DETAILED CORRESPONDENCE
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/9/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-20 are pending.
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 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
As to claim 1, it is unclear what a testing element is attempting to describe. Although the specification attempts to give a definition for the term in [54-62], it is unclear what this term is intended to encompass. The specification describes a test strip, which would be clear and make sense. However, [55] also says that the testing can be based on various principles, and then states that other suitable test elements can be used. However, the specification does not then further describe other test elements aside from a test strip. It is unclear what other elements may be intending to be encompassed here. Is just a reagent sufficient to satisfy the claims? It does not appear that applicants have support for any broad element aside from a test strip, so the claims will be interpreted as a test strip.
Claim 1 recites that the detection chamber is used for testing an analyte in a liquid chamber in lines 3-4. However, t is unclear where this liquid chamber is. First, the liquid chamber is not positively recited, and second it is unclear how this unclaimed liquid chamber would interact with and relate to the claimed detection chamber.
Claims 2-20 are rejected based on further claim dependency.
As to claim 4, it is unclear what is attempting to be recited. There is a seal between the connecting chamber and the detection chamber but then no fluid communication between the sample chamber and connecting chamber. Are applicants attempting to claim a seal between the sample chamber and some other structure? Or are applicants intending that there is no fluid communication between the connecting chamber and detecting chamber? As drafted, the claim is unclear how there is no fluid communication between the sample chamber and connecting chamber as a result of a seal that is not between those structures, but rather is between the connecting chamber and the detection chamber.
In regards to claim 6, it is unclear what “a chamber of a base” is describing in line 3. A base of what? What is a base, and where is this base? The base isn’t described previously and is not part of the claimed device, so it becomes unclear what this base is or how it may relate to the other claimed structures of the device. Similarly, claim 16 recites “the base” where this limitation is similarly unclear.
Appropriate correction and/or clarification is required.
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 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.
(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 1-16 are rejected under 35 U.S.C. 102a1/a2 as being anticipated Gould by et al (US 20060292034; hereinafter “Gould”).
As to claim 1, Gould teaches a device for testing an analyte in a liquid sample (Gould; Fig. 1-9), comprising: a sample chamber for accommodating a sample collector (Gould teaches a sample chamber as the region of space near reference character 21; Fig. 3); a detection chamber with a bottom, wherein a testing element is provided in the detection chamber and used for testing an analyte in a liquid chamber (Gould teaches a detection chamber 44 and also where test strip 14 is received; Fig. 2, 3, 6, 7, [33, 34, 38, 41]); and a connecting chamber, wherein the sample chamber is connected with the detection chamber through the connecting chamber (Gould teaches a connecting chamber as the region of space connecting the bottom of 21 to the well 44, and also from 22 to 21 and 44; Fig. 3, 6), a liquid is accommodated in the sample chamber (The examiner notes that this is intended use as the liquid is not positively recited, but that Gould teaches liquid flowing into the sample chamber as the bottom portion of 21; [36, 40]), and a level of the liquid in the sample chamber is higher than a bottom of the detection chamber (Although related to intended use, Gould teaches that the liquid in chamber at the bottom of 21 would accumulate in 42 and be higher than a bottom of detection chamber 44; Fig. 6, 7).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 2, Gould teaches the device according to claim 1, wherein when the detection chamber is located at a first position, the detection chamber is not in fluid communication with the sample chamber; and when testing needs to be initiated, the detection chamber is allowed to be located at a second position and the detection chamber is kept in fluid communication with the sample chamber through the connecting chamber (Gould teaches the detection chamber being moved from a first position in which 22 is not punctured to a second position in which 22 is punctured; [34, 40], Fig. 3, 4. Gould also teaches the movement of 48; [41], Fig. 6. Either movement, or both movements in combination allow fluid communication with the sample chamber).
As to claim 3, Gould teaches the device according to claim 2, wherein a pierceable sealing film is provided between the connecting chamber and the detection chamber, such that no fluid communication is made between the detection chamber and the connecting chamber (Gould teaches a film on 22 which is not punctured and does not allow fluid connection to the connecting chamber and detection chamber, where the connecting chamber also includes the region of space of 22 and 20, but not 26, connected to 44; Fig. 3. Further, lack of movement of 48, either alone or in combination, also does not allow the fluid communication; Fig. 6).
As to claim 4, Gould teaches the device according to claim 3, wherein the pierceable sealing film is provided between the connecting chamber and the detection chamber, such that no fluid communication is made between the sample chamber and the connecting chamber (Gould teaches a film on 22 which is not punctured and does not allow fluid connection to the connecting chamber and sample chamber; Fig. 3).
As to claim 5, Gould teaches the device according to claim 3, wherein fluid communication is made between the connecting chamber and the sample chamber, and the liquid is also accommodated in the connecting chamber (Gould teaches a film on 22 which once punctured allows fluid connection to the connecting chamber and sample chamber; [34, 40], Fig. 3, 4).
As to claim 6, Gould teaches the device according to claim 5, wherein the detection chamber has the first position and the second position; when the detection chamber is located at the first position, the detection chamber is not in fluid communication with a chamber of a base based on sealing of the sealing film; and when the detection chamber is located at the second position, the detection chamber is in fluid communication with the connecting chamber based on piercing of the sealing film (Gould teaches a detection chamber 44 and also where test strip 14 is received; Fig. 2, 3, 6, 7, [33, 34, 38, 41]. Gould teaches the detection chamber being moved from a first position in which 22 is not punctured to a second position in which 22 is punctured; [34, 40], Fig. 3, 4. Gould also teaches the movement of 48; [41], Fig. 6. Either movement, or both movements in combination allow fluid communication with between the detection chamber and connecting chamber, and also between the detection chamber and a chamber on a base, where the base chamber is any portion around region 40; Fig. 3, 6).
As to claim 7, Gould teaches the device according to claim 6, wherein the device further comprises a piercing element, and the piercing element is capable to make a same position change together with the detection chamber (Gould teaches piercing structure 26 where the detection chamber 44 and also where test strip 14 is received is moved with piercing structure 26; Fig. 2, 3, 6, 7, [33, 34, 38, 41]. Gould teaches the detection chamber being moved from a first position in which 22 is not punctured to a second position in which 22 is punctured; [34, 40], Fig. 3, 4).
As to claim 8, Gould teaches the device according to claim 7, wherein when the detection chamber is located at the first position, a piercing structure does not pierce the sealing film; and when the detection chamber is located at the second position, the piercing structure pierces the sealing film (Gould teaches piercing structure 26 where the detection chamber 44 and also where test strip 14 is received is moved with piercing structure 26; Fig. 2, 3, 6, 7, [33, 34, 38, 41]. Gould teaches the detection chamber being moved from a first position in which 22 is not punctured to a second position in which 22 is punctured; [34, 40], Fig. 3, 4).
As to claim 9, Gould teaches the device according to claim 6, wherein the piercing element is located on the detection chamber and connected with the detection chamber to form an integral structure; the detection chamber further comprises a tubular structure, one end of the tubular structure is in fluid communication with the detection chamber; and the other end of the tubular structure is provided with the piercing element (Gould teaches piercing structure 26 where the detection chamber 44 and also where test strip 14 is received is moved with piercing structure 26; Fig. 2, 3, 6, 7, [33, 34, 38, 41]. Gould teaches the detection chamber being moved from a first position in which 22 is not punctured to a second position in which 22 is punctured; [34, 40], Fig. 3, 4. Gould teaches that annular element 29 of the piercing element is fixed to portion 30 of the detection chamber forming an integral structure; [34], Fig. 4. The piercing element 26 has a tubular body with a piercing element 27 and the other end 28 fluidly connected to the detection chamber; Fig. 3, 4, [34]).
As to claim 10, Gould teaches the device according to claim 9, wherein a channel is provided between the connecting chamber and the detection chamber; the sealing film is used for sealing the channel; the tubular structure is located in the channel; and the piercing element is located on the sealing film (Gould teaches the channel connecting 22 to the detection chamber 44; Fig. 3, 4, 6. Gould teaches that the sealing film seals the upper part of 22, and that the tubular piercing element 26 is located in the channel and also located on the sealing film when piercing it; Fig. 3, 4, [34]).
As to claim 11, Gould teaches the device according to claim 10, wherein when the detection chamber is located at the first position, the tubular structure is located at the first position and the piercing element on the tubular structure does not pierce the sealing film; and when the detection chamber is located at the second position, the piercing element on the tubular structure pierces the sealing film, such that the connecting chamber is in fluid communication with the detection chamber through the channel (Gould teaches piercing structure 26 where the detection chamber 44 and also where test strip 14 is received is moved with piercing structure 26; Fig. 2, 3, 6, 7, [33, 34, 38, 41]. Gould teaches the detection chamber being moved from a first position in which 22 is not punctured to a second position in which 22 is punctured, which connects the connecting chamber and detection chamber through the channel; [34, 40], Fig. 3, 4).
As to claim 12, Gould teaches the device according to claim 11, wherein the liquid comprising a solution for treating a sample is accommodated in the sample chamber, and the solution is also accommodated in the connecting chamber (The examiner notes that this is related to intended use as the liquid is not positively recited. Gould teaches a liquid solution flowing into the sample chamber as the bottom portion of 21, where the fluid is also in the connecting chamber as the portion connecting from 22 to 21 and 44; [36, 40], Fig. 3, 4, 6).
As to claim 13, Gould teaches the device according to claim 12, wherein the sample collector is provided in the sample chamber, and the sample collector comprises a cover for sealing an opening of the sample chamber and a collection area for collecting the sample (The examiner notes that the sample collector and corresponding cover and collection area are not positively recited and therefore what defines these is related to intended use. This is also related to material worked upon by the apparatus and does not further define the device structure; see MPEP 2115).
As to claim 14, Gould teaches the device according to claim 13, wherein the collection area comprises a groove for accommodating the sample and a threaded structure (The examiner notes that the sample collector and corresponding cover and collection area are not positively recited and therefore what defines these is related to intended use. This is also related to material worked upon by the apparatus and does not further define the device structure; see MPEP 2115).
As to claim 15, Gould teaches the device according to claim 14, wherein when the collection area is used for collecting the sample and a sample area is inserted into the sample chamber, the collection area is located in the connecting chamber (The examiner notes that the sample collector and corresponding cover and collection area are not positively recited and therefore what defines these is related to intended use. This is also related to material worked upon by the apparatus and does not further define the device structure; see MPEP 2115).
As to claim 16, Gould teaches the device according to claim 15, wherein the connecting chamber is located on the base, the sample chamber has a recess, and a part of the detection chamber is located in the recess (Gould teaches the connecting chamber as the region of space connecting 22 to 21 and 44, which is all considered part of the base; Fig. 3, 4. Gould teaches that sample chamber 21 which also includes part of structure 12 has a recess that forms detection chamber 44; Fig. 3, 4, 6).
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gould by et al (US 20060292034; hereinafter “Gould”) in view of Lei et al (US 20220226804; hereinafter “Lei”).
As to claims 17-19, Gould teaches the device according to claim 16, where the device enables the movement of the detection chamber from a fixed first position to a second position, the detection chamber is capable to move up and down from the first position to the second position along a longitudinal direction of the sample chamber. (Gould teaches the detection chamber being moved from a first fixed position in which 22 is not punctured to a second position in which 22 is punctured, with relative movement between 22 and the structure supporting 44/14; [34, 40], Fig. 3, 4. The position prior to piercing is considered the fixed position. The movement of the detection chamber is along the same longitudinal direction as sample chamber 21; Fig. 3, 4, 6).
Gould does not teach a snap ring as a limiting structure that is clamped in a groove of the detection chamber such that removal of the ring enables movement between the positions. However, Lei teaches the analogous art of a detection device with test strips and a piercing element that pierces a film to release fluids (Lei; [67, 73, 90, 95, 96, 102, 109], Fig. 1, 2, 6, 9, 11), where a snap ring serves as a limiting structure that is clamped in a groove of the detection chamber such that removal of the ring enables movement between the positions (Lei teaches that elastic snap ring 70 includes portion 44 that is clamped into a groove/gap formed on chamber body, which limits the longitudinal movement of the two components to prevent the piercing element from piercing the fluid chamber; [35, 103-109], Fig. 9, 11). It would have been obvious to one of ordinary skill in the art to have modified the detection chamber that moves relative to a chamber between the first fixed position and second position to pierce and release fluid as in Gould to have included a snap ring between the two moving structures as in Lei because Lei teaches that including the snap ring protecting element helps to prevent the piercing element from piercing the fluid chamber (Lei; [44, 103, 108]).
As to claim 20, Gould teaches the device according to claim 19 (see above), wherein the sample is a fecal sample or a saliva sample, and the analyte is hemoglobin or helicobacter pylori (The examiner notes that the sample and analyte is not positively recited and therefore what defines the sample is intended use. This is also related to material worked upon by the apparatus and does not further define the device structure; see MPEP 2115. Gould teaches saliva; [40]).
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18346625 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to a device for testing an analyte in a liquid sample, with a sample chamber to accommodate a sample collector (claim 1 of ‘625); a detection chamber, wherein a testing element is provided in the detection chamber (claim 1 of ‘625 - “testing chamber…has testing element therein”); and a connecting chamber (claim 1 of ‘625 “liquid chamber”). In claim 1 of ‘625, each of these chambers are interconnected and move liquid from a sample chamber to the detection chamber whereby the path would be considered a connecting chamber. Thus, all of the elements of the invention recited in the instant claims are encompassed by the claims of copending Application No. 18346625.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18490552 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to a device for testing an analyte in a liquid sample, with a sample chamber to accommodate a sample collector (claim 1 of ‘552); a detection chamber, wherein a testing element is provided in the detection chamber (claim 1 of ‘552); and where the detection chamber and sample chamber are connected to provide a fluid connection (claim 1 of ‘552). In claim 1 of ‘552, each of these chambers are interconnected and move liquid from a sample chamber to the detection chamber whereby the path would be considered a connecting chamber. Thus, all of the elements of the invention recited in the instant claims are encompassed by the claims of copending Application No. 18490552.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 7 of copending Application No. 18606983 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to a device for testing an analyte in a liquid sample, with a sample chamber to accommodate a sample collector (claim 7 of ’983 recites a sample collector with “the sample collecting chamber”); a detection chamber, wherein a testing element is provided in the detection chamber (claim 1 of ‘983 recites “a collection chamber”, and claim 2 recites that the collection chamber includes a test element); and where the detection chamber and sample chamber are connected to provide a fluid connection (claims 1 and 7 of ‘983 recite the collection chamber as a detection chamber and a sample chamber). Thus, all of the elements of the invention recited in the instant claims are encompassed by the claims of copending Application No. 18606983.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Katz et al (US 20180339292; hereinafter “Katz”) teaches a device for testing an analyte in a liquid sample (Katz; Fig. 1-10), comprising: a sample chamber for accommodating a sample collector (Katz teaches a sample chamber as the region of space near reference character 3 and 14 in Fig. 6a through which a sample swab is inserted; Fig. 1-10, [45, 52, 54, 55]); a detection chamber with a bottom, wherein a testing element is provided in the detection chamber and used for testing an analyte in a liquid chamber (Katz teaches a detection chamber the bottom region of space except for reference character 14 in Fig. 5, where the detection chamber includes testing element strip 5; Fig. 1-10, [43, 52, 59-60]); and a connecting chamber, wherein the sample chamber is connected with the detection chamber through the connecting chamber (Katz teaches a connecting chamber as the region of space from 12 that connects down to test strip, whereby the connecting chamber also includes 21/22; Fig. 1-10, [44, 46-48, 51-53]), a liquid is accommodated in the sample chamber (Katz teaches liquid flowing into the sample chamber portion 14; [44, 46-48, 51-53]), and a level of the liquid in the sample chamber is higher than a bottom of the detection chamber (Katz teaches that the liquid in chamber 14 would be higher than a bottom of detection chamber holding 5; Fig. 1-10).
Bailey et al (US 20210031184; hereinafter “Bailey”) teaches a sample chamber 1061 and a detection chamber 110 with testing element 112 and connecting chamber 12, where the detection chamber moves between a first position in Fig. 19 to a second position in Fig. 22 such that piercing element 1062 moves together with the detection chamber.
Liang et al (US 20070275475; hereinafter “Liang”) teaches grooves on a sample collector; Fig. 1-2.
Gould et al (US 7507374; hereinafter “Gould II”) teaches similar configuration to Gould and also shows other details; Fig. 16-18.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN R WHATLEY whose telephone number is (571) 272-9892. The examiner can normally be reached Mon- Fri 8am-5pm.
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/Benjamin R Whatley/Primary Examiner, Art Unit 1798
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