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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 21-34, in the reply filed on May 20th, 2026 is acknowledged.
Claim Objections
Claim 30 objected to because of the following informalities: The claim recites “by means of acoustic wave, laser, or magnetic” and should be amended to recite “by means of acoustic wave, laser, or magnet” so as to provide the magnetic aspect as a proper noun. Appropriate correction is required.
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:
“an adsorption device to prevent the substrate from bending and contacting with the sample carrier”, as in Claim 27.
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.
“an object plane” as in para. [0093] of the instant specification filed 09/26/2023. ***Additional clarification is needed. See further the 35 USC 112(b) 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 27 and 28 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.
Claims 27 and 28 recite “an adsorption device...to prevent the substrate from bending” which is interpreted above under 35 USC 112(f) as a generic placeholder (“adsorption device”) appended with particular function (“to prevent the substrate from bending”). However, the only corresponding structure to the adsorption device is “an object plane” as recited by Claim 28 and Applicant’s instant specification. Therein, the “an object plane” is not considered as a particular structure as a “plane” is a mere designation of space or depth of field, such as the viewing planes of a microscope having different depths. As such, the adsorption device remains as indefinitely defined. It appears Applicant intends the object plane to be a surface; however, this is not supported by the specification.
Claim 28 recites that the substrate is adsorbed by the adsorption device (“adsorbing the substrate by an adsorption device to prevent the substrate from bending”). However, adsorption is a process taking place between a surface and a liquid through adhesion forces of the liquid (the process by which a solid holds molecules of a gas or liquid or solute as a thin film). It appears Applicant intends each of the substrate and adsorption device to be independently adsorbed to the liquid layer and, if this is the case, Applicant is recommended to amend the claim accordingly.
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.
Claims 15-17, 22, 25-27, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lemme et al. (US 2006/0019302 A1), hereinafter “Lemme”.
Regarding Claim 15, Lemme teaches a biochemical substance analysis method ([0002]: “a method and apparatus for automated staining of biological samples”), comprising:
controlling a substrate 101 to move towards a reaction platform 60 (See Fig. 6 and [0037]: “A further embodiment shown in FIG. 6 is to oscillate a surface over a membrane that can be changed from one slide to another, as show in FIG. 6 where 101 is a membrane that can be changed from one slide to the next by unrolling from storage drum 103 and pulled onto take-up drum 102. During operation, rolling cap 104 translates and rolls along the slide, held off by spacer lips, 105 which are about 50 microns plus the thickness of the membrane high and are equivalent in function to the sliding guides 21 and 22 of FIGS. 1, 2 and 4. The advantages of this embodiment include being able to use a fresh contact surface on alternate runs, thereby minimizing cross contamination of reagents.”),
wherein the reaction platform 60 comprises a sample carrier 60 carrying samples 50 (See Fig. 2 and [0031]: “Biological sample or tissue 50 is adhered to the slide 60...”);
controlling the substrate 101 to pass over the reaction platform 60 and transfer a liquid with the sample carrier 60 during the substrate 101 passing over the sample carrier 60 ([0010]: “contacting a biological sample suspected of containing a biomarker with a solution containing a conjugate biomolecule” – By this, the “contact” seen through Fig. 6 and [0037] is interpreted as transfer a liquid (the solution containing a conjugate biomolecule) with the sample carrier 60 during the substrate 101 passing over the sample carrier 60 (rolling and passing over the slide).),
in a first condition that the substrate 101 carries the liquid, transferring the liquid from the substrate 101 to the sample carrier 60 during the substrate 101 passing over the sample carrier 60; in a second condition that the sample carrier 60 carries the liquid, transferring the liquid from the sample carrier 60 to the substrate 101 during the substrate 101 passing over the sample carrier 60 (As discussed above and in [0037], the flexible membrane substrate transfers a reaction liquid to the sample carrier so as to coat the tissue sample therein with conjugate biomarkers. Further, [0037] discusses an advantage of the reel-based arrangement as providing for reduced cross-contamination, thereby indicating that a liquid is transferred from the sample carrier at the same time as it is being transferred from the substrate, creating a mixture satisfying both the first and second conditions of the claim.);
causing a reaction between the samples and the liquid on the sample carrier 60 after the first condition ([0022]: “The term “conjugate biomolecule” is used to describe any biomolecule that has an ability to specifically locate and bind to its complementary surface. Examples include an antibody which specifically binds to its complementary epitope, an RNA or DNA probe which hybridizes to its complementary sequence under hybridizable conditions, or a chemical stain which preferentially stains a particular protein such as keratin.” – Such hybridizations are a reaction between the samples and the liquid on the sample carrier. Additionally, as the tissue sample in Lemme is carried on the sample carrier 60 for later detection, the reaction takes place on the sample carrier commensurately as claimed. – See further [0035] specifically discussing particular reaction conditions.); and
detecting the samples after the reaction on the sample carrier 60 is complete ([0025]: “This method is applicable to other common Immunohistochemical processes such as deparaffinization, antigen retrieval, and detection (cell conditioning).” – Further, [0024] describes the biomarkers discussed as being able to be detected. Therein those discussions of paras. [0024-0025], one of ordinary skill in the art would see that Lemme reasonably suggests a detection step subsequent to the biomarker incubation time discussed in para. [0026].),
as in Claim 15.
Regarding Claim 16, the prior art meets the limitations of Claim 15 as discussed above. Further, Lemme teaches the method discussed above wherein, after causing the reaction between the samples and the liquid, further comprises: transferring the sample carrier 60 to a detection device; and detecting the samples after the reaction is complete by the detection device (As discussed above regarding Claim 15, given the general discussions in Lemme of staining the sample with a detection molecule, incubating the detection molecule and the sample for a time under particular incubation conditions, and the specific disclosure of use of the method for cell detection as in para. [0025], one of ordinary skill in the art would reasonably conclude that Lemme suggests detection of the biomarker/conjugate biomolecule complex through common histology methods such as fluorescence microscopy. – Para. [0005] further discusses the use of fixatives to preserve the tissue sample for future analysis, thereby indicating transfer of the carrier to a detector.), as in Claim 16.
Regarding Claim 17, the prior art meets the limitations of Claim 15 as discussed above. Further, Lemme teaches the method discussed above wherein, before controlling the substrate 101 to pass over the reaction platform 60 and transfer the liquid with the sample carrier 60, further comprising: disposing the liquid on the substrate 101 or on the sample carrier 60 (As the conjugate biomolecule-containing liquid of the substrate 101 is transferred to stain the sample held on the sample carrier 60, as discussed above regarding Claim 15, is transferred at the time of use (passing over) of the liquid on the substrate 101 film, the liquid must have been disposed on the substrate before controlling the substrate to pass over the reaction platform and transfer the liquid with the sample carrier.), as in Claim 17.
Regarding Claim 22, the prior art meets the limitations of Claim 17 as discussed above. Further, Lemme teaches the method discussed above wherein disposing the liquid on the substrate or on the sample carrier comprises: disposing the liquid on the substrate by coating, printing, or spraying; disposing the liquid on the substrate or on the sample carrier comprises: disposing the liquid on the sample carrier by coating or spraying (As the liquid applied to the substrate 101 (Fig. 6) forms a coating covering a portion of the substrate 101, the liquid must have been disposed by coating so as to coat at least a portion of the surface of the substrate 101 with the liquid, wherein “coating” is given its broadest reasonable interpretation as merely applying the liquid to the surface in some way.), as in Claim 22.
Regarding Claim 25, the prior art meets the limitations of Claim 15 as discussed above. Further, Lemme teaches the method discussed above wherein, when controlling the substrate 101 to pass over the reaction platform 60 and transfer the liquid with the sample carrier 60, further comprising: controlling a spacing between the substrate 101 and the sample carrier 60 be greater than zero and less than a sum of a thickness of a liquid on the substrate 101 and a thickness of a liquid on the reaction platform 60 ([0037]: “During operation, rolling cap 104 translates and rolls along the slide, held off by spacer lips, 105 which are about 50 microns plus the thickness of the membrane high and are equivalent in function to the sliding guides 21 and 22 of FIGS. 1, 2 and 4.” – As the meniscus 40 (Fig. 6) is formed by contacting the upper liquid with the lower liquid, the spacing provided by the spacer rings 105 must be a spacing of less than a sum of a thickness of a liquid on the substrate and a thickness of a liquid on the reaction platform, otherwise the liquids would not touch for form the meniscus 40. Further, as the spacing allows the substrate and sample carrier not to touch ([0018]), the spacing must be greater than zero.), as in Claim 25.
Regarding Claim 26, the prior art meets the limitations of Claim 25 as discussed above. Further, Lemme teaches the method discussed above wherein controlling a spacing between the substrate 101 and the sample carrier 60 be greater than zero and less than a sum of a thickness of a liquid on the substrate 101 and a thickness of a liquid on the reaction platform 60 comprises: disposing at least one spacer 105 facing towards the substrate 101 on the reaction platform 60, thereby creating the spacing between the substrate 101 and the reaction platform 60 (See Fig. 6 and [0037]: “During operation, rolling cap 104 translates and rolls along the slide, held off by spacer lips, 105 which are about 50 microns plus the thickness of the membrane high and are equivalent in function to the sliding guides 21 and 22 of FIGS. 1, 2 and 4.”), as in Claim 26.
Regarding Claim 27, the prior art meets the limitations of Claim 15 as discussed above. Further, Lemme teaches the method discussed above wherein during controlling the substrate 101 to pass over the reaction platform 60 and transfer the liquid with the sample carrier 60, furthering comprises: adsorbing the substrate 101 by an adsorption device 104 to prevent the substrate 101 from bending and contacting with the sample carrier 40 (See Fig. 6 showing the membrane 101 being “adsorbed” against the roller 104 in as much as is claimed and required herein by preventing the membrane 101 from bending and contacting the slide 60.), as in Claim 27.
Regarding Claim 29, the prior art meets the limitations of Claim 15 as discussed above. Further, Lemme teaches the method discussed above wherein a thickness of the liquid disposed on the substrate 101 is less than 200 microns (See Figs. 4 and 6, and [0018]: “With respect to the figures generally, there is placed over the microscope slide 60 a curved surface 30 in close proximity, about 10-100 microns, from the slide surface.” – The “curved surface” is also suggested to be provided by the membrane-based embodiment of Fig. 6 and [0037].), as in Claim 29.
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.
Claims 18-21 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Lemme in view of Kram (US 2005/0164374 A1), hereinafter “Kram”. Lemme has been discussed above.
Regarding Claim 18, the prior art meets the limitations of Claim 1 as discussed above. Further, Lemme does not specifically teach the method discussed above wherein disposing the liquid on the substrate or on the sample carrier comprises:
disposing a plurality of liquid segments on the substrate according to a preset time sequence, as in Claim 18.
However, Kram teaches a respective tape-based liquid transfer method wherein a plurality of reagents are dispensed onto a tape in a particular preset time sequence so as to introduce different reagents to the sample at their respective required times, so as to allow for more complex reaction processes, such as sequential tissue staining steps performed by a pathologist ([0015]: “A biological tissue sample is finally viewed by a pathologist in an as-mounted state on a glass slide. Much of the processing of biological specimens, therefore, is adapted to the sequential application and removal of multiple fluids to an essentially two dimensional treatment zone on a 1″×3″ glass slide format.” – See paras. [0086-0088] discussing treatment sequence examples. – See para. [0103] discussing the specific reel-based dispensing of reagent droplets. – See further para. [0101] discussing the benefit of such a reagent droplet arrangement minimizing the amount of liquid used throughout the process.).
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 method of Lemme wherein disposing the liquid on the substrate or on the sample carrier comprises: disposing a plurality of liquid segments on the substrate according to a preset time sequence, such as suggested by Kram, so as to enable more complex reaction steps to be performed, such as cell or tissue sample staining sequences, and to minimize the amount of liquid used during a run.
Regarding Claim 19, the prior art meets the limitations of Claim 18 as discussed above. Further, Lemme does not specifically teach the method discussed above wherein disposing the plurality of liquid segments on the substrate according to a preset time sequence comprises:
disposing the plurality of liquid segments connected end to end in sequence, as in Claim 19.
However, merely making integral as one piece what exists in the prior art as separate pieces absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04 (V)(B). Therein, whether the droplets are connected end-to-end as claimed, or merely have a small gap between the droplets, the function of transferring the droplets to the biological sample remains the same, and the reagents are commensurately transferred to the sample whether or not they are connected end-to-end. Further, the claim does not indicate any mixing among the segments, merely that they be in end-to-end contact, thereby representing a mere matter of integral vs separate. Thus, without a showing of criticality or unexpected results, the end-to-enc connection of the segments cannot be considered critical.
Regarding Claim 20, the prior art meets the limitations of Claim 19 as discussed above. Further, Lemme does not specifically teach the method discussed above wherein the plurality of liquid segments comprises a plurality of buffer reagent segments and a plurality of reaction reagent segments, wherein two adjacent of the plurality of reaction reagent segments distributed in the substrate are connected by one of the plurality of buffer reagent segments, a head end and a tail end of the corresponding one of the plurality of buffer reagent segments are overlapped with ends of the two of the plurality of reaction reagent segments, respectively, as in Claim 20.
However, as discussed above, the head-to-tail connection aspect of the reagent segments cannot be considered critical as a mere matter of making integral vs separate, and is commensurately applied to the overlapping aspect of the instant Claim 20. Further, Kram teaches a plurality of reagents dispensed onto the tape, wherein the claimed terms “buffer reagent segments” and “reaction reagent segments” merely amount to nominal segments, wherein the nominal portions “buffer reagent” and “reaction reagent” hold no particular patentable weight to actually being a buffer or reaction reagent. Therefore, the varying reagents of Kram, such as those discussed in paras. [0086-0087] satisfy the limitations of separate, different reagents being disposed on the membrane reel.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the method of Lemme wherein two separate and distinct reagents are dispensed in sequence, such as suggested by Kram, so as to provide all the necessary reagents for a particular assay intended by an operator.
Regarding Claim 21, the prior art meets the limitations of Claim 17 as discussed above. Further, Lemme does not specifically teach the method discussed above wherein disposing the liquid on the substrate or on the sample carrier comprises:
disposing the liquid on the substrate during the substrate is moving, as in Claim 21.
However, Kram Fig. 13B shows the dispenser 92 disposing the droplet onto the membrane 86 as the substrate is moving, as is reasonably suggested by the leftward-pointing arrows indicating advancement of the membrane 86 and the arror about the feed roller 88 indicating it is actively unwound while the dispenser 92 dispenses the droplet. Therein, this arrangement would be expected to save time and thereby increase throughput of the method.
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 method of Lemme wherein disposing the liquid on the substrate or on the sample carrier comprises: disposing the liquid on the substrate during the substrate is moving, such as suggested by Kram, so as to improve the throughput of the device.
Regarding Claim 31, the prior art meets the limitations of Claim 15 as discussed above. Further, Lemme does not specifically teach the method discussed above wherein in a condition that the liquid carried on the substrate is an aqueous coating, the substrate is made of a hydrophilic material; and in a condition that the liquid carried on the substrate is an oil paint, the substrate is made of a lipophilic material, as in Claim 31.
However, Kram provides guidance on substrate material selection with respect to hydrophobicity/hydrophilicity so as to maximize spreading of the fluid reagent on the substrate (See [0036-0043] regarding hydrophobic/hydrophilic, and see also [0018, 0060] discussing spreading of the liquid as a preferred effect.). Therein, spreading of the liquid provides for more even transfer to the sample, and allows for minimal reagent use as a thin layer may be spread onto a surface ([0105]).
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 method of Lemme wherein in a condition that the liquid carried on the substrate is an aqueous coating, the substrate is made of a hydrophilic material; and in a condition that the liquid carried on the substrate is an oil paint, the substrate is made of a lipophilic material, thereby matching the hydrophobicity/hydrophilicity to that of the sample as suggested by Kram, so as to provide for more even transfer to the sample, and allow for minimal reagent use as a thin layer may be spread onto a surface.
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Lemme in view of Kram, as applied to Claims 18-21 and 31 above, and in further view of Pepper et al. (Pepper, M.E., et al.; “Precision Staining of Histological Samples Using Thermal Inkjet Technology”, Department of Electrical Engineering, Department of Bioengineering, & Institute for Biological Interfaces of Engineering Clemson University, Clemson, South Carolina, Society for Biomaterials Annual Conference, 2010.), hereinafter “Pepper”.
Regarding Claim 23, the prior art meets the limitations of Claim 22 as discussed above. Further, Lemme/Kram does not specifically teach the method discussed above wherein disposing the liquid on the substrate or on the sample carrier comprises:
disposing the liquid on the substrate by a liquid arrangement device, the liquid arrangement device comprises a liquid outlet mechanism, the liquid outlet mechanism is a die head, and the die head arranges the liquid by coating, as in Claim 23.
However, Pepper teaches a respective method wherein the staining is performed by a thermal liquid outlet mechanism of a die head (printhead) which arranges the liquid by printing a coating (See Fig. 1 and the “Methods” section.). Therein, such a method allows for reduced reagent volume use and greater precision over reagent deposition (See the “Introduction” section.).
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 method of Lemme/Kram wherein disposing the liquid on the substrate or on the sample carrier comprises: disposing the liquid on the substrate by a liquid arrangement device, the liquid arrangement device comprises a liquid outlet mechanism, the liquid outlet mechanism is a die head, and the die head arranges the liquid by coating, such as suggested by Pepper, so as to allow for minimized reagent use, thereby saving costs, and increased precision of reagent deposition.
Regarding Claim 24, the prior art meets the limitations of Claim 22 as discussed above. Further, Lemme/Kram does not specifically teach the method discussed above wherein disposing the liquid on the substrate or on the sample carrier comprises:
disposing the liquid on the substrate by a liquid arrangement device, the liquid arrangement device is a printing device, an anilox roller, or a screen printing device, as in Claim 24.
However, as discussed above regarding Claim 23, Pepper teaches disposing liquid on a substrate using a printing device (printhead) so as to reduce reagent use and improve reagent deposition precision (See Fig. 1, Introduction, Methods.).
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 method of Lemme/Kram wherein disposing the liquid on the substrate or on the sample carrier comprises: disposing the liquid on the substrate by a liquid arrangement device, the liquid arrangement device is a printing device, such as suggested by Pepper, so as to allow for minimized reagent use, thereby saving costs, and increased precision of reagent deposition.
Claims 28 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Lemme in view of Tanley et al. (WO 2018/119289 A1), hereinafter “Tanley”. Lemme has been discussed above.
Regarding Claim 28, the prior art meets the limitations of Claim 15 as discussed above. Further, Lemme does not specifically teach the method discussed above wherein the adsorption device is an object plane, the object place comprises a surface in contact with the substrate, and the surface of the object plane is coated with a liquid layer and is in parallel with a movement direction of the substrate; and adsorbing the substrate by an adsorption device to prevent the substrate from bending and contacting with the sample carrier comprises:
adsorbing the substrate by the liquid layer on the object plane to prevent the substrate from bending and contacting with the sample carrier, as in Claim 28.
However, Tanley teaches a respective reel-tape reagent coating apparatus for coating a film 370 with a coating 390, wherein the spacing between an adsorption device (slot die) 310 is provided by an elastohydrodynamic force, wherein such force is created by adsorption of the fluid onto the respective substrate tape reel and the die head ([0156]: “the web material passing proximate to the slot die is kept from contact with the slot die only by the elastohydrodynamic force created by the metering of the fluid coating material from the slot die onto the web material”). Therein, such an arrangement represents a mere obvious alternative that of Lemme wherein the identical function of keeping a substrate at a set distance from a sample remains the same.
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 method of Lemme wherein the adsorption device is an object plane, the object place comprises a surface in contact with the substrate, and the surface of the object plane is coated with a liquid layer and is in parallel with a movement direction of the substrate; and adsorbing the substrate by an adsorption device to prevent the substrate from bending and contacting with the sample carrier comprises: adsorbing the substrate by the liquid layer on the object plane to prevent the substrate from bending and contacting with the sample carrier, such as suggested by Tanley, as a mere obvious alternative to the distance-keeping rollers of Lemme achieving the identical function of maintaining a distance between a film and an object against which the film is pressed.
Regarding Claim 34, the prior art meets the limitations of Claim 15 as discussed above. Further, Lemme does not specifically teach the method discussed above wherein the substrate is a coiled material, and the substrate is corona polyethylene terephthalate film, polystyrene film, or polyethylene film, as in Claim 34.
However, Tanley teaches its flexible membrane film tape as being polyethylene or polystyrene ([0084]), so as to provide sufficient materials for providing the sought thin and flexible, yet stretchable and compressible tape for bending over a sample and sample carrier.
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 method of Lemme wherein the substrate is a coiled material, and the substrate is polystyrene film or polyethylene film, such as suggested by Tanley, so as to provide a sufficient material for achieving the desired film properties of thinness and strength while maintaining its structural integrity when stretched and compressed against/above a sample as in Lemme.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Lemme in view of Lopez et al. (EP 3543371 A1), hereinafter “Lopez”. Lemme has been discussed above.
Regarding Claim 30, the prior art meets the limitations of Claim 15 as discussed above. Further, Lemme does not specifically teach the method discussed above wherein during controlling the substrate to pass over the reaction platform and transfer the liquid with the sample carrier, further comprises:
accelerating the liquid transfer between the substrate and the sample carrier by means of acoustic wave, laser, or magnetic, as in Claim 30.
However, Lopez teaches a respective reel-tape liquid transfer system wherein a laser beam 19 accelerates transfer of a fluid of a reel of a tape 2 to a substrate 4 (See Fig. 4 and [0009]: “The present specification describes a system for continuous laser-induced forward transfer of material, where the material to be transferred, deposited onto a donor substrate, transparent to the laser radiation, is transferred to a receiving substrate by laser radiation focused on the interface between the material to be transferred and the donor substrate.”). Therein, this arrangement allows the sample to be kept “as far from the donor substrate as necessary, enables a large actuation surface to be had” ([0002]).
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 method of Lemme wherein during controlling the substrate to pass over the reaction platform and transfer the liquid with the sample carrier, further comprises: accelerating the liquid transfer between the substrate and the sample carrier by means of laser, such as suggested by Lopez, so as to allow the substrate to be kept further from the sample, thereby reducing risks of crushing the sample, and provides for a larger actuation surface of the flexible substrate.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Lemme in view of Wiktor et al. (Wiktor, P., Brunner, A., Kahn, P. et al. Microreactor Array Device. Sci Rep 5, 8736 (2015).), hereinafter “Wiktor”. Lemme has been discussed above.
Regarding Claim 32, the prior art meets the limitations of Claim 15 as discussed above. Further, Lemme does not specifically teach the method discussed above wherein during causing the reaction between the samples and the liquid on the sample carrier after the first condition, further comprises:
pushing the substrate to the reaction platform to seal between the substrate and the reaction platform thereby preventing the liquid from evaporation, as in Claim 32.
However, Wiktor teaches a respective reaction device wherein a membrane (sealing membrane) is actuated/pushed to seal a fluid volume added to a sample carrier reaction platform (microreactor array slide) (See Fig. 1B and the “Introduction section”), wherein this arrangement is suggested by Wiktor as being beneficial for avoiding evaporation (See the “Experimental evaluation of fill & seal methods” section: “The image illustrate fidelity of the microreactor array platform with density greater than 10,000 protein spots expressed on a single microscope slide format with no diffusion or evaporation during three hours incubation.”.).
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 method of Lemme wherein during causing the reaction between the samples and the liquid on the sample carrier after the first condition, further comprises: pushing the substrate to the reaction platform to seal between the substrate and the reaction platform, such as suggested by Wiktor, so as to reduce evaporation from the reaction platform, thereby minimizing measurement errors related to over-concentrated sample solutions.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Lemme in view of Pursche et al. (US 2014/0051265 A1), hereinafter “Pursche”. Lemme has been discussed above.
Regarding Claim 33, the prior art meets the limitations of Claim 15 as discussed above. Further, Lemme does not specifically teach the method discussed above wherein the reaction platform is a movable platform, before causing the reaction between the samples and the liquid on the sample carrier after the first condition, further comprises:
controlling the reaction platform to move away from or closer to the substrate according to a temperature required to cause the reaction between the samples and the liquid, as in Claim 33.
However, Pursche teaches an apparatus for thermal treatment of substrate 3, wherein the “apparatus comprises at least one substrate carrier for supporting a substrate, a heating unit having at least one heating element for heating a substrate located on the substrate carrier and at least one heating element carrier for supporting the at least one heating element. The heating element carrier is designed to allow a local change in distance between the substrate carrier and the heating element, so as to be able to provide locally different heating intensities. In the method such a change in distance is carried out during the thermal treatment.”, thereby allowing the device to be used as a continuous furnace/oven to allow for more rapid heating ([0005-0006]) at a required target temperature for a process to occur.
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 method of Lemme wherein the reaction platform is a movable platform, before causing the reaction between the samples and the liquid on the sample carrier after the first condition, further comprises: controlling the reaction platform to move away from or closer to the substrate according to a temperature required to cause the reaction between the samples and the liquid, such as suggested by Pursche, so as to allow for more rapid and continuous heating to a predetermined target temperature for a desired process to occur, wherein Lemme discloses incubation at such a particular temperature ([0005]).
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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