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
Applicant’s election without traverse of Group I (claims 1-7 and 13-20) in the reply filed on 8/27/2026 is acknowledged.
Claims 8-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/27/2026.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because:
Figure 12D of the Drawings filed 8/27/2024 appears to be mislabeled - the figures are labeled 12A, 12B, 12C, and 12.
Figure 18A of the Drawings filed 10/28/2024 appears to have been copied/pasted over, obscuring part of the figure.
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claims 6, 7, 17, and 19 are objected to because of the following informalities:
Claim 6 recites “the polymer selected from”. Examiner suggests amending to “wherein the polymer is selected from” for clarity.
Claim 7 recites “the composition of claim 6 fabricated as a fiber”. Examiner suggests amending to “The composition of claim 6, wherein the composition is in the form of a fiber” to avoid product-by-process language.
Claim 17 recites “the active compound is less than about 5% by weight of the fiber”, but depends from claim 16, which recites that the active compound is minocycline hydrochloride. Examiner suggests amending claim 17 to recite “the minocycline hydrochloride is less than about 5% by weight of the fiber” for clarity and consistency.
Claim 19 recites “The device claim 19” instead of “The device of claim 19”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 4, 15, and 18-19 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 4 recites “wherein the fibers comprise one or more of poly(γ-benzyl-L-glutamate) (PBG), hydrolyzed copolymer (poly(γ-benzylglutamate) 80-r-(γ-glutamic acid)20) (PBGA), and minocycline hydrochloride (MH).” “Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim. See MPEP 2111.02. Here, the use of the phrase “comprise” in conjunction with “one or more of” followed by “and” renders the scope of the claim indefinite as it is unclear whether all the named elements are essential to the claim, or if the presence of only one element is required. For purposes of compact prosecution, the instant claim is being interpreted as “wherein the fibers comprise one or more of poly(γ-benzyl-L-glutamate) (PBG), hydrolyzed copolymer (poly(γ-benzylglutamate) 80-r-(γ-glutamic acid)20) (PBGA), or minocycline hydrochloride (MH).”
Claim 15 recites “wherein the polymer PBGA”. This claim omits a transitional phrase such as “consisting” or “comprising” rending the scope of the claim indefinite. The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). In contrast, the transitional phrase "consisting of" excludes any element, step, or ingredient not specified in the claim. In re Gray, 53 F.2d 520, 11 USPQ 255 (CCPA 1931); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("consisting of" defined as "closing the claim to the inclusion of materials other than those recited except for impurities ordinarily associated therewith"). Thus, it is unclear whether the instant claim is open to additional, unrecited elements or limited to only what is claimed. For purposes of compact prosecution, the instant claim is being interpreted to read “wherein the polymer comprises PBGA”.
Claim 18 recites “wherein release of the active compound from the fiber does not show two-phase kinetics after 24 hours”. This renders the scope of the claim indefinite because it is unclear if this indicates that two-phase kinetics are shown within 24 hours or if two-phase kinetics are not shown for the entire duration of the product’s use. For purposes of compact prosecution, the instant claim limitation is being interpreted as slow or extended release of the active compound (see instant specification at paragraph 0050).
Claim 19 recites “wherein at least 50% of the fibers are oriented in the same or the opposite direction.” The recitation of “opposite direction” is indefinite because it is unclear if this indicates a perpendicular orientation or parallel orientation. “Opposite direction” seems to indicate directionality (i.e. the fibers themselves having different properties depending on orientation), thus, “opposite direction”, for example, in the case of roads, could indicate a parallel orientation. For purposes of compact prosecution, “opposite” is being interpreted as “perpendicular”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5, and 13 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Hurtado et al. (US 2019/0350688 A1, published 11/21/2019).
Regarding claims 1-2, Hurtado teaches a scaffold comprising at least one layer of highly aligned fibers [claim 15] (reads on majority of fibers oriented substantially parallel, see, e.g. para. 0012), further comprising a therapeutic agent [claim 16] (reads on active compound), which may be nerve growth factor [claim 19].
Regarding claims 5 and 13, Hurtado teaches a scaffold comprising a plurality of fibers comprised of one or more polymers [0015-0017], wherein the scaffold comprises one or more therapeutic agents (reads on active compound) including nerve growth factor and brain-derived neurotrophic factor (reads on trophic factor) [0024-0025].
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, 5, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hurtado et al. (US 2019/0350688 A1, published 11/21/2019)
Regarding claims 1-3, Hurtado teaches a scaffold comprising at least one layer of highly aligned fibers [claim 15] (reads on majority of fibers oriented substantially parallel, see, e.g. para. 0012), further comprising a therapeutic agent [claim 16] (reads on active compound), which may be nerve growth factor (NGF) [claim 19]. The scaffold of Hurtado is used to treat peripheral nerve or spinal cord injury by inducing tissue regeneration [0023]. Hurtado teaches that scaffold provides enough space for regenerating neurons to penetrate into the fiber channels [0063].
Regarding claims 5 and 13, Hurtado teaches a scaffold comprising a plurality of fibers comprised of one or more polymers [0015-0017], wherein the scaffold comprises one or more therapeutic agents (reads on active compound) including nerve growth factor and brain-derived neurotrophic factor (reads on trophic factor) [0024-0025].
Claims 4-7 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hurtado et al. (US 2019/0350688 A1, published 11/21/2019), as applied to claims 1-3 above, and further in view of Wang et al. (published 12/17/2017, citation #18 on the 8/19/2024 IDS ) and Noel (US 2024/0216575 A1, effectively filed 12/21/2022).
Regarding claim 4-7 and 13-16, Hurtado teaches a scaffold comprising a plurality of fibers comprised of one or more polymers [0015-0017], wherein the scaffold comprises one or more therapeutic agents (reads on active compound) including nerve growth factor and brain-derived neurotrophic factor (reads on trophic factor) [0024-0025]. The therapeutic agents may be incorporated into the fiber during fabrication [0097]. The scaffold of Hurtado is used to treat peripheral nerve or spinal cord injury by inducing tissue regeneration [0023]. Hurtado does not explicitly teach that the fibers of the scaffold comprise of poly(γ-benzyl-L-glutamate) and minocycline hydrochloride. The scaffold of Hurtado may comprise of poly-L-lactic acid and include a chemoattractant such as laminin [0007-0008].
Wang teaches scaffold of aligned fibers for tissue engineering for neural regeneration [Abstract]. The scaffold of Wang comprises of poly(γ-benzyl-L-glutamate) (PBG) or PBGA copolymer containing 20 mol% poly(l-glutamic acid) and 80 mol% poly(γ-benzyl-l-glutamate) [2.2]. Wang further teaches that these peptide-based polymeric materials contain glutamic acid, which acts as a neuron stimulant [Introduction] and promotes the rate of cell growth and length of neurite outgrowth [3.4-3-5]. Wang teaches that other polymeric scaffold materials, such as poly-L-lactic acid, lack this biochemical cue to stimulate neurite growth and need to be modified with agents that enhance cell adhesion and tracking, such as laminin [Introduction]. Thus, it would be obvious to modify the teachings of Hurtado with that of Wang, and modify the scaffold of Hurtado to comprise of PBG or PBGA fibers, to obviate the need to include a chemoattractant such as laminin, and also improve the rate of nerve regeneration.
Hurtado teaches that the scaffold may comprise an antimicrobial agent such as minocycline [0037], but does not explicitly specify minocycline hydrochloride. Noel teaches a biopolymer scaffold for use in dermal regeneration [Abstract]. Noel further teaches that the scaffold may comprise of antimicrobial agents, and teaches both minocycline and minocycline hydrochloride as suitable equivalents [0106]. The substitution of known equivalents for the same purpose is prima facie obvious. MPEP 2144.06. Thus, it would be obvious to include minocycline hydrochloride in the scaffold of Hurtado for the same purpose of preventing microbial growth in tissue engineering applications.
Regarding claim 17, Hurtado teaches that the therapeutic agent may comprise from 1-5% by weight of the fiber [0095].
Regarding claim 18, Hurtado teaches that the rate of release of the therapeutic agent from the scaffold may be over a prolonged period of time, up to over 360 days [0100]. The rate of release depends on factors such as the degradation rate of the polymer and the solubility of the therapeutic agent [0101]. One of skill in the art would be able to select the fabrication method of the polymeric scaffold needed to deliver a specific active agent at a desired rate of release. Additionally, active compounds may be encapsulated in materials well-known in the art to control the release rate, and the density of the fibers may be adjusted to change the time over which the active compounds are released from the composition [0101]. Thus, it would be obvious to one or ordinary skill to appropriately modify the scaffold using the teachings of Hurtado in the course of routine optimization to obtain a desired release profile.
Regarding claim 19, Hurtado teaches that 84% of the highly aligned fibers may deviate no more than ±2° from a reference parallel line [0012].
Regarding claim 20, Hurtado teaches that the scaffold is for the treatment of a peripheral nerve or spinal cord injury in a mammalian subject [0023]. However, Examiner would like to note that the instant recitation of “for use in treating a peripheral or central nervous system cell or tissue” is interpreted as intended use and does not constitute a functional limitation. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. MPEP 2111.02. In the instant case, the preamble does not add a structural distinction to the claim. As the prior art makes obvious the claimed structure, the limitations of the claim have been met.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA LYNN CHI whose telephone number is (571)272-0026. The examiner can normally be reached Monday - Friday 9 am-5pm ET.
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/AMANDA LYNN CHI/Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
