DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Preliminary amendment filed on 02/13/2023 has been entered. Claims 8-20 are new. Claims 1-20 are pending in this application. Claims 8-20 are withdrawn. Claims 1-7 are currently under examination.
Priority
This application is a 371 of PCT/CN2020/127708 filed on 11/20/2020 and claims foreign priority of CHINA 202011001303.7 filed on 09/22/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Election/Restrictions
Applicant’s election of Group I invention (claims 1-7) in the reply filed on 12/03/2025 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 Claims 8-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Thus, claims 1-7 are currently under examination.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 02/13/2023 has been considered.
Claim Objections
Claim 2 is objected to because of the following informalities: In claim 2, insert the missing phase “the hydrolyzed heparin-like mucopolysaccharide in” immediately after the recitations “adsorbing” and “eluting”, respectively, in line 9, because “the supernatant” cannot be adsorbed or eluted. Appropriate correction is required.
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 5-7 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 6 and 7 depend from claim 5.
Claim 5 recites the limitation "claim 1, wherein blood vessels" in line 2. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to insert the phrase “in blood vessels” immediately after the recitation “angiogenesis” (line 2 of claim 1).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon or a product of nature without significantly more. The 2019 Revised Patent Subject Matter Eligibility Guidance (issued January 7, 2019)” (https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf) and “October 2019 Update: Subject Matter Eligibility (issued October 17, 2019)” (https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf), are followed here. The claim is directed to a statutory category, e.g., a composition of matter (Step 1: YES). The claim is then analyzed in Step 2A (Prong one) to determine whether it is directed to any judicial exception. The claims 1-7 recite a fish swim bladder-derived heparin-like mucopolysaccharide with a structural unit of α-∆GlcUA-[1→ 3]-GalNAc-4S, which is product of nature. Accordingly, the claim is directed to at least one exception (Step 2A, prong one: YES). The claim is then analyzed in Step 2A (Prong two) and is deemed that this judicial exception is not integrated into a practical application because there is no indication that the recited method of making and effective inhibitory concentration (i.e., 0.5-2 mg/mL or 100-500 mg/mL) changes the structure, function, or other properties of the fish swim bladder-derived heparin-like mucopolysaccharide in any marked way. Instead, the fish swim bladder-derived heparin-like mucopolysaccharide retains its naturally occurring structure and properties (e.g., heparin-like activity or anti-angiogenic activity). Thus, the claimed mixture as a whole does not display markedly different characteristics compared to the closest naturally occurring counterpart. Accordingly, the Step 2A (Prong two) is NO. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because prior to applicant’s invention and at the time of filing the application, the structure of fish swim bladder-derived heparin-like mucopolysaccharide was well-understood, routine and conventional in the field, as evidenced by the reference under the 102 rejection below. The recitation of product-by-process or specific inhibitory concentration does not affect this analysis, because it was also well-understood, routine and conventional. Thus, the fish swim bladder-derived heparin-like mucopolysaccharide, when recited at this high level of generality, does not meaningfully limit the claim, and the claim as a whole does not amount to significantly more than each “product of nature” by itself (Step 2B: NO). The claim does not qualify as eligible subject matter.
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.
Claim interpretation: Claims 2-4 are directed to a product-by-process. Claims 5-7 are directed to a property of fish swim bladder-derived heparin-like mucopolysaccharide. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)”. See MPEP 2113 [R-01.2024][I].
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou et al. (Food Science, 2019, 40(15): 84-91, August 15, 2019, also provided with a machine English translation for citation here, hereinafter referred to as Zhou ‘2019).
With regard to structural limitations “a fish swim bladder-derived heparin-like mucopolysaccharide having the structural unit of α-∆GlcUA-[1→ 3]-GalNAc-4S (or prepared by a process comprising: mixing fish swim bladder dry powder with water to obtain a suspension of fish swim bladder powder; mixing and enzymatic hydrolyzing the suspension of fish swim bladder powder with sodium chloride (or 1.2-1.8% of the mass of the fish swim bladder dry powder) and a protease to obtain enzymatic hydrolyzate; inactivating the enzymatic hydrolyzate and then collecting a supernatant by centrifugation; adsorbing the hydrolyzed heparin-like mucopolysaccharide in the supernatant by macroporous anion-exchange resin and eluting the hydrolyzed heparin-like mucopolysaccharide in the supernatant by an aqueous solution of sodium chloride (or 0.3-1.1 mol/L) to obtain an eluate; precipitating and drying the eluate to obtain the fish swim bladder-derived heparin-like mucopolysaccharide)” (claims 1-4):
Zhou ‘2019 disclosed heparin-like compounds isolated from fish swim bladder by enzymatic hydrolysis, purified and fractionated into four fractions (F1–F4) by anion exchange resin adsorption followed by sodium chloride gradient elution and alcohol precipitation. F4 was identified as chondroitin sulfate-A composed of repeated disaccharide units of [→4GlcUA β1→3GalNAc(4S)β1→]. Specific steps: After drying and crushing, add 20 times the volume of double distilled water and 5.4 mg/mL protease to the swim bladder, and digest it in a water bath at 50 °C for 20 h. Boiling water bath to destroy the enzyme for 10 min, cool and centrifuge. The supernatant was dynamically adsorbed with macroporous anion exchange resin, and then gradient elution was carried out with 0.3, 0.5, 0.9 and 1.1 mol/L sodium chloride solutions, respectively. Basic composition of chondroitin sulfate disaccharide fragments:
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The main disaccharide units of F4 are: ΔDi-4S (pages 1/14 to 2/14, Abstract; page 3/14, para. 1.3.1; page 10/14, Fig. 10 and first para.). Heparinoid from swimming bladder (HSB) was prepared with distilled water to form a 1 mg/mL solution. A solution of 5 mg/mL HSB was prepared. The HSB was prepared with D2O in a solution of 30 mg/mL (page 4/14, para. 1.3.4, 1.3.5, and 1.3.9).
Thus, these teachings of Zhou ‘2019 anticipate Applicant’s claims 1-7 because the ΔDi-4S of Zhou ‘2019 is equivalent to the claimed α-∆GlcUA-[1→ 3]-GalNAc-4S and would also carry the same properties, including “for inhibiting angiogenesis in blood vessels (or human umbilical veins or chick embryo chorioallantoic membrane blood vessels”, and “the effective inhibitory concentration… is 0.5-2 mg/mL (or 100-500 mg/mL)”, recited in claims 1 and 5-7.
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691