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 .
Specification
The disclosure is objected to because of the following informalities:
In [0006], “course portion” should be rewritten as -coarse portion- based on the context of the coarse portion described later in the specification.
Appropriate correction is required.
Claim Objections
Claim 10 is objected to because of the following informalities.
Claim 10 recites the limitation of a “course portion”. This appears to instead mean -coarse portion-.
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.
Claim 9 is 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. In this instance, it appears that the plurality of tubes are connected to a vacuum source, and there does not appear to be a structure described that allows for only one of the tubes to have suction at a time. As such, one of ordinary skill in the art, based on the specification alone, would not be able to reconstruct that aspect of the device.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8, 12-13, and 16-18 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Loske (US 9381329).
Regarding claim 1, Loske discloses a medical device comprising:
a tubular assembly including a plurality of tubes (fig. 33, drainage lines 20), wherein each tube of the plurality of tubes is configured to be coupled to a vacuum source to deliver negative pressure to a distal end of each respective tube of the plurality of tubes (fig. 33, each drainage line 20 configured to be connected to a vacuum source, col. 12 lines 52-67 describes the assembly as a vacuum sponge unit); and
a porous assembly (fig. 33, sponge 10) including a plurality of sections and coupled to a distal end of the tubular assembly (fig. 33, sections of sponge 10 defined by perforation lines 19), wherein each section of the plurality of sections is coupled to a respective tube of the plurality of tubes (fig. 33, each section defined by perforation line 19 coupled to a respective drainage tube 20).
Regarding claim 2, Loske discloses wherein each tube of the plurality of tubes includes one or more walls defining a channel to deliver negative pressure to its respective section of the plurality of sections (fig. 33, tubes 20 have an internal wall with a lumen to deliver vacuum).
Regarding claim 3, Loske discloses wherein a first channel of an innermost tube of the plurality of tubes extends from a proximal end to a distal end of the innermost tube (fig. 33, tube 20 in the middle is interpreted as an innermost tube with a first channel extending from its proximal end and its distal end), and wherein a central longitudinal axis of the medical device extends through the first channel (fig. 33, middle tube 20 at a center of the device, as such a central longitudinal axis extends through the channel).
Regarding claim 5, Loske discloses wherein each section of the plurality of sections includes openings in fluid communication with the channel of the respective tube of the plurality of tubes (fig. 33, sections of sponge 10 each comprise a channel where tube 20 is inserted), and wherein the openings of each section of the plurality of sections are independent of the openings of other sections of the plurality of sections (fig. 33, openings as describes are independent from one another by not sharing an axis).
Regarding claim 6, Loske discloses wherein the channel of each of the plurality of tubes has an open proximal end and an open distal end (fig. 33, each tube 20 has an open proximal end and open distal end in order to convey fluid/vacuum), and wherein the open proximal end of the channel is coupled to the vacuum source and the open distal end is coupled to a proximal end of a respective section of the plurality of sections (fig. 33, distal end of tubes 20 connected to sponge 10 and respective sections, proximal end to be connected to a vacuum for vacuum sponge drainage).
Regarding claim 7, Loske discloses wherein the plurality of sections are configured to be removed individually from a target site within a body lumen (fig. 35 demonstrates the sections of the sponge being individually removable from one another, and therefore capable of being removed individually from a target site within a body lumen).
Regarding claim 8, Loske discloses wherein an outermost tube of the plurality of tubes is coupled to an outermost section of the plurality of sections (fig. 33, outermost tube and outermost section can be interpreted as the leftmost or rightmost sections), and wherein proximal movement of the outermost tube relative to other tubes of the plurality of tubes retracts the outermost section of the plurality of sections over a remainder of the plurality of sections (fig. 35 demonstrates that the sections are separable from one another, and as such moving the rightmost section proximally moves it over the remaining sections and remaining tubes).
Regarding claim 12, Loske discloses wherein a diameter of a distal end of each tube of the plurality of tubes aligns with a diameter of a proximal end of a respective section of the plurality of sections (fig. 33, diameter of the tubing within each section of sponge 10 has an aligned diameter with the opening the sponge 20 has to accommodate the tubing 20).
Regarding claim 13, Loske wherein the porous assembly includes at least four sections (fig. 33, five sections defined by four perforations 19) and the tubular assembly includes at least four tubes (fig. 33, five tubes 20 to match 5 sections), and wherein a first section is coupled to a first tube, a second section is coupled to a second tube, a third section is coupled to a third tube, and a fourth section is coupled to a fourth tube (fig. 33, each of the tubes 20 go into a respective section of sponge 10 defined by perforations 19).
Regarding claim 16, Loske discloses a medical device comprising:
a tubular assembly including at least two tubes (fig. 33, tubular assembly with 5 tubes 20), wherein each tube of the tubular assembly includes a channel (fig. 33, tubes 20 each have a lumen/channel), wherein each channel is configured to be coupled to a vacuum source to deliver negative pressure to a distal end of each tube independently of other channels (as best understood by the instant specification in [0039], delivering negative pressure “independently” is interpreted as one tube of the plurality of tubes not supplying negative pressure to another, and as a separate feature from applying the vacuum to one section at a time. In this instance, fig. 33 shows one tube 20 in one section not applying negative pressure to another section); and
a porous assembly (10) including at least two sections and coupled to a distal end of the tubular assembly (fig. 33, sponge 10 with five sections defined by perforations 19 in between), wherein each section of the porous assembly is coupled to a respective channel of the at least two tubes (fig. 33, each tube 20.
Regarding claim 17, Loske disclose wherein an outermost tube of the at least two tubes is coupled to an outermost section of the at least two sections (fig. 33, outermost tube 20 can be either the leftmost or rightmost tube 20 connected to a respective outermost section of sponge 10), and wherein proximal movement of the outermost tube relative to an innermost tube of the at least two tubes moves the outermost section of the at least two sections proximally over an innermost section of the at least two sections and over the innermost tube of the at least two tubes (fig. 35 demonstrates each of the sections being separable from each other. In this instance, Loske appears capable of having the rightmost section move proximally with respect to a middle tube, and moving proximally over said innermost section and over the respective innermost tube).
Regarding claim 18, Loske discloses wherein a channel of the innermost tube of the at least two tubes is cylindrical (fig. 33 shows the channels of the tubes being cylindrical), and wherein a channel of the outermost tube extends radially around a central longitudinal axis of the medical device.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Loske in view of Locke (US 10155071).
Regarding claim 9, Loske discloses wherein the plurality of tubes are configured to deliver negative pressure to only one section of the plurality of sections at a time
However, Locke teaches a negative pressure wound therapy system (abstract) that has a series of valves for respective flow lines that can be individually controlled to at least partially open and at least partially close (col. 13, lines 44-67), thus the device is capable of and configured to deliver negative pressure to only one section of the plurality of sections at a time. Another embodiment can also close all valves except one at a time to use a treatment pressure sensor on each valve (col. 16, lines 20-39).
Therefore, 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 disclosed in Loske such that the plurality of tubes are configured to deliver negative pressure to only one section of the plurality of sections at a time, as taught by Locke, for the purpose of providing a suitable means of granting a degree of control over what sections need suction at a given time, or alternatively to be able to share a treatment pressure sensor to monitor a pressure applied in the treatment (see Locke, col. 16, lines 35-39)
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Loske in view of Rapp (US 20170290708).
Regarding claim 10, Loske discloses wherein each section of the plurality of sections includes an inner surface and an outer surface (fig. 33, sections of sponge 10 have an outer surface, and an inner surface defining a passage for tube 20 to enter), and wherein the outer surface of each section of the plurality of sections includes one or more of a coarse portion to collect exudates from a target site or a coating to prevent tissue ingrowth.
However, the instant specification recites coatings that prevent tissue ingrowth include material such as PTFE, silicon, PVDF, and/or HDPE. Rapp teaches a negative pressure therapy sponge (abstract) that is coated with PTFE (paragraph 0049).
Therefore, 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 disclosed in Loske by coating it with PTFE such that the sections include a coating to prevent tissue ingrowth, as taught by Rapp, for the purpose of providing rigidity to the negative pressure therapy sponge (see Rapp, paragraph 0049).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Loske in view of Kleiner (US 20150148785)
Regarding claim 11, Loske does not teach wherein each section of the plurality of sections includes a cap at a distalmost face of each section of the plurality of sections
However, Kleiner teaches wherein a sponge for endoluminal vacuum therapy includes an end cap (paragraph 0087).
Therefore, 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 disclosed in Loske such that each section of the plurality of sections includes a cap at a distalmost face of each section of the plurality of sections, as taught by Kleiner, for the purpose of adapting the sponge against egress of bodily substances into the distal end of the sponge to avoid bacterial loading and clogging (see Kleiner, paragraph 0088).
Allowable Subject Matter
Claims 19-20 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 19, the closest prior art of record, Loske, discloses a medical device comprising:
a tubular assembly including a plurality of tubes (fig. 33, tubes 20), wherein each tube of the plurality of tubes is configured to be coupled to a vacuum source to deliver negative pressure to a distal end of each tube (abstract describing vacuum sponge drainage), and
a porous assembly (10) including a plurality of sections coupled to a distal end of the tubular assembly (fig. 33, sponge 10 with sections defined by perforations 19), wherein a proximal section of each section of the plurality of sections is coupled to a distal end of a respective tube of the tubular assembly (fig. 33, proximal ends of sections coupled to distal ends of tubes 20).
Loske does not teach wherein the plurality of tubes are nested within one another, and the porous assembly having a plurality of sections nested within one another.
Ryan (US 20210268157) teaches a sponge (12) connected to one tube (100) that allows for fluid to flow through the tube, including a vacuum source (paragraphs 0029 and 0039), all of which nested within a delivery tube/catheter (102) that also receives negative pressure (paragraph 0038).
However, this does not teach multiple nesting sections of the sponge being coupled to a distal end multiple tubes of a tubular assembly, as the distal end of the delivery catheter (102) is not coupled to the proximal end of the sponge (12). While the sponge (12) could be interpreted as having multiple sections, wherein while the sponge is moving within the delivery catheter (102) there is a point where the distal end of the catheter contacts the proximal section of the sponge, this appears to go beyond the broadest reasonable interpretation of the structures being “coupled” to one another. Further, while the tube (100) is connected to the delivery catheter (see fig. 1, tube 100 connected to flexible shaft 50), and the medical device/sponge (10/12) is connected to the tube (100) (see figs. 2A/2B), this also appears to go beyond broadest reasonable interpretation of the distal end of the catheter being coupled to another section of the sponge
For these reasons, claim 19 is allowable.
Claim 20 is allowable by virtue of being dependent on claim 19.
Claims 4 and 14-15 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 4 and 14-15 are allowable for similar reasons as recited in the analysis of claim 19 above. Notably, each of these claims appears to imply a nesting structure that Loske cannot reasonably be modified to teach.
Claim 4 recites a second channel of an outermost tube extending radially around the central longitudinal axis, which the leftmost or rightmost rube of Loske cannot reasonably teach.
Claim 14 recites a second section extending around a first section, a third section extending around a second section, and a fourth section extending around the third section. While in theory, one of ordinary skill in the art could make the sections of Loske cylindrical such that the first section is cylindrical, the claim implies the nesting nature of the sections that Loske cannot reasonably teach.
Claim 15 recites the tubes being nested within one another, which Loske also does not reasonable teach.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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/Brandon W. Levy/Examiner, Art Unit 3781
