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 .
Amendments
Applicants’ amendments to the claims filed 1/7/2026 have been entered. Any objection\rejections from the previous office action filed 9/25/2005 not addressed below has been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2,7-11 and 18-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In particular the new limitation in claim 1 which recites “administered at or near the site of a sarcoma in a subject” is considered new matter. The examiner did not find support to claim sarcoma in the specification or administering at or near it. Claims 2,7-11 and 18-21 incorporate the indefiniteness by dependency.
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) 1-2,7-11 and 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over LIDGREN (WO 2016/150,876) in view of Lidgren II (2007/0041906) in view of Waddell et al. “DOXORUBICIN-CISPLATIN CHEMOTHERAPY FOR HIGHGRADE NONOSTEOGENIC SARCOMA OF BONE COMPARISON OF TREATMENT AND CONTROL GROUPS”, CJS, Vol. 42, No. 3, June 1999. This new rejection was necessitated by amendment.
Lidgren teaches a biphasic bone substitute for use in surgical intervention, revision arthroplasties and filling voids by pathological lesions including bone cancer, where the bone substitute comprises a first phase of fast resorbable calcium sulfate particles a second phase of slow resorbable calcium phosphate including hydroxyapatite particles (size 0.1 to 50 microns, the data points overlaps and incorporates the ranges of claim 1) along with anti-catabolic bisphosphonates including preferably zoledronic acid (meeting claim 16), chemotherapeutics and antimicrobials. See entire disclosure especially abstract, page 5 lines 13-17, page 7 lines 10-18, page 15 lines 1-8, page 17 line 30-page 18 line 5 and claims, especially 1-4,7-11,13,16-19,24,31 and 51. Regarding the overlapping particle sizes in microns and nm, a prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection. Therefor, based on the described overlap above, the instant claims would have been obvious to one of ordinary skill in the art. MPEP § 2144.05. Regarding claims 2,9-11, since calcium phosphate and calcium sulphate are the same materials claimed it follows they will have the same properties including their resorbability rates in the body.
Lidgren while teaching bone repair for bone cancer and use of chemotherapeutics is silent with respect to administering the bone substitute at or near a sarcoma and the reference is silent with respect to administering chemotherapeutics such as doxorubicin systemically after administration of the bone substitute.
Lidgren II is used for its teaching that calcium phosphate and calcium sulfate bone substitute compositions containing chemotherapeutics could be administered locally for treatment of cancers. See entire disclosure, especially abstract, [0117],[0118] and claim 48,52,59,67 and 69.
Waddell teaches use of chemotherapeutics such as doxorubicin for sarcoma of bone and found that adjuvant systemic chemotherapy in patients administered over a time period, led to significantly better survival rates. See entire disclosure, especially abstract and Fig 1 and 2.
Since Lidgren already suggest use of the bone substitute to fill voids due to surgical procedures from bone cancer and use of chemotherapeutics one of ordinary skill in the art would have a very high expectation of success in administering the bone substitute with chemotherapeutic to a sarcomas of the bone and afterword systemically administer doxorubicin over a period of time to the implantation site to increase survival rate of bone cancer patients as suggested by Waddell. Thus the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Response to Arguments
Applicant's arguments filed 1/7/2026 have been fully considered but they are not persuasive.
Applicants assert Lidgren does not teach treatment of bone cancer.
The examiner disagrees. The reference clearly teaches treatment of bone damaged by cancer and use of chemotherapeutics. To treat cancers treatable by chemotherapeutics would readily be envisage by one of ordinary skill. There is no reason to add chemotherapeutics to a bone substitute other than to treat a cancer. “The biphasic ceramic bone substitute according to the present invention may be used in the treatment of most bone defects where surgical intervention and filling of voids are needed and/or beneficial, such as loss of bone due to i.a. trauma, debriding of infected areas, resection of pathological lesions (e.g. bone cancer), nonunion surgery and in primary or revision arthroplasties. Bones to be treated include, but are not limited to, the spinal cord, bones of the hands, fingers, arms, feet, toes, lower or upper legs, knee, hip, ankle, elbow, wrist, shoulders, skull, jaw and teeth of any animal or a human.” See page 15 lines 1-5.
Applicants next pick on Waddell for not teaching use of hydroxyapatite and calcium sulfate particles.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Waddell was used only for its teaching that adjuvant systemic doxorubicin in patients administered over a time period, led to significantly better survival rates and not for any teaching already covered by the primary reference, such as hydroxyapatite and calcium sulfate.
Applicants assert their new limitation that the composition is administered at or near a sarcoma distinguishes the claims from Lidgren and Waddell.
As noted in the modified rejection above the limitation is considered obvious when the new Lidgren II reference is considered.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618