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 .
Claims 1, 4-13 and 16-23 are pending in this application, Claims 12, 13, 16, 17, 20 and 21 are acknowledged as withdrawn, Claims 1, 4-11, 18 and 19 were examined on their merits.
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.
Claim 18 is newly 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, as necessitated by Applicant’s claim amendments filed 07/21/2026. Claim 18 now recites, "wherein the polymer compound has a larger space than a space of a scaffolding for the production of fibroblasts". It cannot be determined if Applicant means the entire space that the polymer as a whole takes up physically or if the polymer comprises an internal or external space, such as a cavity or hole within the polymer. It is further unclear what “a space of a scaffolding” is, as it could be interpreted as any part of the scaffolding or the entirety of the scaffolding. 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, 4-11, 18 and 19 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, and 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 a larger space than a space of 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 having space enough 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 TM 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 a larger space than a space of 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, as well as meting the limitation of being “a three-dimensional culture substrate for an iPS or ES cell” of Claim 8.
Response to Arguments
Applicant's arguments filed 07/21/2026 have been fully considered but they are not persuasive.
The Applicant argues that the amendment to Claim 18 remedies the indefiniteness issue (Remarks, Pg. 6, Lines 14-20).
This is not found to be persuasive for the reasoning found in the above rejections, specifically that the amendment raises new issues of indefiniteness.
The Applicant argues that Paragraph [0102] of the Specification discloses that the polymer compound can be obtained by reacting PLURONIC™ F127 with hexamethylene diisocyanate in the presence of phosphorus pentoxide. Applicant concludes that the ordinary artisan would recognize that the claimed polymer is not identical to unmodified F127 used by Ghatnekar and none of the other cited references teach the claimed polymer (Remarks, Pg. 8, Lines 7-28 and Pg. 9, Lines 1-2 and Pg. 11, Lines 6-12 and 19-25).
This is not found to be persuasive for the following reasons, Paragraph [0102] of the filed Specification, reproduced below, states:
(Synthesis of F-127 Polymer) The F-127 polymer was obtained in accordance with the above patent literatures by reacting purlonic [sic] F-127 (produced by Asahi Denka Co., Ltd.) (registered trademark) which is a block copolymer of polypropylene oxide and polyethylene oxide, with hexamethylene diisocyanate in the presence of phosphorus pentoxide.
The passage is directed to the synthesis of F127 polymer requiring specific treatment steps, however 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., reacting PLURONIC™ F127 with hexamethylene diisocyanate in the presence of phosphorus pentoxide) are not recited in the rejected broad claim.
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).
Further, even if these limitations (such as found in Claim 19) were incorporated into the broad claim, the Examiner notes that the limitations are directed to a product-by-process wherein the claimed product (F127 polymer) is obtained by the process (reaction with hexamethylene diisocyanate and phosphorus pentoxide). However, this reaction can be interpreted as the addition of as little as one triblock polymer to another triblock copolymer which would result in an F127 polymer still being within the molecular weight range of F127 and not being significantly different functionally than unmodified F127. The Examiner further notes that Tsuchida (JP H06228319 A), translation, discloses that reaction of PLURONIC™ F127 with hexamethylene diisocyanate and phosphorus pentoxide can be used to obtain F127 high and F127 low polymer (Pg. 5, Paragraph [0021]). Thus, the ordinary artisan would recognize that the process would still produce PLURONIC™ F127 polymer, which is the same polymer as provided in the cited prior art of record.
The Applicant argues that the Declaration data shows an efficacy of the claimed composition of epidermal cell proliferation and reduces/suppresses fibroblast cell proliferation (Remarks, Pg. 10, Lines 5-8 and 14-28 and Pg. 11, Line 1).
This is not found to be persuasive for the following reasons, 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. reduced/suppressed fibroblast cell proliferation) 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). As discussed in the prior action, 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 conditions 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.
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.
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.
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/PAUL C MARTIN/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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