DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 14-15 and 18-23 are withdrawn.
Claims 1-9 and 11-13 are pending and represent all claims currently under consideration.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claims 1-9 and 11-13 are considered to have an effective filing date of 02/04/2021.
Election/Restrictions
Applicant’s election of Group I in the reply filed on 02/11/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 14-15 and 18-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/11/2026.
Information Disclosure Statement
The information disclosure statements filed 02/11/2026, 10/29/2023, 02/04/2024, 05/05/2024, 03/05/2025, 12/09/2025, and 12/22/2025 have been considered.
The information disclosure statement filed 01/01/2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Claim Objections
Claims 1 and 7-9 are objected to because of the following informalities. Appropriate correction is required.
Regarding claim 1, “equal or larger” should read “equal to or larger” in both cases.
Regarding claim 7, “comprises” should read “comprising”.
Regarding claim 8, the word “and” should be moved to follow “biocleavable linking moiety;” instead of “hyaluronic acid moiety;” as currently written.
Regarding claim 9, “the group” should read “a group”, and the agent “glutathione” should only be listed once.
Specification
The use of the term TroloxR, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because in Fig 2, the reference character “17” has been used to designate two steps in the scheme shown, while the specification states “step 17 shows the optional attachment of a second hyaluronic acid moiety” (page 5, line 29) which appears to correspond to only the first step designated by “17” in the figure. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 9 and 13 are 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.
Regarding claim 9, the claim recites the limitation "bioactive agent". There is insufficient antecedent basis for this limitation in the claim. This limitation should instead read “bioactive agent moiety”.
Regarding claim 13, the claim refers to “any one of the structures presented in Examples 1-19”. MPEP 2173.05(s) states: Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Appropriate correction is required.
In this case, it is also unclear which structures the Applicant is referring to, because it is unclear if the example structures claimed are meant to refer to the schemes, and there are multiple structures represented in some of the Schemes 1-19 of the specification (e.g., there is no single structure labeled as “Example 1”). The Examiner has interpreted the claim to refer to any one of the structures presented in Schemes 1-19.
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.
Claims 12-13 are 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.
Regarding claim 12, it is unclear how at least one of D1, D2… and Dn can be “a precursor of a bioactive agent”, when it is already limited by the independent claim 1 to be a “bioactive agent moiety”.
Regarding claim 13, as above, it is the Examiner’s interpretation that the phrase “any one of the structures presented in Examples 1-19” refers to “any one of the structures presented in Schemes 1-19”, which includes structures that are not represented by Formula I of the independent claim 1.
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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 13 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Corte (US 20060154915 A1).
Regarding claim 13, Corte teaches Boc-tranexamic acid (i.e., one of the structures presented in Example 1; Corte, page 22, paragraph 0263).
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.
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.
Claims 1-6, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (US 20140199349 A1; IDS reference, 10/08/2023).
Regarding claim 1, Yang teaches a hyaluronic acid compound
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, wherein HA represents a hyaluronic acid unit (i.e., moiety; Yang, page 2, paragraph 0028), A is a biocleavable linkage (i.e., linking moiety), M can be a hydrophobic fragment, and p is an integer of 0-4 (Yang, claim 1), which overlaps the claimed ranges of "n" and "m" (i.e., if n is 2 and m is 1, p would equal 3). Yang further teaches the hydrophobic fragment M can be a lactic acid (i.e., a vitamin/bioactive agent as defined by the instant specification, page 16, line 7; Yang, page 2, paragraph 0031), resulting in a compound of formula I as claimed.
Yang is considered to be analogous to the claimed invention, because both Yang and the instant invention are in the field of drug delivery with hyaluronic acid (Yang, page 1, paragraph 0016). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the claimed invention based on the teachings of Yang under the meaning of 35 U.S.C. 103.
Regarding claim 2, Yang teaches all of the elements of the claimed invention as applied to claim 1. Yang teaches a repeating structure [A-M]p, wherein M can be a hydrophobic fragment (Yang, claim 1), such as lactic acid (i.e., a vitamin/bioactive agent as defined by the instant specification, page 16, line 7; Yang, page 2, paragraph 0031), suggesting each “p” repeat of the bioactive agent M in the structure [A-M] would be the same.
Regarding claim 3, Yang teaches all of the elements of the claimed invention as applied to claim 1. Yang teaches a repeating structure [A-M]p, wherein M can be a hydrophobic fragment (Yang, claim 1), which can be a combination of lactic acid, glycolic acid, and malic acid (i.e., vitamins/bioactive agents as defined by the instant specification, page 16, line 7), and can comprise one or more biocleavable linkage (Yang, page 2, paragraph 0031), which could result in a structure of formula HA-L1-D1-L2-D2-L3-D3 as claimed with each D being a different bioactive agent.
Regarding claim 4, Yang teaches all of the elements of the claimed invention as applied to claim 1. Yang teaches a repeating structure [A-M]p, wherein A can be a biocleavable linker (Yang, claim 1), suggesting each “p” repeat of the biocleavable linker A in the structure [A-M] would be the same.
Regarding claim 5, Yang teaches all of the elements of the claimed invention as applied to claim 1. Yang teaches a repeating structure [A-M]p, wherein M can be a hydrophobic fragment (Yang, claim 1), which can be a combination of lactic acid, glycolic acid, and malic acid (i.e., vitamins/bioactive agents as defined by the instant specification, page 16, line 7), and can comprise one or more biocleavable linkage such as hydrazone, acetal, ketal and imine (Yang, page 2, paragraph 0031), which could result in a structure of formula HA-L1-D1-L2-D2-L3-D3 as claimed with each L being a different biocleavable linker.
Regarding claim 6, Yang teaches all of the elements of the claimed invention as applied to claim 5. Yang teaches the biocleavable linkages can comprise hydrazone, acetal, ketal, and/or imine, which in one example is cleavable from a pH of 6.9 to 1.0 and in another example is cleavable from 6.5 to 3.0 (i.e., different conditions; Yang, page 2, paragraph 0029).
Regarding claim 9, Yang teaches all of the elements of the claimed invention as applied to claim 1. As above, Yang teaches a repeating structure [A-M]p, wherein M can be a hydrophobic fragment (Yang, claim 1), which can be lactic acid, glycolic acid, and/or malic acid (i.e., alpha hydroxy acids as defined by the instant specification, page 16, line 7).
Regarding claim 11, Yang teaches all of the elements of the claimed invention as applied to claim 1. Yang teaches it is readily apparent to those skilled in the art that various modifications can be made (Yang, page 11, paragraph 0077) and specifies the hydroxyl group of the HA is modified (i.e., the HA exhibits at least one functional group modification moiety; Yang, page 2, paragraph 0036).
Claims 7-8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (US 20140199349 A1; IDS reference, 10/08/2023) as applied to claims 1-6, 9, and 11, further in view of Stinchcomb (US 20090036523 A1; IDS reference, 10/08/2023), and as evidenced by Sadozai (US 6548081 B2).
Regarding claim 7, Yang teaches all of the elements of the claimed invention as applied to claim 1. Yang teaches the structure as described above, wherein the hyaluronic acid derivative is linked to a hydrophobic fragment which consists of repeat units of a bioabsorbable polymer (Yang, claim 4). As evidenced by Sadozai, hyaluronic acid is bioabsorbable polymer (Sadozai, abstract). Stinchcomb teaches delivery of active agents (Stinchcomb, page 1, paragraph 0002), wherein a prodrug is linked to two hyaluronic acid esters (Stinchcomb, claims 1 and 4).
Yang and Stinchcomb are both considered to be analogous to the claimed invention, because Yang, Stinchcomb, and the instant invention are in the field of hyaluronic acid drug delivery. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the derivative taught by Yang to include a second hyaluronic acid as one of the hydrophobic fragments, thereby resulting in the claimed structure, because Yang teaches the hydrophobic fragment is a bioabsorbable polymer of repeat units (Yang, claim 4), and further teaches that it is readily apparent to those skilled in the art that various modifications can be made (Yang, page 11, paragraph 0077), while Stinchcomb teaches the delivery of a prodrug wherein two hyaluronic acids are present is known in the art.
Regarding claim 8, Yang and Stinchcomb together teach all the elements of the invention as applied to claim 7. As above, Yang teaches the structure as described above, wherein the hyaluronic acid derivative is linked to a hydrophobic fragment which consists of repeat units of a bioabsorbable polymer (Yang, claim 4). As evidenced by Sadozai, hyaluronic acid is bioabsorbable polymer (Sadozai, abstract). Stinchcomb teaches delivery of active agents (Stinchcomb, page 1, paragraph 0002), wherein a prodrug is linked to two hyaluronic acid esters (Stinchcomb, claims 1 and 4). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the derivative taught by Yang to include a second hyaluronic acid as one of the hydrophobic fragments, thereby resulting in the claimed structure, because Yang teaches the hydrophobic fragment is a bioabsorbable polymer of repeat units (Yang, claim 4), and further teaches that it is readily apparent to those skilled in the art that various modifications can be made (Yang, page 11, paragraph 0077), while Stinchcomb teaches the delivery of a prodrug wherein two hyaluronic acids are present is known in the art.
Regarding claim 12, Yang teaches all of the elements of the claimed invention as applied to claim 1. As above, Yang teaches M can be a hydrophobic fragment (Yang, claim 1), such as lactic acid (i.e., a vitamin/bioactive agent as defined by the instant specification, page 16, line 7; Yang, page 2, paragraph 0031), but Yang does not specify that M can be a precursor of a bioactive agent. Stinchcomb, however, teaches a hyaluronic acid derivative of a prodrug (i.e., a precursor of a bioactive agent; Stinchcomb, claim 18). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the derivative taught by Yang to include a prodrug as taught by Stinchcomb, because Stinchcomb states the prodrug results in skin penetration and availability of the active agent at the site with decreased side effects (Stinchcomb, page 2, paragraphs 0018-0019).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHASITY P JANOSKO whose telephone number is (703)756-5307. The examiner can normally be reached 7:30-3:30 ET.
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613