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 .
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.
Claim(s) 1-10 and 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0199792 (Austin).
1. Austin teaches knee osteoarthritis treatment (see P0023 1 (mentioning acupuncture); Table 1 (listing muscles targeted for treatment in various regions, including muscles relevant to knee function); Examples 11-12), comprising:
performing acupuncture on a first group of muscles associated with an osteoarthritic knee joint (e.g., performing acupuncture/needling to treat musculoskeletal disorders and explicitly references acupuncture (P0023) and quadriceps, gluteal, hamstrings, gastrocnemius/soleus (calf), quadratus lumborum, popliteus as targets for needling/therapy in connection with lower-extremity/knee-related conditions (Table 1)
Austin discloses the invention substantially as claimed as discussed above and further discloses needling the identified muscles for knee-related conditions but does not expressly limit the needle placement to origins or insertions. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select specific needling loci along the same muscles— including the musculotendinous junctions, origins, or insertions— as a matter of routine clinical judgment and optimization to address enthesopathy/tendinopathy, trigger points near attachments, and pain referral commonly associated with those sites. Such selection represents the predictable use of known techniques to achieve the same therapeutic objective taught by Austin (reducing pain/improving function in knee OA) and would have yielded predictable results. See KSR v. Teleflex, 550 U.S. 398 (2007) (allowing reliance on common sense and routine optimization where a combination yields predictable results).
Austin discloses the invention substantially as claimed as discussed above and further discloses needling therapy for knee-related dysfunction involving the same periarticular musculature and associated soft tissues (fascia) but does not expressly name the iliotibial tract. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include associated fascia of the knee joint—such as the iliotibial tract—when applying Austin’s method, because the iliotibial tract is a well-known fascia intimately associated with lateral knee mechanics and knee pain, and needling periarticular fascia along with the implicated muscles is a predictable adjunct to the same therapeutic goal in Austin. Applying acupuncture to the iliotibial tract in this context would have been a routine extension of Austin’s approach, with a reasonable expectation of success, to address tightness/pain in tissues functionally linked to the knee joint. See KSR (routine variation to achieve known goal).
2. The knee osteoarthritis treatment of claim 1, wherein: said Quadriceps muscles comprise: Vastus Lateralis; said Gluteal muscles comprise: Gluteus Maximus, Gluteus Medius;
said Hamstring muscles comprise: Semitendinosus, Semimembranosus, Biceps Femoris Long Head, Biceps Femoris Short Head; said Calf muscles comprise: Gastrocnemius Medial Head, Gastrocnemius Lateral Head (Table 1; Examples 11-12).
3. The knee osteoarthritis treatment of claim 1, wherein: said acupuncture is performed by inserting one or more acupuncture needles into said each muscle origin or said each muscle insertion and said fascia for a period of time and withdrawing said one or more acupuncture needles after said period of time (P0023).
4. The knee osteoarthritis treatment of claim 1, wherein: said knee osteoarthritis treatment relieves taut muscles, muscle strain, muscle tightness, and undue pressure on said osteoarthritic knee joint and knee joint capsule (P0012; Examples 11-12).
5. The knee osteoarthritis treatment of claim 4, wherein: said knee osteoarthritis treatment facilitates and promotes said osteoarthritic knee joint and said knee joint capsule to heal naturally (P0012; Examples 11-12).
6. Austin teaches knee osteoarthritis treatment (see P0023 1 (mentioning acupuncture); Table 1 (listing muscles targeted for treatment in various regions, including muscles relevant to knee function); Examples 11-12), comprising:
performing acupuncture on a first group of muscles associated with an osteoarthritic knee joint (e.g., performing acupuncture/needling to treat musculoskeletal disorders and explicitly references acupuncture (P0023) and quadriceps, gluteal, hamstrings, gastrocnemius/soleus (calf), quadratus lumborum, popliteus as targets for needling/therapy in connection with lower-extremity/knee-related conditions (Table 1)
Austin discloses the invention substantially as claimed as discussed above and further discloses needling the identified muscles for knee-related conditions but does not expressly limit the needle placement to origins or insertions. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select specific needling loci along the same muscles— including the musculotendinous junctions, origins, or insertions— as a matter of routine clinical judgment and optimization to address enthesopathy/tendinopathy, trigger points near attachments, and pain referral commonly associated with those sites. Such selection represents the predictable use of known techniques to achieve the same therapeutic objective taught by Austin (reducing pain/improving function in knee OA) and would have yielded predictable results. See KSR v. Teleflex, 550 U.S. 398 (2007) (allowing reliance on common sense and routine optimization where a combination yields predictable results).
Austin discloses the invention substantially as claimed as discussed above and further discloses needling therapy for knee-related dysfunction involving the same periarticular musculature and associated soft tissues (fascia) but does not expressly name the iliotibial tract. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include associated fascia of the knee joint—such as the iliotibial tract—when applying Austin’s method, because the iliotibial tract is a well-known fascia intimately associated with lateral knee mechanics and knee pain, and needling periarticular fascia along with the implicated muscles is a predictable adjunct to the same therapeutic goal in Austin. Applying acupuncture to the iliotibial tract in this context would have been a routine extension of Austin’s approach, with a reasonable expectation of success, to address tightness/pain in tissues functionally linked to the knee joint. See KSR (routine variation to achieve known goal).
performing deep tissue massage on said first group of muscles associated with said osteoarthritic knee joint, comprising: said Quadriceps muscles; said Gluteal muscles; said Hamstring muscles; said Calf muscles; said Quadratus Lumborum; said Popliteus (P0023, P0124, P0125);
performing deep tissue massage on said fascia associated with said osteoarthritic knee joint (P0023, P0124, P0125);
performing deep tissue massage on a second group of muscles associated with said osteoarthritic knee joint (P0023, P0124, P0125), comprising: Sartorius; said Quadriceps muscles; Psoas Major; Hip Adductors (Table 1).
7. The knee osteoarthritis treatment of claim 6, wherein: said Quadriceps muscles comprise: Rectus Femoris; said Hip Adductors comprise: Gracilis (Table 1, Examples 10-11, 30-31).
8. The knee osteoarthritis treatment of claim 6, wherein: said acupuncture is performed by inserting one or more acupuncture needles into said each muscle origin or said each muscle insertion and said fascia for a period of time and withdrawing said one or more acupuncture needles after said period of time (P0012; Examples 11-12).
9. The knee osteoarthritis treatment of claim 6, wherein: said knee osteoarthritis treatment relieves taut muscles, muscle strain, muscle tightness, and undue pressure on said osteoarthritic knee joint and knee joint capsule (P0012; Examples 11-12).
10. The knee osteoarthritis treatment of claim 9, wherein: said knee osteoarthritis treatment facilitates and promotes said osteoarthritic knee joint and said knee joint capsule to heal naturally (P0012; Examples 11-12).
16. Austin teaches knee osteoarthritis treatment (see P0023 1 (mentioning acupuncture); Table 1 (listing muscles targeted for treatment in various regions, including muscles relevant to knee function); Examples 11-12), comprising:
performing acupuncture on a first group of muscles associated with an osteoarthritic knee joint (e.g., performing acupuncture/needling to treat musculoskeletal disorders and explicitly references acupuncture (P0023) and Vastus Lateralis; Gluteus Maximus; Gluteus Medius; Semitendinosus; Semimembranosus; Biceps Femoris Long Head; Gastrocnemius Medial Head; Gastrocnemius Lateral Head; Biceps Femoris Short Head; Quadratus Lumborum; Popliteus as targets for needling/therapy in connection with lower-extremity/knee-related conditions (Table 1; Examples 11-12)
Austin discloses the invention substantially as claimed as discussed above and further discloses needling the identified muscles for knee-related conditions but does not expressly limit the needle placement to origins or insertions. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select specific needling loci along the same muscles— including the musculotendinous junctions, origins, or insertions— as a matter of routine clinical judgment and optimization to address enthesopathy/tendinopathy, trigger points near attachments, and pain referral commonly associated with those sites. Such selection represents the predictable use of known techniques to achieve the same therapeutic objective taught by Austin (reducing pain/improving function in knee OA) and would have yielded predictable results. See KSR v. Teleflex, 550 U.S. 398 (2007) (allowing reliance on common sense and routine optimization where a combination yields predictable results).
Austin discloses the invention substantially as claimed as discussed above and further discloses needling therapy for knee-related dysfunction involving the same periarticular musculature and associated soft tissues (fascia) but does not expressly name the iliotibial tract. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include associated fascia of the knee joint—such as the iliotibial tract—when applying Austin’s method, because the iliotibial tract is a well-known fascia intimately associated with lateral knee mechanics and knee pain, and needling periarticular fascia along with the implicated muscles is a predictable adjunct to the same therapeutic goal in Austin. Applying acupuncture to the iliotibial tract in this context would have been a routine extension of Austin’s approach, with a reasonable expectation of success, to address tightness/pain in tissues functionally linked to the knee joint. See KSR (routine variation to achieve known goal).
17. The knee osteoarthritis treatment of claim 16, wherein: said acupuncture is performed by inserting one or more acupuncture needles into said each muscle origin or said each muscle insertion and said fascia for a period of time and withdrawing said one or more acupuncture needles after said period of time (P0012; Examples 11-12).
18. The knee osteoarthritis treatment of claim 16, wherein: said knee osteoarthritis treatment relieves taut muscles, muscle strain, muscle tightness, and undue pressure on said osteoarthritic knee joint and knee joint capsule (P0012; Examples 11-12).
19. The knee osteoarthritis treatment of claim 18, wherein: said knee osteoarthritis treatment facilitates and promotes said osteoarthritic knee joint and said knee joint capsule to heal naturally (P0012; Examples 11-12).
20. Austin teaches knee osteoarthritis treatment (see P0023 1 (mentioning acupuncture); Table 1 (listing muscles targeted for treatment in various regions, including muscles relevant to knee function); Examples 11-12), comprising:
performing acupuncture on a first group of muscles associated with an osteoarthritic knee joint (e.g., performing acupuncture/needling to treat musculoskeletal disorders and explicitly references acupuncture (P0023) and Vastus Lateralis; Gluteus Maximus; Gluteus Medius; Semitendinosus; Semimembranosus; Biceps Femoris Long Head; Gastrocnemius Medial Head; Gastrocnemius Lateral Head; Biceps Femoris Short Head; Quadratus Lumborum; Popliteus as targets for needling/therapy in connection with lower-extremity/knee-related conditions (Table 1; Examples 11-12)
Austin discloses the invention substantially as claimed as discussed above and further discloses needling the identified muscles for knee-related conditions but does not expressly limit the needle placement to origins or insertions. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select specific needling loci along the same muscles— including the musculotendinous junctions, origins, or insertions— as a matter of routine clinical judgment and optimization to address enthesopathy/tendinopathy, trigger points near attachments, and pain referral commonly associated with those sites. Such selection represents the predictable use of known techniques to achieve the same therapeutic objective taught by Austin (reducing pain/improving function in knee OA) and would have yielded predictable results. See KSR v. Teleflex, 550 U.S. 398 (2007) (allowing reliance on common sense and routine optimization where a combination yields predictable results).
Austin discloses the invention substantially as claimed as discussed above and further discloses needling therapy for knee-related dysfunction involving the same periarticular musculature and associated soft tissues (fascia) but does not expressly name the iliotibial tract. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include associated fascia of the knee joint—such as the iliotibial tract—when applying Austin’s method, because the iliotibial tract is a well-known fascia intimately associated with lateral knee mechanics and knee pain, and needling periarticular fascia along with the implicated muscles is a predictable adjunct to the same therapeutic goal in Austin. Applying acupuncture to the iliotibial tract in this context would have been a routine extension of Austin’s approach, with a reasonable expectation of success, to address tightness/pain in tissues functionally linked to the knee joint. See KSR (routine variation to achieve known goal).
performing deep tissue massage on said first group of muscles associated with said osteoarthritic knee joint, comprising: said Vastus Lateralis; said Gluteus Maximus; said Gluteus Medius; said Semitendinosus; said Semimembranosus; said Biceps Femoris Long Head; said Gastrocnemius Medial Head; said Gastrocnemius Lateral Head; said Biceps Femoris Short Head; said Quadratus Lumborum; said Popliteus (P0023, P0124, P0125); and
performing deep tissue massage on said fascia associated with said osteoarthritic knee joint (P0023, P0124, P0125);
performing deep tissue massage on a second group of muscles associated with said osteoarthritic knee joint, comprising: Sartorius; Rectus Femoris; Psoas Major; Gracilis (P0023, P0124, P0125);
21. The knee osteoarthritis treatment of claim 20, wherein: said acupuncture is performed by inserting one or more acupuncture needles into said each muscle origin or said each muscle insertion and said fascia for a period of time and withdrawing said one or more acupuncture needles after said period of time (P0012; Examples 11-12)..
22. The knee osteoarthritis treatment of claim 20, wherein: said knee osteoarthritis treatment relieves taut muscles, muscle strain, muscle tightness, and undue pressure on said osteoarthritic knee joint and knee joint capsule (P0012; Examples 11-12)..
23. The knee osteoarthritis treatment of claim 22, wherein: said knee osteoarthritis treatment facilitates and promotes said osteoarthritic knee joint and said knee joint capsule to heal naturally (P0012; Examples 11-12).
Claim(s) 11-15 and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0199792 (Austin) in view of US 2017/0072214 (Liu).
11. Austin teaches knee osteoarthritis treatment (see P0023 (mentioning acupuncture); Table 1 (listing muscles targeted for treatment in various regions, including muscles relevant to knee function); Examples 11-12), comprising:
performing acupuncture on a first group of muscles associated with an osteoarthritic knee joint (e.g., performing acupuncture/needling to treat musculoskeletal disorders and explicitly references acupuncture (P0023) and quadriceps, gluteal, hamstrings, gastrocnemius/soleus (calf), quadratus lumborum, popliteus as targets for needling/therapy in connection with lower-extremity/knee-related conditions (Table 1)
Austin discloses the invention substantially as claimed as discussed above and further discloses needling the identified muscles for knee-related conditions but does not expressly limit the needle placement to origins or insertions. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select specific needling loci along the same muscles— including the musculotendinous junctions, origins, or insertions— as a matter of routine clinical judgment and optimization to address enthesopathy/tendinopathy, trigger points near attachments, and pain referral commonly associated with those sites. Such selection represents the predictable use of known techniques to achieve the same therapeutic objective taught by Austin (reducing pain/improving function in knee OA) and would have yielded predictable results. See KSR v. Teleflex, 550 U.S. 398 (2007) (allowing reliance on common sense and routine optimization where a combination yields predictable results).
Austin discloses the invention substantially as claimed as discussed above and further discloses needling therapy for knee-related dysfunction involving the same periarticular musculature and associated soft tissues (fascia) but does not expressly name the iliotibial tract. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include associated fascia of the knee joint—such as the iliotibial tract—when applying Austin’s method, because the iliotibial tract is a well-known fascia intimately associated with lateral knee mechanics and knee pain, and needling periarticular fascia along with the implicated muscles is a predictable adjunct to the same therapeutic goal in Austin. Applying acupuncture to the iliotibial tract in this context would have been a routine extension of Austin’s approach, with a reasonable expectation of success, to address tightness/pain in tissues functionally linked to the knee joint. See KSR (routine variation to achieve known goal).
performing deep tissue massage on said first group of muscles associated with said osteoarthritic knee joint, comprising: said Quadriceps muscles; said Gluteal muscles; said Hamstring muscles; said Calf muscles; said Quadratus Lumborum; said Popliteus;
performing deep tissue massage on said fascia associated with said osteoarthritic knee joint (P0023, P0124, P0125);
performing deep tissue massage on a second group of muscles associated with said osteoarthritic knee joint (P0023, P0124, P0125), comprising: Sartorius; said Quadriceps muscles; Psoas Major; Hip Adductors (Table 1).
Austin discloses the invention substantially as claimed as discussed above and further discloses treating an osteoarthritic knee joint (Table 1; Examples 11-12) but does not disclose injecting hyaluronic acid into said osteoarthritic knee joint. Liu teaches a knee osteoarthritis treatment in the same field of endeavor including injecting hyaluronic acid into said osteoarthritic knee joint (P0020) for the purpose of clinically treating the joint with an injection (P0020). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment of Austin to include injecting hyaluronic acid into the knee joint as taught by Liu in order to clinically treat the joint with an injection.
12. The knee osteoarthritis treatment of claim 11, wherein: said Quadriceps muscles comprise: Rectus Femoris; said Hip Adductors comprise: Gracilis (Table 1, Examples 10-11, 30-31).
13. The knee osteoarthritis treatment of claim 11, wherein: said acupuncture is performed by inserting one or more acupuncture needles into said each muscle origin or said each muscle insertion and said fascia for a period of time and withdrawing said one or more acupuncture needles after said period of time (P0012; Examples 11-12).
14. The knee osteoarthritis treatment of claim 11, wherein: said knee osteoarthritis treatment relieves taut muscles, muscle strain, muscle tightness, and undue pressure on said osteoarthritic knee joint and knee joint capsule (P0012; Examples 11-12).
15. The knee osteoarthritis treatment of claim 14, wherein: said knee osteoarthritis treatment facilitates and promotes said osteoarthritic knee joint and said knee joint capsule to heal naturally (P0012; Examples 11-12).
24. Austin teaches knee osteoarthritis treatment (see P0023 1 (mentioning acupuncture); Table 1 (listing muscles targeted for treatment in various regions, including muscles relevant to knee function); Examples 11-12), comprising:
performing acupuncture on a first group of muscles associated with an osteoarthritic knee joint (e.g., performing acupuncture/needling to treat musculoskeletal disorders and explicitly references acupuncture (P0023) and Vastus Lateralis; Gluteus Maximus; Gluteus Medius; Semitendinosus; Semimembranosus; Biceps Femoris Long Head; Gastrocnemius Medial Head; Gastrocnemius Lateral Head; Biceps Femoris Short Head; Quadratus Lumborum; Popliteus as targets for needling/therapy in connection with lower-extremity/knee-related conditions (Table 1; Examples 11-12)
Austin discloses the invention substantially as claimed as discussed above and further discloses needling the identified muscles for knee-related conditions but does not expressly limit the needle placement to origins or insertions. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select specific needling loci along the same muscles— including the musculotendinous junctions, origins, or insertions— as a matter of routine clinical judgment and optimization to address enthesopathy/tendinopathy, trigger points near attachments, and pain referral commonly associated with those sites. Such selection represents the predictable use of known techniques to achieve the same therapeutic objective taught by Austin (reducing pain/improving function in knee OA) and would have yielded predictable results. See KSR v. Teleflex, 550 U.S. 398 (2007) (allowing reliance on common sense and routine optimization where a combination yields predictable results).
Austin discloses the invention substantially as claimed as discussed above and further discloses needling therapy for knee-related dysfunction involving the same periarticular musculature and associated soft tissues (fascia) but does not expressly name the iliotibial tract. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include associated fascia of the knee joint—such as the iliotibial tract—when applying Austin’s method, because the iliotibial tract is a well-known fascia intimately associated with lateral knee mechanics and knee pain, and needling periarticular fascia along with the implicated muscles is a predictable adjunct to the same therapeutic goal in Austin. Applying acupuncture to the iliotibial tract in this context would have been a routine extension of Austin’s approach, with a reasonable expectation of success, to address tightness/pain in tissues functionally linked to the knee joint. See KSR (routine variation to achieve known goal).
performing deep tissue massage on said first group of muscles associated with said osteoarthritic knee joint, comprising: said Vastus Lateralis; said Gluteus Maximus; said Gluteus Medius; said Semitendinosus; said Semimembranosus; said Biceps Femoris Long Head; said Gastrocnemius Medial Head; said Gastrocnemius Lateral Head; said Biceps Femoris Short Head; said Quadratus Lumborum; said Popliteus (P0023, P0124, P0125); and
performing deep tissue massage on said fascia associated with said osteoarthritic knee joint (P0023, P0124, P0125);
performing deep tissue massage on a second group of muscles associated with said osteoarthritic knee joint, comprising: Sartorius; Rectus Femoris; Psoas Major; Gracilis (P0023, P0124, P0125);
Austin discloses the invention substantially as claimed as discussed above and further discloses treating an osteoarthritic knee joint (Table 1; Examples 11-12) but does not disclose injecting hyaluronic acid into said osteoarthritic knee joint. Liu teaches a knee osteoarthritis treatment in the same field of endeavor including injecting hyaluronic acid into said osteoarthritic knee joint (P0020) for the purpose of clinically treating the joint with an injection (P0020). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment of Austin to include injecting hyaluronic acid into the knee joint as taught by Liu in order to clinically treat the joint with an injection.
25. The knee osteoarthritis treatment of claim 24, wherein: said acupuncture is performed by inserting one or more acupuncture needles into said each muscle origin or said each muscle insertion and said fascia for a period of time and withdrawing said one or more acupuncture needles after said period of time (P0012; Examples 11-12).
26. The knee osteoarthritis treatment of claim 24, wherein: said knee osteoarthritis treatment relieves taut muscles, muscle strain, muscle tightness, and undue pressure on said osteoarthritic knee joint and knee joint capsule (P0012; Examples 11-12).
27. The knee osteoarthritis treatment of claim 26, wherein: said knee osteoarthritis treatment facilitates and promotes said osteoarthritic knee joint and said knee joint capsule to heal naturally (P0012; Examples 11-12).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
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TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771