Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 Mar 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Amendments to the claims filed 25 Feb 2025 are acknowledged. Claims 1-15 are canceled. Claims 16-22 are newly presented. Claims 16-22 are pending and considered on the merits.
Claim Objections
Claim 18 is objected to as depending from a cancelled claim. To promote compact prosecution, claim 18 is interpreted as depending from claim 17.
Claim Interpretation
The claim limitations "for treating a bone injury" recited in claim 19, "for treating an inflammatory joint disease, cartilage injury or cartilage lesions" recited in claim 20, and "for the treatment of an inflammatory joint disease" recited in claim 22 are interpreted as a statements of intended use. Statements reciting purpose or intended use may impose structural limitations; however, in the instant case the recited intended use does not appear to impart structural limitations on the method claimed, and therefore, is not given patentable weight. See MPEP § 2111.02.
Claim Rejections - 35 USC § 112(b)
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.
Claims 17-19 and 21-22 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 17-18 are rejected under 35 U.S.C. 112(b) on the basis that it is unclear whether the step of "mixing the withdrawn blood with one or more coagulating agents to thereby form said mixture" recited in claim 17 is intended to modify the method of claim 16, from which claim 17 depends, or to act as additional steps of mixing in additional one or more coagulating agents and introducing a second mixture to the site of disease or injury. Because it is unclear whether the method of claim 17 is intended as a modification of the independent claim or as an additional step in the method, the metes and bounds of the claim scope are unclear, rendering the claim indefinite. If the claims are intended to comprise a single mixing step, the following correction is suggested for claim 17:
"The method of claim 16, wherein the whole blood is drawn from the subject and further comprising a step of mixing the withdrawn blood from the subject with the one or more coagulating agents to form the mixture prior to introducing the mixture into the site of disease or injury."
Claim 18 is included in the rejection as it depends from claim 17 but does not resolve the issue.
Claim 19 is rejected under 35 U.S.C. 112(b) on the basis that it is unclear how the step of "adding a bone affecting agent into said mixture" relates to the method of claim 16, from which claim 19 depends. It is unclear whether the method of claim 19 is intended as a modification of the mixing step of claim 16 or as an additional mixing step in the method resulting in a second mixture, thereby rendering the claim indefinite. If the claim is intended to comprise a single mixing step, the following correction is suggested:
"The method of claim 16, wherein the mixture of whole blood and one or more coagulating agents further comprises a bone affecting agent and wherein the one or more coagulating agents and bone affecting agent are mixed with the whole blood prior to introducing the mixture into the site of disease or injury, said agent having the effect of inducing one or more of (i) bone regenerative processes, (ii) amelioration of damage or injury to the bone tissue, and (iii) ameliorating symptoms of disease or damage of the bone."
Claim 21 is rejected under 35 U.S.C. 112(b) on the basis that it is unclear how the step of "adding a joint affecting agent into said mixture" relates to the method of claim 16, from which claim 21 depends. It is unclear whether the method of claim 21 is intended as a modification of the mixing step of claim 16 or as an additional mixing step in the method and introduction of a second mixture into the site of injury or disease, thereby rendering the claim indefinite. If the claim is intended to comprise a single mixing step, the following correction is suggested:
"The method of claim 20, wherein the mixture of whole blood and one or more coagulating agents further comprises a joint affecting agent and wherein the one or more coagulating agents and joint affecting agent are mixed with the whole blood prior to introducing the mixture into the joint, said agent having the effect of inducing one or more of (i) joint regenerative processes, (ii) amelioration of damage or injury to the joint tissue, and (iii) ameliorating symptoms of disease or damage of the joint."
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Balaguer (US 9,561,304 B2, 2017).
Regarding claims 16-18, Balaguer discloses a method for treating bone defects by mixing autologous whole blood (withdrawing blood from a patient, claim 17) with a coagulating agent, which may be chosen from calcium salts including calcium chloride, calcium nitrate, calcium ethanoacetate, or calcium sulfate (one more coagulating agents, claims 16-17), and biphasic calcium phosphate ceramic granules (BCP), which have anti-coagulating properties, (mix with an anti-coagulant, claim 17) into a homogeneous paste that is then applied to the bone defect for reconstruction of lost bone substance (introducing the mixture into the site of disease or injury, claim 16) due to traumatic injury or removal of a bony tumor (treating a bone disease or injury in a subject, claim 16) (col. 1 lines 10-12 and col. 3 lines 43-63). Balaguer notes that addition of a coagulating agent is necessary because BCP has anti-coagulating properties that prevent formation of a blood coagulate (wherein the one or more coagulating agents counters the anti-coagulating effect of the anti-coagulant, claim 18) (col. 3 lines 43-46). Balaguer additionally notes that additional anti-coagulant may be added to prevent premature coagulation (permitting the blood to coagulate in the site of disease or injury) (col. 4 lines 43-49).
Regarding claim 19, the BCP granules in the composition disclosed by Balaguer comprise hydroxyapatite, one of the naturally occurring minerals in bone, and Balaguer notes that BCP granules are osteogenic (a bone affecting agent that induces bone regenerative processes) (col. 2 lines 36-47).
Claims 16-17 and 19-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chevrier (A. Chevrier, et al., Osteoarthritis Cartilage, 2007).
Regarding claims 16-17, Chevrier discloses a method for treating bone and cartilage lesions comprising the following steps: 1) mixing autologous whole blood (withdrawing blood from a patient, claim 17) with a chitosan-glycerol phosphate (GP) buffer, 2) applying the mixture to microdrilled osteochondral defects that extend through the articular cartilage into the subchondral bone in the knee joints of New Zealand White rabbits (treating a bone or joint injury, claim 16), and 3) permitting the mixture to coagulate for 5 to 8 min before closing the wound (permitting the blood to coagulate in the site of disease or injury, claim 16) (Abstract and Materials and Methods pp. 317-318). Chitosan induces platelet aggregation and activation and promotes blood coagulation, and glycerol phosphate is added to the chitosan solution to buffer the solution pH to maintain the solubility of chitosan while allowing the blood-chitosan-GP solution to rapidly coagulate in situ (mixture of whole blood and one or more coagulating agents, claim 16) (Chevrier Introduction p. 17).
Regarding claim 19, Chevrier discloses comparing the treatment of the osteochondral defects using the chitosan-GP-whole blood mixture to control defects that were permitted to bleed to form a clot in situ without additional coagulating agents (Results p. 320). Compared to the control defects, the chitosan-GP-whole blood mixture had better integration of the repair tissue with surrounding tissue, had increased recruitment of cells involved in wound healing, were better vascularized, and promoted bone remodeling (Results p. 322 and Fig. 2E-2F, 4, and 8). Therefore chitosan-GP in the whole blood mixture disclosed by Chevrier is a bone affecting agent with the effect of inducing bone regenerative processes, ameliorating damage or injury to the bone tissue, and ameliorating symptoms of the disease or damage to the bone. Furthermore, Chevrier discloses applying the chitosan-GP-whole blood mixture directly to the osteochondral defects in the knee (introducing said mixture into the site of disease or injury) (Materials and Methods p. 318).
Regarding claims 20-22, Chevrier notes that inflammatory cells are recruited to the osteochondral defects (Discussion p. 323). Therefore, Chevrier discloses a method for treating an inflammatory joint disease (claims 20-22) and a method for treating a cartilage injury and cartilage lesion (claims 20-21). Furthermore, Chevrier notes, in addition to the improvements in bone healing noted above, that the chitosan-GP-whole blood mixture improves the volume and quality of hyaline cartilage in the osteochondral defects (Discussion p. 323). Therefore chitosan-GP in the whole blood mixture disclosed by Chevrier is a joint affecting agent with the effect of inducing joint regenerative processes, ameliorating damage or injury to the joint tissue, and ameliorating symptoms of the disease or damage to the joint (claim 21). Furthermore, Chevrier discloses applying the chitosan-GP-whole blood mixture directly to the osteochondral defects in the knee (introducing said mixture into the joint, claim 21) (Materials and Methods p. 318).
Claims 16-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Snyder (R.J. Snyder, et al., Wounds, 2018) as evidenced by Sohn (K.C. Sohn, et al., Biomol Ther (Seoul), 2013).
Regarding claims 16-17, Snyder discloses a method for treating diabetic foot ulcers that probe to the bone, tendon, or joint capsule (method of treating a bone or joint disease or injury, claim 16) (Abstract and Materials and Methods p. 206). The method comprises 1) drawing blood from a patient (withdrawing blood from the subject, claim 17), 2) mixing the blood with 10% calcium gluconate and kaolin powder to initiate and accelerate coagulation (mixing whole blood with one or more coagulating agents, claim 16), 3) then injecting the coagulating blood into the ulcer (introducing the mixture into the site of disease or injury, claim 16) (Abstract and Materials and Methods pp. 206-207). A blood clot formed 10-12 min after injection (permitting the blood to coagulate in the site of disease or injury, claim 16) (Materials and Methods p. 207).
Regarding claim 18, Snyder further discloses mixing the blood with citrate phosphate dextrose adenine, an anti-coagulant, upon blood withdrawal (wherein the withdrawn blood is mixed with an anti-coagulant) (Materials and Methods p. 206). Snyder notes that calcium gluconate and kaolin powder act to reinitiate blood clotting after anticoagulation with a citrate anticoagulant (wherein the one or more coagulating agents counter the anti-coagulating effect of the anti-coagulant) (Introduction p. 206).
Regarding claims 20 and 22, Snyder notes that the blood clot composition promotes healing by controlling inflammation and that the treated ulcers probe to bone, tendon, or joint capsule (Materials and Methods p. 206 and Discussion p. 211). Therefore, the method disclosed by Snyder is a treatment for an inflammatory joint disease.
Regarding claims 19 and 21, method disclosed by Snyder comprises mixing whole blood with calcium gluconate (Materials and Methods p. 206). As evidenced by Sohn, calcium gluconate suppresses inflammation in a mouse rheumatoid arthritis model (Abstract). Sohn notes that in the rheumatoid arthritis model, calcium gluconate reduces inflammation in peripheral synovial joints, articular cartilage, and bone and suppresses cartilage and bone erosion (Abstract and Discussion p. 297). Therefore, Snyder inherently discloses a bone affecting agent (calcium gluconate) having the effect of ameliorating damage to the bone tissue by preventing bone erosion and ameliorating symptoms of the disease by reducing inflammation in the bone (claim 19). Snyder further inherently discloses a joint affecting agent (calcium gluconate) having the effect of ameliorating damage to articular cartilage (tissue within a joint) by preventing cartilage erosion and ameliorating symptoms of the disease by reducing inflammation in the cartilage (claim 21).
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 16-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of copending Application No. 19/159,593 (reference application, '593 hereafter). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Although the claims at issue are not identical, they are not patentably distinct from each other because every element of claims 16-17 are anticipated by claim 22 of '593.
Claim 22 of '593 is drawn to a method of treating a damaged connective tissue portion in a subject wherein the connective tissue is a tendon, a ligament, or a cartilage (a method for treating a joint injury in a subject, claim 16). Claim 22 of '593 is further drawn to withdrawing whole blood from the subject (claim 17) and mixing the whole blood with one or more coagulating agents (claims 16-17). Claim 22 of '593 is further drawn to injecting the coagulating blood mass into damaged connective tissue portion (introducing the mixture of whole blood and one or more coagulating agents into the site of injury, claim 16) such that the coagulating blood mass coagulates at the damaged portion (permitting the blood to coagulate in the site of injury, claim 16).
Claims 16-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of copending Application No. 18/723,323 (reference application, '323 hereafter) in view of Balaguer (US 9,561,304 B2, 2017). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 22 of '323 is drawn to a method of treating a damaged connective tissue portion in a subject comprising introducing a mixture of whole blood withdrawn from the subject, mixing one or more coagulating agents, and/or anti-anti-coagulating agents prior to complete coagulation of the mixture. Bone is a connective tissue and joints comprise multiple connective tissues, including bone, cartilage, tendons, and ligaments.
Every element of claim 22 is recited in claims 16-18 of the immediate application except that claims 16-18 require that the treated damaged connective tissue be a bone or joint disease or injury.
However, Balaguer teaches a method of treating bone defects by mixing autologous whole blood with a coagulating agent and biphasic calcium phosphate ceramic granules (BCP), which have anti-coagulating properties, into a homogeneous paste that is then applied to the bone defect for reconstruction of lost bone substance due to traumatic injury or removal of a bony tumor, as discussed in the rejection of claims 16-19 under 35 U.S.C. § 102 above (col. 1 lines 10-12 and col. 3 lines 43-63). Balaguer further teaches that new materials for bone reconstruction for large defect sizes are needed due to limited availability of autologous bone, extended culture time required for cultured cell-based bone substitutes, lack of constructability of biomaterials made from non-coagulated blood, and lack of efficacy from biomaterials made from coagulated blood. (col. 1-2).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the method of treating a damaged connective tissue portion recited in claim 22 of '323 to treatment of a bone defect as taught by Balaguer to arrive at the claimed invention. One would be motivated to make such a combination as Balaguer teaches that new biomaterials are needed for reconstruction of bone for large bone defects and as Balaguer teaches treatment of bone injuries using a mixture comprising whole blood, a coagulant, and an anti-coagulant. One would have a reasonable expectation of success in making the combination as Balaguer teaches treatment of bone injuries a connective tissue using a mixture comprising whole blood, a coagulant, and an anti-coagulant.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric B Wright whose telephone number is (571) 272-2607. The examiner can normally be reached Mo - Fr, 09:00 a.m. - 05:00 p.m. Eastern. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Peter Paras can be reached at (571) 272-4517.
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Eric B Wright, PhD
Examiner
Art Unit 1632
/Eric B Wright/Examiner, Art Unit 1632
/VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
