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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/3/2023 and 7/12/2023 are being considered by the examiner.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/490,552 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because
Application 18/346,625 (instant)
Application 18/490,552 (reference application)(claim set 10/19/2023)
Claim 1
Claim 1
A device for testing an analyte in a liquid sample, comprising
A device for detecting an analyte in a liquid sample, comprising:
a cover body, wherein the cover body comprises a sample chamber for accommodating a sample collector and a liquid chamber containing a sample treatment liquid.
a sample chamber for accommodating a collector; and a detection chamber in fluid communication with the sample chamber... and the sample chamber is detachably combined with the detection chamber…[detection chamber is interpreted as the liquid chamber; sample chamber attached to the detection chamber is interpreted as the cover body]
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/490,552 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because
Application 18/346,625 (instant)
Application 18/490,552 (reference application)(claim set 10/19/2023)
Claim 2
Claim 1
The device according to claim 1, wherein the liquid chamber containing a sample treatment liquid is movable relative to the cover body.
...the sample chamber is detachably combined with the detection chamber… [detachable means movable]
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 14 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 18/490,552 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because
Application 18/346,625 (instant)
Application 18/490,552 (reference application)(claim set 10/19/2023)
Claim 14
Claim 3/2/1
The device according to claim 1, wherein a channel is provided in the sample chamber; when the sample collector is inserted into the channel of the sample chamber, an absorption element of the sample collector is squeezed, whereby releasing the liquid sample into the sample chamber; and then the liquid flows out of the sample chamber along the channel.
The device according to claim 2, wherein when the sample chamber comprises the collector, the first absorption element of the collector is capable to be compressed to release the liquid sample, wherein a part of the released liquid sample is capable to flow into the secondary validation test chamber and be absorbed by the second absorption element.[secondary validation test chamber is interpreted as the channel]
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. 18/659,794 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because
Application 18/346,625 (instant)
Application 18/659,794 (reference application)(claim set 05/09/2024)
Claim 1
Claim 1
A device for testing an analyte in a liquid sample, comprising
A device for testing an analyte in a liquid sample, comprising:
a cover body, wherein the cover body comprises a sample chamber for accommodating a sample collector and a liquid chamber containing a sample treatment liquid.
a sample chamber for accommodating a sample collector; 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; and a connecting chamber, wherein the sample chamber is connected with the detection chamber through the connecting chamber, a liquid is accommodated in the sample chamber, and a level of the liquid in the sample chamber is higher than a bottom of the detection chamber.[detection chamber is interpreted as the liquid chamber; the sample chamber, detection chamber and connection chamber is interpreted as the cover body]
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/659,794 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because
Application 18/346,625 (instant)
Application 18/659,794 (reference application)(claim set 05/09/2024)
Claim 2
Claim 2
The device according to claim 1, wherein the liquid chamber containing a sample treatment liquid is movable relative to the cover body.
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.
[movable between first and second location]
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/659,794 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because
Application 18/346,625 (instant)
Application 18/659,794 (reference application)(claim set 05/09/2024)
Claim 3
Claim 2
The device according to claim 2, wherein the liquid chamber comprises a first locking position and a second unlocking position relative to the cover body.
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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 5 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of copending Application No. 18/659,794 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because
Application 18/346,625 (instant)
Application 18/659,794 (reference application)(claim set 05/09/2024)
Claim 5
Claim 17/16/15…9/6/5/3/2/1
The device according to claim 3, wherein the liquid chamber is located at a locking position and locked on the cover body by a locking element.
The device according to claim 16, wherein the device further comprises a limiting structure, such that the detection chamber is located at a fixed position; and the limiting structure comprises a snap ring, and the snap ring is clamped in a groove of the detection chamber, such that the detection chamber is located at the first position.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 6 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of copending Application No. 18/659,794 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because
Application 18/346,625 (instant)
Application 18/659,794 (reference application)(claim set 05/09/2024)
Claim 6
Claim 18/17/16/…9/6/5/3/2/1
The device according to claim 5, wherein the locking element comprises a limiting structure capable of limiting movement of the liquid chamber; and when the limiting structure is detached from the liquid chamber, the liquid chamber changes from a locking state to an unlocking state.
The device according to claim 17, wherein when the limiting structure is removed, the detection chamber is capable to move from the first position to the second position.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 7 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of copending Application No. 18/659,794 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because
Claim 7
Claim 18/17/16/…9/6/5/3/2/1
The device according to claim 6, wherein the liquid chamber in the unlocking state is movable relative to the cover body.
The device according to claim 17, wherein when the limiting structure is removed, the detection chamber is capable to move from the first position to the second position.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 8 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of copending Application No. 18/659,794 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because
Application 18/346,625 (instant)
Application 18/659,794 (reference application)(claim set 05/09/2024)
Claim 8
Claim 19/18/17/…9/6/5/3/2/1
The device according to claim 7, wherein the movement comprises longitudinal movement from a high position to a low position relative to the cover body.
The device according to claim 18, wherein when the limiting structure is removed, 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“locking element” in claim 5;
Perform the same structure the same way
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
In this instant case, the corresponding structure for:
the “locking element” is a snap ring and equivalents thereof.
The examiner notes that for the “limiting structure capable of limiting movement of the liquid chamber” in claim 6, the “limiting structure” is a generic placeholder. However, the interpretation of the locking element which is “snap ring and equivalents thereof” provides sufficient structure of the performing the function of the “limiting structure.”
Furthermore, “piercing element” is not interpreted under 112(f) because “piercing” convey sufficient structure.
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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “wherein the cover body comprises a sample chamber for accommodating a sample collector and a liquid chamber containing a sample treatment liquid” in lines 1-3. It is unclear whether the sample chamber is “for accommodating a sample collector and a liquid chamber containing a sample treatment liquid” or the sample chamber is “for accommodating a sample collector” and the “liquid chamber” is referring back to the cover body. For the purpose of examination, it is being interpreted that the sample chamber is “for accommodating a sample collector” and the “liquid chamber” is referring back to the cover body (Fig. 5, sample chamber 225 does not appears to be for accommodating liquid chamber 205).
Claims 2-20 are indefinite because of their dependence on claim 1.
Claim 5 recites “a locking position” in lines 1-2. It is unclear if the “locking position” is the same physical position as the “first locking position” of claim 3 in view of the specification (para. 0013). Clarification is requested.
Claim 10 recites the limitation "a locking element" in line 2. It is unclear whether this is the same or a different locking element recites in claim 5. For the purpose of examination, it is being interpreted as the same locking element because specification teaches a single locking element in a device.
In addition, claim 10 recites the limitation “the liquid chamber is located at a fixed locking position” in line 3. It is unclear whether the “fixed locking position” is the same physical position as the “locking position” of claim 5. If they are not the same position, then it is unclear how the liquid chamber can simultaneously be located at a “locking position” and a “fixed locking position”. For this reason, the “fixed locking position” is being interpreted as the same position as the “locking position” for the purpose of examination.
Claim 12 recites the limitation “a high position distal to the platform” in line 3. It is unclear where this “high position” is (e.g., is it “high” relative to a point distal to the platform or to the platform? How high is high enough?) Therefore, this limitation is indefinite. Clarification is requested.
In addition, claim 12 recites the limitation “the high position distal to the platform is locked by the locking element” in lines 3-4. It is unclear how a position can be locked. It appears that it may be meant to recite “the liquid chamber at the high position distal to the platform is locked by the locking element.” Clarification is requested.
Furthermore, claim 12 recites “the liquid chamber … is located at a high position distal to the platform” in lines 2-3, and claim 5 and claim 10 recite the liquid chamber is located at “a locking position” and “at a fixed locking position,” respectively. It is unclear whether the “high position distal to the platform” is the same physical position as the “locking position” of claim 5 and the “fixed locking position” of claim 10. If they are not same position, then it is unclear how the liquid chamber can simultaneously be located at a “locking position”, a “fixed locking position” and a “high position distal to the platform”. For this reason, the “high position distal to the platform” is being interpreted as the same position as the “locking position” and the “fixed locking position” for the purpose of examination.
Claim 13 is indefinite because of its dependence on claim 12.
Claim 13 recites “a low position proximal to the platform” in line 3. It is unclear where this “low position” is (e.g., is it “low” relative to a point proximal to the platform or is it low relative to platform? How low is low enough? How does this “low position proximal to the platform” relate to the “high position distal to the platform” in terms of high/low?) Clarification is requested.
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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gould et al. (US 20060292034 A1).
Regarding claim 1, Gould teaches a device for testing an analyte in a liquid sample, comprising a cover body (upper body portion 17 and buffer cup 22)(para. 0033 and Figs 2-3, upper body portion 17 defines cylinder 21), wherein the cover body comprises a sample chamber (cylinder 21) for accommodating a sample collector (31) and a liquid chamber (buffer cup 22) containing a sample treatment liquid (buffer solution)(the sample collector and sample treatment liquid are not positively recited; see also 35 U.S.C. 112b above).
Regarding claim 2, Gould teaches all of the elements of the current invention as stated above with respect to claim 1. Gould further teaches wherein the liquid chamber (buffer cup 22) containing a sample treatment liquid is movable relative to the cover body (para. 0040, buffer cup can move down within 17 when a downward force is applied to buffer button 24).
Regarding claim 3, Gould teaches all of the elements of the current invention as stated above with respect to claim 2. Gould further teaches wherein the liquid chamber comprises a first locking position (the position of buffer cup immediate before it is punctured by spike 26) and a second unlocking position (the position where buffer cup is pushed down and punctured by spike 26) relative to the cover body.
Regarding claim 4, Gould teaches all of the elements of the current invention as stated above with respect to claim 3, wherein when the liquid chamber is located at the first locking position (the position of buffer cup immediate before it is ruptured by spike 26), liquid in the liquid chamber is not released; and when the liquid chamber is located at the second unlocking position (the position where buffer cup is pushed down and ruptured by spike 26), the liquid in the liquid chamber is capable of being released (para. 0040).
Regarding claim 5, Gould teaches all of the elements of the current invention as stated above with respect to claim 3. Gould further teaches wherein the liquid chamber (buffer cup 22) is located at a locking position (the position of buffer cup 22 in Fig. 4) and locked on the cover body by a locking element (button 24)(Fig. 4, button 24 is configured to lock, hold in place from being removed, buffer cup 22 on the cover body while buffer cup 22 is located at position of Fig. 4).
Regarding claim 6, Gould teaches all of the elements of the current invention as stated above with respect to claim 5. Gould further teaches wherein the locking element comprises a limiting structure (the recess at the bottom portion of button 24) capable of limiting movement of the liquid chamber; and when the limiting structure is detached from the liquid chamber, the liquid chamber changes from a locking state to an unlocking state (Fig. 4 and claim 12 teaches button 24 can be engaged, in a locking state, or disengaged , in an unlocking state, with buffer cup 22).
Regarding claim 7, Gould teaches all of the elements of the current invention as stated above with respect to claim 6. Gould further teaches wherein the liquid chamber in the unlocking state is movable relative to the cover body (Fig. 4, claim 12, and para. 0013, in the unlocking state where before the button is slide in to cylinder 20 to engage with buffer cup 22, buffer cup 22 is movable relative to the cover body as the buffer cup 22 is being inserted into the chamber).
Regarding claim 8, Gould teaches all of the elements of the current invention as stated above with respect to claim 7. Gould further teaches wherein the movement comprises longitudinal movement from a high position to a low position relative to the cover body (Figs. 3 and 4, the movement of buffer cup 22 is longitudinal within cylinder 20).
Regarding claim 9, Gould teaches all of the elements of the current invention as stated above with respect to claim 8. Gould teaches wherein the liquid chamber comprises a sealing film (bottom 23)(para. 0034, bottom 23 is formed by a rupturable/pierceable material) easy to pierce (interpreted as an intended use. Moreover, para. 0023, bottom 23 is ruptured by spike 26); and when the liquid chamber moves downward relative to the sealing film, the sealing film is pierced by a piercing element(para. 0034), whereby releasing the liquid in the liquid chamber (para. 0034).
Regarding claim 10, Gould teaches all of the elements of the current invention as stated above with respect to claim 5. Gould further teaches wherein the cover body comprises a docking area (20), the liquid chamber is located in the docking area, and a locking element (button 24)(interpreting as the locking element of claim 5, see 35 U.S.C. 112 (b) above) is located in the docking area (Figs. 3 and 4), such that the liquid chamber is located at a fixed locking position (interpreting this is the same position as the “locking position” of claim 5. See 35 U.S.C 112(b) above)(the position of buffer cup 22 in Fig. 4).
Regarding claim 11, Gould teaches all of the elements of the current invention as stated above with respect to claim 10. Gould further teaches wherein the locking element (button 24) is located in the docking area such that the liquid chamber is hidden in the docking area (Fig. 4); and after the locking element departs from the docking area, the liquid chamber is exposed (Fig. 4 and claim 12).
Regarding claim 12, Gould teaches all of the elements of the current invention as stated above with respect to claim 10. Gould further teaches wherein the docking area comprises a platform (top rim of cylinder 20, Fig. 3), a hole (the hole of cylinder 20) being provided in the platform; and the liquid chamber penetrates through the hole and is located at a high position distal to the platform (interpreted as the same position as the “locking position” of claim 5, see 35 U.S.C. 112 (b) above)(also see the 35 U.S.C. 112(b) above for the rejection relating the indefiniteness of “high position distal to the platform” ); and the high position distal to the platform is locked by the locking element (interpreting the limitation is referring to the liquid chamber at the high position; see 35 U.S.C. 112(b) and claim 5 above).
Regarding claim 13, Gould teaches all of the elements of the current invention as stated above with respect to claim 12. Gould teaches wherein when the locking element is away from or detached from the docking area, the liquid chamber is capable of moving from the high position distal to the platform to a low position proximal to the platform (when button 24 is removed, buffer cup can be taken out of cylinder 20. Therefore, buffer cup 24 can move from the position shown in Fig. 4 which is distal to the platform/rim to a position proximal to the platform/rim as it gets taken out. Since the liquid chamber can moved up and down then it is at a higher/lower position relative to the platform).
Regarding claim 14, Gould teaches all of the elements of the current invention as stated above with respect to claim 1. Gould further teaches wherein a channel is provided in the sample chamber (Fig 3, cylinder 21 provides a channel); when the sample collector is inserted into the channel of the sample chamber, an absorption element (34) of the sample collector is squeezed (para. 0036), whereby releasing the liquid sample into the sample chamber; and then the liquid flows out of the sample chamber along the channel.
Regarding claim 15, Gould teaches all of the elements of the current invention as stated above with respect to claim 7, wherein the device further comprises a testing chamber (base 12, cylinder 21 and the portion of 19A that test strip 14 occupies)(Figs. 2-3) having a testing element (14), the cover body covers an opening of the testing chamber, and the sample chamber and the liquid chamber are located in the testing chamber (Figs. 3, buffer cup 22 is in cylinder 21 and bottom opening 38 of cylinder 21 is in base chamber 39, which is part of base 12).
Regarding claim 16, Gould teaches all of the elements of the current invention as stated above with respect to claim 1, wherein the sample chamber (21) and the liquid chamber (22) extend outward from the cover body in a same direction (Fig. 3, both are cylindrical in shape extending in an up-down direction).
Regarding claim 17, Gould teaches all of the elements of the current invention as stated above with respect to claim 15. Gould further teaches wherein the testing chamber (base 12, cylinder 21 and test element 14) comprises a piercing element (spike 26) capable of piercing the liquid chamber; and when the liquid chamber moves inward the testing chamber relative to the cover body, the piercing element pierces the liquid chamber and enters therein, such that the liquid in the liquid chamber is forced to flow into the testing chamber.
Regarding claim 18, Gould teaches all of the elements of the current invention as stated above with respect to claim 17, wherein the piercing element is provided with a sharp piercing needle (26) and a base (29) connected with the piercing needle, and a diameter of the base is equivalent to that of the liquid chamber (Fig. 4).
Regarding claim 19, Gould teaches all of the elements of the current invention as stated above with respect to claim 15, wherein the testing chamber (base 12, cylinder 21 and the portion of 19A that test element 14 occupies) comprises a carrier (43)(Figs. 2 and 6 and para. 0038) for carrying the testing element (14), and the carrier is provided with a groove (Fig. 6, 43 is a groove) for fixing the testing element (para. 0038).
Regarding claim 20, Gould teaches all of the elements of the current invention as stated above with respect to claim 19, wherein a hole (hollow central portion 19A not including the space occupies by the test element 14 occupies) communicating with atmosphere is provided in the cover body, and a channel extending towards the testing chamber is provided in the hole (Fig 2. and para. 0033).
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 5, 10, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Gould et al. (US 20060292034 A1) in view of Margairaz et al. (US 20180133395 A1).
Regarding claim 5, Gould teaches all of the elements of the current invention as stated above with respect to claim 3.
Gould teaches a device comprises a push button (24) that locates in a cylinder (20) (Fig. 3). Gould further teaches wherein in upon depression of the button, the button moves a liquid chamber (buffer cup) downward in the cylinder, which consequently actuates the release of the liquid in the liquid chamber.
Gould further teaches wherein the liquid chamber is located at a locking position (the position of buffer cup 22 in Fig. 4) and locked on the cover body (Fig. 4).
Gould fails to teach the liquid chamber is locked at the locking position on the cover body by a locking element.
However, Margairaz teaches a dispenser comprising a push button 342, wherein depression of the button actuates the dispensing/release of liquid. Margairaz further teaches the dispenser comprising a locking construct 370 for preventing the push buttons 342 from being depressed accidentally as a security against in advertent activation (para. 0108). Margairaz further teaches the push button 342 comprises a head and a body with the head having a larger diameter than the body (Fig. 11B), the body of the push button locates in an opening, and locking construct 370 sits between the head and the rim of the opening to prevent push button 342 from being advertently depressed (Fig. 11B). Margairaz further teaches in the absence/ removal of locking construct 370, the button 342 is being depressed (Fig. 11C).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the button (24) taught by Gould with the push button comprises a head and a body with the head having a larger diameter than the body, and a locking construct sits between the head and the rim of the opening (the top rim of the cylinder 20 of Gould), taught by Margairaz in order to have a security against in advertent activation of the button with a reasonable expectation of success (Margairaz, para. 0108) (MPEP 2143)(I)(G).
The teachings Gould as modified by Margairaz would yield wherein the liquid chamber is located at a locking position (the position of buffer cup 22 in Fig. 4 of Gould) and locked on the cover body by a locking element (locking construct taught by Margairaz)(locking construct locks the modified button 24 in place which holds/locks buffer cup 22 in place in cylinder 20).
Regarding claim 10, modified Gould teaches all of the elements of the current invention as stated above with respect to claim 5. Gould further teaches wherein the cover body comprises a docking area (20)(Fig. 3), the liquid chamber is located in the docking area, and a locking element (locking construct of Margairaz)(interpreting as the locking element of claim 5, see 35 U.S.C. 112 (b) above) is located in the docking area (Figs. 3 and 4, locates in the area of the top rim of 20), such that the liquid chamber is located at a fixed locking position (interpreting this is the same position as the “locking position” of claim 5. See 35 U.S.C 112(b) above)(the position of buffer cup 22 in Fig. 4).
Regarding claim 12, modified Gould teaches all of the elements of the current invention as stated above with respect to claim 10.
Gould further teaches docking area (20) comprises a hole (the lumen of 20); and the liquid chamber penetrates through the hole (Fig. 4).
Gould further teaches buffer cup 22 is held by a protrusion within the inner wall of cylinder 20 (Fig. 4), but Fig. 4 presents a cross-sectional view, Gould does not explicitly teach the protrusion is a annular platform, and thus Gould fails to teach wherein the docking area comprises a platform and the hole being provided in the platform and the liquid chamber is located at a high position distal to the platform (interpreted as the same position as the “locking position” of claim 5, see 35 U.S.C. 112 (b) above); the high position distal to the platform is locked by the locking element (interpreted as the liquid chamber when at the high position distal to the platform is locked at the locking element, see 35 U.S.C. 112 (b) above).
However, Gould teaches spike 26 also locates in cylinder 20, and is held by an annular shoulder 30.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the protrusion that holds buffer cup 22 in Fig. 4 with an annular shoulder as taught by Fig. 4 and para. 0034 because one of ordinary skill in the art would accordingly have recognized the annular shoulder would result in the predictable result of providing protruding structure that holds buffer cup 22.
The teachings of modified Gould would yield wherein the docking area comprises a platform (annular shoulder that is holding buffer cup 22 in modified Gould), the hole (the lumen of 20) being provided in the platform; and the liquid chamber penetrates through the hole and is located at a high position distal to the platform (interpreted as the same position as the “locking position” of claim 5, see 35 U.S.C. 112 (b) above)(Fig. 4, the chamber is at position higher and distal to the platform; also see the 112(b) above for the rejection relating the indefiniteness of “high position distal to the platform”); and the high position distal to the platform is locked by the locking element (interpreting the limitation is referring to the liquid chamber at the high position distal to the platform is locked by the locking element; see 35 U.S.C. 112(b) and claim 5 above).
Regarding claim 13, modified Gould teaches all of the elements of the current invention as stated above with respect to claim 12.
Gould teaches wherein when the locking element (locking construct) is away from or detached from the docking area, the liquid chamber is capable of moving from the high position distal to the platform to a position proximal to the platform (annular shoulder that is holding buffer cup in modified Gould, Fig. 4)(when the locking construct is removed, the button can be depressed and consequently moving the liquid from the position shown in Fig. 4 to a lower position that is nearer to the platform relative to the “high position distal to the platform”)(Fig. 4, and para. 0034)(see also 35 U.S.C. 112(b) rejection above) .
Conclusion
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/M.L.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758