DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendment and Status of the Claims
2. The preliminary amendment filed 27 June 2024 in which claims 1, 3, 11-14, and 18-19 were amended, claims 4-10, 15-17, and 20-150 were cancelled, and new claims 151-154 were added, is acknowledged and has been entered.
Claims 1-3, 11-14, 18-19, and 151-154 are under prosecution.
Information Disclosure Statement
3. The Information Disclosure Statements filed 22 October 2024 and 19 May 2025 are acknowledged and have been considered.
Specification
4. The use of trade names or marks used in commerce (including but not necessarily limited to ReadyLyse), has been noted in this application. Any trade names or marks should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
5. Claim 13 is objected to because of the following informalities:
Claim 13 contains the text “the microfluid vent channel,” which appears to be a typographical error, as the previous recitation is of a microfluidic vent channel.
Appropriate correction is required.
Claim Interpretation
6. The claims are subject to the following interpretation:
A. Claim 19 recites a “system.” The specification recites a “system” wherein the “system” is defined in terms of structural limitations. In addition, the claim recites structural limitations of the “system.” Thus, the “system” is interpreted to encompass any collection of reagents and parts used together that are not necessarily part of a completely integrated single unitary device. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation on the claimed subject matter.
B. Claim 154 recites “a transfer capsule,” “a storage section,” “ a buffer storage chamber,” “a” processing chamber,” and “a microfluidic section.” Each of these is interpreted as being the same one recited in claim 1, upon which claim 154 depends.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 18, 152, and 154 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.
A. Claim 18 is indefinite in the recitations “the vent channel” and “the inlet channel,” which lack antecedent basis in the previous recitations of “a microfluidic vent cannel” and “a microfluidic inlet channel.”
B. Claims 152 and 154 are each indefinite in the recitation “the first chamber,” which lacks antecedent basis because there is no previous recitation of a “first” chamber.
C. Claim 154 is indefinite in the recitation “the probes,” which lacks antecedent basis in the previous recitation of “a probe.”
Claim Rejections - 35 USC § 102/103
9. 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.
10. 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.
11. 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.
12. Claims 1, 11-12, and 153 are rejected under 35 U.S.C. 102(a)(1)/(a)(2)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Carrera Fabra et al. U.S. Patent Application Publication No. US 2015/0352551 A1, published 10 December 2015).
Regarding claim 1 Carrera Fabra et al. teach a cartridge (Title) comprising a storage section (in the form of a plurality of storage chambers) comprising a storage chamber, a processing section (i.e., a plurality of reaction chambers) comprising a processing chamber (i.e., a reaction chamber), and a microfluidic section, in the form of a fluidic network, which is connected to (and thus in fluid communication with) the processing section, and a transfer capsule, in the form of a hollow transfer module (Abstract, Figure 1, and paragraphs 0035-0038). Carrera Fabra et al. also teach the chambers are connected to a first plurality of ports and the transfer capsule (i.e., module) comprises a second plurality of ports, which allows transfers fluid from chamber to chamber (paragraphs 0009-0011).
Thus, because Carrera Fabra et al. teach all of the claimed limitations, the claim is either anticipated or obvious.
It is noted that the courts have held that “while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). In addition, “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). Therefore, the various uses recited in the claims (e.g., storing a buffer in a storage chamber) fail to define additional structural elements of the claimed cartridge. Because the cited prior art teaches the structural elements of the claim, the claim is anticipated by, or alternatively obvious over, the cited prior art. See MPEP § 2114.
MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, counsel’s mere arguments cannot take the place of evidence in the record.
In addition, Carrera Fabra et al. teach the storage chamber comprises a buffer (paragraph 0038).
Regarding claim 11, Carrera Fabra et al. teach the cartridge of claim 1, further comprising a vent fluidly coupled to a storage chamber (paragraph 0048).
It is reiterated that the courts have held that apparatus claims cover what a device is, not what a device does. Therefore, the various uses recited in the claims (e.g., storing a buffer in the storage chamber) fail to define additional structural elements of the claimed cartridge. Because the cited prior art teaches the structural elements of the claim, the claim is anticipated by, or alternatively obvious over, the cited prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 12, the cartridge of claim 1 is discussed above. Carrera Fabra et al. teach the cartridge comprises a reaction chamber 216 in the microfluidic section, a microfluidic vent channel fluidically connected to vent port 212, and an inlet channel fluidically connecting a processing chamber (i.e., waste chamber 218) to the reaction chamber 216 (Figure 2A and paragraph 0048).
Alternatively, it is reiterated that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device. Thus, any arrangement of the claimed elements is an obvious variant of the prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 153, Carrera Fabra et al. teach the cartridge of claim 1, further comprising a cavity (i.e., chamber bay 120) configured for storage (i.e., insertion) of the transfer capsule (i.e., molecule, paragraph 0038),
It is reiterated that the courts have held that apparatus claims cover what a device is, not what a device does. Therefore, the various uses recited in the claims (e.g., storing the transfer capsule in the cavity) fail to define additional structural elements of the claimed cartridge. Because the cited prior art teaches the structural elements of the claim, the claim is anticipated by, or alternatively obvious over, the cited prior art.
Claim Rejections - 35 USC § 103
12. Claims 1-3, 19, 151-152, and 154 are rejected under 35 U.S.C. 103 as obvious over Carrera Fabra et al. U.S. Patent Application Publication No. US 2015/0352551 A1, published 10 December 2015).
It is noted that this rejection applies to claim 1 to the extent that it is drawn to the embodiments of dependent claims 2-3, 19, 151-152, and 154.
Regarding claim 2, Carrera Fabra et al. teach the cartridge of claim 1 as discussed above in Section 11.
It is noted that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device (In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)). See MPEP §2144.04. Thus, any arrangement of the processing section, storage section, and microfluidic section is an obvious variant of the prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 3, the cartridge of claim 1 is discussed above. Carrera Fabra et al. teach an access port, in the form of swab-receiving sample port 114, located at the top of the cartridge (Figure 1 and paragraph 0039) and connected to a chamber (paragraph 0109). Carrera Fabra et al. also teach the (buffer) storage chambers are connected to fluid channels (i.e., the claimed first access channel; paragraph 0048), and that the transfer capsule (i.e., module) transfers lysis buffer to the swab chamber (paragraph 0127). Carrera Fabra et al. further teach fluidic channels connect chambers to the transfer capsule (i.e., molecule, paragraph 0048).
It is reiterated that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device. Thus, any arrangement of the claimed structures is an obvious variant of the prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 19, the cartridge of claim 1 is discussed above. Carrera Fabra et al. also teach the cartridge is part of a system also including an instrument, in the form of an analyzer, which detects the analyte within the cartridge (paragraphs 0042 and 0046).
Regarding claim 151, the cartridge of claim 1 is discussed above. Carrera Fabra et al. teach the both ends of the transfer capsule (i.e., module) are open and comprises an open lumen (i.e., is hollow; paragraph 0038 and Figure 1).
It is reiterated that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device.
In addition, it is noted that the courts have found that changes in shape are obvious (In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966See MPEP 2144.04 IV B.
Thus, any arrangement and/or shape of the transfer capsule an obvious variant of the prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 152, the cartridge of claim 1 is discussed above. Carrera Fabra et al. teach each storage chamber comprises an inlet port on the top, and that a storage chamber receives a sample (i.e., specimen; Figure 2c and paragraphs (0055-0057).
Carrera Fabra et al. also teach the storage chambers are connected to fluid channels (i.e., the claimed second access channel; paragraph 0048), and that fluidic channels connect chambers to the transfer capsule (i.e., molecule, paragraph 0048).
While Carrera Fabra et al. teach only one access port per storage chamber, the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04 VI.B.
This, it would have been obvious for each storage chamber to have two access ports.
It is reiterated that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device. Thus, any arrangement of the access port, transfer capsule, buffer storage chamber, and access channel is an obvious variant of the prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 154, the cartridge of claim 1 is discussed above.
Carrera Fabra et al. teach the both ends of the transfer capsule (i.e., module) are open and comprises an open lumen (i.e., is hollow; paragraph 0038 and Figure 1).
It is reiterated that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device, and that the courts have found that changes in shape are obvious.
Thus, any arrangement and/or shape of the transfer capsule an obvious variant of the prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Carrera Fabra et al. teach each storage chamber comprises an inlet port on the top, and that a storage chamber receives a sample (i.e., specimen; Figure 2c and paragraphs (0055-0057).
Carrera Fabra et al. also teach the storage chambers are connected to fluid channels (i.e., the claimed first access channel; paragraph 0048), and that fluidic channels connect chambers to the transfer capsule (i.e., module, paragraph 0048).
It is reiterated that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device. Thus, any arrangement of the claimed structures is an obvious variant of the prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Carrera Fabra et al. teach a vent fluidly coupled to a storage chamber (paragraph 0048). Carrera Fabra et al. also teach the storage chambers are connected to fluid channels (i.e., the claimed second access channel; paragraph 0048), and that fluidic channels connect chambers to the transfer capsule (i.e., module, paragraph 0048).
While Carrera Fabra et al. teach only one access port per storage chamber, it is reiterated that the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
This, it would have been obvious for each storage chamber to have two access ports.
It is reiterated that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device. Thus, any arrangement of the claimed limitations is an obvious variant of the prior art.
It is reiterated that the courts have held that apparatus claims cover what a device is, not what a device does. Therefore, the various uses recited in the claims (e.g., storing a buffer in the storage chamber) fail to define additional structural elements of the claimed cartridge. Because the cited prior art teaches the structural elements of the claim, the claim is obvious over the cited prior art.
In addition, Carrera Fabra et al. teach the storage chamber comprises a buffer (paragraph 0038).
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Carrera Fabra et al. teach the cartridge further comprises a cavity (i.e., chamber bay 120) configured for storage (i.e., insertion) of the transfer capsule (i.e., molecule, paragraph 0038),
It is reiterated that the courts have held that apparatus claims cover what a device is, not what a device does. Therefore, the various uses recited in the claims (e.g., storing a buffer in the storage chamber) fail to define additional structural elements of the claimed cartridge. Because the cited prior art teaches the structural elements of the claim, the claim is obvious over the cited prior art.
Carrera Fabra et al teach a lysis chamber (paragraph 0127), and a chamber for hybridizing a probe to a target nucleic acid, in the form of a PCR chamber (paragraph 0053); it is noted that the probe is not actually required to be a part of the claimed cartridge.
Carrera Fabra et al. teach multiple detection chambers (i.e., the claimed fifth and sixth chambers), including one comprising immobilized probes (paragraph 0054: it is noted that the claim does not actually require any capture probes therein.
With respect to the claimed ports, channels, and configurations, it is reiterated that the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
It is also reiterated that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device.
Thus, any number of the claimed limitations and any arrangement thereof is an obvious variant of the prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Carrera Fabra et al. further teach the cartridge comprises a reaction chamber 216 in the microfluidic section, a microfluidic vent channel fluidically connected to vent port 212, and an inlet channel fluidically connecting a processing chamber to the reaction chamber 216 (Figure 2A and paragraph 0048).
With respect to the claimed ports, channels, and configurations, it is reiterated that the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
It is also reiterated that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device.
Thus, any number of the claimed limitations and any arrangement thereof is an obvious variant of the prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
13. Claims 13-14 and 18 are rejected under 35 U.S.C. 103 as obvious over Carrera Fabra et al. U.S. Patent Application Publication No. US 2015/0352551 A1, published 10 December 2015) as applied to claim 12 above in combination with Baldi Coll et al;. (U.S. Patent Application Publication No. US 2020/0030799 A1, published 30 January 2020).
It is noted that this rejection applies to claims 1 and 12 to the extent that they are drawn to the embodiments of dependent claims 13-14 and 18
Regarding claim s13-14 and 18, the cartridges of claims 1 and 12 are discussed above in Section 11.
Carrera Fabra et al. also teach the cartridge has the added advantage of reduced errors, costs, and testing time (paragraph 0008). Thus, Carrera Fabra et al. teach the known techniques discussed above.
While Carrera Fabra et al. teach the ports are associated with valves (paragraph 0010), the valves seal the ports (paragraph 0073), and that the ports are vents and inlets (i.e., claims 13-14) paragraph 0048), Carrera Fabra et al. do not teach wax valves (i.e., wax seals).
However, Baldi Coll et al. teach microfluidic devices comprising inlets and outlets and wax valves at desired locations in microfluidic channels (i.e., claims 13-14; paragraph 0083). Baldi Coll et al. further teach the wax valves are in one position that blocks the microchannel and another position that opens the channel (paragraphs 0071-0072). Baldi Coll et al. also teach the valves have the added advantage of simple operation and design (paragraph 0002). Thus, Baldi Coll et al, teach the known techniques discussed above.
With respect to the claimed seals (i.e., valves), channels, and configurations, it is reiterated that the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
Thus, any number of the claimed limitations and any arrangement thereof is an obvious variant of the prior art.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of the cited prior art to arrive at the instantly claimed cartridges with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in cartridges having the added advantages of reduced errors, costs, and testing time as explicitly taught by Carrera Fabra et al. (paragraph 0008) and simple operation and design as explicitly taught by Baldi Coll et al. (paragraph 0002). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in mechanisms useful in microfluidic devices.
Conclusion
14. No claim ls allowed.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
Prosecution Insights