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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/23/2026 has been entered.
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, for the reasons set forth in the previous action filed 7/23/2026.
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, for the reasons set forth in the previous action filed 7/23/2026.
Response to Arguments
Applicant's arguments filed 1/7/2026 have been fully considered but they are not persuasive.
With regard to the written description rejection applicants assert since they clearly have described treating tumor throughout the specification and discuss osteosarcoma they have not added new matter.
The problem with applicants argument is that the species osteosarcoma does not support the entire genus of sarcoma. The specification simply does not describe treating sarcoma as generically recited in the claims. See In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967) (“If n-propylamine had been used in making the compound instead of n-butylamine, the compound of claim 13 would have resulted. Appellants submit to us, as they did to the board, an imaginary specific example patterned on specific example 6 by which the above butyl compound is made so that we can see what a simple change would have resulted in a specific supporting disclosure being present in the present specification. The trouble is that there is no such disclosure, easy though it is to imagine it.”) (emphasis in original); Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1328, 56 USPQ2d 1481, 1487 (Fed. Cir. 2000). The examiner suggests simply deleting the term “sarcoma” and replacing it with “osteosarcoma”.
Applicants assert Lidgren does not teach treatment of bone cancer as it does not apply the bone cement to treat the sarcoma directly but repairs the bone after surgical intervention.
The examiner disagrees. First applicants claims do not preclude additional steps in the method such as removing cancerous tumor before application of the bone cement. The cement is still used in a method that treats bone cancer. Furthermore, the reference clearly teaches treatment of bone damaged by cancer and use of chemotherapeutics. To treat cancers treatable by chemotherapeutics would readily be envisaged by one of ordinary skill. There is no reason to add chemotherapeutics to a bone substitute other than to treat 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 Lidgren II for teaching incorporation of chemotherapeutics in the implant composition and not subsequently as claimed. 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). Lidgren II was used primarily for its disclosure that bone substitute compositions could be administered locally for treatment of cancer, Waddell covers subsequent administration of chemotherapeutic doxorubicin. 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 examples show that hydroxyapatite has affinity for doxorubicin and is localized to the implanted particles.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., doxorubicin is localized to the hydroxyapatite particles) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally, this feature is a property and is a natural result that would occur when doxorubicin is administered after the hydroxyapatite bone cement of Lidgren is implanted.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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