Prosecution Insights
Last updated: August 14, 2026
Application No. 18/707,629

Method for Treating Skeletal Articulations and Composition and Uses Thereof

Non-Final OA §102§103§112§DP
Filed
May 06, 2024
Priority
Nov 12, 2021 — provisional 63/278,860 +1 more
Examiner
ABBAS, SYED JARAR
Art Unit
1674
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Lonza Greenwood LLC
OA Round
1 (Non-Final)
0%
Grant Probability
At Risk
1-2
OA Rounds
1y 0m
Est. Remaining
0%
With Interview

Examiner Intelligence

Grants only 0% of cases
0%
Career Allowance Rate
0 granted / 2 resolved
-60.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
30 currently pending
Career history
31
Total Applications
across all art units

Statute-Specific Performance

§101
2.6%
-37.4% vs TC avg
§103
17.4%
-22.6% vs TC avg
§102
27.0%
-13.0% vs TC avg
§112
35.7%
-4.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 2 resolved cases

Office Action

§102 §103 §112 §DP
DETAILED ACTION Notice of Pre-AIA or AIA Status 1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claims Status 2. The preliminary amendments filed 05/06/2024 are acknowledged. Claims 1-23 are pending and under examination. Information Disclosure Statement 3. The information disclosure statements (IDS) submitted 05/06/2024 and 09/25/2025 and the references cited therein have been considered, unless indicated otherwise. Specification 4. The use of the term HI-CAP100, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Please review the specification for other Trademarks and correction is required. 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. 5. Claim 4 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. The term “about” in claim 4 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. 6. Claims 6-23 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. The term “at least about” in claims 6-22 and ”generally less than about” in claims 6-23 is a relative term which renders the claim indefinite. The term “at least about” and ”generally less than about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. 7. Claims 6-22 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. The term “amount sufficient to decrease” claims 6-22 is a relative term which renders the claim indefinite. The term “amount sufficient to decrease” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 8. Claim(s) 1 and 5-22 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Bagi, et al. (C.M. Bagi, E.R. Berryman, S. Teo, N.E. Lane, Oral administration of undenatured native chicken type II collagen (UC-II) diminished deterioration of articular cartilage in a rat model of osteoarthritis (OA), Osteoarthritis and Cartilage, Volume 25, Issue 12,2017, Pages 2080-2090, ISSN 1063-4584, https://doi.org/10.1016/j.joca.2017.08.013). The instant claims are drawn to a method of treating a skeletal articulation injury or disease in a mammal comprising: supplying to the mammal a nutraceutical supplement containing effective amount of a joint treat composition, the joint treating composition comprising collage, the joint treating composition being administered in doses, and wherein the therapeutically effective amount is an amount of at least about 0.66 mg/kg of body weight per day and sufficient to lessen the severity the skeletal articulation injury or disease as shown through a change in at least one joint health marker in comparison to administering less than 0.3 mg/kg of body weight per day of the joint treating composition. Bagi, et al. teach osteoarthritis was induced in rats by partial medial meniscectomy tear surgery and treated therapeutically. Bagi, et al. teach supplying to the mammal a nutraceutical supplement containing a therapeutically amount of joint treating composition being undenatured native chicken type II collagen, which was characterized as nutraceutical and administered orally. Bagi, et al. further teach the join treating composition comprises collage (UC-II: collage content 263.0 mg/g). Bagi, et al. teach the teach the composition was administered in doses as an oral daily dose over an 8 week period. Bagi, et al. teach the therapeutic affective amount is at least about 0.66 mg/kg of body weight per day. Bagi, et al. teach administering UC-II at 0.66 mg/kg/day which is equivalent to 40 mg/ day clinical dose for a 60 kg human. Bagi, et al report a statically significant reduction in serum CTX-II, preservative of dynamic weight bearing capacity, and reduced cartilage degeneration and osteophyte size in treatment animal. This change is shown in comparison to administering less than 0.3 mg/kg of body weight per day as the vehicle control group received 0 mg/kg and exhibited higher CTX-II and greater cartilage deterioration against which the treated group was measured. Bagi, et al. teach the collagen comprises undenatured type II collage which satisfy the limitation of instant claim 5. Regarding instant claims 6-22, that recite “decrease serum tumor necrosis factor by at least about 5% and generally less than about 80%”, “decrease serum C-reactive protein by at least about 10% and generally less than about 90%”, “decrease prostaglandin E2 by at least about 8% and generally less than about 80%”, “decrease IL-10 by at least about 10% and generally less than about 100%”, “decrease tumor necrosis factor by at least about 10% and generally less than about 80%”, “decrease cyclooxygenase 2 by at least about 7% and generally less than about 90%”, “decrease nuclear factor kappa B by at least about 10% and generally less than about 80%”, “decrease matrix metallopeptidase 3 by at least about 15% and generally less than about 75%”, “decrease transforming growth factor B by at least about 5% and generally less than about 80%”, “decrease serum cartilage oligomeric matrix by at least about 10% and generally less than about 80%”, “decrease cartilage oligomeric matrix by at least about 10% and generally less than about 80%”, “decrease serum IL-1 by at least about 10% and generally less than about 100%”, “decrease serum IL-6 by at least about 10% and generally less than about 120%”, “decrease IL-1B by at least about 8% and generally less than about 60%”, “decrease interleukin 6 by at least about 10% and generally less than about 80%”, “sufficient to change a Kellgren-Lawrence score of the mammal by at least about 20%”, and “sufficient to change a Mankin score of the mammal by at least about 15%”, such outcomes would be inherent properties of the joint treating composition, because Bagi, et al. teach administering the same composition, at the same dosage to the same patient population and there, the prior method would necessarily possess the same results claimed by the Applicant. It is well settled that “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable (emphasis added); see In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368. Additionally, "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical composition and the properties applicant discloses and/or claims are necessarily present. 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. 9. Claim(s) 1-23 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Bagi, et al. (C.M. Bagi, E.R. Berryman, S. Teo, N.E. Lane, Oral administration of undenatured native chicken type II collagen (UC-II) diminished deterioration of articular cartilage in a rat model of osteoarthritis (OA), Osteoarthritis and Cartilage, Volume 25, Issue 12,2017, Pages 2080-2090, ISSN 1063-4584, https://doi.org/10.1016/j.joca.2017.08.013) in view of Bellamine, et al. (U.S Publication 20190060415 A1, issued February 28, 2019). The instant claims are drawn to a method of treating a skeletal articulation injury or disease in a mammal comprising: supplying to the mammal a nutraceutical supplement containing effective amount of a joint treat composition, the joint treating composition comprising collage, the joint treating composition being administered in doses, and wherein the therapeutically effective amount is an amount of at least about 0.66 mg/kg of body weight per day and sufficient to lessen the severity the skeletal articulation injury or disease as shown through a change in at least one joint health marker in comparison to administering less than 0.3 mg/kg of body weight per day of the joint treating composition. Regarding instant claim 1, Bagi, et al. teach osteoarthritis was induced in rats by partial medial meniscectomy tear surgery and treated therapeutically. Bagi, et al. teach supplying to the mammal a nutraceutical supplement containing a therapeutically amount of joint treating composition being undenatured native chicken type II collagen, which was characterized as nutraceutical and administered orally. Bagi, et al. further teach the join treating composition comprises collage (UC-II: collage content 263.0 mg/g). Bagi, et al. teach the teach the composition was administered in doses as an oral daily dose over an 8 week period. Bagi, et al. teach the therapeutic affective amount is at least about 0.66 mg/kg of body weight per day. Bagi, et al. teach administering UC-II at 0.66 mg/kg/day which is equivalent to 40 mg/ day clinical dose for a 60 kg human. Bagi, et al report a statically significant reduction in serum CTX-II, preservative of dynamic weight bearing capacity, and reduced cartilage degeneration and osteophyte size in treatment animal. This change is shown in comparison to administering less than 0.3 mg/kg of body weight per day as the vehicle control group received 0 mg/kg and exhibited higher CTX-II and greater cartilage deterioration against which the treated group was measured. Regarding instant claim 5, Bagi, et al. teach the collagen comprises undenatured type II collage which satisfy the limitation of instant claim 5. Regarding instant claims 6-22, that recites “decrease serum tumor necrosis factor by at least about 5% and generally less than about 80%”, “decrease serum C-reactive protein by at least about 10% and generally less than about 90%”, “decrease prostaglandin E2 by at least about 8% and generally less than about 80%”, “decrease IL-10 by at least about 10% and generally less than about 100%”, “decrease tumor necrosis factor by at least about 10% and generally less than about 80%”, “decrease cyclooxygenase 2 by at least about 7% and generally less than about 90%”, “decrease nuclear factor kappa B by at least about 10% and generally less than about 80%”, “decrease matrix metallopeptidase 3 by at least about 15% and generally less than about 75%”, “decrease transforming growth factor B by at least about 5% and generally less than about 80%”, “decrease serum cartilage oligomeric matrix by at least about 10% and generally less than about 80%”, “decrease cartilage oligomeric matrix by at least about 10% and generally less than about 80%”, “decrease serum IL-1 by at least about 10% and generally less than about 100%”, “decrease serum IL-6 by at least about 10% and generally less than about 120%”, “decrease IL-1B by at least about 8% and generally less than about 60%”, “decrease interleukin 6 by at least about 10% and generally less than about 80%”, “sufficient to change a Kellgren-Lawrence score of the mammal by at least about 20%”, and “sufficient to change a Mankin score of the mammal by at least about 15%”, such outcomes would be inherent properties of the joint treating composition, because Bagi, et al. teach administering the same composition, at the same dosage to the same patient population and there, the prior method would necessarily possess the same results claimed by the Applicant. It is well settled that “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable (emphasis added); see In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368. Additionally, "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical composition and the properties applicant discloses and/or claims are necessarily present. Bagi, et al. does not teach the composition includes a collagen amount of at least 1 mg/kg, 2 mg/kg, 1.2 to 3 mg/kg or an amount greater than 50 mg per day and generally less than 800 mg per day (instant claim 2-4 and 23). However, Bellamine, et al. teach a method of administering undenatured type II collagen, for treating joint pain specifically individuals with arthritis (claims 1 and 21), and the dosage of collagen can be in an amount from about 1 mg to about 15,000 mg (paragraph 44). Bellamine, et al. further teach the amount of Type II collagen in a dose consumed at any given time will vary with the purpose of the consumption, the severity of symptoms, as well as the condition, age, weight, medical history and general physical characteristics of the subject (human or animal) to be treated. Consequently, the dosages, the frequency, and time period over which the dosages are administered can vary widely (paragraph 42). Bellamine, et al. further teach in one embodiment, the composition or nutritional supplement of the present disclosure is formed into individual dosage vessels that are intended to be taken orally by a human or animal. The dosage vessel, for instance, may comprise a tablet or capsule. In one embodiment, the Type II collagen can be present in each dosage vessel generally in an amount from about 1 milligram to about 15,000 milligrams. Bagi, et al. and Bellamine, et al. teach the same joint treating composition to the same population. One of ordinary skill in the art could reasonably apply the different doses of collagen taught in Bellamine, et al. to Bagi, et al., as both teach the same composition to treat the same population group. One of ordinary skill in the art would be motivated to optimize the concentration of the Bagi’s composition, since "it is the normal desire of scientists or artisans to improve upon what is already generally known". Please note: Paragraph 8 of the instant specification discusses osteoarthritis and further says is generally directed to a method of improving one or more of joint pain, joint health, joint mobility, or inflammation in mammals. Paragraph 12 of the instant of specification further says the joint treating composition can be administered to the mammal in an amount sufficient and over a period of time in order to treat inflammation of the skeletal joints and/or treat a joint injury or disease. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. 10. Claims 1-5 and 23 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 19, 27, 38, 39 of copending Application No. 19321894 (reference application). Application No. 894’ teaches a method of improving joint health and modulate joint repair in a mammal comprising administering a nutritional product comprising undenatured type II collagen at a dose where the collagen amount is 1 mg to 15,000 mg per day. This reads on the limitations of instant claim 1-5 and 23. Although the claims at issue are not identical, they are not patentably distinct from each other because Applicant’s disclosure states in paragraph 6, describing method of treating skeletal articulation injury as methods directed to controlling pain and inflammation. Paragraph 8 discusses it as osteoarthritis and further says it is generally directed to a method of improving one or more of joint pain, joint health, joint mobility, or inflammation in mammals. Paragraph 12 further says the joint treating composition can be administered to the mammal in an amount sufficient and over a period of time in order to treat inflammation of the skeletal joints and/or treat a joint injury or disease This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 11. Claims 1-6, 10-12, 17-21 and 23 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, 7, 14, 15, 16, 17, 21, and 25 of copending Application No. 18833977 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Application No. 977’ teach a method of improving one or more joint pain and inflammation in a mammal, comprising administering undenatured type II collagen from a dose of .3 mg/kg to 3 mg/kg of body weight per day as well as 50 mg to 200 mg, wherein the improvement in one or more of joint pain and inflammation is evidenced by a 10% or greater decrease in serum interleukin-1, interleukin-6, TNF- a, COX-2, SOX-9, MMP-13, and also inhibiting one or more of: interleukin-1 expression, interleukin-6 expression, NF-kB expression, cyclooxygenase-2 (COX-2) expression, inducible nitric oxide synthase (iNOS) expression, 5-lipoxygenase biosynthesis, and tumor necrosis factor-a (TNF-a) expression. This reads on the limitations of instant claims 1-6, 10-12, 17-21 and 23. Although the claims at issue are not identical, they are not patentably distinct from each other because Applicant’s disclosure states in paragraph 6, describing method of treating skeletal articulation injury as methods directed to controlling pain and inflammation. Paragraph 8 discusses it as osteoarthritis and further says it is generally directed to a method of improving one or more of joint pain, joint health, joint mobility, or inflammation in mammals. Paragraph 12 further says the joint treating composition can be administered to the mammal in an amount sufficient and over a period of time in order to treat inflammation of the skeletal joints and/or treat a joint injury or disease This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 12. Claims 1-5 and 23 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 16 of copending Application No. 18040548 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Application No. 548’ teach a method of improving one or more of joint pain, joint health, and joint inflammation comprising administering a supplement to mammal comprising a undenatured type II collagen, at a dose between 1 mg to 5000 mg. This reads on the limitations of instant claim 1-5 and 23. Although the claims at issue are not identical, they are not patentably distinct from each other because Applicant’s disclosure states in paragraph 6, describing method of treating skeletal articulation injury as methods directed to controlling pain and inflammation. Paragraph 8 discusses it as osteoarthritis and further says it is generally directed to a method of improving one or more of joint pain, joint health, joint mobility, or inflammation in mammals. Paragraph 12 further says the joint treating composition can be administered to the mammal in an amount sufficient and over a period of time in order to treat inflammation of the skeletal joints and/or treat a joint injury or disease This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 13. Claims 1-5 and 23 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 15, 19, 27,and 38 of copending Application No. 17260360 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Application No. 360’ teach a method of maintain joint health such as treating arthritis by administering a nutritional product comprising undenatured type II collagen from a dose between 1 mg to 15,000 mg daily. This reads on the limitations of instant claim 1-5 and 23. Although the claims at issue are not identical, they are not patentably distinct from each other because Applicant’s disclosure states in paragraph 6, describing method of treating skeletal articulation injury as methods directed to controlling pain and inflammation. Paragraph 8 discusses it as osteoarthritis and further says it is generally directed to a method of improving one or more of joint pain, joint health, joint mobility, or inflammation in mammals. Paragraph 12 further says the joint treating composition can be administered to the mammal in an amount sufficient and over a period of time in order to treat inflammation of the skeletal joints and/or treat a joint injury or disease This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 14. Claim 1-5 and 23 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, 16, and 26 of copending Application No. 16106348 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Application No. 348’ teach a method of treating arthritic knees in a mammal comprising administering undenatured type II collagen at a dose between 1 mg to 50 mg. Although the claims at issue are not identical, they are not patentably distinct from each other because Applicant’s disclosure states in paragraph 6, describing method of treating skeletal articulation injury as methods directed to controlling pain and inflammation. Paragraph 8 discusses it as osteoarthritis and further says it is generally directed to a method of improving one or more of joint pain, joint health, joint mobility, or inflammation in mammals. Paragraph 12 further says the joint treating composition can be administered to the mammal in an amount sufficient and over a period of time in order to treat inflammation of the skeletal joints and/or treat a joint injury or disease. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Pertinent Art Juturu, et al. (WO 2021154774 A1). Ohran, et al. (Orhan C, Juturu V, Sahin E, Tuzcu M, Ozercan IH, Durmus AS, Sahin N, Sahin K. Undenatured Type II Collagen Ameliorates Inflammatory Responses and Articular Cartilage Damage in the Rat Model of Osteoarthritis. Front Vet Sci. 2021 Mar 4;8:617789. doi: 10.3389/fvets.2021.617789. PMID: 33748207; PMCID: PMC7970046.) Conclusion 15. No claims are allowed 16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Syed J Abbas whose telephone number is (571)272-0015. The examiner can normally be reached M-Th, 9:00AM-4:00PM. 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, Vanessa Ford can be reached at 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /SYED J ABBAS/Examiner, Art Unit 1674 /VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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Prosecution Timeline

May 06, 2024
Application Filed
Jun 17, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
0%
Grant Probability
0%
With Interview (+0.0%)
3y 3m (~1y 0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 2 resolved cases by this examiner. Grant probability derived from career allowance rate.

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