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 .
Note Regarding Prior Art
Examiner cites particular sections, columns, line numbers, paragraphs and figures, in the references as applied to the claims below for the convenience of the Applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the Applicant fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
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.
Claim(s) 1, 7, 11 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tang et al. (CN104391127A; hereinafter “Tang”) in view of Du et al. (CN213854612U; hereinafter “Du”).
Regarding claim 1, Tang teaches an in-vitro diagnostic test cassette with a liquid sample feeding port structure having functions of quantification, sealing and anti-overflow (see description; paragraph 41 and figure 4):
a sample quantification assembly comprising a body, a quantitative chamber being provided in the body (boss 201);
a liquid injection chamber comprising a sample well 313 (i.e., the first chamber) is located in a main body 2, the cylinder (i.e., the partition plate) forming the sample well has a diameter-reducing design structure from the opening end to the bottom thereof, and an annular overflow groove 315 (i.e., the second chamber) is provided around the periphery of the cylinder;
an elastic sealing cover 2 (i.e., the sample quantitative assembly) is provided with a boss 201 (i.e., the body, a quantitative chamber being provided inside the body) which serves as a liquid discharge head, and the root of the boss is in a sealing fit with the sample well 313;
when the elastic sealing cover is tightly closed, the liquid discharge head 201 enters the sample well 313, so that the excessive liquid in the sample well 313 is discharged into the overflow groove 315 through a liquid discharge groove 316, and then discharged to a waste liquid well through a through hole 305; and
when the sealing cover is completely closed, the liquid discharge head 201 completely discharges the excessive liquid, and at the same time, the root of the liquid discharge head 201 seals the sample well, wherein the volume of the liquid is equal to the volume of the sample well minus the volume of the liquid discharge head 201.
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Tang does not specifically teach wherein the sample quantification assembly is configured to be pressed into the liquid injection chamber such that the body extends into the first chamber for quantitative sample injection.
Du teaches a liquid feeding apparatus for a chip (see description; paragraphs 34 – 38 and figure l); when a reagent is injected, a flow guiding block 2 (i.e., the sample feeding column) is first mounted at a sample feeding port of a transparent conductive cover 11, so that a first end of a flow guiding hole 21 on the flow guiding block 2 is in communication with a gap of a chip 1; the reagent is stored in a reagent kit 3, and the reagent kit 3 is mounted on the flow guiding block 2; and a second end of the flow guiding hole 21 is in communication with a chamber of the reagent kit 3, and the reagent is injected into the gap of the chip 1 through the flow guiding hole 21. In other embodiments, the reagent kit 3 can be replaced with a pipetting gun, a sampler, or the like, and can also cooperate with the flow guiding block 2 to inject the reagent. The housing of the reagent kit 3 is a deformable housing, and when the housing is pressed, the housing deforms to compress the space of the chamber of the reagent kit 3, such that the reagent is squeezed and injected into the gap of the chip 1 through the flow guiding hole 21.
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Consequently, as shown by Du, the concept of injecting a sample while performing quantification would have been considered to be suitable and predictable to a person of ordinary skill in the art. Du provides the motivation to compress the space of the chamber of the reagent kit 3 to squeeze and inject the reagent into the gap of the chip through the flow guiding hole of the flow guiding block (i.e. the sample feeding column in the present application). According to this motivation, a person skilled in the art would have been motivated to complete sample injection by using the sample feeding column while pressing the cover body to achieve quantification using the Tang apparatus. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, the Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) has affirmed that the threshold requirement for a prima facie case of obviousness is “demonstrating that each element was, independently, known in the prior art.” Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the sample quantification assembly is configured to be pressed into the liquid injection chamber such that the body extends into the first chamber for quantitative sample injection. Examiner submits that these arguments are in line with the Supreme Court unanimous opinion, KSR International v. Teleflex, Inc., 127 S. Ct. 1727, 1741 (2007), in which the Court stated that “[a] court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions.” Id. at 1731.
Regarding claim 7, Tang teaches a method for quantitatively injecting a test sample into a chip, the method using a system device according to claim 1, the method comprising: injecting a test sample into a first chamber; placing a sample quantification assembly in a liquid injection chamber using a liquid injection chamber comprising a sample well 313 (i.e., the first chamber) is located in a main body 2, the cylinder (i.e., the partition plate) forming the sample well has a diameter-reducing design structure from the opening end to the bottom thereof, and an annular overflow groove 315 (i.e., the second chamber) is provided around the periphery of the cylinder (see description; paragraph 41 and figure 4).
Tang does not specifically teach the step of continuously pressing down the sample quantification assembly such that a body is delivered into a first chamber from an open end of a housing, part of the test sample in the first chamber overflows to a second chamber, and the test sample entering a quantitative chamber flows into a gap chamber to achieve quantitative sample injection.
Du teaches a liquid feeding apparatus for a chip (see description; paragraphs 34 – 38 and figure l); when a reagent is injected, a flow guiding block 2 (i.e., the sample feeding column) is first mounted at a sample feeding port of a transparent conductive cover 11, so that a first end of a flow guiding hole 21 on the flow guiding block 2 is in communication with a gap of a chip 1; the reagent is stored in a reagent kit 3, and the reagent kit 3 is mounted on the flow guiding block 2; and a second end of the flow guiding hole 21 is in communication with a chamber of the reagent kit 3, and the reagent is injected into the gap of the chip 1 through the flow guiding hole 21. In other embodiments, the reagent kit 3 can be replaced with a pipetting gun, a sampler, or the like, and can also cooperate with the flow guiding block 2 to inject the reagent. The housing of the reagent kit 3 is a deformable housing, and when the housing is pressed, the housing deforms to compress the space of the chamber of the reagent kit 3, such that the reagent is squeezed and injected into the gap of the chip 1 through the flow guiding hole 21.
Consequently, as shown by Du, the concept of injecting a sample while performing quantification would have been considered to be suitable and predictable to a person of ordinary skill in the art. Du provides the motivation to compress the space of the chamber of the reagent kit 3 to squeeze and inject the reagent into the gap of the chip through the flow guiding hole of the flow guiding block (i.e. the sample feeding column in the present application). According to this motivation, a person skilled in the art would have been motivated to complete sample injection by using the sample feeding column while pressing the cover body to achieve quantification using the Tang apparatus. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, the Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) has affirmed that the threshold requirement for a prima facie case of obviousness is “demonstrating that each element was, independently, known in the prior art.” Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the sample quantification assembly is configured to be pressed into the liquid injection chamber such that the body extends into the first chamber for quantitative sample injection. Examiner submits that these arguments are in line with the Supreme Court unanimous opinion, KSR International v. Teleflex, Inc., 127 S. Ct. 1727, 1741 (2007), in which the Court stated that “[a] court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions.” Id. at 1731.
Regarding claim 11, as similarly described above for claim 1, Tang in view of Du teaches a system device for quantitatively injecting a test sample into a chip (see description; paragraph 41 and figure 4), the system device being configured to inject a quantitative test sample into a gap chamber of a chip, the system device comprising a liquid injection chamber, wherein the liquid injection chamber comprises:
an open housing;
a partition plate disposed in the housing, the partition plate dividing the housing into a first chamber and a second chamber, the first chamber being configured to accommodate the test sample injected therein and accommodate an assembly which is pressed into the first chamber and forms a seal with an inner wall thereof, and the second chamber being configured to store the sample overflowing from the first chamber; and
at least one sample intake column disposed in the first chamber, a sample injection channel in the sample intake column being configured to communicate the first chamber with the gap chamber of the chip, wherein the sample intake column is higher than the partition plate.
Regarding claim 14, as similarly described above for claim 1, Tang in view of Du teaches a sample quantification assembly for quantitatively injecting a test sample into a chip, the sample quantification assembly comprising: a body, wherein a quantitative chamber is provided in the body, the body is configured to be pressed into a chamber filled with the test sample, and the quantitative chamber is configured to accommodate a sample intake column disposed in the chamber; and a base fixed to the body.
Allowable Subject Matter
Claims 2 – 6, 8, 9, 11 – 13 and 15 – 21 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 2, the cited prior art neither teaches nor fairly suggests the system device according to claim 1, wherein at least one sample intake column, which is in communication with the gap chamber, is disposed in the first chamber, and the at least one sample intake column is configured to extend into the quantitative chamber.
Regarding claim 3, the cited prior art neither teaches nor fairly suggests the system device according to claim 1, wherein a sealing member is disposed on an outer wall of the body.
Regarding claim 4, the cited prior art neither teaches nor fairly suggests the system device according to claim 1, wherein the sample quantification assembly further comprises a base configured to secure the body, and an edge of the base is configured to be in interference fit with the inner wall of the housing during sample injection.
Regarding claim 6, the cited prior art neither teaches nor fairly suggests the system device according to claim 1, wherein a stepped groove is provided on a surface of one side of the partition plate close to the sample quantification assembly; and the stepped groove comprises a first groove and a second groove in a direction along which the body extends into the first chamber, and the first groove has a greater width than the second groove.
Regarding claim 8, the cited prior art neither teaches nor fairly suggests the method according to claim 7, wherein at least one sample intake column, which is in communication with the gap chamber, is disposed in the first chamber, the sample intake column comprises a sample injection channel which runs through the sample intake column and is in communication with the gap chamber, and the quantitative sample injection comprises: continuously pressing down the sample quantification assembly to cause the sample intake column to gradually extend into the quantitative chamber to push the test sample into a gap between the sample intake column and the quantitative chamber, such that the test sample flows into the gap chamber through the sample injection channel.
Regarding claim 9, the cited prior art neither teaches nor fairly suggests the method according to claim 7, further comprising venting during the quantitative sample injection.
Regarding claim 12, the cited prior art neither teaches nor fairly suggests the system device according to claim 11, wherein a stepped groove is provided on a surface of one side of the partition plate close to the open end of the housing, the stepped groove comprises a first groove and a second groove in a direction toward the inside of the housing, and the first groove has a greater width than the second groove.
Regarding claim 13, the cited prior art neither teaches nor fairly suggests the system device according to claim 11, wherein a venting slot is provided on an inner wall of the housing close to an open end.
Regarding claim 15, the cited prior art neither teaches nor fairly suggests the sample quantification assembly according to claim 14, wherein a groove is provided on an outer wall of the body and configured to mount a sealing member.
Regarding claim 16, the cited prior art neither teaches nor fairly suggests the sample quantification assembly according to claim 14, wherein a guide member is provided on a surface of one side of the base close to the body; wherein: a gap is reserved between the body and the guide member; a venting through-hole is provided in a surface of the base; and/or a venting notch is provided at an outer periphery of the base.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
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