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
This application is a DIV of 17941093 filed 09/09/2022 (ABN).
According claims 1-20 of this instant application are afforded the effective filing date of 09/09/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted 10/23/2024 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Status of the Claims
Claims 1-20 are pending in this instant application, and examined herein on the merits for patentability.
Claim Objections
Claims 1, 16, and 19 are objected to because of the following informalities: please remove all dashes (-) in claims 1, 16, and 19. It is noted that [w]here a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i). See MPEP §608.01(m).. 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 and 17 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.
Regarding claims 5 and 17, A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance:
claim 5 recites the broad recitation “active agents,” and the claim also recites “therapeutic agents” and “bioactive agents,” which are the narrower statements of the limitation.
claim 17 recites the broad recitation “a mill with a roll with vertical cutting bars in a container,” and the claim also recites “a PFI type of refiner mill,” which is the narrower statement of the limitation.
The claim(s) 5 and 17 are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claims 5 and 17, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 17, the recitation of “PFI type of refiner mill” renders claim 17 indefinite because first, the metes and bounds of “PFI” is not clear, as there is no disclosure or definition in the specification for what “PFI” stands for. Second, “PFI type” is further unclear because the term “type” makes the metes and bounds of “PFI type of refiner mill” unclear. This is because “type” is similar to the term “like” and such terminologies are indefinite, as claim 17 include elements not actually disclosed (those encompassed by "type” or “like”), thereby rendering the scope of the claim(s) 17 unascertainable. See MPEP § 2173.05(d). It unclear what “type” or how like or dislike, or similar or dissimilar does the PFI has to be, so as to be considered a “type” of refiner mill. Note that “PFI” is also indefinite as discussed supra, and thus, the overall breadth of “PFI type of refiner mill” is unclear and one cannot ascertain the refiner mill to which claim 17 intends to encompass.
As a result, claims 5 and 17 do not clearly set forth the metes and bounds of patent protection desired.
Claim Interpretation
Claims 16-20 are structured as a product-by-process. Thus, claim 16-20 will be interpreted and examined for art rejections purposes (103 rejections) as product-by-process type claims. MPEP §2113 (I) states “[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).
Thus, while the structure implied by the process steps should be consider when assessing patentability of product-by-process claims over the prior art; however, burden of proof is placed upon Applicant to show that the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). Also see MPEP § 2113.
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.
Claim(s) 1-12 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nuopponen (US 2018/0094081 A1; hereafter as “Nuopponen ‘081) in view of Laukkanen et al (US 2015/0367024 A1; hereafter as “Laukkanen-024”).
The product-by-process claim interpretation applies here.
Regarding claims 1 and 16-20, Nuopponen ‘081 teaches a nanofibrillar cellulose hydrogel comprising a plant-derived unmodified nanofibrillar cellulose, wherein the nanofibrillar cellulose has an number-average diameter of fibrils between 2 and 15 nm and storage modulus preferably between 1 and 10 Pa (Abstract; [0010], [0025], [0057]-[0058], [0062], [0069], [0114], [0122], [0126]; claims 1, 3, 8, 11 and 12). Nuopponen ‘081 teaches the nanofibrillar cellulose hydrogel is used in implants ([0014], [0105], [0138]; claim 27), and thereby is injected, implanted or inserted into a patient’s body for a desired treatment. The nanofibrillar cellulose hydrogel of Nuopponen ‘081 does not contain active agents (Nuopponen ‘081: [0034]). Nuopponen ‘081 teaches the nanofibrillar cellulose contains unmodified nanofibrillar cellulose obtained from birch (Nuopponen ‘081: [0010], [0034], [0047], [0062], [0114]).
However, Nuopponen ‘081 does not teach the concentration of nanofibrillar cellulose in the hydrogel of claim 1.
Regarding the concentration of nanofibrillar cellulose in the hydrogel of claim 1, Laukkanen-024 teaches a native, non-derivatized nanofibrillar cellulose hydrogel comprising a plant-derived unmodified nanofibrillar cellulose hydrogel having a concentration of the nanofibrillar cellulose of 1.5% by weight, the nanofibrillar cellulose having a number-average diameter of fibrils and/or fibril bundles of 20-50 nm, and a storage modulus of 10 Pa (Abstract; [0023]-[0030], [0042], [0044], [0038]-[0063], [0075], [0079], [0089]-[0090], [0096]-[0100], [0140] and [0148]-[0160], [0195]-[0196]; claims 39, 43, and 45-54).
It would have been obvious to one of ordinary skill in the art to produce and optimize the nanofibrillar cellulose hydrogel of Nuopponen ‘081 to have unmodified nanofibrillar cellulose hydrogel having a nanofibrillar cellulose concentration in the range of 1.4-3.4% by weight and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Laukkanen-024 teaching the same nanofibrillar cellulose hydrogel as Nuopponen ‘081, provided the guidance for producing and optimizing the concentration of nanofibrillar cellulose in the hydrogel to be 1.5% by weight so as the resultant nanofibrillar cellulose hydrogel is suitable for use in wound treatment (Laukkanen-024: Abstract; [0023]-[0030], [0042], [0044], [0038]-[0063], [0075], [0079], [0089]-[0090], [0096]-[0100], [0140] and [0148]-[0160], [0195]-[0196]; claims 39, 43, and 45-54). Thus, an ordinary artisan seeking to produce a nanofibrillar cellulose hydrogel that is suitable for use in wound treatment would have looked to producing the nanofibrillar cellulose hydrogel of Nuopponen ‘081 to contain nanofibrillar cellulose having a concentration of 1.5% by weight, and produce Applicant’s claimed invention with reasonable expectation of success.
Regarding claims 2 and 3, Nuopponen ‘081 and Laukkanen-024 teach the nanofibrillar cellulose contains unmodified nanofibrillar cellulose obtained from birch (Nuopponen ‘081: [0010], [0034], [0047], [0062], [0114]; Laukkanen-024: [0063] and [0066]).
Regarding claim 4, Nuopponen ‘081 teaches the nanofibrillar cellulose has a zero shear viscosity of in the range of 100-8000 Pa·s and a yield stress in the range of 0.5-8 Pa (Nuopponen ‘081: [0057], [0122]; claim 11). It is noted that the zero shear viscosity taught in Nuopponen ‘081 overlaps the claimed shear viscosity of “in the range of 1500-50000 Pa·s,” where Laukkanen-024 provide the guidance to optimize the zero shear viscosity in the range between 1000 and 10000 Pa·s, as this the preferred range for non-derivatized nanofibrillar cellulose (Laukkanen-024: [0090]). Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results from the claimed parameter, the optimization of zero shear viscosity of the nanofibrillar cellulose would have been obvious before the effective filing date of applicant's invention. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05 (I)-(II).
Regarding claim 5, the nanofibrillar cellulose hydrogel of Nuopponen ‘081 and Laukkanen-024 do not contain active agents (Nuopponen ‘081: [0034]; Laukkanen-024: [0148]-[0160] and [0195]-[0196]).
Regarding claim 6, as discussed above, it is noted that Nuopponen ‘081 teaches the nanofibrillar cellulose hydrogel is used in implants and is non-toxic (Nuopponen ‘081: [0010], [0014], [0096]-[0097], [0103], [0105], [0109]-[0110], [0127], [0138]; claim 27). Furthermore, Laukkanen-024 established that nanofibrillar cellulose hydrogel is non-allergenic, anti-inflammatory, non-toxic, and non-pyrogenic (Laukkanen-024: [0094], [0114], [0131], [0145]-[0146]). Thus, the nanofibrillar cellulose hydrogel of Nuopponen ‘081 in view of Laukkanen-024 would implicitly have the feature/property of “bacterial endotoxins 5.5 EU/g or less determined according to Ph. Eur. 2.6.14,” as claimed, absence of evidence to the contrary. It is noted that [w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Regarding claim 7, as discussed above, the nanofibrillar cellulose hydrogel of Nuopponen ‘081 in view of Laukkanen-024 being an implantable material, as well as, having the same structure as the claimed nanofibrillar cellulose hydrogel. Thus, it would have been reasonably obvious that the structurally same nanofibrillar cellulose hydrogel as the claimed invention would be capable for use as a treatment of the body for 28 days or more.
Regarding claim 8, Laukkanen-024 teaches and provides guidance for the subject to which the nanofibrillar cellulose hydrogel of Nuopponen ‘081 to be administered to for body treatment is a human subject ([0006], [0016], and [0121]).
Regarding claims 9 and 10, Nuopponen ‘081 and Laukkanen-024 teach the nanofibrillar cellulose hydrogel is used for medical and personal care/cosmetic treatments (Nuopponen ‘081: [0014]-[0016], [0105]-[0111], [0137]-[0140], and claims 26-29; Laukkanen-024: [0024]-[0031] and [0117]).
Regarding claims 11 and 12, Nuopponen ‘081 and Laukkanen-024 teach the nanofibrillar cellulose hydrogel is used for tissue repair and tissue engineering (Nuopponen ‘081: [0014], [0034], [0105], and claim 27; Laukkanen-024: [0023]-[0031], [0058]-[0059], and [0115]-[0117]). Laukkanen-024 teaches and provides for using the nanofibrillar cellulose hydrogel as tissue support filler (Laukkanen-024: [0112]-[0113], [0139], [0191], and [0203]).
Regarding claim 15, Laukkanen-024 teaches and provides for using the nanofibrillar cellulose hydrogel as a barrier agent for wound infection and effective wound closure (Laukkanen-024: [0123], [0126], and [0135]).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nuopponen (US 2018/0094081 A1; hereafter as “Nuopponen ‘081) in view of Laukkanen et al (US 2015/0367024 A1; hereafter as “Laukkanen-024”), as applied to claim 1 above, and further in view of Rusu et al (Cellulose Chemistry and Technology, 2019, 53(9-10): 907-923).
The method of claim 1 is discussed above, said discussion being incorporated herein in its entirety.
Regarding claims 13 and 14, Rusu teaches nanocellulose based hydrogel advantageously used in tissue engineering applications such as dermal filler and cartilage tissue repair for treating osteoarthritis (Abstract; pages 907-923).
It would have been obvious to one of ordinary skill in the art to use the nanofibrillar cellulose hydrogel of Nuopponen ‘081 in view of Laukkanen-024 as a dermal filler or cartilage tissue repair for treating osteoarthritis, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Rusu established that nanocellulose based hydrogel advantageously used in tissue engineering applications such as dermal filler and cartilage tissue repair for treating osteoarthritis. Given that Nuopponen ‘081 also established that the nanofibrillar cellulose hydrogel suitable for use in tissue engineering and cosmetic applications (Nuopponen ‘081: [0014]-[0016], [0105]-[0111], [0137]-[0140], and claims 26-29), it would have been reasonably obvious and with an expectation of success that the nanofibrillar cellulose hydrogel of Nuopponen ‘081 in view of Laukkanen-024 can also be effectively used as a dermal filler or cartilage tissue repair for treating osteoarthritis per guidance from Rusu, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10626191 in view of Laukkanen et al (US 2015/0367024 A1; hereafter as “Laukkanen-024”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the Patent ‘191 significantly overlap with the subject matter of instant claims. While the instant claims are a method of use, the method uses substantially the same nanofibrillar cellulose hydrogel as the Patent ‘191, in which the nanofibrillar cellulose hydrogel comprising plant-based unmodified nanofibrillar cellulose hydrogel comprising nanofibrillar cellulose having same or overlapping number-average diameter of fibrils and storage modulus, wherein the nanofibrillar cellulose hydrogel is suitable for use in implants.
While the claims in the Patent ‘191 does not contain a concentration for the nanofibrillar cellulose in the hydrogel being in the range of 1.4-3.4% by weight, it would have been obvious to produce and optimize the nanofibrillar cellulose hydrogel of Patent ‘191 to have nanofibrillar cellulose concentration in the range of 1.4-3.4% by weight based on the guidance from Laukkanen-024, which provides the guidance for producing and optimizing the concentration of nanofibrillar cellulose in the hydrogel to be 1.5% by weight so as the resultant nanofibrillar cellulose hydrogel is suitable for use in wound treatment (Laukkanen-024: Abstract; [0023]-[0030], [0042], [0044], [0038]-[0063], [0075], [0079], [0089]-[0090], [0096]-[0100], [0140] and [0148]-[0160], [0195]-[0196]; claims 39, 43, and 45-54).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No. 10626191 in view of Laukkanen-024.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9833540 in view of Nuopponen (US 2018/0094081 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the Patent ‘540 significantly overlap with the subject matter of instant claims. The instant claims and the claims from the Patent ‘540 are both drawn to medical treatments of the body using substantially the same nanofibrillar cellulose hydrogel comprising plant-based unmodified nanofibrillar cellulose hydrogel comprising nanofibrillar cellulose having overlapping number-average diameter of fibrils, storage modulus and nanofibrillar cellulose concentrations. It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). See MPEP §2144.05 (I)-(II).
While the instant claims are using the nanofibrillar cellulose hydrogel by implanting, it would have been obvious that the nanofibrillar cellulose hydrogel of Patent ‘540 being substantially similar in structure to the nanofibrillar cellulose hydrogel of the instant claims would have been capable of being used as an implant for medical treatment, as per Nuopponen, nanofibrillar cellulose hydrogel is known to be suitable for use in implants (Nuopponen: [0014], [0105], [0138]; claim 27).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No. 9833540 in view of Nuopponen.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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