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Claims 10-20 are withdrawn.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.
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)
Withdrawn Claim Rejections - 35 USC § 112 (b)
The rejection of claims 1-8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Claim Rejections - 35 USC § 102
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.
Claims 1-8 remain rejected and new claim 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ramirez et al. (Cells. 2021 Oct 7;10(10):2683.; henceforth “Ramirez”).
Regarding claim 1, Ramirez discloses a neural organoid (Human Cerebral Organoids; see pg. 3 2nd para. “2.2. Cerebral Organoid Generation”) comprising an inner layer comprising neural cells and outer layer comprising glial cells (“fully differentiated neurons and astrocytes was analyzed by immunostaining with MAP2 (E) and GFAP (F)” see Figure 2 and Figure S3), wherein the organoid is substantially spherical in shape (see Figures S3 and S5) and has an average diameter of at least 2 mm (the CO in Figure S5 has a diameter of slightly more than 3 lengths of the 1 mm scalebar), and wherein the organoid comprises a mechanically injured area (the organoid of Ramirez has been exposed to the controlled cortical impact (CCI) model; abstract; Introduction; pg4-5 “2.7. Controlled Cortical Impact Procedure in Cos” and therefore comprises several mechanically injured areas which were contacted), and non-injured area of the organoid (see Figure S3 which has areas with less GFAP expression, indicating they are structurally indistinguishable from non-injured area) wherein the mechanically injured area contains glial scar-like tissue comprising reactive astrocytes having increased expression of GFAP compared to the expression of GFAP in the astrocytes in the non-injured areas (“CCI also induced a significant increase in GFAP immunoreactivity in COs” pg. 8 1st para.), and wherein a density of the reactive astrocytes within the glial scar-like tissue is increased compared to the density of astrocytes in the non-injured area (“GFAP positive cells in CCI-impacted COs displayed hypertrophic process” and “significant increase in GFAP immunoreactivity” pg. 8 1st para.). Importantly, instant claims only require increased expression of GFAP compared to the expression of GFAP in the astrocytes in the non-injured area and a density of the reactive astrocytes within the glial scar-like tissue is increased compared to the density of astrocytes in the non-injured area which is met by the differences in GFAP expression in the organoid of Ramirez. Instant claims do not require a particular amount of increase, so Ramirez meets instant claims and additionally there is not a specific requirement for the size of the “area” so this encompasses small areas. Furthermore, absent of a definition of non-injured, this encompasses the structure of areas of the organoid of Ramirez that still have function and otherwise meet instant claims.
Regarding the preamble of claim 1, although Ramirez does not recite the organoid is a “human spinal cord organoid (hSCO)” as claimed, the organoid of Ramirez is a human neural organoid that comprises neural cells and glial cells in the required configurations and otherwise meets all the structural limitations as claimed. Therefore, the organoid of Ramirez anticipates the instantly claimed organoid. Because the preamble does not state any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (see MPEP 2111.02)
Regarding claim 2, further to the discussion of claim 1 above, Ramirez discloses the neural
cells express class III beta-tubulin (TUJ-1) (“β tubulin (Tuj1) positive neurons” Figure 2) and the glial cells express glial fibrillary acidic protein (GFAP) (abstract; Table 2; pg.7 1st para.; pg. 8 1st para.; pg. 13 2nd para.; Figures 2-3 and Figure S3).
Regarding claim 3, further to the discussion of claim 1 above, Ramirez discloses the organoid does not comprise detectable microglia or endothelial cells (“they lack microglial cells” and “they also
lack vasculature” pg. 13 3rd para.).
Regarding claim 4, further to the discussion of claim 1 above, as stated above, the organoid disclosed by Ramirez has a diameter of slightly more than 3 lengths of the 1 mm scalebar in Figure S5 and is therefore has an average diameter of at least 2.5 mm (see Figure S5).
Regarding claim 5, further to the discussion of claim 1 above, the organoid disclosed by Ramirez has a diameter of about 3 lengths of the 1 mm scalebar (slightly more than 3 lengths of the scalebar) in Figure S5 and is therefore has an average diameter of about 3 mm (see Figure S5).
Regarding claim 6, further to the discussion of claim 1 above, the organoid of Ramirez has been exposed to the controlled cortical impact (CCI) model (abstract; Introduction; pg. 2 3rd para.; pg. 3 2nd-3rd para.; pg. 4 1st-3rd para.; pg. 5 1st and 3rd-4th para., pg. 7 2nd para., pg. 8 1st para., pg. 10 1st para., pg. 11 1st para., pg. 12 1st, 2nd and 4th para., pg. 13 1st-2nd para. ; Figures 1, 3-5) and therefore comprises an injured areas. The term “lacerated area” is product-by process language that results in an injured area. Since the result of a laceration is an injured area, and the breadth of instant claims encompass all possible lacerations of all sizes, the organoid of Ramirez, which has been exposed to the controlled cortical impact (CCI) model, would be structurally indistinguishable from an organoid that had been subjected to a laceration.
Regarding claim 7, further to the discussion of claim 1 above, the organoid of Ramirez has been cultured for 220 days in vitro (DIV) which is 31.4 weeks prior to mechanical injury and is encompassed by the claimed “at least 12 weeks” (“the CCI procedure was done at 220 days in vitro (DIV)” pg. 3 2nd para.).
Regarding claim 8, further to the discussion of claims 1 and 7 above, as stated above, the organoid of Ramirez has been cultured for 220 days in vitro (DIV) which is 31.4 weeks prior to mechanical injury and is encompassed by the upper range of the claimed “about 24 weeks.”
Furthermore, regarding claims 7-8, further to the discussion of claim 1 above, as set forth previously, the wherein clause recites a product-by-process limitation (the hSCO has been cultured for at least 12 weeks (claim 7) or about 12 weeks to 24 weeks (claim 8)) before mechanical injury. Since the organoid of 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 about 24 weeks (instant claim 8) before mechanical injury creates a structural distinction in the organoid, the organoid of Ramirez anticipates instant claims.
Regarding claim 21, further to the discussion of claim 1 above, the organoid of Ramirez has been exposed to the controlled cortical impact (CCI) model (abstract; Introduction; pg. 2 3rd para.; pg. 3 2nd-3rd para.; pg. 4 1st-3rd para.; pg. 5 1st and 3rd-4th para., pg. 7 2nd para., pg. 8 1st para., pg. 10 1st para., pg. 11 1st para., pg. 12 1st, 2nd and 4th para., pg. 13 1st-2nd para. ; Figures 1, 3-5) and therefore comprises a force impacted area.
Accordingly, by teaching all the limitations, Ramirez anticipates instant claims.
Response to Arguments
Applicants arguments, filed 11th, March, 2026, have been fully considered but are not found persuasive.
Applicant argues “Ramirez does not disclose or suggest a spinal cord organoid” (pg. 6).
In response, as discussed above, the organoid of Ramirez meets the structural requirements of the body of instant claims and therefore meets the intended use as a spinal cord organoid recited in the preamble.
Applicant argues “Figure 3 demonstrates that GFAP expression is increased in the organoid
after injury compared to a sham control, which did not receive any impact injury, However,
Figure 3 provides no indication that the CCI results in the organoid recited in claim 1, which
comprises a mechanically injured area containing glial scar-like tissue comprising reactive
astrocytes having increased expression of GFAP compared to the expression of GFAP in
the astrocytes in the non-injured area, and wherein a density of the reactive astrocytes
within the glial scar-like tissue is increased compared to the density of astrocytes in the non-injured
area. Ramirez Figure S3 also fails to demonstrate that the injury in Ramirez results in the
organoid recited in the instant claims.” (pg. 6). Applicant argues “Figure S3, as with Figure 3, demonstrates that GF AP expression increases in the organoid after CCI compared to GF AP expression in a control organoid. Figure S3 further shows that this increase in GF AP expression is widespread across cortex layer of the organoid. Figure S3 does not demonstrate an organoid having a mechanically injured area containing a glial-scar like tissue containing a high density of reactive astrocytes having
increased expression of GFAP compared to expression of GFAP in the non-mechanically injured area, where both the injured area and the non-injured area are in the outer layer of the same organoid. Phrased alternatively, claim 1 recites an organoid having localized glial scar like tissue in the outer layer of the organoid at or around the mechanically injured area site, and this feature is simply not disclosed in Ramirez.” (pg. 6)
In response, this is not found persuasive because Applicant is not appreciating the broadest reasonable interpretation of the claims. Instant claims do not specifically require a localized glial scar-like tissue as alleged. Instant claims require “an outer layer comprising a mechanically injured area and a non-mechanically injured area” and “wherein the mechanically injured are contains glial scar-like tissue comprising reactive astrocytes having increased expression of GFAP compared to the expression of GFAP in injury in the non-injured area, and wherein a density of the reactive astrocytes within the glial scar-like tissue is increased compared to the density of astrocytes in the non-injured area.” As discussed above, the mechanically injured area is product-by process language which encompasses all possible structures int eh claimed organoid that could result from a mechanical injury. Similarly, a non-mechanically injured area encompasses all possible structures that could result from not being injured. This is encompassed by the organoid of Ramirez for the reasons stated above. Furthermore, the increase in expression of GFAP and density of astrocytes does not require a specific increase and is met by areas in the organoid of Ramirez which have slightly less GFAP expression and astrocyte density.
Concerning product-by process limitations and claims, as stated above Applicant is directed to MPEP 2113 (I) which states that 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). In the instant case the organoid of Ramirez meets the physical limitations of the structure of instant claims for the reasons stated above and therefore meets instant claims.
Applicant argues “The formation of such a localized glial scar like tissue is clearly advantageous in recapitulating the glial-scar like tissue observed in living organisms after injury and enables comparison of the glial-scar like tissue to other, non-injured areas within the same organoid.”
In response, evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973) (MPEP 2131.04). In the instant case, alleged advantages cannot overcome the 35 U.S.C. 102 rejection over Ramirez.
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 remain rejected and new claim 21 is 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”).
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, the laceration as suggested by Rouleau would create a mechanically injured area, (where the punch occurred) and a non-injured areas (other areas of the organoid). Further, the organoid as suggested by Xue in view of Rouleau would comprise a laceration injury and would therefore comprise glial scar like tissue in the injured area as a result of the laceration injury, which would have increased GFAP expression and increased density of reactive astrocytes which are characteristics of glial scar in the injured areas relative to the non-injured areas. Lastly, it is noted that instant claims only require “increased expression of GFAP compared to the expression of GFAP in injury in the non-injured area” and “increased density of reactive astrocytes” which includes very small increased and would obviously be met by the suggested organoid above.
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, 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 would 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 which would result in a lacerated area in the organoid as suggested by Xue in view of Rouleau.
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 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 about 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.
Response to Arguments
Applicants arguments, filed 11th, March, 2026, have been fully considered but are not found persuasive.
Applicant argues “Rouleau is directed to a silk scaffold-based 3D neural tissue, which is distinct from an organoid. Nowhere does Rouleau disclose or suggest that organoids should be lacerated to model injury. Rather, Rouleau expressly discloses that organoids are "undesirable by dint of their rigid developmental phenotypes". Emphasis added. As such, the skilled artisan would not be motivated to apply the laceration injury of Rouleau, which performed on a silk scaffold based 3D neural tissue, to an organoid of Xue, as Rouleau expressly discourages the skilled artisan from doing so (pg. 8-9).
In response, first, the silk scaffold-based 3D neural tissue, this structure would still be considered to fall under the broadest reasonable interpretation of an organoid because it is a 3-dimensional, mini-organ-like structure made by growing stem cells in the laboratory, which an accepted definition of an organoid (see National Cancer Institute; accessed at https://web.archive.org/web/20201012095516/https://www.cancer.gov/publications/dictionaries/cancer-terms/def/organoid).
Additionally, the art of Rouleau is analogous art because it be in the field of the inventor’s endeavor (Neural tissue injury models) See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992), and therefore one of ordinary skill would reasonably look to the Rouleau reference.
Regarding Applicant’s arguments that “Rouleau expressly discourages the skilled artisan,” the Rouleau states that “This approach would represent a marked advantage over organoids, which are comparatively undesirable by dint of their rigid developmental phenotypes (i.e., normal but fixed morphogenic blueprints) that are not subject to selective insertion or deletion of neural tissue elements.” (pg. 15 2nd para.). Applicant is directed MPEP 2123 (II) which states that preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). In the instant case, Rouleau teaches that the silk scaffold-based 3D neural tissue represents a “marked advantage” over organoids which are “comparatively undesirable” which does not constitute a teaching away because it merely describes them as somewhat inferior to the silk-scaffold-based 3D tissue for the same use.
Applicant argues “Furthermore, even if the skilled artisan were to be motivated to apply the laceration injury of Rouleau to the organoid of Xue, which Applicant does not concede, Rouleau does not disclose or suggest that laceration injury produces a glial-scar like tissue comprising reactive astrocytes as recited in claim 1. Rather, Rouleau merely discloses that laceration causes neurite death. There is simply no indication that a glial-scar like tissue as recited in claim 1 is formed after the laceration injury in the 3D neural model of Rouleau. As such, the Examiner's assertions that "laceration injury would therefore comprise glial scar like tissue, which would have increased GFAP expression and increased density of reactive astrocytes which are characteristic of glial scar" are not supported by the disclosure of Rouleau, which doesn't disclose formation of a glial scar after laceration injury, or Xue, which doesn't disclose injury at all” (pg. 8-9).
In response, concerning the a glial-scar like tissue as recited in claim 1, increased expression of GFAP in an injured neural tissue and is a well-known response to injury. Instant claims have been amended to specifically require increased expression of GFAP compared to the expression of GFAP in the non-injured area. Applicant is first directed to the art of record of Ramirez et al. (Cells. 2021 Oct 7;10(10):2683.; henceforth “Ramirez”), which evidences that GFAP is increased in injured neural organoids as compared to non-injured organoids (“CCI also induced a significant increase in GFAP immunoreactivity in COs” pg. 8 1st para.), and therefore a result of increased GFAP in an injured area relative to a non-injured area would also be an expected and obvious result in response to an injury. Further, it is noted that the instant claims do not require a specific amount of increase in GFAP, so some amount of increase in GFAP, which is expected due to injury, would be predicably obvious to occur in the suggested organoid model as stated in the grounds of rejection above.
In order to complete the art of record and rebut Applicant’s arguments, Applicant is additionally directed to the art of Lai et al. (bioRxiv 2020.07.05.180299; doi: https://doi.org/10.1101/2020.07.05.180299; henceforth “Lai”). Lai evidences mechanically injured cortical organoids display increased GFAP (“increased astrocytic coverage by strong GFAP staining (Fig 2G,H); pg. 3 last para.). Lai further evidences the increased GFAP is “similar to post-mortem human samples” additionally evidences the increase in GFAP is a well-known and expected response to injury in neural tissues and organoid models.
As stated above, instant claims are directed to product-by process limitations (mechanically injured area). Regarding product-by process claims, as discussed above (see claim interpretation above and claim rejections above), 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, the structure of the claimed organoid is obvious from the structure of the organoid suggested by Xue in view of Rouleau for the reasons set forth above, and therefore the claims are unpatentable.
Withdrawn Double Patenting
Provisional Non-Statutory Double Patenting
Co-pending Application No. 19/259,714
The provisional rejection of claims 1-8 on the ground of nonstatutory double patenting as being unpatentable over claims 4, 6-8 and 11 of copending application No. 19/259,714 as set forth in the previous Office Action is withdrawn in view of Applicant’s filing of a terminal disclaimer. The Terminal Disclaimer was approved on 11th, March, 2026.
Conclusion
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.
No claim is allowable.
Correspondence
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632 /VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
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