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 preliminary amendment filed on November 15, 2023 is acknowledged. The application will be examined accordingly.
Claim Objections
Claims 19 and 29 are objected to because of the following informalities:
The limitation “are configured” should be changed to “is configured”.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 16-18, 20, 26-28 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 1, 7, 11, 12 and 7 of US 11,772,097 B2, respectively, because the claims of US 11,772,097 B2 anticipate the respective claims of the instant application.
Claims 16 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 16 of US 11,490,839 B2, respectively, because the claims of US 11,490,839 B2 anticipate the respective claims of the instant application.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA (or as subject to pre-AIA ) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if 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 16-20, 22 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson et al. (“Johnson”) (US 2013/0309136 A1).
With respect to claim 16, Johnson discloses a device for collecting a sample, the device comprising (see Fig. 3A):
a housing comprising an open position (see Fig. 3A) and a closed position (see [0050]);
a well 305 for sample collection formed integrally with the housing;
a medium 315 in fluid connection with the well (see Fig. 3A); and
a mechanical actuator 335 configured to cause a volume of the sample to be dispensed from the well to the medium 315 responsive to a transition of the housing from the open position to the closed position (see [0052]-[0053]), wherein the well 305 is exposed to an external environment when the housing is in the open position (see Fig. 3A) and is closed off from the external environment when the housing is in the closed position (see [0050]).
With respect to claim 17, the device further comprises a support element (surface of chamber 385 on which the medium 315 rests) disposed within the housing and providing support for the medium 315 (see [0054] and Fig. 3A).
With respect to claim 18, the mechanical actuator comprises one or more plungers 335 configured to dispense the sample from the well 305 to the medium 315 (see Figs. 3B and 3C).
With respect to claim 19, the housing further comprises (see Fig. 3A):
a first housing piece 320 at a first end (left end) of the housing; and
a second housing piece 310 at a second end (right end) of the housing distal to the first end, wherein at least one of the first housing piece and the second housing piece is configured to transition the housing from the open position to the closed position (see [0050]).
With respect to claim 20, the device further comprises a reagent (inside chamber 355, see [0053]), wherein the reagent is dispensed onto the medium 315 responsive to the transition of the housing from the open position to the closed position (see [0052]).
With respect to claim 22, the sample comprises a biological sample (see [0049]), and the medium 315 comprises:
a loading region 375 for loading blood positioned adjacent to the well; and
a separation region 385 extending from the blood loading region 375 to an end of the medium distal to the blood loading region (see Fig. 3D), wherein the separation region 385 is configured to diffuse the biological sample from the blood loading region across the separation region (see [0054] disclosing that region 385 comprises a lateral flow test).
With respect to claim 24, the medium further comprises a handle* 315 distal to the blood loading region 375.
*The limitation “handle” is anticipated by any structure that can be grasped by the hand and/or fingers.
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 23, 26-30 and 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson.
With respect to claim 23, the medium comprises a wicking material (see [0054]). While Johnson does not explicitly disclose the specifics of the wicking material, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the wicking material from any conventional material known to wick liquid, for example paper or fiber.
With respect to claim 26, Johnson also discloses a method for collecting a sample, the method comprising: providing the device discussed above (see rejection of claim 16).
While Johnson does not explicitly disclose a step of transitioning the housing from the open position to the closed position, based on the fact that the device is intended to be used by transitioning the housing from the open position to the closed position (see [0050]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have transitioned the housing from the open position to the closed position to deliver the sample to the medium 315.
With respect to claim 27, the device further comprises a support element (surface of chamber 385 on which the medium 315 rests) disposed within the housing and providing support for the medium 315 (see [0054] and Fig. 3A).
With respect to claim 28, the mechanical actuator comprises one or more plungers 335 configured to dispense the sample from the well 305 to the medium 315 (see Figs. 3B and 3C).
With respect to claim 29, the housing further comprises:
a first housing piece 320 at a first end (left end) of the housing; and
a second housing piece 310 at a second end (right end) of the housing distal to the first end (see Fig. 3A), wherein at least one of the first housing piece and the second housing piece is configured to transition the housing from the open position to the closed position (see [0050]).
With respect to claim 30, the device further comprises a reagent (inside chamber 355, see [0053]), wherein the reagent is dispensed onto the medium responsive to the transition of the housing from the open position to the closed position (see [0052]).
With respect to claim 32, the sample comprises a biological sample (see [0049]), and the medium 315 comprises:
a loading region 375 for loading blood positioned adjacent to the well; and
a separation region 385 extending from the blood loading region 375 to an end of the medium distal to the blood loading region (see Fig. 3D), wherein the separation region 385 is configured to diffuse the biological sample from the blood loading region across the separation region (see [0054] disclosing that region 385 comprises a lateral flow test).
With respect to claim 33, the medium comprises a wicking material (see [0054]). While Johnson does not explicitly disclose the specifics of the wicking material, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the wicking material from paper or fiber, which are well-known to be wicking.
With respect to claim 34, the medium further comprises a handle* 315 distal to the blood loading region 375.
*The limitation “handle” is anticipated by any structure that can be grasped by the hand and/or fingers.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Polidoro et al. (“Polidoro”) (US 2007/0073226 A1).
With respect to claim 25, Johnson does not disclose one or more tines provided at a first end of the housing and configured to lock the housing in the closed position. Polidoro discloses a syringe comprising a locking mechanism comprising tines that facilitates unidirectional movement of the plunger inside the barrel (i.e. the tines prevent the plunger from being pulled out) (see [0037]). In light of the disclosure of Polidoro, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a first end of the housing of the Johnson device with one or more tines for locking the housing in the closed position. The modification would prevent the actuator (plunger) from moving in reverse, and thus prevent the sample and the reagent from being suctioned back into their respective chambers 340 and 355 (see Fig. 3C), which could compromise the lateral flow test.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson as applied to claims 23, 26-30 and 32-34 above, and further in view of Polidoro.
With respect to claim 35, as discussed above (see rejection of claim 25), in light of the disclosure of Polidoro, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a first end of the housing of the Johnson device with one or more tines for locking the housing in the closed position. The modification would prevent the actuator (plunger) from moving in reverse, and thus prevent the sample and the reagent from being suctioned back into their respective chambers 340 and 355 (see Fig. 3C), which could compromise the lateral flow test.
Allowable Subject Matter
Claims 21 and 31 would be allowable if they are amended to overcome the applicable objection(s) set forth above, and if they are rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Johnson discloses a device for collecting a sample, and a method for using the device to collect a sample, as discussed above.
However, Johnson does not disclose or suggest a window formed on one of the two housing pieces so as to enable viewing of the well 305 when the housing is in the closed position. Moreover, based on the disclosure of Johnson, there is no motivation to modify the device to arrive at the claimed inventions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL S HYUN whose telephone number is (571)272-8559. 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, Luan Van can be reached at 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL S HYUN/ Primary Examiner, Art Unit 1796
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