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
It is noted that preliminary amended claims (including New claims 34-50) were fired on 12/19/24 after the originally filing date of 9/9/22. However, applicant fails to specify where each of the new claims are described in/supported by the originally filed specification. Therefore, 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.
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.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract employs legal terminology such as “comprise” and “comprises”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Drawings
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, the first and second layers defining a fluid channel; waste line and waste region (claims 34 and 38); and second fluidic channel (claim 40) must be shown or the feature(s) canceled from the claim(s). Such layers are not referenced by any reference numbers in the specification and drawings. 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.) and a sample processing instrument (only defined as comprising a plunger). 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.
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.
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 34-50 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 how a sample chamber port (hole, orifice, opening…etc.) can be present without claiming the sample chamber 104 (of the fluidic channel 102). The claim as drafted is not consistent with the specification.
As to claim 34, it is unclear what is structurally required to be considered as “a binding unit” because such is not structurally defined in the claim as comprising any specific structure.
As to claim 34, it is unclear how the first layer and second layer are coupled to each other and define a fluidic channel because the claim does not clearly recite such. It is presumed that the fluidic channel is located between the first and second layers. If so, the claim should clearly recite such. The same is applicable to the waste line of claim 38.
As to claim 34, it is unclear what is structurally required to be considered as “a amplification region” and “a waste region” 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. The term “waste region” does not appear to be disclosed, described, nor mentioned in the specification. As previously stated, it is unclear what is structurally considered as “a waste region” and what structure disclosed in the specification defines such “waste region”. It is noted that the terms “amplification” and “waste” do not provide for any structure of the respective regions. The terms are directed to the intended use of the structurally undefined regions. It is further unclear what is the structural nexus/connectivity of the amplification region and waste region to the prior positively claimed structural elements because the claim does not provide for such. There is nothing precluding one from subjectively labeling any portion of the prior claimed elements as an amplification region and a waste region.
Dependent claims 35-50 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 further 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 lysing chamber port, binding chamber port, and waste line port to the prior claimed lysis chamber, binding chamber, and waste line because the claims do not provide for such. It is presumed that each of the respective chambers and waste line are intended to comprise the respective ports. If so, the claims should clearly recite such.
It is noted that claim 48 does not provide for any further structural element nor any further structure of any positively claimed element. Instead, the claim is directed to what (reagents, not defined as any specific substances, chemicals, materials etc.) is not located on the cartridge (the entire invention being defined) which the claims are intended to structurally define. The claim provides for a negative limitation. However, it is noted that the claim does not preclude a single reagent from being on any positively claimed element of the cartridge nor precludes a single reagent nor reagents from being located in the cartridge (any element of the cartridge).
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 34-50 are 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 the new claims within the originally filed specification. Specifically the examiner fails to locate any description of “a waste region” of claim new claim 34 and the further content of new claims 38, 40, and 48. It is noted that claim 48 is directed to a negative limitation.
Any negative limitation or exclusionary proviso must have basis in the original disclosure. MPEP 2173.05(i) Negative Limitations.
Here, the examiner fails to locate support for the negative limitation.
Therefore, the new claims are directed to new matter.
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) 34-50 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, claim 35) 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 nucleic acid binding unit/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 magnetic beads) 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 nor 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. NGUYEN; Michael Thomas et al. and Southgate; Peter David et al. disclose close cartridge devices.
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..
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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