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 .
Claims 1-10 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/9/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Election/Restrictions
Applicants’ election with traverse of Group I, claims 1-4 in the reply filed on 7/28/2026 is acknowledged. The traversal is on the ground(s) that the groups pertain to a generic concept, are not mutually exclusive and no search burden exists. This is not found persuasive because the process steps in Group II are not required in Group I. Therefore, the angiogenesis material of Group I can be made by a materially different process, such as making a dry mixture comprising calcium, a metal element and a bioabsorbable polymer and then adding an aqueous solution containing phosphorous to the mixture.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 recites “a bone-regeneration-promoting material comprising the angiogenesis material of claim 1” without further limiting the scope of the angiogenesis material. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Peters et al. (US2014/0170202; published June 19, 2014) in view of Chen et al. (Synthesis and Characterization of Copper Ions Doped Octacalcium Phosphate Powders with Enhanced Osteogenic Property, Journal of Biomaterials, 2021, 5(1):10-15).
Applicant claims an angiogenesis material comprising a composite of a metal-octacalcium phosphate-containing material containing octacalcium phosphate, a metal element and a bioabsorbable polymer (claim 1)
With respect to claims 1, 3 and 4, Peters et al. disclose biodegradable composite materials used in bone regeneration (abstract). The composite material comprises at least an inorganic component a), an inorganic component b), and at least one organic component c), wherein the density of a) and b) are different [0025-26]. The inorganic component is preferably selected from bioceramics, especially calcium phosphate [0028-29]. The organic component means a biocompatible organic compound or material selected from gelatin, collagen, polymers of lactic acid or glycolic acid, starch, etc. [0030; 0052-55]. The calcium phosphate is selected from octacalcium phosphate [0038]. The structures allows the composite material to acquire blood vessels (angiogenesis) and tissue for bone healing [0082].
Peters et al. do not include a metal element. With respect to claim 2, Peters et al. do not teach the metal element is Cu or Zn. It is for this reason that Chen et al. is joined. Copper is a cofactor in the production of collagen and bone minerals contain zinc and copper such that doping ions into inorganic bioceramics can simulate bone and promote the formation of new bone (page 11, introduction 1., paragraph 3).
Chen et al. teach copper ion doped octacalcium phosphate which provides a new way to construct bone regeneration biomaterials (abstract). Data compares octacalcium phosphate against various doses of copper doped octacalcium phosphate and there is a noticeable increase in ALP activity after 14 days (Figure 4, page 13). Copper containing biomaterials are desired because they protect cardiovascular systems, promote fracture healing and is widely used in repairing bone and vascular tissue by promoting osteogenic differentiation and angiogenesis (4. Discussion, page 14, paragraph 1). Doping copper ions into inorganic biomaterials slowly release the components to promote better bone formation, are biocompatible and promote the proliferation osteogenic differentiation of mBMSCs (4. Discussion, page 14, paragraph 2-3).
Both Peters et al. and Chen et al. are drawn to bone regeneration composites of inorganic biomaterials comprising octacalcium phosphate. It would have been prima facie obvious to combine the teachings of Peters et al. and Chen et al. to include copper doped octacalcium phosphate with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to use copper doped octacalcium phosphate because Chen et al. teach that copper doped octacalcium phosphate demonstrated higher ALP activity which promotes better bone formation and osteogenic differentiation.
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 1-4 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/906,196 (herein ‘196) in view of Chen et al. (Synthesis and Characterization of Copper Ions Doped Octacalcium Phosphate Powders with Enhanced Osteogenic Property, Journal of Biomaterials, 2021, 5(1):10-15). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to an angiogenesis material and bone regenerating material containing octacalcium phosphate, metal element and bioabsobable polymer whereas ‘196 claims a bone regeneration material comprising a base material comprising octacalcium phosphate and polylactic-co-glycolic acid copolymer and functional molecules adsorbed to the octacalcium phosphate. ‘196 does not specify metal element. It is for this reason that Chen et al. is joined.
Chen et al. teach copper ion doped octacalcium phosphate which provides a new way to construct bone regeneration biomaterials (abstract). Data compares octacalcium phosphate against various doses of copper doped octacalcium phosphate and there is a noticeable increase in ALP activity after 14 days (Figure 4, page 13). Copper containing biomaterials are desired because they protect cardiovascular systems, promote fracture healing and is widely used in repairing bone and vascular tissue by promoting osteogenic differentiation and angiogenesis (4. Discussion, page 14, paragraph 1). Doping copper ions into inorganic biomaterials slowly release the components to promote better bone formation, are biocompatible and promote the proliferation osteogenic differentiation of mBMSCs (4. Discussion, page 14, paragraph 2-3).
Therefore, it would have been prima facie obvious to combine the teachings of ‘196 and Chen et al. to include copper doped octacalcium phosphate with a reasonable expectation of success because Chen et al. teach that copper doped octacalcium phosphate demonstrated higher ALP activity which promotes better bone formation and osteogenic differentiation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,599,702 (herein ‘702). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to an angiogenesis material and bone regenerating material containing octacalcium phosphate, metal element and bioabsobable polymer whereas ‘702 claims a bone regeneration material comprising octacalcium phosphate and gelatin. ‘702 does not specify metal element. It is for this reason that Chen et al. is joined.
Chen et al. teach copper ion doped octacalcium phosphate which provides a new way to construct bone regeneration biomaterials (abstract). Data compares octacalcium phosphate against various doses of copper doped octacalcium phosphate and there is a noticeable increase in ALP activity after 14 days (Figure 4, page 13). Copper containing biomaterials are desired because they protect cardiovascular systems, promote fracture healing and is widely used in repairing bone and vascular tissue by promoting osteogenic differentiation and angiogenesis (4. Discussion, page 14, paragraph 1). Doping copper ions into inorganic biomaterials slowly release the components to promote better bone formation, are biocompatible and promote the proliferation osteogenic differentiation of mBMSCs (4. Discussion, page 14, paragraph 2-3).
Therefore, it would have been prima facie obvious to combine the teachings of ‘702 and Chen et al. to include copper doped octacalcium phosphate with a reasonable expectation of success because Chen et al. teach that copper doped octacalcium phosphate demonstrated higher ALP activity which promotes better bone formation and osteogenic differentiation.
Conclusion
No claims allowable.
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DANIELLE D. JOHNSON
Examiner
Art Unit 1617
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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