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 a device for regenerating musculoskeletal tissue, claims 1-16 in the reply filed on March 3, 2026 is acknowledged. Claims 17-34 and 55-57 drawn to a method of fabricating a musculoskeletal regeneration device are withdrawn without traverse.
Response to Amendment
Claims 1-16 are pending in the application. Claims 17-57 have been cancelled by applicant. No claims have been amended. Claims 1-16 are rejected.
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 1-16 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.
The term “increased tensile and compressive resistance” in claim 1 is a relative term which renders the claim indefinite. The term “increased tensile and compressive resistance” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The originally filed disclosure does not aid in clarifying, and in face is completely silent as to what is meant by “increased tensile and compressive resistance”. The disclosure does not provide any values or definition of what would be sufficient to meet this limitation. Additionally, “increased” is a relative term and it is not clear from the claims or specification what the resulting claimed device is being compared to. Furthermore, it is unclear what would be sufficient to meet this limitation as presently claimed.
Regarding claim 6, 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). Note, claim 6 recites “thermo-responsive materials such as poly(N-isopropylacrylmide) (NIPAAm)” and “pH-responsive materials such as poly(methyl methacrylate) (PMMA)”.
Claim 10 is listed as depending upon claim 11. This is improper and believed to be a typographical error. Claim 10 recites the limitation "said bone phase, said gradient phase and said soft tissue phase " in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, claim 10 is being interpreted as depending from claim 9. Appropriate action is required.
Claims 8 and 13-16 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. Applicant is reminded of the requirements set forth in MPEP §608.01(m) and 608.01(n).
Claim 8 recites “The device of claim 7 wherein said biocompatible materials are
comprised of one or more of the polymers of claim 5.” This is improper. Applicant should either have claim 8 depend from claim 5 or list the group of materials again.
Claim 13 recites “The device of claim 11 wherein said bone phase, said gradient phase and said soft tissue phase are comprised of different materials of claim 2.” This is improper. Applicant should either have claim 13 depend from claim 2 or separately list the desired group of materials.
Claim 14 recites “The device of claim 11 wherein said bone phase, said gradient phase and said soft tissue phase are comprised of different concentrations of the same materials of claim 2.” This is improper. Applicant should either have claim 14 depend from claim 2 or separately list the desired group of materials.
Claim 15 recites “The device of claim 12 wherein said bone phases, said gradient phases and said soft tissue phases are comprised of different materials of claim 2.” This is improper. Applicant should either have claim 15 depend from claim 2 or separately list the desired group of materials.
Claim 16 recites “The device of claim 12 wherein said bone phases, said gradient phases and said soft tissue phases are comprised of different concentrations of the same materials of claim 2.” This is improper. Applicant should either have claim 16 depend from claim 2 or separately list the desired group of materials.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by applicant cited Lu et al. (US Pat. No. 7, 767, 221).
Regarding claim 1, Lu teaches a device (scaffold) for regenerating musculoskeletal tissue (See, for example, Fig. 34) comprising:
a scaffold comprised of a plurality of layers (See, for example, Fig. 18C &34); and
at least one of said layers is comprised of fibers (fibrous mesh – See Col. 6, lines 8-21) adapted1 to provide mechanical integrity to the scaffold in the form of increased tensile and compressive resistance2 and one or more layers are comprised of a biocompatible material (for example, polymers & ceramics – See Col. 11, lines 10-58) adapted to provide mechanical integrity and to provide a suitable biochemical environment in all phases. (See Col. 12, lines 8-68; Col. 18, line 7-35).
Regarding claim 2, Lu teaches the device for regenerating musculoskeletal tissue as required for claim 1 and further teaches the biocompatible material is comprised of one or more from the group comprising: bioceramics, polymers, and hydrogels. (See Col. 11, lines 25-41; Col. 12, lines 56-61)
Regarding claim 3, Lu teaches the device for regenerating musculoskeletal tissue as required for claim 2 and further teaches said biocompatible material is reinforced with one or more of the following: Hydroxyapatite (HAp) nanoparticles (See Col. 13, lines 15-32) and appropriate growth factors for the cells (See Col. 13, lines 44-48; Col. 14, lines 27-30; Col. 21, lines 35-40).
Regarding claim 4, Lu teaches the device for regenerating musculoskeletal tissue as required for claim 1 and further teaches the bioceramics include one or more of the following: hydroxyapatite (See Col. 11, line 39), tricalcium phosphate-based materials (See Col. 11, line 39-40), bioactive glass (See Col. 11, lines 38-39), calcium phosphate (See Col. 11, lines 49-53).
Regarding claim 5, Lu teaches the device for regenerating musculoskeletal tissue as required for claim 2 and further teaches the polymers include one or more of the following: amino acids (See Col. 13, line 24), peptides (See Col. 13, lines 36-40), polylactides (PLA) (See Col. 23, lines 5-12), polyglycolides (PGA) (See Col. 13, lines 31-32), polylactic-co-glycolic acid (PLGA) (See Col. 13, lines 31-32), polycaprolactone (PCL) (See Col. 16, lines10-14), polyphosphazenes (See Col. 16, lines 10-14), polyanhydrides (See Col. 13, line 27), polyorthoesters (See Col. 16, lines 10-14), polycarbonates (See Col. 16, lines 10-14), polyamides (See Col. 16, lines 10-14), and combinations of said polymers.
Regarding claim 6, Lu teaches the device for regenerating musculoskeletal tissue as required for claim 2 and further teaches the hydrogels include one or more of polyethylene glycol (PEG) (See Col. 12, lines 56-61).
Regarding claim 7, Lu teaches the device for regenerating musculoskeletal tissue as required for claim 1 and further teaches said fibers are comprised of one or more biocompatible materials. (See Col. 12, line 62 through Col. 13, line 7).
Regarding claim 8, Lu teaches the device for regenerating musculoskeletal tissue as required for claim 7 and further teaches said biocompatible materials are comprised of one or more of the polymers of claim 5. (See Col. 21, line 63 through Col. 22, line 10 and Col. 27, lines 26-35).
Regarding claim 9, Lu teaches the device for regenerating musculoskeletal tissue as required for claim 1 and further teaches said scaffold has a bone phase adapted to resemble the biophysical and biochemical structure of bone, a soft tissue phase adapted to resemble the biophysical and biochemical structure of the soft tissue to be regenerated, and a gradient phase adapted to resemble the biophysical and biochemical interface between the bone and said soft tissue. (See Col. 12, lines 9-40; Col. 15, lines 46-50)
Regarding claim 10, Lu teaches the device for regenerating musculoskeletal tissue as required for claim 9 and further teaches wherein said bone phase, said gradient phase and said soft tissue phase are comprised of different materials. (See Col. 30, line 55 through Col. 31, line 35)
Regarding claim 11, Lu teaches the device for regenerating musculoskeletal tissue as required for claim 7 and further teaches said fibers extend parallel to said bone, gradient and soft-tissue phases. (See Col. 30, lines 55-68, note this embodiment uses PLGA mesh sheets Vicryl VKML from Ethicon which are known to have fibers extending in both the longitudinal and vertical directions, thus the composite gradient device which employs using Vicryl mesh will have fibers extending parallel to the bone, gradient and soft tissue phases.)
Regarding claim 12, Lu teaches the device for regenerating musculoskeletal tissue as required for claim 7 and further teaches said fibers extend through said bone, gradient, and soft-tissue phases. (See Col. 30, lines 55-68)
Regarding claim 13, Lu teaches the device for regenerating musculoskeletal tissue as required for claim 11 and further teaches said bone phase, said gradient phase and said soft tissue phase are comprised of different materials of claim 2. (See Col. 30, line 55 through Col. 31, line 35)
Regarding claim 14, Lu teaches the device for regenerating musculoskeletal tissue as required for claim 11 and further teaches said bone phase, said gradient phase and said soft tissue phase are comprised of different concentrations of the same materials of claim 2. (See Col. 21, line 63- Col. 22, line 50)
Regarding claim 15, Lu teaches the device for regenerating musculoskeletal tissue as required for claim 12 and further teaches said bone phases, said gradient phases and said soft tissue phases are comprised of different materials of claim 2. (See Col. 30, line 55 through Col. 31, line 35)
Regarding claim 16, Lu teaches the device for regenerating musculoskeletal tissue as required for claim 12 and further teaches said gradient phases and said soft tissue phases are comprised of different concentrations of the same materials of claim 2. (See Col. 22, lines 10-25).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Monday through Thursday between 9:30am and 2:30pm .
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.S.H/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
1 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II).
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