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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submissions filed on 02/10/2026 and 02/17/2026 has been entered.
Status of the Claims
Pursuant to the amendment dated 02/10/2026, claims 2, 5, and 6 have been cancelled.
Claims 1, 3, and 4 are pending and under current examination.
All rejections not reiterated have been withdrawn.
Specification
The amendment filed 07/24/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the specification has been amended (see pages 2-3) to replace the specific substances “Pluronic F68” and “Pluronic F127” respectively with “poly(oxyethylene)-poly(oxypropylene) block copolymer having an average molecular weight of about 8,350 g/mol” and “poly(oxyethylene)-poly(oxypropylene) block copolymer having an average molecular weight of about 12,600 g/mol”. The amended claims are broader in scope in terms of polymers embraced than supported in the original application by the terms “Pluronic F68” and “Pluronic F127”. The phrase “poly(oxyethylene)-poly(oxypropylene) block copolymer” embraces any number of blocks of each polymer type in any combination so long as the polymer has the claimed molecular weight; whereas Pluronic surfactants have the specific structure:
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and each Pluronic surfactant (e.g. F 68) has specific values for x, y, and z in the above formula.
This objection could be overcome by amending the claims to recite the poloxamers corresponding to Pluronic F68 and F127.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, and 4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
This is a new matter rejection. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Each of claim 1 has been amended to replace the specific substances “Pluronic F68” and “Pluronic F127” respectively with “poly(oxyethylene)-poly(oxypropylene) block copolymer having an average molecular weight of about 8,350 g/mol” and “poly(oxyethylene)-poly(oxypropylene) block copolymer having an average molecular weight of about 12,600 g/mol”. The amended claims are broader in scope in terms of polymers embraced than supported in the original application by the terms “Pluronic F68” and “Pluronic F127”. The phrase “poly(oxyethylene)-poly(oxypropylene) block copolymer” embraces any number of blocks of each polymer type in any combination so long as the polymer has the claimed molecular weight; whereas Pluronic surfactants have the specific structure:
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and each Pluronic surfactant (e.g. F 68) has specific values for x, y, and z in the above formula.
This rejection could be overcome by amending the claims to recite the poloxamers corresponding to Pluronic F68 and F127.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the new matter concerns outlined above.
Response to Arguments
Applicant's arguments filed 02/10/2026 have been fully considered but they are not persuasive. On pages 4-5, Applicant cites pages 2-3 of the specification; however, Applicant cites the specification filed 07/24/2023 rather than the specification as originally filed on 06/22/2023. This amendment to the specification filed 07/24/2023 is also considered new matter as it was not supported in the application, as filed.
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, 3, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Sahin et al.(US 2016/0051724; publication date: 02/25/2016) in view of Hassler et al. (US 2011/0002971; publication date: 01/06/2011; cited in the IDS filed 07/21/2023) and further in view of Bulbul et al. (Chemical Papers 74(3):1-9; publication date 09/2019), De Lacharriere et al. (USPat 5,866,168; issue date: 02/02/1999), Chen et al. (Wound Repair Regen, 18(3):319-324, abstract only; publication year 2010), and Fisher et al. (US 2002/0141976; publication date: 10/03/2002).
Sahin discloses a carbopol-based antimicrobial hydrogel composition for wound healing comprising poloxamers and a boron component that prevents scar formation (abstract). Thus, Sahin discloses a formulation in gel form for use in prevention and treatment of wound scars comprising at least one surfactant (poloxamer) and at least one gelling agent with carrier gel properties (carbopol i.e. carboxypolymethylene). With regard to the transitional phrase recited in instant claim 1, “consisting essentially of”, the transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. The key elements of Sahin’s invention are the boron component, poloxamers, and carbopol, thus, the examiner considers Sahin to teach the three listed elements and nothing more in the form a gel, as required by the instant claims.
Sahin does not disclose erbium borate nanoparticles.
Hassler discloses that rare earth salt particles have antimicrobial properties (0013, 0019) and can be applied to wounds (0028) when formulated inter alia as a gel (0037). The term “rare earth” includes erbium (0075) and the anion may be borate (0098: Hassler’s preferred rare earth element in the salt is cerium and Hassler discloses a cerium borate salt; however, it would have been obvious to use any of the rare earth elements as the cation in the salt because such was contemplated by Hassler, as noted above). With regard to the requirement of claim 1 that the erbium borate particles be nanoparticles, Hassler discloses that the particles may have a size from 0.1 nanometers to 1,000 microns (0030). This range overlaps with the range recited in the instant claims. See MPEP 2144.05. One having ordinary skill would have understood in view of Hassler that erbium borate nanoparticles have antimicrobial properties.
Hassler discloses further that the rare earth salt is preferably water insoluble.
Bulbul discloses that “so far, there has been no report about synthesis of water-soluble erbium borate nanoparticles with high stability” (page 2, left col). One having ordinary skill in the art would have understood from this that erbium borate nanoparticles are not water soluble.
De Lacharriere discloses that lanthanides, including erbium, are substance P antagonists (title, abstract).
Chen discloses that substance P can contribute to pathological scar formation (abstract).
One having ordinary skill in the art would have understood in view of De Lacharriere and Chen that erbium can antagonize the effect of substance P and as a consequence reduce pathological scar formation.
It would have been prima facie obvious to use erbium borate nanoparticles as the borate source in Sahin’s composition. The skilled artisan would have been motivated to do so to impart additional antimicrobial and scar prevention properties to the composition, and would have had reasonable expectation of success because this would merely require including the erbium borate particles in Sahin’s gel and because Sahin discloses borate salts to be suitable (0033).
The relevant disclosures of Sahin, Hassler, Bulbul, De Lacharriere, and Chen are set forth above.
Sahin discloses further that “[t]he gel which will be used as a carrier for the active molecules, is prepared by using 1% carbopol. In the process of hydration, carbopol is gelated by adding 1.6 grams of 18% NaOH to a completely water saturated 1 liter solution. 3% boron compound and 4% poloxamer were added to the gel mixture which was homogenized by mixing after hydration was completed. The mixture was stored at 4° C. for 16-24 hours and made ready for use. Sahin discloses further that “[i]n the preparation of the hydrogel of the present invention, sodium pentaborate pentahydrate was specially preferred as the boron compound.” Thus Sahin discloses a gel having carbopol. poloxamer (i.e. Pluronic), and sodium pentaborate within the claimed amounts. With regard to the amount of erbium borate nanoparticles, Hassler discloses including the disinfecting nanoparticles in any amount (0177) and an effective amount (0157). It would have been prima facie obvious for one of ordinary skill to optimize the quantity of erbium borate nanoparticles in order to achieve their known effects of killing pathogens and reducing scar formation. See MPEP 2144.05.
None of these references disclose the specific poloxamers recited in the instant claims.
Fisher discloses that poloxamers are commercially known as Pluronics e.g. F38, F68, F88, F127; 0017).
It would have been prima facie obvious to use Pluronic F68 and F127 as the poloxamers in Sahin’s composition because one having ordinary skill in the art would have recognized these species as members of the genus of surfactants taught by Sahin.
Claims 1, 3, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Sahin’724 (US 2016/0051724; publication date: 02/25/2016) in view of Sahin ‘699 (WO2020/091699; publication date: 05/07/2020; available as prior art under 35 USC 102(a1) and 102(a2); effective filing date 10/31/2018; cited in the IDS filed 07/21/2023) and further in view of Fisher et al. (US 2002/0141976; publication date: 10/03/2002).
Sahin ‘724 discloses a carbopol-based antimicrobial hydrogel composition for wound healing comprising poloxamers and a boron component that prevents scar formation (abstract). Thus, Sahin ‘724 discloses a formulation in gel form for use in prevention and treatment of wound scars comprising at least one surfactant (poloxamer) and at least one gelling agent with carrier gel properties (carbopol). With regard to the transitional phrase recited in instant claim 1, “consisting essentially of”, the transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. The key elements of Sahin’s invention are the boron component, poloxamers, and carbopol, thus, the examiner considers Sahin to teach the three listed elements and nothing more in the form a gel, as required by the instant claims.
Sahin ‘724 does not disclose erbium borate nanoparticles.
Sahin ‘699 discloses that erbium borate nanoparticles have a wound healing effect (abstract).
It would have been prima facie obvious to use erbium borate nanoparticles as the borate source in Sahin’s composition. The skilled artisan would have been motivated to do so to impart additional wound healing properties to the composition, and would have had reasonable expectation of success because this would merely require including the erbium borate particles in Sahin’s gel and because Sahin discloses borate salts to be suitable (0033).
The relevant disclosures of Sahin ‘724 and Sahin ‘699, are set forth above.
Sahin ‘724 discloses further that “[t]he gel which will be used as a carrier for the active molecules, is prepared by using 1% carbopol. In the process of hydration, carbopol is gelated by adding 1.6 grams of 18% NaOH to a completely water saturated 1 liter solution. 3% boron compound and 4% poloxamer were added to the gel mixture which was homogenized by mixing after hydration was completed. The mixture was stored at 4° C. for 16-24 hours and made ready for use. Sahin ‘724 discloses further that “[i]n the preparation of the hydrogel of the present invention, sodium pentaborate pentahydrate was specially preferred as the boron compound.” Thus Sahin ‘724 discloses a gel having carbopol. poloxamer (i.e. Pluronic), and sodium pentaborate within the claimed amounts. With regard to the amount of erbium borate nanoparticles, It would have been prima facie obvious for one of ordinary skill to optimize the quantity of erbium borate nanoparticles in order to achieve their known effects of killing pathogens and reducing scar formation. See MPEP 2144.05.
None of these references disclose the specific poloxamers recited in the instant claims.
Fisher discloses that poloxamers are commercially known as Pluronics e.g. F38, F68, F88, F127; 0017).
It would have been prima facie obvious to use Pluronic F68 and F127 as the poloxamers in Sahin’s composition because one having ordinary skill in the art would have recognized these species as members of the genus of surfactants taught by Sahin.
Response to Arguments
Applicant's arguments filed 02/10/2026 have been fully considered but they are not persuasive.
Applicant’s arguments traversing the rejection over Sahin, Hassler, Bulbul, De Lacharriere, and Chen and traversing the rejection over Sahin ‘724 and Sahin ‘699 are moot as these rejections have been withdrawn due to the amendment incorporating the limitations of claim 2 into claim 1.
Applicant’s arguments are largely cumulative and have been addressed by the examiner in the final Office action mailed 12/05/2025. For completeness, the current arguments are summarized and responded to as follows:
On page 10, Applicant argues that Sahin does not disclose the specific claimed surfactants and Fisher does not supply a formulation-driven reason to select the two specific species of poloxamer together in the claimed gel. On page 12, Applicant argues there is no motivation to select the two species of surfactant together.
As explained previously, this is not persuasive because it ignores the specific rationale explained in the rejection. The examiner notes that, as explained in the rejection, Sahin teaches use of the genus “poloxamer”. Using any known species of poloxamer is then prima facie obvious as one having ordinary skill would have found this suitable. See MPEP 2144.07. Applicant is also referred to MPEP 2144.08. As the record does not establish any particular benefit to the claimed species of poloxamers, the examiner maintains that their selection would have been prima facie obvious to one of ordinary skill, i.e. an individual with an advanced degree in formulations science because this individual would have recognized them to fall within the general category described by Sahin.
On page 11, Applicant argues that there must be a rationale for combining references, argues that Sahin describes sodium pentaborate pentahydrate as specially preferred, and that Hassler teaches a vast genus of lanthanide salts, etc. and not Sahin’s sodium-pentaborate-driven system. Applicant argues that the Office does not explain why a POSITA would select erbium, select borate, insist on nanoparticle form, then integrate that species into a formulation where boron already plays a disclosed role and a specific borate salt is especially preferred. On page 14, Applicant asserts that Hassler provides no direction to choose erbium from a list.
As explained in the Final Office action mailed 12/05/2025, Regarding the preferred compound sodium pentaborate pentahydrate, as noted in the rejection one having ordinary skill in the art would have recognized erbium borate as a suitable source of borate ions. Furthermore, one would have been motivated to select erbium as a counterion in order to capitalize upon it’s wound healing benefits. It would have been obvious to replace the sodium pentaborate pentahydrate with erbium borate it is obvious to substitute substances known for the same purpose and Sahin expressly states that other sources of borate may be used, including other borate salts (0033) and also because one having ordinary skill would have expected the erbium salt to have additional benefits. See MPEP 2123(II): Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
Finally, regarding the selection of erbium, the Examiner also directs attention to Merck &Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Circ. 1989), which states with regards to its more than 1200 combinations: that the prior art “discloses a multitude of effective combinations does not render any particular formulation less obvious. This is especially true because the claimed composition is used for the identical purpose taught by the prior art.” Furthermore, it is noted that Applicants do not identify any secondary consideration demonstrating criticality or anything unexpected about the combination of two known prior art pharmaceutical agents.
Regarding Applicant’s point that Hassler does not teach Sahin’s gel, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant’s comment “the Hassler-driven leap to erbium borate nanoparticles remains unsupported by any articulated reason to modify Sahin’s completed system” is not persuasive because it ignores the reasoning expressly laid out in the rejection, see above.
On pages 13-15, Applicant presents the same arguments as above in traversal of the rejections over Sahin ‘742 and Sahin ‘699 and these arguments are also not persuasive for the reasons explained in the preceding paragraphs.
On pages 14-15, Applicant asserts that the examiner has used impermissible hindsight to reconstruct the claimed invention. Applicant describes the individual teachings of the cited prior art and asserts that all limitations of the claims are not taught in each reference individually.
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).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On pages 16-18, Applicant points to the declaration filed 12/05/2025 as sufficient to overcome the obviousness rejection based on unexpected results and asserts that the examiner has not treated the declaration properly according to MPEP 716.02(b). The examiner disagrees with these assertions and maintains the conclusion that the declaration fails to meet the burden on Applicant to overcome an obviousness rejection with a persuasive showing of unexpected results. The examiner’s analysis in the office action mailed 12/05/2025 is replicated for convenience:
Response to Declaration:
On pages 2-3 of the Declaration, Declarant states that experimental studies demonstrated that the erbium borate-based formulation significantly increased the expression of collagen derivative and fibromodulin, biomarkers of scarless wound healing, and enhanced MMP-9 activity and that in vivo rat studies showed markedly reduced wound scarring compared to control groups. Declarant asserts that the present invention provides an effective cosmetic result by preventing formation of scars that are probable to form after a wound occurs. Declarant states that in addition to several collagen isoforms, MMP-9 activity is increased after erbium borate exposure. Declarant states that these findings were unexpected relative to the cited prior art and are attributable to the claimed erbium borate nanoparticle formulation. Declarant asserts that these unexpected results demonstrate the non-obviousness of the claimed invention and rebut the section 103 rejections.
This is not persuasive because the burden on Applicant to overcome an obviousness rejection with a persuasive showing of unexpected results has not been met. Please refer to MPEP 716.02(b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
In the instant case, a generic statement that “the erbium borate nanoparticle composition” “increased expression” of various biomarkers of scarless wound healing or “markedly reduced wound scarring” in a rat model do not describe any unexpected result because erbium was known to promote wound healing and reduce effects of substance P (linked to reduced scarring, as noted in the rejection above) and borate compounds were known to reduce scarring, increase MMP-9 expression, and reduce relevant collagen expression (Sahin: 0010, 0011, and 0033). Moreover, no side by side comparison to the closest prior art has been described on the record (specifically, comparison to Sahin’s preferred formulation as well as controlling for the effect of erbium itself, which was expected to promote scarless wound healing due to antagonism of substance P). Therefore, the record does not establish an improvement relative to the closest prior art. The generic statement that there is improvement relative to a “control” does not meet the requirement described in MPEP 716.02(b). Finally, the vague statements “increase” or “reduced” do not establish a statistically significant change in the metrics described in the declaration.
On pages 19-20, Applicant summarizes the arguments presented in the preceding pages.
These arguments are not persuasive for the reasons detailed above.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617