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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election of Species B in the reply filed on 12/22/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 6-7, 10 and 13 (which depends on withdrawn claim 10) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/22/2025.
Information Disclosure Statement
The information disclosure statement filed 7/11/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claims 2-5, 8-9, 11-12 and 14-16 are objected to because of the following informalities:
in line 1 of Claim 2, 8, 11-12 and 15-16, insert --,-- after “claim 1”;
in line 2 of Claim 2, delete “the” before “movement”;
in line 1 of Claim 3, insert --,-- after “claim 2”;
in line 2 of Claim 3, delete “a” before “fluid” and insert --the--;
in line 2 of Claim 3, delete “a” before “fluid” and insert --the--;
in line 4 of Claim 8, delete “a” before “fluid” and insert --the--;
in line 1 of Claim 9, insert --,-- after “claim 8”;
in line 1 of Claim 14, insert --,-- after “claim 11”.
Appropriate correction is required.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9, 11 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In Claim 9, it is not clear whether “an open position” for “said valve flap” is attempting to point to the “opened position” of said valve flap” as set forth in the parent claim 8.
Claim 11 recites the limitation "said valve" in line 5. There is insufficient antecedent basis for this limitation in the claim. For examination purpose, this limitation is being interpreted to be “said seal”.
In Claim 14, it is not clear whether “instrument receiving opening” is attempting to set forth a new feature/structure of the sponge or is attempting to a structure that was set forth in another claim, such as claim 12.
Claim 14 recites the limitation "said first end" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-5, 8-9, 11-12, 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw (20110064512) in view of Chiu (20170232121) or Price (6142297).
As to Claim 1, Shaw (‘512) discloses an apparatus (200) for cleaning a medical instrument (see entire document, particularly Figures 28-34 and 36-46, Abstract) comprising:
a housing (202) having a first end (i.e. at 205 and 208) and a second end (i.e. where 212 is connected to 202) (see entire document, particularly Figures 28-34);
a sponge (204) that is adapted to be received within said housing (202) (see Figures 29 and 33-34);
an entrance lid (206) that is removably carried by said first end (i.e. at 205 and 208) of said housing (202) (see Figure 29);
an insertion opening (205) being adapted to receive a medical instrument so that at least a portion of the medical instrument may be inserted into said insertion opening (205) and contact said sponge (204) (see entire document, particularly Figures 29-34 and 46, Abstract);
a bottom (212) that is removably carried by said second end (i.e. where 212 is connected to 202) of said housing (202) (see Figures 32-34), wherein said bottom (212) is adapted to store a disinfecting solution (220) (see Figures 32 and 34); and
a transfer opening (i.e. end where 222 and 224 are located) defined in said second end (i.e. where 212 is connected to 202) of said housing (202), whereby when said bottom (212) is secured to said second end (i.e. where 212 is connected to 202), said bottom (212) is in fluid communication (via 214) with said housing (202) (see Figures 32-34).
Shaw (‘512) does not appear to specifically teach that the insertion opening is defined in said entrance lid.
It was known in the art before the effective filing date of the claimed invention to provide an insertion opening in an entrance lid of an apparatus for cleaning an instrument.
Chiu (‘121) discloses an apparatus (100) for cleaning a medical instrument (200; 210) (see entire document, particularly Figures 1-43) comprising:
a housing (20) having a first end (i.e. at 22) and a second end (i.e. at the opposite side of 22);
a sponge (50) that is adapted to be received within said housing (20) (see Figures 26A-26B, 29A-29C, and 35);
an entrance lid (30) that is removably carried by said first end (i.e. at 22) of said housing (20) (see Figure 35, p. 3 [0049]); and
an insertion opening (via 33) defined in said entrance lid (30), said insertion opening (via 33) being adapted to receive a medical instrument (200; 210) so that at least a portion of the medical instrument (200; 210) may be inserted into said insertion opening (via 33) and contact said sponge (50) (see entire document, particularly Figures 35-43, p. 2 [0048]);
in order to protect the interior of the housing from the external environment or contaminants prior to use as well as to be a static seal when the medical device is inserted into the apparatus so as to prevent leakage (see entire document, particularly Figures 35-43, p. 2 [0044] – lines 11-14, p. 3 [0051]-[0052]).
Price (‘297) also discloses an apparatus (30) for cleaning a medical instrument (6) (see Figure 1) comprising:
a housing (34) having a first end (42) and a second end (46);
a sanitizing medium (52) that is adapted to be received within said housing (34) (see Figure 1);
an entrance lid (60) that is removably carried by said first end of (42) said housing (34) (see Figures 1-4); and
an insertion opening (78) defined in said entrance lid (60), said insertion opening (78) being adapted to receive a medical instrument (6) so that at least a portion (16, 20) of the medical instrument (6) may be inserted into said insertion opening (78) and contact said sanitizing medium (52) (see Figures 1-2);
in order to allow insertion of the medical instrument for cleaning and to substantially seal the sanitizing medium within the apparatus (see entire document, particularly Figures 1-2, Col. 3 lines 8-9 and 11-14).
It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide an insertion opening in the entrance lid of the apparatus of Shaw as a known configuration in order to allow insertion of medical instruments for cleaning but ensure that any sanitizing medium remains substantially within the apparatus as shown by Chiu or Price.
As to Claim 2, while Shaw (‘512) appears to teach that the apparatus (200) further comprises a seal (216) that is removably carried by the bottom (212) so that said seal (216) prevents movement of the fluid (220) from said bottom (212) into said housing (202) when said seal (216) is covering said transfer opening (i.e. where 222 and 224 are positioned) (see Figures 32 and 36), Shaw (‘512) does not appear to specifically teach that the seal (216) is removably carried by said second end (i.e. where 212 is connected to 202) of said housing (202). However, as Shaw (‘512) also discloses an embodiment where a seal (270; 314) is removably carried by a housing (252) at a second end (i.e. at 264; at the end of 308) (see Figures 37-46) in order to provide a flow of disinfectant when desired and so that the seal prevents a flow of disinfectant from said bottom into said housing when said seal is covering said transfer opening (see Figures 37-46), it would have been obvious to and well within the purview of one of ordinary skill in the art before the effective filing date of the claimed invention to provide a seal that is removably carried by said second end of said housing as a known alternate configuration in the apparatus of Shaw as modified by Chiu or Price in order to provide a flow of disinfectant when desired and so that the seal prevents a flow of disinfectant from said bottom into said housing when said seal is covering said transfer opening as shown by Shaw.
As to Claim 3, Shaw (‘512) discloses that the seal (216; 270; 314) includes a closed position (see Figures 32, 38-39 and 44-45) and an open position (see Figures 33 and 46), wherein said closed position inhibits movement of the fluid (220; 274; 316) between said bottom and said housing (202; 256; 302) and said open position allows the movement of the fluid between said bottom (212; 254; 304) into said housing (202; 256; 302) (see Figures 32-33, 38-39 and 44-46).
As to Claim 4, the seal (216; 270; 314) of Shaw (‘512) is placed in said open position when an elongate object/medical instrument is inserted into said transfer opening (see Figures 44-46).
As to Claim 5, the seal (216; 270; 314) of Shaw (‘512) is capable of being placed in said open position when an elongate object/medical instrument is inserted (via 228; 264) into said seal (216; 270; 314) (see Figures 32-34 and 46).
As to Claims 8-9, while neither Shaw (‘512) or Chiu (‘121) nor Price (‘297) appears to specifically teach a valve flap is the closure/openable means located at or adjacent said transfer opening and allows access/flow into/out of said bottom rather than the seal/plug/stopper that is capable of being placed into an opened position when the medical device is inserted into said transfer opening (see Figure 46), it would have been obvious to and well within the purview of one of ordinary skill in the art before the effective filing date of the claimed invention to provide a different type of closure such as a valve flap instead of the seal/stopper disclosed by Shaw in the apparatus of Shaw as modified by Chiu or Price as a known alternate closure/access means in order to allow on-demand access to the fluid within the bottom for sterilization of an instrument. Only the expected results would be attained.
As to Claim 11, Shaw (‘512) discloses that the seal (314) carried by said second end (i.e. at the end of 308) of said housing (302), wherein said seal (314) includes having a first inner diameter (i.e. diameter of the larger portion/end of 314 which contacts 316 in Figures 44-45) adapted to receive/capable of receiving a medical device so that said medical device may pass through said second end (i.e. at the end of 308) of said housing (302) into said bottom (304) and said seal (314) further includes a flange (i.e. shoulder/shelf formed by smaller end portion of 314) carried by an inner wall of said seal (314), said flange (i.e. shoulder/shelf formed by smaller end portion of 314) having a second inner diameter (i.e. diameter of the smaller portion/at the connection between the larger and smaller portions of 314) that is smaller than said first inner diameter (i.e. diameter of the larger portion/end of 314 which contacts 316 in Figures 44-45).
As to Claim 12, Shaw (‘512) as modified by Chiu (‘121) or Price (‘297) discloses that the sponge (204) includes a disinfectant (220) and is arranged so that when a medical instrument (152; 194; 328) enters said housing (202) through said entrance lid, the medical instrument passes through an instrument receiving opening defined in a first end of said sponge and the medical device contacts said disinfectant (see entire document, particularly Figure 46, p. 7 [0106] – 5th – 13th lines from the bottom).
As to Claim 14, Shaw (‘512) discloses that the instrument receiving opening (i.e. slit in 204) defined in said first end of said sponge (204) extends generally parallel to a second end of said sponge (see Figures 29 and 33-34).
As to Claim 16, Price (‘297) discloses that the apparatus (30) further comprises a handle (120) disposed on an outer surface (38) of said housing (34) for carrying or positioning said housing (34).
Thus, Claims 1-5, 8-9, 11-12, 14 and 16 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Shaw (‘512) and Chiu (‘121) or Price (‘297).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Shaw (20110064512) in view of Chiu (20170232121) or Price (6142297) as applied to claim 1 above, and further in view of Hirst (20110146012).
Shaw (‘512) and Chiu (‘121) or Price (‘297) are relied upon for disclosure described in the rejection of claim 1 under 35 U.S.C. 103.
While Shaw (‘512) discloses that the bottom (212) includes a first means (214) that is adapted to engage a second means (222, 224) that is includes on said second end (i.e. where 212 is connected to 202) of said housing (202) so that said bottom (212) can be removably secured (see Figures 29 and 32-34), neither Shaw (‘512) or Chiu (‘121) nor Price (‘297) appears to specifically teach that the first and second means are a first set of screw threads and a second set of screw threads.
It was known in the art before the effective filing date of the claimed invention to provide a bottom that includes a first set of screw threads that are adapted to engage a second set of screw thread that is included on a second end of a housing so that the bottom can be removably secured to the housing in an apparatus for cleaning an instrument/object. Hirst (‘012) discloses an apparatus (100) for cleaning an elongate object/instrument (150) (see Figures 1-4) comprising:
a housing (110, 111) having a first end (i.e. where 112 is connected to 111) and a second end (i.e. where 113 is connected to 111);
a sponge (131 – 131a, 131b) that is adapted to be received within said housing (111) (see Figures 2-3B);
an entrance lid (112) that is removably carried by said first end (i.e. where 112 is connected to 111) of said housing (111);
an insertion opening (114) defined in said entrance lid (112), said insertion opening (114) being adapted to receive an elongate object (150) capable of being a medical instrument so that at least a portion of the elongate object/medical instrument (150) may be inserted into said insertion opening (114) and contact said sponge (131 – 131a, 131b) (see Figures 3a-3b);
a bottom (113) that is removably carried by said second end (i.e. where 113 is connected to 111) of said housing (111) (see Figures 1-4);
a transfer opening (i.e. at the bottom of 111) defined in said second end (i.e. where 113 is connected to 111) of said housing (111) (see Figures 2-3B), whereby when said bottom is secured to said second end, said bottom is in fluid communication with said housing; and
a handle (120) disposed on an outer surface of said housing (110, 111) for carrying or positioning said housing (110, 111) (see Figures 1-2 and 4),
wherein said sponge (131 – 131a, 131b) includes a disinfectant (140) and is arranged so that when the elongate object/medical instrument (150) enters said housing (111) through said entrance lid (112), the elongate object/medical instrument (150) passes through an instrument receiving opening (132a) defined in a first end of said sponge (131) and the elongate object/medical instrument (150) contacts said disinfectant (140) (see Figures 3A-3B);
wherein the bottom (113) that includes a first set of screw threads (see Figures 2-3B) that are adapted to engage a second set of screw thread that is included on a second end of the housing (111) so that the bottom (113) can be removably secured to the housing (111) (see entire document, particularly Figures 2-3B, p. 2 [0020] – lines 7-11),
in order to attach the bottom to the housing (see Figures 1-2).
It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide a first set of screw threads and a second set of screw threads as a known alternate configuration of an attachment/connection means in the apparatus of Shaw as modified by Chiu or Price in order to attach and connect a bottom to the housing as shown by Hirst.
Thus, Claim 15 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Shaw (‘512), Chiu ('121) or Price (‘297), and Hirst (‘012).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following references relate either to the field of the invention or subject matter of the invention, but are not relied upon in the rejection of record: WO2010002757 (related to RU2496523C2 and 20110064512), 20210402031 and KR20150006239 (sponge with an instrument receiving opening), CN102933238 and WO2010112863 (a housing with a handle), 20210187267 and 20240139494 and 20170232121 (English translation of CN106824886) (a cap with a removable lid/ring with an opening), 20150013381 (earring cleaner having a housing, sponge with disinfectant, and seals), 4446965 (an apparatus for cleaning an elongate object with a sponge containing a medium and having am opening that extends through the entire length of the sponge), 20180064604 (a capping device with a sponge attached to a lid), CA2760900 (a container with a sea/flaps).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M YOO whose telephone number is (571)272-6690. The examiner can normally be reached Monday - Friday, 9:00 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REGINA M YOO/ Primary Examiner, Art Unit 1758