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 .
Response to Amendment
The Amendment filed on 9/29/2025 has been entered. Claims 1-20 and 33-42 remain pending in the application.
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 1-7 and 33-42 are 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 recites “the proximal end face is configured to abut a continuous planar surface of the cartridge.” However, the specification doesn’t appear to provide support that the planar surface of the cartridge is continuous. The text of the specification doesn’t mention the surface other than being a surface and the figures only show the surface, but it isn’t clear from the figures that this surface is “continuous.” Therefore, the specification as filed doesn’t appear to provide written description of the surface being continuous.
Claim 2 is 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 2 recites “the sampler body is configured to be secured within a substantially rectangular receptacle.” However, the specification doesn’t appear to provide support for this limitations. The text of the specification doesn’t mention the receptacle other than there being a receptacle and the figures only show the receptacle from a side view and from this side view it isn’t clear what the shape is, as the shape could be rectangular or it could be cylindrical or other shapes and still have the same cross-sectional shape as shown. Therefore, the specification as filed doesn’t appear to provide written description of the receptacle being substantially rectangular.
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.
Claim(s) 1, 4-7, 35 and 37-41 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Application Publication No. 2007/0287965, hereinafter Strong.
Regarding claim 1, Strong teaches a sampler (figure 1) comprising: a sampler body (item 12), a sample port (item 26), and a pump connection port (item 84); wherein the sampler body extends between a distal end face (item 16) and a proximal end face (item 14), each end face being opposite of one another (figure 1), wherein a wall (the walls formed by item 12 between items 14 and 16) of the sampler body is attached to both the distal end face and the proximal end face (figure 1), and wherein the sampler body is configured to hold a sample material (intended use MPEP § 2114 (II) and is taught as the inside of item 12); wherein the sampler body is configured to be secured within a receptacle of a cartridge to removably couple the sampler to the cartridge (intended use MPEP § 2114 (II) the sampler body is capable of being secured within a receptacle of a cartridge); wherein the sample port is configured to be operably connected to a fluidic channel of the cartridge (intended use MPEP § 2114 (II), item 26 would be able to be connected to a fluidic channel of a cartridge); wherein the proximal end (item 14) face is planar (labeled in the annotated figure below), and the sampler extends from the distal end face and terminates at the proximal end face (figure 1), and wherein the proximal end face is configured to abut a continuous planar surface of the cartridge when the sampler body is positioned in the receptacle to form a fluid tight seal defining at least a portion of the fluidic channel of the cartridge (intended use MPEP § 2114 (II)); and wherein the pump connection port is configured to be operably connected to a pump (intended use MPEP § 2114 (II)) configured to cause the sample material to flow through the sample port to the fluidic channel of the cartridge (paragraph [0027]).
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Regarding claim 4, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Strong and the apparatus of Strong is capable of forcing the sample material through the sample port in response to pneumatic forces applied through the pump connection port. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Strong (see MPEP §2114). Further, Strong teaches these limitations in paragraph [0027].
Regarding claim 5, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Strong and the apparatus of Strong is capable of having the pneumatic forces applied to the pump connection port force the sample material out at a controlled flow rate. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Strong (see MPEP §2114). Further, the examiner notes that as the force be applied is controlled, the flow rate would therefore also be controlled and is taught in paragraph [0027].
Regarding claim 6, Strong teaches further comprising a barrier (item 20) positioned within the sampler body between the sample port and the pump connection port (figure 1).
Regarding claim 7, Strong teaches further comprising a puncture portion (item 24) located proximate to the sample port (figure 1) and configured to puncture a second barrier (intended use MPEP § 2114 (II)).
Regarding claim 35, Strong teaches wherein the barrier is a free floating barrier (paragraph [0027]).
Regarding claim 37, Strong teaches further comprising a cap (item 150) removably couplable to the sample port (paragraph [0042]).
Regarding claim 38, Strong teaches wherein the cap is configured to prevent sample material from exiting the sampler body during transport (paragraphs [0042]-[0043]).
Regarding claim 39, Strong teaches wherein the puncture portion is removably couplable to the sample port (paragraph [0026]).
Regarding claim 40, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Strong and the apparatus of Strong is capable of having the sampler body sized to cause the distal end of the sampler to be flush with an outer surface of the cartridge when the sampler is positioned in the receptacle. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Strong (see MPEP §2114). The examiner further notes that the size of the receptacle within the cartridge can dictate whether the sampler body can be flush with the outer surface of the cartridge and the cartridge is not positively recited and therefore limitations on the cartridge has minimal patentable weight (MPEP § 2115).
Regarding claim 41, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Strong and the apparatus of Strong is capable of transporting sample material within the sampler body. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Strong (see MPEP §2114).
Claim Rejections - 35 USC § 103
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strong in view of United States Application Publication No. 2015/0031051, hereinafter Mohan.
Regarding claim 2, Strong teaches wherein the sampler body is configured to be secured within a substantially rectangular receptacle (intended use MPEP § 2114 (II)).
Strong fails to teach the inner surface of the sampler body comprises a hydrophilic material.
Mohan teaches a device which has the inner surface of the device coated with a hydrophilic coating as it would assist in the filling of the channels and containers (Mohan, paragraph [0052]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have coated the inner surface of the sampler body of Strong because it would assist in the filling of the channels and containers (Mohan, paragraph [0052]).
Claim(s) 3 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strong in view of United States Application Publication No. 2016/0114348, hereinafter Cheung.
Regarding claims 3 and 42, Strong teaches all limitations of claim 1; however, Strong fails to teach wherein the pump connection port comprises a vent configured to relieve pressure from within a sampling volume and wherein the vent is positioned between the sampling volume and the exterior environment such that the sample material is prevented from passing through the vent and out of the sampling volume.
Cheung teaches a dispensing apparatus which has a pump connection port (Cheung, item 110) which has a vent (Cheung, vacuum) positioned between the sampling volume and the exterior environment such that the sample material is prevented from passing through the vent and out of the sampling volume (Cheung, figure 1) so that a vacuum can be drawn to prevent the liquid compound from dripping (Cheung, paragraph [0007]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a vent (a vacuum port would function as a vent to reduce pressure) between the sampling volume and the exterior environment because it would allow a vacuum to be drawn to prevent the liquid compound from dripping (Cheung, paragraph [0007]).
Claim(s) 33 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strong in view of United States Application Publication No. 2005/0283113, hereinafter Brinz.
Regarding claims 33 and 34, Strong teaches all limitations of claim 1. Strong is silent with regards to specific material for the piston, therefore, it would have been necessary and thus obvious to look to the prior art for conventional materials for pistons/plungers. Brinz provides this conventional teaching showing that it is known in the art to use PTFE or PVC for the material for a plunger/piston (Brinz, paragraph [0016]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the piston (barrier) from PTFE or PVC motivated by the expectation of successfully practicing the invention of Brinz.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strong and Cheung as applied to claim 3 above, and further in view of Mohan.
Regarding claim 36, Strong and Cheung teach all limitations of claim 3; however, they fail to teach the vent comprises a hydrophobic material.
Mohan teaches a device in which a vent is covered with a porous hydrophobic membrane to mitigate evaporation from a sample (Mohan, paragraph [0410]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a hydrophobic material to the pump port of Strong because it would mitigate evaporation from a sample (Mohan, paragraph [0410]).
Response to Arguments
Applicant's arguments filed 9/29/2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument that the syringe of Strong does not terminate at the collar 30 at least because the dispensing tip and outlet (along other items) extend proximally beyond the collar. The structure of the sampler of Strong which is being utilized for the rejection of the claims is only item 12 and not the dispensing tip or needle of Strong. As the dispensing tip and needle of Strong isn’t considered as part of the sampler, item 12 of Strong would terminate at the collar 30, thereby reading on the instant claims. The device of Strong could additionally be utilized without the dispensing tip and needle and as such would terminate at the collar, thereby reading on the instant limitations.
In response to applicant's argument that the collar of Strong is not configured to abut a continuous planar surface to form a fluid tight sealing defining at least a portion of the fluidic channel of the cartridge, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As described above, the dispensing tip and needle of Strong isn’t required to be utilized when operating the device of Strong and therefore, the collar would be capable of forming a fluid tight seal as described.
In response to applicant's argument that the sampler body is secured in a rectangular receptacle, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The sampler body could be received in rectangular receptacle as there is no structure of Strong which would prevent this ability. The examiner additionally notes that the rectangular receptacle is not part of the claimed invention and therefore as long as the sampler body could be received in a rectangular receptacle, it would read on the instant claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571)272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796