DETAILED ACTION
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 § 112
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.
Claim 11 is 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 11 recites the limitation "pillar" in line 11. There is insufficient antecedent basis for this limitation in the claim. No such term has been introduced in claim 11 or within claim 1, upon which claim 11 depends. Thus, the scope of the claim is rendered indefinite. Appropriate correction is required. For examination purposes, and based upon the context of the specification, it is presented that this term likely refers to the “post” defined within claim 1.
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.
Claim(s) 1-6 and 8-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jiang (U.S. Pat. Pub. No. 2021/0244933 A1).
Regarding claim 1, Jiang discloses a disinfecting cap (10) for attachment to a port of a medical implement (interpreted as intended use, but see Fig. 10, 12, and 17-19, and [0076]), the cap comprising: a cap body comprising: a cavity portion (30) comprising an open end (34), a closed end (end opposite open end 34), and a sidewall extending between the open end and the closed end (see Fig. 1-7, [0083-0089], and [0105-0111], wherein the cap body cavity portion 30 comprises a cylindrical side wall, and a cap body cavity portion endwall that further comprises reagent compartment 50 and that forms the closed end of the cavity portion), the side wall at least partially enclosing an interior cavity (the cylindrical space defined by the sidewall of cap body cavity portion 30 and the cap body endwall), a flange portion (bulb 60, which may be considered a hollow flange due to the fact that it cooperates with the cap body cavity portion end wall to sandwich the skirt endwall 26 between them, thereby performing the role of a flange by coupling the cap body to the skirt end wall 26), and a post (the hollow cylindrical post extending from bulb 60 through the skirt endwall 26 and to the cap body cavity portion endwall, and forming passageway 70) extending between the cavity portion and the flange portion (see Fig. 1-7, [0083], and [0105], wherein the hollow post is positioned between the hollow flange and the cap body cavity portion); a skirt (20) comprising a skirt sidewall (cylindrical sidewall of skirt 20), a skirt end wall (26), an outer surface (see Fig. 1-7), and an aperture (aperture 27, through which the hollow post extends); wherein the skirt covers at least a portion of an exterior surface of the cap body cavity portion (see Fig. 1-7, wherein the skirt covers/contains the entirety of the cap body cavity portion); and wherein the cap body flange portion covers at least a portion of the outer surface of the skirt (see Fig. 1-7, wherein the cap body flange 60 sandwiches, and thereby covers, a portion of the skirt endwall 26 between its lower endwall and the cap body cavity portion endwall).
Regarding claim 2, Jiang further discloses that the cap body post extends through the skirt aperture (see Fig. 1-7).
Regarding claim 3, Jiang further discloses that the skirt sidewall surrounds at least a portion of the cap body cavity portion sidewall (see Fig. 1-7, wherein the cylindrical sidewall portion of the skirt covers/contains the entirety of the cylindrical cap body cavity portion sidewall).
Regarding claim 4, Jiang further discloses that the cap body flange portion comprises a flange portion end wall (bottom/contacting surface of the flange 60, to which the post is attached) that covers at least a portion of the skirt end wall (see Fig. 1-7 and see above discussion in re claim 1).
Regarding claim 5, Jiang further discloses that the cap body flange portion comprises a flange portion sidewall (see Fig. 1-7, wherein it is clear that the cap body flange portion 60 comprises a sidewall that is perpendicular to the flange portion end wall and which circumscribes the flange hollow interior).
Regarding claim 6, Jiang further discloses that the skirt outer surface comprises a first section (the section not overlapped by the flange portion, forming the radially outer portions of the skirt outer surface) and a base section (the section overlapped by the flange portion, including the skirt aperture at its center).
Regarding claim 8, it is first noted that “durometer” is interpreted within the context of the specification as a measure of material hardness. Jiang further discloses that the cap body comprises a first material having a first hardness/durometer (“semi-rigid” materials, such as polyethylene or rubber - see [0087] and [108]), and wherein the skirt comprises a second material having a second hardness/durometer different from the first hardness/durometer (“rigid” materials, such as high density polyethylene- see [0084] and [0106]).
Regarding claim 9, Jiang further discloses that the second hardness/durometer is greater than the first hardness/durometer (see [0084-0087] and [0106-0108], wherein the “rigid” second material for the skirt is of greater hardness than the “semi-rigid” first material of the cap body).
Regarding claim 10, Jiang further discloses that the skirt aperture comprises a channel extending from a skirt end wall inside surface to the skirt outer surface (see Fig. 1-7).
Regarding claim 11, Jiang further discloses that the cap body cavity portion, flange portion, and post are integrally formed in a single piece of a single material (see Fig. 3, and 6-7, wherein it is clear from the shading used in the depictions that the cap body cavity portion, flange portion, and post are formed integrally of a single material).
Regarding claim 12, Jiang further discloses that the cap body cavity portion sidewall comprises a smooth, non-threaded interior surface (31) (see Fig. 1-7, [0086], [0088], and [0109-0110]).
Regarding claim 13, Jiang further discloses that the cap body cavity portion sidewall interior surface engages a thread of a port of the medical implement when the port is inserted into the cap (see Fig. 10, 12, and 17-19, [0086], [0088], and [0109-0110]).
Regarding claim 14, Jiang discloses a disinfecting cap (10) for attachment to a port of a medical implement (interpreted as intended use, but see Fig. 10, 12, and 17-19, and [0076]), the cap comprising: a cap body (assembly of cavity portion 30, hollow flange 60, and post therebetween – see in re claim 1) comprising an open end (34), a closed end (end opposite open end 34), and a sidewall extending between the open end and the closed end (see Fig. 1-7, [0083-0089], and [0105-0111], wherein the cap body cavity portion 30 comprises a cylindrical side wall, and a cap body cavity portion endwall that further comprises reagent compartment 50 and that forms the closed end of the cavity portion), the sidewall at least partially enclosing an interior volume (the cylindrical space defined by the sidewall of cap body cavity portion 30 and the cap body endwall); and a skirt (20) comprising a skirt sidewall (cylindrical sidewall of skirt 20); wherein the skirt sidewall surrounds at least a portion of the cap body sidewall (see Fig. 1-7, wherein the cylindrical sidewall portion of the skirt covers/contains the entirety of the cylindrical cap body cavity portion sidewall).
Regarding claim 15, it is first noted that “durometer” is interpreted within the context of the specification as a measure of material hardness. Jiang further discloses that the cap body comprises a first material having a first hardness/durometer (“semi-rigid” materials, such as polyethylene or rubber - see [0087] and [108]), and wherein the skirt comprises a second material having a second hardness/durometer different from the first hardness/durometer (“rigid” materials, such as high density polyethylene- see [0084] and [0106]).
Regarding claim 16, Jiang further discloses that the second hardness/durometer is greater than the first hardness/durometer (see [0084-0087] and [0106-0108], wherein the “rigid” second material for the skirt is of greater hardness than the “semi-rigid” first material of the cap body).
Regarding claim 17, Jiang further discloses that the cap body further comprises a flange (60) (see in re claim 1).
Regarding claim 18, Jiang further discloses that the cap body flange surrounds a portion of an outer surface of the skirt (see Fig. 1-7, wherein the cap body flange 60 sandwiches a portion of the skirt endwall 26 between its lower endwall and the cap body cavity portion endwall, thereby surrounding the outer surface of the skirt endwall 26 in this sandwiched region).
Regarding claim 19, Jiang further discloses that the cap body further comprises an extension (the hollow post) positioned in a channel (the skirt aperture) of the skirt (see in re claims 1-2).
Regarding claim 20, Jiang further discloses that the skirt further comprises an extension (portion of skirt endwall 26 which is sandwiched between the cap body flange portion endwall and the cap body cavity portion endwall) positioned in a cavity (the gap between the cap body flange portion endwall and the cap body cavity portion endwall) of the cap body (see Fig. 1-7).
Claim(s) 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chiu (U.S. Pat. Pub. No. 2018/0256879 A1).
Regarding claim 14, Chiu discloses a disinfecting cap (100) for attachment to a port (200) of a medical implement (interpreted as intended use, but see Fig. 1-24 and [0030]), the cap comprising: a cap body (inner-threaded liner 108) comprising an open end, a closed end, and a sidewall extending between the open and the closed end (see Fig. 1-24 and [0031]), the sidewall at least partially enclosing an interior volume (see Fig. 1-24 and [0031]); and a skirt (container 106) comprising a skirt sidewall (see Fig. 1-24 and [0031]); wherein the skirt sidewall surrounds all or most of the cap body sidewall (see Fig. 1-24 and [0031]).
Regarding claim 15, it is first noted that “durometer” is interpreted within the context of the specification as a measure of material hardness. Chiu further discloses that the cap body comprises a first material having a first hardness/durometer (see [0042], wherein the cap body 108 may be made of soft polymers/plastics), and wherein the skirt comprises a second material having a second hardness/durometer different from the first durometer (see [0042], wherein the skirt 106 may be made of rigid materials, such as stainless steel, of greater hardness than that of the cap body 108 material).
Regarding claim 16, Chiu further discloses that the second durometer is greater than the first durometer (see in re claim 15).
Regarding claim 17, Chiu further discloses that the cap body further comprises a flange (130) (see embodiment of Fig. 22-24 and [0056-0057]).
Regarding claim 18, Chiu further discloses that the cap body flange surrounds a portion of an outer surface of the skirt (see Fig. 22-24). Here, the flange includes annular rim/extension 134, which together with the flat portion of the flange (130) and the cap body cavity portion sidewall creates a groove in which a portion of the skirt is surrounded. This surrounded portion of the skirt comprises at least one outer surface in the form of a surface which faces radially outward and another surface which faces away from the cap body in the direction of the medical implement. Thus, it is clear that the cap body flange surrounds a portion of an outer surface of the skirt located on this surrounded portion of the skirt.
Regarding claim 19, Chiu further discloses that the cap body further comprises an extension (134) positioned in a channel of the skirt (see Fig. 22-24 and [0056-0057]).
Regarding claim 20, Chiu further discloses that the skirt further comprises an extension (the aforementioned surrounded portion of the skirt) positioned in a cavity (the aforementioned groove) of the cap body (see in re claim 18).
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.
Claim(s) 1-6 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Chiu in view of Brandriff (U.S. Pat. Pub. No. 2015/0114967 A1) and Frisch (U.S. Pat. Pub. No. 2023/0264862 A1).
Regarding claim 1, Chiu discloses a disinfecting cap (100) for attachment to a port (200) of a medical implement (interpreted as intended use, but see Fig. 1-24 and [0030]), the cap comprising: a cap body (inner-threaded liner 108) comprising: a cavity portion comprising an open end, a closed end, and a sidewall extending between the open end and the closed end (see Fig. 1-24 and [0031]), the side wall at least partially enclosing an interior cavity (see Fig. 1-24 and [0031]); a skirt (container 106) comprising a skirt sidewall, a skirt end wall, and an outer surface (see Fig. 1-24 and [0031]); wherein the skirt covers at least a portion of an exterior surface of the cap body cavity portion (see Fig. 1-24 and [0031]). Chiu fails to teach that the cap body comprises a flange portion and a post extending between the cavity portion and the flange portion, that the skirt comprises an aperture, and that the cap body flange portion covers a portion of the outer surface of the skirt. Instead, in the embodiments of Fig. 12-19, Chiu teaches that the cap body and skirt may be couped together via a configuration in which the skirt comprises a flange portion (114A, 114B, 114C, 114D) and a post extending between the cavity portion and the flange portion, the cap body comprises an aperture, and the skirt flange portion covers a portion of the interior surface of the cap body cavity portion end wall (the wall at the closed end) (see Fig. 12-19, and [0046-0052]). This is the opposite configuration to that claimed, yet it is well known within the art that such coupling arrangements may be expected to perform in the same manner and with the same coupling effect if reversed. Further, Brandriff exemplifies that it is known within the art to couple a cap body (2601) of a cap similar to that of Chiu to a surrounding skirt (2603) by configuring the cap body to include a flange portion (annular flange 2620) and a post (1610) extending outward from the closed end of the cap body through an aperture in the skirt (see Fig. 26 and [0066]), the cap body flange portion covering a portion of the outer surface of the skirt (see Fig. 26 and [0066]). While Brandriff teaches an annular flange portion in the shape of a ring, mounted separate from the post, Frisch exhibits a flange portion (136) used to retain a skirt (102) to the closed end of a cap body (106), wherein the flange portion is formed as a single flat disk, similar to flange 114C of Fig. 15A-15B of Chiu, extending to cover, and thereby retain, a portion of the outer surface of the skirt (see Fig. 3-8 and [0031-0034]).
Based on such examples, and the well-understood principle that such coupling configurations may be expected to function equivalently if reversed, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to reverse the coupling arrangement between the cap body and skirt in the disinfecting cap of Chiu, such that the cap body comprises a flange portion (in the manner of any one of 114A-D, for example) and a post extending between the cavity portion and the flange portion (extending outward from the outer surface of the cap body cavity portion end wall), that the skirt comprises an aperture (within the skirt endwall, accommodating the post, in the same manner that the cap body end wall of Chiu formerly comprised an aperture that accommodated the post of the skirt), and that the cap body flange portion covers a portion of the outer surface of the skirt (by overlap, i.e. in the same manner that the flange portion of the skirt of Chiu formerly covered a portion of the inner surface of the cap body cavity portion end wall by virtue of overlapping/sandwiching this portion between the flange portion and remainder of the skirt), as an obvious reversal of parts. See MPEP 2144.04(VI)(A).
Regarding claim 2, the proposed combination exhibits that the cap body post extends through the skirt aperture, since the coupling configuration of Chiu (Fig. 12-19) is reversed in the above modification, such that the cap body comprises a post extending outward from the outer surface of the cap body cavity portion end wall between the cavity portion and the flange portion, and such that that the skirt comprises an aperture accommodating the post, in the same manner that the cap body of Chiu formerly comprised an aperture that accommodated the post of the skirt. See in re claim 1.
Regarding claim 3, Chiu further discloses that the skirt sidewall surrounds at least a portion of the cap body cavity portion sidewall (see Fig. 12-19, wherein the skirt sidewall surrounds all of the cavity portion sidewall).
Regarding claim 4, the proposed combination exhibits that the cap body flange portion comprises a flange portion end wall that covers at least a portion of the skirt end wall, since the coupling configuration of Chiu (Fig. 12-19) is reversed in the above modification, such that the cap body comprises a flange portion in the manner of any one of 114A-D mounted to the closed end of the cap body cavity portion end wall via a post extending between the cavity portion and the flange portion (extending outward from the outer surface of the cap body), such that the cap body flange portion overlaps a portion of the outer surface of the skirt (in the same manner that the flange portion of the skirt of Chiu formerly covered a portion of the inner surface of the cap body cavity endwall by virtue of overlapping/sandwiching this portion between the flange portion and remainder of the skirt). Like the former configuration, the flange portion of the proposed combination comprises an end wall which forms the surface of contact between the flange portion and the underlying portion of the skirt. Thus, the flange of the proposed combination exhibits that the cap body flange portion comprises a flange portion end wall that covers the portion of the skirt end wall which is sandwiched between the flange portion and the outer surface of the cap body cavity portion end wall. See in re claim 1.
Regarding claim 5, the proposed combination further exhibits that the cap body flange portion may comprise a flange portion sidewall (see Fig. 15A-15B and see in re claim 1, wherein the flange portion may be of the flat disc form of 114C, thereby comprising a sidewall perpendicular to the flange portion end wall and circumscribing the flange portion).
Regarding claim 6, Chiu, in light of the proposed combination, further exhibits that the skirt outer surface comprises a first section (the section not overlapped by the flange portion, forming the radially outer portions of the skirt outer surface) and a base section (the section overlapped by the flange portion, including the skirt aperture at its center).
Regarding claim 8, it is first noted that “durometer” is interpreted within the context of the specification as a measure of material hardness. Chiu further discloses that the cap body comprises a first material having a first hardness/durometer (see [0042], wherein the cap body 108 may be made of soft polymers/plastics), and wherein the skirt comprises a second material having a second hardness/durometer different from the first durometer (see [0042], wherein the skirt 106 may be made of rigid materials, such as stainless steel, of greater hardness than that of the cap body 108 material).
Regarding claim 9, Chiu further discloses that the second durometer is greater than the first durometer (see in re claim 8).
Regarding claim 10, the proposed combination further exhibits that the skirt aperture comprises a channel extending from a skirt end wall inside surface to the skirt outer surface, since the coupling configuration of Chiu (Fig. 12-19) is reversed in the above modification, such that the skirt comprises an aperture accommodating the post of the cap body, which extends through the skirt end wall from the inside to the outside, in the same manner that the cap body cavity portion end wall of Chiu formerly comprised an aperture that accommodated the post of the skirt. See in re claim 1.
Regarding claim 11, it is clear from the examples of Brandriff and Frisch, wherein the flanges and posts/supporting structures are integrally formed of the same material as the cap body (see …), that the cap body cavity portion, flange portion, and post of the proposed combination may be integrally formed in a single piece of a single material as part of the above modification in re claim 1.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Chiu as modified by Brandriff and Frisch according to claim 6, and in further view of Gardner (U.S. Pat. Pub. No. 2016/0045629 A1).
Regarding claim 7, Chiu as modified by Brandriff and Frisch according to claim 6 exhibits the disinfecting cap of claim 6. Chiu fails to teach that the cap body flange portion sidewall surrounds the skirt base section.
Gardner exhibits a disinfecting cap similar to that of Chiu, comprising a cap body (114) with a flange portion (132) for coupling the cap body to a skirt (112) surrounding the cap body (see Fig. 1-3B and [0052-0058]). Gardner teaches that such a cap body flange portion may comprise a sidewall (140) that surrounds a base/hook portion (130) of the skirt in an interlocking manner, thereby providing a secure coupling of the flange portion and the skirt, and providing a flat top surface (see Fig. 2A-3B and [0052-0058]).
Based on the teachings and example of Gardner, 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 cap body flange portion and the skirt end wall of Chiu such that the cap body flange sidewall surrounds the skirt base section in an interlocking manner of the kind taught by Gardner, as a means of providing a secure coupling of the flange portion and the skirt (including anti-rotational coupling if the interlock is of an interference fit tightness) while also providing a flat top surface to the disinfecting cap assembly, as exemplified by Gardner and as may be desirable for aesthetic reasons, or reasons of improving user gripping comfort.
Claim(s) 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Chiu as modified by Brandriff and Frisch according to claim 1, and in further view of Burkholz (U.S. Pat. Pub. No. 2016/0325089 A1).
Regarding claim 12, Chiu as modified by Brandriff and Frisch according to claim 1 exhibits the disinfecting cap of claim 1. Chiu fails to teach that the cap body cavity portion sidewall comprises a smooth, non-threaded interior surface. Rather, each embodiment of Chiu exhibits a threaded interior surface in order to allow the cap to be secured onto a port of the medical implement for long-term sterilization/contamination prevention (see threads 108, Fig. 2-24, [0031-0039] and [0044]). Yet, there is a well recognized need within the art for disinfecting caps that may be used to quickly and easily clean a port of a medical implement prior to use of the medical implement, and then be discarded. Burkholz, for example, teaches such a configuration for a disinfecting cap. Burkholz exhibits a disinfecting cap (first cap) comprising a cap body (20) with an open end, a closed end, and a sidewall extending between the open end and the closed end and enclosing an interior cavity (28) (see Fig. 2B and [0017-0022]), each similar to those of Chiu, but teaches that the disinfecting cap may be configured to be used to quickly and easily clean a port of a medical implement prior to use of the medical implement by having a smooth, non-threaded interior surface that may be lined with an antimicrobial pad (30) (see Fig. 2B, [0017-0018], [0021-0022], [0024], and [0029-0030]). It is further evident that such a non-threaded configuration allows the cap to be quickly and easily applied and removed from the port, to be turned while the port is inserted within the cap to facilitate scrubbing/wiping, and accommodates a variety of different thread pitches/angles rather than a single thread pitch/angle. Thus, based on the teachings and example of Burkholz, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the disinfecting cap of Chiu to be used for quick and easy cleaning of a port of a medical implement prior to use of the medical implement by modifying the interior surface of the disinfecting cap of Chiu to have a smooth, non-threaded interior surface that may be lined with an antimicrobial pad in the manner taught by Burkholz, thereby allowing the cap to be quickly and easily applied and removed from the port, to be turned while the port is inserted within the cap to facilitate scrubbing/wiping, and accommodates a variety of different thread pitches/angles rather than a single thread pitch/angle.
Regarding claim 13, Chiu teaches in Fig. 9-10 and [0044-0045] that the disinfecting cap is intended to be turned onto a port of the medical implement in a manner wherein the cap body cavity portion sidewall interior surface engages a thread of a port of the medical implement when the port is inserted into the cap in order to thereby clean the threads. While Chiu has been modified, as described above in re claim 12, to comprise a smooth, non-threaded interior surface lined with an antimicrobial pad, it is clear from Burkholz, [0017-0018], [0022], and [0029-0030], that such a smooth surface lined with an antimicrobial pad may similarly engage a thread of a port of the medical implement when the port is inserted into the cap in order to thereby clean the threads, especially when the cap is turned upon insertion of the port.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. This art includes
Ueda (U.S. Pat. Pub. No. 2016/0088995 A1), which discloses a disinfecting cap comprising a cap body (34) with a post (32) and flange (30) formed integrally with the cap body, and a skirt (20) surrounding the cap body (see Fig. 1-5 and [0025-0034]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric A Lange whose telephone number is (571)272-9202. The examiner can normally be reached on M-F 8:30am-noon and 1pm-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC A LANGE/Examiner, Art Unit 3745
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783