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 .
Information Disclosure Statement
It is noted that an information disclosure statement (IDS) was not included in the electronic file wrapper of the instant application. Applicant is reminded of the duty to disclose information material to patentability as defined by 37 C.F.R. 1.56 (also see MPEP 2001).
Election/Restrictions
Applicant's election of Group I, Claims 1-8 and 20-22, without traverse in the reply filed on 09/08/2025 is acknowledged.
Claim Objection
Claims 1, 3, 6, and 20-22 are objected to because of the following informalities:
Claim 1: please amend “comprising,” in line 1 to –comprising[[,]]:--; “the water binding material” to -- the at least one water binding material--.
Claim 3: please amend “a concentrated sample” to – [[a]] the concentrated sample--.
Claim 6: please amend “a water binding material” to -- [[a]] the at least one water binding material--.
Claims 20-21: please amend “comprising,” in line 1 to –comprising[[,]]:--.
Claim 21: please amend “the final volume” to -- [[the]] a final volume --.
Claim 22: please amend “provide passage of water through the permeable membrane into the active reservoir” to -- provide the passage of water through the permeable membrane into the active reservoir --; “cause the water to bind to the water binding material and” to -- cause the water to bind to the water binding material, and--.
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.
Claim 4, “an adjusting mechanism in communication with the active and sample reservoirs and is configured to control the insertion depth of the active reservoir”, is being interpreted under 35 U.S.C. 112(f) . Prong 1: an adjusting mechanism (uses the generic placeholder), prong 2: configured to control the insertion depth of the active reservoir (functional language), prong 3: sufficient structure for performing the function not recited. Therefore, claim 4 invokes 112(f). A threaded contact region between the active and sample reservoirs for performing the functions is shown in Figs. 2, 4, and 5.
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 2 and 4-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Regarding claim 2, claim 2 recites “the active reservoir includes a plurality of orifices and a permeable membrane covering each of the plurality of orifices”. It is unclear if “a plurality of orifices” is the same as or different than “at least one orifice” of claim 1. It is unclear if “a permeable membrane” of claim 2 is the same as or different than “a permeable membrane” of claim 1. Also it is unclear if claim 2 requires one permeable membrane that covers all of the orifices, or if each orifice is covered by a different permeable membrane. Therefore, the scope of claim 2 is indefinite.
Regarding claim 4, claim 4 recites “the insertion depth”, which lacks antecedent basis. Therefore, the scope of claim 4 is indefinite.
Regarding claim 5, claim 5 recites “wherein the sample reservoir utilized includes an optional sample reservoir having a reduced volume”, which is unclear if the sample reservoir having a reduced volume is optional or required. Furthermore, it is unclear if a “reduced” volume is relative to the volume of the sample reservoir or the volume of the active reservoir. Therefore, the scope of claim 5 is indefinite.
Regarding claim 6, claim 6 recites “a super absorbent polymer”, the term “super absorbent” is a relative term which renders the claim indefinite. The term “super absorbent” 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. In this instant claim, it is unclear what is the amount of liquid that can be absorbed or retained be considered as super absorbent.
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 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.
(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.
Claims 1, 5-6, and 20-21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Indriksons et al. (US5770086A).
Regarding claim 1, Indriksons teaches a device for concentrating liquids (Figs.3A-3B show a device for concentrating liquids introduced into the opening 30a of the cartridge [Col. 5 Ln 59 -Col. 6 Ln 42]) comprising:
a sample reservoir (reservoir of the upper shell 31 in Fig.3B [Col.5 Ln 60-62]) and an active reservoir (reservoir of the lower shell 32 in Fig.3B [Col.5 Ln 60-62]) ,
wherein the active reservoir includes at least one orifice (upper open top of the lower shell 32 in Fig.3B which is covered by a porous supporting substrate 35, a hydrogel-forming polymer 34, and a porous membrane 33 [Col. 6 Ln 4-35]) and a permeable membrane (porous membrane 33/hydrogel-forming polymer 34/porous supporting substrate 35 together is deemed as the permeable membrane) covering the at least one orifice (see Fig.3B) and contains at least one water binding material therein (collapsible sponge or cellular foam member 36 which supports the hydrogel-forming polymer against the porous membrane 33 and allows its expansion as it absorbs liquid [Col. 6 Ln 14-17]; hydrogel-forming polymer 34 absorbs and traps liquids [Col. 6 Ln 11-12]),
wherein the sample reservoir includes at least one orifice (lower open bottom of the upper shell 31 in Fig. 3B) and is configured to receive an aqueous sample (liquids are introduced into the opening 30a [Col. 6 Ln 34-35]), to removably receive the active reservoir therein (For convenience in assembly, the lower skirt portion 31a of the lower shell 31 is formed with an annular groove 31b on its inner surface, and the lower shell 32 is formed with a mouth-forming portion 32a including an annular protuberance 32b so that the upper and lower shells can be snapped together as an assembly with protuberance 32b and groove 31b engaging to fasten the cartridge shells 31 and 32 together [Col. 5 Ln 62-Col. 6 Ln 3]), and to provide contact between the aqueous sample and the permeable membrane (the porous membrane 33 frequently carries one member of an antigen/antibody pair of interest which is exposed to a liquid sample, and other liquids poured into the opening 30a of the cartridge [Col. 6 Ln 5-8]),
and the limitation “wherein the active reservoir is configured to receive, through the permeable membrane, an aqueous portion of the sample from the sample reservoir, retain at least some of the aqueous portion received by the water binding material, and provide a concentrated sample in the sample reservoir” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Indriksons teaches the active reservoir of the lower shell 32 as shown in Fig. 3B configured to receive, through the permeable membrane, an aqueous portion of the sample from the sample reservoir (the hydrogel powder 34 is supported by a porous plastic disc 35, which is in turn supported by a water soluble starch plug 36 [Col. 6 Ln 28-31]; the hydrogel-forming polymer 34 absorbs and traps liquids that pass through the porous substrate 33; collapsible sponge or cellular foam member 36 which supports the hydrogel-forming polymer against the porous membrane 33 allows its expansion as it absorbs liquid [Col. 6, Ln 11-17]), retain at least some of the aqueous portion received by the water binding material (collapsible sponge or cellular foam member 36 which supports the hydrogel-forming polymer against the porous membrane 33 allows its expansion as it absorbs liquid [Col. 6, Ln 11-17]), and provide a concentrated sample in the sample reservoir (Examples 3-6 show a concentrated sample due to the hydrogel-forming polymer [Col. 7 Ln 37 to Col. 8 Ln 60]; and Example 7 shows the porous plug used to capture liquid in the ICON II cartridge has a physical volume of 16.6 cc and will absorb 12.6 cc of liquid; 75.9 percent of its physical volume [Col. 9 Ln 42-44]. Sample is concentrated in the sample reservoir because the porous plug absorbs a large amount of liquid, which reduces the volume of the aqueous portion of the sample in the sample reservoir and accordingly increases the concentration of the sample in the sample reservoir). Thus, the disclosed active reservoir is configured to perform the claimed functions above.
Regarding claim 5, Indriksons teaches the device of claim 1, wherein the sample reservoir utilized includes an optional sample reservoir having a reduced volume (since the claimed sample reservoir having a reduced volume is “optional”, the limitation has no patentable weight).
Regarding claim 6, Indriksons teaches the device of claim 1, wherein the active reservoir includes the water-binding material selected from the group consisting of a hydrogel or a super absorbent polymer (hydrogel-forming polymer 34 absorbs and traps liquids [Col. 6 Ln 11-12]).
Regarding claim 20, Indriksons teaches a device for concentrating liquids (Figs.3A-3B show a device for concentrating liquids introduced into the opening 30a of the cartridge [Col. 5 Ln 59 -Col. 6 Ln 42]) comprising:
a sample reservoir (reservoir of the upper shell 31 in Fig.3B [Col.5 Ln 60-62]) and an active reservoir (reservoir of the lower shell 32 in Fig.3B [Col.5 Ln 60-62]) ,
wherein the sample reservoir is configured to receive an aqueous sample for concentration (liquids are introduced into the opening 30a [Col. 6 Ln 34-35]) and to receive the active reservoir therein (For convenience in assembly, the lower skirt portion 31a of the lower shell 31 is formed with an annular groove 31b on its inner surface, and the lower shell 32 is formed with a mouth-forming portion 32a including an annular protuberance 32b so that the upper and lower shells can be snapped together as an assembly with protuberance 32b and groove 31b engaging to fasten the cartridge shells 31 and 32 together [Col. 5 Ln 62-Col. 6 Ln 3]),
wherein the active reservoir is constructed of a permeable membrane having a water binding material therein (porous membrane 33/hydrogel-forming polymer 34/porous supporting substrate 35 in Fig.3B together is deemed as a permeable membrane having a water binding material [hydrogel-forming polymer 34]; hydrogel-forming polymer 34 absorbs and traps liquids [Col. 6 Ln 11-12]), and a predetermined volume (the active reservoir of the lower shell 32 as shown in Fig.3B inherently has a predetermined volume determined by the volume of the lower shell 32 and the volume of the collapsible sponge or cellular foam member 36),
the limitation “that is configured to control a final volume of an aqueous portion of the sample to be contained in the sample reservoir when the active reservoir is filled and expanded to a maximum volume” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Indriksons teaches the predetermined volume of the active reservoir which is determined by the volume of the lower shell 32 and the volume of the collapsible sponge or cellular foam member 36 which supports the hydrogel-forming polymer against the porous membrane 33 and allows its expansion as it absorbs liquid [Col. 6, Ln 14-17]. Since the collapsible sponge or cellular foam member 36 absorbs liquid from the aqueous portion of the sample to be contained in the sample reservoir, a final volume of an aqueous portion of the sample to be contained in the sample reservoir decreases as the amount of liquid absorbed from the sample reservoir by the collapsible sponge or cellular foam member 36 increases. Therefore, when the active reservoir is filled and expanded to a maximum volume, the collapsible sponge or cellular foam member 36 could not absorb liquid from the sample reservoir any more, and the final volume of the aqueous portion of the sample to be contained in the sample reservoir reaches steady state and does not change with respect to time. Thus, the predetermined volume of the active reservoir is configured to control a final volume of an aqueous portion of the sample to be contained in the sample reservoir when the active reservoir is filled and expanded to a maximum volume.
Regarding claim 21, Indriksons teaches a device for concentrating liquids (Figs.3A-3B show a device for concentrating liquids introduced into the opening 30a of the cartridge [Col. 5 Ln 59 -Col. 6 Ln 42]) comprising:
a sample reservoir (reservoir of the upper shell 31 in Fig.3B [Col.5 Ln 60-62]) and an active reservoir (reservoir of the lower shell 32 in Fig.3B [Col.5 Ln 60-62]) ,
wherein the sample reservoir is configured to receive an aqueous sample for concentration (liquids are introduced into the opening 30a [Col. 6 Ln 34-35]) and to receive the active reservoir therein (For convenience in assembly, the lower skirt portion 31a of the lower shell 31 is formed with an annular groove 31b on its inner surface, and the lower shell 32 is formed with a mouth-forming portion 32a including an annular protuberance 32b so that the upper and lower shells can be snapped together as an assembly with protuberance 32b and groove 31b engaging to fasten the cartridge shells 31 and 32 together [Col. 5 Ln 62-Col. 6 Ln 3]),
wherein the active reservoir is constructed of a permeable membrane having a water binding material therein (porous membrane 33/hydrogel-forming polymer 34/porous supporting substrate 35 in Fig.3B together is deemed as a permeable membrane having a water binding material [hydrogel-forming polymer 34]; hydrogel-forming polymer 34 absorbs and traps liquids [Col. 6 Ln 11-12]),
wherein the active reservoir is included within a rigid caged structure having openwork and a predetermined volume (Fig.3B shows the active reservoir is included within a rigid caged lower shell 32 having openwork [the lower shell 32 is formed with a mouth-forming portion 32a, Col. 5 Ln 65-66] and a predetermined volume [the active reservoir of the lower shell 32 as shown in Fig.3B has a predetermined volume determined by the volume of the lower shell 32 and the volume of the collapsible sponge or cellular foam member 36]),
the limitation “that is configured to limit a final volume of an aqueous portion of the sample to be contained in the sample reservoir when the active reservoir is filled and expanded to a maximum volume” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Indriksons teaches the predetermined volume of the active reservoir which is determined by the volume of the lower shell 32 and the volume of the collapsible sponge or cellular foam member 36 which supports the hydrogel-forming polymer against the porous membrane 33 and allows its expansion as it absorbs liquid [Col. 6, Ln 14-17]. Since the collapsible sponge or cellular foam member 36 absorbs liquid from the aqueous portion of the sample to be contained in the sample reservoir, a final volume of an aqueous portion of the sample to be contained in the sample reservoir decreases as the amount of liquid absorbed from the sample reservoir by the collapsible sponge or cellular foam member 36 increases. Therefore, when the active reservoir is filled and expanded to a maximum volume, the collapsible sponge or cellular foam member 36 could not absorb liquid from the sample reservoir any more, and a final volume of the aqueous portion of the sample to be contained in the sample reservoir reaches steady state and does not change with respect to time. Thus, the predetermined volume of the active reservoir is configured to limit a final volume of an aqueous portion of the sample to be contained in the sample reservoir when the active reservoir is filled and expanded to a maximum volume.
Claim 22 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dorian et al. (WO2004009207A1).
Regarding claim 22, Dorian teaches a device for concentrating liquids (Figs.3-5 show a device for concentrating plasma concentration from plasma 54 [Ln 16-24 on page 16]) comprising a sample reservoir (plasma syringe 52 in Figs. 3-5 [Ln 17 on page 16]) and an active reservoir (syringe device 30 in Figs. 3-5 [Ln 15-22 on page 15]; Fig.2 shows the syringe device 30 [Ln 15-22 on page 15]),
wherein the sample and active reservoirs are configured to provide passage of water into the active reservoir through a permeable membrane (the active reservoir includes a permeable membrane [filter 38 in Fig.2, Ln 17-18 on page 15] covering the inlet/outlet port 50, and Figs. 3-5 show the inlet/outlet port 50 of the syringe 30 and the inlet/outlet port 58 of the syringe 52 are connected with the coupling 56 [Ln 18-19 on page 16]. Movement of plunger 60 toward the inlet/outlet port 58 displaces the plasma 54 through the coupling and inlet/outlet port 50 and through the filter 38 into contact with the desiccated hydrogel beads 44 to the position shown in Fig. 4. Alternatively, the plunger 36 can be moved away from the filter 38, drawing plasma 54 from the syringe 52 into the concentration chamber 32. Reciprocal motion of the syringes along their vertical axis moves the agitator 46 through the plasma-hydrogel mixture, stirring the mixture to minimize gel polarization and facilitating transfer of water from the plasma into the hydrogel beads 44 [Ln 19-24 on page 16]. Thus, the sample and active reservoirs are configured to provide passage of water into the active reservoir through a permeable membrane),
wherein the active reservoir includes a water binding material (hydrogel beads 44 in Fig.2 [Ln 20-22 on page 15]), and
the limitation “wherein the sample reservoir is configured to: contain an aqueous sample in contact with the permeable membrane, provide passage of water through the permeable membrane into the active reservoir, cause the water to bind to the water binding material, and provide a concentrated sample in the sample reservoir” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Dorian teaches the sample reservoir of plasma syringe 52 as shown in Figs. 3-5 configured to contain an aqueous sample (plasma 54) in contact with the permeable membrane (Movement of plunger 60 toward the inlet/outlet port 58 displaces the plasma 54 through the coupling and inlet/outlet port 50 and through the filter 38 into contact with the desiccated hydrogel beads 44 to the position shown in Fig. 4 [Ln 19-24 on page 16]), provide passage of water through the permeable membrane into the active reservoir (displaces the plasma 54 through the coupling and inlet/outlet port 50 and through the filter 38 into contact with the desiccated hydrogel beads 44 to the position shown in Fig. 4; Reciprocal motion of the syringes along their vertical axis moves the agitator 46 through the plasma-hydrogel mixture, stirring the mixture to minimize gel polarization and facilitating transfer of water from the plasma into the hydrogel beads 44 [Ln 19-24 on page 16]), cause the water to bind to the water binding material (facilitating transfer of water from the plasma into the hydrogel beads 44), and provide a concentrated sample in the sample reservoir (provide a plasma concentrate 62 in the syringe 52 as shown in Fig.5). Thus, the disclosed sample reservoir is configured to perform the claimed functions above.
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 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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Indriksons, as applied to claim 1 above, and in view of Pathak (US20070197776A1).
Regarding claim 3, Indriksons teaches the device of claim 1, and further teaches wherein the hydrogel-forming polymer 34 absorbs and traps liquids that pass through the porous substrate 33 and prevents their reverse flow to the porous substrate 33 (Col. 6 Ln 11-13).
Indriksons is silent to wherein the device is configured to operate to provide a concentrated sample regardless of its orientation since Indriksons is silent to wherein the opening 30a is capped.
Pathak teaches a device for concentrating protein as shown in Fig.6, wherein upper opening of the narrow neck region of the sample reservoir (upper region 16 of the plastic/glass bottle 12) is capped (The bottle is inverted every 10 minutes to separate the concentrated (the filter prevents the hydrogel from entering the narrow neck region. In the narrow neck region (upon inversion), the volume of plasma is measured. When the desired volume is reached, the concentrated plasma is removed using a suitable technique [para. 0074]. Since the bottle is inverted every 10 min, the upper opening of the sample reservoir must be capped).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Indriksons by adding a cap to cover/cap the opening 30a of the sample reservoir after introducing the sample into the sample reservoir, as taught by Pathak, since Pathak teaches capping the liquids (i.e., plasma) in the concentrating device during the concentrating process [para. 0074].
Furthermore, the limitations of a cap to cover/cap the opening of the sample reservoir are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results [MPEP 2143(I)(A)].
With the opening 30a of the sample reservoir being capped after introducing the liquids into the sample reservoir of the modified device, the modified device is configured to operate to provide a concentrated sample regardless of its orientation since the opening 30a is capped, and the hydrogel-forming polymer 34 absorbs and traps liquids that pass through the porous substrate 33 and prevents their reverse flow to the porous substrate 33 regardless of the orientation of the device.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Indriksons, as applied to claim 1 above, and in view of Shapiro et al. (US20240158834A1).
Regarding claim 7, Indriksons teaches the device of claim 1, and is silent to wherein the sample reservoir includes a preservative material configured to preserve and stabilize biological and/or chemical materials added thereto (of claim 7), and wherein the preservative material is selected from the group consisting of osmolytes, polyols, sugars, polymers, amino acids, anionic compounds, cationic compounds, surfactants, biocides, and derivatives of thereof (of claim 8).
Shapiro teaches compositions and methods for biological sample processing (title). Compositions may comprise an additive. Examples of additives include bactericides, biocides, biopolymer degrading agents, bleaching agents, bleaching systems, buffers, chelators, enhancing agents, fungicides, polymers, reagents, salts, preservatives, and stabilizing agents [para. 0196]. Salts may be used to maintain osmolarity of a composition. Exemplary salts used include alkali salt, sodium salt, potassium salt, chloride salt, and acetate salt [para. 0203]. Stabilizing agents may be chosen from polyol or sugar [para. 0209].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample reservoir in Indriksons by adding a preservative material selected from the group consisting of polyols, sugars, polymers, anionic compounds (i.e., buffers), cationic compounds (i.e., buffers), and biocides, as taught by Shapiro, since it would allow to preserve the target analytes in the sample [para. 0003, 0285 in Shapiro].
Allowable Subject Matter
Claims 2 and 4 would be allowable if they are rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter.
Regarding claim 2, Indriksons teaches wherein the active reservoir includes one orifice which is upper open of the lower shell 32, which is snapped with the upper shell 31 as shown in Fig.3B. There does not appear to be any teaching, suggestion or motivation for why one skilled in the art would have the lower shell including a plurality of orifices. It would not be obvious to duplicate the one orifice since it would duplicate the lower shell to provide a plurality of lower shells each having an orifice, then the upper shell and the plurality of duplicated lower shells could not be snapped together.
Regarding claim 4, Indriksons and the prior art of the record does not teach and suggest an adjusting mechanism in communication with the active and sample reservoirs and is configured to control an insertion depth of the active reservoir into the sample reservoir.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
The prior arts made of record and not relied upon are considered pertinent to applicant's disclosure: Nambu et al. (US20220251519A1) teaches a concentration device as shown in Fig.37 comprising a sample reservoir (upper reservoir 20 in Fig.37) and an active reservoir (lower reservoir 20 in Fig.37), wherein the active reservoir includes at least one orifice (upper open top of the lower reservoir 20) and a permeable membrane (membrane 30) covering the at least one orifice (see Fig.37) and contains at least one water binding material therein (hydrophilic resin). Mai (US20170138943A1) teaches a concentration device as shown in Figs. 1-2 comprising a sample reservoir (sample well 30 in Fig.1) and an active reservoir (lower reservoir of the housing 20 wherein the absorbing plug 20 is disposed [para. 0028]), wherein the active reservoir includes at least one orifice (upper open top of the lower reservoir of the housing 20 which is covered by the filter membrane 10) and a permeable membrane (membrane 10) covering the at least one orifice (see Fig.1) and contains at least one water binding material therein (absorbing plug 20 in Fig.1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIZHI QIAN whose telephone number is (571)272-3487. The examiner can normally be reached Monday-Thursday 8:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V. Van can be reached on (571) 272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIZHI QIAN/Examiner, Art Unit 1795