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 .
Priority
The present application is a National Stage entry of International application PCT/CA2023/050532 filed 04/20/2023, which claims the benefit of Provisional US application 63363326 filed 04/21/2022.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 10/18/2024, in the matter of Application N° 18/858,026. Said documents have been entered on the record. The Examiner further acknowledges the following:
Claims 1-16 are pending.
Claims 1-16 are presented for examination and rejected as set forth below.
Drawings
The drawings are objected to, because it is unclear what “stat” means within Figure 1a and 2 (i.e., where there is a questioned presumption of some repeating structure and/or a linker unit). Furthermore, without definite knowledge, the PTO Publications team may have issue with the small and/or faint font size and/or structures of Figures 1a, 1b, and 3.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 7 is 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 7 is indefinite as written because there is no reasonable framework in which to judge a degree of oxidation of 0.1 to 1000% (i.e., 100% would be considered fully oxidized, as demonstrated in the Art). For example, Figure 3 on pg 1269 of Kristiansen (Carbohydrate Research, 2010) describes 0%, 5%, 10%, 20%, and 44% oxidation, whereby no value approaches 1000%). It is unclear how 1000% oxidation would be obtained and/or characterized. The Examiner recommends additional detail to specify the instant range, and will not consider the current range during examination, but only that some oxidation occurs and will provide oxidation degree in terms of the Prior Art on record.
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.
Claims 1-3, 10-12, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hill (US20050118230A1).
Applicant’s claims are directed to a lubricating hydrogel composition comprising:(i) an amine-bearing biopolymer, and(ii) an oxidized aldehyde-bearing polysaccharide, wherein the aldehyde groups of the aldehyde-bearing polysaccharide are reversibly cross-linked to the amine groups of the amine-bearing biopolymer.
Note that the terms “derived” in claim 4 (sweet-corn) and claim 12 (bone) is considered to described the origin of said phytoglycogen and said materials, respectively (i.e., “derived” does not imply an indefinite chemical derivatization modification of the ingredients, as read from the Specification at [0005] for sweet corn and at [0020] for bone). Furthermore, that the origin of materials is generally immaterial in terms of structural contribution to composition patentability. It must be remembered: "[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).
Hill teaches hydrogel compositions and methods, based on a polypeptide and long-chain carbohydrate, that are useful for regenerating connective tissue in places of injury such as in loss or damage to cartilage (abstract).
Regarding claim 1-3: Hill teaches a bioactive hydrogel matrix comprises a polypeptide and a long chain carbohydrate (Hill – claim 1), whereby the polysaccharide, such as dextran, cellulose, starch, glycogen, chitosan, etc. (reads on instant claims 1(ii) and 3) (Hill – claim 10) can be oxidized, for example by periodate oxidation [0116-0117] (whereby periodate chemistry is preferred [0119]), to afford aldehyde groups on the modified polysaccharide that would crosslink amine-bearing polypeptides such as gelatin, collagens, etc. (reads on amine-bearing biopolymer of instant claim 1(i) and also claim 2) (Hill – claim 3) through an imine linkage (aka, Schiff base linkage, that represents the instant “reversibly cross-linked” connection of instant claim 1) [0118].
Regarding claim 10: Hill teaches the obviousness of a pH of 7 to 7.6 of the hydrogel [0119].
Regarding claim 11: Hill teaches incorporation of an electrolyte (i.e., KH2PO4) and buffer into the hydrogel matrix [0074-0075].
Regarding claim 12: Hill teaches incorporation of “osteoinductive” materials such as bone morphogenetic proteins, calcium phosphate, collagen, etc. [0101] and stem cells [0126, 0134].
Regarding claim 14-16: Hill teaches an injection formulation [0018], that is intended for regenerating connective tissue and a method where the hydrogel is administered to an area of injury (reads on drug and/or device) for tissue regeneration (abstract). Note, the placement into the synovial joints and the intended use (i.e., filler and/or cosmetic ingredient) do not provide weight in a composition claim.
In summary, Hill teaches the elements and desirability for the components for the instant composition, as described above, and thus, its obviousness. It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Thus, Hill teaches the combination of art-known elements (i.e., hydrogel comprising an amine-bearing biopolymer and oxidized aldehyde-bearing polysaccharide) according to their disclosed beneficial properties (i.e., tissue regeneration) with the resultant product nothing more than one would expect from their combination (i.e., a hydrogel with reversible imine cross-links).
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hill (US20050118230A1), as applied to claims 1-3, 10-12, and 14-16 above, and in further view of Besford (Adv. Mater. 2020), Li (Biomaterials 2014), and Grange (Orthop & Spo Med Op Acc J, 2020).
As discussed above, Hill teaches hydrogels formed by mixing oxidized polysaccharides and amine-bearing biopolymers, via a reversible imine-based crosslink mechanism, are useful for regenerating connective tissue in places of injury. Hill additionally teaches medicaments such as anti-inflammatories to aid in the healing and regenerative process [0105]. Hill also teaches the molecular weight of chitosan can be 500,000 Da (i.e., 500,000 g/mol or 500 kg/mol) ([0054], Hill – claims 64 and 66).
However, Hill does not teach a sweet-corn derived phytoglycogen of a certain hydrodynamic diameter (instant claims 4 and 6), a carboxylated chitosan with a certain molecular weight a degree of substitution/deacetylation (instant claims 5 and 8-9), the polysaccharide degree of oxidation (instant claim 7), and the specified ingredients (instant claim 13).
Besford teaches nanosized glycogen extracted from sweet corn as a platform for bioactive agents (pg 2, paragraph 2; pg 5, paragraph 2; pg 12, paragraph 2), for the purpose of tissue engineering (pg 1, paragraph 2), and phytoglycogen is considered a common glycogen source (pg 4, Table 1) and chemically-modified phytoglycogen (e.g., succinylated conjugates in Figure 4 on pg 8) is used for medicinal constructs (reads on instant claim 4) (pg 13, paragraph 2). Besford teaches diameters of 82 nm for phytoglycogen as obvious (pg 4, table 1). Furthermore, Bedford shows “naked particles” of rabbit liver glycogen and oyster glycogen, having hydrodynamic diameters in between the range of 0-100 nm (pg 18, Figure 12E), whereby the glycogen oxidized particles demonstrate a minor decrease in hydrodynamic volume (pg 7, paragraph 5; pg 9, Figure 5E). With regard to the numerical range (in relation to the range of instant claim 6), note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)).
Li an imine-based (or Schiff-based) mechanism to form hydrogels (abstract) on the basis of the free amine containing N,O-carboxymethyl chitosan (NOCC) (reads on the “carboxylated chitosan” of instant claims 5 and 8-9, by stating “we introduced carboxymethyl groups”) (pg 3904, paragraph 3) and a periodate-oxidized polysaccharide, such as hyaluronic acid (pg 3904, paragraph 3) for use as an injectable hydrogel for postoperative adhesion prevention (abstract), that aids in tissue injury repair (pg 3904, paragraph 1). Li teaches oxidation degree of the polysaccharide hyaluronic acid (pg 3904, ‘synthesis of A-HA’) and measures 21-34% (reads on instant claim 7) (pg 3907, Table 1). Li teaches the determined substitution degree of N, O-carboxymethyl chitosan (NOCC) was 85% (reads on instant claims 8-9), which displays good water-soluble property (pg 3907, paragraph 3), which was the intent of introducing the carboxymethyl groups (pg 3904, paragraph 3). Although Li is silent on the NOCC molecular weight, Hill teaches the obviousness on using 500 kg/mol chitosan in imine-based hydrogels (reads on instant claim 5).
Grange teaches that mannitol and sorbitol protect polysaccharides from ROS degradation (pg 362, paragraph 1). For example, this protection by mannitol and sorbitol occurs when hyaluronic acid is injected into knee for osteoarthritis treatment (reads on instant claim 13) (pg 362, paragraph 1). Therefore, a PHOSITA would expect the same protective effect by mannitol and/or sorbitol for any additional ingredient (i.e., polysaccharides such as hyaluronic acid or otherwise) that is inherently susceptible to ROS damage.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the glycogen generally taught by Hill as a suitable polysaccharide, for the phytoglycogen from sweet corn with a specified hydrodynamic diameter, as taught by Besford, because Besford teaches that phytoglycogen has a diameter of 82 nm, Bedford shows “naked particles” of rabbit liver glycogen and oyster glycogen, having hydrodynamic diameters in between the range of 0-100 nm (pg 18, Figure 12E), and that glycogen can be obtained from sweet corn. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Thus, the specification of these parameters (i.e., form sweet corn and/or a specified hydrodynamic diameter) would allow for the same functional operation of the general glycogen taught by Hill.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hill by replacing the amine-based polypeptide biopolymer with an amine-based polysaccharide biopolymer (such as NOCC) to form a hydrogel by an imine-based mechanism, as taught by Li, because NOCC plays the same role as the amine-based polypeptide of Hill, when Li demonstrates that NOCC (i.e., a “carboxylated chitosan”) can form a hydrogel by mixing with an oxidized polysaccharide (e.g., A-HA, which is periodate oxidized hyaluronic acid), via imine-based reversible bonds (see pg 3906, Figure 1C). The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Furthermore, Li teaches an additional advantage of NOCC, whereby the degree of substation of NOCC (e.g., 85% is demonstrated as a good value) can be adjusted to improve water solubility (pg 3907, paragraph 3), which was the intent of introducing the carboxymethyl groups (pg 3904, paragraph 3). Thus, NOCC would have an advantage over amine-based polypeptides by allowing for modulation of solubility.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to further add to Hill’s compositions the mannitol and/or sorbitol taught by Grange, because Grange teaches that mannitol and sorbitol protect polysaccharides from ROS degradation (pg 362, paragraph 1), e.g., when hyaluronic acid is injected into knee for osteoarthritis treatment (pg 362, paragraph 1), whereby the same effect for any ingredient susceptible to ROS damage. In this case, Hill teaches hydrogels based on a variety of polysaccharides (including hyaluronic acid) (Hill – claim 10), whereby hyaluronic acid is known to be susceptible to ROS degradation.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJAN PRAGANI whose telephone number is (703)756-5319. The examiner can normally be reached 7a-5p EST (M-Th).
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/R.P./Examiner, Art Unit 1614 7/27/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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