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 .
Acknowledgments
In the reply, filed on March 22, 2024, Applicant cancelled claims 1-59.
Applicant added new claims 60-86.
Information Disclosure Statement
The information disclosure statement filed March 26, 2024, fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because:
Non-patent literature citations 2 and 3 are missing a date (with at least the year)
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
The abstract of the disclosure is objected to because:
In lines 2-3, “sliding engagement includes the steps” should be changed to “sliding engagement, the method includes steps”
In line 7, “a coating layer” should be changed to “the coating layer”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 60-76, 78-80, and 83-86 are objected to because of the following informalities:
In regards to claim 60, line 4, “the steps” should be changed to “steps”.
In regards to claim 60, line 10, “a coating layer” should be changed to “the coating layer”.
In regards to claim 61, line 1, “said step a) of providing” should be changed to “said providing”.
In regards to claim 62, line 1, “said step b) of heating” should be changed to “said heating”.
In regards to claim 63, lines 1-2, “a step d) of maintaining” should be changed to “maintaining”.
In regards to claim 64, line 1, “a step e) of feeding” should be changed to “feeding”.
In regards to claim 65, line 1, “said step e) of feeding” should be changed to “said feeding”.
In regards to claim 66, lines 1-2, “said step c) of applying the heated coated composition” should be changed to “said applying the coated composition heated”.
In regards to claim 67, line 1, “said step b) of heating” should be changed to “said heating”.
In regards to claim 68, line 3, “said step b) of heating” should be changed to “said heating”.
In regards to claim 69, lines 1-2, “said step c) of applying the heated coated composition” should be changed to “said applying the coated composition heated”.
In regards to claim 70, lines 1-2, “said step c) of applying the heated coated composition” should be changed to “said applying the coated composition heated”.
In regards to claim 71, lines 1-2, “said step c) of applying the heated coated composition” should be changed to “said applying the coated composition heated”.
In regards to claim 72, lines 1-2, “the step c) of applying the heated coated composition” should be changed to “the applying the coated composition heated”.
In regards to claim 73, line 1, “the dispensing time” should be changed to “a dispensing time”.
In regards to claim 74, lines 1-2, “said step c) of applying the heated coated composition” should be changed to “said applying the coated composition heated”.
In regards to claim 75, lines 1-2, “said step c) of applying the heated coated composition” should be changed to “said applying the coated composition heated”.
In regards to claim 76, lines 1-2, “step c) of applying the heated coated composition” should be changed to “the applying the coated composition heated”.
In regards to claim 76, lines 2-3, “a step f) of subjecting” should be changed to “subjecting”.
In regards to claim 78, line 1, “said irradiation treatment” should be changed to “said irradiation”.
In regards to claim 79, line 1, “said irradiation treatment” should be changed to “said irradiation”.
In regards to claim 80, line 1, “said irradiation treatment” should be changed to “said irradiation”.
In regards to claim 83, lines 1-2, “the average value of the normalized concentration” should be changed to “an average value of a normalized concentration”.
In regards to claim 83, line 5, “the LO” should be changed to “a LO”.
In regards to claim 83, lines 7-8, “the limit value” should be changed to “a limit value”.
In regards to claim 84, lines 1-2, “the average value of the normalized concentration” should be changed to “an average value of a normalized concentration”.
In regards to claim 84, line 5, “the LO” should be changed to “a LO”.
In regards to claim 84, line 8, “the limit value” should be changed to “a limit value”.
In regards to claim 85, lines 1-2, “the average value of the normalized concentration” should be changed to “an average value of a normalized concentration”.
In regards to claim 85, line 5, “the LO” should be changed to “a LO”.
In regards to claim 85, line 8, “the limit value” should be changed to “a limit value”.
In regards to claim 86, lines 1-2, “the following separate components” should be changed to “following separate components”.
In regards to claim 86, line 5, “a plunger configured for a sliding engagement” should be changed to “the plunger configured for the sliding engagement”.
Appropriate correction is required.
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 68, 80, and 83-85 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.
In regards to claim 68, line 1 recites the limitation "said pump". There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 68, line 2 recites the limitation "said dispensing head". There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 80, line 2 recites “extremes included”. It is unclear what said recitation means.
In regards to claim 83, line 2 recites the limitation "the particles". There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 84, line 2 recites the limitation "the particles". There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 84, line 3 recites “a partially cross-linked coating layer”. Claim 84 depends upon claim 81. Claim 81, line 2 recites “a coating layer”. It is unclear whether the two recitations are the same or different.
In regards to claim 85, line 2 recites the limitation "the particles". There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 85, line 3 recites “a partially cross-linked coating layer”. Claim 85 depends upon claim 81. Claim 81, line 2 recites “a coating layer”. It is unclear whether the two recitations are the same or different.
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.
Claims 60, 64, 66, 69, 71, 73-77, 80-82, and 86 are rejected under 35 U.S.C. 103 as being unpatentable over Santucci-Aribert et al (WO 2013/167617).
In regards to claim 60, Santucci-Aribert et al teaches a method of manufacturing (Figures 1-2) a medical injection device (1) comprising a glass cylinder (2) having an inner surface coated with a coating layer (9), the cylinder being configured to receive a plunger (5) with sliding engagement, the method comprising the steps of:
providing a coating composition comprising polydimethylsiloxane having a kinematic viscosity at room temperature of from 11500 cSt to 13500 cSt (page 6, line 22)
heating the coating composition to a temperature (page 8, lines 13-14)
applying the coating composition heated to said temperature onto the inner surface of the cylinder so as to form a coating layer having an average thickness S, measured by optical reflectometry, on said inner surface (page 8, lines 11-14)( page 8, lines 28-29)
Santucci-Aribert et al does not teach providing a coating composition comprising an amount equal to or greater than 92% by weight of polydimethylsiloxane, as Santucci-Aribert et al instead teaches providing a coating composition comprising an amount in the range from 80 to 90% by weight, preferably from 85 to 90% by weight and more preferably 87% by weight of polydimethylsiloxane (page 6, lines 11-17). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify providing the coating composition, of the method of Santucci-Aribert et al, to instead comprise an amount equal to or greater than 92% by weight of polydimethylsiloxane, as Applicant has not disclosed that such a weight of polydimethylsiloxane provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with providing a coating composition comprising an amount in the range from 80 to 90% by weight, preferably from 85 to 90% by weight and more preferably 87% by weight of polydimethylsiloxane, as taught by Santucci-Aribert et al, as a person having ordinary skill in the art would have known how to select the weight of polydimethylsiloxane to ensure a good gliding movement of the plunger within the cylinder when a drug is injected to a patient.
Santucci-Aribert et al teaches heating the coating composition to a temperature (page 8, lines 13-14) but is silent about “to a temperature of from 100° C to 150° C”. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify heating the coating composition to a temperature, of the modified method of Santucci-Aribert et al, to be to a temperature of from 100° C to 150° C, as Applicant has not disclosed that such a temperature provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with simply heating the coating composition, as taught by Santucci-Aribert et al, as a person having ordinary skill in the art would have known how to select the temperature of the coating composition to allow a stronger adherence of the coating composition on the surface of the cylinder.
Santucci-Aribert et al does not teach the coating layer having the average thickness of from 100 to 250 nm, as Santucci-Aribert et al instead teaches the coating layer having the average thickness of at least 350 nm (page 8, lines 28-29). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the coating layer having the average thickness, of the modified method of Santucci-Aribert et al, to instead be from 100 to 250 nm, as Applicant has not disclosed that such an average thickness provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the coating layer having the average thickness of at least 350 nm, as taught by Santucci-Aribert et al, as a person having ordinary skill in the art would have known how to select the average thickness of the coating layer to ensure a good gliding movement of the plunger within the cylinder when a drug is injected to a patient.
Santucci-Aribert et al is silent about wherein the coating layer of the inner surface of the cylinder has a thickness standard deviation, equal to or less than 90 nm. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the coating layer of the inner surface of the cylinder, of the modified method of Santucci-Aribert et al, to have a thickness standard deviation, equal to or less than 90 nm, as Applicant has not disclosed that such a thickness standard deviation provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the coating layer simply having the average thickness of at least 350 nm, as taught by Santucci-Aribert et al, as a person having ordinary skill in the art would have known how to select the average thickness with a thickness standard deviation of the coating layer to ensure a good gliding movement of the plunger within the cylinder when a drug is injected to a patient.
In regards to claim 64, in the modified method of Santucci-Aribert et al, Santucci-Aribert et al teaches a step e) of feeding the heated coating composition to a dispensing head provided with at least one dispensing nozzle (Each composition… is then deposited… with a siliconization bench… The siliconization bench consists, in this case, in a mobile nozzle, working at an atomization and jar pressure of about 2 bars, but any other kind of deposition methods can be used).
In regards to claim 66, in the modified method of Santucci-Aribert et al, Santucci-Aribert et al teaches wherein said step c) of applying the heated coating composition onto the inner surface of the cylinder is carried out by dispensing the coating composition via the dispensing head (Each composition… is then deposited… with a siliconization bench… The siliconization bench consists, in this case, in a mobile nozzle, working at an atomization and jar pressure of about 2 bars, but any other kind of deposition methods can be used).
In regards to claim 69, in the modified method of Santucci-Aribert et al, Santucci-Aribert et al teaches wherein said step c) of applying the heated coating composition onto the inner surface of the cylinder is carried out by dispensing the heated coating composition from the dispensing head at a pressure of from 5 psi (0.34 bar) to 150 psi (10.34 bar) (Each composition… is then deposited… with a siliconization bench… The siliconization bench consists, in this case, in a mobile nozzle, working at an atomization and jar pressure of about 2 bars, but any other kind of deposition methods can be used).
In regards to claim 71, in the modified method of Santucci-Aribert et al, Santucci-Aribert et al teaches wherein said step c) of applying the heated coating composition onto the inner surface of the cylinder comprises imparting a relative motion between the dispensing head and the cylinder while dispensing the heated coating composition (Each composition… is then deposited onto the inner wall of a 50 ml barrel… with a siliconization bench… The siliconization bench consists, in this case, in a mobile nozzle, working at an atomization and jar pressure of about 2 bars, but any other kind of deposition methods can be used).
In regards to claim 73, in the modified method of Santucci-Aribert et al, Santucci-Aribert et al is silent about the dispensing time of the heated coating composition onto the inner surface of the cylinder is of from 0.3 s to 1 s. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the dispensing time of the heated coating composition onto the inner surface of the cylinder, of the modified method of Santucci-Aribert et al, to be of from 0.3 s to 1 s, as Applicant has not disclosed that such a dispensing time provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the heated coating composition simply being dispensed onto the inner surface of the cylinder, as taught by Santucci-Aribert et al, as a person having ordinary skill in the art would have known how to select the dispensing time of the coating composition in order for the resultant coating layer to ensure a good gliding movement of the plunger within the cylinder when a drug is injected to a patient.
In regards to claim 74, in the modified method of Santucci-Aribert et al, Santucci-Aribert et al is silent about wherein said step c) of applying the heated coating composition onto the inner surface of the cylinder comprises dispensing the heated coating composition at a flow rate of from 0.1 μL/s to 5 μL/s. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify dispensing the heated coating composition, of the modified method of Santucci-Aribert et al, to be at a flow rate of from 0.1 μL/s to 5 μL/s, as Applicant has not disclosed that such a flow rate provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the heated coating composition simply being dispensed onto the inner surface of the cylinder, as taught by Santucci-Aribert et al, as a person having ordinary skill in the art would have known how to select the flow rate of the coating composition in order for the resultant coating layer to ensure a good gliding movement of the plunger within the cylinder when a drug is injected to a patient.
In regards to claim 75, in the modified method of Santucci-Aribert et al, Santucci-Aribert et al is silent about wherein said step c) of applying the heated coating composition onto the inner surface of the cylinder comprises applying to the inner surface of the cylinder an amount per unit area of heated coating composition of from 0.2 to 0.4 μg/mm2. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify applying to the inner surface of the cylinder, of the modified method of Santucci-Aribert et al, to be an amount per unit area of heated coating composition of from 0.2 to 0.4 μg/mm2, as Applicant has not disclosed that such an amount per unit area provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the heated coating composition simply being dispensed onto the inner surface of the cylinder, as taught by Santucci-Aribert et al, as a person having ordinary skill in the art would have known how to select the amount per unit area of the coating composition in order for the resultant coating layer to ensure a good gliding movement of the plunger within the cylinder when a drug is injected to a patient.
In regards to claim 76, in the modified method of Santucci-Aribert et al, Santucci-Aribert et al teaches after step c) of applying the heated coating composition onto the inner surface of the cylinder, a step f) of subjecting the coating layer formed on the inner surface of the cylinder to a partial cross-linking treatment of the polydimethylsiloxane (carrying out an irradiation of the coated barrel… so as to cross-link the lubricant composition to form a lubricant coating).
In regards to claim 77, in the modified method of Santucci-Aribert et al, Santucci-Aribert et al teaches wherein said partial cross-linking treatment is carried out by irradiation (carrying out an irradiation of the coated barrel… so as to cross-link the lubricant composition to form a lubricant coating).
In regards to claim 80, in the modified method of Santucci-Aribert et al, Santucci-Aribert et al is silent about wherein said irradiation treatment is carried out for a time of from 0.2 s to 1 s, extremes included. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify said irradiation treatment, of the modified method of Santucci-Aribert et al, to be carried out for a time of from 0.2 s to 1 s, extremes included, as Applicant has not disclosed that such a time provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the partial cross-linking simply to be carried out by irradiation, as taught by Santucci-Aribert et al, as a person having ordinary skill in the art would have known how to select the time of the irradiation treatment in order for the resultant coating layer to ensure a good gliding movement of the plunger within the cylinder when a drug is injected to a patient.
In regards to claim 81, Santucci-Aribert et al teaches a medical injection device (Figures 1-2) comprising a glass cylinder (2) having an inner surface coated with a coating layer (9), the cylinder being configured to receive a plunger (5) with sliding engagement,
wherein said coating layer of the inner surface of the cylinder is substantially made of polydimethylsiloxane having a kinematic viscosity at room temperature of from 11500 cSt to 13500 cSt (page 6, line 22)
Santucci-Aribert et al does not teach wherein said coating layer has an average thickness of from 100 to 250 nm, as Santucci-Aribert et al instead teaches wherein said coating layer has an average thickness of at least 350 nm (page 8, lines 28-29). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the coating layer, of the device of Santucci-Aribert et al, to instead have an average thickness of from 100 to 250 nm, as Applicant has not disclosed that such an average thickness provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the coating layer having the average thickness of at least 350 nm, as taught by Santucci-Aribert et al, as a person having ordinary skill in the art would have known how to select the average thickness of the coating layer to ensure a good gliding movement of the plunger within the cylinder when a drug is injected to a patient.
Santucci-Aribert et al is silent about wherein the coating layer of the inner surface of the cylinder has a thickness standard deviation, equal to or less than 90 nm. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the coating layer of the inner surface of the cylinder, of the modified device of Santucci-Aribert et al, to have a thickness standard deviation, equal to or less than 90 nm, as Applicant has not disclosed that such a thickness standard deviation provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the coating layer simply having the average thickness of at least 350 nm, as taught by Santucci-Aribert et al, as a person having ordinary skill in the art would have known how to select the average thickness with a thickness standard deviation of the coating layer to ensure a good gliding movement of the plunger within the cylinder when a drug is injected to a patient.
In regards to claim 82, in the modified device of Santucci-Aribert et al, Santucci-Aribert et al teaches wherein said coating layer of the inner surface of the cylinder is partially cross-linked (cross-link the lubricant composition to form a lubricant coating).
In regards to claim 86, Santucci-Aribert et al teaches a kit of parts for assembling a medical injection device (Figures 1-2) comprising the following separate components in a sterile package (sterilization):
a glass cylinder (2) having an inner surface coated with a coating layer (9), the cylinder being configured to receive a plunger (5) with sliding engagement
a plunger (5) configured for a sliding engagement in said cylinder
wherein said coating layer of the inner surface of the cylinder is substantially made of polydimethylsiloxane having a kinematic viscosity at room temperature of from 11500 cSt to 13500 cSt (page 6, line 22)
Santucci-Aribert et al does not teach wherein said coating layer has an average thickness of from 100 to 250 nm, as Santucci-Aribert et al instead teaches wherein said coating layer has an average thickness of at least 350 nm (page 8, lines 28-29). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the coating layer, of the kit of Santucci-Aribert et al, to instead have an average thickness of from 100 to 250 nm, as Applicant has not disclosed that such an average thickness provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the coating layer having the average thickness of at least 350 nm, as taught by Santucci-Aribert et al, as a person having ordinary skill in the art would have known how to select the average thickness of the coating layer to ensure a good gliding movement of the plunger within the cylinder when a drug is injected to a patient.
Santucci-Aribert et al is silent about wherein the coating layer of the inner surface of the cylinder has a thickness standard deviation, equal to or less than 90 nm. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the coating layer of the inner surface of the cylinder, of the modified kit of Santucci-Aribert et al, to have a thickness standard deviation, equal to or less than 90 nm, as Applicant has not disclosed that such a thickness standard deviation provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the coating layer simply having the average thickness of at least 350 nm, as taught by Santucci-Aribert et al, as a person having ordinary skill in the art would have known how to select the average thickness with a thickness standard deviation of the coating layer to ensure a good gliding movement of the plunger within the cylinder when a drug is injected to a patient.
Claims 61-62 are rejected under 35 U.S.C. 103 as being unpatentable over Santucci-Aribert et al, as applied to claim 60 above, and further in view of JP 2003-511127.
In regards to claim 61, in the modified method of Santucci-Aribert et al, Santucci-Aribert et al is silent about wherein said step a) of providing the coating composition comprises storing said coating composition in a storage tank. JP 2003-511127 teaches a method comprising storing a coating composition in a storage tank (30) (storage chamber 30 is contained product). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method, of Santucci-Aribert et al, with storing said coating composition in a storage tank, as taught by JP 2003-511127, as such will provide a sealed and completely sealed storage of the coating composition that allows the coating composition to be dispensed and spread (The liquid storage chamber 30 may be of any size, shape, and structure that allows the product to be dispensed and spread… the storage chamber 30 stores a sealed and completely sealed storage).
In regards to claim 62, in the modified method of Santucci-Aribert et al and JP 2003-511127, Santucci-Aribert et al is silent about wherein said step b) of heating the coating composition comprises heating said storage tank so as to bring the coating composition to said temperature of from 100° C to 150° C. JP 2003-511127 teaches heating said storage tank so as to bring the coating composition to a temperature (To heat or cool the product in the storage chamber 30, a heating / cooling element such as a heating / cooling pouch 302 is in close contact with the storage chamber 30 for efficient heat transfer as shown in FIG.)(Figure 59). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method, of Santucci-Aribert et al and JP 2003-511127, with heating said storage tank so as to bring the coating composition to said temperature, as taught by JP 2003-511127, as such will provide a means for efficient heat transfer to the coating composition (To heat or cool the product in the storage chamber 30, a heating / cooling element such as a heating / cooling pouch 302 is in close contact with the storage chamber 30 for efficient heat transfer as shown in FIG.) which is made fluid so that it can be supplied and/or diffused from the storage tank (the product is made fluid by heating so that it can be supplied and / or diffused from the storage chamber 30).
JP 2003-511127 is silent about heating said storage tank so as to bring the coating composition “to said temperature of from 100° C to 150° C”. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify heating said storage tank, of the modified method of Santucci-Aribert et al and JP 2003-511127, to bring the coating composition to said temperature of from 100° C to 150° C, as Applicant has not disclosed that such a temperature provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with simply heating said storage tank to heat the coating composition, as taught by JP 2003-511127, as a person having ordinary skill in the art would have known how to select the temperature of the storage tank to heat the coating composition to allow a stronger adherence of the coating composition on the surface of the cylinder.
Claim 63 is rejected under 35 U.S.C. 103 as being unpatentable over Santucci-Aribert et al and JP 2003-511127, as applied to claim 61 above, and further in view of Weikart et al (US 10,201,660).
In regards to claim 63, in the modified method of Santucci-Aribert et al and JP 2003-511127, Santucci-Aribert et al is silent about further comprising a step d) of maintaining the heated coating composition stored in the storage tank at a pressure of from 5 psi (0.34 bar) to 150 psi (10.34 bar). Weikart et al teaches a method, comprising maintaining a heated coating composition stored in a storage tank (144) at a pressure of from 5 psi to 150 psi (column 12, line 3). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method, of Santucci-Aribert et al and JP 2003-511127, with maintaining the heated coating composition stored in the storage tank at a pressure of 760 Torr, as taught by Weikart et al, which is in the claimed range of from 5 psi (0.34 bar) to 150 psi (10.34 bar), as such will provide the coating composition at a standard pressure for feeding the coating composition to the cylinder (column 11, lines 54-67, to column 12, lines 1-3)(column 5, line 8).
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Santucci-Aribert et al, as applied to claim 64 above, and further in view of Funderburk (US 5,456,940).
In regards to claim 65, in the modified method of Santucci-Aribert et al, Santucci-Aribert et al is silent about wherein said step e) of feeding the heated coating composition to the dispensing head is carried out by means of a circulation pump arranged upstream of the dispensing head. Funderburk teaches a method, wherein feeding a coating composition to a dispensing head (24) is carried out by means of a circulation pump (column 3, line 19: spray atomizer 20 includes a pump) arranged upstream of the dispensing head (Figure 2). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify feeding the heated coating composition to the dispensing head, of the modified method of Santucci-Aribert et al, to be carried out by means of a circulation pump arranged upstream of the dispensing head, as taught by Funderburk, as such will spray the coating composition into the cylinder, in counterflow relation to an air flow stream, which results in turbulent atomization of the sprayed coating composition to coat the internal surfaces of the cylinder with a finely atomized or misted coating which is substantially uniformly dispersed (column 3, lines 6-12).
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Santucci-Aribert et al and Funderburk, as applied to claim 65 above, and further in view of Deshpande et al (US 6,939,576).
In regards to claim 67, in the modified method of Santucci-Aribert et al and Funderburk, Santucci-Aribert et al is silent about wherein said step b) of heating the coating composition comprises heating said dispensing head and/or said pump so as to bring or maintain the coating composition to/at said temperature of from 100° C to 150° C. Deshpande et al teaches a method, comprising heating a dispensing head (20) so as to bring or maintain a coating composition to/at a temperature (column 8, lines 45-49). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify heating the coating composition, of the modified method of Santucci-Aribert et al and Funderburk, to comprise heating said dispensing head so as to bring or maintain the coating composition to/at said temperature, as taught by Deshpande et al, as such will superheat the coating composition, and the superheated coating composition tends to rapidly expand upon leaving the dispensing head, thereby producing very tiny droplets, which will contribute to forming very smooth, uniform coating layers (column 8, lines 45-49)(column 4, lines 40-42).
Deshpande et al is silent about heating said dispensing head so as to bring or maintain the coating composition “to/at said temperature of from 100° C to 150° C”. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify heating said dispensing head, of the modified method of Santucci-Aribert et al, Funderburk, and Deshpande et al, to bring or maintain the coating composition to/at said temperature of from 100° C to 150° C, as Applicant has not disclosed that such a temperature provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with simply heating said dispensing head to heat the coating composition, as taught by Deshpande et al, as a person having ordinary skill in the art would have known how to select the temperature of the dispensing head to heat the coating composition to allow a stronger adherence of the coating composition on the surface of the cylinder.
Claim 68 is rejected under 35 U.S.C. 103 as being unpatentable over Santucci-Aribert et al and JP 2003-511127, as applied to claim 61 above, and further in view of Funderburk and Weikart et al.
In regards to claim 68, in the modified method of Santucci-Aribert et al and JP 2003-511127, Santucci-Aribert et al is silent about wherein said storage tank, said pump and said dispensing head are in fluid communication by means of pipes and wherein said step b) of heating the coating composition comprises heating said pipes so as to bring or maintain the coating composition to/at said temperature of from 100° C to 150° C. Funderburk teaches a method, wherein a storage tank (lubricant 18 from a suitable supply or reservoir), a pump (spray atomizer 20 includes a pump) and a dispensing head (24) are in fluid communication by means of pipes (Figure 2). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method, of Santucci-Aribert et al and JP 2003-511127, with said storage tank, said pump and said dispensing head are in fluid communication by means of pipes, as taught by Funderburk et al, as such will provide an improved system designed to coat internal surfaces of the cylinder with a substantially uniform and thin layer coating of the coating composition (column 3, lines 1-6).
Weikart et al teaches a method, comprising heating pipes so as to bring or maintain a coating composition to/at a temperature (column 37, lines 14-20). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify heating the coating composition, of the modified method of Santucci-Aribert et al, JP 2003-511127, and Funderburk et al, to comprise heating pipes so as to bring or maintain a coating composition to/at a temperature, as taught by Weikart et al, as such will cause the coating composition to evaporate, forming a coating composition vapor effective to form the coating layer (column 4, lines 28-30).
Weikart et al et al is silent about heating said pipes so as to bring or maintain the coating composition “to/at said temperature of from 100° C to 150° C”. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify heating said pipes, of the modified method of Santucci-Aribert et al, JP 2003-511127, Funderburk et al, and Weikart et al, to bring or maintain the coating composition to/at said temperature of from 100° C to 150° C, as Applicant has not disclosed that such a temperature provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with simply heating said pipes to heat the coating composition, as taught by Weikart et al, as a person having ordinary skill in the art would have known how to select the temperature of the pipes to heat the coating composition to allow a stronger adherence of the coating composition on the surface of the cylinder.
Claim 70 is rejected under 35 U.S.C. 103 as being unpatentable over Santucci-Aribert et al, as applied to claim 64 above, and further in view of Weikart et al.
In regards to claim 70, in the modified method of Santucci-Aribert et al, Santucci-Aribert et al is silent about wherein said step c) of applying the heated coating composition onto the inner surface of the cylinder comprises feeding to the dispensing head a dispensing gas having a pressure of from 5 psi (0.34 bar) to 150 psi (10.34 bar). Weikart et al teaches a method, comprising feeding to a dispensing head (110) a dispensing gas having a pressure of from 5 psi to 150 psi (column 11, lines 54-67, to column 12, lines 1-3). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify applying the heated coating composition onto the inner surface of the cylinder, of the modified method of Santucci-Aribert et al, to comprise feeding to the dispensing head a dispensing gas having a pressure of 760 Torr, as taught by Weikart et al, which is in the claimed range of from 5 psi (0.34 bar) to 150 psi (10.34 bar), as such will provide the coating composition at a standard pressure for feeding the coating composition to the cylinder (column 11, lines 54-67, to column 12, lines 1-3)(column 5, line 8).
Claim 72 is rejected under 35 U.S.C. 103 as being unpatentable over Santucci-Aribert et al, as applied to claim 71 above, and further in view of Heinz et al (US 6,586,039).
In regards to claim 72, in the modified method of Santucci-Aribert et al, Santucci-Aribert et al is silent about wherein the step c) of applying the heated coating composition onto the inner surface of the cylinder comprises dispensing the heated coating composition onto the inner surface of the cylinder during a relative insertion movement of the dispensing head into the cylinder. Heinz et al teaches a method, comprising dispensing a coating composition (3) onto an inner surface of a cylinder (1) during a relative insertion movement of a dispensing head (2) into the cylinder (Figure 1). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method, of Santucci-Aribert et al, with dispensing the coating composition onto the inner surface of the cylinder during a relative insertion movement of the dispensing head into the cylinder, as taught by Heinz et al, as such will provide an improved process for providing the coating composition onto the inner surface of the cylinder (column 2, lines 10-22).
Claims 78-79 are rejected under 35 U.S.C. 103 as being unpatentable over Santucci-Aribert et al, as applied to claim 77 above, and further in view of JP 2007-527317.
In regards to claim 78, in the modified method of Santucci-Aribert et al, Santucci-Aribert et al does not teach wherein said irradiation treatment is a plasma irradiation treatment, as Santucci-Aribert et al instead teaches wherein said irradiation treatment is Gamma-rays irradiation, UV or X-Ray irradiation, or plasma polymerization. JP 2007-527317 teaches a method, wherein an irradiation treatment is a plasma irradiation treatment (ionized gas plasma irradiation). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify said irradiation treatment, of the modified method of Santucci-Aribert et al, to be a plasma irradiation treatment, as taught by JP 2007-527317, as such will minimize the seepage movement of the coating composition present on the inner surface (can minimize the seepage movement of the lubricant present on the surface).
In regards to claim 79, in the modified method of Santucci-Aribert et al and JP 2007-527317, Santucci-Aribert et al does not teach wherein said irradiation treatment is an irradiation treatment by means of plasma torch at atmospheric pressure with argon flow, as Santucci-Aribert et al instead teaches wherein said irradiation treatment is Gamma-rays irradiation, UV or X-Ray irradiation, or plasma polymerization. JP 2007-527317 teaches a method, wherein an irradiation treatment is an irradiation treatment by means of plasma torch at atmospheric pressure with argon flow (argon ion plasma treatment in the syringe was performed under atmospheric pressure). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify said irradiation treatment, of the modified method of Santucci-Aribert et al, to be an irradiation treatment by means of plasma torch at atmospheric pressure with argon flow, as taught by JP 2007-527317, as such will minimize the seepage movement of the coating composition present on the inner surface (can minimize the seepage movement of the lubricant present on the surface).
Claims 83-85 are rejected under 35 U.S.C. 103 as being unpatentable over Santucci-Aribert et al, as applied to claim 81 above, and further in view of Foucher et al (US 9,993,597).
In regards to claim 83, in the modified device of Santucci-Aribert et al, Santucci-Aribert et al teaches the particles released in a test solution from the coating layer of the inner surface of the cylinder (the concentrations and the quantities of an acrylate byproduct determined by UPLC-DAD coupled with a MS/MS for the different coatings F1 , F2 and F3. The quantification of this by-product is important to evaluate as it could migrate in the pharmaceutical solution); however, Santucci-Aribert et al is silent about wherein the average value of the normalised concentration of the particles, released in a test solution from the coating layer of the inner surface of the cylinder, and having an average diameter equal to or greater than 10 μm or equal to or greater than 25 μm, determined by means of the LO (Light Obscuration) method according to US standard USP 787 as described in US Pharmacopeia 44-NF39 (2021), after a 3-month storage at a temperature of −40° C., is equal to or less than 60% of the limit value according to said standard. Foucher et al teaches a medical injection device (Figure 1) wherein the average value of the normalised concentration of the particles (A), released in a test solution from a coating layer (5) of an inner surface of a cylinder (2), determined by means of the LO method (column 14, lines 7-25). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device, of Santucci-Aribert et al, with wherein the average value of the normalised concentration of the particles, released in a test solution from the coating layer of the inner surface of the cylinder, determined by means of the LO method, as taught by Foucher et al, as such is routinely used to detect and measure subvisible particles present in parenteral solutions i.e. solutions to be injected in a living body and being easy to use, automated and fast (column 14, lines 11-25).
Foucher et al does not teach the particles having an average diameter equal to or greater than 10 μm or equal to or greater than 25 μm, as Foucher et al instead teaches the particles having an average diameter between 2 and 400 μm (column 14, lines 19-27). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the particles, of the modified device of Santucci-Aribert et al and Foucher et al, to instead have an average diameter equal to or greater than 10 μm or equal to or greater than 25 μm, as Applicant has not disclosed that such an average diameter provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the particles having an average diameter between 2 and 400 μm, as taught by Foucher et al, as a person having ordinary skill in the art would have known how to select the coating layer that exhibits a good compatibility with sensitive drugs stored inside a coated medical injection device for long time period in order to meet the pharmacopeia norms with regard to the level of particles in the drug, while still providing good performance with regard to the gliding of the plunger within the container of the medical injection device, and keeping its integrity over time.
Foucher et al does not teach the LO method according to US standard USP 787 as described in US Pharmacopeia 44-NF39 (2021), as Foucher et al instead teaches the LO method according to United States Pharmacopeia (USP 31 <788>) and the European Pharmacopeia (EP 6 <2.9.19>) (column 3, lines 6-9). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the LO method, of the modified device of Santucci-Aribert et al and Foucher et al, to instead be according to US standard USP 787 as described in US Pharmacopeia 44-NF39 (2021), as Applicant has not disclosed that such an LO method provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the LO method according to United States Pharmacopeia (USP 31 <788>) and the European Pharmacopeia (EP 6 <2.9.19>), as taught by Foucher et al, as a person having ordinary skill in the art would have expected either LO method to detect and measure subvisible particles present in parenteral solutions i.e. solutions to be injected in a living body.
Foucher et al is silent about a 3-month storage at a temperature of −40° C. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the modified device, of Santucci-Aribert et al and Foucher et al, to be at a 3-month storage at a temperature of −40° C, as Applicant has not disclosed that such a storage and temperature provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the particle diameter simply being determined by the LO method according to United States Pharmacopeia (USP 31 <788>) and the European Pharmacopeia (EP 6 <2.9.19>), as taught by Foucher et al, as a person having ordinary skill in the art would have known how to select the storage and temperature of the device using the LO method to detect and measure subvisible particles present in parenteral solutions i.e. solutions to be injected in a living body.
Foucher et al is silent about wherein the average value of the normalised concentration of the particles is equal to or less than 60% of the limit value according to said standard. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the modified device, of Santucci-Aribert et al and Foucher et al, with wherein the average value of the normalised concentration of the particles is equal to or less than 60% of the limit value according to said standard, as Applicant has not disclosed that such an average value of the normalised concentration of the particles provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the level of particles to be carefully controlled, as taught by Foucher et al (column 2, lines 66-67), as a person having ordinary skill in the art would have known how to carefully control the level of particles released into the device that is not hazardous for patients.
In regards to claim 84, in the modified device of Santucci-Aribert et al, Santucci-Aribert et al teaches the particles released in a test solution from a partially cross-linked coating layer of the inner surface of the cylinder (the concentrations and the quantities of an acrylate byproduct determined by UPLC-DAD coupled with a MS/MS for the different coatings F1 , F2 and F3. The quantification of this by-product is important to evaluate as it could migrate in the pharmaceutical solution)(cross-link the lubricant composition to form a lubricant coating); however, Santucci-Aribert et al is silent about wherein the average value of the normalised concentration of the particles, released in a test solution from a partially cross-linked coating layer of the inner surface of the cylinder, and having an average diameter equal to or greater than 10 μm or equal to or greater than 25 μm, determined by means of the LO (Light Obscuration) method according to US standard USP 787 as described in US Pharmacopeia 44-NF39 (2021), after a 3-month storage at a temperature of −40° C., is equal to or less than 10% of the limit value according to said standard. Foucher et al teaches a medical injection device (Figure 1) wherein the average value of the normalised concentration of the particles (A), released in a test solution from a partially cross-linked coating layer (5) of an inner surface of a cylinder (2), determined by means of the LO method (column 14, lines 7-25). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device, of Santucci-Aribert et al, with wherein the average value of the normalised concentration of the particles, released in a test solution from the partially cross-linked coating layer of the inner surface of the cylinder, determined by means of the LO method, as taught by Foucher et al, as such is routinely used to detect and measure subvisible particles present in parenteral solutions i.e. solutions to be injected in a living body and being easy to use, automated and fast (column 14, lines 11-25).
Foucher et al does not teach the particles having an average diameter equal to or greater than 10 μm or equal to or greater than 25 μm, as Foucher et al instead teaches the particles having an average diameter between 2 and 400 μm (column 14, lines 19-27). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the particles, of the modified device of Santucci-Aribert et al and Foucher et al, to instead have an average diameter equal to or greater than 10 μm or equal to or greater than 25 μm, as Applicant has not disclosed that such an average diameter provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the particles having an average diameter between 2 and 400 μm, as taught by Foucher et al, as a person having ordinary skill in the art would have known how to select the coating layer that exhibits a good compatibility with sensitive drugs stored inside a coated medical injection device for long time period in order to meet the pharmacopeia norms with regard to the level of particles in the drug, while still providing good performance with regard to the gliding of the plunger within the container of the medical injection device, and keeping its integrity over time.
Foucher et al does not teach the LO method according to US standard USP 787 as described in US Pharmacopeia 44-NF39 (2021), as Foucher et al instead teaches the LO method according to United States Pharmacopeia (USP 31 <788>) and the European Pharmacopeia (EP 6 <2.9.19>) (column 3, lines 6-9). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the LO method, of the modified device of Santucci-Aribert et al and Foucher et al, to instead be according to US standard USP 787 as described in US Pharmacopeia 44-NF39 (2021), as Applicant has not disclosed that such an LO method provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the LO method according to United States Pharmacopeia (USP 31 <788>) and the European Pharmacopeia (EP 6 <2.9.19>), as taught by Foucher et al, as a person having ordinary skill in the art would have expected either LO method to detect and measure subvisible particles present in parenteral solutions i.e. solutions to be injected in a living body.
Foucher et al is silent about a 3-month storage at a temperature of −40° C. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the modified device, of Santucci-Aribert et al and Foucher et al, to be at a 3-month storage at a temperature of −40° C, as Applicant has not disclosed that such a storage and temperature provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the particle diameter simply being determined by the LO method according to United States Pharmacopeia (USP 31 <788>) and the European Pharmacopeia (EP 6 <2.9.19>), as taught by Foucher et al, as a person having ordinary skill in the art would have known how to select the storage and temperature of the device using the LO method to detect and measure subvisible particles present in parenteral solutions i.e. solutions to be injected in a living body.
Foucher et al is silent about wherein the average value of the normalised concentration of the particles is equal to or less than 10% of the limit value according to said standard. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the modified device, of Santucci-Aribert et al and Foucher et al, with wherein the average value of the normalised concentration of the particles is equal to or less than 10% of the limit value according to said standard, as Applicant has not disclosed that such an average value of the normalised concentration of the particles provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the level of particles to be carefully controlled, as taught by Foucher et al (column 2, lines 66-67), as a person having ordinary skill in the art would have known how to carefully control the level of particles released into the device that is not hazardous for patients.
In regards to claim 85, in the modified device of Santucci-Aribert et al, Santucci-Aribert et al teaches the particles released in a test solution from a partially cross-linked coating layer of the inner surface of the cylinder (the concentrations and the quantities of an acrylate byproduct determined by UPLC-DAD coupled with a MS/MS for the different coatings F1 , F2 and F3. The quantification of this by-product is important to evaluate as it could migrate in the pharmaceutical solution)(cross-link the lubricant composition to form a lubricant coating); however, Santucci-Aribert et al is silent about wherein the average value of the normalised concentration of the particles, released in a test solution from a partially cross-linked coating layer of the inner surface of the cylinder, and having an average diameter equal to or greater than 10 μm or equal to or greater than 25 μm, determined by means of the LO (Light Obscuration) method according to US standard USP 789 as described in US Pharmacopeia 44-NF39 (2021), after a 3-month storage at a temperature of +5° C. or +25° C. or +40° C, is equal to or less than the limit value according to said standard. Foucher et al teaches a medical injection device (Figure 1) wherein the average value of the normalised concentration of the particles (A), released in a test solution from a partially cross-linked coating layer (5) of an inner surface of a cylinder (2), determined by means of the LO method (column 14, lines 7-25). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device, of Santucci-Aribert et al, with wherein the average value of the normalised concentration of the particles, released in a test solution from the partially cross-linked coating layer of the inner surface of the cylinder, determined by means of the LO method, as taught by Foucher et al, as such is routinely used to detect and measure subvisible particles present in parenteral solutions i.e. solutions to be injected in a living body and being easy to use, automated and fast (column 14, lines 11-25).
Foucher et al does not teach the particles having an average diameter equal to or greater than 10 μm or equal to or greater than 25 μm, as Foucher et al instead teaches the particles having an average diameter between 2 and 400 μm (column 14, lines 19-27). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the particles, of the modified device of Santucci-Aribert et al and Foucher et al, to instead have an average diameter equal to or greater than 10 μm or equal to or greater than 25 μm, as Applicant has not disclosed that such an average diameter provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the particles having an average diameter between 2 and 400 μm, as taught by Foucher et al, as a person having ordinary skill in the art would have known how to select the coating layer that exhibits a good compatibility with sensitive drugs stored inside a coated medical injection device for long time period in order to meet the pharmacopeia norms with regard to the level of particles in the drug, while still providing good performance with regard to the gliding of the plunger within the container of the medical injection device, and keeping its integrity over time.
Foucher et al does not teach the LO method according to US standard USP 789 as described in US Pharmacopeia 44-NF39 (2021), as Foucher et al instead teaches the LO method according to United States Pharmacopeia (USP 31 <788>) and the European Pharmacopeia (EP 6 <2.9.19>) (column 3, lines 6-9). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the LO method, of the modified device of Santucci-Aribert et al and Foucher et al, to instead be according to US standard USP 789 as described in US Pharmacopeia 44-NF39 (2021), as Applicant has not disclosed that such an LO method provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the LO method according to United States Pharmacopeia (USP 31 <788>) and the European Pharmacopeia (EP 6 <2.9.19>), as taught by Foucher et al, as a person having ordinary skill in the art would have expected either LO method to detect and measure subvisible particles present in parenteral solutions i.e. solutions to be injected in a living body.
Foucher et al is silent about a 3-month storage at a temperature of +5° C. or +25° C. or +40° C. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the modified device, of Santucci-Aribert et al and Foucher et al, to be at a 3-month storage at a temperature of +5° C. or +25° C. or +40° C, as Applicant has not disclosed that such a storage and temperature provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the particle diameter simply being determined by the LO method according to United States Pharmacopeia (USP 31 <788>) and the European Pharmacopeia (EP 6 <2.9.19>), as taught by Foucher et al, as a person having ordinary skill in the art would have known how to select the storage and temperature of the device using the LO method to detect and measure subvisible particles present in parenteral solutions i.e. solutions to be injected in a living body.
Foucher et al is silent about wherein the average value of the normalised concentration of the particles is equal to or less than the limit value according to said standard. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the modified device, of Santucci-Aribert et al and Foucher et al, with wherein the average value of the normalised concentration of the particles is equal to or less than the limit value according to said standard, as Applicant has not disclosed that such an average value of the normalised concentration of the particles provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the level of particles to be carefully controlled, as taught by Foucher et al (column 2, lines 66-67), as a person having ordinary skill in the art would have known how to carefully control the level of particles released into the device that is not hazardous for patients.
Conclusion
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