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 Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
Claim(s) 1-9, 11 and 18-19 is/are rejected under 35 U.S.C. 102(a1) as being anticipated by either Bicker et al. (US 2010/0075077) or Walther et al. (US 6,599,594).
Bicker, examples, para [0011], [0014], [0024], [0025], [0050]-[0060], claims
18,23,41, discloses a pharmaceutical glass container (examples: vial made of
borosilicate glass: Schott Fiolax) that has been coated in the inner surface with
a silicon-containing layer, by a plasma impulse CVD method, using short pulses
(such as less than 50 μs), and high temperature (such as 200°C or more), and HMDSO as the precursor and a water contact angle of at least 105, wherein the container is a syringe, a cartridge, an ampoule or a glass vial, wherein the coating comprises the elemental species Si, C, O and H, wherein the coating comprises at least one layer having a carbon content of at least 55%.
Walther, example 2, claims, discloses a coated glass container for storing and
preserving pharmaceutical or diagnostic solutions, provided with a 30 nm
coating which has been applied by the PICVD method using a HMDSO
precursor and a water contact angle of at least 105, wherein the container is a syringe, a cartridge, an ampoule or a glass vial, wherein the coating comprises the elemental species Si, C, O and H, wherein the coating comprises at least one layer having a carbon content of at least 55%.
Neither reference discloses the properties of wherein on the coated inner surface the container, based on negative mode Time-of-Flight-Secondary Ion Mass Spectrometry (ToF-SIMS) data, has a relative lipid nanoparticle (LNP)-incubated Multivariate Curve Resolution (MCR) score ratio of lipid factor1 of less than 0.67 or a lipid nanoparticle (LNP)-incubated haze value of less than 50% measured according to the ASTM D 1003-13 standard using illuminant D65 and 2° observer, wherein the LNP-incubation includes freezing to -80 °C, and incubating for 4 weeks at -80 °C. However, said properties are inherent in Bicker and Walther since both references disclose the coating is made via PICVD with HDMSO as the precursor (see above) which is the same method used by applicant (see instant application, [00155-00159]). Something which is old does not become patentable upon the discovery of a new property (MPEP 2112). This same reasoning also applies to the properties recited in claims 2-7.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 10 and 12-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over either Bicker et al. (US 2010/0075077) or Walther et al. (US 6,599,594) in view of Grimm et al. (US 2019/0382303).
Neither Bicker nor Walther discloses applicant’s glass container compositions recited in claims 12-17.
Grimm discloses applicant’s glass container compositions recited in claims 12-17 (paragraphs [0001], [0064-0076] and Tables 1-2) for the purpose of providing improved chemical resistance.
Therefore it would have been obvious to one of ordinary skill in the art at the time applicant’s invention was made to have provided applicant’s glass container compositions recited in claims 12-17 in either Bicker or Walther in order to provide improved chemical resistance as taught or suggested by Grimm.
Neither Bicker nor Walther disclose a wall thickness between 0.50 and 10.0 mm; or a volume capacity of the container of 0.1 ml to 1000 ml. However, a change in size or shape is obvious and well within the level of one of ordinary skill in the art (MPEP 2144.04(IV)). It would have been obvious to one of ordinary skill in the art at the time applicant’s invention was made to have provided applicant’s recited wall thickness and/or volume in order to provide improved strength and/or lower costs via the use of less materials and/or improved carrying capacity.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over either Bicker et al. (US 2010/0075077) or Walther et al. (US 6,599,594) in view of WO2017/075531 (provided herein).
Bicker, examples, para [0011], [0014], [0024], [0025], [0050]-[0060], claims 18,23,41, discloses a pharmaceutical glass container (examples: vial made of
borosilicate glass: Schott Fiolax) that has been coated in the inner surface with
a silicon-containing layer, by a plasma impulse CVD method, using short pulses
(such as less than 50 μs), and high temperature (such as 200°C or more), and HMDSO as the precursor and a water contact angle of at least 105, wherein the container is a syringe, a cartridge, an ampoule or a glass vial, wherein the coating comprises the elemental species Si, C, O and H, wherein the coating comprises at least one layer having a carbon content of at least 55%.
Walther, example 2, claims, discloses a coated glass container for storing and
preserving pharmaceutical or diagnostic solutions, provided with a 30 nm
coating which has been applied by the PICVD method using a HMDSO
precursor and a water contact angle of at least 105, wherein the container is a syringe, a cartridge, an ampoule or a glass vial, wherein the coating comprises the elemental species Si, C, O and H, wherein the coating comprises at least one layer having a carbon content of at least 55%.
Neither reference discloses the properties of wherein on the coated inner surface the container, based on negative mode Time-of-Flight-Secondary Ion Mass Spectrometry (ToF-SIMS) data, has a relative lipid nanoparticle (LNP)-incubated Multivariate Curve Resolution (MCR) score ratio of lipid factor1 of less than 0.67 or a lipid nanoparticle (LNP)-incubated haze value of less than 50% measured according to the ASTM D 1003-13 standard using illuminant D65 and 2° observer, wherein the LNP-incubation includes freezing to -80 °C, and incubating for 4 weeks at -80 °C. However, said properties are necessarily present in Bicker and Walther since both references disclose the coating is made via PICVD with HDMSO as the precursor (see above) which is the same method used by applicant (see instant application, [00155-00159]). Something which is old does not become patentable upon the discovery of a new property (MPEP 2112). It would have been obvious to one of ordinary skill in the art to have provided applicant’s recited properties in order to provide a container with hydrophobic and/or a non-stick surface.
Neither modified Bicker nor Walther disclose a pharmaceutical composition comprising lipid-based carrier systems disposed in the pharmaceutical container.
WO2017/075531 discloses a pharmaceutical composition comprising lipid-based carrier systems disposed in a pharmaceutical container for the purpose of facilitating the intracellular delivery of therapeutic acids (page 1, lines 5-10 and page 39, line 15 through page 41, line 30).
Therefore it would have been obvious to one ordinary skill in the art at the time applicant’s invention was made to have provided a pharmaceutical composition comprising lipid-based carrier systems disposed in the pharmaceutical container in either Bicker or Walther in order to facilitate the intracellular delivery of therapeutic acids as taught or suggested by WO2017/075531.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL C MIGGINS whose telephone number is (571)272-1494. The examiner can normally be reached Monday-Friday, 1-9 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Aaron Austin can be reached at 571-272-8935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL C MIGGINS/Primary Examiner, Art Unit 1782
MCM
March 4, 2026