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 Status
Claims 1-14 are pending and are examined.
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, 2, 3, 4, 6, and 8 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 the limitation "the insert portion". There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the main portion". There is insufficient antecedent basis for this limitation in the claim.
Dependent claims are rejected by virtue of being dependent on a rejected base claim.
Claim Rejections - 35 USC § 102
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.
Claims 1-4 and 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ohse (US Pub 2008/0116204; previously cited).
Regarding Claim 1, Ohse teaches reagent container cap that is mountable to a separate reagent container, and that is adjustable, at least after an initial opening of the cap, between an opened state and a closed state ([0028] As shown in FIGS. 1 through 4, a container 10 with lid in this preferred embodiment comprises: a tubular container body 12),
wherein the reagent container cap defines a cap interior space and has a cap opening;
wherein the cap comprises an annular gap formed between an insert portion and the main portion, the annular gap being adapted to accommodate an upper end of the reagent container ([0031] The side face of the cylindrical portion 16c has a groove portion 16e which extends in circumferential directions),
wherein, under normal operating conditions in which the cap is vertically oriented so that the cap opening faces upwards:
in the opened state of the cap, the cap opening allows access to the cap interior from above (see Fig. 4 for the annular gap), and
in the closed state of the cap, the cap interior space is open only towards a bottom side, and an upper end region of the cap interior space delimited circumferentially and towards the upper side thereof completely and exclusively by surfaces of the insert portion (a first lid portion 14 for opening and closing the opening 12a of the container body 12; a second lid portion 16 for opening and closing an opening 14a which is formed in the first lid portion 14; a first connecting portion 18 which connects the container body 12 with the first lid portion 14; and a second connecting portion 20 which connects the first lid portion 14 with the second lid portion 16.).
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Regarding Claim 2, Ohse teaches the reagent container cap according to claim 1, wherein the main portion comprises a main portion material and the insert portion comprises an insert portion material which is more resistant to a given solvent and/or more flexible than the main portion material ([0032] The central portion of the first connecting portion 18, except for both end portions thereof, is thin to such an extent that it can be folded as shown in FIGS. 11 and 12. Thus, the opening 12a of the container body 12 can be closed by the first lid portion 14 as shown by arrow B in FIG. 4.).
Regarding Claim 3, Ohse teaches the reagent container cap according to claim 2, wherein the main portion material is polypropylene and the insert portion material is a thermoplastic olefin or a low-density polyethylene (The container body 12, first lid portion 14, second lid portion 16, first connecting portion 18 and second connecting portion 20 are made of a flexible resin material, such as polypropylene, having excellent chemical resistance and heat resistance, and are integral-molded by injection molding or the like.).
Regarding Claim 4, Ohse teaches the reagent container cap according to claim 1, wherein the main portion and the insert portion have interlocking structures adapted to engage with each other in order to fixedly connect the main portion and the insert portion ([0028] As shown in FIGS. 1 through 4, a container 10 with lid in this preferred embodiment comprises: a tubular container body 12 having a bottom at the lower end thereof and an opening 12a at the upper end thereof; a first lid portion 14 for opening and closing the opening 12a of the container body 12; a second lid portion 16 for opening and closing an opening 14a which is formed in the first lid portion 14; a first connecting portion 18 which connects the container body 12 with the first lid portion 14; and a second connecting portion 20 which connects the first lid portion 14 with the second lid portion 16.).
Regarding Claim 6, Ohse teaches the reagent container cap according to claim 1, comprising a cap body and a lid hinged thereto so as to be pivotable around a pivot axis (P) between a closed position and an opened position in order to adjust the cap between the closed state and the opened state, the cap body comprising a body main portion and a body insert portion fixedly connected to each other, the lid comprising a lid main portion and a lid insert portion fixedly connected to each other, wherein the main portion of the reagent container cap comprises the body main portion and the lid main portion and wherein the insert portion of the reagent container cap comprises the body insert portion and the lid insert portion ([0032] As shown in FIGS. 1 through 4, the first connecting portion 18 comprises a strip-like portion which substantially linearly extends from a portion near the upper end of the side face of the large-diameter portion 12c of the container body 12 to a portion near the lower end (the lower end in FIGS. 3 and 4) of the side face of the first lid portion 14 to connect the container body 12 with the first lid portion 14. The central portion of the first connecting portion 18, except for both end portions thereof, is thin to such an extent that it can be folded as shown in FIGS. 11 and 12. Thus, the opening 12a of the container body 12 can be closed by the first lid portion 14 as shown by arrow B in FIG. 4.).
Regarding Claim 7, Ohse teaches the reagent container cap according to claim 6, wherein the body insert portion comprises a neck portion defining the cap opening and the lid insert portion comprises a plug portion to be inserted into the neck portion when pivoting the lid to the closed position ([0028] The container 10 with lid in this preferred embodiment further comprises a first sealing member 22 mounted on the first lid portion 14, and a second sealing member 24 mounted on the second lid portion 16.).
Regarding Claim 8, Ohse teaches the reagent container cap according to claim 1, wherein the insert portion has a closure part adapted to be perforated and/or opened by a needle of a pipetting device of an analytical apparatus in order to adjust the cap to the opened state, said closure part furthermore being adapted to automatically adjust the cap to the closed state after the needle is removed ([0034] The closing portion 22d comprises a substantially plate-like portion which is slightly inclined upwards as a distance from the center thereof decreases. The closing portion 22d has a cross-shaped cut 22f which is made therein so as to cross at the center thereof as shown in FIG. 7, so that a pipette chip or like can be inserted into the container body 12 through the cut 22f to pipette a liquid from the container body 12 even if the opening 12a of the container body 12 is closed by the first lid portion 14 as shown in FIG. 12.).
Regarding Claim 9, Ohse teaches the reagent container cap according to claim 1, wherein the reagent container cap is furthermore adapted to be mounted to a support structure for accommodating at least one reagent container (the cap is capable of being mounted to a support structure).
Regarding Claim 10, Ohse teaches the reagent container unit, comprising: a reagent container having a top-side opening, a reagent container cap according to claim 1, the reagent container cap being mounted or mountable to the reagent container ([0032] As shown in FIGS. 1 through 4, the first connecting portion 18 comprises a strip-like portion which substantially linearly extends from a portion near the upper end of the side face of the large-diameter portion 12c of the container body 12 to a portion near the lower end (the lower end in FIGS. 3 and 4) of the side face of the first lid portion 14 to connect the container body 12 with the first lid portion 14. The central portion of the first connecting portion 18, except for both end portions thereof, is thin to such an extent that it can be folded as shown in FIGS. 11 and 12. Thus, the opening 12a of the container body 12 can be closed by the first lid portion 14 as shown by arrow B in FIG. 4.).
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.
Claims 5, 11, 12, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ohse (US Pub 2008/0116204; previously cited), in view of Walsh (US Pub 2019/0030527; previously cited).
Regarding Claim 5, Ohse teaches the reagent container cap according to claim 1.
Ohse is silent to the main portion having an attachment structure, in particular a snap structure or a thread structure, which is adapted to attach the reagent container cap to a reagent container from the outside.
Walsh teaches in the related art of a container and cap. [0446] In some embodiments, the body 1205 may include a flange 1255 that is configured to engage the flange 1254 of the end cap. In some embodiments, the flange 1255 may be disposed circumferentially about the tapered region 1203 of the body 1205 and oriented towards the flange 1254 of the end cap 1250, as shown in the embodiment of FIGS. 225, 226, 228-234, and 236-238. In some embodiments, the flanges 1254, 1255 may be removably or semi-permanently attached to each other. For example, in some embodiments, a threaded connection (not shown), snap connection (not shown), or other removable engagement may be formed between the body flange 1255 and the end cap flange 1254.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a snap, as taught by Walsh, to attach the cap to the container, in the device of Ohse, to allow for a simple attachment for opening and closing.
Regarding Claim 11, Ohse teaches the reagent container unit according to claim 10.
Ohse is silent to the reagent container being made from glass.
Walsh teaches in [0347]. The body (e.g., bodies 105, 505, 705, 905) of the separation container can be molded, blow-molded, or formed using other well-known techniques in the art. In general, any known plastic, glass, or transparent material, or the like, can be used for the separation device.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used glass, as taught by Walsh, to form the reagent container in the device of Ohse, to allow for a container that can be sterilized or autoclaved.
Regarding Claim 12, Ohse teaches the single reagent container unit or at least one of the plurality of reagent container units is a reagent container unit with the features of claim 10 and reagent kit (see teachings of claim 10).
Ohse is silent to a support structure, a single reagent container unit or a plurality of reagent container units accommodated on the support structure, each reagent container unit comprising a reagent container and a reagent container cap mounted or mountable thereto.
Walsh teaches [0346] In some further embodiments, the body 105 may include one or more brackets (e.g., hexagonal bracket 150 shown in FIG. 1) for engaging the centrifugation assembly and providing support for the separation container. The hexagonal bracket 150 may allow the user to grip the separation container and may support the separation container in the centrifuge holder. In some embodiments, the hexagonal bracket 150 may adapt the separation container to one or more different centrifuge holders, and in some embodiments, the hexagonal bracket 150 may suspend the base of the separation container above the base of the centrifuge. The projections may also aid in manufacturing the separation container. For example, the projections may be an alignment aid. In some embodiments, the projections are designed with one or more flat surfaces. For example, two opposing flat surfaces may be used instead of the hexagonal orientation. The one or more flat surfaces engage a socket that is configured to apply consistent torque when securing the seal (e.g., a nut) to the bottom of the separation 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 have added a support structure, a single reagent container unit or a plurality of reagent container units accommodated on the support structure, each reagent container unit comprising a reagent container and a reagent container cap mounted or mountable thereto, as taught by Walsh, to the device of Ohse, to allow for a secure holder to support a device with a container and cap.
Regarding Claim 13, Ohse teaches the reagent kit according to claim 12 and the reagent container cap of the single reagent container unit or of at least one of the plurality of reagent container units is adapted to being fitted to the support structure from above (see teachings of claim 12).
Ohse is silent to the reagent kit comprising a key and slot joint between this reagent container cap and the support structure, the key and slot joint comprising a key part provided on one element of the reagent container cap and the support structure and a slot part provided on the other element of the reagent container cap and the support structure, the key part vertically protruding from an adjacent region of the one element and the slot part comprising two vertical surface portions facing each other and adapted to receive the key part therebetween when the reagent container cap is fitted to the support-structure.
Walsh teaches [0346] In some further embodiments, the body 105 may include one or more brackets (e.g., hexagonal bracket 150 shown in FIG. 1) for engaging the centrifugation assembly and providing support for the separation container. The hexagonal bracket 150 may allow the user to grip the separation container and may support the separation container in the centrifuge holder. In some embodiments, the hexagonal bracket 150 may adapt the separation container to one or more different centrifuge holders, and in some embodiments, the hexagonal bracket 150 may suspend the base of the separation container above the base of the centrifuge. The projections may also aid in manufacturing the separation container. For example, the projections may be an alignment aid. In some embodiments, the projections are designed with one or more flat surfaces. For example, two opposing flat surfaces may be used instead of the hexagonal orientation. The one or more flat surfaces engage a socket that is configured to apply consistent torque when securing the seal (e.g., a nut) to the bottom of the separation container. [0455] As discussed in connection with other embodiments herein, the body 1205 may include a first distal end 1206, a second distal end 1207, a tapered region 1203, a pellet region 1204, a collection region 1202, a widened region 1208, and a wall 1209, each of which may operate and may be structured as described in each embodiment herein. The separation container 1200 may further include a retainer 1232 attached to the body 1205 in the widened region 1208. In some embodiments, with reference to FIGS. 243, 244, 249, and 251, the widened region 1208 of the body 1205 may include one or more slots 1265 which may receive and secure the retainer 1232 therein.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a key and slot joint between this reagent container cap and the support structure, the key and slot joint comprising a key part provided on one element of the reagent container cap and the support structure and a slot part provided on the other element of the reagent container cap and the support structure, the key part vertically protruding from an adjacent region of the one element and the slot part comprising two vertical surface portions facing each other and adapted to receive the key part therebetween when the reagent container cap is fitted to the support-structure, as taught by Walsh, to the device of Ohse, to allow for a secure holder to support a device with a container and cap.
Regarding Claim 14, Ohse teaches the reagent kit according to claim 12, wherein the reagent container cap of the single reagent container unit or of at least one of the plurality of reagent container units is adapted to being mounted to the support structure from above (see teachings of claim 12 above).
Ohse is silent to one element of this reagent container cap and the support structure comprises a deformation protrusion arrangement and the other element comprises a deformation zone associated to the deformation protrusion arrangement, wherein the associated deformation zone is adapted to being deformed by the deformation protrusion arrangement when the reagent container cap is mounted to the support structure.
Walsh teaches [0373] During centrifugation, the body 1005 of the separation container may flex slightly (e.g., as shown in the displacement diagram of FIG. 223) in a radially outward direction under the pressure of the liquid inside the separation container 1000, increasing the diameter of the internal chamber 1011 and wall 1009 of the body 1005 to a second diameter. In such embodiments, the body 1005 may be made of an at least partially flexible material (e.g., low density polyethylene). With reference to FIG. 223, the displacement visualization shows a 0.66 mm displacement in the x (radial) direction. The finite element analysis in FIG. 223 is of a low density polyethylene body 1005 having a 15 mL volume. The applied pressure during the FEA was 3.2 MPa at the base of the body 1005. The second diameter may be greater than the outermost diameter of the rheological control member 1042 such that the deformation of the wall 1009 may release the interference fit between the rheological control member 1042 and the wall 1009 and allow fluid to flow therebetween. [0424] Turning now to FIGS. 90-136, a second embodiment of the separation container 500 is shown without a plunger assembly. The separation container 500 may include a body 505 with a deformable wall 509 that allows a user to squeeze the body to extract the microorganism after centrifugation.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added one element of this reagent container cap and the support structure comprises a deformation protrusion arrangement and the other element comprises a deformation zone associated to the deformation protrusion arrangement, wherein the associated deformation zone is adapted to being deformed by the deformation protrusion arrangement when the reagent container cap is mounted to the support structure, as taught by Walsh, to the device, as taught by Ohse, to allow for a flexible configuration when the device is in use.
Response to Arguments
Applicant’s arguments, see page 6, filed 3/19/26, with respect to the 112b rejection have been fully considered and are persuasive. The 112b rejection of claims 2-14 has been withdrawn.
Applicant's arguments filed 3/9/26 regarding the 102 rejections have been fully considered but they are not persuasive.
First, Applicant argues on page 8 that Ohse does not disclose a cap that is mountable to a separate reagent container. Applicant argues the objective problem is to decrease the probability that part of the reagent container cap made from the main portion material will come into contact with the contents of a separate reagent container on which the cap is mounted.
In response, the examiner notes that the preamble of claim 1 “a reagent container cap that is mountable to a separate reagent container” only positively recites a cap while the container is not part of the claimed invention.
Second, applicant argues that Ohse does not teach an annular gap formed between the main portion and the insert portion. Applicant further argues that the upper end region of the interior space of the cap is not completely delimited in a circumferential direction and towards the upper side by surface of the insert portion, as recited in claim 1.
In response, the examiner notes that the prior art of Ohse teaches an annular gap formed between the main portion and the insert portion. The circumferential grooves form an annular gap.
Conclusion
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 JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-5.
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, 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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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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