zhan is silent on the type of RNA preservative that is used, and Birnboim teaches a suitable RNA preservative used in an analogous device.
Conclusion
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/E.K.M./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791