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 .
Election/Restrictions
Applicant’s election without traverse of Species A.1 one or more reagents for the detection of specific proteins in the sample, in the reply filed on 07/08/2026 is acknowledged.
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 2-6 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim 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.
Claim 2 recites the limitation "the frangible plug" in L1. There is insufficient antecedent basis for this limitation in the claim.
The term “weakness” in claim 2 is a relative term which renders the claim indefinite. The term “weakness” 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.
Claim 3 recites the limitation "the frangible plug" in L1. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the frangible plug" in L2. There is insufficient antecedent basis for this limitation in the claim.
The term “softer plastics material; [...] harder plastics material” in claim 4 is a relative term which renders the claim indefinite. The term “softer”/“harder” 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.
Regarding claim 5, the phrase "similar" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "similar"), thereby rendering the scope of the claim unascertainable.
Claim 6 recites the limitation "the length" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 is unclear reciting “[...] associated with [...]” because it is unclear what structure is being claimed.
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.
Claim(s) 1-10, 13, 15-18, 20, 21 and 23 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Nason (US 5,266,266).
Regarding claim 1, Nason teaches:
1. A device for obtaining biological samples for analysis, comprising:
a nib (e.g., 24) having a working surface exposed or exposable for acquiring a biological sample, and having also a porous structure suitable for the absorption of biological sample matter thus acquired (see C4/L24-34 for example);
a body (e.g., 14, 16) having a form suitable for holding in, and manipulation by, the hand, and wherein the nib is connected or connectable to the body (see Figs. 1-2 for example); and
a reservoir (e.g., 36) located within the body and adapted for fluid communication with the nib to provide the passage of fluid through the nib (see C5/L48-C6/L18 for example);
wherein the device further comprises:
a plug (e.g., 28) located within a fluid passage (e.g., 30) between the reservoir and the nib to prevent passage of fluid between the reservoir and the nib, said plug being frangible so as to open a fluid passage and thereby permit passage of fluid between the reservoir and the nib (see C4/L35-42 for example); and wherein the device further comprises an aperture (e.g., 37) capable of venting located at or adjacent a portion of the body to which the nib is connected or connectable (see Figs. 1-2 for example).
With regard to limitations in claims 1-6, 8-13, 15, 17, 18, 20, 21 (e.g., [...] exposable for acquiring a biological sample, and [...] suitable for the absorption of biological sample matter thus acquired; [...] suitable for holding in, and manipulation by, the hand, [...] to prevent passage of fluid between the reservoir and the nib, [...], etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 2-8, 10, 13, 15-18, 20, 21, 23, Nason teaches:
2. A device according to claim 1 wherein the plug includes a frangible portion (e.g., 26).
3. A device according to claim 1 wherein the plug comprises a tapered portion (e.g., 26), which does not fully restrict the fluid passage (i.e., ‘reduced diameter’ score 26), and an interference portion (e.g., 28), which does fully restrict the fluid passage (i.e., ‘solid rod’ segment 28; see C4/L35-42 for example).
4. A device according to claim 1 wherein the body is formed of a plastics material (C3/L67-C4/L2); and the plug is formed of a plastics material (C4/L30-31).
5. A device according to claim 1 wherein the venting aperture is combined with a pin, a collar, or similar to retain the nib in position in the device (see Fig. 2 for example).
6. A device according to claim 1 wherein the venting aperture comprises a groove provided along a length of the nib (see Figs. 1-2 for example).
7. A device according to claim 1 wherein the venting aperture comprises an opening formed in the body (see Figs. 1-2 for example).
8. A device according to claim 1 wherein the reservoir is operable to push fluid towards the nib and/or to withdraw fluid from the nib (see C5/L48-C6/L18 for example).
10. A device according to claim 1, wherein the reservoir contains a liquid reagent formulation (e.g., 20).
13. A device according to claim 1, further comprising a reaction chamber (e.g., 60) capable of receiving fluid supplied from the reservoir and discharged from the nib after contact with the sample (see C7/L3-21 for example).
15. A device according to claim 1, comprising a reagent formulation (e.g., second reagent in dried form, C7/L1).
16. A device according to claim 15, wherein the reagent formulation is in a lyophilised or dried-down form (e.g., second reagent in dried form, C7/L1).
17. A device according to claim 15, wherein the reagent formulation comprises one or more reagents (e.g., second reagent in dried form, C7/L1).
18. A device according to claim 17, wherein said reagent formulation comprises reagents (e.g., first and second reagents C6/L66-C7/L1).
20. A device according to claim 15 wherein the reagent formulation capable of providing a visual signal (see C4/L15-19 for example).
21. A device according to claim 15 wherein the reagent formulation comprises one or more reagents (see C4/L15-19 for example).
23. A device according to claim 1, provided in kit form (see C1/L55-58 for example).
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.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nason (US 5,266,266) in view of Mao et al. (US 2016/0349153).
Regarding claims 11-12, Nason does not explicitly teach: 11. A device according to claim 1, wherein the nib comprises an agent. 12. A device according to claim 11 wherein the agent comprises one or more membrane-disrupting reagents.
Mao teaches: a nib (e.g., 820a-820c) comprising an active agent for treatment of a sample obtained on the nib, and preferably the nib is functionalised with said active agent (see i.e., nibs may contain functional additives ¶ 0009, 0073-0081). wherein the active agent comprises one or more membrane-disrupting reagents that have the ability to lyse bacteria or viruses (e.g., surfactant ¶ 0009, 0071, 0076).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the nib of Nason, with a functionalized nib capable of lysing bacteria or virus, as taught by Mao, for the purpose of preserving an analyte of interest (Mao ¶ 0009+).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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