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 .
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, 3-13, 16-17 and 19-28 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.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on December 15, 2014 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)). This guidance indicates that claims drawn to nature-based products must pass a two-step eligibility test to avoid rejection under 35 U.S.C. 101. Under this test, the product must (a) be markedly different from its naturally occurring counterpart in its natural state or must (b) contain additional elements that amount to significantly more than the judicial exception itself.
‘Markedly different’ analysis:
The guidance of 12/15/2014 states that markedly different characteristics can be expressed as the product’s structure, function, and/or other properties. Non-limiting examples of characteristics that can determine the presence of a marked difference include biological or pharmacological functions or activities; chemical and physical properties; phenotype, including functional and structural characteristics; and structure and form, whether chemical, genetic, or physical.
Independent claim 1 is drawn to a cartilage-derived implant for treating a cartilage defect, said implant comprising a plurality of cartilage fibers. The Examiner notes that any object can be implanted into a patient, and so the claimed “implant . . . comprising a plurality of cartilage fibers” is sufficiently broad to read on cartilage, which is a naturally occurring substance and, thus, a judicial exception. The claims also recite that the implants “were produced by manipulating and shaping a cohesive mass”, which can incorporate any technique used to excise a piece of cartilage from a subject. Excising cartilage does not render it markedly different from a judicial exception. The claims also recite shapes and sizes for the cartilage fibers. Altering the shape and size of a piece of cartilage does not render it markedly different from a judicial exception, as the piece of cartilage is still a naturally occurring substance.
Claims 3-13, 16-17 and 19-28 do not recite any elements that would distinguish the implant of claim 1 from cartilage, as cartilage fibers in natural cartilage are unbranched (claim 3), a three-dimensional structure (claim 4), produced by manipulating and shaping a cohesive mass (claim 5), conforms to an implant site (claims 6-8 and 11-13), reshaped from a first shape to a second shape (claims 9-10 and 16), are cross-linked (claim 17), produced by grating or scraping (claim 19), contained endogenous cells (claims 20-22), capable of storage above 40 Celsius (claim 23), are cryopreserved (claim 24), contain endogenous cells and are cryopreserved (claims 25-27), have a length of about 5 mm and thickness of from 0.5-5 mm (claim 28). As such, the compositions recited in these claims are also not markedly different from a judicial exception.
In contrast, claims 2, 14-15, 18 and 29 recite limitations of the form of the claimed implant that distinguish the claimed composition from a judicial exception, as naturally occurring cartilage would not be considered a “putty”, a “gel”, or an “injectable mixture”.
‘Significantly more’ analysis:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because claims 1-3, 6-8, and 25 do not recite any additional elements other than the claimed judicial exception.
Therefore, claims 1, 3-13, 16-17 and 19-28 are directed to subject matter that is not patent-eligible and are rejected under 35 U.S.C. 101.
Claim Objections
Claim 5 objected to because of the following informalities: "a treatment site" in line 2 should "the treatment site". Appropriate correction is required.
Claim 9 objected to because of the following informalities: "a treatment site" in line 2 should read "the treatment site". Appropriate correction is required.
Claim 10 objected to because of the following informalities: "a treatment site" in line 3 should read "the treatment site". Appropriate correction is required.
Claim 16 objected to because of the following informalities: "a treatment site" in line 2 should read "the treatment site". Appropriate correction is required.
Claim 29 objected to because of the following informalities: "a treatment site" in line 2 should read "the treatment site". Appropriate correction is required.
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.
Claim 17-18 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 “increased stability” in claim 17 is a relative term which renders the claim indefinite. The term “increased stability” 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 degree of stability has been rendered indefinite by the use of the term increased. Further it is unclear what the measure of stability is being compared to. Dependent claim 18 is likewise rejected.
The term “increased shape retention” in claim 17 is a relative term which renders the claim indefinite. The term “increased shape retention” 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 degree of stability has been rendered indefinite by the use of the term increased. Further it is unclear what the measure of shape retention is being compared to. Dependent claim 18 is likewise rejected.
The term “longer degradation rates” in claim 17 is a relative term which renders the claim indefinite. The term “longer degradation rates” 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 degree of degradation rate has been rendered indefinite by the use of the term longer. Further it is unclear what the measure of degradation rate is being compared to. Dependent claim 18 is likewise rejected.
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.
Claim(s) 1, 4-5, 9-20, 23-25 and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malinin (US 2008/0279825 A1).
Regarding claim 1, Malinin teaches a cartilage-derived implant suitable for administration to a treatment site and capable of remaining at the treatment site for a time sufficient to promote cartilage repair, regeneration, or both, at the treatment site (see entire document, including ¶ [0005]), the implant having a first shape (it has a shape before being implanted) and comprising a plurality of cartilage fibers each of which has a fiber shape comprising an elongated piece of cartilage tissue which is curled sufficiently to intertwine and entangle with other cartilage fibers to form a cohesive mass capable of being manipulated to produce the implant having the first shape (¶ [0013], the Examiner notes that intertwined fibers would inherently be “curled” to at least some extent where the fibers twine with on another), wherein the implant is sufficiently cohesive to retain the selected first shape until reshaped prior to, during, or both prior to and during, administration to the treatment site (¶ [0013]).
Regarding claim 4, Malinin further teaches a three- dimensional structure which includes: a symmetrical shape, an asymmetrical shape, a simple shape, a complex shape, a sheet, a layer, a film, an irregular mass, a block, a disk, a dome, a sphere or portion thereof, a shape of an anatomical structure or portion thereof, or a combination thereof. Cartilage is inherently a three dimensional structure, any fiber of cartilage will have three dimensions, the “fluff” is many fibers intertwined and will also have three dimensions.
Regarding claim 5, Malinin further teaches the implant has the first shape prior to administration to a treatment site (the shape it holds before being molded into the defect would be its first shape), wherein the first shape was produced by manipulating and shaping a cohesive mass of the curled, and entangled cartilage fibers, by one or more techniques selected from: manually manipulating, molding using a container or mold, casting, three- dimensional printing, and combinations thereof.
Claim 5 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a cartilage-derived implant with a first shape prior to administration. Manufacturing steps such as molding, casting, three-dimensional printing and combinations thereof are not given patentable weight in the claim. “[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 (MPEP 2113).”
Regarding claims 9-13, the claims are directed towards an intended us of the device, namely a particular location in which the device is implanted, which is not given patentable weight. The capability of the device to be reshaped prior to administration to a treatment site, the first or second shaped being selected to conform to an implant site wherein the implant site comprises one or more of: at least a portion of a cavity, space, or pocket, formed by action of clinical assessment, treatment or physiologic response to disease or pathology, at least a portion of a cartilage defect, at least a portion of a shaped cavity of a cartilage defect, and at least a portion of an anatomical feature to be treated, repaired, or substituted and scanning or otherwise imaging to determine the first of second shape of the implant to conform to at least a portion of the implant site meets the requirements of the claims.
Regarding claim 14, Malinin further teaches the implant further comprises a carrier or other biologically-compatible material (¶ [0029]) and is in the form of a paste, a putty, a gel, an injectable mixture, or a combination thereof, which is deformable to produce the implant having the first shape, reshapeable from the first shape to a second shape, or both, wherein the implant remains sufficiently cohesive to retain the selected first shape until reshaped (¶ [0029], the Examiner notes a mixture of cartilage fluff and a bioactive glue could be interpreted as “a paste, a putty, a gel, an injectable mixture or a combination thereof”).
Regarding claim 15, Malinin further teaches the implant is an injectable mixture (¶ [0029], the Examiner notes a mixture of cartilage fluff and a bioactive glue is injectable) capable of delivery to an implant site proximate the cartilage defect using a syringe device. The phrase “the implant is an injectable mixture capable of delivery to an implant site proximate the cartilage defect using a syringe device” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the fluff mixture is considered to be capable of delivery to an implant site proximate the cartilage defect using a syringe device.
Regarding claim 16, Malinin further teaches the implant reshapes to a second shape which conforms to and completely fills the shaped of the cartilage defect (¶ [0013]).
The phrase “when the implant is implanted in a shaped space of a cartilage defect at a treatment site” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the cartilage fluff is considered to be capable of being implants in a shaped space of a cartilage defect at a treatment site.
Regarding claim 17, Malinin further teaches at least a portion of the cartilage fibers are cross-linked with one another (animal articular cartilage is formed of type II collagen that is cross-linked by enzymes such as lysly-oxidase), and the implant has increased stability, increased shape retention, and longer degradation rates. The phrase “the implant has increased stability, increased shape retention, and longer degradation rates” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the cartilage fluff made of type II collagen is considered to be capable of having increased stability, increased shape retention, and longer degradation rates than other cartilage fibers prior to cross-linking. As explained in the 35 U.S.C. 112(b) rejections above, it is unclear what these measurements are compared to, the Examiner notes any fully formed cartilage will have increased stability, increased shape retention, and longer degradation rates thank cartilage fibers formed prior to any cross-linking.
Regarding claim 18, Malinin further teaches comprising one or more of: cross-linked collagen, cross-linked non-collagen components, cross-linked collagen that are cross-linked with non-collagen components, cross-linked biological polymers that are cross-linked with synthetic polymers, and combinations thereof (animal articular cartilage is formed of type II collagen that is cross-linked by enzymes such as lysly-oxidase).
Regarding claim 19, Malinin further teaches the curled cartilage fibers were produced by a technique comprising grating or scraping cartilage tissue recovered from one or more donors using a device having a plurality of a raised cutting surfaces each of which includes a cutting edge which was formed by a die stamping technique (¶ [0023], the Examiner notes shaving cartilage info fluff can be interpreted as grating or shaving).
Claim 19 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a cartilage derived implant with curled cartilage fibers. Manufacturing steps such as grating or scraping are not given patentable weight in the claim. “[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 (MPEP 2113).”
Regarding claim 20, Malinin further teaches the plurality of cartilage fibers were produced from cartilage tissue which contained a population of viable endogenous cells located in their natural distribution within the cartilage tissue (¶ [0029], the Examiner notes animal articular cartilage contains endogenous cells) and wherein at least a portion of the plurality of cartilage fibers contains at least a portion of the population of viable endogenous cells which remain viable and located in their natural distribution within the cartilage fibers (¶ [0029]).
Regarding claim 23, Malinin further teaches at least a portion of the cartilage fibers are lyophilized cartilage fibers (¶ [0025]) and capable of storage at temperatures above zero degrees Celsius (¶ [0018]).
Regarding claim 24, Malinin further teaches at least a portion of the plurality of cartilage fibers are cryopreserved cartilage fibers (¶ [0017]).
Regarding claim 25, Malinin further teaches the cryopreserved cartilage fibers were produced from cartilage tissue which contained a population of viable endogenous cells located in their natural distribution within the cartilage tissue (¶ [0009], articular cartilage which contains endogenous cells) and wherein at least a portion of the cryopreserved cartilage fibers contains at least a portion of the population of viable endogenous cells which remain located in their natural distribution within the cryopreserved cartilage fibers (the cells would remain in their natural distribution when cryopreserved, thus at least a portion of the population of endogenous cells remain in their natural distribution).
Regarding claim 29, Malinin further teaches comprising exogenous cells, which may be cultured on the implant, or not, prior to administration to a treatment site (¶ [0029]).
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.
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 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Malinin in view of Tubo (US 5,723,331 A).
Regarding claim 2, Malinin fails to teach synthetic cartilage fibers. However, Tubo teaches compositions for the repair of articular cartilage that includes the cartilage fibers are different from naturally occurring cartilage fibers and the fiber shape of the cartilage fibers has greater dimensions than naturally occurring cartilage fibers (entire document).. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the cartilage fibers of Malinin to include synthetic fibers as taught by Tubo in order to repair articular cartilage defects in a mammal (abstract, Tubo).
Regarding claim 3, Malinin does not explicitly disclose the cartilage is branched, however it would be obvious to try using unbranched cartilage because the implants is made of cartilage fibers. Choosing a type of cartilage fiber merely involves choosing from a finite number of identified, predictable solutions which are known to be successful, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the invention to use unbranched cartilage (see MPEP 2143). The cartilage is either branched or unbranched.
Regarding claim 28, Malinin teaches the claimed invention except for the plurality of cartilage fibers has an average length of at least about 5 millimeters, and an average thickness of from about 0.5 millimeters to about 5 millimeters (¶ [0014]). It would have been an obvious matter of design choice for the plurality of cartilage fibers has an average length of at least about 5 millimeters, and an average thickness of from about 0.5 millimeters to about 5 millimeters, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04).
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Malinin in view of Chen (US 2009/0024224 A1).
Regarding claim 6, Malinin fails to teach the first shape of the implant is selected to conform to an implant site. However, Chen teaches a cartilage implant that includes the first shape of the implant is selected to conform to an implant site which comprises at least a portion of the treatment site (¶ [0009]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the cartilage-derived implant of Malinin to include the first shape of the implant is selected to conform to an implant site as taught by Chen in order for the implant to be contoured to match the curvature of the defect site (¶ [0098], Chen).
Regarding claims 7-8, the claims are directed towards an intended us of the device, namely a particular location in which the device is implanted, which is not given patentable weight. The capability of the device to be implanted in an implant site that comprises one or more of: at least a portion of a cavity, space, or pocket, formed by action of clinical assessment, treatment or physiologic response to disease or pathology, at least a portion of a cartilage defect, at least a portion of a shaped cavity of a cartilage defect, and at least a portion of an anatomical feature to be treated, repaired, or substituted and scanning or otherwise imaging to determine the first of second shape of the implant to conform to at least a portion of the implant site meets the requirements of the claims.
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Malinin in view of Brockbank (US 2014/0113273 A1).
Regarding claim 21, Malinin fails to teach at least a portion of the population of endogenous cells which remain located in their natural distribution within the cartilage fibers comprises at least 50% viable endogenous cells. However, Brockbank teaches preservation of biomaterial that includes at least a portion of the population of endogenous cells which remain located in their natural distribution within the cartilage fibers comprises at least 50% viable endogenous cells (entire document, ¶ [0031]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the preservation of the implant of Malinin to include at least a portion of the population of endogenous cells which remain located in their natural distribution within the cartilage fibers comprises at least 50% viable endogenous cells as taught by Brockbank in order to reduce or prevent the loss of biomaterial properties (¶ [0009], Brockbank).
Regarding claim 22, Malinin fails to teach at least a portion of the population of endogenous cells which remain located in their natural distribution within the cartilage fibers comprises at least 90% viable endogenous cells. However, Brockbank teaches preservation of biomaterial that includes at least a portion of the population of endogenous cells which remain located in their natural distribution within the cartilage fibers comprises at least 90% viable endogenous cells (entire document, ¶ [0031]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the preservation of the implant of Malinin to include at least a portion of the population of endogenous cells which remain located in their natural distribution within the cartilage fibers comprises at least 90% viable endogenous cells as taught by Brockbank in order to reduce or prevent the loss of biomaterial properties (¶ [0009], Brockbank).
Claim(s) 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Malinin in view of Salzmann (US 6,365,405 B1).
Regarding claim 26, Malinin fails to teach the at least a portion of the population of endogenous cells which remain located in their natural distribution within the cryopreserved cartilage fibers comprises at least 50% viable endogenous cells. However, Salzmann teaches preparation of chondrocytes that includes the at least a portion of the population of endogenous cells which remain located in their natural distribution within the cryopreserved cartilage fibers comprises at least 50% viable endogenous cells (entire document, col 5 lines 43-52). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the cryogenic preservation of cartilage fibers of Malinin to include the at least a portion of the population of endogenous cells which remain located in their natural distribution within the cryopreserved cartilage fibers comprises at least 50% viable endogenous cells as taught by Salzmann in order to preserve eucaryotic cells and to freeze them without substantially affecting their viability (col 5 lines 43-52, Salzmann).
Regarding claim 27, Malinin fails to teach the at least a portion of the population of endogenous cells which remain located in their natural distribution within the cryopreserved cartilage fibers comprises at least 65% viable endogenous cells. However, Salzmann teaches preparation of chondrocytes that includes the at least a portion of the population of endogenous cells which remain located in their natural distribution within the cryopreserved cartilage fibers comprises at least 65% viable endogenous cells (entire document, col 5 lines 43-52). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the cryogenic preservation of cartilage fibers of Malinin to include the at least a portion of the population of endogenous cells which remain located in their natural distribution within the cryopreserved cartilage fibers comprises at least 65% viable endogenous cells as taught by Salzmann in order to preserve eucaryotic cells and to freeze them without substantially affecting their viability (col 5 lines 43-52, Salzmann).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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