DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1, 3, 6, 8, and 15 are objected to because of the following informalities:
Regarding claim 1, “the port” should be corrected to “the medical port” for claim language consistency.
Regarding claim 3, “medical” should be corrected to “medial” and “comprise” should be corrected to “comprises” for claim language consistency.
Regarding claim 6, “the group” should be corrected to “a group” for claim language consistency.
Regarding claim 8, “by medical” should be corrected to “by the medical” for claim language consistency.
Regarding claim 15, “wherein the distal end” should be corrected to “wherein the distal collar” for claim language consistency.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: reference 605 is not included in Fig. 6. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the distal collar defining a set of ridges or flanges, subject matter of claim 15, as understood in light of the claim objection above, and “the proximal collar defines a set of threads and grooves”, subject matter of claim 9, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. The Examiner notes that the distal collar is seen defining a ridge or a flange, but not ridges or flanges.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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, 8-9, 11, and 14-15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Walterspiel (US 20200408350 A1).
Regarding claim 1, Walterspiel discloses a contamination guard (connector guard 2100, [0089] & Fig. 16A-16C; also see [0083]) comprising: a proximal collar adapted and configured to engage with a medical port (base 2103 configured to engage valve connector 2104, [0089] & Fig. 16A); an elastomeric medial region coupled to the proximal collar (elastic couplers 2102, [0089] & Fig. 16A-16C); and a distal collar coupled to the proximal collar by the elastomeric medial region (ring 2101, [0089] & Fig. 16A-16C); wherein the elastomeric medial region is adapted and configured to: bias the distal collar to extend at least partially over a distal end of the port when in an unloaded position (elastic couplers 2102 capable of biasing ring 2101 at least partially over a distal end of connector 2104 when unloaded, [0089] & Fig. 16A-16B); and allow the distal collar to resiliently travel proximally when loaded to permit engagement with the distal end of the medical port (“The ring 2101 can be axially (or “longitudinally”) compressed towards the base 2103, thus causing the elastic couplers 2102 to bend or bow outward, for example when a health care worker sterilizes a connector tip, connects an intravenous line…”, [0089] & Fig. 16A-16C; the compression of ring 2101 towards base 2103 permits engagement with the distal end of connector 2104 and, for example, an intravenous line).
Regarding claim 2, Walterspiel discloses all the limitations of claim 1. Walterspiel further discloses the contamination guard wherein the proximal collar and the distal collar are annular (cylindrical base 2103, described as a “second ring”, and ring 2101 are annular, [0089] & Fig. 16A).
Regarding claim 3, Walterspiel discloses all the limitations of claim 1. Walterspiel further discloses the contamination guard wherein the elastomeric medical region comprise a plurality of legs (elastic couplers 2102, seen provided as a set of two, are being interpreted as legs, [0089] & see Figs. 16A-16C).
Regarding claim 4, Walterspiel discloses all the limitations of claim 3. Walterspiel further discloses the contamination guard wherein the plurality of legs are axial (the two elastic couplers 2102 are axial, see Fig. 16A-16C; the Examiner notes that other embodiments of the disclosed connector guards have a plurality of legs that are helical, see Figs. 18A and 19A).
Regarding claim 5, Walterspiel discloses all the limitations of claim 1. Walterspiel further discloses the contamination guard wherein the distal collar is elastomeric (materials for guards may include silicone elastomers, see [0062]; ring 2101 being part of connector guard 2100, [0089]).
Regarding claim 6, Walterspiel discloses all the limitations of claim 1. Walterspiel further disclose the contamination guard wherein the elastomeric medial region is fabricated from silicone (materials for guards may include silicone elastomers, see [0062]; couplers 2102 being part of guard 2100, [0089]).
With regard to claim 8, the contamination guard can alternatively be interpreted as connector guard 2300 (see [0093] & Fig. 18A-18B; also see [0083]) comprising: a proximal collar adapted and configured to engage with a medical port (the final coil of spring portion 2304 at the end opposite ring 2302 and male connector component 2306 are being interpreted as the proximal collar, [0093] & Fig. 18A-18B; component 2306 configured to engage with female connector component 2308, which is being interpreted as the medical port, [0093] & Fig. 18B); an elastomeric medial region coupled to the proximal collar (spring portion 2304, [0093] & Fig. 18A-18B); and a distal collar coupled to the proximal collar by the elastomeric medial region (ring 2302, [0093] & Fig. 18A-18B); wherein the elastomeric medial region is adapted and configured to: bias the distal collar to extend at least partially over a distal end of the port when in an unloaded position (spring portion 2304 capable of biasing ring 2302 over a distal end of component 2308 when unloaded, [0093] & Fig. 18B); and allow the distal collar to resiliently travel proximally when loaded to permit engagement with the distal end of the medical port (“The ring 2302 and each of the coils of the spring portion 2304 has a convex, rounded outer surface and the coils, upon compression, slide over each other”, [0093] & Fig. 18A-18B; compression of the coils of spring portion 2304 would inherently displace ring 2302 proximally and would not prohibit engagement with the distal end of connector component 2308 with connector component 2306).
Accordingly, Walterspiel discloses all the limitations of claim 1. Walterspiel further discloses the contamination guard wherein the proximal collar defines a set of threads and grooves (the final coil of spring portion 2304 at the end opposite ring 2302 and male connector component 2306 define a set of threads and grooves, as seen in Figs. 18A-18B; the set of grooves is being interpreted as the space between the protruding threads, see Fig. 18B), wherein the set of threads and grooves is adapted and configured to couple with another set of threads and grooves defined by medical port (female connector component 2308 defining another set of threads and groove on it’s distal end, as seen in Figs. 18A-18B, which are configured to couple with the threads and grooves of male connector component 2306, as seen in Fig. 18B; the set of grooves is being interpreted as the space between the protruding threads, see Fig. 18B).
Regarding claim 9, Walterspiel discloses all the limitations of claim 1. The limitation of “the proximal collar is permanently coupled to the medical port” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. Walterspiel discloses the connector guard 2100 wherein the cylindrical base 2103 is coupled to connector 2104 (see [0089] & Figs. 16A-16C). Walterspiel further discloses that the guards of the present disclosure can be applied directly to connectors, producing a combined guard product (see [0084]).
The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Regarding claim 11, Walterspiel discloses all the limitations of claim 1. Walterspiel further discloses the contamination guard further comprising: an indicator coating disposed on a surface of the proximal collar, the distal collar, the elastomeric medial region, or a combination thereof (materials for guards may be colored materials that fulfill visibility requirements, [0089]; the surfaces can have color coding, [0089]).
Regarding claim 14, Walterspiel disclose all the limitations of claim 1. Walterspiel further discloses the contamination guard wherein the elastomeric medial region is further adapted and configured to allow the distal collar to travel distally to a neutral position when unloaded (“The ring 2101 can be axially (or “longitudinally”) compressed towards the base 2103, thus causing the elastic couplers 2102 to bend or bow outward, for example when a health care worker sterilizes a connector tip, connects an intravenous line, or places an alcohol cap on a connector tip between infusions.”, [0089]; materials for guards may include silicone elastomers, see [0062]; it is inherent that ring 2101 would return to its original position, a neutral position, when unloaded after being compressed).
Regarding claim 15, Walterspiel discloses all the limitations of claim 1. Walterspiel further discloses the contamination guard wherein the distal end defines a set of ridges extending outwardly away from the distal end (the outermost portion of the rounded outer surface of ring 2101 and the top of ring 2101 are being interpreted as a set of ridges, both of which extend outwardly away from the distal end of valve connector 2104, see [0089] & annotated Fig. 16A below in which the ridges are annotated as “Ridges”).
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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) 7 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walterspiel (US 20200408350 A1) as applied to claim 1 above, and further in view of Jiang (WO 2019199789 A1).
Regarding claim 7, Walterspiel discloses all the limitations of claim 1. Walterspiel further discloses the contamination guard further comprising an aperture defined by the distal collar (ring 2101 defining an opening through which an alcohol cap and sleeve of a male Luer connector can fit through, see [0089] & Fig. 16A-16C).
However, Walterspiel fails to explicitly disclose the contamination guard further comprising a covering seal adapted and configured to be detachably coupled to the distal collar and across an aperture defined by the distal collar.
However, Jiang teaches a contamination guard (device 100 comprising an antimicrobial agent, [0049] & Fig. 1) further comprising a covering seal adapted and configured to be detachably coupled to the distal collar and across an aperture defined by the distal collar (peelable seal 150 on an end face 116 of cap 102, [0055] & Fig. 1; seal 150 inherently configured to be detachably coupled).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the contamination guard of Walterspiel with Jiang to include a covering seal adapted and configured to be detachably coupled to the distal collar and across an aperture defined by the distal collar since such a modification would provide structure to seal the distal aperture prior to use and act as a moisture barrier (see [0073]-[0074] of Jiang).
Regarding claim 13, Walterspiel discloses all the limitations of claim 1. However, Walterspiel fails to explicitly disclose the contamination guard further comprising a sheet of elastomeric material covering a surface of a portion of the proximal collar, the distal collar, the elastomeric medial region, or a combination thereof.
However, Jiang teaches a contamination guard (device 100 comprising an antimicrobial agent, [0049] & Fig. 1) further comprising a sheet of elastomeric material covering a surface of a portion of the distal collar (peelable seal 150, comprising a multi-layer polymer film which is being interpreted as elastomeric material, covers cap open end 110 and is disposed on end face 116 of cap 102, [0055] and [0059] & Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the contamination guard of Walterspiel with Jiang to include a sheet of elastomeric material covering a surface of a portion of the distal collar since such a modification would provide structure to seal the distal aperture prior to use and act as a moisture barrier (see [0073]-[0074] of Jiang).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walterspiel (US 20200408350 A1) as applied to claim 1 above, and further in view of Baumgart (WO 2019243044 A1).
Regarding claim 10, Walterspiel discloses all the limitations of claim 1. Walterspiel discloses that “…guards of this disclosure can be used to prevent unwanted contamination in the pharmaceutical and biotechnology industries, where sterility of connectors is desired” (see [0084]) but fails to explicitly disclose the contamination guard further comprising: an antimicrobial composition disposed on a surface of, or within a composition of, the proximal collar, the distal collar, the elastomeric medial region, or a combination thereof.
However, Baumgart teaches a contamination guard further comprising: an antimicrobial composition disposed on a surface of the proximal collar, the distal collar, the elastomeric medial region, or a combination thereof (first connector 1, which is being interpreted as a contamination guard, includes antimicrobial characteristics, see Page 7 paragraph 3 & Fig. 3-4; antimicrobial substance provided as a coating on a portion of the first connector 1 or the elastic member 14 in connector 1).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the contamination guard of Walterspiel with Baumgart to include an antimicrobial composition disposed on a surface of the proximal collar, the distal collar, the elastomeric medial region, or a combination thereof, since such a modification would provide structure to act against microorganisms and stop their growth, such as bacteria and fungi (see Page 7 paragraph 3 of Baumgart).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walterspiel (US 20200408350 A1) as applied to claim 11 above, and further in view of Crawford (US 20110130727 A1).
Regarding claim 12, Walterspiel discloses all the limitations of claim 11. However, Walterspiel fails to explicitly disclose the contamination guard wherein the indicator coating provides an indication of bacterial contamination, a pH change, an oxidation or material breakdown, or a combination thereof.
However, Crawford teaches a contamination guard (status indicator 138 on device 10, [0082]; paragraph [0085] describing the status indicator used to indicate the disinfection of device 10) wherein the indicator coating (strip 142, of indicator 138, adhered to the surface of device 10, [0081] and [0085] & Fig. 13-15) provides an indication of an oxidation (strip 142 being an oxygen sensitive strip containing an oxidizable compound configured to exhibit some visual change, [0086]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the indicator coating of Walterspiel with Crawford to include the indicator coating providing an indication of an oxidation since such a modification would allow for the tracking of the passage of time, an amount of use of the device, or the disinfection of the device (see [0084]-[0086] of Crawford).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Walterspiel ‘618 (US-20180058618-A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783