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 .
FINAL ACTION
Response to Amendment
The amendment filed on 9/19/2025 has been received and claims 2-8 and 10-20 are pending.
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.
Claims 2-11 are rejected under 35 U.S.C. 103 as being unpatentable over Wallock (5471706) in view of Solomon (20130072908), Hirst (20110146012), and Shaw (20100003067).
As to Claims 2-3 and 10, Wallock (‘706) discloses a cap (9) for disinfecting a surface of a medical instrument/device (34) capable of being a medical fluid connector (see Figures 1-12), the cap (9) comprising:
a cap body (17, 20, 23/23’) having a bottom wall (20) and a sidewall (17) extending therefrom (see Figures 1-2, 5, and 9-10), the sidewall (17) defining a top opening (at 23 or where 28/30 are located), the sidewall including a lower portion (i.e. below 33), an upper portion (i.e. above 33, into 45/65 of 23/23’), and a shoulder (33) therebetween (see Figures 2 and 10);
an antiseptic material (35) contained within the cap body (9); and
a dome insert (28; 30) contacting the cap body (17, 20) and comprising a surface which faces the bottom wall (20) of the cap body (17, 20) (see Figures 1-3, 5-6, and 10-12), the dome insert (28; 30) further comprising a hole (37; 38) therethrough (See Figures 1, 3, and 6) and being deformable and capable of selectively facilitating flow of the antiseptic material through the dome insert (28; 30) (see entire document, particularly Figure 5, Col. 4 lines 14-31 and 35-36), the dome insert (28; 30) positioned within the cap body (17, 20) between the bottom wall (20) and the top opening (at 23) of the sidewall (17), the dome insert (28; 30) being proximate the shoulder (33) of the cap body (17, 20) (see Figures 2 and 10),
wherein the dome insert (28; 30) and the lower portion (i.e. below 33) of the cap body (17, 20) define a chamber (i.e. where 10 and 35 are located) to contain the antiseptic material (35) within the cap body (17, 20), and
wherein the upper portion (i.e. above 33, into 45/65 of 23/23’) of the cap body (17, 20, 23/23’) defines a second chamber (i.e. within 45/65) for receiving and engaging (via 28, 30) an object (34) capable of being a medical fluid connector.
Wallock (‘706) does not specifically teach that the disinfecting cap is for attaching to the medical connector where the sidewall of the cap body (17, 20, 23/23’) is configured to engage a sidewall of the medical connector to secure the cap (300) to the medical connector such that the cap is configured to remain removably engaged to the medical connector and to provide a physical barrier to an access site of the medical connector, or that the cap body comprises an inwardly extending shoulder, or that the dome insert (28; 30) comprises a convex orientation such that a concave surface of the dome insert faces the bottom wall (20) of the cap body (17, 20), nor that the dome insert (28; 30) further comprises an apex including a hole extending through the apex and a radial flange, the dome insert being deformable to selectively facilitate passage of the antiseptic material through the hole and the apex, wherein the radial flange engages the inwardly extending shoulder to prevent the radial flange of the dome insert from moving toward the bottom wall of the cap body.
As to the limitations that the sidewall of the cap body is configured to engage a sidewall of the object and that the dome insert having an apex comprises a convex orientation such that a concave surface of the dome insert faces the bottom wall, it was known in the art before the effective filing date of the claimed invention to provide a cap body with a sidewall configured to engage a sidewall of a medical connector and a dome insert with a convex orientation having an apex with a hole and having a concave surface in a cap. Solomon (‘908) discloses a cap (1400; 1500; 1600; 2200; 2304 - see Figures 1-69, particularly 36-41) for disinfecting a surface of a medical connector (2000) and for attaching to the medical connector (2000) (see entire document, particularly Figures 31-34, 38-39, 42-46, 49, and 66A-69), the cap comprising:
a cap body (1502, 1504; 1602, 1604; 2202, 2204; 2350 – see p. 18 [0219]) having a bottom wall (2354) and a sidewall (2352) extending therefrom (see Figure 41), the sidewall (2352) defining a top opening (i.e. entrance into 2358 – see Figures 40-41) and being configured to engage (via 2342 and the interior sidewall of 2352 within 2358 – see Figures 40-41) a sidewall of the medical connector (2000) to selectively secure the cap (2200; 2304) to an end of the medical connector (2000);
an antiseptic material (2333) contained within the cap body (2202, 2204; 2350); and
a dome insert (2290) contacting the cap body (2202, 2204; 2350) and comprising a convex orientation (see Figures 36-39) such that a concave surface (i.e. underside of 2292 facing 2270) of the dome insert (2290) faces the bottom wall (2354) of the cap body (2202, 2204; 2350), the dome insert (2290) further comprising an apex (i.e. located at the center of 2290 – see p. 16 [0206] – lines 7-11) and a hole (2294 – p.17 [0206], particularly 14th – 15th lines from the bottom) therethrough (see Figures 36-39) and being deformable to selectively facilitate passage of the antiseptic material (2333) through the hole (2294) of the dome insert (2290) (see pp. 16-17 [0206] – 14th – 15th lines from the bottom and [0210]-[0211]), the dome insert (2290) being positioned within the cap body (2202, 2204; 2350) between the bottom wall (2254) and the top opening of the sidewall (2352) (see Figures 36-41),
wherein the dome insert (2290) and the cap body (2202, 2204; 2350) define a chamber (i.e. where 2270 is located) to contain the antiseptic material (2333) within chamber of the cap body (2202, 2204; 2350),
in order to control the flow of antiseptic fluid in the cap (see entire document, particularly p. 17 [0210]-[0211], pp. 17-18 [0214]).
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 cap body with a sidewall configured to engage a sidewall of a medical connector and a dome insert with a convex orientation having an apex with a concave surface and a hole extending through the dome insert in the cap of Wallock in order to allow control over flowing the antiseptic material to the medical connector as shown by Solomon.
As to the limitation that the apex of the dome insert further comprises a hole therethrough and being deformable, it was well known in the art before the effective filing date of the claimed invention to provide a dome insert comprised of an apex including a hole therethrough and being deformable in a disinfecting device. Hirst (‘012) exemplifies a cap (100) for disinfecting a surface of an instrument/device (150) capable of being a medical connector (see Figures 1-4), the cap (100) comprising:
a cap body (111, 112, 113) having a bottom wall (113) and a sidewall (111) extending therefrom (see Figures 1-4), the sidewall (111) defining a top opening (i.e. top opening of 100) (see Figure 2), the sidewall (111) including a lower portion (i.e. top half of 111), an upper portion (i.e. lower half of 111) (see Figures 1-4);
an antiseptic material (140) contained within the cap body (111) (see Figures 3A-3B); and
a dome insert (112) contacting the cap body (111) and comprising a surface which faces the bottom wall (113) of the cap body (111) (see Figures 1-4), the dome insert (112) being positioned within the cap body (111) between the bottom wall (113) and the top opening (i.e. top of 100) of the sidewall (111) (see Figures 1-4),
wherein the dome insert comprises an apex including a hole (114) therethrough (see Figures 1-4) and being deformable (see Figure 3B),
in order to provide a passageway into/through the dome insert (see Figures 3A-3B).
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 deformable dome insert comprising an apex including a hole therethrough in the cap of Wallock as modified by Solomon in order to provide a hole/passageway into/through the dome insert as exemplified by Hirst.
As to the limitations that the cap body comprises an inwardly extending shoulder and that the dome insert comprises a radial flange that engages the inwardly extending shoulder to prevent the radial flange from moving toward the bottom wall of the cap body, while Hirst (‘012) discloses that the cap body (111) comprises a shoulder and that the dome insert (112) comprises a flange (see Figure 3A), none of Wallock, Solomon nor Hirst specifically teach a cap body comprised of an inwardly extending shoulder and a dome insert comprises a radial flange that engages the inwardly extending shoulder to prevent the radial flange from moving toward a bottom wall of the cap body. However, it was known in the art before the effective filing date of the claimed invention to provide a disinfecting cap having a cap body comprised of an inwardly extending shoulder and a dome insert comprised of a radial flange that engages the inwardly extending shoulder to prevent the radial flange from moving toward a bottom wall of the cap body. Shaw (‘067) discloses a disinfecting cap (500) for engaging sidewalls of a medical connector () to provide a physical barrier to an access site of the medical connector, the disinfecting cap (500) comprising:
a cap body (502) comprising:
a bottom wall (end of 504);
a sidewall (sides of 504, 506) extending from the bottom wall; and
an inwardly extending shoulder (at 520)
an antiseptic material (536) positioned within the cap body (502);
a dome insert (514) positioned within the cap body (502) (see Figure 58), the dome insert (514) comprising an apex (532 or 534) and a radial flange (530), the dome insert (514) being deformable to selectively facilitate passage of the antiseptic material (536), wherein the radial flange (530) engages the inwardly extending shoulder (at 520) to prevent the radial flange (530) from moving toward the bottom wall (end of 504) of the cap body (502),
in order to retain the dome insert within the cap body (see entire document, particularly Figure 58, p. 8 [0104] – lines 20-22).
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 cap body comprised of an inwardly extending shoulder and a dome insert comprised of a radial flange that engages the inwardly extending shoulder to prevent the radial flange from moving toward a bottom wall of the cap body in the disinfecting cap of Wallock as modified by Solomon and Hirst as a known means in order to affix and retain the dome insert at a desired location during use as shown by Shaw.
As to Claim 4, the combined teaching of Wallock, Solomon, Hirst, and Shaw meets the claim limitation, where Hirst (‘012) teaches that the dome insert (112) is integrally formed with the cap body (111, 112, 113). In addition, 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 integrally form the cap body with the dome insert as known alternate configuration along the inwardly extending shoulder which is already a known attachment location (see MPEP §2144.04(V)(B)). Only the expected results would be attained.
As to Claim 5, Solomon (‘908) discloses that the cap (2200; 2304 - see Figures 36-41) further comprises a removable film (1537; 1634, 1636; 1934; 2234) attached to a top surface of the cap body (2202, 2204; 2350).
As to Claim 6, Solomon (‘908) discloses that the medical connector (2000) is a luer access device (2020).
As to Claim 7, Solomon (‘908) also discloses that the antiseptic material (2333) comprises alcohol (see entire document, particularly p. 6 [0113] – lines 6-7, p. 7 [0121] – lines 13-16).
As to Claim 8, Solomon (‘908) discloses that the cap body (2202, 2204; 2350) further comprises internal threads/threads (1930, 1931) at least partially along an interior surface of the sidewall of the cap body (2202, 2204; 2350) (see entire document, particularly Figures 28-29, 32 and 37-39), wherein the threads (1930, 1931) are configured to engage corresponding threads of the medical connector (see entire document, particularly Figures 28-29, 32 and 37-39).
As to Claim 11, the combined teaching of Wallock (‘706), Solomon (‘908), Hirst (‘012), and Shaw (‘067) meets the claimed limitation, where Wallock (‘706) teach that the dome insert (28; 30) is deformable from a planar orientation where the hole (38; 38) is closed (see Figures 1, 3, 6, and 10-11) to a concave orientation where the hole (37; 38) located centrally is open when the dome insert is in the concave orientation capable of releasing the antiseptic fluid from the cap body (see entire document, particularly Figure 5, Col. 4 lines 22-31), Solomon (‘908) teaches that the dome insert (2290) has a convex orientation (see Figures 37-39) and Hirst (‘012) discloses that the dome insert (112) is deformable and the hole located centrally is opened when the dome insert (112) is in a concave orientation (see Figures 3A-3B).
Thus, Claims 2-8 and 10-11 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Wallock (‘706), Solomon (‘908), Hirst (‘012), and Shaw (‘067).
Claims 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wallock (5471706) in view of Solomon (20130072908), Hirst (20110146012), and Shaw (20100003067) as applied to claim 2 above, and further in view of Gardner (20130030414).
Wallock (‘706), Solomon (‘908), Hirst (‘012), and Shaw (‘067) are relied upon for disclosure described in the rejection of claim 2 under 35 U.S.C. 103.
As to Claims 12-14, while the combined teaching of Wallock (‘706), Solomon (‘908), Hirst (‘012), and Shaw (‘067) teaches the cap of claim 2 as well as the configuration in claims 13-14, neither Wallock (‘706) nor Solomon (‘908) or Hirst (‘012) or Shaw (‘067) appears to specifically teach a cap holder comprised of a holder sidewall and a holder bottom wall defining an interior for receiving the cap, and a cover removably attached to the holder sidewall to seal the cap within the cap holder prior to use.
It was known in the art before the effective filing date of the claimed invention to provide a cap holder comprised of a holder sidewall and a holder bottom wall defining an interior for receiving a cap and a cover removably attached to the holder sidewall to seal the cap within the cap holder prior to use in a cap assembly. Gardner (‘414) discloses a cap assembly (200; 300; 400; 500; 600; 700; 800) for use with a medical connector (12, 14, 17, 19) comprising:
a cap (210; 310; 410; 510; 610; 710; 810) comprising:
a cap body having a bottom wall (219; top surface of 629) and a sidewall (256; 519, 555; 651) extending therefrom, the sidewall (256; 519, 555; 651) being configured to engage a sidewall of the medical connector (12, 14, 17, 19) to secure the cap (210; 310; 410; 510; 610; 710; 810) to an end of the medical connector (12; 14; 17; 19) such that the cap is configured to remain removably engaged to the medical connector and to provide a physical barrier to an access site of the medical connector (see Figures 4A-4E, 7C, 8C); and
an antiseptic material (within 512; 612 – see p. 1 [0005], p. 5 [0099] - lines 8-9)) contained within the cap body;
wherein the lower portion (513; where 512/612/712 is located) of the cap body define a chamber to contain the antiseptic material (within 512/612/712) within the cap body (see Figures 7B-7C, 8B-8C, 9B), and
wherein the upper portion (517; below 523/623/723 where 523/613/713 is located) of the cap body defines a second chamber for receiving and engaging the medical connector (12; 14; 17; 19) (see Figures 4A-4E, 7A-7C, 8A-8C, 9A-9B, 10); and
a cap holder (230, 250; 330, 350; 530, 550; 630, 650; 730, 750; 830, 850) (see Figures 3, 5, 7A-7B, 8A-8B, 9A-9C, and 10) comprising:
a holder sidewall (221; 557) and a holder bottom wall (223; 559) defining an interior (232; 532) for receiving the cap (210; 310; 410; 510; 610; 710; 810) (see Figures 3, 5, 6B, 8B, 9B-9C, and 10), and
a cover (250; 350; 550; 650; 750; 850) removably attached to the holder sidewall (221; 557) to seal the cap (210; 310; 410; 510; 610; 710; 810) within the cap holder (230, 250; 330, 350; 530, 550; 630, 650; 730, 750; 830, 850) prior to use (see Figures 3, 5, and 7B);
in order to store then apply the cap aseptically (see entire document particularly p. 4 [0090]-[0091], p. 5 [0099] and [0107]-[0108]).
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 cap holder comprised of a holder sidewall and a holder bottom wall defining an interior for receiving the cap of Wallock as modified by Solomon, Hirst and Shaw and a cover removably attached to the holder sidewall to seal the cap of Wallock as modified by Solomon, Hirst, and Shaw within the cap holder prior to use in order to store/retain and then apply the cap aseptically to the medical connector as shown by Gardner.
As to Claims 15-16, the combined teaching of Wallock (‘706), Solomon (‘908), Hirst (‘012), and Shaw (‘067) meets the claimed limitation, where Wallock (‘706) teach that the dome insert (28; 30) is deformable from a planar orientation where the hole (38; 38) is closed (see Figures 1, 3, 6, and 10-11) to a concave orientation where the hole (37; 38) located centrally is open when the dome insert is in the concave orientation capable of releasing/facilitating passage of the antiseptic material from the cap body (see entire document, particularly Figure 5, Col. 4 lines 22-31), Solomon (‘908) teaches that the dome insert (2290) has a convex orientation (see Figures 37-39) and Hirst (‘012) discloses that the dome insert (112) is deformable and the hole located centrally is opened when the dome insert (112) is in a concave orientation (see Figures 3A-3B).
As to Claim 17, the combined teaching of Wallock, Solomon, Hirst, and Shaw meets the claim limitation, where Hirst (‘012) teaches that the dome insert (112) is integrally formed with the cap body (111, 112, 113). In addition, 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 integrally form the cap body with the dome insert as known alternate configuration along the inwardly extending shoulder which is already a known attachment location (see MPEP §2144.04(V)(B)). Only the expected results would be attained.
As to Claim 18, Solomon (‘908) discloses that the medical connector (2000) is a luer access device (2020).
Gardner (‘414) also discloses that the medical connector (12, 14, 17, 19) is a luer access device (see p. 3 [0074]-[0075]).
As to Claim 19, Solomon (‘908) discloses that the antiseptic material (2333) comprises alcohol (see entire document, particularly p. 6 [0113] – lines 6-7, p. 7 [0121] – lines 13-16).
Gardner (‘414) also discloses that the antiseptic material (2333) comprises alcohol (see entire document, particularly p. 3 [0078]).
As to Claim 20, Solomon (‘908) discloses that the cap body (2202, 2204; 2350) further comprises internal threads/threads (1930, 1931) at least partially along an interior surface of the sidewall of the cap body (2202, 2204; 2350) (see entire document, particularly Figures 28-29, 32 and 37-39), wherein the threads (1930, 1931) are configured to engage corresponding threads of the medical connector (see entire document, particularly Figures 28-29, 32 and 37-39).
Gardner (‘414) also discloses that the cap body further comprises internal threads/threads at least partially along an interior surface of the sidewall of the cap body (see entire document, particularly Figures 4E and 6A-6B), wherein the threads are configured to engage corresponding threads of the medical connector (see entire document, particularly Figure 4E).
Thus, Claims 12-20 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Wallock (‘706), Solomon (‘908), Hirst (‘012), Shaw (‘067), and Gardner (‘414).
Response to Arguments
Applicant's arguments filed 9/19/2025 have been fully considered but they are not persuasive.
As to applicant’s arguments in the 8th – 10th lines from the bottom on p. 5 and in the first full paragraph on p. 6 of Remarks that there is no proper teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, examiner points out that the previous as well as this office action state that Solomon in p. 17 [0210]-[0211] and pp. 17-18 [0214] provides motivation/teaching that one of ordinary skill in the art before the effective filing date of the claimed invention would provide a dome insert with a convex orientation having an apex with a concave surface and a hole extending through the dome insert in order to contain and control the flow of an antiseptic fluid in a cap..
As to applicant’s argument in last 6 lines on p. 5 to first 5 lines on p. 6 of Remarks that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, examiner points out that it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In addition, in regards to applicant’s argument in the first full paragraph on p. 6 of Remarks, examiner indicates that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
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.
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