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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/06/2026 has been entered.
Priority
Instant application 17/595,098 filed on 11/09/2021 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 28 and 46-59 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/28/2022 was in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments/Amendments
The amendment filled on 01/06/2026 has been entered.
Applicant amended claims 28, 53, 54, 57 and 59.
Claim 28 was amended to specify that the crosslinkable polymeric composition is a photocroslincable polymeric composition.
Regarding the 103 rejection, Applicant's arguments filed 01/06/2026 have been fully considered and are persuasive.
Applicant pointed that Olejniczak’s photodegradable polymer react in a manner that is unsatisfactory for the intended purpose.
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Further, Applicant submitted that the o-nitrobenzyl functionalized PLGA polymers of Olejniczak are incompatible with Daniloff’s and Young’s croslinkable polymers because the o-nitrobenzyl functionalized PLGA polymers of Olejniczak degrade into smaller pieces upon exposure to light. See also Scheme 1 of Olejniczak (page 3166).
Therefore, the 103 rejection of record is withdrawn.
However, it should be noted that the instant composition comprises both Yang’s polymers, the o-nitrobenzyl-functionalyzed hyaluronic acid polymer and the carbohydrazide-functionalyzed hyaluronic acid polymer of Yang. The novelty of the instant application is in addition of a specific o-nitrobenzyl functionalized PLGA (the elected PLGA-NB species).
Further, it should be noted that the instant specification only shows results for the one, specific o-nitrobenzyl functionalized PLGA (the elected species).
The synthesis of the specific PLGA-NB was described in 2021, by Zhang (Zhang, J., Zheng, Y., Lee, J. et al. A pulsatile release platform based on photo-induced imine-crosslinking hydrogel promotes scarless wound healing. Nat Commun 12, 1670 (2021), https://doi.org/10.1038/s41467-021-21964-0).
Zhang disclosed the synthesis of the instant elected species PLGA-NB (see Supporting information, Figure 1):
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Zhang’s disclosure was published in 2021, thus, Zhang’s reference does not qualify as prior art.
Zhang’s reference is only used to confirm the structure and synthesis of the elected PLGA-NB polymer.
Regarding instant claims, it should be noted that the claims define the polymeric composition comprising o-nitrobenzyl functionalized PLGA using functional language “photocroslincable”. The claims fail to provide correlation between a structure of the o-nitrobenzyl functionalized PLGA and its function.
Further, the scope of the instant claims is not limited to the specific o-nitrobenzyl functionalized PLGA synthetized by Zhang, instead, the claims embrace additional o-nitrobenzyl functionalized PLGA polymers.
The instant specification (see paragraph [0026] and Fig. 5) require that in the presence of ultraviolet light, the o-nitrobenzene group a o-nitrobenzyl-functionalized PLGA becomes oxidized to an o-nitrobenzaldehyde group. Next, the aldehyde in the PLGA polymer reacts with an amine group in carbohydrazide hyaluronic acid to form an imine group that links the hyaluronic acid to the PLGA.
Therefore, the o-nitrobenzyl-functionalized PLGA recited in the instant claims must be capable of forming crosslinking in the presence of ultraviolet light.
However, without the Applicant providing adequate structure-function correlation for a representative number of species a person of ordinary skill cannot determine where the line of o-nitrobenzyl functionalized PLGA capable of forming photocroslincable polymeric composition or not capable of forming photocroslincable polymeric composition can be drawn for the o-nitrobenzyl functionalized PLGA polymers embraced by the instant claims.
Failure to depict o-nitrobenzyl functionalized PLGA polymers with a representative number of species, which would provide and overall depiction of the claimed subject matter, suggests the applicant is not in possession of the whole scope of claimed invention. Therefore, a 112(a) rejection is made below.
Examiner’s Suggestions
In order to place this application in condition for allowance, Examiner suggests adding a structure of the photocroslincable o-nitrobenzyl functionalized PLGA into claim 28.
For example, Applicant may consider adding a general chemical formula of a photocroslincable o-nitrobenzyl functionalized PLGA into claim 28.
Alternatively, Applicant may consider adding a wherein clause to include structural limitations to capture that the phototriggerable amine group of carbohydrazide-functionalized hyaluronic acid reacts with a photocroslincable o-nitrobenzyl functionalized PLGA to form imine crosslinking upon exposure to light.
Furthermore, examiner suggests amending the withdrawn claims. For example, there is insufficient antecedent basis for the limitations recited in claims 47 and 48. Since those claims are withdrawn, no 112(b) rejection is made in this office action.
Election/Restrictions
Applicant’s election without traverse of Group II, directed to a composition comprising a delayed release capsule comprising at least one TGF-β inhibitor and a crosslinkable polymeric composition comprising an o-nitrobenzyl functionalized polymer and a terminal amine functionalized polymer, in the reply filed on 04/29/2025 is acknowledged.
All claims directed to Group I (a method for reducing dermal wound scar) have been canceled by Applicants.
Regarding species election, Applicant’s election without traverse of:
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in the reply filed on 04/29/2025 is acknowledged.
Claims 47, 48, 55-56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/29/2025
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable.
Applicants' combination of elected species, as shown above, does make a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable; the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping.
Claims 28, 46, 49-54 and 57-59 are under current examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 49 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 28 recite a composition comprising o-nitrobenzyl functionalized PLGA.
Claim 49 recites the composition of claim 28, wherein the o-nitrobenzyl functionalized polymer is o-nitrobenzyl functionalized poly(lactic-co-glycolic acid) (PLGA).
Therefore, claim 49 is failing to further limit the subject matter of claim 28.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 28, 46, 49-54 and 57-59 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. 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated that, “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163. While all the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, claims are drawn to a composition comprising a delayed release capsule comprising at least one TGF-P inhibitor and a photocrosslinkable polymeric composition comprising o-nitrobenzyl functionalized poly(lactic-co-glycolic acid) (PLGA) and carbohydrazide-functionalized hyaluronic acid.
It should be noted that claim 28 define the polymeric composition comprising o-nitrobenzyl functionalized poly(lactic-co-glycolic acid) (PLGA) by using functional language: “photocrosslinkable’. The claims implies that the o-nitrobenzyl functionalized PLGA must be capable of forming photocroslincable composition. However, the claims fail to provide correlation between a structure of the o-nitrobenzyl functionalized PLGA and its function.
Olejniczak (Olejniczak et al., Macromolecules 2015, 48, 3166−3172) teaches o-nitrobenzyl functionalized PLGA-based polymer (Scheme 3):
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The o-nitrobenzyl functionalized PLGA of Olejniczak is not capable of forming crosslinking in a reaction with a phototriggerable amine group of carbohydrazide-functionalized hyaluronic acid because the o-nitrobenzyl functionalized PLGA of Olejniczak degrades into smaller pieces upon exposure to light (see Scheme 1):
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The instant specification describes a composition comprising PLGA-NB and HA-NB/HA-CDH and SB431542 inhibitor (see page 15).
It is noted that PLGA-NB and HA-NB/HA-CDH were received from Liaoyang Zhu’s lab and SB431542 inhibitor was purchased from Selleckchem. Inc (see instant specification [0056]).
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The instant specification (see paragraph [0026] and Fig. 5) require that in the presence of ultraviolet light, the o-nitrobenzene group a o-nitrobenzyl-functionalized PLGA becomes oxidized to an o-nitrobenzaldehyde group. Next, the aldehyde in the PLGA polymer reacts with an amine group in carbohydrazide hyaluronic acid to form an imine group that links the hyaluronic acid to the PLGA.
Therefore, the o-nitrobenzyl-functionalized PLGA recited in the instant claims must be capable of forming crosslinking in the presence of ultraviolet light.
However, without the Applicant providing adequate structure-function correlation for a representative number of species one cannot determine where the line of o-nitrobenzyl functionalized PLGA capable of forming crosslinking or not capable of forming crosslinking can be drawn for all the o-nitrobenzyl functionalized PLGA polymers embraced by the instant claims.
The instant specification only shows results for one, specific o-nitrobenzyl functionalized PLGA (the elected species).
One speciated example is a small representation and an insufficient illustration of the claimed genus. Failure to depict o-nitrobenzyl functionalized PLGA polymers with a representative number of species, which would provide and overall depiction of the claimed subject matter, suggests the applicant is not in possession of the whole scope of claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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/I.S./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621