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 Objections
Claims 1, 22, 23 are objected to because of the following informalities:
Claim 1 recites the limitation ‘to first end’ in line 4 of the claim. It is suggested this limitation be changed to ‘to a first end’ to provide proper antecedent basis and grammatical purposes for the limitation.
Claim 22 recites the limitation “to first end” in line 3 of the claim. It is suggested this limitation be changed to ‘to a first end’ to provide proper antecedent basis and grammatical purposes for the limitation.
Claim 23 recites the limitation ‘braded’ in line 2 of the claim. It is suggested this limitation be changed to ‘braided’ for grammatical purposes.
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 4-8 and 19 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 4-8 recites the limitation ‘an inverted tube’ in line 1 of the claims, respectively. It is unclear whether the limitation refers to an additional inverted tube or the same ‘an inverted tube’ recited in line 2 of claim 1. The examiner interprets the limitation to be “the inverted tube” to refer to the limitation ‘an inverted tube’ in line 2 of claim 1.
Claim 19 recites the limitation ‘the inverted tube of absorbent material’ in line 1-2 of the claim. There is insufficient antecedent basis for this limitation in the claim since claim 1 only previously recites “an inverted tube of material” in line 2 of the claim and does not claim an absorbent material. The examiner interprets the claim to be ‘the inverted tube of material’ for examination purposes.
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 1-5, 11-14, 16-19, 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Silverman (US 3589356).
Regarding claim 1, Silverman discloses an inverting swab sleeve device for use with a swab actuator, the device comprising: an inverting swab sleeve (21) comprising an inverted tube (21) of material configured to fit into an ear canal (C:1, L:10-25, cavities, pipes, and openings of all types, sizes shapes and dimensions) and an engagement cap (see image below, 35, 39, 40a, 44) coupled to a first end of the inverting swab sleeve, wherein the inverted tube is inverted over the engagement cap so that the engagement cap is within the inverted tube, further wherein the engagement cap is configured to engage with the swab actuator (17, or other arbitrary actuator to advance member 22 since the actuator is not positively claimed).
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Regarding claim 2, Silverman discloses all of the limitations set forth in claim 1, the inverting swab sleeve comprises an absorbent material (absorbent porous powder 54, C:5, L:20-36, C:6, L:16-25).
Regarding claim 3, Silverman discloses all of the limitations set forth in claim 1, wherein the inverting swab sleeve comprises a non-absorbent material (plastic tubing 21, C:5, L:20-36).
Regarding claim 4, Silverman discloses all of the limitations set forth in claim 1, wherein the inverting swab sleeve comprises an inverted tube of absorbent material (C:5, L:30-36, C:6, L:16-25, porous powder is on the surface of the tube and inverted and thus creates an inverted tube).
Regarding claim 5, Silverman discloses all of the limitations set forth in claim 1, wherein the inverting swab sleeve comprises an inverted tube of non-absorbent material (plastic tubing 21).
Regarding claim 11, Silverman discloses all of the limitations set forth in claim 1, further comprising a loading tube (10, 14, 16, 17, 18) covering the inverting swab sleeve.
Regarding claim 12, Silverman discloses all of the limitations set forth in claim 11, wherein the loading tube (10, 14, 16,17) comprises a centering securement (15, 16, 17, 18) configured to releasably hold the engagement cap in a radially centered region of the loading tube (figure 1, 3, 4).
Regarding claim 13, Silverman discloses all of the limitations set forth in claim 12, wherein the centering securement comprises (15, 16, 17, 18) a projection configured to hold the engagement cap in the radially centered region of the loading tube (18).
Regarding claim 14, Silverman discloses all of the limitations set forth in claim 12, wherein the centering securement comprises (15, 16, 17, 18) a tapered distal end region (see image below) configured to hold the engagement cap in the radially centered region of the loading tube (figure 1).
Regarding claim 16, Silverman discloses all of the limitations set forth in claim 1, wherein the engagement cap comprises a bullet shape (see image below).
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Regarding claim 17, Silverman discloses all of the limitations set forth in claim 1, wherein the engagement cap comprises a plurality of projections on an outer surface of the engagement cap (see image below).
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Regarding claim 18, Silverman discloses all of the limitations set forth in claim 17, wherein the plurality of projections comprise one or more of: ridges, bumps, rings, or dimples (figure 4, see image above).
Regarding claim 19, Silverman discloses all of the limitations set forth in claim 1, further comprising a cuff (13 or 12) at a second end of the inverted tube of material.
Regarding claim 21, Silverman discloses all of the limitations set forth in claim 19, wherein the cuff (12) comprises a tapered and funnel-shaped inner diameter (figure 1, smooth tapered cylindrical shape) .
Regarding claim 22, Silverman discloses an inverting swab sleeve device for use with a swab actuator, the device comprising: an inverting swab sleeve (21) comprising an inverted tube (21) of absorbent material (absorbent porous powder 54, C:5, L:20-36, C:6, L:16-25), an engagement cap (see image above, 40a, 41, 39, 35, 36, 45, 44) coupled to a first end of the inverting swab sleeve, wherein the inverted tube is inverted over the engagement cap so that the engagement cap is within the inverted tube; and a cuff (13, 12) at a second end of the inverted tube of absorbent material.
Regarding claim 23, Silverman discloses an inverting swab sleeve device for use with a swab actuator, the device comprising: an inverting swab sleeve (21) comprising an inverted tube of absorbent material (absorbent porous powder 54, C:5, L:20-36, C:6, L:16-25) configured to fit into an ear canal (C:1, L:10-25, cavities, pipes, and openings of all types, sizes shapes and dimensions) and an engagement cap (see image below, 40a, 41, 39, 35, 36, 45, 44) coupled to first end of the inverting swab sleeve, wherein the inverted tube is inverted over the engagement cap so that the engagement cap is within the inverted tube (figures 1-4), further wherein the engagement cap is configured to engage with the swab actuator (17, or other arbitrary actuator to advance member 22 since the actuator is not positively claimed) ; and a cuff (13) at a second end of the inverted tube of absorbent material (figure 1).
Claim Rejections - 35 USC § 103
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 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 6, 8, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Silverman (US 3589356) as applied to claim 1 above, and further in view of Heaton et al (US 6200288).
Regarding claims 6 and 8, Silverman discloses all of the limitations set forth in claim 1, but does not disclose the inverting swab sleeve comprises an inverted tube of a cellulose fiber material. Heaton et al (hereafter Heaton) teaches an inverting toroid device (1) for insertion into a body cavity comprising an inverting swab sleeve comprising an inverted tube of a cellulose fiber or woven synthetic material (C:3, L:60) to provide suitable flexibility and inverting characteristics. Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make the inverting swab sleeve of Silverman further comprise a cellulose fiber or a woven material, as taught as a known material in the art at the time of the invention for inverting swab sleeves by Heaton, in order to provide suitable flexibility and inverting characteristics since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claims 9 and 10, Silverman discloses all of the limitations set forth in claim 1, wherein the invention can be used in openings, cavities, and pipes of all types, sizes, shapes and dimensions, but does not disclose the dimensions of the inverting swab sleeve. However, Heaton teaches an inverting toroid device for insertion into a body cavity comprising an inverting swab sleeve comprising an inverted tube (1), wherein the inverting swab sleeve has a diameter of between 2 to about 30mm, or 6-8mm, and a length that is about 5-40 times the diameter, which could result in a device between 1.5-15 cm long. Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to configure the swab sleeve of Silverman to have a diameter of between 3mm and 10mm and be between 1.5 and 15 cm long, as taught as known dimensions in the art at the time of the invention by Heaton, depending on the specific cavity into which it is inserted since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Silverman (US 3589356) as applied to claim 19 above, and further in view of Wallace et al (US 20190343538).
Regarding claim 7, Silverman discloses all of the limitations set forth in claim 1, but does not teach the inverting swab sleeve comprises an inverted tube of knitted material. However, Wallace et al (hereafter Wallace) teaches an inverting tube for the introduction into body lumens, wherein Wallace teaches it was known in the art at the time of the invention that woven, braided, and knitted materials were known materials for flexible inverting tubes at the time of the invention (paragraph 0041). Therefore, it would have been obvious to make the inverting swab sleeve comprise an inverted tube of knitted material in the device of Silverman, as taught as a known material by Wallace, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Silverman (US 3589356).
Regarding claim 15, Silverman discloses all of the limitations set forth in claim 1, but does not disclose the engagement cap (40a) comprises a rubber material. However, Silverman discloses that the tube (which includes engagement cap 40a on a distal end thereof) is flexible to bend around the twists and turns of the body cavity (C:4, L:20-32). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the engagement cap 40a on the distal end of the tube (40) of Silverman out of a rubber material as a known material for flexible tubing for medical devices, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Silverman (US 3589356) as applied to claim 19 above, and further in view of Place (US 5482039).
Regarding claim 20, Silverman discloses all of the limitations set forth in claim 19, but does not disclose the material of the cuff (12). Place teaches that it was known in the art at the time of the invention to make devices for insertion into body cavities and lumens relatively soft and flexible for purposes of comfort and merely sufficient rigidity to facilitate insertion (C:5, L:51-60). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make the outer cuff (12) for insertion in the device of Silverman to comprise a low durometer material, as taught as known in the art at the time of the invention for devices inserted into the body by Place, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH T DANG/Primary Examiner, Art Unit 3771