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 .
Status of Claims
There are two (2) sets of claim submitted 21 FEBUARY 2024. In the claim set submitted consisting of five(5) pages, Claims 3-7, 10, 13, 15, 20, 23-25, 27, 30-32 and 34 are ‘Cancelled’; Claims 1, 2, 8, 9, 11, 12, 14, 16-19, 21, 22, 26, 28, 29, 33 and 35-37 are ‘Original’.
Current pending claims are Claims 1, 2, 8, 9, 11, 12, 14, 16-19, 21, 22, 26, 28, 29, 33 and 35-37 are and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 21 FEBUARY 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 35 is 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.
It is unclear to the Examiner what a ‘self-sample collection device’ is. The term ‘self-sample’ is unfamiliar with this terminology.
For examination purposes, it is interpreted by the Examiner that a ‘self-sample collection device’ is a device that can obtain and collect a sample.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 8, 9, 11, 14, 16, 17, 19, 21, 22, 26, 28, 29, 33, 35, 36 and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by TARTARO, EP 3 220 832 B1, submitted on the Information Disclosure Statement on 21 FEBARURY 2024; Foreign Patent Documents Cite No. BA.
Applicant’s invention is directed towards a device.
Regarding Claim 1, the reference TARTARO discloses a sample collection device, Figure 1-5, comprising:
(a) a first tube accommodating a sample, Figure 5, body 12, [0009, 0010]; wherein the first tube comprises an opened end part, Figure 5, at end where threading 20 is located is opened end part ;
(b) a second tube accommodating a sample transport medium, Figure 3 and 5, receptacle 24 with solution S, [0011]; wherein the second tube comprises an opened end part, Figure 5, at end where bottom edge 28 is located is opened end part; and
(c) an adapter, Figure 5 and 7, filter 24/wall 44 and wall 46 is considered the adapter, [0012]; wherein the adapter comprises a first accommodating part formed such that the opened end part of the first tube is inserted, a second accommodating part formed to be coupled to the opened end part of the second tube and a sealing part that comprises a first surface facing the first accommodating part and a second surface facing the second accommodating part, and partitions the first accommodating part and the second accommodating part, Figures 1-3 8 and 9, membrane 26, [0012, 0013, 0016], and wherein a breaking line is formed on the sealing part such that the sealing part is broken by a contact pressure, see from Figure 8 to 9, tearable membrane 26 can be torn by puncturing member 54 with pressure/pressed , [0011-0013], also see from Figure 3 to 4.
Additional Disclosures Included are: Claim 2: wherein the sample collection device according to claim 1, wherein the sample is selected from the group consisting of a saliva sample, a saliva swab sample, a nasopharyngeal swab sample, an oropharyngeal swab sample, a nasal sample, a nasal swab sample, a nostril sample and a nostril swab sample. The instant claim language is directed to material or article to be worked upon. The type of sample to be used in the device does further define the device structurally. TARTARO discloses the device to allow analysis from a living organism, [0002]. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). ; Claim 8: wherein the sample collection device according to claim 1, wherein the sample transport medium moves from the second tube to the first tube after the sealing part is broken, see from Figures 3 to 4, solution (S) in receptacle 24 moves to the body 12 after puncturing member 54 tears the membrane 26 , [0012]. ; Claim 9: wherein the sample collection device according to claim 1, wherein the contact pressure is provided by the first tube inserted into the first accommodating part, see in Figures 3 and 8, puncturing member 54 is in body 12, [0012, 0013].; Claim 11 : wherein the sample collection device according to claim 1, wherein the sealing part is formed in one body with the first accommodating part and the second accommodating part, Figure 3, 4, 6, 7-9, [0012, 0013], membrane 26 is in receptacle 24.; Claim 14: wherein the sample collection device according to claim 1, wherein a thickness of a central portion of the sealing part is thicker than a thickness of an edge portion, Figure 7, [0012, 0013].; Claim 16: wherein the sample collection device according to claim 1, wherein the breaking line is formed on an edge portion of the sealing part, see from Figure 8 to 9, tearable membrane 26 can be torn by puncturing member 54 with pressure/pressed , [0011-0013], also see from Figure 3 to 4.; Claim 17: wherein the sample collection device according to claim 1, wherein the breaking line is formed inside an edge portion of the sealing part, see from Figure 8 to 9, tearable membrane 26 can be torn by puncturing member 54 with pressure/pressed , [0011-0013], also see from Figure 3 to 4.; Claim 19: wherein the sample collection device according to claim 1, wherein the sealing part comprises a first protrusion part that is protruded from the first surface and is contacted with the first tube inserted into the first accommodating part such that the contact pressure provided by the first tube inserted into the first accommodating part breaks the sealing part, Figure 3, at mouth 18 with thread 20 , at top edge of body 12 under safety ring 66, [0014].; Claim 21: wherein the sample collection device according to claim 19, wherein the first protrusion part is located on a breaking line formed on the first surface or is located inside or outside of the breaking line formed on the first surface, Figure 3, at mouth 18 with thread 20 is located inside or outside of the breaking line, [0010].; Claim 22: wherein the sample collection device according to claim 19, wherein the first protrusion part is located on the first surface to be supported on an edge portion of the opened end part of the first tube, Figure 3, at mouth 18 with thread 20 is located at edge of body 12, [0010]. ; Claim 26: wherein the sample collection device according to claim 1, wherein the first tube comprises a second protrusion part formed to protrude in a direction to be inserted into the first accommodating part to be contacted with the sealing part such that a contact pressure provided by the first tube inserted into the first accommodating part breaks the sealing part, Figure 3, mouth 18 has threads 20 which are protrusions, [0010, 0017].; Claim 28: wherein the sample collection device according to claim 26, wherein the second protrusion part is located on an edge portion of the opened end part of the first tube, Figure 3, at top of mouth there is a threading 20, [0010, 0017].; Claim 29: wherein the sample collection device according to claim 26, wherein the second protrusion part is located on an opening of the first tube, and the first tube comprises a supporting part for supporting the second protrusion part, see in Figure 3, 4, 8, 9 how device is assembled.; Claim 33: wherein the sample collection device according to claim 1, wherein the second tube comprises a plurality of protrusions disposed on an outer circumferential surface, and the second accommodating part comprises a plurality of grooves disposed on an inner circumferential surface and engaged with the protrusions, Figure 3-5, 8 and 9, see threadings engage with grooves, [0011].; Claim 35: wherein the sample collection device according to claim 1, wherein the device is a self-sample collection device, abstract, [0009], biopsy samples which can be obtain and directly placed into the container are blood, urine, saliva, stool, tears, sweat or seminal fluid.
Applicant’s invention is directed towards a device.
Regarding Claim 36, the reference TARTARO discloses a sample collection device, Figure 1-5, comprising:
(a) a first tube accommodating a sample, Figure 5, body 12 to contain a sample, [0009, 0010]; wherein the first tube comprises an opened end part, Figure 5, at end where threading 20 is located is opened ended part; and
(b) a second tube accommodating a sample transport medium, Figure 3 and 5, receptacle 24 with solution S, [0011]; wherein the second tube comprises an accommodating part formed at one end of the second tube such that the opened end part of the first tube is inserted, Figure 5, at end where bottom edge 28 is located is opened end part is inserted through other pieces to the body 12, and a sealing part that comprises a first surface facing the accommodating part and a second surface facing the other end of the second tube and partitions the second tube, Figures 1-3 8 and 9, membrane 26, [0012, 0013, 0016], and wherein a breaking line is formed on the sealing part such that the sealing part is broken by a contact pressure, see from Figure 8 to 9, tearable membrane 26 can be torn by puncturing member 54 with pressure/pressed , [0011-0013], also see from Figure 3 to 4.
Applicant’s invention is directed towards a method.
Regarding Claim 37, the reference TARTARO discloses a method for collecting a sample, [0010], comprising:
(a) accommodating a collected sample in a first tube, Figure 4, sample C is placed in body 12, [0010]; wherein the first tube comprises an opened end part, Figure 5, at end where threading 20 is located is opened end part ;
(b) inserting the first tube accommodating the sample into an adapter coupled with a second tube accommodating a sample transport medium, Figure 4, [0011]; wherein the second tube comprises an opened end part, Figure 5, Figure 5, at end where bottom edge 28 is located is opened end part, wherein the adapter comprises a first accommodating part formed such that the opened end part of the first tube is inserted, Figure 5 and 7, filter 24/wall 44 and wall 46 is considered the adapter, [0012], a second accommodating part formed to be coupled to the opened end part of the second tube and a sealing part that comprises a first surface facing the first accommodating part and a second surface facing the second accommodating part, and partitions the first accommodating part and the second accommodating part, Figures 1-3, 8 and 9, membrane 26, [0012, 0013, 0016], and wherein a breaking line is formed on the sealing part such that the sealing part is broken by a contact pressure, see from Figure 8 to 9, tearable membrane 26 can be torn by puncturing member 54 with pressure/pressed , [0011-0013], also see from Figure 3 to 4; and (c) breaking the sealing part and moving the sample transport medium accommodated in the second tube to the first tube, see from Figure 3 to 4 and 8 to 9, [0014-0019].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
20. 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.
21. 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.
22. Claims 12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over TARTARO, EP 3 220 832 B1, submitted on the Information Disclosure Statement on 21 FEBARURY 2024; Foreign Patent Documents Cite No. BA.
23. Regarding Claim 12, the TARTARO reference discloses the claimed invention but is silent in regards to the preferred material of wherein the sealing part is made of the same material as the first accommodating part and the second accommodating part.
24. TARTARO discloses the membrane is of aluminum or polymeric material, [0011]. Using the broadest reasonable interpretation of a ‘polymeric material’, is a material composed of repeating structural units called monomers. They can be natural, such as cellulose and proteins, or synthetic, like polyethylene and nylon. These materials exhibit a wide range of properties and applications, making them essential in various industries, including packaging, textiles, and construction .
25. Since the device of TARTARO is to be used for the sampling and collection of biopsied samples it would be obvious to one having ordinary skill in the art before the effective filing date to have the sealing part is made of the same material as the first accommodating part and the second accommodating part such as a polymeric material to achieve a high strength to weight ratio of the overall device, to precisely engineer the desired properties such as flexibility, rigidity, elasticity or thermal resistance, to optimize on the low cost of polymeric materials and to have the device be non-reactive and resistance to corrosion. In addition, “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).”
26. Regarding Claim 18, the TARTARO reference discloses the claimed invention but is silent in regards to the sealing part is formed such that a thickness of a portion where the breaking line is formed is thinner than a thickness of the other portion.
27. TARTARO discloses the membrane 26 is designed to be teared or punctured by the puncturing member, [0013]. TARTARO further teaches membrane 26 is attached, for example by gluing, to an annular bottom edge 28 of the receptacle 24, [0011]. Since TARTARO teaches the thickness of the membrane is designed to be punctured or teared and the edges of the membrane are attached by gluing to the bottom edge of the receptacle, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the shape and thickness of the sealing part such that it is formed such that a thickness of a portion where the breaking line is formed is thinner than a thickness of the other portion so it can be securely attached to the receptacle creating a seal without a risk of leaks and to have the thickness have a portion where the breaking line is formed thinner to ensure puncturing and/or tearing by pressure of the puncturing device without risk of breaking the puncturing member upon pressure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Patent 4,353,868 to JOSLIN discloses a sample collection device, abstract, Figure 1-3, comprising: (a) a first tube accommodating a sample, Figure 1, container 12; wherein the first tube comprises an opened end part, Figure 1, end portion 22 receives reservoir 16; (b) a second tube accommodating a sample transport medium, Figure 1, reservoir 16 has medium 20; wherein the second tube comprises an opened end part, Figure 1 reservoir 16 is inserted into container 12, implying it has a opened end part; and (c) an adapter, Figure 2, sleeve 46; and wherein a breaking line is formed on the sealing part such that the sealing part is broken by a contact pressure, Figure 1, seal 44 is pierceable/breakable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LYLE ALEXANDER can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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