Prosecution Insights
Last updated: April 19, 2026
Application No. 17/554,181

SYSTEMS FOR SAMPLE ANALYSIS

Non-Final OA §102§103§112§DP
Filed
Dec 17, 2021
Examiner
GIAMMONA, FRANCESCA FILIPPA
Art Unit
1681
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Biomeme Inc.
OA Round
3 (Non-Final)
36%
Grant Probability
At Risk
3-4
OA Rounds
3y 8m
To Grant
87%
With Interview

Examiner Intelligence

Grants only 36% of cases
36%
Career Allow Rate
24 granted / 66 resolved
-23.6% vs TC avg
Strong +51% interview lift
Without
With
+50.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
66 currently pending
Career history
132
Total Applications
across all art units

Statute-Specific Performance

§101
8.5%
-31.5% vs TC avg
§103
42.0%
+2.0% vs TC avg
§102
10.3%
-29.7% vs TC avg
§112
30.8%
-9.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 66 resolved cases

Office Action

§102 §103 §112 §DP
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/26/2025 has been entered. Applicant’s arguments and amendments have been thoroughly reviewed and considered. Claims 187-194 remain withdrawn. Claims 175-186 are pending and are examined on the merits herein. Information Disclosure Statement The information disclosure statement (IDS) submitted on 9/26/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Response to Applicant’s Amendments and Arguments 35 USC 102 Rejections Claims 175-186 were previously rejected under 35 USC 102(a)(1) as being anticipated by Ching et al. (US 2010/0288897). In light of Applicant’s amendments to the claims and further search and consideration, these rejections have been withdrawn, but see new grounds of rejection below. These new grounds of rejection do not involve the use of Ching, and do teach use of a single monolithic heating block (see the single sample block of the Baumgartner reference below). Applicant’s arguments regarding these previous rejections are therefore rendered moot. Double Patenting Rejections Claims 175-186 were rejected on the ground of non-statutory double-patenting as being unpatentable over claims 12-20 of US 12,121,901. After further consideration of this rejection, these rejections have been maintained. It is noted that Applicant argues that the amendments to step (a)(ii) of claim 175 render the claims at issue not identical (Remarks, page 9). While the exact language of instant claim 175 and claim 12 of the ‘901 patent are not identical, they are not patentably distinct from each other because claim 12 of the ‘901 patent encompasses the invention of instant claim 175, particularly with regard to step (a)(ii). (a)(ii) of claim 12 recites “at least one heating block” where said heating block can hold “a plurality of assay tubes.” This would encompass the use of a single heating block with three or more assay tubes. Therefore, these arguments were not considered persuasive. Drawings The drawings are objected to because Figures 41 and 43 are not legible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: reference characters 1609, 1610, and 2601-2610. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Objections Claim 175 is objected to because of the following informality: in the final line of step (d), “said light path” should read “said first light path.” Appropriate correction is required. Claim Rejections - 35 USC § 112(b) 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. Claim 177 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 177 recites the limitation "said emission energy" in line 2. There is insufficient antecedent basis for this limitation in the claim, as “emission energy” is not recited in claim 175, from which this claim depends. It is noted that “emission energy” is recited in claim 176, and so it is unclear if Applicant intended to have claim 177 depend from claim 176. Claim Rejections - 35 USC § 103 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 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 175-186 are rejected under 35 U.S.C. 103 as being unpatentable over Baumgartner et al. (US 2016/0265040 A1; cited in Applicant’s IDS). Baumgartner teaches a portable testing device with an optical assembly that is capable of analyzing biological samples (Abstract). The device includes housing that forms the overall body of said device (para. 101). Figure 22A shows an optical assembly where moveable housing (ref. 606) holds a sample block (ref. 604) that contains a plurality of wells (ref. 620) that may be used to hold tube arrays (ref. 602). See paras. 209-211. The optical assembly is generally held in the overall housing of the device (Abstract, paras. 4, 117, and 172 for example). The optical assembly also includes a heat block, light-emitting diodes, and photodetectors (para. 119, and see Figure 5). The actual heating component can be separate from the sample holder (see paras. 103 and 125). Specifically, Figure 7 shows a heating element and a sample block where the heating element (ref. 192) is connected to the sample block (ref. 190) containing wells (ref. 196). See paras. 130-131. The sample block holds the biological samples to be tested (paras. 103, 115, 128, and 132 for example, the last two of which specifically mention the biological sample is in the tube array). As Baumgartner teaches a single sample block for use with their holder, this block is considered analogous to the claimed monolithic heating block. The heating element is specifically stated to be attached to the sample block (para. 130) and is stated to provide heating to each of the wells (para. 131), thus making it analogous to the claimed heating unit. Para. 148 specifically notes that the light-emitting diodes emit radiation to excite a fluorescent dye in the biological sample mixtures in the wells, thus making it analogous to the claimed excitation source. Figure 23 provides a cross-sectional view of the optical assembly. Ref. 640 is an excitation filter, ref. 634 is a first light path, and ref. 636 is a second light path (see para. 214). A photodetector (ref. 630) is also displayed. The light-emitting diode is ref. 632. Light is emitted from said diode, where it then hits the excitation filter and travels along ref. 636, reflects off of ref 638, moves along ref. 634, and reaches the well (ref. 620) to excite the biological sample (para. 222). Then, emitted radiation passes from the well back through ref. 634, through the emission filter (ref. 638), and into the photodetector (ref. 630). See para. 223. In considering these teachings in light of the claims, the excitation and emission filters themselves are analogous, and the entire path from the light-emitting diode to the well can be considered the claimed first path, while the entire path from the well to the photodetector can be considered the claimed second path. It is noted that these do not necessarily correlate with the “first path” and “second path” described by Baumgartner. It is also noted that the analogous first and second path here do overlap, which is prohibited by the instant claims. As noted above, this embodiment is associated with moveable housing. In para. 212, Baumgartner teaches that moveable housing includes multiple detection modules that can detect biological materials at different wavelengths. Three or more positions may be incorporated, where during movement, different detection modules will be associated with different wells. This movement can be accomplished through the use of an actuator (instant claim 179, where the claimed positions can be the positions of the moveable housing associating the wells with at least two different detectors). Para. 213 notes that such moveable housing is an advantageous way to test a plurality of radiation wavelengths. The reference states, “Without a moving optical assembly 600, more space would be required for placement of multiple detection modules that can read at different radiation wavelengths. Because movable housing 606 moves in optical assembly 600, the different detection modules can be easily repositioned to read from each of wells 620 in sample block 604. This saves significant space in the portable testing device, as the number of detection modules needed to test each of wells 620 is greatly reduced.” Baumgartner also states that though in Figure 23, the first path and second path are shown as threaded, that they may also be smooth (para. 218). Figure 25 and paras. 238-239 show an alternative configuration where light-emitting diodes emit light down first paths, through an excitation filter (ref. 732), and into the sample tube (ref. 702). Emitted light can then travel along a second path and hit emission filters (refs. 748 and 750) before reaching the photodetectors (refs. 740 and 742). Although this configuration involves the use of multiple light-emitting diodes, emission filters, and photodetectors, the use of multiple of these elements is not prohibited by the instant claims, which comprise the stated elements (and the claimed movable carriage is also stated to comprise its listed elements specifically). Additionally, the embodiment shown in Figure 25 is not stated to be specifically in a moveable housing. The reference also states that this configuration can be compact and thus advantageous in a portable device, and that utilizing multiple photodetectors can limit cross-talk (para. 240). Given all of these teachings regarding light emission and detection in Baumgartner as described in the paragraphs above, it would be prima facie obvious that the above embodiments could be combined to arrive at the moveable carriage of the instant invention. Baumgartner teaches the benefits of utilizing a moveable carriage (e.g. it requires less space for detecting multiple wavelengths of light), and provides these benefits in an embodiment in which a well is exposed to a single wavelength at a time, and therefore there is detection of a single wavelength at a time, where the optical assembly can move to accommodate sequential detection of additional (e.g. second, third, etc.) wavelengths of light. Here, the path for both excitement and detection overlap. Baumgartner then teaches an embodiment where multiple excitement light-emitting diodes and detectors are used with no overlap between the paths for excitement and detection, but it is not clear if this is moveable. In combining these embodiments, a moveable housing where the paths for excitement and detection do not overlap would be possible for the ordinary artisan. Such a combination could be used to analyze single wavelengths at a time, so particular targets in a sample could be focused on, without the potential noise or complications that may occur when using multiple wavelengths simultaneously. This would also allow for more flexibility in design, as more excitation wavelengths could be used, as there would not be a restriction based on the space available for detection directly next to a particular tube. This would be particularly useful in the field, where samples may contain many types of nucleic acids, and many potential targets may be possible. There would be a reasonable expectation of success as Baumgartner teaches that threading of the excitation path is not necessary with the moveable housing, thus putting this embodiment more in line with the smooth paths shown in Figure 25, and this would simply involve a combination of elements already discussed by Baumgartner. Additionally, the actual excitation and detection mechanisms would not be changing. Thus, this combination reads on the moveable carriage of the instant claims. It is also noted that in this combination, the optical detector (the photodetector in Baumgartner), would remain in the housing, as it is in all of the embodiments of Baumgartner described above. This would therefore read on instant claim 176. Additionally, as Baumgartner teaches that a plurality of wavelengths could be used, in this combination, those additional wavelengths require their own detectors, as shown in Figure 25 and described in para. 212. These paths from the assay tubes to the additional photodetectors can be considered additional light paths, thus meeting the limitation of instant claim 178. As the moveable carriage moves into the additional positions, there would also be additional light paths from each new excitation element to the assay tube, and as noted above, the different light-emitting diodes can emit light at different wavelengths. Thus, this would also read on instant claims 180-181. A power assembly can be included in the lower portion of the testing device, where the power assembly includes a battery that allows for the device to be used in the field – thus powering the entirety of the device, rendering it analogous to the claimed power supply (paras. 191-192). An electronic assembly is connected to the housing display and the power assembly via circuitry (paras. 121-122). Said assembly also includes a microprocessor (para. 124). The devices of Baumgartner may be connected to an internal display or a removable external tablet computer (see Figures 4A and 15A for respective examples). In para. 125, Baumgartner notes that signals from photodetectors can be placed into an electronic assembly for processing, which communicates with the internal display. Such signal transferring is also described in the Abstract. The display can be used to control the optical assembly to test the biological sample, and when the electronic assembly receives the signal data, it can also transmit the data back to the display (para. 124). This paragraph also notes that the electronic assembly can transmit data wirelessly to an external device. Para. 164 notes additional circuitry of the electronic assembly, and states that this assembly includes a communication board that allows for wireless communication. Para. 99 explicitly states that the device can include a display on the device or on a tablet computer, and para. 173 states that the power assembly is also capable of being connected to a tablet computer that is connected to the assembly via a wireless connection. Para. 196 notes that the tablet computer can be used to set up the assay protocol, receive data from the testing device, and display results in real-time. Additionally, it is noted that though para. 204 states that the tablet computer may come into direct contact with the overall device by sitting in a cradle, this cradle is described as a simple groove in the housing unit where the tablet may rest for ease of positing, and there are no direct, required connections that are described as required via the use of the cradle (see paras. 174 and 196). The instant specification does not define the use of “external,” and so as this tablet can operate via wireless connection to the device and does not require direct contact, this tablet is considered external to the housing. Though Baumgartner does not specifically state that the electronic assemblies perform the same functions whether connected to the internal display or the external tablet computer, it would be prima facie obvious to develop the device such that this would be the case. This is because when the display is not present but the tablet computer is, said tablet is performing the same functions that the display performs. Thus, in order to ensure the overall device functions as intended, the electronic assembly needs to be in communication with the tablet. As the electronic assembly is specifically stated to have wireless capacities, such an embodiment would be possible to develop given the teachings of Baumgartner. Thus, the electronic assembly is considered analogous to the claimed processing unit. The tablet computer can be used to begin the excitation and detection reactions of the optical system (para. 206). As noted above, the tablet computer can be used to set up the assay protocol, receive data from the testing device, display results in real-time (para. 196), and can provide information to the device wirelessly (para. 173). As the tablet computer communicates with the overall device via the electronic assembly and its associated communication, and the electronic assembly is recited to control the operations of the testing device (para. 121) and can have wireless capabilities (para. 164), this tablet computer control is considered to be analogous to step (b) of claim 175 of the claimed invention. The assay of the optical assembly can involve heating the biological samples with an amplification reaction (para. 173). Baumgartner states that their device is specifically capable of performing PCR reactions (paras. 99, 131, 171, 208) as well as isothermal amplification (paras. 99, 131, 171, 173, 189, and 208). The heating component of the device can include a thermal cycler in order to perform said PCR (para. 131). The amplification is specifically noted to act on the wells/biological sample (e.g. paras. 117, 131, 179, 210). These teachings meet the limitations of step (c) of claim 175 of the claimed invention. The moveable housing of Baumgartner can have many possible positions, as noted above and in para. 212, where these positions correspond to particular excitement/detection wavelengths (see the discussion of the combination of the excitement/detection configurations above). Paras. 212, 224-225, 228-229, and 233 of the reference all explicitly note the movement of the moveable housing into different positions for particular excitement/detection occurrences. Thus, it would be prima facie obvious that upon initiation of the assay, the moveable housing would be capable of moving into a first position to begin a first excitation/detection relative to a particular well, reading on step (d) of claim 175 of the claimed invention. Therefore, claims 175-176 and 178-181 are prima facie obvious over Baumgartner. Regarding claim 177, one of the main goals of Baumgartner is to detect the biological sample (e.g. paras. 117, 128). The reference also notes that their results can indicate the presence of a harmful pathogen or toxin (paras. 98-99, 104, 170, and 207). As the focus of the biological sample of Baumgartner is generally nucleic acids (e.g. paras. 171 and 224), it would be prima facie obvious that the nucleic acids detected within the biological sample could be indicative of a presence of a particular harmful pathogen, and thus it would be motivating to target those particular nucleic acids. For example, para. 176 teaches obtaining samples related to corn plants, and so a particular pathogen related to corn crop could be targeted, which would have effects on pesticide choices for a corn field. Furthermore, paras. 147, 206, 211, 216, 237 (for example) note that the detection of the reference is based on the emissions from the biological sample resulting from the excitation process. Thus, taken together, these teachings of Baumgartner render obvious detecting the emission energy from a biological sample to determine the presence or absence of a nucleic acid, where said nucleic acid is a target nucleic acid associated with a harmful pathogen. Regarding claim 182, as noted above in the rejection of claim 175, Baumgartner teaches that their device can perform isothermal amplification reactions, and that communication between the tablet computer and the electronic assembly provides direction for the initiation of the assay by the optical assembly. As isothermal amplification involves the use of a constant temperature (see for example para. 189), and para. 131 explicitly teaches the use of a constant temperature to heat the wells, these teachings would read on the instant claim. Regarding claim 183, Baumgartner teaches that the device can include a sample preparation area (e.g. paras. 172, 174, and 199). Said sample preparation can include heating components and the addition of reaction buffer and/or master mix (para. 199). This paragraph also specifically notes the use of cell lysis. Additionally, the focus of the biological sample of Baumgartner is generally nucleic acids (e.g. paras. 171 and 224). As the term “extracting” has no specific definition in the instant specification, the lysis of cells to release and then further analyze nucleic acids would read on the broadest reasonable interpretation of this term. Regarding claim 184, Baumgartner generally teaches that their portable device can be used in the field (e.g. paras. 1-3 and 98). In para. 176, the reference states that sampling locations can occur in a corn field to monitor particular corn plants. Thus, it would be prima facie obvious that a plant sample (from the corn itself) or a soil sample associated with a particular corn plant could be used in the method of Baumgartner in accordance with this embodiment. Regarding claim 185, as noted above in the rejection of claims 175 and 177, Baumgartner teaches or renders obvious detecting the presence of a target nucleic acid, and the device is capable of performing PCR reactions and thermal cycling via assay initiation with the tablet computer. Such PCR would involve multiple heating and cooling cycles to generate amplification products. Para. 179 states that the heating components of their invention can go from ambient temperature to a temperature of about 95°C, showing it is further capable of such temperature variation. As the detection of the device is specifically noted to depend on the amplification process (e.g. paras. 117, 125, and 224), and a PCR amplification process involves multiple cycles of heating and cooling, these teachings would read on the instant claim. Regarding claim 186, if the claimed data exchange unit provides function (i) as stated in the claim (i.e. receives instructions from said mobile electronic device), then said data exchange unit would have to be situated within the processing unit of claim 175, as the processing unit receives the instructions from the mobile electronic device as stated in step (b) of instant claim 175. Such a configuration is not prohibited by the claim, and so the claim is not considered to lack clarity/be indefinite for this reason. Additionally, positioning of the data exchange unit either within or external to the processing unit will be considered to be possible for data exchange units that meet option (ii) of the instant claim. Baumgartner teaches that the electronic assembly receives the data from the optical assembly (Abstract and para. 4), and notes that the display of the invention can show data that was collected during testing (paras. 99, 101, 105, 107). Para. 121 also teaches that the data collected during testing can be communicated to the electronic assembly for transmission to the display and for later retrieval/transfer. Paras. 124 and 169 also note the flow of data from the optical assembly to the electronic assembly to the display. Para. 173 notes that data collected during testing can be transmitted to the tablet computer specifically, and para. 196 also notes the data being received by the tablet computer. On the electronic assembly, there is a communications board with USB ports, where these aspects allow for wireless communication (such as would be required with the tablet computer; para. 164). As noted in the rejection of claim 175 above, the tablet computer of Baumgartner communicates with the portable device to initiate assays, and so because the tablet computer is specifically communicating with the communications board in the electronics assembly, said communications assembly meets limitation (i) of the instant claim. Additionally, as the tablet computer is capable of receiving data resulting from the assay, the communications board is also considered to meet limitation (ii) of the claim. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claim 175-186 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-20 of U.S. Patent No. 12,121,901 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 12 of the ‘901 patent encompasses the invention of instant claim 175. Step (a)(ii) of claim 12 recites “at least one heating block” where said heating block can hold “a plurality of assay tubes.” This would encompass the use of a single heating block with three or more assay tubes. Though (a)(iv) of claim 12 utilizes multiple excitation sources, this would include a single excitation source (as recited in the instant claim), and the instant claim does not prohibit the use of additional elements (i.e. the portable analytic device comprises the listed elements). In (d) of claim 12, though moving into a first position associated with the first light path is not explicitly stated, in (a)(v)(a) of the claim, such a capability is disclosed. The general moveable carriage of (a)(v) in claim 12 reads on the moveable carriage of (a)(v) of instant claim 175. Additionally, the other elements in each of the claims (e.g. the heating unit, the power supply, the processing unit, and the mobile electronic device) serve the same function(s) in both inventions. The overall methods also serve the same purpose – to analyze a biological sample through use of a portable analytic device. Thus, claim 12 of the ‘901 patent reads on instant claim 175. Regarding instant claim 176, the optical detector of claim 12 of the ‘901 patent is noted to be the end of the second light path, wherein said light path is part of the housing for detecting emission energy in the assay tubes (see (a)(v)(b) of claim 12). Thus, it would be obvious that the optical detector would also be in this housing, and so would read on this instant claim. Claim 13 of the ‘901 patent recites the same limitation as instant claim 177, and so reads on this claim. Claim 14 of the ‘901 application recites a first position that further corresponds with (d) of instant claim 175, and a second position that corresponds with that described in instant claim 180. Instant claim 180 does depend on instant claim 179, which requires the use of an actuator to move the movable carriage from the first to the second position. However, as the moveable carriage of the ‘901 patent is powered by the power supply of (a)(vi) of claim 12, it would be obvious to the ordinary artisan that the movable carriage could be moved entirely by mechanisms within the portable analytic device. Thus, claim 14 reads on instant claims 179-180. Additionally for claim 14 of the ‘901 patent, as three light paths are described within the moveable carriage, this claim reads on instant claim 178. Claim 15 of the ‘901 patent recites the same limitations as instant claim 181, and so reads on this claim. Claim 16 of the ’901 patent recites the same limitations as instant claim 182, and so reads on this claim. Claim 17 of the ‘901 patent recites the same limitation as instant claim 183, and so reads on this claim. Regarding instant claim 184, the ‘901 patent does not specify the same sample types recited in the instant claim. However, claim 17 of the ‘901 patent does generally recite the use of nucleic acids, and claim 13 of the ‘901 patent recites indicating the presence or absence of a target, and thus it would be obvious that said nucleic acids could test for the presence of particular organisms (i.e. targets), such as pathogens. In detecting pathogens, it would also be obvious to the ordinary artisan that agricultural or medical contexts would be important for detecting potential diseases in patients or crops, and so the use of the sample types in instant claim 184 would be utilized in these contexts. Claim 18 of the ‘901 patent recites the same limitations as instant claim 185, and so reads on this claim. Claim 19 of the ‘901 patent recites the same limitations as instant claim 186, and so reads on this claim. Claim 20 of the ‘901 patent recites a cooling unit. As claim 12 already recites the use of heating, and claim 18 recites utilizing heating and cooling for amplification, the teachings of this claim can be used to read on instant claim 185. Conclusion No claims are currently allowable. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRANCESCA F GIAMMONA whose telephone number is (571)270-0595. The examiner can normally be reached M-Th, 7-5pm. Examiner interviews are available via telephone, in-person, 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. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at (571) 272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /FRANCESCA FILIPPA GIAMMONA/Examiner, Art Unit 1681
Read full office action

Prosecution Timeline

Dec 17, 2021
Application Filed
Jan 23, 2025
Non-Final Rejection — §102, §103, §112
Apr 25, 2025
Response Filed
Jul 09, 2025
Final Rejection — §102, §103, §112
Sep 05, 2025
Response after Non-Final Action
Sep 26, 2025
Request for Continued Examination
Oct 07, 2025
Response after Non-Final Action
Feb 23, 2026
Non-Final Rejection — §102, §103, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12595515
PROGNOSIS METHOD OF CANCER
2y 5m to grant Granted Apr 07, 2026
Patent 12584177
DETECTING ENDOMETRIAL CANCER
2y 5m to grant Granted Mar 24, 2026
Patent 12577621
LRRK2 MUTATIONS AS BIOMARKERS FOR THE PREDICTION OF IMMUNE CHECKPOINT RESPONSE IN CANCER
2y 5m to grant Granted Mar 17, 2026
Patent 12545964
DETECTION OF INFECTIOUS AGENTS FROM ENVIRONMENTAL AIR DUST
2y 5m to grant Granted Feb 10, 2026
Patent 12503732
DIAGNOSTIC MARKER OF MILD COGNITIVE IMPAIRMENT (MCI) DUE TO ALZHEIMER'S DISEASE (AD) AND USES THEREOF
2y 5m to grant Granted Dec 23, 2025
Study what changed to get past this examiner. Based on 5 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

3-4
Expected OA Rounds
36%
Grant Probability
87%
With Interview (+50.9%)
3y 8m
Median Time to Grant
High
PTA Risk
Based on 66 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month