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 Status
Claims 19-35 are pending.
Claim Objections
Claims 19, 25-27, 29 and 33 are objected to because of the following informalities:
Claim 19 recites “between 15 and 30 0 kilo pounds” which appears to be a typographical error and has an extra 0 after 30.
Claims 25, 29 and 33 each recite a point of comparison of a “method or use.”
Specifically, claims 25 and 33 each recite “a corresponding method or use comprising a step of performing mechanical lysis at a pressure of 5 kpsi,” and claim 29 recites “a corresponding method or use not comprising the step of depth filtration.” It is unnecessarily redundant to include both “method” and “use” comprising the step because uses comprising the steps are also methods. It is recommended that Applicant amend to compare to a “method” comprising the recited steps for comparison (e.g. this comparison in claim 25 would be written as “a corresponding method comprising a step of performing mechanical lysis at a pressure of 5 kpsi.”
Claims 26-27 each recite “further comprises” which is incorrectly conjugated and would be correctly written as “further comprising.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 29-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Specifically, claim 29 recited the limitations of the required results of “(i) the step of depth filtration increases a viral genome titre of the preparation comprising recombinant AAV; and/or
(ii) the preparation comprising recombinant AA V has increased the viral genome titre when
compared to a preparation comprising recombinant AAV produced by a corresponding method
not comprising a step of performing depth filtration; and/or
(iii) the step of depth filtration increases the viral genome titre of the preparation comprising
recombinant AA V by at least 5%, at least 10%, at least 15%, at least 20%, or at least 25%,
when compared to a preparation comprising recombinant AAV produced by a corresponding
method or use not comprising the step of depth filtration.”
Which are not enabled for the reasons stated below.
Claim 30 is also rejected because it depends on and therefore requires all the limitations of claim 29.
Wands Factors
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The Court in Wands states: “Enablement is not precluded by the necessity for some 'experimentation.'” Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
Breadth of the Claims
Instant claims encompass:
“depth filtration” which encompasses all possible depth filter types including all possible organic or inorganic filters with all possible micron ratings.
Importantly, instant claims require the functional results of
(i) the step of depth filtration increases a viral genome titre of the preparation comprising
recombinant AAV; and/or
(ii) the preparation comprising recombinant AA V has increased the viral genome titre when
compared to a preparation comprising recombinant AAV produced by a corresponding method
not comprising a step of performing depth filtration; and/or
(iii) the step of depth filtration increases the viral genome titre of the preparation comprising
recombinant AA V by at least 5%, at least 10%, at least 15%, at least 20%, or at least 25%,
when compared to a preparation comprising recombinant AAV produced by a corresponding
method or use not comprising the step of depth filtration.
Therefore, instant claims as written require that the functional results of (i), (ii) and/or (iii) above are obtainable with all possible depth filter types including all possible organic or inorganic filters with all possible micron ratings.
For the reasons stated below, in view of all the many factual considerations required to determine enablement, the preponderance of the evidence is that the required results functional results of (i), (ii) and or (iii) are not obtainable because the data of the specification shows a “normalized” vg/capsid titre value that is increased and does describe how the data is normalized. Because depth filtration is a filtration step and not a concentration or a propagation step, it cannot result in more viral genomes than the initial sample. Therefore, the preponderance of the evidence is that the claims as written are not enabled and that an enabled scope cannot be derived from Applicant’s disclosure concerning the results of (i), (ii) and/or (iii) required by instant claims.
Direction or Guidance Presented
While contemplating depth filtration (pg. 3-5, 38-40, 42, 44, 46, 48, 50, 59-61; Example 3),
Applicant provides limited guidance on specific depth filter types (Figure 3; Examples 2-3).
Present Working Examples
The working example considered pertinent to the present rejection is discussed below.
Example 2
To decrease the turbidity, depth filtration was tested using the following filters: the synthetic COSP and the organic COHC filter, both with an area of 23 cm2 and a micron rating of 0.2-1.1 µm.
In comparison to the control (cells lysed with MF at 20 kpsi without depth filtration), the COSP and COHC depth filtration resulted in similar cap titres (see Figure 3A).
Applicant states the vg titres (see Figure 3B) and vg/cap ratios(see Figure 3C) were decreased for the synthetic COSP filter and increased for the organic COHC filter.
It is noted that figure 3B appears to show a value of 125% normalized viral genome titres for the COHC filter. The example does not state how the data is normalized and Figure 3A shows the normalized capsid titres are all 100% or below.
Because depth filtration is a filtration step and not a concentration step, and does not propagate or multiple viral genome amount, it cannot result in an increase of genome titre.
State of the Art and Unpredictability of the Art
Regarding AAV titre after depth filtration, Applicant is directed to the prior art of Cherradi et al. (2020; accessed at https://www.pharmasalmanac.com/articles/robust-harvest-clarification-for-adeno-associated-viral-vectors-via-depth-filtration).
Cherradi evidences that depth filters can have highly variable AAV recovery (see Figure 2 which compares yield for calculations across various depth filters for clarification of rAAV
from SF9 and HEK293 cell culture and is copied below)
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(Figure 2 of Cherradi).
Specifically, for all the filters tested, the yield is less than 100%. Therefore, the data of Cherradi supports that obtaining higher viral titre from depth filtration alone would not be predictable as the decreased yield indicates a titre decrease rather than an increase and further the data indicates that the yield results are highly variable for different filter types.
In other words, because depth filtration is a filtration step and not a concentration or propagation step, it cannot result in an increase of genome titre in view of the state of the art.
Evidence of the Specification of Unpredictability of the Art
As stated above, Example 2 of Applicant’s specification indicates that in comparison to the control (cells lysed with MF at 20 kpsi without depth filtration), the COSP and COHC depth filtration resulted in similar cap titres (see Figure 3A; Example 2). In other words, there evidence of the specification contradicts the required results of increased viral titre because it evidences that depth filtration does not changes the capsid amount.
Unpredictability of the Art and the Quantity of Experimentation Necessary
As the art of Cherradi and the evidence of the specification demonstrates, the obstacles that hinder obtaining the claimed results after depth filtration are not easy tasks to be done or solely routine experimentation to enable of the claimed method with the claimed results. The type of experimentation would require new methodologies. This level of experimentation goes beyond what would be routine optimization know at the time of filing. As such, the amount of experimentation would be undue.
The physiological art is recognized as unpredictable (MPEP 2164.03). As set forth in In re Fisher, 166 USPQ 18 (CCPA 1970), compliance with 35 USC 112(a) requires: “That scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; in cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific laws; in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved.” Moreover, the courts have also stated that reasonable correlation must exist between scope of exclusive right to patent application and scope of enablement set forth in the patent application (27 USPQ2d 1662 Ex parte Maize!.). In view of the foregoing, due to the lack of sufficient guidance provided by the specification regarding the issues set forth above, the state of the relevant art, and the breadth of the claims, it would have required undue experimentation for one skilled in the art to practice the instant broadly claimed invention.
Scope of Enablement - Conclusion
In conclusion, the claims lack enablement because the specification provides limited working examples and does not provide guidance on how the vg/capsid titres are normalized. The art at the time of effective filing fail to provide specific guidance that supplement to shortcomings of the specification and further teaches that the breadth of claims cannot predictably be performed. Further, a great deal of new methodology would need to be developed to enable the claims and this level of experimentation is undue.
Claim Rejections - 35 USC § 112 (b)
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 19-35 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.
Claims 19 and 32 each recite “preferably” with no disclosed corresponding definition of “preferably.” If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim (see MPEP 2173.05(d). Therefore, it is unclear which aspect(s) of the claim is/are intended to be within the scope(s) of the claim(s) (see also MPEP 2173.05(b)).
By nature of their ultimate dependency on claim 19, claims 20-31 are also rejected because they do not clarify the issue.
By nature of their ultimate dependency on claim 32, claims 33-35 are also rejected because they do not clarify the issue.
Claim 21 recites “the method or use of claim 20.” However, claim 20 does not recite a use. Therefore there is improper antecedent basis for the “use of claim 20,” the metes and bounds of this limitation are indefinite, and it is unclear what the scope of “use of claim 20,” is intended to encompass.
Claim 28 contains many recitations of the term “and/or” which makes the metes and bounds of the claims indefinite because it is unclear which embodiments are required and which are alternatives.
Claim Interpretation
As stated above, claim 19 recites “between 15 and 30 0 kilo pounds” which appears to be a typographical error and has an extra 0 after 30. Because the instant specification recites values and ranges including 30 kpsi, but does not include any recitation of 300 kpsi alone or as part of a range, this range is interpreted as to encompass “between 15 and 30.”
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.
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.
Claims 19-20, 22-23, 26, 31-32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Atkinson et al. (EP-1009808-B1; published 12th May, 2012; henceforth “Atkinson”).
Regarding claims 19 and 32, Atkinson discloses a method for producing a preparation comprising recombinant adeno-associated virus (AAV) (“A method of generating a population of recombinant adeno-associated virus (rAAV) particles” claim 1; see also para. [0001]), wherein the method comprises a step of performing mechanical lysis on mammalian producer cells (“viral nucleic acid is generally released by lysis of the mammalian cell” para. [0122]; see also “Mechanical lysis using techniques such as microfluidization are thus preferable” para. [0143] and “Lysis by microfluidization” para. [0221]; para. [0243]; claims 6 and 9) comprising the recombinant AAV at a pressure of about 8 kpsi (8000 psi or about 8000 psi para. [0129, 0144, 0243, 0252, 0260]; Example 9).
However, regarding claims 19 and 32, although, as stated above, Atkinson teaches the mechanical lysis at a pressure of about 8 kpsi (8000 psi or about 8000 psi para. [0129, 0144, 0243, 0252, 0260]; Example 9), which is very close to 10 kpsi which is the lower end of the claimed range of between 10 and 30 kpsi, Atkinson is silent to pressures for mechanical lysis within the claimed range of between 10 and 30 kpsi.
Nevertheless, regarding claims 19 and 32, Applicant is reminded that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP section 2144.05 and Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985), In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) and Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997)).
Therefore, regarding claims 19 and 32, one of ordinary skill would not consider the difference between the 8 kpsi lysis of Atkinson and the 10 kpsi of instant claims to be inventive because the values are so close that prima facie one skilled in the art would have expected them to have the same properties (see MPEP section 2144.05 and Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)), and the reference process differs from the claims only in that the reference process is performed at 8 kpsi while the claims perform the process at a range which includes 10 kpsi (see MPEP section 2144.05 and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955; see also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) where under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0) (MPEP 2144.05).
Additionally, regarding claims 19 and 32 Applicant is reminded that generally, differences in amounts will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such amounts are critical (MPEP 2144.05 II). Moreover, at the time of the claimed invention, one of ordinary skill in the art would have been motivated by routine practice to optimize the pressure of the lysis step to effectively lyse the cells with a reasonable expectation for success.
Regarding the preambles of claims 19 and 32, Atkinson discloses the method is methods for generating high titre preparations of recombinant AAV vectors (para. [0001]) which is both “a method for producing a preparation comprising recombinant adeno-associated virus (AAV)” (instant claim 19) and “a method for increasing the viral genome titre” (instant claim 33).
Furthermore, regarding the preambles of claims 19 and 32, the preambles merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations and therefore the preamble is not considered a limitation and is of no significance to claim construction (see MPEP 2111.02) See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"). As set forth above, Atkinson teaches and makes obvious the active method steps of the instantly claimed methods from the structurally complete invention in the claim body and therefore makes them obvious.
Regarding claims 20 and 34, further to the discussion of claims 19 and 32 above, respectively, as stated above (see claims 19 and 32 rejections above), Atkinson teaches performing mechanical lysis comprises carrying out microfluidisation (Mechanical lysis using techniques such as microfluidization are thus preferable” para. [0143] and “Lysis by microfluidization” para. [0221]; para. [0243]; claims 6 and 9; Example 9).
Regarding claim 22, further to the discussion of claim 19 above, Atkinson teaches the mammalian producer cells are 293-1 cells which are HEK293- derived cells (para. [0818]; Example 1), or HeLa C37 cells which are a type of HeLa cells (para. [0186, 0207, 0218]; Examples 2 and 5-6).
Regarding claim 23, further to the discussion of claim 19 above, Atkinson teaches a step of culturing the mammalian producer cells in cell culture medium before the step of performing mechanical lysis (“the AAV producer cells can be grown under conditions (including media, temperature and the like) that are generally suitable for growth of the mammalian cells, which are generally also permissive for the replication of AAV. For example, DMEM/F12 suspension medium is preferred for growth of the cells and DMEM medium alone is preferred for AAV vector production” para. [0141]; see also Example 9 para. [0243] where cells are grown in DMEM before infection and lysis and Example 1).
Regarding claim 26, further to the discussion of claim 19 above, Atkinson teaches performing a step of endonuclease treatment which occurs after the step of mechanical lysis (“The lysate can be treated with a nuclease (e.g.. Benzonase) for one hour at 37°C” para. [0129]).
Regarding claim 31, further to the discussion of claim 19 above, Atkinson teaches
purifying the recombinant AAV (see “purify the AAV preparation” para. [0135]; see also para. [0026, 0030, 0109, 0125, 0240]; claims 1, 4 and 27).
Hence, the claimed invention as a whole was prima facie obvious.
Claims 21 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Atkinson et al. (EP-1009808-B1; published 12th May, 2012; henceforth “Atkinson”) as applied to claims 19 and 32 above, and in further view of Mundle et al. (Vaccine. 2016 Jul 12;34(32):3690-6. Epub 2016 May 26.; henceforth “Mundle”).
The teachings of Atkinson above are incorporated herein in their entirety.
Regarding claims 21 and 35, further to the discussions of claims 19 and 32 above, respectively, Atkinson is silent to the microfluidisation consisting of one pass.
Nevertheless, regarding claims 21 and 35, Mundle teaches a comparison of virus titre between microfluidisation consisting of one pass and microfluidisation consisting of multiple passes (Supplementary Figure 1; copied below for reference) and Mundle teaches increasing the pass number decreases the viral titre.
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Supplementary Figure 1 of Mundle for reference
Therefore, regarding claims 21 and 35, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the method as suggested by Atkinson, and combine the known prior art element of reducing to one pass of microfluidisation Mundle to obtain the predictable result of a Lysate. One of ordinary skill would have been motivated to do so to increase viral titre because the data Mundle teaches the pass number is a results effective variable and that increasing the pass number decreases the viral titre (Supplementary Figure 1). Regarding the reasonable expectation of success, Mundle evidences effectively lysing cells and obtaining lysates with a single pass of microfluidisation (pg. 3693 col 2- pg. 3604 col. 1; Supplementary Figure 1).
Hence, the claimed invention as a whole was prima facie obvious.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Atkinson et al. (EP-1009808-B1; published 12th May, 2012; henceforth “Atkinson”) as applied to claims 19 and 32 above, and in further view of Mesite (2017, accessed at: https://www.microfluidics-mpt.com/blog/advantages-of-microfluidizer-processor-for-cell-disruption)
The teachings of Atkinson above are incorporated herein in their entirety.
Regarding claim 24, further to the discussion of claim 19 above, Atkinson is silent to the temperature of the microfluidisation.
Nevertheless, regarding claim 24, Mesite teaches a method step of performing microfluidisation at a temperature of 4°C with the cooling devices including an ice-water bath to reduce the amount of time of elevated temperatures (pg. 2 “High Yield Cell Disruption”). Mesite teaches that during the cell disruption process, cooling is extremely important because the contents of the biological cells are typically temperature sensitive and in many cases, they start to denature at temperatures above 4°C (pg. 2 “High Yield Cell Disruption”).
Therefore, regarding claim 24, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the method suggested by Atkinson, and combine the known prior art element of the method step of performing microfluidisation at a temperature of 4°C of Mesite to obtain the predictable result of cell lysis. One of ordinary skill would have been motivated to do so as taught by Mesite to reduce the amount of time of elevated temperatures during cell lysis because the contents of the biological cells are typically temperature sensitive and in many cases, they start to denature at temperatures above 4°C (pg. 2 “High Yield Cell Disruption”). Regarding the reasonable expectation of success, Atkinson evidences lysis of cells with microfluidisation above and Mesite evidences the Microfluidizer® with the cooling devices including an ice-water bath to reduce the amount of time of elevated temperatures (pg. 2 “High Yield Cell Disruption”).
Hence, the claimed invention as a whole was prima facie obvious.
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Atkinson et al. (EP-1009808-B1; published 12th May, 2012; henceforth “Atkinson”) as applied to claims 19 and 32 above, and in further view of Cherradi et al. (2020; accessed at https://www.pharmasalmanac.com/articles/robust-harvest-clarification-for-adeno-associated-viral-vectors-via-depth-filtration).
The teachings of Atkinson above are incorporated herein in their entirety.
Regarding claim 27, further to the discussion of claims 19 and 26 above, although Atkinson teaches performing a step of filtration (“lysate can be clarified through a filter” para. [0129]; see also para. [0021-0023, 0143, 0144, 0243]), Atkinson is silent to using depth filtration with the method.
Nevertheless, regarding claim 27, Cherradi teaches Normal flow filtration (NFF) using depth and membrane filters is the most popular approach for clarification of rAAV, as NFF generally provides good yields for rAAV vectors at a reasonable cost with minimal process development complexity (pg. 2 3rd. para. ). Cherradi teaches Depth filters can clarify a wide range of cell culture feed streams in a single-use format and It is also easy to link a polishing membrane filter to a depth filter in series to provide a fully single-use flow path and efficient operation (pg. 2 3rd. para. ).
Therefore, regarding claim 27, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the method as suggested by Atkinson and combine the known prior art element of the Normal flow filtration (NFF) using depth and membrane filters of Cherradi to obtain the predictable result of a filtering step. One of ordinary skill would have been motivated to do so as taught by Cherradi to clarify a wide range of cell culture feed streams in a single-use format, to provide a fully single-use flow path and efficient operation and because Cherradi teaches Normal flow filtration (NFF) using depth and membrane filters is the most popular approach for clarification of rAAV (pg. 2 3rd. para.). Regarding the reasonable expectation of success, Cherradi evidences Normal flow filtration (NFF) using depth and membrane filters for various serotypes of rAAV (Figures 1-2).
Regarding claim 28, further to the discussion of claims 19 and 27 above, Atkinson teaches :
the step of filtration occurs after the step of mechanical lysis (“the lysate can be clarified through a filter” para. [0129]; see also para. [0152, 0154, 0197, 0211, 0212, 0213, 0218, 0224, 0230-0232, 0235, 0237, 0241, 0243, 0245, 0260]),
and it would therefore be obvious to combine the Normal flow filtration (NFF) using depth and membrane filters of Cherradi for the reasons set forth above (see claim 27 rejection above) after the step of mechanical lysis.
Pertinent Art
The prior art of Cecchini et al. (Hum Gene Ther. 2011 Aug;22(8):1021-30. Epub 2011 May 16.; henceforth “Cecchini”) made of record but not relied upon is considered pertinent to Applicant’s disclosure.
Cecchini teaches a method for producing a preparation comprising recombinant adeno-associated virus (AAV), wherein the method comprises a step of performing mechanical lysis on
insect sf9 producer cells comprising the recombinant AAV at a pressure of 15 kpsi for a single pass (15,000 kpsi; see Materials and Methods “Downstream processing” pg. 1022 col. 2 last para. and pg. 1023 col. 1 1st para.).
Cecchini does not teach mammalian producer cells.
Examiner’s Remark
Claims 25 and 33 are free of the prior art. However, these claims are not allowable because they are dependent on rejected claim 1, are objected to due to informalities above and are rejected under 35 USC § 112 (b) above.
Conclusion
No claim is allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANA N EBBINGHAUS whose telephone number is (703)756-4548. The examiner can normally be reached M-F 9:30 AM to 5:30 PM ET.
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632
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