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 § 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.
Claim 28 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 28 recites the limitation "kit of claim 1, wherein a pharmaceutical solution made by.." in lines 1-2. It is unclear if this is a method of making claim or it a prat of the kit. For the purpose of examination, the examining, the examiner will interpret that the pharmaceutical agent as final product.
Claim 28 recites the limitation "kit of claim 1, wherein a pharmaceutical solution made by.." in lines 1-2. It is unclear if the “wherein a pharmaceutical solution” is referring to the a pharmaceutical composition” as in claim1, line 4 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the limitation in claim 1.
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, 4, 11, 28, 35-37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Winter et al. (US. 5662918) (‘Winter”).
Re Claim 1, Winter discloses a kit, comprising: a prefilled syringe (syringe, Col. 1, lines 5-15. Col. 1, lines 47-68) comprising an ammonium sulfate treated glass barrel (barrel of the syringe, Col. 1, lines 5-15. Col. 1, lines 47-68) containing an aqueous diluent (water, Col. 1, lines 5-15. Col. 1, lines 47-68, Clm, 10-11, 20-22); and a container containing a pharmaceutical composition comprising an aluminum-sensitive active agent (agent stored in a vial, Col.1, line 47-Col. 2 line 54 , and wherein the agent in Col. 2, lines 56-67 with active material that can be reactive with aluminum so that the surface of the glass is treated to prevent aluminum ion in the injection) .
Re Claim 4, Winter discloses wherein the ammonium sulfate treated glass barrel comprises a siliconized inner surface (Col. 1, lines 55-68).
Re Claim 11, Winter discloses wherein the aqueous diluent is water for injection water, Col. 1, lines 5-15. Col. 1, lines 47-68, Clm, 10-11, 20-22).
Re Claim 28, Winter discloses wherein a pharmaceutical solution made by mixing the pharmaceutical composition with the aqueous diluent contained by the glass barrel of the syringe comprises about 5 mM to about 60 mM sodium chloride ( Col. 3, lines 9-25), about 0.5 mM to about 10 mM calcium chloride, about 5 mg/mL to about 50 mg/mL glycine, about 0.1% (w/v) to about 10% (w/v) sucrose, about 5 mM to about 50 mM histidine, and about 20 ppm to about 200 ppm polysorbate 80 ( see 112 rejection , the agent Col. 2, lines 56-67).
Re Claim 35, Winter discloses a method of preparing a medicament for administration, comprising: obtaining the kit according to claim 1( see the rejection of claim 1); mixing the pharmaceutical composition with the aqueous diluent, thereby forming a pharmaceutical solution (Col. 1, lines 47-68).
Re Claim 36, Winter discloses wherein the mixing comprises injecting the aqueous diluent into the container containing the pharmaceutical composition (solution in a vial, Col. 1, lines 47-68).
Re Claim 37, Winter discloses, further comprising drawing the pharmaceutical solution into the syringe (solution in a vial is capable to be transfer to the syringe, Col. 1, lines 47-68).
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) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over winter in view of Summers (US 20080185561 A1).
Re Claim 2, Winter discloses wherein the glass barrel leaches aluminum into the aqueous diluent (table 2, Col. 6, lines 15-30 show amount of aluminum in the solution after 13 week and it, and table 5, Col. 4, lines 5-15 show the percentage of aluminum in the solution after 50 week is about 0.13 ppm which close to 130 ppb) when stored for about 18 weeks at about 40 degree C ( degree 30-50 see Table 3, Col. 5, lines 5-15 which about 40 degree), but it fails to specifically disclose that glass barrel leaches less 100 ppb amount of aluminum, and relative humidity is about 75% relative humidity.
However, Winter discloses that percentage of the aluminum that in the solution depends on sterilizing with gas, pH of the solution, storage temperature, storage periods ( tables 1-5), so it percentage of Aluminum in the solution in 18 week can be controlled with all these condition,
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify condition of solution to so that the glass barrel leaches less than 100 ppb aluminum into the aqueous diluent and stored in 18 week for the purpose reducing the percentage of aluminum in the solution ( Col. 1, lines 35-46).
However, Summers discloses solution of ammonium sulfate will have a relative humidity around 75% (¶0069),
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify condition of solution of Winter to so that a relative humidity around 75 % as taught by Summers for the purpose of having the humidity of the closed container ( Summers ¶0069).
Re Claim 3, Winter discloses wherein the glass barrel leaches aluminum into the aqueous diluent (table 2, Col. 6, lines 15-30 show amount of aluminum in the solution after 13 week and it, and table 5, Col. 4, lines 5-15 show the percentage of aluminum in the solution after 50 week/ 12 months about 0.13 ppm which close to 130 ppb) when stored for about 18 weeks at about 25 degree C ( degree 30-50 see Table 3, Col. 5, lines 5-15 which about 40 degree), but it fails to specifically disclose that glass barrel leaches less 100 ppb amount of aluminum, and relative humidity is about 75% relative humidity.
However, Winter discloses that percentage of the aluminum that in the solution depends on sterilizing with gas, pH of the solution, storage temperature, storage periods ( tables 1-5), so it percentage of Aluminum in the solution in 12 months can be controlled with all these condition,
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify condition of solution to so that the glass barrel leaches less than 100 ppb aluminum into the aqueous diluent and stored in 12 month for the purpose reducing the percentage of aluminum in the solution ( Col. 1, lines 35-46).
However, Summers discloses solution of ammonium sulfate will have a relative humidity around 75 % (¶0069),
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify condition of solution of Winter to so that a relative humidity around 75 % as taught by Summers for the purpose of having the humidity of the closed container ( Summers ¶0069).
Claim(s) 5-10, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over winter in view of Schellenberger et al. (US 20210322518A1) (“Schellenberger”).
Re Claim 5, Winter fails to disclose wherein the aluminum-sensitive active agent is a bioactive polypeptide.
However, Schellenberger discloses wherein the aluminum-sensitive active agent is a bioactive polypeptide (PEGylated , Antihemophilic Facto, ¶0279 table 12).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the aluminum-sensitive active agent so that the aluminum-sensitive active agent is a bioactive polypeptide as taught by Schellenberger for the purpose of treating specific condition of the subject ( Schellenberger ¶0236).
Re Claim 6, Winter fails to disclose wherein the aluminum-sensitive active agent comprises antihemophilic factor or a functional variant thereof.
However, Schellenberger discloses wherein the aluminum-sensitive active agent comprises antihemophilic factor or a functional variant thereof (PEGylated , Antihemophilic Facto, ¶0279 table 12).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the aluminum-sensitive active agent of Winter so that the aluminum-sensitive active agent comprises antihemophilic factor or a functional variant thereof as taught by Schellenberger for the purpose of treating specific condition of the subject ( Schellenberger ¶0236).
Re Claim 7, Winter fails to disclose wherein the aluminum-sensitive active agent is full- length antihemophilic factor.
However, Schellenberger discloses wherein the aluminum-sensitive active agent is full- length antihemophilic factor (PEGylated , Antihemophilic Facto, ¶0279 table 12).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the aluminum-sensitive active agent of Winter so that the aluminum-sensitive active agent is full- length antihemophilic factor as taught by Schellenberger for the purpose of treating specific condition of the subject ( Schellenberger ¶0236).
Re Claim 8, Winter fails to disclose wherein the aluminum-sensitive active agent is a B- -3- domain deleted antihemophilic factor.
However, Schellenberger discloses wherein the aluminum-sensitive active agent is a B- -3- domain deleted antihemophilic factor (PEGylated , Antihemophilic Facto, ¶0279 table 12).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the aluminum-sensitive active agent of Winter so that the aluminum-sensitive active agent is a B- -3- domain deleted antihemophilic factor as taught by Schellenberger for the purpose of treating specific condition of the subject ( Schellenberger ¶0236).
Re Claim 9, Winter fails to disclose wherein the antihemophilic factor, or the functional variant thereof, is recombinant antihemophilic factor or a functional recombinant antihemophilic factor variant.
However, Schellenberger discloses wherein the antihemophilic factor, or the functional variant thereof, is recombinant antihemophilic factor or a functional recombinant antihemophilic factor variant. (PEGylated , Antihemophilic Facto, ¶0279 table 12).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the aluminum-sensitive active agent of Winter so that the antihemophilic factor, or the functional variant thereof, is recombinant antihemophilic factor or a functional recombinant antihemophilic factor variant. as taught by Schellenberger for the purpose of treating specific condition of the subject ( Schellenberger ¶0236).
Re Claim 10, Winter fails to disclose wherein the antihemophilic factor, or the functional variant thereof, is PEGylated.
However, Schellenberger discloses wherein the antihemophilic factor, or the functional variant thereof, is PEGylated.. (PEGylated , Antihemophilic Facto, ¶0279 table 12).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the aluminum-sensitive active agent of Winter so that the antihemophilic factor, or the functional variant thereof, is PEGylated. as taught by Schellenberger for the purpose of treating specific condition of the subject ( Schellenberger ¶0236).
Re Claim 12, Winter fails to disclose wherein the pharmaceutical composition comprises one or more pharmaceutically acceptable excipients.
However, Schellenberger discloses wherein the pharmaceutical composition comprises one or more pharmaceutically acceptable excipients (PEGylated , Antihemophilic Facto, ¶0279 table 12).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the aluminum-sensitive active agent of Winter so that the pharmaceutical composition comprises one or more pharmaceutically acceptable excipients as taught by Schellenberger for the purpose of treating specific condition of the subject ( Schellenberger ¶0236).
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over winter in view of Nashed-Samuel et al. (US 20210078055 A1) (“Nashed-Samuel”).
Re Claim 32, Winter fails to disclose wherein the glass of the glass barrel is a borosilicate glass.
However, Nashed-Samuel discloses wherein the glass of the glass barrel is a borosilicate glass (¶0055).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the glass of Winter the glass of the glass barrel is a borosilicate glass as taught by Nashed-Samuel for the purpose of using the acceptable glass for storing pharmaceutical agent with acid ( Nashed-Samuel , ¶0055).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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