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 .
Withdrawn Objections/Rejections
All the objections and rejections in the previous Office Action not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2, 10, 19, 26, 33, 98, 101-106, 109-114, 117-122, 125-130 and 133-137 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Amended independent claims recite the limitation "wherein the surface of said constrictions is sufficiently smooth so that it improves the endocytosis of the transfection material into the cells," however, said limitation constitute new matter. The instant specification, as originally filed, does not disclose the phrase “sufficiently smooth,” and neither the specification nor the claims define what constitutes “sufficiently smooth.” That is, there is no objective boundary distinguishing a “sufficiently smooth” surface from one that is not. Further, the specification discloses smooth walls only as a base structural embodiment (FIG. 2U), without any discussion of sufficiently smooth surface that improves the endocytosis of the transfection material into the cells. Further, the specification does disclose improved transfection efficiency (see [0122]), but such improvements are attributed to the roughness of the surface. As such, said limitation constitutes new matter.
Claims 98, 101-106, 109-122, 125-130 and 133-137 are included in this rejection by virtue of their dependency upon a rejection base claim.
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, 19, 26, 33, 98, 101-106, 109-114, 117-122, 125-130 and 133-137 are rejected under 35 U.S.C. 112(b) 10, 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.
Claims 2, 10, 19, 26 and 33 recite the limitation "the surface." There is insufficient antecedent basis for this limitation in the claim. Claims 98, 101-106, 109-122, 125-130 and 133-137 are included in this rejection by virtue of their dependency upon a rejection base claim.
Claims 2, 10, 19, 26 and 33 recite the limitation "the endocytosis of the transfection material." There is insufficient antecedent basis for this limitation in the claim.
Claims 2, 10, 19, 26 and 33 recite the limitation " wherein the surface of said constrictions is sufficiently smooth so that it improves the endocytosis of the transfection material into the cells". However, it is unclear what degree of smoothness the surface must possess to meet said limitation. The specification provided no objective boundary distinguishing a “sufficiently smooth” surface from one that is not.
Appropriate correction is required.
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 for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 10, 19, 26, 98, 101-103, 106, 109-110, 114, 117-119, 122, 125-126 and 130 are rejected under 35 U.S.C. 103 as being unpatentable over Pawell (US 2018/0346865) in view of Sharei et al. (previously cited, US 2014/0287509; hereinafter “Sharei”), Wang et al. (previously cited, US 2014/0017150; hereinafter “Wang”), Diefenbach (US 2012/0064518) and Ditommaso et al (US 2019/0017072; hereinafter “Ditommaso”).
Regarding claims 2 and 101-103, Pawell discloses an assembly comprising: a channel having a first inner diameter, wherein the channel is contiguous (contact) with the sample solution volume (FIG. 1: a device comprising a channel having a diameter; [0131]); the channel having a shape and a plurality of constriction sections contiguous within the channel, wherein the plurality of constriction sections has a shape and has a second inner diameter that is smaller than the first inner diameter of the channel (see FIG. 1, [0123], [0131] and [0133]); wherein the plurality of constriction sections each has a diameter which ranges from about 9 µm to about 12000 µm (see [0058]-[0062], [0131]-[0133], [0157]), wherein a smallest constriction of the plurality of constrictions is large enough to avoid any mechanical squeezing or constraints of the largest cells within the sample (each of the plurality of constriction sections within the at least one channel is configured to allow cells and transfection materials to pass therethrough without mechanically squeezing the cells; see [0058]-[0062], [0131]-[0133]); and an open distal end ([0177]); wherein a minimum constriction diameter of the plurality of constrictions is larger than the cells (each of the plurality of constriction sections within the channel is configured to allow cells to pass through without mechanically squeezing the cells; see [0058]-[0062], [0131]-[0133]).
Pawell discloses wherein the assembly includes said channel having said plurality of constriction sections (FIGS. 1 and 8-10; [0155], [0177]), but does not explicitly disclose a rigid container having a proximal and distal end, a first inner diameter, and inner and outer walls extending between the proximal and distal ends, wherein the container comprises a sample solution volume, and a plurality of circular channels having a plurality of circular constriction sections. Sharei discloses an assembly comprising a rigid container having a proximal and distal end, a first inner diameter, and inner and outer walls extending between the proximal and distal ends, wherein the container comprises a sample solution volume (FIGS. 5-6: a container comprising a chamber havening an inlet and an outlet; [0019], [0021], [0097] and [0104]), and a plurality of circular channels having a plurality of circular constriction sections (the assembly includes a plurality of channels having a plurality of constriction sections; see FIGS. 5-6; further, cross-section of the channels and constriction sections can vary; the cross-section of the channels and constriction sections can be circular, for example; [0095]), and wherein the plurality of constrictions within each channel of the plurality of channels has a same inner diameter (plurality of constrictions have an inner diameter of 8 µm; [0008], [0188]). In view of Sharei, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention of the claimed invention to have modified the assembly of Pawell with the assembly of Sharei such that the assembly of Pawell includes a rigid container coupled to a plurality of channels, each having a plurality of circular constriction sections. One of ordinary skill in the art would have made said modification by including a rigid container and duplicated the channel of Pawell for the purpose of increasing the throughput of the assembly of Pawell, as disclosed by Sharei ([0143], [0187]). Further, one of ordinary skill in the art would have made said modification by constructing the plurality of constriction sections and the channel of Pawell in a circular shape since Sharei discloses that the plurality of constriction sections and channels can have various shapes including circular shape(Sharei at [0095]). Pawell discloses wherein a fluid conveying means is coupled to the inlet of the assembly (e.g., pressure pump; [00155]), but does not explicitly disclose wherein the fluid conveying means is a removable proximal plunger insertable into the container at the proximal end of the container, which is contiguous with the sample solution volume. However, Sharei discloses wherein a fluid conveying means is coupled to the inlet of the assembly (e.g., pressure pump; [0011]). Wang discloses that a plunger can be used in place of pumps for conveying fluid through channels ([0005] and [0043]). In view of Wang, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the plunger of Wang with the container Of modified Pawell, because Wang discloses that a plunger can be used in place of pumps for conveying fluid through the channel (Wang at [0005] and [0043]). Thus, modified Pawell discloses all of the structural features of the claimed assembly and thus fully capable to “move(s) to pass a sample solution containing cells and the transfection material through the plurality of constriction sections within the plurality of channels.” Modified Pawell does not explicitly disclose wherein the plurality of channels are constructed as a removable insert. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have constructed the plurality of channels of modified Pawell as a removable insert, since it has been held that constructing formerly integral structure in various elements involves only routing skill in art. Furter, one would have been motivated to make the elements separable because said modification would have resulted in a system having the added advantage of interchanging removable inserts having channels with various dimensions and channels with constrictions having different dimensions, without replacing the entire container. See also M.P.E.P. § 2144.04 VI (C). Modified Pawell discloses wherein the proximal plunger is coupled to a moving means but does not explicitly disclose wherein the moving means is an arm coupled to a motor. However, it would have been prima facie obvious to one of ordinary skill in the art to have coupled an arm coupled to a motor to the plunger of modified Pawell for the purpose of providing means for moving the plunger in the container. Further, doing so would have been the simple substitution of one known moving means for another for the predictable result of moving a plunger through a container. Modified Pawell discloses wherein the length of each of the plurality of channels can be varied and can have a length of 5.5 mm or 7.5 mm (Pawell at [0177]). Modified Pawell does disclose wherein the constriction forms a flow path having a length but does not explicitly disclose wherein the length is about 0.2-10 mm. Sharei further discloses that constriction length can be optimized to increase delivery efficiency and cell viability ([0234]). Diefenbach in the same field of endeavor, discloses as assembly for introducing transfection materials into a cell ([0119]) comprising a reservoir ([0022], [0028], [0038]) and an insert comprising a plurality of constrictions (tip assembly arranged within the reservoir; [0203]). The constrictions can have a length of 0.3 mm ([0062]). In view of Diefenbach, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the constriction length of the channels of Pawell to comprise the length as disclosed by Diefenbach. One of ordinary skill in the art would have made said modification for the purpose of optimizing the constriction length and thereby increasing delivery efficiency and cell viability as disclosed by Sharei ([0234]).
Modified Pawell discloses wherein the assembly includes said channel having said plurality of constriction sections (FIGS. 1 and 8-10; [0155], [0177]), but does not explicitly disclose wherein the surface of said constrictions is sufficiently smooth so that it improves the endocytosis of the transfection material into the cells. Ditommaso discloses a system for delivering materials into a cell including passing a cell suspension through a constriction (see abstract). Ditommaso further discloses the that constriction/pore surface can be any of smooth, electropolished, rough, or plasma treated ([0100], [0112]). In view of Ditommaso, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a smooth surface finish for the surfaces of the plurality of constriction sections of modified Pawel, since Ditommaso identifies smooth as one of finite, known set of suitable surface finishes for constriction-based cell delivery ([0100], [0112]), and selecting among a finite number of identified, predictable options is a matter of routine engineering choice. One would have a reasonable expectation of success because both references concern the same filed of constriction-mediated intracellular delivery. Modified Pawell discloses all of the structural features of the claimed assembly and thus considered to be fully capable of performing the recited function of “wherein successful transfection occurs when an appropriate constriction diameter is combined with the sample solution being passed through the constriction about 10-90 times using back and forth movements of the plunger(s) such that the cells to be transfected are not mechanically squeezed.”
Furthermore, it is noted that the sample solution, transfection material, and cells are material worked on and not elements of the claimed assembly. It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2115. Furthermore, it is noted that the recitation of functional language "for introducing transfection material in a sample solution into cells " is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). Furthermore, the intended uses of the apparatus do not further define any structural features to the assembly but rather only define how the assembly may be used. The prior art discloses all of the structural features of the claimed assembly and thus since the structure is the same, the claimed functions are apparent.
Regarding claims 10 and 107, Pawell discloses an assembly for introducing transfection materials in a sample solution into cells, the assembly comprising: a container having a proximal and distal end, a sample solution containing cells and the transfection materials, and at least one channel which has a first inner diameter (FIG. 1: microfluidic device comprising an inlet, an outlet and a channel having a first inner diameter; FIGS. 1 and 8-10; [0131]-[0132], [0155], [0177]); the at least one channel having a plurality of constriction sections contiguous within the at least one channel, wherein the plurality of constriction sections have a second inner diameter that is smaller than the channel first inner diameter, wherein the channel is contiguous with the sample solution containing cells and the transfection materials (at least one channel comprising a plurality of constrictions forming gaps that have diameter smaller than the first diameter of the channel; FIGS. 1 and 8-10; [0058]-[0062], [0123], [0131]-[0133], [0157]); wherein the plurality of constrictions each independently have the same inner diameter, wherein the plurality of constrictions have a diameter which ranges from about 9 µm to about 12000 µm and is at least 1.2 times to 100 times the diameter of the cells to be transfected (at least one channel comprising a plurality of constrictions forming gaps that have diameter smaller than the first diameter of the channel; FIGS. 1 and 8-10; [0058]-[0062], [0123], [0131]-[0133], [0157]), wherein a smallest constriction of the plurality of constrictions is large enough to avoid any mechanical squeezing or constraints of the largest cells within the sample (each of the plurality of constriction sections within the at least one channel is configured to allow cells and transfection materials to pass therethrough without mechanically squeezing the cells; see [0058]-[0062], [0131]-[0133]); and an open distal end, which is contiguous with the sample solution containing cells and the transfection materials (FIGS. 1 and 8-10; [0177]); wherein a minimum constriction diameter is larger than the cell (each of the plurality of constriction sections within the channel is configured to allow cells to pass through without mechanically squeezing the cells; see [0058]-[0062], [0131]-[0133]). Pawell does not explicitly disclose wherein the at least one channel and the plurality of constriction sections are circular in shape. Sharei discloses an assembly comprising a rigid container having a proximal and distal end, a first inner diameter, and inner and outer walls extending between the proximal and distal ends, wherein the container comprises a sample solution volume (FIGS. 5-6: a container comprising a chamber havening an inlet and an outlet; [0019], [0021], [0097] and [0104]), and a plurality of circular channels having a plurality of circular constriction sections (the assembly includes a plurality of channels having a plurality of constriction sections; see FIGS. 5-6; further, cross-section of the channels and constriction sections can vary; the cross-section of the channels and constriction sections can be circular, for example; [0095]), and wherein the plurality of constrictions within each channel of the plurality of channels has a same inner diameter (plurality of constrictions have an inner diameter of 8 µm; [0008], [0188]). In view of Sharei, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention of the claimed invention to have modified the assembly of Pawell with the assembly of Sharei such that the at least one channel and the plurality of constriction sections of Pawell are circular in shape. One of ordinary skill in the art would have made said modification because Sharei discloses that the plurality of constriction sections and at least one channel can have various shapes including circular shape (Sharei at [0095]). Pawell discloses wherein a fluid conveying means is coupled to the inlet of the assembly (e.g., pressure pump; [00155]), but does not explicitly disclose wherein the fluid conveying means is a removable proximal plunger insertable into the container at the proximal end of the container, which is contiguous (contact) with the sample solution containing cells and the transection materials. However, Sharei discloses wherein a fluid conveying means is coupled to the inlet of the assembly (e.g., pressure pump; [0011]). Wang discloses that a plunger can be used in place of pumps for conveying fluid through channels ([0005] and [0043]). In view of Wang, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the plunger of Wang with the container Of modified Pawell, because Wang discloses that a plunger can be used in place of pumps for conveying fluid through the channel (Wang at [0005] and [0043]). Thus, modified Pawell discloses all of the structural features of the claimed assembly and thus fully capable to “move(s) to pass a sample solution containing cells and the transfection material through the plurality of constriction sections within the plurality of channels.” Modified Pawell discloses wherein the length of each of the plurality of channels can be varied and can have a length of 5.5 mm or 7.5 mm (Pawell at [0177]). Modified Pawell does disclose wherein the constriction forms a flow path having a length but does not explicitly disclose wherein the length is about 0.2-10 mm. Sharei further discloses that constriction length can be optimized to increase delivery efficiency and cell viability ([0234]). Diefenbach in the same field of endeavor, discloses as assembly for introducing transfection materials into a cell ([0119]) comprising a reservoir ([0022], [0028], [0038]) and an insert comprising a plurality of constrictions (tip assembly arranged within the reservoir; [0203]). The constrictions can have a length of 0.3 mm ([0062]). In view of Diefenbach, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the constriction length of the channels of Pawell to comprise the length as disclosed by Diefenbach. One of ordinary skill in the art would have made said modification for the purpose of optimizing the constriction length and thereby increasing delivery efficiency and cell viability as disclosed by Sharei ([0234]). Modified Pawell discloses all of the structural features of the claimed assembly and thus considered to be fully capable of performing the recited function of “wherein successful transfection occurs when an appropriate constriction diameter is combined with the sample solution being passed through the constriction about 10-90 times using back and forth movements of the plunger(s) such that the cells to be transfected are not mechanically squeezed.” Modified Pawell discloses wherein the assembly includes said channel having said plurality of constriction sections (FIGS. 1 and 8-10; [0155], [0177]), but does not explicitly disclose wherein the surface of said constrictions is sufficiently smooth so that it improves the endocytosis of the transfection material into the cells. Ditommaso discloses a system for delivering materials into a cell including passing a cell suspension through a constriction (see abstract). Ditommaso further discloses the that constriction/pore surface can be any of smooth, electropolished, rough, or plasma treated ([0100], [0112]). In view of Ditommaso, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a smooth surface finish for the surfaces of the plurality of constriction sections of modified Pawel, since Ditommaso identifies smooth as one of finite, known set of suitable surface finishes for constriction-based cell delivery ([0100], [0112]), and selecting among a finite number of identified, predictable options is a matter of routine engineering choice. One would have a reasonable expectation of success because both references concern the same filed of constriction-mediated intracellular delivery.
Furthermore, it is noted that the recitation of functional language "for introducing transfection material in a sample solution into cells " is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). Furthermore, the intended uses of the apparatus do not further define any structural features to the assembly but rather only define how the assembly may be used. The prior art discloses all of the structural features of the claimed assembly and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 19, Pawell discloses an assembly for introducing transfection materials in a sample solution into cells, the assembly comprising: a channel having a first inner diameter, wherein the channel is contiguous (contact) with the sample solution volume (FIG. 1: a device comprising a channel having a diameter; [0131]); the at least one channel having a plurality of constriction sections contiguous within the at least one channel, wherein the plurality of constriction sections have a second inner diameter that is smaller than the channel first inner diameter, wherein the channel is contiguous with the sample solution containing cells and the transfection materials (at least one channel comprising a plurality of constrictions forming gaps that have diameter smaller than the first diameter of the channel; FIGS. 1 and 8-10; [0058]-[0062], [0123], [0131]-[0133], [0157]); wherein the plurality of constrictions each independently have the same inner diameter, wherein the constrictions have a diameter which ranges from about 9 µm to about 12000 µm and is at least 1.2 times to 100 times the diameter of the cells to be transfected (at least one channel comprising a plurality of constrictions forming gaps that have diameter smaller than the first diameter of the channel; FIGS. 1 and 8-10; [0058]-[0062], [0123], [0131]-[0133], [0157]), wherein a smallest of the plurality of constrictions is large enough to avoid any mechanical squeezing or constraints of the largest cells within the sample (each of the plurality of constriction sections within the at least one channel is configured to allow cells and transfection materials to pass therethrough without mechanically squeezing the cells; see [0058]-[0062], [0131]-[0133]); and an open distal end, which is contiguous with the sample solution containing cells and the transfection materials (FIGS. 1 and 8-10; [0177]); wherein a minimum constriction diameter is larger than the cell (each of the plurality of constriction sections within the channel is configured to allow cells to pass through without mechanically squeezing the cells; see [0058]-[0062], [0131]-[0133]). Pawell discloses wherein the assembly includes said at least one channel having said plurality of constriction sections and a sample solution containing cells and the transfection materials (FIGS. 1 and 8-10; [0155], [0177]), but does not explicitly disclose a flexible container having a proximal and distal end, a first inner diameter, and inner and outer walls extending between the proximal and distal ends, wherein the container comprises a sample solution containing cells and the transfection materials, and a plurality of circular channels having a plurality of circular constriction sections. Sharei discloses an assembly comprising a container having a proximal and distal end, a first inner diameter, and inner and outer walls extending between the proximal and distal ends, wherein the container comprises a sample solution volume (FIGS. 5-6: a container comprising a chamber havening an inlet and an outlet; [0019], [0021], [0097] and [0104]), and a plurality of circular channels having a plurality of circular constriction sections (the assembly includes a plurality of channels having a plurality of constriction sections; see FIGS. 5-6; further, cross-section of the channels and constriction sections can vary; the cross-section of the channels and constriction sections can be circular, for example; [0095]), and wherein the plurality of constrictions within each channel of the plurality of channels has a same inner diameter (plurality of constrictions have an inner diameter of 8 µm; [0008], [0188]). In view of Sharei, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the assembly of Pawell with the assembly of Sharei such that the assembly of Pawell includes a container coupled to a plurality of channels, each having a plurality of constriction sections. One of ordinary skill in the art would have made said modification by including a container and duplicated the at least one channel of Pawell for the purpose of increasing the throughput of the assembly of Pawell, as disclosed by Sharei ([0143], [0187]). Further, one of ordinary skill in the art would have made said modification by constructing the plurality of constriction sections and the plurality of channels of Pawell in a circular shape since Sharei discloses that the plurality of constriction sections and the plurality of channels can have various shapes including circular shape(Sharei at [0095]). Modified Pawell does not explicitly disclose wherein the container is a flexible container. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the container of modified Pawell with a flexible material to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known material for another for the predictable result of forming a container for sample processing. Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07). Modified Pawell does not explicitly disclose wherein the plurality of channels are constructed as a removable insert. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have constructed the plurality of channels of modified Pawell as a removable insert, since it has been held that constructing formerly integral structure in various elements involves only routing skill in art. Furter, one would have been motivated to make the elements separable because said modification would have resulted in a system having the added advantage of interchanging removable inserts having channels with various dimensions and channels with constrictions having different dimensions, without replacing the entire container. See also M.P.E.P. § 2144.04 VI (C). Pawell discloses wherein a fluid conveying means is coupled to the inlet of the assembly (e.g., pressure pump; [00155]), but does not explicitly disclose wherein the fluid conveying means is a removable proximal plunger insertable into the container at the proximal end of the container, which is contiguous (contact) with the sample solution containing cells and the transection materials. However, Sharei discloses wherein a fluid conveying means is coupled to the inlet of the assembly (e.g., pressure pump; [0011]). Wang discloses that a plunger can be used in place of pumps for conveying fluid through channels ([0005] and [0043]). In view of Wang, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the plunger of Wang with the container Of modified Pawell, because Wang discloses that a plunger can be used in place of pumps for conveying fluid through the channel (Wang at [0005] and [0043]). Thus, modified Pawell discloses all of the structural features of the claimed assembly and thus fully capable to “move(s) to pass a sample solution containing cells and the transfection material through the plurality of constriction sections within the plurality of channels.” Modified Pawell discloses wherein the length of each of the plurality of channels can be varied and can have a length of 5.5 mm or 7.5 mm (Pawell at [0177]). Modified Pawell does disclose wherein the constriction forms a flow path having a length but does not explicitly disclose wherein the length is about 0.2-10 mm. Sharei further discloses that constriction length can be optimized to increase delivery efficiency and cell viability ([0234]). Diefenbach in the same field of endeavor, discloses as assembly for introducing transfection materials into a cell ([0119]) comprising a reservoir ([0022], [0028], [0038]) and an insert comprising a plurality of constrictions (tip assembly arranged within the reservoir; [0203]). The constrictions can have a length of 0.3 mm ([0062]). In view of Diefenbach, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the constriction length of the channels of Pawell to comprise the length as disclosed by Diefenbach. One of ordinary skill in the art would have made said modification for the purpose of optimizing the constriction length and thereby increasing delivery efficiency and cell viability as disclosed by Sharei ([0234]). Modified Pawell discloses all of the structural features of the claimed assembly and thus considered to be fully capable of performing the recited function of “wherein successful transfection occurs when an appropriate constriction diameter is combined with the sample solution being passed through the constriction about 10-90 times using back and forth movements of the plunger(s) such that the cells to be transfected are not mechanically squeezed.” Modified Pawell discloses wherein the assembly includes said channel having said plurality of constriction sections (FIGS. 1 and 8-10; [0155], [0177]), but does not explicitly disclose wherein the surface of said constrictions is sufficiently smooth so that it improves the endocytosis of the transfection material into the cells. Ditommaso discloses a system for delivering materials into a cell including passing a cell suspension through a constriction (see abstract). Ditommaso further discloses the that constriction/pore surface can be any of smooth, electropolished, rough, or plasma treated ([0100], [0112]). In view of Ditommaso, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a smooth surface finish for the surfaces of the plurality of constriction sections of modified Pawel, since Ditommaso identifies smooth as one of finite, known set of suitable surface finishes for constriction-based cell delivery ([0100], [0112]), and selecting among a finite number of identified, predictable options is a matter of routine engineering choice. One would have a reasonable expectation of success because both references concern the same filed of constriction-mediated intracellular delivery. Furthermore, it is noted that the recitation of functional language "for introducing transfection material in a sample solution into cells " is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). Furthermore, the intended uses of the apparatus do not further define any structural features to the assembly but rather only define how the assembly may be used. The prior art discloses all of the structural features of the claimed assembly and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 26, Pawell discloses a microfluidic device assembly for introducing transfection materials in a sample solution into cells, the assembly comprising: a container having a proximal and distal end, a sample solution containing cells and the transfection materials, and at least one channel which has a first inner diameter (FIG. 1: microfluidic device comprising an inlet, an outlet and a channel having a first inner diameter; FIGS. 1 and 8-10; [0131]-[0132], [0155], [0177]); the at least one channel having a plurality of constriction sections contiguous within the at least one channel, wherein the plurality of constriction sections have a second inner diameter that is smaller than the channel first inner diameter, wherein the channel is contiguous with the sample solution containing cells and the transfection materials (at least one channel comprising a plurality of constrictions forming gaps that have diameter smaller than the first diameter of the channel; FIGS. 1 and 8-10; [0058]-[0062], [0123], [0131]-[0133], [0157]); wherein the plurality of constriction section each independently have the same inner diameter, wherein the constrictions have a diameter which ranges from about 9 µm to about 12000 µm and is at least 1.2 times to 100 times the diameter of the cells to be transfected (at least one channel comprising a plurality of constrictions forming gaps that have diameter smaller than the first diameter of the channel; FIGS. 1 and 8-10; [0058]-[0062], [0123], [0131]-[0133], [0157]), wherein a smallest constriction is large enough to avoid any mechanical squeezing or constraints of the largest cells within the sample (each of the plurality of constriction sections within the at least one channel is configured to allow cells and transfection materials to pass therethrough without mechanically squeezing the cells; see [0058]-[0062], [0131]-[0133]); and an open distal end, which is contiguous with the sample solution containing cells and the transfection materials (FIGS. 1 and 8-10; [0177]); wherein a minimum constriction diameter is larger than the cell (each of the plurality of constriction sections within the channel is configured to allow cells to pass through without mechanically squeezing the cells; see [0058]-[0062], [0131]-[0133]). Pawell does not explicitly disclose wherein the at least one channel and the plurality of constriction sections are circular in shape. Sharei discloses an assembly comprising a rigid container having a proximal and distal end, a first inner diameter, and inner and outer walls extending between the proximal and distal ends, wherein the container comprises a sample solution volume (FIGS. 5-6: a container comprising a chamber havening an inlet and an outlet; [0019], [0021], [0097] and [0104]), and a plurality of circular channels having a plurality of circular constriction sections (the assembly includes a plurality of channels having a plurality of constriction sections; see FIGS. 5-6; further, cross-section of the channels and constriction sections can vary; the cross-section of the channels and constriction sections can be circular, for example; [0095]), and wherein the plurality of constrictions within each channel of the plurality of channels has a same inner diameter (plurality of constrictions have an inner diameter of 8 µm; [0008], [0188]). In view of Sharei, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the assembly of Pawell with the assembly of Sharei such that the at least one channel and the plurality of constriction sections of Pawell are circular in shape. One of ordinary skill in the art would have made said modification because Sharei discloses that the plurality of constriction sections and at least one channel can have various shapes including circular shape (Sharei at [0095]). Pawell discloses wherein a fluid conveying means is coupled to the inlet of the assembly (e.g., pressure pump; [00155]), but does not explicitly disclose wherein the fluid conveying means is a removable proximal plunger insertable into the container at the proximal end of the container, which is contiguous (contact) with the sample solution containing cells and the transection materials. However, Sharei discloses wherein a fluid conveying means is coupled to the inlet of the assembly (e.g., pressure pump; [0011]). Wang discloses that a plunger can be used in place of pumps for conveying fluid through channels ([0005] and [0043]). In view of Wang, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the plunger of Wang with the container Of modified Pawell, because Wang discloses that a plunger can be used in place of pumps for conveying fluid through the channel (Wang at [0005] and [0043]). Thus, modified Pawell discloses all of the structural features of the claimed assembly and thus fully capable to “move(s) to pass a sample solution containing cells and the transfection material through the plurality of constriction sections within the plurality of channels.” Modified Pawell discloses wherein the length of each of the plurality of channels can be varied and can have a length of 5.5 mm or 7.5 mm (Pawell at [0177]). Modified Pawell does disclose wherein the constriction forms a flow path having a length but does not explicitly disclose wherein the length is about 0.2-10 mm. Sharei further discloses that constriction length can be optimized to increase delivery efficiency and cell viability ([0234]). Diefenbach in the same field of endeavor, discloses as assembly for introducing transfection materials into a cell ([0119]) comprising a reservoir ([0022], [0028], [0038]) and an insert comprising a plurality of constrictions (tip assembly arranged within the reservoir; [0203]). The constrictions can have a length of 0.3 mm ([0062]). In view of Diefenbach, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the constriction length of the channels of Pawell to comprise the length as disclosed by Diefenbach. One of ordinary skill in the art would have made said modification for the purpose of optimizing the constriction length and thereby increasing delivery efficiency and cell viability as disclosed by Sharei ([0234]). Modified Pawell discloses all of the structural features of the claimed assembly and thus considered to be fully capable of performing the recited function of “wherein successful transfection occurs when the appropriate constriction diameter is combined with the sample solution being pulled into the container and pushed back out again such that the cells to be transfected are not mechanically squeezed.” Modified Pawell discloses wherein the assembly includes said channel having said plurality of constriction sections (FIGS. 1 and 8-10; [0155], [0177]), but does not explicitly disclose wherein the surface of said constrictions is sufficiently smooth so that it improves the endocytosis of the transfection material into the cells. Ditommaso discloses a system for delivering materials into a cell including passing a cell suspension through a constriction (see abstract). Ditommaso further discloses the that constriction/pore surface can be any of smooth, electropolished, rough, or plasma treated ([0100], [0112]). In view of Ditommaso, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a smooth surface finish for the surfaces of the plurality of constriction sections of modified Pawel, since Ditommaso identifies smooth as one of finite, known set of suitable surface finishes for constriction-based cell delivery ([0100], [0112]), and selecting among a finite number of identified, predictable options is a matter of routine engineering choice. One would have a reasonable expectation of success because both references concern the same filed of constriction-mediated intracellular delivery.
Furthermore, it is noted that the recitation of functional language "for introducing transfection material in a sample solution into cells " is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). Furthermore, the intended uses of the apparatus do not further define any structural features to the assembly but rather only define how the assembly may be used. The prior art discloses all of the structural features of the claimed assembly and thus since the structure is the same, the claimed functions are apparent.
Regarding claims 98 and 130, Application is remined that the transfection materials are material worked on and not elements of the claimed assembly. It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2115.
Regarding claims 106, 114, 119 and 122, modified Pawell further discloses wherein the transfection material comprises genetic material, peptides, proteins, carbohydrates, lipids, inorganic compounds, synthetic polymers, drugs, pharmaceutical compositions, or mixtures thereof (see Pawell at [0024]).
Regarding claims 109-110, 117-118 and 125-126, modified Pawell discloses wherein the proximal plunger is coupled to a moving means but does not explicitly disclose wherein the moving means is arm coupled to a motor. However, it would have been prima facie obvious to one of ordinary skill in the art to have coupled an arm coupled to a motor to each of the plungers of modified Pawell for the purpose of providing means for moving the plunger in the container. Further, doing so would have been the simple substitution of one known moving means for another for the predictable results of moving plunger in the container.
Claims 33 and 133-134 are rejected under 35 U.S.C. 103 as being unpatentable over Pawell (US 2018/0346865) in view of Sharei (previously cited, US 2014/0287509), Wang (previously cited, US 2014/0017150”), Cho et al. (previously cited, US 2015/0192504; hereinafter “Cho”), Diefenbach (US 2012/0064518) and Ditommaso et al (US 2019/0017072; hereinafter “Ditommaso”).
Regarding claim 33, Pawell discloses a system comprising: a channel having a first inner diameter, wherein the channel is contiguous (contact) with the sample solution volume (FIG. 1: a device comprising a channel having a diameter; [0131]); the channel having a shape and a plurality of constriction sections contiguous within the channel, wherein the plurality of constriction sections has a shape and has a second inner diameter that is smaller than the first inner diameter of the channel (see FIG. 1, [0123], [0131] and [0133]); wherein the plurality of constriction section second has a diameter which ranges from about 9 µm to about 12000 µm (see [0058]-[0062], [0131]-[0133], [0157]), wherein a smallest constriction of the plurality of constrictions is large enough to avoid any mechanical squeezing or constraints of the largest cells within the sample (each of the plurality of constriction sections within the at least one channel is configured to allow cells and transfection materials to pass therethrough without mechanically squeezing the cells; see [0058]-[0062], [0131]-[0133]); and an open distal end ([0177]); wherein a minimum constriction diameter is larger than the cell (each of the plurality of constriction sections within the channel is configured to allow cells to pass through without mechanically squeezing the cells; see [0058]-[0062], [0131]-[0133]).
Pawell discloses wherein the assembly includes said channel having said plurality of constriction sections (FIGS. 1 and 8-10; [0155], [0177]), but does not explicitly disclose a rigid container having a proximal and distal end, a first inner diameter, and inner and outer walls extending between the proximal and distal ends, wherein the container comprises a sample solution volume, and a plurality of circular channels having a plurality of circular constriction sections. Sharei discloses an assembly comprising a rigid container having a proximal and distal end, a first inner diameter, and inner and outer walls extending between the proximal and distal ends, wherein the container comprises a sample solution volume (FIGS. 5-6: a container comprising a chamber havening an inlet and an outlet; [0019], [0021], [0097] and [0104]), and a plurality of circular channels having a plurality of circular constriction sections (the assembly includes a plurality of channels having a plurality of constriction sections; see FIGS. 5-6; further, cross-section of the channels and constriction sections can vary; the cross-section of the channels and constriction sections can be circular, for example; [0095]), and wherein the plurality of constrictions within each channel of the plurality of channels has a same inner diameter (plurality of constrictions have an inner diameter of 8 µm; [0008], [0188]). In view of Sharei, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the assembly of Pawell with the assembly of Sharei such that the assembly of Pawell includes a rigid container coupled to a plurality of circular channels, each having a plurality of circular constriction sections. One of ordinary skill in the art would have made said modification by including a rigid container and duplicated the channel of Pawell for the purpose of increasing the throughput of the assembly of Pawell, as disclosed by Sharei ([0143], [0187]). Further, one of ordinary skill in the art would have made said modification by constructing the plurality of constriction sections and the channel of Pawell to have a circular shape, because Sharei discloses that the plurality of constriction sections and channels can have various shapes including circular shape (Sharei at [0095]). Pawell discloses wherein a fluid conveying means is coupled to the inlet of the assembly (e.g., pressure pump; [00155]), but does not explicitly disclose wherein the fluid conveying means is a removable proximal plunger insertable into the container at the proximal end of the container, which is contiguous (contact) with the sample solution volume. However, Sharei discloses wherein a fluid conveying means is coupled to the inlet of the assembly (e.g., pressure pump; [0011]). Wang discloses that a plunger can be used in place of pumps for conveying fluid through channels ([0005] and [0043]). In view of Wang, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the plunger of Wang with the container Of modified Pawell, because Wang discloses that a plunger can be used in place of pumps for conveying fluid through the channel (Wang at [0005] and [0043]). Thus, modified Pawell discloses all of the structural features of the claimed assembly and thus fully capable to “move(s) to pass a sample solution containing cells and the transfection material through the plurality of constriction sections within the plurality of channels.” Modified Pawell does not explicitly disclose wherein the plurality of channels are constructed as a removable insert. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have constructed the plurality of channels of modified Pawell as a removable insert, since it has been held that constructing formerly integral structure in various elements involves only routing skill in art. Furter, one would have been motivated to make the elements separable because said modification would have resulted in a system having the added advantage of interchanging removable inserts having channels with various dimensions and channels with constrictions having different dimensions, without replacing the entire container. See also M.P.E.P. § 2144.04 VI (C). Modified Pawell discloses wherein the proximal plunger is coupled to a moving means but does not explicitly disclose wherein the moving means is an arm coupled to a motor. However, it would have been prima facie obvious to one of ordinary skill in the art to have coupled an arm coupled to a motor to the plunger of modified Pawell for the purpose of providing means for moving the plunger in the container. Further, doing so would have been the simple substitution of one known moving means for another for the predictable result of moving a plunger through a container. Modified Pawell does not explicitly disclose wherein the plurality of constriction sections is formed by at least one movable wedge or at least one movable roller, the movable wedge or movable roller. However, Sharei does disclose wherein the plurality of constriction sections can have various shapes and configuration (FIGS. 16A-C; [0114]-[0116]). Cho discloses a particle processing device comprising a first wall having a first surface (FIGS. 2 and 9B: substrate 102 having a first surface; ¶ [0066]) and a second wall having a second surface (FIGS. 2 and 9B: substrate 100 having a second surface; ¶ [0066]). The first wall comprising a deformable layer including a plurality of movable wedges forming adjustable constriction sections (FIG. 9B). The adjustable constriction sections facilitate selective separation of desired particles flowing through the channel (Cho at ¶ [0103]).
In view of Cho, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have modified the plurality of constriction sections of modified Pawell such that the plurality of constriction sections formed by a movable wedge, as disclosed by Cho (Cho at ¶ [0103]). One of ordinary skill in the art would have been motivated to have made said modification because said modification would have resulted in a cell processing apparatus having the added advantage of selectively separating particles having different sizes, as disclosed by Cho (¶ [0006]). Modified Pawell does not explicitly disclose wherein the movable wedge is attached to the at least one arm that is attached to a motor configured to axially move the at least one arm. However, Sharei discloses wherein the cell delivery system can be automated ([0026]). Modified Sharei further discloses wherein a compression of the container can be employed to form constrictions ([0115]). It would therefore have been obvious to one of ordinary skill in the art to have coupled an arm coupled to a motor to the movable wedge of modified Pawell for the purpose of automating the movement of the movable wedge. Further, doing so would have been the simple substitution of one known moving means for another for the predictable results of moving the movable wedge. Modified Pawell discloses wherein the length of each of the plurality of channels can be varied and can have a length of 5.5 mm or 7.5 mm (Pawell at [0177]). Modified Pawell does disclose wherein the constriction forms a flow path having a length but does not explicitly disclose wherein the length is about 0.2-10 mm. Sharei further discloses that constriction length can be optimized to increase delivery efficiency and cell viability ([0234]). Diefenbach in the same field of endeavor, discloses as assembly for introducing transfection materials into a cell ([0119]) comprising a reservoir ([0022], [0028], [0038]) and an insert comprising a plurality of constrictions (tip assembly arranged within the reservoir; [0203]). The constrictions can have a length of 0.3 mm ([0062]). In view of Diefenbach, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the constriction length of the channels of Pawell to comprise the length as disclosed by Diefenbach. One of ordinary skill in the art would have made said modification for the purpose of optimizing the constriction length and thereby increasing delivery efficiency and cell viability as disclosed by Sharei ([0234]). Modified Pawell discloses all of the structural features of the claimed assembly and thus considered to be fully capable of performing the recited function of “wherein successful transfection occurs when an appropriate constriction diameter is combined with the sample solution being passed through the constriction about 10-90 times using back and forth movements of the plunger(s) such that the cells to be transfected are not mechanically squeezed.” Modified Pawell discloses wherein the assembly includes said channel having said plurality of constriction sections (FIGS. 1 and 8-10; [0155], [0177]), but does not explicitly disclose wherein the surface of said constrictions is sufficiently smooth so that it improves the endocytosis of the transfection material into the cells. Ditommaso discloses a system for delivering materials into a cell including passing a cell suspension through a constriction (see abstract). Ditommaso further discloses the that constriction/pore surface can be any of smooth, electropolished, rough, or plasma treated ([0100], [0112]). In view of Ditommaso, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a smooth surface finish for the surfaces of the plurality of constriction sections of modified Pawel, since Ditommaso identifies smooth as one of finite, known set of suitable surface finishes for constriction-based cell delivery ([0100], [0112]), and selecting among a finite number of identified, predictable options is a matter of routine engineering choice. One would have a reasonable expectation of success because both references concern the same filed of constriction-mediated intracellular delivery.
Furthermore, it is noted that the sample solution, transfection material, and cells are material worked on and not elements of the claimed assembly. It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2115. Furthermore, it is noted that the recitation of functional language "for introducing transfection material in a sample solution into cells " is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). Furthermore, the intended uses of the apparatus do not further define any structural features to the assembly but rather only define how the assembly may be used. The prior art discloses all of the structural features of the claimed assembly and thus since the structure is the same, the claimed functions are apparent.
Regarding claims 133-134, modified Pawell discloses wherein the proximal plunger is coupled to a moving means but does not explicitly disclose wherein the moving means is arm coupled to a motor. However, it would have been prima facie obvious to one of ordinary skill in the art to have coupled an arm coupled to a motor to each of the plungers of modified Pawell for the purpose of providing means for moving the plunger in the container. Further, doing so would have been the simple substitution of one known moving means for another for the predictable results of moving plunger in the container.
Claims 104-105, 112-113, 120-121 and 128-129 are rejected under 35 U.S.C. 103 as being unpatentable over Pawell in view of Sharei, Wang, Diefenbach and Ditommaso as applied to claims 2, 10, 19 and 26 above, and further in view of Chang et al. (US 2016/0059234; hereinafter “Chang”).
Regarding claims 104-105, 112-113, 120-121 and 128-129, modified Pawell discloses the assembly and the microfluidic device according to claims 2, 10, 19 and 26 as set forth above. Modified Pawell does not explicitly disclose wherein an inner wall of each of the plurality of channels has an average roughness of less than 10 µm, and wherein the roughness of an inner wall of each channel of the plurality of channels is smooth. Chang discloses that the roughness of a surface of a channel can be varied according to need (e.g., flow direction or desired analyte; [0058]). The surface of the channel can be rough or smooth (e.g., undulating shaped surface). In view of Chang, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have modified the surface roughness of the inner wall of the channels of modified Pawell to have the claimed roughness including a smooth surface to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because Chang discloses that the roughness of a surface of a channel can be varied according to need (e.g., based on flow direction or desired analyte size needed; [0058]).
Claims 111, 119 and 127 are rejected under 35 U.S.C. 103 as being unpatentable over Pawell in view of Sharei, Wang, Diefenbach and Ditommaso as applied to claims 2, 10, 19 and 26 above, and further in view of Chang (US 2016/0059234).
Regarding claims 111, 119 and 127, modified Pawell discloses the assembly and the microfluidic device according to claims 2, 10, 19 and 26 as set forth above. Modified Pawell does not explicitly disclose wherein the channel includes ripples that protrude away from an interior wall of each channel of the plurality of channels. Chang discloses that the roughness of a surface of a channel can be varied according to need (e.g., based on flow direction or desired analyte size needed; [0058]). The surface of the channel can be rough or smooth (e.g., undulating shaped surface). In view of Chang, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have modified the surface roughness of the inner wall of the channels of modified Pawell to have the claimed ripples to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because Chang discloses that the roughness of a surface of a channel can be varied according to need (e.g., flow direction or desired analyte size; [0058]).
Claim 135 is rejected under 35 U.S.C. 103 as being unpatentable over Pawell in view of Sharei, Wang, Cho, Diefenbach and Ditommaso as applied to claim 33 above, and further in view of Chang (US 2016/0059234).
Regarding claim 135, modified Pawell discloses the system according to claim 33 as set forth above. Modified Pawell does not explicitly disclose wherein the channel includes ripples that protrude away from an interior wall of each channel of the plurality of channels. Chang discloses that the roughness of a surface of a channel can be varied according to need (e.g., based on flow direction or desired analyte size needed; [0058]). The surface of the channel can be rough or smooth (e.g., undulating shaped surface). In view of Chang, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have modified the surface roughness of the inner wall of the channels of modified Pawell to have the claimed ripples to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because Chang discloses that the roughness of a surface of a channel can be varied according to need (e.g., flow direction or desired analyte size; [0058]).
Claims 136-137 are rejected under 35 U.S.C. 103 as being unpatentable over Pawell in view of Sharei, Wang, Cho, Diefenbach and Ditommaso as applied to claim 33 above, and further in view of Chang (US 2016/0059234).
Regarding claims 136-137, modified Pawell discloses the system according to claim 33 as set forth above. Modified Pawell does not explicitly disclose wherein an inner wall of each of the plurality of channels has an average roughness of less than 10 µm, and wherein the roughness of an inner wall of each channel of the plurality of channels is smooth. Chang discloses that the roughness of a surface of a channel can be varied according to need (e.g., based on flow direction or desired analyte size needed; [0058]). The surface of the channel can be rough or smooth (e.g., undulating shaped surface). In view of Chang, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have modified the surface roughness of the inner wall of the channels of modified Pawell to have the claimed roughness including a smooth surface to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because Chang discloses that the roughness of a surface of a channel can be varied according to need (e.g., flow direction or desired analyte size; [0058]).
Response to Arguments
Applicant’s arguments with respect to claims 2, 10, 19, 26, 33, 98, 100-106, 108-114, 116-122, 124-130 and 132-137 have been considered but are moot in view of the new ground of rejection. 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.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799
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