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
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/26/2026.
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 7-12 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.
Claims 7-12 are dependent on claim 1 and are directed to an embodiment in which the sample collecting material is on an exterior surface of the bag. However, claim 1, lines 6-7 recite that when the bag is inverted the interior surface is on the outside. Therefore when bag is re-inverted and sealed after sampling as recited in claim 1, lines 10-11 the interior surface must be on the outside.
Since claims 7-12 recite that the sample material in on the exterior surface of the bag, these claim are in conflict with claim 1, because if the bag of claims 7-12 is inverted and re-inverted after sample collection, the sample collection material will be on the wrong side of bag for sample collection and after sample collection when re-inverted.
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.
1. Claims 1-3, 5, 6, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over International Patent Application Publication No. WO2019/079563 to Brown et al. in view of U.S. Patent Application Publication No. 2004/0116828 to White, JR.
Brown et al. teaches a sampling device that comprises a bag 10 that includes a sealable top opening and a sample collection material 30 is secured to an inside surface of the bag by an adhesive or by heat seal. [0021].
In use, sample collection is conducted by a person who places their hand in the inverted bag to facilitate the contacting of at least one food surface of a food product. [0035].
Brown et al. does not teach a sampling port in the bag opposite the sealable opening through with collected sample and be withdrawn from the bag.
White, JR teaches a sampling device that comprises a bag 12 that includes an access port 14 located near the bottom 16 of the collection bag 12 for accessing the specimen contained in the collection bag 12. [0031]
It would have been obvious to one of ordinary skill in the art to modify Brown et al to include a sampling port opposite the sealable opening of the bag as taught by White, JR to extract collected sample from the bag for analysis.
I.) Regarding applicant’s claim 1, as noted above Brown et al. in view of White, JR teaches all the elements of claim 1.
Therefore, Brown et al. in view of White, JR renders claim 1 obvious.
II.) Regarding applicant’s claim 2, as noted above Brown et al. in view of White, JR renders claim 1 obvious from which claim 2 depends.
Claim 2 recites that the sealable opening is a zip style closure, folded closure, twisted closure, or adhesive closure.
Brown et al. teaches that The bag 10 comprises a sealable top opening 20. In an aspect, the bag comprises a closure structure having cooperating interlocking or coupling structures that are engaged together- which is interpreted as a zip style closure. [0018]
Therefore, Brown et al. in view of White, JR renders claim 2 obvious.
III.) Regarding applicant’s claim 3, as noted above Brown et al. in view of White, JR renders claim 1 obvious from which claim 3 depends.
Claim 3 recites that collection material includes one or more layers of hydrophobic foam, hydrophilic foam, open cell foam, non-woven, woven, membrane, fiber, depth, electret, hydrophobic, hydrophilic, or cover-web filtering materials.
Brown et al. teaches that the sample collection material 30 is selected from the group consisting of sponge, cloth or gauze. [0022]
Therefore, Brown et al. in view of White, JR renders claim 3 obvious.
IV.) Regarding applicant’s claim 5, as noted above Brown et al. in view of White, JR renders claim 1 obvious from which claim 5 depends.
Claim 5 recites that collection material is bonded to the bag using one or more of adhesive, glue, tape, solvent bonding, ultrasonic weld, friction weld, laser welding, thermal bonding, or heat laminating.
Brown et al. teaches that the sample collection material 30 is secured to an inside surface of the bag by an adhesive or by heat seal. [0021]
Therefore, Brown et al. in view of White, JR renders claim 5 obvious.
V.) Regarding applicant’s claim 6, as noted above Brown et al. in view of White, JR renders claim 1 obvious from which claim 6 depends.
Claim 1 recites that the collection material is bonded to the interior surface of the bag.
As noted above, Brown et al. teaches that the sample collection material is on an inner surface of the bag.
Therefore, Brown et al. in view of White, JR renders claim 6 obvious.
VI.) Regarding applicants claim 13 as noted above, Brown et al. in view of White, JR renders claim 1 obvious from which claim 13 depends.
Claim 13 recites that the sampling port is bonded into the bag using one or more of adhesive, glue, tape, solvent bonding, ultrasonic weld, friction weld, laser welding, thermal bonding, or heat laminating.
White, JR teaches that the access port is “sealingly secured to and passes through the wall 102 of the collection bag 12.” [0056]
In Brown et al. in view of White, JR it would have been obvious to secure and seal the access port by any conventional means, including one or more of adhesive, glue, tape, solvent bonding, ultrasonic weld, friction weld, laser welding, thermal bonding, or heat laminating.
Therefore, Brown et al. in view of White, JR renders claim 13 obvious.
VII.) Regarding applicants claim 14 as noted above, Brown et al. in view of White, JR renders claim 1 obvious from which claim 14 depends.
Claim 14 recites multiple bags are nested inside of each other such that a user can remove one bag at a time by placing a hand into the bag and removing it from said nest.
In Brown et al. in view of White, JR it would have been obvious to provide multiple bags for multiple testing. Further, storing the bags inside one another would have been an obvious manner to package multiple bags.
Therefore, Brown et al. in view of White, JR renders claim 14 obvious.
2. Claim 4 is rejected under 35 USC 103 as being unpatentable over Brown et al. in view of White, JR as applied to claim 3 above and further in view of U.S. Patent Application Publication No. 2016/0045187 to Terbrueggen et al.
I.) Regarding applicant’s claim 4, as noted above Brown et al. in view of White, JR renders claim 3 obvious from which claim 4 depends.
Claim 4 recites that hydrophobic foam is polyester, polyurethane or a mix of polyester and polyurethane.
While, as noted above, Brown et al. teaches collection material includes one or more layers of hydrophobic foam, hydrophilic foam, open cell foam, non-woven, woven, membrane, fiber, depth, electret, hydrophobic, hydrophilic, or cover-web filtering materials, Brown et al. does not specifically teach a hydrophobic foam that is polyester, polyurethane or a mix of polyester and polyurethane.
Terbrueggen et al. teaches a sample collection material that is a sponge like wicking material comprising cellulosic, polyester, polyvinyl alcohol, foam, porous media or other suitable materials.
It would have been obvious to one of ordinary skill in the art to provide Brown et al. in view of White, JR with a sample collection material in the form of a polyester sponge as taught by Terbrueggen et al. as a simple substitution of one known element for another to obtain predictable results. (MPEP 2143(I)).
Therefore, Brown et al. in view of White, JR and Terbrueggen et al. renders claim 4 obvious.
3. Claims 7-12 and 15 are rejected under 35 USC 103 as being unpatentable over Brown et al. in view White, JR as applied to claim 1 and further in view of U.S. Patent application Publication No. 2020/0241020 to Oshinski.
I.) Regarding applicant’s claim 7, as noted above Brown et al. in view of White, RJ renders claim 1 obvious from which claim 7 depends.
Claim 7 recites that the collection material is bonded to the exterior surface of the bag.
Brown et al. in view of White, JR does not teach that the collection material is bonded to the exterior surface of the bag.
In use, Brown et al. teaches that the sample collection material is exposed on the outer surface of the bag for purposes of sample collection after the bag is inverted. [0004]
Oshinski teaches that it is known cover swab material 435 (sample collecting material) with a cap 410 for purposes of, upon removing the cap, exposing the swab material for sample collection purposes.
It would have been obvious to one of ordinary skill in the art to modify Brown et al. in view of White, JR and provide the sample collection material on the exterior surface of the bag with a removable cap/cup that can be removed to expose the sample collection material for sampling purposes
Therefore, Brown et al. in view of White, JR and Oshinski renders claim 7 obvious.
II.) Regarding applicants claim 8 as noted above, Brown et al. in view of White, JR renders claim 1 obvious from which claim 8 depends.
Claim 8 recites that the collection material is covered by a protective cup that is sealed to an external surface of the bag.
Claim 8 recites that the collection material is covered by a protective cup that is sealed to an external surface of the bag.
As noted above, it would have been obvious to one of ordinary skill in the art to modify Brown et al. in view of White, JR and provide the sample collection material on the exterior surface of the bag with a removable cap/cup that can be removed to expose the sample collection material for sampling purposes
Therefore, Brown et al. in view of White, JR and Oshinski renders claim 8 obvious.
III.) Regarding applicants claim 9 as noted above, Brown et al. in view of White, JR and Oshinski renders claim 8 obvious from which claim 9 depends.
Claim 9 recites that the protective cup is removably bonded to the bag using one or more of adhesive, glue, tape, solvent bonding, ultrasonic weld, friction weld, laser welding, thermal bonding, or heat laminating.
Brown et al. in view of White, JR and Oshinski does not teach that the protective cup is removably bonded to the bag using one or more of adhesive, glue, tape, solvent bonding, ultrasonic weld, friction weld, laser welding, thermal bonding, or heat laminating.
It would have been obvious to one of ordinary skill in the art to provides the protective cap in Brown et al. in view of White, JR and Oshinski in any convenient manner that prevents the cap from inadvertently being removed, but allows user to remove the cap for sampling purposes, including bonding the protective cup to the bag using one or more of adhesive, glue, tape, solvent bonding, ultrasonic weld, friction weld, laser welding, thermal bonding, or heat laminating.
Therefore, Brown et al. in view of White, JR and Oshinski renders claim 9 obvious.
IV.) Regarding applicants claim 10 as noted above, Brown et al. in view of White, JR and Oshinski renders claim 8 obvious from which claim 10 depends.
Claim 10 recites that collection material is filled with collection and extraction fluid before sealing the protective cup to the bag external surface.
Brown et al. in view of White, JR and Oshinski does not teach that the collection material is filled with collection and extraction fluid before sealing the protective cup to the bag external surface.
Oshinski teaches that the swab (sample collection material) can include a buffer and that surfactants can be provided to facilitate interaction of samples with other molecules. [0022], [0050]
It would have been obvious to one of ordinary skill in the art to modify Brown et al in view of White, JR and Oshinski to provide the collection material with collection and extraction fluids as taught by Oshinski for preparing collected samples for analysis.
Therefore, Brown et al. in view of White, JR and Oshinski renders claim 10 obvious.
V.) Regarding applicants claim 11 as noted above, Brown et al. in view of White, JR and Oshinski renders claim 10 obvious from which claim 11 depends.
Claim 11 recites that the collection and extraction fluid contains a buffer.
As noted above, Oshinski teaches that the swab (sample collection material) can include a buffer and that surfactants can be provided to facilitate interaction of samples with other molecules. [0022], [0050]
It would have been obvious to one of ordinary skill in the art to modify Brown et al in view of White, JR and Oshinski to provide the collection material with collection and extraction fluids including a buffer as taught by Oshinski for preparing collected samples for analysis.
Therefore, Brown et al. in view of White, JR and Oshinski renders claim 11 obvious
VI.) Regarding applicants claim 12 as noted above, Brown et al. in view of White, JR and Oshinski renders claim 10 obvious from which claim 12 depends.
Claim 12 recites that the collection and extraction fluid contains a surfactant.
As noted above, Oshinski teaches that the swab (sample collection material) can include a buffer and that surfactants can be provided to facilitate interaction of samples with other molecules. [0022], [0050]
It would have been obvious to one of ordinary skill in the art to modify Brown et al in view of White, JR and Oshinski to provide the collection material with collection and extraction fluids including a surfactant as taught by Oshinski for preparing collected samples for analysis.
Therefore, Brown et al. in view of White, JR and Oshinski renders claim 12 obvious
VII.) Regarding applicants claim 15 as noted above, Brown et al. in view of White, JR renders claim 1 obvious from which claim 15 depends.
Claim 15 recites that collection material is used dry and a liquid extraction fluid is added to the bag after collecting a sample.
As noted above, Oshinski teaches that the swab (sample collection material) can include a buffer and that surfactants can be provided to facilitate interaction of samples with other molecules. [0022], [0050]
It would have been obvious to one of ordinary skill in the art to modify Brown et al in view of White, JR and Oshinski to provide the collection material in a dry form and add collection and extraction fluids to the bag after sample collection as taught by Oshinski for preparing collected samples for analysis.
Therefore, Brown et al. in view of White, JR and Oshinski renders claim 15 obvious
4. Claim 16 is rejected under 35 USC 103 as being unpatentable over Brown et al. in view of White, JR and Oshinski.
As noted above, Brown et al. teaches a sampling device that comprises a bag 10 that includes a sealable top opening and a sample collection material 30 is secured to an inside surface of the bag by an adhesive or by heat seal. [0021].
In use, sample collection is conducted by a person who places their hand in the inverted bag to facilitate the contacting of at least one food surface of a food product. [0035].
Brown et al. does not teach a sampling port in the bag opposite the sealable opening through with collected sample and be withdrawn from the bag.
White, JR teaches a sampling device that comprises a bag 12 that includes an access port 14 located near the bottom 16 of the collection bag 12 for accessing the specimen contained in the collection bag 12. [0031]
It would have been obvious to one of ordinary skill in the art to modify Brown et al to include a sampling port opposite the sealable opening of the bag as taught by White, JR to extract collected sample from the bag for analysis.
As further noted above, In use, Brown et al. teaches that the sample collection material is exposed on the outer surface of the bag for purposes of sample collection after the bag is inverted. [0004]
Oshinski teaches that it is known cover swab material 435 (sample collecting material) with a cap 410 for purposes of, upon removing the cap, exposing the swab material for sample collection purposes.
It would have been obvious to one of ordinary skill in the art to modify Brown et al. in view of White, JR and provide the sample collection material on the exterior surface of the bag with a removable cap/cup that can be removed to expose the sample collection material for sampling purposes
Therefore, Brown et al. in view of White, JR and Oshinski renders claim 16 obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL S. GZYBOWSKI whose telephone number is (571)270-3487. The examiner can normally be reached M-F 8:30-5:00.
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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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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798