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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/26/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-6 and 17-29 are pending.
Claim Objections
Claims 1, 3-4, 6, 21, and 25-29 objected to because of the following informalities:
Claim 1 recites the limitation “configured to allow the passage of liquid” should read as “configured to allow the passage of a liquid” in line 3;
claim 4 recites the limitation “wherein inner surface of the opening” should read as “wherein an inner surface of the opening” in line 2;
claim 6 recites the limitation “a container for storing liquid” should read as “a container for storing the liquid” in line 2;
claim 21 recites the limitation “the container is reduced to squeeze liquid” should read as “the container is reduced to squeeze the liquid” in line 2;
claim 25 recites the limitation “the at least one biological sample” should read as “the one or more biological samples” in lines 2-3;
claim 26 recites the limitation “the at least one biological sample” should read as “the one or more biological samples” in lines 2-3 and line 4;
claim 27 recites the limitation “the at least one biological sample” should read as “the one or more biological samples” in line 3;
claim 28 recites the limitation “the at least one biological sample” should read as “the one or more biological samples” in line 3; and
claim 29 recites the limitation “the at least one biological sample” should read as “the one or more biological samples” in lines 3-4. Appropriate correction is required.
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 26-28 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.
Claim 26 recites the limitation "a reaction between a reagent and the at least one biological sample is an element" in lines 2-3. Claim 26 is dependent upon claim 25 and claim 25 recites the limitation “an element for indicating and/or measuring a reaction between a reagent and the at least one biological sample”. Thus, the limitation is unclear as to whether claim 26 is reciting a “new reaction” between a different reagent and different element. Specifically, is the Applicant claiming additional reagents and elements within that indicate something different from claim 25? For purpose of prosecution, the Examiner interprets the structures to be the same.
Claim 26 recites the limitation “the mixture of the liquid from the container and of the at least one biological sample” in lines 3-4. Specifically, there is no antecedent basis for “the mixture” between the liquid and the at least one or more biological sample. There is insufficient antecedent basis for this limitation in the claim, thus the limitation is unclear.
Claim 27 recites the limitation “the mixture of the liquid from the container and of the at least one biological sample” in lines 2-3. Specifically, there is no antecedent basis for “the mixture” between the liquid and the at least one or more biological sample. There is insufficient antecedent basis for this limitation in the claim, thus the limitation is unclear.
Claim 28 recites the limitation “the mixture of the liquid from the container and of the at least one biological sample” in lines 2-3. Specifically, there is no antecedent basis for “the mixture” between the liquid and the at least one or more biological sample. There is insufficient antecedent basis for this limitation in the claim, thus the limitation is unclear.
Claim Rejections - 35 USC § 102
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 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 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.
Claim(s) 1-6 and 17-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson et al (US 20110092915 A1; hereinafter “Olson”).
Regarding claim 1, Olson teaches a device for collecting one or more biological samples1 (Olson; Abstract) comprising a housing (Olson; Fig. 1A; the device 100) and a collector element, wherein the collector element is configured to allow the passage of liquid (Olson; Fig. 3; para [63]; the syringe 110 is delivered through the needle 110 to the patient by the downward movement of plunger rod 115 and plunger 112 within syringe 118; Examiner interprets the collector element to comprise the needle, syringe, plunger, and needle guard), and wherein the collector element extends between a first end and a second end, the first end of the collector element protruding out of the housing for collecting the one or more biological samples, the second end of the collector element being arranged within the housing (Olson; Fig. 3, 7; the first end is interpreted as the needle end outside of the syringe and the second end is interpreted as the needle end within the syringe), wherein the device further comprises a coil element which is arranged between collector element and the housing (Olson; Fig. 4; para [68]; needle guard return element 114…Needle guard return may be any element capable of causing needle guard 108 to extend over needle 110 including, without limitation, a spring; the needle guard return element is within the lower housing 102 and surrounds the needle guard 108 which extends over needle 110).
The limitation “collecting one or more biological samples” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The device disclosed by Olson teaches all of the structural limitations of the claim and thus is configured for and capable of performing the intended use and/or function language of collecting one or more biological samples.
Regarding claim 2, Olson teaches the device according to claim 1, wherein the coil element at least partially surrounds the part of the collector element, which is arranged within the housing (Olson; Fig. 7, 8; the coil element is interpreted as needle guard return element 114 which surrounds the needle 110 and positioned within the lower housing 102), wherein the housing has an opening for holding the collector element, and wherein the coil element engages the opening of the housing (Olson; Fig. 8, 9; para [68]; Needle guard return may be any element capable of causing needle guard 108 to extend over needle 110; the examiner interprets the opening to be the portion of the lower housing 102 in which the needle guard 108 extends over when the needle exposed).
Regarding claim 3, Olson teaches the device according to claim 2, wherein the coil element, the collector element, and the opening of the housing are designed such that the inner surface of the coil element at least partially deforms the collector element (Olson; Fig. 8, 9; para [68]; Needle guard return may be any element capable of causing needle guard 108 to extend over needle 110). The needle guard as depicted in Figures 8 through 9 is extended/deformed to cover the needle 110
Regarding claim 4, Olson teaches the device according to claim 2, wherein inner surface of the opening has grooves and/or protrusions for engaging the outer surface of the coil element (Olson; Fig. 8, 9). The Examiner interprets the protrusion to be the surface that extends perpendicular to the housing surfaces as this surface engages with the needle guard return in order to extend the needle guard.
Regarding claim 5, Olson teaches the device according to claim 1, further comprising an abutment surface or a stop for limiting the movement of the collector element into the housing.
Regarding claim 6, Olson teaches the device according to claim 1, further comprising a container for storing liquid (Olson; Fig. 3; para [3, 63]; a drug inside the syringe 110).
Regarding claim 17, Olson teaches the device according to claim 6, wherein the liquid is a buffer solution and/or a reagent solution (Olson; Fig. 3; para [3, 63]; a drug inside the syringe 110). The “liquid” limitation is not a positively recited limitation. Specifically, the limitation is intended use of the “container”. As such, it is deemed that the claimed container is not differentiated from the container of Olsen (see MPEP §2114), therefore “the liquid” is not a required limitation. Further, the Examiner notes that “the drug” would comprise a buffer and/or reagent solution.
Regarding claim 18, Olson teaches the device according to claim 6, wherein the housing comprises or encloses a channel for guiding the liquid stored in the container to the collector element (Olson; Fig. 3). The channel is interpreted as the structure/passage between the needle 110 and the syringe 118.
Regarding claim 19, Olson teaches the device according to claim 18, further comprising a valve and/or release mechanism for opening a passage from the container to the channel so that liquid stored in the container can enter the channel from the container and reach the collector element (Olson; para [58, 63]; The pressure of the palm on interlock button 105 causes it to deflect downwardly, as shown in FIG. 1C, which in turn unlatches needle guard latch 124, shown in FIG. 5, allowing the needle guard 108 to slide upwardly, and exposing needle 110… a drug inside the syringe 110 is delivered through the needle 110). The Examiner interprets the “release mechanism” to be the interlock button which exposes the needle that delivers the drug. The limitation is directed to the function and/or the manner of operating the release mechanism, all the structural limitations of the claim has been disclosed by Olson and the releasing mechanism of Olson is capable of “opening a passage from the container to the channel so that liquid stored in the container can enter the channel from the container and reach the collector element”. As such, it is deemed that the claimed release mechanism is not differentiated from the release mechanism of Olson (see MPEP §2114).
Regarding claim 20, Olson teaches the device according to claim 18, wherein liquid stored in the container can reach the collector element through the channel when the valve and/or release mechanism is open, wherein at least part of the liquid can pass through the collector element by gravity acting on the liquid when the container is in a position vertically above the collector element (Olson; para [58, 63]; The pressure of the palm on interlock button 105 causes it to deflect downwardly, as shown in FIG. 1C, which in turn unlatches needle guard latch 124, shown in FIG. 5, allowing the needle guard 108 to slide upwardly, and exposing needle 110… a drug inside the syringe 110 is delivered through the needle 110). The Examiner interprets the “release mechanism” to be the interlock button which exposes the needle that delivers the drug. The limitation is directed to the function and/or the manner of operating the release mechanism, all the structural limitations of the claim has been disclosed by Olson and the releasing mechanism of Olson is capable of “opening a passage from the container to the channel so that liquid stored in the container can enter the channel from the container and reach the collector element”. As such, it is deemed that the claimed release mechanism is not differentiated from the release mechanism of Olson (see MPEP §2114). Further, the “liquid” limitation is not a positively recited limitation. Specifically, the limitation is intended use of the “container”. As such, it is deemed that the claimed container is not differentiated from the container of Olsen (see MPEP §2114), therefore “the liquid” is not a required limitation. Further, the Examiner notes that “the drug” be capable of passing through the collector element due to gravity.
Regarding claim 21, Olson teaches the device according to claim 18, wherein the volume of the container is reduced to squeeze liquid from the container into the channel (Olson; Fig. 7, 8; para [63]; As shown in FIGS. 3, 4, 7 and 8 a plunger rod 115 pushes on a plunger 112. Plunger rod 115 is connected fixedly to the upper housing 101 and syringe 118 is secured to or held in a cylinder formed within lower housing 102). The limitation is directed to the function and/or the manner of operating the container, all the structural limitations of the claim has been disclosed by Olson and the container of Olson is capable of “reduc[ing] the volume”. As such, it is deemed that the claimed container is not differentiated from the container of Olson (see MPEP §2114). The Examiner notes that the plunger of Olson can reduce the volume to squeeze liquid out from the container.
Regarding claim 22, Olson teaches the device according to claim 18, wherein the volume of the container is reduced such that liquid is released from the container into the channel and passes through the collector element (Olson; Fig. 7, 8; para [63]; As shown in FIGS. 3, 4, 7 and 8 a plunger rod 115 pushes on a plunger 112. Plunger rod 115 is connected fixedly to the upper housing 101 and syringe 118 is secured to or held in a cylinder formed within lower housing 102). The limitation is directed to the function and/or the manner of operating the container, all the structural limitations of the claim has been disclosed by Olson and the container of Olson is capable of “reduc[ing] the volume”. As such, it is deemed that the claimed container is not differentiated from the container of Olson (see MPEP §2114). The Examiner notes that the plunger of Olson can reduce the volume to squeeze liquid out from the container.
Regarding claim 23, Olson teaches the device according to claim 21, wherein the volume of the container is reduced by a movable plunger (Olson; Fig. 7, 8; para [63]; As shown in FIGS. 3, 4, 7 and 8 a plunger rod 115 pushes on a plunger 112. Plunger rod 115 is connected fixedly to the upper housing 101 and syringe 118 is secured to or held in a cylinder formed within lower housing 102).
Regarding claim 24, Olson teaches the device according to claim 1, further comprising a cap element which can be fitted on the housing on the side on which the collector element is arranged (Olson; Fig. 1B; para [56]; cap 103).
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 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 25-29 are rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Wickstead et al (US 20040014203 A1; hereinafter “Wickstead”).
Regarding claim 25, Olson teaches the device according to claim 24, with the cap element.
Olson does not teach wherein an element for indicating and/or measuring a reaction between a reagent and the at least one biological sample is arranged within or on the cap element.
However, Wickstead teaches an analogous art of a sample testing device (Wickstead; Fig. 1; Abstract;) comprising a collection device (Wickstead; para [75]; the user could take a hypodermic syringe containing a sufficient amount of the buffer fluid, and drive the syringe needle through the self-sealing material. Once the needle is inside the buffer container 10, the user would inject the buffer fluid into the buffer container and withdraw the needle therefrom) and an element for indicating and/or measuring a reaction between a reagent and the at least one biological sample is arranged within the sample testing device (Wickstead; para [60, 101]; the test strip 40 in place in the chamber 56… A sample of material (not shown) to be tested is introduced into the sample collector 20. Examples of fluids which may be used as samples in the testing system of the present invention include, but are not limited to, saliva, cerebrospinal fluid, serum, whole blood, plasma, vaginal fluid, semen, and urine). The Examiner interprets cap element to be the sample testing device of Wickstead, as Wickstead teaches a needle may be inserted into the container/cap to dispense the contents. It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cap element of Olson to comprise the element for indicating a reaction between a reagent and the one or more biological samples as taught by Wickstead, because Wickstead teaches the test strip indicates the test results (Wickstead; para [45]).
Regarding claim 26, Olson teaches the device according to claim 25 (the cap element of Olson is modified to comprise the element as taught by Wickstead discussed above in claim 24), wherein the element for indicating and/or measuring a reaction between a reagent and the at least one biological sample is an element indicating the pH value of the mixture of the liquid from the container and of the at least one biological sample (Wickstead; para [45, 60, 101]; the test strip to indicate the results of the test…the test strip 40 in place in the chamber 56… A sample of material (not shown) to be tested is introduced into the sample collector 20. Examples of fluids which may be used as samples in the testing system of the present invention include, but are not limited to, saliva, cerebrospinal fluid, serum, whole blood, plasma, vaginal fluid, semen, and urine). The Examiner interprets cap element to be the sample testing device of Wickstead, as Wickstead teaches a needle may be inserted into the container/cap to dispense the contents. It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cap element of Olson to comprise the element for indicating a reaction between a reagent and the one or more biological samples as taught by Wickstead, because Wickstead teaches the test strip indicates the test results (Wickstead; para [45]).
Regarding claim 27, Olson teaches the device according to claim 24, with the cap element.
Olson does not teach wherein the cap element comprises a reagent which is released to the mixture of liquid from the container and of the at least one biological sample.
However, Wickstead teaches an analogous art of a sample testing device (Wickstead; Fig. 1; Abstract;) comprising a collection device (Wickstead; para [75]; the user could take a hypodermic syringe containing a sufficient amount of the buffer fluid, and drive the syringe needle through the self-sealing material. Once the needle is inside the buffer container 10, the user would inject the buffer fluid into the buffer container and withdraw the needle therefrom) and a reagent which is released to the mixture of liquid from the container and of the at least one biological sample (Wickstead; para [60, 101]; the test strip 40 in place in the chamber 56… A sample of material (not shown) to be tested is introduced into the sample collector 20. Examples of fluids which may be used as samples in the testing system of the present invention include, but are not limited to, saliva, cerebrospinal fluid, serum, whole blood, plasma, vaginal fluid, semen, and urine). The Examiner interprets cap element to be the sample testing device of Wickstead, as Wickstead teaches a needle may be inserted into the container/cap to dispense the contents. It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cap element of Olson to comprise a reagent which is released to the mixture of liquid from the container and of the at least one biological sample as taught by Wickstead, because Wickstead teaches the test strip indicates the test results (Wickstead; para [45]).
Regarding claim 28, Olson teaches the device according to claim 24, with the cap element.
Olson does not teach wherein the cap element comprises an element comprising a reagent which is released to the mixture of liquid from the container and of the at least one biological sample.
However, Wickstead teaches an analogous art of a sample testing device (Wickstead; Fig. 1; Abstract;) comprising a collection device (Wickstead; para [75]; the user could take a hypodermic syringe containing a sufficient amount of the buffer fluid, and drive the syringe needle through the self-sealing material. Once the needle is inside the buffer container 10, the user would inject the buffer fluid into the buffer container and withdraw the needle therefrom) and an element comprising a reagent which is released to the mixture of liquid from the container and of the at least one biological sample (Wickstead; para [60, 101]; the test strip 40 in place in the chamber 56… A sample of material (not shown) to be tested is introduced into the sample collector 20. Examples of fluids which may be used as samples in the testing system of the present invention include, but are not limited to, saliva, cerebrospinal fluid, serum, whole blood, plasma, vaginal fluid, semen, and urine). The Examiner interprets cap element to be the sample testing device of Wickstead, as Wickstead teaches a needle may be inserted into the container/cap to dispense the contents. It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cap element of Olson to comprise an element comprising a reagent which is released to the mixture of liquid from the container and of the at least one biological sample as taught by Wickstead, because Wickstead teaches the test strip indicates the test results (Wickstead; para [45]).
Regarding claim 29, Olson teaches the device according to claim 24, with the cap element.
Olson does not teach wherein the cap element comprises a window which is arranged such that a user can at least partially see the element for indicating and/or measuring a reaction between the reagent and the at least one biological sample.
However, Wickstead teaches an analogous art of a sample testing device (Wickstead; Fig. 1; Abstract;) comprising a collection device (Wickstead; para [75]; the user could take a hypodermic syringe containing a sufficient amount of the buffer fluid, and drive the syringe needle through the self-sealing material. Once the needle is inside the buffer container 10, the user would inject the buffer fluid into the buffer container and withdraw the needle therefrom) and a window (Wickstead; Fig. 1; para [72]; at least one transparent window 55 could be formed in the chamber 56 of the test strip container 55 so that test strip 40 can be viewed therethrough) which is arranged such that a user can at least partially see the element for indicating and/or measuring a reaction between the reagent and the at least one biological sample (Wickstead; para [60, 101]; the test strip 40 in place in the chamber 56… A sample of material (not shown) to be tested is introduced into the sample collector 20. Examples of fluids which may be used as samples in the testing system of the present invention include, but are not limited to, saliva, cerebrospinal fluid, serum, whole blood, plasma, vaginal fluid, semen, and urine). The Examiner interprets cap element to be the sample testing device of Wickstead, as Wickstead teaches a needle may be inserted into the container/cap to dispense the contents. It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cap element of Olson to comprise an element comprising a reagent which is released to the mixture of liquid from the container and of the at least one biological sample as taught by Wickstead, because Wickstead teaches the test strip indicates the test results (Wickstead; para [45]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at (571) 272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.Q.L./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
Prosecution Insights