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 .
Claim Objections
Claim 17 is objected to because of the following informalities: The word “crating” in line 2 is misspelled. 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 2, 5, 8, 11 – 13 and 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.
Regarding claims 2, 5, 8, 11 and 16, the phrase “preferably” which is considered equivalent to the phrases: “such as,” “for example,” “in particular,” “specifically,” and “or the like,” is considered indefinite. The metes and bounds of the claim scope are not clear. It is not clear if the claim limitation is optional or not. Furthermore, without knowing this information, one of ordinary skill in the art would not know whether they are infringing on the claims or not.
Regarding claim 2, the phrase “… the frame portion comprises a further elastomeric material, wherein preferably the further elastomeric material is the same as the elastomeric material” is not clear. For claim interpretation and examination purposes, the frame portion is interpreted as being a comprised of an elastomeric material.
Claim 17 provides for the use of a fluidic device, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claim 17 is rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
Claim 19 provides for a method of manufacturing a microfluidic device or kit for a microfluidic device, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
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 (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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 – 7, 9, 10, 12, 14, 15 and 17 – 19 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Breinlinger et al. (US 2016/0158757 A1; “Breinlinger”).
Regarding claim 1, Breinlinger teaches a fluidic device (microfluidic device 420) (paragraphs 174, 175 and 183; figures 4A, 4B and 5) comprising:
a flow chamber (part of channel 122) for accommodating a biological specimen on a carrier portion (enclosure layer 430 can comprise deformable surfaces 432) and at least one flow channel (channel 122) fluidly connected to the flow chamber, the fluidic device having a structure comprising a bottom plate (452), a cover plate (450) and an insert (416 and 430) in between the bottom plate and the cover plate, the insert comprising the carrier portion (deformable surface 432) and a frame portion (416) surrounding the carrier portion, the carrier portion comprising of an elastomeric material (a self-sealing, pierceable material comprising rubber or polydimethylsiloxane materials; paragraph 241), wherein the carrier portion is provided with an incision for accomodating the biological specimen (the deformable surface is pierceable to allow introduction and withdraw of fluidic media and sample; paragraphs 234 and 241).
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Regarding claim 2, Breinlinger teaches the fluidic device of claim 1, wherein the frame portion (416) comprises an elastomeric material (a rubber, plastic, elastomer, silicone, or polydimethylsiloxane material; paragraph 182).
Regarding claim 3, Breinlinger teaches the fluidic device of claim 1, wherein the carrier portion (deformable surface 432) and/or the frame portion (416) is characterized by a Shore A hardness within the range of 2 to 80. The frame portion (416) comprises an elastomeric material (a rubber, plastic, elastomer, silicone, or polydimethylsiloxane material; paragraph 182). Since the prior art teaches the same material for the disclosed components, the material properties are presumed to be the same. Regarding composition claims, if the composition is the same, it must have the same properties (see MPEP § 2112.01, II.). Furthermore, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). The Courts have held that with regard to chemical homologs that the greater the physical and chemical similarities between the claimed species disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner (see Dillon, 99 F.2d at 696, 16 USPQ2d at 1904).
Regarding claim 4, Breinlinger teaches the fluidic device of claim 1, wherein the incision defines an opening in the carrier portion (deformable surface 432) when the carrier portion is in an undeformed state (the deformable surface 432 is made of a self-sealing material; paragraph 241).
Regarding claim 5, Breinlinger teaches that the elastomeric material can be comprised of a silicone material (e.g., a rubber, plastic, elastomer, silicone, or polydimethylsiloxane material; paragraph 182).
Regarding claim 6, Breinlinger teaches the fluidic device of claim 1, wherein the carrier portion (deformable surface 432) is porous, or microporous. (the deformable surface 432 is pierceable to allow introduction and withdraw of fluidic media and sample; paragraphs 234 and 241).
Regarding claim 7, Breinlinger teaches the fluidic device of claim 1, wherein the flow chamber (part of channel 122) and the at least one flow channel (channel 122) are formed by structuring a lower surface and/or on an upper surface of the insert (416 and 430).
Regarding claim 9, Breinlinger teaches the fluidic device of claim 1, wherein the bottom plate (452) and/or the cover plate (450) comprises at least one port (e.g., port 460; paragraph 176; figures 4A and 5) fluidly connected to the at least one flow channel (channel 122).
Regarding claim 10, Breinlinger teaches the fluidic device of claim 1, wherein the bottom plate (452) and/or the cover plate (450) is UV/VIS transparent (e.g., polydimethylsiloxane (PDMS) is a transparent material PDMS; paragraphs 67, 88 and 182).
Regarding claim 12, Breinlinger teaches an insert (416 and 430) for a microfluidic device (microfluidic device 420) (paragraphs 174 and 175; figures 4A, 4B and 5), the insert comprising: a carrier portion (432) and a frame portion (416) surrounding the carrier portion, the insert comprising an elastomeric material (a self-sealing, pierceable material comprising rubber or polydimethylsiloxane materials; paragraph 241), and wherein the carrier portion is provided with an incision for accomodating a biological specimen (the deformable surface is pierceable to allow introduction and withdraw of fluidic media and sample; paragraphs 234 and 241) , optionally wherein the insert is further defined in claim 2.
Regarding claim 14, Breinlinger teaches a system or kit comprising an insert (416 and 430), a bottom plate (452) and a cover plate (450), wherein the bottom plate, the insert and the cover plate, when stacked in this order, form a fluidic device as defined in claim 1.
Regarding claim 15, Breinlinger teaches the system or kit of claim 14, further comprising:
a fluidic device (microfluidic device 420; paragraphs 174 and 175; figures 4A, 4B and 5) comprising: a flow chamber (part of channel 122) for accommodating a biological specimen on a carrier portion and at least one flow channel fluidly connected to the flow chamber, the fluidic device having a structure comprising a bottom plate (452), a cover plate (450) and an insert (416 and 430) in between the bottom plate and the cover plate, the insert comprising the carrier portion and a frame portion surrounding the carrier portion, the carrier portion comprising an elastomeric material (a self-sealing, pierceable material comprising rubber or polydimethylsiloxane materials; paragraph 241), wherein the carrier portion is provided with an incision for accomodating the biological specimen (the deformable surface 432 can be pierced by a hollow needle forming a hole or incision; paragraph 241),
an insert (416 and 430) for a microfluidic device, the insert comprising: a carrier portion and (enclosure layer 430 can comprise deformable surfaces 432) a frame portion (416) surrounding the carrier portion, the insert comprising an elastomeric material (a self-sealing, pierceable material comprising rubber or polydimethylsiloxane materials; paragraph 241), and wherein the carrier portion is provided with an incision for accomodating a biological specimen (the deformable surface 432 can be pierced by a hollow needle forming a hole or incision; paragraph 241), and
a holder (e.g., stage 410; paragraph 167; figure 3D) for holding the fluidic device.
Regarding claim 17, Breinlinger teaches the use of a fluidic device (microfluidic device 420; paragraphs 174 and 175; figures 4A, 4B and 5) as claimed in claim 1, or: an insert (416 and 430) for a microfluidic device, the insert comprising: a carrier portion (enclosure layer 430 can comprise deformable surfaces 432) and a frame portion (416) surrounding the carrier portion, the insert comprising an elastomeric material (a self-sealing, pierceable material comprising rubber or polydimethylsiloxane materials; paragraph 241), and wherein the carrier portion is provided with an incision for accomodating a biological specimen (the deformable surface 432 can be pierced by a hollow needle forming a hole or incision; paragraph 241), or a system or kit comprising an insert (416 and 430), a bottom plate (452) and a cover plate (450), wherein the bottom plate, the insert and the cover plate, when stacked in this order.
Regarding claim 18, Breinlinger teaches a method of manufacturing an insert for a microfluidic device (microfluidic device 420; paragraphs 174 and 175; figures 4A, 4B and 5) comprising the step of creating an incision within a region of a carrier portion (enclosure layer 430 can comprise deformable surfaces 432) of an insert (416 and 430) (the deformable surface is pierceable to allow introduction and withdraw of fluidic media and sample; paragraphs 234 and 241) comprising the carrier portion (deformable surface 432) and a frame portion (416) surrounding the carrier portion, where the insert comprises or consists of an elastomeric material (a self-sealing, pierceable material comprising rubber or polydimethylsiloxane materials; paragraph 241) and the carrier portion includes a region for making an incision (the deformable surface 432 can be pierced by a hollow needle forming a hole or incision; paragraph 241).
Regarding claim 19, Breinlinger teaches a method of manufacturing a microfluidic device (microfluidic device 420; paragraphs 174 and 175; figures 4A, 4B and 5) or a kit for a microfluidic device comprising the method of claim 18.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Breinlinger et al. (US 2016/0158757 A1; “Breinlinger”).
Regarding claim 11, Breinlinger does not specifically teach the specific dimensions of the various components of the disclosed apparatus as claimed.
However, Breinlinger does teach various dimensions (i.e., layer thickness, microfluidic channel dimensions and volume sizes) of various components of the disclosed apparatus (e.g., paragraphs 62 – 64, 118 and 125 – 128). Figures 4A, 4B and 5, for example, show various relative size dimensions of the various layers and components (i.e., bottom plate, cover plate) of the disclosed apparatus. Furthermore, the size of an article is not a matter of invention (see MPEP § 2144.04). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the recited sized dimensions of the disclosed apparatus depending on design choice.
Regarding claim 13, Breinlinger teaches the insert of claim 11, wherein the insert contains a plurality of carrier portions (deformable surfaces 432), each carrier portion being surrounded by the frame portion (416) (figures 4A and 4B).
Allowable Subject Matter
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Claims 8 and 16 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 8, the cited prior art does not specifically teach fluidic device of claim 1, wherein the microporous carrier portion separates the flow chamber in a lower flow chamber region and an upper flow chamber region, and wherein at least one lower flow channel is fluidly connected to the lower flow chamber region and at least one upper channel is fluidly connected to the upper flow chamber region.
Regarding claim 16, the cited prior art does not specifically teach a method for clamping a biological specimen comprising: providing an insert as defined in claim 11, wherein the microporous carrier portion of the insert is provided with an incision for accomodating the biological specimen, and further clamping the biological specimen between adjacent cut ends defined by the incision.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth A Robinson can be reached at (571) 272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796