DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Action is in response to the papers filed 12/17/2023.
Claims 1, 4, 7, 8, 11, 14, 19, 23, 25, 34, 40, 41, 45, and 47-53 are currently pending and examined on the merits. Claims 1, 4, 7, 8, 11, 14, 19, 23, 25, 34, 40, 41, 45 are amended, claims 3 and 15 are canceled and claims 47-53 are newly added.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/EP2021/056193 filed March 11, 2021.
Applicant’s claim for the benefit of a prior-filed Australian foreign application AU2020900743 filed March 11, 2020.
Thus, the earliest possible priority for the instant application is March 11, 2020.
Response to arguments
Withdrawn objections/ Rejections in response to Applicants’ arguments or amendments
Claim Rejections - 35 USC § 112(b)
The rejection of claims 1, 3, 4, 7, 8, 11, 14, 15, 19, 23, 25, 34, 40, 41, and 45 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn.
Applicant’s amendments and arguments filed 12/17/2025 have been considered and are persuasive. Particularly, claims 3 and 15 have been canceled, all recitations of “and/or” have been corrected, “improvement” has been corrected, “moderate to severe” has been corrected, claim 1 has been amended to characterize “partial” and Markush groups have been amended to the proper format.
Claim Rejections - 35 USC § 112(a) Written Description
The rejection of claims 1, 3, 4, 7, 8, 11, 14, 15, 19, 23, 25, 34, 40, 41, and 45 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn.
Applicant’s amendments and arguments filed 12/17/2025 have been considered and are persuasive. Particularly, mentions of “prevention” have been removed, Applicant’s remarks regarding inflammatory bowel disease pathology are persuasive as a genus and the scope of the route has been narrowed to administered to the colon or intravenous.
Claim Rejections - 35 USC § 102
The rejection of claims 1, 3, 4, 7, 8, 11, 14, 15, 19, 23, 25, 34, 40, and 41 under 35 U.S.C. 102(a)(1) as being anticipated by Molendjik (Gastroenterology 2015;149:918–927) is withdrawn.
Applicant’s amendments and arguments filed 12/17/2025 have been considered and are persuasive. Particularly, claim 1 has been amended to exclude fistulizing CD.
Claim Rejections - 35 USC § 102
The rejection of claims 1, 3, 4, 7, 8, 11, 14, 15, 19, 25, 34, 40, and 41 under 35 U.S.C. 102(a)(1) as being anticipated by Gregoire is withdrawn.
Applicant’s amendments and arguments filed 12/17/2025 have been considered and are persuasive. Particularly, claim 1 has been amended to explicitly include measurements of SES-CD where there is no CD-EIS or SES measured in Gregoire.
Claim Rejections - 35 USC § 103
The rejection of claim 45 under 35 U.S.C. 103 as being unpatentable over Molendjik (Gastroenterology 2015;149:918–927) in view of Crowe (US20070026377) and Lei (CN104873542A; Published 2015, Google Patents Machine Translation) is withdrawn.
Applicant’s amendments and arguments filed 12/17/2025 have been considered and are persuasive. Particularly, claim 1 has been amended to exclude fistulizing CD.
Maintained objections/ Rejections in response to Applicants’ arguments or amendments
Claim Objections
Claim 1 remains objected to because of the following informalities:
Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i). Moreover, the indentation does not require the inclusion of a dash/hyphen.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (a) Enablement
Claim 1, 4, 7, 8, 11, 14, 19, 23, 25, 34 and 45 are rejected and new claims 50, 52, and 53 are newly rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
a method of treating inflammatory bowel disease in a human subject in need thereof, comprising administering 75 million to 150 million MSCs via multiple injections submucosally in the colon or intravenously.
does not reasonably provide enablement for:
a method of treating inflammatory bowel disease in a human subject which does not have fistulizing Crohn’s via administering any dosage of MLPSCs.
This rejection has been modified as necessitated by Applicant’s arguments and amendments made 12/17/25.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The claimed invention a method of treating inflammatory bowel disease in a human subject via administering any dosage of MSCs which is “effective”. The breadth of the claims is extremely broad encompassing any dosage of MSCs.
In the case of dependent claims which detail an “effective” dosage, such numbers as 7.5 x 107 cells (Claim 40), 1.5 x 108 cells (Claim 40), 1 x 107 cells and 2 x 108 cells (Claim 41), greater than 6.68 x 106 cells/mL (Claim 50), 6 x 107 cells to 2 x 108 cells (Claim 52) and 1.25 x 103 cells/kg to 1.25 x 107 cells/kg (Claim 53). These limitations all are described within ranges known in the art below as well as are reflected in the data of the specification. However, in the case of claim 1, there is no guidance as to what the lowest effective number of MSCs is to predictably result in the claimed results within the wherein clauses.
The specification’s only guidance for what the lowest effective dosage is that “for example, the composition comprises about lx105 stem cells to about lx109 stem cells or about 1.25x103 stem cells to about 1.25x107 stem cells/kg (80 kg subject). The exact amount of cells to be administered is dependent upon a variety of factors, including the age, weight, and sex of the subject, and the extent and severity of the disorder being treated” (para. 0123-125).
The prior art such as Gregoire (Correspondence /Digestive and Liver Disease 50(2018)1249–1256) teaches a method of treating refractory Crohn’s Disease (CD; i.e. inflammatory bowel disease) in a human subject in need thereof (p. 1251, 2nd column). The method comprises administering BM-MSCs (i.e. MLPSCs) to patients with CD (p. 1251, 2nd column). Patients were refractory to Infliximab and other anti-TNF therapies (i.e. biologic therapy) and administered two injections of 1.5-2.0 x 106 cells/kg at week 0 and week 4 for total dosages of 2.00 – 4.11 x 106 cells/kg (p. 1252, 1st column, Table 1).
Therefore, the art enables intravenous injections at 2-4.11 x 106 cells/kg for the treatment of Crohn’s Disease.
Prior art such as Molendjik (Gastroenterology 2015;149:918–927) teaches the treatment of refractory fistulizing Crohn’s Disease (CD) via administering bone marrow MSCs (i.e. MLPSC) (Abstract, p. 919, 1st column). Molendjik utilized total dosages of 1 x 107, 3 x 107, and 9 x 107 MSCs (i.e. less than 600 million) administered through multiple injections locally in the gastrointestinal wall (p. 919, 2nd column).
Therefore, the art enables local/gastrointestinal wall injections at 1 x 107, 3 x 107, and 9 x 107 MSCs through multiple injections for the treatment of CD.
However, the prior art appears to be silent as treating inflammatory bowel disease via any dosage.
The only working examples utilized detail the treatment of CD in human subjects, comprising administering 75 million to 150 million MSCs via multiple injections into the submucosal layer of the colon (para. 0154, 0161).
The instant specification fails to provide any guidance or direction on how one would ascertain the dosage necessary in administering the MSCs of the present invention to result in effectively showing improvements and potential remission in at least 28 days.
Without any guidance/direction from the instant specification other than the limited embodiment, and based on the evidence presented by the references above, it is highly unpredictable that any inflammatory bowel disease would be prevented by the claimed method. MPEP§2164.03 states “The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required.
A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required.”
Without any guidance or direction for the treatment of inflammatory bowel disease via any dosage, presenting a burden of undue experimentation.
Based on the above discussion, it is concluded that the instant specification does not enable any person skilled in the art to make/use the invention commensurate in scope with these claims.
In response to Applicant’s arguments regarding the 112a Enablement rejection set forth in the previous office action,
Applicant’s arguments and amendments filed 12/17/2025 have been considered, however they are not persuasive regarding the dosage limitation.
Applicant argues that the claims are “clearly enabled by the specification data” and that an “effective dosage” is shown in the two working examples with no undue burden on a person of ordinary skill in the art. Thus, Applicant believes the full breadth of the claim to be enabled with the recitation of an “effective dosage.”
Examiner disagrees. The full scope of the claims are not enabled by the specification data. As Applicant points out, there are two working examples which provide for 75 million and 150 million MSCs, these are enabled. As detailed above, other dosages are additionally known in the art which are above 10 million. However, there is no way from Applicant’s disclosure to ascertain what the lowest effective dosage is to obtain the claimed results, therefore, this provides for undue experimentation in discerning the dosage. The specification’s lowest disclosed dosage is 100,000 MSCs which is not tested in a working example and much lower than that of the 75 million MSCs or even 10 million MSCs enabled by the working examples and state of the art.
The state of the art shows 2-4.11 x 106 cells/kg and 1 x 107, 3 x 107, and 9 x 107 MSCs through multiple injections for the treatment of CD. This amounts to the 75 million to 150 million shown in the working examples. Applicant’s scope encompasses from 1 cell/kg to 2 x 108 as the minimal effective dosage based on the broad recitation in claim 1.
As dosages that are enabled for by the art and instant specification are recited in claims 40, 41, 47, 48, 59 and 51 they are not part of the scope of enablement rejection. Additionally, the routine optimization for these dosages is obvious as a skilled artisan would know based on the art that 2 x 106 cells/kg is a minimal effective dosage for treating Crohn’s disease.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, 7, 8, 11, 14, 19, 23, 25, 34, 40, 41, and 45 remain and claims 48-53 are newly provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 6, 8-13, 17, 21,23-25, 31, 32, 34, 36 and 37 of copending Application No. 17/906,160 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Application ‘160 teaches treating an inflammatory bowel disease in a human subject in need thereof, comprising administering MLPSCs (MSCS) to the submucosal layer of the colon and the subject is refractory to anti-TNF (biologic) therapy wherein the subject has a clinical response, endoscopic response or remission at least 28 days after treatment (Claims 1, 6, 11). The subject does not have fistulizing Crohn’s disease (claim 1). This reads on independent claim 1 of the present application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In response to Applicant’s arguments regarding the provision double patenting rejection set forth in the previous office action,
Applicant requests the rejection be held in abeyance. This request is denied and the rejection is maintained.
Response to arguments
New objections/ Rejections in response to Applicants’ arguments or 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.
Claim(s) 1, 4, 7, 8, 11, 14, 19, 23, 25, 34, 40, 41 and 47-53 are rejected under 35 U.S.C. 103 as being unpatentable over Forbes (Clinical Gastroenterology and Hepatology 2014;12:64–71; IDS Reference) in view of Martín Arranz (Stem Cell Research & Therapy (2018) 9:95) as evidenced by Annese (Journal of Crohn's and Colitis, Volume 7, Issue 12, December 2013, Pages 982–1018)
Regarding claims 1, 8, 14 and 34, Forbes teaches a method of treating luminal Crohn's disease (CD) refractory to biologic therapy such as anti-tumor necrosis factor therapy by administering allogeneic mesenchymal stem cells (MSCs) (Abstract; p. 65, 1st column). The subject having luminal CD taught by Forbes is considered to read on the limitation of the subject not having fistulizing CD. Forbes et al. teach that the MSCs are infused intravenously (Abstract, Methods). Forbes states that 42 days after the first administration of MSCs decreases in CDAI were observed gradually over the 3 weeks (21 days) following the MSC infusions at days 0, 7, 14, and 21 (Figure 1, Abstract). Moreover, 8 subjects had clinical remission (CDAI decrease of over 150) and several had clinical responses (Table 2). Additionally, Forbes measured the CD endoscopic index of severity (CDEIS) for improvements which would constitute a clinical response in patients, of which seven patients had scores which decreased significantly (Abstract, Table 2).
However, Forbes does not explicitly teach the specific measurement of SES-CD. Forbes teaches that the average decrease in CD-EIS is 21.5 to 11 (Abstract). As evidenced by Annese, CD-EIS can be converted to CD-SES and vice versa through an equation (CD-EIS=0.76 * CD-SES + 0.29). Therefore, through these calculations the average decrease in CD-SES is 27.9 to 14.09 which is a 49% decrease and therefore within the claimed range for a partial clinical response and clinical response.
As each and every limitation is taught by Forbes, the results from the claimed method steps would additionally produce the same results with a reasonable expectation of success at days of at least 28 compared to that of the 21 days measured.
Regarding claim 4, Forbes teaches that the subjects are refractory towards anti-tumor necrosis factor therapy (p. 69, 2nd column).
Regarding claim 7, Forbes teaches various prior biologics of subjects such as azathioprine and 6-MP (Table 1).
Regarding claim 11, Forbes teaches that 2 of seven subjects had CRP which became normal after treatment (p. 68, 2nd column).
Regarding claim 19, Forbes teaches clinical responses of CDAI decreasing by 100 points occurred in 12 of 15 patients (p. 68, 1st column). As discussed above regarding the SES-CD value, the average decrease in CD-SES is calculated to be 27.9 to 14.09 which is a 49% decrease and therefore within the claimed range for a partial clinical response and clinical response.
Regarding claim 23, Forbes teaches clinical remission as CDAI decreasing the index to less than 150 which occurred in 8 of 15 patients with endoscopic improvement (p. 68, 1st column). Additionally, 2 patients established a CRP level below 2 (Table 3). As discussed above regarding the SES-CD value, a formula can be utilized to calculate SES-CD from the CD-EIS numbers of Forbes. Patient 8 in Table 2 showed remission and had an endpoint of 0.3 CD-EIS. Utilizing the formula of Annese above, this is a 0.01 value of CD-SES which is within the range for remission.
Regarding claim 25 and partially 41, Forbes does not teach that the MSCs are administered to the colon and/or rectum, intra-luminally, at multiple sites or via endoscope at multiple sites.
Martín Arranz teaches administering MSCs as a submucosal injection with endoscopy in inflammatory bowel disease which included CD as well as ulcerative colitis which would allow for direct cell delivery to the damaged area while also enabling the evaluation of the severity of the disease (Abstract; p. 2, 2nd column). Mice were injected at four different sites with a total dose of 107 adipose MSCs (p. 3-4, bridging paragraph).
It would have been obvious to one of ordinary skill in the art to administer the MSCs of Forbes via submucosal injection with endoscopy as taught by Martín Arranz with a reasonable expectation of success. An artisan would have been motivated to utilize submucosal injection with endoscopy as Martín Arranz teaches the method would allow for direct cell delivery to the damaged area while also enabling the evaluation of the severity of the disease (Abstract; p. 2, 2nd column).
Regarding claims 40, 41, 50, 52 and 53, Forbes teaches the total dose of MSC (Table 1) which is about 9x106/kg to 1x10⁷/kg which taking into account the average human being around 70-80kg, would translate to about 7 x 107 cells to 8 x 107.
Forbes does not directly teach the dose being 7.5x10⁷ or 1.5x10⁸ cells, greater than 6.68 x 106 cells/mL, or that the cells are 1 x 107 and 2x108 .
However, it would have been obvious to a person skilled in the art to modify the total dosage of the MSCs utilized based on the number of sites/points being injected. For example, Martín Arranz teaches four different sites with a total dose of 107 adipose MSCs (p. 3-4, bridging paragraph) and Forbes details that other studies have utilized multiple infusions of 1 x 107 cells/kg as well as 8 x 106 cells/kg (p. 66, Dose determination). Forbes additionally states that dose ranging and dose interval evaluations are required (p. 71). This suggests that the amount or concentration of cells can be routinely optimized for the desired outcome of effective treatment with a reasonable expectation of success.
It is well settled that routine optimization is not patentable, even if it results in significant improvements over the prior art. In support of this position, attention is directed to the decision in In re Aller, Lacey, and Haft, 105 USPQ 233 (CCPA 1955): Normally, it is to be expected that a change in temperature, or in concentration, or in both, would be an unpatentable modification. Under some circumstances, however, changes such as these may impart patentability to a process if the particular ranges claimed produce a new and unexpected result which is different in kind and not merely in degree from the results of the prior art. In re Dreyfus, 22 C.C.P.A. (Patents) 830, 73 F.2d 931,24 USPQ 52; In re Waite et al., 35 C.C.P.A. (Patents) 1117, 168 F.2d 104, 77 USPQ 586. Such ranges are termed "critical" ranges, and the applicant has the burden of proving such criticality. In re Swenson et al., 30 C.C.P.A. (Patents) 809, 132 F.2d 1020, 56 USPQ 372; In re Scherl, 33 C.C.P.A. (Patents) 1193, 156 F.2d 72, 70 USPQ 204. However, even though applicant's modification results in great improvement and utility over the prior art, it may still not be patentable if the modification was within the capabilities of one skilled in the art. In re Sola, 22 C.C.P.A. (Patents) 1313, 77 F.2d 627, 25 USPQ 433; In re Normann et al., 32 C.C.P.A. (Patents) 1248, 150 F.2d 708, 66 USPQ 308; In re Irmscher, 32 C.C.P.A. (Patents) 1259, 150 F.2d 705, 66 USPQ 314. More particularly, where 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 Swain et al., 33 C.C.P.A. (Patents) 1250, 156 F.2d 239, 70 USPQ 412; Minnesota Mining and Mfg. Co. v. Coe, 69 App. D.C. 217, 99 F.2d 986, 38 USPQ 213; Allen et al. v. Coe, 77 App. D. C. 324, 135 F.2d 11,57 USPQ 136. (Emphasis added). With regards to determining experimental parameters, such as time in culture, the court has held that "[d]iscovery of optimum value of result effective variable in known process is ordinarily within skill of art (In re Boesch and Slaney, 205 USPQ 215 (CCPA 1980)).
The adjustment of particular conventional working conditions (e.g., cell concentration or dosage) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan having the cited reference before him/her.
Regarding claim 47, 48 and 51, Forbes teaches that patients have a CDAI in the range of 200 and up to 600 (Table 2) and Forbes et al. teach that 15 patients are with moderate to severe active CD (p.69, Discussion).
Regarding claim 49, Regarding claim 4, Forbes teaches that the subjects had primary failure of infliximab and adalimumab (p. 66, 2nd column).
Therefore, the invention would have been obvious to one of ordinary skill in the art at the time of the effective filing date
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Forbes (Clinical Gastroenterology and Hepatology 2014;12:64–71; IDS Reference) in view of Martín Arranz (Stem Cell Research & Therapy (2018) 9:95) as applied to claims 1, 4, 7, 8, 11, 14, 19, 23, 25, 34, 40, 41 and 47-53 above in view of Crowe (US20070026377) and Lei (CN104873542A; Published 2015, Google Patents Machine Translation).
Forbes and Martin Arranz teach a method of treating CD by administering MSCs to a patient in need thereof intravenously or to the colon via endoscope. Moreover, Forbes teaches a cryopreservation composition comprising the MSCs in 10% dimethylsulfoxide, 50% PlasmaLyte, 20% sodium chloride, and 20% human serum albumin which were then thawed and utilized for the therapy (p. 66, 1st column).
Regarding claim 45, the above references do not teach wherein the composition comprising the MSCs further comprises 70% Plasma-Lyte A, 10% DMSO, and 25% HSA solution comprising 5% HSA and 15% buffer.
Crowe teaches utilizing a cryopreservation solution wherein a human MSCs were frozen in mixture of 10% DMSO, 5% human serum albumin, and 70% Plasma Lyte A until they were needed (para. 0158). As described in the instant application, the final composition comprises 70% plasma-lyte, DMSO at 10% and 25% HSA (20% comprising 5% HSA and 15% buffer) (para. 0148). Therefore, the critical elements are taught by Crowe.
Likewise, Lei teaches an umbilical cord mesenchymal stem cell injection which comprises mesenchymal stem cells and a frozen stock solution, wherein the frozen stock solution comprises the following components: a balanced electrolyte solution (such as Plasma Lyte A) with the volume percentage of 25-70 percent, clinical-grade DMSO with the volume percentage of 5-20% and 20% human albumin with the volume percentage of 1-50 percent. The prepared umbilical cord mesenchymal stem cell injection is free of animal serum, safe, high in cell viability after cryopreservation resuscitation, can be used for treating inflammatory bowel disease, has a good effect and has no toxic or side effects (Abstract).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to store the MSCs of Forbes and Martin Arranz in the solution of Crowe and Lei with a reasonable expectation of success and then administer said cells for a treatment method. An artisan would have been motivated to do so as Forbes and Martin Arranz teaches that their MSCs are cryopreserved until use and Crowe teaches a cryopreservation solution known in the art to be utilized for MSCs comprising 70% Plasma Lyte A, 10% DMSO, and 5% HSA. Moreover, Lei teaches that MSC solutions formulated for injection comprising these components are used for IBS and has no adverse effects (Abstract).
Therefore, the invention would have been obvious to one of ordinary skill in the art at the time of the effective filing date
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 34 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 34 teaches a limitation wherein the MSCs are allogeneic, however claim 1 on which it depends has been amended to recite the limitation of allogeneic. Therefore, claim 34 does not further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
No claims are 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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/ALEXANDRA F CONNORS/Examiner, Art Unit 1634
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631