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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because “comprising” is legalese. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The use of the terms ORTOGEL501, X-AIR, IRGANOX 1010, IRGANOX 1035, CY-ANOX 1790, CYANOX 2777, REPLACE, EX-PANCEL, DABCO 33LV, POLY-Q-40-800, DABCO DC 193, DABCO DC 5241, MAXEMUL 6106, LIPIODOL, HYPAQUE, OMNIPAQUE, OP1, and INFUSE, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 22 is objected to because of the following informalities:
“1,1,1 -tri s-(4- isocyanatophenoxymethyl)-propane” is a typographical error and should read “1,1,1-tris-(4-isocyanatophenoxymethyl)-propane”.
“and 0-5%% of one or more additive material(s)” is a typographical error and should read “and 0-5% of one or more additive material(s)”.
“tetrakis (2- hydroxyethyl)ehylenediamine” is a typographical error and should read “tetrakis(2-hydroxyethyl)ethylenediamine”.
Appropriate correction is required.
Claim 23 is objected to because of the following informalities: “1,1,1 -tri s-(4- isocyanatophenoxymethyl)-propane” is a typographical error and should read “1,1,1-tris-(4-isocyanatophenoxymethyl)-propane”. Appropriate correction is required.
Claim 30 is objected to because of the following informalities: “claims 29” is a typographical error and should read “claim 29”. Appropriate correction is required.
Claim 34 is objected to because of the following informalities: “period time” is a typographical error. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 23 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 23 recites “and 10-20% of one or more additive material(s), based upon the weight of putty B”. Claim 22, upon which claim 23 depends, recites “and 0-5%% of one or more additive material(s), based upon the weight of putty B”. Thus, claim 23 fails to further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 22 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites “a composition comprising a set of at least two reactive putties” and “each putty being physically separated from the other putty of the composition”. It is unclear and indefinite how a single composition may comprise at least two components which are physically separated from each other.
Claim 22 recites “the polyol or polyamine component of both putty A and putty B comprise one or more polyols”. It is unclear and indefinite how a polyol or polyamine component must comprise a polyol.
Dependent claims 23-35 are similarly rejected by their dependence on indefinite claim 22.
Claim 23 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 23 recites “the polyol or the polyamine component of putty A comprises trimethylolpropane ethoxylate (TMPE)”. It is unclear and indefinite how a polyol or polyamine component must comprise a specified polyol.
Claim 23 recites “of molecular weight 450” and “of molecular weight 170” as claim limitations but provides no measurement basis, units, or method for determining said parameters. The specification similarly provides no measurement basis, units, or method.
Claim 31 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 31 recites the limitation "the sternotomy". There is insufficient antecedent basis for this limitation in the claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 22, 24-27, and 29-35 are rejected under 35 U.S.C. 103 as being unpatentable over Pacifico et al (US 9827349 B1), in view of Roby et al (US 20060111537 A1).
Regarding claim 22, Pacifico discloses settable compositions for use as surgical implants which comprise a set of two putties, A and B, which "which, upon mixing, react and cure into a final hardened form over a period of time, preferably at room or body temperature" (page 2, column 2, lines 47-52) with the following features:
Putty A comprises 15-40% of an isocyanate component, 0.5-5% of a polyol component, and 50-75% of a particulate material, based on the total weight of Putty A. The isocyanate component consists of a diisocyanate which is aromatic or aliphatic (page 3, column 3, lines 47-52). A prima facie case of obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05(I).
Putty B comprises 1-10% of an isocyanate component, 3-15% of a polyol component, and 65-95% or 75-85% of a particulate material, based on the total weight of Putty B (page 3, column 3, lines 52-55). A prima facie case of obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05(I).
The polyol component of Putty A or B may particularly be a crosslinker such as triethanolamine or QUADROL (BASF Corp, which is tetrakis(2-hydroxypropyl)ethylenediamine) (page 11, column 20, lines 25-34).
The particulate material of Putty A or B may be calcium phosphate, siliconized calcium phosphate, substituted calcium phosphates, calcium pyrophosphate, hydroxyapatite, polymethyl methacrylate, or tricalcium phosphate (page 4, column 6, lines 4-17). Pacifico also particularly discloses biphasic calcium phosphate/hydroxyapatite (page 4, column 6, lines 24-25).
The compositions of Putty A and Putty B may optionally comprise additives, present between 0.01 to 0.5% or 0.1 to 5% by weight of the component putty (page 12, column 22, line 62 to page 13, column 23, line 1). A prima facie case of obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05(I).
Pacifico does not particularly disclose that Putty A or Putty B comprise 25-45% or 2-5%, respectively, of 1,1,1-tris-(4-isocyanatophenoxymethyl)-propane (TMPI).
In the same field of endeavor, Roby discloses bioabsorbable adhesive compounds. These multi-component compounds comprise trifunctional compounds endcapped with aromatic diisocyanates, with trifunctional compounds including 1,1,1,-trimethylolpropane [0014] and aromatic diisocyanates including 1,1′-methylenebis(4-isocyanatobenzene) along with similar structures [0011]. The resulting structure reads on applicant’s claimed TMPI.
Roby further discloses that these compounds and compositions are useful as surgical adhesives, meshes, fasteners, implants, and the like [0022]. It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the compositions of Pacifico and Roby, as the two are considered to be equivalents known for the same purpose. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Regarding claim 24, the combination of Pacifico and Roby discloses all limitations of claim 22 as set forth above. Pacifico further discloses that the additives to Putty A or B may be a colorant or dye (page 2, column 2, lines 34-41), an antioxidant, a therapeutic agent (page 3, column 4, lines 41-43), an active chemical hemostat (page 5, column 7, lines 55-60), steroid, calcium stearate, tocopheryl acetate, or triacetin (page 12, column 22, lines 57-59).
Regarding claims 25 and 26, the combination of Pacifico and Roby discloses all limitations of claim 22 as set forth above. Pacifico further discloses that the composition of Putty A or B may contain one or more therapeutic agents which are selected from one or more of an anti-cancer agent, an antimicrobial agent, an antibiotic, a local anesthetic or analgesic, and an anti-inflammatory agent (page 7, column 11, lines 62-67). The antibiotic may be selected from a broad spectrum antibiotic, such as gentamicin, clindamycin, and erythromycin, or a gram positive and gram negative family antibiotic such as an ampicillin and a cephalosporin, a local anesthetic or analgesic selected from lidocaine, bupivacaine, tetracaine, and ropivacaine, or fentanyl, anti-inflammatory substances selected from a non-specific anti-inflammatory such as ibuprofen and aspirin, or a COX-2 specific inhibitor such as rofecoxib and celeboxib (page 11, column 22, lines 32-49).
Regarding claim 27, the combination of Pacifico and Roby discloses all limitations of claim 22 as set forth above. Pacifico further discloses that softeners may be added, such as nonreactive surfactants, hydrophilic compounds or polymers such as polyethylene glycol dialkyl ethers, etcetera (page 4, column 6, lines 49-51).
Regarding claims 29 and 33, the combination of Pacifico and Roby discloses all limitations of claim 22 as set forth above. Pacifico further discloses methods of making and using the settable compositions set forth above (page 2, column 2, lines 44-45), including in the repair and reconstruction of cranial bones or the sternum (sternotomy) (page 6, column 10, lines 23-26). Pacifico particularly discloses mixing, reacting, and curing the set of compositions into a final hardened form over a period of time, preferably at room or body temperature (page 2, column 2, lines 45-52) and that the compositions adhere to the bone surface following mixing components to initiate the curing reaction (page 5, column 7, lines 42-46).
Regarding claim 30, the combination of Pacifico and Roby discloses all limitations of claim 29 as set forth above. Pacifico also discloses that the composition is suitable for accepting surgical hardware, particularly a screw (page 2, column 2, lines 8-10). "A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989). See MPEP 2131.02. In the instant case, the species of screw anticipates the genus of surgical hardware. Pacifico does not particularly disclose affixing the composition-hardware component to the surface of a bone fracture or cut surface of a sternotomy. However, it would have been obvious to one of ordinary skill in the art to use surgical hardware, such as applicant’s claimed composition-hardware component, in surgical applications.
Regarding claims 31 and 32, the combination of Pacifico and Roby discloses all limitations of claim 22 as set forth above. Pacifico further discloses methods of making and using the settable compositions set forth above (page 2, column 2, lines 44-45), including in the repair and reconstruction of the sternum or the cranium (page 6, column 10, lines 23-26) as well as its suitability for use in bone repair, as bone void fillers, bone cements, and bone hemostats in addition to use in soft tissue repair (page 2, column 1, lines 61-67). Pacifico particularly discloses mixing, reacting, and curing the set of compositions into a final hardened form over a period of time, preferably at room or body temperature (page 2, column 2, lines 45-52) and that the compositions adhere to the bone surface following mixing components to initiate the curing reaction (page 5, column 7, lines 42-46). Pacifico also discloses that the composition is suitable for accepting surgical hardware, particularly a screw (page 2, column 2, lines 8-10). As set forth above with respect to claim 30, it would have been obvious to use surgical hardware, such as applicant’s claimed composition-hardware component, in surgical applications.
Regarding claims 34 and 35, the combination of Pacifico and Roby discloses all limitations of claim 22 as set forth above. Pacifico further discloses “a biocompatible settable composition consisting of a plurality of component parts which, upon mixing, react to form a cured final composition at room or body temperature over a period time, the final composition optionally being biodegradable under physiological conditions” (page 3, column 4, lines 22-27). Pacifico’s optional limitation of biodegradability necessarily teaches embodiments wherein the composition is nonabsorbable.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Pacifico et al (US 9827349 B1) in view of Roby et al (US 20060111537 A1) as applied to claim 22 above, and further in view of Swan et al (WO 2008130590 A2, attached).
The above discussion with respect to Pacifico and Roby as applied to claim 22 is incorporated herein by reference in its entirety.
Regarding claim 23, the combination of Pacifico and Roby discloses all limitations of claim 22 as set forth above. The compositions taught by Pacifico (Putty A: 15-40% of an isocyanate component, 0.5-5% of a polyol component, 50-75% of a particulate material, 0.01 to 0.5% or 0.1 to 5% of additive materials, based on the total weight of Putty A; Putty B: 1-10% of an isocyanate component, 3-15% of a polyol component, 65-95% or 75-85% of a particulate material, 0.01 to 0.5% or 0.1 to 5% of additive materials, based on the total weight of Putty B) combined with the specific embodiments taught by Pacifico (the particulate material of Putty A may be biphasic hydroxyapatite and 3-tricalcium phosphate, the polyol of Putty A may be tocopheryl acetate, the polyol or polyamine of Putty B may be triethanolamine or tetrakis(2-hydroxypropyl)ethylenediamine, the particulate material(s) of Putty B may be hydroxyapatite, the additive material(s) of Putty B may be tocopheryl acetate and triacetin) and Roby (the 1,1,1-tris-(4-isocyanatophenoxymethyl)-propane present in Putty A and Putty B) read on the limitations of claim 23.
Neither Pacifico or Roby disclose that the polyol or polyamine component of Putty A or Putty B comprises trimethylolpropane ethoxylate (TMPE).
In the same field of endeavor, Swan discloses biodegradable matrix materials suitable for implantable medical devices such as implants, coatings, in-situ formed matrices, stents, tubes, aneurysm coils, and the like as well as for in-situ delivery (such as cell delivery or bioactive agent delivery), and as tissue sealants (Abstract). Swan particularly discloses that such compositions include hydroxyl-functional compounds (polyols) such as trimethylolpropane ethoxylate, among others (page 5, lines 8-10). Trimethylolpropane ethoxylate is particularly disclosed in a short list of representative examples, and the example material synthesized with trimethylolpropane ethoxylate produced a clear oil (page 23, lines 4-18).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine the compositions taught by Pacifico and Roby with the specific polyol particularly disclosed by Swan with a reasonable expectation of success.
It is noted that neither Pacifico, Roby, or Swan particularly disclose the limitations of claim 23 relative to molecular weight. However, a physical property not directly disclosed by the prior art in an invention which was otherwise obvious over the prior art is not sufficient to establish patentability. See, for example, In re Wiseman (596 F.2d 1019, 201 USPQ 658 (CCPA 1979)), in which the Appellant argued that a structure suggested by the prior art, and, hence, potentially in possession of the public, was patentable to them because it also possessed an inherent, but hitherto unknown, function which they claimed to have discovered. The CCPA found that "[t]his is not the law. A patent on such a structure would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. See In re Finsterwalder, 436 F.2d 1028, 58 CCPA 871, 168 USPQ 530 (1971).”
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Pacifico et al (US 9827349 B1) in view of Roby et al (US 20060111537 A1) as applied to claim 27 above, and further in view of Yanagi et al (JP 2012213658 A, translation attached).
The above discussion with respect to Pacifico and Roby as applied to claim 27 is incorporated herein by reference in its entirety.
Regarding claim 28, the combination of Pacifico and Roby discloses all limitations of claim 27 as set forth above. Neither Pacifico nor Roby particularly discloses mineral oil as a suitable softener.
In the same field of endeavor, Yanagi discloses a polymer composition suitable for a self-curable bone repairing paste (page 1, lines 15-16) which includes a polyisocyanate component which acts as a reactive stabilizing component (page 6, lines 32-51). Yanagi particularly discloses that the polymer composition includes softeners, such as mineral oil (page 7, lines 4-9).
It would have been obvious to one of ordinary skill in the art at the time of the invention to use mineral oil as the softener in the composition taught by Pacifico and Roby with a reasonable expectation of success, as mineral oil is a recognized softener in the art, as disclosed by Yanagi. It has been established that selection of a known material based on its suitability for its intended use is prima facie obvious (Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” (325 U.S. at 335, 65 USPQ at 301.). See MPEP 2144.07.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tamareselvy (CN 101535350 B, translation attached) discloses a polymer composition designed for use in applications requiring biocompatibility, such as personal care products in contact with the eyes or skin, which comprises a trimethylolpropane ethoxylate monomer and mineral oil as an emollient (softener).
Kronenthal (EP 3821916 A1, attached) discloses a two-putty settable bone hemostatic and adhesive composition, wherein the first putty comprises 15-40% of a polyfunctional isocyanate, tocopheryl acetate, 40-85% of calcium phosphate, and 0.5-5% of a polyol, and the second putty comprises 1-10% of a polyfunctional isocyanate, 65-95% of calcium phosphate, 3-15% of at least one polyol, a fatty acid salt, and tocopheryl acetate. The fully set and hardened composition possesses sufficient mechanical properties to be weight-bearing, for example as a bone implant, bone void filler, or bone cement. The composition may further comprise a therapeutic agent such as an anti-cancer agent, an antimicrobial agent, an antibiotic, a local anesthetic or analgesic, a statin, or an anti-inflammatory agent.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Savannah G Phillips whose telephone number is (571)270-0822. The examiner can normally be reached M-Th 8-6 ET.
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, Joseph Del Sole can be reached at (571)272-1130. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAVANNAH G. PHILLIPS/Examiner, Art Unit 1763
/JOSEPH S DEL SOLE/Supervisory Patent Examiner, Art Unit 1763
Prosecution Insights