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 specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The examiner fails to locate any description of the diluent chamber has a fluid sub-chamber and a gas sub-chamber that are fluidly connected to each other to allow condensed gas to flow from the gas sub-chamber to the fluid sub-chamber as provided for in claim 11; and the cartridge comprising a vapor barrier that encloses the cartridge as provided for in claim 22.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the tear path, fluid sub chamber and gas sub-chamber must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that the claims mention a patient sample, mixing chamber, a patient sample chamber, fluid, and gas. However, none of such are positively claimed as elements of cartridge. All of such are considered as materials and/or articles intended be, than can be used with or worked upon by the cartridge. The claims are directed to an apparatus, not a method. There is no requirement for the apparatus to be used in any method at all, including to collect any sample from a patient, nor to perform any other actions/steps including those recited in the respective “when” clauses recited in the claims (collecting, moving, puncturing, releasing, mixing, condensing, etc.).
It is noted that the “to allow condensed gas…” of claim 11 is clause is directed to intended use.
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 1-22 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.
As to claim 1, it is unclear how the capillary channel and capillary slide are considered as defining a single cartridge because the channel and slide are not required be structurally connected to each other. It is noted that the wherein clause is directed to a condition as indicated by the “when” clause. The structures are only mated (connected) when the capillary slide is moved from the first position to the second position. It is noted that positions are not defined in the claim as being any structure and the longitudinal axis is not structure but is any intangible line that one chooses. The claims are directed to an apparatus, not a process of use. There is no requirement for the slide to ever be moved at all, nor mated (connected to) the capillary channel. The conditional process step provided for by the “when” clause is never required to occur, be performed. This also applicable to the “when” clauses recited in claims 6-9 and 16-17.
As to claim 1, it is unclear what is structurally required to define “a capillary slide” because such is not structurally defined in the claim. Such slide is not claimed as comprising any capillary nor any other structure that can provide for any capillary force. As such, it is unclear what is required of a slide to be considered as “a capillary slide”. It appears as if such “capillary slide” is not a slide such as conventionally known microscope slide or other similar flat planar structures generally known to be or could be referenced, categorized as “slides”.
Claims 2-22 are rejected via dependency upon a rejected claim.
As to claim 2-4, it is unclear if each of the capillary slide and capillary channel both individually have an annular shape, cylindrical shape, and tapered end or if the combination of both the capillary slide and capillary channel together as a unit have/form an annular shape, cylindrical shape, and tapered end because the claim does not clearly recite such.
Furthermore, it is unclear what is structurally required by the term “mating” because the claim does not provide for such. The term does not provide for any further structure. It is unclear what is required of an annular shape, cylindrical shape, and tapered end to be considered as a mating annular shape, mating cylindrical shape, and mating tapered end because the claims do not clearly recite such. There is no requirement for any of the shapes nor end to be mated with/to anything.
As to claim 6, it is unclear what is the structural nexus/connectivity of the diluent chamber to the capillary channel and capillary slide because the claim does not recite such. It is noted that the specification describes the capillary channel as comprising a diluent chamber. However the claim does not provide for such.
Claim 7-9 recites the limitation "the diluent stored in the diluent chamber" in 2. There is insufficient antecedent basis for this limitation in the claim. There is no prior requirement for the diluent chamber to comprise/contain diluent stored in the diluent chamber, nor is any patient sample positively claimed an element of the cartridge (not required to be located, contained in anything). It is unclear what is further structurally required by the claims because the claims do not provided for any further structural element nor any further structure of any prior positively claimed structural element. Instead, the claims are directed to conditional process steps that are never required to occur. Furthermore, if applicant intends for the capillary channel to comprise a mixing chamber containing a patient sample and a sample chamber containing a patient sample, then the claims should clearly recite such.
It is unclear what is further structurally required by claims 10-12 because the claims do not provided for any further structural element nor any further structure of any prior positively claimed structural element. Instead, claim 10 is directed to a process step. See claim interpretations. In claim 10, it is unclear if it intended for “a tear path” to be structure and a structural element of the fluid barrier because the claim does not recite such. As presently drafted “a tear path” is not structurally defined in the claim and not positively claimed as a structural element of the invention. Furthermore, it there is no controlling of such tear path required to be performed. However, it is unclear what is considered as a “feature” of the piercing element because such is not structurally defined in the claim. Anything can be considered as a “feature”. There is no distinction between “shape” and “feature”.
As to claim 11, it is unclear what is the structural distinction between a fluid sub chamber and a gas sub-chamber because the claim does not provide for such. Gas is a fluid. Therefore, the gas sub-chamber is a fluid sub-chamber. However, no gas nor fluid is positively claimed, required to be present.
The term “thin blade” in claim 13 is a relative term which renders the claim indefinite. The term “thin” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no definitive structural basis, thickness value recited in the claim to determine what is required of a blade to be considered as “thin”. What may be considered as thin by one person may not be considered as such by another and vice versa. Furthermore, it is unclear what is meant by “point” it is noted that any location on the piercing element can be considered as a point. If applicant intends to claim that the piercing element has a shape that tapers, forming/to a point, then the claim should clearly recite such.
Claim 16 recites the limitation "the vent" in line 1. There is insufficient antecedent basis for this limitation in the claim.
It is unclear what is structurally meant, required by claims 18 and 19 because there is no indication that the capillary slide is made of any material, such as an elastic material that allows the slide to be stretched, extended to larger lengths and retracted to smaller length (than an initial length). It is noted that this is different from the amount of the length of the slide that can be exposed out of the capillary channel. If applicant intends to refer to such, then the claims should clearly recite such.
As to claim 19, it is unclear what is structurally meant, required by the phrase “associated with” because the claim does not clearly provide such. It is noted that any two or more things can be subjectively considered as being “associated with” each other.
As to claim 21, it is unclear what is the structural nexus/connectivity of the capillary stop to the capillary channel and capillary slide because the claim does not clearly recite such. If it is intended for the capillary channel to comprise shoulders that define a mechanical stop, then the claim should clearly recite such.
It is unclear what is the structural nexus/connectivity of the vapor barrier to prior positively claimed elements of claim 1 because the claim does not provide for such. It is unclear how the cartridge (the entire invention being defined by the claims) can comprise a vapor barrier that encloses the cartridge (the entire invention including the vapor barrier). The vapor barrier does not and can not enclose itself, the vapor barrier. The claim also contradicts the specification. The vapor barrier is not described/disclosed as being an element of the cartridge.
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.
(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.
Claim(s) 1, 3-19, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by GB 2459122 A to Orion Diagnostica Oy (Orion).
As to claim 1, Orion discloses a diagnostic cartridge (device for diagnostic assays of a liquid specimen, Abstract), comprising: a capillary channel (see Box VIII) (see auxiliary vessel 22 comprising an inner channel 23 to receive a mixture 24 of a sample 21 and reagents 13, 15a, Fig 7; the sample is forced out through sampling channel 27 into the internal space 23 of vessel 22 to comprise mixture 24 of sample 21 and reagents 13 and 15a, pg 15, In 17-22);
a capillary slide (see container 2 comprising sliding sampler 1, Fig 5; sampler 1 and container 2, pg 11, In 4) moveable from a first position in which the capillary slide is structured to collect a controlled volume of a patient sample (see a first position of container 2 and sampler 1 configured to collect patient sample 21 within capillary passage 27, Fig 5; first step collects the sample of blood using the sampler 1, pg 14, In 9-15) to a second position along a longitudinal axis (see how the sampler 1 is moved longitudinally upward relative to the container to a second position, Fig 7),
wherein a portion of the capillary slide is mated within the capillary channel when the capillary slide moves from the first position to the second position (see how the bottom of 1 is mated within the interior of 23 as the sampler 1 is moved from the first to second positions, Fig 5-7).
As to claim 3, Orion discloses, wherein the capillary slide and the capillary channel have a mating cylindrical shape (see how the bottom of sampler 1 and interior channel 23 have mating cylindrical shapes, Fig 6; the auxiliary vessel 22 is a test tube hence cylindrical and sampler 1 is a hollow rod, pg 15, In 1-8).
As to claim 4, Orion discloses wherein the capillary slide and the capillary channel have a mating tapered end (see how 22 tapers at its upper end and how 1 tapers below its stopper 12 to mate together, Fig 5-6).
As to claim 5, Orion discloses the cartridge further comprising a piercing element attached to the capillary slide (see sharp end 9 attached to 1, Fig 5; sharp end 9 to penetrate a penetrable member 3, pg 15, In 6-7).
As to claim 6, Orion discloses the cartridge further comprising a diluent chamber (see liquid reagent chamber 15, Fig 5; liquid reagent chamber 15, pg 15, In 9; one or more chambers 15, 16 for storing gas or liquid reagents needed for analytical assays, pg 11, In 4- 6; reagents for dilution of the sample, pg 3, In 3-5) having a fluid barrier (see penetrable member 3 at the bottom of chamber 15, Fig 5; penetrable member comprises an elastic membrane, pg 10, In 19-21 ), the piercing element positioned to puncture the fluid barrier when the capillary slide is moved to the second position (see how 9 is configured to puncture 3 when sampler 1 is moved upward relative to container 2, Fig 5-7; movement causes the penetration of 3 by sharp end 9 to allow passage from chamber 15, pg 15, In 4-7; to force liquid reagent 15a out from chamber 15 through the formed open passage, pg 15, In 17-22).
As to claim 7, Orion discloses the cartridge wherein, when the fluid barrier is punctured by the piercing element, the diluent stored in the diluent chamber is released into a mixing chamber (see how liquid in chamber 15a is released into channel 27 to mix with sample 21, Fig 6; liquid reagent 15a flows through 27 after barrier 3 is punctured, pg 15, In 4-11 ), and the patient sample is also released into or present within the mixing chamber (see how sample 21 is present within channel 27, Fig 6; 21 is a blood sample from the patient, pg 14, In 13-15).
As to claim 8, Orion discloses the cartridge wherein, when the fluid barrier is punctured by the piercing element, the diluent stored in the diluent chamber is released into a patient sample chamber in which the patient sample is stored after collection (see how liquid in chamber 15a is released into channel 27 to mix with the patient sample 21, Fig 6; liquid reagent 15a flows through 27 after barrier 3 is punctured, pg 15, In 4-11; 21 is a blood sample from the patient, pg 14, In 13-15).
As to claim 9, Orion discloses the cartridge, wherein when the fluid barrier is punctured by the piercing element, the diluent stored in the diluent chamber is released to mix with the patient sample (see how liquid in chamber 15a is released into channel 27 to mix with the patient sample 21, Fig 6; liquid reagent 15a flows through 27 after barrier 3 is punctured, pg 15, In 4-11; 21 is a blood sample from the patient, pg 14, In 13-15), the patient sample released before, after, or simultaneously with the diluent (further movement of sampler 1 flushes the sample and liquid reagent together into the auxiliary vessel to create the ready-to-measure mixture 24, pg 15, In 13-22).
As to claim 10, Orion discloses the cartridge, wherein the piercing element punctures the fluid barrier along a tear path (see how 9 creates a tear path through 3, Fig 6).
As to claim 11, Orion discloses the cartridge, wherein the diluent chamber has a fluid sub-chamber and a gas sub-chamber that are fluidly connected to each other (see how in an embodiment there are two chambers 15 and 16 storing reagents 15a and 16a that are fluidly connected when the puncturing element 9 punctures barriers 3 and 4, Fig 3; chambers 15 and 16 for storing gas or liquid reagents, pg 11, In 4-6) to allow condensed gas to flow from the gas sub-chamber to the fluid sub-chamber (see how gas reagent 16a is configured to flow from chamber 16 to chamber 15 after 9 punctures 4, Fig 4).
As to claim 12, Orion discloses the cartridge, wherein the tear path is controlled by a shape or feature of the piercing element (see how the shape of 9 determines how 3 is torn, Fig 6).
As to claim 13, Orion discloses the cartridge, wherein the piercing element includes a point or thin blade (see how 9 includes a sharp point 28, Fig 6).
As to claim 14, Orion discloses the cartridge, wherein the piercing element is asymmetrical, annular, or semiannular (see how 9 is tapered to form an asymmetrical blade at sharp point 28, Fig 5).
As to claim 15, Orion discloses the cartridge, wherein the capillary slide has a vent (see ventilation holes 14 in flange 11 of sampler 1, Fig 5; ventilation holes 14 in the flange 11 of the sampler 1, pg 11, In 3-4 ).
As to claim 16, Orion discloses the cartridge, wherein the vent is open when the capillary slide is in the first position (see how the ventilation holes 14 allow air to escape during sampling hence in the first position of collecting the patient sample, Fig 5, pg 10, In 9-11) and is closed when the capillary slide is in the second position (see how in the second position the flange 11 has moved upward with portion 12 closing the interior of container 2, Fig 7).
As to claim 17, Orion discloses the cartridge, wherein the capillary slide has multiple vents (see ventilation holes 14 in flange 11 of sampler 1, Fig 5; ventilation holes 14 in the flange 11 of the sampler 1 hence multiple ventilating holes, pg 11, In 3-4 ), the multiple vents open when the capillary slide is in the first position (see how the ventilation holes 14 allow air to escape during sampling hence in the first position of collecting the patient sample, Fig 5, pg 10, In 9-11) and is closed when the capillary slide is in the second position (see how in the second position the flange 11 has moved upward with portion 12 closing the interior of container 2, Fig 7).
As to claim 18, Orion discloses the cartridge, wherein a length of the capillary slide is variable (see how a length of portions 1 and 2 is variable depending on the position of 1 relative to 2, Fig 5-7).
As to claim 19, Orion discloses the cartridge, wherein the capillary slide is adjustable from a first length (see a first length of portions 1 and 2, Fig 5) to a second length (see a second length of portions 1 and 2, Fig 7), the first length associated with a first exposed surface area of the capillary slide (see a first exposed surface area of sampler 1 outside of container 2, Fig 5) and the second length associated with a second exposed surface area that differs from the first exposed surface area (see a second different exposed surface area of sampler 1 outside of container 2, Fig 7).
As to claim 21, Orion discloses the cartridge further comprising a capillary slide stop (see 12, Fig 5; stopper 12 to limit penetration of 1 into the container, pg 14, In 29-30) that prevents movement of the capillary slide along the longitudinal axis beyond the second position (see how 12 abuts against the container to prevent further movement along the vertical longitudinal axis, Fig 7, pg 14, In 28-30).
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.
Claim(s) 2, 20, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orion, GB 2459122 as applied above.
As to claim 2, Orion discloses the cartridge of claim 1, but does not explicitly teach wherein the capillary slide and the capillary channel have a mating annular shape.
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
Orion teaches wherein the capillary channel may have any shape or function including a test tube, cuvette, cassette, or flow through assay device (pg 15, In 1-3).
Accordingly, it would have been within the common sense, knowledge, and skill and obvious to and a person having ordinary skill in the art before the effective filing date to modify the capillary channel and capillary slide to comprise mating annular shapes in order to connect the capillary slide to an annular capillary channel vessel used for the flow through diagnostic assay device.
As to claim 20, Orion discloses the cartridge of claim 1, but does not explicitly teach wherein the capillary slide has a lubricating or anticoagulating coating.
Orion teaches wherein the capillary slide should slide easily within the upper cylinder shaped container (the container 2 is configured such that the sampler 1 may slide easily, Fig 5; pg 14, In 28-29).
Accordingly, it would have been within the common sense, knowledge, and skill and obvious to and a person having ordinary skill in the art before the effective filing date to modify the capillary slide to comprise a lubricating coating in order to allow the capillary slide ,to slide more easily within the upper container portion.
As to claim 22, Orion discloses the cartridge of claim 1, but does not explicitly teach further comprising a vapor barrier that encloses the cartridge.
Orion teaches wherein the capillary slide portion of the cartridge is enclosed within a vapor barrier (see how capillary slide components 1 and 2 are enclosed within packaging 29 hence within vapor barriers, Fig 20-21) in order to be packaged and preserved for later use (container 2 and sampler 1 are in a package 29 to be later combined to form the device, pg 17, In 21-32), but does not explicitly teach wherein the capillary channel component of the cartridge is also enclosed in the vapor barrier packaging.
However, it would have been within the common sense, knowledge, and skill and obvious to and a person having ordinary skill in the art before the effective filing date to further package the capillary channel component together with the capillary slide component such that the entire diagnostic cartridge device may be better stored and packaged within a vapor barrier for future use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Truitt; Patrick et al.; Sherman; Audrey A. et al.; Choy; Si-Lam J. et al.; HAO; Yunling; LING; Shisheng; GALEN; Peter et al.; Freeman; Dominique M. et al.; Nguyen, Hoa et al. and Ayres; Waldemar et al. disclose capillary devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/ Primary Examiner, Art Unit 1798
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