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
Claim 1is objected to because of the following informalities: Claim 1 recites “the lower housing” in lines 9 and 10. The lower house has been amended to a conduit housing. Therefore for purposes of examination, the lower housing in lines 9 and 10 is being interpreted as the conduit housing. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 and 40 and all dependents thereof are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In claim 1 and 40, “a valve activation member” that is defined as “extending from a distal end of the lower/conduit housing and defining a smaller diameter than the distal end of the lower/conduit housing” are recited. However, the specification and drawings do not appear to support or describe such a separate structure. [0008] and [0016] state that the conduit housing can define a valve activation member indicating that the activation member is formed because of the conduit housing which is broken up into a lower and upper housing and a fluid passageway therethrough. It does not appear the conduit defines a separate structure considered the valve activation member. Other paragraphs throughout the specification also simply recite the valve activation member as just being the conduit housing and not a separate structure. Further, [0085] and [0094] appear to describe the use of the device in which what appears to be the distal portion of the lower/conduit housing comes into contact with a valve 100 such that it can open (activated) or close (not activated) the valve. Lastly, there is no reference number in the specification that indicates the valve activation member and there is no description on the diameter of the valve activation member in comparison to the lower housing. Therefore, it appears that the valve activation member is just a portion of the lower/conduit housing that contacts and opens the valve of the medical device and not really a separate structure that extends from a distal end of the lower housing with a diameter smaller than the distal end of the lower/conduit housing. For purposes of examination, the valve activation member is simply being interpreted as the distal portion of the lower housing that contacts and opens the valve of the medical device.
Second, claim 1 and 40, as amended, recites “a resilient member extending from the distal end of the upper housing, wherein the resilient member and the distal end of the upper housing each define the same diameter at the transition from the upper housing to the resilient member”. There does not appear to be support for this amendment. Reference to a resilient member appears to point to Fig. 6 through Fig. 15c. However, in all of these figures the resilient member is coupled to the proximal portion of the upper housing proximal portion of the upper housing. See what is considered distal end of the upper housing (Fig. 6b, element 232). Proximal portion of upper housing is generally being interpreted to where 217 is pointing. It appears the resilient members are connected at the proximal end and not the distal end. None of the figures or embodiments show resilient member that extend from the distal end of the upper housing. Further, there doesn’t appear to be support for the resilient member and the distal end of the upper housing defining the same diameter at the transition from the upper housing to the resilient member. See labeled drawing below as to where each of these locations appears to be and how the diameters different between these locations. Clarity to the claim limitations would be needed to overcome the rejection. For purposes of examination, the diameter of the transition between upper housing and resilient member, as labeled below, will be interpreted to be the diameter of the recited claim limitations.
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Claim Rejections - 35 USC § 102
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)(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, 4-5, 8-10, 12, 19, 21 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Abitabilo et al. (US 2017/0239443 A1).
With regard to claim 1, Abitabilo discloses A priming cap (Fig. 29A-30B) being configured to engage a medical connector and facilitate withdrawal of air from the medical connector ([0181]), the priming cap comprising:
an upper housing (see Fig below)),
a conduit housing (see Fig. below) extending from a distal end of the upper housing (see Fig below), the conduit housing defining a smaller diameter than the distal end of the upper housing (see Fig. 29c, showing the upper housing (at 198) and the conduit housing at 196, where 198 has larger diameter (both internal and external) than the nose 196. Further [0171] teaches that the nose 196 tapers and thus has a gradually decreasing diameter),
a fluid passageway (208) extending through the upper housing and the conduit housing,
a valve activation member (see Fig below) extending from a distal end of the conduit housing, the valve activation member defining a smaller diameter than the distal end of the lower housing ([0020], [0171], the entirety of element 196 which encompasses the lower housing and the valve activation member are tapered to form a better seal with the needleless connector. Thus the tapering of element 196 would necessarily make the valve activation member have a smaller diameter than that the distal end of the lower housing because the valve activation member is located distally of the distal end of the lower housing),
a plug (198) positioned within the upper housing at a proximal end thereof (see Fig below, the parameters of where the second housing is located is not structurally limited thus, as indicated below, the plug can be considered located at the proximal end of the second housing), the plug being configured to facilitate venting of air within the medical connector while the priming cap is engaged with the medical connector ([0173]), the plug being further configured to inhibit liquid from passing between the conduit housing and an exterior of the priming cap while the priming cap is engaged with the medical connector ([0178]) while permitting fluid to pass from the conduit housing into the upper housing (a portion of fluid may flow into the space created in the upper housing, defined by the circle in the annotated figure below, as it does not contain the plug),
and a window ([0021], entire nose or vent path is made transparent which is considered a window that allows for viewing of at least a portion of the fluid passageway) configured to allow visualization of at least a portion of the fluid passageway located in the upper housing ( the entire device may be made transparent [0021], thus the upper housing made of this transparent material would be considered a window located in the upper housing. The claims do not limit the window to being only in the upper housing nor does the claim define the window to be of a certain structure, such as an aperture or other structure in the upper housing);
and a resilient member (204) spaced laterally from the conduit housing (see Fig. 29b or 30a, showing the resilient member 204 spaced away from 196, conduit housing) and extending from the upper housing (see Fig. 29b), wherein the resilient member and the distal end of the upper housing each defin the same diameter at the transition from the upper housing to the resilient member (Fig. 30a, shown the resilient member connected to the upper housing and the diameter at that location being the same between the upper housing and the resilient member, see also 112(a) above for the interpretation being taken for this limitation) extending past a distal end of the lower housing and shaped to at least partially surround an interior volume of the priming cap configured to receive a portion of a medical connector (Fig. 30a/b) , the resilient member comprising a retaining feature (203) extending laterally across a portion of the resilient member, wherein the retaining feature is configured to secure the priming cap to the portion of the medical connector ([0175]).
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With regard to claim 4, Abitabilo discloses wherein the retaining feature includes a bumper (203) that extends outwardly from an interior surface of the resilient member, and wherein the bumper is configured to secure the priming cap to a securement feature of the medical connector ([0175]).
With regard to claim 5, Abitabilo discloses wherein the retaining feature (203) secures the priming cap to the medical connector in a first position (fig. 30a), wherein when in the first position, the valve activation member does not open a seal of the medical connector to establish a fluid flow path between the medical connector and the fluid passageway of the conduit housing ([0095], [0172]).
With regard to claim 8, Abitabilo discloses wherein the upper housing includes a venting notch (fig. 29a, element 214) formed within a side wall of the upper housing, and wherein the venting notch is configured to further allow trapped air to be vented out of the priming cap ([0174]).
With regard to claim 9, Abitabilo discloses wherein the venting notch further comprises a venting hole (opening in top of 202 adjacent to notch 214 in Fig. 29a) passing between an interior of the upper housing and an exterior of the priming cap.
With regard to claim 10, Abitabilo discloses wherein the plug further comprises a hydrophobic filter ([0173], plug is made of a matrix material that acts as a hydrophobic filter that allows air to pass but fluid is inhibited).
With regard to claim 12, Abitabilo discloses wherein the resilient member comprises at least two resilient arms (204, Fig. 29b), wherein each of the at least two resilient arms is shaped in an arrow configuration (see Fig. 29B and 29C, showing the ends of the resilient arms being in an arrow shape), and wherein the arrow configuration is configured to indicate to a user a proper orientation of the priming cap relative to the medical connector (the shape of the resilient arms would be capable of indicating to a user the proper orientation).
With regard to claim 19, Abitabilo discloses wherein the resilient member further comprises an indicator (arrow shaped end of 204 can be considered a visual indicator. Applicant is asked to provide additional limitations to better define what is meant by an indicator).
With regard to claim 21, Abitabilo discloses wherein the window is located on the upper housing of the conduit housing ([0021], the entire nose portion which includes the upper housing is transparent which creates a window).
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) 40-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abitabilo et al. (US 2017/0239443 A1) in view of Welp (US 2015/0298893 A1).
With regard to claim 40, Abitabilo discloses A priming cap (Fig. 29A-30B) being configured to engage a medical connector and facilitate withdrawal of air from the medical connector ([0181]), the priming cap comprising:
an upper housing (see Fig below)),
a conduit housing (see Fig. below) extending from a distal end of the upper housing (see Fig below), the conduit housing defining a smaller diameter than the distal end of the upper housing (see Fig. 29c, showing the upper housing (at 198) and the conduit housing at 196, where 198 has larger diameter (both internal and external) than the nose 196. Further [0171] teaches that the nose 196 tapers and thus has a gradually decreasing diameter),
a fluid passageway (208) extending through the upper housing and the conduit housing,
a valve activation member (see Fig below) extending from a distal end of the conduit housing, the valve activation member defining a smaller diameter than the distal end of the lower housing ([0020], [0171], the entirety of element 196 which encompasses the lower housing and the valve activation member are tapered to form a better seal with the needleless connector. Thus the tapering of element 196 would necessarily make the valve activation member have a smaller diameter than that the distal end of the lower housing because the valve activation member is located distally of the distal end of the lower housing),
a plug (198) positioned within the upper housing at a proximal end thereof (see Fig below, the parameters of where the second housing is located is not structurally limited thus, as indicated below, the plug can be considered located at the proximal end of the second housing), the plug being configured to facilitate venting of air within the medical connector while the priming cap is engaged with the medical connector ([0173]), the plug being further configured to inhibit liquid from passing between the conduit housing and an exterior of the priming cap while the priming cap is engaged with the medical connector ([0178]) while permitting fluid to pass from the conduit housing into the upper housing (a portion of fluid may flow into the space created in the upper housing, defined by the circle in the annotated figure below, as it does not contain the plug),
and a window ([0021], entire nose or vent path is made transparent which is considered a window that allows for viewing of at least a portion of the fluid passageway) configured to allow visualization of at least a portion of the fluid passageway located in the upper housing ( the entire device may be made transparent [0021], thus the upper housing made of this transparent material would be considered a window located in the upper housing. The claims do not limit the window to being only in the upper housing nor does the claim define the window to be of a certain structure, such as an aperture or other structure in the upper housing);
and a resilient member (204) spaced laterally from the conduit housing (see Fig. 29b or 30a, showing the resilient member 204 spaced away from 196, conduit housing) and extending from the upper housing (see Fig. 29b), wherein the resilient member and the distal end of the upper housing each defin the same diameter at the transition from the upper housing to the resilient member (Fig. 30a, shown the resilient member connected to the upper housing and the diameter at that location being the same between the upper housing and the resilient member, see also 112(a) above for the interpretation being taken for this limitation) extending past a distal end of the lower housing and shaped to at least partially surround an interior volume of the priming cap configured to receive a portion of a medical connector (Fig. 30a/b) , the resilient member comprising a retaining feature (203) extending laterally across a portion of the resilient member, wherein the retaining feature is configured to secure the priming cap to the portion of the medical connector ([0175]).
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However, Abitabilo does not disclose an antiseptic material.
Welp teaches a similar cap device (Fig. 4-6, Fig. 10 and 11) having an upper (7) and lower housing (20) and resilient member (at 6). Welp further teaches an antiseptic material (8) positioned at a proximal end of the priming cap (proximal and distal ends have not been defined in the claims and thus the antiseptic material 8 being located at one end of the cap could be considered the proximal end of the cap) inserted into the cap at the upper housing ([0032], [0034], [0035]) and would permit the antiseptic material to interact with the medical connector when the priming cap is not secured to the medical connector (the term interact and does not impart and specific limitations on the claims, thus when the medical connector is disconnected from the priming cap it can be brought into contact with the antiseptic material that is located at a proximal end of the cap and this could be considered an interaction between the antiseptic material and the medical connector). Thus this antiseptic pad (8) can be added into the upper housing of Abitabilo such that it may interact with the medical connector when the priming cap is not secured to the medical connector.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ramsey with the antiseptic materials as taught by Welp for the purpose of preventing germs from forming in the cap ([0010)).
With regard to claim 41, Abitabilo discloses wherein the retaining feature includes a bumper (203) that extends outwardly from an interior surface of the resilient member, and wherein the bumper is configured to secure the priming cap to a securement feature of the medical connector ([0175]).
With regard to claim 42, Abitabilo discloses wherein the retaining feature (203) secures the priming cap to the medical connector in a first position (fig. 30a), wherein when in the first position, the valve activation member does not open a seal of the medical connector to establish a fluid flow path between the medical connector and the fluid passageway of the conduit housing ([0095], [0172]).
With regard to claim 43, Abitabilo discloses wherein the upper housing includes a venting notch (fig. 29a, element 214) formed within a side wall of the upper housing, and wherein the venting notch is configured to further allow trapped air to be vented out of the priming cap ([0174]).
With regard to claim 44, Abitabilo discloses wherein the venting notch further comprises a venting hole (opening in top of 202 adjacent to notch 214 in Fig. 29a) passing between an interior of the upper housing and an exterior of the priming cap.
With regard to claim 45, Abitabilo discloses wherein the plug further comprises a hydrophobic filter ([0173], plug is made of a matrix material that acts as a hydrophobic filter that allows air to pass but fluid is inhibited).
With regard to claim 46, Abitabilo discloses wherein the resilient member comprises at least two resilient arms (204, Fig. 29b), wherein each of the at least two resilient arms is shaped in an arrow configuration (see Fig. 29B and 29C, showing the ends of the resilient arms being in an arrow shape), and wherein the arrow configuration is configured to indicate to a user a proper orientation of the priming cap relative to the medical connector (the shape of the resilient arms would be capable of indicating to a user the proper orientation).
With regard to claim 47, Abitabilo discloses wherein the resilient member further comprises an indicator (arrow shaped end of 204 can be considered a visual indicator. Applicant is asked to provide additional limitations to better define what is meant by an indicator).
With regard to claim 48 and 49, Abitabilo discloses the claimed invention except for an antiseptic.
Welp teaches a similar cap device (Fig. 4-6, Fig. 10 and 11) having an upper (7) and lower housing (20) and resilient member (at 6). Welp further teaches an antiseptic material (8) inserted into the cap at the upper housing ([0032], [0034], [0035]). Thus this antiseptic pad (8) can be added into the upper housing in any location of Abitabilo such that it may interact with the medical connector when the priming cap is not secured to the medical connector.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ramsey with the antiseptic materials as taught by Welp for the purpose of preventing germs from forming in the cap ([0010)).
With regard to claim 50, Abitabilo discloses wherein the resilient member (204) is engaged with a deformable portion (see Fig. 30b , where 120 is pointing at an upper end of the resilient member that forms a flexible hinge allowing 204 to flex outwardly and back), wherein the resilient member and the deformable portion have a first configuration such that the resilient member engages the portion of the medical connector (Fig. 30b), and wherein the resilient member and the deformable portion have a second configuration such that the resilient member disengages the portion of the medical connector (when the cap is removed).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4-5, 8-10, 12, 19, 21, 40-50 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.
The amendments to the claims are still be rejected under Abitabilo because the change from “lower housing” to “conduit housing” does not change the structure or impart any limitation other than changing the name of the housing. As is seen by the annotated drawing the conduit housing does extend from the distal end of the upper housing and has a smaller diameter than the upper housing. The amendments regarding the resilient member being sapced laterarally from the conduit hosuing is taught by Abitabilo as best shown in Fig. 30a where the resilient members 204 are spaced asway from the conduit housing 196.
Applicant also files remarks on p. 8 of the Remarks indicating that Abitabilo teaches resilient members that extend from the sides of the upper housing in contrast to the claimed features. However, as shown in Applicant’s drawings in, for example Fig. 6d, the reseilient members 214 also extend from the sides of the upper housing. The claims also recite that the resilient member extends from the upper housing, so it is unclear how Abitabilo does not teach the claimed limitation or how it is different than Applicant’s invention.
With regard to claim 40, Applicant states that Welp does not provide an antiseptic material that can be used with a medical connector when the medical connector is not secured the priming cap because the antiseptic material is sealed within the cap of Welp. However, as shown in Fig. 3 of Welp, the antiseptic material is open to the exterior of the cap via aperture 19. Therefore, the aperture would allow for some type of medical connector to interact with the antiseptic pad 8 when not connected. The claim language does not positively recite the medical connector and thus the antiseptic pad must only be capable of interacting with a medical connector. Due to the aperture, this is possible. Further limitations regarding the medical connector or how the antiseptic material is interacting with the medical connector would be needed to overcome the prior art of record.
Applicant is also asked to revisit the 112(a) rejection which still applies. The valve activation member is still being claimed as a separate distinct structure and there is no support for this structure in the specification. Therefore the 112(a) has not been withdrawn and Applicant is asked to amend the claims.
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.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783