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 on 07/26/2024. Claims 1-20 are
currently pending. Claims 1 is an independent claim.
Therefore, claims 1-20 are examined on their merits to which the following
grounds of rejection are applicable.
Priority
Applicant’s claim for the benefit of a prior-filed US Provisional application number 63/580,669 filed 9/05/2023 is acknowledged.
Thus, the earliest possible priority for the instant application is 9/05/2023.
Claim Objection
Claim 20 is objected to because abbreviations such as HMGB1 should be spelled out at the first encounter in the claims. Appropriate correction is required
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.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring product without significantly more.
In accordance with MPEP § 2106, claims found to recite statutory subject matter (e.g., compositions of matter) (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). The claims recite a mesenchymal stem cell (MSC) useful for the treatment of orthopedic conditions and possess enhanced regenerative activity and optionally possess enhanced antioxidant activity. Mesenchymal stem cells are a naturally occurring cell type that can be isolated from human bone marrow, epidermis, intestinal tissue, fat tissue, dental pulp, placenta, and many other in vivo origins, as evidenced by Tonk et al (Mesenchymal Stem Cells, Chapter 2, page 23, 2020). Furthermore, MSCs naturally have regenerative properties including the ability to maintain and repair the respective tissue in vivo and ability to undergo extensive self-proliferation, hence their use in regenerative medicine applications, as evidenced by Tonk (Mesenchymal Stem Cells, Chapter 2, page 22-23, 2020), and thus, the claims as recited do not indicate that the MSCs harbor any properties that are markedly different than their naturally occurring counterpart. Therefore, the resulting cells remain the same type of naturally occurring MSC which innately have regenerative activity.
MPEP 2106.04(c) states that if a claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim recites a "product of nature" exception, and requires further analysis in Step 2A Prong Two to determine whether the claim as a whole integrates the exception into a practical application (Step 2A, Prong One: YES).
The judicial exception is not integrated into a practical application because the do not recite any elements in addition to the recited judicial exception. MPEP 2106.04(d), subsection III states that a judicial exception alone is not eligible subject matter; therefore, if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. As such, Claims 1-20 are directed to a natural product with no additional elements to demonstrate that the claims as a whole integrate the exception into a practical application (Step 2A, Prong 2: NO).
The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception. MPEP 2106.05, subsection I states that additional elements in the claims must be evaluated to determine whether they amount to an inventive concept, which requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself. Any additional steps, such as generating the MSCs by culturing pluripotent stem cells in a decellularized bone matrix (claim 4), are routine in the art and do not transform the nature of the claim to be something distinct from their naturally occurring counterpart. Hence, because claims 1-20 do not contain additional elements to demonstrate the claims as a whole integrate the exception into a practical application, the claim simultaneously does not recite significantly more than the exception itself. Since there is no meaningful limitation in the claim that transforms the exception into a patent-eligible application, such that the claim does not amount to significantly more than the exception itself, Therefore, claims 1-20 are directed to a judicial exception without significantly more and does not have an eligible subject matter under 35 U.S.C. §101.(Step 2B: NO).
Claim Rejections - 35 USC § 112 (b)
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 1-20 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 1 is indefinite for its recitation of the term “enhanced” at line 3. 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.
Claim 1 is indefinite in its use of the term "optionally" at line 3. As written, it is unclear exactly what that applicant intends to claim. Therefore, the metes and bounds are unclear and the claim is rendered indefinite. Applicant must plainly recite what they intend to claim.
Claims 1-20 inherit these deficiencies insofar as they depend on claim 1.
Claim 4, 12, 13, and 16 recites the limitation "said cell" in line 11, 1, 4, and 10, respectively. There is insufficient antecedent basis for this limitation in the claims as it is unclear if said cell is the pluripotent stem cell or the mesenchymal stem cell.
Claims 5-7, 14, 15, and 17-20 inherit these deficiencies insofar as they depend on claim 1.
Claim 7 is indefinite for its recitation of the phrase “a time period and intensity sufficient to allow for nuclear translocation of hypoxia inducible factor” at line 18-20. The term “sufficient” 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.
Claim 10 and 11 recites the limitation "mesenchymal stem cells" in line 26 of claim 10 and “mesenchymal stem cell” in line 27 of claim 11. There is insufficient antecedent basis for the limitation of “mesenchymal stem cell(s)”. It is unclear which mesenchymal stem cell the claims are referring to as claim 10 recites “mesenchymal stem cell(s)” twice and claim 11, which depends on claim 10, recites” mesenchymal stem cell”, but unclear as to which recitation of mesenchymal stem cell to claim 10 it is referring to.
Claim 18 is vague and indefinite in the recitation of “…capable of…” , since this phrase refers to a latent ability, and it is unknown whether the ability is expressed or observed in the invention. Note, it has been held that the recitation that an element is “capable of” performing a function is not a positive limitation, but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchinson, 69 USPQ 138.
Claim 20 recites the limitation "said quercetin" in line 18. There is insufficient antecedent basis for this limitation in the claim.
Claim Interpretation
Claim 12 recites “wherein said cell is engineered to possess increased expression of bone morphogenic protein 2 as compared to a non-engineered mesenchymal stem cell”. The phrase “is engineered to possess” is interpreted to mean that the engineered cell can possess the capability of increased expression of bone morphogenic protein 2, but is not required to have expressed increased bone morphogenic protein 2.
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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sheyn et al (Stem Cells Translational Medicine. 2016, pages 1447-1460), as evidenced by Ruiz et al (Nature Communications, 2015, pages 1-8).
Note that claims 2-20 are included in this rejection because they are directed to product by process claims or intended uses of the claimed rnesenchymal stem cell of claim 1 which do not impart any distinctive structural characteristics to the claimed rnesenchymal stem cell. "[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 application, claims 1-20 are directed to a mesenchymal stem cell (MSC) having the following characteristics and functions:
useful for the treatment of orthopedic conditions (claim 1)
possess enhanced regenerative activity (claim 1)
optionally possesses enhanced antioxidant activity (claim 1)
is engineered to possess increased expression of bone morphogenic protein 2 as compared to a non-engineered mesenchymal stem cell (claim 12).
This MSC claimed is taught in its entirety by Sheyn, in which its teachings that anticipate the instant claims are further described below. Therefore, the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Regarding claim 1-3, 9, Sheyn teaches Mesenchymal stem cells (MSCs) that are differentiated from induced pluripotent stem cells (iPSCs), thus termed “iMSCs” (iPSC-derived MSCs) and could be used for bone regeneration as tested in bone fracture experiments (abstract, page 1; page 1451, left col, para 4-5), rendering obvious a mesenchymal stem cell useful for the treatment of orthopedic conditions, wherein said mesenchymal stem cell is: a) generated from a pluripotent stem cell; b) possess enhanced regenerative activity; and c) optionally possesses enhanced antioxidant activity (claim 1) and said orthopedic condition is a bone fracture (claim 2) and said pluripotent stem cell is an induced pluripotent stem cell (claim 9).
The limitation “useful for the treatment of orthopedic conditions” (claim 1), the “condition is selected from the group” (claim 2), and “the osteoarthritis is associated with increased expression of MMP-1” (claim 3) are all intended use. If the prior art composition taught by primary reference is capable of performing the recited intended use, this limitation is met. See e.g. In re Schreiber, 128 F.3d 1473, 1477; 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); MPEP 2114.
Regarding claim 4, the teachings of Sheyn render obvious claims 1. Moreover, the recitation “said cell is generated by culture of pluripotent stem cells in a decellularized bone matrix” is a product-by-process claim wherein the cell generated by the culture in a decellularized matrix is equivalent to a cell cultured by methods recited in Sheyn, absent evidence to the contrary.
Regarding claim 5, the teachings of Sheyn render obvious claims 1 and 4. Moreover, Sheyn teaches that iPSCs can form embryoid bodies (EBs) as iPSCs are first dissociated and cultured in non-adherent plates (i.e. suspension culture) and form EBs (page 1449, left col, iMSC Derivation), rendering obvious wherein said pluripotent stem cell is first cultured in a suspension culture, wherein said suspension culture allows for said pluripotent stem cells to form embryoid bodies.
Regarding claim 6, the teachings of Sheyn render obvious claims 1, 4, and 5. Moreover, the recitation “wherein said suspension culture is performed under conditions of hypoxia” is a product-by-process claim wherein the cell generated by the culture in a hypoxic condition is equivalent to a cell cultured by methods recited in Sheyn, absent evidence to the contrary.
Regarding claim 7, the teachings of Sheyn render obvious claims 1 and 4-6. Moreover, the recitation “wherein said hypoxia is performed for a time period and intensity sufficient to allow for nuclear translocation of hypoxia inducible factor.” is a product-by-process claim wherein the cell generated by the culture in hypoxic conditions is equivalent to a cell cultured by methods recited in Sheyn, absent evidence to the contrary.
Regarding claim 8, the teachings of Sheyn render obvious claims 1. Moreover, Sheyn that the pluripotent stem cell is an iPSC, which is a cell that has been induced to have stem-properties via dedifferentiation and the process of reprogramming cells to be pluripotent known to cause stress to a dedifferentiating cell at the replication fork, as evidenced by Ruiz (page 2, left col, para 1), rendering obvious said pluripotent stem cell is a stressed induced dedifferentiated stem cell.
Regarding claim 10, the teachings of Sheyn render obvious claims 1 and 9.
Moreover, the recitation “wherein said induced pluripotent stem cells are generated from mesenchymal stem cells” is a product-by-process claim wherein the iPS cell generated from a mesenchymal stem cell is equivalent to an iPS cell cultured by recited in Sheyn, absent evidence to the contrary.
Regarding claim 11, the teachings of Sheyn render obvious claims 1, 9, and 10.
Moreover, the recitation “wherein said mesenchymal stem cell is purified from perinatal tissue” is a product-by-process claim wherein the mesenchymal stem cell purified from perinatal tissue is equivalent to the mesenchymal stem cell recited in Sheyn, absent evidence to the contrary.
Regarding claim 12, the teachings of Sheyn render obvious claims 1. Moreover, Sheyn teaches cells that have been transfected (i.e. engineered) with plasmids to overexpress EGFP or BMP6, rendering obvious cell is engineered to possess increased expression of bone morphogenic protein 2 as compared to a non-engineered mesenchymal stem cell.
Regarding claim 13-20, the teachings of Sheyn render obvious claims 1. Moreover, the limitations “wherein” :
“cell is utilized to enhance engraftment of a chondrocytic progenitor” (claim 13),
“said chondrocytic progenitor is allogeneic to the recipient” (claim 14),
“said chondrocytic progenitor is utilized to treat a defect of hyalin cartilage” (claim 15),
“said cell is utilized to treat a non-union bone fracture” (claim 16),
“said mesenchymal stem cell is administered together with an anti-inflammatory agent” (claim 17),
“said anti-inflammatory agent is capable of inhibiting activation of NF-kappa B” (claim 18),
“said anti-inflammatory agent is n-acetylcysteine” (claim 19), and
“said quercetin is administered at a concentration sufficient to increase production of IL-10 from mesenchymal stem cells stimulated with HMGB1 by over 25% as compared to baseline”,
are intended use. If the prior art composition taught by primary reference is capable of performing the recited intended use, this limitation is met. See e.g. In re Schreiber, 128 F.3d 1473, 1477; 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); MPEP 2114.
Claim Rejections - 35 USC § 112 (a) – Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
M.P.E.P. § 2163 recites, “The written description requirement for a claimed
genus may be satisfied through sufficient description of a representative number of
species by actual reduction to practice (see i)(A), above), reduction to drawings (see
i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or
other physical and/or chemical properties, by functional characteristics coupled with a
known or disclosed correlation between function and structure, or by a combination of
such identifying characteristics, sufficient to show the applicant was in possession of the
claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.”
Further, the written description inquiry is limited to that which is contained within the four
corners of the specification, not the extent to which the skilled artisan, given his or her
knowledge of the art, would have considered it to expand with only routine
experimentation. See Ariad Pharms. Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed.
Cir. 2010) (en banc); see also id. at 1352 (“[I]t is the specification itself that must
demonstrate possession. A description that merely renders the invention obvious does
not satisfy the requirement.").
The claims recite a mesenchymal stem cell useful for treating orthopedic conditions wherein said mesenchymal stem cell is: a) generated from a pluripotent stem cell; b) possess enhanced regenerative activity; and c) optionally possesses enhanced antioxidant activity. The claims are broadly but reasonably interpreted as
a mesenchymal stem cell to treat a genus of orthopedic conditions, e.g, bone fracture; non-union bone fracture; osteoarthritis; rheumatoid arthritis; cartilage degeneration; torn meniscus; and degenerative disc disease.. There is not structure/ function correlation for the mesenchymal stem cell, its structure of possessing enhanced regenerative activity, and the corresponding genus of orthopedic conditions to be treated by the said mesenchymal stem cell.
The specification discloses that the invention aims to generate cellular therapies for orthopedic conditions involving cartilage and bone through generation of stem cells and progenitor cells from pluripotent stem cells that possess enhanced features including ability to produce growth factors, ability to deposit extracellular matrix, ability to differentiate and ability to provide cells with reduced or absent immunogenicity (para 0012). The specification discloses that the preferred embodiments are directed to a mesenchymal stem cell useful for the treatment of orthopedic conditions, wherein said mesenchymal stem cell is: a) generated from a pluripotent stem cell; b) possess enhanced regenerative activity; and c) optionally possesses enhanced antioxidant activity (para 0013) and wherein said orthopedic condition is selected from a group of conditions comprising: a) bone fracture; b) non-union bone fracture; c) osteoarthritis; d) rheumatoid arthritis; e) cartilage degeneration; f) torn meniscus; and g) degenerative disc disease (para 0014). The specification contemplates methods of generation of pluripotent stem cells i.e. dedifferentiating cells (para 0607-061), various methods for exposing cells (chondrogenic cells and stem cells) to low oxygen conditions to enhance proliferation and differentiation of chondrogenic cells (para 0613-0616), use of a cell therapeutic agent (which can be a mesenchymal stem cell) through injection in the joint of a patient or implanted with a scaffold that has characteristics such as being biocompatible, bioabsorbable, or capable of remodeling, and offer a framework for facilitating the growth of new tissue. (para 0618-0619). The specification contemplates that the composition or cell therapeutic agent of the present invention may be applied to a damaged portion of cartilage of a human or non-human organism, e.g., a non-human mammal such as a cow, monkey, bird, cat, mouse, rat, hamster, pig, dog, rabbit, sheep, and horse, to promote cartilage regeneration (differentiation), or be administered into a joint by injection for treating a cartilage disease (para 0619). However, the specification is silent about any in vivo example of generated mesenchymal stem cells that have the structure of enhanced regenerative activity and are used for the treatment of any orthopedic condition. There is not structure/function correlation for the claimed genus of mesenchymal stem cells.
The prior art of Lukomska teaches that while mesenchymal stem cells have potential use as a clinical therapeutic, including in cases of orthopedic conditions, there remains substantive issues with the generation and implementation of mesenchymal stem cells for treating disease. For instance, Lukomska teaches that “cellular heterogeneity of mesenchymal stem cells makes consistent conclusions about mesenchymal stem cell therapeutic potential difficult, because the obtained results are frequently variable and may depend on the different mesenchymal stem cell origin as well as harvesting and culture procedures” (page 1, right col, para 2). Similarly, Lukomska “the quality of the human MSC product depends on the isolation and culture
methods as well as the age, genetic traits, and medical history of the donor” (page 2, left col, 2. Heterogeneity of MSCs). Han teaches that “Despite the unique characteristics of each MSC product, the existing data remain inadequate to conclusively ascertain how variations in tissue sources, isolation techniques, and culture processes influence their therapeutic efficacy, in addition to valuable observational findings (page 29, left col, para 3).
The specification does not identify disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. Rather, in the instant application, the specification invites the skilled artisan to test each and every culture condition to generate mesenchymal stem cells from pluripotent stem cells in order to treat an array of orthopedic conditions.
Further, the prior art indicates there is unpredictability in use of mesenchymal stem cells for therapeutic purposes such as treating orthopedic conditions. Furthermore, characterization of mesenchymal stem cells remains imperative to best utilize them as a therapeutic agent, and the current specification lacks indication of any structure/characterization to elicit their function of treatment of any orthopedic condition. In this case, the skilled artisan would not have reasonably concluded at the time of the invention that applicant was in possession of the invention as claimed. Any claim
not specifically recited is included in the rejection because it depends from a
rejected claim.
Provisional Rejection, Obviousness Type Double Patenting-No secondary
Reference(s)
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 1-20 are provisionally rejected on the ground of nonstatutory double
patenting as being unpatentable over claims 1-20 of copending Application No. 19/015,393 as per claims filed on 01/09/2025. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the cited claims of Application 19/015,393.
Claim 1 of copending application no. 19/015,393 is directed to a canine-derived mesenchymal stem cell derived from an induced pluripotent stem cell (iPSC).
Claim 1 of the invention is directed to a mesenchymal stem cell useful for the treatment of orthopedic conditions, wherein said mesenchymal stem cell is: a) generated from a pluripotent stem cell; b) possess enhanced regenerative activity; and c) optionally possesses enhanced antioxidant activity.
Claim 1 of the instant application is drawn to a broad genus of mesenchymal stem cells that have enhanced regenerative activity. Claim of 1 of 19/015,393 is drawn to canine-derived mesenchymal stem cell. Said canine-derived mesenchymal stem cells are members of the claimed genus of the instant claim 1.
It is well established that a species of a claimed invention renders the genus obvious. In re Schaumann , 572 F.2d 312, 197. Furthermore, the claimed property of regenerative activity is an inherent property of MSCs, as evidenced by Tonk et al (Mesenchymal Stem Cells, Chapter 2, page 22-23, 2020), therefore the claimed MSC of co-pending application 19/015,393 also inherently possesses the claimed property of regenerative activity. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is noted that, if the prior art discloses identical chemical structure, the properties applicant discloses and/or claims are necessarily present, In re Spada, 911 F.2d 705, 709, 15 USPQ2d.
This is a provisional obviousness-type double patenting rejection because the
conflicting claims have not in fact been patented.
Conclusion
Claims 1-20 are rejected.
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/JULIANA IRENE CANDELARIA/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
Prosecution Insights