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 .
Election/Restrictions
Applicants’ election of Group I (claims 1-17) drawn to an aerogel comprising a mixture of nanofibers and microfibers, is acknowledged. The election was made without traverse.
As the requirement for restriction is deemed proper, it is maintained and hereby made FINAL.
Claims 18-20 are hereby withdrawn from further consideration by the Examiner, pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. The instant claims have been examined commensurate with the scope of the elected invention. Applicants timely responded to the restriction requirement in the reply filed 12/15/25.
Accordingly, claims 1-17 are under current examination.
Status of Claims
No new claim set was filed.
Claim Objections
Claim 13 is objected to because of the following informalities: the claim recites “an/or” in line 2. The Examiner suggests amending to read “and/or” in order to obviate the objection.
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.
Claim 9 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 9 recites “wherein the ratio of nanofibers to microfibers is from about 25:75 to about 75:25”. The claim does not recite the unit of measurement. Thus, the metes and bounds of the claims cannot be determined and the claims are indefinite. It is noted that the instant specification (e.g., Summary of the Invention) recites “In certain embodiments, the weight ratio of nanofibers to microfibers is from about 25:75 to about 75:25” and therefore, has support for the ratio being a weight ratio. The Examiner suggests amending the claim to “weight ratio” in order to obviate the instant rejection.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 5-8 and 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gong et al. (US 2015/0114907; published: 4/30/15).
Gong is directed to highly porous, lightweight, and sustainable organosilane-coated organic aerogels with ultra-low densities and excellent material properties [Abstract].
With regards to instant claim 1, Gong teaches an aerogel comprising cellulose fibrils, which include both nanofibrils and microfibrils [claims 1 and 5-6].
With regards to instant claims 2-3 and 5-7, Gong teaches that the abovementioned aerogel further comprises a water-soluble organic polymer such as a polyvinyl alcohol or polyethylene glycol, wherein the water-soluble organic polymer is cross-linked to the abovementioned cellulose fibrils with glutaraldehyde [claims 1-2, 8 and 15].
With regards to instant claims 8 and 10-11, Gong teaches wherein the cellulose nanofibrils have an average diameter in the range of about 1 to about 100 nm (e.g., 100 nm) [0040] and wherein the cellulose microfibrils have an average diameter in the range of about 100 to about 1000 nm (e.g., 1 µm) [0041]. That is, if the abovementioned nano- and microfibrils are on the lower end of the ranges (e.g., 1 nm and 100 nm), then the microfibrils are 100 times greater than the nanofibrils. And vice versa, if the abovementioned nano- and microfibrils are on the upper end of the ranges (e.g., 100 nm and 500 nm), then the microfibrils are 5 times greater than the nanofibrils. This provides evidence of “sufficient specificity” that Gong teaches a substantially overlapping or entirely encompassing range compared to the instant claims (See MPEP §2131.03). Gong teaches that the average length of the cellulose nanofibrils and/or microfibrils are about 10nm to 1000nm and in other embodiments the average lengths range from about 1000 nm to about 3000 nm [0042], which reads on the ranges recited in instant claims 10-11. It is noted that the wherein clauses in instant claim 10 are separated by an “or” and therefore the prior art reads on the claim even if it only teaches one of the wherein clauses.
With regards to instant claims 12-13, Gong teaches aerogels that include cellulose nanofibers (CNF) and/or microfibers (i.e., the same polymer) in combination with a water-soluble thermoplastic polymer (e.g., PVA) that is crosslinked to itself and/or the cellulose fibers (i.e., comprising different polymers) [0051].
Therefore, by teaching all the limitations of claims 1-3, 5-8 and 10-13, Gong anticipates the instant invention as claimed.
Claims 1-5, 12-14 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mo et al. (CN 111068112; published: 4/28/20).
The English language machine translation of CN 111068112 is attached herein. The passages cited below which indicate the teachings of the ‘112 publication are based on its English translation.
Mo is directed to knitted micron fiber combined with nano fiber aerogel tendon scaffold, which overcomes the defect that the existing technology cannot simulate the fiber structure of the extracellular matrix of tendon tissue and matches the mechanical properties of natural tendons [Title, p. 3].
With regards to instant claims 1-5, 14 and 16, Mo teaches a knitted knitted micron fiber combined with nanofiber aerogel tendon support, which is obtained by filling electrospun nanofiber aerogel into the knitted microfiber support [p. 2]. The electrospinning step (see step (2)) involves dissolving a polymer (e.g., gelatin, polycaprolactone– p. 4) in a solvent and performing electrostatic spinning to obtain a nanofiber membrane [p. 3].
With regards to instant claims 12-13, Mo teaches an embodiment wherein the microfibers are made of PLLA and the nanofibers are made of silk fibroin and PLLA [Example 2].
With regards to instant claim 17, Mo teaches that anti-inflammatory and tissue adhesion preventing drugs or growth factors can be added to the electrospun nanofiber aerogel [p. 4].
Therefore, by teaching all the limitations of claims 1-5, 12-14 and 16-17, Mo anticipates the instant invention as claimed.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
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.
Claims 1-5, 9, 12-14 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Mo et al. (CN 111068112; published: 4/28/20).
The English language machine translation of CN 111068112 is attached herein. The passages cited below which indicate the teachings of the ‘112 publication are based on its English translation.
As noted in the anticipation rejection above Mo anticipates claims 1-5, 12-14 and 16-17 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103 over Mo for the reasons set forth below ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Mo is directed to knitted micron fiber combined with nano fiber aerogel tendon scaffold, which overcomes the defect that the existing technology cannot simulate the fiber structure of the extracellular matrix of tendon tissue and matches the mechanical properties of natural tendons [Title, p. 3].
With regards to instant claims 1-5, 14 and 16, Mo teaches a knitted knitted micron fiber combined with nanofiber aerogel tendon support, which is obtained by filling electrospun nanofiber aerogel into the knitted microfiber support [p. 2]. The electrospinning step (see step (2)) involves dissolving a polymer (e.g., gelatin, polycaprolactone– p. 4) in a solvent and performing electrostatic spinning to obtain a nanofiber membrane [p. 3].
With regards to instant claims 12-13, Mo teaches an embodiment wherein the microfibers are made of PLLA and the nanofibers are made of silk fibroin and PLLA [Example 2].
With regards to instant claim 17, Mo teaches that anti-inflammatory and tissue adhesion preventing drugs or growth factors can be added to the electrospun nanofiber aerogel [p. 4].
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Mo does not teach wherein the abovementioned ratio of nanofibers to microfibers is from about 25:75 to about 75:25, as required by instant claim 9.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The amount of nanofibers and microfibers is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of nanofibers and microfibers in the aerogel in order to best achieve the desired results as such would provide advantageous biological effect. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. 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, 105 USPQ 233 (CCPA 1955). In the instant case, Mo teaches that electrospun nanofibers are widely used as scaffolds for tissue repair because they can imitate the filamentous structure of the extracellular matrix of tissues. A large number of studies have shown that nanofiber tissue repair materials can significantly promote cell adhesion, proliferation and differentiation, regulate signal pathways in cells that control transcriptional activity and gene expression, guide the orientation of cytoskeletal proteins, and nanoscale scaffolds (such as nano (Fibers) Larger specific surface area facilitates the adsorption of more proteins and can provide more adhesion sites for receptors on the cell membrane. The adsorbed proteins can also expose more hidden adhesion sites by changing the conformation, which is beneficial to Cell adhesion [Background technique Section]. Mo, also teaches that the microfiber is used as the support structure [Summary of the Invention Section]. The Examiner considers it prima facie obvious to optimize the amounts of any biologically active agent to achieve their known biological effect, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the ratio of nanofibers to microfibers in the claimed aerogel would impact the cell adhesion, proliferation an differentiation and therefore be an optimizable variable.
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 would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Claims 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mo et al. (CN 111068112; published: 4/28/20) as applied to claims 1-5, 9, 12-14 and 16-17 above, and further in view of Bauer et al. (WO 2010/126792; published: 04/11/10).
The English language machine translation of CN 111068112 is attached herein. The passages cited below which indicate the teachings of the ‘112 publication are based on its English translation.
As noted in the anticipation rejection above Mo anticipates claims 1-5, 12-14 and 16-17 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103 over Mo for the reasons set forth below ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Mo is directed to knitted micron fiber combined with nano fiber aerogel tendon scaffold, which overcomes the defect that the existing technology cannot simulate the fiber structure of the extracellular matrix of tendon tissue and matches the mechanical properties of natural tendons [Title, p. 3].
With regards to instant claims 1-5, 14 and 16, Mo teaches a knitted knitted micron fiber combined with nanofiber aerogel tendon support, which is obtained by filling electrospun nanofiber aerogel into the knitted microfiber support [p. 2]. The electrospinning step (see step (2)) involves dissolving a polymer (e.g., gelatin, polycaprolactone– p. 4) in a solvent and performing electrostatic spinning to obtain a nanofiber membrane [p. 3].
With regards to instant claims 12-13, Mo teaches an embodiment wherein the microfibers are made of PLLA and the nanofibers are made of silk fibroin and PLLA [Example 2].
With regards to instant claim 17, Mo teaches that anti-inflammatory and tissue adhesion preventing drugs or growth factors can be added to the electrospun nanofiber aerogel [p. 4].
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Mo does not teach wherein the abovementioned aerogel further comprises a poloxamer, as required by instant claim 15. However, this deficiency is cured by Bauer.
Bauer is directed to aerogel compositions comprising fibers [Abstract]. Bauer teaches that treating a hydrophobic aerogel with a surfactant produces a hydrophilic coating and wherein the surfactant can be PluronicTM P84 [0026-0031]. Bauer teaches that increasing the amount of surfactant tends to increase the depth to which the aqueous phase can penetrate and thus the thickness of the hydrophilic coating surrounding the hydrophobic aerogel core [0032].
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Mo and Bauer are both directed to aerogels comprising fibers. Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the invention was effectively filed, to modify the aerogel of Mo by further incorporating a poloxamer (e.g., PluronicTM P84) taught by Bauer to achieve the predictable result of obtaining a composition suitable for biomaterials. One of ordinary skill in the art would have been motivated to do so because Bauer teaches that it is advantageous for providing a hydrophilic coating surrounding the hydrophobic aerogel.
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 would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Conclusion
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/GENEVIEVE S ALLEY/Primary Examiner, Art Unit 1617