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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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: “a dispensing mechanism” in claim 1; “a piercing member” in claim 1; “sealing member” in claim 1.
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.
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 28 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.
Claim 28 recites the limitation "diagnostic test apparatus configured to receive the device of claim 1." However, the structure of the diagnostic test apparatus that receives the device of claim 1 is not clearly defined in the claim. Applicant’s specification describes the diagnostic test apparatus to comprise multiple components including a mechanical sensor (para [0084] of the application publication), one or more optical sensors (para [0144], [0146]), means for receiving optical signals from the diagnostic test reservoir to detect an analyte of interest ([0144]), and one or more heat blocks (902,904) ([0143]). Thus, it is unclear as to the components that constitute the claimed diagnostic test apparatus as claimed. Further clarification is requested, and appropriate correction is required.
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 1-11 and 14-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hopper (already of record, US 2020/0278368).
Regarding claim 1, Hopper discloses a device comprising: a sample preparation reservoir configured to receive a sample at a first end and comprising an interior surface defining sides of at least one chamber at a second end (FIG. 2; para [0195]-[0198]; cartridge body (1), with sample preparation fluid (11) with first end adjacent cap (2) and second end adjacent diagnostic reservoir tube (3) with mating location (7)); at least one diagnostic test reservoir (FIG. 2: test reservoir (3); para [0195]-[0198]); at least one seal disposed between the sample preparation reservoir and the at least one diagnostic test reservoir (FIGS. 2, 5, 9; para [0196], [0199], [0215], [0218]; liquid reagents (11) forming sample volume (6) a predetermined sub-volume between sealing ring (24) perforation tip (26) bore (1) and pierceable foil membrane on diagnostic reservoir tube (3) as shown with 7); and a dispensing mechanism configured to be inserted into the first end of the sample preparation reservoir (FIG. 5; para [0216]-[0218], [0226]; dispensing insert (22) inserted at first end adjacent cap (20) slides to fit with the cylindrical body (1)) and translated toward the second end of the sample preparation reservoir (FIG. 5; para [0216]-[0218], [0226]; dispensing insert (22) inserted at first end adjacent cap (20) slides to fit with the cylindrical body (1) and pierces the foil section at the base of the tube with the piercing tip (26)), the dispensing mechanism comprising a piercing member and a sealing member (FIG. 5; para [0065], [0226]; dispensing insert (22) engages interior surfaces of the cylindrical body (1) and also has piercing tip (26) with a sealing O-ring (24)), the sealing member configured to engage the sides of the at least one chamber as the dispensing mechanism translates toward the second end of the sample preparation reservoir (FIG. 5; para [0215]-[0217]; plunger (22) forms a seal by close fit with the cylindrical bore (1)), a predetermined volume of fluid defined between the sealing member, the piercing member, the sides of the at least one chamber at the second end of the sample preparation reservoir (FIGS. 2, 5, 9; para [0196], [0199], [0215], [0218]; liquid reagents (11) forming sample volume (6), a predetermined sub-volume between sealing ring (24) perforation tip (26), bore (1) and pierceable foil membrane on diagnostic reservoir tube (3) as shown), and the at least one seal when the sealing member engages the sides of the at least one chamber (FIGS. 2, 5, 9; para [0215]-[0217]; plunger (22) forms a seal by close fit with the cylindrical bore (1), and seal (24) improves the seal of the piston as it slides within the bore), the piercing member configured to pierce the at least one seal after the predetermined volume is defined (FIGS. 2, 5, 9; para [0196], [0199], [0215], [0218]; liquid reagents (11) forming sample volume (6) and a predetermined sub-volume for injection between sealing ring (24) perforation tip (26) and bore (1) when the plunger (22) engages with top (7) of cap (2) as shown ... further, this is functional language and since the elements of the device are configured as claimed, the device is capable of functioning in the intended way), and the sealing member and the piercing member configured to dispense the defined volume from the sample preparation reservoir to the at least one diagnostic test reservoir after the seal is pierced (FIGS. 2, 5, 9, para [0217], [0223], [0226]-[0227]; predetermined volume of fluid formed as the plunger traps fluid volume in the body (1) to dispense into the diagnostic reservoir tube through a perforation in the foil made by the piercing tip (26) and fluid flows into the sample tube (3)).
Regarding claim 2, Hopper further discloses wherein the sealing member is configured to directly contact the interior surface defining the sides of the at least one chamber as the dispensing mechanism translates toward the second end of the sample preparation reservoir (FIGS. 2, 5, 9; para [0215]-[0217]; plunger (22) forms a seal by close fit with the cylindrical bore (1) and seal (24) improves the seal of the piston as it slides within the bore to dispense fluid into diagnostic reservoir tube (3)).
Regarding claim 3, Hopper further discloses wherein the piercing member does not move relative to the sealing member as the defined volume is dispensed to the at least one diagnostic test reservoir (FIGS. 5, 9; para [0222], [0227]-[0228]; fluid trapped in the cylindrical section between the insert (22) and the piercing tip (26) is fixed and predetermined before being dispensed into diagnostic reservoir tube (3)).
Regarding claim 4, Hopper further discloses wherein the piercing member comprises at least one spiked rod and the sealing member comprises at least one gasket encircling the at least one spiked rod (FIG. 5; para [0216]-[0218], [0221], [0226]; dispensing insert (22) inserted at first end adjacent cap (20) slides to fit with the cylindrical body (1) with sealing O-ring (24) and pierces the foil section at the base of the tube with the piercing tip (26) shown as a spike tip from rod (21)).
Regarding claim 5, Hopper further discloses wherein a single action of translating the dispensing mechanism toward the second end of the sample preparation reservoir (a) defines the predetermined volume of fluid between the sealing member, the piercing member, the sides of the at least one chamber, and the at least one seal (FIGS. 5, 9; para [0221]-[0222], [0227]-[0228]; fluid trapped in the cylindrical section between the insert (22) and the piercing tip (26) is fixed and predetermined with ring (24) formed with groove (25)); (b) pierces the at least one seal (FIGS. 2, 5, 9; para [0196], [0199], [0215], [0218]; liquid reagents (11) forming sample volume (6), a predetermined sub-volume between sealing ring (24) perforation tip (26) bore (1) and pierces foil membrane on diagnostic reservoir tube (3) as shown at 7); and ( c) dispenses the defined volume into the at least one diagnostic test reservoir (FIGS. 2. 5, 9, para (0217], [0223], [0226]-[0227]; predetermined volume of fluid formed as the plunger traps fluid volume in the body (1) to dispense into the diagnostic reservoir tube through a perforation in the foil made by the piercing tip (26) and fluid flows into the sample tube (3)).
Regarding claim 6, Hopper further discloses wherein the sample preparation reservoir, the at least one diagnostic test reservoir, and the at least one seal are connected to form a joined structure (FIG. 2; para [0192], (0196], [0219]; chamber (1) connected to threaded cap (2), as shown, and tube (3) with securing clip (4) and seal (5)).
Regarding claim 7, Hopper further discloses wherein the interior surface at the second end of the sample preparation reservoir defines at least one cylindrical chamber (FIGS. 5, 9; para [0222], [0227]-[0228]; fluid trapped in the cylindrical section between the insert (22) and the piercing tip (26) is fixed and predetermined before being dispensed into tube (3)).
Regarding claim 8, Hopper further discloses wherein the interior surface at the second end of the sample preparation reservoir defines two cylindrical chambers (FIGS. 5, 9; para [0207], [0215], (0222], [0227]-(0228]; sample reagent fluid (11) from chamber (1) has a sub-volume trapped in the cylindrical section between the insert (22) and the piercing tip (26) is fixed and predetermined).
Regarding claim 9, Hopper further discloses a notch in a portion of the interior surface between the two cylindrical chambers, and wherein the predetermined volume is defined, at least in part, by a depth of the notch (FIGS. 5, 9; para [0221]-[0222], (0227]-[0228]; fluid trapped in the cylindrical section between the insert (22) and the piercing tip (26) is fixed and predetermined with ring (24) formed with groove (25)).
Regarding claim 10, Hopper further discloses wherein the sealing member is configured to be in direct contact with a lower interior surface of the at least one chamber when the defined volume has been dispensed from the sample preparation reservoir to the at least one diagnostic test reservoir (FIGS. 5, 9; para [0222], [0227]-[0228]; fluid trapped in the cylindrical section between the insert (22) and the piercing tip (26) is fixed and predetermined before being dispensed into tube (3) with contact between tip (26) and sealing member (7) of cap (3)).
Regarding claim 11, Hopper further discloses wherein the interior surface at the second end of the sample preparation reservoir defines two cylindrical chambers (FIGS. 19-25; para [0232)-(0233]; two tubes (107, 108) comprising detection probes), each of the two cylindrical chambers configured to dispense the predetermined volume of fluid (FIGS. 2, 5, 9, 19-25; para [0196], [0199], [0215], [0218], (0233], (0248]; liquid reagents (11) forming sample volume (6), a predetermined sub-volume between sealing ring (24) perforation tip, 26 307 308, bore (1) and pierceable foil membrane on diagnostic two reservoir tubes (3,103)), wherein the piercing member comprises two spiked rods (FIGS. 5, 19-25; para [0216]-[0218], [0221], (0226]; dispensing inserts (22, 122) inserted at first end adjacent cap (20) slides to fit with the cylindrical body with the piercing tips (26, 307, 308), shown as a spike tip from rod (21, 121)), wherein the sealing member comprises a gasket encircling each of the two spiked rods (FIGS. 5, 19-25; para [0216]-[0218], [0221], [0226], [0239]-[0241 ]; dispensing inserts (22, 122) inserted at first end adjacent cap (20) slides to fit with the cylindrical body (1) with sealing O-ring (24) and pierces the foil section at the base of the tube with the piercing tips (26, 307, 308) shown as a spike tip from rod (21, 121)), and wherein the device further comprises a test container comprising two diagnostic test reservoirs (FIGS. 19-25; para [0232], [0248]; two tubes (107, 108) comprising detection probes), each diagnostic test reservoir configured to receive the predetermined volume of fluid from one of the two cylindrical chambers (FIGS. 2, 5, 9, 19-25; para (0196], (0199], [0215], [0218], [0233], [0248]; liquid reagents (11) forming sample volume (6), a predetermined sub-volume between sealing ring (24), perforation tip (26, 307, 308), bore (1) and pierceable foil membrane on diagnostic two reservoir tubes (3,103)).
Regarding claim 14, Hopper further discloses wherein the piercing member comprises one or more spikes (FIG. 5; para [0216)-(0218], [0221], [0226]; dispensing insert (22) inserted at first end adjacent cap (20) slides to fit with the cylindrical body (1) with sealing O-ring (24) and pierces the foil section at the base of the tube with the piercing tip (26) shown as a spike tip from rod (21)).
Regarding claim 15, Hopper further discloses wherein each of the one or more spikes comprises a cross-shaped cross-section comprising concave surfaces and a chamfered surface (FIGS. 5, 9; para [0221]-[0222], [0227]-[0228]; piercing tip (26) holds ring (24) shown with a concave shape in rod (21) and adjacent detent groove (25)).
Regarding claim 16, Hopper further discloses wherein the sample preparation reservoir comprises a sample preparation fluid (FIGS. 5, 9; para [0207], (0215], [0222], (0227]-[0228]; sample reagent fluid (11) from chamber (1) has a sub-volume trapped in the cylindrical section between the insert (22) and the piercing tip (26) is fixed and predetermined).
Regarding claim 17, Hopper further discloses wherein the at least one seal comprises a first seal configured to seal the second end of the sample preparation reservoir and a second seal configured to seal the diagnostic test reservoir (FIG. 5; para [0215], [0217], [0226]; mating recess (54) to align dispense insert (22) of reservoir (1) to tube(3) with foil or plastic membrane over the top of the tube).
Regarding claim 18, Hopper further discloses wherein the at least one seal comprises a foil (FIG. 5; para [0215), [0217], [0226]; mating recess (54) to align dispense insert (22) of reservoir (1) to tube(3) with foil or plastic membrane over the top of the tube).
Regarding claim 19, Hopper further discloses wherein the sample preparation reservoir is configured to receive a swab comprising the sample (para [0186], [0207]).
Regarding claim 20, Hopper further discloses wherein the second end of the sample preparation reservoir comprises a lip configured to be joined to the diagnostic test reservoir (FIG. 5; para [0215], (0217], [0226]; mating recess (54) to align dispense insert (22) of reservoir (1) to tube (3)).
Regarding claim 21, Hopper further discloses wherein the sample preparation reservoir is configured to contain a volume of fluid ranging from 1-3 mL and the predetermined volume ranges between 10 μL and 1 mL (para [0246]; 1 mL to 100 μL).
Regarding claim 22, Hopper further discloses wherein the sample preparation reservoir is configured to contain a fluid volume that is 1 to 300 times greater than the predetermined volume (para [0246]; 1 mL to 100 μL, which is 10 times greater).
Regarding claim 23, Hopper further discloses wherein the sample preparation reservoir is configured to contain a fluid volume of 1-3 mL and the predetermined volume is about 100 μL (para [0246]).
Regarding claim 24, Hopper further discloses wherein the dispensing mechanism comprises a cap configured to engage the first end of the sample preparation reservoir (FIG. 2; para [0195]-[0198]; cartridge body (1) with sample preparation fluid (11) with first end adjacent cap (2)).
Regarding claim 25, Hopper further discloses wherein the cap is configured to rotate relative to the piercing member (FIG. 2; para [0192], [0196], [0219]; chamber (1) connected to threaded cap (2) as shown).
Regarding claim 26, Hopper further discloses wherein the first end of the sample preparation reservoir comprises threads configured to engage threads of the cap (FIG. 2; para [0192], (0196], [0219]; chamber (1) connected to threaded cap (2) as shown).
Regarding claim 27, Hopper further discloses wherein the cap is configured to lock to the first end of the sample preparation reservoir, preventing substantial motion of the cap relative to sample preparation reservoir, and wherein the cap comprises a plug seal configured to engage a top end of the sample preparation reservoir, the plug seal configured to block fluid flow when engaged to the top end of the sample preparation reservoir (FIGS. 25-26, para [0247] [0248]; cap is locked onto dispensing cartridge), and wherein the cap comprises a plug seal configured to engage a top end of the sample preparation reservoir, the plug seal configured to block fluid flow when engaged to the top end of the sample preparation reservoir (FIGS. 21-26; para [0237]-[0248]; fluid tight seal with insert (122) that is inserted into the dispensing cartridge bore).
Regarding claim 28, Hopper further discloses a diagnostic test apparatus configured to receive the device of claim 1 (para [0049], [0202], [0259]) configured to receive the device of claim 1.
Therefore, Hopper meets and anticipates the limitations set forth in claims 1-11 and 14-28.
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 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hopper as applied to claim 1 above.
Regarding claim 12, Hopper discloses the device of claim 1. Hopper discloses wherein the interior surface at the second end of the sample preparation reservoir defines multiple cylindrical chambers, and wherein the device comprises multiple diagnostic test reservoirs (FIGS. 19-25; para [0232], [0238], (0248]; two bores and two tubes (107, 108) comprising detection probes). Hopper does not specifically disclose four chambers and four reservoirs. However, Hopper does disclose the use of the device with multiple wells and sets of test wells (see para [0044], [0105], [0129]). It therefore would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have multiplied the chambers and test reservoirs in the device of Hopper, since it has been held that a mere duplication of working parts of a device involves only routine skill in the art (see MPEP § 2144.04 VI. B.). One would have been motivated to have duplicated the chambers and reservoirs in the device of Hopper for the purpose of conducting multiple tests simultaneously and thereby increasing the device throughput.
Regarding claim 13, Hopper discloses the device of claim 1. Hopper discloses wherein the sealing member comprises a material but does not explicitly disclose wherein the material comprises an elastomeric material. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the sealing member with elastomeric material because said modification would have been the simple substitution of one known material for another. Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799
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