--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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 6, 2026 has been entered.
Priority
This application is a 371 of PCT/EP2021/067220 filed on 06/23/2021, which claims
foreign priority in French application FR2006571 filed on 06/23/2020.
Claim Status
Claims 1-12, 14-20, 22-24, 26, and 27 are pending. Claims 13, 21, and 25 were canceled. Claims 3-5, 11, 12, and 19 remain withdrawn. Claim 27 was newly added and reads on the elected invention. Claims 1, 2, 6-10, 14-18, 20, 22-24, 26, and 27 are examined.
Claim Objections
Claim 26 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claim 26 is objected to for depending from a rejected claim. Claim 26 was amended to require the one or more PHA copolymers a) to be solubilized in the fatty medium b). This limitation is not obvious over Seattone because Seattone requires the one or more PHA copolymers to be in the form of particles in the composition and it would not have been obvious to solubilize the copolymers in the fatty phase in view of the prior art of record.
Maintained and New Claim Rejections -35 USC§ 103
as Necessitated by Amendment
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.
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.
Claims 1, 2, 6-10, 14-18, 20, 22-24, and 27 are rejected under 35 U.S.C. 103 as being
unpatentable over Saettone (WO 2018/0178899 Al Published October 4, 2018 - of record in
PTO-892 dated 02/20/2025).
The claims encompass a composition comprising one or more PHA copolymers which
contain two different repeating units chosen from units A and B, and a fatty medium comprising
one or more fatty substances, wherein A is different from B.
The teachings of Saettone are related to a cosmetic composition comprising: from 70%
by weight to 99.9% by weight of a cosmetically acceptable base formulation comprising an oily
phase; from 0.1 % by weight to 30% by weight of at least one polyhydroxyalkanoate (PHA) in
the form of particles having an average diameter ( d50) of from 0.1 um to 100 um; the
percentages being expressed with respect to the total weight of the composition (Abstract). The
PHA is a polymer containing repeating units of formula I
-O-CHR1-(CH2)n-CO- (I)
where: Rl is selected from -H, Cl-C12 alkyls, cycloalkyls, C2-C12 alkenyls, optionally
substituted with at least one group selected from: halogen (F, Cl, Br), -CN, -OH, -COOH, -OR, -
COOR, wherein R is Cl-C4 alkyl or benzyl; and n is zero or an integer of from 1 to 6 (paragraph
bridging pages 6-7). PHAs include homopolymers, copolymers, and terpolymers. In the case of
copolymers and terpolymers, different repeating units of formula I are present (page 7 lines 4-
14 ). Particularly preferred PHAs include poly(3-hydroxyoctanoate-co-3-hydroxyundecen-10-
enoate) (PHOU) (page 7 lines 20-28). The oily phase generally comprises at least one
fatty substance of vegetable, animal, mineral or synthetic origin, which can be in liquid (oils) or
solid (waxes) form at room temperature (25 °C) (page 9 lines 5-8). Suitable oils are described
from page 9 line 17 through page 10 line 18, and include fatty acid esters such as cetearyl
isononate. The cosmetically acceptable base formulation may possibly additionally comprise an
aqueous phase, which is preferably present in an amount not higher than 50% by weight, with
respect to the weight of the base formulation. The aqueous phase, in addition to water, can
comprise products miscible in water, such as ethanol or isopropanol (page 10 lines 19-27).
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 comprising from 0.1
% by weight to 30% by weight of poly(3- hydroxyoctanoate-co-3-hydroxyundecen-10-enoate)
and from 70% by weight to 99.9% by weight of a fatty medium comprising one or more fatty
substances, with a reasonable expectation of success because Saettone teaches a cosmetic
composition comprising from 70% by weight to 99.9% by weight of a cosmetically acceptable
base formulation comprising an oily phase and from 0.1 % by weight to 30% by weight of at
least one polyhydroxyalkanoate (PHA) of formula I where the preferred PHA comprises poly(3-
hydroxyoctanoate-co-3-hydroxyundecen-10-enoate) and further teaches that the oily phase
comprises one or more fatty substances. Poly(3-hydroxyoctanoate-co-3-hydroxyundecen-10-
enoate) is encompassed by claimed PHA when Rl is a linear C8 alkenyl (unit A corresponds to
repeating unit 3-hydroxyundecen-10-enoate) and R2 is a linear saturated C5 hydrocarbon (unit B
corresponds to repeating unit 3-hydroxyoctanoate). The claimed concentration ranges of a) and
b) are obvious because the ranges overlapping with the corresponding ranges in Seattone' s
composition, and it has been held that a case of prima facie case of obviousness exists where a
claimed range and the prior art range overlap.
Seattone's copolymer poly(3-hydroxyoctanoate-co-3-hydroxyundecen-l 0-enoate) falls in the genus of claimed PHA copolymers, and it would have been reasonable to expect Seattone's copolymer to be film forming when placed under the same conditions as claimed copolymer. Film-forming is a property, and since the prior art meets the structure of the claimed copolymer, it would have been reasonable to expect the prior art polymer to possess said property.
The limitations of claim 1 are obvious over Saettone' s composition described above.
Regarding claim 2, it would have been obvious to have formed the PHA copolymer
having a weight average molecular weight (Mw) in the range from 10,000 to 1,000,000 Da
because Saettone teaches said range as suitable for PHAs (page 7 lines 29-31). The resulting
copolymer would have contained the two repeating units in range of greater than or equal 1,
which renders the claimed range obvious.
Regarding claim 6, it would have been obvious to have modified the PHA by replacing
the C8 linear alkenyl with a Cl-Cl2 alkyl, with a reasonable expectation of success because
Seattone teaches that the Rl substituent is selected from Cl-Cl2 alkyls. Thus, Seattone intended
to encompass copolymers having two different repeating units in which the Rl variable is
selected from Cl-12 alkyl groups, which includes ClO, Cl 1, and Cl2 which are encompassed by
the claimed range of Cl0-C30. There are a limited number of alkyl groups to select from and the
skilled artisan would have known that alkyls are either linear, branched, or cyclic and any one of
the three configurations would have been obvious. Therefore, a linear ClO, Cl 1, and Cl2 alkyl
would have been obvious as the Rl substituent in unit A.
Regarding claims 7 and 20, Saettone does not limit the polymers by R and S configuration. It would have been obvious to have formed the PHA having R, S, or a
combination of the two.
Regarding claim 8, the limitation is met by repeating unit 3-hydroxyundecen- 10-enoate,
which corresponds to unit A when Rl is a linear C8 alkenyl.
Regarding claims 9 and 10, the limitations are met by repeating unit 3-hydroxyoctanoate,
which corresponds to unit B when R2 is a linear C5 alkyl.
Regarding claim 14, it would have been obvious to have selected cetearyl isononate to
form the oily phase because Saettone teaches that cetearyl isononate is suitable for forming the
oily phase. Cetearyl isononate is an ester oil.
Regarding claims 15 and 17, it would have been obvious to have formed the composition
with 70%-99.9% by weight of a cosmetically acceptable base formulation comprising an oily
phase, with a reasonable expectation of success because Saettone teaches 70-99.9 wt. % as a
suitable concentration range of the oily phase in the composition. The claimed range is obvious
because it overlaps with the prior art ranges.
Regarding claim 16, it would have been obvious to have formed the composition to
comprise a solvent, with a reasonable expectation of success because Saettone teaches forming
the composition with a solvent such as ethanol.
Regarding claim 18, it would have been obvious to have formed the composition with
dyes and pigments, with a reasonable expectation of success because Seattone teaches that the
composition contains products typically used in cosmetic compositions such as dyes and
pigments (page 11 lines 8-25).
Regarding claim 22, poly(3-hydroxyoctanoate-co-3-hydroxyundecen- 10-enoate) is
encompassed by claimed PHA (2') because unit A corresponds to repeating unit 3-
hydroxyundecen-10-enoate which contains a linear C8 alkenyl as Rl and unit B corresponds to
repeating unit 3-hydroxyoctanoate which contains a linear C5 alkyl as R2.
The chemical structure of 3-hydroxyoctanoic acid:
PNG
media_image1.png
132
347
media_image1.png
Greyscale
The chemical structure of 3-hydroxyundec-10-enoic acid:
PNG
media_image2.png
109
466
media_image2.png
Greyscale
.
It is readily apparent from the structures of the monomers that claimed PHA (2') has the
same Rl and R2 as poly(3-hydroxyoctanoate-co-3-hydroxyundecen-10-enoate). The number of
each repeating unit would have been equal to or greater than one in the copolymer, which
renders claimed ranges for m and n being greater than or equal to 1. Seattone does not limit the
copolymer stereochemistry, however it would have been obvious to have formed the copolymer
having an Rand/or S configuration at the two chiral centers. The two chiral carbon atoms will
either have R or S configuration and both would have been equally obvious.
Regarding claim 23, 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
comprising from 0.1 % by weight to 30% by weight of poly(3- hydroxyoctanoate-co-3-
hydroxyundecen-10-enoate) and from 70% by weight to 99.9% by weight of a fatty medium
comprising one or more fatty substances, with a reasonable expectation of success because
Saettone teaches a cosmetic composition comprising from 70% by weight to 99.9% by weight of
a cosmetically acceptable base formulation comprising an oily phase and from 0.1 % by weight
to 30% by weight of at least one polyhydroxyalkanoate (PHA) of formula I where the preferred
PHA comprises poly(3- hydroxyoctanoate-co-3-hydroxyundecen-10-enoate) and further teaches
that the oily phase comprises one or more fatty substances. Poly(3-hydroxyoctanoate-co-3-
hydroxyundecen-10- enoate) is encompassed by claimed PHA when Rl is a linear C8 alkenyl
(unit A corresponds to repeating unit 3-hydroxyundecen-10-enoate) and R2 is a linear saturated
C5 hydrocarbon (unit B corresponds to repeating unit 3-hydroxyoctanoate). The claimed
concentration ranges of a) and b) are obvious because the ranges overlapping with the
corresponding ranges in Seattone' s composition, and it has been held that a case of prima facie
case of obviousness exists where a claimed range and the prior art range overlap.
Regarding molar concentrations of units A and B in the copolymer, Seattone does not
limit the amounts of the repeating units in the copolymer. It would have been obvious to have
varied the concentration of each unit in a ranges from the smallest measurable amount (such as
0.1 mole%) and up to the largest amount possible (99.9 mole%), where the combined
concentration of the two monomers is always 100%. The claimed concentration ranges are
obvious over the prior art. The specification was reviewed and there is no evidence that the
claimed molar concentrations are critical.
It would have been obvious to have formed the PHA copolymer having a weight average
molecular weight (Mw) in the range from 10,000 to 1,000,000 Da because Saettone teaches said
range as suitable for PHAs (page 7 lines 29-31). The claimed molecular weight range is obvious
it overlaps with the prior art range. The resulting copolymer would have contained the two
repeating units in range of greater than or equal 1, which renders the claimed range obvious.
The claimed composition is obvious because combining prior art elements according to known
methods to obtain predictable results supports obviousness.
Regarding claim 24, poly(3- hydroxyoctanoate-co-3-hydroxyundecen-10-enoate)
contains an n-octenyl group that corresponds to Rl, and n-pentyl group that corresponds to R2.
Regarding claim 27, it would have been obvious to have formed the cosmetic composition as a homogenous mixture because in example 4 Seattone teaches a method of making a lipstick where the lipstick is described as having uniformity of pigmentation and homogeneity of stroke. The skilled artisan would have recognized that the cosmetic composition would have to be formed as a homogenous mixture in order to have uniform pigmentation and homogeneity of stroke (pages 16 and 17).
Maintained and New Double Patenting Rejections
Necessitated by Amendment
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 Longi, 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 1.321(c) or 1.321(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 1.321(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 I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 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 auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 6-12, 14-18, 20, 22-24, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of the copending application in view of Saettone as follows:
-claims 1-24 of copending application 18/707,648 (reference application)
-claims 25-44 of copending application 18/723,216 (reference application)
-claims 24-43 of copending application 18/723,248 (reference application)
-claims 24-43 of copending application 18/723,263 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each
other because present claims and copending claims teach compositions comprising a
polyhydroxyalkanoate (PHA) copolymer and a fatty medium/substance. The scope of each of
these polymers at least overlaps in scope with the limitations presented by the instant application.
Any deficiencies, if present, in the copending claims are remedied by the teaches of Saettone as
described above.
The skilled artisan would have recognized the obvious variations of the present claims
over the copending applications.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 6-12, 14-18, 20, 22-24, and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,257,336 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed composition and the composition of the patented claims are limited to PHAs and a fatty phase that overlap in scope.
Response to Arguments
Applicant's arguments submitted in the remarks dated February 6, 2026, were fully
considered but are not persuasive for the following reasons.
On pages 10 and 11, applicant refers to the specification for a teaching of benefits of the
claimed invention. These teachings are not sufficient to obviate the grounds of rejection because
any benefits observed by the applicant would have been present in Seattone's composition
because Seattone' s composition meets all of the structural requirements of the instantly claimed
invention.
On page 10, applicant stated that instant invention achieves surprising results and refers
to Example 5 of the specification for results obtained for a commercial copolymer PHB-co-HV
and argues that said copolymer is Seattone' s preferred copolymer.
Argument Applicant's argument regarding unexpected results is not persuasive because
the applicant did not meet the requirements set forth in MPEP 716.02. It is not clear why the
applicant considers the observed results unexpected. Table 7 shows solubility of five PHA
copolymers where example 5 is a comparative PHA. The applicant then formed films from the
four inventive PHAs and tested the four films under various conditions. PHA of comparative
example 5 is structurally different from the other four PHAs and it is not clear why the applicant
considers the solubility of PHA of example 5 in different solvents as surprising. The claims are
not limited to the four PHAs that produced the asserted unexpected properties and the applicant
did not show with data that the observed asserted unexpected result would have occurred over
the entire breadth of the claims.
In response to applicant's argument that the references fail to show certain features of the
invention, it is noted that the features upon which applicant relies (i.e., the PHA polymers,
according to Seattone, instead of being dissolved in the cosmetically acceptable base
formulation, are in the form of particles on pages 12-13) are not recited in the rejected claim(s).
Although the claims are interpreted in light of the specification, limitations from the specification
are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir.
1993). Instant claims do not limit how the PHA is incorporated into the composition, thus it is
irrelevant that Seattone teaches PHA in the form of particles.
On pages 11-12, applicant argued that Seattone does not motivate nor lead the skilled artisan to fabricate the copolymer within the scope of the claimed invention from the innumerable possibilities therein. Applicant cited Seattone' s preferred polymers highlighting PHBV, and stated that none of the preferred polymers are within the claimed genus of polymers.
Arguments are not persuasive because Seattone teaches a genus of copolymers that
overlap with the instantly claimed genus, and specifically teaches poly(3-hydroxyoctanoate-co-3-
hydroxyundecen-10-enoate) which is a species of the instantly claimed polymer. These teachings
are sufficient to render the claimed polymer obvious. Poly(3-hydroxyoctanoate-co-3-
hydroxyundecen-10-enoate) is listed among particularly preferred polymers in Seattone.
On page 12, applicant argued that Seattone teaches away from the claimed invention
because Seattone dissuades or teaches persons skilled in the art away from adding a fatty
substance that would be absorbed by PHA; and Seattone leads person of ordinary skill from
using PHAs to obtain a film resistant to water, oil and sebum.
Arguments are not persuasive because Seattone does not teach away from the invention
as claimed. Applicant's statement on the bottom of page 14 regarding PHA solubility in fatty
substances as described in paragraph 0005 of USSN '753 is not persuasive because it is not
relevant to the instant rejection. Instant claims are not limited to a composition in which PHAs
are solubilized is a fatty medium.
On pages 13-16, applicant referred to a decision in FR 3 111 811 Bl, which is the French
counterpart ofUSSN '753.
The arguments were fully considered, however they are not sufficient to obviate present
rejections because the standard for rejection in USPTO is different from France and it would be
improper for the USPTO to rely on the French decision for reasons to withdraw obviousness
rejections.
On pages 16-18, applicant referred to a declaration by Portal submitted in application
17/794,753 to show unexpected properties.
The declaration was not considered because it was not specifically prepared for the
present application and all statements made in the declaration are regarding application
17/794,753.
On page 19, applicant cited page 4 of the previous Office Action, and argued that
examiner's conclusion is not tenable since Seattone does not lead the skilled artisan to select the
particular PHA copolymers required by the present invention to obtain films resistant to water,
oil, and sebum.
The argument is not persuasive because Seattone teaches a genus of PHA polymers that
overlaps with the instantly claimed genus of PHA polymers, and Seattone specifically teaches
the copolymer poly(3-hydroxyoctanoate-co-3-hydroxyundecen-10-enoate) as preferred, which is
a species of the instantly claimed polymer. Thus, Seattone leads the skilled artisan to PHAs
encompassed by instant claims. The statement "to obtain a film resistant to water, oil and sebum"
describes an intended use of the PHA and does not structurally affect the scope of the claims. The obviousness rejection is proper because Seattone teaches compositions that meet all of the structural limitations of instant claims, which is sufficient for an obviousness rejection.
On page 19, applicant referred examiner's response in the last Office Action related to
unexpected results, and stated that the argument is inconsistent with the conclusion of
obviousness since the Examiner seems to suggest that any of PHA copolymer within the scope of
Seattone is expected to provide similar results.
To further clarify examiner's statement, applicant made an assertion that the claimed
invention has unexpected properties and the examiner simply explained that applicant has not
met the requirements of MPEP 716.02, which states that the claimed composition is required to
be commensurate in scope with the composition(s) that exhibited unexpected properties. In the
instant case, applicant referred to Table 7 which provides data for 4 inventive compositions and
one comparative composition. The claimed composition is not commensurate in scope with the
four inventive compositions that assertedly have unexpected properties.
On pages 19-20, applicant traversed the provisional double patenting rejections because
copending applications have a later filing date.
Provisional rejections are maintained because the provisional double patenting rejections
are not the only rejections remaining.
On page 22, applicant traversed the double patenting rejection over US patent '336
because the definition of R1 in the instant claims is different from the definition of R1 in the patented claims.
The argument is not persuasive because R1 in instant claims is defined as (C10-C30)alkyl, which under broadest reasonable interpretation includes linear alkyl groups. The claimed C5-C9 linear alkyl is obvious because the range of carbon atoms is close enough in number to C10-C30 and the skilled artisan would have expected them to have the same properties. C5-C9 linear alkyl is homolog of C10-C30 linear alkyl where the two differ by one methylene group.
Conclusion
No claims are allowed. Claims 1, 2, 6-10, 14-18, 20, and 22-27 are rejected and claim 26 is objected to.
Any inquiry concerning this communication or earlier communications from the
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/ALMA PIPIC/Primary Examiner, Art Unit 1617