DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s response filed June 4, 2026 has been received and entered into the application file. All arguments have been fully considered. Claims 1, 4-7, 9-12, 15-18, 20-25, 27-29, and 32-34 are currently pending. Claims 2-3, 8, 13-14, 19, 26, and 30-31 are cancelled. Claims 1, 23 and 32 are currently amended. Claim 34 is newly added.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/4/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
REJECTION(S) WITHDRAWN
Claim Rejections - 35 USC § 103
RE: Rejection of Claims 1, 4, 9, 12, 15 and 20 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Attawia, as evidenced by Castro-Malaspina (Blood 1980) and Morikawa:
Applicant’s remarks regarding culturing in hypoxic conditions, in view of Attawia’s teaching of administering uncultured cells, is found persuasive. Therefore, the previous rejection of record is withdrawn.
Rejection of Claims 5 and 16 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Attawia, as evidenced by Blood 1980 and Morikawa, and further in view of Leckie;
Rejection of Claims 6-7, 10, 17-18 and 21 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Attawia, as evidenced by Blood 1980 and Morikawa, and further in view of Singh; and
Rejection of Claims 11 and 22 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Attawia, as evidenced by Blood 1980 and Morikawa, and further in view of Song:
For the reasons discussed above, the rejection over Attawia, as evidenced by Castro-Malaspina (Blood 1980) and Morikawa is withdrawn, and thus the rejection of claims 5-7, 10-11, 16-18, 21 and 22 that is based on the same basis is likewise withdrawn.
Rejection of Claims 23-25 and 31 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Singh:
Applicant’s amendment submitted 6/4/2026 has cancelled claim 31 and amended claim 23 to now recite the limitation “delivering by injection”.
Applicant’s remarks are found persuasive regarding the limitation directed to “injection” and the teaching of Singh regarding the disclosed transplantation. Therefore, the previous rejection of record is withdrawn.
Rejection of Claims 27-29 and 33 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Singh, in view of Song et al., and as evidenced by R&D Systems; and
Rejection of Claim 32 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Singh, in view of Leckie:
For the reasons discussed above, the rejection over Singh is withdrawn, and thus the rejection of claims 27-29 and 32-33 that is based on the same basis is likewise withdrawn.
NEW GROUND(S) OF REJECTION
Claim Rejections - 35 USC § 112
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.
Claim 34 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating an individual in need of cartilage repair, comprising the steps of: isolating and culturing fibroblasts from a biopsy from a donor; and delivering by injection the fibroblasts to a joint of the individual, thereby treating said individual, wherein fibroblasts were exposed to hypoxic conditions, wherein the fibroblasts are cultured in hypoxic conditions for 1 or more days prior to delivering the composition, wherein the joint comprises a joint between vertebrae and/or intervertebral discs, and wherein the fibroblasts are not subjected in vitro to exogenous growth factors, exogenous matrix molecules, mechanical strain that comprises intermittent compressive mechanical strain, or a combination thereof, the specification does not reasonably provide enablement for a method of treating an individual in need of cartilage repair, comprising the steps of: isolating and culturing fibroblasts from a biopsy from a donor; and delivering by injection the fibroblasts to a joint of the individual, thereby treating said individual, wherein fibroblasts were exposed to hypoxic conditions, wherein the fibroblasts are cultured in hypoxic conditions for 1 or more days prior to delivering the composition, wherein the joint comprises a joint between vertebrae and/or intervertebral discs, and wherein the fibroblasts are not subjected in vitro to:
(1) any endogenous growth factors (e.g., fibroblast growth factor);
(2) any endogenous matrix molecules (e.g., collagen); or
(3) any mechanical strain (e.g. intermittent pipetting of cells in culture medium or buffer when passaging cells).
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. The court in Wands states: “Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue’, not ‘experimentation.’” (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary; (2) the amount or direction or guidance presented; (3) the presence or absence of working examples; (4) the nature of the invention; (5) the state of the prior art; (6) the relative skill of those in the art; (7) the predictability or unpredictability of the art; and (8) the breadth of the claims. While all these factors are considered, a sufficient number are discussed below so as to create a prima facie case.
Nature of the invention: new claim 34 recites:
“The method of claim 23, wherein the fibroblasts are not subjected in vitro to growth factors, matrix molecules, mechanical strain, or a combination thereof.”
Breadth of the claims: Claim 34, as currently drafted, broadly encompasses delivering fibroblasts to a joint of an individual for the purpose of treating an individual in need of cartilage repair in vivo, wherein prior to the delivery of the fibroblasts, and in the in vitro setting, the cells are manipulated such that they are not subjected to:
1) any growth factors, including those endogenously secreted by fibroblasts, e.g., fibroblast growth factor, or those present in serum supplemented to the in vitro culture,
2) any matrix molecules, including those endogenously secreted by fibroblasts (e.g. collagen), or
3) any mechanical strain, including the intermittent addition of fresh culture medium during normal in-vitro expansion of fibroblasts,) or shear fluid stress (e.g. intermittent pipetting of cells in culture medium or buffer when passaging cells).
The state of the prior art/ predictability or unpredictability of the art:
Caplan et al., (discussed below, U.S. Patent No. 4,609,551; PTO-892) is directed to cell-based methods for enhancing local chondrogenesis or osteogenesis. Caplan teaches initially exposing fibroblasts, in vitro, to a soluble bone protein in order to initiate chondrogenesis in the fibroblasts, and thereafter suspending (i.e., mechanical strain) the fibroblasts in a solution suitable for intra-articular injection (i.e., mechanical strain). (Abstract; col. 2, lines 3-17, 23-26 and 59-62). Caplan teaches isolating and culturing fibroblasts from skin biopsies (i.e., mechanical strain) (col 3, lines 10-20).
Sevrain et al., (U.S. Patent Application Publication No. US 2007/0184033; IDS 11/21/2021), discloses methods and compositions for repairing damaged cartilage using human dermal fibroblasts (HDFs) in combination with an inert structure (Abstract). The HDFs are differentiated into chondrocyte-like cells (paragraph [0022]). Sevrain teaches obtaining the human dermal fibroblasts by non-invasive harvesting, such as a punch biopsy of skin tissue and dissection to remove fat and deep dermis, followed by mechanical separation of dermal and epidermal fragments, thus the punch biopsy followed by mechanical separation (i.e., mechanical strain) are steps that apply intermittent hydrostatic pressure to the dermal fibroblasts (paragraph [0121]).
The relative skill of those in the art: The relative skill of those in the art is high.
The amount of direction or guidance presented: The specification speaks generally about obtaining human dermal fibroblasts from biopsy specimens, at paragraphs [0012], [0034]-[0035], [0041] and [0048], prior to delivering the cells to a joint of an individual. However, guidance is not given that identifies obtaining the fibroblasts, prior to the delivery of the human dermal fibroblasts, wherein in the in vitro setting the cells are not subjected to any type of innate growth factors, endogenous matrix molecules (e.g. collagen) and mechanical strain such as the intermittent addition of fresh culture medium during normal in-vitro expansion of fibroblasts,) or shear fluid stress (e.g. intermittent pipetting of cells in culture medium or buffer when passaging cells). No guidance is provided as to how the fibroblasts that are in vitro cultured prior to delivery are prevented from producing endogenous growth factors and extracellular matrix. No guidance is provided as to how the fibroblasts are obtained, prior to delivery to a joint of an individual, without in vitro shear fluid stress such as pipetting of cells in buffer or culture medium, when cells are passaged, for example.
The presence or absence of working examples: No working examples are provided for:
(i) delivering fibroblasts to a joint of an individual, wherein prior to delivering, the fibroblasts are not subjected in vitro to any endogenous growth factors, or endogenous matrix molecules or any type of mechanical strain (claim 34).
As such the specification fails to provide specific guidance to such methods and one would not expect to be able to extrapolate the guidance provided in the specification to include delivering fibroblasts to a joint of an individual, wherein prior to delivering, the fibroblasts are not subjected to endogenous growth factors, endogenous matrix molecules and any type of mechanical strain e.g., intermittent hydrostatic pressure or shear fluid stress. See MPEP 2164.
The quantity of experimentation necessary: Accordingly, in view of the lack of teachings or guidance provided by the specification, with regard to (i) delivering fibroblasts to a joint of an individual, wherein prior to delivering, the fibroblasts are not subjected to in vitro endogenous growth factors, endogenous matrix molecules and any type of mechanical stress, such as intermittent hydrostatic pressure or shear fluid stress, at the time of filing the skilled artisan would need to perform an undue amount of experimentation without a predictable degree of success to implement the invention as claimed.
It is again noted, as discussed above, Applicant is enabled for culturing the fibroblasts in an in-vitro culture prior to delivering the fibroblasts to a joint of an individual, and during the in-vitro cell culture the cells are not exposed to serum (i.e. contains exogenous growth factors), the cells are not exposed to exogenous matrix molecules or antibiotics, the cells are not exposed to intermittent compressive mechanical strain.
Written Description:
Claim 34 is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 34 recites the limitation “wherein the fibroblasts are not subjected in vitro to growth factors, matrix molecules, mechanical strain, or a combination thereof.”
Upon review of the specification, the specification shows that Applicants have not provided sufficient description of the invention to support they were in possession of the claimed treatment method wherein the fibroblasts are not subjected in vitro to any growth factors (e.g., endogenous growth factors produced by fibroblasts), any matrix molecules (e.g., collagen produced by fibroblasts), any mechanical strain (e.g. intermittent pipetting of cells in culture medium or buffer when passaging cells), or a combination thereof.
In the instant case the specification at [0017] and [0019] discloses:
“In certain embodiments, the fibroblasts are not provided growth factors, matrix molecules, mechanical strain, or a combination thereof, prior to or during or following implantation into a vertebrae.”
The specification at [0037.1] discloses:
“In certain aspects, the invention generates natural tissue in vitro. Such as from stem cells, chondrocytes, and so forth. More particularly, but not exclusively, the present invention relates to a method for growing and differentiating Human Fibroblasts into chondrocyte-like cells, for example. The cells, which are autologous in certain embodiments, are put into a scaffold matrix made of one or more biopolymers. Such as to mimic a natural matrix. The scaffold may be seeded in vitro, and in certain aspects growth factors are provided to the cells, the matrix, or both. The scaffold is put into a bioreactor, which is a system for perfusion of medium and allows application of mechanical force to the scaffold. Following delivery of the force, cells are assisted in differentiation, especially for generation of cartilage.”
A review of the specification shows that Applicants have not provided sufficient description of the invention to support they were in possession of the fibroblasts are not subjected in vitro to any growth factors (e.g., endogenous growth factors produced by fibroblasts), any matrix molecules (e.g., collagen produced by fibroblasts), any mechanical strain (e.g. intermittent pipetting of cells in culture medium or buffer when passaging cells), or a combination thereof.
Accordingly, the claims are considered to lack sufficient written description and are properly rejected under 35 USC 112, first paragraph.
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 34 is 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 pre-AIA the applicant regards as the invention.
Regarding claim 34 and the phrase “are not subjected in vitro to growth factors, matrix molecules, mechanical strain, or a combination thereof”, it is noted that claim 34 depends from claim 23 and claim 23 requires the fibroblasts are cultured for 1 or more days prior to delivering to an individual. Thus, it is unclear as to how the fibroblasts are cultured for 1 or more days without being subjected to native growth factors and matrix molecules that are produced by the cells. It is unclear how the culturing is conducted to avoid any in vitro mechanical strain, e.g., physical manipulation of culture vessels or shear fluid stress, that would occur when culture medium is replenished or cells are passaged.
Appropriate clarification is appreciated.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 4, 6-7, 9-10, 12, 15, 17-18, 20-25, 27-29 and 33 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Caplan et al., (US Patent No. 4,609,551; PTO-892) (“Caplan”), in view of Taylor et al., (J. Cell Physiol. (1978) 95; 33-40; see PTO-892) (“Taylor”) and Singh et al., (previously cited).
Regarding claims 1, 12 and 23, Caplan is directed to cell-based methods for enhancing local chondrogenesis or osteogenesis. Caplan teaches initially exposing fibroblasts to a soluble bone protein in order to initiate chondrogenesis in the fibroblasts. Subsequent to the exposing of the fibroblasts to the soluble bone protein, the fibroblasts are administered in manner that that prevents diffusion away from the implantation site thus promoting in vivo chondrogenesis. Caplan teaches delivery of the fibroblasts includes suspending in a solution suitable for intra-articular injection (reads on “composition consists of fibroblasts and an amount of fluid needed to suspend the fibroblasts” (claim 1) and reads on “wherein the composition consists essentially of fibroblasts and an amount of fluid needed to suspend the fibroblasts” (claim 12) ) (Abstract; col. 2, lines 3-17, 23-26 and 59-62). Caplan teaches the fibroblasts are resuspended in 10% sucrose (i.e., amount of fluid needed to suspend the fibroblasts) and injected intra-articularly to a joint cavity (reads on “delivering a composition to one or more joints of the individual” (claim 1) and reads on “delivering by injection the fibroblasts to a joint of the individual” (claim 23)), wherein the sucrose solution facilitates attachment of the fibroblasts to damaged cartilage surface, thus improving joint function at surfaces damaged by trauma or disease (i.e., treating an individual in need of cartilage repair) (col 3, lines 49-60).
Further regarding claim 23 and the limitation “isolating and culturing fibroblasts from a biopsy from a donor”, Caplan teaches isolating and culturing fibroblasts from skin biopsies (col 3, lines 10-20).
Further regarding claims 1, 12 and 23 and the limitation that the joint comprises a joint between vertebrae and /or intervertebral discs, it is noted that although Caplan teaches delivery to a joint, Caplan does not further specify treating a joint that is between vertebrae and /or intravertebral discs. However, Thorne is directed to methods for providing pain relief and enhancing the healing of painful disruptions associated with damaged or degenerated joints. Thorne teaches methods for repairing damaged or degenerated synovial joints or spinal discs (intervertebral discs) by injecting a cell-based composition, e.g., dermal fibroblasts between intervertebral discs, wherein the fibroblasts are injected alone, and thereafter fibrin or other in situ curable material is subsequently injected (Abstract; paragraphs [0005], [0016], [0037]-[0038] and [0043]; Claims 1, 3 and 4).
Thorne’s method consists of (1) manipulating the fibroblasts during in vitro culture prior to delivery and (2) subsequently delivering by injection the manipulated fibroblasts to spinal discs (a joint), specifically delivery into the nucleus pulposus or within the annulus fibrosus of the spinal disc (paragraphs [0016] and [0054]).
Thus, Thorne has established it was known that fibroblasts cold be administered to intervertebral discs for treating damaged or degenerated intervertebral discs.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer Caplan’s fibroblast composition to intervertebral discs.
The person of ordinary skill in the art would have been motivated to modify the method of Caplan to include treating intervertebral discs, as taught by Thorne, for the predictable result of successfully promoting chondrogenesis in damaged /degenerated intervertebral discs, thus meeting the limitation of claim 1.
The skilled artisan would have had a reasonable expectation of success in combining the teachings of Caplan and Thorne because each of these teachings are directed at therapeutic uses of fibroblasts for treating degenerated cartilage.
Further regarding claims 1, 12 and 23 and the limitation the fibroblasts have been exposed to hypoxic conditions, wherein the fibroblasts have been cultured in hypoxic conditions for 1 or more days prior to delivery of the cell composition, it is noted that Caplan does not further comment on the fibroblasts have been cultured in hypoxic conditions for 1 or more days prior to delivery of the cell composition.
However, Taylor teaches subjecting fibroblasts (WI-38 cells) to hypoxic culture conditions (1% O2) which resulted in enhanced cell survival and proliferation (Abstract; Fig. 1; Effect of P02 on life span of human diploid fibroblasts, pages 36-38) and Singh is directed to evaluating neonatal human dermal fibroblasts (nHDFs) as a potential cell source for treating intervertebral disc repair (Abstract), and teaches hypoxia culture conditions (2% O2) have been found to influence human dermal fibroblasts grown in monolayers by up-regulating the synthesis of transforming growth factor (TGF)-β1 which is a known chondrogenic factor (page 2, left col, first full paragraph).
Therefore, taking into hand the teachings of Taylor and Singh, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include culturing the fibroblasts in hypoxic conditions for 1 or more days prior to delivering the composition.
The person of ordinary skill in the art would have been motivated to modify the method of Caplan to include culturing the fibroblasts in hypoxic conditions for 1 or more days prior to delivering the composition for the predictable result of successfully enhancing fibroblast cell survival and proliferation, as well as promoting chondrogenesis, thus meeting the limitation of claims 1, 12 and 23.
The skilled artisan would have had a reasonable expectation of success in combining the teachings of Caplan with Taylor and Singh because each of these teachings are directed at therapeutic uses of fibroblasts.
Regarding claims 4 and 15, Caplan teaches delivery by injection, thus meeting the limitation of claims 4 and 15.
Regarding claims 9, 20 and 24, Caplan teaches allografts (col 2, lines 26-29), i.e., the fibroblasts are allogeneic, thus meeting the limitations of claims 9, 20 and 24.
Regarding claims 10 and 21, Caplan teaches dermal fibroblasts (col 3, lines 10-20), thus meeting the limitations of claims 10 and 21.
Regarding claims 11, 22, 27 and 33, Caplan teaches the fibroblasts are suspended in fluid that is 10% sucrose, thus meeting the limitation of claims 11, 22, 27 and 33.
Regarding claim 25, Caplan teaches the biopsy is a skin biopsy (col 3, lines 10-20), thus meeting the limitation of claim 25.
Regarding claims 6-7, 17-18 and 28-29 and the limitations directed to the fluid needed to suspend the fibroblasts comprises buffer, amino acids, salts, glucose and/or vitamins (claims 6, 17 and 28) and said buffer, amino acids, salts, glucose and/or vitamins are components of DMEM (claims 7, 18 and 29), it is noted that although Caplan teaches the fluid needed to suspend the fibroblasts comprises 10% sucrose (col 3, lines 49-60). Caplan does not further comment on the fluid comprising growth medium comprising components of DMEM. However, Singh is directed to evaluating human dermal fibroblasts as a potential cell source for treating intervertebral disc repair (Abstract) and teaches the use of DMEM as a growth medium for the human fibroblasts (page 2, Cell expansion).
Thus, Singh has established it was known at the time of filing the instant invention to use DMEM as a growth medium for therapeutic fibroblasts. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time of filing the invention to include DMEM growth medium with the sucrose solution since both are known fluids for suspending fibroblasts. Therefore, one of ordinary skill in the art would recognize this as simply substituting one type of fibroblast suspension fluid for another useful for the same purpose ((KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007) pg 14 and 12).
The skilled artisan would have had a reasonable expectation of success in combining the teachings of Singh with Caplan because each of these teachings are directed at using fibroblasts for disc degeneration therapy.
Claims 5, 16 and 32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Caplan, in view of Taylor and Singh, as applied to claims 1, 4, 9-10, 12, 15, 20-25, 27 and 33, and further in view of Leckie et al., (Spine J. 2011 Oct 22;12(1):7–20; previously cited) (“Leckie”).
The teaching of Caplan, in view of Taylor and Singh, is set forth above.
Regarding claims 5, 16 and 32, although Caplan teaches delivery via injection, Caplan does not further comment on the injection is conducted with a syringe. However, Leckie is directed to methods of treating intervertebral disc degeneration wherein the therapeutic agent is delivered into the nucleus pulposus of intervertebral discs (Abstract). Leckie teaches delivering the therapeutic agent to L2-L3 discs using a Hamilton 100-mL syringe and a Hamilton 30-gauge sharp-tipped needle (Injection surgery, left column, page 10). Thus, Leckie has established it was known at the time of filing the invention to deliver therapeutic agents to intervertebral discs by using a needle and syringe.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time of filing the invention to substitute a needle and syringe, as disclosed by Leckie, for Caplan’s injection device since both apparatuses are known to successfully deliver therapeutic agents for treating intervertebral disc degeneration. Therefore, one of ordinary skill in the art would recognize this as simply substituting one type of injection apparatus for another useful for the same purpose ((KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007) pg 14 and 12).
The skilled artisan would have had a reasonable expectation of success in combining the teachings of Leckie with Caplan because each of these teachings are directed at treating intervertebral disc degeneration.
Response to Remarks
Rejections under 35 USC 103:
As set forth above the previous rejections of record have been withdrawn.
Conclusion
No claim is allowed.
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E. YVONNE PYLA
Primary Examiner
Art Unit 1633
/EVELYN Y PYLA/ Primary Examiner, Art Unit 1633
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