--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 .
Applicant’s response dated February 23, 2026 is acknowledged.
Priority
This application claims benefit in provisional application 62/838,789 filed on April 25,
2019.
Claim Status
Claims 1, 11-19, 25, 27-35, and 37-42 are pending and examined. Claims 2-10, 20-24,
26, 36, and 43-47 were canceled. Claims 1 and 32 were amended.
Withdrawn Claim Rejections -35 USC§ 112
New matter rejections of claims 1, 11-19, 25, 27-35, and 37-47 are withdrawn because claims 43-47 were canceled and claims 1 and 32 were amended by deleting “is less than” from "wherein the weight amount of bupivacaine free base in the composition is less than the weight amount of polymer network; wherein the diameter of a hydrated composition is more than the diameter of a hydrated composition; and wherein the length hydrated composition is less than the diameter of a hydrated composition" and by adding actual wt.% concentrations of the two components; and by amending the last two “wherein” clauses to recite the correct dimensions in dry and hydrated states.
Indefiniteness rejections of claims 1, 11-19, 25, 27-35, and 37-47 are withdrawn because claims 1 and 32 were amended to clarify the dimensions of the composition in its dry and hydrated states; and claims 43-47 were canceled.
Rejections of the remaining dependent claims are withdrawn because the claims no longer depend from an indefinite base claim or a claim that contains new matter.
New Claim Rejections – 35 USC § 112
Necessitated by Amendment
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 40 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.
Claim 40 does not further limit claim 1 because it broadens the scope of the concentration of bupivacaine free base. Claim 1 requires 27 wt. %, whereas claim 40 requires about 27 wt. % which is broader. This rejection is necessitated by amendment of claim 1.
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.
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 CPR 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, 11-19, 25, 27-35, and 37-42 are rejected under 35 U.S.C. 103 as being
unpatentable over the combination of Sawhney et al. (US 20180085307; Pub. Date: March 29,
2018), Shen et al. (Pub. No.: US 2019/0167574; Pub. Date: Jun. 6, 2019; Filing Date: Dec. 6,
2018), and Jarrett et al. (Patent No.: US 8,563,027; Date of Patent: Oct. 22, 2013).
Regarding claims 1, 11-19, 25, 27-31, 33-35, and 37 Sawhney discloses the use of
hydrogel for delivering active ingredients to the eye. See Para [0002]. The release over time is
taught in Para [0003]. The placement of hydrogel in the iridocorneal angle is taught in Para
[0007] and [0008]. The active agents being disposed in a biodegradable microspheres ([0098]
and [0029]), made of PLGA and PLA (see paragraphs [0027], [0099], [0098], [0043]), wherein
the microparticles have a diameter size of 40 microns or less or 10-53 microns [0136]. The use of
polyethylene glycol as a family of hydrophilic nonionic polymers are used to form the preferred
hydrogel structures. See Para [0032] and wherein the formulation used to deliver the active agent
is combined with trilysine and sodium phosphate ([0040], [0073], and Tables 1 and 8). The use
of an anesthetic, such as bupivacaine is taught in Para [0127]. Sawhney teaches that the depot of
the example 1, comprises the active ingredient travoprost; PLGA microparticles containing
encapsulated travoprost; and the inactive delivery platform, a polyethylene glycol covalently
crosslinked matrix conjugated with fluorescein. Sawhney additionally discloses deposits wherein
the hydrogel is made from the specific components of 4a20k PEG and 8a20K PEG NH2 ((0096]
Table). The hydrogel was made from 8-armed, wherein the precursors include PEG-SAZ [0073],
[0092], with a molecular weight range explicitly contemplated between 5,000 and 35,000 [0075].
The depot was formulated to deliver travoprost polyethylene glycol terminated in succinimidyl
adipate combined with trilysine and sodium phosphate [0054]. The depot was formulated to
deliver travoprost in a sustained release manner for approximately 100 days. See Para [0040].
The treatment of ocular conditions is taught in Para [0024]. Table one teaches the use of
polyethylene glycol, SAP in combination with poly (DL-lactide), NHS Fluorescein, trilysine
acetate, and sodium phosphate.
Although, Sawhney teaches the use of travoprost in the examples, Sawhney discloses
various therapeutic agents that can be used in the (ocular composite depot) including bupivacaine
([0118] and [00127]). Sawhney further discloses wherein the composite depot is made from the
claimed components of 4 and 8 arm PEG SS, SG, SAP and SAZ with a molecular weight
between 15 to 20K 8a20K PEG NH2 ([0096] Table). The matrix being formed by covalently
crosslinking one or more multiple-arm polyethylene glycol precursors, which are hydrolytically
degradable to be multiple-arm polyethylene glycol molecules with arms that terminate in
hydroxyl or carbonyl end group. See Claim 21.
While Sawhney teaches the active agent including bupivacaine ((0118] and [00127]),
Sawhney does not teach bupivacaine in free base form or the microspheres comprising sodium
chloride.
However, in the same field of endeavor of pharmaceutical gels comprising drugs to be
applied to the eye structure [0081], [0119], Shen discloses wherein the gel comprises the active
bupivacaine (abstract) wherein bupivacaine is in free base form ([(0194] and Fig. 1 and [0203]).
Additionally, in the same field of endeavor of hydrogel for release of therapeutic agent to an eye (abstract) wherein said therapeutic agent includes bupivacaine (column 26 line 27), Jarrett
discloses wherein the microparticles comprises sodium chloride and polyvinyl alcohol (column
42 Example 17 A).
With respect to the claim language of the composition being adapted to deliver the
anesthetic to the eye in a sustained manner for a period of about 12 hours or longer, wherein said
composition provides a decreasing bupivacaine free base release rate between 0 hours and 120
hours in tear fluid after administration of the composition to a subject, wherein after ocular
administration, the hydrogel composition comprises a clearance zone that is devoid of the
undissolved bupivacaine free base prior to release of bupivacaine and wherein the size of the
clearance zone increases as a function of the amount of free base release, and wherein the
bupivacaine is present in the tear fluid for at least five days after ocular administration, the
combination of Sawhney and Shen teach, as fully set forth above, the instantly claimed hydrogel
composition with the instantly claimed bupivacaine free base anesthetic to achieve a sustained
release profile of approximately 100 days (Sawhney paragraph [0040]), and therefore the
hydrogel comprising microparticles composition of Sawhney is adapted to deliver the anesthetic
to the eye in a sustained manner for a period of about 12 hours or longer. Moreover, the instant
specification discloses that upon ocular administration the drug gradually diffuses out of the
hydrogel creating a "zone clearance" devoid of undissolved anesthetic (Fig 1A and Fig lB). As
Sawhney discloses the instantly claimed hydrogel and drug, placed into the same environment, it
would be expected that diffusion would occur to create the same type of "zone clearance' and
release profile as described in the instant specification and as claimed. "Products of identical
chemical composition cannot have mutually exclusive properties." A chemical composition and
its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure,
the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d
705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
With respect to the claim language "wherein the hydrogel implant is fully degraded
following at least 90% release of the bupivacaine free base" this is a property of the implant in
terms of release profile and degradation rate. As the combination of Sawhney and Shen discloses
the instantly claimed hydrogel and drug, specifically, the polymer network of 4 and 8 arm PEG
SS, SG, SAP and SAZ with a molecular weight between 15 to 20K 8a20K PEG NH2 ((0096]
Table); wherein the polymer network matrix is formed by covalently crosslinking one or more
multiple-arm polyethylene glycol precursors, which are hydrolytically degradable to be multiple arm polyethylene glycol molecules with arms that terminate in hydroxyl or carbonyl end group
(claim 21), trilysine and sodium phosphate ([0050] and Table 1) and wherein the hydrogel
releases anesthetic, such as bupivacaine [0127] as fully set forth above, the hydrogel of Sawhney
wherein the bupivacaine is in free base form as disclosed by Shen it would be expected to fully
degraded following at least 90% release of the anesthetic. "Products of identical chemical
composition can not have mutually exclusive properties." A chemical composition and its
properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the
properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705,
709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Moreover, the instant claims do not limit the
environment in which the hydrogel degradation or anesthetic release take place. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430,433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775,227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.). MPEP 2112.01 (1).
Regarding claim 32 Sawhney discloses the use of hydrogel for delivering active
ingredients to the eye. See Para [0002]. The release over time is taught in Para [0003]. The
placement of hydrogel in the iridocomeal angle is taught in Para [0007] and [0008]. The active
agents being disposed in a biodegradable micro spheres ({ 0098] and [0029) ), such as PLGA. See Para [0027] and [0029], wherein the microparticles have a diameter size of 40 microns or less or 10-53 microns [0136]. The use of polyethylene glycol as a family of hydrophilic nonionic
polymers are used to form the preferred hydrogel structures. See Para [0032]. The use of an
anesthetic, such as bupivacaine is taught in Para [0127]. Sawhney teaches that the depot of the
example 1, comprises the active ingredient travoprost; PLA microparticles containing
encapsulated travoprost; and the inactive delivery platform, a polyethylene glycol covalently
crosslinked matrix conjugated with fluorescein. It would have been obvious to have formed the
polymer network from 4a20K PEG and trilysine acetate, with a reasonable expectation of
success because Sawhney discloses hydrogels made from the specific components of 4a20k PEG
and trilysine acetate ([0096] Table). The depot was formulated to deliver travoprost in a
sustained release manner for approximately 100 days. See Para [0040]. The treatment of ocular
conditions is taught in paragraph [0024]. Table one teaches the use of polyethylene glycol, SAP
in combination with poly (DL-lactide), NHS Fluorescein and trilysine acetate.
Although, Sawhney teaches the use of travoprost in the examples, Sawhney discloses
various therapeutic agents that can be used in the (ocular composite depot) including bupivacaine
([0118] and [00127]). The matrix being formed by covalently crosslinking one or more multiple arm polyethylene glycol precursors, which are hydrolytically degradable to be multiple-arm
polyethylene glycol molecules with arms that terminate in hydroxyl or carbonyl end group. See
Claim 21.
While Sawhney teaches the active agent including bupivacaine ((0118] and [00127]),
Sawhney does not teach bupivacaine in free base form or wherein the microcapsule comprises
polyvinyl alcohol or sodium chloride.
However, in the same field of endeavor of pharmaceutical gels comprising drugs to be
applied to the eye structure [0081], [0119], Shen discloses wherein the gel comprises the active
bupivacaine (abstract) wherein bupivacaine is in free base form ([(0194] and Fig. 1 and [0203]).
Additionally, in the same field of endeavor of hydrogel for release of therapeutic agent to an eye
(abstract) wherein said therapeutic agent includes bupivacaine (column 26 line 27), Jarrett
discloses wherein the microparticles comprises sodium chloride and polyvinyl alcohol (column
42 Example 17 A).
With respect to the claim language of the composition being adapted to deliver the
anesthetic to the eye in a sustained manner for a period of about 12 hours or longer, wherein said
composition provides a decreasing bupivacaine free base release rate between 0 hours and 120
hours in tear fluid after administration of the composition to a subject, wherein after ocular
administration, the hydrogel composition comprises a clearance zone that is devoid of the
undissolved bupivacaine free base prior to release of bupivacaine and wherein the size of the
clearance zone increases as a function of the amount of free base release, and wherein the
bupivacaine is present in the tear fluid for at least five days after ocular administration, the
combination of Sawhney and Shen teach, as fully set forth above, the instantly claimed hydrogel
composition with the instantly claimed bupivacaine free base anesthetic to achieve a sustained
release profile of approximately 100 days. See Sawhney Para [0040] and therefore the hydrogel
comprising microparticles composition of Sawhney is adapted to deliver the anesthetic to the eye
in a sustained manner fora period of about 12 hours or longer. Moreover, the instant specification
discloses that upon ocular administration the drug gradually diffuses out of the hydrogel creating
a "zone clearance" devoid of undissolved anesthetic (Fig IA and Fig lB). As Sawhney, Shen,
and Jarrett discloses the instantly claimed hydrogel and drug, placed into the same environment,
it would be expected that diffusion would occur to create the same type of "zone clearance" and
release profile as described in the instant specification and as claimed. "Products of identical
chemical composition can not have mutually exclusive properties." A chemical composition and
its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure,
the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d
705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
With respect to the claim language "wherein the hydrogel implant is fully degraded
following at least 90% release of the bupivacaine free base" this is a property of the implant in
terms of release profile and degradation rate. As the combination of Sawhney and Shen discloses
the instantly claimed hydrogel and drug, specifically, the polymer network of 4a20K PEG SG
and trilysine acetate ([0096] Table); wherein the polymer network matrix is formed by
covalently crosslinking one or more multiple-arm polyethylene glycol precursors, which are
hydrolytically degradable to be multiple-arm polyethylene glycol molecules with arms that
terminate in hydroxyl or carbonyl end group (claim 21), trilysine and sodium phosphate ([0050]
and Table 1) and wherein the hydrogel releases anesthetic, such as bupivacaine [0127] as fully
set forth above, the hydrogel of Sawhney wherein the bupivacaine is in free base form as
disclosed by Shen it would be expected to fully degraded following at least 90% release of the
anesthetic. "Products of identical chemical composition can not have mutually exclusive
properties." A chemical composition and its properties are inseparable. Therefore, if the prior art
teaches the identical chemical structure, the properties applicant discloses and/or claims are
necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Moreover, the instant claims do not limit the environment in which the hydrogel degradation or
anesthetic release take place.
Where the claimed and prior art products are identical or substantially identical in
structure or composition, or are produced by identical or substantially identical processes, a
prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d
1252, 1255, 195 USPQ 430,433 (CCPA 1977). "When the PTO shows a sound basis for
believing that the products of the applicant and the prior art are the same, the applicant has the
burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658
(Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the
prior art products do not necessarily possess the characteristics of the claimed product. In re
Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d
775,227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-
0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium
alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal
Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely
within the claimed ranges. The court went on to say that it was immaterial what properties the
alloys had or who discovered the properties because the composition is the same and thus must
necessarily exhibit the properties.). MPEP 2112.01 (1).
Regarding claim 37, Sawhney discloses wherein the active agent is 50% w/w or 100%
w/w of the particles used to encapsulate the agent [0110] meeting the instantly claimed 1:1
weight ratio. It would have been obvious to a person skilled in the art to use the exact arms for
polyethylene glycol unit, motivated by the teachings of Sawhney, which teaches multiple arms
for PEG unit in the polymer network. The substitution of bupivacaine for travoprost would have
been obvious to a person skilled in the art, considering that Sawhney teaches the use of
bupivacaine in the biodegradable hydrogel composition. The use of amorphous or crystalline
polymer forms is taught in Para [0099]. The sustained release manner for the period of hundred
days is also taught by Sawhney. The intracanalicular and fornix administration is taught in Para
[0147]. The hydrogel being fully degraded is taught in Para [0036], [0037], [0042] and claims 2
and 7. The determination of the period the bupivacaine will be delivered to the eye is considered
to be within the skill of the artisan in the absence of evidence to the contrary.
It would have been prima facie obvious to one of ordinary skill in the art at the time of
filing to combine Sawhney et al. and Shen et al. to utilize the free base form of bupivacaine as
disclosed by Shen in the hydrogel for delivering active ingredients to the eye [0002], wherein the
active agents being disposed in a biodegradable microspheres ([0098] and [0029]), such as
PLGA. See Para [0027] and [0029], as disclosed by Sawhney as a matter of combining prior art
elements according to known methods to yield predicable results, as instantly claimed, with a
reasonable expectation of success. One of ordinary skill would be motivated to use the free base
form of bupivacaine as it has a lower water solubility than the salt form and delays the release of
the active agent ([0203] and [0202]) and the free base form extends the analgesic response due at
least in part to the slower dissolution ((0194] and Fig. 1) as evidenced by the teachings of Shen.
One who would have practiced this invention would have had reasonable expectation of
success because Sawhney had already disclosed a hydrogel for delivering active ingredients to
the eye [0002], wherein the active agents being disposed in a biodegradable microspheres
([0098] and [0029]), while Shen provided guidance with respect to the use of bupivacaine is in
free base form ([0194] and Fig. 1 and [0203]) of pharmaceutical gels comprising drugs to be
applied to the eye structure [0081], [0119]. It would have only required routine experimentation
to utilize bupivacaine in free base form as required by the instantly claimed invention.
It would have been prima facie obvious to one of ordinary skill in the art at the time of
filing to combine Sawhney et al., Shen et al., and Jarrett to include sodium chloride and PV A in
the PLGA microparticles in the hydrogel for delivering active agents to the eye as disclosed by
Jarrett (abstract and column 42 Example 17 A) as a matter of combining prior art elements
according to known methods to yield predicable results, as instantly claimed, with a reasonable
expectation of success. One of ordinary skill would be motivated to include sodium chloride and
PVA as they allow for denser microspheres with increased drug encapsulation as evidenced by
Jarrett (column 47 lines 30-51). One who would have practiced this invention would have had
reasonable expectation of success because Sawhney had already disclosed a hydrogel for
delivering active ingredients to the eye [0002], wherein the active agents being disposed in a
biodegradable microspheres ({ 0098] and [0029]), Shen provided guidance with respect to the use of bupivacaine is in free base form ([0194] and Fig. 1 and [0203]) of pharmaceutical gels
comprising drugs to be applied to the eye structure [0081], [0119]) while Jarrett disclosed
including sodium chloride and PVA in the hydrogel for delivering active agents to the eye
(abstract and column 42 Example 17 A). It would have only required routine experimentation to
include sodium chloride and PV A required by the instantly claimed invention.
Therefore, the claimed invention would have been prima facie obvious to one of ordinary
skill at the time of filing.
Claim 1 require the polymer network to comprise the reaction product of a plurality of
4a20K polyethylene glycol (PEG) succinimidyl glutarate (SG) units and trislysine acetate,
sodium phosphate monobasic, and sodium phosphate dibasic. It would have been obvious to
have formed the polymer network from PEG and trilysine, with a reasonable expectation of
success because Sawhney teaches forming the inactive delivery platform from a polyethylene
glycol (PEG) and trilysine. It would have been obvious to have selected 4a20K PEG
succinimidyl glutarate as the PEG because Sawhney teaches hydrogels formed from trilysine and
4a20K PEG SG (paragraph 0096). It would have been obvious to have selected trilysine acetate
because Sawhney teaches forming a delivery depot with trilysine acetate (paragraph 0191). It
would have been obvious to have used sodium phosphate dibasic and a sodium phosphate
monobasic in the synthesis of the polymer network, with a reasonable expectation of success
because Sawhney teaches using the combination of sodium phosphate dibasic and sodium
phosphate monobasic in the synthesis of a polymer network from trilysine acetate and PEG.
Combining prior art elements according to known methods to obtain predictable results supports obviousness.
Regarding claim 38, Sawhney teaches compositions comprising a PEG derivative in
a concentration of 34.6, 54, and 36 w/w % (paragraph 0149), and compositions comprising a
PEG derivative in a concentration of 50.9 and 60.9 w/w % (paragraph 0191). It would have been
obvious to have formed the composition in Sawhney having a concentration of 4a20K PEG in a
concentration of from 34.6 w/w % to 60.9 w/w % because Sawhney teaches these two endpoints
of concentrations in the examples. The claimed concentration range is obvious because it is
encompassed by the prior art range.
Regarding new claim 39, Sawhney teaches compositions comprising trilysine acetate in a
concentration of 0.4 and 0.6 w/w % (paragraph 0149), and compositions comprising trilysine
acetate in a concentration of 3.5 and 4.2 w/w (paragraph 0191). It would have been obvious to
have formed Sawhney's composition having trilysine acetate in a concentration range from 0.4 to
4.2 w/w %, with a reasonable expectation of success because Sawhney teaches said end points in
exemplified compositions and it would have been obvious to vary the concentration range
between the two endpoints. The claimed concentration range is obvious because it is
encompassed by the prior art range.
Regarding new claim 40, Sawhney teaches that a xerogel comprises the agent in an
amount of 1-75% w/w (paragraph 0137). It is apparent from the teachings that agent refers to
therapeutic agent. Table 1 in paragraph 0149 teaches examples of compositions having 25 .5 wt.
% of travoprost. Example in paragraph 0191 teaches a composition having 18 .5 wt. % and 21.9
wt. % of travoprost. It would have been obvious to have formed the composition to comprise free
base bupivacaine in a concentration of 1-75 w/w %, with a reasonable expectation of success
because Sawhney teaches 1-75 w/w % as a suitable concentration range for therapeutic agent and
exemplifies compositions having 25.5, 18.5, and 21.9 w/w % of therapeutic agent. The claimed
concentration is obvious because it is encompassed by the prior art range.
Regarding new claim 41, Sawhney teaches compositions comprising sodium phosphate
in a concentration of 3.3, 3, and 5 w/w % (paragraph 0149), and compositions comprising
sodium phosphate monobasic in a concentration of 1 and 1.2 w/w % (paragraph 0191). It would
have been obvious to have formed Sawhney's compositions to comprise sodium phosphate
monobasic in a concentration range from 1 to 5 w/w %, with a reasonable expectation of success
because Sawhney teaches a composition comprising 1 w/w % sodium phosphate monobasic and
teaches a composition comprising 5 w/w % of sodium phosphate, without specifying if it is
monobasic. The claimed concentration range is obvious because it overlaps with the prior art
range. Alternatively, the claimed range is obvious because it encompasses 1 w/w %, which is an
exemplified concentration of sodium phosphate monobasic in the composition.
Regarding new claim 42, Sawhney teaches compositions comprising sodium phosphate
in a concentration of 3.3, 3, and 5 w/w % (paragraph 0149), and compositions comprising
sodium phosphate monobasic in a concentration of 1.8 and 2.1 w/w % (paragraph 0191). It
would have been obvious to have formed Sawhney's compositions to comprise sodium
phosphate dibasic in a concentration range from 1.8 to 5 w/w %, with a reasonable expectation of
success because Sawhney teaches a composition comprising 1.8 w/w % sodium phosphate
dibasic and teaches a composition comprising 5 w/w % of sodium phosphate, without specifying
if it is dibasic. The claimed concentration range is obvious because it overlaps with the prior art
range.
The three amended "wherein" clauses in claims 1 and 32 are obvious for the following
reasons.
According to Table 1 in Example 1 (paragraph 0149), the drug is present in a
concentration of 25.5 wt. %, and the polymer network is made from at the least the following
components: 34.6 wt. % 8al5K PEG SAP, 0.4 wt. % trilysine acetate, and 3.3 wt. % sodium
phosphate.
Sawhney teaches that a xerogel comprises the agent in an amount of 1-75% w/w (paragraph 0137). It is apparent from the teachings that agent refers to therapeutic agent. Table 1 in paragraph 0149 teaches examples of compositions having 25 .5 wt. % of travoprost. Example in paragraph 0191 teaches a composition having 18 .5 wt. % and 21.9 wt. % of travoprost. It would have been obvious to have varied the concentration of bupivacaine free base in a range of 1-75 w/w %, with a reasonable expectation of success because Sawhney teaches 1-75 w/w % as a suitable concentration range for therapeutic agent and exemplifies compositions having 25.5, 18.5, and 21.9 w/w % of therapeutic agent. The claimed concentration of 27 wt. % of bupivacaine free base is obvious because it is encompassed by 1-75 wt. %, and alternatively because it is close enough in number to 25.5 wt. % that person of ordinary skill in the art would have expected the two values 27 wt. % and 25.5 wt. % to have the same properties and effects.
It would have been further obvious to have modified the composition in example 1 by varying the concentration of the multi-arm PEG SAP the range of 34.6-50.9 wt. %, with a reasonable expectation of success because Sawhney teaches in example 5 that the multi-arm PEG SAP is present in a concentration of 50.9 wt. % (example 5 in paragraph 0191).
The polymer network in example 1 is made from at the least the following components: 34.6 wt. % 8al5K PEG SAP, 0.4 wt. % trilysine acetate, and 3.3 wt. % sodium phosphate, which adds up to 38.3 wt. %. By increasing the weight of the multi-arm PEG SAP to 50.9, the amount of the network increases to 54.6 wt. %. Therefore, concentration of the polymer network ranges from 38.3 wt. % to 54.6 wt. %, which renders the claimed concentration of 43 wt. % obvious because it is encompassed by the prior art range.
Sawhney teaches that the composite depot may be made in a size and shape suitable to its intended site of use, therefore it would have been obvious to have formed the composition in the shape of a rod because Sawhney teaches that the composition may be rod shaped (paragraphs 0113 and 0138). Regarding the limitations related to diameter and length, it would have been obvious to have formed the rod shaped depot having a diameter in the range of 0.1-10 mm, with a reasonable expectation of success because Sawhney teaches 0.1-10 mm as a suitable range of depot diameters (paragraph 0135). Sawhney does not limit the diameter to hydrated diameter or dry diameter and it would have been obvious to have formed the depot having the diameter of 0.1-10 mm whether the depot is dry or hydrated. The claimed diameters are obvious because they are encompassed by the prior art range.
It would have been obvious to have formed the rod shaped depot having a length of 0.1-10 mm, with a reasonable expectation of success because Sawhney teaches 0.1-10 mm as a suitable length of the composite depot (paragraph 0135). Sawhney does not limit the length to hydrated length or dry length and it would have been obvious to have formed the depot having the length of 0.1-10 mm whether the depot is dry or hydrated. The claimed lengths are obvious because they are encompassed by the prior art range.
Sawhney additionally teaches an embodiment of a depot having a 0.2 to 1.5 mm diameter and 0.5-5 mm length, wherein in regards to these dimensions, artisans will immediately appreciate that all ranges and values between the explicitly stated bounds are contemplated, with, e.g., any of the following being available as an upper or lower limit: 0.2, 0.3, 0.5, 0.7, 0.9, 1, 1.1, 1.3, 1.5 mm (diameter) or 0.5, 0.6, 0.8, 1, 1.2, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 mm (length) (paragraph 0144). This embodiment is not limited to a hydrogel (hydrated state) or a xerogel (dry state), therefore it would have been obvious to have formed the composition having these dimensions in either the dry or hydrated state, with a reasonable expectation of success because Sawhney does not limit the dimensions to hydrated or dry states.
It would have been obvious to have formed the rod shaped composition where it undergoes a change in shape after its xerogel form has been exposed to aqueous media where upon exposure it decreases in length and increases in diameter, with a reasonable expectation of success because Sawhney teaches Figure 3, where a xerogel prepared from a matrix, e.g., hydrogel or organogel, undergoes a change in shape after it has been exposed to aqueous media. For example, it may decrease length and increase in other dimensions. In case of a rod, the other dimension would be a diameter. This embodiment meets the claimed embodiment, where a hydrated diameter is larger than a dry diameter and where a hydrated length is shorter than a hydrated length of the composition. A xerogel is dried form of a hydrogel.
Response to Arguments
In the remarks dated February 23, 2026, applicant traversed the rejections in view of
amendments to claims 1 and 32, and argued that the composition of the prior art increases in both
diameter and length upon hydration and cited Sawhney's examples 5 and 6 to show that the
diameter and the length increase upon hydration of a dry composition.
Applicant's arguments and newly added limitations were fully considered but are not
persuasive and sufficient to obviate the grounds of rejection because Sawhney teaches embodiments of compositions which upon hydration decrease in length and increase in other dimensions. The rejection is based on a rod shaped composition, therefore the other dimension would be the diameter. Figure 3, shows three embodiments of hydrogels that shorten in length, lengthen, and remain the same upon going from dry state to hydrated state. The embodiment where the rod shortens in length, the diameter increases because the diameter is the only other dimension in the rod. Sawhney is not limited by examples 5 and 6, and in view of the general teachings of the references the newly added limitations are obvious.
Arguments against Shen and Jarrett are not persuasive because Sawhney is not deficient for reasons described above.
Conclusion
No claims are allowed.
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.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617