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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claim 1-12, drawn to a removable detection card, classified in A61B 5/14552.
II. Claim 13-20, drawn to a detection method for a removable detection card, classified in A61B 5/157.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the method can be practiced with a different apparatus such an a removable detection card comprising a control unit, which is not required by the removable detection card of Invention I.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classification, the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or the inventions require a different field of search (e.g., Invention II requires a reagent pack that is not required by Invention I).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Leong Lei on 1/8/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-12. Affirmation of this election must be made by applicant in replying to this Office action. Claims 13-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in CN on December 31, 2021. It is noted, however, that applicant has not filed a certified copy of the 202011629595.9 application as required by 37 CFR 1.55. A “Request to Retrieve Electronic Priority Application” was filed by the Applicant on 6/28/2023; however an attempt by the Office to electronically retrieve the application has failed on 8/28/2023. A “Failure Status Report” in response to the Applicant’s request was sent on 08/28/2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/28/2023 and 12/16/2024 are being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
claim 1, lines 8-9, “an in-invitro medical diagnosis device” should read “the in-invitro medical diagnosis device”;
claim 3, line, “wherein the photochemical sensor or the electrochemical sensor are located” should read “wherein the photochemical sensor or the electrochemical sensor is located”
claim 3, line 4, “the hemoglobin and derivatives” should read “the hemoglobin and its derivatives” to be consistent with claims 1 and 2;
claim 4, line 5, “at least greater than 7 mm” should read “at least 7 mm” or “greater than 7 mm”;
claim 7, line 2, “an elastomeric material and/or valve” should read “an elastomeric material and/or a valve”.
Appropriate correction is required.
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 first control part configured to control on-off between the waste liquid area and the internal pipeline” in claim 6;
“a second control part configured to control the on-off between the sample to be detected inlet and the internal pipeline” in claim 6;
“a third control part configured to control the on-off between the internal pipeline and the hemoglobin and derivatives detection area” in claim 6;
“at least two control parts; in an initial state, the two control parts are configured to enable the pipelines corresponding to the two control parts to be in a cut-off state; and after the removable detection card enters an operation state, the two control parts are configured to enable the pipelines corresponding to only one control part to be in a conduction state at the same time” in claim 9;
“a first control part controls on-off between the waste liquid area and the internal pipeline in response to calibrating the sensor in the detection card or requiring discharge of the calibration liquid to the waste liquid area” in claim 10;
“a second control part controls on-off between the sample to be detected inlet and the internal pipeline in response to injecting a sample to be detected into the removable detection card” in claim 11;
“a third control part controls on-off between the internal pipeline and the hemoglobin and its derivatives detection area in response to transferring the sample to be detected in the blood gas detection area to the hemoglobin and its derivatives detection area” in claim 12.
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.
For this instant case, the correspond structures for:
“a first control part configured to control on-off between the waste liquid area and the internal pipeline” is a valve (para. 0074) or equivalents thereof.
“a second control part configured to control the on-off between the sample to be detected inlet and the internal pipeline” is a valve (para. 0074) or equivalents thereof.;
“a third control part configured to control the on-off between the internal pipeline and the hemoglobin and derivatives detection area” is a valve (para. 0074) or equivalents thereof.;
“at least two control parts; in an initial state, the two control parts are configured to enable the pipelines corresponding to the two control parts to be in a cut-off state; and after the removable detection card enters an operation state, the two control parts are configured to enable the pipelines corresponding to only one control part to be in a conduction state at the same time,” ” are valves (para. 0074) or equivalents thereof (the examiner is interpreting the first, second and third control parts in claims 10-12 are the at least two control parts, and thus the “at least control parts” have the equivalent structure of valves. The examiner notes the specification does not provide structures for two control parts with the stated functions of “to be in a cut-off state; and after the removable detection card enters an operation state, the two control parts are configured to enable the pipelines corresponding to only one control part to be in a conduction state at the same time.”);
“a first control part controls on-off between the waste liquid area and the internal pipeline in response to calibrating the sensor in the detection card or requiring discharge of the calibration liquid to the waste liquid area” is a valve (para. 0074) or equivalents thereof.;
“a second control part controls on-off between the sample to be detected inlet and the internal pipeline in response to injecting a sample to be detected into the removable detection card” is a valve (para. 0074) or equivalents thereof.;
“a third control part controls on-off between the internal pipeline and the hemoglobin and its derivatives detection area in response to transferring the sample to be detected in the blood gas detection area to the hemoglobin and its derivatives detection area” is a valve (para. 0074) or equivalents thereof..
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 1-12 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “ at least two external interfaces comprising a calibration liquid inlet and a sample to be detected inlet” in lines 5-6. It is unclear whether (1) one of the at least two external interfaces comprises a calibration liquid inlet and another one of the at least two external internal interfaces comprises a sample to be detected inlet, OR (2) the at least two external interfaces comprises both inlets. For the purpose of examination, it is being interpreted as the at least two external interfaces comprises both inlets.
Claim 3 recites the limitation “comprising a photochemical sensor or an electrochemical sensor wherein the photochemical sensor or the electrochemical sensor are located in the one or more first cavities, and/or the one or more second cavities are configured to detect the hemoglobin and derivatives by colorimetric or electrochemical method in lines 1-4. It is unclear how a single sensor can be in more than one cavities since the limitation could include one or more first cavities and/or the one or more second cavities. For the purpose of examination, it is being interpreted that there is a sensor in each cavity. It is also unclear because parent claim 2 recites the first cavities are for blood detection and the second cavities are for detecting the hemoglobin and its derivatives, but this limitation is indicating that both first cavities and second cavities are for detecting hemoglobin and its derivatives. Clarification is requested.
Claim 4 recites the limitation “distance between the one or more first cavities is at least greater than 7 mm” in lines 4-5, and “a liquid path width between the one or more first cavities is 1 mm” in line 6. Since “one or more first cavities” requires only one first cavity, but these limitations recites “between the one or more first cavities” which would require at least two cavities. Therefore, these limitations are indefinite. For the purpose of examination, “one or more first cavities” is being interpreted as at least two first cavities.
Claim 8 recites the limitation "the waste zone" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, it is being interpreted as the “waste area” in claim 5.
Claim 9 recites the limitation "the pipelines" in lines 3 and 4. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites “an internal pipeline”, para. 0074 of the specification reads “[t]he internal liquid path 9 is divided into a main liquid path and three controllable liquid paths.” For the purpose of examination, it is being interpreted as “pipelines” that are parts of the “internal pipeline” of claim 1 (para. 0074). In addition, claim 9 also recites the limitation “the two control parts are configured to enable the pipelines corresponding to only one control part to be in a conduction state at the same time” in lines 3-4. It is unclear what this limitation is trying to convey. Clarification is requested. For the purpose of examination, it is being interpreted the two control parts are configured to enable the pipelines corresponding to each control part to be in a conduction state at the same time.
Claim 10 recites the limitation “a first control part” in line 1. It is unclear whether the “first control part” is one of the “at least two control parts” in claim 9 or in additional to the “at least two control parts”. For the purpose of examination, it being interpreted as it is one of the “at least two control parts”. Claim 10 also recites the limitation "the sensor" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, it is being interpreted as “a sensor”.
Claim 11 also recites “a second control part” in line 2. It is unclear if the second control part is one of the at least two control parts in claim 9, or if the second part is an additional control part. For the purpose of examination, it being interpreted as it is one of the “at least two control parts”.
Claim 12 recites “a third control part” in line 2. It is unclear if the third control part is one of the at least two control parts in claim 9, or if the third part as it is one of the “at least two control parts”. For the purpose of examination, it being interpreted as a separate control part.
All claims of 1-12 are rejected due to their dependency on Claim 1.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3 and 5-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lawi et al. (“A Microfluidic Cartridge System for Multiplexed Clinical Analysis” JALA Charlottesv Va. 2009 Dec 1;14(6):407–412).
Regarding claim 1, Lawi teaches a removable detection card for an in-vitro medical diagnosis device, comprising:
a blood gas detection area (the area occupied by the first reaction chamber from left position in Fig. 3);
a hemoglobin and its derivatives detection area (the area occupied the sixth reaction chamber from the left in Fig. 3);
an internal pipeline (common fluid passage, waste channel and channels that connect directly between the reaction chambers and the waste channel)(Fig. 4); and
at least two external interfaces comprising a calibration liquid inlet (the fill port to the reagent compartment at the top left position in Fig. 3) and a sample to be detected inlet (the fill port to the reagent compartment at the top middle position in Fig. 3 and the reagent component)(under “Cartridge System”, sample is added to a reagent storage component), wherein the removable detection card is configured to allow a calibrating liquid required by the removable detection card to enter the removable detection card through the calibration liquid inlet after being mounted in a detection area of an in-vitro medical diagnosis device (interpreted as an intended use. the in-vitro medical diagnosis device is not positive recited. A device comprising a syringe can be mounted to the port and fill the reagent component with calibration fluid.)
Regarding claim 2, Lawi teaches all of the elements of the current invention as stated above with respect to claim 1. Lawi further teaches wherein one or more first cavities (the first reaction chamber from the left in Fig. 3) for blood gas detection is located in the blood gas detection area (Fig. 4)(interpreted as an intended use. Blood gas is not positively recited. The reaction chamber meets the structural limitation of the intended use), and one or more second cavities (the sixth reaction chamber from the left in Fig. 3) for detecting a hemoglobin and its derivatives is located in the hemoglobin and its derivatives detection area (Fig. 4)(interpreted as an intended use. A hemoglobin and its derivatives are not positively recited. The reaction chamber meets the structural limitation of the intended use).
Regarding claim 3, Lawi teaches all of the elements of the current invention as stated above with respect to claim 2. Lawi furth teaches the removable detection card further comprising a are capable of being modified for the detection of proteins. Hemoglobin and derivatives are proteins by electrochemical method).
Regarding claim 5, Lawi teaches all of the elements of the current invention as stated above with respect to claim 1. Lawi further teaches the removable detection card further comprising a waste liquid area (waste chamber, which is to top right reagent compartment in Fig. 3)(“Cartridge System”, Figs. 3 and 4), wherein the internal pipeline (common fluid passage, waste channel and channels that connect directly between the reaction chambers and the waste channel) is configured to provide a flow path (waste channel) between the blood gas detection area (area occupied the first reaction chamber from the left in Fig. 3), the hemoglobin and its derivatives detection area (area occupied the sixth reaction chamber from the left in Fig. 3), and the waste liquid area (Fig. 4, the waste channel is shared by all three areas).
Regarding claim 6, Lawi teaches all of the elements of the current invention as stated above with respect to claim 5. Lawi further teaches the removable detection card further comprising a first control part (waste channel delivery valve) configured to control on-off between the waste liquid area and the internal pipeline (common fluid passage, waste channel and channels that connect directly between the reaction chambers and the waste channel) (Fig. 4), and/or a second control part (reagent storage compartment valve corresponds to the top-middle reagent compartment in Fig. 3) configured to control the on-off between the sample to be detected inlet (the fill port to the reagent compartment at the top middle position in Fig. 3 and the reagent component) and the internal pipeline (Fig. 3), and/or a third control part (the reaction chamber delivery valve correspond to the sixth reaction chamber from the left in Fig. 3) configured to control the on-off between the internal pipeline and the hemoglobin and derivatives detection area (area occupied the sixth reaction chamber from the left in Fig. 3)(Fig. 4).
Regarding claim 7, Lawi teaches all of the elements of the current invention as stated above with respect to claim 1. Lawi further teaches the removable detection card further comprising an elastomeric material and/or valve (flexible valve membrane) inside or on a surface of the removable detection card, the elastomeric material and/or valve is configured to implement on-off (Fig. 5).
Regarding claim 8, Lawi teaches all of the elements of the current invention as stated above with respect to claim 5. Lawi further teaches wherein the waste liquid zone (interpreted as the waste liquid area of claim 5. 35 U.S.C 112(b) above) has an external interface (fill port corresponding to the waste chamber, which is to top right reagent compartment in Fig. 3) for communicating with ambient air pressure, and
Regarding claim 9, Lawi teaches all of the elements of the current invention as stated above with respect to claim 5. Lawi further wherein the detection card comprises at least two control parts (valves shown in Fig. 4)(in the case if it is determined that the first, second and third control parts are not part of the at least two control part, then the at least two control parts are all the valves shown in Fig. 4 except the valves corresponds to the first, second and third control parts in claims 10-12); in an initial state, the two control parts are configured to enable the pipelines corresponding to the two control parts to be in a cut-off state; and after the removable detection card enters an operation state, the two control parts are configured to enable the pipelines corresponding to only one control part to be in a conduction state at the same time (p. 2-3, “Fluid Distribution Component” and Figs. 4 and 5 teaches he valves in Fig. 4 are capable of being in an on-state and an off-state to block and allow fluid flow, and they are capable of allowing flow at the same time;).
Regarding claim 10, Lawi teaches all of the elements of the current invention as stated above with respect to claim 9. Lawi teaches wherein a first control part (waste channel delivery valve) controls on-off between the waste liquid area and the internal pipeline (common fluid passage, waste channel and channels that connect directly between the reaction chambers and the waste channel)
Regarding claim 11, Lawi teaches all of the elements of the current invention as stated above with respect to claim in claim 10, wherein a second control part (the reagent storage valve corresponding to the reagent compartment in the top-middle position in Fig. 3) controls on-off between the sample to be detected inlet (the fill port to the reagent compartment at the top-middle position in Fig. 3 and the reagent component) and the internal pipeline (common fluid passage, waste channel and channels that connect directly between the reaction chambers and the waste channel) in response to injecting a sample to be detected into the removable detection card (Fig. 4, the valve is capable of moving from closed to open to allow the sample to flow from inlet to internal pipeline.).
Regarding claim 12, Lawi teaches all of the elements of the current invention as stated above with respect to claim 11. Lawi further teaches wherein a third control part (the reaction chamber delivery valve corresponds to the sixth reaction chamber from the left in Fig. 3) controls on-off between the internal pipeline (common fluid passage, waste channel and channels that connect directly between the reaction chambers and the waste channel) and the hemoglobin and its derivatives detection area (the area occupies by the sixth reaction chamber from the left in Fig. 3) in response to transferring the sample to be detected in the blood gas detection area to the hemoglobin and its derivatives detection area (Fig. 4, the valve is capable of moving from closed to open to allow the sample to flow from internal pipeline to the reaction chamber); and/or each of the first control part, the second control part and the third control part in the removable detection card controls on-off of a corresponding pipeline (Fig. 4) in response to a power drive in a host of the in-vitro medical diagnosis device (interpreted as an intended use. A power drive, a host and an in-vitro medical diagnostic device are not positively recited. The first, second, third controls parts are structural limitation of the intended use.).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lawi et al. (“A Microfluidic Cartridge System for Multiplexed Clinical Analysis.” JALA Charlottesv Va. 2009 Dec 1;14(6):407–412)) in view of Heller (US 20030201194 A1).
Regarding claim 4, Lawi teaches all of the elements of the current invention as stated above with respect to claim 2.
Lawi teaches a microfluidic device for detection of analytes using electrochemical methods. Lawi teaches the device comprises reaction chambers wherein at the bottom of each reaction chamber has an electrode modified with a sensing layer for detecting a target analyte. Lawi teaches the design of the device is to minimum sample volume.
Lawi teaches the overall size of the cartridge is 90 mm × 48 mm × 7.5 mm, but Lawi does not explicitly teaches wherein the second cavity is thinner than the first cavity, and/or a diameter of the second cavity is greater than a diameter of the first cavity; and/or the first cavity has a thickness of 0.6 mm to 0.9 mm, and/or the second cavity has a thickness of 0.1 mm to 0.5 mm; and/or a distance between the one or more first cavities is at least greater than 7 mm, and/or the one or more first cavities have an interior width of 2.5 mm, 3.5 mm, or 4.5 mm; and/or a liquid path width between the one or more first cavities is 1 mm.
However, Heller teaches a biosensing device for detecting analyte based on electrochemical reaction (abstract, para. 0012). Heller further teaches the device comprises the sample chamber (26) wherein at the bottom of each sample chamber has an electrode (22) modified with a sensing layer (32)(Fig. 4) for detecting a target analyte. Heller further teaches the thickness of the sample chamber is less than about 0.2 mm (para.0076). Heller teaches the thickness is small to promote rapid electrolysis of the analyte, as more of the sample will be in contact with the electrode surface for a given sample volume (para. 0076).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the thickness of the reaction chambers taught by Lawi less than 0.2 mm as taught by Heller in order to promote rapid electrolysis of the analyte, as more of the sample will be in contact with the electrode surface with a reasonable expectation of success (Heller, para. 0076) (MPEP 2143)(I)(G). In addition, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to select the reaction chamber thickness to be between 0.1 to 0.2 mm, the portion of modified Lawi’s teaching that corresponds to the claimed range. MPEP 2144.05.
The teachings of Lawi as modified by Heller yields the second cavity has a thickness between 0.1 mm to 0.2 mm.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY CHIU whose telephone number is (571)272-1054. The examiner can normally be reached 9 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.L.C./ Examiner, Art Unit 1758
/REBECCA M FRITCHMAN/ Primary Examiner, Art Unit 1758