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 (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 20-22, 24, 26-32, 38, 40, 42, 44, 47, and 50-52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kral (US 6,555,054).
Regarding claim 20, Kral (US 6,555,054) discloses –
An article connector for connecting to an open end of a lumen of an article to be sterilized to a sterilization apparatus (Fig. 7 hanger device 44), the article connector comprising:
a body (hanger 44 in combination with the fitting 46) having
a first portion (the left part of the hanger 44 including the fitting 46 at tube 42, see also fig. 3) and
a second portion (the right part of hanger 44), the first portion having an outlet (Fig. 3 shows the fitting 46 of hanger 44 having an outlet on either the top of bottom in connection with the rest of the fluid flow path),
the first portion being configured to be coupled to the sterilization apparatus to fluidly couple the outlet to the sterilization apparatus (Col. 4 lines 3-7 discloses the fittings 46 being in fluid communication with a sterilization source and coupling the outlet thereto),
the second portion being sized, shaped, and configured to be inserted into the lumen of the article via the open end of the lumen (Fig. 7 shows the porous material 45 on external surface 48 which is well capable of being inserted into a lumen of an article, and reasonably expected to do so – MPEP 2114 II),
the second portion having an inlet (channel 52 has apertures formed about the hanger 44, each of them reading on the limitation of an inlet), the inlet arranged to be disposed in and in fluid communication with the lumen when the second portion is inserted into the lumen (Col. 4 lines 3-7 fluid flow therethrough),
the outlet being in fluid communication with the inlet (Fig. 7 shows this); and
a porous member supported by the second portion of the body (Fig. 7 shows the porous material 45 supported on the right side of hanger 44),
the porous member having an interconnected porous structure (Col. 4 lines 43-57 discloses a porous structure),
the porous member being configured to be inserted into the lumen via the open end of the lumen with the second portion (Fig. 7 shows the porous material 45 on external surface 48 which are both well capable of being inserted into a lumen of an article, and reasonably expected to do so – MPEP 2114 II),
the porous member being configured to engage an interior of the article that bounds the lumen (Fig. 7 shows the porous material 45 on external surface 48 which is well capable of being inserted into a lumen of an article and engaging an interior of the article, and reasonably expected to do so – MPEP 2114 II.)
Regarding claim 21, Kral further teaches a portion of the porous member is disposed radially outboard of an exterior surface of the second portion of the body (Fig. 7 shows the porous material 45 being disposed on the exterior surface of hanger 44, and being exterior thereto in a radial direction).
Regarding claim 22, Kral further teaches the porous member extends circumferentially around an exterior surface of the second portion of the body (Fig. 7 shows the porous material 45 being disposed on the exterior surface of hanger 44, and surrounding it circumferentially – Col. 5 lines 10-21 “sponge jacket”).
Regarding claim 24, Kral further teaches the porous member is the one and only porous member of the article connector (Fig. 7 shows only one piece of material 45 associated with the hanger 44).
Regarding claim 26, Kral further teaches the porous member has an annular shape (Fig. 7, Col. 5 lines 10-21 “sponge jacket” or “sleeve”).
Regarding claim 27, Kral further teaches the porous member comprises an open cell material (Claim 4 specifies an open cell material, and Col. 4 lines 43-57 discloses open cell plastic material and polytetrafluoroethylene).
Regarding claim 28, Kral further teaches the open cell material is selected from the group consisting of a porous silicon, a porous polytetrafluoroethylene, and a synthetic rubber (lines 43-57 discloses polytetrafluoroethylene).
Regarding claim 29, Kral further teaches the porous member comprises a resilient material (lines 43-57 discloses a rigid and therefore resilient material).
Regarding claim 30, Kral further teaches the body includes a fluid passageway extending between and fluidly coupling the inlet and the outlet (internal channel 52 connects the apertures of hanger 44 to the outlet defined by fitting 46).
Regarding claim 31, Kral further teaches the porous member engages the second portion of the body (Fig. 7 shows the member 45 and the hanger 44 in direct contact).
Regarding claim 32, Kral further teaches the interconnected porous structure comprises a matrix of interconnected pores (Col. 4 lines 43-45 discloses the interconnected passageways).
Regarding claim 38, Kral further teaches the article connector of claim 20, in combination with the sterilization apparatus, wherein the first portion of the body is coupled to the sterilization apparatus such that the outlet is fluidly coupled to the sterilization apparatus (Fig. 7, tube 42 couples the hanger 44 and the fitting 46 to the source of sterilization; Col. 3 lines 17-29, see also Fig. 1).
Regarding claim 40, Kral further teaches the sterilization apparatus includes a conduit, the first portion of the body being coupled to an end of the conduit (tube 42 connects to fitting 46).
Regarding claim 42, Kral further teaches the exterior surface of the second portion is cylindrical in shape (Fig. 2 shows the profile of the hanger 44 being circular, therefore the surface of the second portion being cylindrical).
Regarding claim 44, Kral further teaches the second portion of the body has a cylinder shape (Fig. 2 shows the profile of the hanger 44 being circular, therefore the second portion being cylindrical).
Regarding claim 47, Kral further teaches the porous member has an opening through which sterilant flows as sterilant flows through the inlet and toward the outlet (Fig. 7 shows the porous member 45 which would have some opening at the pores through which sterilant would flow).
Regarding claim 50, Kral further teaches the body defines a flow path for sterilant extending from the inlet to the outlet (Fig. 7 shows the hanger 44 defining a flow path therein), the porous member having a length extending along the flow path (the thickness of porous member 48 is a dimension that extends along a flow path radially outwards from the holes of hanger 44, which reads on a length as the dimension is arbitrarily defined), the second portion having a length extending along the flow path (the right-hand portion of hanger 44 has a dimension from left to right that reads on a length as the dimension is arbitrarily defined), the length of the porous member being less than half the length of the second portion (Fig. 7 shows a thickness of the porous member 48 being less than half a length of the hanger 44 from left to right).
Regarding claim 51, Kral further teaches the inlet of the second portion faces in a first direction (the holes on hanger 44 face some radially outwards direction), the second portion being configured to be inserted into the lumen of the article via the open end of the lumen by moving the second portion in the first direction relative to the open end of the lumen (the hanger 44 could be inserted into some generic and arbitrarily large lumen by moving it at least partially in a radially outwards direction, and the lumen is not part of the claimed invention; the device is well capable of performing the claimed function and is reasonably expected to do so, MPEP 2114, II).
Regarding claim 52, Kral further teaches the inlet is disposed at an end of the second portion (Fig. 7 shows at least one of the apertures on hanger 44 has being at an end on a right-hand side of the hanger).
Claims 46-49, and 51-52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malchesky (US 5,552,115).
Regarding claim 46, Malchesky (US 5,552,115) teaches –
An article connector for connecting to an open end of a lumen of an article to be sterilized to a sterilization apparatus (Fig. 6 article connector at sleeve 90, which has an opening well capable of receiving an article), the article connector comprising:
a body having a first portion and a second portion (left and right portions), the first portion having an outlet (the left portion in fig. 6),
the first portion being configured to be coupled to the sterilization apparatus to fluidly couple the outlet to the sterilization apparatus (fig. 4 shows hose 76 connected to connectors for antimicrobial solution; Col. 7 lines 23-33),
the second portion being sized, shaped, and configured to be inserted into the lumen of the article via the open end of the lumen, the second portion having an inlet (the right hand side in Fig. 6 which is further capable of performing this function),
the inlet arranged to be disposed in and in fluid communication with the lumen when the second portion is inserted into the lumen (the aperture at the right side proximate sleeve 90 can be inserted into a lumen),
the outlet being in fluid communication with the inlet (there is one continuous flow path in fig. 6); and
a porous member supported by the second portion of the body (porous member 80, Col. 7 lines 46-49),
the porous member having an interconnected porous structure (Col. 7 lines 46-49), the porous member being configured to be inserted into the lumen via the open end of the lumen with the second portion (the porous member can be inserted into a lumen as claimed, MPEP 2114, II),
the porous member being configured to engage an interior of the article that bounds the lumen (the porous member can perform this function as claimed, MPEP 2114, II),
and, the inlet of the second portion is arranged relative to the porous member such that sterilant flows into the inlet from the lumen of the article without flowing through the interconnected porous structure of the porous member when the second portion is inserted into the lumen (the open end of the right side of the connector including the second portion can receive sterilant without flowing through the porous structure of the porous member).
Regarding claim 47, Malchesky similarly teaches all of the limitations of claim 20 from which this claim depends (see above with respect to claim 46) and further teaches the porous member has an opening through which sterilant flows as sterilant flows through the inlet and toward the outlet (the right hand side shows this opening of the porous member proximate the sleeve 90).
Regarding claim 48, Malchesky further teaches the second portion of the body extends into the opening of the porous member (a part of the second portion of the body at sleeve 90 extends into the opening of the porous member).
Regarding claim 49, Malchesky further teaches the second portion of the body extends through the opening of the porous member (a part of the second portion of the body at sleeve 90 extends through the opening of the porous member).
Regarding claim 51, Malchesky similarly teaches all of the limitations of claim 20 from which this claim depends (see above with respect to claim 46) and further teaches the inlet of the second portion faces in a first direction, the second portion being configured to be inserted into the lumen of the article via the open end of the lumen by moving the second portion in the first direction relative to the open end of the lumen (the inlet that is the aperture at the right-hand side in Fig. 6 can be moved in a rightward direction for insertion which is the same direction the aperture faces).
Regarding claim 52, Malchesky further teaches the inlet is disposed at an end of the second portion (Fig. 6 shows this).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
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.
Claims 23, 25, 34-37, 41, 43, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Kral (US 6,555,054).
Regarding claim 23, Kral is set forth with regards to claim 22 above, but appears to be silent in the cited embodiment with regards to an extent.
However, Kral discloses a porous member including an outer-most circumferential extent disposed radially outward of the exterior surface of the second portion of the body (Fig. 8, protrusion 57 is an extent and is the outmost surface of member 45, the protrusion having a width extending along at least part of a circumference of the largest portion of member 45 at protrusion 57 and thus reading on the limitation of circumferential). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the porous member of fig. 7 such that there is an outer-most circumferential extent disposed radially outward of the exterior surface of hanger 44 as disclosed in Fig. 8 of Kral in order to arrive at the claimed invention. One would have been motivated to do so to better secure the item to be treated on the hanger 44 (Col. 5 lines 22-30).
Regarding claim 25, Kral is set forth above with regards to claim 20 and further teaches the porous member includes an interconnected porous structure (col. 4 lines 43-58), but appears to be silent with regards to a second porous structure.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kral such that there are two porous members to arrive at the claimed invention. One would have been motivated to do so as this modification is merely the duplication of existing parts, and the mere duplication of parts has no patentable significance unless a new and unexpected result is produced, and the only result of duplicating the porous member 45 would be further filtering of the fluid which is only an expected result. MPEP 2144.04(VI)(B).
Regarding the limitation that the second porous member is arranged to be inserted into the lumen and engage the interior of the article that bounds the lumen: Apparatus claims cover what a device is, not what a device does and a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (see MPEP 2114, II).
Regarding claim 34, Kral is set forth with regards to claim 20 above, but appears to be silent in the cited embodiment with regards to a stop arranged to the body including a stop.
However, in the embodiment of Fig. 8 Kral discloses a hanger 44 that where the porous member 45 acts as both the body of the article connector and the porous member, and the hanger 44 is formed such that there is a stop arranged to engage the article (protrusion 57), and would perform the claimed function of inhibit further insertion of the second portion of the body in the lumen (see MPEP 2114, II). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the hanger 44 disclosed in fig. 7 such that there is formed thereon a stop 57 to arrive at the claimed invention. One would have been motivated to do so to better secure the item to be treated on the hanger 44 (Col. 5 lines 22-30).
Regarding claim 35, modified Kral further teaches the stop includes a curved surface, the curved surface being arranged to engage the article (fig. 8 shows a curved surface at protrusion 57).
Regarding claim 36, modified Kral further teaches the stop is disposed radially outboard of an exterior surface of the second portion of the body (protrusion 57 is radially outwards with respect to the more narrow portions of the hanger 44).
Regarding claim 37, Kral is set forth with regards to claim 20 above, but appears to be silent in the cited embodiment with regards to the body including a curved surface to engage an exterior surface of the article to inhibit further insertion of the second portion of the body in the lumen.
However, in the embodiment of Fig. 8 Kral discloses a hanger 44 that where the porous member 45 acts as both the body of the article connector and the porous member, and the hanger 44 is formed such that there is curved surface arranged to engage the article (protrusion 57), and would perform the claimed function of engaging an exterior surface to inhibit further insertion of the second portion of the body in the lumen (see MPEP 2114, II). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the hanger 44 disclosed in fig. 7 such that there is formed thereon a curved surface to arrive at the claimed invention. One would have been motivated to do so to better secure the item to be treated on the hanger 44 (Col. 5 lines 22-30).
Regarding claim 41, Kral is set forth above with regards to claim 20 but appears to be silent with regards to the body being a one-piece component.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kral such that the body including hanger 44 and fitting 46 are formed as a one-piece component to arrive at the claimed invention. One would have been motivated to do so, as the formation of existing prior art components as a one-piece construction is only a matter of obvious engineering choice, and there would be no new or unexpected result from forming the components as one-piece as opposed to multiple. MPEP 2144.04(V)(B).
Regarding claim 43, Kral is set forth with regards to claim 23 above and further teaches the body includes a proximal end (See fig. 7, the right side of hanger 44) and a distal end (the left side proximal coupling 46), the inlet being adjacent the distal end (see the right side in fig. 7 where the holes in the hanger are formed) and the outlet being adjacent the proximal end (the left side where coupling member 46 defines openings), and wherein the outer-most circumferential extent of the porous member is spaced proximal of the proximal end of the body (the protrusion 57 is arranged proximal to both ends and reads on this limitation).
Regarding claim 45, Kral is set forth above with regards to claim 20, but in the cited embodiment appears to be silent with regards to a distal end portion being tapered.
However, In figs. 5 and 6 of Kral, a hanger 44 with a body including a proximal end (left side of hanger 44 towards the fitting 46) and a distal end (right side of hanger 44), a second portion of the body having a distal end portion forming the distal end where the distal end portion is tapered (Figs. 5 and 6 shows hanger 44 at the rightmost tip tapering to the end as it reduces in thickness continuously towards the end). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the hanger 44 in Fig. 7 such that it is tapered at a distal end to arrive at the claimed invention. One would have been motivated to do so to avoid the implementation of sharp edges that could scratch or damage the endoscopes and other medical devices and their fragile components to arrive at an improved sterilization device. Furthermore, this modification is merely a change in shape, and changes in shape have no patentable significance unless the particular configuration is somehow significant, MPEP 2144.04 (IV)(B).
Claims 33 and 48-49 are rejected under 35 U.S.C. 103 as being unpatentable over Kral (US 6,555,054) as applied to claim 20 above and further in view of Malchesky (US 5,552,115).
Regarding claim 33, Kral is set forth above with regards to claim 20, and further teaches in fig. 8 that the first portion 56 can be a coupling member (Col. 5 lines 23-30), but appears to be silent with regards to the first portion being a barbed hose fitting.
Malchesky discloses an article connector including connections that include barbed hose fittings (Figs. 4, 6, and 10, fitting 78 is shown as being a barbed hose connection all show barbed hose fitting connection means for connecting conduits to each other for fluid communication) Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first portion of the hanger 44 at fitting 46 to be or include a barbed hose fitting to arrive at the claimed invention. One would have been motivated to do so to successfully and reversibly connect the hanger to the sterilization device for use as is familiar in the art to arrive at an replaceable, easy-to-use, and toolless article connector. The combination of familiar prior art elements for the same purpose together as separate, like fittings and barbed hose fittings, according to known means to arrive at results that are nothing more than predictable including fluid communication is prima facie obvious. MPEP 2143(I)(A).
Regarding claim 48, Kral is set forth above with regards to claim 47 but appears to be silent with regards to the second portion of the body extending into the opening of the porous member.
Malchesky further teaches an article connector (Fig. 6, showing article connector with sleeve 90 for easy handling, col. 7 lines 52-60) wherein the porous member of the article connector (porous member 80) has an opening through which sterilant flows (Col. 7 lines 23-33 discloses tube 76 is for delivering fluid) wherein the second portion of the body extends into the opening of the porous member (Fig. 6 shows an interior portion of sleeve 90 being interior to and extending into the opening of porous member 80). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kral such that the hangers 44 have a portion that extends into an opening formed by the porous member as disclosed by Malchesky to arrive at the claimed invention. One would have been motivated to do so to facilitate easier handling of the hanger 44 by way of sleeve 90 of Malchesky.
Regarding claim 49, modified Kral further teaches he second portion of the body extends through the opening of the porous member (see fig. 6 of Kral, the interior portion of sleeve member 90 extends through an opening of the porous member).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Kral (US 6,555,054) as applied to claim 38 above and further in view of Kuroshima (US 8,182,759).
Regarding claim 39, Kral is set forth with regards to claim 38 above but appears to be silent with regards to the connector in combination with the article wherein the second portion of the body and porous member are disposed in the lumen.
Kuroshima (US 8,182,759) discloses an article connector (Fig. 5 liquid supply mouthpiece 200) and an article (fig. 4 shows channel mouthpiece 110 of endoscope 100) wherein a second portion of the body of the article connector is inserted into the lumen (Fig. 5 shows first channel member 120 of the supply mouthpiece 200 being inside the channel mouthpiece 110 of the endoscope 100). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kral such that the second portion is inside the article and the porous member engaging therein as taught by Kuroshima to arrive at the claimed invention. One would have been motivated to do so to facilitate a better and more secure fit to the article for less leakage and more effective sterilization. Furthermore, the combination of familiar prior art elements, including porous members and article connecting members, according to known means for the same purpose together as separate and to arrive at results that are nothing more than predictable is prima facie obvious. MPEP 2143(I)(A).
Response to Arguments
Applicant's arguments filed 12/30/25 have been fully considered but they are not persuasive.
Applicant’s arguments directed towards claim 20 are not persuasive. Applicant argues the hangers 44 cannot be used in such a way to meet the claim limitation that the porous member is “configured to” be inserted into a lumen which is not persuasive. The hangers 44 are elongated structures that could easily and would readily be inserted into a lumen as claimed.
Applicant argues on page 9 that the term “configured to” requires a structure designed to accomplish the specific objective, which is not persuasive. Firstly, the hangers 44 could readily perform the claimed function of being inserted into a lumen. The insertion of a component and the engaging of a surface as a result of the insertion is a step that is performed by the device, and therefore a function. It cannot be construed as a structure. Applicant cites judicial decisions on the same page explaining that the language “adapted to” should be interpreted to mean that the structure is made to accomplish the specific objective, not that the structure “can be made to serve that purpose”, which is further not persuasive because claim does not recite the limitation “adapted to”. The claim instead recites “configured to”, and therefore the argument is not commensurate with the scope of the claims. Furthermore, the hangers 44 would not need to be modified (“made to”, as set forth in the quoted portion of Aspex Eyewear, Inc. v. Marchon Eyewear, Inc.) in order to satisfy the claimed limitation. The hangers 44 would, as depicted by the prior art reference and without structural modification, be capable of and expected to perform the claimed function. There is no structural difference between the claim and the prior art and the function of “being configured to be inserted into the lumen” does not impart any structure to the claimed device that is not present in the prior art. The prior art device is well capable of performing this claimed function as well as the other functions of the claim and therefore all of the claimed limitations are met. See MPEP 2114, II. Claim 20 remains rejected. Applicant does not present any specific arguments with respect to the other claims attacking the references for the manner in which they are applied in the rejections above, and therefore those arguments are not persuasive similarly. The remaining claims remain rejected.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BRENDAN A HENSEL/Examiner, Art Unit 1758