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 a preliminary amendment to the claims filed on 08/09/2023 is acknowledged.
Election/Restriction
Applicant's election without traverse of Group I, claims 32-41 in the Reply filed on 01/23/2026 is acknowledged. By way of applicant’s election, claims 42-51 have been withdrawn from further consideration. Since the election was made without traverse, the requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 32-41 are examined on the merits to which the following grounds of rejections are applicable.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/01/2024 was filed before the mailing date of the instant first action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith.
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, 33 and 37 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.
Claims 32, 33 and 37 are indefinite because these claims include a concentration range in the form of %(w/w) without indicating what is the basis for the range. Is the range based on the total weight of the composition? Clarification is requested.
Further, claim 33 recites “the HMP is present at a concentration of about 50% to about 100% in each of the first and second films”. It is not clear how the first and second films can contain the claimed initial water content when the concentration of HMP in each first/second films is e.g., about 100%. Clarification is requested.
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 are 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 08/09/2023:
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Prior Art
Zheng teaches high-methoxy pectin-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 37%-about 43% and about 9% to about 13%. 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.
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 are 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 is identical to the claimed range (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 claim 33 is obvious over Zheng in view of Mentzer.
Conclusion
All the examined claims are rejected.
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.
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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.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613