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 10/22/2025 has been entered. Claims 1 and 12 have been amended. Claims 2, 5-6, 9, 11, and 16 are cancelled. Claims 1, 3-4, 7-8, 10, 12-15, 17-20 remain pending in this application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. A new grounds of rejection is made under Hayton in view of Daniels. Caillouette is no longer relied upon.
Applicant points to fig. 8A-8B for support for the amendment to claim 1. However, claim 1 recites the inner assembly comprising a handling element. Fig. 8A-8B show the handling element as being handling element 804. However, the handling element is a part of the sheath (802) rather than the inner assembly. Thus, fig. 8A-8B do not support the amendment to claim 1 requiring the inner assembly to comprise a handling element.
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, 3-4, 7-8, 10, 12-15, 17-20 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 “an inner assembly, comprising: a handling element; an actuator; one or more fluid chamber elements; and a swab element”. The specification fails to describe such embodiment. Fig. 1 and 2 describe embodiments without an actuator. Fig. 3 describes an embodiment without the inner assembly comprising one or more fluid chamber elements. Fig. 6 and 8 describe embodiments where the handling area is an element of the sheath and not the inner assembly. For the purposes of compact prosecution, claim 1 will be interpreted as “an inner assembly, comprising: an actuator, one or more fluid chamber elements, and a swab element”.
Claims 3-4, 7-8, 10, 12-15, 17-20 are rejected due to dependency on claim 1.
Claim 3 recites wherein the handling element is located at a proximal end of the inner assembly. As discussed above, the specification fails to describe such embodiment of the inner assembly comprising a handling element; an actuator; one or more fluid chamber elements; and a swab element. While fig. 1-2 illustrate the handling element located at a proximal end of the inner assembly, fig. 1-2 omit the actuator. Fig. 3 illustrates the actuator being located at a proximal end of the inner assembly. For the purposes of compact prosecution, claim 3 will be interpreted as “wherein the actuator is located at a proximal end of the inner assembly…”.
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) 1, 3-4, 8, 10, 12-15, 17 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayton et al. (Pub. No.: US 2002/0136665 A1) in view of Daniels (Pub. No.: US 2011/0021950 A1).
Regarding claim 1, Hayton discloses (fig. 1) a device (swab assembly 10) for collecting a material specimen (¶ 0001), comprising:
A sheath (external housing 11); and
An inner assembly (hollow tubular member 14), comprising:
One or more fluid chamber elements (see chamber where reagent 18 is housed); and
A swab element (swab material 16) (¶ 0016);
Wherein:
The one or more fluid chamber elements and the swab element are connected and arranged along a first axis (fig. 1, ¶ 0016) ;
The one or more fluid chamber elements retain a fluid (¶ 0016).
Hayton fails to disclose the inner assembly comprising an actuator connected with the one or more fluid chamber elements and the swab element and arranged along a first axis; the sheath includes a second axis, and the first axis of the inner assembly is configured to slide coaxially along the second axis sheath; the inner assembly operable to slide within the sheath between a first position and a second position; the first position comprises the swab element being in a retracted position within the sheath; the second position comprises the swab element being in a non-retracted position outside of the sheath while at least a portion of the inner assembly remains within the sheath; the inner assembly is configured such that actuating the actuator causes the inner assembly to slide from the first position to the second position breaks a seal in the one or more fluid chamber elements and permits the fluid to flow from the one or more fluid chamber elements to the swab element.
Daniels teaches (fig. 1-2) a device (medical device 10) for collecting a material specimen (¶ 0018), comprising:
A sheath (12); and
An inner assembly (probe 18), comprising:
An actuator element (characterized by proximal end of probe and handle 24); and
A swab element (collector 20);
Wherein:
The actuator and the swab are connected and arranged along a first axis (fig. 1);
The sheath includes a second axis (fig. 1), and the first axis of the inner assembly is configured to slide coaxially along the second axis of the sheath (fig. 1-2, ¶ 0018);
The inner assembly is operable to slide within the sheath between a first position (fig. 1) and a second position (fig. 2) (¶ 0018);
The first position comprises the swab element being in a retracted position within the sheath (¶ 0030, fig. 1);
The second position comprises the swab element being in a non-retracted position outside of the sheath while at least a portion of the inner assembly remains within the sheath (¶ 0030, fig. 2),
The inner assembly is configured such that actuating the actuator causes the inner assembly to slide from the first position to the second position (¶ 0020).
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 device of Hayton such that the inner assembly comprises an actuator, the actuator being connected and arranged along a first axis; the sheath includes a second axis, and the first axis of the inner assembly is configured to slide coaxially along the second axis sheath; the inner assembly operable to slide within the sheath between a first position and a second position; the first position comprises the swab element being in a retracted position within the sheath; the second position comprises the swab element being in a non-retracted position outside of the sheath while at least a portion of the inner assembly remains within the sheath, the inner assembly is configured such that actuating the actuator causes the inner assembly to slide from the first position to the second position, as taught by Daniels, in order to aid in the collection and storage of a material specimen that limits contamination (Daniels, ¶ 0009).
Further, Hayton discloses a seal (sealing element 17), breaking a seal in the one or more fluid chamber elements and permitting the fluid to flow from the one or more fluid chamber elements to the swab element (¶ 0016), the seal being broken by distorting the seal (¶ 0016).
Thus, the modification of the inner assembly of Hayton such that it comprises the actuator of Daniels, disposed at an end of the inner assembly adjacent the seal, would allow the seal to be broken upon actuating the actuator which would distort the seal. Thus, Hayton in view of Daniels disclose that the inner assembly is configured such that actuating the actuator to cause the inner assembly to slide form the first position to the second position breaks a seal in the one or more fluid chamber elements and permits the fluid to flow from the one or more fluid chamber elements to the swab element.
Regarding claim 3, Hayton in view of Daniels disclose wherein the actuator is located at a proximal end of the inner assembly, the swab element is located at a distal end of the inner assembly, and the one or more fluid chamber elements are located intermediately between the proximal end of the inner assembly and the distal end of the inner assembly (Hayton fig. 1, Daniels fig. 1, see rejection of claim 1 above.
Regarding claim 4, Hayton discloses wherein the inner assembly includes a shaft that extends along the first axis between the one or more fluid chamber elements and the swab element (fig. 1, ¶ 0016).
Regarding claim 8, Hayton discloses wherein the device is configured to collect material specimens of different types (¶ 0002).
Regarding claim 10, Hayton in view of Daniels fail to disclose wherein the swab element is a modular component that is removably connected to the inner assembly.
However, Hayton discloses (fig. 2) an embodiment wherein the swab element (swab material 107) is a modular component that is removably connected to the inner assembly (¶ 0026).
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 device of Hayton in view of Daniels such that the swab element is a modular component that is removably connected to the inner assembly, as taught by fig. 2 of Hayton, in order to allow the swab element to be retained in sterile conditions (Hayton, ¶ 0028).
Regarding claim 12, Hayton in view of Daniels disclose wherein the actuator comprises a plunger configured at a proximal end of the inner assembly (Daniels, fig. 1, ¶ 0020); and the swab element is configured to at a distal end of the inner assembly (Hayton, fig. 1).
Regarding claim 13, Hayton in view of Daniels disclose wherein the plunger comprises a button (Daniels ¶ 0030).
Regarding claim 14, Hayton in view of Daniels disclose wherein actuating the plunger comprises twisting the plunger around a central axis (Daniels ¶ 0020).
Regarding claim 15, Hayton in view of Daniels disclose wherein actuating the plunger comprises depressing the plunger into the sheath (Daniels ¶ 0030).
Regarding claim 17, Hayton in view of Daniels fail to disclose wherein the swab element is detachable from the inner assembly.
However, Hayton discloses (fig. 2) an embodiment wherein the swab element (swab material 107) is detachable from the inner assembly (¶ 0026).
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 device of Hayton in view of Daniels such that the swab element is detachable from the inner assembly, as taught by fig. 2 of Hayton, in order to allow the swab element to be retained in sterile conditions (Hayton, ¶ 0028).
Regarding claim 19, Hayton in view of Daniels disclose wherein depressing the plunger causes the inner assembly to slide within the sheath from the first position to the second position (Daniels ¶ 0030, ¶ 0033).
Regarding claim 20, Hayton in view of Daniels disclose wherein pulling up on the plunger causes the inner assembly to slide within the sheath from the second position to the first position (¶ 0030).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayton in view of Daniels, as applied to claim 1 above, and further in view of Kindt et al. (Pub. No.: US 2015/0315564 A1).
Regarding claim 7, Hayton in view of Daniels fail to disclose wherein the material specimen comprises saliva, urine, blood or serum of a person.
Kindt teaches (fig. 1-2) a device for collecting a material specimen (abstract) and thus in the same field of endeavor, wherein the material specimen comprises saliva, urine, blood or serum of a person (¶ 0009).
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 device of Hayton in view of Daniels such that the material specimen comprises saliva, urine, blood or serum of a person, as taught by Kindt, as such material specimen are suitable for being analyzed (Kindt, ¶ 0009).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayton in view of Daniels, as applied to claim 12 above, and further in view of Beach et al. (Pub. No.: US 2012/0061392 A1).
Regarding claim 18, Hayton in view of Daniels fail to disclose wherein a second swab element can be connected to the shaft of the inner assembly.
Beach teaches (fig. 6, 9) a device for collecting a material specimen (abstract) and thus in the same field of endeavor, comprising: an inner assembly (containing apparatus 70), comprising: a shaft (tube 54) and a swab element (sample collection implement 60); wherein a second swab element can be connected to the shaft of the inner assembly (fig. 9, ¶ 0075).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention modify the device of Hayton in view of Daniels such that a second swab element can be connected to the shaft of the inner assembly, as taught by Beach, in order to allow two samples to be obtained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bennington (US Pat. No.: 3,958,571) discloses an inner assembly comprising one or more fluid chamber elements and a swab. Feldsine et al. (Pub. No.: US 2003/0143752 A1) discloses an inner assembly comprising an actuator.
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 MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MEAGAN NGO/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781