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 .
Amendment Entered
This Office action is responsive to the Amendment filed on July 23rd, 2025. The examiner acknowledges the cancellation of claims 18-22. Claims 1, 2, 4, and 7 remain pending in the application.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 have been fully considered but are not persuasive.
At pages 5-6, Applicant argues that the combination of Okada and Franz does not disclose, teach, or suggest “the dipstick cap including a second projection configured to seal the open-ended cone with the dipstick cap coupled to the first open end” and “wherein the dipstick is removable coupled to the second projection of the dipstick cap” as Franz does not disclose that the conical sealing element 22 is related to the retaining the sample holder 11 and further that the only reason that exists to modify Okada’s annular holding portion or fitting groove 3b based on Franz’s conical sealing element is based on the Applicant’s own disclosure. Examiner respectfully disagrees.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Furthermore, Franz discloses that the closure should preferably have a seal that seals the closure with respect to the first container, that the seal may include a conical sealing element, and further that in order to achieve an effective seal between the first container and the closure, an internal contour on the first container may preferably be formed to have a conical shape forming a sealing edge (para. [0026-0028]). Franz further discloses the stripping device 21 having calibration hole 19 (as seen in fig. 1c) (open-ended cone as recited in claim 1) which is shown as being formed within the conical contour of the first container.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Okada such that the dipstick cap further comprises the second projection configured to seal the open-ended cone with the dipstick cap coupled to the first open end, in view of the teachings of Franz, as such a modification would have been merely a substitution of through hole of Okada for the conical shaped internal contour having the stripping device and calibration hole of Franz, and incorporating the conical sealing element of Franz into the annular holding portion of Okada for the obvious advantage of achieving an effective seal between the container and the closure as the closure is placed on the container to seal it tightly.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Okada (US 20110146420 A1) in view of Franz (US 20200170626 A1).
Regarding claim 1, Okada discloses extraction device (a container for specimen, fig. 48) comprising: a tube (“intermediary unit 4 … tube”, para. [0213], fig. 48) having a first open end (4a/4a2, as seen in fig. 48) and a second open end generally opposite from the first open end (4a/4a1, as seen in fig. 48) (“both ends of the connection portion 4a are opened”, para. [0213]); the tube further including an open-ended cone (vicinity of the through hole 4b.sub.1 is formed in the shape of a cone to slope toward the through hole 4b.sub.1, para. [0214, 0431], figs. 48 & 54B); a dipstick (specimen picking rod 2, fig. 48) configured to (Examiner’s Note: functional language, i.e., capable of) be inserted into the tube at the first open end (as seen in fig. 48, rod 2 holding the specimen is pushed into the through hole, para. [0219]), the dipstick having one or more grooves at a first end (specimen picking rod 2 includes a specimen-picking groove 2e, para. [0375], fig. 48), the one or more grooves (specimen-picking groove 2e, fig. 48) configured to (Examiner’s Note: functional language, i.e., capable of) retain a predefined amount of collected material (hold a predetermined amount of a specimen in a state of the specimen-picking rod, para. [0146]) in which the dipstick is inserted prior to inserting the dipstick into the tube (as seen in figs. 54A-54D); a dipstick receiver cap (container 1, fig. 48) removably coupled to the tube (intermediary unit 4, para. [0213]) at the second open end (intermediary unit 4 is formed in such a way that the one end of the connection portion 4a can be removably fit to the open end of the container body 1 through the threads 4a11 and the other end of the connection portion 4a can be removably fit to the cover member 3 through the threads 4a21, fig. 1A, para.[0213]), including the first projection (convex removing portion 6/specimen-pushing portion 4e including specimen-pushing groove 4e1, figs. 1A & 48) configured to (Examiner’s Note: functional language, i.e., capable of) have a complementary fit (“threadedly fit”, para. [0375]) with the one or more grooves so as to remove at least some of the predefined amount of collected material from the one or more grooves (specimen picking groove 2e and the specimen-pushing groove 4e can be threadedly fit to each other; the specimen … pushed out by the specimen-pushing portion 4e; the picked specimen is fragmented to become easy to disperse in the preservation liquid, para. [0375, 0380]); and a dipstick cap (cover member 3) removably coupled to the tube at the first open end (“the connection portion 4a can be removably fit to the cover member 3”, para. [0213], fig. 48), the dipstick cap (cover member 3, fig. 31B) including a second projection (annular holding portion 3b, figs. 16A-C, para. [0306]), wherein the dipstick is removably coupled to the second projection of the dipstick cap (cover member 3 may be formed in such a way that the cover member 3 is provided with the fitting groove 3b as in the tenth embodiment which is shown in FIG. 16 and is furthermore provided with a thread, a concave-convex portion, or the like for example so that the specimen-picking rod 2 can be removably fit to the cover member 3, para. [0416]).
Okada does not disclose the second projection configured to seal the open-ended cone with the dipstick cap coupled to the first open end.
However, Franz discloses an open-ended cone (the first container may have a conical inner contour at the first container opening; stripping device 21, fig. 5b, para. [0028, 0094]); and dipstick cap (closure 17, para. [0097]) including the second projection (conical sealing element 22, para. [0097]) configured to (Examiner’s Note: functional language, i.e., capable of) seal the open-ended cone with the dipstick cap coupled to the first open end (as seen in fig. 2c, conical sealing element; in order to achieve an effective seal between the first container and the closure, an internal contour on the first container may preferably be formed to have a conical shape; the first container may have a conical inner contour at the first container opening which forms a sealing edge; closure 17 has been placed on the first container 1 to seal it tightly, para. [0026, 0028, 0091, 0101]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Okada such that the dipstick cap further comprises the second projection configured to seal the open-ended cone with the dipstick cap coupled to the first open end, in view of the teachings of Franz, as such a modification would have been merely a substitution of through hole of Okada for the conical shaped internal contour having the stripping device and calibration hole of Franz, and incorporating the conical sealing element of Franz into the annular holding portion of Okada for the obvious advantage of achieving an effective seal between the container and the closure as the closure is placed on the container to seal it tightly.
Claims 2 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Okada in view of Franz, as applied to claim 1 above, and further in view of Zhou (US 20040019295 A1).
Regarding claim 2, Okada, as modified by Franz hereinabove, further discloses the extraction device of claim 1. Okada, as modified by Franz hereinabove, does not disclose wherein the one or more grooves comprise a helical groove.
However, Zhou discloses wherein the one or more grooves comprise a helical groove (stick 12 has sample holding portion 15 which has helicoidal grooves to hold a sample, fig. 1, para. [0006, 0010]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Okada, as modified by Franz hereinabove, such that the one or more grooves comprise a helical groove as disclosed by Zhou as such a modification would have been merely a substitution of the specimen-picking groove of Okada for the well-known sample holding portion of Zhou to collect and retain material.
Regarding claim 7, Okada, as modified by Franz hereinabove, further discloses the extraction device of claim 1, wherein the open-ended cone (vicinity of the through hole 4b.sub.1 is formed in the shape of a cone to slope toward the through hole 4b.sub.1, para. [0214, 0431], figs. 48 & 54B) is configured to (Examiner’s Note: functional language, i.e., capable of) remove excess collected material from the dipstick upon the dipstick being inserted through the open-ended cone (as seen in fig. 54B, “a surplus part of the picked artificial stool E which adhered to the side surface of the specimen-picking rod 2 was removed to the upper portion of the through hole 4b.sub.1 of the penetration wall 4b “para. [0431]). Okada, as modified by Franz hereinabove, does not expressly disclose wherein a profile of the open- ended cone matches a cross-section of the dipstick.
However, Zhou discloses wherein a profile of the open-ended cone matches a cross-section of the dipstick (fig. 1, para. [0006, 0010, 0015] cross-section of the non-grooved part of the sample-holding portion closely match the cross-sectional profile of the aperture).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Okada, as modified by Franz hereinabove, such that a profile of the open-ended cone matches a cross-section of the dipstick, in view of the teachings of Zhou, as such a modification would have yielded predictable results, namely ensuring that excess material is removed from the sampling portion so that only a predefined amount of material is left on the sampling portion to be diffused into a fluid for testing by providing a cross-section of the sample-holding portion that closely matches the profile of the aperture (Zhou, para. [0015]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Okada in view of Franz, as applied to claim 1 above, and further in view of Flanigan (US 20090030342 A1).
Regarding claim 4, Okada, as modified by Franz hereinabove, further discloses the extraction device of claim 1. Okada does not expressly disclose wherein the first projection is an annular ring.
However, Flanigan discloses wherein the first projection (abrasion element 50B, fig. 3) is an annular ring (annular ring 53, fig. 3, para. [0054]). Flanigan further discloses the abrasion element physically dislodges and removes the sample material from the sample acquisition device (para. [0042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Okada, as modified by Franz hereinabove, such that the first projection is an annular ring, in view of the teachings of Flanigan, as such a modification would have been merely a substitution of the cylinder-shaped specimen-pushing portion for the annular ring of Flanigan to push specimen to dislodge and remove sample material from the sample acquisition device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: De Luca (EP 1366715 A1), which discloses an extraction and sampling device having a top cap 4 comprising stem 46, tang 48, and seal 48’, a small rod 49 provided axially beneath the tang, and a container 2 having a hole 26 with a tapered part 26’ that is sealably engaged with the seal 48’, para. [0034-0035, 0041].
THIS ACTION IS MADE FINAL. 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 ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
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http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached on (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/A.E.H./Examiner, Art Unit 3791