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 .
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 (i.e., changing from AIA to pre-AIA ) 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 without traverse of the species tenogenic induced mesenchymal stem cells (MSCs), claims 11-14, 18 in the reply filed on 1/5/26 is acknowledged.
Claims 1-19 are currently pending.
Claims 15-17, 19 are withdrawn as directed to non-elected species.
Claims 1-14, 18 are elected and examined on the merits.
Claim Interpretation
With respect to claims 1, 11-14, claim scope is not limited by language that does not limit the claim to a particular structure. That is, intended use of an apparatus or composition is insufficient to distinguish the structure of the apparatus or composition from the prior art. See MPEP §§ 2111.02 and 2111.04. Therefore, only language that clearly defines structural limitations is considered with respect to patentability analysis. For example, “for treating trauma” does not clearly define a structural limitation of the apparatus or composition. Consequently, this limitation is not considered in analyzing the patentability of the apparatus or composition. For examination purposes claim 1 is interpreted as a composition comprising isolated mesenchymal stem cells (MSCs) wherein the MSCs are tenogenic induced (“activation of cell type specific genes or molecules in a multipotent or pluripotent stem cell, thereby driving such cell towards a more defined, specialized or differentiated cell lineage or cell type” or Specification p7 ln 30-32).
With respect to claim 18, applicant's invention is interpreted as comprising product-by-process limitations. Under MPEP § 2113, product-by-process claims are not limited to the recited method steps, but are limited only by the resultant structure. Therefore, method steps are only considered in a patentability analysis to the extent that the method steps result in structural changes to the product. It is not clear that induction of MSCs towards tenogenesis by culturing in a media comprising 5 ng/ml FGF-2 results in a significantly different cell population than cells induced by other methods (e.g., different concentration of FGF-2 or use of FGF-5). Therefore, this limitation is not considered in analyzing the patentability of the apparatus or composition.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claims 11-14, 18 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
As noted above, claims 11-14 contain intended use limitations. Claim 18 contains a product-by-process limitation. None of claims 11-14 and 18 contain any limitations beyond the intended use or product-by-process limitations; the only structural limitations recited (those limitations considered in the patentability analysis) are those present in the base claim from which claims 11-14 and 18 depend. Therefore, claims 11-14 and 18 are considered duplicate claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
In view of the MPEP § 2106, claims 1-8, 11-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Subject Matter Eligibility Guidance
A three part inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101 for process claims that involve laws of nature. See Subject Matter Eligibility Guidance. This inquiry comprises answering: 1) Is the claimed invention directed to one of the four statutory patent-eligible subject matter categories: process, machine, manufacture, or composition of matter? 2A) Does the claim recite or involve one or more judicial exceptions? Judicial exceptions include abstract ideas, laws of nature/natural principles, natural phenomena, and natural products. 2B) Does the claim as a whole recite something significantly more than the judicial exception(s)?
Claim Interpretation
With respect to claims 1-8, 11-14 applicant’s invention is interpreted as comprising a composition comprising isolated, tenogenic-induced MSCs.
Analysis in View of Claim Interpretation and Subject Matter Eligibility Guidance
1) Statutory Subject Matter
Claims 1-8, 11-14 are directed to a population of cells, which is a composition. Therefore, claims 1-8, 11-14 are directed to statutory subject matter.
2A) Judicial Exception
1) Does the claim recite a judicial exception?
Claims 1-8, 11-14 recite a judicial exception because the claims are directed to a composition comprising a population of cells, which is a product of nature.
2) Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claims 1-7, 11-14 do not recite additional elements that integrate the judicial exception into a practical application because the claims do not include any additional limitations beyond the cells; the additional limitations further characterize the cells. With respect to claim 8, the additional limitation is directed to a medium comprising a cryoprotectant. Known cryoprotectants include natural products, such as trehalose. Therefore, in some embodiments, the additional limitation of claim 8 is likewise directed to a judicial exception.
2B) Significantly More
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as noted above, the claims do not recite any additional elements, or are limited to reciting additional natural products.
Summary
On balance the relevant factors weigh against eligibility and claims do not qualify as eligible subject matter under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 112
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 5, 7, 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 contains the limitation “wherein said MSCs are allogenic MSCs”. Claim 5 is directed to a composition, not a method of treating. It is unclear how the MSCs may be allogenic unless there are present in a subject.
Claim 7 contains the limitation “comprising platelet-rich plasma (PRP), hyaluronic acid and/or glycosaminoglycans”. The use of “and/or” without a preceding Oxford comma renders it unclear which limitations are requirements and which are recited in the alternative. For examination purposes, this limitation is interpreted as “comprising at least one component selected from the group consisting of platelet-rich plasma (PRP), hyaluronic acid and[[/or]] glycosaminoglycans”.
Claim 12 contains the limitation “administered to a subject”. Claim 12 depends from claim 1 which contains the limitation “for treating trauma in a subject”. It is unclear if the subject of claim 12 is the same or a different subject than that of claim 1. For examination purposes, this limitation is interpreted as “administered to [[a]]the subject”.
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.
Claim(s) 1, 6, 11-14, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Loo, T.S., (2013) Investigating GDF5-induced tenogenesis in mesenchymal stem cells for the potential improvement of tendon repair. University of Malaya, Thesis (hereinafter Loo).
Regarding claims 1, 6, 11-14, 18, Loo discloses compositions comprising GDF5-induced MSCs for tendon repair (Abstract). Loo discloses that MSCs cultured in low-glucose Dulbecco’s Modified Eagle’s Medium (DMEM) supplemented with GDF5 demonstrate significant upregulation of tenogenic markers and lineage commitment in the cells as compared to controls (2.5.1.1, 3.3.4, 3.4.2, Figs. 3.10-3.11, Tables 2.2, 3.3).
Regarding claim 6, Loo discloses treating an infraspinous tendon lesion with 1 to 2 x 106 cells (4.2, Table 4.1).
Therefore, every limitation of claims 1, 6, 11-14, and 18 is present in Loo and the subject matter is anticipated.
Claim(s) 1, 4, 11-14, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lovati et al., (2012) Tenogenic differentiation of equine mesenchymal progenitor cells under indirect co-culture. Int J Artif Organs, 35(11): 996-1005 (hereinafter Lovati).
Regarding claim 1, 4, 11-14, and 18, Lovati discloses methods of tenogenic inducing equine MSCs (Abstract, Introduction). Lovati discloses that equine MSCs co-cultured with tendon fragments demonstrate upregulation of tenogenic markers indicating tenogenic commitment (Gene expression after tenogenic differentiation, Fig. 3).
Therefore, every limitation of claims 1, 4, 11-14, and 18 is present in Loo and the subject matter is anticipated.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lovati as applied to claims 1, 4, 11-14, and 18 above, and further in view of Koerner et al., (2006) Equine peripheral blood-derived progenitors in comparison to bone marrow-derive mesenchymal stem cells. Stem Cells, 24(6): 1613-1619 (hereinafter Koerner).
Regarding claims 2-3, Lovati does not disclose that the MSCs are peripheral blood derived MSCs.
Koerner compares characteristics of peripheral blood-derived and bone marrow-derived equine MSCs (Abstract). Koerner explains that peripheral blood-derived MSCs are easy to obtain from equine subjects, are safer to obtain, and demonstrate multilineage differentiation potential (though at a lesser degree than bone marrow-derived MSCs) (Discussion). Koerner concludes that peripheral blood-derived MSCs may be useful for clinical applications in bone, tendon, and ligament repair (Discussion, Conclusion). Therefore, there is a suggestion present in Koerner that peripheral blood-derived MSCs could be substituted for bone marrow-derived MSCs for bone, tendon, and ligament applications. A skilled artisan would be motivated to use the peripheral blood-derived MSCs of Koerner in the methods of Lovati as an easy and safe substitute for bone marrow-derived MSCs.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loo as applied to claims 1, 6, 11-14, and 18 above, and further in view of Zhang et al., (2010) Platelet-rich plasma releasate promotes differentiation of tendon stem cells into active tenocytes. The American Journal of Sports Medicine, 38(10): 2477-2486 (hereinafter Zhang).
Regarding claim 7, Loo does not disclose that the composition further comprises platelet rich plasma (PRP).
Zhang examines the effect of PRP on tendon stem cells (TSCs) for tendon repair (Abstract, Introduction). Zhang discloses culturing TSCs in the presence of PRP clot releasate (Cell culture experiment). PRP clot releasate specifically induces differentiation into tenocytes (and not other cell types), increases proliferation, and increases collagen production (Results, Discussion, Figs. 2-4, 8). Zhang concludes that treating stem cells with PRP may be highly effective for treating injured tendons in vivo (Discussion).
As both Loo and Zhang are directed to cellular based treatment methods for tendons it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would be motivated to incorporate the PRP of Zhang into the composition of Loo to improve tendon healing as disclosed by Zhang.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loo as applied to claims 1, 6, 11-14, and 18 above, and further in view of R. Ian Freshney, “Cryopreservation.” In: Culture of Animal Cell: A Manual of Basic Technique and Specialized Applications. (Hoboken, NJ, John Wiley & Sons, Inc., 2010), pp. 317-334. QH585.2.F74 2010 (hereinafter Freshney).
Regarding claims 8-10, Loo does not disclose that the MSCs are suspended in a media containing dimethyl sulfoxide (DMSO).
Freshney explains that it is essential to protect cells through cryopreservation for a multitude of reasons, including distribution to others (e.g., for therapeutic administration) (19.1). Freshney explains that DMSO is a well-understood, routine, and conventional cryopreservative (19.3.3, Protocol 19.1). Typically DMSO is added to the cell growth media at a concentration of between 5% and 15% (19.3.3, Protocol 19.1). As cryopreservation with DMSO is a well-understood, routine, and conventional means for preserving cells, it would be obvious to one of ordinary skill in the art that the cells of Loo could be cryopreserved accordingly. A skilled artisan would be motivated to cryopreserve the cells of Loo for distribution to others for therapeutic administration as disclosed by Freshney.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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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.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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