DETAILED ACTION
In application filed on 02/27/2024, Claims 1-11 are pending. The claim set submitted on 02/27/2024 is considered because this is the most recent claim set. Claims 1-11 are considered in the current office 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 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.
Claims 1-6 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by De La Rosa et al. (US20140038172A1).
Regarding Claim 1, De La Rosa teaches a system for stabilizing analytes in blood samples for use in delayed extraction and tests in human and veterinary applications (See Abstract…a device, system, and methods of use comprising an absorbent hydrophobic polyolefin matrix, and methods of use thereof, for storage, preserving, and recovering liquid suspension of biological specimens containing analytes of interest in a dry state), said system comprising:
a device for holding a blood sample (See Para 0013…The polyolefin fiber matrix of the invention absorbs greater than 0.05 ml of a liquid suspension of biological specimens absorbed and dried thereon; See Para 0022…the biological specimens include, but are not limited to, whole blood);
a desiccant compound (See Para 0105… desiccant used in the device is commonly known in the art, including but is not limited to montmorillonite clay, lithium chloride, activated alumina, alkali alumino-silicate, DQ11 Briquettes, silica gel, molecular sieve, calcium sulfate, and calcium oxide.);
a deoxygenation compound (See Para 0107…Another composition which protects against degradation which may be optionally used is an oxygen scavenger element. As used herein, the term “oxygen scavenging element” refers to is a substance that consumes, depletes or reduces the amount of oxygen from a given environment without negatively affecting the samples of interests…An example of an iron oxygen scavenging element is D500 from Multisorb…); and
a sealable container (referred to as the container 20 [Para 0113; Fig. 1A, ref. 20]) for holding there within, a in sealed environment (See Para 0113… is cylindrical and has side walls 22, a bottom 24 and an openable lid 26, which sealingly engages the container 20 opening), said device (referred to as the container 20 [Para 0113]) for holding said blood sample (See Para 0090… In certain embodiments, the matrix can be loaded with a biological specimen and dried, and placed into a single container which serves both a protective, dry transportation vessel and is configured for compression of the reconstituted matrix for release of the analyte of interest; See Para 0022…the biological specimens include, but are not limited to, whole blood), said desiccant compound (See Para 0113… A desiccant 40 may be optionally placed inside the container 20,) and said deoxygenation compound (See Para 0090… In certain embodiments, the matrix can be loaded with a biological specimen and dried, and placed into a single container which serves both a protective, dry transportation vessel and is configured for compression of the reconstituted matrix for release of the analyte of interest; See Para 0106…polyolefin fiber matrix of the invention may optionally include a composition absorbed to the matrix wherein the composition protects against degradation of the analytes of interest contained in the biological specimens; See Para 0107…Another composition which protects against degradation which may be optionally used is an oxygen scavenger element.).
In addition, Claim 1 recites a device, and a sealable container and recites how these strcutures function. Claim 1 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 2, De La Rosa teaches wherein said device for holding said blood sample (See Para 0013…The polyolefin fiber matrix of the invention absorbs greater than 0.05 ml of a liquid suspension of biological specimens absorbed and dried thereon; See Para 0022…the biological specimens include, but are not limited to, whole blood) further comprises an enclosure (See Annotated Fig. 1A) comprised of
a first region (See Annotated Fig. 1A) for holding an absorbent medium (referred to as cellulose matrix) and
a second region (See Annotated Fig. 1A) for holding said desiccant compound (See Para 0113… A desiccant 40 may be optionally placed inside the container 20,),
wherein said enclosure (See Annotated Fig. 1A) allows for free air circulation between (See Para 0113… A desiccant 40 may be optionally placed inside the container 20, separated with the matrix 30 by an optional air permeable barrier 42, for in vaporous communication with the matrix 30 to control humidity or moisture therein.) said first region (See Annotated Fig. 1A) and said second region (See Annotated Fig. 1A).
In addition, Claim 2 recites a device and an enclosure and recites how these structures function. Claim 2 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
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Annotated Fig. 1A, De La Rosa
Regarding Claim 3, De La Rosa teaches wherein said absorbent medium (referred to as cellulose matrix [Para 0012, 0133) further comprises cellulose-based paper (referred to as cellulose matrix [Para 0012, 0133).
Regarding Claim 4, De La Rosa teaches wherein said absorbent medium (referred to as cellulose matrix [Para 0012, 0133) further comprises synthetic paper (referred to as cellulose matrix [Para 0012, 0133); See Para 0019… the hydrophilic cellulose acetate matrix, thereby teaching “synthetic”).
Regarding Claim 5, De La Rosa teaches wherein said first region (See Annotated Fig. 1A) further having a hole (See Annotated Fig. 6) that exposes a portion of said absorbent medium (referred to as cellulose matrix [Para 0012, 0133; the cellulose matrix under BRI has a part or portion) for allowing said blood sample (See Para 0022…the biological specimens include, but are not limited to, whole blood) to be directly deposited onto (See Para 0155…Sample processed through the ViveST devices with cellulose fiber matrix or the polyolefin fiber matrix; See Para 0036…plasma sample) said portion of said absorbent medium (referred to as cellulose matrix [Para 0012, 0133; the cellulose matrix under BRI has a part or portion).
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Annotated Fig. 6, De La Rosa
Regarding Claim 6, De La Rosa teaches wherein said first region (See Annotated Fig. 1A and said second region (See Annotated Fig. 1A) are linked via a plurality of air circulation channels (referred to as an air permeable barrier [Para 0105;See Fig. 1A, ref. 42]).
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.
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over De La Rosa et al. (US20140038172A1) as applied to claim 2 above, and further in view of Whitson et al. (US5866007A)
Regarding Claim 7, De La Rosa teaches said enclosure(See Annotated Fig. 1A) is comprised of two parts (See Annotated Fig. 1A); and a volume (See Annotated Fig. 1A) therewithin that forms wherein at least said first region (See Annotated Fig. 1A and said second region (See Annotated Fig. 1A).
De La Rosa does not teach “wherein said enclosure is comprised of two parts having a locking mechanism that allows the two parts to lock to one another to form a volume”.
In the analogous art of a method and apparatus for separating a blood sample having a volume of up to about 20 milliliters into cellular and acellular fractions, Whitson teaches “wherein said enclosure (referred to as apparatus [Fig. 1]) is comprised of two parts (See Fig. 1A, ref. 18…plate; and Fig. 1A, ref. 24…back plate) having a locking mechanism (See Fig. 1, ref. 20…flanges.… the flanges 20 adhere to a back plate 24, thereby teaching the “locking mechanism”) that allows the two parts (See Fig. 1A, ref. 18…plate; and Fig. 1A, ref. 24…back plate) to lock to one another (See Col. … Referring back to FIG. 1, once the device is assembled the flanges 20 adhere to a back plate 24,) to form a volume (See Fig. 1, ref 10…the device having an internal volume”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of De La Rosa to include “wherein said enclosure is comprised of two parts having a locking mechanism that allows the two parts to lock to one another to form a volume”, as taught by Whitson for the benefit of providing a substantially water tight seal around the filter card 22 and absorbent matrix 30 using any suitable means known in the art. (Whitson, Col. 5, lines 63-67), allowing to provide a simple, inexpensive method and apparatus for passively separating cellular (or solid) and acellular fractions of clinically useful volumes of bodily fluids, for substantially simultaneously or subsequently analyzing said bodily fluids for one or more analytes, and for prolonged preservation of said analytes (Whitson, Col. 1, lines 20-26).
Regarding Claim 8, De La Rosa teaches wherein said device for holding said blood sample (See Para 0013…The polyolefin fiber matrix of the invention absorbs greater than 0.05 ml of a liquid suspension of biological specimens absorbed and dried thereon; See Para 0022…the biological specimens include, but are not limited to, whole blood).
De La Rosa does not explicitly teach wherein said device for holding said blood sample, further comprises a dried blood spot device.
In the analogous art of a method and apparatus for separating a blood sample having a volume of up to about 20 milliliters into cellular and acellular fractions, Whitson teaches wherein said device for holding said blood sample, further comprises a dried blood spot device (referred to as filter card [Col. 6, lines 25-26]; See Col. 6, lines 25-26… The blood or other bodily fluid passes through the filter card 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of De La Rosa to include “wherein said device for holding said blood sample, further comprises a dried blood spot device”, as taught by Whitson for the benefit of separating a blood sample having a volume of up to about 20 milliliters into cellular and a cellular fractions (Whitson, Abstract; Col. 4, lines 63-67), allowing to provide a simple, inexpensive method and apparatus for passively separating cellular (or solid) and acellular fractions of clinically useful volumes of bodily fluids, for substantially simultaneously or subsequently analyzing said bodily fluids for one or more analytes, and for prolonged preservation of said analytes (Whitson, Col. 1, lines 20-26).
Regarding Claim 9, the system of claim 8 is obvious over De La Rosa in view of Whitson.
The combination of De La Rosa and Whitson does not teach that said dried blood spot device further comprises cellulose-based cards.
In the analogous art of a method and apparatus for separating a blood sample having a volume of up to about 20 milliliters into cellular and acellular fractions, Whitson teaches that said dried blood spot device (referred to as filter card [Col. 6, lines 25-26]; See Col. 6, lines 25-26… The blood or other bodily fluid passes through the filter card 22) further comprises cellulose-based cards (See Col. 4, lines 41-45…suitable materials for the filter card 22 include, but are not limited to, cellulose fibers, natural organic fibers, semi synthetic fibers, synthetic fibers, and hydrophilic polymeric gels).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of De La Rosa to include that said dried blood spot device further comprises cellulose-based cards, as taught by Whitson for the benefit of separating a blood sample having a volume of up to about 20 milliliters into cellular and a cellular fractions (Whitson, Abstract; Col. 4, lines 63-67), wherein the filter card 22 may be composed of any suitable fibrous material having a large surface area, an appropriate density, and an appropriate average pore size…permitting the use of a smaller volume of fibrous material to separate the components of the fluid (Col. 4, lines 28-35), allowing to provide a simple, inexpensive method and apparatus for passively separating cellular (or solid) and acellular fractions of clinically useful volumes of bodily fluids, for substantially simultaneously or subsequently analyzing said bodily fluids for one or more analytes, and for prolonged preservation of said analytes (Whitson, Col. 1, lines 20-26).
Regarding Claim 10, the system of claim 8 is obvious over De La Rosa in view of Whitson.
The combination of De La Rosa and Whitson does not teach that said dried blood spot device further comprises synthetic paper-based cards.
In the analogous art of a method and apparatus for separating a blood sample having a volume of up to about 20 milliliters into cellular and a cellular fractions, Whitson teaches that said dried blood spot device (referred to as filter card [Col. 6, lines 25-26]; See Col. 6, lines 25-26… The blood or other bodily fluid passes through the filter card 22) further comprises synthetic paper-based card (See Col. 4, lines 41-45…suitable materials for the filter card 22 include, but are not limited to…semi synthetic fibers, synthetic fibers, and hydrophilic polymeric gels).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of De La Rosa to include that said dried blood spot device further comprises cellulose-based cards, as taught by Whitson for the benefit of separating a blood sample having a volume of up to about 20 milliliters into cellular and a cellular fractions (Whitson, Abstract; Col. 4, lines 63-67), wherein the filter card 22 may be composed of any suitable fibrous material having a large surface area, an appropriate density, and an appropriate average pore size…permitting the use of a smaller volume of fibrous material to separate the components of the fluid (Col. 4, lines 28-35), allowing to provide a simple, inexpensive method and apparatus for passively separating cellular (or solid) and acellular fractions of clinically useful volumes of bodily fluids, for substantially simultaneously or subsequently analyzing said bodily fluids for one or more analytes, and for prolonged preservation of said analytes (Whitson, Col. 1, lines 20-26).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over De La Rosa et al. (US20140038172A1) as applied to claim 1 above, and further in view of Bernstein et al. (US20110105951A1)
Regarding Claim 11, De La Rosa teaches wherein said device for holding said blood sample (See Para 0013…The polyolefin fiber matrix of the invention absorbs greater than 0.05 ml of a liquid suspension of biological specimens absorbed and dried thereon; See Para 0022…the biological specimens include, but are not limited to, whole blood).
De La Rosa does not teach “a fiber stick having an absorbent paper portion for absorbing a preset amount of blood”.
In the analogous art of systems and methods for treating, sanitizing, and/or shielding blood on the surface of the skin or devices applied to the skin, Bernstein teaches “a fiber stick (referred to as absorbent material [Para 0093; Fig. 10, ref. 19]; Under BRI, the absorbent material has a stick shape) having an absorbent paper portion (referred to as absorbent material [Para 0093; Fig. 10, re. 19]) for absorbing a preset amount of blood (See Para 0093…For example, absorbent material may be formed of a porous material that is able to “wick” blood into the material, e.g., via capillary action) ”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of De La Rosa to include t “a fiber stick having an absorbent paper portion for absorbing a preset amount of blood”, as taught by Bernstein for the benefit of , upon the release of blood or other bodily fluid from the skin, the blood may contact absorbent material 19 and be absorbed therein (Bernstein, Para 0093), allowing for the provision of techniques for withdrawing a fluid, such as blood, from a mammal that have one or more features such as added simplicity and flexibility of use (Bernstein, Para 0003)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797
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