DETAILED ACTION
Claims 1-6 are currently pending and under examination.
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 .
Priority
The instant application is a national stage entry of PCT/KR2021/011352, filed 08/25/2021, which claims priority to KR10-2020-0142058, filed 10/29/2020.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 04/28/2023 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “lyophilizing same” which is grammatically awkward. It would remedial to use “lyophilizing the same”. Appropriate 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.
Claims 2-6 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.
Claims 2-6 contain the limitations (w/v), (v/v) and (w/w). The use of parenthesis makes it unclear if the limitations are required or optional, thus leading to unclear metes and bounds of the instant claims. For examination purposes the limitations in the parenthesis will be interpreted as optional.
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.
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.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR20140090481 in view of US 2012/0230977 and US 4,515,637 (Applicant provided).
Regarding claim 1, the limitation of a collagen composition for bone regeneration characterized in that the composition is manufactured by homogenizing a hydrated collagen, a mixed solution of lidocaine and epinephrine is met by the ‘481 publication teaching sustained release of a composition including lidocaine, epinephrine and collagen [0001]. The concentration of lidocaine is taught to be 1 to 3 w/v% [0022] wherein the concentration of epinephrine, a component of the present invention is preferably 1:50,000 to 1:200,000 (v/v) [0023]. The collagen membrane component is taught to have excellent effect of retaining a pharmacologically active substance to be delivered and can be use in all possible forms such as directly injecting into various bone types [0025]. New bone formation and vascular regeneration is taught [0006]. The ingredients are taught to be mixed [0016]. The collagen was taught to be soaked in the mixture [0044].
Regarding claims 3, the limitation of wherein a lidocaine content in the mixed solution is 1 to 3% is met by the ‘481 publication teaching the concentration of lidocaine is taught to be 1 to 3 w/v% [0022].
Regarding claim 4, the limitation epinephrine in the mixed solution is 1:50,000 to 200,00 (v/v) relative to lidocaine is met by the ‘481 publication teaching sustained release of a composition including lidocaine, epinephrine and collagen [0001]. The concentration of lidocaine is taught to be 1 to 3 w/v% [0022] wherein the concentration of epinephrine, a component of the present invention is preferably 1:50,000 to 1:200,000 (v/v) [0023]. The collagen membrane component is taught to have excellent effect of retaining a pharmacologically active substance to be delivered and can be use in all possible forms such as directly injecting into various bone types [0025]. The composition is taught to be used to treat osteopathy [0001] to treat bone remodeling deficiency-related disease when applied to the oral cavity [0009].
The ‘481 publication does not specifically teach a sponge-type composition comprising thrombin and lyophilizing (claim 1).
The ‘481 publication does not specifically teach hydrated collagen is 3 to 6% w/v (claim 2) and thrombin in the mixed solution is 1 to 3% w/v (claim 5).
The ‘637 patent teaches a collagen-thrombin hemostatic composition is comprised of forming a homogeneous aqueous admixed of collagen and thrombin and lyophilizing the collagen-thrombin admixture to form a stable collagen sponge having thrombin therein. The collagen is taught as storage stable (abstract). A homogenous dispersion or solution of the collagen-thrombin admixture, the solution is placed in an appropriate container and freeze dried. After freeze drying it is free of moisture, it is in the form of a collagen sponge having thrombin distributed throughout (column 3, lines 55-65). The collagen product is storage stable and is particularly effective as a hemostat, wherein the hemostat must remain in the body. The collagen product is paced to stop wound bleeding (column 3, lines 60-67).
The ‘977 publication teaches a composition for promoting wound healing comprising hemostatic compositions including collagen molecules and biological agents (abstract). The compositions are taught to be reconstituted at 100-150 mg/mL in physiological fluid with or without thrombin (Figure 2A). The liquid vehicle is taught to include water, saline or combinations thereof [0007], thus leading to hydrated collagen as water is present in the composition. The collagen concentration is taught to be 50 to 200 mg/mL [0008]. The composition is taught to be easily dispensed from a syringe [0012]. The percentage of solids is expressed in mg material per mL, wherein 1% solids is approximately 10 mg/mL [0048]. The collagen may be 0.1 to 10% solids [0061] wherein the amount of collagen can be varied to provide hemostats of differing viscosities and strengths [0065]. Any type of syringe is taught which may be carrying 1 cc to 20 cc of material [0065]. Thrombin acts as a catalyst for fibrinogen to provide fibrin. The thrombin may be present in the composition in a concentration of from about 0.01 to 1000 or greater international units/ml of activity [0083]. The composition is taught as tailored to provide the most desirable hemostatic or wound healing device [0139]. The composition is taught to be freeze dried (abstract, [0037]).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to lyophilize the composition of the ‘481 publication as the ‘481 publication teaches the scaffold to be used to limit bleeding ([0017]-0021]) and the ‘637 publication teaches a lyophilized structure of collagen and thrombin to be used as a hemostat to stop bleeding. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to lyophilize the composition of the ’481 publication as the ‘637 publication teaches the storage stability of the freeze-dried composition. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘481 publication and the ‘637 publication are both directed to compositions comprising a mixture of collagen to be used to prevent bleeding in vivo and the ‘481 publication teaches the structure to be in any medically possible form [0025], thus providing a reasonable expectation of success.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to include thrombin in the composition as taught by the ‘481 publication because the ‘977 publication teaches the use of an injectable composition of collagen and thrombin for wound healing and as a hemostatic composition and the ‘481 publication teaches the desire for hemostatic components at wound sites [0017]. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘481 publication and the ‘977 publication are both directed to injectable compositions including collagen and active agents to be used at wound sites with the desire for hemostasis. Thus the introduction of thrombin into the composition of the ‘481 publication would have motivation and an expectation of success as the ‘481 publication and the ‘977 publication teach overlapping ingredients to be used for the same administration of injection at a wound site.
That being said and in lieu of objective evidence of unexpected results, the dosage of collagen, thrombin, lidocaine and epinephrine can be viewed as a variable which achieves the recognized result of successfully treating a specific patient. The optimum or workable range of dosing can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of dosage nonobvious, thus reading on claims 2-6.
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 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/003,073 in view of US 4,515,637. The instant application and the ‘073 application are directed compositions for bone regeneration the composition comprising 6% hydrated collagen, thrombin, lidocaine and epinephrine, wherein the epinephrine is 1:100,00 v/v relative to lidocaine, the lidocaine is 1 to 3 w/v and the thrombin is 1 to 3% w/v.
The instant application differs in that the collagen is a sponge type composition which was lyophilized.
The ‘637 patent teaches a collagen-thrombin hemostatic composition is comprised of forming a homogeneous aqueous admixed of collagen and thrombin and lyophilizing the collagen-thrombin admixture to form a stable collagen sponge having thrombin therein. The collagen is taught as storage stable (abstract). A homogenous dispersion or solution of the collagen-thrombin admixture, the solution is placed in an appropriate container and freeze dried. After freeze drying it is free of moisture, it is in the form of a collagen sponge having thrombin distributed throughout (column 3, lines 55-65). The collagen product is storage stable and is particularly effective as a hemostat, wherein the hemostat must remain in the body. The collagen product is paced to stop wound bleeding (column 3, lines 60-67).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to lyophilize the composition of the ‘073 application as the ‘637 publication teaches a lyophilized structure of collagen and thrombin to be used as a hemostat to stop bleeding. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to lyophilize the composition of the ‘073 application as the ‘637 publication teaches the storage stability of the freeze-dried composition. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘073 application and the ‘637 publication are both directed to compositions comprising a mixture of collagen and thrombin.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613