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 .
This action is responsive to papers filed 01/27/2026.
Claim 11 has been amended. Claim 17 has been newly canceled and no claims have been newly added.
Claims 11-16 and 18-24 are currently pending.
Claims 18-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 08/01/2025.
Claims 11-16 have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
Claim(s) 11, 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 2014/0072951-from IDS filed 01/30/2023).
Regarding claim 11, 13-16, Johnson disclose an electrospun polymer scaffold comprising a plurality of polymer fibers seeded with biological cells (differentiated cells for example)(page 1 para 14) which include an embodiment comprising blends of different polymers electrospun together (co-spun) and one polymer preferentially dissolved (degraded) to increase scaffold porosity (page 2 para 16). The precursor solution may be controlled to optimize the degradation rate (page 2 para 16). A properly constructed scaffold will permit substantially complete cellular penetration (and provide an optimal cell infiltration rate) and uniform seeding for proper function and prevention of necrotic areas developing (page 2 para 16). The degradation rate of the polymer that degrades first inherently forms pores in the scaffold and this will correlate (correspond) with the rate that the cells are able to infiltrate into the scaffold.
The degradable polymers include polylactic acid and polyglycolic acid (polyglycolide) which degrade upon implantation and exposure to tissue (page 2 para 15, page 3 para 21). Exemplary embodiments and variants include one with separate scaffold layers or sheets seeded independently to form different types of tissue and an electrospun fiber scaffold made from a single layer of orientated fibers or a composite comprising a plurality of layers of orientated fibers to correspond to a native structure and help orient and differentiate cells (page 3 para 23).
The specific combination of features claimed is disclosed within the broad genera of polymer types, scaffold shapes (sheet and layers) and cell types taught by Johnson, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any specific teaching to select this specific combination of variables, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have selected various combinations of polymer types, scaffold shapes (sheet and layers) and cell types from within the disclosure of Johnson to arrive at methods and compositions “yielding no more than one would expect from such an arrangement”.
The motivation and reasonable expectation of success in making these combinations comes from the fact that Johnson suggests that all these cited variables are suitable for inclusion in their method/composition.
Therefore, the teaching of Johnson renders obvious Applicant’s invention as claimed.
Claim(s) 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 2014/0072951-from IDS filed 01/30/2023) in view of Mauck et al (US 2012/0093717-from IDS filed 01/30/2023) and El-Kurdi et al (WO 2008/094971).
Regarding claims 11-16, the teaching of Johnson renders obvious the claimed invention as described above, but does not specifically disclose all the claimed polymers or wherein the first degradation rate is about 1 week and the second degradation rate is about 4 months.
Mauck teaches an engineered fibrous scaffold compositions that comprises one or more first fibers comprising a first polymeric material (polycaprolactone (PCL)), the first polymeric material having a first rate of degradation when contacted with an fluid medium and one or more second fibers comprising a second polymeric material, the second polymeric material (polyethylene oxide) having a second rate of degradation when contacted with an fluid medium, where the second rate of degradation being faster than the first rate of degradation (i.e., a degradation rate different from the first; paragraphs 7, 52 and 86).
Mauck teaches that the scaffold may be formulated such that one or more polymeric materials remain in place for days or even weeks, where if needed the polymeric materials are chosen and formulated so as to achieve faster degradation of the scaffold (paragraph 51). Mauck also teaches that the second fibers have a second rate of degradation that is slower (i.e., longer) than the first rate of degradation (paragraph 52).
Further, Mauck teaches that the optimal degradation profile will be dictated by the user's needs and will be easily achieved by manipulation of the polymeric materials and of process parameters, such as fiber thickness (which is controlled by, e.g., electrospinning process parameters) and the overall density of fibers (paragraph 51).
Mauck teaches that one or more first fibers are suitably intertwined with one or more second fibers which provides that the enhanced porosity that results from erosion of one fiber component of a scaffold (leaving behind the second fiber) enhances the ability of cells to infiltrate into the scaffold so as to proliferate and grow within the scaffold (i.e., the first degradation rate substantially corresponds to a cell infiltration rate; paragraph 44).
El-Kurdi teaches bioerodible electrospun vascular graft compositions (i.e. a scaffold) that can be tubular and used for arterial (venous) graft (AVG) applications (Abstract). El-Kurdi also teaches the graft (implantable scaffold) is prepared by electrospinning, where the polymer fibers can comprise any useful bioerodible polymer composition including the fibers that comprise a polymer chosen from one or more of a polylactide, a poly(lactide-co-glycolide), a poly(L- lactide-co-caprolactone), a polyglycolic acid (PGA), (page 13 last paragraph to page 14 first paragraph). These bioerodible polymers once implanted and placed in contact with bodily fluids and tissues will degrade typically and preferably over a time period of days, weeks, or months (page 28 last paragraph). El-Kurdi also teaches that cells can be associated with the matrix (scaffold), where the one or more of cells include differentiated cells and stems cells (e.g. mesenchymal stem cells) (page 14 last paragraph).
One of ordinary skill in the art would have been motivated to select polymers from polylactide, a poly(lactide-co-glycolide), a poly(L- lactide-co-caprolactone), a polyglycolic acid (PGA) with a reasonable expectation of success for the method of Johnson because El-Kurdi teach and suggest that these bioerodible polymers are beneficial and suitable for use in an electrospun scaffold and both Johnson and El-Kurdi are drawn to electrospun scaffolds that include polylactide and polyglycolide. One of ordinary skill in the art would have been motivated to select a first degradation rate of about 1 week and a second degradation rate of about 4 months for the method of Johnson because Mauck also teaches that the second fibers have a second rate of degradation that is slower (i.e., longer) than the first rate of degradation (paragraph 52). One of ordinary skill in the art would have had a reasonable expectation of success because Johnson also suggests using polymers with different degradation rates to provide for porosity in the scaffold and El-Kurdi teach that these bioerodible polymers will degrade typically and preferably over a time period of days, weeks, or months (page 28 last paragraph).
Therefore, the combined teachings of Johnson, Mauck et al and El-Kurdi et al render obvious Applicant’s invention as claimed.
Response to Arguments
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive.
Applicant argues that none of Johnson, Mauck and El-Kurdi disclose the limitation wherein at least one of the first degradation rate or the second degradation rate corresponds to a cellular infiltration rate.
This is not found persuasive. The term “corresponds” has been broadly interpreted as meaning that the polymer degradation rates and cell infiltration rate are connected and correlate with each other. There is nothing in Applicant’s disclosure that requires a 1:1 equivalence to these rates, only a suggestion that these rates will go up and down proportionally (see page 2 para 8 and page 18 para 100 of Applicant’s Specification). It is clear that there is a natural correlation between the rate that the cell infiltrates the scaffold and the rate that the polymer degrades. The degradation of the polymer provides space for the cells to infiltrate into the polymer scaffold and these are connected.
In the references cited in the obviousness rejections, Johnson specifically discloses that the precursor solution may be controlled to optimize the degradation rate (page 2 para 16). A properly constructed scaffold will permit substantially complete cellular penetration (and provide an optimal cell infiltration rate) and uniform seeding for proper function and prevention of necrotic areas developing (page 2 para 16). The degradation rate of the polymer that degrades first inherently forms pores in the scaffold and this will inherently correlate (correspond) with the rate that the cells are able to infiltrate into the scaffold.
In addition, Mauck teaches that one or more first fibers are suitably intertwined with one or more second fibers which provides that the enhanced porosity that results from erosion of one fiber component of a scaffold (leaving behind the second fiber) enhances the ability of cells to infiltrate into the scaffold so as to proliferate and grow within the scaffold (i.e., the first degradation rate substantially corresponds to a cell infiltration rate; paragraph 44).
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhang et al., “Effect of porosity on long-term degradation of poly (ε-caprolactone) scaffolds and their cellular response”, Polymer Degradation and Stability, 2013, Vol. 98, pp. 209-218.
Azevedo et al., “Controlling the degradation of natural polymers for biomedical applications”, Natural-Based Polymers for Biomedical Applications, 2008, Chapter 4, pp. 106-128.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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