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 9 and 11 are objected to.
Applicant is advised that should claim 9 be found allowable, claim 11 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claims 8-11 are 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 8 recites “preferably”, and a broad then narrow range. The term “preferably” renders the claim unclear as to whether the recitations following the term are required. Additionally, the presence of two different ranges in the claim renders it unclear which one is required.
Claim 9 recites “a quantity of the second silicone oil”. Claim 1 already introduces “a quantity of the second silicone oil” and it is therefore unclear whether Claim 9 is referring the quantity recited in Claim 1 or a new quantity.
Claim 10 recites “the silicone oil”. Claim 1 recites first and second silicone oils, so it is unclear which one is being referred to in Claim 10.
Claim 11 recites “a quantity of the first silicone oil”. Claim 1 already introduces “a quantity of the first silicone oil” and it is therefore unclear whether Claim 11 is referring the quantity recited in Claim 1 or a new quantity.
Claim 11 recites “a quantity of the second silicone oil”. Claim 1 already introduces “a quantity of the second silicone oil” and it is therefore unclear whether Claim 11 is referring the quantity recited in Claim 1 or a new quantity.
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.
Claims 1-7, 10 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kawachi (US20130012886A1) in view of Santucci-Aribert (US20150322366A1).
Claim 1
Kawachi teaches a method for treating a tip cover (10) for an injection device (20) to reduce the pull out force of the tip cover (¶0057 teaches silicone oil added to the cap.), comprising: applying a quantity of a first silicone oil having a first viscosity to an inner surface of a tip cover (¶0058 teaches silicone coil added to the inner layer (12) of the cap (10).), the inner surface configured to engage an outer surface of a tip of an injection device (12C contacts 21B)
Kawachi does not disclose applying a quantity of a second silicone oil to the inner surface of the tip cover, the second silicone oil having a second viscosity, the second viscosity being different from the first viscosity; and treating the first and second silicone oils to form a cross-linked silicone coating on the inner surface of the tip cover.
However, Santucci-Aribert teaches applying a quantity of a first silicone oil (non-reactive silicone) having a first viscosity (¶0080 “the non-reactive silicone consists of PDMS 12 500 cSt”); applying a quantity of a second silicone oil, the second silicone oil having a second viscosity (acrylate and vinyl based silicone), the second viscosity being different from the first viscosity (¶0080, ¶0086, ¶0093 teach the silicone components have different viscosities.); and treating the first and second silicone oils to form a cross-linked silicone coating on the inner surface of the tip cover. (¶0119 “irradiation leads to the cross-linking of the coating composition”)
One of ordinary skill would have been motivated to substitute the known first and second cross linked silicone oil composition of Santucci-Aribert for the silicone oil in Kawachi in order to form a lubricant coating comprising a three-dimensional solid structure formed of cross-linked reactive functional groups of the reactive silicone and a liquid phase comprising non-reactive silicone, said liquid phase being retained within said three-dimensional solid structure. (Santucci-Aribert ¶0027); the gel structure provides advantageous behavior of the coating both on a static and a dynamic point of view. (Santucci-Aribert ¶0129)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed, to substitute the known first and second cross linked silicone oil composition of Santucci-Aribert for the silicone oil in Kawachi because it has been held to be prima facie obvious to substitute one known element for another to yield predictable results. See MPEP 2143(I)(B).
Claim 2
Kawachi in view of Santucci-Aribert teaches the method of claim 1, wherein the first or second silicone oil comprises poly(dimethyl siloxane). (Santucci-Aribert, ¶0075 “the non-reactive silicone of the coating may comprise poly-(dimethylsiloxane) (PDMS)”)
Claim 3
Kawachi in view of Santucci-Aribert teaches the method of claim 1, wherein the tip cover comprises an elastomeric material (Kawachi, ¶0031 “the inner layer section 12 as the interior member is formed of a transparent elastomer”), the cross-linked silicone coating disposed on the elastomeric material. (Kawachi, ¶0057 “inner layer section 12 of the syringe needle cap 10 according to one embodiment to which a lubricant agent like silicone oil is added.”)
Claim 4
Kawachi in view of Santucci-Aribert teaches the method of claim 3, wherein the elastomeric material comprises rubber. (¶0035 “silicone rubber”)
Claim 5
Kawachi in view of Santucci-Aribert teaches the method of claim 1, wherein treating the first and second silicone oils to form the cross-linked silicone coating comprises one of plasma treating, heat treating, or radiation treating the first and second silicone oils. (Santucci-Aribert, ¶0119 teaches irradiation treatment.)
Claim 6
Kawachi in view of Santucci-Aribert teaches the method of claim 1, wherein applying a quantity of first and second silicone oils to the inner surface of the tip cover comprises applying first and second silicone oils having a viscosity in a range from 300 to 35,000 centiStokes (cSt), inclusive. (Santucci-Aribert, ¶0080, ¶0086, ¶0093 teach the silicone components have different viscosities within the claimed range.)
Claim 7
Kawachi in view of Santucci-Aribert teaches the method of claim 1, wherein the second viscosity is less than the first viscosity. (Santucci-Aribert, ¶0080, ¶0086, ¶0093 teach the silicone components have different viscosities. The viscosity of the PDMS is greater than the second and third silicone components.)
Claim 10
Kawachi in view of Santucci-Aribert teaches the method of claim 1, wherein a pull out force for removing the tip cover from the tip of the injection device is in a range from 5% to 35% less than a pull out force for removing a tip cover of a same configuration and having a same quantity of the silicone oil thereon that is not cross-linked. (Kawachi in view of Santucci-Aribert teaches all of the limitations required by Claim 1 to arrive at the claimed cross-linked first and second silicone composition. No specific method steps, variables, etc were claimed in Claim 1 to arrive the range as claimed in Claim 10 and therefore it is respectfully asserted that the composition taught by the prior art obviates the claimed range. See MPEP 2112.01 (I): “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).”)
Claim 12
Kawachi in view of Santucci-Aribert teaches a tip cover (Kawachi, Item 10) comprising the cross-linked silicone coating formed by the method of claim 1. (See rejection of Claim 1 above.)
Claim 13
Kawachi in view of Santucci-Aribert teaches the tip cover of claim 12, comprising a needle shield (Kawachi, Item 11 and 12) having: an inner needle shield (Kawachi, Item 12) formed of an elastomeric material (Kawachi, ¶0035), the inner needle shield having an inner surface configured to sealingly engage a needle of an injection device therein (Kawachi, Figure 5); and a rigid (Kawachi, ¶0031 teaches the outer section (11) is made from a resin.) outer needle shield surrounding the inner needle shield (Kawachi, Figure 3 shows Item 11 surrounds the inner (Item 12) shield.); wherein the cross-linked silicone coating is disposed on the inner surface of the inner needle shield. (Kawachi, ¶0057 teaches silicone oil added to the inner shield (12). Santucci-Aribert teaches the cross linked silicone coating as discussed in the rejection of Claim 1 above.)
Claim 14
Kawachi in view of Santucci-Aribert teaches the tip cover of claim 12, comprising a unitary tip cap (Kawachi, Figure 3 teaches the cap is made into a unitary structure.), the unitary tip cap comprising an inner surface (Kawachi, Item 12) configured to sealingly engage a luer tip of an injection device (Kawachi, Figure 5), wherein the cross-linked silicone coating is disposed on the inner surface of the unitary tip cap. (Kawachi, ¶0057 teaches silicone oil added to the inner shield (12). Santucci-Aribert teaches the cross linked silicone coating as discussed in the rejection of Claim 1 above.)
Claim 15
Kawachi in view of Santucci-Aribert teaches an injection device comprising: a barrel (Kawachi, Figure 1, Item 21) having a cavity (Kawachi, Figure 1) configured to retain a medicinal fluid therein (Kawachi, ¶0027 “prefilled”), the barrel having a proximal end and a distal end (Kawachi, Figure 1), the distal end comprising a fluid passageway (Kawachi, Item 21A) for passage of the medicinal fluid therethrough; and the tip cover of claim 12 disposed on the distal end of the barrel. (See rejection of Claim 12 above.)
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kawachi (US20130012886A1) in view of Santucci-Aribert (US20150322366A1), as applied in Claim 1, further in view of Hioki (US20170056923A1).
Claim 8
Kawachi in view of Santucci-Aribert teaches the method of claim 1.
Kawachi in view of Santucci-Aribert does not explicitly disclose wherein applying a quantity of the first and second silicone oils to the inner surface of the tip cover comprises applying from 10 to 300 μg/cm2 of the first and second silicone oils to the inner surface of the tip cover, preferably from 20 to 200 μg/cm2 of the first and second silicone oils.
However, Hioki teaches wherein applying a quantity of the first and second silicone oils to the medical device comprises applying from 10 to 300 μg/cm2 of the first and second silicone oils to the medical device, preferably from 20 to 200 μg/cm2 of the first and second silicone oils. (Hioki teaches a silicone oil coating (¶0053) that is formed in the range of 5 to 50 micrograms per centimeter squared (¶0053), preferably 10 to 30 (¶0075).)
One of ordinary skill would have been motivated to apply the known oil amount technique of Hioki to the tip cap coating method of Kawachi in order to ensure sufficient slidability (Hioki ¶0020) while keeping the amount of silicone oil low (Hioki ¶0023).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed, to apply the known oil amount technique of Hioki to the tip cap coating method of Kawachi because it has been held to be prima facie obvious to apply a known technique to a known method/apparatus to yield predictable results. See MPEP 2143(I)(D).
Claims 1, 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kawachi (US20130012886A1) in view of Santucci-Aribert (US20150322366A1).
Claim 1
Kawachi teaches a method for treating a tip cover (10) for an injection device (20) to reduce the pull out force of the tip cover (¶0057 teaches silicone oil added to the cap.), comprising: applying a quantity of a first silicone oil having a first viscosity to an inner surface of a tip cover (¶0058 teaches silicone coil added to the inner layer (12) of the cap (10).), the inner surface configured to engage an outer surface of a tip of an injection device (12C contacts 21B)
Kawachi does not disclose applying a quantity of a second silicone oil to the inner surface of the tip cover, the second silicone oil having a second viscosity, the second viscosity being different from the first viscosity; and treating the first and second silicone oils to form a cross-linked silicone coating on the inner surface of the tip cover.
However, Santucci-Aribert teaches applying a quantity of a first silicone oil (acrylate and vinyl based silicone) having a first viscosity (¶0086 ¶0093); applying a quantity of a second silicone oil, the second silicone oil having a second viscosity (non-reactive silicone), the second viscosity being different from the first viscosity (0080, ¶0086, ¶0093 teach the silicone components have different viscosities.); and treating the first and second silicone oils to form a cross-linked silicone coating on the inner surface of the tip cover. (¶0119 “irradiation leads to the cross-linking of the coating composition”)
One of ordinary skill would have been motivated to substitute the known first and second cross linked silicone oil composition of Santucci-Aribert for the silicone oil in Kawachi in order to form a lubricant coating comprising a three-dimensional solid structure formed of cross-linked reactive functional groups of the reactive silicone and a liquid phase comprising non-reactive silicone, said liquid phase being retained within said three-dimensional solid structure. (Santucci-Aribert ¶0027); the gel structure provides advantageous behavior of the coating both on a static and a dynamic point of view. (Santucci-Aribert ¶0129)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed, to substitute the known first and second cross linked silicone oil composition of Santucci-Aribert for the silicone oil in Kawachi because it has been held to be prima facie obvious to substitute one known element for another to yield predictable results. See MPEP 2143(I)(B).
Claim 9
Kawachi in view of Santucci-Aribert teaches the method of claim 1, wherein the quantity of the first silicone oil applied to the inner surface of the tip cover is less than a quantity of the second silicone oil applied to the inner surface of the tip cover. (Santucci-Aribert, ¶0077 teaches the quantity of the PDMS within the oil composition is greater than the other silicone components.)
Claim 11
Kawachi in view of Santucci-Aribert teaches the method of claim 1, wherein the quantity of the first silicone oil applied to the inner surface of the tip cover is less than a quantity of the second silicone oil applied to the inner surface of the tip cover. (Santucci-Aribert, ¶0077 teaches the quantity of the PDMS within the oil composition is greater than the other silicone components.)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure can be found on the PTO-892 Notice of References Cited form.
Document
Date
Description of Relevant Subject Matter
US20130012886A1
2011-02-25
Kawachi teaches the use of silicone oil on the inner layer section of a syringe needle cap (¶0058). The oil can be dimethylsiloxane (¶0059). The cap (10) has an inner layer (12) that is made from rubber (¶0035).
US20160243308A1
2014-10-07
Giraud teaches the use of PDMS as a lubricant in a medical device. (¶0009)
US20160001006A1
2015-09-15
Takemoto teaches a syringe cap (3) that includes a non-stick surface (9) made from PDMS (¶0070).
US20150322366A1
2013-05-07
Aribert teaches a lubricant for a medical container that comprises a reactive and non-reactive silicone oil mixture (¶0069). The medical container can be a syringe (¶0070). The viscosity of the PDMS non-reactive silicone is 12500cSt (¶0080). The viscosity of the reactive silicone 800 to 1200 cSt (¶0086) and 80 and 120cSt (¶0093). The mixture is cross linked using irradiation (¶0119) or plasma treatment (¶0118). The sliding force is measured for different compositions in ¶0173 with the amount for the tri-cross linked composition of the invention (F3) having a lower force than the compositions (F1 and F2) that are not tri cross linked. The thickness of the coating is 350nm (¶0048) and the coverate is 90% (¶0049).
US20020012741A1
2001-07-26
Heinz teaches a lubricant for a syringe made from silicone oil mixtures (¶0032). The mixture is them heat treated (¶0035) to attach the lubricant to the wall of the syringe. ¶0046 teaches the viscosity of the oils. The oil can include PDMS (¶0050). The mixture is cross0linked (¶0044) by radiation (¶0043). The thickness of the coating is between 10nm and 1micrometer (¶0048).
US20010004466A1
1998-12-04
Heinz teaches a lubricant for a medical container made from a mixture of silicone oils (¶0022) The cross linking between the two silicone oils is done through UV radiation or plasma (¶0056).
US20200078523A1
2019-09-09
Mangold teaches a sliding layer for a pharmaceutical product including two silicone oils that are cross linked (¶0009). The non-reactive oil can be PDMS (¶0022). The viscosity of the oils is in the range of 5000 to 5500 cSt (¶0045). The cross linking occurs by heating or plasma (¶0051). The thickness of the layer lies between 3 microns and 0.5 micons (¶0052).
US20150196715A1
2013-06-26
Lanier teaches a lubricant made from a mixture of silicone oils (¶0155-¶0157) that are cross linked by irradiation (¶0154).
US20240189517A1
2020-12-29
Delong teaches a silicone oil coating (¶0051) that has a surface density of 25 micrograms/centimeter squared (¶0052). The lubricant decreases force required by 10-30%. (¶0055)
US20170056923A1
2016-11-15
Hioki teaches a silicone oil coating (¶0053) that is formed in the range of 5 to 50 micrograms per centimeter squared (¶0053), preferably 10 to 30 (¶0075). This amount ensures sufficient slidability (¶0020) while keeping the amount of silicone oil low (¶0023).
US20200397951A1
2020-08-31
Petisce teaches a comparison between a crosslinked (Example 2 ¶0064 Figures 9A-9B) and non-cross linked lubricant (Example 3 ¶0065 Figures 10A-10B) where the cross linked lubricant results in smaller forces. (See the values on the charts of 9B and 10B)
US4767414A
1987-04-10
Williams teaches a comparison between plasma treated silicone oil (Col. 2 Lines 40-45) vs an untreated where the force is significantly lower. The plasma treatment causes cross linking (Col. 4, Lines 55-60).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael W Hotchkiss whose telephone number is (571)272-3854. The examiner can normally be reached Monday-Friday from 0800-1600.
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/MICHAEL W HOTCHKISS/Primary Examiner, Art Unit 3726
