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
Claims 3, 4, 17-19, 34-40 are objected to because of the following informalities: the claim status markings should state as withdrawn. Appropriate correction is required.
Claims 7, 8, 11 are dependent from currently canceled claim 5. Accordingly, the claims have not been further treated on the merits.
Election/Restrictions
Newly submitted claims 41-45 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the claims are directed to previously withdrawn species, see the 06/05/2025 Restriction Requirement.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 41-45 have been withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Non-elected species remain withdrawn, while the cancellation of previously elected species in the amended claims is noted. Since claim 10 excludes previously elected species, it has been withdrawn from consideration. The general policy of the Office is that applicants are not permitted to shift to claim another invention after an election is made and an Office action on the merits is made on the elected invention.
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 21 and 32 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 21 contains the trademark/trade name Teflon. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the membrane and, accordingly, the identification/description is indefinite.
Claim 32 recites the limitation "the height [...] the width [...] the length of the cell chamber" in L2-4. There is insufficient antecedent basis for this limitation in the 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 (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, 2, 9, 12-16, 20-33 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Unger et al. (US 2008/0277005).
Regarding claim 1, Unger et al. teach:
1. A microfluidic device (¶ 0308+) for applying pressure to a cell assembly, comprising
at least one cell chamber (e.g., flow channel 4202/4501/4604), wherein the at least one cell chamber comprises:
an inlet (see i.e., “FLUID FLOW” with an arrow towards flow channels 4108 in Fig. 41 & ¶ 0352) capable of introducing a cell assembly into the cell chamber (see ¶ 0192 for example),
at least one mechanical pressing means (e.g., movable elastomeric membrane 4008/4208/4502/4606 ¶ 0358, 0361-0362, 0379, 0383+) capable of applying pressure to the cell assembly and capable of being operable between a releasing position and a pressing position (see Figs. 42B-42C for example) via an actuation line (e.g., control channel 4204/4207/4504/4608), wherein the at least one mechanical pressing means has a cell assembly contact surface facing the interior of the cell chamber (see Figs. 42, 45, 46 for example), wherein the cell assembly contact surface has at least one structured portion (e.g., 4208/4502/4606),
wherein the at least one structured portion of the cell assembly contact surface is formed from at least one protrusion (e.g., 4008/4208/4502/4602), protruding into the interior of cell chamber (see Figs. 42, 45, 46 for example), wherein the cross-section of the at least one protrusion, which cross-section is transverse to the pressing direction of the mechanical pressing means, decreases in direction towards the interior of the cell chamber (see Figs. 45B, 46B for example).
With regard to limitations in claims 1, 2, 13, 14, 15, 16, 20, 24, 30 (e.g., [...] for introducing a cell assembly into the cell chamber, [...] being operable between a releasing position and a pressing position via an actuation line; [...] for sensing a property of the cell assembly within the cell chamber; [...] the at least one sensor converts [...], etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus 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). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 2, 9, 12-16, 20-29, 31-33, Unger et al. teach:
2. The microfluidic device according to claim 1, wherein the at least one mechanical pressing means has at least one sensor capable for sensing a property of the cell assembly within the cell chamber (see ¶ 0400, 0429; 0237-0244+, 0291 for example).
9. The microfluidic device according to claim 1, wherein the cell chamber is formed by a first wall and a second wall that is opposite to the first wall, wherein the cell assembly contact surface of the mechanical pressing means forms at least a portion of the first wall (see Figs. 19, 41-42 for example).
12. The microfluidic device according to claim 2, wherein the at least one sensor is formed within the cell assembly contact surface (see ¶ 0400, 0429 for example).
13. The microfluidic device according to claim 2, wherein the at least one sensor is a chemical sensor and is capable of using an optical transducer (see ¶ 0429 for example).
14. The microfluidic device according to claim 2, wherein the at least one sensor is capable of converting a property (see ¶ 0429 for example).
15. The microfluidic device according to claim 2, wherein the at least one sensor is capable of being formed by a coating (see ¶ 0424-0434 for example).
16. The microfluidic device according to claim 1, wherein at least a portion of the actuation line is capable of being formed by an actuation chamber (e.g., control channel 4204/4207/4504/4608) which is separated from the cell chamber by the flexible membrane (see Figs. 42, 45B, 46B for example).
20. The microfluidic device according to claim 1, wherein the cell assembly contact surface of the at least one mechanical pressing means is capable of being formed by a flexible membrane (e.g., movable elastomeric membrane 4008/4208/4502/4606 ¶ 0358, 0361-0362, 0379, 0383+).
21. The microfluidic device according to claim 20, wherein the membrane comprises Polydimethylsiloxan (PDMS) (see ¶ 0185 for example).
22. The microfluidic device according to claim 1, wherein the inner surface of the cell chamber wall that is opposite to the cell assembly contact surface of the mechanical pressing means is substantially planar (see Figs. 19, 41-42 for example).
23. The microfluidic device according to claim 1, wherein the inner surface of the cell chamber wall that is opposite to the cell assembly contact surface of the mechanical pressing means is coated with at least one polypeptide (see ¶ 0291 for example.
24. The microfluidic device according to claim 1, wherein the operation range of the cell assembly contact surface of the mechanical pressing means has essentially circular shape (see Figs. 7H, 42H for example).
25. The microfluidic device according to claim 1, wherein the micro fluidic device has, at least in the area of the at least one cell chamber, a sandwich structure with a top layer (e.g., upper 24 in Fig. 7B), an intermediate layer (e.g., lower 24 in Fig. 7B) and a bottom layer (e.g., 14 in Fig. 7B), wherein the mechanical pressing means is formed by the intermediate layer (see Fig. 7B for example).
26. The microfluidic device according to claim 25, wherein side walls of the cell chamber are formed by the bottom layer and by the intermediate layer (see Fig. 7B for example).
27. The microfluidic device according to claim 25 or 26, wherein at least a portion of the actuation line (e.g., 32 in Fig. 7B) is formed within the top layer (see Fig. 7B for example).
28. The microfluidic device according to claim 1, wherein the actuation line is a pneumatic line (see ¶ 0210, 0221 for example).
29. The microfluidic device according to claim 1, wherein the at least one cell chamber comprises an outlet (see i.e., “FLUID FLOW” with an arrow away flow channels 4108 in Fig. 41), wherein a flow path is defined in the cell chamber between the inlet and the outlet (see Fig. 41 for example).
31. The microfluidic device according to claim 1, wherein the microfluidic device has a flat cross section and elongated shape (see Figs. 41-42 for example).
32. The microfluidic device according to claim 1, wherein a height of the cell chamber is smaller than 1 mm and wherein a width of the cell chamber amounts between 200 µm and 5 mm and wherein a length of the cell chamber amounts between 2 mm and 10 cm (see ¶ 0144-0148 for example).
33. The microfluidic device according to claim 1, wherein the microfluidic device comprises a plurality of cell chambers (see ¶ 0273, 0461 for example).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 9, 12-16, 20-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sticker et al. (EP 3231860 A1) in view of Unger et al. (US 2008/0277005).
Regarding claim 1, Sicker et al. teach:
1. A microfluidic device (e.g., 1, ¶ 0074-0078+) for applying pressure to a cell assembly (e.g., 14), comprising
at least one cell chamber (e.g., 2), wherein the at least one cell chamber comprises:
an inlet (e.g., 5) for introducing a cell assembly (e.g., 14) into the cell chamber,
at least one mechanical pressing means (e.g., flexible membrane 13) for applying pressure to the cell assembly and being operable between a releasing position and a pressing position (see Fig. 1 for example) via an actuation line (e.g., 7),
wherein the at least one mechanical pressing means (13) has a cell assembly contact surface (e.g., 11) facing the interior of the cell chamber, wherein the cell assembly contact surface has at least one structured portion (see the flexible membrane 13 in Fig. 3 for example),
wherein the at least one structured portion of the cell assembly contact surface is formed from at least one protrusion, protruding into the interior of cell chamber (see annotated Fig. 3 for example).
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Regarding claim 1, Sticker et al. further teach various cross-sectional shapes (see i.e., In a preferred embodiment the cell chamber and/or the microfluidic device has a flat cross section and/or elongated shape. The shape of the microfluidic device may be any one. However, it is particularly preferred that the cell chamber has an elongated shape. ¶ 0039; In the embodiment of Fig. 1 the operation range of the mechanical excluding means 13 has essentially circular shape. However, any other shape, e.g. polygonal shape would be possible. ¶ 0081; The inner surface of the chamber wall that is opposite to the mechanical excluding means 13 is substantially planar. Alternatively, a concave or convex curved shape would be possible. ¶ 0079; The microfluidic device 1 has a flat cross section (Fig. 1 and 3) and elongated shape (Fig. 2 and 4). ¶ 0086). However, Sticker et al. do not explicitly teach: wherein the cross-section of the at least one protrusion, which cross-section is transverse to the pressing direction of the mechanical pressing means, decreases in direction towards the interior of the cell chamber.
See Unger et al. above.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the cross-section of the at least one protrusion of Sicker et al., with the teaching of Unger et al., to manipulate organisms or other biological material (Unger et al. ¶ 0375).
With regard to limitations in claims 1, 2, 13, 14, 15, 16, 20, 24, 30 (e.g., [...] for introducing a cell assembly into the cell chamber, [...] being operable between a releasing position and a pressing position via an actuation line; [...] for sensing a property of the cell assembly within the cell chamber; [...] the at least one sensor converts [...], etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus 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). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 2, 9, 12-16, 20-33, modified Sicker et al. teach:
2. The microfluidic device according to claim 1, wherein the at least one mechanical pressing means has at least one sensor (see i.e., surface modifications of the membrane for monitoring cells, ¶ 0101-0106+) capable for sensing a property of the cell assembly within the cell chamber (see ¶ 0101-0106+ & Claim 9 for example).
9. The microfluidic device according to claim 1, wherein the cell chamber is formed by a first wall and a second wall that is opposite to the first wall, wherein the cell assembly contact surface of the mechanical pressing means forms at least a portion of the first wall (see Fig. 3 for example).
12. The microfluidic device according to claim 2, wherein the at least one sensor is formed within the cell assembly contact surface (see ¶ 0101-0106+ & Claim 9 for example).
13. The microfluidic device according to claim 2, wherein the at least one sensor is a chemical sensor and is capable of using an optical transducer (see ¶ 0092-0093, 0103-0104 for example).
14. The microfluidic device according to claim 2, wherein the at least one sensor is capable of converting a property (see ¶ 0092-0093, 0103-0104 for example).
15. The microfluidic device according to claim 2, wherein the at least one sensor is capable of being formed by a coating (see ¶ 0101-0106+ for example).
16. The microfluidic device according to claim 1, wherein at least a portion of the actuation line (7) is capable of being formed by an actuation chamber (see Claim 1 for example) which is separated from the cell chamber by the flexible membrane (see Fig. 3 for example).
20. The microfluidic device according to claim 1, wherein the cell assembly contact surface of the at least one mechanical pressing means is capable of being formed by a flexible membrane (e.g., PDMS membrane ¶ 0091+).
21. The microfluidic device according to claim 20, wherein the membrane comprises Polydimethylsiloxan (PDMS) (see ¶ 0091 for example).
22. The microfluidic device according to claim 1, wherein the inner surface of the cell chamber wall that is opposite to the cell assembly contact surface of the mechanical pressing means is substantially planar (see Fig. 3 for example).
23. The microfluidic device according to claim 1, wherein the inner surface of the cell chamber wall that is opposite to the cell assembly contact surface of the mechanical pressing means is coated with at least one polypeptide (see ¶ 0080 & Claim 5 for example.
24. The microfluidic device according to claim 1, wherein the operation range of the cell assembly contact surface of the mechanical pressing means has essentially circular shape (¶ 0023, 0081+) and wherein the operation range of the cell contact surface of the mechanical pressing means has an area between 0.2 mm2 and 5 mm2 (see ¶ 0081 for example).
25. The microfluidic device according to claim 1, wherein the micro fluidic device has, at least in the area of the at least one cell chamber, a sandwich structure with a top layer (e.g., 8), an intermediate layer (e.g., 9) and a bottom layer (e.g., 10), wherein the mechanical pressing means is formed by the intermediate layer (see Fig. 3 for example).
26. The microfluidic device according to claim 25, wherein side walls of the cell chamber are formed by the bottom layer and by the intermediate layer (see Fig. 3 for example).
27. The microfluidic device according to claim 25 or 26, wherein at least a portion of the actuation line is formed within the top layer (see Fig. 3 for example).
28. The microfluidic device according to claim 1, wherein the actuation line (7) is a pneumatic line (see Claim 8 for example).
29. The microfluidic device according to claim 1, wherein the at least one cell chamber comprises an outlet (e.g., 6), wherein a flow path is defined in the cell chamber between the inlet (5) and the outlet (see Fig. 2 for example).
30. The microfluidic device according to claim 29, wherein in a cross section perpendicular to the flow path lateral areas of the cell chamber are outside of the operation range of the mechanical pressing means (see ¶ 0082 for example).
31. The microfluidic device according to claim 1, wherein the microfluidic device has a flat cross section and elongated shape (see ¶ 0086 for example).
32. The microfluidic device according to claim 1, wherein a height of the cell chamber is smaller than 1 mm and wherein a width of the cell chamber amounts between 200 µm and 5 mm and wherein a length of the cell chamber amounts between 2 mm and 10 cm (see ¶ 0040 for example).
33. The microfluidic device according to claim 1, wherein the microfluidic device comprises a plurality of cell chambers (see ¶ 0041 for example).
Response to Arguments
Applicant’s arguments have been considered but are moot in view of the new ground(s) of rejection.
The objections to the Drawing are withdrawn.
Applicant is encouraged to amend the claims to include additional structural elements of the device. Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798