DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 5 recites a “flow-control means” which is a tap or pincer as described in the specification.
Claim 14 recites, “means to facilitated heating of the nib or other component of the device”. The specification describes an element capable of being heated by induction. The broadest reasonable interpretation can be any material can be heated by an outside source. Therefore, plastic would read on a material that can be heated.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-2,4-7,9-10,13-14,16-31 are rejected under 35 U.S.C. 103 as being unpatentable over Bommarito et al. (US 2009/0019953) with supporting document Nason (US 5,869,003).
Regarding claim 1, Bommarito teaches a device for obtaining liquid biological samples for analysis, comprising:
a nib (fig. 1, ref. 30) having a working surface exposed or exposable for acquiring a liquid biological sample, and having also a porous structure (para 39, porous medium) suitable for the absorption of biological sample matter thus acquired (this limitation does not further structurally limit the instant claim. The biological sample matter can be added to the nib at a later time);
an elongate body (24) having a form suitable for holding in, and manipulation by, the hand, and wherein the nib is connected or connectable to the body (24); and
the body having a conduit (28 is hollow) leading at one end to the nib (30) and at the other end to a reservoir (26) manually operable to push fluid towards and through the nib to thereby elute acquired biological sample from the nib adapted for fluid communication with the nib to provide the passage of fluid through the nib (this limitation does not further structurally limit the instant claim. A fluid can be added to the reservoir at a later time. Applicant can positively recite a fluid by stating “a reservoir comprising a fluid”);
wherein the nib comprises a lyophilised or dried active agent for treatment of the liquid biological sample (US 5,869,003 is fully incorporated by reference and teaches the reagent is in a dry form impregnating a porous filter 54 and is being interpreted as being incorporated in the nib of Bommarito). While Bommarito does not specifically teach the use of a dried active agent in the nib, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Bommarito to employ a dried active agent in the nib in order to interact with the collected sample as taught by Nason.
Regarding claim 2, a device according to claim 1 wherein the reservoir is located within the body (the body is being interpreted as structures 24,12,26).
Regarding claim 4, a device according to claim 1 wherein the reservoir is pressurized to provide fluid to the nib (this limitation does not further structurally limit the instant claim because the reservoir can be squeezed to increase the pressure).
Regarding claim 5, a device according to claim 1, wherein a flow-control means is operable to allow the flow of fluid between the reservoir and the nib (valve 32 is broken).
Regarding claim 6, a device according to claim 1, wherein the nib comprises a colorimetric agent to provide is associated with a hydrochromic mark to indicate the quantity of aqueous material acquired (para 50-51).
Regarding claim 7, a device according to claim 1, wherein the reservoir contains a liquid reagent formulation for treatment of the sample obtained on the nib (para 40).
Regarding claim 9, a device according to claim 1 wherein the active agent comprises one or more membrane-disrupting reagents that have the ability to lyse bacteria or viruses (this limitation does not further structurally limit the instant claim. Applicant has not claimed a specific lysing agent).
Regarding claim 10, a device according to claim 1, wherein the active agent is non-toxic to humans (this limitation does not further structurally limit the instant claim. A buffer is nontoxic).
Regarding claim 13, a device according to claim 1, wherein said active agent is in lyophilised or dried-down form (dried agent as modified as taught in claim 1, and the reservoir contains aqueous fluid (buffer) for re-hydrating the active agent.
Regarding claim 14, a device according to claim 1 which comprising an induction-heater element (plastic housing) to facilitate heating of the nib or other component of the device.
Regarding claim 16, a device according to claim 14, comprising a colorimetric agent (para 50-51) to provide wherein a thermochromic mark is provided to indicate that an appropriate temperature range has been achieved.
Regarding claim 17, a device according to claim 1, further comprising a reaction chamber (fig. 1, ref. 16) to receive fluid supplied from the reservoir and discharged from the nib after contact with the sample (see fig. 1).
Regarding claim 18, a device according to claim 17, wherein the reaction chamber is located within the body (the body further comprising structures of 10).
Regarding claim 19, a device according to claim 17, wherein the reaction chamber can be removably located so as to cover the nib (12 can be removed from the housing).
Regarding claim 20, a device according to claim 17, wherein the chamber has a transparent region for viewing the interior (fig. 1; 50-51).
Regarding claim 21, a device according to claim 17, comprising a reagent formulation (18) for treatment of the sample in the reaction chamber (16).
Regarding claim 22, a device according to claim 21, wherein the reagent formulation is in a lyophilised or dried-down form (see claim 1).
Regarding claim 23, a device according to claim 21, wherein the reagent formulation comprises one or more reagents (50-51,65-66) for the detection of specific nucleic acid targets in the sample.
Regarding claim 24, a device according to claim 23, wherein said reagent formulation comprises reagents for isothermal amplification of nucleic acid (18).
Regarding claim 25, a device according to claim 24, wherein the isothermal amplification is recombinase polymerase amplification (18).
Regarding claim 26, a device according to claim 23 wherein the reagent formulation provides a visual signal in the event of detection of said specific nucleic acid targets (para 50-15,65-66).
Regarding claim 27, a device according to claim 21 wherein the reagent formulation comprises one or more reagents for the detection of specific proteins, peptides, and/or lipids in the sample (para 50-51,65-66).
Regarding claim 28, a device according to claim 27 wherein the reagent formulation comprises one or more reagents for immunoassay-based detection of a target in the sample (para 50-51,65-66).
Regarding claim 29, a device according to claim 17, wherein:(a) the nib is located in an outlet from the reservoir (see fig. 1), from which it projects for sample collection, and for subsequent connection to an inlet of the reaction chamber (fig. 1); or (b) the nib is located in an inlet to the reaction chamber, from which it projects for sample collection, and for subsequent connection to an outlet from the reservoir.
Regarding claim 30, a device according to claim 1, wherein the nib is removably connectable to the body (this limitation does not further structurally limit the claim as the nib can be removed with enough force), and comprising a plurality of replaceable nibs (this limitation does not further structurally limit the instant claim because the replaceable nibs can be added at a later time).
Regarding claim 31, device according to claim 1, provided in kit form (this limitation does not further structurally limit the instant claim).
Claim(s) 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Bommarito et al. (US 2009/0019953) with supporting document Nason (US 5,869,003) and in further view of Mao et al. US (2016/0349153).
Regarding claim 11, a device according to claim 1, the modified Bommarito does not teach wherein the active agent comprises one or more agents selected from the group consisting of Citral, Eucalyptus oil, Tea tree oil, Chlorhexidine ,triterpenoid saponin ,Polyphylla saponin I, Povidone- iodine, Cetylpyridinium chloride (CPC), Benzalkonium chloride (BAC), Dequalinium chloride. Mao teaches a liquid sampling and testing device which provides a nib with active agent thereon for interacting with a sample (para 75-76, 99-100). It would have been obvious to one having an ordinary skill in the art at the time of the invention to modify Bommarito to employ an active agent listed above as chaotropic agents as taught by Mao.
Regarding claim 12, a device according to claim 1, wherein the active agent comprises cetyl pyridinium chloride. Mao teaches a liquid sampling and testing device which provides a nib with active agent thereon for interacting with a sample (para 75-76, 99-100). It would have been obvious to one having an ordinary skill in the art at the time of the invention to modify Bommarito to employ an active agent listed above as chaotropic agents as taught by Mao.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2, 4-7, 9-14 and 16-31 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL P SIEFKE whose telephone number is (571)272-1262. The examiner can normally be reached Monday, Tuesday, Thursday, Friday, 8-6.
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/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758