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 .
Claim Status
Claims 1 – 20 are pending.
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 6 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 5 recites the limitation “is administered” in line 2. The Examiner suggests that the composition be configured for injection/administration. The invention is related to a product and claim 5 implies a method step, which is considered an improper mixing of statutory classes. Therefore the scope of the claim is indefinite. See MPEP 2173.05(p).
Claim 6 recites the limitation “facilitating in vivo 3D printing” in line 2. Paragraph 37 of the specification contemplates the idea of “facilitating in vivo 3D printing” but does not fully explain the concept in a manner that a person of ordinary skill in the art would understand. The Examiner requests a more detailed explanation of how the invention facilitates in vivo 3D printing.
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 – 4, 6, 7, 8 – 14 and 17 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over Van Belleghem et al. (U.S. Patent Application Publication No. 2020/0324021 A1; hereinafter Van Belleghem) in view of Patel et al. (Drawn-on-Skin Sensors from Fully Biocompatible Inks toward High-Quality Electrophysiology. Small (2022); hereinafter Patel).
Regarding claims 1 – 3, 6, 8, 12 and 20, Van Belleghem discloses an implantable 3D printed scaffold using a synthetic ink formulation coprinted with a biodegradable bioink (Abstract) that can comprise: a therapeutic agent (para. [0029]; paras. [0116 – 0118]; discusses the release), tissue regeneration (para. [0052]) and repair (para. [0090]). Van Belleghem teaches all of the elements of the current invention as stated above except a bio-sensing matter that is configured to detect one biological parameter. Van Belleghem further discloses (para. [0023 – 0024]) how the bonding of synthetic and/or natural hydrogel materials are utilized to create stable, biomimetic soft tissue constructs. However, Patel discloses/provides the motivation for adding a bio-sensing element to bioink by generating Drawn-on-Skin (DoS) sensors from fully biocompatible inks that can detect (p. 5 – 8, 2.4. DoS Sensor and Wiring Scheme) ECG and EMG signals (p. 8, 2.5 DoS Sensor…).
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 combine the technology of Patel’s DoS sensor/wiring configuration with Van Belleghem’s implantable 3D printed scaffold. Doing so would generate an implantable tissue that has electrophysiological monitoring capabilities.
Regarding claims 4, 7 and 10 – 11, Van Belleghem discloses a nipple-areola complex via 3D printing (para. [0092]) which comprises a microporous backbone and a hybrid nose print produced with a mesh structure (para. [0038], Fig. 5).
Regarding claims 9 and 20, Van Belleghem discloses that their invention allows for physiologically relevant properties (para. [0057]).
Regarding claims 12 and 13, Van Belleghem discloses additional therapeutic agents (paras. [0116 – 0118]) that are configured to meet the limitations of claims 12 and 13.
Regarding claim 14, Van Belleghem discloses synthetic ink material (para. [0023], e.g., a polyether, a polyacrylamide, etc. ).
Regarding claim 18, Van Belleghem discloses that the therapeutic agent can be a (para. [0029]) growth hormone.
Claims 5 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Van Belleghem and Patel as applied to claims 1 – 4, 6, 7, 8 and 9 – 14 above, and further in view of Hauser et al. (U.S. Patent Application Publication No. US2016/0375177 A1; hereinafter Hauser).
Regarding claims 5 and 19, Van Belleghem and Patel teach all of the element of the current invention as stated above except an implantable device that is administered as an injectable. However, Hauser discloses self-assembling peptides as building blocks for biofabrication and printing, in which the peptides are suitable as inks (para. [0023]) and are injectable (para. [0124]). Hauser discloses that the advantage/motivation for injectable formulation over ex vivo techniques is for preparing nanofibrous scaffolds, such as electrospinning, without having to be surgically implanted.
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 utilize the injectable ink of Hauser in the implantable 3D scaffold/bio-sensing model of Van Belleghem and Patel. Doing so would provide an alternative embodiment for a nanofibrous bio-sensing scaffold tissue structure to be implanted in vivo instead of a surgical procedure.
Claims 15 – 17 are rejected under 35 U.S.C. 103 as being unpatentable over Van Belleghem and Patel as applied to claims 1 – 4, 6, 7, 8 and 9 – 14 above, and further in view of Campbell et al. (U.S. Patent Application Publication No. 2010/0254900 A1; hereinafter Campbell).
Regarding claims 15 – 16, Van Belleghem and Patel teach all of the elements of the current invention as stated above except a dental tissue regeneration configuration. However, Campbell discloses biocompatible polymers and scaffolds (para. [0008]), in which wound dressings are fabricated with therapeutic bio-inks (para. [0161]). Campbell discloses the motivation for manufacturing biopolymers (para. [0004 – 0007] is for avoiding the disadvantages of known processing techniques, such as increased temperature and pressure and/or the difficulty in retaining desirable physical characteristics of the plastics (para. [0006])). Campbell provides the motivation for using the wound dressing for dental surgery applications by disclosing (para. [0160]) the treatment of periodontal disease and repair. Campbell further discloses (para. [0166]) in other exemplary embodiments, the methods, compositions, and apparatus may be used to create 3D structures that deliver antibiotics, antivirals, anti-inflammatories, etc.
Regarding claim 17, Campbell discloses the range of uses for wound dressings includes cardiovascular surgery applications (para. [0160]) that encompasses the limitations of claim 17.
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 incorporate the dental and cardiovascular therapeutic (i.e. antibiotics, antivirals, etc.) implant embodiments of Campbell in the implantable 3D scaffold/bio-sensing model of Van Belleghem and Patel. Doing so would provide a bio-sensing, heat-sensitive/pressure-sensitive biocompatible material with anisotropic properties that is capable of providing treatment and repair of periodontal disease and/or cardiovascular surgery.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached M-F 9:00A - 5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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