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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/06/2026 has been entered.
Claims 1, 4-13 and 16-21 are pending in this application, Claims 12, 13, 16 and 17 are acknowledged as withdrawn. The Examiner notes that New Claims 20 and 21 depend from withdrawn Claim 12 and have therefore also been considered to be withdrawn for purposes of examination. Claims 1, 4-11, 18 and 19 were examined on their merits.
Response to Amendment
The Declaration under 37 CFR 1.132 filed 04/06/2026 is insufficient to overcome the rejection of claims 1 and 4-11 based upon Oka et al. (US 8,304,393 B2) and Ghatnekar et al. (2009), McDonnell et al. (1999), Yeh et al. (2017), and as evidenced by Meng et al. (2017) as set forth in the last Office action because:
The Declarant has provided an exemplary experiment wherein particular cells (KER/keratinocyte, LLC/lung cancer, PC-9/adenocarcinoma and HLF-1/fibroblast) were used, the cells being cultured and passaged under particular conditions, seeded onto the claimed substrate and allowed to proliferate under particular conditions for 7 days before analysis of the culture supernatant. Applicant notes that the disclosed substrate allows epidermal and cancer cells to proliferate while inhibiting proliferation of the fibroblast cells.
This is not found to be persuasive for the following reasons, the showing (Exhibit 1) in the Declaration is not commensurate in scope with the claimed invention, being drawn to particular epithelial and fibroblast cell types cultured under particular conditions while the claims are drawn to any epithelial and fibroblast cells and are silent with regard to the culturing thereof. Further, the Examiner notes that the data in the Declaration Figures depicts that fibroblast cells actually do proliferate on the substrate, albeit not to the degree that non-fibroblast cells do.
Thus, fibroblast cells are not “prevented” from proliferation on the substrate as claimed and the alleged unexpected result is also not commensurate in scope with the claims. Finally, the data does not represent a comparison with the closest cited prior art, which is the PLURONIC™ F-127 polymer of Ghatnekar.
The Declaration also offers an opinion that the cited prior art do not disclose or suggest the claimed polymer combination which possesses the excellent property described in Claim 1 (Declaration, Pg. 1).
This is not found to be persuasive for the reasoning provided above, and the weight of evidence of record provided in the prior action and below in making a case for obviousness. See the MPEP at 716.01(c), III.
Claim Interpretation
Claim 19 has been interpreted as product by process claims, wherein the product is the polymer which is prepared by the recited process. Consistent with the MPEP at 2113, I and II, the Examiner has determined patentability based on the product itself and not its method of production and a determination of anticipation or obviousness is based on the sameness of similarity to the prior art polymer, even if produced by a different process.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18 is rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 18 recites, “wherein the polymer compound has more space than space enough to be a scaffolding for the production of fibroblasts”. It is unclear what “more space than space enough” means such that the metes and bounds of the claim can be readily determined. Does the limitation mean that the polymer compound does not have enough space to be a scaffolding for fibroblast production? Or that the polymer has enough space to be a scaffolding for fibroblast production? For purposes of examination, the Examiner has construed the claim as the polymer compound not having space to be a scaffolding for fibroblast production.
Claim Rejections - 35 USC § 103
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.
Claims 1 and 4-11 are rejected under 35 U.S.C. § 103 as being unpatentable over Oka et al. (US 8,304,393 B2) and Ghatnekar et al. (2009), McDonnell et al. (1999), Yeh et al. (2017), and as evidenced by Meng et al. (2017), all of record.
Oka et al. teaches a composition comprising at least one member selected from
water-soluble oligopeptides consisting of 3 to 7 amino acid units containing a prolyl-
isoleucyl-glycyl unit or an isoleucyl-glycyl-seryl unit as an active ingredient, or a water-
soluble salt thereof, and a carrier (Column 17, Claim 1),
wherein the water-soluble oligopeptide is prolyl-isoleucyl-glycine, wherein the
water-soluble oligopeptide is isoleucyl-glycyl-serine or wherein the water-soluble
oligopeptide comprises a prolyl-isoleucyl-glycyl unit and a glycyl unit or a seryl unit
(Column 17, Claims 2-4);
wherein the water-soluble oligopeptide is at a concentration of 0.0001 to 5% by
mass in an aqueous medium as the carrier, wherein the aqueous medium comprises a
mixture of water and a water soluble organic solvent,
wherein the water soluble organic solvent comprises at least one polymer selected from the polyols glycerin/glycerol and 1,3-butylene glycol (Column 18, Claims 11-13), and reading on Claim 1.
With regard to Claim 1, Oka et al. further teaches the oligopeptide promotes the
growth of epithelial cells (for example, skin regeneration) (Abstract) and has no effect on
the proliferation of fibroblasts (Fig. 14).
With regard to Claim 5, the Oka et al. reference teaches the composition can
additionally include a disinfectant (Column 5, Lines 19-22). McDonnell et al. teaches
that disinfectants have antibacterial action (therefore are bactericides) (Pg. 151, Table
2).
The Oka et al. reference further teaches applying the composition to a cell
culture of epithelial cells (hair bulb keratinocytes/HBK) (Column 9, Lines 31-57), and
reading on Claims 10-11.
Oka et al. did not teach a composition wherein the polymer component: has a sol-gel transition temperature, reversibly transforming to a sol state at a temperature lower than the transition temperature,
comprises hydrophobic and hydrophilic portions, is a crosslinked polyalkylene
oxide block copolymer, as required by Claim 1;
has a sol-gel transition temperature in a range of 20-45 °C, as required by
Claim 4;
wherein the polymer compound has more space than space enough to be a scaffolding for the proliferation of fibroblasts, as required by Claim 18;
or wherein the polymer compound is prepared by reacting a block copolymer of polypropylene oxide and polyethylene oxide with hexamethylene diisocyanate in the presence of phosphorus pentoxide, as required by Claim 19.
The Examiner notes that the instant Specification utilizes F-127 polymer (see Pg.
23, Paragraph [0101]), and therefore with respect to Claim 1; the F127 polymer
compound would be expected to have the claimed properties of having a sol-gel
transition temperature, reversibly transforming to a sol state at a temperature lower than
the transition temperature and comprising hydrophobic and hydrophilic portions;
and with respect to Claims 4 and 18, the F127 polymer would be expected to have a sol-gel transition temperature in a range of 20-45 °C and consistent with the Claim Interpretation above, not have space to be a scaffolding for the proliferation of fibroblasts.
Ghatnekar et al. teaches a method of treating a skin wound in a murine model
comprising administering the therapeutic peptide ACT1 in the polyol PLURONIC™ F-
127 and promoting regenerative healing of cutaneous wounds (Pg. 4, Lines 20-24 and
Pg. 12, Line 15).
Meng et al. evidences that PLURONIC™ block copolymers consist of hydrophilic polyethylene oxide (PEO) and hydrophobic poly propylene oxide (PPO) segments arranged in a basic tri-block structure: PEO-PPO-PEO (reading on PLURONIC™ F-127) (Pg. 2, Lines 8-10). The Examiner notes that Pg. 3, Paragraph [0057] of the published Specification states:
The polymer compound comprising the hydrophobic portion and the hydrophilic portion of the present disclosure is, for example, a polyalkylene oxide block copolymer represented by a block copolymer of polypropylene oxide and polyethylene oxide
Thus, the prior art PLURONIC™ block copolymers of Ghatnekar would also be expected to be polyalkylene oxide block copolymers.
Yeh et al. teaches that PLURONIC™ F127 can be crosslinked with gelatin to
form a tunable, composite thermo-responsive hydrogel with in vivo applications and in
vitro 3D cell culture applications at body temperature (e.g., 37 °C) ( Pg. 21252, Abstract
and 21253, Scheme 1 and Fig. 1).
It would have been obvious to those of ordinary skill in the art before the effective
filing date of the claimed invention to modify the skin regeneration composition of Oka et
al. comprising water soluble oligopeptide and at least one of the polymer polyols glycerin/glycerol and 1,3-butylene glycol to substitute the polyol F-127 of Ghatnekar et
al. in place of the glycerin/glycerol and 1,3-butylene glycol, because all of the polyols
were known in the art as polymer carriers for delivering wound treating therapeutic
peptides.
Those of ordinary skill in the art would have been motivated to make this
modification based on the availability of polyol compounds and artisan preference.
There would have been a reasonable expectation of success in making this modification
because both references are reasonably drawn to the same field of endeavor, that is,
compositions comprising polyols and skin wound treating/regenerating peptides and the
use thereof.
It would have been further obvious to those of ordinary skill in the art to modify
the skin regeneration composition of Oka et al. and Ghatnekar et al. comprising water
soluble oligopeptide and PLURONIC™ F127 to use a gelatin-crosslinked F127 polymer as taught by Yeh et al. because this would allow the adjustment of the polymer
properties (such as gelation and stiffness). Those of ordinary skill in the art would have
been motivated to make this modification in order to obtain a composition with artisan
customized mechanical properties. There would have been a reasonable expectation of
success in making this modification because both references are reasonably drawn to
the same field of endeavor, that is, compositions comprising polyols and the use thereof
in biomedical applications.
With regard to Claims 1 and 18, the Specification as published states at Pg. 5, Paragraph [0086] that:
Scaffolding is necessary for the proliferation of fibroblasts, and the polymer compound of the present disclosure has more space than space enough to be the scaffolding. Thus, it is considered that the fibroblasts cannot proliferate in the composition of the present disclosure or the affected portion
As the prior art teaches the same polymer polyol compound (PLURONIC™ F127 of Ghatnekar) as claimed/exemplified, it would be expected to have the same functional
properties and characteristics, including prevention of fibroblast proliferation and not having space to be a scaffolding for fibroblast production.
As the combined prior art makes obvious the prior art composition which can be
used as "a coating agent", "a cell culturing substrate" and "a living-tissue transporting
substrate", the prior art intrinsically teaches/suggests these limitations set forth in the
preambles of Claims 6, 7 and 9 respectively.
Response to Arguments
Applicant's arguments filed 04/06/2026 have been fully considered but they are not persuasive.
The Applicant argues that Declaration demonstrates that the claimed crosslinked polymer is distinct from the cited prior art resulting in unexpected properties (Remarks, Pg. 5, Lines 13-26 and Pg. 7, Lines 12-20).
This is not found to be persuasive for the following reasons, as discussed above, the filed Declaration is not commensurate in scope with the current claims. Further, the Declaration does not provide any explanation as to how or why the PLURONIC™ F127 polymer of the prior art is distinct from the claimed polymer.
The Examiner notes that Yeh was not cited for its’ teaching of a crosslinked copolymer of PLURONIC™ F127 and gelatin and Meng was not cited for its’ teaching of a polymeric mixed micelle of PLURONIC™ F127 and D-α-tocopheryl polyethylene glycol succinate.
The Examiner notes that the instant Specification utilizes F-127 polymer (see Pg. 23, Paragraph [0101]), and therefore the prior art polymer PLURONIC™ F127
would be expected to have the same properties and characteristics of the claimed polymer.
The Applicant argues that the claimed invention requires a crosslinked polymer network and the Examiner’s rejection is based on the assumption that the prior art PLURONIC™ F127 polymer would result in the same functional properties as claimed. The Applicant notes that the crosslinked polymer network is structurally distinct from the non-crosslinked composite of the prior art and the feature cannot be considered to be inherent (Remarks, Pg. 7, Lines 21-24 and Pg. 8, Lines 1-7).
This is not found to be persuasive for the following reasons, the Examiner’s rationale was not that the prior art PLURONIC™ F127 polymer would inherently result in the claimed properties but rather that; 1) the PLURONIC™ F127 polyol polymer of Ghatnekar could be substituted for the polyol polymers of Oka and 2) that in view of the teaching of Yeh that crosslinking of the PLURONIC™ F127 polyol polymer with gelatin
forms a tunable, composite thermo-responsive hydrogel with in vivo applications and in
vitro 3D cell culture applications at body temperature. Thus, it would have been obvious to those of ordinary skill in the art to modify the skin regeneration composition of Oka and Ghatnekar comprising water soluble oligopeptide and PLURONIC™ F127 to use a gelatin-crosslinked F127 polymer as taught by Yeh because this would allow the adjustment of the polymer properties (such as gelation and stiffness). Those of ordinary skill in the art would have been motivated to make this modification in order to obtain a composition with artisan customized mechanical properties.
The Applicant argues that the cited prior art do not teach or suggest a cross-linked F127 polymer, noting that crosslinking structurally changes the polymer and its mechanical properties (Remarks, Pg. 8, Lines 8-25).
This is not found to be persuasive for the following reasons, the claims only require that the polymer compound “is a crosslinked polyalkylene oxide block copolymer”.
Ghatnekar teaches PLURONIC™ F127 polymer, Meng evidences that PLURONIC™ block copolymers consist of hydrophilic polyethylene oxide (PEO) and hydrophobic polypropylene oxide (PPO) segments (the Specification as published at Pg. 3, Paragraph [0057] that:
“The polymer compound comprising the hydrophobic portion and the hydrophilic portion of the present disclosure is, for example, a polyalkylene oxide block copolymer represented by a block copolymer of polypropylene oxide and polyethylene oxide”
Thus, the prior art PLURONIC™ block copolymers of Ghatnekar would also be expected to be polyalkylene oxide block copolymers.
Finally, it would have been obvious to those of ordinary skill in the art to modify the skin regeneration composition of Oka and Ghatnekar comprising water soluble oligopeptide and PLURONIC™ F127 to use a gelatin-crosslinked F127 polymer as taught by Yeh because this would allow the adjustment of the polymer properties (such as gelation and stiffness). Thus, the prior art makes obvious a cross-linked F127 polymer, which would be expected to have the same structural and mechanical properties as the claimed polymer.
The Applicant argues that Meng and Yeh respectively disclose a polymeric mixed micelle of PLURONIC™ F127 and D-α-tocopheryl polyethylene glycol succinate and that PLURONIC™ F127 can be crosslinked with gelatin. Applicant asserts that neither reference discloses that the PLURONIC™ F127 is crosslinked with itself (Remarks, Pg. 8, Lines 26-27 and Pg. 9, Lines 1-2).
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., that the PLURONIC™ F127 is crosslinked with itself) 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).
The Applicant argues, citing the Declaration data, that the claimed composition can unexpectedly promote epithelial and cancer cell proliferation while inhibiting proliferation of fibroblast cells (Remarks, Pg. 9, Lines 3-14).
This is not found to be persuasive for the following reasons, as discussed above, the showing (Exhibit 1) in the Declaration is not commensurate in scope with the claimed invention, being drawn to particular epithelial and fibroblast cell types cultured under particular conditions while the claims are drawn to any epithelial and fibroblast cells and are silent with regard to the culturing thereof. Further, the Examiner notes that the data in the Declaration Figures depicts that fibroblast cells actually do proliferate on the substrate, albeit not to the degree that non-fibroblast cells do. Thus, fibroblast cells are not “prevented” from proliferation on the substrate as claimed and the alleged unexpected result is also not commensurate in scope with the claims. Finally, the data does not represent a comparison with the closest cited prior art, which is the PLURONIC™ F-127 polymer of Ghatnekar.
The Applicant argues that while Ghatnekar teaches PLURONIC™ F-127 polymer, the reference does not teach crosslinked PLURONIC™ F-127 which provides the alleged unexpected results (Remarks, Pg. 10, Lines 1-8).
This is not found to be persuasive for the following reasons, as acknowledged by Applicant, Ghatnekar teaches PLURONIC™ F-127 polymer. Yeh teaches that crosslinking of the PLURONIC™ F127 polyol polymer with gelatin forms a tunable, composite thermo-responsive hydrogel with in vivo applications and in vitro 3D cell culture applications at body temperature. Thus, it would have been obvious to those of ordinary skill in the art to modify the skin regeneration composition of Oka and Ghatnekar comprising water soluble oligopeptide and PLURONIC™ F127 to use a gelatin-crosslinked F127 polymer as taught by Yeh because this would allow the adjustment of the polymer properties (such as gelation and stiffness). Thus, the prior art makes obvious a cross-linked F127 polymer, which would be expected to have the same structural and mechanical properties as the claimed polymer.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAUL C MARTIN/ Examiner, Art Unit 1653 04/13/2026
Prosecution Insights