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 .
Applicant’s election without traverse of Group I claims 1-18 in the reply filed on 20 August 2025 is acknowledged. The election/restriction requirement is deemed proper and is therefore made FINAL. An Action on the merits of claims 1-18 is contained herein below.
Group II claims 19-20 and Group III claims 21-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Applicant’s statement regarding the eligibility of Group II for rejoinder upon allowance of Group I is noted.
Priority
This application claims the benefit of 63294118 filed 12/28/2021.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2 (parts i), ii), iii) (a-i)), 3-5, 12-15 and 17-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims are drawn to a composition comprising i) neutral pH soluble collagen, ii) glycosaminoglycan, and iii) optionally other active ingredients.
This judicial exception is not integrated into a practical application, and claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The test regarding Patent Subject Matter Eligibility comprises the questions:
(1) Is the claim directed to one of the four statutory categories, i.e., a process, machine, manufacture, or composition of matter? For claims 1, 2(parts i), ii), iii) a-i), 3-5, 12-15 and 17-18 the answer is “Yes” because the claim is to a composition.
(2) Prong 1: Does the claim recite or involve a judicial exception? The answer is “Yes” because the claimed composition has components which are products of Nature.
(3) Prong 2A: Is the claim directed to a Law of Nature, A Natural Phenomenon (product of Nature) or an Abstract Idea? The answer is “Yes” because the claims are directed to a product of Nature.
1. Gauza-Wlodarczyk et al (Materials Science and Engineering C, 2017, 80, 468-471) teaches that collagen present in living organisms (Introduction).
2. Conrad et al (US 5,380,716) teaches that heparin and heparan sulfate are obtained from natural sources (col. 5, lines 3-6; col. 7, lines 2-5).
3. Nagasawa et al (US 3,454,560) teaches that chondroitin sulfate is obtained from natural sources, mainly cartilage of animals (col. 1, lines 33-34).
4. Olson (US 7,435,432) teaches that cartilage from natural sources contains keratan sulfate, dermatan sulfate and hyaluronic acid (col. 3, lines 9-20). Falk et al US 5,942,498-hyaluronic acid present in nature (col. 1, lines 37-50).
5. Pavlovich et al (Open Med., 2016, 11, 242-247) teaches that platelet-rich plasma is present in human blood (Abstract).
6. Deng et al (Stem Cell Research & Therapy, 2020, 11:50, 1-10) teaches that cell free fat extract is obtained from a patient (page 2, left col., CEFFE preparation).
7. Jung et al (Science Advances, 2020, 25 March, 1-13) teaches that stem cells which secrete EV’s are present in human tissues (Introduction).
8. Kalac (J. Of the Sci. Food and Agric., 2013, 93, 209-218; published online 21 Nov. 2012) teaches that mannitol is present in mushrooms (Tables 3-5 and page 214, left col.).
9. Claim 2 recites in part (f) that polynucleotide (PN) and/or polydeoxyribnucleotide (PDRN) are extracted from salmon which is naturally occurring.
10. Guan et al (AAPS PharmSciTech., 2017, 18(8), 3172-3181) that alginate is obtained from seaweed and is a natural stabilizer.
11. Borba et al (Carbohydrate Polymers, 2016, 137, 350-359) teaches the alginate as a dissolution promoter (page 350, right col., first full para).
12. Joksimovic et al (Updates Surg, 2012, 64, 195-210) teaches that methyl sulfonyl methane is a natural compound (page 196, left col., first para) and prevents hyaluronic acid (Glycosaminoglycan) breakdown, which reads on stabilizer (page 199, left col., para under Fig. 4).
13. Hou et al (Adv Nutr, 2018, 9, 849-851) teaches that fresh plant- and animal foods are sources of essential amino acids (EAA) (page 850, right col., first para).
Prong 2B: Do the claims as a whole recite additional elements that amount to something significantly more than the judicial exception(s)? The answer is “No.” As set forth above, beyond the actual judicial exceptions, there are no additional elements that amount to significantly more.
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 15 and 17 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.
Claim 15 recites the limitation "before crosslinking" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 is drawn to the use of oligomers rich in amino groups and further recites lysine which is a monomer. The term lysine should be deleted since poly-lysine is recited.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-2, 4-9, 13, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jinting et al (CN 107441561 A; machine English Translation, pages 1-13; cited in IDS filed 09/20/2024).
Jinting et al teaches a composition comprising collagen which is derivatized by treatment with anhydrides like succinic anhydride and glycosaminoglycan (paras 0015-0016; limitation of claim 1; limitation of claim 2, part i)-derivatized collagen; limitation of claim 9). The ratio of glycosaminoglycan to collagen is 1:8-20 (para 0021; limitation of claim 4). Since the collagen is derivatized (by acylation) it should have the properties recited in claims 6-8). The collagen can be from animal tissue (para0025; as in claim 5). The glycosaminoglycan is hyaluronic acid and chondroitin sulfate (paras 0021; as in claim 13). The molecular weight of the glycosaminoglycan before crosslinking is 40kDa (para 0045; limitation of claim 15). The crosslinking is then done with EDC/NHS crosslinking system and the degree of crosslinking is adjusted with polylysine (para 0046; limitation of claims 16-17).
Therefore, Jinting et al anticipates claims 1-2, 4-9, 13, and 15-17.
A person shall be entitled to a patent unless –
(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.
Claim(s) 1-3, 5, 13-14, and 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Freeman et al (US 2005/0142161 A1).
Freeman et al teaches a composition comprising crosslinked collagen-glycosaminoglycan composite (paras 0036 and 0080; components recited in claim 1, parts i) and ii); and claim 2, part ii)). The collagen can be neutral soluble (para 0064; as in claim 1, part i)). The composition can contain anesthetics like lidocaine and procaine, alginates and polyethylene glycol (paras 0050, 0058; as in claim 2, part iii) (g), (h)-alginates reads on stabilizer and polyethylene glycol reads on dissolution promoter, and claim 3-lidocaine and procaine). According to Freeman other active agents can be added to its composition comprising collagen and glycosaminoglycan in an amount between 1% to 30% by weight (para 0045). Since Freeman teaches the use of alginates (reads on stabilizer) and polyethylene glycol (reads on solubilizer) as active agents that can be added the percentages taught are for these two components too (as in claim 3 for components (g) and (h). These can be included in a dosage sufficient for effective treatment The collagen used in the composition can be from any source (para 0078; limitation of claim 5). The glycosaminoglycans that can be used are chondroitin sulfate, heparin, hyaluronic acid, dermatan sulfate and keratan sulfate (para 0068; limitation of claim 13). They can be obtained from animal sources (paras 0067-0068; as in claims 14 and 18).
Therefore, Freeman et al anticipates claims 1-3, 5, 13-14, and 18.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Devore et al (US 10,111,981 B2) in view of Pavlovich et al (Open Med., 2016, 11, 242-247) and further in view of Deng et al (Stem Cell Research & Therapy, 2020, 11:50, 1-10), and Prikhnenko (Clinical, Cosmetic and Investigational Dermatology, 2015, 8, 151-157; cited in IDS filed 08/20/2025).
Devore teaches injectable acid soluble collagen compositions comprising a neutralized solution of an acid soluble collagen, EDTA and preferably a polyol, wherein the composition is injectable at physiological pH and the acid soluble collagen polymerizes upon exposure to tissue and forms a gel (i.e., rapidly polymerizing collagen gel) (Abstract). Said composition is suitable for soft tissue augmentation (Abstract; paragraph bridging cols 2-3). Devore exemplifies a rapidly polymerizing collagen gel comprising a neutralized solution comprising an acid soluble collagen, EDTA, and a polyol, wherein the soluble collagen comprises collagen selected from the group consisting of Type 1 collagen, Type III collagen and combinations thereof (Abstract; col. 8, Example 5; part of the limitation of claims 1-2 and limitation of claim 10). Devore teaches that the collagen is present in a concentration between 5-70 mg/ml (0.5-7.0%) (col. 4, lines 14-18; as in claim 11).
Devore teaches that the acid soluble collagen is in a concentration of between 5 and 70 mg/ml, the EDTA is disodium EDTA, the EDTA is in a concentration of between 10 and 50 mM, the polyol is D-mannitol, the polyol is in a concentration of between 2.5 to 4%, and the osmolarity of the composition is 280-360 mmol/kg (col. 4, lines 29-39; as in claims 11-12).
Devore does not teach the said other active ingredients as in claims claim 2, iii) (a), (b) and (e), and the concentration of these components as in claim 3.
Pavlovich teaches that platelet rich plasma has several growth factors including TGF-b. This growth factor stimulates the product of collagen and prevents collagen breakdown (page 243, right col., first and second full paras; limitation of claim 2, iii) (a)).
Deng et al teaches that cell-free fat extract promotes tissue regeneration during tissue expansion and was able to reduce tissue necrosis and retraction (page 6, right col., lines 1-5; limitation of claim 2, iii), b)).
According to Prikhnenko amino acids represent relevant substrates required to build extracellular matrix proteins, mainly collagens. Hyaluronic acid, a glycosaminoglycan, is also used in soft tissue facial filler treatments (page 154, left co., first full para, and right col., see under sub-title: Safety of mesotherapy; limitation of claim 2, iii), (e)).
The teachings of the secondary references render obvious the inclusion of the other components in the composition and also provide motivation to do so. The artisan can adjust the percentages of the components (a), (b) and (e) in claim 3 for the purpose of obtaining a composition which will give optimal results for the use taught in the prior art. It would also be obvious to the artisan to include the ingredients recited in claim 2(iii)(c) also in view of the teachings of the secondary references.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings compositions comprising neutral pH soluble collagen and glycosaminoglycans are known in the art to be used for tissue augmentation, promoting soft tissue regeneration, etc. (Devore-abstract).
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. Product improvement is the motivation. One of ordinary skill in the art would look for alternative compositions that exhibit improved durability for soft tissue augmentation. (Devore- col.1, lines 41-43).
Claim(s) 1-3, 5, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Jinting et al (CN 107441561 A; machine English Translation, pages 1-13; cited in IDS filed 09/20/2024) in view of Pavlovich et al (Open Med., 2016, 11, 242-247) and further in view of Deng et al (Stem Cell Research & Therapy, 2020, 11:50, 1-10), Prikhnenko (Clinical, Cosmetic and Investigational Dermatology, 2015, 8, 151-157), Jung et al (Science Advances, 2020, 6, 1-13), Damrach et al (Purinergic Signaling, 2011, 7, 193-206), and Wang et al (RSC Adv, 2015, 5, 96725-96732).
The teachings of Jinting are set forth above. In view of Jinting’s teaching regarding the use of collagen from animals, one of ordinary skill in the art will also use collagen from all the other sources as in claim 5. In view of Jinting’s teaching regarding the molecular weight of hyaluronic acid and crosslinking with EDC, the artisan will substitute hyaluronic acid having the molecular weight range as in claim 15, use the other crosslinking agents in claims 16 and 17 and also the oligo-hyaluronan and hyaluronic acid from the other sources as in claim 18 in order to look for alternate compositions having optimal properties for the uses taught by Jinting.
Jinting does not teach the limitations of claims 2(iii)(d), (e) and (f), part of the limitations of claim 3 regarding the percentage of components (d), (e), (f).
Pavlovich teaches that platelet rich plasma has several growth factors including TGF-b. This growth factor stimulates the product of collagen and prevents collagen breakdown (page 243, right col., first and second full paras; limitation of claim 2, iii) (a)).
Deng et al teaches that cell-free fat extract promotes tissue regeneration during tissue expansion and was able to reduce tissue necrosis and retraction (page 6, right col., lines 1-5; limitation of claim 2, iii), b)).
According to Prikhnenko amino acids represent relevant substrates required to build extracellular matrix proteins, mainly collagens. Hyaluronic acid, a glycosaminoglycan, is also used in soft tissue facial filler treatments (page 154, left co., first full para, and right col., see under sub-title: Safety of mesotherapy; limitation of claim 2, iii), (e)).
Jung et al teaches that stem cell derived extracellular vehicles offer alternative approaches to stem cell-based therapy for regenerative medicine. They can be used as cell-free therapeutic systems by inducing tissue specific differentiation (Abstract). They are use widely for tissue repair and regeneration (Introduction). This tells one of ordinary skill in the art that stem cell derived extracellular vehicles can be used as a component in the composition of Jinting. (limitation of claim 2, (iii)(d)).
Darmach teaches that purines and pyrimidines are involved in proliferation of keratinocytes acting synergistically with growth factors shown to stimulate the process of wound healing. Resulting nucleotide-enhanced proliferation of cells in the basal layer may promote healing of an epidermal wound by replacing damaged epidermis (page 200, right col., both paragraphs). This is a suggestion to the artisan to include polynucleotides and the related polydeoxyribonucleotides as in claim 2 (iii) (f) as components in the composition of Jinting.
Wang et al teaches that methylsulfonylmethane (MSM) was beneficial for cartilage tissue regeneration and is useful for tissue engineering. It promoted expression of collagen type II and I (Abstract; page 96730, right co., through page 96731, Conclusion; active ingredient (h) as in claims 2 and 3). Wang teaches the use of 0.01wt% to 10 wt % of MSM (page 96726, left col., para under sub-title: Fabrication and Characterization of MSM-loaded mats). This renders obvious the use of MSM as a component in the composition of Jinting.
The teachings of the secondary references also render obvious the use of any combinations thereof as in claim 2(iii)(i). The percentages of the components (a)-(f) will be adjusted to be in the range recited in claim 3 via routine experimentation for the purpose of obtaining compositions that provide optimal benefits for the uses taught in the prior art.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings compositions comprising neutral pH soluble collagen and glycosaminoglycans are known in the art to be used as wound repair materials (Jinting-para 008).
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. Product improvement is the motivation. One of ordinary skill in the art would look for alternative compositions that exhibit optimal benefits for the use taught in the prior art.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains Terminal Disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 5, and 10-11 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10, 13 and 14 of U.S. Patent No. 10,111,981 B2) in view of Jinting et al (CN 107441561 A; machine English Translation, pages 1-13; cited in IDS filed 09/20/2024) and further in view of Pavlovich et al (Open Med., 2016, 11, 242-247), Deng et al (Stem Cell Research & Therapy, 2020, 11:50, 1-10), Prikhnenko (Clinical, Cosmetic and Investigational Dermatology, 2015, 8, 151-157), Jung et al (Science Advances, 2020, 6, 1-13), Damrach et al (Purinergic Signaling, 2011, 7, 193-206), and Wang et al (RSC Adv, 2015, 5, 96725-96732). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Claim 1 is drawn to a composition comprising neutral pH soluble collagen, a glycosaminoglycan and optionally other active ingredients. Claim 5 is drawn to the source of the collagen and/or collagen selected form full collagen, atelocollagen or recombinant collagen. Claim 10 is drawn to rapidly forming collagen gels and which comprises an acid soluble collagen, EDTA/EGTA and a polyol, wherein the acid soluble collagen in selected form Type I, Type II and Type III collagen. Claim 11 is drawn to concentration of the acid soluble collagen, disodium salt of EDTA and EGTA, concentration of EDTA and EGTA, polyol being sugar alcohol, its concentration, collagen gel further comprising a disaccharide, fructose or combination thereof and the collagen gel having an osmolarity of 280-360mmol/kg.
Claim 1 of ‘981 is drawn to a composition comprising neutralized acid soluble collagen, EDTA and polyol wherein the collagen is selected from Type I or Type III and combination thereof. Dependent claims 2-10, and 13-14 are drawn to concentration of collagen, concentration of EDTA, polyol being a sugar alcohol and D-Mannitol, concentration of polyol, composition further comprising disaccharide, fructose and combination thereof
The claims of ‘981 differ from the instant claims in that the instant claims can also have a glycosaminoglycan and optionally other active ingredients. However, it would have been obvious to one of ordinary skill in the art before the filing date of the instant invention to modify the composition of ‘981 to arrive at the claimed composition with a reasonable expectation of success in view of the teachings of the secondary references which are set forth above.
In the instant case ‘981 teaches a composition comprising acid soluble collagen and some of the other ingredients applicant claims. Although the claims of '981 do not include optionally other active ingredients one of ordinary skill in the art would readily recognize that the composition taught by '981 could be modified in view of the teachings of the secondary references to arrive at the claimed composition with a reasonable expectation of success. One of ordinary skill in the art would make the claimed composition an alternative to that of the prior art since the combined teachings of the prior art suggest the claimed components are useful as fillers and in regenerative medicine.
Conclusion
1. Elected claim 1-18 (Group I) are rejected.
2. Group II claims 19-20 and Group III claims 21-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
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/GANAPATHY KRISHNAN/ Primary Examiner, Art Unit 1693