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 .
DETAILED ACTION
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election of Invention I, claims 1, 3, 4, 6, 11, 16, 41 and 42, in the reply filed on Jan. 26, 2026 is acknowledged. It is noted that Applicant initially elected groups I and III, since they have been amended to share a common technical feature, and if rejoining is not possible they elected Invention I. As indicated by the rejections below, the groups do not share the special technical feature which contributes over the prior art at the time the invention was made.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1, 3, 4, 6, 11, 16, 41 and 42 remain pending in the current application, claims 18, 19, 26, and 44-47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Claims 1, 3, 4, 6, 11, 16, 41 and 42 have been considered on the merits.
Status of the Claims
Claims 1, 3, 4, 6, 11, 16, 18, 19, 26, 41, 42, and 44-47 are currently pending.
Claims 18, 19, 26, and 44-47 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 2, 5, 7-10, 12-15, 17, 20-25, 27-40, 43, and 48 are cancelled.
Claims 1, 3, 4, 6, 11, 16, 41 and 42 have been considered on the merits.
Specification
The disclosure is objected to because of the following informalities: the use of trademarks.
The use of the terms: Ficoll® in 0031, 0129-0130 and 0151; Sepax® in 0031, 0129-0130, 0151, and 0168; NutriStem® in 0036-0037, 0133, and 0151; GlutaMAX™ in 0134, and 0151; NUNC™ flask in 0149 and 0151, which are a trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
The disclosure is objected to because of the following informalities:
Claims 6, 11, 16 and 41 are objected to the phrase “The in vitro population of claim 1” in line 1, and in the interest of improving claim form, it is suggested that the recited phrase be amended to recite “The in vitro population of eMSCs of claim 1” to consistent with claims 3 and 4.
Claim 11 is objected to because of the following informalities: The periods after the letters denoting the steps need to be replaced with a parenthesis. For example, in claim 1 "a." should be corrected to "a)" in line 2. In other words, a claim should only contain one period. Please see MPEP 608.01(m).
In addition, claim 11 is objected to the term “MSC” in lines 3, 4, 5 and 6, and in the interest of improving claim form, it is suggested that the recited term be amended to recite “eMSC” to be consistent with claim 1.
Appropriate correction is appreciated.
Claim Rejections - 35 USC § 112
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.
Claim 6 is 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 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 pre-AIA the inventors, at the time the application was filed, had possession of the claimed invention.
The instant claim is drawn to an in vitro population of enhanced mesenchymal cells (MSCs) with increased secretion of insulin like growth factor protein 1 (IGFBP-1) and neurotrophin 3 (NT-3) compared to naturally occurring MSCs which is characterized by enhanced pro-neurogenic capacity, enhanced immunosuppression, enhanced immunomodulation, enhanced anti-inflammatory capacity, enhanced pro- angiogenic capacity, enhanced neuroprotection, enhanced anti-apoptotic capacity, enhanced myelinogenic capacity, enhanced anti-fibrotic capacity, enhanced oligodendrocyte support, enhanced axonal support, enhanced neuronal differentiation or a combination thereof. The limitations of “enhanced pro-neurogenic capacity, enhanced immunosuppression, enhanced immunomodulation, enhanced anti-inflammatory capacity, enhanced pro- angiogenic capacity, enhanced neuroprotection, enhanced anti-apoptotic capacity, enhanced myelinogenic capacity, enhanced anti-fibrotic capacity, enhanced oligodendrocyte support, enhanced axonal support, enhanced neuronal differentiation” are being interpreted as characteristics of the in vitro population of eMSCs or functional as explained in the rejection under 35 U.S.C. §112 (b). Thus, the claims are broadly drawn to any MSC which has increased secretion of IGFBP-1 and NT-3 compared to naturally occurring MSCs and which is capable of the listed functions. Therefore, the claims encompasses any MSCs which are not described by their structure or relation thereto. The specification only lists this functions and does not disclose the structure or feature of the MSCs that impart any of the claimed functions (0011, 0089 and 0104 of published application). The specification does not disclose the diverse genus or the structures of the MSCs that responsible for these characteristics or functions.
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.
Claims 1, 3, 4, 6, 11, 16, 41 and 42 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.
The term "enhanced" in claim 1 is a relative term which renders the claim indefinite. The term "enhanced" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term "enhanced" in claim 6 is a relative term which renders the claim indefinite. The term "enhanced" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
In claim 6, the phrase “said population is characterized by enhanced pro-neurogenic capacity, enhanced immunosuppression, enhanced immunomodulation, enhanced anti-inflammatory capacity, enhanced pro- angiogenic capacity, enhanced neuroprotection, enhanced anti-apoptotic capacity, enhanced myelinogenic capacity, enhanced anti-fibrotic capacity, enhanced oligodendrocyte support, enhanced axonal support, enhanced neuronal differentiation or a combination thereof”, renders the claim and its dependents indefinite, since it is unclear if these limitations are intended uses or characteristics the in vitro population of eMSCs must have. In addition, if the phrase is intended to be a list of functional limitations or characteristics of the cells, it is unclear what structure or feature of the cells imparts this characteristic. For the purposes of compact prosecution, in the claims will be interpreted to mean that the in vitro population of eMSCs must be capable of at least one of the listed functions or characteristics.
In claim 11, line 2, the phrase "said expression" lacks sufficient antecedent basis and renders the claim and its dependents indefinite.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under USC 112 for the reasons set forth above.
Appropriate correction is required.
Claim Rejections - 35 USC § 102/103
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 3, 4, 6, 11 and 16 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Çelebi et al. (Cytokine, 2012) (ref. of record) as evidenced by Wagner et al. (Stem Cells, 2007) (ref. of record).
With respect to claim 1, Celebi teaches an in vitro population of irradiated mesenchymal stem cells (MSCs) that express and secrete higher levels of neurotophin-3 (NT-3) (abstract and pg. 329 para. 3). Celebi reports that MSCs express IGFBP-1-3 and secrete them at higher levels when cultured with hematopoietic progenitor cells (HPCs) (pg. 327 Col. 2 para. 1). Expression of IGFBP-1 is inherent to MSCs as further evidenced by Wagner. Wagner reports mesenchymal stem cells express insulin-like growth factor binding protein 1 (IGFBP-1) and (pg. 2642 Col. 1 para. 1 and pg. 2645 Col. 1). Therefore, the irradiate population of MSCs in cultured with HPCs has increased secretion compared to naturally occurring MSCs of IGFBP-1 and NT-3.
With respect to claim 11, Celebi teaches the expression is protein secretion and the MSCs are human (abstract and pg. 328 Col. 1 para. 2).
Celebi is silent as to what markers are positive or negative in the in vitro population of MSCs that have increased secretion of IGFBP-1 and NT-3 compared to naturally occurring MSCs and does not teach the cells further comprising surface expression of NPC intracellular cholesterol transporter 1 (NPC1), and CD206 as recited in claim 3 or that the cells are devoid of surface expression of at least one of protein selected from: CD271, SSEA-4, SSEA-3, CD133,CD106, CD146, CD54, CD58, CD62L and CD9 as recited in claim 4. Similarly, Celebi is silent with respect to the functional characteristics of the cells and does not explicitly teach that the cells have any of the functional characteristics listed in claim 6. Additionally, Celebi does not teach the in vitro population containing 2 subpopulations where the first subpopulation contains at least 80% eMSCs and the surface protein NPC and the second subpopulation contains at least 70% eMSCs and the surface protein CD206 as recited in claim 16.
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicants' generated MSCs differ, and if so to what extent, from the cells of Celebi. The cells taught by Celebi are the same or similar because they have increase secretion of increased secretion of IGFBP-1 and NT-3 compared to naturally occurring MSCs. Celebi teaches the claimed MSCs expressing and secreting higher levels of NT-3 and IGFBP-1. The cited art taken as a whole demonstrates a reasonable probability that the MSCs are either identical or sufficiently similar to the claimed MSCs that whatever differences exist are not patentably significant. Therefore, the burden of establishing novelty or unobviousness by objective evidence is shifted to applicants. Clear evidence that the MSCs of the cited prior art does not possess a critical characteristic that is possessed by the claimed cells (for example, that the cells of Celebi lack NPC1 and CD206, express CD271, SSEA-4, SSEA-3, CD133,CD106, CD146, CD54, CD58, CD62L and CD9, and do not have any of the claimed characteristics listed in claim 6) would help advance prosecution.
Therefore, the invention reference anticipates the claimed subject matter or the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 1, 3, 4, 6, 11, 16, 41 and 42 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Lee et al. (Biomaterials, 2012).
With respect to claim 1, Lee teaches an in vitro population of human embryonic stem cell-derived MSCs (hESC-MSC) spheres that express and secrete IGFBP-1 and NT-3 at higher levels than control MSCs (abstract and Fig. 5). Therefore, the hESC-MSC spheres have increased secretion compared to naturally occurring MSCs of IGFBP-1 and NT-3. With respect to claim 6, Lee teaches the hESC-MSC spheres repair injured nerves which requires regeneration of axons (enhanced axon support) (abstract and pg. 7039 para. 1). With respect to claim 11, Lee teaches the expression is protein secretion and that the MSCs are human (abstract). With respect to claim 41, Lee teaches a pharmaceutical composition containing the hESC-MSC spheres (pg. 7040 last para.). With respect to claim 42, Lee teaches the pharmaceutical composition is formulated for administration to a subject (pg. 7040 last para.).
Lee is silent as to what markers are positive or negative in the in vitro population of MSCs that have increased secretion of IGFBP-1 and NT-3 compared to naturally occurring MSCs and does not teach the cells further comprising surface expression of NPC intracellular cholesterol transporter 1 (NPC1), and CD206 as recited in claim 3 or that the cells are devoid of surface expression of at least one of protein selected from: CD271, SSEA-4, SSEA-3, CD133,CD106, CD146, CD54, CD58, CD62L and CD9 as recited in claim 4. Similarly, Lee does not teach the in vitro population containing 2 subpopulations where the first subpopulation contains at least 80% eMSCs and the surface protein NPC and the second subpopulation contains at least 70% eMSCs and the surface protein CD206 as recited in claim 16.
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicants' generated MSCs differ, and if so to what extent, from the cells of Lee. The cells taught by Lee are the same or similar because they have increase secretion of increased secretion of IGFBP-1 and NT-3 compared to naturally occurring MSCs. Lee teaches the claimed MSCs expressing and secreting higher levels of NT-3 and IGFBP-1. The cited art taken as a whole demonstrates a reasonable probability that the MSCs are either identical or sufficiently similar to the claimed MSCs that whatever differences exist are not patentably significant. Therefore, the burden of establishing novelty or unobviousness by objective evidence is shifted to applicants. Clear evidence that the MSCs of the cited prior art does not possess a critical characteristic that is possessed by the claimed cells (for example, that the cells of Lee lack NPC1 and CD206, and express CD271, SSEA-4, SSEA-3, CD133,CD106, CD146, CD54, CD58, CD62L and CD9) would help advance prosecution.
Therefore, the invention reference anticipates the claimed subject matter or the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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