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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 8, 9 and 23 are objected to because of the following informalities: please correct the scientific notation and exponents on the values and units. 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 7, 9, 10 and 16 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.
Claim 7 provides for the limitation “mechanically robust.” It is unclear what physical properties are included in the term “mechanically robust.” Since the term is undefined, and largely subjective, there is no reasonable manner for determining the metes and bounds of this limitation. As such, this specific limitation cannot be examined; as the claim provides for other limitations, these will be discussed in the rejections below.
Claim 9 provided for a needle gauge in parenthesis. It is unclear if the needle gauge is relevant to the claim limitation, and how its inclusion in parenthesis is supposed to affect the claim scope. For the sake of examining the claim on its merit, the flow rate of the material appears to be the only relevant limitation.
Claim 10 provides for the limitation “configured as a cell carrier.” It is unclear if this limitation is describing a functional property of the material, or if the claim is trying to include cells in the composition. Based upon the claim language, the former interpretation will be assumed.
Claim 16 is indefinite because it is unclear what specifically must be done in order to configure the material to be injectable into a tissue. It is unclear if the claim is trying to include additional ingredients, or if the claim is merely restating the injectability of the material, and should be rejected under 35 USC 112(d).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. It is unclear how the limitations of claim 13 further limit the formulation of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 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.
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 1-19 and 26-31 are rejected under 35 U.S.C. 103 as being unpatentable over Burdick, et al (US Pat. 9,827,321) and Wang, et al (Materials Science & Engineering C, 101, 650-659, 2019) and evidenced by Tan, et al (Journal of Biomedical Materials Research Part A, 87, 1034-1043, 2008). Burdick teaches a hydrogel composition comprising two separate hyaluronic acid backbones, wherein one backbone supports a guest adamantane, and the other supports a host β-cyclodextrin. Burdick indicates that the composition is capable of shear-thinning, which means that it would be an injectable composition. See column 3, lines 5-14. Burdick does not state that the composition has been subjected to an electrospinning apparatus, nor is it stated that the material is fibrous.
Wang provides a review paper that discusses the state-of-the-art, with respect to electrospinning particular compounds. Notably, Wang indicates that polymers with pendant β-cyclodextrin have been successfully electrospun. Wang indicates that both β-cyclodextrin and adamantane can be grafted onto hyaluronic acid backbones, and further suggests that this material can be electrospun. See page 654, right column, first [full] paragraph. As such, Wang shows that Burdick’s material should be predictably compatible with electrospinning methods, and further provides for an explicit motivation to try. Wang does not state that this material would be expected to be a fibrous and injectable composition. However, it must be noted that Burdick explicitly stating that the material is a shear-thinning material would suggest that the electrospun material of Wang must also be injectable, as it is composed of the same materials.
Tan is provided to indicate that if a material is electrospun, it would necessarily be considered “fibrous.” See page 1034, “Introduction” section. Therefore, there is a reasonable expectation that the material that Wang suggests must also be “fibrous.”
With respect to claims 1 and 13, Burdick teaches the claimed material, but does not teach or suggest electrospinning. Wang teaches a material that is the same as Burdick’s and suggests that the material could be electrospun. Burdick notes that the material is an injectable hydrogel, and Tan indicates that an electrospun material is fibrous.
With respect to claim 2, Burdick indicates that the hyaluronic acid backbone can be methacrylate functionalized. See column 3, lines 15-20.
With respect to claim 3, Burdick teaches crosslinking with a UV-based photo-initiator. See column 3, lines 12-14.
With respect to claims 4 and 5, although both Burdick and Wang are silent with respect to the hydrophobicity of the composition, both references explicitly describe the same guest-host interaction as that claimed. As such, it would be reasonable to suggest that the claimed interaction is inherent a composition comprising 2 separate hyaluronic acid backbones, one with adamantane, and the other with β-cyclodextrin as pendant groups. See MPEP 2112.
With respect to claim 6, Burdick teaches a 1:1 ratio. See column 3, line 28.
With respect to claims 7 and 9, as discussed above, Burdick teaches a shear-thinning material. Since Burdick teaches one of the main physical properties claimed, and describes the claimed material, it can be reasonably asserted that Burdick’s material possesses the same properties as those claimed.
With respect to claim 8, although Burdick does not state the claimed constant, Burdick describes the same composition with the same ratio. As such, Burdick’s material likely possessed the claimed constant.
With respect to claim 10, Burdick indicates that the material can be configured to receive cells. See column 1, lines 60-67.
With respect to claim 11, Burdick suggests that the material would have ECM-like stability. See column 1, lines 27-32.
With respect to claim 12, Burdick appears to suggest inclusion of the same ligands. See column 10, lines 58-67.
With respect to claim 14, Burdick suggests the inclusion of encapsulated cells. See column 1, lines 60-67.
With respect to claim 15, although Burdick does not state the post injection survival rate, there is nothing claimed to suggest that Burdick’s rate is any different.
With respect to claims 16 and 17, Burdick indicates that the material is injectable. Although the potential flow rate of the material is not described, there is nothing in the claims to suggest that the material of Burdick would flow any differently.
With respect to claim 18, Burdick indicates that the material is dispersed in water. See column 5, lines 22-30. Water is an acceptable carrier.
With respect to claim 19, although Burdick does not state the claimed physical properties, Burdick describes the same composition and as such, must describe a composition that possesses the same properties.
With respect to claims 26-30, Burdick teaches the same methods of treating tissue. See column 1, lines 15-33.
With respect to claim 31, Burdick suggests the inclusion of any number of stem and progenitor cells. See column 13, lines 1-9. Based upon this, the ordinary artisan would understand that any number of tissues could be treated, including those of the musculoskeletal system.
Claims 20-25 are rejected under 35 U.S.C. 103 as being unpatentable over Burdick, et al (US Pat. 9,827,321) Wang, et al (Materials Science & Engineering C, 101, 650-659, 2019) and Seon-Lutz, et al (Carbohydrate Polymers, 207, 276-287, 2019) and evidenced by Tan, et al (Journal of Biomedical Materials Research Part A, 87, 1034-1043, 2008). See the discussion of Burdick, Wang, and Tan, above. As discussed above, Wang describes methods of electrospinning the claimed composition, but performed the electrospinning method in air.
Seon-Lutz provides for methods of electrospinning hyaluronic acid, with β-cyclodextrin is capable of being successfully, and predictably electrospun into a “polymer solution” of water. Seon-Lutz performs this method as a means of making a wound dressing. See page 276, “Abstract” section. Based upon Seon-Lutz’s evidence that the claimed material can be subjected to an electrospinning method, wherein the material is spun into a polymer solution, and the fact that Seon-Lutz provides motivation to perform the claimed method, the ordinary artisan would find the claimed method to be obvious. See page 276 and 277, “Introduction” section.
With respect to claim 20, Burdick teaches the claimed polymers and methods of UV crosslinking. Wang suggests that the material of Burdick can be electrospun, and it would have utility. Seon-Lutz shows that the material of Burdick can be electrospun into a polymer solution, and provides motivation to perform this method step.
With respect to claim 21, Burdick includes the same anhydrides. See column 12, line 35.
With respect to claim 22, Burdick describes the same preparation method. See columns 18 and 19.
With respect to claim 23, since Seon-Lutz does not explicitly electrospin the claimed material, the claimed parameters would likely be slightly different. However, the ordinary artisan possesses ample knowledge of electrospinning methods and would understand that all compounds must undergo some amount of obvious optimization of the parameters.
With respect to claim 24, Burdick shows a time-course of UV crosslinking’s affects on the composition’s physical properties. See figure 10B. The figure shows crosslinking data that includes the claimed time range. Additionally, since Burdick teaches the same photoinitiator, Burdick used the same wavelengths.
With respect to claim 25, there is nothing non-obvious about modifying the size of the electrospun fibers.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Weidner can be reached at 571-272-3045. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651