-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 March 2, 2026 is acknowledged.
Priority
This application is a divisional of 16/826,577 filed on 03/23/2020, which claims benefit
in provisional application 62/822,319 filed on 03/22/2019.
Claim Status
Claims 1, 2, 7-12, and 16-26 are pending and examined. Claims 3-6 and 11-15 were
canceled.
Maintained Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C.
102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the
statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a
new ground of rejection if the prior art relied upon, and the rationale supporting the rejection,
would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness
rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.
Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35
U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the
claims the examiner presumes that the subject matter of the various claims was commonly
owned as of the effective filing date of the claimed invention(s) absent any evidence to the
contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and
effective filing dates of each claim that was not commonly owned as of the effective filing date
of the later invention in order for the examiner to consider the applicability of 35 U.S.C.
102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 11, 12, and 20-26 are rejected under 35 U.S.C. 103 as being unpatentable
over the combination of Kipshidze et al. (Patent No.: US 9,572,700; Date of Patent: Feb. 21,
2017-ofrecord in PTO-892 dated 01/31/2024), Fu et al. (Radiology Oct. 2018; 289:83-89;
Online Pub. Date; Ju. 10. 2018 - of record in PTO-892 dated 01/31/2024), Hohn et al. (Pub.
No.: WO 2015/033093; Pub. Date: March 12, 2015 - of record in PTO-892 dated 06/11/2024),
and Caine (Journal of the Mechanical Behavior of Biomedical Materials, 2018, 78, 46-55).
The claims recite a method of bariatric arterial embolization, a method of inducing
weight loss or of slowing weight gain in a subject in need thereof, and a method for the treatment
of obesity in a subject in need thereof, each of the methods comprising delivering to a blood
vessel supplying a gastric fundus of a subject, an effective amount of a composition comprising a
population of polymeric microspheres comprising a polymer and having native size distribution
in which not more than 10% of the microspheres have a diameter of less than 120 microns and
not more than 10% the microspheres have a diameter greater than 200 microns, wherein the
polymeric microspheres have a mean compression modulus ranging from 2,000 kPa to 30,000
kPa and wherein the polymer comprises polyvinyl alcohol having pendant iodinated aromatic
groups.
Kipshidze discloses a method of promoting weight loss and treating obesity by introducing a microcatheter into the gastric artery to deliver a plurality of particles with the distal
portion of the subjects left gastric artery (title and column l lines 39-55 and column 4 lines 14-
39) which involves modifying the atrial blood flow to the gastric fundus by means of
percutaneous endovascular flow reduction in the distal portion of the left gastric artery (column 2
lines 14-17). The particles disclosed by Kipshidze are preferably made of polyvinyl alcohol
(column 2 lines 34-55). Additionally, Kipshidze discloses that the size of the particles is
important to their use in such embolization, noting that 50-100 um particles "can result in
mucosal necrosis of the [stomach's] fundus, and gastric ulcers" as well as "non-target
embolization of, for example, the esophagus, the liver, and/or the spleen." (column 67 through
column 6 line 7) and particles of the size from 700-1,000 um can result in gastric ulcers, and
non-target embolization of, for examples, the esophagus, the liver and the spleen (column 4 lines
6- 10). According to Kipshidze, "by using the correct size of the correct material and delivering
it to the correct location, many of the problems associated with other approaches are avoided,
and the [bariatric arterial embolization] procedure can be made safe." (page 4 lines 27-30).
Kipshidze does not disclose the claimed particle size range, polyvinyl alcohol
microspheres having pendant iodinated aromatic groups, and microspheres having a mean
compression modulus ranging from 2000 kPa to 30,000 kPa.
However, in the same field of endeavor of bariatric arterial embolization using
microspheres (Title), Fu discloses that size ranges from 300-500 micron were not sufficient to
suppress weight gain or reduce ghrelin expressing cells in pigs (page 86 Figure 3) and that
smaller microspheres of the size range of 100-300 um were more effective than larger
microspheres in reducing weight gain and suppressing fundal and gastric body ghrelin expression
(page 84 column 1 Implications for Patient care 88 column 2 paragraph 3). The findings suggest
that BAE with smaller embolic microspheres may be more effective at reducing long-term
weight gain and suppressing fundal ghrelin expression than sham treatment but may cause more
gastric ulceration. Large embolic microspheres were not effective compared with sham
treatment for measurable variables. In patients with obesity, GCEs have much higher density and
expression levels in the gastric mucosa than in normal-weight individuals. Such high
concentration of GECs in the stomach makes ghrelin-targeting interventions conceivable by
gastric artery embolization (Discussion on page 87). In conclusion, smaller embolic
microspheres appear to be more effective than larger microspheres in reducing weight gain
and suppressing fundal and gastric body ghrelin expression without compensatory upregulation
of GECs in other parts of the stomach for up to 16 weeks. However, the high ulceration rate in
pigs embolized with smaller microspheres highlights the need to balance safety and efficacy
when choosing embolic particle size before clinical translation (paragraph bridging pages 88-89).
Additionally, in the same field of endeavor of microparticles made of poly(vinyl alcohol)
used for embolization (page l lines 13-18), Hohn discloses iodinated polyvinyl alcohol (page 2
line 8) wherein the iodinated polyvinyl alcohol is synthesized utilizing a low molecular weight
aldehyde comprising iodine and coupling it to the PVA by reactions with 1,3 diol groups or 1,3
glycols of the polymer which forms a cyclic acetal or a dioxane ring, wherein the halogenated
group with the iodine comprises an aromatic group (page 4 line 17 through page 5 line 2).
Imaging of embolization procedures is important because it provides the clinician with
visual feedback both during and after the procedure. In this way, the clinician can monitor the
precise location of the embolic material and ensure that it is administered to, and remains in, the
correct position in the vasculature, thus improving procedural outcomes and reducing procedural
risk. However, imaging is currently only possible when using inherently radiopaque embolic
materials or by mixing non-radiopaque embolic particles with radiopaque materials. For
example, iodinated polyvinyl alcohol (1-PVA) is a radiopaque embolic material in the form of a
viscous liquid which precipitates in aqueous conditions such as those encountered in vivo.
However, embolization with precipitating liquid can be inconsistent in terms of controlling the
precise location at which the embolus is formed and there is always a risk of precipitation
occurring in an undesired location outside the target area (page 2 lines 1-13).
The teachings of Caine are related to embolic microspheres (Abstract and Introduction).
Table 4 on the bottom of page 50 provides data for compressive modulus for commercially
available embolic microspheres. The range of compressive moduli ranges from 1.6±0.3 kPa to
27,200±5460 kPa.
Regarding claims 1, 11, and 20, 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 practiced
a method of promoting weight loss and treating obesity by introducing a microcatheter into the
gastric artery to deliver a plurality of 300-500 micron compressible microspheres comprising
polyvinyl alcohol with the distal portion of the subjects left gastric artery which involves
modifying the atrial blood flow to the gastric fundus by means of percutaneous endovascular
flow reduction in the distal portion of the left gastric artery, with a reasonable expectation of
success because Kipshidze teaches embolization in order to promote weight loss and treat
obesity by introducing a microcatheter into the gastric artery to deliver a plurality of particles
with the distal portion of the subjects left gastric artery (title and column l lines 39-55 and
column 4 lines 14- 39) which involves modifying the arterial blood flow to the gastric fundus by
means of percutaneous endovascular flow reduction in the distal portion of the left gastric artery
(column 2 lines 14-17), where particles are compressible and formed from polyvinyl alcohol and
a particle size in the range of 300-500 micron (column 2 lines 28-39).
It would have been obvious to have modified the method of Kipshidze by replacing the
300-500 microns microspheres with microspheres having a particle size in the range of 100-300
microns, with a reasonable expectation of success because it was known from Fu that
microspheres of the size range of 100-300 microns were more effective than microspheres
having a 300-500 micron size in reducing weight gain and suppressing fundal and gastric body
ghrelin expression, and Fu teaches that BAE with smaller microspheres may be an effective,
minimally invasive approach for the treatment of obesity. One of skill would have been
motivated to make this modification because the modification would have improved Kipshidze's
method.
The claimed native size distribution is obvious over 100-300 microns because the ranges
overlap. The specification was reviewed, and the claimed native size distribution is not a critical
parameter. The claimed microspheres are required to have particles in which no more than 10%
of the microspheres have diameter of less than 120 microns and no more than 10% of the
microspheres have a diameter greater than 200 microns, which also means that at least 80% of
particles have a diameter in the range of 120-200. The claimed parameters of the native size
distribution extend the particle size range from 1 micron to 1000 microns because no more than
10% of particles having a diameter less than 120 microns extends the range down to 1 micron
and no more than 10% of particles having a diameter of greater than 200 microns extends the
range up to 1000 microns. The claims require microspheres which are known as spherical
particles having a diameter in the micron range or 1-1000 microns, therefore the claimed
microspheres are limited to this range. The specification was reviewed, and there is no evidence
that the claimed particle size distribution is critical.
Claims 21-23 further define the native size distribution by requiring no more than 5% of
the microspheres to have a diameter of less than 100 microns and not more than 5% of
microspheres to have a diameter greater than 200 microns, which also means that at least 90% of
particles have a diameter in the range of 100-200. The claimed parameters of the native size
distribution extend the particle size range from 1 micron to 1000 microns because no more than
5% of particles having a diameter less than 100 microns extends the range down to 1 micron and
no more than 5% of particles having a diameter of greater than 200 microns extends the range up
to 1000 microns. The claims require microspheres which are known as spherical particles having
a diameter in the micron range or 1-1000 microns, therefore the claimed microspheres are
limited to this range. The claimed particle size range is obvious because it overlaps with 100-300
micron range. The specification was reviewed, and there is no evidence that the claimed particle
size distribution is critical.
Claims 24-26 further define the native size distribution by requiring the particle size in
the range of 100-200 microns. The claimed range is obvious because it overlaps with 100-300
microns.
It would have been further obvious to have replaced polyvinyl alcohol with iodinated
polyvinyl alcohol synthetized utilizing a low molecular weight aldehyde comprising iodine and
coupling it to the PVA wherein the halogenated group with the iodine comprises an aromatic
group, with a reasonable expectation of success because Hohn provided guidance with respect to
polymeric microspheres of iodinated polyvinyl alcohol (page 2 line 8) wherein the iodinated
polyvinyl alcohol is synthesized utilizing a low molecular weight aldehyde comprising iodine
and coupling it to the PVA wherein the halogenated group with the iodine comprises an aromatic
group (page 4 line 17 through page 5 line 2). It would have only required routine
experimentation to modify the microspheres of Kipshidze to comprise polyvinyl alcohol
microspheres with pendant iodinated aromatic groups as required by the claimed invention. One
of ordinary skill would have been motivated to use microparticles made from PVA with pendant
iodinated aromatic groups as they are known to be a radiopaque embolic material that can
provide the clinician with visual feedback during and after an embolization procedure to ensure
the embolic material is administered to and remains in the correct position during the procedure
(page 2 lines 1-10 and page 4 lines 1-5).
It would have been obvious to have formed the microspheres for use in Kipshidze's
embolization method to have a compression modulus from about from 1.6±0.3 kPa to 27,200±
5460 kPa, with a reasonable expectation of success because Caine teaches compressive moduli
for twenty commercially available compositions of embolic microspheres where the lowest
compression modulus is 1.6±0.3 kPa and the highest compression modulus is 27,200±5460 kPa.
It would have been obvious to have varied the compression modulus within said range because said range of compression modulus is suitable for microspheres intended for embolization. The claimed particle size range is obvious because it overlaps with prior art range. Claimed compression modulus range is obvious because it overlaps with prior art range. Present
application was reviewed and there is no evidence that claimed particle size range and
compression modulus range are critical.
Regarding claims 2 and 12, Kipshidze discloses that the method of delivery of the
microspheres is practiced by introduction through a catheter (column l lines 39-55 and column 3
lines 5-44).
Therefore, the claimed invention would have been prima facie obvious tone of ordinary
skill in the art at the time of filing.
Claims 7-10 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over the
combination of Kipshidze et al., Fu et al., Hohn et al., and Caine as applied to claims 1, 2, 11, 12,
and 20-26 above, and further in view of Lewis et al. (Pub. No.: WO: 2006/013376; Pub. Date:
Feb. 9, 2006 - of record in PTO-892 dated 01/31/2024), and Lloyd (Standard Sieves and Mesh
Sizes 2000 delloyd.5Omegs.com/moreinfo/mesh.html - of record in PTO-892 dated
01/31/2024).
Kipshidze et al., Fu et al., Hohn et al., and Caine are relied upon as summarized above,
however they do not teach the limitations of claims 7-10 and 16-19.
However, in the same field of endeavor of delivery of microparticles for an embolic
effect of vessels in patients in need of embolization therapy (page 16 lines 15-19 page 7 line 30
through page 8 line 3) wherein the microparticles comprises polyvinyl alcohol (abstract), Lewis
discloses microspheres comprising crosslinked polyvinyl alcohol - AMPS microspheres (page 23
and 24) and sieving the microspheres into fractions based upon mesh size of 100 to 1200 um, to
obtain a distribution including 100 to 300 um particle size (page 26 top). Lewis discloses the
same method as described in the instant specification for making the microspheres (Instant
specification para 0105).
Additionally, in the same field of endeavor of seizes for microparticles, Lloyd discloses
that sieve standard Mesh Sizes include 160 and 212 microns (Third column DIN-4188).
It would have been prima facie obvious to have formed the composition of microspheres
of Kipshidze as modified with Fu, Hohn, and Caine, using polyvinyl alcohol-AMPS and sieving
into fractions as disclosed by Lewis and Lloyd to obtain a microsphere population having a
particle size in the range of 100-300 microns, with a reasonable expectation of success because
Lewis teaches sieving a population of microparticles having a size of 100-1200 microns into
fractions to obtain a distribution of particles in the range of 100-300 microns. Kipshidze's
modified method requires a particle size range of 100-300 microns. One of skill would have been
motivated to use microspheres made from PV A as they are known to be particularly suitable as
hydrogels and are well known in the art (page 5 lines 10-14) and the crosslinked PVA-AMPS
microspheres are water insoluble, but biodegradable, substantially biostable, and water swellable
so that a drug may be released substantially by erosion of the polymer matrix, so that a drug may
be released by erosion of the polymer matrix (page 7 lines 16-30) utilizing a commercially
available mesh to achieve the size disclosed by Lewis. One of skill would have had a reasonable
expectation of success because Kipshidze and Fu disclosed a method of delivery of particles for
embolization in order to promote weight loss and treat obesity by introducing a microcatheter
into the gastric artery to deliver a plurality of particles with the distal portion of the subjects left
gastric artery (title and column l lines 39-55 and column 4 lines 14-39) which involves
modifying the atrial blood flow to the gastric fundus by means of percutaneous endovascular
flow reduction in the distal portion of the left gastric artery (column 2 lines 14-17), while Lewis
disclose a method of preparing polymeric microspheres (page 23 and 24) and sieving the
microspheres into fractions based upon mesh size of 100 to 1200 micron, to obtain a distribution
including 100 to 300 micron particle size (page 26 top) for the purpose of embolization of
vessels (page 8 lines 1-5). It would have only required routine experimentation to modify the
microparticles of Kepshidze to comprise polyvinyl alcohol-AMPS in the claimed diameter
range with the inherent features of penetration values.
With respect to the penetration values in claims 7-10 and 16-19, it would have been
reasonable to expect Kipshidze's microspheres as modified in view of Fu, Hohn, Caine, Lewis,
and Lloyd to have a range of penetration values that at least overlap with the claimed ranges of
penetration values when administered under the same conditions as claimed microspheres
because Kipshidze' s modified microspheres meet all the of structural limitations of claimed
microspheres and Kipshidze's microsphere population of 100-300 micron size was obtained
using sieving method. The office does not have the facilities and resources to provide the factual
evidence needed in order to establish that the composition of the prior art does not possess the
properties of the claimed composition. In the absence of evidence to the contrary, the burden is
on Applicant to prove that the claimed composition is different from that taught by the prior art
and to establish patentable differences. Present application was reviewed and there is no
evidence that claimed penetration values are critical.
See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ
2"4 1992 (PTO Bad. Pat. App. & Int. 1989). 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, 9171 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 USPO 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.
Therefore, the claimed invention would have been prima facie obvious tone of ordinary
skill in the art at the time of filing.
Response to Arguments
Applicant’s arguments submitted in the remarks dated March 2, 2026 were fully considered but are not persuasive for the following reasons.
Kipshidze and Fu tested 300-500 micron particle compositions on different subject populations, thus the skilled artisan would not have expected their results to be the same. The rejection is not based on a rationale that the skilled artisan would have expected results observed for 100-300 micron particles in Fu to be reproduced with the particles of Kipshidze. The rejection is based on a rationale that there would have been a reasonable expectation of success in practicing Kipshidze’s method using 100-300 micron particles as described by Fu. One would have had a reasonable expectation of success because Fu teaches that 100-300 micron particles may be used for treating obesity.
Kipshidze teaches that particles are commercially available and include particles made from PVA, and particles made from trisacryl crosslinked with gelatin (column 2 lines 40-47). Kipshidze’s discussion of the effects of particle size in columns 3 and 4 are not limited to particles made from any specific material, and it would have been reasonable to apply said teachings to particle made from any of the materials discussed by Kipshidze. Argument’s related to differences in material between PVA particles and trisacryl crosslinked gelatin particles are not persuasive because applicant did not present any evidence that Kipshidze’s teachings about the effects of particle size and Fu’s teachings about the effects of particle size would not be applicable to particles made from any of the materials taught by Kipshidze and Fu. Neither Fu nor Kipshidze teach that the effects of particle size are unique to any specific material from which the particles are made.
It cannot be conclusively determined that the physiological differences between test subjects were the reason as to why 300-500 micron particle size was not sufficient to suppress weight gain or reduce ghrelin expressing cells in the young, healthy, growing swine in Fu, whereas 300-500 micron particles yielded significant progressive weight loss and reduction on plasma ghrelin levels in the obese adult swine. Kipshidze discussed the effects of particles having a range of particle sizes of 50-100 microns, 300-500 microns, and 700-1000 microns, and concluded that 300-500 micron range provided the best results out of the three ranges. Fu compared the effects of particle having a particle size range of 100-300 microns to the effects of particles having a particle size range of 300-500 microns, and concluded that 100-300 micron range provided the best results. Kipshidze selected 300-500 micron range because it produced the most effective result relative to the other two ranges. Kipshidze did not test 100-300 micron range, thus it cannot be concluded that 100-300 micron particles would have produced less effective results compared to the 300-500 micron particles, in obese adult swine. Even if physiological differences between the two sets of test subjects affected the effectiveness of particles in BAE, that still does not take away the fact that 100-300 micron particles were shown to be effective for weight loss and suppression of ghrelin, and superior relative to 300-500 micron particles.
In response to applicant's argument that the examiner's conclusion of obviousness is
based upon improper hindsight reasoning, it must be recognized that any judgment on
obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so
long as it takes into account only knowledge which was within the level of ordinary skill at the
time the claimed invention was made, and does not include knowledge gleaned only from the
applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392,
170 USPQ 209 (CCPA 1971). Motivation and determination of a reasonable expectation of
success in modifying Kipshidze by Fu is present in Fu, which states that smaller (100-300
micron) embolic microspheres appear to be more effective than larger (300-500 micron)
microspheres in reducing weight gain and suppressing fundal and gastric body ghrelin expression
without compensatory upregulation of GECs in other parts of the stomach for up to 16 weeks. Fu
also suggested that BAE with smaller microspheres may be an effective, minimally invasive
approach for the treatment of obesity.
Argument related to ulceration rates observed in Fu are not persuasive because Fu
described all ulcers as mild and had healed by week 16 (Figure 5). Fu taught that all five pigs
treated with smaller microsphere, and three of five pigs treated with larger microspheres
developed superficial mucosal ulceration in the targeted fungus or nontargeted gastric body
along the lesser or greater curvature proximate to the fundus (Fig 5). These ulcers were mild and
healing at 1 week after embolization. No ulceration was observed in the other parts of the
stomach (paragraph bridging pages 85-86). Fu also explained that the ulceration rate observed
might be explained by the timing of endoscopy at 1 week after embolization instead of 3 weeks
as reported in other preclinical studies (bottom of left column on page 88). Fu does not describe
the 100-300 micron particles as unsuitable for BAE. In fact, Fu concludes that BAE with smaller
particles may be an effective, minimally invasive approach for the treatment of obesity. These
teachings would not have disincentivized the skilled artisan from modifying Kipshidze by Fu.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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
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