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 .
DETAILED ACTION
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 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.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-13, in the reply filed on Jun. 20, 2025 is acknowledged. Claims 14, 15, 17, 19, 20, 23 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
Applicant states that claims 14, 15, 17, 19, 20, 23 and 24 were amended to depend from claim 1 and the claims include all the limitations of claim 1. However, even though claims 14, 15, 17, 19, 20, 23 and 24 depend from claim 1, they are considered separate and distinct inventions as set forth in the restriction requirement. Therefore, the inventions would require the searching of different fields. Moreover, a reference that may anticipate one group, may not anticipate or even make obvious the invention of another group.
The requirement for the restriction of Inventions I and II is still deemed proper and is therefore made FINAL.
Claims 1-13 are presented for examination on the merits.
Status of the Claims
Claims 1-15, 17, 19, 20, 23 and 24 are currently pending.
Claim 14 is amended.
Claims 14, 15, 17, 19, 20, 23 and 24 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 16, 18, 21, and 22 are cancelled.
Claims 1-13 have been considered on the merits.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description: 9 and 15. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
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 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Srouji et al. (US 2010/0172952 A1) as evidenced by Simpson et al. (US 2004/0037813 A1) (ref. of record).
With respect to claim 1, Srouji teaches an porous scaffold comprising electrospun polymeric nanofibers (0001 and 0011). Srouji teaches the scaffold where polymeric nanofibers contains biodegradable polymers that includes polycaprolactone (PCL) and poly(lactic-co-glycolic) acid (PLGA)(0020-0021). Srouji teaches the porous scaffold comprising co-polymers (0091). Srouji teaches the scaffold further containing particles that are embedded between the polymeric nanofibers and where the particles are osteoconductive (0026-0027). Srouji teaches the osteoconductive particle can be graphite (0098). Although Srouji does not specifically disclose a single example or specific embodiment of the claimed fibrous polymeric scaffold, given the teachings of Srouji, it would have been obvious to one of ordinary skill in the art to design the claimed scaffold in the course of routine experimentation to enhance the utility of the manufactured material in bone and cartilage tissue engineering.
With respect to claim 2, Srouji teaches the scaffold further containing cartilage cells (encase a cartilage graft) (0051).
With respect to claim 10, Srouji teaches the particles comprising at least 1% of the scaffold volume (0110). Although Srouji does not teach the ranges recited in claim 10, one of ordinary skill in the art would recognize that the concentration of the graphite particles is a result effective variable and that the amount of graphite particles would be matter of routine optimization as evidenced by Srouji. Srouji teaches the particle size affects the weight-per-volume of the electrospun scaffold (0111). Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here 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 454,456, 105 USPQ 233,235 (CCPA 1955) -MPEP § 2144.05.
With respect to claim 12, Srouji teaches the polymeric nanofibers can have a random orientation (unaligned)(0107). With respect to claim 13, Srouji teaches the polymeric nanofibers have a diameter of 100-400 nm.
Srouji does not teach the graphite particles in the fibers impart electroactivity to the fibrous polymeric scaffold to biomimic native properties of the host cartilage operating as a mechano-transducer as recited in claim 3. Similarly, Srouji does not teach that the graphite particles embedded in the electrospun fibers of the fibrous polymeric scaffold attract cell adhesion proteins from the host cartilage as recited in claim 4. Srouji does not teach that the graphite particles embedded in the electrospun fibers of the fibrous polymeric scaffold attract fibronectin and laminin from the host cartilage as recited in claim 5. Srouji does not teach that the graphite particles embedded in the electrospun fibers of the fibrous polymeric scaffold enhance chondrocyte proliferation in the host cartilage as recited in claim 6. Srouji does not teach that the host cartilage includes a zone of chondrocyte death (ZoCD), and the graphite particles embedded in the electrospun fibers of the fibrous polymeric scaffold facilitate chondrocyte repopulation in the ZoCD of the host cartilage as recited in claim 7. Srouji does not teach that the graphite particles embedded in the electrospun fibers of the fibrous polymeric scaffold enhance glycosaminoglycan deposition in the host cartilage as recited in claim 8. Srouji does not teach that the graphite particles embedded in the electrospun fibers of the fibrous polymeric scaffold enhance collagen production in the host cartilage as recited in claim 9. Srouji does not teach that the graphite particles embedded in the electrospun fibers of the fibrous polymeric scaffold enhance cell attachment to the fibrous polymeric scaffold as recited in claim 11.
Although, Srouji does not teach these claimed functional characteristics of the graphite particles in the fibers as recited in claims 3-9 and 11, these appear to be inherent characteristics of graphite particles as evidenced by Simpson. Simpson teaches that graphite is an electrically active material (0009). Additionally, the instant specification states that “the graphite particles embedded in the fibrous polymeric scaffold impart electroactivity to the scaffold which mimics the native nature of cartilage” (0136). The specification further describes that:
“the fibrous polymeric scaffold containing graphite may also attract negatively charged cell adhesion proteins such as fibronectin and laminin, which will enhance cell attachment to the scaffold. Improved cell adhesion to the fibrous polymeric scaffold containing graphite, teamed with strategic biomimicry of cartilage electroactivity, may facilitate chondrocyte repopulation of the ZoCD and subsequent matrix deposition by chondrocytes to integrate cartilage grafts with host cartilage” (0137).
There does not appear to be any additional modification to the graphite particles to impart these claimed characteristics. Accordingly, the graphite particles of the Srouji are the same as those claimed by applicant. Thus, the claimed functional characteristics of the graphite particles is also inherent in the graphite particles of the Srouji.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632