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 .
Response to Amendment
The preliminary amendment filed on March 15, 2023 is acknowledged. The application will be examined accordingly.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 3, 2023 is being considered by the examiner.
Claim Objections
The claims are objected to because of the following informalities:
Nomenclature should be consistent throughout the claims. Otherwise, it can render the claims indefinite. Consequently, the limitations, “the fluid inlet”, “the channel”, “the first chamber”, “the biological chip”, “the second chamber” and “”the groove” throughout the claims should be changed to “the at least one fluid inlet”, “the at least one channel”, etc.
In claim 1, the limitation “prevents the fluidic communication” should be changed to “prevents fluidic communication”.
In the last line of claim 14, the limitation “to” should be deleted.
In claim 14, both instances of the limitation “connection of” should be changed to “connecting”.
In claim 16, the limitation “connected to” should be changed to “integrated to”.
In claims 19 and 20, the limitation “from body” at the end of the claims should be changed to “from the body”.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
In the event the determination of the status of the application as subject to AIA (or as subject to pre-AIA ) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the rationale supporting the rejection would be the same under either status.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 2, 3, 6, 12, 13 and 17-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 2 is indefinite because of the recitation “an opposite side of the fluid inlet”. The claim provides no point of reference for ascertaining a location that corresponds to “opposite side of the fluid inlet” (i.e. what even is “opposite side” of the fluid inlet? One of the sides of the fluid inlet or a side of the cartridge opposite the fluid inlet?).
Claim 3 is indefinite because the subject matter of the claim is ambiguous. Specifically, it is unclear whether the limitation “is placed inside” intends to recite a method step or an arrangement. Because the claimed invention is directed to a device (as opposed to a method), the intent alters the scope of the claimed invention. If the claim intends to recite an arrangement, then the claim should be amended to convey the intent unequivocally, by amending the claim to recite, “…wherein the cartridge further comprises at least one chip holder inside the at least one first chamber…”
Likewise, the limitations “is placed inside” in claims 6 and 18, and “is provided” in claims 12 and 13 are indefinite.
In claim 13, the scope of the limitation “at least a definitive information” is indefinite. The limitation” at least” does not denote a number, and thus without any additional context, it is unclear what the “at least” intends to encompass (i.e. in addition to definitive information, what else?).
In claims 14 and 17, there is no antecedent basis for the limitation “the cover of the first chamber” recited at the end of the claims. The claims do not previously specify that the cover is a part of the first chamber. In fact, claim 1 recites the cover and the first chamber as separate elements.
In claim 17, the limitation “preferably” renders the claim indefinite because it is unclear whether the limitation intends to be limiting.
In addition, there is no antecedent basis for “the surface which is facing the cover” in claim 17. Relatedly, it is unclear how the limitation “inserted into the body from an opposite side of the surface which is facing the cover” in claim 17 relates to “insertion into the body from an opening that is not facing to the cover” recited in claim 14.
Claims not explicitly rejected are rejected due to dependency.
Claim Interpretation
Claim 1 recites that the “cover prevents…fluidic communication between the channel and an outer environment in a fluid-tight manner” even though the cartridge, and hence the channel, must be in fluid communication with the outer environment via the at least one fluid inlet. Consequently, the recitation is being interpreted as conveying that the cover overlies the body in a fluid-tight manner at locations corresponding to the channel.
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 1, 2, 4-8, 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ly et al. (“Ly”) (US 2006/0078986 A1) in view of Castro et al. (“Castro”) (US 2011/0150703 A1).
With respect to claim 1, Ly teaches a microfluidic (see [0080]) cartridge comprising (see Figs. 2A-2B):
a body (“cut-out”),
at least one fluid inlet (opening in registration with “sample port”) located on the body,
at least one channel connected to the fluid inlet from one end thereof and allowing fluid flow there through (see fluid flow depicted by arrows in Fig. 2B),
at least one first chamber (chambers housing “substrate” and “porous material”) arranged on the body so as to be in a fluidic communication with the at least one channel,
at least one biological chip (“porous material”) placed inside the at least one first chamber and configured to hold predetermined components of the fluid (the chip is porous and hence it can wick liquid), and
at least one cover (“top cover”) connected to the body, wherein the at least one cover prevents fluidic communication between the at least one channel and an outer environment in a fluid-tight manner (see [0095] and Fig. 3B illustrating exemplary assembled cartridge), and wherein at least a portion of the at least one cover corresponding to the at least one biological chip has a light-transmitting structure (see [0027]).
The cartridge taught by Ly differs from the claimed invention in that Ly does not disclose that the at least one channel comprises at least one inclined region extending substantially from the at least one fluid inlet to the at least one first chamber such that the inclined region raises from the at least one fluid inlet to the at least one first chamber.
Castro discloses a lateral flow device (see [0087]) comprising a tortuous path static mixer for facilitating mixing (see Fig. 1), wherein the device comprises inclined regions (152, 160) (see Fig. 6 and [0010]). In light of the disclosure of Castro, it would have been obvious to one of ordinary skill in the art before the effective filing date of the application to have provided the at least one channel of the Ly device with various inclined regions extending substantially from the at least one fluid inlet to the at least one first chamber (chamber with the porous material) such that the inclined regions raise in a direction from the at least one fluid inlet to the at least one first chamber. The modification would facilitate mixing of the sample with a reagent (see [0010]) prior to detection.
With respect to claim 2, if the Ly cartridge is modified as suggested above, then the modified cartridge would comprise a plurality of inclined obstacles with linear regions situated between individual obstacles (see Fig. 6 of Castro). Naturally, the at least one channel would comprise at least one linear region almost linearly extending between an end of the at least one inclined region and the at least one first chamber.
With respect to claims 4 and 19, the cartridge further comprises at least one fluid outlet (absorbent) arranged on the body so as to be in fluidic communication with the channel and which enables removal of fluid passing through the first chamber (see [0009], [0026] and 7A).
With respect to claims 5 and 6, the cartridge further comprises at least one second chamber (absorbent) on the body in fluidic communication with the channel and configured to allow accumulation of at least an amount of fluid passing from the first chamber by absorbing the fluid entering into the at least one second chamber (see [0009], [0026] and 7A).
With respect to claims 7 and 8, the at least one cover is connected to the body by use of a glue material in the form of a double-sided tape (see [0095]). With respect to claim 8, while Ly teaches that the body itself can be made from the double-sided tape (see [0095]), Ly also teaches a variety of materials from which the body can be made (see [0102]-[0103]). If a non-adhesive material like polycarbonate is used to form the body, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the application to have used a separate double-sided tape to adhere the body to the cover so as to arrive at the claimed invention.
With respect to claim 12, the body comprises at least one connection hole (hole in registration with read window, see Fig. 8) for optical connection of the body to an optical system performing sample analysis.
Claims 3, 14-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ly in view of Castro as applied to claims 1, 2, 4-8, 12 and 19 above, and further in view of Nielsen et al. (“Nielsen”) (US 2013/0115607 A1).
With respect to claims 3 and 18, neither Ly nor Castro disclose the claimed at least one chip holder. However, it is well-known in the art to mount/affix a microfluidic chip inside a cartridge using an intermediary structure (i.e. a chip holder) (see [0104] of Nielsen disclosing a frame that mounts a microfluidic chip inside a cartridge). In light of the disclosure of Nielsen, it would have been obvious to one of ordinary skill in the art before the effective filing date of the application to have provided the modified Ly cartridge with an intermediary chip holder for affixing the biological chip inside the at least one first chamber. The modification would improve the physical integrity of the cartridge by preventing accidental dislodgement of the biological chip inside the first chamber.
With respect to claim 14, Ly also discloses a method of assembling the cartridge, the method comprising the steps of:
providing the body, wherein the at least one first chamber comprises a through hole form (“cut-out” is open at its top and bottom and only enclosed after assembly) (see Fig. 2A),
connecting the at least one cover to the body (see [0095]), and
inserting the at least one biological chip in the body.
While Ly does not disclose a step of integrating the at least one biological chip to a chip holder, as discussed above (see rejection of claims 3 and 18), it would have been obvious to one of ordinary skill in the art before the effective filing date of the application to have affixed the biological chip inside the at least one first chamber using a chip holder. If the modification is made, then the method would naturally comprise a step of integrating the at least one biological chip to the chip holder and connecting the chip holder to the body of the cartridge. Regarding the limitation “insertion into the body from an opening that is not facing to the cover…”, it would have been obvious to one of ordinary skill in the art before the effective filing date of the application to have inserted the integrated chip holder into the body via either opening (top or bottom opening) of the body when assembling the cartridge (see Fig. 2A of Ly).
With respect to claim 15, the at least one cover is connected to the body by use of at least a glue in the form of a double-sided tape (see [0095]).
With respect to claim 16, while Nielsen does not disclose how the microfluidic chip is integrated to the chip holder, it would have been obvious to one of ordinary skill in the art before the effective filing date of the application to have integrated the at least one biological chip of the modified Ly cartridge to its chip holder using any conventional method, for example using a glue.
With respect to claim 17, as discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the application to have inserted the chip holder into the body via either opening (top or bottom opening) of the body when assembling the cartridge.
With respect to claim 20, the cartridge comprises at least one fluid outlet (absorbent) arranged on the body so as to be in fluidic communication with the channel and which enables removal of fluid passing through the first chamber (see [0009], [0026] and 7A).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ly in view of Castro as applied to claims 1, 2, 4-8, 12 and 19 above, and further in view of Ono (US 7,226,564 B2).
With respect to claim 9, neither Ly nor Castro disclose the use of a fluid glue to bond layers of a microfluidic device. However, it is well-known in the art to bond layers of a microfluidic device using liquid adhesive injected into at least one bonding groove formed on a mating surface of two layers (see abstract and Figs. 3-4B of Ono). In light of the disclosure of Ono, it would have been obvious to one of ordinary skill in the art before the effective filing date of the application to have bonded the body and the at least one cover of the modified Ly cartridge by injecting a liquid adhesive into at least one bonding groove formed on a mating surface of the layers. The modification would constitute substitution of equivalents (double-sided tape for liquid adhesive) known for the same purpose, which is considered obvious.
With respect to claim 10, as discussed above, the body of the modified Ly cartridge would comprise at least one groove for receiving the fluid glue.
With respect to claim 11, the at least one bonding groove 4 taught by Ono comprises at least one glue escape channel 5 extending from the at least one groove 4 to an inside of substrate 1 (see Figs. 3-4B and line 65, col. 8-line 2, col. 9 disclosing that channel 5 serves as a dam for collecting excessive glue). Naturally, the modified Ly cartridge would comprise at least one glue escape channel extending from the at least one groove to an inside of the body.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ly in view of Castro as applied to claims 1, 2, 4-8, 12 and 19 above, and further in view of Handique (US 2009/0130719 A1).
With respect to claim 13, neither Ly nor Castro disclose the claimed at least one tag. However, it is well known in the art to provide a tag (e.g. a bar code) on a microfluidic cartridge for identifying it and its contents (e.g. see [0115]-[0116] of Handique). In light of the disclosure of Handique, it would have been obvious to one of ordinary skill in the art before the effective filing date of the application to have provided the modified Ly cartridge with a tag encoding information relevant to a sample to be analyzed by the cartridge. The modification would enable automated/machine processing of the cartridge, thus improving efficiency.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796