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
Claims 32-51 are currently pending and amendment to the claims filed on 06/24/2026 is acknowledged. By way of applicant’s election of 01/23/2026, claims 32-41 are examined on the merits to which the following grounds of rejections are applicable.
Withdrawn rejections:
Applicant's amendments/arguments and a Rule 1.130 filed 06/24/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
New Grounds of Rejections --- as necessitated by amendment
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 32 and 34-41 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.
Each of claim 32, 33 and 38 recites the term “high methoxy pectin (HMP)”, but which refers to relative term which renders the claims indefinite because “high” varies widely in the art depending on the individual situation as well as the person making the determination of factors which mainly depends on various ingredients and their amounts in the bioadhesive polymer composition. In this regard, claim 33 provides certain degree of HMP. But claim 32 does not require any degree of HMP. The remaining claims are also rejected due to the rejection of base claim 32.
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.
Claim Rejections - 35 USC § 102
(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.
Claims 32 and 34-41 remain rejected under 35 U.S.C. 102(a)(1) as anticipated by Zheng et al. “Water-dependent blending of pectin films: the mechanics of conjoined biopolymers”, Molecules, 2020, pp. 1-11 (IDS of 08/01/2024).
Applicant claims the below claim 32 filed on 06/24/2026:
PNG
media_image1.png
253
832
media_image1.png
Greyscale
Prior Art
Zheng teaches high-methoxy pectin (HMP)-based films for biomedical applications; Zheng provides pectin polymers consisting of a first gel phase film (38-41% water content) which is adhered to a second glass phase film (10-13% water content) to form a conjoined film (see e.g., abstract on page 1 and Fig. 1 on page 3) wherein the said water contents are within the claimed ranges of about 38%-about 41% and about 10% to about 13%, respectively. MPEP 2131.03: anticipation of ranges - “If the prior art discloses a point within the claimed range, the prior art anticipates the claim.” UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023) (instant claim 32); the adhesivity between the first gel film and the second glass film is 25±3N (see e.g., page 3, second para. and Fig. 2A) which is within the instant range of about 22N to about 28N. MPEP2131.03 above (instant claim 34); the conjoined first gel/second glass film shows cross-grain adhesion (see e.g., abstract, page 7, Fig.6)(instant claim 35); the initial water content of the first gel phase and second glass phase is a water content before and during an initial period of time after the first gel and second glass film are adhered to each other, and here the initial period of time is 0 to about 600 seconds (=10 minutes) at most (see e.g., Fig. 3A-B on page 4)(instant claim 36); after the initial period of time, the final water content of the gel phase film and the glass phase film is 20-30%, in particular 25% (see e.g., Fig. 3A and B on page 4)(instant claim 37); interdiffusion of water and HMP between a first gel phase and a second glass phase occurs within 10 minutes (see e.g., section 2.2 on page 3, and Figs. 3A-3B) (instant claim 38); the diffusion coefficient of water through the pectin films was estimated to be 2.5- to 5-fold slower than the self-diffusion coefficient of water (see e.g., section 2.2 on page 3 and Figure 3B on page 4)(instant claim 39); the water content at the interface between the first gel film and the second glass film differs from bulk of each film (see e.g., Fig. 1A on page 3) (instant claim 40); and the glass film has a thickness of about 40 microns and the gel film has a thickness of about 62 microns (see, e.g., section 4.2 on page 8) and conjoined films have a work of cohesion of 100 to 150J/m2, both ranges are identical to the claimed ranges (instant claim 41).
In light of the foregoing, instant claims 32 and 34-41 are anticipated by Zheng.
Response to Arguments
Applicant’s arguments based on 1.130 Declaration to antedate the Zheng reference have been fully considered, but are not persuasive.
The Examiner would like to have applicant’s attention to the followings: “The provisional application must support the claimed subject matter. In order to gain the benefit of the filing date of an earlier application under 35 U.S.C. § 120, each application in the chain leading back to the earlier application must comply with the written description requirement of 35 U.S.C. § 112. In re Hogan, 559 F.2d 595, 609, 194 USPQ 527, 540 (CCPA 1977). The conditions for being entitled to an earlier filing date can only be satisfied by what is described in the applications themselves, not to any ideas implied by them. Lockwood v. American Airlines, Inc, 107 F.3d 1565 (Fed Cir. 1997). It is the disclosures of the applications that count. Entitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed. It extends only to that which is disclosed.”
Here, in the instant case, the features of “about 38% to about 41%” in line 3 of instant claim 32; “about 10% to about 13%” in line 5 of instant claim 32; and “initial water content” in lines 3-4 of instant claim 32 do not appear to be supported by the provisional application having an earliest filing date of 02/09/2021. Specifically, according to page 6, second paragraph of the instant 371 specification, the term “about” refers to an amount that is near the stated amount by about 10%, 5% or 1% and means a range including the particular value and ranging from 10% below that particular value and spanning to 10% above that particular value. However, the provisional application discloses exact amounts of those values, which does not fall within ±10% of the recited values, and the claimed ranges are supported by the PCT applicant filed on 02/09/2022, rather than an effective filing date of 02/09/2021 of the provisional application. Further, [0005] of the provisional specification discloses “the progressive evaporation of water created the gel phase and glass phase films used in these studies. (B,C) The films in the gel phase (38-41% w/w Wc) were soft and flexible. The glass phase films (10-13% w/w Wc) were hard and brittle.” That is, the disclosure of the provisional application appears to refer to the remaining water amount after evaporation, not the initial water amount, and thus, the term “initial water amount” is not supported by the provisional application and rather by the PCT applicant filed on 02/09/2022. Further, claim 33 reciting “about 50% to about 90%” of HMP concentration is not supported by the provisional application because the provisional application discloses pectin polymers with a greater than 50% degree of methoxylation (Mean = ± 9%)([0035] of provisional application), and however, e.g., “about 50%” may also embrace even e.g., 48, 49, 49.5% … ; and it appears that at least claims 34 (“about”), 36 (entire features), 37 (entire features); and 41 (entire features) are not supported by the provisional application. Therefore, the earliest filing date of those claims is 02/09/2022 (international filing date), not a 02/09/2021 (provisional application filing date). Consequently, since the Zheng reference was published on 04/30/2020, which is one year before 02/09/2022 of international filing date, the applied reference is still valid.
Thus, the rejection is maintained until applicant provides a proper amendment to the claims.
If applicant disagrees, please provide locations of supports along with detailed explanations for each pending claims.
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.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 32-41 remain rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. “Water-dependent blending of pectin films: the mechanics of conjoined biopolymers”, Molecules, 2020, pp. 1-11 (IDS of 08/01/2024) as applied to instant claims 32 and 34-41 in view of Mentzer et al. (US2018/0311403A1, IDS of 08/01/2024).
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Zheng was discussed above with respect to instant claims 32 and 34-41.
Zheng teaches pectin binds the mesothelial glycocalyx of visceral organs suggesting a potential role as a mesothelial sealant (see page 2, first para.).
Although Zheng discloses the amount 88±1mg of HPM (see section 2.4 on page 5), Zheng does not expressly teach the concentration of about 50% to about 100% of HPM recited in instant claim 33. The deficiency is cured by Mentzer.
Mentzer discloses pectin-CMC mesothelial sealants and protectants (title); and teaches bioadhesive pectin-based polymer composition, wherein the composition comprises high methoxy pectin (HMP) in an amount of 50-100% ([0010]) which overlaps the claimed range of about 50-90% (instant claim 33).
One of the ordinary skill in the art would have been motivated to combine the teachings of Zheng and Mentzer to achieve the claimed range, as it is a result-effective variable and the optimization would have been routine experimentation.
In light of the foregoing, instant claims 32-41 are obvious over Zheng in view of Mentzer.
Response to Arguments
Regarding applicant’s arguments based on 102(b)(1)(A), the above Examiner’s response applies hereto.
Further the Mentzer was relied on for disclosing the concentration of HMP, not for the claimed elements of first/second films comprising each i) and ii). In this respect, please see [O]ne cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In reKeller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In reMerck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). MPEP 2145.
In light of the foregoing, applicant’s arguments are not persuasive.
Conclusion
All the examined claims are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KYUNG S CHANG/Primary Examiner, Art Unit 1613
Prosecution Insights