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 .
This office is NON-Final as a result of new ground of rejection.
Claim Status
Claims 2, 4-8, 14-15, and 25-37 are pending.
Claims 1, 3, 9-13, and 16-24 are cancelled.
Claims 14-15 are withdrawn as being directed to a non-elected method invention, the election having been made on 12/9/2019.
Claims 2, 4-8 and 25-37 have been examined.
Priority
This application is a DIV of 14/818662 filed on 08/05/2015 (Now PAT 10258717),
14/818662 has PRO of 62033599 filed on 08/05/2014.
Withdrawn Rejection
The rejection of claims 2, 28-29, and 36-37 under 35 U.S.C. 103 as being unpatentable over Hamzeh et al. in view of Okabayashi et al. is withdrawn because Okabayashi et al. is no longer qualified as a prior art as a result of amendment to claim 2.
The rejection of claims 2, 29, 31, and 36-37 under 35 U.S.C. 103 as being unpatentable over Moavenian et al. in view of Okabayashi et al. is withdrawn because Okabayashi et al. is no longer qualified as a prior art as a result of amendment to claim 2.
The rejection of claims 2, 4-6, 29, 32-33, 36-37 under 35 U.S.C. 103 as being unpatentable over Moavenian et al. in view of Okabayashi et al. and Adkins is withdrawn because Okabayashi et al. is no longer qualified as a prior art as a result of amendment to claim 2.
The prior rejection #4 of claims 2-5, 7, 25-26, 28-31, 33-34, and 36-37 under 35 U.S.C. 103 as being unpatentable over Liao et al. in view of Wallace et al. and Moavenian et al. in OA (page8, dated 6/18/2025) is modified and consolidated. Any further rejections (#5/page 11; #6/page 12; #7/page 14) based on Liao et al. in view of Wallace et al. and Moavenian et al. in the prior office action dated 6/18/2025 are also modified and/or consolidated in the following.
New Ground of Rejection
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.
Claim 5 is 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 5 is unclear with respect to the phrase “comprises 2-4 layers of the membrane”. The word “comprises” is an open-end word followed by a close-end range of 2-4 layers. Thus, the metes and bounds of claim 5 are indefinite. For the purpose of this examination, the examiner interprets the layers of membrane in claim 5 no more than 4 layers.
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.
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.
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.
1. Claims 2, 25-26, 28-31, and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Moavenian et al. (GB 2519072 A, previously cited 10/28/2022) in view of Liu (US 2001/0037014 A1).
Claim 2 is drawn to a membrane comprising:
(a) a biodegradable polymer not a silk protein;
(b) a honey mixed with the biodegradable polymer; and
(c) a hydroxyapatite (HA),
wherein the membrane is provided in solid form and promotes soft tissue healing when
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contacted with damaged or diseased soft tissue.
With respect to the limitations (a) and (b), Moavenian et al. teach a wound dressing composition comprising collagen and honey to form a porous sponge or membrane for topical administration to the skin (Abstract, Fig 1 shown as follows), reding on the limitation (a) and (b). Moavenian et al. further teach honey is known to have application in promoting healing of wounds. Specific commercially available grades of honey (e.g., Manuka honey, p3, para 3) have been identified as exhibiting unique antibacterial (naturally-occurring antibiotic) and anti-inflammatory properties which can aid in wound healing of skin (p2, para 1-2; Table 1).
Moavenian et al. do not teach the composition further comprising a hydroxyapatite.
Liu teaches the use of a strong thin flexible mineralized collagen membrane for guided tissue regeneration and skin wound repair (Abstract). Liu teaches the strong, thin flexible mineralized collagen membrane of the present invention provides mechanical properties superior to those of pure collagen membranes and has important medical applications, such as use for a barrier for wound healing [0030] and the resorption rate of non-mineralized membranes is difficult to match with the normal tissue-healing process [0018]. Liu teaches the calcium phosphate compounds used for making the mineralized collagen membrane of the present invention are preferably as hydroxyapatite or functionally equivalent compounds well known in the art [0049]. Liu further teaches the mineralized collagen membranes of the present invention can also incorporate bioactive compounds comprising antibiotics (including the naturally-occurring antibiotic of Manuka honey), growth factors, and others agents [0057]. Because Liu teaches (i) mineralized collagen membrane of the present invention provides mechanical properties superior to those of pure collagen membranes as a barrier for skin wound healing [Abstract, 0030], (ii) the resorption rate of non-mineralized membranes is difficult to match with the normal tissue-healing process [0018], and (iii) mineralized collagen membranes of the present invention can also incorporate antibiotics (including the naturally-occurring antibiotic of Manuka honey) [0057], one of ordinary skill in the art would have found it obvious to beneficially add hydroxyapatite to improve the mechanical property of Moavenian’s collagen membrane comprising antibiotic of Manuka honey as a “superior” barrier for skin wound healing as taught by Liu [Abstract; 0030, 0049], reading on the limitation (c) in claim 2.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Moavenian et al. and (ii) Shin’s hydroxyapatite. because (a) Moavenian et al. teach the use of a collagen membrane comprising naturally-occurring antibiotic of Manuka honey and (b) Liu teaches a mineralized collagen membrane beneficially comprising hydroxyapatite to (1) provide mechanical properties superior to those of pure collagen membranes as a barrier for skin wound healing [Abstract, 0030], (2) improve resorption rate of non-mineralized collagen membranes for tissue-healing process, and (3) the mineralized collagen membranes can also incorporate antibiotics (e.g., Manuka honey) as a drug carrier [0057]. The combination would have reasonable expectation of success because both references teach the use of a collagen membrane comprising an antibiotic for skin wound healing.
With respect to claim 25, Moavenian et al. teach honey relative to collagen by weight from about 0.05% to 5.0% (Abstract). Liu teaches the mineralized collagen membrane comprising 30% to 70% calcium phosphate minerals (hydroxyapatite) by weight [0022, 0049], equivalent to the ratio of hydroxyapatite to collagen from 0.43 to 2.3 by weight.
With respect to claim 26, Moavenian et al. teach the wound dressing membrane subject to lyophilization (p9, para 2).
With respect to claim 28, Moavenian et al. teach the honey is Manuka honey with Unique Manuka Factor above 12 (p6, para 2).
With respect to claims 29-30, Moavenian et al. teach the protein is collagen (Abstract).
With respect to claim 31, Moavenian et al. teach the membrane is subject to physical or chemical cross-linking (p9, para 3).
With respect to claim 33, Liu teaches the mineralized collagen comprising antibiotics (plural of antibiotic), reading on at least one additional antibiotic.
With respect to claim 34, Moavenian et al. teach a wound dressing composition comprising collagen and honey to form a porous sponge or membrane for topical administration to the skin (Abstract, Fig 1). Moavenian et al. teach honey relative to collagen by weight from about 0.05% to 5.0% (Abstract), reding on the limitations of (a) and (b) as well as the wherein clause. Liu teaches the mineralized collagen membrane comprising 30% to 70% calcium phosphate minerals (hydroxyapatite) by weight [0022, 0049], equivalent to the ratio of hydroxyapatite to collagen from 0.43 to 2.3 by weight, reading on the limitation (c).
Response to Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive because the arguments are not apply to the new ground of rejection. In particular, Okabayashi is no longer cited for rejection and a new reference of Liu (US 2001/0037014 A1) is cited for the current rejection.
2. Claims 2, 4-8, 25-26, 28-31, and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Moavenian et al. in view of Liu as applied to claims 2, 25-26, 28-31, and 33-34 and further in view of Adkins (Home Healthc Nurse. 2013 May;31(5):259-67, previously 8/24/2020).
Claim 4 is drawn the membrane comprising at least two layers.
Moavenian et al. in view of Liu teach wound dressing membrane as applied to claims 2, 25-26, 28-31, and 33-34 above
Moavenian et al. in view of Liu do not teach layers of wound dressing membrane.
Adkins teaches wound care dressing comprising honey and/or collagen (p262, col 1, Leptospermum Honey; p262, col 2, Collagen Dressings). Adkins teach the use of multiple layers of wound dressing if exudate is heavy (p261, col 1, last line). Thus, one of ordinary skill in the art would recognize the layer number of membrane in a wound dressing is a result effective variable that can be determined by the amount of exudate, reading on claims 4-6.
With respect to claims 7-8, Moavenian et al. show wound dressing membrane are crosslinked (Fig 2) by a crosslinker of glutaraldehyde to provide strength and desirable properties (p9, para 3). Adkins teach the use of multiple layers of wound dressing for a patient with heavy exudate. A cross-linked multi-layered collagen membrane would have desired strength and/or properties for a patient with heavy exudate.
With respect to claim 33, Adkins teaches silver has antimicrobial activity against an extensive range of aerobic, anaerobic, gram-negative, and gram-positive bacteria, yeast, fungi, and viruses. Adkins further suggest beneficial use of silver in combination with collagen in wound dressing (p262, col 1, last para to col 2, line 1-2).
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Moavenian et al. in view of Liu with (ii) Adkins because (a) Moavenian et al. in view of Liu teach a collagen membrane for skin wound healing and (b) Adkins teach beneficial use of multiple layers of wound dressing if exudate is heavy (p261, col 1, last line). The combination would have reasonable expectation of success because both Moavenian et al. and Adkins teach wound dressing comprising collagen and honey.
Response to Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive because the arguments are not apply to the new ground of rejection. In particular, Okabayashi is no longer cited for rejection and a new reference of Liu (US 2001/0037014 A1) is cited for the current rejection.
3. Claims 2, 4-8, 25-34, and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Moavenian et al. in view of Liu and Adkins as applied to claims 2, 4-8, 25-26, 28-31, and 33-34 and further in view of Peran et al. (Materials 2013, 6, 1333-1359) and Miraftab et al. (GB 2484319, previously cited 6/8/2021).
Claim 27 is drawn to the membrane is formed by electronspun mats or membrane or a sponge to compression.
Moavenian et al. in view of Liu and Adkins teach a multi-layered collagen containing membrane as applied to claims 2, 4-8, 25-26, 28-31, and 33-34 above.
Moavenian et al. in view of Liu and Adkins did not specify the use of electronspun to make a membrane.
Peran et al. teach application of nano-engineered scaffolds designed to replace or restore the followed tissues: (i) skin; (ii) cartilage; (iii) bone; (iv) nerve; and (v) cardiac (Abstract). Peran et al. teach the most widely chosen technique is electrospinning to allow the production of nanofibrous scaffolds with specific and desired properties and functionality. Importantly, nanofibrous scaffolds possess an extremely high surface-to-volume ratio, tunable porosity, and malleability to conform to a wide variety of sizes and shapes with a desirable 3D pattern (p1334, last para). Peran et al. teach the use of electrospun technology to make collagen membrane to increase the epithelialization rate and formed a well-organized dermis (p1337, para 2). Because Peran et al. teach (i) the most widely chosen technique is electrospinning to allow the production of nanofibrous scaffolds with specific and desired properties and functionality and (ii) the use of electrospun technology to make collagen membrane to increase the epithelialization rate and formed a well-organized dermis, one of ordinary skill in the art would have found it obvious to beneficial use the electrospinning process to make a collagen membrane followed by crosslinking to make multi-layer collagen membrane of wound dressing. Similarly, Miraftab et al. teach the use of electrospun fibers to produce a membrane comprising honey (Abstract and
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Fig 1). Miraftab et al. teach electrospinning is the cheapest and most simple method for providing nanomaterials. Miraftab et al. teach electrospinning was developed from electrostatic spraying and now represents an attractive approach for polymer biomaterials processing, with the opportunity for control over morphology, porosity and composition using simple equipment (p1, para 2), reading on claim 27.
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With respect to claim 32, Peran et al. teach fibroblasts are the cell type best indicated for wound healing proposes. Peran et al. teach the use of poly(L-lactic acid)-co-poly(ε-caprolactone) and gelatin (PLACL-G-P) nanofibrous scaffolds made by electrospinning process to provide enough space for fibroblast ingrowth and induce the formation of a dermal substitute for skin wound healing processes (p1337, 2nd last para) shown in figure 3 as follows, reading on the biodegradable polymer comprising poly(lactic acid) and a blend with gelatin or collagen.
With respect to claim 36-37, Peran et al. teach the biodegradable polymer is a synthetic polymer of a copolymer of polylactic acid and a copolymer of polycaprolactone (p1337, 2nd last para). Peran et al. further teach a biodegradable synthetic polymer can also be polyglycolic acid (PGA), polylactic acid (PLA), and their copolymers, poly (D,L-lactide-coglycolide) (PLGA) in tissue engineering applications (p1334, 2nd last para).
One of ordinary skill in the art before the effective filling date of this invention would have found it obvious to combine (i) Moavenian et al. in view of Liu and Adkins with (ii) electrospun technology taught by Peran et al. and Miraftab et al. because (a) Moavenian et al. in view of Liu and Adkins teach the use of a crosslinked multi-layered collagen membrane for wound healing of skin, (b) Peran et al. teach the use of electrospun technology to make collagen membrane to increase the epithelialization rate and formed a well-organized dermis (p1337, para 2) and suggest addition of poly(L-lactic acid)-co-poly(ε-caprolactone) and gelatin (PLACL-G-P) to a membrane made by electrospinning process to provide enough space for fibroblast ingrowth and induce the formation of a dermal substitute for skin wound healing processes (p1337, 2nd last para) shown in figure 3, and (c) Miraftab et al. teach electrospinning is the cheapest and most simple method for providing nanomaterials for control over morphology, porosity and composition using simple equipment (p1, para 2 and Fig 1). The combination would have reasonable expectation of success because both Peran et al. teach and Miraftab et al. teach the use of electrospun technology to make wound dressings.
Response to Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive because the arguments are not apply to the new ground of rejection. In particular, Okabayashi is no longer cited for rejection as well as new references of Liu (US 2001/0037014 A1) and Peran et al. (Materials 2013, 6, 1333-1359) are further cited for the current rejection.
4. Claims 2, 4-8, and 25-37 are rejected under 35 U.S.C. 103 as being unpatentable over Moavenian et al. in view of Liu, Adkins and Peran et al. and Miraftab et al. as applied to claims 2, 4-8, 25-34, 36-37 and further in view of Morganti et al. (J. Appl. Cosmetol. 2006 (July/September); 24: 105-114, previously cited 8/24/2020).
Claim 35 is drawn to the membrane is formed by subjecting electrospun mats, electrospun membranes, or a sponge to compression of at least 3000 pounds.
Moavenian et al. in view of Liu, Adkins and Peran et al. and Miraftab et al. teach a multi-layered wound dressing membrane made by electron spun process as applied to claims 2, 4-8, 25-34, and 36-37.
Moavenian et al. in view of Liu, Adkins and Peran et al. and Miraftab et al. do not specify compression of membrane at least 3000 pounds.
Morganti et al. teach wound dressings membrane used for scar-less healing (p111, col 2, wound dressings for scar-less healing). Morganti et al. teach the composite of polymer (e.g., protein) was freeze-dried and hot-pressed at 20 MPa (about 2900 pounds) for 10 min at 140ºC to make a desired thickness for a membrane (p108, col 2, Composites with soy protein isolates), reading on the limitation of the membrane formed by electrospun and compression. Morganti et al. teach the thickness of a wound dressing is a result effective variable and can be optimized by pressing force and temperature. MPEP 2144.05 states “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)”.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine the teachings (i) Moavenian et al. in view of Liu, Adkins and Peran et al. and Miraftab et al. with (ii) Morganti’s electronspun and compression of a polymer membrane because (a) Moavenian et al. in view of Liu, Adkins, Peran et al. and Miraftab et al. teach a multi-layered wound dressing membrane comprising collagen made by electron spun process and (b) Morganti et al. teach the use of hot-compression of a membrane to make a desired thickness for a protein-containing membrane (p108, col 2, Composites with soy protein isolates). The combination would have reasonable expectation of success because the references teach a protein membrane for therapeutic use.
Response to Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive because the arguments are not apply to the new ground of rejection. In particular, Okabayashi is no longer cited for rejection as well as new references of Liu (US 2001/0037014 A1) and Peran et al. (Materials 2013, 6, 1333-1359) are further cited for the current rejection.
5. Claims 2, 4-6, 25-26, 28-31, 33-34, and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Liao et al. (Biomaterials 26 (2005) 7564–7571, previously cited 6/18/2025) in view of Liu (US 2001/0037014 A1), Effendy et al. (Evidence-Based Complementary and Alternative Medicine Volume 2012, Article ID 938574, pages, previously cited 1/21/2020), and Moavenian et al. (GB 2519072 A, previously cited 10/28/2022).
Claim 2 is drawn to a membrane comprising:
(a) a biodegradable polymer not a silk protein;
(b) a honey mixed with the biodegradable polymer; and
(c) a hydroxyapatite (HA),
wherein the membrane is provided in solid form and promotes soft tissue healing when contacted with damaged or diseased soft tissue.
Liao et al. teach a three-layered nano-carbonated hydroxyapatite/collagen/PLGA composite membrane for guided tissue regeneration (Title). Liao et al. teach the membrane can be used for repairing hard tissues of periodontal defects, membranes for covering bone defect surgery and for bone substitutes as well as skin wound repair and healing, skin sealing, and as a carrier for antibiotic (p7565, col 2, para 2; p7569, col 2, para 1), Liu is cited to show both carbonated hydroxyapatite and hydroxyapatite are preferred compounds for mineralized collagen membrane [0049]. Liu et al. further teach a hydroxyapatite mineralized collagen membrane can be used for guided tissue regeneration (GTR [0003]) including for covering bone defect surgery and for bone substitutes, skin wound repair and healing, skin sealing, and as a carrier for antibiotic [0065], consistent with Liao’s teaching and reading on the limitations (a) and (c) as well as a solid form of membrane capable of promoting soft tissue healing when contacted with damaged or diseased soft tissue.
Liao et al. in view of Liu do not specify the hydroxyapatite/collagen membrane further comprising honey.
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Effendy et al. teach effects of tualang honey on bone metabolism (Title and Abstract). Effendy et al. teach honey does not only exhibit antioxidative effects but it also possesses anti- inflammatory effects. Effendy et al. further teach honey was able to increase bond density and suggest honey was able to restore osteoporotic bone (p4, col 1, para 2; Fig 1), reading on honey capable of promoting bone regeneration. Thus, one of ordinary skill in the art would have been suggested and/or motivated to beneficially add Effendy’s honey to the 3-layered hydroxyapatite/collagen membrane for the same purpose of promoting bone regeneration, reading on the limitation (b) in claim 2. Moavenian et al. is further cited to show collagen and honey in a membrane also able to promote wound healing of the skin (Abstract, Fig 1).
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Liao et al. in view of Liu with (ii) Effendy et al. in view of Moavenian et al. because (a) both Liao and Liu teach a hydroxyapatite/collagen membrane to treat guided tissue regeneration of bone and skin. Liu further teaches both carbonated hydroxyapatite and hydroxyapatite are preferred compounds for mineralized collagen membrane [0049] and (b) Effendy et al. teach honey does not only exhibit antioxidative effects but it also possesses anti- inflammatory effects. Effendy et al. further teach honey was able to increase bond density and suggest honey was able to restore osteoporotic bone (p4, col 1, para 2; Fig 1). Moavenian et al. is further cited to show collagen and honey in a membrane also for promoting wound healing of the skin (Abstract, Fig 1). The combination would have reasonable expectation of success because all references teach the use of a collagen membrane comprising one or more active agents for tissue regeneration of bone and/or skin.
With respect to claims 4-5, Liao et al. teach the membrane is 3 layers (Title).
With respect to claims 7-8, Moavenian et al. show wound dressing membrane are crosslinked (Fig 2) by a crosslinker of glutaraldehyde to provide strength and desirable properties (p9, para 3). Liao et al. teach the membrane is 3 layers (Title).
With respect to claim 25, Moavenian et al. teach honey relative to collagen by weight from about 0.05% to 5.0% (Abstract). Liu teaches the mineralized collagen membrane comprising 30% to 70% calcium phosphate minerals (hydroxyapatite) by weight [0022, 0049], equivalent to the ratio of hydroxyapatite to collagen from 0.43 to 2.3 by weight.
With respect to claim 26, Moavenian et al. teach the wound dressing membrane subject to lyophilization (p9, para 2).
With respect to claim 28, Moavenian et al. teach the honey is Manuka honey with Unique Manuka Factor above 12 (p6, para 2).
With respect to claims 29-30, Moavenian et al. teach the protein is collagen (Abstract).
With respect to claim 31, Moavenian et al. teach the membrane is subject to physical or chemical cross-linking (p9, para 3).
With respect to claim 33, Liu teaches the mineralized collagen comprising antibiotics (plural of antibiotic), reading on at least one additional antibiotic.
With respect to claim 34, Moavenian et al. teach a wound dressing composition comprising collagen and honey to form a porous sponge or membrane for topical administration to the skin (Abstract, Fig 1). Moavenian et al. teach honey relative to collagen by weight from about 0.05% to 5.0% (Abstract), reding on the limitations of (a) and (b) as well as the wherein clause. Liu teaches the mineralized collagen membrane comprising 30% to 70% calcium phosphate minerals (hydroxyapatite) by weight [0022, 0049], equivalent to the ratio of hydroxyapatite to collagen from 0.43 to 2.3 by weight, reading on the limitation (c).
With respect to claims 37-38, Liao et al. teach a three-layered nano-carbonated hydroxyapatite/collagen/PLGA membrane. PLGA means Poly Lactic-co-Glycolic Acid reading on claims 37-38.
Response to Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive because the arguments are not apply to the new ground of rejection. In particular, the new reference Liu teaches that both carbonated hydroxyapatite and hydroxyapatite are preferred compounds for mineralized collagen membrane [0049]. Liu et al. further teach a hydroxyapatite mineralized collagen membrane can be used for guided tissue regeneration (GTR [0003]) including for covering bone defect surgery and for bone substitutes, skin wound repair and healing, skin sealing, and as a carrier for antibiotic [0065], reading on promoting soft tissue healing when contacted with damaged or diseased soft tissue.
Modified 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.
Claims 2, 4-8, and 25-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-8, and 11-12 of copending Application No. 17/230,023 (the ‘023 application dated 9/12/2025) in view of Moavenian et al. (GB 2519072 A, previously cited 10/28/2022), Liu (US 2001/0037014 A1), Adkins (Home Healthc Nurse. 2013 May;31(5):259-67, previously 8/24/2020), Peran et al. (Materials 2013, 6, 1333-1359), Miraftab et al. (GB 2484319, previously cited 6/8/2021), and Morganti et al. (J. Appl. Cosmetol. 2006 (July/September); 24: 105-114, previously cited 8/24/2020).
Claim 1 of the ‘023 application disclosed a composition comprising honey and one or more biodegradable polymers capable of promoting soft tissue regeneration when in contact with the soft tissue in a subject.
Claim 2 of the ‘023 application disclosed the composition in a solid and multi-layer membrane.
Claims 1-2 of the ‘023 application did not disclose the implantable multi-layer membrane comprising hydroxyapatite.
The relevancy of Moavenian et al. in view of Liu, Adkins, Peran et al., Miraftab et al., and Morganti et al. teach beneficial addition of hydroxyapatite in a collagen membrane as applied to claims 2, 4-8, and 25-37 not repeated here.
Because Liu teaches a mineralized collagen membrane beneficially comprising hydroxyapatite to (1) provide mechanical properties superior to those of pure collagen membranes as a barrier for skin wound healing [Abstract, 0030], (2) improve resorption rate of non-mineralized collagen membranes for tissue-healing process, and (3) the mineralized collagen membranes can also incorporate antibiotics (e.g., Manuka honey) [0057], one of ordinary skill in the art would have found it obvious to add hydroxyapatite to the multi-layered membrane taught by claim 1 or 2 of the ‘023 application to enhance mechanical properties as well as add other benefits taught by the cited prior art references.
Thus, claims 1-2 of the ‘023 application in view of Moavenian et al., Liu, Adkins, Peran et al., Miraftab et al., and Morganti et al. are obvious to the instant claims 2, 4-8, and 25-37.
Claims 11-12 of the ‘023 application disclosed at least one of the first layer or the second layer is cross-linked, further satisfying the instant claims 7 and 31.
Claim 6 of the ‘023 application disclosed the biodegradable polymer comprising gelatin or collagen protein, further satisfying the instant claims 29-30.
Claims 7-8 of the ‘023 application disclosed the biodegradable polymers further comprising a synthetic polymer of polylactic acid (PLA), further satisfying the instant claims 32 and 36.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments (Remarks, p11, II. Double Patenting) filed 12/18/2025 have been fully considered but they are not persuasive because this provisional rejection is not the only rejection due to many prior art rejections shown above.
Conclusion
No claim is allowed.
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/J.L/Examiner, Art Unit 1658
15-February-2026
/LI N KOMATSU/ Primary Examiner, Art Unit 1658