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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-15, in the reply filed on 12/3/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claim 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II-III, there being no allowable generic or linking claim. The requirement is still deemed proper and is therefore made FINAL.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 102
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 1-2, 5-6, 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5330446 A Weldon et al. (hereinafter Weldon).
Regarding claim 1, Weldon discloses a medical device (abstract, col. 2 line 8 – col. 3 line 19) comprising:
a handle (see annotated Fig. 8 below, col. 7 line 44-47, handle is a syringe) having a fluid source (col. 7 line 41-47, liquid or gas is within the syringe);
a conduit (72, Fig. 8-10) coupled to the handle (as seen in Fig. 8-10); and
a distal portion (56, Fig. 8-10) coupled to a distal end of the conduit (as seen in Fig. 8-10, col. 7 line 47-57), wherein the distal portion comprises:
an outer portion (outer wall portion of 56, Fig. 8-10) defining a lumen (62); and
an inner portion (inverted portion of 64, Fig. 8-9, col. 7 line 22-24), wherein the inner portion defines a cavity having a distal opening (as seen in Fig. 8-9, col. 7 line 19-27, inner portion forms a pocket with a distal opening), and wherein the cavity is configured to contain a material (65, Fig. 8-10) (as seen in Fig. 8-10, col. 7 line 19-27),
wherein, in a first configuration of the distal portion, the material is disposed within the inner portion (as seen in Fig. 8, col. 7 line 19-27) and the inner portion is disposed within the lumen of the outer portion (as seen in Fig. 8), and
wherein delivery of a fluid (col. 7 line 41-47, liquid or gas is within the syringe) from the fluid source into the lumen of the outer portion transitions the distal portion from the first configuration to a second configuration and causes the inner portion to move distally relative to the outer portion and deliver at least a portion of the material (as seen in Fig. 8-10, 11-13, col. 7 line 41 – col. 8 line 19).
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Regarding claim 2, Weldon discloses the limitations of claim 1, and further discloses wherein the fluid is a gas (col. 7 line 41-47).
Regarding claim 5, Weldon discloses the limitations of claim 1, and further discloses wherein the distal portion is detachable from the conduit (as seen in Fig. 8-10, col. 7 line 44-57).
Regarding claim 6, Weldon discloses the limitations of claim 1, and further discloses wherein:
in the first configuration, the inner portion has a first length (see annotated Fig. 8 above, inverted portion of 64 has a first length from the base of inverted portion 64 to distal end 60 of distal portion 56);
in the second configuration, the inner portion has a second length (as seen in Fig. 9-10, col. 7 line 41-44, as pressurized gas is introduced into the lumen 62 to inflate 64, the first length of the inverted portion of 64 shrinks as it is everted and fully everted out of the distal end 60 of tube 56); and
the first length is greater than the second length (as seen in annotated Fig. 8 above and Fig. 9-10, the first length of inverted portion 64 is greater than the second length of the inverted portion 64 when pressurized gas is introduced into the lumen 62 to inflate 64, the length of the inverted portion of 64 shrinks as it is everted and fully everted out of the distal end 60 of tube 56).
Regarding claim 8, Weldon discloses the limitations of claim 1, and further discloses wherein the inner portion is a bladder (col. 7 line 11-24, inner portion 64 is a balloon, which in essence is a bladder).
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.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Weldon as applied to claim 1 above, and further in view of US 5042819 A LaFata.
Regarding claim 3, Weldon discloses the limitations of claim 1.
Weldon is silent on wherein the handle includes a first arm and a second arm, wherein the fluid source is a sac disposed between the first arm and the second arm, wherein, upon movement of the first arm towards the second arm, the sac is compressed.
However, LaFata teaches a bubble generating system (50, Fig. 1) having a handle (51, 55) that includes a first arm (51) and a second arm (55), wherein a fluid source (58) is a sac disposed between the first arm and the second arm (col. 8 line 21-25, fluid source (58) is a bellows), wherein, upon movement of the first arm towards the second arm, the sac is compressed (col. 8 line 21-25, 30-39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Weldon with the teachings of LaFata to have wherein the handle includes a first arm and a second arm, wherein the fluid source is a sac disposed between the first arm and the second arm, wherein, upon movement of the first arm towards the second arm, the sac is compressed in order to provide a consistent and even stream of compressed fluid from the fluid source.
Regarding claim 4, the combination of Weldon and LaFata teaches the limitations of claim 3, and LaFata further discloses wherein the sac (58) is corrugated (as seen in Fig. 1-2, 9-10, 14-15, 21).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Weldon in view of US 3721231 A Hubert.
Regarding claim 7, Weldon discloses the limitations of claim 1, and further discloses wherein the distal portion is rigid or semi-rigid (col. 7 line 5-6, tube 56 is made of plastic material).
Weldon is silent on wherein the conduit is flexible.
However, Hubert teaches a medical catheter (Fig. 1) for high pressure applications (abstract, col. 1 line 4-9) having a conduit (52, Fig. 1) that is a well-known flexible LUER-LOK connecting set available from Becton, Dickinson and Co. (col. 4 line 18-22). It is also noted that the conduit (72) of Weldon is a male luer fitting that connects with a female luer connector fitting (74, Fig. 8-10, col. 7 line 44-57 of Weldon).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the conduit taught by Weldon with conduit as taught by Hubert since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; the flexible LUER-LOK connection set of Hubert would be sufficient to provide a secure connection between the handle and the distal portion.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Weldon in view of US 20230025333 A1 Patel et al. (hereinafter Patel).
Regarding claim 9, Weldon discloses the limitations of claim 8.
Weldon is silent on wherein a color of the bladder indicates a volume of the bladder.
However, Patel teaches a urine collection container (120, Fig. 1c) that displays different colors according to different collected volumes of urine (abstract, paragraph 6) wherein the container comprises a flexible wall (bladder 132a, Fig. 1c, paragraph 69) that forms a first shape when a first volume of urine is disposed within the container and second shape when a second volume of urine is disposed within the container (paragraph 9), the flexible wall (132a) including a hologram film (132, Fig. 1c) that displays a first color when disposed in the first shape and a second color when disposed in the second shape (paragraph 10, 69).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Weldon with the teachings of Patel to have wherein a color of the bladder indicates a volume of the bladder in order to provide a user with a visual indicator that provides continuous feedback on a volume of the bladder.
Claims 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Weldon in view of US 9028401 B1 Bacich et al. (hereinafter Bacich).
Regarding claim 10, Weldon discloses the limitations of claim 1.
Weldon is silent on wherein the outer portion includes a distal valve through which the material is delivered.
However, Bacich teaches an everting balloon system for delivering a material (166, Fig. 10a-c) (abstract, Fig. 10a-c, col. 22 line 4 – col 23 line 11) wherein an outer portion (outer portion of everting balloon 18, Fig. 10a-c) includes a distal valve (168, Fig. 10a-c, col. 22 line 4-5) through which the material is delivered.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Weldon with the teachings of Bacich to have wherein the outer portion includes a distal valve through which the material is delivered in order to block or interrupt fluid communication between an inner lumen of the device and an outside target area as disclosed by Bacich (col. 22 line 8-11).
Regarding claim 11, the combination of Weldon and Bacich teaches the limitations of claim 10, and Bacich further discloses wherein the distal valve is a one-way valve (Fig. 10a-c, col. 22 line 4-5, distal valve 168 is a check valve).
Regarding claim 12, Weldon discloses the limitations of claim 1.
Weldon is silent on wherein the inner portion and the outer portion form one continuous structure.
However, Bacich teaches an everting balloon system for delivering a material (166, Fig. 10a-c) (abstract, Fig. 10a-c, col. 22 line 4 – col 23 line 11) that comprises an outer portion (outer wall portion of everting balloon 18, Fig. 10a-c) and an inner portion (inner wall portion of everting balloon 18, Fig. 10a-c) that form a continuous structure (seen in Fig. 10a-c).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Weldon with the teachings of Bacich to have wherein the inner portion and the outer portion form one continuous structure in order to reduce manufacturing steps and the possibility of leakage.
Regarding claim 13, the combination of Weldon and Bacich teaches the limitations of claim 12, and Weldon further discloses wherein, in the first configuration, the inner portion is disposed within the outer portion (inverted portion of 64 is within outer wall portion of 56, Fig. 8-9, col. 7 line 22-24), and wherein, in the second configuration, the inner portion extends distally relative to the outer portion (as seen in Fig. 9-10, 11-13, col. 7 line 41 – col. 8 line 19).
Regarding claim 14, the combination of Weldon and Bacich teaches the limitations of claim 13, and Weldon further discloses wherein, in the second configuration, the inner portion is turned inside out to release the material (as seen in Fig. 9-10, 11-13, col. 7 line 41 – col. 8 line 19).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Weldon in view of US 20090234380 A1 Gabel et al. (hereinafter Gabel).
Regarding claim 15, Weldon discloses the limitations of claim 1.
Weldon is silent on wherein the material is a patch.
However, Gabel teaches a medical device (100, Fig. 1) for delivering a material (210, Fig. 26) disposed at a distal end (104, Fig. 26), wherein the material is a patch (paragraph 19, 25-26, 114).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Weldon with the teachings of Gabel to have wherein the material is a patch in order to stop and/or control bleeding as disclosed by Gabel (paragraph 124).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771