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 .
DETAILED ACTION
Pursuant to the preliminary amendment dated 12/8/2023, claims 1-29 are cancelled and claims 30-49 are newly added.
Claims 30-49 are pending in the instant application and are examined on the merits herein.
Priority
The application is a National Stage entry of PCT/US2021/058319 filed on 11/5/2021, which claims priority to provisional application 63/109900 filed on 11/5/2020.
Information Disclosure Statement
The information disclosure statements (IDS) dated 7/25/2024 and 1/6/2025 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
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.
Claims 30-33, 36 and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dublanchet et al. (US 2016/0051458A1, IDS).
Dublanchet et al. discloses a hyaluronic acid based cosmetic active agent having the structure: (¶0476-0483)
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where the hyaluronic acid polymer has a molecular weight between 500 kDa and 2 MDa and has a degree of Z substitution between 2-30%. It is noted that the R’ group of Dublanchet meets the instant limitation of a methylene linker.
Accordingly, the instant claims are anticipated by the prior art.
Claims 30-33, 36-38, 40, 41 and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chodorowski et al. (US 2013/0017164A1, IDS).
Chodorowski et al. discloses a hyaluronic acid based cosmetic or dermatological active agent having the structure below, where the hyaluronic acid active agent may be part of a composition comprising other cosmetic active agents and adjuvants: (Claims 1, 2; ¶0040)
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where the hyaluronic acid polymer has a molecular weight between 500 kDa and 2 MDa and has a degree of Z substitution between 2-30%. It is noted that the R’ group of Chodorowski meets the instant limitation of a methylene linker. Chodorowski also discloses that the hyaluronic acid based cosmetic or dermatological active agent may be administered to the skin to treat fine lines and wrinkles or restoring volume. (Claim 7) Chodorowski also discloses a method of making the hyaluronic acid based cosmetic or dermatological active agent by combining an alkyl amine derivatized ureidopyrimidinone with hyaluronic acid and 1-ethyl-3-(3-(dimethylamino)propyl) carbodiimide. (Example 1)
Accordingly, the instant claims are anticipated by the prior art.
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 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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 34 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Dublanchet et al. (US 2016/0051458A1, IDS), or in the alternative over Chodorowski et al. (US 2013/0017164A1, IDS), in view of Dankers et al. (US 2017/0233745A1, PTO-892).
The disclosure of Dublanchet or Chodorowski are referenced as discussed above. Neither reference teaches the linker claimed.
Dankers et al. discloses a ureidopyrimidinone moiety connected to a targeting moiety (“Z”) via a linker, having the structure of formula (III), where the targeting moiety can be hyaluronic acid: (Claim 6; ¶0125)
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the methylene linker Dublanchet or Chodorowski with the mixed urea-methylene linker of Dankers, thereby arriving at the instant invention. The obviousness of such a substitution lies in the essence of a linker, which is a structure connecting two or more active moieties together. Any structure known in the art to perform the function of a linker, especially when connecting the same two active moieties (i.e. hyaluronic acid and ureidopyrimidinone), would be expected to be an equivalent solution. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 39, 42, 43, 45-47 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Dublanchet et al. (US 2016/0051458A1, IDS), or in the alternative over Chodorowski et al. (US 2013/0017164A1, IDS), in view of Ma et al. (US 2018/0094106A1, IDS), further in view of Ushida et al. (US 9,095,551 B2; 2015, PTO-892).
The disclosure of Dublanchet or Chodorowski are referenced as discussed above. Neither reference teaches the linker claimed.
Ma et al. discloses ureidopyrimidinone-methylene-polymer compounds, where the polymer may be hyaluronic acid. (Figure 2; Claim 13) Ma also discloses that the ureidopyrimidinone-methylene-polymer compounds may be employed in various applications, including tissue engineering, drug delivery, tissue bulking, adhesive, cosmetics, wound dressing, and surgical dressing. (¶0019)
Ushida et al. discloses that hyaluronic acid based compositions are used in methods of treating, lubricating and providing chondroprotection for arthritic and osteoartiritic joints, including knee joints, more particularly the anterior cruciate ligament of the knee joint. (Col. 1, Ln. 45-50; Col. 2, Ln. 18; Col. 10, Ln. 5-20; Figure 3; Example 2) Ushida also discloses that treatment of OA may involve growth factors. (Col. 3, Ln. 35-40)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the hyaluronic acid compound of Dublanchet or Chodorowski, to treat osteoarthritis or an injury to a knee joint, or relieve arthritic pain, or provide chondroprotection or provide joint lubrication, thereby arriving at the instant invention. One would find such an application of the compound of Dublanchet or Chodorowski obvious because Ma suggests that ureidopyrimidinone-methylene-hyaluronic acid compounds may be employed in various applications, including tissue engineering, drug delivery, tissue bulking, adhesive, cosmetics, wound dressing, and surgical dressing. Within the field of tissue engineering, Ushida provides guidance that hyaluronic acid based compounds are known to be effective to treat osteoarthritis or an injury to a knee joint, or relieve arthritic pain, or provide chondroprotection or provide joint lubrication. Thus, the application of the specific hyaluronic acid compound of Dublanchet or Chodorowski, to any method of use discloses by Ushida would be obvious to one of ordinary skill in the art.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 39 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Dublanchet et al. (US 2016/0051458A1, IDS), or in the alternative over Chodorowski et al. (US 2013/0017164A1, IDS), in view of Ma et al. (US 2018/0094106A1, IDS), further in view of Faour et al. (US 2008/0050335 A1, PTO-892).
The disclosure of Dublanchet or Chodorowski are referenced as discussed above. Neither reference teaches the linker claimed.
Ma et al. discloses ureidopyrimidinone-methylene-polymer compounds, where the polymer may be hyaluronic acid. (Figure 2; Claim 13) Ma also discloses that the ureidopyrimidinone-methylene-polymer compounds may be employed in various applications, including tissue engineering, drug delivery, tissue bulking, adhesive, cosmetics, wound dressing, and surgical dressing. (¶0019)
Faour et al. discloses that hyaluronic acid based compositions are used in methods of lubricating the eye or treating dry eye disease. (Claims 65 and 66) Faour also discloses that treatment may involve growth factors or steroidal anti-inflammatory agents. (¶0032-0033)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the hyaluronic acid compound of Dublanchet or Chodorowski, to lubricate the eye or treat dry eye disease, thereby arriving at the instant invention. One would find such an application of the compound of Dublanchet or Chodorowski obvious because Ma suggests that ureidopyrimidinone-methylene-hyaluronic acid compounds may be employed in various applications, including tissue engineering, drug delivery, tissue bulking, adhesive, cosmetics, wound dressing, and surgical dressing. Faour provides guidance that hyaluronic acid based compounds are known to be effective to lubricate the eye or treat dry eye disease. Thus, the application of the specific hyaluronic acid compound of Dublanchet or Chodorowski, to any method of use discloses by Faour would be obvious to one of ordinary skill in the art.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DALE R MILLER/Primary Examiner, Art Unit 1693