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 .
Claims status
Applicant’s reply filed 7/2/2026 is acknowledged
Claims 8 is/are cancelled. Claims 1-7, 9-24 is/are currently pending with claims 18-23 is/are withdrawn. Claims 1-7, 9-17, 24 is/are under examination.
Withdrawn Objections
The objections presented herein represent the full set of objections currently pending in this application. Any objections not specifically reiterated are hereby withdrawn.
Claim Objections – New, necessitated by claim amendments
Claim 1 is objected to because of the following informalities: Claim 1 recites “elongation deformation strain treatment” in line 6 and also “the extrinsic elongation deformation strain treatment”. For the sake of consistency, Applicant is recommended to use the same terminology across the claim set. The remarks filed 7/2/2026 appear to indicate that extrinsic application of the mechanical strain is in the intended feature (page 12, lines 1-7), thus it is recommended that claim 1 recite “a extrinsic elongation deformation strain treatment” in line 6.
Appropriate correction is required.
Applicant is advised that should claim 11 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Although claim 11 recites “wherein the mechanical stimulation is performed as a strain treatment” and claim 14 recites “wherein the mechanical stimulation is performed as an extrinsic deformation”, these are both appear to be directed to the same mechanical stimulation of claim 1 which is “performed by elongation deformation strain treatment applied along a load axis of the biocompatible matrix” (see 112b rejection below).
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112(b) – New, necessitated by claim amendments
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.
Rejection of Claims 1-17, 24 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 is withdrawn in light of claim amendments.
Claims 7, 11, 14, 24 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 7 recites “wherein the mechanical stimulation on the cells is performed by a static strain treatment or a ramp strain treatment.”. Claim 7 depends from claim 1 that is now amended to recite a specific mechanical stimulation: “wherein the mechanical stimulation on the cells is performed by elongation deformation strain treatment applied along a load axis of the biocompatible matrix”. It is unclear if the static strain treatment or a ramp strain treatment of claim 7 is in addition or an alternate to the mechanical stimulation method of claim 1. For the purpose of compact prosecution, the claim(s) 7 is/are interpreted as “wherein the extrinsic elongation deformation strain treatment on the cells is performed by a static strain treatment or a ramp strain treatment.”
Claim 11 recites “wherein the mechanical stimulation is performed as a strain treatment”. Claim 11 depends from claim 1 that is now amended to recite a specific mechanical stimulation: “wherein the mechanical stimulation on the cells is performed by elongation deformation strain treatment applied along a load axis of the biocompatible matrix”. It is unclear if the strain treatment of claim 11 is in addition or an alternate to the mechanical stimulation method of claim 1. For the purpose of compact prosecution, the claim(s) 11 is/are interpreted as “wherein the extrinsic elongation deformation strain treatment
Claim 14 recites “wherein the mechanical stimulation is performed as an extrinsic deformation”. Claim 14 depends from claim 1 that is now amended to recite a specific mechanical stimulation: “wherein the mechanical stimulation on the cells is performed by elongation deformation strain treatment applied along a load axis of the biocompatible matrix”. It is unclear if the extrinsic deformation of claim 14 is in addition or an alternate to the mechanical stimulation method of claim 1. For the purpose of compact prosecution, the claim(s) 14 is/are interpreted as “wherein the strain treatment
Claim 24 recites “an axis of strain from the mechanical stimulation”. It is unclear if the mechanical stimulation produces a different axis of strain than the load axis of claim 1. In other words, a relationship between the axis of strain along which the cell align and the load axis along which the strain is applied is not clearly identified. Based on the specification, cells align along the load axis (Figure 5 and 10). For the purpose of compact prosecution, the claim(s) 24 is/are interpreted as “wherein the cells are aligned along the load axis”.
Claim Interpretation - Reiterated
Claim 1 recites “Schwann cell-like cells”. The specification does not explicitly define this term however on page 5, it guides that “The present invention provides preferably cell constructs comprising primary Schwann cells, isolated from tissues, or Schwann cell-like cells differentiated from other cell types such as mesenchymal stem cells, fibroblasts or induced pluripotent stem cells etc., and a biocompatible matrix”. Thus, the broadest reasonable interpretation of “Schwann cell-like cells” are cells that are differentiated from other cell types and have some characteristic of a Schwann cell. For example, the specification teaches Adipose stem cell derived Schwann cell-like cells in Section 3 and 4 on page 34-35.
Claim Rejections - 35 USC § 102 - Withdrawn
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.
Rejection of Claim(s) 1-6, 8-10, 12, 24 under 35 U.S.C. 102(a)(1) as being anticipated by Georgiou et al (Biomaterials 34 (2013) 7335-7343; IDS 12/20/2022) as evidenced by Phillips et al (Micro-structured Materials and Mechanical Cues in 3D Collagen Gels. Chapter 12: Methods Mol Biol 2011;695:183-196) and Phillips et al (TISSUE ENGINEERING, Volume 11, Number 9/10, 2005; hereinafter Phillips 2005) is withdrawn in light of claim amendment that requires that the mechanical stimulation to be extrinsic and repeated throughout the cultivation period.
Claim Rejections - 35 USC § 102/103 - Withdrawn
The text of those sections of Title 35, U.S. Code not included in this section can be found above.
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.
Rejection of Claim(s) 13 under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Georgiou as evidenced by Phillips, Phillips 2005, Heher et al (Acta Biomaterialia 24 (2015) 251–265; IDS 12/20/2022) and Raub et al (Acta Biomater. 2010 December ; 6(12): 4657–4665) is withdrawn because, as noted above, Georgiou does not teach an extrinsic, repeated mechanical stimulation,
Claim Rejections - 35 USC § 103 – New, necessitated by claim amendments
The text of those sections of Title 35, U.S. Code not included in this section can be found above.
Rejection of Claim(s) 7, 11, 14-16 under 35 U.S.C. 103 as being unpatentable over Georgiou as evidenced by Phillips, Phillips 2005 as applied to claim 1 above, and further in view of Heher et al (Acta Biomaterialia 24 (2015) 251–265; IDS 12/20/2022) is withdrawn due to withdrawal of the rejection to claim 1 that this rejection relied upon.
Rejection of Claim(s) 17 under 35 U.S.C. 103 as being unpatentable over Georgiou as evidenced by Phillips and Phillips 2005 as applied to claim 1 above, and further in view of Anderson et al (Crit Rev Biomed Eng. 2015 ; 43(2-3): 131–159; IDS 12/20/2022) is withdrawn due to withdrawal of the rejection to claim 1 that this rejection relied upon.
Claim(s) 1-7, 9-16, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over and Georgiou et al (Biomaterials 34 (2013) 7335-7343; IDS 12/20/2022) and Heher et al (Acta Biomaterialia 24 (2015) 251–265; IDS 12/20/2022) as evidenced by Phillips et al (Micro-structured Materials and Mechanical Cues in 3D Collagen Gels. Chapter 12: Methods Mol Biol 2011;695:183-196; ref of record).
Regarding claims 1 and 24, Georgiou teaches a method for producing a cell construct comprising Schwann cells wherein the cells are longitudinally aligned along the axis of mechanical stimulation allowing for axonal guidance i.e. Bands of Bungner-like structures form in Georgious’s method (Figure 1, 2, 5). Georgiou’s method comprising mixing (=claimed contacting) Schwann cells with collagen gel (=claimed biocompatible matrix; =claimed protein as required for claim 2) and culturing (=claimed cultivation) the mixture to produce a cell construct (Section: 2.1. Fabrication of Schwann cell EngNT). The Schwann cells and collagen gel mixture is cultivated on a mould such that the cell-gel mixture is exposed to at least two different mechanical forces (=administer mechanical stimulation): (1) Cell-generated mechanical tension due to tethering of cell-gel mixture to the ends of the mould to “allow for alignment to develop” and, (2) Plastic compression (also mechanical force) to maintain alignment (page 7336, col. 1, para 1 and 2; Figure 1). Furthermore, since the Schwann cells were mixed with the collagen gel, the cells are embedded in the biocompatible matrix.
Regarding claims 5 and 6, in Georgiou method the tethering step that allows for cell-generated mechanical tension was performed for 1 day while the plastic compression step was performed for 1 minute (=claimed 1-60days of mechanical stimulation as required by claim 6; Section: 2.1. Fabrication of Schwann cell EngNT). Subsequently, the cell construct is further cultured for various durations, with ring-shaped constructs cultured for “upto 24 hours prior” to their use in in vivo experimentation (Section: 2.1. Fabrication of Schwann cell EngNT) and the sheet-shaped construct cultured for additional 3 days with neurons (Section: 2.4. Assessment of EngNT in co-culture with neurons). Taken together, Georgiou method comprises culturing the cell construct for various durations depending on use, with at least a 3 day duration recited for in vitro testing (=claims 3-60days of cultivation as required by claim 5).
Regarding claim 10, Georgiou does not explicitly state that the culture steps were performed in aseptic condition however using sterile technique in cell culture is standard practice. To this end, Georgiou refers to Philip as the source of their method and Phillips evidences use of sterile technique with the very first step of the method reciting sterilization of moulds (page 187, step 1.)
Thus, Georgiou teaches a base method for producing a cell construct comprising Schwann cells aligned to form Bands of Bungner-like structures but Georgiou does not teach a method wherein the mechanical stimulation is performed by elongation deformation strain treatment applied along a load axis of the biocompatible matrix and repeated during cultivation.
Heher also teaches a comparable method for producing a cell construct wherein the cells are longitudinally aligned along a load axis (Figure 1, 2; as required by claim 24). Heher’s method also comprises contacting cells with a biocompatible matrix, wherein cells are embedded in the matrix, and cultivating the cells in a bioreactor system that allows for a mechanical stimulation to be performed on the cells by elongation deformation strain treatment applied along a load axis of the biocompatible matrix and repeated during cultivation (2.2. Preparation and culture of fibrin rings; 2.3. MagneTissue bioreactor system; 2.5. Mechanical stimulation of fibrin rings; Figure 1).
Regarding claim 2, Heher also teaches a protein biocompatible matrix (2.2. Preparation and culture of fibrin rings).
Regarding claim 3, Heher teaches performing culture in their specific bioreactor that allows for the extrinsic mechanical stimulation (2.3. MagneTissue bioreactor system).
Regarding claim 4, Heher teaches that the biocompatible matrix is in a 3D ring form (2.2. Preparation and culture of fibrin rings; Figure 1).
Regarding claims 5 and 6, Heher cultures the cells for at least 9 days with mechanical stimulation for at least 6 days (Figure 1; 2.5. Mechanical stimulation of fibrin rings).
Regarding claim 7, Heher teaches that elongation deformation strain treatment can be static strain or ramp strain (2.5. Mechanical stimulation of fibrin rings; pg 262, col. 2, para 1; Figure 1, 4).
Regarding claim 9, 12, Heher teaches that the ring-shaped cell construct has a length of 30mm and a diameter of 2mm i.e. 15:1 (Figure 1).
Regarding claim 13, Heher teaches Young’s modulus of their ring-shaped cell construct is 10-40kPa (Figure 2A).
Regarding claim 11, 14, 15, Heher teaches that the their bioreactor system can be used to perform mechanical strain treatment that causes a pre-defined change in the length of the construct along the load axis, such as a 10% change in length and also 3% change in length exemplified in Figure 1, which is at least 2% (2.5. Mechanical stimulation of fibrin rings).
Thus, Heher teaches a comparable method for producing a cell construct which improved a prior method that was similar to Georgiou.
Heher teaches that “The majority of previously reported 3D skeletal muscle engineering
approaches use scaffold anchoring as the primary source of strain to generate alignment, with the limitation that the extent and type of strain cannot be properly controlled” (pg 252, col. 2, para 1). Thus, Heher teaches that alignment in prior cell constructs comprising skeletal muscle was produced by tethering, which is similar to Georgiou. However, Heher teaches an improvement to the prior constructs by using the technique of controlled mechanical stimulation. Heher teach “we have designed a novel closed bioreactor system (MagneTissue) that allows for adjustable cyclic or static mechanical stimulation of cells embedded in a free standing ring-shaped fibrin matrix via strain transmission through magnetic force” which can be used to test defined stimulation protocols (pg 252, col. 2, para 1).
The combination of prior art cited above under 35 U.S.C. 103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S., 82 USPQ2d 1385 (2007). See MPEP 2143 for exemplary rationales that may support a conclusion of obviousness.
In the present situation, rationale C (Use of Known Technique To Improve Similar Devices (Methods, or Products) in the Same Way) is applicable. MPEP 2143 guides that for rationale C “Office personnel must articulate the following: (1) a finding that the prior art contained a "base" device (method, or product) upon which the claimed invention can be seen as an "improvement;" (2) a finding that the prior art contained a "comparable" device (method, or product that is not the same as the base device) that has been improved in the same way as the claimed invention; (3) a finding that one of ordinary skill in the art could have applied the known "improvement" technique in the same way to the "base" device (method, or product) and the results would have been predictable to one of ordinary skill in the art; and (4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.”.
(1) The prior art of Georgiou comprised the base method for producing a cell construct comprising Schwann cells aligned to form Bands of Bungner-like structures. Georgiou’s method comprises cell-generated mechanical stimulation due to tethering of the construct which allows for alignment of the Schwann cells. However, Georgiou’s method does not comprise a controllable, definable mechanical stimulation as is claimed.
(2) The prior art of Heher improves a comparable method for producing cell constructs wherein cells are aligned along a load axis by providing a technique for controllable, definable mechanical stimulation of cell constructs, as claimed.
3) An ordinary artisan could apply Heher’s improved technique for applying controllable, definable mechanical stimulation to cell constructs to Georgiou’s method by cultivating Georgiou’s Schwann cells in the ring-shaped construct of Heher that could be placed in Heher’s bioreactor system. An ordinary artisan would predict that using Heher’s improved technique for applying controllable, definable mechanical stimulation to cell constructs comprising Schwann’s cells would allow for alignment of Schwann’s cells because Georgiou already shows that Schwann cells have the tendency to align along the axis of strain. Furthermore, Georgiou also teaches that other means for producing aligned constructs were known, such as mechanical loading. Critically, Georgiou taught that methods for producing aligned constructs need not be cell specific – teaching anisotrophy/alignment as a key feature of various tissues and suggesting the utility of their own method to produce aligned constructs from any suitable alternative cell (page 7335, col. 1, para 1; page 7336, col. 1, para 1; Conclusion). This suggests to an ordinary artisan that other alternative means, such as mechanical stimulation, could be used to generate aligned Schwann cell constructs.
Therefore, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR. Therefore, it would be obvious to a person of ordinary skill in the art to use the known technique of Heher to improve the similar method of Georgiou’s to produce a predictable result of a method of producing aligned Schwann cell construct comprising bands of Bungner-like structure.
Regarding claim 16, Heher does not teach explicitly teach a mechanicals stimulation that causes a change in length of the load axis of 8%. However, Heher’s system can be used to perform mechanical strain treatment that causes any pre-defined change in the length of the construct along the load axis. Heher exemplify both 10% change in length and also 3% change in length (2.5. Mechanical stimulation of fibrin rings; Figure 1). An ordinary artisan using Heher’s technique to improve Georgiou’s method would use routine optimization to identify the amount and duration of mechanical stimulation to achieve desired alignment in the construct. According to MPEP 2144.05(II), "[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)”. See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."). Therefore, in teaching a technique that allows for control of mechanical stimulation to achieve desired change in length of the load axis, Heher renders the instantly claimed 8% change prima facie obvious since an ordinary artisan would use routine optimization to identify the optimal mechanical stimulation when combining Georgiou and Heher.
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.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Georgiou and Heher as evidenced by Phillips as applied to claim 1 above, and further in view of Anderson et al (Crit Rev Biomed Eng. 2015 ; 43(2-3): 131–159; IDS 12/20/2022).
The teachings of Georgiou, Heher and evidence from Phillips, as detailed in the U.S.C. 103 rejection above are relied upon for the instant rejection.
Georgiou and Heher teach the method of claim 1.
Georgiou nor Heher expose the construct to electrical stimulation.
Anderson teaches that electrical stimulation of Schwann cells increases secretion of neurotrophic factors from these cells and suggests electrical stimulation of Schwann cell constructs to promote peripheral nerve regeneration (page 14, para 3; Figure 15).
Therefore, based on Anderson’s teachings, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to electrically stimulate Georgiou and Heher’s Schwann cell construct. An ordinary artisan would be motivated to electrically stimulate Georgiou and Heher’s Schwann cell construct to increase neurotrophic factors secretion from the construct. An ordinary artisan reasonably expects to deliver electrical stimulation to a Schwann cell construct using nerve growth conduits already known in the art (see Table 3 of Anderson).
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.
Response to Arguments
Applicant’s arguments, see pages 11-13, filed 7/2/2026, with respect to the U.S.C. 102 rejection(s) of claim(s) 1-6, 8-10, 12, 24 and U.S.C. 102/103 rejection(s) of claim(s) 13 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Georgiou and Heher.
Applicant’s arguments with respect to the U.S.C. 103 rejection of claim(s) 7, 11, 14-16 have been considered but are moot because the new ground of rejection necessitated by claim amendments.
Arguments pertinent to instant rejection are addressed below.
Applicant argues that “Heher is directed entirely to skeletal muscle cells” and only identify tendons and ligaments as additional application fields such that “A skilled artisan reading Heher would follow its own authors toward muscle disease models, tendons, and ligaments - not toward non-contractile glial cells of the peripheral nervous system” (page 14, para 3). Distinguishing muscle and Schwann cells, Applicants reference non-patent literature that allegedly show that “prior art involving external stretch of muscle cells builds on a well-established mechanobiological framework where such stimuli are expected to drive alignment, maturation, and function” while “Schwann cells, by contrast, are non-contractile glial support cells of the peripheral nervous system existing in comparably soft, low-strain environments, where peripheral nerves are physiologically shielded from external mechanical forces by 6-15 layers of connective tissue” (page 14, 15, bridging para). These literature were not provided.
In response, although Heher is directed to skeletal muscles, an ordinary artisan is not limited to this singular prior art. Both skeletal muscles and Schwann’s cells are anisotropic tissue that align along an axis. Georgiou taught that methods for producing aligned constructs need not be cell specific – teaching anisotrophy/alignment as a key feature of various tissues and suggesting the utility of their own method to produce aligned constructs from any suitable alternative cell (page 7335, col. 1, para 1; page 7336, col. 1, para 1; Conclusion). Thus, if Georgiou’s method could be used to make non-Schwann cell constructs then this suggests to an ordinary artisan that other alternative means, such as mechanical stimulation, that are known to work for other anisotropic cells could also be used to generate aligned Schwann cell constructs. Georgiou references methods developed in other tissues, such as muscle, to select appropriate techniques for their methos (see reference #19 to Micol et al, Biomaterials 32 (2011) 1543e1548 in Georgiou, Introduction, para 5).
Furthermore, Schwann’s cells, the role of mechanical cues (=stimulation) was known. This is evident from Manganas et al (Front. Cell. Neurosci. 16:948454. PTO-892) cited by the Applicant. When discussing “The effect of mechanical properties”, Manganas teach “Schwann cells in peripheral nerves are physiologically exposed to mechanical stimuli such as shear and compressive and tensile stress, which can occur due to injuries or diseases, as well as during development and adulthood (Zhang et al., 2015; Belin et al., 2017). […] SCs are very sensitive to the surrounding stiffness and possess great plasticity. In case of injury of the peripheral nerves, myelinated SCs can dedifferentiate and guide the regeneration of peripheral axons (Jessen and Mirsky, 2016; Boerboom et al., 2017). Generally, in peripheral nerves, myelinated fibres are surrounded by 6–15 layers of connective tissue, which shield the SCs and the axons from mechanical forces originating from the external environment. It is known that the relative elasticity or stiffness of the peripheral nerves can affect the mechanical cues that the SCs are exposed to, while SC architecture and basal lamina integrity play key roles in the SC response to mechanical stress (Belin et al., 2017). In vitro studies have shown that mechanical stimulation at low levels may activate SC mitogenic pathways, independently of the regulation occurring between SCs and axons after axonal injury (Salzer and Bunge, 1980).” (page 2, col. 2, para 2). Thus, although Schwann cells maybe protected from mechanical force originating outside the body, they are exposed to mechanical stimulus nonetheless. Critically, during injury the exposure to external force and its effects on Schwann cells dedifferentiation to allow for nerve guidance was known.
Regarding Georgiou, Applicant allege that Georgiou presents it tethering approach “as an alternative to that prior art - not as a stepping stone toward externally applied stretch.” (page 15, para 2).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Georgiou teaches the tethering approach while Heher teaches an improvement to such a tethering approach, which is application of external mechanical stimulation.
Finally, Applicant appear to allege unexpected results pointing a patent literature not provided with the response. Applicant allege that the “externally applied, defined strain to Schwann cell-laden 3D fibrin matrices induces the formation of bands of Bungner-like structures with stable alignment over days, upregulation of neurotrophic factors, increased expression of p75NTR, and enhanced axon guidance in vitro - a synergistic and reproducible response to controlled external deformation that was neither disclosed nor suggested in the prior art”
In response, it is unclear how this result overcomes the prior art of Georgiou and Heher that together teach the claimed method. Both Georgiou and Heher’s method are capable of producing stable, aligned cell constructs (Figure 2 in Georgiou and Figure 4 in Heher). Regarding upregulation of neurotrophic factors, increased expression of p75NTR, and enhanced axon guidance in vitro, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant’s arguments with respect to the U.S.C. 103 rejection of claim(s) 17 have been considered but are moot because the new ground of rejection necessitated by claim amendments.
Arguments pertinent to instant rejection are addressed below.
Applicant argue that Anderson “addresses a general stimulatory effect on Schwann cell biology; it does not suggest combining electrical stimulation with the specific process of producing a Schwann cell construct through extrinsic deformation strain treatment to form bands of Bungner-like structures.” (page 16, para 2).
In response, Anderson provides the requisite motivation to additionally include electrical stimulation when generating Schwann cell constructs wherein the mechanical stimulation produces alignment while electrical stimulation increases secretion of neurotrophic factors from these cells which would promote peripheral nerve regeneration.
Of note, no electrical stimulation was performed in the instant specification.
Conclusion
No claim is allowed.
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.
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/MATASHA DHAR/Examiner, Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632
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