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 I, claims 1-8, 13, and 14, in the reply filed on 02/02/2026 is acknowledged. The traversal is on the ground(s) that the new amendments to claim 1 render the claim novel over the prior art and specifically Huang, cited in the restriction requirement, does not teach the newly added product by process limitations. This is not found persuasive because Huang teaches the technical feature presented in the claims at the point of restriction and the newly included limitation of claim 1 which reads “the graft is a chondroid graft formed by inoculating the BMSCs in the decalcified bone matrix carrier and subjected to in vitro chondrogenic induction culture for 0.5-8 weeks”, is a product by process limitation where the process of obtaining the product carries little patentable weight. Additionally, the recited product by process limitation does not appear to impart a structural change to the claimed graft. The claim is directed to a product comprising human bone marrow stromal stem cells and the induction step does not appear to structurally alter these cells. If the chondrogenic induction culture is to be interpreted to structurally alter the graft such that the inoculated BMSCs are differentiated into chondrogenic lineages, then the product is no longer a tissue-engineered bone graft comprising BMSCs. If the chondrogenic induction culture merely primes BMSCs towards chondrogenic lineages but does not differentiate the BMSCs, then it does not appear to impart a structural change in the claimed graft. The requirement is still deemed proper and is therefore made FINAL.
Claims 9-12 and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Groups, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/02/2026.
Status of the Claims
Claims 1-15 are currently pending.
Claims 1 and 7 are amended.
Claims 9-12 and 15 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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 1-8, 13, and 14 have been considered on the merits.
Claim Objections
Claim 6 is objected to because of the following informalities: the claim reads “wherein the cancellous bone comprises: ilium, sternum, ribs” and an “and”, “or”, or “and/or” should be included between the terms “sternum” and “ribs”. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: the term “wherein” should be inserted after the preamble and before the phrase “the shape”. 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 13 and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claim 13 recites “a use of bone graft of claim 1 for preparing a drug for preparing a medicant for repairing inferior turbinate defects”. Thus, claim 13 does not positively recite any steps, and does not define a statutory process. Claim 14 depends from claim 13 and limits the type of inferior turbinate defect, which also does not define a statutory process. The claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
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 1-8, 13, and 14 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 recites the limitation "the decalcification degree" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claims 2-8, 13, and 14 are included in this rejection due to dependency on claim 1.
Claim 1 recites the limitation "the thickness" in line 5. There is insufficient antecedent basis for this limitation in the claim. Claims 2-8, 13, and 14 are included in this rejection due to dependency on claim 1.
Claim 8 recites the limitation "the shape" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the inferior turbinate defect site" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the human body” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 contains the phrase “the shape of the inferior turbinate defect site that the human body needs to be transplanted” in lines 2-3, which renders the claim indefinite. It is unclear what limitation the phrase “that the human body needs to be transplanted” is meant to impart on the claim. Appropriate clarification is required.
Claims 13-14 provides for the use of a bone graft “for preparing a drug for preparing a medicant for repairing inferior turbinate defects”, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). Claim 14 is included in this rejection due to dependency on claim 13.
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 1-4, 7-8, 13, and 14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Huang et al (US20120251609A1).
Claim Interpretation:
Claim 1 contains a product by process limitation in which the process of forming the graft by inoculating the BMSCs in the decalcified bone matric carrier and subjected to in vitro chondrogenic induction culture for 0.5-8 weeks, carries little patentable weight. It is only the product, which is anticipated by the prior art and not the process by which the product was made. This is because the final product (a tissue-engineered bone graft) is not distinguished by any particular features or characteristics resulting from the process by which it was made. As such, the limitations of the claimed process of inoculating the BMSCs in the decalcified bone matric carrier and subjected to in vitro chondrogenic induction culture for 0.5-8 weeks are met by any process of inoculating BMSCs in the prior art. Patentability of a product-by-process claim is determined by the novelty and nonobviousness of the claimed product itself without consideration of the process for making it which are encompassed by the claimed process of inoculating the BMSCs in the decalcified bone matric carrier and subjected to in vitro chondrogenic induction culture for 0.5-8 weeks of claim 1.
Claim 8 contains the phrase “the shape of the tissue engineered bone graft corresponds to the shape of the inferior turbinate defect site that the human body needs to be transplanted”, in lines 1-3. This limitation recites an intended use of the graft to be transplanted for an inferior turbinate defect site, which carries little patentable weight. However, shaping the tissue engineered bone graft carries patentable weight and is addressed below.
Claim 13 contains the phrase “a use of bone graft of claim 1 for preparing a drug for preparing a medicant for repairing inferior turbinate defects”, in lines 1-2. This limitation recites an intended use of the graft of claim 1, which carries little patentable weight.
Claim 14 depends from claim 13 and contains the phrase “the inferior turbinate defect is selected from the base of the inferior turbinate, the peripheral tissue of the inferior turbinate, and the lateral wall of the nasal cavity”, in lines 1-3. This limitation recites an intended use of the graft of claim 1, which carries little patentable weight.
Regarding claim 1, Huang teaches a decalcified bone matrix carrier ([0001]) comprising human bone marrow stromal stem cells (BMSC) ([0081] and [0149]/Example 5). Huang teaches that the decalcification degree is at least between 95-80% demineralized ([0011]). Huang teaches that the thickness of the decalcified bone matrix is between 1-10 mm thick ([0099]). Huang teaches that the graft is a solid cell material composite and the concentration of BMSCs in the composite is 2 x 107 cells/ml (identical units to cells/cm3) ([0149]). Additionally, Huang teaches that the graft may contain chondrocytes meeting the limitations of “chondroid graft” ([0081]). Huang teaches the graft is formed by inoculating the decalcified bone matrix carrier with BMSCs and subjecting the carrier to in vitro culture for a range of 1 day to about 4 weeks ([0097]).
Regarding claim 2, Huang teaches that the decalcification degree is at least between 95-80% demineralized ([0011]).
Regarding claim 3, Huang teaches that the thickness of the decalcified bone matrix is between 1-10 mm thick ([0099]).
Regarding claim 4, Huang teaches that the cells are autologous ([0081]).
Regarding claim 7, Huang teaches that the graft is a solid cell material composite and the concentration of BMSCs in the composite is 2 x 107 cells/ml (identical units to cells/cm3) ([0149]).
Regarding claim 8, Huang teaches that the bone graft can be used to treat bones of the skull, which meets the claim limitation that the bone graft is used to treat a defect in the inferior turbinate ([0110]). Huang also teaches that the graft can be sized and can conform to the shape of the implant site ([0010]).
Therefore, Huang anticipates claims 1-4, 7-8, 13, and 14.
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.
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.
Claims 1 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al (US20120251609A1), in view of Caplan et al (US5486359A).
Claim Interpretation: Claim 6 requires “wherein the cancellous bone comprises: ilium, sternum, ribs”, which has been objected to above. The claim is being interpreted to require that the cancellous bone comprises: ilium, sternum, and/or ribs.
Regarding claims 5-6, the limitations of the independent claim 1 are taught above.
Huang teaches a decalcified bone matrix carrier ([0001]) comprising human bone marrow stromal stem cells (BMSC) ([0081] and [0149]/Example 5).
Huang does not specify the type of bone the bone marrow is derived from. Huang does not teach that the BMSCs are derived from cancellous bone as required by claim 5. Huang does not teach that the cancellous bone is ilium, sternum, or ribs as required by claim 6.
However, Caplan teaches methods of isolating human mesenchymal stem cells for therapeutic uses. Caplan teaches the use of the human MSCs derived from the iliac crest, part of the ilium, in bone grafts which formed bone in 3 different samples (col. 20, para 2-3).
Regarding claims 5-6, Caplan teaches that bone marrow is the soft tissue occupying the medullary cavities of long bones, some haversian canals, and spaces between trabeculae of cancellous/spongy bone (col. 5, para 2-3). Caplan teaches that MSCs can be derived from bone marrow obtained from the iliac crest which is the top part of the ilium, ribs, spine, femora, tibiae, or other medullary spaces (col. 2, para 2).
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the bone graft comprising human bone marrow derived mesenchymal stem cells taught by Huang with the bone marrow derived from cancellous bones taught by Caplan to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Huang teaches the use of bone marrow derived MSCs and Caplan teaches the use of the human MSCs derived from the iliac crest, part of the ilium, in bone grafts which formed bone in 3 different samples (col. 20, para 2-3). One of ordinary skill in the art would have a reasonable expectation of success when combining Huang with Caplan because both teach the necessary information to produce bone grafts from bone marrow derived MSCs.
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.
Examiner Contact Information
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
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632
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