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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 127 & 117 of Fig. 1b. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Applicant’s originally filed specification (pg. 9, lines 20 – 34) clarifies “at least one of the openings (134 & 136) is located at an edge of the first bondable polymeric layer” as shown in Figs. 1B - 1C, which are copied below. However, these Figures show openings 134 & 136 are located along an edge of the device between the second polymeric layer (120) and hydrophilic mask (114), which is not at an edge of the first bondable polymeric layer (110).
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Therefore, the “at least one of the openings is located at an edge of the first bondable polymeric layer” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 6 & 16 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.
With regard to claim 6, the claim recites, “…the first major surface of the first bondable polymeric layer has a linear shape that comprises a straight portion, a curved portion, or combination thereof.” By definition, the term “linear” means a straight line. A linear shape with a curved portion is a contradiction in terms. It is assumed Applicant intended to recite the shape of the surface is elongated (length greater than width, as recited in claim 5). The specification fails to provide clarity for this limitation. Clarification required.
With regard to claim 16, the claim recites “a gap between a first edge of the first bondable polymeric layer and a directly adjacent first edge of the second polymeric layer of up to 5 µm.”
First, the claim language does not clarify whether “a gap” is a synonym of the recited interstitial space and/or opening(s) of claim 1 or a separate and distinct feature of the recited device. Clarification by amendment is requested.
Second, with regard to the size of the gap, Applicant’s originally filed specification directs the reader to the openings 134 & 136 of Fig. 1C for clarity. However, the gap that forms openings 134 & 136 at the edges is formed by the distance between the second polymer layer and the hydrophilic mask, not between the edges of the recited polymer layers. Therefore, it is unclear whether the recited gap is referring to the distance between the recited polymer layers, regardless of whether that gap contains other materials, such as hydrophilic mask, or whether the recited gap is referring to the openings, which does not include the thickness of the hydrophilic mask. Clarification via amendment is requested.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 – 6, 8 – 9, & 13 – 17 are rejected under 35 U.S.C. 103 as being unpatentable over DeRosa et al. (US 2012/052250 A1), in view of Burns et al. (U.S. Patent No. 6,379,929 B1).
*Biolin Scientific
With regard to claim 1, DeRosa et al. teach a fluidic device comprising:
A polymeric sheet (140 without layer 110) (i.e., “first bondable polymeric layer”) having a first major surface
A polymeric film (400) (i.e. “a second polymeric layer”) having a first major surface; and
A hydrophilic interconnected microporous network (110) (i.e., Applicant’s “hydrophilic mask”) and a patterned intermediate layer (300) material disposed on a first portion of the first major surface of the first bondable polymeric layer (140) (Figs. 9 – 18).
In a second portion of the first major surface of the first bondable polymeric layer is bonded via an intermediate layer (300) that is a double-sided pressure sensitive adhesive layer (paragraph [0089]) or thermal bonding (paragraphs [0089] – [0090]) to a first portion of the first major surface of the second polymeric layer, wherein the interconnected microporous network material and a second portion of the first major surface of the second polymeric layer are in direct contact with each other at at least one point (Fig. 9 region without interconnected network), wherein an open volume is defined by interstitial space (120, 310, 510 of Figs. 4, 8 – 9, & 11, 13 – 18) located between the interconnected microporous network material and the second portion of the first major surface of the second polymeric layer. The channels 120 & 310 (i.e., “the open volume”) comprises two or more openings (410 of Figs. 8 – 12) via the polymeric film (410).
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DeRosa et al. do not explicitly teach a surface of the hydrophilic interconnected network material exhibits an advancing [maximum] contact angle with water of less than 90 degrees.
However, as evidenced by *Biolin Scientific, a person of ordinary skill in the art understands the definition of hydrophilic is a surface that has a contact water of less than 90 degrees. Therefore, a contact angle with water of less than 90 degrees is inherent to the hydrophilic mask 110 taught by DeRosa et al.
MPEP 2112 [R-3] states:
The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983).
DeRosa et al. do not explicitly teach wherein at least one of the openings is located at an edge of the polymeric film (140) (i.e., “first bondable polymeric layer”)
However, DeRosa et al. teach the channels (120) are formed inside the interconnected microporous structure of layer (110), wherein the pores are interconnected such that fluid may travel between pores or interstices from one surface of the structure to another surface of the structure (paragraph [0041]).
It is understood by one of ordinary skill in the art that the interconnected microporous structure contains interconnected open pores in contact with the first major surface of the polymer film (140) free of the microporous structure, and where the first major surface of said polymer film, the interconnected microporous structure, and an edge of said polymer film intersect. Therefore, DeRosa et al. teaches an interconnected microporous structure that inherently defines an indirect fluid route between an open volume defined by the interstitial space (120) and open pores at the edge of the layer 110 (i.e., “openings”) at an edge of the first bondable polymeric layer.
Applicant’s specification explicitly defines “substantially planar” as “a surface of the layer is essentially free of recesses and/or protrusions extending above and/or below a plane of the layer, the recesses and/or protrusions having a depth or height of greater than 5 micrometers (pg. 6). In other words, the term “substantially planar” refers to a surface having a surface roughness of 5 µm or less.
DeRosa et al. do not explicitly teach the first major surfaces (facing inward of the device) of the first bondable polymer layer (140 without 110) and the second polymeric layer (400) have a surface roughness of 5 µm or less (i.e., “substantially planar”).
Burns et al. teach to improve hydrophilicity of a surface, several cleaning procedures are tried because it has been reported that surface contamination and/or roughness can reduce the hydrophilicity of surfaces (Col. 74, Lines 53 – 64).
Therefore, based on the teachings of Burns et al., it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to adjust the surface roughness (i.e., planarity) of the first major surfaces of both first and second polymer layers through routine experimentation in order to achieve surfaces of desired hydrophilicity. It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
With regard to claims 2 – 3, the first portion of the first major surface of the first bondable polymeric layer on which the hydrophilic mask material is disposed is a continuous area that extends from a first edge of the first bondable polymeric layer to each of an opposing second edge of the first edge bondable polymeric layer and a third edge of the first bondable polymeric layer that is located between the first edge and the second edge of the first bondable polymeric layer, wherein the first portion extends along an entirety of the third edge (see Fig. 11 above).
With regard to claim 4, DeRosa et al. teach channels (120) formed on a portion of the polymeric sheet (i.e., “a pattern defining a fluid path”) (paragraph [0070]).
DeRosa et al. do not explicitly teach the pattern of channels has an outlet at portions of the first, second, and third edges of the bondable polymeric layer.
However, as discussed above for claim 1, DeRosa et al. teach open pores at the edge of the layer 110 (i.e., “openings”) at each edge (first edge, second edge, third edge) of the first bondable polymeric layer. The pores of the interconnected microporous structure are connected such that fluid may travel between pores from one surface of the structure to another surface of the structure (paragraph [0041]), wherein a pore is defined as having at least one outer opening at a surface of the article (paragraph [0042]). The channels are formed with sidewalls being a portion of the interconnected microporous network, and thus the channels have a fluid path with each of the first, second, and third outer edges.
With regard to claims 5 – 6, DeRosa et al. do not explicitly teach the first portion of the first major surface of the first bondable polymeric layer (adhered to interconnected network) has a shape that has a length that is at least 10 times greater than a width of the shape.
However, as shown in Example 2 (Fig. 23 below), DeRosa et al. teach the design and shape of the surface of the first portion comprising the pattern of channels formed by the hydrophilic microporous network layer, wherein the pattern of said portions comprises straight portions and curved portions may have an overall length greater than width (i.e., “linear”) (claim 6) for optimizing the path of gas diffusion and liquid perfusion (paragraphs [0128] – [0129]).
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Therefore, based on the teachings of DeRosa et al. as discussed for claim 6 above, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to adjust the dimensions (i.e., length vs. width) of the shape of first portion of the first major surface comprising the pattern of channels through routine experimentation in order to achieve the desired path for optimum gas diffusion and liquid perfusion (claim 5). It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
With regard to claims 8 – 9, DeRosa et al. teach the polymeric films (400) (i.e., “second polymeric layer”) comprises cyclic olefin copolymers (i.e., “a polyolefin”) (paragraph [0092]). Furthermore, the polymeric sheet (140) (i.e., “first bondable polymeric layer”) may be formed from the same material as the polymeric film (400) (paragraph [0094]).
With regard to claim 13, DeRosa et al. do not teach the interstitial space comprises a volume of 500 nanoliters or less per square centimeter (nL/cm2) of the first portion of the first major surface of the first bondable polymeric layer.
However, DeRosa et al. teach the volume of the pores or interstices of an average diametric size of less than 1000 µm to allow for fluid (e.g., liquid, gas, or vapor) to travel between pores or interstices from one surface of the structure to the other for a variety of chemical and biological applications (paragraph [0041] – [0053] & [0082]).
Furthermore, Burns et al. teach a device comprising channels for a biological application of transporting liquids, fluids, and/or gasses (Col. 5, Lines 14 – 26), such as for amplifying nucleic acid (Col. 1, Lines 1 – 16). Each chip is designed to move samples in the 5 – 50 nL range (Col. 42, Lines 8 – 9) and the dimensions of the channels (i.e., “interstitial space”) allow for 0.01 – 100 nL of microdroplets (total) (Col. 5, Lines 36 – 45), which are both less than 500 nL/cm2.
Therefore, based on the teachings of DeRosa et al., it would have been obvious to one of ordinary skill in the art to adjust the volume of the pores, interstices, and channels of the hydrophilic microporous network at the first major surface based on the desired chemical and biological application of the device. It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
With regard to claim 14, as discussed above for claim 1, DeRosa et al. teach openings (i.e., “a channel”) (410) which connects a first portion of a first major surface of the first bondable layer to a second major surface of the second polymeric layer (400) (Fig. 9). DeRosa et al. also teach similar openings serving as inlets or outlets to the fluid conduits may also or alternatively be created in the polymeric sheet (i.e., “which connect a first portion of the first major surface of the first bondable polymeric layer at least one of a second major surface of the first bondable polymeric layer”) (paragraph [0093]).
With regard to claim 15, as discussed above for claim 1, the surface roughness is optimizable for achieving desired degree of hydrophilic properties.
As discussed above for claim 1, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to adjust the surface roughness of the first major surface taught by DeRosa et al. for achieving the desired hydrophilic properties of said surface.
With regard to claim 16, De Rosa et al. teach the average pore size can range between 1 micrometer and 500 micrometers (paragraph [0064]), which overlaps with Applicant’s claimed range of up to 5 µm for a gap (i.e., an opening) between the edges of the recited polymeric layers.
As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With regard to claim 17, DeRosa et al. teach the interconnected microporous network (i.e., “hydrophilic mask”) may be formed only on the surface of the polymer sheet, having a thickness, for example, of about 10 micrometers to about 100 micrometers (paragraph [0062]). DeRosa et al. do not teach an example wherein the hydrophilic mask material has an average thickness of 1 nm to 1 µm.
However, DeRosa et al. teach the hydrophilic interconnected microporous network layer (i.e., hydrophilic mask) forms the walls of the channels (Fig. 4 & paragraph [0084]), and thus the thickness of the hydrophilic interconnected microporous network layer determines the height and volume of each channel. Furthermore, DeRosa et al. teach the extent that the microporous network 110 extends through the depth of the polymeric sheet 140 (i.e., the thickness of “hydrophilic mask”) can vary or be made to vary as desired, such as desired exchange of ambient gases (paragraph [0085]).
Therefore, based on the teachings of DeRosa et al., it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to adjust the depth of the hydrophilic interconnected microporous network (i.e., “average thickness of the hydrophilic mask”) through routine experimentation based on the intended application, such as desired exchange of ambient gases. It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over DeRosa et al. & Burns et al., as applied to claim 1 above, and further in view of Somasiri et al. (*WO 2007/075665 A1).
*submitted by Applicant with IDS filed 4/05/2024
With regard to claim 7, DeRosa et al. teach the hydrophilic microporous network layer is formed from polystyrene (paragraph [0051]) and made hydrophilic via any known method for hydrophilic treatment, including plasma treatment (paragraph [0076]).
However, DeRosa et al. but do not explicitly teach the hydrophilic microporous network layer (i.e., “mask material”) comprises plasma deposited silicon/oxygen materials or diamond-like glass, a nanostructure, a surfactant, a polyester, a polyamide, a polyurethane, a poly(vinyl alcohol), a poly(alkylene glycol), a poly(alkylene oxide), a poly(vinyl pyrrolidone), a rubber elastomer, or a combination thereof.
Somasiri et al. teach a microfluidic device having hydrophilic microchannels. A hydrophilic layer is deposited on the surface of the microchannel by plasma deposition of silicon containing compounds. The silicon containing compounds include at least about 20% by weight silicon and at least about 40% by weight oxygen (Pg. 2, Lines 3 – 10, Pg. 6, Lines 2 – 24). The hydrophilic surface enhances the flow rate of the test fluid passing through the microchannel by reducing the frictional resistance at the surface of the microchannel (Pg. 7, Lines 11 – 14).
Therefore, based on the teachings of Somasiri et al., it would have been obvious to one of ordinary skill in the art prior to the effective filing date to form use a silicon/oxygen plasma deposition for the hydrophilic treatment of the microporous network layer taught by DeRosa et al. for achieving enhanced flow rate of test fluid through the channels and pores of the microporous network.
Claim(s) 10 – 12 are rejected under 35 U.S.C. 103 as being unpatentable over DeRosa et al. & Burns et al., as applied to claim 9 above, and further in view of Swanson et al. (*WO 2021/124165 A1).
*submitted by Applicant with IDS filed 4/05/2024
With regard to claim 10, DeRosa et al. do not teach the first bondable polymeric layer has a Vicat softening temperature (Tg) of 100°C or less.
Swanson et al. teach a fluid collection article comprising channels. Suitable polymeric materials for the film layer (i.e., “first bondable polymeric layer”) include a polyolefin (pg. 14) with a Vicat softening temperature (Tg) of 100°C or less and the cover layer (i.e., “second polymeric layer”) has a Vicat softening temperature of 110°C or less and 85°C or more for desired heat bonding of the two layers while minimizing conformation of the cover layer to the shape of capillary channels beneath the cover layer (pg. 15).
Therefore, based on the teachings of Swanson et al., it would have been obvious to one of ordinary skill in the art prior to the effective filing date to form both the first bondable polymeric layer and the second polymeric layer as taught by DeRosa et al. having a Vicat softening temperature (Tg) of 100°C or less for achieving desired heat bonding between said layers without conforming to the shape of channels in the hydrophilic layer there between.
With regard to claim 11, DeRosa et al. do not explicitly teach at least one of the first bondable polymeric layer or the second polymeric layer comprises a reagent configured to react with a sample and provide a response selected from electrochemical, optical, fluorescent, chemiluminescent, or a combination thereof.
With regard to claim 12, DeRosa et al. do not explicitly teach at least one of the first bondable polymeric layer or the second polymeric layer further comprises a detector.
Swanson et al. teach a fluid collection article comprising channels. The article comprises at least one reagent, preferably configured to react with a (e.g., fluid) sample and provide a response, e.g., selected from an electrochemical response, an optical response, a fluorescent response, a chemiluminescent response, or combination thereof. Suitable reagents include fluorogenic or chromogenic indicators, electrochemical reagents, fluorescent or phosphorescent beads (Pg. 11, Lines 11 – 26). The article further comprises a sensor (i.e., “detector”) configured to communicate with a wireless network (Pg. 11, Lines 27 – 32). The sensor may be heat bonded to the capillary channels of the film layer (i.e., “first bondable layer”) or the cover layer (i.e., “the second polymeric layer”), or both (pg. 15). The reagents are configured react with the sample for providing information about said sample or change the pH (Pg. 11 Lines 11 – 26).
Therefore, based on the teachings of Swanson et al., it would have been obvious to one of ordinary skill in the art prior to the effective filing date to bond a reagent or sensor (detector) to the first or second polymeric layers taught by DeRosa et al. in order to provide desired information about fluid traveling through the channels or change the pH of the fluid.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE T GUGLIOTTA whose telephone number is (571)270-1552. The examiner can normally be reached M - F (9 a.m. to 10 p.m.).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frank Vineis can be reached at 571-270-1547. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE T GUGLIOTTA/Examiner, Art Unit 1781
/FRANK J VINEIS/Supervisory Patent Examiner, Art Unit 1781
