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 .
DETAILED ACTION
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 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.
Response to Amendments
Applicant’s amendments and response filed Jan. 2, 2026 have been received and entered into the case.
Status of the Claims
Claims 1, 3, 5, 6, 8, 10, and 35-42 are currently pending.
Claims 1 and 35 are amended.
Claims 5 and 38 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 2, 4, 7, 9, and 11-34 are cancelled.
Claims 1, 3, 6, 8, 10, 35-37 and 39-42 have been considered on the merits
Claim Rejections - 35 USC § 112
The claim rejections under 35 USC § 112, (a) or first paragraph (pre-AIA ), are withdrawn due to amendment.
Claim Rejections - 35 USC § 103
The claim rejections under 35 USC § 103 are maintained.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 8, 35-37, 40 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Wozney et al. (US 6,187,742) (ref. of record) in view of Drapeau et al. (US 2010/0111829 A1) (ref. of record).
With respect to claim 1 and step (b) of claim 1 and claim 35, Wozney teaches a method of treating a mammal having a rotator cuff condition by administering a composition comprising an osteogenic protein where the protein is human bone morphogenetic protein (BMP) and the BMP is BMP-5 (abstract, Col. 1 line 59 to Col. 2 line 14, Col. 3 lines 25-35). With respect to step (a) of claim 1, Wozney teaches treating patients with detached or degenerated attachments of the tendon, accordingly one of ordinary skill would easily recognize that this would require identifying a patient as having need for reducing or reversing tendon degeneration, enhancing tendon healing, or increasing tendon strength of a rotor cuff (Col. 1 lines 59-67). With respect to step (b) of claim 1, Wozney teaches the protein is applied to the site in need of tissue repair by injection (administering a composition containing a BMP polypeptide to a rotator cuff injury) (Col. 1 lines 59-67 and Col. 5 lines 58-65). With respect to claims 1, 8, 35 and 40, Wozney teaches the direct injection or application of the composition to repair the tissue in need of repair (Col. 5 lines 58-65) and where the tissue is rotator cuff tendon (Col. 1 lines 59-67).
It is noted that Wozney does not teach that their method can be used in the manner instantly claimed for reducing or reversing tendon degeneration, enhancing tendon healing and increasing tendon strength as recited in claims 1 and 35. However, the teachings of Wozney teach the claimed methods of the direct injection or application of a composition comprising BMP-5 to repair the tissue in need of repair including a rotator cuff (Col. 2 lines 47-49). Once administered to the subject the BMP-5 peptide would treat whatever conditions are present. Thus, the claimed result of reducing or reversing tendon degeneration, enhancing tendon healing and increasing tendon strength must be inherent to the method as taught by Wozney and a necessary effect of practicing the method.
With respect to the limitation of the mammal being a human as recited claim 1 and claim 36, based on the disclosure of Wozney one of ordinary skill in art the art would understand that Wozney is directed to treating humans (for example see Col. 1). With respect to claims 1, 3, 35 and 37, Wozney teaches the method where the composition containing the osteogenic protein is applied to the site in need of reconstructive surgery or the site of a defect, tear or detachment of connective tissue to the bone (Col. 3 lines 5-10) and where the site is the rotator cuff (the rotator cuff condition is partially torn) (Col. 2 lines 47-48).
Wozney does not teach the method where the BMP-5 polypeptide is a human BMP-5 polypeptide as recited in claims 1 and 41. However, Wozney teaches the method using human BMP-2 (Example 1 and claims 8 and 9) and based on the disclosure, one of ordinary skill in the art would understand Wozney is directed towards the treatment of humans. For example, Wozney discusses the treatment of patients and reconstructive surgery (Col. 1). Accordingly, at the time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Wozney so that the BMP-5 in the composition is human for the benefit of treating human patients, since Wozney suggest the treatment of patients with BMPs and teaches using human BMP-2. It would have been obvious to one of ordinary skill in the art to modify the method of Wozney so that the BMP-5 in the composition is human for the purpose being able treat a rotator cuff condition, since Wozney teaches the method of treating a rotator cuff condition using human BMP-2 and teaches the method using BMP-5. Such a modification merely involves the substitution of one known type of BMP-5 for another for the treatment of a rotator cuff condition using human BMP-5.
Although, Wozney teaches administration by injection of the recombinant osteogenic protein to a site in need of regeneration of the connective tissue, bone and the functional attachment apparatus (Col. 3 lines 5-25 and Col. 5 lines 58-65), Wozney does not specify a time of when to administer the composition and does not explicitly state that the injection is not at the time of surgical repair as stated in step (b) of claim 1. However, Drapeau teaches a similar method of treating a condition by administering a therapeutic agent to a tendon (abstract) where the condition is injury to a rotator cuff (0128). Drapeau further teaches the method where composition comprising BMP-5 or rhBMP-5 (0042) and where the composition is injected (0012). In addition, Drapeau teaches the flowable composition containing the therapeutic agent, before, during or after the medical and/or surgical procedure (0141). Drapeau further teach treating osteoarthritis by administering the composition where there is no surgery (0136). Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Wozney so that the BMP-5 polypeptide is administered not at the time of surgical repair or when no surgery is needed for the benefit of treating the condition when appropriate as taught by Drapeau. It would have been obvious based on the teachings of Drapeau to modify the method of Wozney so that the BMP-5 composition is delivered not during the surgical procedure, since similar methods of treating tendons were known to inject BMP-5 before and after the surgical procedure as taught by Drapeau. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to Wozney, since Drapeau teaches that A BMP-5 composition can be injected at any time to aid in the repair of a damaged tendon and Wozney.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 6 and 39 are rejected under 35 U.S.C. 103(a) as being unpatentable over Wozney in view of Drapeau (as applied to claims 1, 3, 8, 35-37, 40 and 41 above), and further in view of Burch et al. (US 2013/0303620 A1) (ref. of record).
The teachings of Wozney and Drapeau can be found in the previous rejection above.
Wozney does not teach the method where the injection is an intra-articular injection as recited in claims 6 and 39. However, Burch teaches treating rotator cuff injuries by intra-articular injection of a therapeutic composition into a joint space (0013, 0022, 0094 and 0101). In further support, Drapeau reports intraarticular injection of corticosteroids, hyaluronan or hylan to treat osteoarthritis (0003). Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the teachings of Wozney in such a way that the composition is injected by an intra-articular injection into joint space for the purpose being able to deliver the composition to a rotator cuff to treat a rotator cuff condition as taught by Burch and Drapeau. Furthermore, it would have been obvious to one skilled in the art to have further modified Wozney such that injection is an intra-articular injection into a joint space, since methods of treating rotator cuff conditions were known to inject therapeutic composition by intra-articular injection into a joint space as taught by Burch and Drapeau. Furthermore, it would have been obvious to a person of ordinary skill in the art to recognize administering the composition when treating a rotator cuff injuries to the rotator cuff tendons and the nearby joint area including the subacromial space during routine experimentation
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 10 and 42 are rejected under 35 U.S.C. 103(a) as being unpatentable over Wozney in view of Drapeau (as applied to claims 1, 3, 8, 35-37, 40 and 41 above), and further in view of Qin et al. (WO 2013/033680 A1)(ref. of record) and NCBI (“Bone Morphogenetic Protein 5 isoform 3 precursor (Homo sapiens)”, NP 001316685.1, accessed Sept. 15, 2025, earliest sequence from 1990) (ref. of record).
The teachings of Wozney and Drapeau can be found in the previous rejection above.
Wozney does not teach the method where the BMP-5 polypeptide has the amino acid sequences of SEQ ID NO. 1 as recited in claims 10 and 42. However, Qin teaches the growth factor peptides, including BMP-5 proteins, may be used in the treatment of bone, cartilage and/or connective defects and in wound healing (0031, 0082 and 00173). Qin further teaches amino acid sequences for human BMP-5 with 98.5% homology with SEQ ID NO. 1 of claims 10 and 42 (SEQ ID NO. 1 of Qin). The sequence of Qin has 100% homology with amino acid residues 1-342, but does not contain amino acid residues 343-348 or GSSDVS from the N-terminus end of the sequence and contains a different N-terminus. However, the sequence of SEQ ID NO. 1 has 100% homology with isoform 3 of BMP5, NP 00131665.1 as taught by NCBI. Accordingly, at the time of filing of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the method of Wozney to include BMP-5 with amino acid sequences similar to SEQ ID NO. 1, since a sequence similar to the claimed BMP-5 sequence was already known for use in treating cartilage defects and the claimed sequence is a known isoform of BMP5 taught by NCBI. It would have been obvious to one of ordinary skill in the art that similar BMP-5 sequences and isoforms can be used in a method of treating rotator cuff injuries, since similar sequences were known to be used for treating cartilage defects and the claimed sequence is a known isoform. Furthermore, one of ordinary skill in the art would have had reasonable expectation of success in modifying the method of Wozney to include BMP-5 with the amino acid sequence of SEQ ID NO. 1, since the sequence is significantly similar or shares significant homology to BMP-5 sequences already known for use in treating cartilage defects as taught by Qin and would be predicted to behave similar to the claimed sequence and the sequence taught by Qin comprises SEQ ID NO. 1 as claimed.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed Jan. 2, 2026 have been fully considered but they are not persuasive. The majority of the arguments were previously presented in the Appeal Brief filed on Feb. 13, 2025 and were responded to in the last office action mailed on Oct. 3, 2025 and are maintained.
With respect to the rejections under 35 U.S.C. §103, Applicant argues that Wozney does not teach successfully treating a rotator cuff condition with BMP-5 and does not provide any data showing the successful treatment of a rotator cuff condition with any BMP; and only discloses limited knee data in dog where sponges loaded with BMP-2 are surgically positioned around knee tendons and only mentions BMP-5 in list of other potential factors (pg. 7 para. 2). Applicant further argues that the only reasoning provided by the Examiner to why a person of ordinary skill in the art would have had a reasonable expectation of success in using BMP-5 is that Wozney includes it in a list of known BMPs with osteogenic activity and other growth and differentiation activities and that Wozney fails to provide any experimental data showing that any of the BMPs or members of the TGF-beta family would have any actual use as such other than BMP-2 (pg. 8 para. 1-2). However, these arguments were not found to be persuasive, and it is maintained that a prior art reference is presumed to be operable or enabled. Furthermore, it is noted that the instant specification does not provide any experimental data showing that BMP-5 reduces or repairs tendon degeneration in a subject with a partially torn rotator cuff or rotator cuff tendonitis.
Applicant argues that they have previously provided references demonstrating that a number of the listed BMPs in Wozney would not be predicted to be successful at treating rotator cuff conditions. For example, Applicant argues that Gulotta reports that BMP-13 did not improve healing in a rat model of rotator cuff repair and Neuwirth reports that both BMP-2 and BMP-7 promote structural degeneration of the rotator cuff (pg. 8-9 bridging para.). These arguments were still not found to be persuasive. It is maintained, as stated in the previous office actions filed on Nov. 5, 2024 pgs. 13-14, Jan. 22, 2024 pgs. 11-12 and Oct. 3, 2025 pgs. 18-19 on careful reading of the Gulotta, they report that the administration of mesenchymal stem cells overexpressing BMP-13 did not improve healing in a rat model of rotator cuff repair (abstract) and not the actual administration of BMP-13 protein. In addition, Gulotta reports that BMP-13 has been shown to induce neotendon/neoligament formation when delivered subcutaneously or intramuscularly in rodents (pg. 181 Col. 1 para. 1). The authors further questioned why they did not see any improvement and suggested that it could be that the dosage of cells used was too low, the timing of the study was too short and/or that the BMP-13 expressed by the MSCs was not tested for biological activity (pg. 185 last para. to pg. 186 para. 1). Accordingly, the conclusion from Gulotta appears to be that there may not have been enough BMP-13 present to see an effect. Therefore, is not convincing based on Gulotta that BMP-13 would not improve healing in a rat model of rotator cuff repair.
Although Neuwirth found BMP-2 and BMP-7 are involved in promoting structural degeneration of the rotator cuff, other references have found BMPs can improve the healing of cartilage. For instance, Miljkovic et al. (Osteoarthritis and Cartilage, 2008)(ref. of record) reports that BMP-4 can improve the healing process of an articular cartilage defect (abstract) and that BMP-2 and BMP-7 improve cartilage repair when combined with different types of artificial cartilage repair plugs comprising either collagen or hydroxyapatite blended with biodegradable polymers (pg. 1121 Col. 2 para. 3). In addition, Miljkovic lists BMP-5 for potential cartilage repair (Table 1) and reports that the expression of BMP-4 and BMP-5 are needed for the formation of a normal synovial lining and adding these to the joints of patient with OA (osteoarthritis) and RA (rheumatoid arthritis) could be beneficial (pg. 1127 Col. 2 para. 1). In addition, Rosen et al. (US 5,939,388) (ref. of record) teaches the BMP-5 proteins may be used in the treatment of bone and/or cartilage defects and in wound healing and related tissue repair (abstract). Therefore, it is maintained that Wozney teaches a method of treating a mammal having a rotator cuff condition by administering a composition comprising an osteogenic protein where the protein is bone morphogenetic protein (BMP) and the BMP is BMP-5 (abstract, Col. 1 line 59 to Col. 2 line 14 and Col. 3 lines 25-35). Additionally, Lamplot et al. (The American Journal of Sports Medicine, published online Sept. 5, 2014) (ref. of record) further reports that the adenoviral delivery of BMP13 increased the expression of type III collagen, fibronectin, tenascin C, and scleraxis genes associated with tendon healing in injured rotator cuffs (pg. 2881 Col. 2 para. 2-4 and Fig. 3). Overall, the prior art appears to at least suggest that the majority of BMPs listed in Wozney aid in tendon healing.
Applicant argues that the references, Gulotta and Neuwirth, in combination with the two declarations submitted by Dr. Scott Riester make it clear that the list of BMPs from Wozney is not a list of BMPs that are successful for treating a rotator cuff condition as the Examiner contends (pg. 9-10 bridging para.). However, this argument was not found to be persuasive, and it is maintained that since Gulotta was not actually treating with BMP-13, but cells engineered to over-express the protein and the teachings of the prior art disclose the potential benefits of BMP-5 in tendon repair and tissue repair as evidenced by Miljkovic and Rosen. Furthermore, Lamplot found adenoviral delivery of BMP13 helped with tendon healing and repair in injured rotator cuffs (abstract).
Applicant argues that as Dr. Riester explains in the declaration, that explanations of why BMP-13 failed to improve healing in the rat model of rotator cuff repair does not take way from the conclusion of the paper, that BMP-13 does not improve rotator cuff healing in a rat model (pg. 9-10 bridging para. 1). However, this argument was not found to be persuasive, since the explanations in Gulotta are directed to whether or not the levels of BMP-13 expressed by the transfected mesenchymal stem cells were sufficient to improve healing within the timeframe of the study (pg. 185 Col. 2 last para.). It is clear from the discussion in Gulotta that the conclusion that BMP-13 failed to improve healing in a rat model of rotator cuff repair was for the particular experimental conditions used (i.e. mode of delivery, dose, and time frame) in the paper and BMP-13 might improve healing under other conditions. Furthermore, Gulotta reports that BMP-13 has been shown to improve tendon-to-tendon repairs and their study looked at tendon-to-bone repairs (pg. 185 Col. 2 para. 2-4).
Applicant further argues that the fact that the BMP-13 was deliver by over-expressing cells does not diminish the assertion that BMP-13 is ineffective, since Gulotta shows that there is an increase in BMP-13 staining in the repair site of rats treated with the over-expressing BMP-13 stem cells compared to rats treating with stem cells not over-expressing BMP-13 (pg. 9-10 bridging para.). However, this argument was not found to be persuasive, for the reasons stated above and since Gulotta questions whether the amount secreted by the stem cells was sufficient and whether treatment time was long enough (pg. 185 Col. 2 para. 2-4). The authors further questioned why they did not see any improvement and suggested that it could be that the dosage of cells used was too low, the timing of the study was too short and/or that the BMP-13 expressed by the MSCs was not tested for biological activity (pg. 185 last para. to pg. 186 para. 1). So even if they showed the protein was expressed in the tissue it may not have been active. Additionally, others have reported that BMP-13 aids in tendon repair. For instance, Lamplot found adenoviral delivery of BMP13 helped with tendon healing and repair in injured rotator cuffs (abstract).
Applicant argues, as explained in the declaration submitted by Dr. Riester, a person of ordinary skill in the art would have been aware of the Neuwirth publication and that BMP-2 and BMP-7 are involved in promoting structure degeneration of the rotator cuff and, therefore, would not have had a reasonable expectation of success that BMP-5 would reduce or reverse tendon degeneration, enhance tendon healing or increase tendon strength of a rotator cuff when administered via an intra-articular injection into a joint space or a direct injection into a damaged tendon not at the time of surgical repair as claimed (pg. 10 para. 2). Applicant argues that the Examiner points to two additional references, Miljkovic and Rosen to support their arguments that show that BMP-4, BMP-2 and BMP-7 aid in cartilage repair (pg. 10-11 bridging para.). This was not found to be persuasive, since the a person of ordinary skill in the art would have been aware of other publications showing the benefits of BMPs in tendon repair. It is acknowledged that Neuwirth teaches BMP-2 and BMP-7 are involved in promoting structure degeneration of the rotator cuff, however, the overall teachings in the art at the effective time of filing of the claimed invention was that BMP-5 may be used for cartilage and bone repair as support by Miljkovic and Rosen.
Applicant further argues that Dr. Riester stated that Miljkovic only discloses that inhibiting BMP-4 and BMP-5 signaling might be a potential therapeutic strategy and this teaching does not provide a person of ordinary skill in the art a reasonable expectation of success based on the teachings of Wozney that BMP-5 would reduce or reverse tendon degeneration, enhance tendon healing or increase tendon strength of a rotator cuff (pg. 11 para 2). Applicant argues that the teachings in Miljkovic that BMP-5 out of the at least eight BMPs could have potential in cartilage repair and the teaching that BMP-4 and BMP-5 could have a potential benefit in treating OA and RA because of their role in the formation of synovial lining do not provide reasonable expectation of using BMP-5 to reduce tendon degeneration, enhance tendon healing or increase strength in a rotator cuff condition (pg. 11 para. 3). These arguments were not found to be persuasive, since even though Miljkovic does not explicitly shows BMP-5 repairs or heals cartilage and/or bone, Miljkovic clearly teaches the potential of BMP-5 for such based on the knowledge of BMP-5’s role in forming the synovial lining and its known decrease in expression in OA and RA patients joints. Furthermore, the instant specification does not provide any experimental data showing that BMP-5 reduces or repairs tendon degeneration in a subject with a partially torn rotator cuff or rotator cuff tendonitis.
Applicant argues that the reference, Lamplot, relied upon by the Examiner to show BMP-13 increases the expression of genes associated with tendon healing in injured rotator cuff, fails to provide a reasonable expectation of using BMP-5 to reduce tendon degeneration, enhance tendon healing or increase strength in a rotator cuff condition (pg. 12 para. 2). This argument was not found to be persuasive, since Lamplot is not a reference being relied upon for the prior art rejections or for showing BMP-5 would be used to treat tendons. Lamplot is being used as evidenced in the response to arguments to demonstrate that the list of BMPs of Wozney includes BMPs known to aid in tendon healing.
Applicant argues that no data has been present in Wozney demonstrating any BMP, other BMP-2, might be successful in treating rotator cuff conditions and that BMP-13, BMP, 2 and BMP-7 were known to not to work; and, therefore, the list of BMPs disclosed in Wozney would have been known to a person of ordinary skill in the art not to be a list of BMPs which are successful in treating a rotator cuff condition (pg. 12 para. 3). However, this argument was not found to be persuasive, since as stated above, the overall teachings in the art at the effective time of filing of the claimed invention was that BMP-5 may be used for cartilage and bone repair as support by Miljkovic and Rosen.
Applicant argues that Drapeau does not correct the deficiencies of Wozney and only describes flowable compositions for delivering drugs under the skin and lists potential drugs to be included (pg. 13 para. 1). However, this argument was not found to be persuasive, since the arguments with respect to the rejections over Wozney were not found to be persuasive as explained above.
Applicant argues that the combination of Wozney and Drapeau fail to teach the use of BMP-5 to reduce or reverse tendon degeneration, enhance tendon healing, or increase tendon strength of a rotator cuff as claimed and, specifically, neither teach administering BMP-5 via an intra-articular injection into a joint space or a direct injection into damaged tendo not at the time of surgical repair (pg. 13-14 bridging para.). Applicant argues that Wozney is directed to facilitating the functional attachment of ligaments or tendons to bone during reconstructive surgery and has been explained in Declaration II submitted by Dr. Riester (pg. 15 para. 1). Additionally, Applicant argues that there is no motivation or suggestion in Drapeau that the method taught by Wozney of facilitating the functional attachment of ligaments or tendons to bone during reconstructive surgery should be modified to a method that involves an intra-articular injection into a joint space or direct injection into a damaged tendon not at a time of surgical repair (pg. 15-16 bridging para.). Applicant further argues that Drapeau just teaches flowable compositions for delivering drugs under the skin and does not suggest that reconstructive surgery methods such as those taught by Wozney should be changed (pg. 15 last para. to pg. 16 para. 2). However, these arguments were not found to be persuasive, since as stated in the rejection, Drapeau teaches a similar method of treating a condition by administering a therapeutic agent to a tendon (abstract) where the condition is injury to a rotator cuff (0128). Drapeau further teaches the method where composition comprising BMP-5 or rhBMP-5 (0042) and where the composition is injected (0012). In addition, Drapeau teaches the flowable composition containing the therapeutic agent, before, during or after the medical and/or surgical procedure (0141). Drapeau further teach treating osteoarthritis by administering the composition where there is no surgery (0136). It is maintained based on the teachings of Drapeau, that one of ordinary skill in the art would have been motivated to modify the method of Wozney so that the BMP-5 polypeptide is administered not at the time of surgical repair or when no surgery is needed for the benefit of treating the condition when appropriate. It would have been obvious based on the teachings of Drapeau to modify the method of Wozney so that the BMP-5 composition is delivered not during the surgical procedure, since similar methods of treating tendons were known to inject BMP-5 before and after the surgical procedure as taught by Drapeau. Furthermore, the teachings in Wozney is not limited to treating patients with reconstructive surgery, but also for other procedures for the regeneration of a functional attachment between connective tissue and bone (Col. 1 lines 12-20).
Applicant argues that the Examiner failed to effectively address Dr. Riester’s arguments in the Dr. Riester Declaration II that the combination of Wozney and Drapeau do not render the present claims obvious, since Drapeau failed to suggest modifying reconstructive surgeries like those taught in Wozney and that modifying the methods of Wozney by not performing reconstructive surgery would render Wozney unsatisfactory for intended purpose of facilitating the functional attachment of ligaments or tendons to bone during reconstructive surgery (p. 16 para. 3 to pg. 17 first para.). However, these arguments not found to be persuasive, since the teachings in Wozney are not limited to treating patients with reconstructive surgery, but also for other procedures for the regeneration of a functional attachment between connective tissue and bone (Col. 1 lines 12-20). It is maintained that the combined teachings of Wozney and Drapeau teach the limitation of administering a therapeutic composition for the repair of tendons not at the time of a surgery of the tendon as explained in the rejection.
Applicant argues that Burch fails to remedy the deficiencies of Wozney and Drapeau and does not involve using any protein including BMP-5 and provides no motivation to modify the method of facilitating the functional attachment of ligaments or tendons to bone during reconstruction surgery of Wozney to include the intra-articular injection into a joint space or a direct injection into a damaged tendon not at a time of surgical repair as explained in Dr. Riester Declaration II (pg. 18 para. 2). However, this argument was not found to be persuasive, since the arguments with respect to the rejections over Wozney and Drapeau were not found to be persuasive as explained above.
Applicant argues that Qin fails to remedy the deficiencies of Wozney and Drapeau and does not disclose using BMP-5 or any other BMP protein to reduce or reverse tendon generation, enhance tendon healing, or increase tendon strength of a rotator cuff and only teaches growth factor peptides may be used in the treatment of bone, cartilage, and/or connective defects in wound healing (pg. 19 para. 3). However, this argument was not found to be persuasive, since the arguments with respect to the rejections over Wozney and Drapeau were not found to be persuasive as explained above.
Applicant further argues there is nothing in the NCBI reference provides a person of ordinary skill in the art with a reasonable expectation of success or to use a BMP5 sequence with 100% homology with SEQ ID NO: 1 (pg. 19 para. 3). However, this argument was not found to be persuasive, since it would have been obvious to one of ordinary skill in the art to use known isoforms of BMP-5 such as that taught by NCBI in the method of Wozney. As stated in the rejection, one of ordinary skill in the art would have had reasonable expectation of success in modifying the method of Wozney to include BMP-5 with the amino acid sequence of SEQ ID NO. 1, since the sequence is significantly similar or shares significant homology to BMP-5 sequences already known for use in treating cartilage defects as taught by Qin and would be predicted to behave similar to the claimed sequence and the sequence taught by Qin comprises SEQ ID NO. 1 as claimed.
Applicant argues that European Patent Office (EPO) found the claims allowable over Wozney, since Wozney provides no evidence that BMP-5 is effective in treating rotator cuff conditions and the only example concerns BMP-2. Additionally, the EPO examiner noted that all the other documents found by them refer to BMP-2, BMP-4, BMP-6, BMP-7, BMP-12 and BMP-13 with heterogenous results (pg. 20 para. 1 to pg. 22 para. 1). Applicant argues that the Examiner dismissed the comments by the EPO and did not provide an adequate explanation as to why the comments were insufficient (pg. 22 last para.). Applicant further argues that the Examiner just reiterated what Wozney teaches and stated that proof of efficacy is not necessary for a prior art reference to be enabled and that neither of these remarks address the point that at the effective date there was no evidence in the art that BMP-5 would be effective in treating rotator cuff conditions (pg. 22-23 bridging para.). The reasons for allowance presented by the EPO and which applicant has argued, that Wozney does not provided experimental evidence that BMP-5 is effective in treating rotator cuff conditions and the list of BMPs presented in Wozney have heterogenous results were not found to be persuasive, since Wozney is presumed to be operable or enabled as stated above. Furthermore, the art in general teaches the potential of BMP-5 in repairing cartilage and bone. Again, it is noted that the instant specification does not provide any experimental evidence showing that BMP-5 reduces or repairs tendon degeneration in a subject with a partially torn rotator cuff or rotator cuff tendonitis.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 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, Peter Paras can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EMILY A CORDAS/Primary Examiner, Art Unit 1632