DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is responsive to papers filed 02/24/2026
Claims 1, 5, 14, 16-17, 21, 24, and 27 have been amended. Claim 4 has been newly canceled and no claims have been newly added.
Claims 1-3, 5, 8, 10-11, 14-17, 21-22, 24-25, 27, 29-32, 34, 36-39 are currently pending.
Claims 5 and 24-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/12/2025.
Claims 1-3, 8, 10-11, 14-17, 21-22, 27, 29-32, 34, 36-39 have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claims 24-25 are objected to because of the following informalities:
Claims 24 and 25 have the wrong status as both claims have been withdrawn and are not under examination. The status of claim 24 should have been “Withdrawn-Currently Amended” and the status of claim 25 should have been “Withdrawn”.
Appropriate correction is required.
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) 1-3, 8, 10-11, 14-17, 27, 29, 32, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Silveira et al (PLOS ONE, 2014-from IDS filed 03/24/2022) in view of O’Heeron et al (US 2014/0314726-from IDS filed 03/24/2022) and Rawal et al (Journal of Periodontal Research 2011-from IDS filed 03/24/2022).
Regarding claims 1-3, 8, 14, 27 and 34, Silveira disclose a method of treating a degenerative disc disease in an individual comprising administering cannabidiol to an individual wherein the cannabidiol was administered by intradiscal injection (abstract, page 3).
Silveira do not disclose also administering at least one therapeutic intervention for degenerative disc disease in addition to the cannabidiol, such as fibroblasts.
O’Heeron disclose methods of treating degenerative disc disease by administering fibroblasts for the repair of spinal discs (page 1 para 11, page 5 claims 9-10). In some cases, the fibroblasts are manipulated following being obtained (page 2 para 17).
Rawal disclose the use of cannabidiol for augmenting the regenerative activity of fibroblasts by increasing the production of extracellular matrix and TGF-beta while simultaneously decreasing its degradation (page 1 conclusion, page 2 column 3, page 4 results, page 6). The cannabidiol used is from Sigma Aldrich and supplied in concentrations of 1.0 ml/ml (which corresponds to the CAS registry number 13956-29-1, thus (-)-cannabidiol)(page 2, column 3).
One of ordinary skill in the art would have been motivated to include administering a therapeutic intervention along with cannabidiol to a patient with degenerative disc disease because it is deemed prima facie obvious to combine compositions known for the same purpose. “[T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (MPEP 2144.06). One of ordinary skill in the art would have been motivated to include administering a therapeutically effective amount of augmented fibroblasts along with cannabidiol to a patient with degenerative disc disease because both compositions are known in the art for the beneficial treatment of degenerative disc disease. Additional motivation is provided by O’Heeron which teaches co-administering one or more agents together with the fibroblasts in particular for the treatment of a disc medical condition (page 1 para 13). O’Heeron disclose that the co-administration can be before, during or after delivery of the fibroblasts (page 1 para 13). O’Heeron disclose that the fibroblasts can be manipulated in some cases (page 2 para 17) and as such agents, such as cannabidiol which enhance the production of extracellular matrix in fibroblasts as taught by Rawal, enhance the very fibroblast property that O’Heeron states provides tissue regeneration when fibroblasts are administered to the disc (page 4 para 44). One of ordinary skill in the art would have had a reasonable expectation of success because Rawal disclose the use of cannabidiol for augmenting the regenerative activity of fibroblasts by increasing the production of extracellular matrix and TGF-beta while simultaneously decreasing its degradation (page 1 conclusion, page 2 column 3, page 4 results, page 6).
Regarding claims 10-11, 15, Silveira disclose administering cannabidiol to an individual wherein the cannabidiol was administered by intradiscal injection (abstract, page 3). O’Heeron also disclose that their fibroblasts are to be administered in nucleus pulposus (page 5 claim 10) which is located within the disc for individuals with degenerative disc disease. One of ordinary skill in the art would have been motivated with a reasonable expectation of success to administer both cannabidiol and fibroblasts by intra-disc injection which would then provide exogenous cells to the nucleus pulposus within the disc. Utilizing a dosage and frequency of cannabidiol that reduced apoptosis of cells in the nucleus pulposus .would have been obvious as this would allow for alleviation of the symptoms of the degenerative disc disease and a matter of routine experimentation and optimization.
Regarding claims 16-17, while the cited references do not explicitly disclose these claimed features of the fibroblasts, they do render obvious the combination of cannabidiol and fibroblasts for coadministration into an individual with a degenerative disc disease. Providing guidance on instances where the method steps of the prior art and instant claims are the same, Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) states “[T]hat since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims.”
Regarding claims 29 and 32, while Silveira does not disclose administering cannabidiol at the claimed total daily amount or the number of daily doses, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05).
The selection of specific concentrations and daily dosage number clearly would have been a routine matter of optimization and experimentation on the part of the artisan of ordinary skill, said artisan recognizing that the therapeutic effectiveness of the treatment would have been affected by these concentrations and amounts.
Therefore, the combined teachings of Silveira et al, O’Heeron et al and Rawal et al render obvious Applicant’s invention as claimed.
Claim(s) 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Silveira et al (PLOS ONE, 2014-from IDS filed 03/24/2022) in view of O’Heeron et al (US 2014/0314726-from IDS filed 03/24/2022) and Rawal et al (Journal of Periodontal Research 2011-from IDS filed 03/24/2022) as applied to claims 1-3, 8, 10-11, 14-17, 27, 29, 32, and 34 above, and further in view of Hicks et al (WO 2016/077565).
Regarding claims 21-22, the combined teachings of Silveira et al, O’Heeron et al and Rawal et al render obvious Applicant’s invention as described above, but do not explicitly disclose treating the fibroblasts with human chorionic gonadotropin (hCG).
Hicks disclose that hCG is beneficial and useful for treating chronic pain in disorders such as disc herniation (abstract, page 12 para 49, page 32 para 122). Hicks also disclose that hCG can be administered in various forms such as injections and can be mixed with any conventional additive or excipient (pages 12-13 para 52). The dosage is taught to vary depending on the symptoms, age, body weight, nature and severity of the disorder, route of administration and form in general and a daily dosage can be 0.01 to 5000 IU of hCG (page 13 para 52).
One of ordinary skill in the art would have been motivated to administer hCG along with fibroblasts with cannabidiol in the method of Silveira because both Hicks and O’Heeron teach and suggest that these are agents that are beneficial and useful in the treatment of degenerative disc disease. O’Heeron specifically indicate that fibroblasts can be combined for co-administration with pain killers (page 1 para 13) and Hicks teach that hCG is beneficial for the chronic pain caused by disc herniation. The co-administration of fibroblasts and hCG would provide the contact of the fibroblasts with hCG and thus treating them. The concentration of the hCG used would have been a matter of routine optimization and experimentation as suggested by Hicks (page 13 para 52). One of ordinary skill in the art would have had a reasonable expectation of success because Hicks teach that hCG can be administered in various forms, including by injection.
Therefore, the combined teachings of Silveira et al, O’Heeron et al, Rawal et al and Hicks et al render obvious Applicant’s invention as claimed.
Claim(s) 36-39 are rejected under 35 U.S.C. 103 as being unpatentable over Silveira et al (PLOS ONE, 2014-from IDS filed 03/24/2022) in view of O’Heeron et al (US 2014/0314726-from IDS filed 03/24/2022) and Rawal et al (Journal of Periodontal Research 2011-from IDS filed 03/24/2022) as applied to claims 1-3, 8, 10-11, 14-17, 27, 29, 32, and 34 above, and further in view of Isa et al (Science Advances 2018).
Regarding claims 36-39, the combined teachings of Silveira et al, O’Heeron et al and Rawal et al render obvious Applicant’s invention as described above, but do not explicitly disclose wherein the cannabidiol is administered with a localization composition such as hyaluronic acid.
Isa disclose that therapeutic applications of high-molecular weight hyaluronic acid (long chain hyaluronic acid) attenuate inflammation and pain in a number of clinical conditions, including IVD (intravertebral disc) degeneration (pages 1-2). The hyaluronic acid has potential use as a carrier system in IVD therapeutic strategies (page 2 column 1).
One of ordinary skill in the art would have been motivated to administer hyaluronic acid (HA), specifically high molecular weight HA (long chain HA) along with fibroblasts with cannabidiol in the method of Silveira because both Isa and O’Heeron teach and suggest that these are agents that are beneficial and useful in the treatment of degenerative disc disease. O’Heeron specifically indicate that fibroblasts can be combined for co-administration with pain killers (page 1 para 13) and Isa teach that high molecular weight HA (long chain HA) is beneficial for the treatment of pain caused by disc degeneration. One of ordinary skill in the art would have had a reasonable expectation of success because Isa teach that HA can be administered in various forms, including by injection (page 14 column 1).
Therefore, the combined teachings of Silveira et al, O’Heeron et al, Rawal et al and Isa et al render obvious Applicant’s invention as claimed.
Claim(s) 1-3, 8, 10-11, 14-17, 27, 29-32, 34, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Silveira et al (PLOS ONE, 2014-from IDS filed 03/24/2022) in view of Messenheimer et al (WO 2019/034985), O’Heeron et al (US 2014/0314726-from IDS filed 03/24/2022) and Rawal et al (Journal of Periodontal Research 2011-from IDS filed 03/24/2022).
Regarding claims 1-3, 8, 14, 27, 29-32, 34 and 36, Silveira disclose a method of treating a degenerative disc disease in an individual comprising administering cannabidiol (abstract, page 3).
Silveira do not disclose also administering at least one therapeutic intervention for degenerative disc disease in addition to the cannabidiol and do not include a permeation enhanced gel.
Messenheimer disclose the use of cannabidiol formulated for the treatment of back pain caused by osteoarthritis (page 6 para 39). The cannabidiol can be combined with a permeation enhancer (therapeutic intervention), a bulking agent or a thickening agent (localization components)(page 6 para 40) and can be formulated as a permeation-enhanced gel (localization component)(page 3 para 13). The cannabidiol includes (-)-cannabidiol (page 3 para 12) and can be administered in two daily doses (page 3 para 16) and in an effective amount of 250-500 mg daily (page 3 para 11).
One of ordinary skill in the art would have been motivated to include administering a therapeutic intervention along with cannabidiol to a patient with degenerative disc disease because it is deemed prima facie obvious to combine compositions known for the same purpose. “[T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (MPEP 2144.06). One of ordinary skill in the art would have been motivated to include administering a therapeutically effective amount of cannabidiol enhanced as suggested by Messenheimer along with the intra-discal administration of cannabidiol as taught by Silveira to a patient with degenerative disc disease because both compositions are known in the art for the beneficial treatment of back pain caused by damaged joints (degenerative discs). Additional motivation is provided by Messenheimer to co-administered (-)-cannabidiol with additional agents to enhance the therapeutic pain relief from joint pain particularly joint pain in the back (spinal disc pain). The addition of a permeation enhancer (an additional therapeutic intervention) as well as other agents such as an antioxidant, bulking agent, thickening agent or pH modifier would have been obvious because they would have enhanced the therapeutic pain-relieving effect of the cannabidiol as suggested by Messenheimer. One of ordinary skill in the art would have had a reasonable expectation of success because Messenheimer teach and suggest that their treatment provided reduced frequency and severity of pain experienced by the patient with limited side-effects (page 3 para 9) and include concentrations and dosage frequency of cannabidiol as well.
Silveira do not disclose also administering at least one therapeutic intervention for degenerative disc disease in addition to the cannabidiol, such as fibroblasts.
O’Heeron disclose methods of treating degenerative disc disease by administering fibroblasts for the repair of spinal discs (page 1 para 11, page 5 claims 9-10). In some cases, the fibroblasts are manipulated following being obtained (page 2 para 17).
Rawal disclose the use of cannabidiol for augmenting the regenerative activity of fibroblasts by increasing the production of extracellular matrix and TGF-beta while simultaneously decreasing its degradation (page 1 conclusion, page 2 column 3, page 4 results, page 6). The cannabidiol used is from Sigma Aldrich and supplied in concentrations of 1.0 ml/ml (which corresponds to the CAS registry number 13956-29-1, thus (-)-cannabidiol)(page 2, column 3).
One of ordinary skill in the art would have been motivated to include administering a therapeutic intervention along with cannabidiol to a patient with degenerative disc disease because it is deemed prima facie obvious to combine compositions known for the same purpose. “[T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (MPEP 2144.06). One of ordinary skill in the art would have been motivated to include administering a therapeutically effective amount of augmented fibroblasts along with cannabidiol to a patient with degenerative disc disease because both compositions are known in the art for the beneficial treatment of degenerative disc disease. Additional motivation is provided by O’Heeron which teaches co-administering one or more agents together with the fibroblasts in particular for the treatment of a disc medical condition (page 1 para 13). O’Heeron disclose that the co-administration can be before, during or after delivery of the fibroblasts (page 1 para 13). O’Heeron disclose that the fibroblasts can be manipulated in some cases (page 2 para 17) and as such agents, such as cannabidiol which enhance the production of extracellular matrix in fibroblasts as taught by Rawal, enhance the very fibroblast property that O’Heeron states provides tissue regeneration when fibroblasts are administered to the disc (page 4 para 44). One of ordinary skill in the art would have had a reasonable expectation of success because Rawal disclose the use of cannabidiol for augmenting the regenerative activity of fibroblasts by increasing the production of extracellular matrix and TGF-beta while simultaneously decreasing its degradation (page 1 conclusion, page 2 column 3, page 4 results, page 6).
Regarding claims 8, 10-11, 15, Silveira disclose administering cannabidiol to an individual wherein the cannabidiol was administered by intradiscal injection (abstract, page 3). O’Heeron also disclose that their fibroblasts are to be administered in nucleus pulposus (page 5 claim 10) which is located within the disc for individuals with degenerative disc disease. One of ordinary skill in the art would have been motivated with a reasonable expectation of success to administer both cannabidiol and fibroblasts by intra-disc injection which would then provide exogenous cells to the nucleus pulposus within the disc. Utilizing a dosage and frequency of cannabidiol that reduced apoptosis of cells in the nucleus pulposus .would have been obvious as this would allow for alleviation of the symptoms of the degenerative disc disease and a matter of routine experimentation and optimization.
Regarding claims 16-17, while the cited references do not explicitly disclose these claimed features of the fibroblasts, they do render obvious the combination of cannabidiol and fibroblasts for coadministration into an individual with a degenerative disc disease. Providing guidance on instances where the method steps of the prior art and instant claims are the same, Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) states “[T]hat since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims.”
Regarding claims 29 and 32, while Silveira does not disclose administering cannabidiol at the claimed total daily amount or the number of daily doses, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05).
The selection of specific concentrations and daily dosage number clearly would have been a routine matter of optimization and experimentation on the part of the artisan of ordinary skill, said artisan recognizing that the therapeutic effectiveness of the treatment would have been affected by these concentrations and amounts.
Therefore, the combined teachings of Silveira et al, Messenheimer et al, O’Heeron et al, and Rawal et al render obvious Applicant’s invention as claimed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 8, 10-11, 14-17, 21-22, 27, 29-32, 34, 36-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 11,034,934 in view of Silveira et al (PLOS ONE, 2014-from IDS filed 03/24/2022), O’Heeron et al (US 2014/0314726-from IDS filed 03/24/2022), Rawal et al (Journal of Periodontal Research 2011-from IDS filed 03/24/2022), Hicks et al (WO 2016/077565), Isa et al (Science Advances 2018), and Messenheimer et al (WO 2019/034985).
Claim 12 of patent ‘934 is drawn to a method of a method generating regenerative fibroblast having improved anti-inflammatory activity by contacting the fibroblasts with one or more biologically active substances comprising hyaluronic acid and wherein a therapeutically effective amount of the fibroblasts are provided to the disc of an individual in need of disc repair.
The patent claims do not specifically include cannabidiol with the fibroblasts (therapeutic intervention for degenerative disc disease) for administration to an individual with degenerative disc disease or the details regarding administration as claimed.
However, one of ordinary skill in the art would have been motivated to include the addition of (-)-cannabidiol with the fibroblasts because Silveira disclose a method of treating a degenerative disc disease in an individual comprising administering cannabidiol to an individual wherein the cannabidiol was administered by intradiscal injection (abstract, page 3).
It is deemed prima facie obvious to combine compositions known for the same purpose. “[T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (MPEP 2144.06). One of ordinary skill in the art would have been motivated to include administering a therapeutically effective amount of augmented fibroblasts along with cannabidiol to a patient with degenerative disc disease because both compositions are known in the art for the beneficial treatment of degenerative disc disease. Additional motivation is provided by O’Heeron which teaches co-administering one or more agents together with the fibroblasts in particular for the treatment of a disc medical condition (page 1 para 13). O’Heeron disclose that the co-administration can be before, during or after delivery of the fibroblasts (page 1 para 13). One of ordinary skill in the art would have had a reasonable expectation of success because Rawal disclose the use of cannabidiol for augmenting the regenerative activity of fibroblasts by increasing the production of extracellular matrix and TGF-beta while simultaneously decreasing its degradation (page 1 conclusion, page 2 column 3, page 4 results, page 6).
The combined teachings of Silveira et al, O’Heeron et al, Rawal et al, Hicks et al, Isa et al, Messenheimer et al render obvious the details regarding the administration of the combination of cannabidiol and an additional therapeutic intervention as described above. One of ordinary skill in the art would have had a reasonable expectation of success because they are all directed to the treatment and alleviation of back joint pain such as found in individuals with degenerative disc disease.
Therefore, the combined teachings of patent ‘934 claim, Silveira et al, O’Heeron et al, Rawal et al, Hicks et al, Isa et al, and Messenheimer et al render obvious Applicant’s invention as claimed.
Response to Arguments
Applicant's arguments filed 02/24/2026 have been fully considered but they are not persuasive. Applicant’s arguments have been addressed in so far as they relate to the new rejections above as previous rejections not maintained have been withdrawn due to claim amendments.
Applicant argues that none of the cited references in the 103 rejection teaches all the limitations of amended independent claim 1 as well as the dependent claims.
This is not found persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The current 103 rejections address all the required claim limitations as described above.
Applicant argues that Silveira discloses intradiscal injection of cannabidiol at various doses following disc injury and that only the highest dose achieved any therapeutic effect. Applicant asserts that Silveira demonstrates a failure of low-dose cannabidiol for treating disc injury.
This is not found persuasive. The claims do not require a specific dose for administration of cannabidiol, only a total daily amount in claim 29.
Applicant argues that O’Heeron teaches differentiating fibroblasts into chondrocyte-like cells for treatment of cartilage disfunction and Rawal disclose the biphasic effects of cannabidiol on various functions of gingival fibroblasts. Applicant argues that Rawal does not address regenerative activity of fibroblasts and that the word of regenerative does not appear in Rawal. Applicant argues that Rawal concludes that CBD (cannabidiol) may promote fibrotic gingival enlargement which is a pathological condition and not a therapeutic benefit and thus teaches away from using CBD in combination with fibroblasts for regenerative purposes. Applicant argues that the Office has not established how increasing extracellular matrix or TGF-beta corresponds to regenerative activity in the context of disc repair.
This is not found persuasive. The cited O’Heeron reference (Applicant’s own disclosure) indicates that the delivery of the fibroblasts to the degenerative disc form scar tissue and that such scar tissue is beneficial by providing stability, strength, cushion, seal of annular fissures and so forth (page 2 para 25). O’Heeron discloses that the fibroblasts’ enhancement of matrix formation aids in disc repair and tissue regeneration (page 4 para 44). Therefore, the very effect of cannabidiol on fibroblasts with regard to increasing extracellular matrix and TGF-beta which in turn increase fibrosis and scar tissue, are the very fibroblast properties that O’Heeron state enhance tissue regeneration when used in treatment of degenerative disc disease. O’Heeron also suggest that the manipulation of the fibroblasts is desirable in some cases (page 2 para 17).
Applicant argues that the Office mischaracterizes Rawal’s teachings. Applicant asserts that Rawal does not teach that cannabidiol increases TGF-beta while simultaneously decreasing its degradation. Applicant asserts that Rawal demonstrates that CBD has a biphasic effect on TGF-beta expression based on dose with higher doses decreasing TGF-beta production and that it is TGF-beta itself (not CBD) that increases matrix protein synthesis and decreases degradation. Applicant asserts that applying the Office’s rationale that one of ordinary skill in the art would not have combined the high dose required by Silveira to achieve any effect with fibroblasts because Rawal teaches that such high doses would decrease TGF-beta production and the opposite purported benefit. Applicant asserts that Rawal teaches away from the proposed combination.
This is not found persuasive. First, the Office has not made any statements or rationale with regard to the size of any dosage to be used in the method of Silveira as modified by the teachings of O’Heeron and Rawal because that feature is not recited in the claims. In general, it is well known in combination therapy that one of the benefits is the ability to use lower therapeutic doses when combining therapeutic agents and thus avoiding potential toxicity and side effects of higher doses. The only reference by the Office to the amount of cannabidiol used in the method was in addressing Applicant’s claim 29 in which the prior art reference of Messenheimer is cited to demonstrate that the effective daily amounts as claimed by Applicant were well known in the prior art.
Second, Rawal is not deemed to teach away from the proposed combination as the very effect of cannabidiol on fibroblasts with regard to increasing extracellular matrix and TGF-beta which in turn increase fibrosis and scar tissue as disclosed by Rawal, are the very fibroblast properties that O’Heeron state enhance tissue regeneration when used in treatment of degenerative disc disease. O’Heeron also suggest that the manipulation of the fibroblasts is desirable in some cases (page 2 para 17).
Applicant argues that Rawal, as a whole, studies the effects of CBD on gingival fibroblasts in the context of periodontal disease while the claimed invention is directed to the use of fibroblasts for treating degenerative disc degeneration. Applicant argues that these are distinct fields and that the Examiner has not established that findings regarding gingival fibroblasts would be applicable to disc fibroblasts or that one of ordinary skill in the art would look to periodontal research when developing treatments for disc degeneration. Applicant asserts that lacking such a showing that the proposed combination lacks adequate motivation.
This is not found persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Rawal disclose the effects that cannabidiol have had on fibroblasts and it is this teaching combined with the O’Heeron reference that discloses how fibroblasts are used to repair a degenerative disc that provide the required motivation to include fibroblasts with the cannabidiol being administered in the Silveira method of treating degenerative disc disease.
Applicant argues that the declaration of Dr. Thomas Ichim presents experimental data demonstrating the synergistic effects of treating disc degermation with cannabidiol and fibroblasts. Applicant asserts that the data shows that cannabidiol at 31.8 nM alone had no effect on disc degeneration, while fibroblasts alone showed some improvement. Applicant asserts that the combination of fibroblasts and approximately 30 nM cannabidiol produced a two-fold better outcome than fibroblasts alone. Applicant asserts that these results are unexpected in view of the cited prior art. Applicant asserts that Silveira demonstrated that cannabidiol at 30 and 60 nmol failed to show any therapeutic effect, making the successful combination of cannabidiol at approximately 30 nM with fibroblasts even more surprising and further evidence of non-obvious.
This is not found persuasive. The declaration of under 37 CFR 1.132 filed 02/24/2026 is insufficient to overcome the rejection of claims 1-3, 8, 10-11, 14-17, 21-22, 27, 29-32, 34, 36-39 based upon Silveira, O’Heeron and Rawal applied under 35 USC 103 as set forth in the last Office action because: The showing of non-obviousness is not commensurate in scope with the claims.
The claims do not require a specific dose of cannabidiol or fibroblasts for co-administration. Also, the claims are broadly drawn to the treatment of an individual in general, while the evidence provided in the declaration only show wherein the recipient is a rat and doses that would correspond to a rat. Applicant’s arguments and evidence are all drawn to the dose of cannabidiol used in their specific evidence all of which are not claimed and not commensurate in scope with the claimed method.
In addition, it is well known in the art that cannabidiol provides a protective effect for fibroblasts due to their anti-oxidant property preventing cell death and this is expected to enhance the viability of fibroblasts as evidenced by Chen et al (The Journal Of Pharmacology and Experimental Therapeutics, 2000, page 811, Discussion).
Applicant argues that the dependent claims rejected under 103 are non-obvious because the independent claim is non-obvious.
This is not found persuasive. The independent claim has been found obvious as described above.
Applicant argues that the claims of the patent US 11,034,934 do not add any teachings that would render the combination of fibroblasts and cannabidiol obvious given the arguments in section IV of Applicant’s response papers.
This is not found persuasive. The combination of cannabidiol and fibroblasts have been deemed obvious for the treatment of degenerative disc disease as described above.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chen et al., “Cannabinoids Protect Cells from Oxidative Cell Death: A Receptor-Independent Mechanism”, The Journal Of Pharmacology and Experimental Therapeutics, 2000, Vol. 293, No. 3, pp. 807-812.
He et al., “Combination therapeutics in complex diseases”, Journal of Molecular Medicine, 2016, Vol. 20, No. 12, pp. 2231-2240.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
Prosecution Insights