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 § 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(s) 1 – 3 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Byeong Cheol Kim (KR 10-2010-0010792 A; hereinafter “Kim”) in view of Kei Shibazaki (JP2017-026554A; hereinafter “Shibazaki”).
Regarding claim 1, Kim teaches a specimen collection kit apparatus comprising: a lower body 300 having a nozzle 322 having an accommodation space formed to accommodate a stick 230 therein and discharge contents therethrough, and having an opening to which an upper body 200 having the stick 230 coupled thereto to coupled; a knob 210 screw-coupled to the lower body 300; and a cover 500 assembled with the nozzle (see paragraphs 28 – 44 and figures 4 and 10).
Kim does not specifically teach a specimen guiding portion which is provided in the inner surface of a tube body at an outlet side, which prevents an outlet from being clogged by a collection means, and guides a specimen to flow to the outlet.
However, Shibazaki teaches a specimen collection container comprising an extract container 14 which accommodates a swab 20 therein, which has a thin wall portion 32A provided to a bottom part 26A, and can discharge an extract, a swab holding part 36 is provided to the bottom part of the extract container 14 to fix a cotton ball part of the swab thereto, and the swab holding part 36, a structure in which 5 ribs 96 are formed to protrude from a sidewall 26B of an extract container 94 is provided (e.g., paragraphs 9, 24, 51 – 55 and 60 and figures 1 – 14). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the specimen guiding portion as claimed in order to facilitate effective sample handling and collection.
Regarding claim 2, Kim does not specifically teach the specimen collection kit according to claim 1, wherein the tube body is formed of an elastically deformable soft material to allow the collection unit in the accommodation space to be pressed by external force. However, Kim teaches that the lower body 300 includes a soft material so that contents can be pushed and squeezed (paragraph 28, and it is shown that a portion of the lower body 300 is thinner than the other portion thereof (see figure 9). The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). Furthermore, the prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The Courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. Id. at 1366, 80 USPQ2d at 1649. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the tube body is formed of an elastically deformable soft material to allow the collection unit in the accommodation space to be pressed by external force.
Regarding claim 3, Kim does not specifically teach the specimen collection kit according to claim 2, wherein the tube body comprises a pressing portion configured to enable an examiner to press the collection unit by applying external force to the pressing portion from outside, and wherein the pressing portion is formed to have a smaller thickness than the tube body.
However, Kim teaches that the lower body 300 includes a soft material so that contents can be pushed and squeezed (paragraph 28, and it is shown that a portion of the lower body 300 is thinner than the other portion thereof (see figure 9). The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). Furthermore, the prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The Courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. Id. at 1366, 80 USPQ2d at 1649. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the tube body comprises a pressing portion configured to enable an examiner to press the collection unit by applying external force to the pressing portion from outside, and wherein the pressing portion is formed to have a smaller thickness than the tube body.
Regarding claim 7, these additional recited features could be readily derived by a person of ordinary skill in the art from the features taught by Kim wherein the lower body 300 also comprises a space in which a stick 230 is accommodated, and a male screw part 310 to which knob 210 is coupled and comprises nozzle 322 having a less cross-sectional area than the accommodation space and a male screw part 330 to which the cover 500 is coupled (see figure 3). The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). Furthermore, the prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02).
Claim(s) 4 – 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Byeong Cheol Kim (KR 10-2010-0010792 A; hereinafter “Kim”) in view of Kei Shibazaki (JP2017-026554A; hereinafter “Shibazaki”), and further in view of Fiechtner et al. (US 2018/0267030 A1; hereinafter “Fiechtner”).
Regarding claim 4, Kim teaches the specimen collection kit according to claim 2, as discussed above wherein the tube body comprises: a pressing portion configured to enable an examiner to press the collection unit by applying external force to the pressing portion from outside, but does not teach wherein the pressing portion comprises a plurality of gripping grooves formed in an outer side surface of the tube body.
However, Fiechtner teaches a related collection apparatus comprising gripping grooves 305 to facilitate grip by a user (paragraph 69; figures 3A – 3C). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). Furthermore, the prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The Courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. Id. at 1366, 80 USPQ2d at 1649. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the pressing portion comprises a plurality of gripping grooves formed in an outer side surface of the tube body. Similarly, regarding claims 5 and 6, the incorporation of gripping grooves would have been within the ambit of a person of ordinary skill in the art due to routine design choice in order to facilitate effective gripping of the apparatus by a user.
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 8, the cited prior art neither teaches nor fairly suggests the specimen collection kit according to claim 7, wherein the specimen guiding portion comprises a plurality of protrusions located in the inner passage, formed so as to protrude from an inner circumferential surface of the coupling portion, and disposed so as to be spaced apart from each other along the inner circumferential surface of the coupling portion to form inter-protrusion passages therebetween to allow the specimen to flow through the inter-protrusion passages.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ohtsuka et al. (US 2011/0239793 A1) teach an extraction method and apparatus. Kirby (US 2009/0215159 A1) teaches a device for handling and analysis of a biological sample. Flanigan et al. (US 2009/0030342 A1) teach a sampling apparatus and method. Tuite et al. (US 2004/0267181 A1) teach a swab sample collection and recovery device.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796