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 .
Response to Arguments
Applicant’s response from 7/14/2025 is acknowledged.
Claim Rejections - 35 USC § 112
Claim Rejections - 35 USC § 103
Applicant’s arguments with respect to both rejections turn on the claim amendments, and on their claim construction. Accordingly, the Examiner has addressed them extensively vis-à-vis the modified 35 USC § 112 rejection below, and incorporated her interpretation of Applicant’s claims in the 35 USC § 103 rejection below. They explicitly address arguments by Applicant as well as renders Applicant’s arguments moot.
With respect to the rejection under 35 USC 103, the Examiner would like to just note the following. To cut it to the chase in view of Applicant’s new claim amendments, Applicant has first moved in the rejection as primary reference that of Brien.
Applicant has argued vis-à-vis O’Brien as follows:
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In response, the Examiner explicitly notes in response, that the disclosure of O’Brien is far more specific on this, and very much according to Applicant’s claims as amended, as already addressed in the office action. “Even more explicit on this, O’Brien is prior art by Dr. Philip O’Brien, a chiropractic physician, whose practice centers around sports injuries, complicated spinal pain cases musculoskeletal issues, nutritional consultation and athletic supplementation. (p. 2). The article pertains to nutritional approach to tendon and muscle health, which highlights the importance of vitamin A among four total vitamins. In most relevant part, it provides: “I use Vitamin A with many of my tendon injuries such as tennis elbow, knee strains, wrist strains, whiplash from car accidents, low back and neck strains, and basically any injury that affects a joint complex. Vitamin A helps the tendons repair themselves . . . I find a quality supplement is the easiest and fastest way to jump start the healing process.” (p. 1).
Claims 1-4, 7, 8, 17-19 and 26-32 are pending, and have been examined herewith. Claims 21-25 are withdrawn from consideration as directed to a non- elected invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 7, 8, 17-19 and 26-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Applicant’s new claim amendment to independent claim 1 recites the limitation “wherein the vitamin A is the only non-cellular, non-antibiotic, pharmaceutically active agent administered to the subject for the treatment of tendon or ligament injury”. The limitation is vague and indefinite and subject to many different interpretations.
The limitation is found in a single place in Applicant’s specification in the following paragraph, which provides.
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(p. 19).
The issue presented is, what is encompassed within the meaning of “wherein the vitamin A is the only non-cellular, non-antibiotic, pharmaceutically active agent administered to the subject for the treatment of tendon or ligament injury”. Amended claim 1 recites:
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Let us take a look at the support in the specification for this supplement. It makes is abundantly clear that the references is to, or includes, standard dietary supplements. See, e.g.:
[0029] Vitamin A is available for human consumption in multivitamins and as a stand-alone supplement, often in the form of retinyl acetate or retinyl palmitate. A portion of the vitamin A in some supplements is in the form of beta-carotene and the remainder is preformed vitamin A; others contain only preformed vitamin A or only beta-carotene. Supplement labels usually indicate the percentage of each form of the vitamin. The amounts of vitamin A in stand-alone supplements range widely. Multivitamin supplements typically contain 2,500 to 10,000 international units (IU) vitamin A, often in the form of both retinol and beta-carotene.
[0030] Vitamin A is listed on food and supplement labels in international units (IUs). However, Recommended Dietary Allowance (RDA) (average daily level of intake sufficient to meet the nutrient requirements of nearly all (97%-98%) healthy individuals) for vitamin A is given as micrograms (μg; mcg) of retinol activity equivalents (RAE) to account for the different bioactivities of retinol and provitamin A carotenoids (see Table 1). Because the body converts all dietary sources of vitamin A into retinol, 1 mcg of physiologically available retinol is equivalent to the following amounts from dietary sources: 1 mcg of retinol, 12 mcg of beta-carotene, and 24 mcg of alpha-carotene or beta-cryptoxanthin. From dietary supplements, the body converts 2 mcg of beta-carotene to 1 mcg of retinol.
[…]
[0037] The Food and Nutrition Board (FNB) at the Institute of Medicine of the National Academies (formerly National Academy of Sciences) has established tolerable Upper Intake Level (UL) (maximum daily intake unlikely to cause adverse health effects) for preformed vitamin A that apply to both food and supplement intakes. The FNB based these ULs on the amounts associated with an increased risk of liver abnormalities in men and women, teratogenic effects, and a range of toxic effects in infants and children. The FNB has not established ULs for beta-carotene and other provitamin A carotenoids.
So, the issue presented, what does this language of vitamin A in a supplement form mean “wherein the vitamin A is the only non-cellular, non-antibiotic, pharmaceutically active agent administered to the subject for the treatment of tendon or ligament injury”, as it turns on the issue of what is the “only pharmaceutically active agent administered to the subject for the treatment of tendon or ligament injury”?
It should further be noted that Applicant’s claims do not use the transitional phrase “consisting of”, which precludes the presence of other ingredients beyond vitamin A.
Let us first turn on this issue to Applicant’s specification at p. 20. It discloses what it considers to be, arguable not labelled to be pharmaceutically active agents, but but just merely optional physiologically acceptable carriers and/or stabilizers.
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(Specification, p. 20).
Of note, these include, inter alia, compounds which are very well for ligament repair, e.g. gelatin, ascorbic acid (vitamin C), glucosamine, N-methylglycosamine, galactosamine, neuraminic acid. Applicant does not call them, however, active agents, per se, but rather optional physiologically acceptable carriers and/or stabilizers, which are thus presumably included within the meaning of the claim term.
The following is a link to the Dietary Supplement Label Database (DSLD) of the NIH. https://dsld.od.nih.gov/
Home | Dietary Supplement Label Database (DSLD) | NIH Office of Dietary Supplements
Here the Examiner did a search for “vitamin A” on it, and further used filters for “on market” year 2019 and before to show the on market labels before Applicant’s priority date.
https://dsld.od.nih.gov/search/vitamin%20A/bWFya2V0X3N0YXR1cz1vbl9tYXJrZXQvZW50cnlfZGF0ZT0yMDExLDIwMTkvc29ydD1tYXRjaC9wYWdlX3NpemU9MjAv
The results show “37,956 labels found (20.1% of database).”.
Let us start with the first label, which opens up- Bluebonnet, Vitamin A, entered into DSLD 10/2028, available at https://dsld.od.nih.gov/label/176789 (“Bluebonnet Vitamin A label”).
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The Bluebonnet Vitamin A supplement has Vitamin A 10,000 IU softgels. As other (formulation) ingredients it contains fish (cod), soybean, gelatin, glycerin, purified water and soybean oil.
First, let’s start with a notation that the product discloses gelatin, and that gelatin is an overlapping ingredient with the disclosure in Applicant’s specification, p. 20, of what Applicant merely deems to be physiologically acceptable carriers and/or stabilizers, but which in fact, is a well known ingredient of ligament repair too.
So let’s take a look at these other ingredients. Nutrition can help with recovery - specifically a tendon injury, May 24, 2017, available at https://www.hovephysio.com/our-articles/2017/05/nutrition-recovery-tendon-injury (“Hovephysio”, of record) provides the following with respect to tendon ruptures.
“Tendon ruptures: Let’s take a look at protein considerations for a ruptured tendon. Tendons are the connection between the bone and muscle and made up of approximately 85% collagen. So, at a basic level the nutrients required to build tendons can help repair a rupture. Collagen is a protein, which is made from smaller building blocks called amino acids, and the major amino acids in tendon collagen are glycine and proline.
Good sources include: Gelatin products, soy beans, chicken and cheese (glycine). Avocado, asparagus, eggs and cottage cheese (proline)”
(emphasis added)
In its response from 8/8/2025 Applicant takes the position that:
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(Response at p. 7).
In response, the distinction made by Applicant is difficult to appreciate. Collagen, although broken down in the gut, is assembled back as collagen. So, it is the collagen, which directly causes the tendon tissue repair. In a similar fashion, vitamin A from food is also broken down and absorbed in the gut, specifically in the small intestine. Animal-based vitamin A (retinyl esters) is broken down into retinol, while provitamin A carotenoids (from plant-based foods) are converted into retinol. This conversion process is facilitated by enzymes and other factors within the intestinal cells. Further, it is not the vitamin A, which is directly active in the body, as retinol is then oxidized to retinal and retinoic acid, the two main active vitamin A metabolites in the body.
In sum, this Bluebonnet label of a stand-alone vitamin A supplement by itself establishes that the claimed limitation of “wherein the vitamin A is the only non-cellular, non-antibiotic, active agent administered to the subject” in the vitamin A supplement is vague and indefinite.
Kohnke continues to be relevant, to include in view of the above considerations. It provides as follows:
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(p. 1).
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(p. 2).
As can be seen from the Handy Hint section on p. 1, Kohnke specifically states that “supplements of Retinol (Vitamin A) … can significantly reduce the significance of tendon and ligament failure.” It does not say that about zinc, copper and macronutrients. Specifically, it does not say they are given to reduce tendon and ligament failure, but rather explicitly states “zinc, copper and micronutrients to maintain collagen strength.” It further explicitly states as to Kohnke’s Own BCS that they are “nutrients which have a role in the maintenance of collagen and elastic tissue in the lungs, tendons and ligaments.” Similarly, the bold section on management of tendon and ligament strain solely bolds out to provide a supplement of vitamin A- p. 2, section 3. But as to copper, zinc and manganese, it explicitly characterizes them as “cartilage trace minerals”, and only states as to the combination that it is “to help improve tendon elasticity and healing during training.” Thus, Kohnke is explicit that only vitamin A is listed as the ingredient, which can reduce tendon and ligament injury. The other micronutrients and nutrients are only listed as cartilage trace elements having a beneficial role in maintaining collagen strength, which is not the same as treating tendon and ligament failure.
So, the issue again is, what is the “only pharmaceutically active agent administered to the subject for the treatment of tendon or ligament injury”?
Kohnke does not state the zinc, copper and macronutrients to significantly reduce the significance of tendon and ligament failure, as it does for vitamin A alone. Thus, zinc, copper, manganese and macronutrients are not excluded, per se, from Applicant’s supplement comprising vitamin A.
Next, moving on to Welch, the office action provides:
“Welch, in an article explicitly titled “Vitamins for Ligament Repair Vitamin C Vitamin E Vitamin A”, discloses three vitamins with a role in ligament repair, to include vitamin A. Per Welch: “Vitamins for ligament repair can help your joints and muscles operate properly . . . Make certain to eat a well-balanced diet, which is the best way to obtain the needed amounts of vitamins to promote ligament repair, according to the National Institutes of Health 2 3 4 . . . Vitamin A plays a major role in maintaining and forming healthy soft and skeletal tissue, according to the National Institutes of Health 2 3 4. As an antioxidant, this nutrient can fight free radicals that attack your synovial fluid, which lubricates your joints. Try eating animal-based products including fortified foods, eggs, meat and fish, whole milk and animal liver. Vitamin A also comes in the form of beta carotene. Eat brightly-colored fruits and vegetables to get your beta carotene. Vitamin A plays a major role in maintaining and forming healthy soft and skeletal tissue, according to the National Institutes of Health 2. As an antioxidant, this nutrient can fight free radicals that attack your synovial fluid, which lubricates your joints.” (pages 1 and 3).”
Thus, as can be seen from the above, Welch teaches the importance of a well-balanced diet, to include of three vitamins with a role in ligament repair. However, it individually describes the role of vitamin A. That there are two other vitamins with a role in vitamin repair does not mean that Welch teaches that the combination of all three simultaneously is required for the effect to take place. Nowhere does Welch teach such a requirement.
Next, moving on to O’Brien, the office action provides:
“Even more explicit on this, O’Brien is prior art by Dr. Philip O’Brien, a chiropractic physician, whose practice centers around sports injuries, complicated spinal pain cases musculoskeletal issues, nutritional consultation and athletic supplementation. (p. 2). The article pertains to nutritional approach to tendon and muscle health, which highlights the importance of vitamin A among four total vitamins. In most relevant part, it provides: “I use Vitamin A with many of my tendon injuries such as tennis elbow, knee strains, wrist strains, whiplash from car accidents, low back and neck strains, and basically any injury that affects a joint complex. Vitamin A helps the tendons repair themselves . . . I find a quality supplement is the easiest and fastest way to jump start the healing process.” (p. 1).
Thus, again, O’Brien too explicitly singles out the role of vitamin A for various soft tissue injuries. It does not list any other ingredient as required for this, but only that “a quality supplement is the easiest and fastest way to jump start the healing process” (emphasis added), which is not at all the same as treating soft tissue injury. Rather, the healing process is a reflection of a whole body being well nourished and supplemented so that it functions as normal, so that immunity altogether is normal, etc., which is very different from specifically treating the soft tissue injury itself.
Further, as noted above, Applicant’s claims contain the transitional phrase “comprising”. Thus, they most certainly do not exclude giving any other ingredients, to include zinc, etc., outside of this supplement with vitamin A. Applicant’s claims 18 and 19 require that the vitamin A be administered for at least a week, at least a month, at least 6 months, and up to 6 years from the day of first administration to the subject. Certainly, this further provides that the subject receives nutrition, to include full balanced nutrition.
Another way to exemplify the Examiner’s points on Applicant’s claim construction is by reference to a reference from Applicant’s most recent IDS from 4/17/2023- Linus Pauling Institute, Vitamin A, 2018, available at https://lpi.oregonstate.edu/mic/vitamins/vitamin-A (“Linus”, of record):
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Linus is a reference with general information on Vitamin A. Linus explicitly states as to nutrient interactions with zinc that: “Zinc deficiency is thought to interfere with vitamin A metabolism in several ways”. Yet, Applicant’s proposed claimed construction seemingly excludes zinc.
In its response from 5/1/2024 Applicant states that: “Regarding the Office’s assertion on page 11 that “zinc deficiency is thought to interfere with vitamin A metabolism in several ways’, yet the proposed claim construction excludes zinc, Applicant submits that the claims are not limited to subjects with zinc deficiency, and therefore there is no requirement to include in the supplement other vitamins and minerals, such as zinc . . . The Office’s assertion regarding zinc deficiency is further rendered moot as it is clear that the amended claims do not prevent administration of zinc to the subject by means other than by the claimed supplement.” (Response at p. 8-9).
In response to this, again, Applicant’s claim amendments do not preclude the administration of other necessary ingredients, such as the micronutrient zinc, and Applicant itself admits it. So, whether the administration of zinc is done within or outside of the supplement, Linus does provide that zinc is a necessary micronutrient, and does not limit the findings to subjects with zinc deficiency, as Applicant has twisted it, but rather speaks that zinc deficiency in general interferes with vitamin A metabolism in several ways.
Last but not least, Applicant itself has a product posted on the internet called Nutra Sport Regenerall1, which is promoted as a post work out drink. It has, in fact, a substantial overlap with ingredients noted in Applicant’s specification at p. 20 above. This drink includes also micronutrients, as in the art below.
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So, if Applicant solely markets one of its products as the sole product for ligament repair after injury, and the other product as post work out, with both comprising what the art below describes as useful for various aspects of ligament repair, does this not create a disclosure, through a different marketing strategy, of two products given independently, both for use after work out, to include for tendon/ ligament injuries?
Or if Applicant markets the two products both for tendon/ ligament injuries, just each administered separately, even though vitamin A may be considered to be the “only therapeutically active agent in one of them, is this also not indicative of fully practicing a method of treating tendon/ ligament repair with two products with multiple ingredients known in the art for tendon/ ligament repair? In fact, as a google search reveals, Applicant does in fact also market Regenall for post-chronic tendon/ligament injuries, as seen from this link and clip.2
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This exemplifies how Applicant’s claim term can be, and is, vague and indefinite through Applicant’s own marketing and products.
For the foregoing reasons, Applicant’s claims as amended are vague and indefinite, and subject to many different interpretations.
Claim Rejections - 35 USC § 103
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.
Claims 1-4, 7, 8, 17-19 and 26-32 are rejected under 35 U.S.C. 103 as being unpatentable over O’Brien, Nutritional Approach to Tendon and Muscle Health, 2017 (“O’Brien, ref. 43 from Applicant’s IDS from 3/2/2022, of record), Kohnke, Bowed Tendons & Ligament Strain, 2013 available at https://www.animalfeedsolutions.com/site_files/13038/upload_files/C5-BowedTendonsandLigamentStrain.pdf?dl=1 (“Kohnke”, of record), and further in view of McKiernan, Estimating a horse’s weight, February 2007, Primefact 494, available at http://www.dpi.nsw.gov.au/__data/assets/pdf_file/0008/109988/estimating-a-horses-weight.pdf (“McKiernan”, of record), Welch, Vitamins for Ligament Repair, available at https://healthfully.com/vitamins-for-ligament-repair-5185421.html, November 28, 2018, ref. 43 from Applicant’s IDS from 3/2/2022 (“Welch”, of record), Carlson, Vitamin A, 15,000 IU, 240 Soft Gells, available at https://www.iherb.com/pr/carlson-vitamin-a-15-000-iu-240-soft-gels/13728, product stated to be Date First Available: November 19 2008, and partial list of Questions and Answers pertaining thereto showing online comments at least as early as Nov. 12, 2017 (“Carlson”, of record), and Greenwald et al., Zone Il Flexor Tendon Repair: Effects of Vitamins A, E, b-Carotene, J. Surgical Research, 49-96-102 (1990) (“Greenwald”, of record).
Claim interpretation
The Examiner interprets Applicant’s new claim 1 limitation “wherein the vitamin A is the only non-cellular, non-antibiotic, active agent administered to the subject” in accordance with the 35 USC 112(b) rejection above.
Applicant previously amended claim 1 to be solely directed to a human administration “wherein the subject is administered >10% and up to 50% of a maximum safe dose of vitamin A for the subject per day”. Applicant also previously added claims 26-32, which recite with respect to administering to a horse “wherein the horse is administered >15% to 50% of a maximum safe dose of vitamin A for the subject per day”. The Examiner interprets this dose for a human to be in line with Applicant’s claim 7, which provides “at a dose of >10,000 and up to 50,000 IU vitamin A per day”. The following Table 2 from Applicant’s specification provides what Applicant perceives to be the maximum safe dose. As can be seen from it, it varies depending on the age of the subject starting at 600 mg RAE (2,000 IU) for a human subject 0-12 months, and going to 3,000 mcg RAE (10,000 IU) for human subject 19+ years, of preformed Vitamin A.
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(specification, p. 7).
Based on that, it appears that the amounts of “>10% and up to 50%” for a human being will vary from >660 mcg/ 2,200 IU and up to 900 mcg/ 3,000 IU for human subjects up to 3 years of age, and from >3,300 mcg/ 11,000 IU, and up to 4500 mcg/ 15,000 IU for human subjects who are 19+ years old.
The Examiner also interprets this dose for a horse to be in line with Applicant’s claim 28, which provides “at a dose of >150 and up to 500 IU/kg of body weigh vitamin A per day”. (See also Applicant’s response from 9/28/2022 at p. 12).
Rejection
Applicant’s new claim amendment to independent claim 1 recites the limitation “wherein the vitamin A is the only non-cellular, non-antibiotic, pharmaceutically active agent administered to the subject for the treatment of tendon or ligament injury”. To cut it to the chase on this claim amendment first, the Examiner moved the reference of O’Brien as the primary reference.
O’Brien is prior art by Dr. Philip O’Brien, a chiropractic physician, whose practice centers around sports injuries, complicated spinal pain cases musculoskeletal issues, nutritional consultation and athletic supplementation. (p. 2). The article pertains to nutritional approach to tendon and muscle health, which highlights the importance of vitamin A among four total vitamins. In most relevant part, it provides: “I use Vitamin A with many of my tendon injuries such as tennis elbow, knee strains, wrist strains, whiplash from car accidents, low back and neck strains, and basically any injury that affects a joint complex. Vitamin A helps the tendons repair themselves . . . I find a quality supplement is the easiest and fastest way to jump start the healing process.” (p. 1).
Thus, O’Brien explicitly singles vitamin A for alone, for tendon repair after injury. That O’Brien further teaches a basic multivitamin for general health- as Applicant has argued-- is not at all therefore contrary to the Examiner’s claim construction, as these other multivitamins fall within the meaning of the claim term “wherein the vitamin A is the only non
O’Brien does not explicitly provide the dose, as per Applicant’s claims, but does provide guidance on e.g. using a “quality supplement [as] the easiest and fastest way to jump start the healing process”.
O’Brien does not explicitly disclose the dose of vitamin A.
Kohnke relates to tendon and ligament injury in horses, and to its treatment with daily oral administration of vitamin A. “Studies have indicated that supplements of Retinol (Vitamin A) at 50,000 IU (15mg Retinol) daily given to race horses on grain and cereal hay diets can significantly reduce the incidence of tendon and ligament failure during training. A daily supplement of 40g Kohnke’s Own Cell-Vital, or 60g Kohnke’s Own Harness Special or 120g Kohnke’s Own Cell-Vital PREMIUM contains more than 50,000 IU of Retinol, as well as zinc, copper and micronutrients to help maintain collagen strength. The individual Supplets® of vitamins and separate trace-mineral pellets in the Kohnke’s Own products help ensure that the potency of all vitamins, including Vitamin A, is maintained during storage and when mixed into feed.” (p. 1, Handy Hint; see also p. 2, col. 2). Kohnke relates to daily oral supplementation, so it places no limits on the number of days or years, and is thus inclusive of the time limit of Applicant’s claims18 and 19. Per Applicant’s claim 20, the retinol is noted as the only active agent in the supplement- “provide a supplement of vitamin A”. (p. 2, col. 2). The disclosure of supplement indicates that there is delivery with a pharmaceutically acceptable carrier.
The language of “can significantly reduce the incidence of tendon and ligament failure during training” indicates that the method is one of both prevention as well as reduction of tissue damage after injury. Moreover, additional art below, used in combination, further explicitly relates to ligament repair after injury. (See, e.g., O’Brien).
The disclosure on Vitamin A explicitly relates to helping improve “healing”, and to daily administration, in day to day management, while it also discloses that the whole step-wise program takes place over 26 weeks.
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(p. 2, col. 1-2).
O’Brien or Kohnke do not disclose the 50,000 IU of Retinol in IU/ kg body weight. However, as further evidenced by McKiernan, this dose corresponds to the doses in IU/kg of Applicant’s claims 12-14.
McKiernan discloses a table of approximate weights of horses by type and size. (Table 1).
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Thus, 50,000 IU for a 200 kg horse corresponds to 250 IU/kg, which simultaneously meets the limitations of all of claims 26-29. 50,000 IU for a 250 kg horse corresponds to 200 IU/kg, which meets the limitations of claims 26-28.
Applicant has argued in its response from 3/2/2022 and thereafter that the disclosure of “to help improve tendon elasticity and healing during training” is akin to preventing, not treating tissue damage after an injury. The Examiner notes that neither the explicit language of Kohnke quoted above, nor the rest of the disclosure, support such an interpretation. The language is clear that it is “during training”. Kohnke further explicitly discloses that the treating is “after tendon and suspension injury”: “A step-wise program to increase loading after tendon and suspensory injury is now known to increase the long term success of rehabilitation.” (p. 1, col. 1, emphasis in the original). With respect to vitamin A, it explicitly provides that it is “it is to help improve tendon elasticity and healing during training.” (p. 2, col. 2, emphasis added).
In addition to O’Brien, as additional prior art disclosing the utility of the instant method for treating a human, the Examiner includes in the rejection Welch.
Welch, in an article explicitly titled “Vitamins for Ligament Repair Vitamin C Vitamin E Vitamin A”, discloses three vitamins with a role in ligament repair, to include vitamin A. Per Welch: “Vitamins for ligament repair can help your joints and muscles operate properly . . . Make certain to eat a well-balanced diet, which is the best way to obtain the needed amounts of vitamins to promote ligament repair, according to the National Institutes of Health 2 3 4 . . . Vitamin A plays a major role in maintaining and forming healthy soft and skeletal tissue, according to the National Institutes of Health 2 3 4. As an antioxidant, this nutrient can fight free radicals that attack your synovial fluid, which lubricates your joints. Try eating animal-based products including fortified foods, eggs, meat and fish, whole milk and animal liver. Vitamin A also comes in the form of beta carotene. Eat brightly-colored fruits and vegetables to get your beta carotene. Vitamin A plays a major role in maintaining and forming healthy soft and skeletal tissue, according to the National Institutes of Health 2. As an antioxidant, this nutrient can fight free radicals that attack your synovial fluid, which lubricates your joints.” (pages 1 and 3).
O’Brien does not explicitly provide the dose, as per Applicant’s claims, but does provide guidance on e.g. using a “quality supplement [as] the easiest and fastest way to jump start the healing process”.
Carlson discloses that Vitamin A was available as a dietary supplement at a dose of 15,000 I.U. (4,500 mcg RAE) of each gel. The serving size is one gel daily of vitamin A (as retinyl palmitate from retinol). The bottle size is 240 soft gels.
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The dose of preformed Vitamin A of 15,000 I.U. (4,500 mcg RAE) of Carlson meets the dose limitations of Applicant’s claims 1-4 and 7, and the frequency administrations of Applicant’s claims 17, 18 and 19 (daily, with 240 capsules being able to last for about 8 months, which also meets the limitation of up to 6 years). The Vitamin A of Carlson is the only active ingredient in a supplement, per Applicant’s claim 20.3
As was noted in the calculations pertaining to Applicant’s Table 2 from the specification above, the dose of Applicant’s claim 8 lacks antecedent basis from claim 1.
But even assuming, arguendo, that some of the doses and administration regimens were not disclosed, it should further be noted that as these doses are disclosed in the art above to be result-effective variables, it would have been fully within the realm of obvious with a reasonable expectation of success for the skilled artisan before the effective filing date of the claimed invention to optimize them in order to achieve optimal therapeutic efficacy and balance it out against toxicity. This conclusion holds true for both Applicant’s claim relating to humans, as well as to horses. In this respect, it is further noted that Kohnke relates to horses, and the references relating to human doses, both provide motivation to optimize the dose, as well as extend the duration of treatment in daily supplements to months and beyond. Moreover, the art of record provides motivation to administer either just Vitamin A as a stand-alone supplement, or Vitamin A in combination with other active agents, which have also been shown in the art to have treatment utility, particularly where the skilled artisan would be guided by considerations of whether overlapping treatment utility is needed or not.
Moreover, the utility of vitamin A for treating tissue damage following an injury is known across a number of species, and in such species, the dose of Vitamin A has been upward adjusted even more. Greenwald discloses the effects of vitamins A, E, and beta-carotene on tendon repair in an in-vivo chicken model. Animals fed vitamin A (150,000 TU/kg chow) were shown to have increased breaking strength compared to control (see Figure 1 and Abstract), and therefore it concluded that vitamin A increases breaking strength in composite tendon wounds.
The Examiner interprets Applicant’s new claim 1 limitation “wherein the vitamin A is the only non-cellular, non-antibiotic, active agent administered to the subject for the treatment of the tendon or ligament injury” present in the supplement in accordance with the 35 USC 112(b) rejection above. As was noted in this rejection, the Examiner is of the view that both the art of record supports administering vitamin A alone in a supplement for treating soft tissue injury as claimed by Applicant, and that Applicant’s proposed claim construction is vague and indefinite, and so expansive that it renders the claims meaningless.
Accordingly, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to combine the teachings of O’Brien, Kohnke, Welch, Carlson and Greenwald in order to practice Applicant’s claimed method with a reasonable expectation of success. The skilled artisan would have been motivated to do so because the role of vitamin A in treating tissue damage following an injury is known across a number of species, to include horses, humans and chickens. Moreover, it would have been obvious to the skilled artisan to optimize the specific doses in each species, particularly knowing that vitamin A is a lipid soluble vitamin, and thus liver toxic, but also in view of general knowledge that for each species, it is necessary to optimize and adjust the therapeutic doses below the maximum safe doses, in order to balance therapeutic efficacy versus toxicity, as well as accordingly the therapeutic regimens of administration.
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 SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
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/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627
1 Available at https://nutrasport.hu/products/regenall-regeneration#:~:text=warning%20%3B%20REGENOR%20MATRIX%20MSM,%20Glucosamine%20sulfate,,Chondroitin%20sulfate,%203250%20mg,%201250%20mg%20%3B
2 https://www.regenall.com/human
3 In its responses, to include from 7/14/2025, Applicant has attacked Carlson that it is not for use in the treatment of tissue damage, and that the capsules are for cosmetic use. (Response at p. 12). In response, the Examiner reminds Applicant that it is impermissible to attack references singly when the Examiner relies upon the combined teachings of the references, nor may they attack a reference for not teaching a limitation of the claim when the Examiner has explicitly relied upon another reference as teaching that limitation. See In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000)). Moreover, Applicant’s own specification avers that cosmetic treatment of the method is also encompassed within the purview of Applicant’s invention. (p. 23, l. 10 of the Specification as filed).