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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 23, 2026 has been entered.
Any previous objection/ rejection not repeated herein has been withdrawn. Applicant's arguments have been thoroughly reviewed but are deemed moot in view of the amendments, withdrawn rejections and new grounds for rejection. New and/or modified grounds for rejection, necessitated by the amendments, are discussed.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-11 and 13-20 remain rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Galvin et al., (WO 2019/018099; hereinafter “Galvin”, see corresponding US 2021/0147924 for citations below).
Note: The instant device claims 1-15 contain a large amount of functional language (e.g.: “such that the plurality of compartments of the test strip are squeezed and destroyed by the pressure roller and the test strip rotating roller when the test strip passes through the gap”’; “suitable for performing a loop-mediated isothermal amplification reaction”, etc.).
However, functional/process language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function. Therefore, if the prior art structure is capable of performing the function or intended use, then the prior art meets the limitation in the claims. The manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim (see MPEP § 2114 & § 2173.05(g)). Regardless, the examiner has mapped the claim limitations that are functional/process against the Galvin reference, see below.
Note: due to the outstanding amendment to the apparatus type claims 1-15, the test strip with a plurality of compartments is now considered positively recited as part of the device system and therefore has received patentable weight.
Regarding claims 1 and 16, Galvin discloses an integrated nucleic acid loop-mediated isothermal amplification, mobile device system and method of using the same
comprising:
a test strip 510 with a plurality of compartments (522, 544, 548, 566, 580) concatenated in a straight series (see examiner modified Fig. 3 below) and spaced apart from each other by sealing (seals 838, 843, 852, 853,862, and 865) located in channels 562, 553, 552, 543 connecting at least compartments (522, 544, 548, 566, 580);
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a main body (800) comprising:
a delivery unit comprising a pressure roller and a test strip rotating roller arranged opposite to each other to form a gap therebetween (Galvin discloses at para [0079] that Fig 1 is adapted for an automated instrument featuring actuator elements positioned over each of the blisters and channels, it is also contemplated that the actuators could remain stationary, and the pouch 510 could be transitioned in one or two dimensions such that a small number of actuators could be used for several of the processing stations including sample disruption, nucleic-acid capture, first and second-stage PCR, and other applications of the pouch 510 such as immuno-assay and immuno-PCR. Rollers acting on channels and blisters could prove particularly useful in a configuration in which the pouch is translated between stations,
wherein the delivery unit delivers the test strip such that the plurality of compartments of the test strip are squeezed and destroyed by the pressure roller and the test strip rotating roller when the test strip passes through the gap;
a heating unit comprising a Peltier heating means 886, 888 (see para [0087] et seq., Peltier devices include two electrically insulating but thermally conductive ceramic plates to sandwich semiconductor pellets and metal interconnects, hence, a ceramic heating chip) and a temperature sensor (the Peltier heaters are controlled and must require at least one temperature sensor) to provide a temperature suitable for performing a loop-mediated isothermal amplification reaction (see para [0057] et seq.); and
a control unit 894 electrically connected to the delivery unit and the heating unit to control operations of the delivery unit and the heating unit; and
a power supply electrically connected to the main body to drive the operations of the delivery unit, the heating unit and the control unit (inherent to operate the automated device 800 of Galvin).
As to claim 2, Galvin teaches the plurality of compartments in the test strip include a first compartment located at one end of two sides of the test strip, wherein the first compartment is configured to be used for injecting a sample to be detected, wherein the sample to be detected is selected from one of DNA, RNA, blood, urine, body fluids, feces, secretions and tissues (see para [0090] et seq.)
As to claim 3, note that the sample is not positively recited and therefore considered an intended use, however, Galvin does teaches the sample to be detected is DNA or RNA (see para [0051] et seq.)
As to claim 4, the reagent, a primer and a polymerase is considered an intended use and has not received patentable weight. Nevertheless, Galvin teaches the plurality of compartments in the test strip include a second compartment, a third compartment and a fourth compartment for placing a reagent, a primer and a polymerase, respectively (see para [0068] et seq.)
As to claim 5, the components of the reagent comprise dNTP, buffer solution and magnesium sulfate have not received patentable weight. Nevertheless Galvin teaches these reagents (see para [0071] et seq.)
As to claim 6, the primer is not positively recited as part of the device. However, Galvin teaches the primer is designed according to a nucleic acid sequence of the sample to be detected (see para [0071] et seq.)
As to claims 7 and 8 , the type of polymerase has not received patentable weight, however, Galvin teaches the polymerase is selected from a group consisting of Bst DNA polymerase, TwistAmp nucleic acid amplification special polymerase, Taq DNA polymerase, AmpliTaq DNA polymerase, DNA polymerases I to V and other DNA or RNA polymerases used in nucleic acid amplification reactions (para [0074] et seq.)
As to claims 9-11, 19 and 20, Galvin teaches the plurality of compartments of the test strip further include a fifth compartment (see Fig. 1). The marker for marking a product obtained by the loop-mediated isothermal amplification reaction has not received patentable weight. Nevertheless, Galvin teaches the marker is ethidium bromide or SYBR Green I (see para [0076] et seq.)
As to claim 13 and 17, Galvin teaches the temperature is between 4°C and 95°C see para [0093] et seq.)
As to claim 14, it is inherent that the power supply in Galvin is a generator or a battery.
As to claim 15, Galvin teaches a unit comprising a camera unit 896 and an ultraviolet light source 898 (see para [0088] et seq.)
As to claim 18, Galvin teaches a time for performing the loop-mediated isothermal amplification reaction is between 30 minutes and 3 hours (30 minutes, see para [0071] et seq.)
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 12 remains rejected under 35 U.S.C. 103 as being unpatentable over Galvin.
Regarding claim 12, Galvin teaches a motor (see para [0079] et seq.) Galvin does not specifically disclose a lever structure block and a compression spring, wherein the lever structure block is connected to the pressure roller and the compression spring, and an anti-slip silicone cover is disposed outside the test strip rotating roller so as to adjust a travel path of the test strip in the delivery unit. However, the particular means of attachment of the rollers using a lever structure block and compression spring would have been obvious to one of ordinary skill in the art at the time the claimed invention was effectively filed, since is expected that the skilled artisan would construct the device considering such things as the cost of available construction materials and desired unit footprint without undue burden.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Response to Arguments
Applicant's arguments filed March 23, 2026 have been fully considered but they are not persuasive. In response to the rejection under Galvin applicant argues that the compartments in Galvin are not in a straight series. The examiner respectfully disagrees. The examiner has modified Fig. 3 of Galvin to show that at least compartments 544, 548, 566 and 580 are in a straight series, (see the straight line connecting the compartments). Applicant also argues that the compartments in Galvin are interconnected rather than spaced apart from each other by sealing. It is noted that having channels with the seals clearly meets the claim recitation “separated apart by sealing” (i.e., seals 838, 843, 852, 853,862, and 865). The claims have been interpreted using BRI consistent with applicant’s specification. However, the features upon which applicant relies (i.e., configuration shown in Fig. 2) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Thus, for the reasons delineated above, the claims remain rejected over the prior art.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Schnipelsky et al., (US 6,645,758) teach A cuvette and a method of use prevent nucleic acid amplified by PCR technology from being released to the atmosphere, while still proceeding to a detection step to determine whether or not the nucleic acid is present. Detection reagents are either pre-incorporated into compartments in the cuvette or added after amplification. In the latter case, a check valve prevents amplified nucleic acid from being released. Transfer of liquids between compartments is achieved via the use of flexible compartment walls and an external pressure source, or via pistons that are part of the cuvette and operate on the compartments as a piston within a piston chamber.
Chianese (US 5804141) teaches A reagent strip slide treating apparatus includes a reagent strip comprised of a plurality of chambers. A reagent passageway on the strip connects to each of the chambers and connects to a common passageway. The chambers are arranged at variable predetermined distances along the strip. A double slide is provided which is comprised of a first and a second slide spaced apart by a predetermined distance and adapted to have therebetween biological material to be treated sequentially by a plurality of reagents. A tube connects the common passageway of the reagent strip to the space between the space slides. The capsules containing reagents are provided within the chambers on the strip. The capsules are provided with thin walls which are adapted to burst upon the application of pressure. A press moving at a constant speed is provided to press the reagent strip and capsules in the chambers causing the capsules to burst. The spacing between the chambers determines the timing of the application of the reagents. The strip may preferably be straight, although it may be curved such as an arc or a roller may be mounted on a radial arm; and
Woodbridge (US 4065263) teaches an analytical test strip apparatus for chemical, physical and biological experiments on small samples of fluids or fluid-like materials, consists of a thin, flat, hollow, pliable strip the interior including a channel completely filled with a thin layer of an inert liquid, preferably of a grease like consistency, into which liquid is introduced a small amount of the fluid to be tested, to form a movable "blister". The blister is propelled through the inert liquid, which confines it at all times front and rear, by applied external pressure. A plurality of chemical, physical, biological or detection stations are typically located in said channel. A physical station might consist of a filter membrane; a chemical station of a small pocket of chemical reagent; a detecting station of a material sensitive to pH. The stations are confined by the inert liquid filling the interior channel of the strip. In addition to forming the front and rear walls of the movable blister, the inert liquid also prevents migration of reagent located in a station, excludes air and other matters and prevents escape of noxious material being analyzed. In operation, a small portion of fluid is introduced into the strip top and the top is pinched to form a bubble or blister therein. The pinch line is drawn down the strip length forcing the blister ahead of it. As the blister proceeds down the tube, it is subjected to chemical, physical, biological and detecting operations as it passes through the different stations. One side of the tube being preferably transparent, results of the operations may be visible to the eye.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached on 9:30am-7:30 pm EST.
Examiner interviews are available via telephone and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P. Kathryn Wright/Primary Examiner, Art Unit 1798
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