The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Formal Matters
Claims 2-11 are pending and under examination.
Priority
This application is a continuation of 17/244,910 filed on 4/29/2021, which is a continuation of 15/294,954 filed on 10/17/2016, which is a continuation of 13/173,701 filed on 6/30/2011, which claims priority to provisional application 61/361,177 filed on 7/2/2010.
Information Disclosure Statement
The information disclosure statement filed on 1/23/2025 has been considered.
Claim Interpretation
The claim is considered patent eligible because although calcium sulfate, calcium phosphates and some of the pharmacologic agents such as hormones and some RANKL inhibitors are naturally occurring, the claim is structured to be “a particulate composition suitable for injection or implantation into the body and adapted to set upon mixing with an aqueous solution into a cement”. This preamble provides the structure of particulate while also providing the composition has to be suitable for injection or implantation and adapted to set upon mixing with an aqueous solution. These limitations provide the particulate composition is formulated for injection or implantation as well as made to be able to set upon contact with an aqueous solution to form a cement that will contain the pharmacologic agent for its delivery in the body, which are not characteristics of the naturally occurring compounds on their own. Thus, the composition with all its limitations (ingredients, structure and function) provides the combination of natural products with markedly different characteristics.
Objection to Abstract
In this case, the specification is objected to because it does not discuss the claimed invention of a particulate composition, but rather a combination suction and irrigation device. Applicant should change the content of the abstract accordingly, but ensure not to add new matter to the abstract/specification.
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
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.
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.
Claim 2-11 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 pre-AIA the applicant regards as the invention.
Claim 2 recites the phrase “pharmacologic agent composition selected from one or more of….”, but it is unclear if this group is meant to be closed as with the Markush structures “selected from the group consisting of….and…” or the Markush structure “is….or…”, or alternatively if applicant intends the pharmacologic agent composition to be open as in the manner of “pharmacologic agent composition comprises…..or…”. This would also clarify the use of “pharmacologic agent composition comprises…” in dependent claims because if the group in claim 2 is mean to be closed use of “pharmacologic agent composition comprises” would appear to try and reopen the group while if applicant clarifies with proper language that this group in claim 2 is open, then the use of “pharmacologic agent composition comprises” would be fine. However, note the use of language “selected from the group comprising” is improper if considering an amendment for clarification.
Claims 3-11 are rejected as being dependent on indefinite claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 2-6, and 8-9 are rejected under 35 U.S.C. 103(a) as being unpatentable over Lidgren US 20070041906.
Lidgren teaches “An injectable bone mineral substitute material composition with the capability of being hardened in a body fluid in vivo, which comprises at least one calcium phosphate component and at least one calcium sulfate component as a dry mixture mixed with an aqueous liquid, and at least one accelerator, the at least one calcium sulfate component being particulate hardened calcium sulfate, which has a specified particle size that is in order to confer injectability to the composition” (abstract). Lidgren teaches adding an additive such as a hormone, a bisphosphonate or a protein (paragraphs 37-38). Lidgren teaches bone inducing substances include hormones as an option (paragraph 38). Note “bone inducing” is desired in treating conditions like osteoporosis. Lidgren teaches parathyroid hormones (paragraph 40). This would encompass the recombinant and natural forms. Lidgren teaches bone growth factors including osteoprotegrin (paragraph 39, this compound is a natural RANKL inhibitor). Lidgren teaches bone breakdown inhibitors including bisphosphonates (paragraph 43). Paragraph 66 provides for different “at least one calcium phosphate” including monocalcium phosphate, tricalcium phosphate and others. Example 3 provides for injecting the composition in vivo (paragraphs 129-131). Lidgren teaches filling defects in osteoporotic bone (paragraph 25). Lidgren teaches forming cement in the bone mineral substitute material (paragraphs 55-57).
Example 2 of Lidgren have hydroxyapatite as the calcium phosphate, calcium sulfate and gentamicin (antibiotic as the active).
Lidgren does not provide an embodiment with all the components namely two or more calcium phosphates and one of the pharmacologic agents of applicant’s claim.
One of ordinary skill in the art before the time of invention would have been capable of combining calcium sulfate and at least one calcium phosphate with additives such as bisphosphonates, RANKL inhibitor compounds and parathyroid hormones in order to produce a suitable composition for treating bone conditions using the teachings of Lidgren. Thus, there was a reasonable expectation of success in using the teachings of Lidgren to produce a powder/particulate formulation of calcium sulfate, two or more calcium phosphates (based on one or more in Lidgren and its teachings of different calcium phosphates) and pharmacologic agents for bone like hormones, a RANKL inhibitor/osteoprotegin or bisphosphonates.
Claims 7 and 11 in addition to Claims 2-6, and 8-9 are rejected under 35 U.S.C. 103(a) as being unpatentable over Lidgren US 20070041906 and Uebelhart et al (Z Rheumatol, 2003, volume 62, pages 512-517).
Lidgren teaches the claims as discussed above.
Lidgren does not teach the agents of claim 7 or 11.
Uebelhart teaches drugs that are used for therapy of osteoporosis including bisphosphonates that inhibit bone resorption, SERMs (Raloxifene) that inhibits bone resorption and teriparatide with a strong anabolic effect (Summary of Uebelhart).
One of ordinary skill in the art before the time of invention would have considered other bone/osteoporosis therapeutic agents including those have Uebelhart’s teachings as Lidgren motivates the addition of such therapeutic additives to its formulations and Uebelhart teaches these can have therapeutic value for treating osteoporosis in a subject. Therefore, there was a reasonable expectation of success in combining the teachings of the references to provide for a particulate composition having calcium sulfate, calcium phosphates and osteoporosis treating agents such as SERMs and teriparatide that will aid in treating osteoporotic bone.
Claim 10 in addition to Claims 2-6, and 8-9 are rejected under 35 U.S.C. 103(a) as being unpatentable over Lidgren US 20070041906 and Karim US 20110028394.
Lidgren teaches the claims as discussed above.
Lidgren does not teach a proton pump inhibitor.
Karim teaches therapeutic agents for treatment including ATP proton pump inhibitors (paragraphs 163 and 201). Karim teaches treating conditions like bone diseases including osteoporosis (abstract).
One of ordinary skill in the art before the time of invention would have utilized ATP proton pump inhibitors as a therapeutic agent in treating bone diseases by teachings of Karim and utilized such ATP proton pump inhibitors as being an acceptable therapeutic/pharmacologic agent for composition for treatments of bone diseases taught in Lidgren. Thus, there was a reasonable expectation of success in utilizing an ATP proton pump inhibitor in a therapeutic composition for bone diseases like osteoporosis by the combined teachings of Lidgren and Karim.
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 2-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9, and 35 of U.S. Patent No. 9550010 in view of Lidgren US 20070041906, Uebelhart et al (Z Rheumatol, 2003, volume 62, pages 512-517) and Karim US 20110028394. Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for particulate forms of a composition that has calcium sulfate, two or more calcium phosphates and the claims of ‘010 further allow bone regenerative materials such as anti-osteoporotic materials.
‘010 claims do not provide for the pharmacologic agents of applicant’s claims.
Lidgren teaches adding an additive such as a hormone, a bisphosphonate or a protein (paragraphs 37-38). Lidgren teaches bone inducing substances include hormones as an option (paragraph 38). Lidgren teaches parathyroid hormones (paragraph 40). Lidgren teaches bone growth factors including osteoprotegrin (paragraph 39, this compound is a natural RANKL inhibitor). Lidgren teaches bone breakdown inhibitors including bisphosphonates (paragraph 43).
Uebelhart teaches drugs that are used for therapy of osteoporosis including bisphosphonates that inhibit bone resorption, SERMs (Raloxifene) that inhibits bone resorption and teriparatide with a strong anabolic effect (Summary of Uebelhart).
Karim teaches therapeutic agents for treatment including ATP proton pump inhibitors (paragraphs 163 and 201). Karim teaches treating conditions like bone diseases including osteoporosis (abstract).
One of ordinary skill in the art would use these known agents that have therapeutic utility for bone and treating osteoporosis in the formulation provided by ‘010’s claim which allows for different bone treatment agents including anti-osteoporosis agents/material.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613
