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 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 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) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—
(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; or
(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 16, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wales; Ryan V. et al. (US 20210267813 A1).
Regarding claim 16, Wales discloses a medical device (¶ [0002], [0006], [0020], devices, systems, and methods for endoluminal vacuum therapy (EVAC); ¶ [0022] FIG. 1 … an exemplary medical device 100; ¶ [0030] FIG. 2 … a medical device 200; ¶ [0031] FIG. 3 … a medical device 300);
comprising: a sponge (¶ [0022], sponge 102);
including one or more perforated tear surfaces that divide the sponge into a plurality of predefined subunits (¶ [0031], a single, rectangular sponge may be perforated to divide the sponge into sections 331, 332, 333, 334, 335, 336; ¶ [0032] Adjacent sections 331, 332, 333, 334, 335, 336 may be separated by perforations 361, 362, 363, 364, 365 … Perforations 361, 362 may provide a means for a user to select the size of sponge 302 prior to insertion of sponge 302 into a body of a patient); and
a tube, wherein a distal end of the tube is coupled to a proximal end of the sponge (¶ [0022], vacuum tube 104; ¶ [0030] FIG. 2 … vacuum tube 204; ¶ [0031] FIG. 3 … vacuum tube 304).
Regarding claim 19, Wales discloses a medical method (¶ [0002], [0006], [0020], devices, systems, and methods for endoluminal vacuum therapy (EVAC); ¶ [0022] FIG. 1 … an exemplary medical device 100; ¶ [0030] FIG. 2 … a medical device 200; ¶ [0031] FIG. 3 … a medical device 300);
comprising: removing a portion of a sponge along a tear surface of the sponge in order to change the sponge from a first, predefined shape or size to a second, predefined shape or size (¶ [0032], Perforations 361, 362 may provide a means for a user to select the size of sponge 302 prior to insertion of sponge 302 into a body of a patient);
inserting the sponge into a body lumen of a patient (¶ [0034] FIGS. 4A-4D show side views of medical device 100 in use within a body lumen 452 of a patient … To position medical device 100 at a wound region 450 within a body of a patient, a user may insert an endoscope (or other medical device) into the patient and locate wound region 450 … the user may insert medical device 100 into a working channel of the endoscope and move medical device 100 distally through the working channel … In other examples, a user may not use an endoscope and may insert medical device 100 into the body of the patient directly and not within a working channel of a separate medical device); and
connecting a tube coupled to the sponge to a source of vacuum (¶ [0022], vacuum tube 104; ¶ [0030] FIG. 2 … vacuum tube 204; ¶ [0031] FIG. 3 … vacuum tube 304).
Regarding claim 20, Wales discloses that removing a portion of the sponge includes removing an outer portion of the sponge from an inner portion of the sponge and removing a detachable layer of the inner portion of the sponge (¶ [0031], a single, rectangular sponge may be perforated to divide the sponge into sections 331, 332, 333, 334, 335, 336; ¶ [0032] Adjacent sections 331, 332, 333, 334, 335, 336 may be separated by perforations 361, 362, 363, 364, 365 … Perforations 361, 362 may provide a means for a user to select the size of sponge 302 prior to insertion of sponge 302 into a body of a patient);
Regarding the outer portion, inner portion and detachable layer, Wales’s sponge includes a plurality of subunits or sections (¶ [0031], sections 331, 332, 333, 334, 335, 336; ¶ [0032] Adjacent sections 331, 332, 333, 334, 335, 336 may be separated by perforations 361, 362, 363, 364, 365). These sections 331, 332, 333, 334, 335, 336 can be variously designated into groups including an outer portion, inner portion and detachable layer.
Claims 16, 17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Loske; Gunnar et al. (US 20130023840 A1).
Regarding claim 16, Loske discloses a medical device (¶ [0001] The invention relates to a vacuum sponge unit; ¶ [0012], [0019], [0024], [0072] An embodiment according to the invention is shown in FIGS. 1-7; ¶ [0089] Another embodiment in accordance with the invention is shown in FIGS. 33-37);
comprising: a sponge (¶ [0072], compressed sponge 10; ¶ [0089], FIG. 33 shows a view of a sponge 10);
including one or more perforated tear surfaces that divide the sponge into a plurality of predefined subunits (¶ [0089], The sponge is perforated between the drainage tubes (perforation line 19). FIG. 34 shows a cross-sectional view of FIG. 33); and
a tube, wherein a distal end of the tube is coupled to a proximal end of the sponge (¶ [0089], FIG. 33 shows a view of a sponge 10 into which a plurality of drainage tubes 20 perforated at their distal end have been inserted).
Regarding claim 19, Loske discloses a medical method (¶ [0001], a method for inserting the vacuum sponge system into a human or animal body);
comprising: removing a portion of a sponge along a tear surface of the sponge in order to change the sponge from a first, predefined shape or size to a second, predefined shape or size (¶ [0089], The sponge is perforated between the drainage tubes (perforation line 19); ¶ [0090] FIG. 35 shows the separation of a subunit 10a from sponge 10. FIG. 36 shows the complete separation of a subunit 10a from sponge 10);
inserting the sponge into a body lumen of a patient (¶ [0091] FIG. 37 shows a schematic view of vacuum sponge drainage units 2 of different sizes arranged in the abdominal cavity 200); and
connecting a tube coupled to the sponge to a source of vacuum (¶ [0089], FIG. 33 shows a view of a sponge 10 into which a plurality of drainage tubes 20 perforated at their distal end have been inserted).
Regarding claims 17 and 20, Loske discloses that each of the plurality of predefined subunits is a cube or a rectangular prism (Figs. 33-36, each subunit 10a is shaped as a rectangular prism);
wherein removing a portion of the sponge includes removing an outer portion of the sponge from an inner portion of the sponge and removing a detachable layer of the inner portion of the sponge (¶ [0089], The sponge is perforated between the drainage tubes (perforation line 19); ¶ [0090] FIG. 35 shows the separation of a subunit 10a from sponge 10. FIG. 36 shows the complete separation of a subunit 10a from sponge 10).
Regarding the outer portion, inner portion and detachable layer, Loske’s sponge includes a plurality of subunits 10a (Figs. 33-36 depict five subunits 10a). These subunits 10a can be variously designated into groups including an outer portion, inner portion and detachable layer.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wales; Ryan V. et al. (US 20210267813 A1) in view of Hartwell; Edward Yerbury (US 20160166744 A1).
Regarding claim 1, Wales discloses a medical device (¶ [0002], [0006], [0020], devices, systems, and methods for endoluminal vacuum therapy (EVAC); ¶ [0022] FIG. 1 … an exemplary medical device 100; ¶ [0030] FIG. 2 … a medical device 200; ¶ [0031] FIG. 3 … a medical device 300);
comprising: a sponge (¶ [0022], sponge 102);
wherein the sponge includes a plurality of perforations that form one or more tear surfaces (¶ [0031], a single, rectangular sponge may be perforated to divide the sponge into sections 331, 332, 333, 334, 335, 336; ¶ [0032] Adjacent sections 331, 332, 333, 334, 335, 336 may be separated by perforations 361, 362, 363, 364, 365);
wherein the one or more tear surfaces define a predefined location for removing a first portion of the sponge from a second portion of the sponge (¶ [0032], Perforations 361, 362 may provide a means for a user to select the size of sponge 302 prior to insertion of sponge 302 into a body of a patient); and
a tube coupled to a proximal portion of the sponge (¶ [0022], vacuum tube 104; ¶ [0030] FIG. 2 … vacuum tube 204; ¶ [0031] FIG. 3 … vacuum tube 304).
Wales’s tear surfaces do not explicitly form a boundary between a radially inner surface of the first portion and a radially outer surface of the second portion. Hartwell discloses a medical device (¶ [0003], apparatuses, methods, and systems for the treatment of wounds; ¶ [0012] Embodiments of the present invention relate to negative pressure wound closure devices, methods, and systems);
comprising: a sponge (¶ [0136] As shown in FIG. 1, a body 10 of porous material, such as foam; ¶ [0161], Again, the body 100 can be formed from any suitable material, such as reticulated polyurethane foam of very high free internal volume. Some embodiments may call for the use of polyvinyl alcohol (PVA) foam);
wherein the sponge includes a plurality of perforations that form one or more tear surfaces (¶ [0025], It is desirable that the partial pre-cuts define a repeating pattern of severed regions with intervening frangible regions, i.e. perforation);
wherein the one or more tear surfaces define a predefined location for removing a first portion of the sponge from a second portion of the sponge (¶ [0138] The three sets of partial pre-cuts 14, 16, 18 are intermittent, the gaps in the pre-cuts defining frangible regions 20 on each internal face of each portion 12 (in other words they are perforated for easy removal of the portions));
wherein the one or more tear surfaces form a boundary between a radially inner surface of the first portion and a radially outer surface of the second portion (¶ [0161], As shown in FIG. 8C, in embodiments, the shape may have elliptical and/or concentric cuts 101).
Hartwell provides an alternative way to divide a sponge into frangible subunits. A skilled artisan would have been able to modify Wales with Hartwell’s concentric tear surfaces by constructing Wales’s sponge from a solid sponge and applying one or more radially-extending, concentric perforations according to Hartwell. One would be motivated to modify Wales with Hartwell’s concentric tear surfaces since Wales calls for constructing the sponge with concentric layers that can detach from each other (¶ [0023], Each of the other sections 114, 112, 110, 108 may extend circumferentially around the central section 116 forming concentric, ring-like cylindrical sections 114, 112, 110, 108 that are nested within one another; ¶ [0024], In some examples, a layer of mesh, adhesive, or agent may be positioned between each section 116, 114, 112, 110, 108 and the adjacent section 116, 114, 112, 110, 108, which may facilitate removal of each section 116, 114, 112, 110, 108. In other examples, any other suitable material, capable of coupling adjacent sections together yet permitting them to release from one another upon a suitable force, may be used between adjacent sections. Such materials can include a suitable adhesive layer sandwiched between adjacent sections). Therefore, it would have been obvious to modify Wales with Hartwell’s concentric tear surfaces in order for Wales’s concentric layers to detach from each other.
Regarding claim 2, Wales discloses that the sponge includes an outer portion and an inner portion (¶ [0023], Each of the other sections 114, 112, 110, 108 may extend circumferentially around the central section 116 forming concentric, ring-like cylindrical sections 114, 112, 110, 108 that are nested within one another).
Wales does not explicitly disclose that one or more tear surfaces separate the outer portion from the inner portion, or that the outer portion has a different shape from the inner portion. Hartwell discloses a sponge that includes an outer portion and an inner portion, wherein the one or more tear surfaces separate the outer portion from the inner portion (¶ [0161] As shown in FIG. 8C, in embodiments, the shape may have elliptical and/or concentric cuts 101); and
wherein the outer portion has a different shape from the inner portion (¶ [0161], As depicted in FIG. 8A, in certain embodiments, the body 100 may have a cuboidal shape with straight cuts 101).
A skilled artisan would have been able to modify Wales with Hartwell’s tear surfaces, outer portion and inner portion by constructing the sponge from a rectangular sponge, and then applying concentric cuts to divide it into multiple layers. This will leave an outermost layer that has a rectangular outer surface and a cylindrical inner surface. One would be motivated to modify Wales with Hartwell’s various tear surfaces and rectangular shape to streamline its manufacture. For example, stock foams are often provided in rectangular shapes, which have been cut from larger, continuously-cast sheets. Therefore, it would have been obvious to modify Wales with Hartwell’s tear surfaces and differently shaped outer portion in order to construct the sponge from easily obtained stock materials, or to omit a step during manufacturing.
Regarding claims 2-7 and 10-15, Wales discloses a sponge including an inner portion and multiple concentric layers (¶ [0023], Each of the other sections 114, 112, 110, 108 may extend circumferentially around the central section 116 forming concentric, ring-like cylindrical sections 114, 112, 110, 108 that are nested within one another).
Wales lacks tear surfaces that form layers of the inner portion. Hartwell discloses a medical device and method wherein the inner portion includes at least one of the one or more tear surfaces; wherein the at least one of the one or more tear surfaces of the inner portion forms one or more detachable layers of the inner portion (¶ [0161], As shown in FIG. 8C, in embodiments, the shape may have elliptical and/or concentric cuts 101);
wherein the one or more detachable layers include two detachable layers, and wherein an outer surface of a first detachable layer of the two detachable layers is adjacent to an inner surface of a second detachable layer of the two detachable layers; wherein the first detachable layer is concentric with the second detachable layer; wherein the inner portion further includes a core, wherein the first detachable layer is adjacent to the core (Fig. 8C shows at least eight concentric layers, each divided by concentric and planar cuts 101);
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wherein the outer portion has a first surface and a second surface, and wherein at least one of the one or more tear surfaces extends from the first surface to the second surface between the inner portion and the outer portion; wherein the outer portion includes at least one of the one or more tear surfaces; wherein the at least one tear surface of the outer portion is configured to fragment the outer portion and allow one or more fragments of the outer portion to be separated from the inner portion (Fig. 8C, cuts 101 include concentric cylindrical cuts and planar cuts that further divide each cylindrical layer);
where the at least one tear surface of the outer portion is configured to fragment the outer portion into at least four fragments (Fig. 8C, sponge 102 includes ten vertically stacked layers which are divided by planar cuts);
wherein the one or more tear surfaces are configured to define a plurality of sizes of an implantable portion of the sponge; wherein the one or more tear surfaces define a grid (Fig. 8C shows at least eight concentric layers, each divided by concentric and planar cuts 101).
Hartwell demonstrates how to partition a sponge into multiple subunits with variously shaped cuts (Figs. 8A-8C). One would be motivated to modify Wales with Hartwell’s various cylindrical and planar cuts since Wales calls for dividing the sponge into both concentric (¶ [0023], each section 116, 114, 112, 110, 108 may extend longitudinally in the direction of central longitudinal axis A); and planar segments (¶ [0032] Adjacent sections 331, 332, 333, 334, 335, 336 may be separated by perforations 361, 362, 363, 364, 365). Therefore, it would have been obvious to modify Wales with Hartwell’s cylindrical and planar cuts in order to construct a sponge that can be divided concentrically and into planar subunits.
Regarding claims 8 and 9, Wales discloses a sponge including portions that contact the tube (Figs. 1-3, sponge 102, 202, 302 contacts vacuum tube 104, 204, 304).
Wales lacks a proximal portion of the detachable layers that extends proximally of the proximal surface of the outer portion. Hartwell discloses a device wherein the outer portion includes a proximal surface, and wherein a proximal portion of at least one of the one or more detachable layers extends proximally of the proximal surface of the outer portion (Fig. 8C, sponge 102 includes ten vertically stacked layers which are divided by planar cuts).
Regarding the proximal portion of the at least one of the one or more detachable layers that contacts the tube, Fig. 8C includes eight concentric cylinders and ten vertically stacked layers. A user can selectively remove an outer layer comprising the topmost and lowermost layers and the outermost cylinder. In the combined device of Wales and Hartwell, the lowermost layer contacts the tube.
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Hartwell demonstrates how to partition a sponge into multiple subunits with variously shaped cuts (Figs. 8A-8C). Regarding the rationale and motivation to modify Wales with Hartwell’s proximally extending detachable layer and removable cylindrical layers, see the discussion of claim 1 above.
Regarding claim 17, Wales lacks subunits defined as a cube or a rectangular prism. Hartwell discloses a device wherein each of the plurality of predefined subunits is a cube or a rectangular prism (¶ [0137], The three sets of partial pre-cuts 14, 16, 18 define individual cubic portions 12 of approximately equal volume; ¶ [0161], As depicted in FIG. 8A, in certain embodiments, the body 100 may have a cuboidal shape with straight cuts 101).
Hartwell demonstrates how to partition a sponge into multiple subunits with variously shaped cuts (Figs. 8A-8C). One would be motivated to modify Wales with Hartwell’s cubic or rectangular prism subunits to offer other options for segmenting the sponge since Wales calls for dividing the sponge into both concentric and planar segments (¶ [0023], [0032]). Therefore, it would have been obvious to modify Wales with Hartwell’s cubic or rectangular prism subunits in order to divide the sponge into concentric and/or planar segments.
Regarding claim 18, Wales lacks a plurality of rows, including a longer proximalmost row. Hartwell discloses a device wherein the plurality of predefined subunits are arranged in a plurality of rows, wherein a proximalmost row of the plurality of rows is longer than the other rows of the plurality of rows (Fig. Fig. 8C shows at least eight concentric layers, each divided by concentric and planar cuts 101).
Although Hartwell depicts the ten stacked vertical layers as having substantially equal thicknesses, Hartwell’s sponge can be redefined as comprising multiple equal-thickness rows and one thicker proximalmost row. Annotated Fig. 8C shows how to designate one of the lower parallel cuts, for example the third from bottom, as a boundary to define the short upper rows and longer lower row.
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Hartwell partitions a sponge into subunits with selectively arranged cuts (Figs. 8A-8C). One would be motivated to modify Wales with Hartwell’s various rows since Wales calls for dividing the sponge into both concentric and planar segments (¶ [0023], [0032]). Regarding the rationale and motivation to modify Wales with Hartwell’s rows, see the discussion of claim 1 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Smith; Morley L CA 1220449 A
Neubauer; Norbert DE 202009011664 U1
Neubauer; Norbert DE 202015000910 U1
Townsend, Jr.; Charles E. US 5351356 A
Greener; Bryan US 20110319804 A1
Brennan; Kevin et al. US 20140343478 A1
Locke; Christopher Brian et al. US 20160000608 A1
Tumey; David M. US 20160022500 A1
Korteweg; Wayne US 20200268564 A1
Rice; Justin R. et al. US 20210113748 A1
Weston; Richard US 20210379255 A2
Kornel; Ezriel US 20240197980 A1
Balasubramaniam; Swarna US 20250275872 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
Prosecution Insights