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 16 May 2023.
Claims 23-98 are canceled.
Claims 1-22 are presently pending in this application.
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 1-22 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.
The term “free or substantially free of” in claims 1, 4, 10, and 20-22 is a relative term which renders the claims indefinite. The term “free or substantially free of” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Additionally, the term “substantially free of” is further indefinite, as it is contradictory; something which is “substantially free” is not “free”. The following limitations are rendered indefinite by this term:
“a liquid lubricant” (claim 1)
“the liquid lubricant silicone” (claim 10)
“fatty acid particles” (claims 1, and 20-22)
“surfactant” (claim 4)
The limitation “the surfactant” of claim 5 is, therefore, indefinite, as the formulation cannot include and exclude “the surfactant” simultaneously.
The limitation “fatty acid particles” of claim 18 and 19 is, therefore, indefinite, as the formulation cannot include and exclude “fatty acid particles” simultaneously.
For the purposes of examination, the term “free or substantially free of” in claims 1, 4, 10, and 20-22 is interpreted to mean –free of--.
All other claims are rejected as they depend from independent claim 1.
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 1-22 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.
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) being free 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) is free of fatty acid particles (method prevents or reduces the formation of fatty acid particles in a formulation; para. 0007).
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).
Regarding claim 2, Rusch in view of Kim discloses the device above, wherein the active pharmacological agents (Rusch: para. 0053 and 0056) comprise proteins, antibodies, cytokines, growth factors, coagulation factors, proteases, kinases, phosphatases, vaccines, peptides, small interfering RNAs (siRNAs), small interfering DNAs (siDNAs), messenger RNAs (mRNAs), messenger RNAs (mRNAs), aptamers, and/or any combination thereof (therapeutic compounds can include antibodies, proteins, RNA interference, etc.; para. 0053 and 0056).
Regarding claim 3, Rusch in view of Kim 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 discloses the device above, wherein the therapeutic formulation (Rusch: 135) is free of surfactant. 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 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 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 view of Kim 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 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 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 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 discloses the device above, wherein the stopper and the barrel are free of the liquid lubricant silicone (Rusch: free of silicone oil; para. 0006).
Regarding claim 11, Rusch in view of Kim 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 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 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 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 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 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 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 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 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 discloses the device above, wherein the therapeutic formulation (Rusch: 135) is free or substantially free of fatty acid particles 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 discloses the device above, wherein the therapeutic formulation is free or substantially free of fatty acid particles 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 discloses the device above, wherein the therapeutic formulation is free or substantially free of fatty acid particles 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.
Conclusion
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783