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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant's election with traverse of a device (Group I), claims 14-29 in the reply filed on October 28, 2025 is acknowledged. The traversal is on the ground(s) that the Ismagilov does not describe a device comprising capillary means, wherein the capillary means is configured to collect and dry a blood sample but rather a flow through channel. Applicant also argues that Ismagilov does not present PLD and/ or anything about using the device to inhibit an enzyme such as PLD. Applicant argues that claims 15-20 and 22-29 are not anticipated by Ismagilov.
This is not found persuasive because Ismagilov teaches the capillary means in as much as positively claimed.
The requirement is still deemed proper and is therefore made FINAL.
Claims 30-31 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected electrode structure (Group II), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on October 28, 2025.
Claim status
Claims 1-13 are canceled.
Claims 14-29 are pending.
Claims 30-31 are withdrawn.
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 limitation “capillary means” in claims 14-15 and 21-22 has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “means” coupled with functional language “capillary” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claims 14-15 and 21-22 has/have been interpreted to cover “a porous paper or polymer” corresponding to structure described in the specification that achieves the claimed function, and equivalents thereof (Spec., para 0043, 0044).
Claim Objections
Claim 14, the recitation “A device configured to receive a blood sample comprising a capillary means,” is missing a comma between “sample” and “comprising”. Appropriate correction is needed.
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 14-21, 25-29 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Yeliz et. al. (Clinical feasibility of dried blood spots: Analytics, validation, and applications).
Regarding claim 14, Yeliz teaches “A device” (Title, Device and method for dried fluid spot analysis). The recitation “configured to receive a blood sample” is capability of the device. Yeliz discloses the positively claimed structural elements of the device as claimed, such device are said to be fully capable of the recited adaption in as much as recited and required herein. Additionally, Yeliz teaches within but taught within (Page 7, Once a capillary blood drop is disposed on the inlet). Further taught “comprising a capillary means,” (Page 7, The sampling of capillary whole blood in a capillary, followed by centrifugation and displaying the plasma onto a filter paper card is one way to generate plasma samples by a fingerpick). The recitation “wherein the capillary means is configured to collect and dry the blood sample and comprises an effective amount of a distributed inhibitor of phospholipase D (PLD).” is capability of the device. Yeliz discloses the positively claimed structural elements of the capillary means as claimed, such capillary means are said to be fully capable of the recited adaption in as much as recited and required herein. Yeliz does teach (Page 7 and 10, These issues have been overcome by developing a plasma extraction card (Noviplex™) which separates the blood cells out of a capillary whole blood drop by filtration and generating a dried plasma sample. Xu et al. tested DBS applicability in currently running pharmacokinetic studies evaluating a new tyrosine kinase inhibitor. The development of a holding cartridge for commercially available DBS filter paper cards allows the microfluidic-based accurate sampling of 5 or 10 μL of capillary whole blood 159]. Four sized capillaries get filled with capillary whole blood, when attached to the blood drop). Therefore it has a capillary which is capable of holding the Phospholipase inhibitor.
Regarding claim 15, Yeliz teaches all of claim 14 as above. The recitation “wherein the device is configured to transport and collect a blood sample,” is capability of the device. Yeliz discloses the positively claimed structural elements of the device as claimed, such device are said to be fully capable of the recited adaption in as much as recited and required herein. Further taught “the device comprises a compartment in fluid connection with the capillary means.” (Page 7, After closing the device, the filter paper card gets in contact with the sampled blood at the outlet of the capillaries creating 4 DBS with an accurate blood volume.).
Regarding claim 16, Yeliz teaches all of claim 14 as above in addition to “wherein the capillary means is a porous paper or polymer” (Page 7, After closing the device, the filter paper card gets in contact with the sampled blood at the outlet of the capillaries creating 4 DBS with an accurate blood volume.) Therefore the filter paper is the porous paper. The recitation “configured to admit capillary transport to and from the compartment of the blood sample.” is capability of the capillary means however taught within page 7 as above.
Regarding claim 17, Yeliz teaches all of claim 14 as above. The recitation “wherein the distributed PLD inhibitor is selected from at least one of salt of a transition metal belonging to column 5 or 6 of the periodic table.” is capability of the device. The device is capable of holding such inhibitor and therefore taught within Yeliz.
Regarding claim 18, Yeliz teaches all of claim 14 as above. The recitation “wherein the distributed PLD inhibitor is selected from at least one of a salt of vanadium and a salt of tungsten.” is capability of the device. The device is capable of holding such inhibitor and therefore taught within Yeliz.
Regarding claim 19, Yeliz teaches all of claim 14 as above. The recitation “wherein the inhibitor is selected from at least one of a salt comprising a vanadium oxyanion and a salt comprising a tungsten oxyanion.” is capability of the device. The device is capable of holding such inhibitor and therefore taught within Yeliz.
Regarding claim 20, Yeliz teaches all of claim 19 as above. The recitation “wherein the inhibitor is selected from at least one of NaVO3 (sodium metavanadate) and Na2WO4 (sodium tungstate).” is capability of the device. The device is capable of holding such inhibitor and therefore taught within Yeliz.
Regarding claim 21, Yeliz teaches “A device” (Title, Device and method for dried fluid spot analysis). The recitation “configured to receive a blood sample,” is capability of the device, Yeliz discloses the positively claimed structural elements of the device as claimed, such device are said to be fully capable of the recited adaption in as much as recited and required herein. Yeliz teaches the capability within (Page 7, Once a capillary blood drop is disposed on the inlet); “wherein the device is a microfluidic device comprising an inlet portion, an outlet portion comprising a capillary means” (Page 7, Another sampling device consists of a Whatman 903 filter paper layer and a microfluidic layer on top with an inlet, a capillary, and an outlet). The recitation “configured to collect and dry the blood sample” is capability of the device. Yeliz does teach (Page 7, These issues have been overcome by developing a plasma extraction card (Noviplex™) which separates the blood cells out of a capillary whole blood drop by filtration and generating a dried plasma sample.). The recitation “optionally a metering function” is an optional feature within the device and not required. The recitation “wherein the microfluidic device comprises an effective amount of a distributed inhibitor of phospholipase D (PLD).” is capability of the device. Yeliz does teach (Page 7 and 10, Xu et al. tested DBS applicability in currently running pharmacokinetic studies evaluating a new tyrosine kinase inhibitor. The development of a holding cartridge for commercially available DBS filter paper cards allows the microfluidic-based accurate sampling of 5 or 10 μL of capillary whole blood 159]. Four sized capillaries get filled with capillary whole blood, when attached to the blood drop). Therefore, it has a capillary which is capable of holding the Phospholipase inhibitor.
Regarding claim 25, Yeliz teaches all of claim 24 as above in addition to “wherein the metering function comprises a metering channel for metering a controlled volume of 5-50 microliters of blood transported to the PVA film, the absorbent paper, or the polymer with distributed PLD inhibitor located in the outlet.” (Page 7, The development of a holding cartridge for commercially available DBS filter paper cards allows the microfluidic-based accurate sampling of 5 or 10 μL of capillary whole blood 159]. Four sized capillaries get filled with capillary whole blood, when attached to the blood drop. After closing the device, the filter paper card gets in contact with the sampled blood at the outlet of the capillaries creating 4 DBS with an accurate blood volume.). Therefore the four sized capillaries is the metering channel for te 5 to 10 microliters which is within 5-50 microliters of blood which is transported to the filter paper which is the absorbent paper.
Regarding claim 26, Yeliz teaches all of claim 21 as above. The recitation “wherein the distributed PLD inhibitor is selected from at least one of salt of a transition metal belonging to column 5 or 6 of the periodic table.” is capability of the device. The device is capable of holding such inhibitor and therefore taught within Yeliz.
Regarding claim 27, Yeliz teaches all of claim 26 as above. The recitation “wherein the distributed PLD inhibitor is selected from at least one of a salt of vanadium and a salt of tungsten.” is capability of the device. The device is capable of holding such inhibitor and therefore taught within Yeliz.
Regarding claim 28, Yeliz teaches all of claim 27 as above. The recitation “wherein the inhibitor is selected from at least one of a salt comprising a vanadium oxyanion and a salt comprising a tungsten oxyanion.” is capability of the device. The device is capable of holding such inhibitor and therefore taught within Yeliz.
Regarding claim 29, Yeliz teaches all of claim 28 as above. The recitation “wherein the inhibitor is selected from at least one of NaVO3 (sodium metavanadate) and Na2WO4 (sodium tungstate).” is capability of the device. The device is capable of holding such inhibitor and therefore taught within Yeliz.
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 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Yeliz et. al. (Clinical feasibility of dried blood spots: Analytics, validation, and applications) in view of Li et. al. (US 20150125879 A1).
Regarding claim 22, Yeliz teaches all of claim 21 as above but does not teach “wherein the PLD inhibitor is distributed in a water soluble film, preferably a polyvinyl alcohol (PVA) film, or in an absorbent paper or polymer or in the capillary means.”.
Li teaches Layer-By-Layer (LBL) film coated on at least a surface of the substrate, which LBL film comprises binding agents that specifically interact with cells in addition to “wherein the PLD inhibitor is distributed in a water soluble film, preferably a polyvinyl alcohol (PVA) film, or in an absorbent paper or polymer or in the capillary means.” (Paras [0995], [0097], [0061], [0105], and [0096], There is a particular interest in achieving delivery of payload entities such as vaccines and/or therapeutic agents. Such agents may be associated with the LBL films disclosed herein. A therapeutic agent is or comprises an antibiotic, anti-viral agent, anesthetic, anticoagulant, anti-cancer agent, inhibitor of an enzyme. Decomposition of LBL films is characterized by substantially sequential degradation of at least a portion of the polyelectrolyte layers that make up LBL films. Degradation may be at least partially hydrolytic, at least partially enzymatic, at least partially thermal, and/or at least partially photolytic. Degradable polyelectrolytes and their degradation byproducts may be biocompatible so as to make LBL films amenable to use in vivo. (therefore the partially hydrolytic is water soluble. The channel connects two openings, used as inlet and outlet reservoirs for the delivery of solutions of the present invention. An agent can be a drug formulation including various forms, such as liquids, liquid solutions, gels, hydrogels, solid particles (e.g., microparticles, nanoparticles), or combinations thereof.) Therefore the therapeutic agents which are enzyme inhibitors on the film which films are at least partially hydrolytic teach to the PLD inhibitor distributed in a water soluble film. In addition, it is taught that the enzyme inhibitor (solution) are within the inlet and outlet reservoirs.
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 Yeliz to incorporate the teachings of Li wherein the wherein the PLD inhibitor is distributed in a water soluble film. Doing so would allow the inhibitor to be dissolved and emersed within the blood sample evenly.
Regarding claim 23, modified Yeliz teaches all of claim 22 as above in addition to teaching “wherein the PVA film, the absorbent paper or the polymer with the distributed PLD inhibitor is located in the inlet portion, or in the outlet portion.” (Page 7, Once a capillary blood drop is disposed on the inlet, the sized capillary fills with an accurate volume of blood and breaks through a dissolving film at the outlet generating an exact DBS.). Therefore the film is located in the outlet portion as it is dissolved at the outlet. In addition, Li teaches that the film can be within the inlet or outlet as above within claim 22.
Regarding claim 24, modified Yeliz teaches all of claim 23 as above in addition to teaching “wherein the PVA film, the absorbent paper or the polymer with distributed PLD inhibitor is located in the outlet portion.” (Page 7, Once a capillary blood drop is disposed on the inlet, the sized capillary fills with an accurate volume of blood and breaks through a dissolving film at the outlet generating an exact DBS.). Therefore the film is located in the outlet portion as it is dissolved at the outlet. In addition, Li teaches that the film can be within the inlet or outlet as above within claim 22.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is (571)272-1557. The examiner can normally be reached M-F.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798