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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-11; drawn to a preservation composition) in the reply filed on August 25, 2025, is acknowledged.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (Groups II and III), there being no allowable generic or linking claim. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant further elected the following species:
a. Applicant elected HIV as the species of lentiviral vector
DETAILED ACTION
The amended claims filed on February 27, 2026, have been acknowledged. Claims 3 and 8 were cancelled. Claims 1-2, 5-7. And 9-11 were amended. In light of the Applicant’s elected invention, claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-2, 4-7, and 9-11 are pending and examined on the merits.
Rejections and/or objections not reiterated from the previous office action mailed November 5, 2025, are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Priority
The applicant claims foreign priority from CN2020103287013 filed on April 23, 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, received October 13, 2022 and a certified translation of the foreign priority documents, received on February 27, 2026. Claims 1-2, 4-7, and 9-11 find support in foreign application CN2020103287013 filed on April 23, 2020.
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 2, 4-7, and 9-11 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. This is a new rejection made in response to Applicant’s amendments to the claims.
Claim 2 refers to concentrations of components in “the preservation composition”, claims 5-6 refer to physical characteristics of “the preservation composition”, and claim 7 claims that “the preservation solution” further comprises retroviral vectors, however, as identified by claim 4, the first reagent and the second reagent can be separate or mixed. Although claims 2 and 5-7 include the clause “wherein the first preservation reagent and the second preservation reagent are mixed”, it is unclear whether “the preservation composition” refers to the mixed preservation composition or the preservation composition of claim 1 that encompasses a separated preservation composition. Therefore, it is unclear whether these reagent concentrations and physical characteristics of the media are associated with the separate first and/or second reagent or a mixed composition of the two reagents and whether the viral vectors are in the separate first and/or second reagent or a mixed composition of the two reagents.
Claims 9-11 are also rejected because they are dependent on claim 7
Claim 2 recites the limitations "sucrose", “potassium dihydrogen phosphate or sodium dihydrogen phosphate”, “disodium hydrogen phosphate or dipotassium hydrogen phosphate”, and “sodium chloride”. There is insufficient antecedent basis for this limitation in the claims. Claim 2 refers to concentrations of components in “the preservation composition”, however, as identified by claim 4, the first reagent and the second reagent can be separate or mixed. Although claim 2 includes the clause “wherein the first preservation reagent and the second preservation reagent are mixed”, it is unclear whether “the preservation composition” refers to the mixed preservation composition or the preservation composition of claim 1 that encompasses a separated preservation composition. Claim 2 is dependent on claim 1 but claim 1 recites a first preservation reagent and a second preservation reagent with sucrose, potassium dihydrogen phosphate or sodium dihydrogen phosphate, disodium hydrogen phosphate or dipotassium hydrogen phosphate, and sodium chloride. It is unclear whether the concentrations associated with each of these components are referring to the concentration of the first preservation reagent, the second preservation reagent, or the mixed preservation composition.
Claim 4 recites that the first preservation and the second preservation reagent can be mixed or separated. However, it is unclear the concentrations identified in claim 1 can be associated with a mixed or separated first and second reagents. As noted in claim 2, the presumed concentrations of the mixed solution fall outside of the range identified in claim 1. Therefore, it is unclear how the preservation composition of claim 1 can either be mixed or separated as mixing inherently alters the concentration of the reagent components. Furthermore, as identified in the specification, the method includes the following steps: (i) adding component A (the first reagent) during a production and purification process of a lentiviral vector; (ii) adding component B (the second reagent) prior to aliquoting to finally form a preservation solution of the lentiviral vector (page 5, lines 26-30). Therefore, Applicant appears to consider the solution a preservation solution only once the first reagent and second reagent are mixed together and not when they are separated.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. This is a new rejection made in response to Applicant’s amendments to the claims.
Claim 2 refers to concentrations of components in “the preservation composition”, however, as identified by claim 4, the first reagent and the second reagent can be separate or mixed. Although claim 2 includes the clause “wherein the first preservation reagent and the second preservation reagent are mixed”, it is unclear whether “the preservation composition” refers to the mixed preservation composition or the preservation composition of claim 1 that encompasses a separated preservation composition. Claim 2 is dependent on claim 1 but claim 2 recites component concentration ranges that are outside of the range identified in claim 1, such as albumin (40 g/L to 33 g/L in claim 1 and 20 g/L to 150 g/L in claim 2).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-2, 4, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application No. 20190184004 (Livengood) and further in view of United States Patent No. 7485448 (Yoshioka). This is a new rejection made in response to Applicant’s amendments to the claims that is substantially similar to a previous rejection. Any aspect of Applicant’s traversal that is relevant to the new rejection of record is addressed below.
As an initial matter, regarding the limitation in claim 1 “A preservation composition for preserving retroviral vectors,” this limitation is considered to be an “intended use” of the claimed composition. As the preservation composition of claim 1 does not require a retrovirus, this limitation is not found to add any structural limitations. See MPEP 2111.02.
Regarding claims 1 and 4 and the first preservation reagent, Livengood teaches media formulations for stabilizing flaviviruses. Livengood teaches kits that can include any composition or formulation disclosed herein and at least one container. Livengood teaches that the formulation can comprise sucrose with a concentration of 10% (w/v) which equates to 100 g/L. Livengood teaches that the formulation can comprise a buffer including a combination of potassium phosphate (KH2PO4), disodium phosphate (Na2HPO4), and sodium chloride (NaCl). Livengood teaches that the concentration for sodium chloride (NaCl) can be within the range of 145-171 mM (equates to 8.5-10 g/L) (paragraphs 0005-0020, 0058, and 0094).
Livengood does not specifically identify that their compositions include water. However, it is well understood that buffers can use water as a base for adding different salts to generate the buffer.
Regarding the second preservation reagent, Livengood also teaches media formulations that comprise sucrose with a concentration of 10% (w/v) which equates to 100 g/L. Livengood teaches that the formulation can comprise albumin at a concentration of about 2% w/v (~20 g/L). Livengood teaches that the formulation can comprise a buffer including a combination of potassium phosphate (KH2PO4), disodium phosphate (Na2HPO4), and sodium chloride (NaCl). Livengood teaches that the concentration for sodium chloride (NaCl) can be within the range of 145-171 mM (equates to 8.5-10 g/L) (paragraphs 0005-0010, 0058, and 0094).
Livengood does not identify the concentration of the potassium phosphate (KH2PO4) and disodium phosphate (Na2HPO4) nor wherein the concentration of the albumin is 40 g/L.
However, Livengood does teach that the salt concentration can be adjusted to near physiological levels (e.g. 150 mM total salt) (paragraphs 0058 and 0094).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the concentrations of potassium phosphate (KH2PO4) and disodium phosphate (Na2HPO4) of Livengood to be within 0.8 mmol/L to 1.2 mmol/L (or 0.1 mmol/L to 1.2 mmol/L) and 2.6 mmol/L - 3.2 mmol/L (or 0.5 mmol/L - 3 mmol/L), respectively, and the albumin to 40 g/L to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to make the modification with a reasonable expectation of success because Livengood teaches that the salt concentration can be adjusted to near physiological levels (e.g. 150 mM total salt). As Livengood already teaches that the sodium chloride salt concentration can be about 146 mM, it would have been well understood that the remaining salt compounds would have concentrations that, when added together with the sodium chloride salt concentration, would equate to a total salt concentration of 150 mM. Therefore, the concentrations of potassium phosphate (KH2PO4) and disodium phosphate (Na2HPO4) could be distributed to fall within the limitations of claim 1 and reach the total salt concentration of 150 mM as taught by Livengood. Furthermore, Livengood teaches that the albumin can be about 20 g/L.
As taught by MPEP 2144.05 (II)(A), generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."). Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Furthermore, as per claim 4, these reagents are considered to be separate formulations. As shown by Tables 3-4 and Tables 6-9, Livengood contemplates generating a multitude of media formulations comprising sugar with and without human serum albumin and other preservative components for assessing whether the flavivruses maintain stability in these formulations. Therefore, it would have been obvious that another formulation (a second preservation reagent) could be generated at the same time as the first formulation identified above (a first preservation reagent) to assess whether human serum albumin improves flavivirus stability. Furthermore, as Livengood is comparing the efficacy of different media formulations for maintaining flavivirus stability, it would have been well understood that one would want to use the same volume for the media formulation between experimental groups. Thus, it would have been obvious that the volume ratio of the first and second preservation reagents would be 1:1 in their separate containers before adding flaviviruses.
Livengood does not teach wherein the second formulation also comprises sodium caprylate and N-acetyltrytophan.
However, Yoshioka teaches a media formulation for viral vector production comprising albumin. Yoshioka teaches that some commercially available serum human albumin formulations contain sodium caprylate and sodium N-acetyl-tryptophan as stabilizing agents. Yoshioka teaches that the concentration of sodium caprylate is 10-100 mg/mL (~.06-.6 mM) and the concentration of sodium N-acetyl-tryptophan 10-200 mg/mL (~.04-.75 mM) (column 3, lines 30-52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included sodium caprylate and sodium N-acetyl-tryptophan in the medium formulation with serum albumin, as identified by Yoshioka, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to include sodium caprylate and sodium N-acetyl-tryptophan in the medium with human serum albumin with a reasonable expectation of success because Yoshioka teaches that sodium caprylate and sodium N-acetyl-tryptophan are routinely included with human serum albumin as stabilizing agents. Regarding the difference in concentrations between Yoshioka and the instant claim 1, as stated supra, MPEP 2144.05 (II)(A), generally, states that differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Regarding claims 2 and 6, these claims are interpreted as product-by-process claims as the mixing step is a process step while the claim is directed to a product (a preservation composition). As such, only the positively recited structures of the mixed preservation composition are considered germane to the patentability of the composition. The recited structures of the composition of claim 2 are considered:
sucrose at a concentration of 100 g/L to 250 g/L
albumin at a concentration of 20 g/L to 150 g/L
potassium dihydrogen phosphate at a concentration of 0.5 mmol/L to 1 mmol/L
disodium hydrogen phosphate at a concentration of 1.6 mmol/L to 3 mmol/L
sodium chloride at a concentration of 5.5-10 g/L
sodium caprylate at a concentration of 1.6 mmol/L to 10 mmol/L
sodium N-acetyltryptophan at a concentration of 1.6 mmol/L to 10 mmol/L
As stated supra, Livengood teaches media formulations that comprise sucrose with a concentration of 10% (w/v) which equates to 100 g/L. Livengood teaches that the formulation can comprise albumin at a concentration of about 2% w/v (~20 g/L). Livengood teaches that the formulation can comprise a buffer including a combination of potassium phosphate (KH2PO4), disodium phosphate (Na2HPO4), and sodium chloride (NaCl). Livengood teaches that the concentration for sodium chloride (NaCl) can be within the range of 145-171 mM (equates to 8.5-10 g/L) (paragraphs 0005-0010, 0058, and 0094).
Livengood does not identify the concentration of the potassium phosphate (KH2PO4) and disodium phosphate (Na2HPO4).
However, Livengood does teach that the salt concentration can be adjusted to near physiological levels (e.g. 150 mM total salt) (paragraphs 0058 and 0094).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the concentrations of potassium phosphate (KH2PO4) and disodium phosphate (Na2HPO4) of Livengood to be within 0.5 mmol/L to 1 mmol/L and 1.6 mmol/L - 3. mmol/L, respectively, to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to make the modification with a reasonable expectation of success because Livengood teaches that the salt concentration can be adjusted to near physiological levels (e.g. 150 mM total salt). As Livengood already teaches that the sodium chloride salt concentration can be about 146 mM, it would have been well understood that the remaining salt compounds would have concentrations that, when added together with the sodium chloride salt concentration, would equate to a total salt concentration of 150 mM. Therefore, the concentrations of potassium phosphate (KH2PO4) and disodium phosphate (Na2HPO4) could be distributed to fall within the limitations of claim 2 and reach the total salt concentration of 150 mM as taught by Livengood.
Regarding the sodium caprylate and sodium N-acetyl-tryptophan concentrations, Yoshioka teaches a media formulation for viral vector production comprising albumin. Yoshioka teaches that some commercially available serum human albumin formulations contain sodium caprylate and sodium N-acetyl-tryptophan as stabilizing agents. Yoshioka teaches that the concentration of sodium caprylate is 10-100 mg/mL (~.06-.6 mM) and the concentration of sodium N-acetyl-tryptophan 10-200 mg/mL (~.04-.75 mM) (column 3, lines 30-52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included sodium caprylate and sodium N-acetyl-tryptophan in the medium formulation with serum albumin, as identified by Yoshioka, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to include sodium caprylate and sodium N-acetyl-tryptophan in the medium with human serum albumin with a reasonable expectation of success because Yoshioka teaches that sodium caprylate and sodium N-acetyl-tryptophan are routinely included with human serum albumin as stabilizing agents. Regarding the difference in concentrations between Yoshioka and the instant claim 1, as stated supra, MPEP 2144.05 (II)(A), generally, states that differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Regarding claim 6, Livengood teaches that the buffering media can be at a pH of 7.0 (paragraph 0094).
The recitation of a process limitation in claims 2 and 6 is not viewed as positively limiting the claimed product absent a showing that the process of making recited in claims 2 and 6 imparts a novel or unexpected property to the claimed product, as it is assumed that equivalent products are obtainable by multiple routes. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced products. The method in which the endosteal surface, central marrow, and perivascular microenvironments of bone marrow were produced is immaterial to their patentability.
"Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
Response to Arguments
Applicant's arguments filed February 27, 2026, are acknowledged.
Applicant argues that the amendments to claim1 to use consisting of language overcomes the rejection because Livengood and Yoshioka fail to teach a first or second preservation reagent which contains only the recited components at the claimed concentration ranges (page 6, paragraph 1-page 7, paragraph 3).
Applicant's arguments have been fully considered but they are not persuasive.
As stated in the rejection above. The combined teachings of Livengood and Yoshioka are considered to teach a first and a second preservation reagent which contains only the recited components at the claimed concentration ranges. Furthermore, Applicant does not identify any component that is included within Livengood or Yoshioka that would cause the combined teachings of Livengood and Yoshioka to fall outside of the limitations of claim 1.
Applicant further argues that a skilled artisan would not have been motivated to combine Livengood and Yoshioka. Livengood is titled "Compositions and Methods for Stabilizing Flaviviruses with Improved Formulations", and teaches "compositions and methods for stabilizing Flaviviruses" (Livengood, Abstract). Completely differently, Yoshioka teaches cell culture media for producing retroviruses, not for preserving retroviruses. Specifically, Yoshioka is titled "Serum-Free Medium for Producing Retroviruses" and teaches cell culture media, including "a serum-free medium for cultivation of a virus producer cell" (Yoshioka, Abstract; emphasis added), and "a novel serum- free tissue culture medium useful for cultivation of a virus producer cell" (Yoshioka, Col. 1, lines 7-8; emphasis added) (page 7, paragraph 4).
Applicant's arguments have been fully considered but they are not persuasive.
As stated in the rejection above, Livengood does not teach a formulation that comprises albumin and sodium caprylate and N-acetyltrytophan.
However, Yoshioka teaches a media formulation for viral vector production comprising albumin. Yoshioka teaches that some commercially available serum human albumin formulations contain sodium caprylate and sodium N-acetyl-tryptophan as stabilizing agents. Yoshioka teaches that the concentration of sodium caprylate is 10-100 mg/mL (~.06-.6 mM) and the concentration of sodium N-acetyl-tryptophan 10-200 mg/mL (~.04-.75 mM) (column 3, lines 30-52).
One of ordinary skill in the art would have a reason to include sodium caprylate and sodium N-acetyl-tryptophan in the medium with human serum albumin with a reasonable expectation of success because Yoshioka teaches that sodium caprylate and sodium N-acetyl-tryptophan are routinely included with human serum albumin as stabilizing agents. Therefore, there is a clear nexus between using albumin with sodium caprylate and sodium N-acetyl-tryptophan as they act as stabilizing agents for albumin. As such, a skilled artisan would have been motivated to combine Livengood and Yoshioka as increased stabilization of albumin would be a distinct benefit in the media formulations.
Claims 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application No. 20190184004 (Livengood) and further in view of United States Patent No. 7485448 (Yoshioka) as applied to claim 1 above, and further in view of Choi et al. (PLoS ONE 10: 1-22. 2015; referenced in IDS). This is a new rejection made in response to Applicant’s amendments to the claims that is substantially similar to a previous rejection. Applicant’s traversal has been addressed above.
As an initial matter, as claim 5 uses the same process language of claims 2 and 6, claim 5 is also interpreted as a product-by-process claim as the mixing step is a process step while the claim is directed to a product (a preservation composition). As such, only the positively recited structures of the mixed preservation composition are considered germane to the patentability of the composition.
As stated in the rejection above, the combined teachings of Livengood and Yoshioka teach preservation reagent A, preservation reagent B, and the mixed product. Therefore, this will not be readdressed here. As per the 112b above, there is a lack of clarity as to which preservation solution is required to have the osmotic range of claim 5. However, as the combined teachings of Livengood and Yoshioka teach all three products, it would be well understood that each of them could have their osmotic pressure adjusted to the required osmotic pressure of claim 5.
The teachings of Livengood and Yoshioka are as discussed above.
Livengood teaches that their formulations can facilitate the storage, distribution, delivery and administration of viral vaccines (paragraph 0091).
The combined teachings of Livengood and Yoshioka are silent as to the osmotic pressure of the composition(s).
However, Choi teaches that they measured the stability of viral vaccines in a DPBS solution mixed with a sugar solution in PBS comprising carboxymethyl cellulose sodium salt using inactivated viral vaccines and found that the viruses did not show a significant drop in activity when mixed with a solution with a high sugar concentration and high osmolarity and a mOsm difference of 682 mOsm and up to 1351 mOsm from the Cos of 300 mOsm (i.e 982-1651 mOsm) (page 4, paragraph 1-page 11, paragraph 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that one of ordinary skill in the art could generate a sugar solution with a mOsmol/kg between 900-1400 to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to use a solution with a mOsmol/kg between 900-1400 with a reasonable expectation of success because Livengood and Choi are focused on maintaining stability of viral vaccines in sugar buffer solutions and Choi teaches that sugar PBS solutions with mOsmol between 982-1651 did not cause a drop in viral vaccine activity when used with carboxymethyl cellulose sodium salt. Therefore, these osmolarity levels can be used with a preservation solution for viral vector vaccines without negatively impacting viral activity. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Claims 1, 7, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application No. 20190184004 (Livengood) and further in view of United States Patent No. 7485448 (Yoshioka) as applied to claim 1 above, and further in view of United States Patent Application No. 20140302091 (Stinchcomb). This is a new rejection made in response to Applicant’s amendments to the claims
As an initial matter, as claim 7 uses the same process language of claims 2 and 6, claim 7 is also interpreted as a product-by-process claim as the mixing step is a process step while the claim is directed to a product (a preservation composition). As such, only the positively recited structures of the mixed preservation composition are considered germane to the patentability of the composition.
As stated in the rejection above, the combined teachings of Livengood and Yoshioka teach preservation reagent A, preservation reagent B, and the mixed product. Therefore, this will not be readdressed here. As per the 112b above, there is a lack of clarity as to which preservation solution is required to have the retroviral vectors of claim 7. However, as the combined teachings of Livengood and Yoshioka teach all three products, and Livengood teaches that each of their media formulations are for stabilizing flaviviruses, it would be well understood that each of them could include viral vectors.
The teachings of Livengood and Yoshioka are as discussed above.
The combined teachings of Livengood and Yoshioka do not teach that the media formulations comprise retroviruses.
However, Stinchcomb teaches media compositions to reduce or prevent deterioration or inactivation of a live attenuated virus composition. Stinchcomb that their media formulations can include albumin and sucrose in a buffer and can be used to stabilize flaviviruses or retroviruses, including HIV-1 or HIV-2 (paragraphs 0014-0026 and 0043-0053).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that one of ordinary skill in the art could use the media formulations of the combined teachings of Livengood and Yoshioka for stabilizing HIV-1 or HIV-2 retroviruses to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to use the media formulations of the combined teachings of Livengood and Yoshioka for stabilizing HIV-1 or HIV-2 retroviruses with a reasonable expectation of success because Livengood teaches that their media formulations can be used to stabilize flaviviruses and Stinchcomb teaches that similar media formulations comprising albumin and sucrose in a buffer can be used to stabilize flaviviruses and retroviruses. Therefore, it would have been obvious that one could use the media formulations of the combined teachings of Livengood and Yoshioka for stabilizing HIV-1 or HIV-2 retroviruses as Stinchcomb identifies that media formulations that can stabilize flaviviruses could also be used to stabilize retroviruses. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEENAN A BATES whose telephone number is (571)270-0727. The examiner can normally be reached M-F 7:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Doug Schultz can be reached at (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KEENAN A BATES/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631
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