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
Formal Matters
Claims 11-24 are pending. Claims 16-17, 19-20, and 22-24 are withdrawn. Claims 11-15, 18 and 21 are under examination.
Priority
This application is a national stage entry of PCT/FR2021/051394 filed on 7/26/2021 claims priority from French application FR2007834 filed on 7/24/2020.
Objections and Rejections Withdrawn
The objection over the abstract is withdrawn as applicant has submitted a new abstract that meets the requirements.
The objection over the drawing is withdrawn as applicant has submitted replacement drawings over the objected drawings.
The objection over claims 11 and 18 is withdrawn per applicant’s corrections to the claims.
The rejection under USC 112(b) over claims 11 and 12 and claims 13-15 and 21 is for lack of antecedent basis for “the dry extract” is withdrawn per applicant’s amendments. However, note that the rejection over claim 18 is maintained as applicant did not make similar amendment.
The rejections under USC 112(b) over claims 11 and 18 and claims 12-15 and 21 for apparent molecular mass and “comprised between” are withdrawn per applicant’s amendment to the claim to convert it to “average molecular mass” and the removal of “comprised”.
The rejection under USC 102 over Nenonene is withdrawn per applicant’s amendments and arguments.
As these objections and rejections have been withdrawn, applicant’s arguments toward these objections and rejections are moot. The amendments to claims 11 and 18 to include “substantially free of polyphenols” and “the extract is obtainable by a process comprising a step of ultrafiltration” needed further consideration of the claims and further search of the prior art.
Maintained Rejections- Modified As Necessitated by Amendment
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 11-15, 18 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to products of nature without significantly more. These claims provide for a composition having polysaccharides extracted/isolated from flowers of Bombax costatum where the apparent molecular mass is comprised between 1500 to 6000 KDa. These polysaccharides that have been extracted/isolated are natural compounds found in the flowers of Bombax costatum. Such isolated/extracted polysaccharides are made up of galactose, rhamnose, galacturonic acid and glucuronic acid and have a molecular mass of applicant’s claims as seen in applicant’s analysis of these extracted polysaccharides in example 1 of applicant’s specification. Thus, this is the natural composition of the extracted/isolated natural polysaccharides. Claim 15 is to the process of extracting and as the extracting is only isolating or concentrating natural material (the polysaccharides), it is not changing the structure of the natural material. Claim 18 provides for a composition, but the claim only indicates the presence of the extracted polysaccharides themselves and indicates them as being an active ingredient, which is based on activities that are provided by the natural polysaccharides. The claims do not provide for additional ingredients or structure that would provide markedly different characteristics than what the natural bombax costatum flower polysaccharides have. Benalaya et al (International Journal of Molecular Sciences, 2024, volume 25, pages 1-32) teaches natural polysaccharides from plants of various types (abstract and pages 3-7 with celluloses, hemicelluloses, starches, pectins, etc.). There does not appear to be a characteristic that provides significantly more than what would be due to the natural polysaccharides. Isolating a natural compound does not make the compound different from the natural polysaccharides. Note “Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), (Supreme Court), decided that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” In this case, the natural polysaccharides of the indicated molecular weights and composition that are isolated from the flowers remain identical to those found in the flower before extraction. Claiming these by the process (product-by-process) used to isolate them or indicating them as a composition without including anything additional to such a process or composition that would make these polysaccharides markedly different from what occurs in nature or provide significantly more to the natural polysaccharides does not change them from what occurs in nature. Applicant may consider further limitations from the originally filed disclosure that will change the characteristics or provide significantly more to these products of nature. The following is in regards to applicant’s amendments. The additional limitation of “extract obtainable by a process comprising a step of ultrafiltration” is a product-by-process limitation toward the isolation/purification of the natural product and the limitation of “substantially free of polyphenols” is toward the absence or near absence of polyphenols due to purification, but the polysaccharides remain products of nature. Applicant’s data is toward how the more purified polysaccharides function in different activities, but does not compare it to non-processed polysaccharides to show markedly different characteristics exist via much improved activity and/or other characteristics.
Claim Rejections - 35 USC § 112(b)
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.
Claim 18 is still 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.
Claim 18 recites the limitation "the dry extract" in the claim without a prior indication of the extract being dry or dried. There is insufficient antecedent basis for this limitation in the claim. A polysaccharide rich extract does not necessarily have to be dry. Applicant could consider amending to “relative to the total weight of a dry extract of the polysaccharide-rich extract”.
There was not an amendment to claim 18 to repair this deficiency under USC 112(b).
New Rejection – As Necessitated by Applicant’s Amendments
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 11-13, 15, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nenonene et al (Bangladesh J Sci Ind Res, 2009, volume 44, pages 247-253, in applicant’s IDS filed on 4/12/2023) and Xie et al (Carbohydrate Polymers, 2014, volume 101, pages 479-483) as evidenced by applicant’s work (specification).
Nenonene teaches mucilage and pectin fractions (both are polysaccharides) of flower sepal/calyx of Bombax costatum were investigated (abstract and title) for use as bioadhesives. Nenonene teaches aqueous extraction (abstract). Nenonene teaches yield from 12% to 45% depending on the plant organ (abstract). Nenonene teaches extraction of mucilage with sepal powder of B costatum using water with heating and with centrifugation (Extraction of mucilage, page 248). Yield of mucilage was 45% for B costatum (page 250 and table II). The mucilage of B costatum has glucuronic acid and rhamnose (table II). Nenonene recognizes no detectable galactose in the B costatum mucilage (second column of page 250). As Nenonene provides for a process of using water, heating and centrifugation to extract mucilage (polysaccharides) from B costatum flowers and applicant’s specification example 1 provides that such a method including use of water, heating and centrifugation of B costatum flowers, one will obtain an amount of polysaccharides in the range of molecular mass of 3711 kDa. Nenonene will have collected such molecular weight mucilage/polysaccharides in its extract. Even if Nenonene does not concentrate its mucilage polysaccharides, it will still have these molecular weight polysaccharides in some amounts within the extract based on similarities in the extraction process. Nenonene teaches depending on the plant species and extraction method the content of extractible carbohydrates varied (conclusion).
Nenonene does not teach ultrafiltration as part of its processes, and the removal of polyphenols.
Xie teaches using an ultrafiltration process to separate polysaccharides from a plant (Cyclocarya paliurus (Batal.) Iljinskaja (C. paliurus)) (abstract). Xie teaches “Four fractions were obtained and named as CPPS-A, CPPS-B, CPPS-C and CPPS-D, respectively. CPPS-A and CPPS-B contained approximately 69.5% and 12.7% of polysaccharides” (abstract). Xie teaches “Compared with ethanol precipitation and gel permeation chromatography techniques, ultrafiltration showed many advantages, and also provided theoretical support for industrial manufacturing of C. paliurus polysaccharides in separation.” (abstract). Xie teaches that ultrafiltration leads to higher processing capacity, shorter durations, and very small reagent use (table 1). Xie teaches isolating polysaccharides with different molecular weights using ultrafiltration (section 4). Xie teaches “All experiments were carried out with a hollow fiber ultrafiltration module (Suntar Membrane Technology Co., Ltd., Xiamen, China) with different nominal molecular weight cut-offs (300 kDa, 100 kDa and 6 kDa) polysulfone hollow fiber membranes (effective membrane area: 0.15 m2)” (section 2.3). Xie teaches “Briefly, the dried leaves powder (500 g) were extracted with 5000 mL of 80% ethanol for 24 h at room temperature to remove the interference components such as monosaccharide, disaccharide and polyphenol in the samples” (section 2.2). Thus, polyphenols are seen as a residual compound to be removed due to interference. The conclusion of Xie provides that ultrafiltration may be used for the separation of biologically active polysaccharides from other plant materials (section 4). Xie teaches “The ideal separation method should be capable of producing high quantities of polysaccharides and be non-destructive with a shorter separation time (Sheng et al., 2007). Therefore, the use of ultrafiltration process for separation of molecular weight-specific polysaccharides with particular biological activities has received increased attention” (section 1).
One of ordinary skill in the art before the time of filing would have been motivated to use ultrafiltration on polysaccharides extracted from Bombax costatum flowers as Nenonene recognizes a use for its polysaccharides and Xie sees the advantages of ultrafiltration for extraction and separation of plant polysaccharides of different sizes and the removal of polyphenols as being a residual compound of the polysaccharide extracts. Thus, one would seek to combine teachings of Xie with teachings of Nenonene to obtain useful polysaccharides of molecular weights selected by different ranges based on the ultrafiltration membranes used and the further removal of compounds like polyphenols as being residual compounds with a reasonable expectation of success in obtaining selective B costatum polysaccharides that could be used for bioadhesives or other purposes by teachings of the prior art. Xie recognizes advantages of its process including higher processing capacity, shorter durations, and very small reagent use, which would be seen as beneficial to one of ordinary skill in the art.
Response to Applicant’s Arguments over the Rejection under USC 101 and the Nenonene reference
Applicant argues that claims 11 and 18 now requires that the extract be made with a step of ultrafiltration and that the extract be substantially free of polyphenols, and thus, is patent eligible. Ultrafiltration is a way to obtain a more restricted molecular mass range of the polysaccharides and to remove other compounds, but does not change the natural structure of the more isolated polysaccharides. It remains that the extracted compounds (the polysaccharides from the flowers of Bombax costatum and other natural extracted materials) are products of nature. The extract is allowed to have up to 100% of the polysaccharides with the range of average molecular masses of the claim. The composition of claim 18 only has to have the extracted polysaccharides as well. There is no evidence provided that shows that there are no polysaccharides from Bombax costatum that have average molecular weights in that range especially as polysaccharides and oligosaccharides have a wide range of molecular masses and breakdown of sugars does occur naturally. The examples in the specification do show an efficacy of the extracts of polysaccharides, but does not compare them to extracts that did not undergo processing (either the ultrafiltration in the amended claims or optionally other steps that are not yet mentioned in the claims). These unprocessed isolated polysaccharides would represent the closest product of nature for comparison. Thus, these activities in applicant’s examples represent the activities are of the naturally occurring polysaccharides until it is shown otherwise by objective evidence that the processing step allows them to have substantially more activity than this closest natural counterpart. If additional steps are necessary with showing of objective evidence, then these may be needed as additional product-by-process steps. It is reminded that evidence that is not already in applicant’s specification can be provided by way of a rule 132 affidavit/declaration.
Applicant is directed to the Patent Eligibility guidance (December 14, 2014 Nature-based products examples) and its example regarding purified amazonic acid, which is noted as patent ineligible because although purified/isolated remains a natural compound with its natural properties. Applicant should also note the example on Antibiotic L versus purified Antibiotic L. In this example of the guidance, the specification notes that the purification limits, by definition and data, Antibiotic L to a tetrahedral crystal form that does not encompass the naturally occurring compound. Thus, there is an importance in showing that the characteristic and/or activity provided by the purification or extraction is actually markedly different from the product that occurs in nature. There is no showing that these average molecular weights/masses do not occur naturally. There is no example in applicant’s specification that points out a markedly different characteristics or a characteristic considered to be significantly more (whether activity or unique structural property) between extracted/isolated polysaccharides vs. the forms that undergone ultrafiltration. Simply further purifying the natural compounds and testing activities without comparison to the closest natural product is not enough to make the natural products patent eligible.
In terms of the composition claims, as another suggestion, applicant could provide the extract to compositions that are not of nature (e.g. creams or lotions, etc.) and/or add other ingredients to the composition that provide markedly different characteristics and/or significantly more to the combination. This is an alternative way to provide for a composition that is patent eligible.
Applicant argues that Nenonene does not provide a process similar to applicant and does not provide ultrafiltration or substantially no polyphenols. The examiner has considered this argument after the amendment and agrees that with the amendments it can longer be a rejection under USC 102 for anticipation. However, note the rejection under USC 103 due to the amendments with its explanation above.
Applicant argues that the hydrolysis conditions of Nenonene are too harsh to provide for polysaccharides in the claimed range. However, Nenonene provides mucilage and pectin fractions (polysaccharides) from Bombax costatum. Mucilage and pectin are polysaccharides. Applicant does not provide evidence that Nenonene could not achieve such polysaccharide rich extracts. Also, note that both the extract and composition claims use “comprising” as a transition phrase (See MPEP 2111.03) and would be open to other compounds.
In regards to processing of the material, there is an expectation that even with differences in processing, one can obtain similar products by different processes (see MPEP 2113 on product-by-process). However, the examiner will address this in terms of applicant’s indication that ultrafiltration is meant to select by molecular weights.
Conclusion
No claims are allowed.
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 MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached on M-F 9:00 am to 6:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached on (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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/MARK V STEVENS/Primary Examiner, Art Unit 1613