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 .
Status of Claims
There are two (2) sets of claims submitted on 02 FEBRUARY 2024. The claim set considered is the claim set consisting of four (4) pages and the claims have status identifiers.
In the claim set, Claims 1, 2, 6 and 8 are ‘Original’; Claims 4, 5, 7, 12-14, 16, 17, 26, 27, 31, 33, 34, 44 and 49 are ‘Currently Amended’; Claims 3, 9-11, 15, 18-25, 28-30, 32, 35, 37-43, 45-48 and 50-59 are ‘Cancelled’.
Current pending claims are Claims 1, 2, 4-8, 12-14, 16, 17, 26- 27, 31, 33, 34, 36, 44 and 49 and are considered on the merits below.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02 FEBRUARY 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A “float member, arranged within the sample collection chamber, configured to float on a fluid sample within the sample collection chamber” in Claim 14.
A ‘member’ does not connote any particular structure. The specification describes the float member to be a partially porous or may comprise an opening to allow fluid to pass through or a ring w a hole at the center or maybe made from low density polyethylene or may be any configuration that enable it to float on top of the fluid sample.
A “restriction arrangement configured to prevent movement” in Claim 27.
An ‘arrangement’ does not connote any particular structure. The specification describe the restriction arrangement may comprise “a protrusion extending from the sample collection chamber arranged to engage with a recess provided on the inlet cap.”
A “sample analysis device, configured to analyze the sample” in Claim 44.
A ‘device’ does not connote any particular structure. The specification describes the sample analysis device’ to be in in any form, for example a vertical flow assay or a lateral flow test, or a device configured to change colour upon detecting the presence of a particular material, chemical or biological agent.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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.
(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, 2, 4-8, 12, 13, 16, 17, 26, 27, 31, 33, 34, 36, 44 and 49 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by DARRIGRAND, US Publication No. 2009/024060 A1, submitted on the Information Disclosure Statement on 02 FEBRUARY 2024, US Patent Application Publications Cite No. 6.
Applicant’s invention is directed towards a device.
Regarding Claim 1, the DARRIGRAND reference discloses a sample collection device, abstract, collector, for collecting a fluid sample, abstract, sample of bodily fluid, [0013, 0042], comprising:
a sample collection chamber for collecting a sample therein, Figure 6D, character 648, wherein the chamber comprises a chamber outlet through which a fluid sample can pass, Figure 6D, character 660;
a sample collection conduit extending through an opening of sample collection chamber to an outside of the sample collection chamber, Figure 6A-6D, characters 633 and 642, wherein the sample collection conduit comprises a conduit inlet for receiving a fluid sample and a conduit outlet for allowing the fluid sample to pass into the sample collection chamber, Figure 6A, characters 638 and 649, respectively; and
a plunger configured to expel the fluid out of the sample collection chamber through the chamber outlet, Figure 6A-6E, character 610 and 633.
Additional Disclosures Included are: Claim 2: wherein the sample collection device of claim 1, wherein the sample collection conduit is moveable relative to the sample collection chamber and wherein the sample collection conduit and plunger are operatively linked such that movement of the sample collection conduit causes movement of the plunger within the sample collection chamber, Figure 6A-E, [0112].; Claim 4: wherein the sample collection device of claim 1, wherein the sample collection chamber comprises a first sub-chamber defined between the plunger and the chamber outlet, wherein the conduit outlet is arranged in the first sub-chamber and wherein the sample collection chamber comprises a first fluid passageway arranged to allow fluid to pass out of the first sub-chamber, Figure 6D, character 648 and character 660.; Claim 5: wherein the sample collection device of claim 1, wherein the sample collection device comprises a further plunger arranged within the sample collection chamber, and wherein a second sub-chamber is defined between the plunger and further plunger, Figure 6A-6E, character 614.; Claim 6: wherein the sample collection device of claim 5, wherein the further plunger is configured to move together with the plunger, and wherein the sample collection chamber comprises a second fluid passageway arranged to allow fluid to pass out of the second sub-chamber, Figure 6A, 6B, see how characters 610/633/614 work together.; Claim 7: wherein the sample collection device of claim 1, wherein the plunger is movable to a first intermediate position in which the first fluid passageway is closed, Figure 6A to 6B, see different position of 610 from 6A to 6B.; Claim 8: wherein the sample collection device of claim 7, wherein the further plunger is movable into a corresponding first intermediate position whereby the second fluid passageway is also closed, Figure 6A and 6B.; Claim 12: wherein the sample collection device of claim 1, comprising a volume control arrangement which determines how far the plunger can be advanced into the sample collection chamber, Figure 6B, character 612.; Claim 13: wherein the sample collection device of claim 1, comprising a relief valve arranged to open when the plunger and/or the sample collection conduit approaches a final position in the sample collection chamber, Figure 6E, character 635, [0112].; Claim 16: wherein the sample collection device of any preceding claim 1, wherein at least a portion of the sample collection chamber is defined by single skin, at least partially transparent, outer wall such that there is only one wall between the fluid sample collected within the sample collection chamber and an exterior of the sample collection device, Figure 6A-E.; Claim 17: wherein the sample collection device of claim 1, comprising an inlet cap arranged to seal the sample collection chamber, Figure 2A, cap 240, [0065, 0067].; Claim 26: wherein the sample collection device of claim 17, comprising a further plunger, and wherein the inlet cap is arranged to drive the further plunger into the sample collection chamber, and wherein as the further plunger is advanced into the sample collection chamber, the further plunger presses a wall of the sample collection chamber and a wall of the inlet cap together, thereby sealing the opening of the sample collection chamber, Figure 2A, cap 240, [0065-0067].; Claim 27: wherein the sample collection device of claim 17, comprising a restriction arrangement configured to prevent movement of the inlet cap relative to the sample collection chamber in at least one direction, Figure 2A, threads 241, [0067].; Claim 31: wherein the sample collection device of claim 1,comprising an outlet cap, arranged to cover the chamber outlet, Figure 6E, character 660, [0113]. ; Claim 33: wherein the sample collection device of claim 31 , wherein the chamber outlet is closed by a seal, and wherein at least part of the outlet cap is adjacent the seal such that the seal cannot be broken when the outlet cap is attached to the sample collection device, Figure 3A, screens 323, [0080], Figure 6A, 6B, character 637.; Claim 34: wherein the sample collection device of claim 1, comprising a further component connected fluidly downstream of the chamber outlet, Figure 6A-B, character 650, [0106].; Claim 36: wherein the sample collection device of claim 34, further comprising an outlet tamper element connected to a body of the device or the further component, wherein the outlet tamper element is configured such that when the further component is separated from the chamber outlet, the outlet tamper element breaks away from the body of the device or the further component, Figure 6C-E, character 660, [0113]. ; Claim 44 : wherein the sample collection device of claim 34, wherein the further component comprises a sample analysis device, configured to analyze the sample, Figure 7B, [0116, 0122].; and Claim 49 : wherein the sample collection device of claim 1,comprising a connection arrangement arranged fluidly downstream of the chamber outlet, for connecting a further component to the sample collection device, Figure 6A, 6B, character 650, [0106].
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over DARRIGRAND, US Publication No. 2009/024060 A1, submitted on the Information Disclosure Statement on 02 FEBRUARY 2024, US Patent Application Publications Cite No. 6, and further in view of CAMPTON, US Publication No. 2014/0287487 A1.
Regarding Claim 14, the DARRIGRAND reference discloses the sample collection device of claim 1, but is silent in regards to a float member, arranged within the sample collection chamber, configured to float on a fluid sample within the sample collection chamber.
CAMPTON discloses a sample collection device, Figure 5A, 5B, system 500, [0045], for collecting a fluid sample, comprising:
a sample collection chamber for collecting a sample therein, Figure 5A, 5B, tube 502, [0045], wherein the chamber comprises a chamber outlet through which a fluid sample can pass, Figure 5A, location where plug 514 is , if removed; further comprising a float member, arranged within the sample collection chamber, configured to float on a fluid sample within the sample collection chamber, Figure 5A, 5B, float 504, [0045, 0046, 0048, 0049, 0051].
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention of DARRIGRAND to include the float member as taught by CMAPTON so that it settles at the same axial position as the target analyte depending upon the material of the float, [0055].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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