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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/04/2026 has been entered.
Response to Amendment
The amendment filed 06/04/2026 has been entered. Claim 1 has 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
The amendments to claim 1 overcome the 112(a) rejection and the 112(a) rejection is therefore withdrawn. Applicant argues that the claims have been amended to delete the referencing handling element and that the claims are fully supported by the written description. However, claims 3-4 recite the handling element and remain rejected under 35 USC §112(a).
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 Dodge in view of Daniels. Hayton is no longer relied upon.
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 3-4 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 3 recites “wherein the handling element is located at a proximal end of the inner assembly”. 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 4 is rejected due to dependency on claim 3.
Claims 3-4 and 10 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 3 recites the limitation "the handling element" in ln. 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 is rejected due to dependency on claim 3.
Claim 10 recites the limitation “the handling element” in ln. 1-2. There is insufficient antecedent basis for this limitation in the claim.
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, 7-8, 12-15, 17 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dodge et al. (Pub. No.: US 2009/0012425 A1) in view of Daniels (Pub. No.: US 2011/0021950 A1).
Regarding claim 1, Dodge discloses (fig. 3) a device (sample acquisition assembly 30) for collecting a material specimen (abstract) and thus in the same field of endeavor, comprising:
An inner assembly (characterized by sample acquisition device 20 and syringe 32, ¶ 0029), comprising:
An actuator (plunger member 36);
One or more fluid chamber elements (chamber 38); and
A swab element (porous medium 24);
Wherein:
The actuator, the one or more fluid chamber elements, and the swab element are connected and arranged along a first axis (fig. 3);
The one or more fluid chamber elements retain a fluid (¶ 0030);
The inner assembly is configured such that actuating the actuator breaks a seal (frangible membrane) in the one or more fluid chamber elements (¶ 0032) and moves the fluid from the one or more fluid chamber elements to the swab element (¶ 0035).
Dodge fails to disclose: a sheath; wherein: the sheath includes a second axis, and the first axis of the inner assembly is configured to slide coaxially along the second axis of the 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 to causes the inner assembly to slide from the first position to the second position.
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);
Such configuration aiding in the collection and storage of a material specimen that limits contamination (¶ 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 Dodge such that it comprises a sheath; wherein: the sheath includes a second axis, and the first axis of the inner assembly is configured to slide coaxially along the second axis of the 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 to 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).
Regarding claim 3, Dodge discloses 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 (fig. 3).
Regarding claim 4, Dodge discloses wherein the inner assembly further includes a shaft (22) that extends along the first axis between the one or more fluid chamber elements and the swab element (fig. 3, ¶ 0035).
Regarding claim 7, Dodge discloses wherein the material specimen comprises saliva, urine, blood or serum of a person (the sample source can be from the throat, ¶ 0015).
Regarding claim 8, Dodge discloses wherein the device is configured to collect material specimens of multiple types (¶ 0015).
Regarding claim 12, Dodge discloses wherein: the actuator comprises a plunger configured at a proximal end of the inner assembly (fig. 3, ¶ 0030; and the swab element is configured at a distal end of the inner assembly (fig. 3).
Regarding claim 13, Dodge discloses wherein the plunger comprises a button (top portion 36A, ¶ 0032, fig. 3).
Regarding claim 14, Dodge in view of Daniels fail to disclose wherein actuating the plunger comprises twisting the plunger around a center axis.
Daniels teaches wherein: the actuator comprises a plunger (probe 18 and handle 22, fig. 1), wherein actuating the plunger comprises twisting the plunger around a center axis (¶ 0030) in order to facilitate corresponding movement of the swab element (collector 20, ¶ 0030).
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 plunger of Dodge in view of Daniels such that actuating the plunger comprises twisting the plunger around a center axis, in order to facilitate corresponding movement of the swab element (Daniels ¶ 0030).
Regarding claim 15, Dodge discloses wherein actuating the plunger comprises depressing the plunger (¶ 0032). As discussed above in claim 1, 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 Dodge such that it includes the sheath of Daniels. Daniel further teaches wherein the actuator comprises a plunger (fig. 1) and actuating the plunger comprises depressing the plunger into the sheath (fig. 2).
Regarding claim 17, Dodge in view of Daniels fail to disclose wherein the swab element is detachable from the inner assembly.
Daniels teaches wherein the swab element is detachable from the inner assembly (¶ 0036) in order to allow for the sheath to be sealed and avoid contamination of the sample such that the sample can be sent for analysis (¶ 0036).
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 swab element of Dodge in view of Daniels such that it is detachable from the inner assembly, as taught by Daniels, in order to allow for the sheath to be sealed and avoid contamination of the sample such that the sample can be sent for analysis (Daniels ¶ 0036).
Regarding claim 19, as discussed above in claim 1, 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 Dodge such that the inner assembly is operable to slide within the sheath between a first position and a second position, as taught by Daniels. Daniels further teaches wherein the actuator comprises a plunger (probe 18 and handle 22), wherein depressing the plunger causes the inner assembly to slide within the sheath from the first position to the second position (see arrow 50, ¶ 0030, fig. 1-2).
Regarding claim 20, as discussed above in claim 1, 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 Dodge such that the inner assembly is operable to slide within the sheath between a first position and a second position, as taught by Daniels. Daniels further teaches wherein the actuator comprises a plunger (probe 18 and handle 22), wherein pulling the plunger causes the inner assembly to slide within the sheath from the second position to the first position (see arrow 52, ¶ 0030, ¶ 0035 fig. 1-3).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dodge in view of Daniels, as applied to claim 1 above, and further in view of Davis et al. (Pub. No.: US 2004/0152206 A1).
Regarding claim 10, Dodge in view of Daniels fail to disclose wherein the swab element is a modular component that is removably connected to the inner assembly.
Davis teaches (fig. 1) a device for collecting a material specimen (abstract) and thus in the same field of endeavor, comprising: an inner assembly (sample collection device 22) comprising a swab element (fixture head 42, ¶ 0044), wherein the swab element is a modular component that is removably connected to the inner assembly (¶ 0042) in order to adapt the device to be used with a variety of sample collection components (¶ 0043).
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 swab element of Dodge in view of Daniels such that it is a modular component that is removably connected to the inner assembly, as taught by Davis, in order to adapt the device to be used with a variety of sample collection components (Davis ¶ 0043).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dodge 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, Dodge 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) in order to allow two samples to be obtained (¶ 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 Dodge 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 (Beach ¶ 0075).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bayloff et al. (Pub. No.: US 2007/0244368 A1) discloses a device having a plunger actuator. McSherry (Pub. No.: US 2014/0073988 A1) discloses an inner assembly having a first position and a second position.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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