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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/18/2026 has been entered.
Response to Amendments
The Amendment filed 05/18/2026 has been entered.
Claims 2, 10-13, and 20 has been cancelled.
Claims 1, 3-9, and 14-19 remain pending in the application.
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 1, 4, 6, 8, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chiappetta et al. (U.S. Patent No. 5989229), hereinafter Chiappetta, and further in view of Castellino et al. (U.S. Patent No. 5737788 ), hereinafter Castellino.
Regarding claim 1, Chiappetta discloses a needle cover (needle cover assembly 10; the Examiner notes that all reference characters cited below refer to FIGS. 1-5 unless otherwise stated)) comprising:
a needle shield (inner sleeve 20);
a mount (distal end of sleeve 20) coupled to the needle shield (see Examiner annotated FIG. 2 below);
a disinfecting pad (absorbent material 25; “a drug in a liquid state is absorbed by absorbent material 25. The drug used can be an antimicrobial agent such as alcohol”, Col 3 Lines 4-6) coupled to the mount (see FIG. 3), wherein the disinfecting pad is fixedly coupled to the mount with an adhesive (“Absorbent material 25 can be bonded to inner sleeve 20 by any standard means such as by mechanical engagement, solvent bonding, sonic welding or by use of an adhesive.”, Col 3 Lines 1-3), and wherein the disinfecting pad is a porous material impregnated with a disinfectant (“Preferably the absorbent material 25 is cotton. However, other materials that can easily absorb liquid can be used… other materials that can be used to form absorbent material 25 include nylon, rayon, urethane or a blend of any of the previously mentioned materials.”, Col 2 Lines 61-67; the Examiner notes that cotton is a porous material).
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However, Chiapetta does not expressly state where in the mount is removably coupled. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to make the mount removably coupled, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177.
Further, Chiappetta does not expressly state wherein the disinfecting pad is a precut foam having a plurality of columnar structures.
Castellino teaches a multi-layered pad primarily intended to prevent and treat decubitus ulcers (Abstract) wherein the disinfecting pad is a precut foam having a plurality of columnar structures (“includes a fluid bladder layer 17 which is positioned above a foam layer 19 which has pillars or columns 21 cut into it”, Col 3 Lines 28-41).
It would have been an obvious matter of design choice to modify the pad to be precut foam with columnar structures. Doing so would allow the facilitation of relative movement of the columns, as taught by Castellino (see Col 3 Lines 4-6).
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to make the disinfecting pad of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 4, Chiappetta in view of Castellino teaches the claimed invention as discussed above concerning the rejection of claim 1, and Chiappetta further teaches wherein the disinfecting pad (absorbent material 25) is substantially round (see FIG. 2).
Regarding claim 6, Chiappetta in view of Castellino teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Chiappetta in view of Castellino does not expressly state wherein the disinfecting pad is substantially rectangular.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to make the disinfecting pad of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 8, Chiappetta in view of Castellino teaches the claimed invention as discussed above concerning the rejection of claim 1, and Chiappetta further teaches wherein the disinfecting pad (absorbent material 25) is impregnated with an alcohol (“a drug in a liquid state is absorbed by absorbent material 25. The drug used can be an antimicrobial agent such as alcohol”, Col 3 Lines 4-6).
Regarding claim 14, Chiappetta in view of Castellino teaches the claimed invention as discussed above concerning the rejection of claim 1, and Chiappetta further teaches wherein the mount (outer sleeve 30) comprises a pad mount (distal end of sleeve 30) coupled to the disinfecting pad and a shield sleeve (proximal end of sleeve 30) surrounding a distal end of the needle shield (see Examiner annotated FIG. 2 below).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Chiappetta et al. (U.S. Patent No. 5989229), hereinafter Chiappetta, and further in view of Castellino et al. (U.S. Patent No. 5737788 ), hereinafter Castellino, and further in view of Singh et al. (U.S. Patent Pub. 20050175786), hereinafter Singh.
Regarding claim 3, Chiappetta in view of Castellino teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Chiappetta in view of Castellino does not expressly state wherein the disinfecting pad has a thickness (T) of approximately 2 mm to approximately 4 mm.
Singh teaches an applicator/dispenser having a tubular body with a solution chamber (Abstract) wherein the disinfecting pad has a thickness (T) of approximately 2 mm to approximately 4 mm (“The applicator pad may be of varying thicknesses, but advantageously is around 1-5 millimeters thick”< [0030]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the pad of Chiappetta in view of Castellino to be between 2-4mm thick. Doing so provides an advantageous range for applying film forming solution to substrate surfaces, as taught by Singh (see [0030]).
Further, it would have been an obvious matter of design choice to modify the thickness of the pad to be approximately 2mm-4mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the thickness of the pad to be approximately 2mm-4mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Chiappetta et al. (U.S. Patent No. 5989229), hereinafter Chiappetta, and further in view of Castellino et al. (U.S. Patent No. 5737788 ), hereinafter Castellino, and further in view of Hadden et al. (U.S. Patent No. 8628501), hereinafter Hadden.
Regarding claim 5, Chiappetta in view of Castellino teaches the claimed invention as discussed above concerning the rejection of claim 4, however, Chiappetta in view of Castellino does not expressly state wherein the disinfecting pad has a diameter (D) of approximately 5 mm to approximately 15 mm.
Hadden teaches a sterilization cap carried on a needle support end of a syringe (Abstract) wherein the disinfecting pad (sponge 30) has a diameter (D) of approximately 5 mm to approximately 15 mm (“The second end of the main body 12 is also cylindrical having a hollow sponge cavity 24 and an outwardly extending annular flange 28 defining the opening of the second end of the main body 12. A disc-shaped absorbent matrix or sponge 30 is sized to snugly fit within the sponge cavity 24 and is saturated with a sterilizing liquid such as isopropyl alcohol”, Col 4 Lines 31-36; see FIG. 4). As such, the modification is disclosed to be a result effective variable in that changing the modification changes the result. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the pad of Chiappetta in view of Castellino to have said a diameter between 5-15mm, as it involves only adjusting the dimension of a component disclosed to require adjustment.
Therefore, it would have been obvious to have one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pad of Chiappetta by making the diameter to be between 5-15mm as a matter of routine optimization since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or working ranges by routine experimentation". In re Aller, 220 F.2, , d USPQ , (CCPA 1995).
Further, it would have been an obvious matter of design choice to modify the diameter of the pad to be approximately 5mm-15mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 7, Chiappetta in view of Castellino teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Chiappetta in view of Castellino does not expressly state wherein the disinfecting pad has a width (W) approximately 10 mm to approximately 30 mm and a height (H) of approximately 5 mm to approximately 15 mm.
Hadden teaches a sterilization cap carried on a needle support end of a syringe (Abstract) wherein the disinfecting pad (sponge 30) has a width (W) approximately 10 mm to approximately 30 mm and a height (H) of approximately 5 mm to approximately 15 mm (“The second end of the main body 12 is also cylindrical having a hollow sponge cavity 24 and an outwardly extending annular flange 28 defining the opening of the second end of the main body 12. A disc-shaped absorbent matrix or sponge 30 is sized to snugly fit within the sponge cavity 24 and is saturated with a sterilizing liquid such as isopropyl alcohol”, Col 4 Lines 31-36; see FIG. 4). As such, the modification is disclosed to be a result effective variable in that changing the modification changes the result. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the pad of Chiappetta to have said a diameter between 5-15mm, as it involves only adjusting the dimension of a component disclosed to require adjustment.
Therefore, it would have been obvious to have one of ordinary skill in the art before the effective filing date of the claimed invention to modify the width and height of the pad to be approximately 10mm-30mm and 5mm-15mm respectively as a matter of routine optimization since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or working ranges by routine experimentation". In re Aller, 220 F.2, , d USPQ , (CCPA 1995).
Further, it would have been an obvious matter of design choice to modify the width and height of the pad to be approximately 10mm-30mm and 5mm-15mm respectively, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Chiappetta et al. (U.S. Patent No. 5989229), hereinafter Chiappetta, hereinafter Chiappetta, and further in view of Castellino et al. (U.S. Patent No. 5737788 ), hereinafter Castellino, and further in view of Steube et al. (U.S. Patent Pub. 20100331726), hereinafter Steube.
Regarding claim 9, Chiappetta in view of Castellino teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Chiappetta in view of Castellino does not expressly state wherein the disinfecting pad is impregnated with approximately 70% isopropyl alcohol.
Steube teaches a medical device with incorporated disinfecting wipe and method of using same ([0039]) wherein the disinfecting pad is impregnated with approximately 70% isopropyl alcohol (“Lid 150 is provided with a pad, wipe, swab or the like 160 adhered, bonded or otherwise secured to a surface thereof. Pad 160 is secured to lid 150 such that pad 160 is disposed or retained within cylindrical chamber 122 when lid 150 is secured to finger flange 124 of blood collector barrel 120. Pad 160 comprises a disinfecting solution. In some embodiments, pad 160 is saturated with a quantity of a disinfecting solution or the like, such as, for example, alcohol, benzalkonium chloride, or a solution of 70% isopropyl alcohol.”, [0045].
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the pad of Chiappetta in view of Castellino to be impregnated with approximately 70% isopropyl alcohol. Doing so provides a disinfecting solution for cleaning the injection site, as taught by Steube (see [0045]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Chiappetta et al. (U.S. Patent No. 5989229), hereinafter Chiappetta, hereinafter Chiappetta, and further in view of Castellino et al. (U.S. Patent No. 5737788 ), hereinafter Castellino, and further in view of O’Connor et al. (U.S. Patent No. 4751731), hereinafter O’Connor.
Regarding claim 15, Chiappetta in view of Castellino teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Chiappetta in view of Castellino does not expressly state comprising a protective film coupled with the disinfecting pad.
O’Connor teaches a disinfecting device (Abstract) comprising a protective film (protective layer 60) coupled with the disinfecting pad (disinfectant carrying pad 55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Chiappetta in view of Castellino to comprising a protective film coupled with the disinfecting pad. Doing so, to protects the pad from the elements to which the device may be exposed prior to its installation, as taught by O’Connor (Col 4 Line 65 – Col 4 Line 25).
Claims 16, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Chiappetta et al. (U.S. Patent No. 5989229), hereinafter Chiappetta, hereinafter Chiappetta, further in view of Zelten et al. (U.S. Patent No. 8535257), hereinafter Zelten, and further in view of Castellino et al. (U.S. Patent No. 5737788 ), hereinafter Castellino.
Regarding claim 16, Chiappetta discloses a syringe (“a hypodermic syringe”, Col 2 Line 50; medical device 60) comprising:
a needle hub (needle hub 50);
a needle (needle 55) coupled to the needle hub; and
a needle cover (needle cover assembly 10) removably coupled to the needle hub; the needle cover comprising:
a needle shield (inner sleeve 20);
a mount (distal end of sleeve 20) coupled to the needle shield (see Examiner annotated FIG. 2 below);
a disinfecting pad (absorbent material 25; “a drug in a liquid state is absorbed by absorbent material 25. The drug used can be an antimicrobial agent such as alcohol”, Col 3 Lines 4-6) coupled to the mount (see FIG. 3), wherein the disinfecting pad is fixedly coupled to the mount with an adhesive (“Absorbent material 25 can be bonded to inner sleeve 20 by any standard means such as by mechanical engagement, solvent bonding, sonic welding or by use of an adhesive.”, Col 3 Lines 1-3), and wherein the disinfecting pad is a porous material impregnated with a disinfectant (“Preferably the absorbent material 25 is cotton. However, other materials that can easily absorb liquid can be used… other materials that can
be used to form absorbent material 25 include nylon, rayon, urethane or a blend of any of the previously mentioned materials.”, Col 2 Lines 61-67; the Examiner notes that cotton is a porous material).
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However, Chiapetta does not expressly state where in the mount is removably coupled. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to make the mount removably coupled, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177.
Further, Chiappetta does not expressly state a syringe comprising a barrel and a plunger at least partially received in the barrel.
Zelten teaches a syringe and swab system (Abstract) comprising a barrel (barrel 40, see FIG. 1) and a plunger (plunger 30, see FIG. 1) at least partially received in the barrel.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Chiappetta to include a syringe comprising a barrel and a plunger at least partially received in the barrel being that Chiappetta is designed for use with hypodermic syringes and Zelten teaches an improved syringe and swab system that provides an absorbent swab generally fixed to a syringe needle safety cover (see Col 1 Lines 14-16).
However, Chiappetta in view of Zelten does not expressly state wherein the disinfecting pad is a precut foam having a plurality of columnar structures.
Castellino teaches a multi-layered pad primarily intended to prevent and treat decubitus ulcers (Abstract) wherein the disinfecting pad is a precut foam having a plurality of columnar structures (“includes a fluid bladder layer 17 which is positioned above a foam layer 19 which has pillars or columns 21 cut into it”, Col 3 Lines 28-41).
It would have been an obvious matter of design choice to modify the pad to be precut foam with columnar structures. Doing so would allow the facilitation of relative movement of the columns, as taught by Castellino (see Col 3 Lines 4-6).
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to make the disinfecting pad of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 17, Chiappetta in view of Zelten in view of Castellino teaches the claimed invention as discussed above concerning the rejection of claim 16, and Chiappetta further teaches wherein a proximal end of the needle cover is removably coupled to the needle hub (“The proximal end of inner sleeve 20 fits snugly on the needle hub 50 “, Col 3 Lines 10-11; See FIG. 2).
Regarding claim 19, Chiappetta in view of Zelten in view of Castellino teaches the claimed invention as discussed above concerning the rejection of claim 16, and Chiappetta further teaches wherein comprising a protective film (outer sleeve 30) coupled with the disinfecting pad (absorbent material 25; see FIG. 3).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Chiappetta et al. (U.S. Patent No. 5989229), hereinafter Chiappetta, hereinafter Chiappetta, further in view of Zelten et al. (U.S. Patent No. 8535257), hereinafter Zelten, further in view of Castellino et al. (U.S. Patent No. 5737788 ), hereinafter Castellino, and further in view of Steube et al. (U.S. Patent Pub. 20100331726), hereinafter Steube.
Regarding claim 18, Chiappetta in view of Zelten in view of Castellino teaches the claimed invention as discussed above concerning the rejection of claim 16, however, Chiappetta in view of Zelten in view of Castellino does not expressly state wherein the disinfecting pad is impregnated with approximately 70% isopropyl alcohol.
Steube teaches a medical device with incorporated disinfecting wipe and method of using same ([0039]) wherein the disinfecting pad is impregnated with approximately 70% isopropyl alcohol (“Lid 150 is provided with a pad, wipe, swab or the like 160 adhered, bonded or otherwise secured to a surface thereof. Pad 160 is secured to lid 150 such that pad 160 is disposed or retained within cylindrical chamber 122 when lid 150 is secured to finger flange 124 of blood collector barrel 120. Pad 160 comprises a disinfecting solution. In some embodiments, pad 160 is saturated with a quantity of a disinfecting solution or the like, such as, for example, alcohol, benzalkonium chloride, or a solution of 70% isopropyl alcohol.”, [0045].
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the pad of Chiappetta in view of Zelten in view of Castellino to be impregnated with approximately 70% isopropyl alcohol. Doing so provides a disinfecting solution for cleaning the injection site, as taught by Steube (see [0045]).
Response to Arguments
Applicant's arguments filed 05/18/2026 have been fully considered but they are not persuasive. In regards to the Applicant’s argument that
Applicant’s arguments, see Reamrks, filed 05/18/2026, with respect to the rejection(s) of claim(s) 1, 4, 6, 8, 10, 11, 13, and 15 under 35 U.S.C. § 103 as allegedly obvious over U.S. Patent No. 5,989,229 to Chiappetta ("Chiappetta") in view of U.S. Patent No. 5,737,788 to Castellino et al. ("Castellino") have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. § 103 as allegedly obvious over Chiappetta in view of Castellino.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. 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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
05/27/2026 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights