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 .
Reopening of Prosecution After Appeal Brief
In view of the appeal brief filed on 12 January 2026, PROSECUTION IS HEREBY REOPENED. A new grounds of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783
Response to Arguments
Applicant argues that Yacoby-Zeevi is not analogous art because it does not address any kind of problem of healing between two parts. Applicant argues that the problems identified by the examiner from the specification are not problems faced by the inventor, instead they are definitions. The examiner respectfully disagrees. The specification describes lubricant composition within the valve slit as preventing healing of the valve during sterilization. McKinnon already includes the claimed silicone oil lubricant but is silent to a thickener. The art of record already teaches that including a lubricant within a valve slit will prevent healing (Andrus (US 2014/0194833 A1) [0030] “Another advantage of using a lubricant is that a formation of natural bonding between some grades of elastomers of the resilient elements may be prevented or minimized.”, Lee et al (US 7,857,285 B2) Col 1 lines 55-56 “sterilization via gamma irradiation may facilitate the re-knitting process” Col 2 lines 15-16 “Such agent delivers surface lubricity and avoid slit plane re-knitting”). The inclusion of the thickener has the additional purpose of providing the lubricant with steadfastness as described in the specification of the instant application ([0031] “The aforementioned thickeners have been found particularly advantageous for giving the composition according to the present disclosure a certain wettability and, in particular, steadfastness, as a result of which the separation effect of the composition can be exhibited particularly well.”). Maintaining the lubricant in its intended position was a problem faced by the inventor when deciding to include a thickener.
The examiner previously applied Yacoby-Zeevi et al. which teaches a thickener, and while this thickener is also intended to provide steadfastness to a lubricant, it is not clear that one of ordinary skill faced with the problem of providing a lubricant with steadfastness would look to a reference related to pharmaceutically acceptable transdermal compositions. Instead, one of ordinary skill in the art would look to Matsumoto et al. which is related to stabilizing lubricant compositions and preventing oil separation and diffusion.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 10, 12-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon et al. (US 20080132832 A1) in view of Matsumoto et al. (JP 2000109874 A).
Regarding claim 1, McKinnon et al. discloses a medical device (10 Fig 1) comprising an elastically deformable functional part (22 Fig 4) having a slit arrangement (24 Fig 4) that is openable ([0005] “The septum may be opened with a blunt cannula, a male Luer of a medical device, or other suitable medical device.”), wherein the slit arrangement widens or opens upon an elastic deformation of the elastically deformable functional part and recloses upon cessation of the elastic deformation ([0013] “septum comprising an elastomeric material”, “provide selective expansion and contraction of the passage through the septum”), wherein slit wall faces (52, 54 Fig 4) of the slit arrangement are coated with a composition ([0044] “the lubricating material 84 may be disposed on one or more of the slit surfaces 52, 54”), wherein the composition comprises a silicone oil ([0047] “fluorinated silicone oil”).
However, McKinnon et al. fails to disclose the composition comprises a thickener.
Matsumoto et al. teaches a composition comprises a silicone oil and a thickener ([0014] “a non-diffusible fluorine-based grease composition, which is obtained by mixing 0.1 to 50% of various silicone oils with a fluorine-based grease composed of a fluorine oil and a thickener”). Matsumoto et al. teaches that parts of devices that require a lubricant are subject to problems such as contact failure due to leakage or diffusion of the lubricant, and further, teaches that a lubricant composition with the silicone oil and the thickener leads to a non-diffusible composition, thus preventing the composition from leaking or diffusing out ([0012] “to prevent oil separation and syneresis from grease components, and to allow oil to exist only in a portion used for lubrication and not to flow out to other portions.”, [0031] “oil separation and syneresis from the grease component were eliminated, and the oil content was kept only in the portion to be lubricated. It is possible to obtain a composition that is present and has excellent non-diffusivity and does not flow to other parts”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the composition of McKinnon et al. to include the thickener as taught by Matsumoto et al. to obtain a composition which stays at a position where a lubricant is required and does not diffuse or leak out [0009].
Regarding claim 2, modified McKinnon et al. teaches the medical device according to claim 1. McKinnon et al. further teaches wherein the silicone oil is a fluorinated silicone oil ([0047] “fluorinated silicone oil”).
Regarding claim 3, modified McKinnon et al. teaches the medical device according to claim 1. Modified McKinnon et al. further teaches wherein the silicone oil has a proportion of 0.1% by weight to 99.9% by weight based on the total weight of the composition (Matsumoto et al. [0014] “mixing 0.1 to 50% of various silicone oils with a fluorine-based grease composed of a fluorine oil and a thickener”, in Table 1, Example 1, the silicone oil KF96-20 is 2% of the composition, [0026] “in Example 1, the effect of adding 2% of KF96-20 (viscosity 20 Cp/20° C.) as a silicone oil was tested”).
Regarding claim 4, modified McKinnon et al. teaches the medical device according to claim 1. Modified McKinnon et al. further teaches wherein the thickener is selected from the group consisting of: aluminium soap, aluminium complex soap, barium soap, barium complex soap, calcium soap, calcium complex soap, lithium soap, lithium complex soap, sodium soap, sodium complex soap, polytetrafluoroethylene (PTFE), inorganic thickener, bentonite, polyurea, silica, glucose, ascorbic acid, starch and mixtures of at least two of the aforementioned thickeners (Matsumoto et al.-[0026] “PTFE was used as the thickener component”).
Regarding claim 5, modified McKinnon et al. teaches the medical device according to claim 1. Modified McKinnon et al. further teaches wherein the thickener is polytetrafluoroethylene (PTFE), silica or a mixture of polytetrafluoroethylene (PTFE) and silica (Matsumoto et al.- [0026] “PTFE was used as the thickener component”).
Regarding claim 6, modified McKinnon et al. teaches the medical device according to claim 1. Modified McKinnon et al. further teaches wherein the thickener has a proportion of 0.1% by weight to 99.9% by weight based on the total weight of the composition (Matsumoto et al.- Table 1, Example 1: PTFE is 30% of the composition).
Regarding claim 10, modified McKinnon et al. teaches the medical device according to claim 1. Modified McKinnon et al. further teaches wherein the composition is a viscous or pasty composition (Matsumoto et al.- [0015] “0015] Further, as the silicone oil, a silicone oil having a viscosity of 1 to 1000 mm@2 /S at 25 DEG C. is used.”, [0023] “a slightly hardened grease-like substance”).
Regarding claim 12, modified McKinnon et al. teaches the medical device according to claim 1. Modified McKinnon et al. further teaches wherein the elastically deformable functional part is made of an elastically deformable material ([0013] “septum comprising an elastomeric material”, elastomeric materials are elastically deformable materials).
Regarding claim 13, modified McKinnon et al. teaches the medical device according to claim 12. Modified McKinnon et al. further teaches wherein the elastically deformable material is an elastomer ([0013] “septum comprising an elastomeric material”, [0040] “silicone rubber”).
Regarding claim 14, modified McKinnon et al. teaches the medical device according to claim 1. Modified McKinnon et al. further teaches wherein the slit arrangement is formed as a longitudinal slit arrangement (See the longitudinal extension of the slit 24 in Fig 4).
Regarding claim 15, modified McKinnon et al. teaches the medical device according to claim 1. Modified McKinnon et al. further teaches wherein the elastically deformable functional part is formed as a valve body (22 forms the slit valve that prevents fluid flow when in the sealed position as shown in Fig 1).
Regarding claim 16, modified McKinnon et al. teaches the medical device according to claim 1. Modified McKinnon et al. further teaches wherein the elastically deformable functional part has a head region (46 Fig 3), wherein the slit arrangement is formed along a transverse extent of the head region (See the slit 24 across 46 in Fig 3) and extends centrally along a central longitudinal axis through the head region (See the slit 24 extending centrally through 46 in Fig 4).
Regarding claim 17, modified McKinnon et al. teaches the medical device according to claim 1. Modified McKinnon et al. further teaches wherein the medical device is a medical device for infusion therapy ([0003] “The vascular access device may be used for continuous infusion therapy or for intermittent therapy.”).
Regarding claim 19, McKinnon et al. discloses an elastically deformable functional part (22 Fig 4) for a medical device (10 Fig 1), the elastically deformable functional part comprising a slit arrangement (24 Fig 4) that is openable ([0005] “The septum may be opened with a blunt cannula, a male Luer of a medical device, or other suitable medical device.”), wherein the slit arrangement widens or opens upon an elastic deformation of the elastically deformable functional part and recloses upon cessation of the elastic deformation ([0013] “septum comprising an elastomeric material”, “provide selective expansion and contraction of the passage through the septum”), wherein slit wall faces (52, 54 Fig 4) of the slit arrangement are coated with a composition ([0044] “the lubricating material 84 may be disposed on one or more of the slit surfaces 52, 54”), wherein the composition comprises a silicone oil ([0047] “fluorinated silicone oil”).
However, McKinnon et al. fails to disclose the composition comprises a thickener.
Matsumoto et al. teaches a composition comprises a silicone oil and a thickener ([0014] “a non-diffusible fluorine-based grease composition, which is obtained by mixing 0.1 to 50% of various silicone oils with a fluorine-based grease composed of a fluorine oil and a thickener”). Matsumoto et al. teaches that parts of devices that require a lubricant are subject to problems such as contact failure due to leakage or diffusion of the lubricant, and further, teaches that a lubricant composition with the silicone oil and the thickener leads to a non-diffusible composition, thus preventing the composition from leaking or diffusing out ([0012] “to prevent oil separation and syneresis from grease components, and to allow oil to exist only in a portion used for lubrication and not to flow out to other portions.”, [0031] “oil separation and syneresis from the grease component were eliminated, and the oil content was kept only in the portion to be lubricated. It is possible to obtain a composition that is present and has excellent non-diffusivity and does not flow to other parts”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the composition of McKinnon et al. to include the thickener as taught by Matsumoto et al. to obtain a composition which stays at a position where a lubricant is required and does not diffuse or leak out [0009].
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon et al. (US 20080132832 A1) in view of Matsumoto et al. (JP 2000109874 A) and Ma (US 2016/0235944 A1).
Regarding claim 7, modified McKinnon et al. teaches the medical device according to claim 1. However, modified McKinnon et al. fails to teach wherein the composition further comprises a solid which is not a thickener.
Ma teaches a composition (60 Fig 5, [0034] “Antimicrobial lubricant 60”) further comprises a solid which is not a thickener ([0035] “The antimicrobial agent can be solid particles that are insoluable in the lubricant or in liquid form.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the composition of modified McKinnon et al. to include the solid with the limitations as taught by Ma to provide the lubricant composition with “an antimicrobial or biocidal agent effective against various forms and strains of bacteria which may cause infection within a patient.” [0034]
Regarding claim 8, modified McKinnon et al. teaches the medical device according to claim 7. Modified McKinnon et al. further teaches wherein the solid is selected from the group consisting of salts, saccharides, vitamins and mixtures of at least two of the aforementioned solids (Ma- [0035] “benzethonium chloride” this is a salt).
Regarding claim 9, modified McKinnon et al. teaches the medical device according to claim 7. Modified McKinnon et al. further teaches wherein the solid has a proportion of 0.01% (w/v) to 10.0% (w/v) of the composition (Ma- [0036] “In some embodiments, lubricant 60 comprises one or more antimicrobial agents in an amount from approximately 0.01% (w/v) to approximately 10.0% (w/v) of lubricant 60. In other embodiments, lubricant 60 comprises one or more antimicrobial agents in an amount from approximately 0.001% (w/v) to approximately 5.0% (w/v) of lubricant 70. Further, in some embodiments lubricant 60 comprises one or more antimicrobial agents in an amount from approximately 0.01% to approximately 10.0% (w/v).”).
However, modified McKinnon et al. fails to explicitly disclose wherein the solid has a proportion of 0.01% by weight to 99.99% by weight based on the total weight of the composition as claimed.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the proportion of the solid of modified McKinnon et al. from between .01% (w/v) to 10.0% (w/v) to between 0.01% to 99.99% as applicant appears to have placed no criticality on the claimed range (see [0033] indicating the proportion “preferably” is within a different range of 10% by weight to 90% by weight) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over McKinnon et al. (US 20080132832 A1) in view of Matsumoto et al. (JP 2000109874 A) and Lopez et al. (US 2011/0282302 A1).
Regarding claim 11, modified McKinnon et al. teaches the medical device according to claim 1. However, modified McKinnon et al. fails to teach wherein the elastically deformable functional part is at least sectionally transparent or light-transmissive.
Lopez et al. teaches a medical device wherein the elastically deformable functional part (60 Fig 3) is at least sectionally transparent or light-transmissive ([0066] “The seal 60 is generally transparent”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the elastically deformable functional part to be at least sectionally transparent or light-transmissive as taught by Lopez et al so that the internal conduit and fluid flowing therethrough is visible [0066].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Andrus (US 2014/0194833 A1) teaches a silicone access port with a silicone oil lubricant where the lubricant prevents healing of the slit ([0030] “Another advantage of using a lubricant is that a formation of natural bonding between some grades of elastomers of the resilient elements may be prevented or minimized.”)
Harding (US 2016/0008569 A1) teaches a catheter port valve with a silicone oil lubricant having a thickener ([0039] “The viscosity of the lube can be modified by adding fumed silica in concentrations up to 3%.”) and solid particles ([0037] “a matrix is provided which comprises solid antimicrobial agent particles in an amount representing approximately 0.1-40% w/w of the matrix.”)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Vargas whose telephone number is (571)270-3873. The examiner can normally be reached Mon-Fri 4:00 PM-9:00 PM EST.
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/A.E.V./Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights