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 December 02, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on March 21, 2024 are accepted.
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.
Claims 57, 64, 64, 66, 74, 78, 83 and 94-95 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.
The term “about” in claims 57, 64, 64, 66, 74, 78, 83 and 94-95 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Dependent claims are rejected as depending on a rejected claim.
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.
Claims 21-22, 25-26, 29, 32, 38-39 and 84 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qinwei (US 2010/0137145 A1) (“Qinwei”).
Regarding claim 21, Qinwei discloses A cartridge assembly comprising (Abstract and entire document):
an inlet component comprising a port configured to receive a blood sample (FIG. 1-7, [0119], “Fluid sample entry into the analytical device 30 is from sample application means in registry with a sample flow channel formed from an indent 40 in the bottom surface 42 of upper half 32 of the device to include indent 36 in the upper half 32 of the device.” Port 36 see also fig. 5 showing component 200/78);
an elongated strip comprising a matrix configured to separate and collect plasma from the blood sample (FIG. 1-7, “membrane array 10”, including separation membranes);
a backing plate configured to couple to the inlet component and secure a proximal portion of the elongated strip between the inlet component and the backing plate (FIG. 1-7, backing strip 52); and
an elongated housing configured to releasably couple to the inlet component, the elongated housing comprising an enclosure for receiving the elongated strip (FIG. 1-7 and [0119], “The device has an upper half 32 and a lower half 34 that cooperate to enclose the membrane array 10.”).
Regarding claim 22, Qinwei discloses The cartridge assembly of claim 21, wherein the port comprises a tapered profile, and wherein an angle of the tapered profile ranges from about 0 degrees to about 45 degrees (As shown in FIG. 5).
Regarding claim 25, Qinwei discloses The cartridge assembly of claim 21, wherein a diameter at a distal end of the port is less than a diameter at a proximal end of the port (As shown in FIG. 5).
Regarding claim 26, Qinwei discloses The cartridge assembly of claim 21, wherein the inlet component comprises one or more turn features that are configured to induce a change in direction of flow of the blood sample for counteracting gravitational force on the flow (As shown in FIG. 1, 18c/20a acts as a turn feature that changes the direction of flow).
Regarding claim 29, Qinwei discloses The cartridge assembly of claim 26, wherein the inlet component comprises a reservoir that is configured to collect, aggregate, or pool a volume of the blood sample as wicking of another portion of the blood sample occurs along the matrix (FIG. 1-7 and [0119], “Fluid sample entry into the analytical device 30 is from sample application means in registry with a sample flow channel formed from an indent 40 in the bottom surface 42 of upper half 32 of the device to include indent 36 in the upper half 32 of the device. There are open areas 44 and 46 where the bottom surface 42 of upper half 32 comes into contact with the top surface 48 of the lower half 34 of the device. Open areas 44 and 46 act to inhibit the flow of sample from the sample flow channel into the space between the two halves of the device. The open areas 44 and 46 extend to area 54 to prevent sample from flowing out of the membrane array 10 into the space between the two surfaces 42 and 48.” See also [0120]).
Regarding claim 32, Qinwei discloses The cartridge assembly of claim 21, wherein the inlet component comprises a pressure bar that is configured to regulate a flow speed of the blood sample and ensure proper wicking of the blood sample along the matrix for optimal separation of the plasma from the blood sample (FIG. 1-7 and [0120], “The sample flow channel terminates at the apex of the upstream end 18a of first separation membrane 18 which is supported by a Y-shaped protrusion 52 extending from the top surface 48 of lower half 34. It will be noted that the downstream end of the sample flow channel has a constriction 50 so that the sample flows horizontally and uniformly into the first separation membrane 18 at the apex 18a through the thickness of the first separation edge 19.” And [0122], “The overlapping membranes configured in a stair-step manner permit continuous flow of the sample from the sample flow channel to the crosswise channel 50 and through the membrane array 10 to its closed end 22c. To obtain rapid movement of the sample through the membrane segments and yet retain the capture line 24 and control line 26 sufficiently distanced from each other so as to be visible through the viewing window 64”).
Regarding claim 38, Qinwei discloses The cartridge assembly of claim 21, wherein the backing plate comprises one or more spacers that are configured to create a gap between the inlet component and the backing plate (FIG. 1-7, spacer 40).
Regarding claim 39, Qinwei discloses The cartridge assembly of claim 38, wherein the gap is configured to be used in part with a pressure bar on the inlet component to regulate a flow speed of the blood sample and ensure proper wicking of the blood sample along the matrix (FIG. 1-7 and [0120], “The sample flow channel terminates at the apex of the upstream end 18a of first separation membrane 18 which is supported by a Y-shaped protrusion 52 extending from the top surface 48 of lower half 34. It will be noted that the downstream end of the sample flow channel has a constriction 50 so that the sample flows horizontally and uniformly into the first separation membrane 18 at the apex 18a through the thickness of the first separation edge 19.” And [0122], “The overlapping membranes configured in a stair-step manner permit continuous flow of the sample from the sample flow channel to the crosswise channel 50 and through the membrane array 10 to its closed end 22c. To obtain rapid movement of the sample through the membrane segments and yet retain the capture line 24 and control line 26 sufficiently distanced from each other so as to be visible through the viewing window 64”).
Regarding claim 84, Qinwei discloses The cartridge assembly of claim 38, wherein the pressure bar comprises the gap (FIG. 1-7 and [0120], “The sample flow channel terminates at the apex of the upstream end 18a of first separation membrane 18 which is supported by a Y-shaped protrusion 52 extending from the top surface 48 of lower half 34. It will be noted that the downstream end of the sample flow channel has a constriction 50 so that the sample flows horizontally and uniformly into the first separation membrane 18 at the apex 18a through the thickness of the first separation edge 19.” And [0122], “The overlapping membranes configured in a stair-step manner permit continuous flow of the sample from the sample flow channel to the crosswise channel 50 and through the membrane array 10 to its closed end 22c. To obtain rapid movement of the sample through the membrane segments and yet retain the capture line 24 and control line 26 sufficiently distanced from each other so as to be visible through the viewing window 64”).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 48 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Qinwei in view of Davis et al. (US 2007/0031283 A1) (“Davis”).
Regarding claim 48, Qinwei discloses The cartridge assembly of claim 21, Qinwei fails to disclose wherein the elongated strip further comprises a substrate on which the matrix is supported.
However, in the same field of endeavor, Davis teaches wherein the elongated strip further comprises a substrate on which the matrix is supported (FIG. 1-3B, and [0049], “A base 206 may also fit into the backbone 203 to provide additional mechanical support for a blood collection element 250. The collection element 250 may consist of a sample media (also called a membrane herein) 209 that is supported and/or held in place by other components that assist with handling the sample media 209 when it is removed from the device 101 for processing by a laboratory. These other parts of the collection element 250 may include the base 206, a top frame 208, media support 210, and bottom frame 211. The top 208 and bottom 211 frame may have extensions 222A-, 222-B on an outboard end. The extensions 222 further assist with handling the collection element 250 during and after its removal from the housing 101.” Including multiple layers in the matrix interpreted as a substrate and liner in the matrix).
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 assembly as taught by Qinwei to include wherein the elongated strip further comprises a substrate on which the matrix is supported as taught by Davis to assist with handling the media ([0049]).
Regarding claim 52, Qinwei as modified discloses The cartridge assembly of claim 48, Qinwei fails to disclose wherein the elongated strip further comprises a liner disposed between and separating the substrate and the matrix.
However, in the same field of endeavor, Davis teaches wherein the elongated strip further comprises a liner disposed between and separating the substrate and the matrix (FIG. 1-3B, and [0049], “A base 206 may also fit into the backbone 203 to provide additional mechanical support for a blood collection element 250. The collection element 250 may consist of a sample media (also called a membrane herein) 209 that is supported and/or held in place by other components that assist with handling the sample media 209 when it is removed from the device 101 for processing by a laboratory. These other parts of the collection element 250 may include the base 206, a top frame 208, media support 210, and bottom frame 211. The top 208 and bottom 211 frame may have extensions 222A-, 222-B on an outboard end. The extensions 222 further assist with handling the collection element 250 during and after its removal from the housing 101.” Including multiple layers in the matrix interpreted as a substrate and liner in the matrix).
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 assembly as taught by Qinwei to include wherein the elongated strip further comprises a liner disposed between and separating the substrate and the matrix as taught by Davis to assist with handling the media ([0049]).
Claims 57, 64, 64, 66, 74, 78, 83 and 94-95 are rejected under 35 U.S.C. 103 as being unpatentable over Qinwei in view of Yang et al. (US 2007/0134810 A1) (“Yang”).
Regarding claim 57, Qinwei discloses The cartridge assembly of claim 21, Qinwei fails to explicitly disclose wherein a ratio of a length to a width of the elongated strip is about 2.3:1 to about 7:1.
However, in the same field of endeavor, Yang teaches wherein a ratio of a length to a width of the elongated strip is about 2.3:1 to about 7:1 ([0007], “It should be appreciated that the sample meter is not limited by dimensions or shape. For example the separation membrane may have a length of between about 3 to about 12 mm, and the overlap region between the separation and storage membranes may be between about 1 mm to about 3 mm. The storage membrane may have a length of between about 10 mm to about 40 mm. In a particular embodiment, the sample meter is an elongated member having a width of between about 1 mm to about 5 mm, and a length of between about 25 mm to about 40 mm. The separation membrane may extend to the first end of the sample meter, and the storage membrane may extend to an opposite second end of the sample meter.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have wherein a ratio of a length to a width of the elongated strip is about 2.3:1 to about 7:1 as a mere change in shape as part of a design choice. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Furthermore, it would have been obvious to one of ordinary skill in the art, through routine optimization, to determine the optimal ratio, including wherein a ratio of a length to a width of the elongated strip is about 2.3:1 to about 7:1. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the fixed distance ratio is such, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 62, Qinwei discloses The cartridge assembly of claim 21, Qinwei fails to explicitly disclose wherein a distance from a distal end of the port to a proximal end of the elongated strip is about 5 mm to about 15 mm.
However, in the same field of endeavor, Yang teaches wherein a distance from a distal end of the port to a proximal end of the elongated strip is about 5 mm to about 15 mm ([0007], “It should be appreciated that the sample meter is not limited by dimensions or shape. For example the separation membrane may have a length of between about 3 to about 12 mm, and the overlap region between the separation and storage membranes may be between about 1 mm to about 3 mm. The storage membrane may have a length of between about 10 mm to about 40 mm. In a particular embodiment, the sample meter is an elongated member having a width of between about 1 mm to about 5 mm, and a length of between about 25 mm to about 40 mm. The separation membrane may extend to the first end of the sample meter, and the storage membrane may extend to an opposite second end of the sample meter.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have wherein a distance from a distal end of the port to a proximal end of the elongated strip is about 5 mm to about 15 mm as a mere change in shape as part of a design choice. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Furthermore, it would have been obvious to one of ordinary skill in the art, through routine optimization, to determine the optimal dimensions, including wherein a distance from a distal end of the port to a proximal end of the elongated strip is about 5 mm to about 15 mm. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the fixed distance ratio is such, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 64, Qinwei discloses The cartridge assembly of claim 21, Qinwei fails to explicitly disclose wherein a distance from a distal end of the port to a distal end of the elongated strip is about 35 mm to about 115 mm.
However, in the same field of endeavor, Yang teaches wherein a distance from a distal end of the port to a distal end of the elongated strip is about 35 mm to about 115 mm ([0007], “It should be appreciated that the sample meter is not limited by dimensions or shape. For example the separation membrane may have a length of between about 3 to about 12 mm, and the overlap region between the separation and storage membranes may be between about 1 mm to about 3 mm. The storage membrane may have a length of between about 10 mm to about 40 mm. In a particular embodiment, the sample meter is an elongated member having a width of between about 1 mm to about 5 mm, and a length of between about 25 mm to about 40 mm. The separation membrane may extend to the first end of the sample meter, and the storage membrane may extend to an opposite second end of the sample meter.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have wherein a distance from a distal end of the port to a distal end of the elongated strip is about 35 mm to about 115 mm as a mere change in shape as part of a design choice. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Furthermore, it would have been obvious to one of ordinary skill in the art, through routine optimization, to determine the optimal dimensions, including wherein a distance from a distal end of the port to a distal end of the elongated strip is about 35 mm to about 115 mm. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the fixed distance ratio is such, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 66, Qinwei discloses The cartridge assembly of claim 32, Qinwei fails to explicitly disclose wherein a distance from an edge of the reservoir to the pressure bar is about 0 mm to about 5 mm.
However, in the same field of endeavor, Yang teaches wherein a distance from an edge of the reservoir to the pressure bar is about 0 mm to about 5 mm ([0007], “It should be appreciated that the sample meter is not limited by dimensions or shape. For example the separation membrane may have a length of between about 3 to about 12 mm, and the overlap region between the separation and storage membranes may be between about 1 mm to about 3 mm. The storage membrane may have a length of between about 10 mm to about 40 mm. In a particular embodiment, the sample meter is an elongated member having a width of between about 1 mm to about 5 mm, and a length of between about 25 mm to about 40 mm. The separation membrane may extend to the first end of the sample meter, and the storage membrane may extend to an opposite second end of the sample meter.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have wherein a distance from an edge of the reservoir to the pressure bar is about 0 mm to about 5 mm as a mere change in shape as part of a design choice. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Furthermore, it would have been obvious to one of ordinary skill in the art, through routine optimization, to determine the optimal dimensions, including wherein a distance from an edge of the reservoir to the pressure bar is about 0 mm to about 5 mm. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the fixed distance ratio is such, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 74, Qinwei discloses The cartridge assembly of claim 32, Qinwei fails to explicitly disclose wherein a ratio of a width to a length of the pressure bar is about 5:1 to about 14:1.
However, in the same field of endeavor, Yang teaches wherein a ratio of a width to a length of the pressure bar is about 5:1 to about 14:1 ([0007], “It should be appreciated that the sample meter is not limited by dimensions or shape. For example the separation membrane may have a length of between about 3 to about 12 mm, and the overlap region between the separation and storage membranes may be between about 1 mm to about 3 mm. The storage membrane may have a length of between about 10 mm to about 40 mm. In a particular embodiment, the sample meter is an elongated member having a width of between about 1 mm to about 5 mm, and a length of between about 25 mm to about 40 mm. The separation membrane may extend to the first end of the sample meter, and the storage membrane may extend to an opposite second end of the sample meter.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have wherein a ratio of a width to a length of the pressure bar is about 5:1 to about 14:1 as a mere change in shape as part of a design choice. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Furthermore, it would have been obvious to one of ordinary skill in the art, through routine optimization, to determine the optimal ratio, including wherein a ratio of a width to a length of the pressure bar is about 5:1 to about 14:1. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the fixed distance ratio is such, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 78, Qinwei discloses The cartridge assembly of claim 32, Qinwei fails to explicitly disclose wherein an edge of the elongated strip is at a distance of about 0 mm to about 10 mm from the pressure bar.
However, in the same field of endeavor, Yang teaches wherein an edge of the elongated strip is at a distance of about 0 mm to about 10 mm from the pressure bar ([0007], “It should be appreciated that the sample meter is not limited by dimensions or shape. For example the separation membrane may have a length of between about 3 to about 12 mm, and the overlap region between the separation and storage membranes may be between about 1 mm to about 3 mm. The storage membrane may have a length of between about 10 mm to about 40 mm. In a particular embodiment, the sample meter is an elongated member having a width of between about 1 mm to about 5 mm, and a length of between about 25 mm to about 40 mm. The separation membrane may extend to the first end of the sample meter, and the storage membrane may extend to an opposite second end of the sample meter.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have wherein an edge of the elongated strip is at a distance of about 0 mm to about 10 mm from the pressure bar as a mere change in shape as part of a design choice. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Furthermore, it would have been obvious to one of ordinary skill in the art, through routine optimization, to determine the optimal distance, including wherein an edge of the elongated strip is at a distance of about 0 mm to about 10 mm from the pressure bar. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the fixed distance ratio is such, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 83, Qinwei discloses The cartridge assembly of claim 38, Qinwei fails to explicitly disclose wherein a size of the gap is about 0 mm to about 4 mm.
However, in the same field of endeavor, Yang teaches wherein a size of the gap is about 0 mm to about 4 mm ([0007], “It should be appreciated that the sample meter is not limited by dimensions or shape. For example the separation membrane may have a length of between about 3 to about 12 mm, and the overlap region between the separation and storage membranes may be between about 1 mm to about 3 mm. The storage membrane may have a length of between about 10 mm to about 40 mm. In a particular embodiment, the sample meter is an elongated member having a width of between about 1 mm to about 5 mm, and a length of between about 25 mm to about 40 mm. The separation membrane may extend to the first end of the sample meter, and the storage membrane may extend to an opposite second end of the sample meter.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have wherein a size of the gap is about 0 mm to about 4 mm as a mere change in shape as part of a design choice. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Furthermore, it would have been obvious to one of ordinary skill in the art, through routine optimization, to determine the optimal dimensions, including wherein a size of the gap is about 0 mm to about 4 mm. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the fixed distance ratio is such, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 94, Qinwei discloses The cartridge assembly of claim 21, Qinwei fails to explicitly disclose wherein a ratio of an area of the cartridge assembly to an area of the elongated strip is about 1.5:1 to 2:1.
However, in the same field of endeavor, Yang teaches wherein a ratio of an area of the cartridge assembly to an area of the elongated strip is about 1.5:1 to 2:1 ([0007], “It should be appreciated that the sample meter is not limited by dimensions or shape. For example the separation membrane may have a length of between about 3 to about 12 mm, and the overlap region between the separation and storage membranes may be between about 1 mm to about 3 mm. The storage membrane may have a length of between about 10 mm to about 40 mm. In a particular embodiment, the sample meter is an elongated member having a width of between about 1 mm to about 5 mm, and a length of between about 25 mm to about 40 mm. The separation membrane may extend to the first end of the sample meter, and the storage membrane may extend to an opposite second end of the sample meter.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have wherein a ratio of an area of the cartridge assembly to an area of the elongated strip is about 1.5:1 to 2:1as a mere change in shape as part of a design choice. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Furthermore, it would have been obvious to one of ordinary skill in the art, through routine optimization, to determine the optimal ratio, including wherein a ratio of an area of the cartridge assembly to an area of the elongated strip is about 1.5:1 to 2:1. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the fixed distance ratio is such, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 95, Qinwei discloses The cartridge assembly of claim 94, Qinwei fails to explicitly disclose wherein the ratio is about 1.8:1.
However, in the same field of endeavor, Yang teaches wherein the ratio is about 1.8:1 ([0007], “It should be appreciated that the sample meter is not limited by dimensions or shape. For example the separation membrane may have a length of between about 3 to about 12 mm, and the overlap region between the separation and storage membranes may be between about 1 mm to about 3 mm. The storage membrane may have a length of between about 10 mm to about 40 mm. In a particular embodiment, the sample meter is an elongated member having a width of between about 1 mm to about 5 mm, and a length of between about 25 mm to about 40 mm. The separation membrane may extend to the first end of the sample meter, and the storage membrane may extend to an opposite second end of the sample meter.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have wherein the ratio is about 1.8:1 as a mere change in shape as part of a design choice. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Furthermore, it would have been obvious to one of ordinary skill in the art, through routine optimization, to determine the optimal ratio, including wherein the ratio is about 1.8:1. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the fixed distance ratio is such, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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/JOSEPH A TOMBERS/Examiner, Art Unit 3791