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 .
Claims 1-20 are being examined on the merits.
Claim Objections
Claims 1, 8, 9, and 15 are objected to because of the following informalities:
In Claims 1, 8, and 9, the scientific name “perna canaliculus” should instead read
---Perna canaliculus---. Binomial scientific names should be presented in italics, with the first letter of the genus name capitalized.
In Claim 15, the phrase “green tea lead” should instead read ---green tea leaf---.
Appropriate correction is required.
Claim Interpretation
It is noted that Claims 17-20 are being interpreted as “wherein the composition further comprises…” rather than “further comprising.” This is due to the percentages in Claim 1 being defined as weight percentages calculated based on a percentage of the total weight of the active ingredients, not including fillers, colorants, preservatives, or other additives as defined in the specification at paragraph [0068]. The composition of Claim 1 consists essentially of the listed ingredients wherein the weights given in percentage are relative to each other, totaling 100%, and thus the composition may further comprise the ingredients of Claims 17-20 in any amount.
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.
Claims 1, 2, and 4-15 are rejected under 35 U.S.C. 103 as being unpatentable over Comblain et al. (J Vet Pharmacol Therap, 2016, 1-15) in view of Ruff et al. (Vet Med Res Reps, 2016, 113-121) and Luk et al. (Antioxidants, 2020, 28 pages).
The instant claims are as of record, drawn to a joint-related composition comprising eggshell membrane, Perna canaliculus, curcumin, avocado or soybean unsaponifiables, green tea leaf extract, and collagen.
INGREDIENT
DOSE
SPECIFICATION EXAMPLES
ACTIVE INGREDIENT RANGE (weight %)
36 lb (16.3 kg) Samoyed
53 lb (24.0 kg) Dalmatian
87 lb (39.5 kg) Pyrenees
Total (mg)
%Active
Total (mg)
%Active
Total (mg)
%Active
Eggshell membrane
13.5 mg/kg
220.05
13.2 - 20.1
324
13.2 - 20.2
533.25
13.3 - 20.2
13.2 - 20.2
Perna canaliculus
20-49 mg/kg
326 - 798.7
29.8 - 48.0
480 - 1176
29.9 - 48.1
790 - 1935.5
30.0 - 48.2
29.8 - 48.2
Curcumin
4 mg/kg
65.2
3.9 - 6.0
96
3.9 - 6.0
158
3.9 - 6.0
3.9 - 6.0
Avocado/Soybean unsaponifiables
4-10 mg/kg
65.2 - 163
6.0 - 9.8
96 - 240
6.0 - 9.8
158 - 395
6.0 - 9.8
6.0 - 9.8
Green tea leaf extract
25 mg/kg
407.5
24.5 - 37.3
600
24.5 - 37.4
987.5
24.6 - 37.5
24.5 - 37.5
Collagen
10 mg
10
0.6 - 0.9
10
0.4 - 0.6
10
0.2 - 0.4
0.2 - 0.9
Comblain et al. teach various dietary supplements for the management of osteoarthritis in dogs (join-related composition), including green-lipped mussel (Perna canaliculus) given in a dosage range of 20-49 mg/kg, curcumin given at a dose of 4 mg/kg, avocado/soya unsaponifiables given in a dosage range of 4-10 mg/kg, and collagen, including unsaturated type II collagen, given at a dose 10 mg per day (Comblain et al., Table 1, pages 5-11; as required for instant Claims 1 and 2). Ruff et al. teach eggshell membrane at a dose of 13.5 mg/kg for the treatment of suboptimal joint function in dogs (Ruff et al., Subjects and methods, page 113; as required for instant Claim 1), and Luk et al. teach the green tea leaf extract (Luk et al., Table 1), epigallocatechin gallate, given to mice at a dose of 25 mg/kg in a post-traumatic osteoarthritis model (Luk et al., Table 2, page 9). If these dosages are taken together and applied to the examples as provided in the specification, the resulting weight percentages based upon total weight of the active ingredients would be as summarized in the following table:
As can be seen, the range of weight percentages of active ingredient, based upon known effective doses in the prior art, overlap the claimed ranges for eggshell membrane (instant Claims 1 and 6), curcumin (instant Claims 1, 10, and 11), and collagen (instant Claims 1, 4, and 5).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the joint-related compounds of Comblain et al., Ruff et al., and Luk et al. to arrive at the instantly claimed composition. A skilled artisan would be motivated to combine the claimed ingredients because undenatured type II collagen provides high levels of glycine and proline, which are essential for stability and regeneration of cartilage (Comblain et al., page 2); avocado/soybean unsaponifiables increase TGF-β1 and TGF-β2 levels in synovial fluid and also decrease the size and severity of cartilage lesions (Comblain et al., page 3); curcumin has anti-inflammatory effects, increases type II collagen synthesis, and inhibits macrophage proliferation (Comblain et al., pages 3-4); green-lipped mussel (Perna canaliculus) increases omega-3 fatty acid plasma concentration, improves mobility, and reduces pain (Comblain et al., Table 1, page 10); eggshell membrane reduces joint paint, improves joint function, and provides a chondroprotective effect (Ruff et al., Conclusion, page 113); and the green tea leaf extract epigallocatechin gallate decreases progression of early and mid-stage osteoarthritis, decreases pain symptoms, and decreases degradation of type II collagen and aggrecan in articular cartilage (Luk et al., Table 2, page 9). Given the different effects and mechanisms of action of the various ingredients, a skilled artisan would be motivated to combine them into a single join-related compound as active ingredients and could do so with a reasonable expectation of success.
Comblain et al., Ruff et al., and Luk et al. are relied upon for the reasons discussed above. If not expressly taught by the prior art, based upon the overall beneficial teaching provided by this reference with respect to dosages and the beneficial use of ingredients for treatment of joint-related symptoms in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable Perna canaliculus (instant Claims 1, 8, and 9), avocado/soybean unsaponifiables (instant Claims 1, 12, and 13), eggshell membrane (instant Claim 7), and green tea leaf (instant Claims 1, 14, and 15) weight range), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Comblain et al. (J Vet Pharmacol Therap, 2016, 1-15) in view of Ruff et al. (Vet Med Res Reps, 2016, 113-121) and Luk et al. (Antioxidants, 2020, 28 pages) as applied to Claims 1, 2, and 4-15 above, and further in view of Gencoglu et al. (Animals, 2020, 24 pages).
The claims and teachings of Comblain et al., Ruff et al., and Luk et al. are as of record.
Comblain et al., Ruff et al., and Luk et al. do not teach wherein the collagen is chicken collagen.
Gencoglu et al. teach that undenatured type II collagen is a nutritional supplement derived from chicken sternum cartilage (Gencoglu et al., Introduction, page 2; as required for instant Claim 3) which can provide health benefits for companion animals with osteoarthritis.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the joint-related compounds of Comblain et al., Ruff et al., Luk et al., and Gencoglu et al. to arrive at the instantly claimed composition. A skilled artisan would know that chickens are a common source of undenatured type II collagen and could therefore incorporate this chicken collagen into the instant composition with a reasonable expectation of success.
Claims 1, 2, and 4-20 are rejected under 35 U.S.C. 103 as being unpatentable over Comblain et al. (J Vet Pharmacol Therap, 2016, 1-15) in view of Ruff et al. (Vet Med Res Reps, 2016, 113-121) and Luk et al. (Antioxidants, 2020, 28 pages) as applied to Claims 1, 2, and 4-15 above, and further in view of Frondoza et al. (US 2020/0384052 A1).
The claims and teachings of Comblain et al., Ruff et al., and Luk et al. are as of record.
Comblain et al., Ruff et al., and Luk et al. do not teach wherein the composition is in the form of a powder or additional ingredients of a filler, a flavoring, a colorant, or a preservative.
Frondoza et al. teach orally administerable compositions comprising avocado/soybean unsaponifiables and active ingredients beneficial to connective tissue including green tea extracts, curcumin, and egg shell membrane (Frondoza et al., [0035], page 5). These compositions can be in the form of a powder (Frondoza et al., [0033], page 5; as required for instant Claim 16) and comprise non-active pharmaceutical ingredients such as fillers, flavoring agents (flavoring), coloring agents (colorant), and those that serve to preserve (preservatives; Frondoza et al., [0034], page 5; as required for instant Claims 17-20).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of the joint-related compounds of Comblain et al., Ruff et al., and Luk et al., and the composition of Frondoza et al. to arrive at the instantly claimed composition. The additional non-active ingredients help provide the active ingredients in a preparation that is safe, convenient, and otherwise acceptable for use (Frondoza et al., [0034], page 5) and oral dosage forms, such as a powder, are convenient (Frondoza et al., [0033], page 5). A skilled artisan would therefore be motivated to provide the active ingredients of Comblain et al., Ruff et al., and Luk et al. in powder form with additional non-active ingredients of Frondoza et al. and could do so with a reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. 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, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
Prior Art Made of Record but not Relied Upon
Bierer and Bui (J Nutr, 2002, 1634S-1636S) teach that dogs fed a green-lipped mussel powder supplement or processed treat showed reduced arthritic signs including joint pain and swelling.
Bland (Southern Illinois University Carbondale, 2016, 133 pages) teaches that curcumin reduces pain in osteoarthritic dogs and improved daily life activity without and adverse side effects.
Rialland et al. (Canada J Vet Res, 2013, 66-74) teach that a diet enriched with green-lipped mussel modified gait in dogs with osteoarthritis by improving peak vertical force.
Conclusion
No claims are allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655