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 .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-12 in the reply filed on 05/15/2026 is acknowledged.
Claims 13-15, 17-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/15/2026.
Status of Claims
Claims 1-15, 17-21 remain pending in the application, with claims 1-12 being examined and claims 13-15, 17-21 remaining withdrawn pursuant to the election filed 05/15/2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the grinding assembly disposed above the first chamber as described in claim 3 and the plurality of apertures that enable fluid communication between the receptacle and the first chamber described in claim 8 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
With reference to claim 3, it appears that the figures are showing the embodiment when the chamber is defined between the first frangible barrier and second frangible barrier and the grinding assembly is located within the chamber. However, there are no figures showing where the grinding assembly is disposed above the first reaction chamber.
With reference to claim 8, it appears that this claim is based on when the first chamber is placed somewhere between the first and second barriers and the grinding assembly is disposed above the first reaction chamber, and because as described above that the figures show the embodiment where the chamber is defined between the two barriers the figures do not show the feature described in claim 8. Please see 112 section below for further details regarding claim 8.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because in figure 7 reference number 155 is used twice and appears to be pointing to different components, as the first 155 is generally pointing to the component as a whole and the second 155 appears to be pointing to a sidewall. Throughout the specification, 155 is used to describe the chamber. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 line 19 recites “in response to the each of the first and second frangible barriers” where it is suggested that this be amended to recite “in response to .
Appropriate correction is required.
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 1-12 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.
Claim 1 recites “a first chamber is formed between the first frangible barrier and the second frangible barrier” on lines 13-14, where it is unclear if it is stating that the first chamber is placed somewhere between these two barriers or if the first chamber is defined by the first frangible barrier and second frangible barrier.
[0005] of the instant specification does describe where in some embodiments the grinding assembly is disposed above the first chamber, and “In other embodiments, the grinding assembly includes a support member, which is configured to concentrically fit within the first chamber such that an outer perimeter defined by an upper surface of the support member is adjacent an inner surface of the first chamber.”
As described above the in the drawings objection section, the figures only appear to be showing the instance where the first chamber is defined by the first frangible barrier and second frangible barrier. In particular, [0037] describes figures 4-5 where “a chamber 155, which is defined between a first frangible barrier (e.g., foil, polymeric membrane) 160 extending across a first section (i.e., a first cross-section) of the device 100 and a second frangible barrier (e.g., foil, polymeric membrane) 165 extending across a second section (i.e., a second cross-section) of the device 100… Each of the first and second barriers 160, 165 are coupled to the upper most surface of each of the chamber 155.” and [0038] recites “the chamber 155 houses a grinding assembly 170,” This is better seen in Figure 7 where the chamber is understood to be the space defined between barrier 160 and 165 and what appears to be sidewalls that are labeled with reference number 155.
Because the specification and drawings only appear to show the instance where the first chamber is defined by the first frangible barrier, one suggested amendment to lines 13-14 may be:
a first chamber defined by
However, please note that if claim 1 is amended to more clearly describe that the first chamber is defined by the first and second barriers (and therefore if the grinding assembly is disposed between the two barriers the grinding assembly would be understood to be within the first chamber) this would make claim 3 unclear because if the grinding assembly is within the first chamber, it cannot at the same time be above the first chamber.
Claims 2-12 are rejected by virtue of being dependent on a rejected claim.
Claim 4 recites “the grinding assembly comprises a support member, the support member configured to concentrically fit within the first chamber” on lines 1-3, where this is unclear because it appears to contradict claim 3.
Claim 3 recites “the griding assembly is disposed above the first chamber”, where now in claim 4 if the grinding assembly comprises a support member that fits within the first chamber how can the grinding assembly be both disposed above the first chamber and within the first chamber at the same time?
Claims 5-8 are rejected by virtue of being dependent on a rejected claim.
Please note that claim 8 describes “the plurality of apertures enable fluid communication between the receptacle and the first chamber.” which may be unclear depending on if the first chamber is disposed somewhere between the first and second barriers or if the first chamber is defined by the first and second barriers. [0050] of the instant specification describes facilitating fluid communication between chamber 155 and repository 200 where the support member 330 includes a plurality of apertures 347 disposed through the upper portion 355. The repository 200 being understood to be different from the receptacle, as receptacle has reference number 300 and is seen in Figure 6. [0052] further describes Figures 9-12 showing the flow through the device where it describes that the piercer member 280 piercing frangible barrier 160 allows contents of receptacle 300 to pass into the first chamber 155, and then as cap 105 is turned the grinding assembly 170 grinds the good within the receptacle 300 and the ground good then flows into the chamber 155 through the apertures of the support member where the good within the chamber 155 is then mixed with buffer solution within the chamber 155. Depending on how claim 1 is amended, claim 8 should be amended so that it is clear how the apertures enable fluid communication between components.
Claim 11 recites “the first foil” on line 5, where there is insufficient antecedent basis for this limitation as no first foil has been recited prior. Should this instead be the “first frangible barrier”?
Claim 12 is rejected by virtue of being dependent on a rejected claim.
Allowable Subject Matter
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, the prior art of record does not teach or suggest each and every limitation of claim 1 as described below.
Bernstein (US-4770853-A) teaches a collection device holder (cap) with a collection device 2 (first piercer member) and a cylindrical tube 13 (collar) with one or more sealed reagent compartments 15 and 20 (column 4 lines 22-28, Figures 1-4). As seen in Figure 4 and described in column 4 lines 46-50 there are two seals 7 shown, where the tip 5 breaks though the seals 7. However, Bernstein does not teach or even suggest a grinding assembly disposed between a first frangible barrier and a second frangible barrier, the grinding assembly comprising a second piercer member. Further, it would not be obvious to one skilled in the art to modify one of the reagent compartments 15 or 20 to have within it a grinding assembly.
Bearinger (WO-2015/061480-A1) teaches an apparatus 100 comprising a reaction chamber 400 (collar) and a punch element 500 (cap) ([0058], Figure 11a-b). [0061] describes that the punch element 500 comprises a cutting element 512 (first piercer member) and liquid chamber 514, and [0059] describes that reaction chamber 400 includes a cutting element 412 (grinding assembly comprising a second piercer member) and reagent chamber 414 where there is a seal 404 seen in Figure 11b. Bearinger does not teach or even suggest where the cutting element is located between a first and second frangible barrier, where the frangible barriers are located in the collar.
Pierce (US-2017/0336305-A1) teaches a blood collector 510 (cap) with a piercing tip 520 (first piercing member) ([0027], Figures 8a-b). It is further described in [0030] and seen in Figure 8A that there is a foil 340 that is broken by the piercing tip 520 when it is inserted, and there is a bottom foil 345 and a piercing projection 830. However, Pierce does not teach or even suggest to have a grinding assembly comprising a second piercer member to be between foil 340 and 345. Additionally, it would not be obvious to one skilled in the art to move the piercing projection 830 to be between these two foils.
DiCesare (US-2002/0001539-A1) teaches where at 53 a piercing member comprised of a circular base 54 and a point 52 ([0063], Figures 4-5). However, the top 19 of sampling wand 17 does not have a first piercing member. Additionally, even though there is an upper seal 29 and first and second seals 49, 50 where the piercing member is seen to be between these components, the chamber formed between these two components does not comprise a buffer solution ([0061], [0065]).
Sundvor (US-2017/0003285-A1) teaches where a first chamber 110 and second chamber 130 are separated by a magnetic diaphragm ([0042]). However, Sundvor does not teach a first and second frangible barrier, or a grinder assembly comprising a second piercing member.
Roswech (US-2022/0128555-A1) teaches where a first rupturing object 123 has a first sharp point or edge 123a facing into a first chamber 117a towards a rupturable ampoule 400 and a second sharp point 123b facing into second chamber 117b ([0055], Figure 5). However, Roswech does not teach frangible barriers extending across a first and second cross section of a collar, nor a cap comprising a first piercer member.
Gire (US-2022/0396836-A1) teaches where a piercer (e.g., a floating piercer) is disposed within a disruptable member 406 (e.g., within the preservation solution) ([0144], Figure 5). However, Gire does not teach a second frangible film nor a grinding assembly comprising a second piercer member.
Claims 2-12 would be allowable by virtue of being dependent on an allowable claim, however please note above 112(b) rejections.
Please note that claims 13-15 and 17-21 are currently withdrawn, but require the limitations of claim 1, and therefore would be allowable by virtue of being dependent on an allowable claim. However, it is respectfully noted that in the event of a rejoinder, the following would be set forth:
Claim 15 would be objected to because lines 3 describes the second piercer moving from a first position to a second position, were lines 4-5 recites “wherein the second end of the piercer is disposed above the second frangible barrier when in the first position, and wherein the second end of the piercer extends below the second cross-section.” where it appears that “when in the second position” or similar should be added to the end of the claim as currently it sounds as though the claim was intending to describe the first and second position but only describes the first.
Claim 18 would be rejected under 112(b) as it recites “a sensor disposed within the collar” on line 13, where because claim 18 requires “placing the food sample within the collar of the device of claim 1” it is unclear if the sensor described on line 13 is the same or different from the sensor described on line 11 of claim 1.
Conclusion
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
