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 .
Election/Restrictions
Applicant's election with traverse of Group II, claims 47-53 and 55, in the reply filed on 02/20/2026 is acknowledged. The traversal is on the ground(s) that there is not a search burden between the groups and that Noble does not teach the specific method of obtaining the claimed cells nor specifically provide “the kind of hard ‘cell line stability’ evidence” as provided in the instant application. This is not found persuasive because the features on which Applicant relies, specifically the method in which the cells are produced, are not claimed aspects of the inventive groups and are therefore not required to be taught by Noble to break unity.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 4-8, 10, 13, 15-16, 20-21, and 60-61 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/20/2026.
Status of the Claims
Claims 1, 4-8, 10, 13, 15-16, 20-21, 47-53, 55, and 60-61 are currently pending.
Claims 47 and 53 are amended.
Claims 1, 4-8, 10, 13, 15-16, 20-21, and 60-61 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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 2-3, 9, 11-12, 14, 17-19, 22-46, 54, 56-59, and 62 are cancelled.
Claims 47-53 and 55 have been considered on the merits.
Claim Objections
Claim 47 is objected to because of the following informalities: step (a) includes three options however the second option which reads “that expresses less aggrecan (ACAN), type II collagen (Col2A1), SOX9, matrilin-3 (MATN3), and/or lubricin (PRG4) relative to chondrocytes derived from healthy adult tissue” appears to be an identical duplicate of the first option. Appropriate correction is required.
Claim 53 is objected to because of the following informalities: step (a) includes three options however the second option which reads “that expresses less aggrecan (ACAN), type II collagen (Col2A1), SOX9, matrilin-3 (MATN3), and/or lubricin (PRG4) relative to chondrocytes derived from healthy adult tissue” appears to be an identical duplicate of the first option. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 51 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim 51 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: Claim 51 states “wherein the degenerative cartilage disease is selected from” and provides a list of diseases, may of which are not considered degenerative cartilage diseases, nor result in cartilage degradation. Diseases listed which are inflammatory in nature however cause degradation of cartilage tissue are not excluded from the Markush group of claim 51.
The claim lists “achondroplasty” which appears to refer to either “chondroplasty” which is not a disease, but a surgical procedure, or “achondroplasia” which is a genetic bone growth disorder and not considered a degenerative cartilage disease. The claim lists “costochondritis” which is not considered a degenerative cartilage disease, rather an inflammatory condition which does not involve cartilage breakdown. The claim lists “undifferentiated chronic arthritis” which is an inflammatory joint condition and not considered a degenerative cartilage disease. The claim lists “systemic lupus erythematosus arthritis” which is not a considered a degenerative cartilage disease and does not usually result in a mechanical breakdown of cartilage. The claim lists “Crohn’s disease arthritis” which is not considered a degenerative cartilage disease and does not result in the mechanical breakdown of cartilage. The claim lists “traumatic rupture or detachment of cartilage” which is not considered a degenerative cartilage disease. The claim lists “arthritis due to osteoporosis” which is not considered a degenerative cartilage disease, rather a metabolic bone disease. The claim lists “aseptic osteonecrosis” which is not considered a degenerative cartilage disease, rather a degenerative bone disease. The claim lists “benign and malignant bone tumors” which are not considered a degenerative cartilage disease.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 102
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.
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.
Claims 47-48, 51-53, and 55 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Noble et al (US 2015/0240208 A1).
Regarding claim 47, Noble teaches a method of regenerative or repairing cartilaginous tissue in an individual in need thereof ([0025]), the method comprising obtaining a stable chondroprogenitor cell line that expresses less collagen II or collagen X relative to the “expression seen in a population of fully differentiated chondrocytes” ([0022]/[0099]/[0103]) which is interpreted to meet the claim limitation of “relative to chondrocytes derived from healthy adult tissue”. Noble teaches that the method next comprises administering or transplanting the population of dedifferentiated committed chondrocyte progenitor cells (DCCPCs) to an individual (([0025]).
Regarding claim 48, Noble teaches wherein the individual has a degenerative cartilage disease ([0025]).
Regarding claim 51, Noble teaches wherein the degenerative cartilage disease is arthritis, osteoarthritis, or rheumatoid arthritis ([0031]/[0122]).
Regarding claim 52, Noble teaches that the individual is a human being ([0190]).
Regarding claim 53, Noble teaches a method of treating arthritis or articular cartilage injuries in an individual in need thereof ([0025]/[0031]), the method comprising obtaining a stable osteochondro-progenitor cell line that expresses less collagen II or collagen X relative to the “expression seen in a population of fully differentiated chondrocytes” ([0022]/[0099]/[0103]) which is interpreted to meet the claim limitation of “relative to chondrocytes derived from healthy adult tissue”. Noble teaches that the method next comprises administering or transplanting the population of dedifferentiated committed chondrocyte progenitor cells (DCCPCs) to an individual (([0025]). Noble teaches that the cells are characterized by a the presence of nuclear markers for both chondrocytes and osteogenesis and that the cells have transdifferentiation potential into osteoblasts unless the cells are grown in a defined minimal growth media and cultured to further differentiate into the chondrocyte line ([0018]).
Regarding claim 55, Noble teaches that the individual is a human being ([0190]).
Therefore, Noble anticipates the claims.
Claim Rejections - 35 USC § 103
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.
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.
Claims 47 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Noble et al (US 2015/0240208 A1), in view of Rochester (University of Rochester Medicine, “Researchers Detail How Aging Undermines Bone Healing”, 2009).
Regarding claim 49, Noble teaches the limitations of the independent claim 47 above.
Noble does not teach that the individual in need of treatment has a bone fracture as required by claim 49.
However, Rochester teaches about the role in COX-2 in bone repair and states that they confirmed that a layer of cartilage progenitor cells first form around a fracture to guide bone building (pg. 1, para 4) and that the enzyme is known from past studies to drive stem ells to differentiate into cartilage, which then matures into bone (pg. 1, para 3).
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to apply the method of repairing or regenerating cartilage tissue taught by Noble to bone fractures, which begin healing through the recruitment of chondroprogenitor cells as taught by Rochester to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Rochester teaches about the role in COX-2 in bone repair and states that they confirmed that a layer of cartilage progenitor cells first form around a fracture to guide bone building (pg. 1, para 4) and that the COX-2 enzyme is known from past studies to drive stem cells to differentiate into cartilage, which then matures into bone (pg. 1, para 3). One of ordinary skill in the art would have a reasonable expectation of success when combining Noble with Rochester because Noble already teaches the method of repairing or regenerating cartilaginous tissue in an individual in need thereof and Rochester teaches the first step of bone fracture healing is the recruitment of chondroprogenitor cells.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claims 47 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Noble et al (US 2015/0240208 A1), in view of Van der Kraan et al (Osteoarthritis and Cartilage, 2007).
Regarding claim 50, Noble teaches the limitations of the independent claim 47 above.
Noble does teach the treatment of osteoarthritis however, Noble does not explicitly teach that the individual in need of treatment has a bone spur as required by claim 50.
However, Van Der Kraan teaches that bone spurs, also known as osteophytes, are an integral component of osteoarthritis pathogenesis (abstract).
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to apply the method of treating osteoarthritis taught by Noble to treat bone spurs, which are an integral part of osteoarthritis as taught by Van Der Kraan to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Van Der Kraan teaches that bone spurs, also known as osteophytes, are an integral component of osteoarthritis pathogenesis (abstract). One of ordinary skill in the art would have a reasonable expectation of success when combining Noble with Van Der Kraan because Noble already teaches the method of repairing or regenerating cartilaginous tissue in an individual with osteoarthritis and Van Der Kraan teaches Bone spurs are a symptom of osteoarthritis.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632
