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 .
Claim Objections
Claim 1 is objected to because of the following informalities: The claim recites “A biological sample analysis device analyzing a biological sample...” and should be amended to recite “A biological sample analysis device for analyzing a biological sample...”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: The claim recites “the flow passage has such shape that a liquid flow of the liquid is bent at least once” and should be amended to recite “the flow passage has a shape which causes a liquid flow of the liquid to be bent at least once”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: The claim recites “a first protrusion impeding a liquid flow flowing in to the first compartment; or a second protrusion promoting a liquid flow flowing in to the second compartment” and should be amended to recite “a first protrusion configured to impede a liquid flow through the first pore; or a second protrusion configured to promote a liquid flow through the second pore”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: The claim recites “a computation unit analyzing the biological sample” and should be amended to recite “a computation unit configured to analyze the biological sample”. Appropriate correction is required.
Claim 15 further recites “wherein the computation unit analyzes” and should be amended to recite “wherein the computation unit is further configured to analyze”
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“compartment forming portion...configured so that speed of the liquid to diffuse” as in Claim 10.
“a first compartment opening portion” as in Claim 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
“a part of the nanopore substrate 103, may be a separate component contacting the nanopore substrate 103, and may be a part of a flow cell accommodating the nanopore substrate”, as in para. [0081] of Applicant’s instant pre-grant publication US 2024/0238782 A1, and equivalents thereof.
***No corresponding structure appears within Applicant’s instant disclosure. See the 35 USC 112 section below.***
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-15 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.
Claim 1 recites “a substrate including first and second pores” wherein it is unclear if the “first and second pores” are individual pores or groupings of pores. It appears through Applicant’s disclosure that Applicant intends two individual pores. If this is the case, Applicant may wish to amend the claim to recite something on the order of “a substrate including a first pore and a second pore” so as to clarify the claim.
Claim 1 further recites “the biological sample passing through the first and second pores” wherein this recitation is drawn to a process recitation. As the claims are drawn to a device, such process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II). It is thereby unclear the limitations Applicant intends through such recitation. Applicant may wish to amend the claim to recite “wherein the first pore and the second pore are configured for the biological sample to pass through the first pore and the second pore”, or merely strike the recitation from the claim.
Claim 1 further recites “the first pore is disposed at a position allowing the first compartment and the second chamber to communicate with each other, the second pore is disposed at a position allowing the second compartment and the second chamber to communicate with each other” wherein the phrase “communicate with each other” is not clear. Applicant may wish to amend the claim to recite something on the order of “the first pore is configured to provide fluid communication between the first compartment and the second chamber, the second pore is configured to provide fluid communication between the second compartment and the second chamber” so as to indicate the arbitrary “communication” as a fluid communication.
Claim 1 further recites “a liquid displacement efficiency when liquid within the first compartment is displaced by separate liquid in a first region is lower than a liquid displacement efficiency when liquid within the second compartment is displaced by separate liquid in a second region, the first region being closer to the first pore than an opening portion of the first compartment, the second region being closer to the second pore than an opening portion of the second compartment” wherein the “liquid displacement efficiency” is not particularly defined in the instant specification, the claim fails to identify what particular parameter constitutes displacement efficiency or how such efficiency is determined. Liquid displacement efficiency is further known to be affected by fluid properties such as flow rate and viscosity, thereby rendering the prior art device as fully capable of displaying the claimed displacement efficiency difference depending on the samples inserted into the device and its mode of operation.
Claim 2 recites “wherein a volume of liquid the first compartment can accommodate is less than a volume of liquid the second compartment can accommodate” wherein the volume the compartments “can” accommodate are unclear as what a compartment “can” hold is subjective and determined by a user. Applicant may wish to cancel the claim or amend the claim to recite something on the order of “wherein an interior volume the first compartment is less than an interior volume of the second compartment”.
Claim 3 recites “wherein a size of a first opening on a side not contacting the first pore of the first compartment is smaller than a size of a second opening on a side not contacting the second pore of the second compartment” wherein the “a first opening” and the “a second opening” are not particularly oriented in the device as having a structural or functional relation to any other structure of the device, thereby rendering their arrangement within the device unclear. The recitation is further convoluted and narrative in nature. Applicant may wish to merely cancel the claim.
Claims 4 and 13 recite “a side wall of the first compartment includes a portion higher than a side wall of the second compartment” wherein the “a side wall” is not clearly understood as being the full structure of the compartment forming element which forms the side wall, or merely refers to an interior surface of the compartments. Examiner suggests Applicant may wish to cancel Claim 4 which is read broadly in terms of the orientation of the device in regard to the “higher” aspect, as discussed in the 35 USC 102 section below. Further, Examiner suggests Applicant may wish to amend Claim 13 to recite something on the order of “wherein an interior of the first compartment has lower hydrophilicity than an interior of the second compartment” so as to clarify the particular portion which comprises the side wall.
Claim 6 recites the limitation " the right angle ". There is insufficient antecedent basis for this limitation in the claim. Applicant may wish to cancel the claim or amend it to recite something on the order of “a side wall of the second compartment has a second angle nearer to a 90 degree angle than the first angle”
Claim 8 recites “a flow passage feeding liquid to the first chamber, wherein it is configured...” wherein it is unclear if the “it” refers to the flow passage or the first chamber.
Claim 9 recites “the second compartment is disposed at a corner of the flow passage having been bent” wherein it is unclear what constitutes the “corner” as a bend is not necessarily formed at 90 degrees, and such a “bend” would not be expected for form a pointed corner. Further, the “flow passage having been bent” lacks antecedence as the “bent” aspect refers to the liquid flow, no the flow passage. Applicant may wish to cancel the claim.
Claim 10 recites “wherein height of the compartment forming portion is configured so that speed of the liquid to diffuse within the first compartment or within the second compartment becomes faster than speed of the liquid to diffuse between the first compartment and the second compartment” wherein the “becomes faster” aspect is unclear with regard to each of the shapes of the compartments, and is indefinitely broad as a shape resulting in varying diffusion may have infinite configurations. Applicant may wish to claim the actual shape responsible for the claimed differences in diffusion, or cancel the claim.
Claim 12 recites “a first compartment opening portion” interpreted under 35 USC 112(f) as discussed in the Claim Interpretation section above. However, no particular corresponding structure appears within Applicant’s instant disclosure, no reference of the portion is made to the drawings in the instant specification. As such, the metes and bounds of the “a first compartment opening portion” are indefinite. Applicant may wish to clarify the particular structure thereto or cancel the claim.
Claim 14 recites “wherein it is configured that viscosity of liquid filled within the first compartment before feeding the biological sample to the first compartment becomes higher than viscosity of liquid filled within the second compartment before feeding the biological sample to the second compartment” wherein it is unclear as to which element the “it” refers to regarding the particular viscosity configuration. Further, it appears that applicant’s viscosity requirements are merely drawn to viscosity drag as discussed in the 35 USC 102 section below, and it is unclear what configuration of an element of the device would particularly result in the claimed process, and such a configuration may embody numerous aspects which could potentially result in the claimed viscosity differences. Applicant may wish to clarify the particular element and its physical configuration which results in the claimed process, or cancel the claim.
Claim 15 recites “using a blockage current value generated when the biological sample passes through a pore” wherein it is unclear to what elements of the device the blockage current is related to and/or generated from given that the claim does not recite any electrodes of the device for determining a current across the pores.
Claim 15 further recites “wherein the computation unit analyzes the biological sample using a current value obtained by summing the blockage current value of the time when the biological sample passes through the first pore and the blockage current value of the time when the biological sample passes through the second pore” wherein it is unclear what amounts to the “using” of the current value to perform further undefined analysis of the biological sample. Further, the claim is narrative in nature referring to “the time when the biological sample passes through the first pore” and “the time when the biological sample passes through the second pore” and it is unclear what constitutes the “time” of passing through the pore as the strand passes through the pore over a period of time to generate a sequence, not one specific time point.
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.
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 1-6 and 8-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rena et al. (WO2018142480A1 – as seen through the machine translation available on Google Patents and attached herein), hereinafter “Rena”.
Regarding Claim 1, Rena teaches a biological sample analysis device analyzing a biological sample, the biological sample analysis device comprising:
a substrate 111A/B including first and second pores 110, the biological sample passing through the first and second pores 110 (“The nanopore substrate 111 has a structure in which a thin film 111A in which the nanopore 110 is opened is sandwiched between a lower thin film fixing member 111C and an upper thin film fixing member 111B.”); and
first 105 and second 104 chambers opposingly disposed through the substrate 111A/B (See Fig. 1 showing the second chamber 104 (upper), and the first chamber 105 (lower) formed as connected tanks 105.),
wherein the first chamber includes a first compartment and a second compartment, the first compartment and the second compartment being separated by a compartment forming portion (See Figs. 1 and 2 showing compartments 105 of the first chamber 105 (lower) being formed by the compartment forming portions of the film fixing member 111C. – “Have. Corresponding to the plurality of nanopores 110 provided on the nanopore substrate 111, a plurality of individual tanks 105 are provided between the nanopore substrate 111 and the electrode substrate 113.” – “The upper liquid tank is a common tank 104, and the lower liquid tank is further divided into a plurality of liquid tanks.”),
the first pore is disposed at a position allowing the first compartment and the second chamber to communicate with each other, the second pore is disposed at a position allowing the second compartment and the second chamber to communicate with each other (See Figs. 1 and 11, and “Each individual tank 105 communicates with the common tank 104 via the nanopore[s] 110.”), and
a liquid displacement efficiency when liquid within the first compartment is displaced by separate liquid in a first region is lower than a liquid displacement efficiency when liquid within the second compartment is displaced by separate liquid in a second region, the first region being closer to the first pore than an opening portion of the first compartment, the second region being closer to the second pore than an opening portion of the second compartment (Given the commensurate arrangement of pores, chambers, and compartments of Rena as in the instant claim, the device of Rena commensurately displays the claimed differences in liquid displacement efficiency, especially given that the particular respective boundaries of the first and second regions are not specifically limited, and that the liquid displacement efficiency of a region closer to a point where liquid is being injected to displace an already present liquid implicitly has a different displacement efficiency as the liquid nearer to the injection point is displaced directly by the injected liquid. Further, the claim is predicated on a conditional process recitation (“when liquid within the first compartment is displaced by separate liquid in a first region”) which is not positively required by the claim and, as the claims are drawn to a device, such a process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II).),
as in Claim 1.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Rena teaches the analysis device discussed above wherein a volume of liquid the first compartment can accommodate is less than a volume of liquid the second compartment can accommodate (See Fig. 15 showing the individual tanks 105A and 105B having differing sizes. – Further note that a volume a compartment “can” hold is subjective. Applicant may wish to amend the claim to merely recite the first compartment has a volume smaller than the second compartment.), as in Claim 2.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Rena teaches the analysis device discussed above wherein a size of a first opening on a side not contacting the first pore of the first compartment is smaller than a size of a second opening on a side not contacting the second pore of the second compartment (See Fig. 15 showing different sized openings connecting to the different sized compartments 105A and 105B not contacting the first or second pores. – See also the 35 USC 112 section above.), as in Claim 3.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Rena teaches the analysis device discussed above wherein a side wall of the first compartment includes a portion higher than a side wall of the second compartment (When the device is oriented and viewed 90 degrees with respect to the representation shown through Fig. 1, the side wall of the first compartment includes a portion “higher than” a side wall of the second compartment; the phrase “higher than” is relative depending on the orientation in which the device is viewed.), as in Claim 4.
Regarding Claim 5, the prior art meets the limitations of Claim 1 as discussed above. Further, Rena teaches the analysis device discussed above wherein an upper surface of the compartment forming portion includes a portion not parallel to the substrate (See Fig. 15 showing an embodiment where the substrate 117A is not parallel to the compartment forming elements 111C.), as in Claim 5.
Regarding Claim 6, the prior art meets the limitations of Claim 1 as discussed above. Further, Rena teaches the analysis device discussed above wherein a side wall of the first compartment has a first angle with respect to the substrate, and a side wall of the second compartment has a second angle nearer to the right angle than the first angle with respect to the substrate (See Fig. 15 showing the inclined substrate 117A, wherein a sidewall (the right sidewall) of a first of the compartments 105 is at a first angle with respect to the substrate, and a sidewall (the left sidewall) is nearer to a right angle than the left sidewall with respect to the substrate given that the left sidewall approaches at an angle more normal to the substrate, and the right sidewall approaches more in convergence with the substrate (greater than 90 degrees as seen through the figure).), as in Claim 6.
Regarding Claim 8, the prior art meets the limitations of Claim 1 as discussed above. Further, Rena teaches the analysis device discussed above further comprising:
a flow passage feeding liquid to the first chamber, wherein it is configured that the flow passage starts to feed the liquid to the second compartment before starting to feed the liquid to the first compartment (See Fig. 1 showing a flow passage formed by the sidewall 114 and connecting member 117B feeding liquid to the first chamber through the pores. Further, as the flow passage is positioned on a side of the device, said flow will flow along to the pores from one direction, thereby filling the compartments of the first chamber sequentially commensurately as claimed.), as in Claim 8.
Regarding Claim 9, the prior art meets the limitations of Claim 1 as discussed above. Further, Rena teaches the analysis device discussed above wherein the flow passage has such shape that a liquid flow of the liquid is bent at least once (See Fig. 1 showing the flow passage bending from a vertical direction to a horizontal direction so as to feed into the second chamber.), and the second compartment is disposed at a corner of the flow passage having been bent (See Fig. 11 showing the leftmost compartment 105 being located at a corner of the flow passage bending against the left sidewall toward a horizontal, as well as at a corner of the flow passage bending back from the horizontal to a downward vertical through the film fixing member 111B before traveling through the pore.), as in Claim 9.
Regarding Claim 10, the prior art meets the limitations of Claim 1 as discussed above. Further, Rena teaches the analysis device discussed above wherein height of the compartment forming portion is configured so that speed of the liquid to diffuse within the first compartment or within the second compartment becomes faster than speed of the liquid to diffuse between the first compartment and the second compartment (Given the commensurate arrangement of chambers, pores, and compartments of Rena as in the instant claims, the device of Rena is commensurately expected to display the claimed speed of diffusion within and between the first and second compartments, particularly given that the first and second compartments are separated by a greater distance through the first chamber, thereby having slower diffusion than fluid merely diffusing within each of the compartments.), as in Claim 10.
Regarding Claim 11, the prior art meets the limitations of Claim 1 as discussed above. Further, Rena teaches the analysis device discussed above further comprising:
a first protrusion impeding a liquid flow flowing in to the first compartment (See Fig. 1 showing protrusion of the thin film 111A extending across the opening housing the first pore, the protrusion narrowing the pore and thereby impeding a liquid flow flowing in to the first compartment.), as in Claim 11.
Regarding Claim 12, the prior art meets the limitations of Claim 1 as discussed above. Further, Rena teaches the analysis device discussed above further comprising a first compartment opening portion 117 allowing a size of the first opening to become smaller than a size of the second opening by covering a part of an opening portion of the first compartment (See Fig. 9 showing the actuatable member 117 which when inserted into the common tank/second compartment 104 covers a part of an opening portion in the substrate (above the pore) of the first compartment allowing the opening to become smaller in size and the flow to be impeded.), as in Claim 12.
Regarding Claim 13, the prior art meets the limitations of Claim 1 as discussed above. Further, Rena teaches the analysis device discussed above wherein hydrophilicity of a side wall of the first compartment is lower than hydrophilicity of a side wall of the second compartment (The recitation provides for a mere qualitative requirement of the comparative hydrophilicity of the sidewalls. No two structures, even when coated with an identical hydrophilic coating, have identical hydrophilicity down to an infinitesimal number of significant figures. As such, the broad, qualitative aspect of merely having differing hydrophilicity is accounted for by mere manufacturing discrepancies among the wells. The prior art appears to lack a structure of Applicant’s seeming intent of significantly different hydrophobicity/hydrophilicity. Applicant should claim the particular coatings or structure which accounts for the difference so as to progress the case towards allowance.), as in Claim 13.
Regarding Claim 14, the prior art meets the limitations of Claim 1 as discussed above. Further, Rena teaches the analysis device discussed above wherein it is configured that viscosity of liquid filled within the first compartment before feeding the biological sample to the first compartment becomes higher than viscosity of liquid filled within the second compartment before feeding the biological sample to the second compartment (Given that, as discussed above, the flow from the second chamber fills the compartments in a sequential fashion, it would be expected that fluid reaching the first compartment would be a higher viscosity than fluid reaching the second compartment because, in a pipe, the fluid’s velocity is highest at the center and lowest at the walls due to viscous drag, thus a fluid reaching a terminal (end) compartment will have a higher viscosity within the terminal compartment as the core fluid flows intot he terminal compartment but bypasses earlier compartments along the pipe.), as in Claim 14.
Regarding Claim 15, the prior art meets the limitations of Claim 1 as discussed above. Further, Rena teaches the analysis device discussed above further comprising:
a computation unit 130 (“The measurement value of the ammeter 121 is output to the computer 130.”) analyzing the biological sample using a blockage current value generated when the biological sample passes through a pore (“the DNA strand 116 is introduced into the plurality of nanopores at a desired speed, and the blocking current is measured by the plurality of individual electrodes 115B”), wherein the computation unit analyzes the biological sample using a current value obtained by summing the blockage current value of the time when the biological sample passes through the first pore and the blockage current value of the time when the biological sample passes through the second pore (The recitation “the computation unit analyzes” is drawn to a process recitation. As the claims are drawn to a device, such process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II). Herein, the commensurately structured pores and computer of Rena are fully capable of performing the claimed process. Applicant may wish to amend the claims to recite “the computation unit is configured to analyze” so as to satisfy the configured/programmed to language required for patentable weight in a computer-implemented process.), as in Claim 15.
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Rena in view of Akeson et al. (US PAT 6,267,872 B1), hereinafter “Akeson”.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Rena does not specifically teach the analysis device discussed above wherein the first compartment has a shape becoming narrower from the first pore toward an opening portion of the first compartment, and the second compartment has a shape becoming narrower from an opening portion of the second compartment toward the second pore, as in Claim 7.
However, Akeson teaches a respective electrode pore DNA sequencing device (“For example, a single stranded nucleic acid may be translocated through the nanopore and the effect of each base on the current flowing through the nanopore monitored and recorded. From the resultant recorded current fluctuations, the base sequence of the nucleic acid can be determined.”) wherein a first compartment 4 (“conical aperture capping element 4”) has a shape becoming narrower from the first pore toward an opening portion of the first compartment 4, and a second compartment 2 has a shape becoming narrower from an opening portion of the second compartment 2 toward the second pore (See Fig. 1.). Therein, such cis and trans compartment arrangements (“The subject devices comprise cis and trans chambers connected by an electrical communication means.”) are common in the art of pore electrode DNA sequencing primarily due to the distinct electrical properties of different nucleotide bases. The cis side is the anode, where the DNA moves towards, and the trans side is the cathode, where the DNA moves away. The electric field disrupts the ionic current across the nanopore, causing a characteristic pattern of current changes that can be detected and interpreted to determine the nucleotide sequence. Thus, it would be obvious to provide a side where DNA is funneled into a channel such as that of Akeson connecting the chambers so as to funnel DNA into the channel and then funnel the DNA again through the pore electrode arrangement.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Rena wherein the first compartment has a shape becoming narrower from the first pore toward an opening portion of the first compartment, and the second compartment has a shape becoming narrower from an opening portion of the second compartment toward the second pore, such as suggested by Akeson, so as to provide a sequential funneling arrangement for guiding DNA to the pore, or from one pore to another pore as would be implemented in Rena having a multiple-pore configuration where DNA would be released from the substrate.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi, can be reached at telephone number (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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.
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 https://www.uspto.gov/patents/uspto-automated-interview-request-air-form.
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 visit 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 need assistance from a USPTO Customer Service Representative, call (800) 786-9199 (IN USA OR CANADA) or (571) 272-1000.
/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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