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 .
Response to Amendment
The amendment filed 4/14/26 has been entered. Claims 1-15 are pending in the application. Applicant’s amendments to the claims have overcome each and every claim objection, but not each and every drawing objection, previously set forth in the Non-Final Office Action mailed 11/14/26.
Drawings
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 “proximal collar defines a set of threads and grooves”, subject matter of claim 8, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 § 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.
Claim 15 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 15 recites the limitation "the distal end" in line 2-3. There is insufficient antecedent basis for this limitation in the claim. The Examiner is unsure if “the distal end” is intended to be in reference to the distal collar, or another, different distal end of the adaptor. Both claims 1 and 15 do not introduce “a distal end”. Based on the specification and drawings, the Examiner believes the distal end of the adaptor is the distal collar. For purposes of examination, the Examiner is interpreting the claim to limit the ridge or flange defined by the distal collar to extend outwardly away from a central axis of the adaptor.
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) 1-5, 9, and 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lacroix (FR 2820325 A1).
Regarding claim 1, Lacroix discloses a contamination guard (page 1 paragraph 3-page 2 paragraph 1) comprising:
a female coupling adaptor (female type connection end piece 3, page 5 third paragraph & Fig. 1-6), comprising: a proximal collar adapted and configured to engage with a medical port (proximal end of piece 3, opposite female conduit portion 5, configured for connection with a medical device/port, is being interpreted as the proximal collar, see page 5 second paragraph & fig. 1-6); an elastomeric medial region coupled to the proximal collar (bellows 8, Fig. 1-6; “the bellows (8) of the end pieces (2, 3) is made by portions of walls, the articulation of which is obtained by the flexibility and elasticity of the material used. Thus, the bellows ( 8) is made of plastic material such as a TPE (thermoplastic elastomer polyester) or an EPDM (ethylene propylene diene) for example or of any other material having the required flexibility and elasticity characteristics “, page 7 first paragraph; bellows 8 coupled to the proximal end of piece 3, page 7 last 2 lines and page 3); and a distal collar coupled to the proximal collar by the elastomeric medial region (annular bearing surface 20 coupled to the proximal end of piece 3 by bellows 8, page 8 first paragraph & Fig. 1-6); 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 medical port when in an unloaded position; and allow the distal collar to resiliently travel proximally when loaded to permit engagement with the distal end of the medical port (“According to the preferred embodiment and as shown in FIG. 4, the bellows ( 8), when unfolded, extends toward the front of the male end-piece ( 2) from a base ( 10) to exceed the end ( 4 a) of the conduit portion ( 4). Its length (L 3) is greater than the length of the conduit portion (LI) both measured from the rear base of the bellows ( 8); similarly, for the female end-piece ( 3) where the length (L 4) of the bellows ( 8) in the unfolded position is advantageously greater than the length (L 2) of the conduit portion, as shown in FIG. 5.”, page 7 second paragraph and see page 8 first paragraph & Fig. 1-6); and
a male coupling adaptor (male end piece 2, page 7 second paragraph & Fig. 1-6), comprising: a male proximal collar adapted and configured to engage with a medical port (base 10 configured for connection with a medical device/port, page 5 second paragraph & fig. 1-6); a male medial region coupled to the proximal collar (bellows 8 of piece 2 coupled to base 10, page 6 last paragraph & Fig. 1-6); and a male distal collar coupled to the male proximal collar by the male medial region (annular bearing surface 20 of piece 2 coupled to base 10 by bellows 8, page 6 last paragraph, page 7 second paragraph, and page 8 first paragraph & Fig. 1-6);
wherein a width of the male distal collar is approximately equivalent to an interior width of the distal collar of the female coupling adaptor (the width of surface 20 of piece 2 is approximately equivalent to an interior width of surface 20 of piece 3, see Fig. 1-6) such that the male distal collar is configured to couple with the distal collar of the female coupling adaptor (“This annular surface ( 20) makes it possible to avoid contamination by forming a rim at the end of the bellows ( 8) and promotes the cooperation of the bellows with one another during the assembly of the coupling by creating a distinct bearing surface between the bellows which thus forces them to mutually undergo crushing along the longitudinal axis (ZZ'), as shown in FIG. 6. “, page 8 first paragraph & Fig. 1-6).
Regarding claim 2, Lacroix discloses all the limitations of claim 1. Lacroix further discloses the contamination guard wherein the proximal collar and the distal collar are annular (the proximal collar of piece 3 and annular bearing surface 20 are annular, see Fig. 1-6).
Regarding claims 3-4, Lacroix discloses all the limitations of claim 1. Lacroix further discloses the contamination guard wherein the elastomeric medial region comprises a plurality of legs (“Thus, for the Luerlock type connectors illustrated… the female end piece (3) has a bellows (8) with three flanges.”, page 7 last 2 lines & Fig. 4-6; each one of the three flanges may be interpreted as a branch or part of bellows 8, or legs), wherein the plurality of legs are axial (the flanges of bellows 8 extend axially as they have length, see Fig. 1-6).
Regarding claim 5, Lacroix discloses all the limitations of claim 1. Lacroix further discloses the contamination guard wherein the distal collar is elastomeric (annular bearing surface 20 being elastomeric as it is the distalmost part of bellows 8, page 8 first paragraph & Fig. 1-6).
Regarding claim 9, Lacroix discloses all the limitations of claim 1. Lacroix further discloses the contamination guard wherein the proximal collar is permanently coupled to the medical port (“The invention relates to connectors for standard connectors on the market in order to allow the medical equipment equipped therewith to be assembled. It goes without saying that although the invention is described and illustrated preferentially for the fittings of Luerlock type, it could nevertheless also be implemented in fittings for medical use of a different type, without however departing from the scope of protection of the invention.” (page 5 second paragraph); female type connection end piece 3 is capable of remaining coupled without interference).
Regarding claim 14, Lacroix discloses all the limitations of claim 1. Lacroix 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 (“It may be noted that the natural position of the bellows at rest is to be unfolded, its elasticity automatically returning it to the unfolded position when it is no longer stressed. “, page 7 first paragraph & Fig. 1-6).
Regarding claim 15, Lacroix discloses all the limitations of claim 1. Lacroix further discloses the contamination guard wherein the distal end collar defines a ridge or flange extending outwardly away from the distal end (“the bellows (8) has at its front end a support surface (21) of divergent or open conical shape intended to cooperate with a similar surface situated on the bellows of the other end piece. It may be noted that the cooperation of these bearing surfaces (21) also tends to cause the compression of the bellows during the assembly of the end pieces.”, page 8 second paragraph & Fig. 8; surface 21 extending outwardly from piece 2/3, Fig. 8).
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lacroix (FR 2820325 A1) as applied to claim 1 above, and further in view of Walterspiel (US 20200408350 A1).
Regarding claim 6, Lacroix discloses all the limitations of claim 1. Lacroix discloses the contamination guard comprised of elastomeric material (page 7 first paragraph & Fig. 1-6) but fails to explicitly disclose the contamination guard wherein the elastomeric medial region is fabricated from a group consisting of: silicone and Methyl Methacrylate Acrylonitrile Butadiene Styrene (MABS).
However, Walterspiel teaches a contamination guard (connector guard 2100/2300, [0089] and [0093] & Fig. 16A-16C and 18A-18B; also see [0083]) wherein the elastomeric medial region is fabricated from silicone (materials for guards may include silicone elastomers, see [0062]).
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 guard of Lacroix with Walterspiel to include the elastomeric medial region fabricated from silicone since Walterspiel teaches silicone to be an art effective material for an elastomeric region of a contamination guard configured to flex upon axial compression and such a modification would yield the same predictable results pertaining to guard flexion (see [0089] of Walterspiel).
Claim(s) 7 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lacroix (FR 2820325 A1) as applied to claim 1 above, and further in view of Jiang (WO 2019199789 A1).
Regarding claim 7, Lacroix discloses all the limitations of claim 1. Lacroix further discloses the contamination guard comprising an aperture defined by the distal collar (surface 20 defining an aperture from which conduit 5 extends, see Fig. 1-6).
However, Lacroix 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 Lacroix 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, Lacroix discloses all the limitations of claim 1. However, Lacroix 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 Lacroix 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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lacroix (FR 2820325 A1) as applied to claim 1 above, and further in view of Schultz (US 20190022369 A1).
Regarding claim 8, Lacroix discloses all the limitations of claim 1. Lacroix discloses that “The invention relates to connectors for standard connectors on the market in order to allow the medical equipment equipped therewith to be assembled” (page 5 second paragraph) but fails to explicitly disclose the contamination guard wherein the proximal collar defines a set of threads and grooves, wherein the set of threads and grooves is adapted and configured to couple with another set of threads and grooves defined by the medical port.
However, Schultz teaches a luer type connector (reduced touch contamination device 102’ with luer connector 106’, [0076] & Fig. 1B) wherein the proximal collar defines a set of threads and grooves (luer-type connector 106’ defining internally threaded bore 119 including threads, [0073] & Fig. 1A), wherein the set of threads and grooves is adapted and configured to couple with another set of threads and grooves defined by the medical port (internally threaded bore 119 is configured to couple with another luer connector 110, [0078] & Fig. 1B; “…Luer-type connector 110 of the present embodiment is preferably configured to be removably engageable with compatible male locking Luer-type connectors having male 6% conical fittings 125.”, [0078] and [0008]).
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 guard of Lacroix with Schultz to include the proximal collar defining a set of threads and grooves, wherein the set of threads and grooves is adapted and configured to couple with another set of threads and grooves defined by the medical port, since such a modification would provide structure to connect the connector to another, threadably engaged, connector to facilitate device connection to other medical fittings and yield predictable results pertaining to secure connection between medical ports ([0008], [0078], and claim 1 of Schultz).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lacroix (FR 2820325 A1) as applied to claim 1 above, and further in view of Baumgart (WO 2019243044 A1).
Regarding claim 10, Lacroix discloses all the limitations of claim 1. However, Lacroix 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 Lacroix 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) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lacroix (FR 2820325 A1) as applied to claim 1 above, and further in view of Crawford (US 20110130727 A1).
Regarding claims 11-12, Lacroix discloses all the limitations of claim 1. However, Lacroix fails to explicitly disclose 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, 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 (device 10, [0082]) comprising: an indicator coating disposed on a surface of the proximal collar (status indicator 138 adhered onto 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 guard of Lacroix with Crawford to an indicator coating disposed on a surface of the proximal collar, wherein the indicator coating provides 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).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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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
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