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
This is a first action on the merits for this regular application filed on 07/05/2023
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 46-47, 50, 52 and 56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jones et al. (US 2005/0006307 A1).
Regarding claim 46, Jones et al. discloses a method for microbial bioburden reduction of a chromatography matrix [0003], comprising:
contacting a chromatography matrix with a composition comprising about 0.1 M acetic acid [0005] and about 20% ethanol [0039], wherein the contacting step is performed for about 1 hour to about 4 hours (page 5, Table 2).
Regarding claim 47, Jones et al. discloses that the composition further comprises benzyl alcohol (col.6, Table 2).
Regarding claim 50, Jones et al. discloses that the contacting step is capable of a reduction in the amount of gram-positive bacteria ([0010] Staphylococci is gram-positive bacterial) by at least 5 log10 (Pages 4-5, Table 1) in the chromatography matrix.
Regarding claim 52, Jones et al. teaches that the contacting step is capable of a reduction in the amount of gram-positive bacteria ([0010] Staphylococci is gram-positive bacterial) in the chromatography matrix, to below the limit of detection [0018] as determined by a sterility test (Example I in pages 3-5).
Regarding claim 56, Jones et al. discloses that the chromatography matrix comprises a proteinaceous ligand [0014] coupled to a support.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 37-40, 42-45, 48, 51 and 54-55 are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (US 2005/0006307 A1).
Regarding claim 37, Jones et al. discloses a method for microbial bioburden reduction of a chromatography matrix [0003], consisting comprising:
contacting a chromatography matrix with a composition consisting essentially (Jones et al. teaches against using NaOH [0024] and claim 37 does not preclude a second composition being applied, i.e., Guanidine Chloride, to the chromatography matrix) of about 0.1 M acetic acid [0005] and about 20% ethanol [0039], wherein the contacting step is performed for about 1 hour to about 4 hours (page 5, Table 2).
Jones et al. teaches that the 0.1M acetic acid is combined with guanidine chloride [0038-0039] in a step preceding exposure to the buffer (20% ethanol) in order to inactivate various types of pathogens [0003]. Therefore, 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 to contact a chromatography matrix with a composition comprising about 0.1 M acetic acid and about 20% ethanol in order to inactivate various types of pathogens.
Regarding claim 38, Jones et al. discloses that the contacting step is capable of a reduction in the amount of gram-positive bacteria ([0010] Staphylococci is gram-positive bacterial) by at least 5 log10 (Pages 4-5, Table 1) in the chromatography matrix.
Regarding claims 39 and 51, Jones et al. teaches that the contact step is performed for about 3 hours (Page 5, Table 2).
Jones et al. appears silent to disclose that the contact step is performed for about 4 hours. However, depending on the degree of inactivation of pathogens [0018] that is sought, one of ordinary skilled in the art would readily recognize that the optimal contact-time step would vary (increase or decrease) depending on the type of pathogen or degree of contamination or pH, or temperature in order to achieve substantial inactivation of pathogens [0020]. Therefore, 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 to increase the time of the contact step Jones et al. from 3 hours to 4 hours in order to achieve substantial inactivation of the pathogens.
Regarding claim 40, Jones et al. teaches that the contacting step is capable of a reduction in the amount of gram-positive bacteria ([0010] Staphylococci is gram-positive bacterial) in the chromatography matrix, to below the limit of detection [0018] as determined by a sterility test (Example I in pages 3-5).
Regarding claim 42, Jones et al. teaches that the composition has pH between about 2 and about 3 [0006].
Regarding claims 43-44 and 54-55, Jones et al. teaches that the contacting temperature ranges from about 0oC to about 10oC [0011] and also teaches that the pH is between 2 and 3 [0011].
Jones et al. appears silent to disclose that the contacting temperature is conducted between 15°C and 30°C or between 20°C and 25°C. However, Jones et al. teaches that the optimal combination of the composition, including the concentration, pH, and temperature can be determined by one of skill in the art for specific circumstances based on the guidance provided therein [0012]. Therefore, 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 to increase Jones et al. contact temperature range from about 0oC to about 10oC to about 15°C and 30°C or between 20°C and 25°C in order to achieve substantial degrees of inactivation for different types of pathogens.
Regarding claim 45, Jones et al. discloses that the chromatography matrix comprises a proteinaceous ligand [0014] coupled to a support.
Regarding claim 48, Jones et al. teaches using benzyl alcohol (page 6, Table 2).
Jones et al. appears silent to specifically disclose the concentration range values for benzyl alcohol. However, Jones et al. teaches that the optimal combination of the composition, including the concentration, pH, and temperature can be determined by one of skill in the art for specific circumstances based on the guidance provided therein [0012]. Therefore, 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 to modify Jones et al. inherent concentration values of benzyl alcohol to about 1% to about 2% in order to achieve substantial degrees of inactivation for different types of pathogens.
Claims 41 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (US 2005/0006307 A1) as applied to claims 40, 52, and further in view of Leese (US 8,343,912 B2).
Regarding claims 41 and 53, Jones et al. appears silent to list Stenotrophomonas maltophilia as gram-negative bacteria.
Leese discloses antibacterial compounds against a diverse range of gram-negative bacteria (col.2, lines 33-37) including Stenotrophomonas maltophilia (col.21, lines 5-6) since such a bacteria can cause and exacerbate infections (col.21, lines 3-6). 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 to add Stenotrophomonas maltophilia bacteria to Jones et al. list of pathogens to be inactivated since Stenotrophomonas maltophilia can cause and exacerbate infections.
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (US 2005/0006307 A1) as applied to claim 46 and further in view of Gluck (US 4,919,837).
Jones et al. teaches that the composition can further include salts [0004].
Jones et al. appears silent to teach the use of an acetate salt.
Gluck discloses an antiseptic cleansing composition (col.1, lines 7-11) for animate and inanimate objects and surfaces (col.2, lines 44-48) where the composition includes acetate salts (col.1, line 34) and acetic acid (col.4, lines 1-2) in order to combine washing and disinfectant action in one single operation (col.1, lines 25-26). 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 to add Gluck acetate salts to Jones et al. method in order to combine washing and disinfectant action in one single operation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONZER R CHORBAJI whose telephone number is (571)272-1271. The examiner can normally be reached M-F 5:30-12:00 and 6:00-9:00.
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/MONZER R CHORBAJI/Primary Examiner, Art Unit 1798