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
Claim 19 is objected to because of the following informalities: in lines 1-2, “first longitudinal body configured to be” should apparently read --first longitudinal body is configured to be--. Appropriate correction is required.
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 16-20 are 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.
Claims 16-20 recite a first longitudinal body with a first balloon to be positioned with a stomach, along with a second longitudinal body with a second balloon to be positioned proximate a penile bulb, wherein the second longitudinal body is positionable within the first longitudinal body. However, this is not taught by the specification as-filed. Instead, the specification (Fig. 4) teaches a first longitudinal body associated with a first balloon to be positioned with a stomach, a second longitudinal body associated with a second balloon to be positioned proximate a penile bulb, wherein the first longitudinal body is positionable within the second longitudinal body.
Claims 16-20 further recite that the second balloon is coupled to a distal portion of the second longitudinal body. This is also not taught by the specification as-filed. Instead, the second balloon is taught to be coupled to a middle portion, positioned between distal and proximal ends of the second longitudinal body.
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 5 and 9-20 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 5 recites the limitation “wherein, in a first configuration, the second balloon is filled with barium sulfate” in lines 1-2. It is not clear if this is intending to positively recite the barium sulfate as part of the claimed medical device or merely that the second balloon is able to be filled with barium sulfate (intended use).
Claim 9 recites the limitation “a urethra” in line 5. It is not clear if this is intended to refer to the same urethra recited in line 3 or to a separate urethra.
Claim 14 recites the limitation “a stomach of the patient” in lines 1-2. This limitation has several issues. If this is intended to recite the actual stomach of the patient, it is not clear how the longitudinal body can be positioned within the urethra while the first balloon is within the stomach. The specification appears to indicate that this “stomach” is intended to be a portion of the bladder. However, this is not a remotely common definition for a portion of the bladder; the examiner was unable to find a single reference in the relevant field of art that uses this term. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “stomach” appears to be used by the claim to mean “an internal portion of the bladder,” while the accepted meaning is “an organ that is part of the digestive system [that is completely separate from the bladder].” The term is indefinite because the specification does not clearly redefine the term. For sake of compact prosecution, this term will be taken herein to refer to the bladder.
Claims 10-15 are rejected by virtue of their dependence upon claim 9.
Claim 16 (as detailed supra) recites a first longitudinal body with a first balloon to be positioned with a stomach, along with a second longitudinal body with a second balloon to be positioned proximate a penile bulb, wherein the second longitudinal body is positionable within the first longitudinal body. It is not clear how the second ballon would be deployable/inflated in this recited configuration, as it would necessarily still be within the first longitudinal body. For sake of compact prosecution, this claim will be interpreted as taught in the specification; namely, that the first longitudinal body is positionable within the second longitudinal body (instead of the other way around).
Claim 16 also recites the limitation “with a stomach” in line 9. This limitation has several issues. First, it is not clear what is meant by “with”; e.g., does this mean next to, or accompanying, or is it a typographical error for “within”? Second, if this is intended to recite the actual stomach of the patient, it is not clear how the longitudinal body can be positioned within the urethra while the first balloon is within the stomach. The specification appears to indicate that this “stomach” is intended to be a portion of the bladder. However, this is not a remotely common definition for a portion of the bladder; the examiner was unable to find a single reference in the relevant field of art that uses this term. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “stomach” appears to be used by the claim to mean “an internal portion of the bladder,” while the accepted meaning is “an organ that is part of the digestive system [that is completely separate from the bladder].” The term is indefinite because the specification does not clearly redefine the term. For sake of compact prosecution, this term will be taken herein to refer to the bladder.
Claim 18 recites the limitation “at least one marking” in line 1. It is not clear if this is a typographical error for “marker” which is used more frequently in the specification, or if it merely means some sort of mark/indication.
Claims 16-20 are rejected by virtue of their dependence upon at least one rejected base claim.
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 1-3, 5, 6, 8, and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Browne et al. (U.S. Pub. No. 2019/0038882 A1; hereinafter known as “Browne”).
Regarding claim 1, Browne discloses a medical device capable of use during radiation therapy (Abstract; Figs. 1, 3, 5), comprising: a longitudinal body 103 configured to be positioned within a urethra ([0032]-[0033]), wherein the longitudinal body includes a lumen 201/207/213, a distal end 113, and a proximal end 107 ([0034]; [0039]); a first balloon 119 coupled to a distal portion of the longitudinal body and fluidly connected to a first port 143 at the proximal end of the longitudinal body ([0034]; [0036]); and a second balloon 115 positioned between the first balloon and the proximal end of the longitudinal body and fluidly connected to a second port 149 at the proximal end of the longitudinal body ([0034]; [0038]).
Regarding claim 2, Browne discloses that the medical device is a urinary catheter ([0032]-[0033]).
Regarding claim 3, Browne discloses at least one marker proximate to the second balloon ([0042]).
Regarding claim 5, Browne discloses that, in a first configuration, the second balloon is filled with barium sulfate (capable of such intended use; [0038]; [0040]).
Regarding claim 6, Browne discloses that each of the first port and the second port is configured to couple to a syringe ([0036]-[0038]; [0040]-[0041]).
Regarding claim 8, Browne discloses a third balloon 215 positioned proximate to the second balloon (Fig. 5; [0044]).
Regarding claim 16, Browne discloses a medical device capable of use during radiation therapy (Abstract; Figs. 1, 3, 5), comprising: a first longitudinal body 103 configured to be positioned within a urethra ([0032]-[0033]), wherein the longitudinal body includes a first lumen 201/207/213, a first distal end 113, and a first proximal end 107 ([0034]; [0039]); a second longitudinal body 301 configured to be positioned around the first longitudinal body (i.e., the first longitudinal body being positionable within the second longitudinal body), wherein the second longitudinal body includes a second lumen, a second distal end 313, and a second proximal end 307 ([0040]); a first balloon 119 coupled to a distal portion of the first longitudinal body and fluidly connected to a first port 143 at the first proximal end of the first longitudinal body, wherein the first balloon is configured to be positioned with a stomach (Fig. 1; [0034]; [0036]); and a second balloon 115 coupled to a distal portion of the second longitudinal body and fluidly connected to a second port 149 at the second proximal end of the second longitudinal body (Figs. 1, 3; [0034]; [0038]; [0041]), wherein the second balloon is configured to be positioned proximate to a penile bulb (Figs. 1, 5; [0006]) and is configured to block radiation (capable of such intended use; e.g., being filled with a radiation blocking material).
Regarding claim 17, Browne discloses that the medical device is a urinary catheter ([0032]-[0033]).
Regarding claim 18, Browne discloses at least one marking proximate to the second balloon ([0042]).
Regarding claim 19, Browne discloses that the first longitudinal body is configured to be moveable relative to the second longitudinal body ([0040]-[0043]).
Regarding claim 20, Browne discloses that the second distal end of the second longitudinal body is proximal of the first balloon (Figs. 3, 5).
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.
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.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Browne as applied to claim 3 above, and further in view of Cioanta et al. (U.S. Pub. No. 2004/0230316 A1; cited in the IDS filed 26 April 2024; hereinafter known as “Cioanta”). Browne discloses the invention as claimed, see rejection supra, and further discloses that the at least one marker is a first marker, and the medical device further comprises a second marker ([0042]). Browne fails to expressly disclose that the first marker is positioned on an opposite side of the second balloon from the second marker. Cioanta discloses a similar medical device (Abstract; Fig. 5A) comprising first and second markers 77 positioned on opposite sides of a balloon 22 in order to better confirm the location of the balloon in imaging ([0079]). 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 invention of Browne with such oppositely positioned markers, as taught by Cioanta, in order to better confirm the location of the balloon in imaging.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Browne as applied to claim 1 above, and further in view of Bacich (U.S. Pub. No. 2015/0142045 A1). Browne discloses the invention as claimed, see rejection supra, and further discloses that the second balloon is configured to transition between a fully retracted configuration and a fully expanded configuration ([0039]). Browne fails to expressly disclose that the second balloon has a diameter between 7 millimeters and 12 millimeters in the fully expanded configuration. Bacich discloses a similar medical device (Abstract) comprising a dilating balloon 62 with a diameter between 7 millimeters and 12 millimeters in a fully expanded configuration for use in a urethra ([0114]). 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 invention of Browne with such a balloon diameter, as taught by Bacich, as this is a known effective diameter for use in a urethra.
Allowable Subject Matter
Claims 9-15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: while urinary catheters are known to be used in radiation therapy (e.g., U.S. Pub. No. 2017/0113066 A1), none of the prior art of record teaches or reasonably suggests positioning such a medical device within a urethra so that the second balloon is positioned proximate to a penile bulb, inflating the second balloon, and applying radiation to the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M. Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791
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