-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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on August 3, 2026 has been entered.
Priority
This application is a 371 of PCT/US2021/013315 filed on 01/13/2021, and claims benefit
in provisional application 62/961,602 filed on 01/15/2020.
Claim Status
Claims 1, 5-9, 18-20, 24-27, 29-31, and 35-38 are pending. Claims 18-20, 24-27, 29-31,
and 35-38 are withdrawn. Claims 2-4, 10-17, 21-23, 28, 32-34, and 39 were canceled. Claim 1 was amended. Claims 1 and 5-9 are examined.
Maintained Claim Rejections - 35 USC§ 103
Modified as Necessitated by Amendment
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 1 and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Zheng (US
10,028,503 B2 Date of Patent July 24, 2018 – of record in IDS dated 07/18/2022).
The claims encompass a composition for platelet storage comprising platelets and a
compound of formula as depicted in claims, wherein the compound is present in an amount of
from 1 uM to 9 uM.
The teachings of Zheng are related to compositions for slowing, preventing, or reversing
platelet damage, wherein the compositions comprise one or more RHOA inhibitors and a
pharmaceutically acceptable carrier (Abstract). Patented claim 1 teaches a composition for cold
platelet storage comprising platelets; a RHOA inhibitor selected from
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or a pharmaceutically acceptable salt thereof,
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or pharmaceutically acceptable salt thereof, or combinations thereof; and a physiologically
acceptable carrier, wherein said R-G04, S-G04, or a combination thereof, is present in an amount
of at least about 10 uM. Patented claims 21-23 further limit the concentration to from about 10 to about 500 uM, from about 25 uM to about 300 uM, and from about 50 uM to about 200 uM, respectively.
Regarding instant claim 1, it would have been prima facie obvious to a person of ordinary
skill in the art before the effective filing date of the claimed invention to have formed a
composition for platelet storage comprising platelets and a compound of formula
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in a concentration of at least about 10 uM, or from about 10 um to about 500 uM, with a reasonable expectation of success because Zhang
teaches a composition for platelet storage comprising an RHOA inhibitor selected from
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, wherein the S-G04 is present in an amount of at least about 10 uM, or from about 10 uM to about 500 uM. S-G04 is identical to the instantly claimed compound. The claimed concentration range of from 1 uM to 9 uM is obvious because it is close enough to about 10 uM, that the skilled artisan would have expected the upper end of the range "9 uM" to have the same properties as the lower end of Zhang’s range of "about 10 uM". Zhang defines “about” to mean within an acceptable error range for the particular value as determined by the skilled artisan, which will depend in part on how the value is determined or measured, e.g. the limitations of the measurement system. For example, “about” can mean within 1 or more than 1 standard deviations, per the practice in the art (column 3 lines 52-61). The application was reviewed and there is no evidence that the claimed concentration range is critical.
It would have been obvious to have formed the composition to contain only the S-G04
compound, which is the S form of the compound, without the R-S04 because it is apparent from
patented claim 1 that Zheng intended to encompass embodiments where the composition
contains the S form, the R form, or a combination of the two forms. Additionally, Zheng teaches
that individual stereoisomers of the compounds can be substantially free of other isomers, or can
be admixed, for example, as racemates or with all other or other selected, stereoisomers. The
chiral centers of the preferred embodiments can have the S or the R configuration as defined by the IUPAC 1974 Recommendations (column 13 lines 38-45). In view of this teaching, it would have been obvious to form the composition to contain only the S isomer. The limitation that requires the compound to have at least 95% purity is obvious over the embodiment of the composition that contains only the S isomer. The claim is drawn to a composition comprising the compound, and the claim does not exclude anything that could be considered an impurity. The at least 95% purity of a compound is interpreted as describing the purity of the compound prior to using the compound to form the composition. Since the claim recites the transitional phrase "comprising" and does not exclude any compounds that are considered impurities, the prior art composition meets the claimed limitation.
Regarding claim 5, it would have been obvious to have formed a platelet storage
composition comprising platelets and a compound of formula
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, wherein the S form of the compound is
present in an enantiomeric excess of at least approximately 94%, with a reasonable expectation
of success because Zhang teaches a platelet storage composition comprising platelets and an
RHOA inhibitor of formula
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.
It would have been obvious to have formed the composition to contain only the S-G04
compound, which is the S form of the compound, without the R-S04 because it is apparent from
patented claim 1 that Zheng intended to encompass embodiments where the composition
contains the S form, the R form, or a combination of the two forms. Additionally, Zheng teaches
that individual stereoisomers of the compounds can be substantially free of other isomers, or can
be admixed, for example, as racemates or with all other or other selected, stereoisomers. The
chiral centers of the preferred embodiments can have the S or R configuration as defined by the
IUPAC 1974 Recommendations (column 13 lines 38-45). In view of this teaching, it would have
been obvious to form the composition to contain only the S isomer. The claimed ranges of at
least approximately 94% enantiomeric excess of the S form and has at least 95% purity are
obvious because Zheng teaches an embodiment where the S isomer is the only isomer in the
composition. The claim is drawn to a composition comprising the compound, and the claim does
not exclude anything that could be considered an impurity. The at least 95% purity of a
compound is interpreted as describing the purity of the compound prior to using the compound to
form the composition. Since the claim recites the transitional phrase "comprising" and does not
exclude any compounds that are considered impurities, the prior art composition meets the
claimed limitation.
Regarding claim 6, it would have been prima facie obvious to a person of ordinary skill
in the art before the effective filing date of the claimed invention to have formed a composition
for platelet storage comprising platelets and a compound of formula
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in a concentration of at least about 10 uM or
from about 10 uM to about 500 uM, with a reasonable expectation of success because Zhang teaches a composition for platelet storage comprising an RHOA inhibitor selected from
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, wherein the S-G04 is present in
an amount of at least about 10 uM and from about 10 uM to about 500 uM. S-G04 is identical to the instantly claimed compound. The "wherein" clause requires the compound to be present in an amount sufficient to achieve claimed properties. Zheng teaches that the compound is present in the range of at least about 10 uM and from about 10 uM to about 500 uM. These ranges overlap with ranges disclosed in the instant specification in paragraph 0038. It would have been reasonable to expect the S-G04 compound in Zheng's composition to achieve the claimed properties when tested under the same conditions as instantly claimed composition because Zheng's composition contains the same components as claimed where S-G04 is present in a range of amounts that overlaps with amounts disclosed by applicant's specification. The concentration ranges in patented claims are sufficient to achieve the claimed properties, absent evidence to the contrary.
It would have been obvious to have formed the composition to contain only the S-G04
compound, which is the S form of the compound, without the R-S04 because it is apparent from
patented claim 1 that Zheng intended to encompass embodiments where the composition
contains the S form, the R form, or a combination of the two forms. Additionally, Zheng teaches
that individual stereoisomers of the compounds can be substantially free of other isomers, or can
be admixed, for example, as racemates or with all other or other selected, stereoisomers. The
chiral centers of the preferred embodiments can have the S or R configuration as defined by the
IUPAC 1974 Recommendations (column 13 lines 38-45). In view of this teaching, it would have
been obvious to form the composition to contain only the S isomer. The limitation that requires
the compound to have at least 95% purity is obvious over the embodiment of the composition
that contains only the S isomer. The claim is drawn to a composition comprising the compound,
and the claim does not exclude anything that could be considered an impurity. The at least 95%
purity of a compound is interpreted as describing the purity of the compound prior to using the
compound to form the composition. Since the claim recites the transitional phrase "comprising"
and does not exclude any compounds that are considered impurities, the prior art composition
meets the claimed limitation.
Regarding claim 7, it would have been obvious to have formed the composition to
contain S-G04 isomer as the only isomer in the composition because Zheng teaches an
embodiment where S-G04 is the only isomer in the composition, which renders the claimed
range of approximately 97% of enantiomeric excess of the S isomer obvious because
approximately 97% is close enough to 100% that the skilled artisan would have expected them to
have the same properties. Paragraph 0022 of the instant specification defines "approximately" or
"about" to mean within an acceptable error range of the particular value as determined by one of
ordinary skill in the art. Alternatively, "about" can mean a range of up to 20%, up to 10%, up to
5%, and up to 1 % of a given value. It would have been reasonable to interpret these teachings to
apply to "approximately" as well because the specification refers to "approximately" and "about"
as equivalents. Thus, approximately 97% is a range of values that extents to a value greater than
97%.
Alternatively, patented claim 1 teaches combinations of S-G04 and R-G04, therefore it
would have been obvious to have varied the concentrations of each of the two isomers from the
smallest measurable amount to the largest measurable amount of each as long as there is some
amount of each isomer in the composition, with a reasonable expectation of success because
Zheng does not limit the amount of each isomer in the racemic mixture. The claimed range of
"approximately 97%" would have been obvious over this embodiment because the claimed range
overlaps with Zheng's range. Zheng teaches that individual stereoisomers of the compounds can
be substantially free of other isomers, or can be admixed, for example, as racemates or with all
other or other selected, stereoisomers. The chiral centers of the preferred embodiments can have
the S or R configuration as defined by the IUP AC 197 4 Recommendations (column 13 lines 3 8-45). In view of this teaching, it would have been obvious to form the composition to contain only the S isomer and alternatively to form a composition having a racemic mixture of the two
isomers. The claimed range of approximately 97% enantiomeric excess of the S form is obvious
because Zheng teaches an embodiment where the S isomer is the only isomer in the composition,
which is close enough in number to approximately 97%; and Zheng teaches a racemic mixture
where the amount of the S isomer would have overlapped with approximately 97%.
Regarding claims 8 and 9, it would have been obvious to have formed the composition
with a physiologically acceptable carrier such as a buff er, with a reasonable expectation of
success because Zheng teaches that the composition contains a physiologically acceptable carrier
such as a buffer (column 14 lines 25-33).
Combining prior art elements according to known methods to obtain predictable results
supports obviousness. The instant application was reviewed and there is no evidence that the
claimed ranges are critical.
Maintained Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine
grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or
improper timewise extension of the "right to exclude" granted by a patent and to prevent possible
harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where
the conflicting claims are not identical, but at least one examined application claim is not
patentably distinct from the reference claim(s) because the examined application claim is either
anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg,
140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d
2010 (Fed. Cir. 1993); In re Langi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van
Ornum, 686 F.2d 937,214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
(CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR l.32l(c) or l.32l(d) may
be used to overcome an actual or provisional rejection based on nonstatutory double patenting
provided the reference application or patent either is shown to be commonly owned with the
examined application, or claims an invention made as a result of activities undertaken within the
scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination
under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §
2146 et seq. for applications not subject to examination under the first inventor to file provisions
of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR l.32l(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory
double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be
accompanied by a reply requesting reconsideration of the prior Office action. Even where the
NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection LB. I.
For a reply to a non-final Office action, see 37 CFR 1.11 l(a). For a reply to final Office action,
see 3 7 CFR 1.113 ( c). A request for reconsideration while not provided for in 3 7 CFR 1. 113 ( c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used.
Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in
which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or
PTO/ AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely
online using web-screens. An eTerminal Disclaimer that meets all requirements is autoprocessed
and approved immediately upon submission. For more information about eTerminal
Disclaimers, refer to www.uspto.gov/patents/anply/applying-online/eterminal-disdaimer.
Claims 1 and 5-9 are rejected on the ground of nonstatutory double patenting as being
unpatentable over claims 1-26 of U.S. Patent No. 10,028,503 B2. Although the claims at issue
are not identical, they are not patentably distinct from each other because patented claims are
drawn to compositions for platelet storage, comprising platelets; an RHOA inhibitor selected
inhibitor selected from
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or a pharmaceutically acceptable salt thereof,
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or pharmaceutically acceptable salt thereof, or combinations thereof; and a physiologically
acceptable carrier, wherein said R-G04, S-G04, or a combination thereof, is present in an amount
of at least about 10 uM, where patented claims 21-23 further limit the concentration to from about 10 uM to about 500 uM, from about 25 uM to about 300 uM, and from about 50 uM to about 200 uM, respectively.
Instant claim 1 is obvious over patented claim 1 because the claimed compound is
identical to S-G04 and the claimed concentration range of the compound is close enough to the
patented range that the skilled artisan would have expected them to have the same properties.
Instant claim 5 is obvious over patented claim 1 because the claimed structure is identical
to S-G04 and patented claim 1 teaches an embodiment where the RHOA S-G04 is the only
isomer. This is apparent because patented claim 1 teaches that the RHOA is selected from SG04,
R-G04, or a combination thereof. Therefore, patented claim 1 encompasses embodiments
where only one of the isomers is present in the composition. The claimed range of at least
approximately 94% is obvious because it contains an embodiment where the S isomer is the only
isomer in the composition.
Instant claim 6 is obvious over patented claims 1 and 21-23 because patented claims
teach the same compound as claimed and ranges of concentrations of the compound that overlap
with the ranges disclosed in the instant specification paragraph 0038. It would have been
reasonable to expect the S-G04 compound in patented composition to achieve the claimed
properties when tested under the same conditions as instantly claimed composition because
patented composition contains the same components as claimed where S-G04 is present in a
range of amounts that overlaps with amounts disclosed by applicant's specification. The
concentration ranges in patented claims are sufficient to achieve the claimed properties, absent
evidence to the contrary.
Instant claim 7 is obvious over patented claim 1 because the patented claim encompasses
embodiments where S-G04 is the only isomer present, which renders the claimed range of
approximately 97% of enantiomeric excess of the S isomer obvious because approximately 97%
is close enough to 100% that the skilled artisan would have expected them to have the same
properties. Paragraph 0022 of the instant specification defines "approximately" or "about" to
mean within an acceptable error range of the particular value as determined by one of ordinary
skill in the art. Alternatively, "about" can mean a range of up to 20%, up to 10%, up to 5%, and
up to 1 % of a given value. It would have been reasonable to interpret these teachings to apply to
"approximately" as well because the specification refers to "approximately" and "about" as
equivalents. Thus, approximately 97% is a range of values that extents to a value greater than
97%. Furthermore, patented claim 1 teaches combinations of S-G04 and R-G04, therefore it
would have been obvious to have varied the concentrations of each of the two isomers from the
smallest measurable amount to the largest measurable amount of each as long as there is some
amount of each isomer in the composition. The claimed range of "approximately 97%" would
have been obvious over this embodiment because the claimed range overlaps with the patented
range.
Instant claim 8 is obvious over patented claim I because patented claim I teaches a
pharmaceutically acceptable carrier.
Instant claim 9 is obvious over patented claim 2 which teaches buffer.
The limitation that requires 95% purity of the compound is obvious over patented claims
because patented claims encompass embodiments where S-G04 is the only isomer present. The
claim is drawn to a composition comprising the compound, and the claim does not exclude
anything that could be considered an impurity. The at least 95% purity of a compound is
interpreted as describing the purity of the compound prior to using the compound to form the
composition. Since the claim recites the transitional phrase "comprising" and does not exclude
any compounds that are considered impurities, the prior art composition meets the claimed
limitation.
Claims 1 and 5-9 are rejected on the ground of nonstatutory double patenting as being
unpatentable over claims 1-17 of U.S. Patent No. 10,405,538 B2 (of record in IDS dated
07/18/2022). Although the claims at issue are not identical, they are not patentably distinct from
each other because patented claims are drawn to a method for preserving platelet function and/or
activity in a platelet subjected to cold storage comprising said platelet with a composition
comprising a RHOA inhibitor selected from
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or a pharmaceutically acceptable salt thereof,
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or pharmaceutically acceptable salt thereof, or combinations thereof (claim 1); wherein said
RHOA inhibitor is present in a concentration in said composition in an amount of at least about
10 uM (claim 4) and from about 10 uM to about 500 uM (claim 5); and wherein said
composition comprises a buffer (claims 6 and 7).
Instant claim 1 is obvious over the composition that is formed by patented method where
platelets are contacted with a composition comprising S-G04 in a concentration of at least about
10 uM or a concentration from about 10 to about 500 uM. Thus, the patented method forms a composition comprising platelets, S-G04, and a buffer. The claimed compound is the same as S-G04. The composition formed by patented method would have contained S-G04 in a concentration that less than at least about 10 uM or that is less than 10-500 uM because the addition of platelets would have diluted the amount of S-G04 in the composition. The claimed concentration range of the compound is obvious because it overlaps with the ranges of less than 10 uM.
Instant claim 5 is obvious over patented claims because the claimed structure is identical
to S-G04 and patented claim 1 teaches an embodiment where the RHOA S-G04 is the only
isomer. This is apparent because patented claim 1 teaches that the RHOA is selected from SG04,
R-G04, or a combination thereof. Therefore, patented claim 1 encompasses embodiments
where only one of the isomers is present in the composition. The claimed range of at least
approximately 94% is obvious because it contains an embodiment where the S isomer is the only
isomer in the composition.
Instant claim 6 is obvious over patented claims because patented claims teach the same
compound as claimed and ranges of concentrations of the compound that overlap with the ranges
disclosed in the instant specification paragraph 0038. It would have been reasonable to expect
the S-G04 compound in patented composition to achieve the claimed properties when tested
under the same conditions as instantly claimed composition because patented composition
contains the same components as claimed where S-G04 is present in a range of amounts that
overlaps with amounts disclosed by applicant's specification. The concentration ranges in
patented claims are sufficient to achieve the claimed properties, absent evidence to the contrary.
Instant claim 7 is obvious over patented claims because the patented claim encompasses
embodiments where S-G04 is the only isomer present, which renders the claimed range of
approximately 97% of enantiomeric excess of the S isomer obvious because approximately 97%
is close enough to 100% that the skilled artisan would have expected them to have the same
properties. Paragraph 0022 of the instant specification defines "approximately" or "about" to
mean within an acceptable error range of the particular value as determined by one of ordinary
skill in the art. Alternatively, "about" can mean a range ofup to 20%, up to 10%, up to 5%, and
up to 1 % of a given value. It would have been reasonable to interpret these teachings to apply to
"approximately" as well because the specification refers to "approximately" and "about" as
equivalents. Thus, approximately 97% is a range of values that extents to a value greater than
97%. Furthermore, patented claims teach combinations of S-G04 and R-G04, therefore it would
have been obvious to have varied the concentrations of each of the two isomers from the smallest
measurable amount to the largest measurable amount of each as long as there is some amount of
each isomer in the composition. The claimed range of "approximately 97%" would have been
obvious over this embodiment because the claimed range overlaps with the patented range.
Instant claim 8 is obvious over patented claims 6 and 7 because patented claims teach a
buffer.
Instant claim 9 is obvious over patented claims 6 and 7 which teaches a buffer.
The limitation that requires 95% purity of the compound is obvious over patented claims
because patented claims encompass embodiments where S-G04 is the only isomer present. The
claim is drawn to a composition comprising the compound, and the claim does not exclude
anything that could be considered an impurity. The at least 95% purity of a compound is
interpreted as describing the purity of the compound prior to using the compound to form the
composition. Since the claim recites the transitional phrase "comprising" and does not exclude
any compounds that are considered impurities, the prior art composition meets the claimed
limitation.
Claims 1 and 5-9 are rejected on the ground of nonstatutory double patenting as being
unpatentable over claims 8-23 of U.S. Patent No. 11,172,673 B2 (of record in IDS dated
07/18/2022). Although the claims at issue are not identical, they are not patentably distinct from
each other because patented claims are drawn to a method for improving platelet survival upon
transfusion comprising infusing treated platelets into a subject, wherein prior to said infusing, the
platelets have been treated by contacting platelets with a RHOA inhibitor selected from
inhibitor selected from
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or a pharmaceutically acceptable salt thereof,
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or pharmaceutically acceptable salt thereof (claim 8); wherein the inhibitor is present in a concentration of from about 1 uM to about 500 uM (claim 9); wherein prior to infusing, the platelets have further been contacted with a physiologically acceptable carrier
(claim 12); and wherein the carrier is selected from a buffer (claim 13).
Instant claim 1 is obvious over the composition that is formed by patented method where
platelets are contacted with a composition comprising S-G04 in a concentration of 1-500 uM.
Thus, the patented method forms a composition comprising platelets, S-G04, and a buffer. The
claimed compound is the same as S-G04. The composition formed by patented method would
have contained S-G04 in a concentration that less than 1-500 uM because the addition of
platelets and the buffer would have diluted the amount of S-G04 in the composition. The claimed
concentration range of the compound is obvious because it overlaps with the range that is less
than 1-500 uM.
Instant claim 5 is obvious over patented claims because the claimed structure is identical
to S-G04 and patented claim 1 teaches an embodiment where the RHOA S-G04 is the only
isomer. This is apparent because patented claim 1 teaches that the RHOA is selected from SG04,
R-G04, or a combination thereof. Therefore, patented claim 1 encompasses embodiments
where only one of the isomers is present in the composition. The claimed range of at least
approximately 94% is obvious because it contains an embodiment where the S isomer is the only
isomer in the composition.
Instant claim 6 is obvious over patented claims because patented claims teach the same
compound as claimed and ranges of concentrations of the compound that overlap with the ranges
disclosed in the instant specification paragraph 0038. It would have been reasonable to expect
the S-G04 compound in patented composition to achieve the claimed properties when tested
under the same conditions as instantly claimed composition because patented composition
contains the same components as claimed where S-G04 is present in a range of amounts that
overlaps with amounts disclosed by applicant's specification. The concentration ranges in
patented claims are sufficient to achieve the claimed properties, absent evidence to the contrary.
Instant claim 7 is obvious over patented claims because the patented claim encompasses
embodiments where S-G04 is the only isomer present, which renders the claimed range of
approximately 97% of enantiomeric excess of the S isomer obvious because approximately 97%
is close enough to 100% that the skilled artisan would have expected them to have the same
properties. Paragraph 0022 of the instant specification defines "approximately" or "about" to
mean within an acceptable error range of the particular value as determined by one of ordinary
skill in the art. Alternatively, "about" can mean a range ofup to 20%, up to 10%, up to 5%, and
up to 1 % of a given value. It would have been reasonable to interpret these teachings to apply to
"approximately" as well because the specification refers to "approximately" and "about" as
equivalents. Thus, approximately 97% is a range of values that extents to a value greater than
97%. Furthermore, patented claims teach combinations of S-G04 and R-G04, therefore it would
have been obvious to have varied the concentrations of each of the two isomers from the smallest
measurable amount to the largest measurable amount of each as long as there is some amount of
each isomer in the composition. The claimed range of "approximately 97%" would have been
obvious over this embodiment because the claimed range overlaps with the patented range.
Instant claim 8 is obvious over patented claims 6 and 7 because patented claims teach a
buffer.
Instant claim 9 is obvious over patented claims 6 and 7 which teaches a buffer.
The limitation that requires 95% purity of the compound is obvious over patented claims because
patented claims encompass embodiments where S-G04 is the only isomer present. The claim is
drawn to a composition comprising the compound, and the claim does not exclude anything that
could be considered an impurity. The at least 95% purity of a compound is interpreted as
describing the purity of the compound prior to using the compound to form the composition.
Since the claim recites the transitional phrase "comprising" and does not exclude any compounds
that are considered impurities, the prior art composition meets the claimed limitation.
The instant application was reviewed and there is no evidence that the claimed ranges are
critical.
Response to Arguments
Applicant's arguments submitted in the remarks dated August 3, 2026 were fully
considered but are not persuasive for the following reasons.
Amendment of claim 1 is not sufficient to overcome the rejections because prior art teaches “about 10 uM” as the lower end of the range, and defines “about” in column 3 lines 52-61. The claimed upper end of the claimed range “9 uM” is close enough to “about 10 uM” that a person skilled in the art would have expected them to have the same properties. The specification was reviewed and there is no evidence that the claimed range is critical. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
The data submitted in Appendix I is not sufficient to overcome the rejections with secondary considerations because the data was not submitted in an affidavit nor in a journal publication. Any new or additional data submitted after filing of the application has to be submitted in an affidavit, otherwise it is considered attorney’s opinion.
In the interest of compact prosecution, the data in the Appendix was reviewed and the following were noted. Page 1 describes Figures 1 through 6, however none of the subsequent figures are marked and figure numbers in the actual figures cannot be determined.
Graph C in the “Dose comparison of R-G04 vs. S-G04 in inhibiting human platelet activation” does not have error bars and it cannot be determined whether the values for R and the S isomer are of statistical significance.
The data in the bar graphs A, B, and C in the “Comparable effects by S-G04 (10 uM) and R-G04 (75uM) on 7-day cold stored human platelet activation” would not be sufficient because the plotted bars are indistinguishable and cannot be matched to the legend provided. All data points are printed with a similar shade of gray. Additionally, the resolution is poor and it cannot be determined if there is an overlap in error bars among tested samples.
The data submitted in the bar graphs A and B in the “S-G04 at 10 uM prevent the loss of normal sized platelets similarly as R-G04 at 75 uM during cold storage” would not be sufficient because the plotted bars are indistinguishable and cannot be matched to the legend provided. All data points are printed with a similar shade of gray. Additionally, the resolution is poor and it cannot be determined if there is an overlap in error bars among tested samples.
The line graph and the bar graph in the “Comparable effects by S-G04 (10 uM) and R-G04 (75uM) in preserving murine platelet recovery after transfusion upon 14-day cold storage” would not be sufficient to overcome the rejections because data points plotted in the line graph are indistinguishable and cannot be matched to the legend because they are labeled with similar shades of gray. The bars in the bar graph are also indistinguishable and cannot be matched to the legend because they are all a similar shade of gray.
The examiner maintains that the applicant has not met the requirements set forth in MPEP 716.02 for reasons of record.
Double patenting rejections are maintained because applicant did not traverse the rejections nor filed a terminal disclaimer.
Conclusion
No claims are allowed.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617
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