DETAILED ACTION
Notice of AIA Status
The present application, filed on 12/20/2023, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-14 are pending.
Claims 1-5 and 12-14 are rejected.
Claims 1-13 are objected.
Claim Objections
Claims 1-13 are objected to because of the following informalities:
Claim 1 recites “A pipette tip adapter (1) detachably connectable between a pipetting device (10) and a pipette tip (15), comprising:…”. For clarity consider rephrasing to ‘A pipette tip adapter (1) detachably connectable between a pipetting device (10) and a pipette tip (15), the pipette tip adapter comprising:…’.
Claim 2 recites “the volume of the recess”. For consistency of terminology, consider rephrasing to ‘the inner volume of the recess’.
Claim 8 recites “at least one distance element (24) is configured as elongated distance bar that extend continuously…”. For clarity, consider rephrasing to ‘at least one distance element (24) is an elongated distance bar extending continuously ….’.
Claim 9 recites “based on absolute capacitance and/or impedance”. For clarity, consider rephrasing to ‘based on impedance or on absolute capacitance or both’.
Claim 11 recites “the electrically conductive tab (13) is aligned in part radially from the proximal end of the internal wall (23) towards the outer casing (21) without contacting it galvanically”. For clarity on antecedent of the recited pronoun ‘it’, consider replacing ‘it’ with ‘the outer casing”. Additionally, for consistency in terminology with claim 8, consider replacing “the proximal end of the internal wall” with ‘the proximal opening of the internal wall’. That is, consider rephrasing the phrase to ‘the electrically conductive tab (13) is aligned in part radially from the proximal opening of the internal wall (23) towards the outer casing (21) without galvanically contacting the outer casing (21)’.
Claims dependent on an objected claim are objected to because any claim in dependent form is construed to incorporate by reference all the limitations of the claim to which it refers.
In addition, claims 6-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Claim 2 is rejected under 35 U.S.C. 112(b) 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 2 recites the phrase “that liquid (18) in the interior compartment (7) does not enter the volume of the recess (3) when the pipette tip adapter (1) is arranged above the pipette tip adapter (1)” which renders the scope of claim 2 unclear because it is ambiguous whether the second-recited pipette tip adapter (1) refers to the first-recited pipette tip adapter (1) or whether the second-recited pipette tip adapter (1) is an additional pipette tip adapter (1).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe (US20200368738) in view of Smith (US20080095665).
With respect to claim 1, Watanabe (US20200368738) teaches a pipette tip adapter (1) (injection tip 16 in [0054]) detachably connectable to a pipetting device (10) (genetic testing device in [0004], which recites “ the injection tip mounted on a pipette head of the genetic testing device”) (see Fig.17, which illustrates the injection tip detachably mounted onto the pipette head 3 of the genetic testing device), (the pipette tip adapter (1) (injection tip 16) comprising:
a body (2) (reservoir 31 in [0066], which recites “as illustrated in FIGS. 3 to 5, the injection tip 16 has a reservoir 31”) (see also [0067], which recites “reservoir 31 has a cylindrical portion 33”) with an interior compartment (7) (internal space A in [0068], which recites “the cylindrical portion 33 is a part that forms the internal space A) for holding a liquid (18) (sample solution in [0068], which recites “the cylindrical portion 33 is a part that forms the internal space A where the sample solution is stored”);
a recess (3) (flange portion 34 in [0067], which recites “reservoir 31 has …, a flange portion 34”) entering into a part (upper end in [0068]) of the body (2) (reservoir 31) (see Figs. 3 and 17) for detachably receiving a connector (11) (pipette head 3 in [0068]) of the pipetting device (10) (genetic testing device) and having a first opening (5) (opening 36 in [0068], which recites “formed at the upper end of the cylindrical portion 33 is an opening 36”) pneumatically connected with the interior compartment (7) (internal space A) (see [0107], which recites “a groove functioning as an air vent may be formed in the inner peripheral surface of the reservoir”),
a tube section (4) (needle tube 42 in [0072]) projecting from the pipette tip adapter (1) (injection tip 16) and having a second opening (6) (which is an end opening of the holding hole 37 hydraulically connected with the interior compartment, see Fig. 5) hydraulically connected with the interior compartment (7) (internal space A) (see [0067], which recites “reservoir 31 has …a holding portion 35) (see [0070], which recites “a holding hole 37, where the injection needle 32 is held, is formed in the holding portion 35. The holding hole 37 extends in the up-down direction and communicates with the internal space A”).
Watanabe fails to teach the pipette tip adapter (1) (injection tip 16 in [0054]) is detachably connectable between the pipetting device (10) (genetic testing device in [0004]) and a pipette tip (15); and that the tube section is detachably securable with a pipette tip (15).
In the analogous art of devices for transferring samples, Smith (US20080095665) teaches a pipette tip adapter (ergonomic barrel adapter 85 in [0082]) detachably connectable between a pipetting device (standard pipetter barrel 48 in [0088], which recites “FIGS. 12, 13 and 14 illustrate a new ergonomic barrel adapter 85 that is adapted to fit between a standard pipette tip 55 and the pipetter barrel 48 of a pipetter”) and a pipette tip (standard pipette tip in [0084], which recites “fluid 60 that has been aspirated into standard pipette tip 29 from the pipetter”).
In addition, Smith (US20080095665) teaches a tube section (lower portion 40 in [0088]) detachably securable with a pipette tip (one or more standard pipette tips in [0088], which recites “FIGS. 17 and 19 illustrate a standard pipetter barrel 48 shown being installed into the upper portion 42 of barrel adapter 85 similar to FIG. 16. The upper portion in this embodiment is connected to one or more lower portion 40 allowing the barrel adapter 85 to be installed onto one or more standard pipette tips”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pipette tip adapter disclosed by Watanabe by securely and detachably connecting the pipette tip disclosed by Smith (US20080095665) to the projecting tube section (4) (needle tube 42) of Watanabe with a reasonable expectation of success such that the pipette tip adapter (1) is detachably connectable between the pipetting device (10) and a pipette tip (15); and that the tube section is detachably securable with a pipette tip (15) for the benefit of preventing cross-contamination and protecting sample. With the incorporation of the detachable pipette tip of Smith, the pipette tip can be removed and discarded after a single use ensuring that any residual liquid, reagents, or biological material from the previous sample is not carried over into the next one, maintaining sample purity and experimental accuracy which is desirable in sensitive applications such as genetic PCR testing, cell culture, or work with hazardous chemicals, where contamination can invalidate results or damage the device for transferring samples.
With respect to claim 14, Watanabe (US20200368738A1) teaches a pipette tip adapter (1) (injection tip 16 in [0054]) detachably connectable to a pipetting device (10) (genetic testing device in [0004]), (the pipette tip adapter (1) (injection tip 16) comprising:
a body (2) (reservoir 31 in [0066], which recites “as illustrated in FIGS. 3 to 5, the injection tip 16 has a reservoir 31”) (see also [0067], which recites “reservoir 31 has a cylindrical portion 33”) with an interior compartment (7) (internal space A in [0068], which recites “the cylindrical portion 33 is a part that forms the internal space A) for holding a liquid (18) (sample solution in [0068], which recites “the cylindrical portion 33 is a part that forms the internal space A where the sample solution is stored”);
a recess (3) (flange portion 34 in [0067], which recites “reservoir 31 has …, a flange portion 34”) entering into a part (upper end in [0068]) of the body (2) (reservoir 31) (see Figs. 3 and 17) for detachably receiving a connector (11) (pipette head 3 in [0068]) of the pipetting device (10) (genetic testing device) and having a first opening (5) (opening 36 in [0068], which recites “formed at the upper end of the cylindrical portion 33 is an opening 36”) pneumatically connected with the interior compartment (7) (internal space A) (see [0107], which recites “a groove functioning as an air vent may be formed in the inner peripheral surface of the reservoir”),
a tube section (4) (needle tube 42 in [0072]) projecting from the pipette tip adapter (1) (injection tip 16) and having a second opening (6) (which is an end opening of the holding hole 37 hydraulically connected with the interior compartment, see Fig. 5) hydraulically connected with the interior compartment (7) (internal space A) (see [0067], which recites “reservoir 31 has …a holding portion 35) (see [0070], which recites “a holding hole 37, where the injection needle 32 is held, is formed in the holding portion 35. The holding hole 37 extends in the up-down direction and communicates with the internal space A”).
Watanabe fails to teach that the pipette tip adapter (1) is part of an automated pipetting system for preparing liquid reactions and is detachably connectable between the pipetting device (10) and a pipette tip (15); and that the tube section is detachably securable with a pipette tip (15).
In the analogous art of devices for transferring samples, Smith (US20080095665) teaches an automated pipetting system (100) (automating equipment in [0019], which recites “invention is designed with an angled apex end or provides separate channels for the fluid to flow through when the ergonomic pipette tip contacts any surface. This concept is especially beneficial in use with multi-pipetters and automating equipment when the user or the machine can be designed to touch the bottom surface of its container to insure that the entire valuable sample is removed and dispensed”) for preparing liquid reactions (the automated pipetting system of Smith is capable of preparing liquid reactions, see [0034], which recites “reagent or reactant within the pipette tip. It also includes an optional apex end configuration for insuring fluid transfer when the apex end contacts the surface of a container”).
In addition, Smith (US20080095665) teaches a pipette tip adapter (ergonomic barrel adapter 85 in [0082]) detachably connectable between a pipetting device (standard pipetter barrel 48 in [0088]) and a pipette tip (standard pipette tip in [0084], which recites “fluid 60 that has been aspirated into standard pipette tip 29 from the pipetter”).
In addition, Smith (US20080095665) teaches a tube section (lower portion 40 in [0088]) detachably securable with a pipette tip (one or more standard pipette tips in [0088], which recites “FIGS. 17 and 19 illustrate a standard pipetter barrel 48 shown being installed into the upper portion 42 of barrel adapter 85 similar to FIG. 16. The upper portion in this embodiment is connected to one or more lower portion 40 allowing the barrel adapter 85 to be installed onto one or more standard pipette tips”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pipette tip adapter disclosed by Watanabe by detachably connecting the pipette tip disclosed by Smith (US20080095665) such that the pipette tip of Smith (US20080095665) detachably secured to the projecting tube section (4) (needle tube 42) of Watanalbe with a reasonable expectation of success such that the automated pipetting system (100) comprises a pipette tip adapter (1) for preparing liquid reactions, the pipette tip adapter (1) detachably connectable between the pipetting device (10) and a pipette tip (15); and the tube section detachably securable with a pipette tip (15) for the benefit of preventing cross-contamination and protecting sample. With the incorporation of the detachable pipette tip of Smith, the pipette tip can be removed and discarded after a single use ensuring that any residual liquid, reagents, or biological material from the previous sample is not carried over into the next one, maintaining sample purity and experimental accuracy which is desirable in sensitive applications such as PCR, cell culture, or work with hazardous chemicals, where contamination can invalidate results or damage the device for transferring samples.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe (US20200368738) in view of Smith (US20080095665) in view of Sternick (US10799871).
With respect to claim 3, Watanabe in view of Smith (US20080095665) teaches the pipette tip adapter (1) according to claim 1 wherein the body (reservoir 31) comprises an outer casing (cylindrical portion 33 in [0067], which recites “The reservoir 31 has a cylindrical portion 33”) (see Fig. 5)
Watanabe in view of Smith (US20080095665) fails to teach that the body comprises a cover (22) and an internal wall (23).
In the analogous art of pipette tip adapters, Sternick (US10799871) teaches a body of a pipette tip adapter (aspirator adapter 30) comprising a cover (22) (cap portion 32 in column 5 (see Fig. 4) and an internal wall (23) (inner section 54 in column 8) (see Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pipette tip adapter disclosed by Watanabe in view of Smith (US20080095665) by incorporating the cover and the internal wall disclosed by Sternick into the body with a reasonable expectation of success for the benefit of facilitating the uptake of media container in a collection tube (see column 8 of which recites “An uptake tube 122 may be connected to the inner section 54 of the pipette interface portion 50 ( see e.g. , FIG. 16 ) , and may be positioned in the interior of the collection tube or collection container to facilitate the uptake of media contained within the interior into the pipette connected thereto”).
With respect to claim 5, Watanabe (US20200368738) in view of Smith (US20080095665) in view of Sternick (US10799871) teaches the pipette tip adapter (1) according to claim 3, wherein the internal wall (23) (inner section 54 in Sternick) is in a form of a cup (see Fig. 4 of Sternick, which illustrates the inner section 54 as a hollow, cup-shaped member extending from the cap portion and defining an interior cavity).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Watanabe (US20200368738) in view of Smith (US20080095665) in view of Sternick (US10799871) in view of Hong (CN213854618U, mapped to the English Translation).
With respect to claim 4, Watanabe in view of Smith (US20080095665) in view of Sternick teaches the pipette tip adapter according to claim 3.
Watanabe in view of Smith (US20080095665) in view of Sternick fails to teach the outer casing (21) and the cover (22) are joined by interference fit, and the cover (22) and the internal wall (23) are joined by interference fit.
In the analogous art of pipetting devices, Hong (NC213854618U) teaches interference fit is an effective way of joining a first given pipette component to a second given pipette component (see page 4, which recites “the sealing layer 15 is in interference fit with the inner wall of a pipette 2, and the sealing layer 15 increases the tightness between the partition plate 9 and the inner wall of the pipette 2 and the suction head 7, so that the pipette 2 can be used more accurately, and the possibility that contaminants on the upper side of the partition plate 9 enter the lower side of the partition plate 9 is reduced”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pipette tip adapter disclosed by Watanabe in view of Smith (US20080095665) in view of Sternick by applying the interference-fit joining technique as disclosed by Hong to the the outer casing (21) and the cover (22) and to the cover (22) and the internal wall (23) disclosed by Sternick such that the outer casing (21) and the cover (22), and the cover (22) and the internal wall (23) are joined by interference fit as recited in claim 4 with a reasonable expectation of success for the benefit of effectively retaining the components while reducing contaminant ingress and eliminating the need of fasteners or adhesives (see page 4 of Hong).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Watanabe (US20200368738) in view of Smith (US20080095665) in view of Wingo (US20130203089).
With respect to claim 12, Watanabe in view of Smith (US20080095665) teaches the pipette tip adapter (1) according to claim 1.
Watanabe in view of Smith (US20080095665) fails to teach a filter (9) is placed within the recess (3), such that gas entering the recess (3) must pass the filter (9) before reaching the interior compartment (7) through the first opening (5).
In the analogous art of providing pipette tip adapters, Wingo teaches a filter (porous filter in adapter in Fig. 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pipette tip adapter disclosed by Watanabe in view of Smith (US20080095665) by placing the filter disclosed by Wingo within the recess of the pipette tip adapter such that gas entering the recess (3) must pass the filter (9) before reaching the interior compartment (7) through the first opening (5) with a reasonable expectation of success for the benefit of enhancing protection of the pipetting device from contaminating fluids or aerosolized droplets (see [0056], which recites [0056], which recites “the pipette tip contains a filter, the combination of a filtered adapter with a filtered pipette tip provides enhances protection of the pipetting device from contaminating fluids or aerosolized droplets”).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Watanabe (US20200368738) in view of Smith (US20080095665) in view of Smith (US8343438).
With respect to claim 13, Watanabe in view of Smith (US20080095665) teaches the pipette tip adapter (1) according to claim 1.
Watanabe in view of Smith (US20080095665) fails to teach that the interior compartment (7) of the body (2) further comprises one or more depots of active substances.
In the analogous art of pipette tip adapters, Smith (US8343438) teaches a depots of active substances (see column 15, which recites “dried reagent or reactant 61 with a predetermined amount of sample fluid 60 into the pipette tip 55 allowing it to contact and mix to perform a particular diagnostic test or other reactions. This not only saves valuable time and additional vials or containers that are normally used for this purpose but more importantly uses all of the sample the pipette tip draws within its cavity since none is lost due to the transfer from one vial to another”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pipette tip adapter disclosed by Watanabe in view of Smith (US20080095665) by loading the predetermined quantity of dry reagent of reactant disclosed by Smith (US8343438) within interior compartment (internal space A in Watanabe) of the body (reservoir 31 in Watanabe) with a reasonable expectation of success such that the interior compartment (7) of the body (2) further comprises one or more depots of active substances for the benefit effectively enabling a sample introduced into the interior compartment to contact the loaded reagent and thereby perform desired reactions for a diagnostic test while reducing handling steps and minimizing sample loss.
Allowable Subject Matter
Claim 2 would be allowable if rewritten to overcome the rejection under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
With respect to claim 2, Watanabe in view of Smith (US20080095665) fails to teach one or more continuous flow paths (8) connect an inner volume of the recess (3) with the interior compartment (7) of the body (2), such that the one or more continuous flow paths (8) are arranged along the recess (3) from the first opening (5) in the center of the body (2) towards a periphery of the body, such that liquid (18) in the interior compartment (7) does not enter the volume of the recess (3) when the pipette tip adapter (1) is arranged above the pipette tip adapter (1).
Claims 6-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
With respect to claims 6-8, Watanabe (US20200368738) in view of Smith (US20080095665) in view of Sternick (US10799871) fails to teach the internal wall (23) or the cover (22) comprise one or more distance elements (24) to hold the internal wall (23) in place and arranged such that one or more continuous flow paths (8) are formed from the first opening (5) to the interior compartment (7).
With respect to claims 9-11, Watanabe (US20200368738) in view of Smith (US20080095665) in view of Sternick (US10799871) fails to teach the outer casing (21) is electrically conductive, whereas the cover (22) and the internal wall (23) are electrically non-conductive for measuring liquid volumes based on absolute capacitance and/or impedance.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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/JONATHAN BORTOLI/Examiner, Art Unit 1797
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