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 Arguments
Applicant’s arguments with respect to claims 1-20 filed 6/1/2026 have been considered but are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
The previous rejection of claims 1-20 under 35 U.S.C. 112(b) are withdrawn in view of the amendments to the claims. However, amendments to the claims present new issues under 35 U.S.C. 112(b) discussed below.
Claim Objections
Claim 2 is objected to because of the following informalities:
In claim 2, line 5, “not in fluid communicating” appears to be a typographical error and should read “not in fluid communication”.
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 2-16 and 18-20 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.
Regarding claim 2, the phrase “the third bag not in fluid communication with the first bag or the second bag” renders the claim indefinite in light of the specification. This appears inconsistent with the specification disclosure - see [0023] and Fig. 4 describing and showing third bag in fluid communication with the first bag and second bag (MPEP § 2173.03).
Claims 3-16 are similarly rejected as they depend upon rejected claim 2.
Claims 3 and 18 each recite the limitation "the separator bag" in lines 4-5 and line 15 respectively. There is insufficient antecedent basis for this limitation in the claim. For examination on the merits, the separator bag will be interpreted as the separation bag as preceding claims or limitations provide sufficient antecedent basis.
Further regarding claim 18, the phrases “the fourth bag not in fluid communication with the first bag or the second bag or the third bag” and “the fifth bag not in fluid communication with the first bag or the second bag or the third bag or the fourth bag” each render the claim indefinite in light of the specification. It is unclear how the fourth bag or fifth bag with other bags as this appears inconsistent with the specification disclosure (see [0025] describing fluid connection between bags of note via bags, tube lengths and a connector, also see Fig. 4) (MPEP § 2173.03). For examination on the merits, the limitations will be interpreted as the fourth bag not in fluid communication with the first bag or the second bag or the third bag during operation of the disposable bag set and the fifth bag not in fluid communication with the first bag or the second bag or the third bag or the fourth bag as this appears to be consistent with the written disclosure (see [0063] describing controlling of flow to and from fourth bag during operation).
Claims 4-16 and 19-20 are similarly rejected as they depend upon rejected claims 3 and 18, respectively.
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.
Claims 1-3 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holmes et al. (US 2004/0104182 A1) (already of record).
Regarding claim 1, Holmes discloses a disposable bag set (abstract; [0102], lines 25-27) for separating discrete volumes of a composite fluid, the disposable bag set comprising:
a separation bag (Fig. 3, separation bag 11) including the composite fluid ([0062], “Whole blood…may then be passed from bag 20 into separation container 11”) to be separated;
a first bag in indirect fluid communication with the separation bag (Fig. 3, component container 14 in indirect fluid communication with separation bag 11 through in-line filter 72 and connector 31 – see [0063] defining 31 as a connector), the first bag configured to receive a first component of the composite fluid from the separation bag; and
a second bag in fluid communication with the first bag and not the separation bag (Fig. 3, satellite bag 75 in fluid communication with component container 14), the second bag configured to receive fluid directly from the first bag and not directly from the separation bag (Fig. 3 shows that the second bag would receive fluid directly from component container 14 and indirectly from separation bag 11), the second bag configured to receive a product formed using the first component.
The limitation “configured to receive a first component of the composite fluid from the separation bag” is directed toward the intended manner of operating the claimed first bag and does not differentiate the claimed first bag from the prior art first bag because all structural limitations are taught in the prior art (MPEP § 2114 II). The first bag taught by Holmes would be fully capable of achieving every claimed intended use because the prior art first bag is capable of receiving a component from a separation bag ([0075]).
The limitation “configured to receive a product formed using the first component” is directed toward the intended manner of operating the claimed second bag and does not differentiate the claimed second bag from the prior art second bag because all structural limitations are taught in the prior art (MPEP § 2114 II). The second bag taught by Holmes would be fully capable of achieving every claimed intended use because the prior art second bag is capable of receiving a product formed by a component ([0111]).
The limitation wherein a product is formed using the first component is directed towards the material or article worked upon by the claimed apparatus and does not limit the claim which it depends upon (MPEP § 2115).
Regarding claim 2, Holmes discloses the disposable bag set of claim 1, wherein the disposable bag set further includes:
a third bag in fluid communication with the separation bag (Fig. 3, third collection bag 24 in fluid communication with separation bag 11), the third bag configured to receive fluid from the separation bag, the third bag not in fluid communication with the first bag or the second bag (Fig. 3, third collection bag 24 not connected to collection bag 14 or satellite bag 75), the third bag configured to receive a second component of the composite fluid from the separation bag, the second component being different from the first component and the product.
The limitation “configured to receive fluid from the separation bag” is directed toward the intended manner of operating the claimed third bag and does not differentiate the claimed third bag from the prior art third bag because all structural limitations are taught in the prior art (MPEP § 2114 II). The third bag taught by Holmes would be fully capable of achieving every claimed intended use because the prior art third bag can receive a component from a separation bag ([0018]).
The limitation wherein the second component is different from the first component and the product is directed towards the material or article worked upon by the claimed apparatus and does not limit the claim which it depends upon (MPEP § 2115).
Regarding claim 3, Holmes discloses the disposable bag set of claim 2, wherein the disposable bag set further includes:
a fourth bag in fluid communication with the separation bag (Fig. 3, component container 12 connected to separation bag 11), the fourth bag configured to receive fluid from the separation bag, the fourth bag not in fluid communication with the first bag or the second bag or the third bag (Fig. 3, component container 12 not connected to bags 14, 75, or 24), the fourth bag configured to receive a third component of the composite fluid from the separation bag, the third component being different from the first component, the second component, and the product.
The limitations “configured to receive fluid from the separation bag” and “configured to receive a third component of the composite fluid from the separation bag” are directed toward the intended manner of operating the claimed fourth bag and do not differentiate the claimed fourth bag from the prior art fourth bag because all structural limitations are taught in the prior art (MPEP § 2114 II). The fourth bag taught by Holmes would be fully capable of achieving every claimed intended use because the prior art fourth bag can receive a component of whole blood ([0078]).
The limitation wherein the third component is different from the first component, the second component, and the product is directed towards the material or article worked upon by the claimed apparatus and does not limit the claim which it depends upon (MPEP § 2115).
Regarding claim 17, Holmes discloses the disposable bag set of claim 1, wherein a tube length establishes fluid communication between the first bag and the second bag (Fig. 3, line 77).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes in view of Nguyen et al. (US 2011/0312481 A1) (already of record – hereinafter referred to as Nguyen).
Regarding claim 4, Holmes discloses the disposable bag set of claim 3, wherein the disposable bag set further includes:
a collection of tubes connecting the separation bag to the first bag, the second bag, and the fourth bag (Fig. 3, tubes 15, 77, and 13).
Holmes is silent to the collection of tubes including: a first tube length establishing fluid communication between the separation bag and a connector; a second tube length establishing fluid communication between the connector and the first bag; a third tube length establishing fluid communication between the connector and the third bag; and a fourth tube length establishing fluid communication between the connector and the fourth bag.
However, Nguyen in the art of blood component separation teaches it is known in the art to use a collection of tube lengths to establish fluid communication between separation bags, component collection bags, and a connector (Fig. 1, tubes 18, 32, 46, and 36, and connector 34).
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 the disposable bag set of Holmes to further comprise the collection of tubes as claimed, as Nguyen teaches such a form is suitable for separating blood.
Claims 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Holmes.
Regarding claim 5, Holmes discloses the disposable bag set of claim 3.
Holmes is silent to a fifth bag in fluid communication with the separation bag and claimed limitations associated with a fifth bag.
Although Holmes is silent to a fifth bag, it would have been obvious to one of ordinary skill in the art to modify the prior art combination disposable bag set to further comprise a fifth bag in fluid communication with the separation bag as such a modification represents mere duplication of the fourth bag in fluid communication with the separation bag. It has been held that the duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP §2144.04 VI B). Such a modification would predictably enhance collection capabilities of the disposable bag set.
Modified Holmes would meet the limitation “the fifth bag not in communication with the first bag or the second bag or the third bag” as the fourth bag is not in fluid communication with the first bag or the second bag or the third bag, and the fifth bag was discussed to be a duplication of the fourth bag.
The limitations “configured to receive fluid from the separation bag” and “configured to receive a fourth component of the composite fluid from the separation bag” are directed toward the intended manner of operating the claimed fifth bag and does not differentiate the claimed fifth bag from the prior art fifth bag because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art fifth bag would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
The limitation “the fourth component being different form the first component, the second component the third component and the product” is directed towards the material or article worked upon by the claimed apparatus and does not limit the claim which it depends upon (MPEP § 2115).
Regarding claim 6, Holmes teaches the disposable bag set of claim 5.
Holmes is silent to a tube length and limitations associated with the tube length as claimed in claim 6.
However, Holmes teaches it is known in the art to use a tube length with a clamp and a filter to establish fluid communication between a separation bag and a component collection bag ([0014] and [0070] teach clamps can be used on any tube; Fig. 3, tube length 19 with leukoreduction filter 70). Holmes teaches that the clamp allows for the control of flow through the tubes ([0096]-[0098] discusses using clamps to shut tubes) and the filter is a leukoreduction filter which allows for improved product recovery ([0019]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Holmes to further comprise a tube length, wherein the tube length including a clamp and a filter because the tube length establishes fluid communication between the separation bag and the fifth bag, the clamp would control flow through the tube, and the filter would improve product recovery, as taught by Holmes.
The limitation “configured to move between an open position and a closed position, and in the close position, the clamp is configured to at least partially occlude movement through the tube length” is directed toward the intended manner of operating the claimed clamp and does not differentiate the claimed clamp from the prior art clamp because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art clamp would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Regarding claim 7, Holmes teaches the disposable bag set of claim 6, wherein the filter is a red blood cell leukoreduction filter as set forth above.
Regarding claim 8, the disposable bag set of claim 5, wherein the composite fluid includes whole blood as set forth above (see rejection for claim 1 under 35 U.S.C. 103).
The limitations “the first component includes plasma” and “the product formed using the first component includes cryoprecipitate” are directed towards the material or article worked upon by the claimed apparatus and do not limit the claim which it depends upon (MPEP § 2115). All preceding recitations of a/the first component and a/the product formed using the first component are in an intended use (see instant claims 1-3, and 5).
Regarding claims 9-11, the claims as written are directed towards the material or article worked upon by the claimed apparatus and does not limit the claim which it depends upon (MPEP § 2115). All preceding recitations of a/the second component, a/the third component, and a/third fourth component are in an intended use (see instant claims 2, 3, and 5). In the absence of further positively recited structure, the prior art applied to claim 8 above applies to claims 9, 10, and 11.
Claims 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Holmes in view of Sano (US 2011/0238030 A1) (already of record).
Regarding claim 12, Holmes discloses the disposable bag set of claim 3.
Holmes is silent to the disposable bag set further includes a sixth bag in fluid communication with the separation bag and configured to aid in the collection of the composite fluid.
However, Sano teaches a blood bag system for treating and separating blood (abstract) with a separation bag (Fig. 1, first bag 1) in fluid communication with a sixth bag (Fig. 1, testing blood bag 12, connected to first bag 1 via blood collecting tube 11) configured to aid in the collection of a composite fluid ([0042], collection of blood).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disposable bag set of Holmes to further include a sixth bag in fluid communication with the separation bag, the sixth bag being configured to aid in the collection of the composite fluid, as this method for improving Holmes’ disposable bag set was well known in the art.
Regarding claim 13, the prior art combination teaches the disposable bag set of claim 12.
Sano of the prior art combination teaches wherein the disposable bag set further includes: a collection of tubes connecting the separation bag to the sixth bag (Fig. 1, tubes between bags 1 and 12), the collection of tubes including: a first tube length establishing fluid communication between the separation bag and a connector (Fig. 1, tube length between 1 and y-connector); and a second tube length establishing fluid communication between the sixth bag and the connector (Fig. 1, tube length between 12 and y-connector), the connector being joined to a needle (Fig. 1, y-connector joined to needle 10, where needle is for collecting blood; [0042]).
Regarding claims 14 and 15, the prior art combination teaches the disposable bag set of claim 13.
Holmes teaches it is known in the art for a tube length includes a clamp ([0014] and [0070] teach clamps can be used on any tube).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination disposable bag set to include a clamp on the first tube and second tube length because the clamp would allow a user to control flow through the tube.
The limitations “configured to move between an open position and a closed position, and in the close position” and “configured to at least partially occlude movement through the first tube length” are directed toward the intended manner of operating the claimed clamp and does not differentiate the claimed clamp from the prior art clamp because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art clamp would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Regarding claim 16, the prior art combination teaches the disposable bag set of claim 13.
Sano of the prior art combination teaches wherein the collection of tubes further includes: a needle injury protector disposed between the connector and the needle (Fig. 1, mis-stick preventative implement 13).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Corash et al. (US 2018/0318348 A1) (already of record – hereinafter referred to as Corash).
Regarding claim 18, Nguyen discloses a disposable bag set (Fig. 1, set of bags – see annotated figure below) for separating whole blood ([0024], lines 1-3), the disposable bag set comprising:
a separation bag including the whole blood to be separated (Fig. 1, separation bag 12; [0024], lines 1-3 disclose whole blood);
a first bag in indirect fluid communication with the separation bag (Fig. 1, first component bag 14 – indirect fluid communication via connector 34), the first bag configured to receive a plasma from the whole blood held by the separation bag;
a third bag in indirect fluid communication with the separation bag and the first bag or the second bag (Fig. 1, second component bag 16 in indirect fluid communication with separation bag 12 and first bag 14 via tubes 18, 32, and 36 and connector 34 – indirect fluid communication via connector 34), the third bag configured to received platelets from the whole blood held by the separation bag ([0027], lines 4-6);
a fourth bag in indirect fluid communication with the separation bag (Fig. 1, discard bag 44 in indirect fluid communication with separation bag via tubes and connectors – indirect fluid communication via connector 34), the fourth bag configured to receive fluid from the separator bag ([0028], lines 13-16), the fourth bag configured to receive residual leukocytes from the whole blood held by the separation bag ([0028], lines 13-16); and
a fifth bag in fluid communication with the separation bag (Fig. 1, third component bag 38 in indirect fluid communication with separation bag via tubes and connectors – indirect fluid communication via connector 34), the fifth bag configured to receive fluid direct from the separation bag ([0027], lines 11-12), the fifth bag configured to receive red blood cells from the whole blood held by the separation bag ([0027], lines 11-12).
The limitations “the fourth bag not in fluid communication with the first bag or the second bag or the third bag” and “the fifth bag not in fluid communication with the first bag or the second bag or the third bag or the fourth bag” are interpreted according to Examiner’s understanding (see Claim Rejections - 35 USC § 112 section above). The interpreted limitations are contingent on the operation of the disposable bag set and have been given appropriate patentable weight (MPEP § 2111.04 II). No further prior art rejections are required as all structures necessary to meet the limitations is taught and/or anticipated by the prior art of record.
Nguyen is silent to a second bag and all associated limitations as claimed in claim 18.
However, Corash teaches a processing set (i.e., disposable bag set) with a plasma bag (i.e., first bag) in fluid communication with a larger bag (i.e., second bag), the larger bag configured to receive cryoprecipitate formed using the plasma (Fig. 1, processing set 100, plasma bag 102, larger bag 124; [0180] teaches cryoprecipitate formed using plasma).
Corash teaches that cryoprecipitate is used for therapeutic applications ([0004], lines 19-23).
It would have been obvious to one of ordinary skill in the art to modify the bag set of Nguyen to include a second bag in fluid communication with the first bag, as taught by Corash, to receive cryoprecipitate formed using the plasma for therapeutic applications.
The prior art combination is silent to the second bag being configured to receive fluid directly from the first bag and not directly from the separation bag.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination disposable bag set such that the second bag is configured to receive fluid directly from the first bag and not directly from the separation bag because the first bag would provide plasma to the second bag for the production of cryoprecipitate, and an ordinarily skilled artisan would be motivated to provide high purity plasma to produce high purity cryoprecipitate.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen and Corash as applied to claim 18 above, and further in view of Sano.
Regarding claim 19, the prior art combination teaches the disposable bag set of claim 18.
The prior art combination is silent to the disposable bag set further including a sixth bag in fluid communication with the separation bag and configured to aid in the collection of the whole blood.
However, Sano discloses a blood bag system for treating and separating blood (abstract) with a first bag (Fig. 1, first bag 1) in fluid communication with a sixth bag (Fig. 1, testing blood bag 12 connected to first bag 1 via blood collecting tube 11) configured to aid in the collection of blood ([0042]).
It would have been obvious to one of ordinary skill in the art to modify the disposable bag set of the prior art combination to incorporate the sixth bag, as taught by Sano, because it would provide the whole blood for separation to the separation bag.
Regarding claim 20, the prior art combination teaches the disposable bag set of claim 19.
Nguyen of the prior art combination further teaches wherein the disposable bag set further includes: a first collection of tubes connecting the separation bag to the first bag, the second bag, and the fourth bag, the first collection of tubes including:
a first tube length establishing fluid communication between the separation bag and a connector (Fig. 1, first tube 18 connects separation bag 12 and x connector 34);
a second tube length establishing fluid communication between the connector and the first bag (Fig. 1, plasma collection tube 32 connects x connector 34 and first bag);
a third tube length establishing fluid communication between the connector and the third bag (Fig. 1, platelet collection tube 36 connects x connector 34 and third bag); and
a fourth tube length establishing fluid communication between the connector and the fourth bag (Fig. 1, discard tube 46 connects x connector 34 and fourth bag);
a fifth tube length establishing fluid communication between the separation bag and the fifth bag (Fig. 1, third tube 22 connects separation bag 12 and fifth bag);
The prior art combination is silent to a sixth tube length establishing fluid communication between the first bag and the second bag; and a second collection of tubes connecting the separation bag to the sixth bag, the second collection of tubes including: a first tube length establishing fluid communication between the separation bag and a connector; and a second tube length establishing fluid communication between the sixth bag and the connector, the connector being joined to a needle.
However, Corash teaches it is known in the art to use a tube length to connect blood processing bags to establish fluid communication between two bags and the prior art combination teaches the second bag in fluid communication (see claim 18 rejection under 35 U.S.C. 103).
Corash teaches tubing between multiple bags which facilitates the transfer of plasma between the bags ([0180]).
It would have been obvious to one of ordinary skill in the art to modify the disposable bag set of the prior art combination to incorporate a tube length between the first and second bag, as taught by Corash, because it would allow for the transfer of plasma.
Further, Sano teaches a collection of tubes (Fig. 1), including a first tube length establishing fluid communication between the separation bag and a connector (Fig. 1, blood collecting tube 11 connects separation bag and y-connector); and a second tube length establishing fluid communication between the sixth bag and the connector (Fig. 1 shows a tube connecting y-connector and testing blood bag 12), the connector being joined to a needle (Fig. 1, blood collecting needle 10 joined to needle). The prior art combination teaches the sixth bag in fluid communication with the separation bag (see claim 19 rejection under 35 U.S.C. 103).
It would have been obvious to one of ordinary skill in the art to modify the prior art combination disposable bag set to incorporate a second collection of tubes including: a first tube length establishing fluid communication between the separation bag and a connector; and a second tube length establishing fluid communication between the sixth bag and the connector, the connector being joined to a needle because the connector would facilitate the tubes and needle, the tubes would allow the movement of whole blood from the sixth bag to the separation bag for processing, and the needle would extract the whole blood for processing.
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 ADRIAN J CARREON whose telephone number is (571)272-6818. The examiner can normally be reached Monday - Friday 8:30 AM - 5 PM.
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/A.J.C./ Examiner, Art Unit 1799
/William H. Beisner/ Primary Examiner, Art Unit 1799