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 .
Double Patenting
1. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
2. 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.
3. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18545103. Although the claims at issue are not identical, they are not patentably distinct from each other because, although the instant claims and the copending claims differ very slightly in scope, they overlap to the extent that one practicing the instantly claimed inventions would practice the copending claimed inventions and vice versa.
It is noted that “including” and “comprising” of the instant claims and copending claims respectively are synonymous, open terms. See MPEP 2111.03 Transitional Phrases [R-01.2024], particularly “I. COMPRISING
The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” It is therefore the examiner’s position that these different terms do not create any scope difference between the instant claims and the copending claims.
The copending claims do not recite “for use in medical applications”. This intended use of the instant claims is expected to place requirements on the compositions per se that are not in claims which do not recite this limitation. This scope difference is taken being sufficient to eliminate any statutory double patenting rejection between the instant claims and the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
4. Claims 17-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18545103 in view of US Pat. Application Publication No. 2017/0239292 Clarkin et al. and EP 2124867 Primus et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because, although the instant claims and the copending claims differ very slightly in scope, they overlap to the extent that one practicing the instantly claimed inventions would practice the copending claimed inventions and vice versa.
It is noted that “including” and “comprising” of the instant claims and copending claims respectively are synonymous, open terms. See MPEP 2111.03 Transitional Phrases [R-01.2024], particularly “I. COMPRISING
The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” It is therefore the examiner’s position that these different terms do not create any scope difference between the instant claims and the copending claims.
The copending claims do not recite “for use in medical applications”. This intended use of the instant claims is expected to place requirements on the compositions per se that are not in claims which do not recite this limitation. This scope difference is taken being sufficient to eliminate any statutory double patenting rejection between the instant claims and the copending claims.
Clarkin and Primus disclose cements which are similar to those of the copending claims and which may contain Barium cements for use in the methods of the instant claims 17-23. See the entireties of these documents.
It would have been obvious to one of ordinary skill in the art to use the copending claimed inventions in the methods of the instant claims 17-23 because they would have been expected to function in such methods similarly to the compositions of Clarkin and Primus and additionally would have been expected to impart their properties, including their inherent properties, to the medical methods of Clarkin and Primus.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
5. 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.
6. Claims 1-23 are rejected under 35 U.S.C. 103 as being unpatentable over US Pat. Application Publication No. 2008/0299093 Yang et al. in view of US Pat. Application Publication No. 2017/0239292 Clarkin et al.
Regarding claims 1, 2, and 5-16:
Yang discloses premixed cement pastes for use in medical applications which include a premixed paste containing calcium silicates that are capable of hydration reaction with water to form a hydrogel and a nonaqueous liquid carrier that is hydrophilic and able to undergo an exchange with water-based liquid when the premixed paste is exposed to an environment where water-based liquids are present. The hardening reaction of Yang involves crosslinking between the reactive sites to form a crosslinked matrix which will necessarily contain water in the environment where water-based liquids are present. The hardened material of Yang is therefore a hydrogel. See Yang, the abstract and paragraphs [0002], [0003], [0010], [0012], noting the hydration and gel formation, [0013], noting the hydrate gel, [0014], [0025], [0026], [0027], noting the formation of “hydro-gel”, [0028], of which the water-free liquids include those of the instant claims 1 and 12, [0029], noting the amounts therein which fall within the amounts of the instant claims 5-8 and 10-11, [0030], [0031], [0036]-[0038], noting the salts, oxides, hydroxides, ceramics and other compounds which fall within the scope of the instant claims 9 and 13-14, [0039], noting the barium sulfate which shows that the compositions of Yang may contain barium compounds, [0040], [0041], noting the hermetically sealed package of the instant claim 2 and the calcium silicate hydrate gel, [0045], noting the organic dispersants that fall within the scope of the instant claims 15-16, and the remainder of the document.
Yang differs from the instant claims in that it does not use the instantly claimed barium cements.
Regarding claims 17-23:
The method steps per se of using the compositions of Yang fall within the scope of the method steps of the instant claims 17-23 though the compositions of Yang differ in that they do not use the instantly claimed barium cements.
Regarding claims 1-23:
Clarkin discloses compositions for use in medical methods which give a hydrogel of calcium silicate. Clarkin teaches that at least part of the calcium can be replaced with barium to give increased radiopacity and increased strength ([0042]). See Clarkin, the entire document, particularly paragraphs [0001], [0008], [0010]-[0017], [0035], [0038]-[0041], and the remainder of the document.
It would have been obvious to one of ordinary skill in the art prior to the instantly claimed invention to replace a portion of the calcium ions of Yang’s calcium silicates with barium, including in amounts of barium to give the 2% thereof of the instant claim 4 and the barium compounds of the instant claim 3, in order to make the cements of Yang more radiopaque and stronger because Clarkin teaches replacing calcium in calcium silicate cements makes them more radiopaque and makes them stronger at paragraph [0042] and this increased radiopacity and strength would have been expected in the compositions of Yang in proportion to the amount of barium added.
Conclusion
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK D NILAND whose telephone number is (571)272-1121. The examiner can normally be reached on Monday to Friday from 10 to 5.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert S Jones, can be reached at telephone number 571-270-7733. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK D NILAND/Primary Examiner, Art Unit 1762