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 .
Claim Status
Claims 1-8 and 10-21 are pending.
Claims 10-20 are withdrawn.
Claims 1-8 and 21 are under examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6th, July, 2026 has been entered.
Claim Interpretation
Instant claims are drawn to an hSCO that comprises a “mechanically injured area” which is a product-by-process limitation. As set forth previously, Applicant is reminded that product-by process claims are not limited by the manipulation of the recited steps, only the structure implied by the steps. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP 2113).
New Claim Rejections - 35 USC § 112 (a)
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is rejected because it recites the new limitations below that appear to be new matter. Claims 2-8 and 21 are also rejected because they are dependent on claim 1.
In the amendment filed on 5th, June, 2026 , claim 1 was amended to recite the following new limitations which appear to be new matter.
“the mechanically injured area covers at least 5% of the outer layer of the hSCO” and “the non-injured area is larger than the mechanically injured area and covers the remainder of the outer layer”
This newly recited limitation appears to be new matter because it recites specific ranges and amounts that are not specifically recited in the originally filed disclosure and are also not implicitly ore inherently supported by the originally filed disclosure. There is no recitation of the specific range of “the mechanically injured area covers at least 5% of the outer layer.” Furthermore, there is no recitation of any specific ranges or amounts of % coverage of the mechanically injured area. The only support for specific amounts of coverage of the mechanically injured area appear to the images of Figure 2D and 2H, which show an image of an organoid which each have one specific value of coverage of the injured area which is not quantified. Two specific values of % coverage of the mechanically injured area, that are not specifically quantified, do not provide support for the full breadth of the range of “at least 5% of the outer layer.”
Similarly, the limitation of “the non-injured area is larger than the mechanically injured area and covers the remainder of the outer layer” therefore encompasses a range of 95% to just over 50% (“the remainder of the outer layer” as claimed that is also larger). There is not specific support for these ranges and the closest support is also the specific examples discussed above which of Figure 2D and 2H, which show an image of an organoid which each have one specific value of coverage of the non-injured area which is not quantified. Two specific values of % coverage of the non-injured area, that are not specifically quantified, do not provide support for the full breadth of the range.
Applicant is directed to MPEP 2163.05 (III) which states that with respect to changing numerical range limitations, the analysis must take into account which ranges one skilled in the art would consider inherently supported by the discussion in the original disclosure. See also General Hosp. Corp. v. Sienna Biopharmaceuticals, Inc., 888 F.3d 1368, 1372, 126 USPQ2d 1556, 1560 (Fed. Cir. 2018) (written description support for the claimed concentration is lacking where the specification discloses a range of optical densities and several discrete values in the range with no explicitly defined maximum concentration; and even if the specification may be read to convert each disclosed value into a range, there is insufficient written description for the entire claimed range where the disclosed range minimally overlaps with the claimed range).
In the instant case, the specific examples of the % of the outer layer injured area and non-injured areas, in Figures 2D and 2H, which visually appear to be somewhere in the range of at least 5% injured, or 95% to just over 50% non-injured respectfully, but are not specifically quantified do not provide support for the full breadth of the claimed ranges because the specific examples of the % of the outer layer in Figures 2D and 2H minimally overlap with the full breadth of the claimed ranges (see MPEP 2163.05 (III) and General Hosp. Corp. v. Sienna Biopharmaceuticals, Inc., 888 F.3d 1368, 1372, 126 USPQ2d 1556, 1560 (Fed. Cir. 2018)).
Furthermore, the specific limitation that the “non-injured area is larger than the mechanically injured area” is also not supported by the originally filed disclosure. There is no specific disclosure of this limitation, and furthermore the closest support for this limitation also is the disclosure of the specific examples discussed above which of Figure 2D and 2H, which show an image of an organoid which each have one specific value of coverage of the non-injured area which is not quantified and do not provide support for the full breadth of the genus of injured and non-injured area sizes encompassed by the limitation of the “non-injured area is larger than the mechanically injured area.”
The “average” density of the reactive astrocytes “throughout” the glial scar-like tissue is “at least double” the average density of astrocytes “throughout” the non-injured area.
This new limitation appears to be new matter. There is not specific recitation of this new limitation. “At least double” is a range of density of reactive astrocytes. The closest support for this limitation is the specific amount of density of reactive astrocytes shown visually in Figure 2, specifically Figures 2I, 2K, 2L, 2N, 2O, 2P and 2N and Figure 2N which shows visually the density of reactive astrocytes in both the injured and non-injured area. Only figure 2N shows a specific comparison of the density of reactive astrocytes in both the injured and non-injured area which visually appears to be single point within the claimed range of “at least double” but has not been quantified. As set forth above, a single point within the claimed range does not provide support for the full breadth of the claimed range. Specifically, because the single disclosed value of Figure 2N, which is not quantified, minimally overlaps with the full breadth of the claimed range (see MPEP 2163.05 (III) and General Hosp. Corp. v. Sienna Biopharmaceuticals, Inc., 888 F.3d 1368, 1372, 126 USPQ2d 1556, 1560 (Fed. Cir. 2018)), there is insufficient support for the claimed range, and the new limitation appears to be new matter.
As noted by MPEP 608.04(a), new matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. In the instant case, for the reasons set forth above, one skilled in the art would NOT consider the limitations above to be explicitly, implicitly, or inherently supported by Applicant’s disclosure.
Hence, there is insufficient written descriptions support for the instantly claimed limitation of and Applicant has not shown possession of the invention.
Response to Arguments
Applicant’s arguments, filed 5th, June, 2026, have been fully considered but are not found persuasive.
Applicant argues “Support for the amendments can be found in FIG. 2. For example, FIG. 2A, FIG. 2B, FIG. 2D, FIG. 2E, FIG. 2F, FIG. 2H, FIG. 2I, FIG. 2M, and FIG. 2N show graphical representations and/or actual images of a mechanically injured organoid, clearly evidencing that the injured area covers at least 5% of the outer surface of the hSCO and the non-injured area is larger than the mechanically injured area and covers the remainder of the outer layer. FIG. 21, FIG. 2K, FIG. 2L, FIG. N, FIG. 20, and FIG. 2P show the density of reactive astrocytes within the mechanically injured area and FIG. 2N demonstrates that the average density of astrocytes within the injured area is clearly at least double the average density of astrocytes throughout the non-injured area” (pg. 5).
In response, Figure 2 is discussed in the new grounds of rejection above. In brief, Figure 2 does not support the full breadth of the newly claimed ranges because figure 2 disclose 1-2 specific points which minimally overlaps with the full breadth of the claimed range and therefore do not support the full breadth of the claimed range (see MPEP 2163.05 (III) and General Hosp. Corp. v. Sienna Biopharmaceuticals, Inc., 888 F.3d 1368, 1372, 126 USPQ2d 1556, 1560 (Fed. Cir. 2018)).
Withdrawn Claim Rejections - 35 USC § 102
The rejection of claims 1-8 and 21 under 35 U.S.C. 102(a)(1) as being anticipated by Ramirez et al. (Cells. 2021 Oct 7;10(10):2683.; henceforth “Ramirez”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
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 1-8 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Xue et al. (iScience. 2022 Dec 26;26(1):105898. eCollection 2023 Jan 20.; see IDS filed 5th, February, 2025; Supplementary Information attached: henceforth “Xue”) in view of Rouleau et al. (Biomolecules. 2020 Aug 17;10(8):1196.; henceforth “Rouleau”), Fitch et al. (Exp Neurol . 2008 Feb;209(2):294-301. Epub 2007 May 31.; henceforth “Fitch”) and Ramirez et al. (Cells. 2021 Oct 7;10(10):2683.; henceforth “Ramirez”).
Regarding claim 1, Xue discloses a human spinal cord organoid (hSCO) (ehSC-organoids) comprising an outer layer comprising neural cells (“spinal cord neurons in ehSC-organoids” pg. 5 2nd para. ;see also Figure 2) and an outer layer containing glial cells (GFAP positive cells Figure 2 and S2), wherein the hSCO is substantially spherical in shape (Figure 4A and S2) and has an average diameter of at least 2 mm (The day 42 organoid in Figure 4A has a diameter of more than 6 lengths of the 500 µm scalebar which is more than 3 mm diameter). Because the organoid of Xue has not been injured, it comprises several non-injured areas.
However, regarding claim 1, although Xue teaches the spinal cord organoid can be used for developing spinal cord injury therapies (Introduction; pg. 1 1st para. ), Xue does not teach the spinal cord organoid has been mechanically injured and therefore comprises a mechanically injured area.
Nevertheless, regarding claim 1, Rouleau teaches lacerating a neural organoid to model laceration injury (pg. 4 2nd para. “2.2. Laceration Procedure”; see also figure 1) which creates an organoid that comprises a mechanically injured area where the laceration occurred (area around the central core of neural tissue (pg. 4), and a non-injured area where the laceration did not occur (the rest of the organoid).
Therefore, regarding claim 1, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to prepare the organoid of Xue, and combine the laceration step of Rouleau to obtain the predictable result of a neural organoid comprising a mechanically injured area for modeling laceration injury. One of ordinary skill would have been motivated to do so as taught by Rouleau to simulate laceration-based injury (abstract; Figure 1; pg. 4 2nd para. “2.2. Laceration Procedure”). Regarding the reasonable expectation of success, Rouleau performing a laceration injury on neural organoids (pg. 4 2nd para. “2.2. Laceration Procedure”; see also figure 1).
Regarding claim 1, concerning (c), the laceration procedure suggested and made obvious by Rouleau above includes a 2mm punch (pg. 4 2nd para. “2.2. Laceration Procedure”) which would amount to 2mm punch diameter on each side of the organoid removed. The area surrounding the 2mm punch on either side would be consider to be the “injured area” while the majority of the organoid, which was not submitted to the punch, would be the uninjured areas and therefore the suggested organoid meets the limitation that the non-injured area is larger than the mechanically injured area and covers the remainder of the outer layer.
Regarding claim 1, concerning (c), as stated above, the organoid suggested by Xue has a diameter of more than 6 lengths of the 500 µm scalebar which is more than 3 mm diameter (Figure 4A). For the purposes of estimating the surface area, an estimate is made that the total outer surface area would be similar to that of a sphere with a 3 mm diameter. The surface area of a 3 mm diameter sphere is (A=4πr2) is 28.27 mm2. Creating a punch laceration injury as suggested by Rouleau above includes a 2mm punch which would include an estimated removal of (A=πr2) of about 3.14 mm2 (since a punch through a sphere is not exactly a flat circle, this is an estimation) from each side which is a total estimated removal of about 6.28 mm2. Therefore, after the punch injury, an estimate can be made that the organoid as suggested by Xue in view of Rouleau would have a total outer surface area of about 21.99 mm2 (28.27 mm2 of total surface area - 6.28 mm2 from both sides of the punch). From Rouleau, the suggested injured area would be the area surrounding each side of the 2mm punch. From Rouleau Figure 2B, the neighboring regions (“affecting the neighboring regions that became cell-sparse (orange, middle ring, 2), though sparing the lateral-most regions (yellow, outer ring, 3); Figure 2B and legend) appear to extend about 500 µm past the laceration cite. With 2 punch sites (one on either side), the total surface area that would be suggested to be injured based on the injury pattern of Rouleau would be estimated to be about 9.81 mm2 (from 2 x π1.252- about 6.28 mm2) an estimate 9.81 mm2 injured area of a total of 28.27 mm2 outer surface area is about 34% of the area is injured. Therefore, based on the prior art of Rouleau, which teaches a .5 mm diameter around the laceration site as a clear injured area, an injured area amount of about 34% of the outer surface as injured is an expected result of the laceration injury suggested by the prior art of Rouleau (see also “regions most proximal to the injured core became more cell-sparse over time (Figure 2B)”)
Notably, regarding claim 1 (c), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). It is routine procedure to optimize component amounts to arrive at an optimal product that is superior for its intended use, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See M.P.E.P. §2144.05. For the reasons set forth above, since the suggested about 34% of the outer surface as injured area lies within the claimed range of the mechanically injured area covers at least 5% of the outer layer of the hSCO and the non-injured area covers remainder of the outer layer, it makes these ranges obvious.
Additionally, regarding claim 1 (c), Applicant is reminded that generally, differences in ranges will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating the range is critical (MPEP 2144.05 II). Moreover, at the time of the claimed invention, one of ordinary skill in the art would have been motivated by routine practice to optimize the amount of injured area with a reasonable expectation for modeling spinal cord injury (see Rouleau pg. 4 2nd para. “2.2. Laceration Procedure”; see also figure 1.
Regarding claim 1 (d) and (e), although Xue teaches the organoids comprise an outer layer containing astrocytes that are glial cells that express GFAP (GFAP positive cells Figure 2 and S2), and Rouleau suggests and makes obvious a laceration injury as discussed above, Xue and Rouleau are silent to the presence of glial scar-like tissue that has increased GFAP expression and at least double the average density reactive astrocytes relative to the non-injured area.
Nevertheless, regarding claim 1 (d) and (e), Fitch teaches that glial scar occurs in spinal cord tissue in response to injury and includes cellular hypertrophy and increases in glial fibrillary acidic protein (GFAP) that are the hallmarks of astrocyte reactivity and occur rapidly after CNS injury (pg. 296 col. 1 4th para.; see also “Traditional definitions of astrocyte activation are based on morphology, numbers, and increases in GFAP expression and/or detection” pg. 296 col. 2 2nd para.)
Additionally, regarding claim 1 (d) and (e), Ramirez teaches a neural injury model (controlled cortical impact (CCI) model) that results in increased GFAP expression and increased density of reactive astrocytes in an injured neural organoid relative to a non-injured organoid (“CCI also induced a significant increase in GFAP immunoreactivity in COs” pg. 8 1st para.; “GFAP positive cells in CCI-impacted COs displayed hypertrophic process” and “significant increase in GFAP immunoreactivity” pg. 8 1st para). Ramirez teaches that neural injury in an organoid model results in more than double integrate density of GFAP (about 67 in control vs about. 201 in CCI injury model from Figure 3C).
Therefore, regarding claim 1 (d) and (e), it would have been obvious to a person of ordinary skill in the art that the organoid as suggested by Xue in view of Rouleau, which includes glial scar and reactive astrocytes and has undergone an injury would have the property of increased GFAP expression and increased density of reactive astrocytes in the injured area because Fitch teaches this is an expected result of neural tissue undergoing an injury and having glial scar. Furthermore, Ramirez specifically evidences that neural organoids that have undergone injury have increase GFAP expression and more than double the density of GFAP (about 67 in control vs about. 201 in CCI injury model from Figure 3C) and therefore it would be obvious that the suggested organoid of Xue in view of Rouleau would display these results in the area of the injury.
Furthermore, regarding claim 1 (d) and (e), as stated above, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) and generally, differences in ranges will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating the range is critical (MPEP 2144.05 II). In the instant case, the increased GFAP expression and more than double the density of GFAP which labels astrocyte processes (about 67 in control vs about. 201 in CCI injury model from Figure 3C) overlap with the instantly claimed ranges and thereby make them obvious.
Finally, regarding claim 1 (d) and (e), Applicant is reminded that expected beneficial results are evidence of obviousness (see MPEP 716.02(c)(II)) In the instant case, the increased GFAP expression and more than double reactive astrocyte density is an expected result in an injured neural tissue area as evidenced by Fitch and Ramirez for the reasons set forth above and is thereby evidence of obviousness.
Regarding claim 2, further to the discussion of claim 1 above, Xue teaches the neural cells of the organoid express class III beta-tubulin (TUJ-1) (TUBB3 Figure 5; see also “Immunofluorescence staining” pg. 19 col. 2) and the glial cells express glial fibrillary acidic protein (GFAP) (Figure S2).
Regarding claim 3, further to the discussion of claim 1 above, Xue is silent to detectable microglia or endothelial cells. Therefore, it would be obvious that the organoid taught by Xue would not comprise detectable microglia or endothelial cells and it would naturally follow that the organoid suggested by Xue in view of Rouleau, Fitch and Ramirez would also not comprise detectable microglia or endothelial cells.
Regarding claims 4-5, further to the discussion of claim 1 above, as stated above, the organoid taught by Xue has a diameter of more than 6 lengths of the 500 µm scalebar which is more than 2.5 (instant claim 4) or 3 mm (instant claim 5) diameter (Figure 4A).
Regarding claim 6, further to the discussion of claim 1 above, as stated above, Rouleau suggests a laceration injury with a 2 mm punch which would result in a lacerated area in the organoid as suggested by Xue in view of Rouleau, Fitch and Ramirez
Regarding claims 7-8, further to the discussion of claim 1 above, the wherein clause recites a product-by-process limitation (the hSCO has been cultured for at least about 12 weeks (claim 7) or about 12 weeks to about 24 weeks (claim 8) prior to mechanical injury.
Regarding claims 7-8, Applicant is reminded that product-by process claims are not limited by the manipulation of the recited steps, only the structure implied by the steps. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP 2113).
In the instant case, regarding claims 7-8, since the organoid as suggested by Xue in view of Rouleau, Fitch and Ramirez meets the structural limitations of instant claims, and there is no evidence that merely “culturing” for at least 12 weeks (instant claim 7), or about 12 weeks to 24 weeks (instant claim 8) before mechanical injury creates a structural distinction in the organoid, the organoid as suggested by Xue in view of Rouleau meets instant claim limitations.
Regarding claim 21, further to the discussion of claim 1 above, as discussed above, Rouleau suggests a laceration injury which is performed by removing the core of the organoid by biopsy punches. Since biopsy punches apply a force, the laceration injury suggested by Rouleau would also result in an area which falls under the broadest reasonable interpretation of a force-impacted area.
Hence, the claimed invention as a whole was prima facie obvious.
Examiner’s Remark
Applicant’s amendments necessitated the new grounds of rejection over a new combination of art above. For the sake of compact prosecution, arguments considered pertinent to the new grounds of rejection above are addressed below.
Response to Arguments
Applicants arguments, filed 5th, June, 2026, have been fully considered but are not found persuasive.
In response, the art as it applies to the newly amended claims is discussed above.
Applicant specifically argues “Ramirez does not evidence that the formation of a localized glial-scar like tissue as recited in claim 1 would necessarily occur in an organoid after mechanical injury. Rather, as shown in the cutout panel from Supplementary Figure 3 above, Ramirez presents two
different organoids in which the expression of GFAP in the area that the skilled artisan
would reasonably infer have been subjected to closed cortical impact is actually less than the
expression of GFAP throughout the remaining non-injured surface” (pg. 9).
In response, the prior arts of both Fitch and Ramirez evidence that glial scar-like tissue in response to an injury is an expected result of the art as discussed above and therefore the formation of glial scar-like tissue is an expected result of the suggested injury. The CCI model evidenced by Ramirez mechanically injures most of the organoid, and shows that the injured organoid has reactive gliosis (increased GFAP and reactive astrocyte process density) and therefore evidences that injured areas (most of the injured organoid of Ramirez) have reactive gliosis as compared to non-injured organoids. Therefore, it would be an obvious and expected result that injured areas of one organoid would exhibit gliosis while non-injured areas would not. This is further evidenced by the prior art of Rouleau above which teaches that damage in an organoid after injury is localized to the areas close to the injury site, so that it would be obvious that a single organoid would have an injured area with reactive gliosis and non-injured areas with more normal tissue.
Applicant further specifically argues “Ramirez does not present a single organoid wherein the mechanically injured area (which covers at least 5% of the outer layer of the hSCO) contains glial scar-like tissue comprising reactive astrocytes, wherein the average expression of GFAP in the reactive astrocytes throughout the glial scar-like tissue is increased compared to the average expression of GFAP in astrocytes throughout the non-injured area (which is larger than the mechanically injured area and
covers the remainder of the outer layer), and the average density of the reactive astrocytes
throughout the glial scar-like tissue is at least double the average density of astrocytes
throughout the non-injured area” (pg. 9).
In response to applicant's arguments against the Ramirez reference 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). In the instant case, in the new grounds of rejection above, each limitation is specifically addressed by the preponderance of the evidence in view of the combination of art above. Arguments directed to why Ramirez alone are not found persuasive because the combination of art as a whole makes the instantly claimed invention obvious for the reasons set forth above.
Applicant argues “modeling the localized glial-scar like response to mechanical injury is precisely the advantage that the presently claimed organoid, and no other organoid in any reference cited by the Examiner, confers” (pg. 10).
In response, as discussed in the new grounds of rejection above, Applicant is reminded that expected beneficial results are evidence of obviousness (see MPEP 716.02(c)(II)). In the instant case, the increased GFAP expression and more than double reactive astrocyte density is an expected result in an injured neural tissue area as evidenced by Fitch and Ramirez for the reasons set forth above and is therefore evidence of obviousness.
Furthermore, modeling the localized glial-scar like response to mechanical injury is known in the art and has previously been performed, such as in mouse models of spinal cord laceration. To complete the art of record and rebut Applicant’s arguments, Applicant is directed to the art of Wang et al. (Mol Neurobiol. 2016 Jul;53(5):3448-3461. Epub 2015 Jun 18.; henceforth “Wang”). Wang is one example of an art that evidences a model of localized glial scar formation by performing spinal cord laceration in mice (“mice with dorsal laceration SCI” pg. 3457 col. 2). Therefore, because “modeling the localized glial-scar like response to mechanical injury” is known in the art, it cannot be an advantage that overcomes the obviousness rejection above.
Conclusion
No claim is allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANA N EBBINGHAUS whose telephone number is (703)756-4548. The examiner can normally be reached M-F 9:30 AM to 5:30 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632
/EMILY A CORDAS/Primary Examiner, Art Unit 1632
Prosecution Insights