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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-5, 7-12 and 14-16 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 has claim limitation which were not described in the specification, “a lateral flow test strip disposed within said vial”. The specification makes it clear that the test strip is added to the vial when the vial as been punctured by distal portion of the probed. Claim 1 has a vial that is position able between a first position (sealed and connected to the housing body) and second position (seal broken and removed from the housing body). It is the second position to which the test strip is added to the vial by hand by a user in order to place the test strip into contact with the sample and reagent within the vial. The specification does not provide a test strip in a sealed vial in a first position that is connected to the housing body as seen in fig. 1. Further the specification does not provide a lateral flow test strip packaged within a sealed compartment of said system, the system comprising a housing body, a sample collection device, a sampling probe and a vial. The lateral flow test strip is not packaged within any of these structure but is packaged in a standalone package (blister package) that is opened and then placed within the vial. The specification states the test strip may be housed in a blister package. The sample collection device and the lateral flow test strip may be housed in a single-use assembly. Therefore there is not disclosure that states the test strip is disposed within said sealed vial.
Further it is not disclosed in the specification how the “system remains self-contained throughout sample collection, transport, and analyte detection in said removed second position.” When the vial is moved to the second position it is removed from the housing where a user can place a test strip in the punctured top opening to come into contact with the mixed sample and reagents in order to test for analytes. How is this self-contained when the vial is removed from the housing?
Claim 1 recites, “a sampling probe having a breakable sampling distal portion adapted to be separated along a defined breaking location and collect and retain a surface. The specification is silent regarding a defined breaking location. The specification only recites that the sampling probe has a breakable sampling distal end.
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 1, 3-5, 7-12 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Salter et al (US 2007/0148724 with fully incorporated reference to US 5,965,453 para 38) in view of Engel et al. (US 2012/0094303).
Salter discloses a system comprising:
5a. a housing body (fig. 3, ref 7) having at least one aperture adjacent a plurality of threads (bottom aperture having threads therein);
b. a sample collection device removable from said housing and including
i. a handle (fig. 1, ref. 2),
ii. a plurality of opposing threads (interior of 2 having opposing threads to body 7 threads, see fig. 3 when sample collection device is mated to housing body; fig. 8a of US 5,965,453 shows threads 56 on the interior of cover 52), and
iii. a sampling probe (swab) having a breakable sampling distal portion adapted to be separated along a defined breaking location and collect and retain a surface sample (this limitation does not further structurally limit the sampling probe. The swab of Salter is structurally capable of being broken with enough force at the distal portion that collects a sample. The sample collection probe is removably couplable to the housing, see fig. 1-2. Claim 1 does not provide any structure or material that would differ from the prior art. The probe of Salter is structurally capable of performing this function; the sample swab 1 as shown in fig. 1 is structurally capable of having a breakable distal sample end when enough force is applied to the stem of the swab to break off; further the sample is not positively claimed and can be added at a later time); and
10c. a vial (fig. 3, ref. 4) aligned in said housing (7, vial is threaded to housing 7) in a first position and separable from said housing to a second removed position (the vial 4 is structurally capable of being removed from the housing (vial has threads that attached to housing 7) and having a penetrable barrier seal (fig. 5, ref. 12 or 13) preventing access to said vial until at least one penetrable activation of said breakable sample distal portion of said probe (this limitation is directed to intended use and does not further structurally limit the instant claim; further penetrable barrier seal 12 prevents access to the vial until the swab penetrates the seal as seen in fig. 7 and 9), the second removed position can be used for further testing of the contents of the vial; and wherein said vial comprises a buffer solution enclosed beneath said penetrable barrier seal (see fig. 5, ref. 11, extractant or liquid diluent, para 36); and
wherein said system remains a single-use, self-contained assembly including a sample collection device, said vial (when structures 2, 7 and 4 are assembled it is self-contained as shown in fig. 2) collecting and supporting said introduced surface sample during transport to detect a presence, or an 15absence, of at least one analyte (this limitation is directed to intended use and does not further structurally limit the instant claim. Further the device of Salter is directed to collecting a sample and supporting a swab within housing to detect a presence or absence of at least one analyte due to the reagent being present within the device which reacts with an analyte if present. Applicant has not positively claimed a sample or reagent or reaction element which would provide a presence or absence of an analyte being present within the vial. The sample can be collected and added at a later time to the assembly).
Salter does not teach a lateral flow test strip having at least one control line and at least one test line that undergoes a change, when said analyte is present, within said removed vial to detect at least one analyte, when present (the at least one analyte is not positively recited in the claims and can be present or not in the sample), when contacted with said sample supplied by said sampling probe into said vial in a removed position (this limitation does not further structurally limit the instant claims because the sample is not positively recited as being present within the vial).
Engel teaches a device for assaying analytes in bodily fluids that comprises a container (fig. 1, ref. 16), a sample collecting device (20) and a lateral flow test strip having at least one control line (para 65), and a test line (para 65) for detecting an analyte within a sample fluid (para 65). It is well known in the art that test strips are employed to test for various analytes in bodily fluids as shown by Engel. Therefore, it would have been obvious to one having an ordinary skill in the art to employ a test strip having various reagents thereon to test for analytes within a bodily fluid as disclosed by Engel and is well known in the art. The state at which the lateral flow test strip is placed in the removed vial is not given patentable weight as the vial is in a second state (removed from the housing) and is directed to an intended use/process of using the system. Further the modified Salter is structurally capable of performing the claimed intended use of removing a vial from a housing and placing a test strip of Engel therein in order to test for various analytes in bodily fluids. The modified Salter is adapted upon penetration of seal by distal sampling portion and mixing with a reagent the test strip develops a result indicative of a presence or absence of at least one analyte.
Regarding claim 203, the system of Claim 2, wherein said sampling probe comprises a premoistened tip (this limitation does not further structurally limit the instant claim due to the claim being unclear what percent water content Applicant is referring to when “premoistened tip” is recited. Further a swab used in a humid environment would collect moisture from the surrounding air when exposed. This would constitute a premoistened tip because the swab would absorb surrounding water content from the ambient humid air. Finally, para 10 states a buffer can be added to the sample swab).
Regarding claim 4, the system of Claim 2, wherein said breakable sampling distal end comprises a predetermined length adapted to be substantially received within said vial after penetration of said barrier seal (swab 1 fits within housing 7 as seen in fig. 2).
Regarding claim 5, the system of Claim 1, wherein said sample collection device includes a removable cap (can 2 can be removed from swab 1 with force).
Regarding claim 7, the system of Claim 6, wherein said buffer comprises a deactivation buffer (stabilizing buffer succinate is disclosed in para 41).
Regarding claim 8, the system of Claim 6, wherein said buffer includes at least one preservative (succinate is a stabilizing buffer).
Regarding claim 9, the system of Claim 6, wherein said buffer includes a transport medium (agar is disclosed, para 10).
Regarding claim 10, the system of Claim 1, wherein said vial being removable about said sample collection device to a second position (this limitation does not further structurally limit the instant claims. The vial is removable from sample collection device due to the mating threads as seen in fig. 3, 7. The swab (sample collection device).
Regarding claim 11, the system of Claim 1, wherein said vial being repositionable within said housing body (this limitation does not further structurally limit the instant claims; the vial moves relative to the housing body via the threaded connection; see fig. 7).
Regarding claim 12, the system of Claim 1, wherein said assembly adapted to support sensitive 15detection of at least one analyte selected from a viral antigen, viral antibody toxin, antibiotic, or small molecule (this limitation does not further structurally limit the instant claims because a reactant or reagent is not positively claim. Para 39, 64 states indicators that change color when an analyte is present).
Regarding claim 14, the system of Claim 1, wherein said assembly adapted to collect and support an environmental surface sample (this limitation does not further structurally limit the instant claims, the sample swab is structurally capable of collecting and supporting an environmental surface sample).
Regarding claim 15, the system of Claim 14, wherein said environmental surface sample 25comprising an orbiting surface (this limitation does not further structurally limit the instant claims because the sample is not positively recited. The prior art is structurally capable of collecting an orbiting surface if exposed to said surface).
Regarding claim 16, the system of Claim 14, wherein said environmental surface sample comprising a moon dust (this limitation does not further structurally limit the instant claims because the sample is not positively recited. The prior art is structurally capable of collecting an orbiting surface if exposed to said surface having moon dust).
Response to Arguments
Applicant's arguments filed 1/5/26 have been fully considered but they are not persuasive.
Applicant argues, “Applicant respectfully maintains the principal teachings of the cited references are clearly distinct from Applicant's patentably-unique assembly collection and vial concept. For at least these reasons, reconsideration and immediate allowance is respectfully requested.” No specific argument is made to the previous rejection. Salter teaches a sampling probe (swab) having a breakable sampling distal portion collecting and receiving a surface sample (this limitation does not further structurally limit the sampling probe. The swab of Salter is structurally capable of being broken with enough force at the distal portion that collects a sample. Claim 1 does not provide any structure or material that would differ from the prior art. The probe of Salter is structurally capable of performing this function; further the sample is not positively claimed and can be added at a later time). Further, the prior art of Engel provides a test line that undergoes a change, when said analyte is present, to detect at least one analyte. Claim 1 is directed to a device and therefore the structural components. The claim recites intended use limitation of when an analyte is present but has not positively claim an analyte within the device. The sample can be added at a later time to the device. The modified Salter is adapted upon penetration of seal by distal sampling portion and mixing with a reagent the test strip develops a result indicative of a presence or absence of at least one analyte.
Conclusion
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