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
As previously stated in the prior Office Action, it is noted that preliminary amended claims (including New claims 34-50) were filed on 12/19/24 after the original filing date of 9/9/22. However, applicant fails to specify where each of the new claims and claims as now amended are described in/supported by the originally filed specification. Therefore, the prior request is maintained. It is hereby requested that applicant provide for the specific text of the originally filed specification that supports each of the new claims and all further amendments.
Response to Arguments
Applicant's arguments filed July 22, 2026 have been fully considered but they are not persuasive.
As to the drawings, applicant asserts that the replacement drawings overcome the drawing objections. The examiner disagrees. It is noted that in Figure 1A the reference numeral 102 and leading lines do not appear to be directed to a fluidic channel. Instead, the lines appear to be directed to the junction 136f (that is not a channel) and waste line 118 that is not same as the fluidic channel as claimed and fluidic channel 102 described in the specification. Furthermore, in Figure 1A, the leading line from reference numeral 202 does not appear to directed to a second layer. The line appears to be directed to a channel. There are no structurally distinct first and second layers 201,202 provided for, shown in Figure 1A. Furthermore, it is noted that reference numeral 202 now refers to the second layer 202 and pump 202. This is improper. See for example paragraph [0044] and the reference numeral table in the US Publication and submitted amendments to the specification.
Furthermore, it is unclear what/which channel shown in the drawings and described in the specification is the second fluidic channel connecting the binding chamber and the amplification region; and an occlusion point at the second fluidic channel. The examiner fails to locate any description of such in the specification. It is noted that while the specification discloses second fluidic channel 304, second fluidic channel 508, and second fluidic channel 708, the examiner fails to locate any of such being described as provided for in claim 40 and where such a second fluidic channel of claim 40 is shown in any of the Figures. The leading lines from reference numerals 304 in Figure 3, 508 in Figure 5, and 708 in Figure 7 do not appear to be directed to a single channel, but appear to be directed to a collection of elements all of which are not a single second fluidic channel as claimed.
Claim 40, which is not an originally filed claim, appears to be directed to new matter. It is hereby requested that applicant provide for the specific text of the specification that describes such and indicate which channel described in the specification and shown in the drawings is the second channel recited in claim 40.
The claims have not been amended to sufficiently address all of the prior 112 rejections.
It is noted that instead of amending claim 1 to positively claim a sample chamber including a sample port configured to receive a sample, applicant has amended the claim to refer to a broad unspecified port. However, it is noted that the specification describes a number of different ports that are ports of corresponding structures recited in the specification, but applicant has not specified which port disclosed in the specification is the port now recited in the claim. Since no sample chamber is claimed it is presumed that such port as now claimed is not the sample chamber port, nor any other port of any other chamber or structure not claimed positively claimed as element of the of the invention. Such port is presumed to be the lysis chamber port 124 or such can be any other port to which the lysis chamber is connected to. If applicant intends for the such port to be the lysis chamber port, then the claim should clearly recite such. However, as presently drafted, such port is not limited to the lysis chamber port. However, if applicant asserts that the port is of another structured not claimed, the examiner maintains the previously stated position that is unclear how a port (such as sample chamber port) can be claimed as being present without providing for the respective structure (such as a sample chamber) that comprises such port.
“As to the phrases “binding unit” and “amplification region” applicant asserts that
Applicant submits that this applies an incorrect standard, because § 112(b) does not require a claim to recite specific structure. Read in light of the specification, these terms apprise a skilled artisan of their scope with reasonable certainty. The specification describes the "nucleic acid binding unit" (element 146) as a component of the binding chamber on which nucleic acids are captured as the lysate is passed through it. See paragraphs [0031] and [0039] of the specification as filed. The specification likewise describes the "amplification region" as the region of each fluidic channel to which reaction units are transported and amplified. See paragraphs [0060] and [0067] of the specification as filed. A person of ordinary skill in the art would therefore understand the scope of these terms with reasonable certainty.”
The examiner disagrees. "Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim.” (MPEP 2111 Claim Interpretation; Broadest Reasonable Interpretation [R-10.2019]; II. IT IS IMPROPER TO IMPORT CLAIM LIMITATIONS FROM THE SPECIFICATION). Therefore, although the specification provides for what such region and area could possibly be, that which is disclosed in the specification but not recited in the claims will not be read into the claims. There is no definition in the specification that states a “binding unit” is/means…. Such for the phrase to be limited to any specific structural definition that is read into the claims. Here, a binding unit in the binding chamber can be anything that can provide for binding of a nucleic acid.
As to “amplification region”, there is no specifical definition provided for in the specification to limit, define such region by any specific structures. The examiner maintains that the application region is not defined as any being specific structure(s) in the claim. There is no indication in the claim that provides for what is structurally required to define “an amplification region”. The claim does not require the fluidic channel to comprise an “amplification region” and does not provide for what is structurally required of the channel nor anything else to be considered as “an amplification region”. The same is applicable to “waste area”. One can choose to name any location, “region”, area of the cartridge, channel as one desires.
As to the term “rigid” applicant does not refer to any clearly and definitive structural definition of the term in the specification nor claim 35. Instead, applicant refers to specific examples of “rigid” materials disclosed in the specification. None of such examples will be read into the claim. See prior remarks above. If applicant intends for the second layer to limited to comprising such materials, then the claim should clearly provide for such. Therefore, the rejection is hereby maintained.
As to claim 36, no plunger nor broad, structurally undefined sample processing instrument (only required to be a plunger) is positively claimed as a structural element of the cartridge. The claim as drafted does not provide for any additional structural element of the cartridge nor any further structure of any prior positively claimed structural element of the cartridge. The claim is directed to what can be done with, how the cartridge (the entire invention being defined) can be, is intended to be used with a further broad, unclaimed sample processing instrument (only defined as comprising a plunger). One can chose to “interface” the cartridge with any further structure that one desires by any suitable interfacing means as one desires. There is no requirement for the cartridge to be interfaced with, used with a sampling processing instrument nor any other unclaimed structures that are not elements of the invention.
Claims 41-43 are rejected as given herein.
As to the 102 rejection, applicant states:
“The magnetic beads taught by Eberhart are not means for lysing-they are capture particles used to bind and immobilize nucleic acids after lysis has already occurred. Eberhart states that "[a]fter lysis, lysate can be moved through a fluidic channel on the cartridge into isolation chamber 2130... Magnetically responsive particles, e.g., beads 2184, can be introduced into the isolation chamber... [and] [p]olynucleotides can be captured on the particles and immobilized by application of a magnetic force." Eberhart, paragraph [0144]. Eberhart describes these beads as performing capture and purification-not lysis.
Second, Eberhart teaches that its beads are located in a separate isolation chamber that is downstream of, and distinct from, the lysis chamber. Only "[a]fter lysis" is the "lysate... moved through a fluidic channel on the cartridge into isolation chamber 2130 by opening valve 2116," and "[m]agnetically responsive particles, e.g., beads 2184, can be introduced into the isolation chamber." Eberhart, paragraph [0144]. Eberhart thus moves the lysate out of the lysis chamber and into a separate isolation chamber before the beads are used, so the beads are not in or part of the lysis chamber at all.
Thus, Eberhart does not teach or suggest all the features of claim 34. Applicant respectfully requests withdrawal of the rejection of claim 34 and its corresponding dependent claims under 35 U.S.C. § 102.
Eberhart does not teach or suggest all features of dependent claim 35
Claim 34 recites "a first layer and a second layer, the first layer being coupled to the second layer" and "a fluidic channel connecting the lysis chamber and the binding chamber, the first and second layers defining the fluidic channel, and the first layer being deformable relative to the second layer to occlude the fluidic channel." Claim 35 further recites that "the first layer is elastomeric and the second layer is rigid."
With respect to claim 35, the Office Action asserts that Eberhart's channel floor corresponds to a "rigid layer." Eberhart explicitly teaches that the channel floor is malleable. Eberhart states that "[a]t least the valve body of the cartridge body comprises a malleable material" Eberhart, paragraph [0034]. As such, Eberhart does not teach or suggest a second layer that is rigid.
Thus, Eberhart does not teach or suggest all the features of claim 35. Applicant respectfully requests withdrawal of the rejection of claim 35 under 35 U.S.C. § 102.”
The examiner disagrees. Applicant’s specification states “a means for lysing (for example, a magnetic bar 142 and beads 144 depicted in FIG. 1B).” As acknowledged by applicant, Eberhart discloses a chamber including beads. Applicant is not asserting that the reference does not teach any claimed structural element, but is asserting that the same structure disclosed by the reference that is disclosed in applicant’s specification is not used for lysing. The claims are directed to an apparatus that is defined by the positively claimed structural elements listed in the claims. The apparatus is not defined by any intended, possible use of any structural elements nor possible process steps. There is no requirement for the claimed invention to be used in any process at all, including for any lysing or any other use. Whether or not an owner, purchasers, user, etc. of the instant invention chooses to use claimed invention for anything at all is a matter of choice not a requirement. Even if one were to decide to use the invention, one can use the invention as one desires including for something other than lysing. Here, the same is applicable to the apparatus of Eberhart. Although, no lysing is required to be performed and performing lysis does not structurally define the claimed apparatus, one could choose to employ the isolation chambers and beads of Eberhart for lysing if one chooses.
A recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. The claims must provide for a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Here, applicant has not provided for any patentable structural distinction. Therefore, the rejection is hereby maintained.
As applicants remarks directed to the term “rigid”, The term is indefinite, subjective as previously stated in the prior Office Action. The argument appears to be asserting that “malleable” means not rigid. The examiner disagrees. The terms are not mutually exclusive. A material can be subjectively considered as “rigid” and yet also simultaneously be malleable. Therefore, the rejection of claim 35 is maintained.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
The drawings were received on July 22, 2026. These drawings are unacceptable. See Response to Arguments above and objection herein below.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, second fluidic channel (and further elements as recited in claim 40) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that the apparatus claims mention a sample (not defined as any specific material, chemical, etc.), nucleic acid, a sample processing instrument (only defined as comprising a plunger), and cells. However, none of the prior are positively claimed as structural elements of the apparatus (cartridge). The prior are mentioned in terms of intended use and are considered as materials and/or articles that are intended be, can be possibly used with and/or worked upon by the apparatus.
It is noted that the various “configured to…” clauses recited throughout the claims do not provide for any further positively claimed structural elements. For example, in claim 36, what (a plunger of a broad sampling processing instrument) that can be used to deform first layer does not structurally define the claimed invention. Although no deforming of the first layer is ever required to be performed, one can choose to use any means (a hand, finger, or any structure) one desires to deform the first layer. Employing the term “configured to” prior all possibly recitations of intended use and/or process steps relative structures that are not elements of the claimed the invention does not provide for any further structure of the claimed invention.
Furthermore, the various “to…” clauses such as “to receive…”; “ to occlude…”; and such similar clauses are directed to intended use. As noted above, no sample is positively claimed as an element of the apparatus and the claims are not directed to a process. Therefore, there is no requirement for any sample receiving, lysing, binding, deforming, occluding, amplifying, processing, etc. of anything to ever occur nor any actions/process steps to be performed, using the apparatus in nor to perform any actions, including those as may be intended by applicant.
It is noted that claim 37 appears to be redundant in view of claim 34 which already states the first layer is deformable relative to the second layer to occlude the fluidic channel (inherently as some point of the fluidic channel). Therefore, claim 39 is also redundant in view of claim 39 in view of claim 38 for the same reasons.
It is noted that claim 49 is directed to the unclaimed sample that is not a structural element of the invention and does not further structurally define the invention.
As to claim 51, there is no requirement for any lysing of any cells to be performed. The claim does not provide any further structure or structural distinct between the means of claim 1. The claim is directed to intended, possible use…what the means for lysing can possibly be employed to perform.
It is noted that clam 52 is directed to a conditional process step that is never required to occur as indicated by the “when” clause. The apparatus is defined by the positively claimed structural elements not by any process step. There is no requirement of for any deforming of the first layer to ever be performed.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 34-36, 38, 40-47, and 49-52 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.
As to claim 34, it is unclear what is structurally required to be considered as “an amplification region” and “a waste area” because such are not defined as being any specific structures, nor defined by any structural dimensions/boundaries so as to determine where such regions begin and end to structurally distinguish such regions from each other and any other structural element.
As previously stated, it is unclear what is structurally considered as “a waste area” and what structure disclosed in the specification defines such “waste area”. It is noted that the terms “amplification” and “waste” do not provide for any structure of the respective region and area. The terms are directed to the intended use of the structurally undefined region and area. However, there is no requirement for any amplification of anything to be performed and there no requirement for any subjective “waste” to be present any positively claimed structural element of the invention. It is further unclear what is the structural nexus/connectivity of the amplification region and waste area to each other and to the prior positively claimed structural elements because the claim does not provide for such. It is noted that a list of structures that are not required to be structurally connected do not define a single cartridge. There is nothing precluding one from subjectively labeling any portion the cartridge including that of the prior positively claimed elements as an amplification region and a waste area.
Dependent claims 35-36, 38, 40-47, and 49-52 are rejected via dependency upon a rejected claim.
The term “rigid” in claim 35 is a relative term which renders the claim indefinite. The term “rigid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. What (degree of flexibility, elasticity, etc.) may be considered as “rigid” to one person may not be considered as such to another and vice versa.
As to claim 36, it is unclear what is further structurally required by the claim because the claim does not provide for any further structural element of the invention/cartridge nor any additional structure of any prior positively claimed structural element. The claim is directed to what can be done with, how the cartridge (the entire invention being defined) can be, is intended to be used with a further broad, unclaimed sample processing instrument (only defined as comprising a plunger). One can chose to “interface” the cartridge with any further structure that one desires by any suitable interfacing means as one desires.
As to claims 41-43, it is unclear what is the structural nexus of the respective recited ports to the prior a port of claim 34, because the claim does not clearly provide for such. The port of claim 1 does not appear to be any of the ports recited in the claims. Therefore, if not any of such ports, it is unclear what is the port of claim 1 an element of and how such port can be present without providing for the specific structure that comprises such port. It is presumed to refer to the sample chamber port as the claim prior to the amendment stated. However, as previously stated, no sample chamber is positively claimed as an element of the invention.
It is unclear what structurally required by claim 49 because the claim does not provide for any further structural element of the invention/cartridge nor any additional structure of any prior positively claimed structural element. The claim is directed to the sample that is not claimed as an element of the invention. There is no requirement for any sample to present. See Claim Interpretations.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 40 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The examiner fails to locate any description/support for new claim 40 within the originally filed specification. See explanation above in Response to Arguments.
Claim Rejections - 35 USC § 102
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.
Claim(s) 34-36, 38, 40-47, and 59-52 is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Eberhart et al., US 2017/0002399.
Eberhart discloses a fluidic cartridge having a body comprising a malleable material and a layer comprising a deformable material bonded to a surface of the body that seals one or more fluidic channels that communicate with one or more valve bodies formed in a surface of the body. The valve can be closed by applying pressure to the deformable material sufficient to crush and close off a fluidic channel in the body (channels formed by deformable layer that can be occluded at occlusion points). Also provided are a cartridge interface configured to engage the cartridge. Also provided is a system including a cartridge interface and methods of using the cartridge and system. (Abstract)
The cartridge comprises a) a body comprising a malleable material; and (b) a layer comprising a deformable material bonded to a surface of the body and sealing one or more fluidic channels (fluidic channel, formed of deformable/elastomeric layer and connecting chambers; claims 34-35 and 37-40) that communicate with one or more valve bodies formed in a surface of the body; wherein: (i) the one or more valve bodies comprise: (A) a segment of the channel comprising a wall having a pair of ridges and a floor depressed into the surface; and (B) reliefs depressed into the surface and defining depressions that flank the ridges on two sides of the segment of the channel; and (iii) the layer is bonded to the surface of the body and to the ridges such that the one or more channels, channel segments and reliefs are sealed; and wherein a valve body sealed with the layer forms a valve closable by forcing the layer against the floor (rigid layer, claims 35 and 52) of the segment of the channel. In one embodiment the cartridge of comprises elements of a fluidic circuit including a fluid inlet (sample port), a fluid outlet and at least one compartment, which elements are fluidically connected through fluidic channels, wherein at least one fluidic channel comprises a valve body. In another embodiment the cartridge comprises at least one compartment selected from a reagent compartment, a sample compartment (including a sample port), a mixing compartment, a reaction compartment and a waste compartment (including waste port and can be considered as a waste region connected to waste line, second channel, formed by deformable layer that can be occluded).
At least one reagent compartment comprising reagents for performing PCR (e.g., PCR primers, nucleotides and a DNA polymerase), wherein the at least one reagent chamber (binding chamber including a port and nucleic acid binding unit (reagents)/amplification region) comprises an openable seal that, when opened, puts the reagent chamber in fluidic communication with the reaction chamber. … one of the chambers is configured as a lysis chamber configured to accept a biological sample, one of the chambers is configured as an isolation chamber (can be referenced as a lysis chamber with lysis port; claims 41, 44-47) configured to receive magnetically responsive capture particles (lysis means…moveable, mechanical magnetic beads claim 51) and to immobilize said particles when a magnetic force is applied to the isolation chamber, ….(paragraph 0012; and Figures and descriptions of such and Examples 1-7).
As to claim 36, one can choose to interface the cartridge with a sample processing instrument by any suitable means.
As to claim 48, reagents are not required to be stored on the cartridge.
As to claim 50, “the cartridge comprises a filter to filter liquid from a biological sample, such as a cell lysate. One such embodiment is shown in FIG. 26. The exemplary cartridge comprises filter chamber 2630 comprising a filter, in a flow path between lysis chamber 2620 and reaction chamber 2622, and typically between the sample chamber and a first valve, e.g., 2646. The filter can be a size exclusion filter having pores no greater than any of 100 microns, 50 microns, 25 microns, 10 microns or 5 microns. The filter can be, for example, a mixed cellulose ester, such as a Millipore™ Membrane Filter. Such a filter can be useful to capture particles that may clog valves or chambers in the flow path. In another embodiment, the filter is included around the outlet of the lysis chamber.” (paragraph 0063).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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, Charles Capozzi can be reached at 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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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
