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 .
CONTINUING DATA
This application is a 371 of PCT/KR2021/001989 02/17/2021
FOREIGN APPLICATIONS
KOREA, REPUBLIC OF 10-2020-0029805 03/10/2020
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 2, 2026 has been entered.
The rejection of claims 1, 3-5, and 8-13 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn. Applicant’s argument that experimentation would be routine and not undue is persuasive. MPEP 2164 states that the fact that experimentation may be complex does not necessarily make it undue.
The following rejection of record is maintained.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 3-5, and 8-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jang (WO2020013580A1, January 16, 2020, previously cited by the examiner). EP3804770 is used as an English equivalent.
Jang teaches a hyaluronic acid filler which has properties of a monophasic filler and a biphasic filler simultaneously [0012]. The product is prepared by crosslinking with BDDE and sodium hydroxide and contains lidocaine [0054]. The product is included in a syringe [0052]. The storage elastic modulus G’ was 448 or 708. Compression force was 36 or 44. Injection force was 22 or 21. See Table 1. Strain was 3.3 or 3.5 (Table 2). The crosslinking agent is present at a concentration of 1 to 10 mol% (claim 12). The filler contains 1-3% HA [0030]. 10 mg/mL to 30 mg/mL as recited in current claim 9 corresponds to 1-3%. The degree of modification is 1-7% [0019].
Jang is silent about critical strain, tack force, and viscous modulus G” as measured in the current claims, but these properties are inherent in Jang’s product. MPEP 2112 states that in relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art. The basis in fact and/or technical reasoning that Jang’s product inherently meets the claim limitations is that Jang’s product is prepared using the same crosslinking agent, has a degree of modification which falls within the preferred range given in the current specification (pages 8-9), has both monophasic and biphasic characteristics simultaneously, the concentration of HA is the same as recited in current claim 9, and other properties such as G’, compression, and injection force overlap with the claim limitations. Thus, Jang’s product appears to be the same as a product of the current claims. MPEP 2112 states that the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Since the Office does not have the facilities for preparing the claimed materials and comparing them with prior art inventions, the burden is on Applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980).
Response to Arguments
Applicant argues that the examples disclosed in the specification exhibit higher viscoelasticity and higher compression resistance compared to Jang, so Jang does not disclose a product having the claimed critical strain, tack force, and elastic modulus. This argument is not persuasive because Jang does teach that compression is 36 or 44, which meets the limitation of claim 4. Jang teaches a product wherein G’ is about 700, which meets the G’ limitation in claim 1. As was mentioned in the advisory action mailed February 11, 2026, the fact that Jang’s exemplary compositions are not identical to Applicant’s exemplary compositions does not mean that Jang’s compositions do not meet the limitations of the claims, which are broader than Applicant’s examples.
Applicant argues that Jang fails to disclose a product with G’ within the range of 600 to 1800 Pa. this argument is not persuasive because Jang’s Example 2 has G’ 707, which is acknowledged on page 7 of Applicant’s arguments submitted March 2, 2026. 707 is within the range of 600 to 1800.
Applicant argues that the present invention achieves superior persistence and a higher cross-linking degree compared to Jang’s composition. This argument is not persuasive because persistence and cross-linking degree are not claimed. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims.
For these reasons, the rejection is maintained.
Conclusion
No claims are allowed.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693