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 .
Applicant’s response to restriction requirement filed 2/6/26 is acknowledged. Applicant elected Group II, without traverse.
Claims 9, 16-20 are under examination on the merits.
Claims 10-15 are hereby withdrawn as drawn to non-elected invention.
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 9, 16-20 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. The phrase “has a fibrous supramolecular structure with length greater than 300 nm” in claim 9 (and its dependent claims 16-20) is unclear. It is totally unknown why the reconstructed TSP has been characterized only by length. As applicant is aware, TSP is usually in the form of an agglomerate (see Zheng 2024, cited below) and it is totally unknown how mere recitation of length will adequately characterize such reconstructed TSP agglomerate.
Claims 16-20 are merely rejected for depending from claim 9.
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9 and 16-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 9 (and its dependent claims 16-20) is directed to a genus of reconstructed tamarind seed polysaccharides (TSPs) with a fibrous supramolecular structure having a length of more than 300 nm, wherein said genus is inadequately described in the disclosure.
Applicant has not provided any structural information about “fibrous supramolecular structure” of reconstructed tamarind seed polysaccharide (TSP), apart from the fact that it is supramolecular structure having a length of more than 300 nm.
To start with, in terms of structural information, no critical information about the structure of starting TSP ( or its end product, namely reconstructed TSP) is found in the disclosure. Applicant in the specification, has merely provided some examples of weight-average molecular mass of said starting TSP, without specifying the exact weight average molecular mass thereof. Further the morphology (conformation) of the starting TSP is not defined. Thus, by looking at claim 9 one does know what one exactly starts with.
Looking at the level of knowledge about TSP structures in the prior art, Zheng, (see Zheng et al., Food Hydrocolloids, 155, Oct 2024, pages 1-14, see specially pages 3-4.) discloses the following parameters which help define the structural features of TSPs :
(1) The molecular weight: the molecular weight (Mw) of TSP can be affected by a variety of factors, such as the methods and conditions for determination, the source of raw materials, and the methods for extraction and purification. Overall, the Mw of TSP generally ranges from 102 to 103 kDa. The Mw of TSP30, TSP55, and TSP80 extracted at different temperatures were determined as 393.3, 196.1, and 435.8 kDa, respectively (Han, et al., 2018).
(2) Conformational parameters, in solution, polysaccharides can present in various conformations, such as random coil, semi-rigid chain, rod-like chain, oblate ellipsoid or spherical shell, which are related to the inner rotation of C–C single bond of polysaccharide. At present, there are two main methods to describe the conformation of polysaccharides (Zhang, et al., 2018): (1) Calculating the conformation parameters (α) of polysaccharides by Mark-Houwink equation ([η] = KMα). The α values of <0.5, 0.5–0.8 and > 0.8 represent conformations of rigid sphere, random coil and rigid or rod-like (rigid) chain of polysaccharide chains, respectively; (2) Calculating the structural parameter (ρ) of polysaccharides on the basis of mean square radius of gyration (Rg) and hydrodynamic radius (Rh) (ρ = Rg/Rh).
(3) Light Scattering parameters: TSP in aqueous solution was reported to form aggregates easily. Different scattering techniques identified that TSP in aqueous solution consisted of multi stranded aggregates with high degree of particle stiffness, presenting as typical wormlike chains (Lang & Kajiwara, 1993). The galactose distribution played an important role in the aggregation effect of TSP. Guo et al. (2022) found that partial degalactosylation of TSP promoted the formation of large aggregates via hydrophobic interactions, and this aggregation effect affected the viscosity, amorphous-crystalline transition, and thermal stability of polysaccharide. Further study indicated that the partial galactose removal increased the chain rigidity and dwindled the chain stiffness, thus exhibiting stronger and larger-scale hydrophobic aggregations with more compact and asymmetrically-extended architecture (Guo, et al., 2023). Therefore, it can be concluded that the conformation and solution properties of TSP were galactose-related.
However, in claim 9, applicant has provided no such structural characteristics shown as 1-3 above, for either its staring TSP or its reconstructed TSP (or ice recrystallization inhibitor).
Further, according to Zheng mentioned above, there are different types of TSPs, e.g. TSP30, TSP55, and TSP80 but claim 9 does not specify instant inhibitor is the reconstructed form of which specific TSP type.
In generic claim 16, which is a product by process claim, some more information as how said reconstructed TSP is prepared is provided but looking at said claim closely, once again, the structure of starting TSP is unknown and further, one of skill in the art does not know the exact concentrations, temperatures and reaction times used. More specifically, in claim 16, line 6, the dialysis time allowed is unknown ( see [0049] wherein some preferred dialysis times are referred to without clearly specifying dialysis periods employed in claims 16-20)], and in line 10 of claim 16, once again the reaction temperature and the exact source of beta-galactosidase used are unknown (see [0013], wherein some preferred embodiments are specified without clarifying the exact temperatures and concentrations utilized). Furthermore, in lines 14-15 of generic claim 16, the term “ alcohol “ is used generically but the disclosure only refers to ethanol (a single species).
Given the fact that all the reaction factors (conditions) listed above will affect the final structure of the reconstructed TSP such that it is formed as “fibrous supramolecular structure with a length of more than 300 nm”, some more information regarding the conformation of the at least the starting TSP and the reaction conditions utilized to prepare said reconstructed TSP deems necessary to ensure the integrity and consistency of the inhibitor claimed. However, said information is currently lacking in the disclosure.
In claims 17-20, some more information about the method used to prepare instant recrystallization inhibitor are presented but each claim only identifies one or two determining parameters in TSP reconstruction method, leaving all other critical reaction conditions in generic form, without adequate disclosure support.
Therefore, based on the information provided, one of skill in the art cannot reasonably conclude that applicant had full possession the invention before the effective filing of this application.
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) 9, 16-20 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Sun et al., “Sun” (International Journal of Biological Macromolecules, 252, 1-11, Aug 2023).
It is noted that Sun has common inventors with instant application, however, applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
In view of said fact, Sun in its abstract discloses, the preparation and enhanced performance of ice recrystallization inhibitor (IRI), by exposing TSP to enzymatic depolymerization and degalactosylation-induced self-assembly. According to Sun, TSP was depolymerized and subsequently removed -40 % Gal, which induced the formation of supramolecular rod-like fiber self-assembles inherently having a length of more than 300 nm and exhibited a severalfold enhancement of IRI.
In page 3, section 2.2., according to Sun, TSP was firstly depolymerized to a certain degree of molecular weight via cellulase hydrolysis under previously reported conditions. More specifically, 200 units of cellulase were dissolved in 2.0 mL of water and added to the 1.0 L of 1 wt% TSP aqueous solution (pH - 5.5 adjusted by 0.5 M sodium acetate buffer) with continuous stirring. After incubation at room temperature for 2 h, the mixture solution was boiled for 20 min to deactivate the enzyme and then centrifugated (10,000g, 20 min, 4 °C) to remove precipitates. The obtained supernatant was dialyzed (MWCO 14000) for 72 h to obtain a retentate and subsequently freeze-dried to obtain depolymerized TSP (DTSP) samples.
In the second step, DTSP was partially degalactosylated via ~-galactosidase hydrolysis. A 10.0 g of DTSP was dissolved in 1.0 L of water (pH - 4.5 adjusted by 1.0 M sodium acetate buffer), and a 1.5 U/ mL of ~-galactosidase was added with continuous stirring at 37 °C. After incubation for 0 h, 1 h, 4 h, 12 h, 24 h, and 48 h, a certain volume of the solution was collected and boiled for 20 min to stop the reaction. Finally, the partially degalactosylated DTSP fractions were collected via 76 % v/ v EtOH precipitation (24 h), followed by redissolving, dialysis (MWCO 14000, 72 h), and freeze-drying to obtain DDTSP samples.
Therefore, the teachings of Sun anticipate claims 9, 16-20 of this invention.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARYAM MONSHIPOURI whose telephone number is (571)272-0932. The examiner can normally be reached full-flex.
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/MARYAM MONSHIPOURI/Primary Examiner, Art Unit 1651