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 DIV of 17/260,266 01/14/2021 PAT 11938145
17/260,266 is a 371 of PCT/CA2019/051026 07/24/2019
PCT/CA2019/051026 has PRO 62/861,223 06/13/2019
PCT/CA2019/051026 has PRO 62/861,235 06/13/2019
PCT/CA2019/051026 has PRO 62/861,228 06/13/2019
PCT/CA2019/051026 has PRO 62/793,654 01/17/2019
PCT/CA2019/051026 has PRO 62/793,514 01/17/2019
PCT/CA2019/051026 has PRO 62/755,318 11/02/2018
PCT/CA2019/051026 has PRO 62/755,328 11/02/2018
PCT/CA2019/051026 has PRO 62/755,311 11/02/2018
PCT/CA2019/051026 has PRO 62/722,135 08/23/2018
PCT/CA2019/051026 has PRO 62/722,137 08/23/2018
PCT/CA2019/051026 has PRO 62/713,399 08/01/2018
PCT/CA2019/051026 has PRO 62/713,392 08/01/2018
PCT/CA2019/051026 has PRO 62/713,413 08/01/2018
PCT/CA2019/051026 has PRO 62/711,335 07/27/2018
PCT/CA2019/051026 has PRO 62/711,372 07/27/2018
PCT/CA2019/051026 has PRO 62/711,364 07/27/2018
Claims 1, 4, 8, 12, 17, 21, 24, 29, 33, 36, 39-40, 46, 49, 52-53, 58, 64, 66-67, 69, 72, 74-79, 86, and 93 are pending.
Claim Objections
Claim 33 is objected to because of the following informalities: claim 33 recites “any one of claim 17,” which perhaps should simply read “claim 17.” 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 17, 21, 24, 29, 33, 36, 39, 40, 46, 49, 52-53, 58, 64, 66-67, 69, 72, 74-78, 86, and 93 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 17, 36, 39, 49, 52, 53, 58, 64, and 86 depend from claim 16, which is cancelled. It is impossible to determine the metes and bounds of a cancelled claim. Claims which depend from claims 17, 36, 39, 49, 52, 53, 58, 64, and 86 are unclear for the same reason.
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, 4, 8, 12, 17, 21, 24, 29, 33, 36, 39-40, 46, 49, 52-53, 58, 64, 66-67, 69, 72, 74-79, 86, and 93 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite a compound derived from natural sources. This judicial exception is not integrated into a practical application, and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The claim(s) recite(s) a fucan-low endotoxin composition comprising less than about 0.2 endotoxin units per milligram of the fucan. Claim 64 recites that the composition is in a medically acceptable buffer or diluent. Claim 86 requires a particular concentration of the composition, and wherein the composition is configured and composed to treat a disease.
Subject matter that is not patent eligible is determined by evaluating a claim for patentability based on the eligibility test set forth below:
(1) Is the claim directed to one of the four statutory categories, i.e., a process, machine, manufacture, or composition of matter? For the instant claims, the answer is “Yes” because the claims are to a composition of matter.
(2a) Prong 1: Does the claim recite or involve a judicial exception? The answer is “Yes” because the product (a fucan) is a naturally occurring compound. Fucan (fucoidan), may be derived from various natural sources, such as seaweed. The closest counterpart is the fucan as it exists in the seaweed or other source. The fucan composition has been purified to remove endotoxin. MPEP 2106 states that in order to be markedly different, the inventor must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart. The counterpart should be in its natural state, but examiners should take care not to confuse the counterpart with other material that may occur naturally with, or adjacent to, the counterpart. The counterpart is naturally-occurring fucan and the claimed fucan does not possess properties or structural or functional characteristics which are different from that of the naturally-occurring fucan. Endotoxin is other material that may occur naturally with or adjacent to the fucan.
(2a) Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application? The answer is “No” because some claims recite “medically acceptable” or “agent for treating fibrous adhesion,” these are merely statements of intended use.
(2b) Does the claim as a whole recite additional elements that amount to something significantly more than the judicial exception(s)? The answer is “No.” The claims are drawn to a product comprising a naturally occurring product. The recited product, fucan (fucoidan), may be derived from various natural sources, such as seaweed. The closest counterpart is the fucan as it exists in the seaweed or other source.
Claims 1, 4, 8, 12, 36, 39-40, 46, 49, 52-53, 58, recite a fucan, per se, that is purified to minimize the presence of endotoxin. Generally speaking, purifying a composition to afford one lacking an unwanted component, such as endotoxin, does not result in eligibility for the natural product. There is nothing to suggest that this purified product comprises any marked difference in structure or function.
With respect to claims 64, 66-67, 69, 72, 74-75, and 86 and 93, these claims further require a medically acceptable buffer or diluent or are contained within a dosage form. The addition of such components is well understood, conventional and routine in the art. See, for example, Springate (WO 2011/011881) at [00024]. These additions are recited at a high level of generality and do not favor eligibility.
With respect to claims 36, 39-40, 46, 49, and 52-53, these claims recite structural limitations that are generally consistent with fucans. See Fitton et al (Mar. Drugs, 2015) at Table 1 and page 5926, 3% paragraph.
With respect to claims 17, 21, 24, 29, 33, and 76-78, these claims are drawn to a particular molecular weight fraction. Fractionation of a polymeric natural product without a change in structure of the molecules amounts to removal of unwanted components (the individual molecules having undesired molecular weight). The remaining components have the structure and function as they did in nature. Some of these claims also require a medically acceptable buffer or diluent, which was addressed above.
In view of the foregoing, it is determined that the claims are drawn to a judicial exception without significantly more or any markedly different characteristics. Therefore, it is determined that the recited product is not patent eligible.
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, 4, 17, 21, 24, 29, 33, 36, 39-40, 46, 49, 52-53, 58, 64, 66, 67, 69, 72, 74-78, 86, and 93 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kopplin (ACS Appl. Bio Mater. 2018, 1, 1880-1892, and supporting information).
Kopplin teaches purified fucan samples which had an endotoxin level of 6.9 EU/g. Page 1882, Purification for Inflammatory Property Assessment. 6.9 EU/g corresponds to 0.069 EU/mg. The molecular weight was 469 kDa (see abstract). Figure S2 in the supporting information illustrates the polydispersity of the fucan. The vast majority of the composition has a molecular weight greater than 100 kDa. The fucans were tested at a concentration of 10 or 100 µg/mL in saline (a medically acceptable diluent). Page 1882, Assessment in Whole Blood, and abstract. The sulfate level was 53.8% (see abstract). The fucan was 97.8% fucose and 2.2% galactose (see abstract).
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Kopplin’s molecular weight was measured in a different way than recited in the current claims. The basis in fact or technical reasoning that Kopplin’s product meets the claim limitations is that molecular weights measured in two other ways meet the claim limitations. Kopplin is silent about the color of the fucan and its clarity in water and its viscosity measured in cP as recited in the claim. The basis in fact or technical reasoning that Kopplin’s product meets the claim limitations is that it is highly purified and of a molecular weight similar to that recited in the claims. Kopplin is silent about the total carbohydrate content. The basis in fact or technical reasoning that Kopplin’s product meets the claim limitations is that Kopplin refers to the compound as a polysaccharide molecule isolated from L. hyperborea, comprising primarily fucose. Page 1889, Structure). The basis in fact or technical reasoning that Kopplin’s product meets the limitations of claims 66-67, 69, and 72 is that the endotoxin level fucan is very low and the compositions prepared were small.
Once a reference teaching a product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant. MPEP 2112.
The limitation “for treating a fibrous adhesion” recited in claim 58 is interpreted to be an intended use which does not limit the structure of the claim.
Conclusion
No claims are allowed.
It is noted that claims 8 and 12 were not rejected as obvious over Kopplin because endotoxins are notoriously difficult to remove from natural products. Du et al (Appl. Microbiol. Biotechnol, 2017) demonstrates the difficulty in purifying a naturally occurring, sulfated polysaccharide. See pp 6602-6603. Wang etal (Mar. Drugs, 2021) teaches the use of fucoidans in bone formation. The reference notes that such natural products may be contaminated with endotoxins and that products that may contact blood must be “endotoxin- free.” See Section 3, 5‘ paragraph. The “endotoxin-free” products deemed suitable for testing contained about 0.07 EU/mL. See Table 2. The samples were tested at 100 ug/mL. Converting to the claimed units: 0.07 EU/mL = 0.07 EU/100 pg = 0.7 EU/mg. It is noted that the reference is post-filng, but it is illustrative of what might be termed “endotoxin-free” in the art. Therefore, without sensitive testing to demonstrate the finding, a product designated “endotoxin-free” is determined unlikely to meet the recited limitations.
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/LAYLA D BERRY/ Primary Examiner, Art Unit 1693