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 09/01/2023 has been entered. Claims 1-20 are pending in the application.
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.
Claims 1, 3-4, 10-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McKinnon (US 2008/0132832).
Regarding Claim 1, McKinnon discloses a medical device (10, Fig 3) comprising an elastically deformable functional part (22, Fig 3) having an openable slit arrangement (24, Fig 3) that widens or opens upon an elastic deformation of the elastically deformable functional part and recloses upon cessation of the elastic deformation (Para 0030, 0037), the slit arrangement comprising slit wall faces (52, 54, Fig 4) that are at least partially coated with a separating agent (84, Fig 5) comprising or consisting of a solid (Para 0046).
Regarding Claim 3, McKinnon discloses the elastically deformable functional part is made of at least one of a silicone elastomer (“silicone rubber”, Para 0041) and a thermoplastic elastomer.
Regarding Claim 4, McKinnon discloses only the slit wall faces (52, 54, Fig 4) of the slit arrangement are at least partially coated with the separating agent (Para 0044, “the lubricating material 84 may be disposed on one or more of the slit surfaces 52, 54”).
Regarding Claim 10, McKinnon discloses the slit arrangement (24, Fig 3) comprises a longitudinal slit arrangement (See Fig 4).
Regarding Claim 11, McKinnon discloses the elastically deformable functional part (22, Fig 3) comprises a valve body (See Fig 4).
Regarding Claim 12, McKinnon discloses the elastically deformable functional part (22, Fig 3) has a head region (46, Fig 4), and the slit arrangement is formed along a transverse extent of the head region and extends centrally along a central longitudinal axis through the head region (See Figs 3 and 4).
Regarding Claim 13, McKinnon discloses the medical device is configured for infusion therapy (Para 0002).
Regarding Claim 14, McKinnon discloses an elastically deformable functional part (22, Fig 3) for a medical device (10, Fig 3), the elastically deformable functional part having an openable slit arrangement (24, Fig 3) that widens or opens upon an elastic deformation of the elastically deformable functional part and recloses upon cessation of the elastic deformation (Para 0030, 0037), the slit arrangement comprising slit wall faces (52, 54, Fig 4) that are at least partially coated with a separating agent comprising or consisting of a solid (Para 0046).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over McKinnon (US 2008/0132832) in view of King (US 2006/0149293).
Regarding Claim 2, McKinnon discloses all of the elements of the invention as discussed above, however is silent regarding the elastically deformable functional part is at least sectionally transparent.
King teaches an analogous elastically deformable function part (30, Fig 11) that is at least sectionally transparent (Para 0051).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elastically deformable function part to be transparent as taught by King in order to allow the user to view the inside of the valve to allow for verification of placement of a device (Para 0051).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon (US 2008/0132832) in view of Hamada (US 2022/0054717).
Regarding Claim 5, McKinnon discloses the separating agent may be selected from among the presently known and yet to be developed lubricants (Para 0045) and describes that one suitable separating agent can be a parylene coating which is a solid, however, is silent regarding the solid comprises a powder.
Hamada teaches a separating agent (“solid lubricant”) for a medical device; the separating agent comprising a powder (Para 0008, 0039-0040).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the separating agent or lubricating material to be a powder as taught by Hamada in order to have a material that has a high lubricity and maintains the lubricity during repeated use and for a long term (Para 0008).
Regarding Claim 6, McKinnon discloses the separating agent may be selected from among the presently known and yet to be developed lubricants (Para 0045) and describes that one suitable separating agent can be a parylene coating which is a solid, however, is silent regarding the solid has a particle size of < 400 μm.
Hamada teaches a separating agent (“solid lubricant”) for a medical device; the separating agent comprising a solid having a particle size of < 400 μm (Para 0008, 0039-0040).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the separating agent or lubricating material to be a solid having a particle size of < 400 μm as taught by Hamada in order to have a material that has a high lubricity and maintains the lubricity during repeated use and for a long term (Para 0008).
Claims 7, 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon (US 2008/0132832) in view of Kosaka (US 2017/0037211).
Regarding Claim 7, McKinnon discloses the separating agent may be selected from among the presently known and yet to be developed lubricants (Para 0045) and describes that one suitable separating agent can be a parylene coating which is a solid, however, is silent regarding the solid is a salt.
Kosaka teaches a separating agent for a deformable medical device; the separating agent comprising a solid that is a salt (“alkali metal salt” Para 0042, 0056).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the separating agent to comprise an alkali metal salt such as sodium chloride as taught by Kosaka in order to have a surface with excellent lubricity and excellent lubricant durability to repeated movements, i.e. a durability such that there will be little reduction in lubricity (Para 0024).
Regarding Claim 16, the modified invention of McKinnon and Kosaka discloses the salt is an alkali metal salt (“alkali metal salt” Para 0042, 0056 -Kosaka).
Regarding Claim 17, the modified invention of McKinnon and Kosaka discloses the alkali metal salt is sodium chloride (Para 0042 -Kosaka).
Claims 8, 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon (US 2008/0132832) in view of Scheckel (US 2016/0256620).
Regarding Claim 8, McKinnon discloses the separating agent may be selected from among the presently known and yet to be developed lubricants (Para 0045) and describes that one suitable separating agent can be a parylene coating which is a solid, however, is silent regarding the solid is a saccharide.
Scheckel teaches a separating agent between two parts of a medical device; the separating agent comprising a solid that is a saccharide (“glucose solution”, Para 0043).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the separating agent to comprise a glucose solution as it is biocompatible and also physiological (Para 0043).
Regarding Claim 18, the modified invention of McKinnon and Scheckel discloses the saccharide is a monosaccharide (Para 0043 -Scheckel, glucose is a monosaccharide).
Regarding Claim 19, the modified invention of McKinnon and Scheckel discloses the monosaccharide is glucose (Para 0043 -Scheckel).
Claims 9, 20 are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon (US 2008/0132832) in view of Suppiger (US 2020/0390690).
Regarding Claim 9, McKinnon discloses the separating agent may be selected from among the presently known and yet to be developed lubricants (Para 0045), however, is silent regarding the separating agent comprises a solid that is a vitamin.
Suppiger teaches that Vitamin C or ascorbic acid can be added to a formulation to preserve the formulation during gamma-ray or X-ray-irradiation (Para 0071).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the separating agent to further include ascorbic acid in order to preserve the separating agent (ascorbic acid is consumed for scavenging the radicals released during sterilization by gamma-ray or X-ray-irradiation) (Para 0071).
Regarding Claim 20, the modified invention of McKinnon and Suppiger discoes the vitamin is L-(+)-ascorbic acid (Para 0071 -Suppiger).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over McKinnon (US 2008/0132832) in view of Tingey (US 6,866,656).
Regarding Claim 15, McKinnon discloses coating or loading the slit wall faces of the slit arrangement with the separating agent (Para 0046), however is silent regarding a method for establishing sterilization resistance of the elastically deformable functional part according to claim 14, the method comprising the step of: b) sterilizing the elastically deformable functional part.
Tingey teaches an analogous elastically deformable functional part (20, Fig 1) for a medical device (100, Fig 1) and a method for establishing sterilization resistance of the elastically deformable functional part, the method comprising the steps of: a) coating or loading the slit wall faces of the slit arrangement with the separating agent (Col 3, lines 39-40 “It will be appreciated that the coating could also be applied to the interior walls of the slit 21”); and b) sterilizing the elastically deformable functional part (Col 5, lines 60-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to include sterilizing the elastically deformable functional part as taught by Tingey in order to have a sterilized device that can reduce the chance of infection to a patient (Col 1, line 66- Col 2, line 2).
Conclusion
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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