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 .
Status of Claims
This office action is responsive to the amendment filed 17 March 2026.
Claims 2 and 23-98 are canceled.
Claims 1, 4, 10, and 20-22 are amended.
Claims 1 and 3-22 are presently pending in this application.
Claim Objections
Claim 1 is objected to because of the following informalities:
“the one more pharmacological agents” – missing –or--. Interpreted as --one or more--
Appropriate correction is required.
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 1 and 3-22 are rejected under 35 U.S.C. 103 as being unpatentable over Rusch et al (Foreign Patent Publication No. WO 2017123840 A1), hereinafter Rusch, in view of Kim et al. (Foreign Patent Publication No. CA 3130457 A1), hereinafter Kim, in further view of Abrams et al. (US Patent Publication No. 20190240354 A1), hereinafter Abrams.
Regarding claim 1, Rusch discloses a pre-filled injection device (Rusch: Fig. 1, syringe 10 is pre-filled; para. 0030) comprising: a stopper (Fig. 1, stopper 100) ; a barrel (Fig. 1, barrel 15); a solid lubricant (Fig. 1, laminate layers 130) on the stopper (Fig. 1, laminate layers 130 are disposed on stopper 100), the pre-filled injection device (10) includes from about 0 picograms to about 5 micrograms of a liquid lubricant (inner surface of barrel 15 is free of silicone oil; para. 0006); and a therapeutic formulation (Fig. 1, pharmaceutical composition 135) and comprising at least about 1 mg/ml (104 mg/ml; para. 0060) of one or more active pharmacological agents (therapeutic compounds can include antibodies, proteins, RNA interference, etc.; para. 0053 and 0056), wherein the therapeutic formulation (135) includes from about 0 wt.% to about 0.1 wt.% concentration of surfactant (method prevents or reduces the formation of fatty acid particles in a formulation; para. 0007) and from about 0 to about 600 fatty acid particles of a size greater than 25 microns (the formulation of Rusch may or may not comprise fatty acid particles; para. 0007. Therefore, examiner interprets that the formulation of Rusch comprises 0 particles of fatty acid), and wherein the one or more pharmacological agents comprise RNA interference (therapeutic compounds can include antibodies, proteins, RNA interference, etc.; para. 0053 and 0056).
Rusch does not expressly disclose the therapeutic formulation having lipase activity.
Kim teaches a therapeutic formulation (Kim: formulation: para. 0041) having lipase activity (formulation can comprise lipase enzyme; para. 0041).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the therapeutic formulation of Rusch such that the therapeutic formulation has lipase activity as taught by Kim in order to hydrolyze polysorbate surfactant to form fatty acid particles (Kim: para. 0071) to control particle formation, increase turbidity, and decrease time of initial dose-dependent response (para. 0081).
Rusch In view of Kim and Abrams does not expressly disclose the one or more pharmacological agents comprise small interfering RNAs (siRNAs), small interfering DNAs (siDNAs), messenger RNAs (mRNAs), messenger RNAs (mRNAs), aptamers, and/or any combination thereof.
Abrams teaches one or more pharmacological agents (Abrams: therapeutic nucleic acid; para. 0077) comprise small interfering RNAs (siRNAs), small interfering DNAs (siDNAs), messenger RNAs (mRNAs), messenger RNAs (mRNAs), aptamers, and/or any combination thereof (mRNA; para. 0077).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the pharmacological agents of Rusch in view of Kim such that the one or more pharmacological agents comprise small interfering RNAs (siRNAs), small interfering DNAs (siDNAs), messenger RNAs (mRNAs), messenger RNAs (mRNAs), aptamers, and/or any combination thereof as taught by Abrams in order to perform mRNA-directed expression of an amount of a protein that causes a desirable effect in the subject (Abrams: para. 0077).
Regarding claim 3, Rusch in view of Kim and Abrams discloses the device above, wherein the therapeutic formulation (Rusch: 135) includes the one or more active pharmacological agents (para. 0053 and 0056) at a concentration from about 1 mg/ml to about 200 mg/ml (104 mg/ml; para. 0060).
Regarding claim 4, Rusch in view of Kim and Abrams discloses the device above, wherein the therapeutic formulation (Rusch: 135) includes from about 0 wt.% to about 0.1 wt.% concentration of surfactant and from about 0 to about 600 fatty acid particles of a size greater than 25 microns. Rusch is silent to the formulation comprising surfactant. Rusch is also silent to the formulation comprising polysorbate 20, 40, 60, and/or 80. Therefore, examiner interprets that the formulation of Rusch is free of surfactant.
Regarding claim 5, Rusch in view of Kim and Abrams discloses the device above, wherein the therapeutic formulation (Rusch: 135) includes the surfactant at a concentration from 0 wt.% to about 0.1 wt.%. Rusch is silent to the formulation comprising surfactant. Rusch is also silent to the formulation comprising polysorbate 20, 40, 60, and/or 80. Therefore, examiner interprets that the formulation of Rusch comprises surfactant at 0 wt.%.
Regarding claim 6, Rusch in view of Kim and Abrams discloses the device above.
Rusch does not expressly disclose the therapeutic formulation comprises a buffer having a pH from about 4.0 to about 9.5, from about 4.5 to about 9.0, from about 5.0 to about 8.5, from about 5.5 to about 8.0, from about 5.5 to about 7.5, from about 5.5 to about 7.0, or from about 5.5 to about 6.5.
Kim teaches a therapeutic formulation (Kim: formulation: para. 0041) comprises a buffer (buffered solution; para. 0074) having a pH from about 4.0 to about 9.5 (buffered solution has a pH of 7.5).
it would have been an obvious matter of design choice to modify the therapeutic formula of Rusch to comprise a buffer of a pH from about 4.0 to about 9.5, from about 4.5 to about 9.0, from about 5.0 to about 8.5, from about 5.5 to about 8.0, from about 5.5 to about 7.5, from about 5.5 to about 7.0, or from about 5.5 to about 6.5, as taught by Kim, since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the pH is from about 4.0 to about 9.5, from about 4.5 to about 9.0, from about 5.0 to about 8.5, from about 5.5 to about 8.0, from about 5.5 to about 7.5, from about 5.5 to about 7.0, or from about 5.5 to about 6.5, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 7, Rusch in view of Kim and Abrams discloses the device above, wherein the therapeutic formulation (Rusch: 135) comprises a sugar having a concentration from 0 wt.% to about 15 wt.%, from about 0.1 wt.% to about 15 wt.%, from about 1 wt.% to about 15 wt.%, from about 1.5 wt.% to about 10 wt.%, from about 2 wt.% to about 10 wt.%, from about 3 wt.% to about 10 wt.%, and/or from about 5 wt.% to about 10 wt.%. The formulation of Rusch may or may not comprise sugar (dextrose; para. 0060). Therefore, examiner interprets that the formulation of Rusch comprises sugar at 0 wt.%.
Regarding claim 8, Rusch in view of Kim and Abrams discloses the device above, wherein the therapeutic formulation (Rusch: 135) comprises a polyol having a concentration from 0 wt.% to about 5 wt.%, from about 0.1 wt.% to about 5 wt.%, from about 1 wt.% to about 5 wt.%, from about 1.5 wt.% to about 5 wt.%, from about 2 wt.% to about 5 wt.%, and/or from about 3 wt.% to about 5 wt.%. The formulation of Rusch may or may not comprise polyol (mannitol; para. 0060). Therefore, examiner interprets that the formulation of Rusch comprises polyol at 0 wt.%.
Regarding claim 9, Rusch in view of Kim and Abrams discloses the device above, wherein the therapeutic formulation (Rusch: 135) comprises an arginine salt having a concentration from 0 wt.% to about 5 wt.%, from about 0.1 wt.% to about 5 wt.%, from about 1 wt.% to about 5 wt.%, from about 1.5 wt.% to about 5 wt.%, from about 2 wt.% to about 5 wt.%, and/or from about 3 wt.% to about 5 wt.%. The formulation of Rusch may or may not comprise arginine salt (arginine hydrochloride; para. 0060). Therefore, examiner interprets that the formulation of Rusch comprises arginine salt at 0 wt.%.
Regarding claim 10, Rusch in view of Kim and Abrams discloses the device above, wherein the stopper and the barrel includes from about 0 picograms to about 5 micrograms of the liquid lubricant silicone (Rusch: free of silicone oil; para. 0006).
Regarding claim 11, Rusch in view of Kim and Abrams discloses the device above, wherein the barrel (Rusch: 15) is made of at least one of a glass material (barrel is made of glass; para. 0006).
Regarding claim 12, Rusch in view of Kim and Abrams discloses the device above, wherein the solid lubricant (Rusch: 130) is a low coefficient of friction polymer layer (laminate layer 130 is a low coefficient of friction fluoropolymer layer; para. 0029 and 0031) and the stopper (100) comprises an elastomeric body (Fig. 1, elastomeric body 125) and the low coefficient of friction polymer layer (130; para. 0029 and 0031) positioned on the elastomeric body (Fig. 1, 130 is positioned on 125; para. 0029 and 0031).
Regarding claim 13, Rusch in view of Kim and Abrams discloses the device above, wherein the low coefficient of friction polymer layer (Rusch: 130; para. 0029 and 0031) comprises a fluoropolymer (laminate layer 130 may include a fluoropolymer layer; para. 0029 and 0031).
Regarding claim 14, Rusch in view of Kim and Abrams discloses the device above, wherein the fluoropolymer (Rusch: 130 may include a fluoropolymer layer; para. 0029 and 0031) of the low coefficient of friction polymer layer (130; para. 0029 and 0031) is an expanded fluoropolymer (fluoropolymer may be expanded fluoropolymer; para. 0032).
Regarding claim 15, Rusch in view of Kim and Abrams discloses the device above, wherein the elastomeric body (Rusch: 125) is at least partially imbibed into the expanded fluoropolymer (para. 0032) of the low coefficient of friction polymer layer (elastomeric body 125 may partially penetrate porous layer 150 of laminate layers 130; para. 0037).
Regarding claim 16, Rusch in view of Kim and Abrams discloses the device above, wherein the fluoropolymer of the low coefficient of friction polymer layer (Rusch: 130; para. 0029 and 0031) is an expanded polytetrafluoroethylene (ePTFE) (fluoropolymer may be ePTFE; para. 0033).
Regarding claim 17, Rusch in view of Kim and Abrams discloses the device above, wherein the fluoropolymer of the low coefficient of friction polymer layer (Rusch: 130; para. 0029 and 0031) comprises a composite fluoropolymer film (fluoropolymer film; para. 0032) having a barrier layer (Fig. 3, barrier layer 140) and a porous layer (Fig. 3, porous layer 150), the barrier layer (140) comprising expanded polytetrafluoroethylene (ePTFE) (fluoropolymer may be ePTFE; para. 0033).
Regarding claim 18, Rusch in view of Kim and Abrams discloses the device above, wherein the therapeutic formulation (Rusch: 135) in the pre-filled injection device (10) includes fatty acid particles of a size greater than 25 microns from 0 to about 600 particles. The formulation of Rusch may or may not comprise fatty acid particles (para. 0007). Therefore, examiner interprets that the formulation of Rusch comprises 0 particles of fatty acid.
Regarding claim 19, Rusch in view of Kim and Abrams discloses the device above, wherein the therapeutic formulation (Rusch: 135) in the pre-filled injection device (10) includes fatty acid particles of a size greater than 10 microns from 0 to about 6000 particles, from 0 to about 3000 particles, from 0 to about 1000 particles, from 0 to about 200 particles, from 0 to about 50 particles, from 0 to about 20 particles, and/or from 0 to about 10 particles. The formulation of Rusch may or may not comprise fatty acid particles (para. 0007). Therefore, examiner interprets that the formulation of Rusch comprises 0 particles of fatty acid.
Regarding claim 20, Rusch in view of Kim and Abrams discloses the device above, wherein the therapeutic formulation (Rusch: 135) includes from about 0 wt.% to about 0.1 wt.% concentration of a surfactant and from about 0 to about 600 fatty acid particles of a size greater than 25 microns when stored at 2 °C to 8 °C for at least about 1 year. The formulation of Rusch may or may not comprise fatty acid particles (para. 0007). Therefore, examiner interprets that the formulation of Rusch comprises no particles of fatty acid.
Regarding claim 21, Rusch in view of Kim and Abrams discloses the device above, wherein the therapeutic formulation includes from about 0 wt.% to about 0.1 wt.% concentration of a surfactant and from about 0 to about 600 fatty acid particles of a size greater than 25 microns when stored at 2 °C to 8 °C for at least about 2 years. The formulation of Rusch may or may not comprise fatty acid particles (para. 0007). Therefore, examiner interprets that the formulation of Rusch comprises no particles of fatty acid.
Regarding claim 22, Rusch in view of Kim and Abrams discloses the device above, wherein the therapeutic formulation includes from about 0 wt.% to about 0.1 wt.% concentration of a surfactant and from about 0 to about 600 fatty acid particles of a size greater than 25 microns after being subjected to accelerated aging, which involves heating the therapeutic formulation to 40 °C for 2 months and then cooling the therapeutic formulation to 5 °C for at least 24 hours. The formulation of Rusch may or may not comprise fatty acid particles (para. 0007). Therefore, examiner interprets that the formulation of Rusch comprises no particles of fatty acid.
Response to Arguments
Applicant’s arguments, see page 7-10, filed 17 March 2026, with respect to the rejections of claims 1 and 3-22 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Rusch in view of Kim and Abrams cited above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LEI GONZALEZ/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
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