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 .
Claim Objections
Claim 1 is objected to because of the following informalities: the claim does not end with a period. MPEP 608.01(m) requires that “[e]ach claim begins with a capital letter and ends with a period.” A period should be added to the end of claim 1. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: the claim appears to be missing units (i.e., “-10” should read “-10⁰C”). Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coward et al (US 2016/0332382 A1).
With regards to claim 1, Coward discloses a 3D printed anatomical prosthesis having the mechanical properties, including hardness, of bodily tissue (i.e., a three-dimensional object featuring a hardness of soft bodily tissue) formed by 3D printing lines of a composition comprising cured elastomeric material and filler (i.e., the object being formed of voxels of a material and hardened form of a formulation which comprises curable materials and non-curable materials) (Coward: [0013], [0033]-[0034], [0079], [0085], and [0103]). More particularly, Coward discloses its composition as including 20% by weight of filler (i.e., non-curable material), which is within the claimed range of 10 to 49 % by weight based on the total weight of the formulation, and further, Coward discloses its 3D printed anatomical prosthesis as having a Shore A hardness of, for example, about 6, which is within the claimed range of lower than 10 (Coward: para. [0037] and [0078]).
With regards to claim 2, Coward discloses its formulation as including 20% by weight filler and 80% by weight polydimethyl siloxane (PDMS) (i.e., Coward lists all of its materials, and no biological materials are present) (Coward: para. [0078]).
With regards to claim 3, the 3D printed anatomical prosthesis is in the shape of, for example, a nose (Coward: para. [0103]).
Claim Rejections - 35 USC § 103
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.
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Coward as applied to claim 1 above, and in further view of Cohn (US 2017/0369628 A1).
With regards to claim 13, Coward discloses a prosthesis as applied to claim 1 above (see above discussion). Although Coward discloses its prosthesis as formed from 20 wt. % of a non-curable material, Coward does not appear to more specifically disclose its no-curable material as a polymeric material (see above discussion).
Cohn is directed to a polypropylene block copolymer for use with 3D printing techniques to form a suture material (Cohn: para. [0198]-[0199]). Cohn teaches that its polymer can be manipulated easily to form a great variety of articles for medical purposes (Cohn: para. [0006]). Furthermore, the material of Cohn has a high degree of crystallinity, which results in a reduced degree of degradation (Cohn: para. [0006]-[0010]). Coward and Cohn are analogous art in that they are related to the same field of endeavor of 3D printed biomaterials. A person of ordinary skill would have found it obvious to have selected the polypropylene block copolymer of Cohn for the filler material of Coward in order to provide easier manipulation during manufacture and reduce the degree of degradation of the formed product (Cohn: para. [0006]-[0010]).
With regards to claim 14, the polypropylene block copolymer of Crohn has a molecular weight of 1,000 to 3,000 Daltons or more, or further, 5 million Daltons or more (i.e., effectively, 1,000 or more Daltons). A person of ordinary skill would have found it obvious to have selected the polypropylene block copolymer of Cohn for the filler material of Coward (i.e., the polypropylene block copolymer having a molecular weight as taught by Cohn) in order to provide easier manipulation during manufacture and reduce the degree of degradation of the formed product (Cohn: para. [0006]-[0010]). With regards to the claimed glass transition temperature, Cohn teaches that the glass transition temperature of its polymer can be set by controlling the lengths of the individual blocks within the polymer, and further, that its glass transition temperature should be “very low” (Cohn: para. [0321]). Therefore, a person of ordinary skill in the art would have found it obvious to have optimized the glass transition temperature of the polymer of Cohn, and in addition, a person of ordinary skill would have tended toward the claimed range as Cohn desires the glass transition temperature of its polymer to be as low as possible (Cohn: para. [0321]).
With regards to claim 15, the non-curable polymeric material is a polypropylene glycol block copolymer (see above discussion). A person of ordinary skill would have found it obvious to have selected the polypropylene block copolymer of Cohn for the filler material of Coward in order to provide easier manipulation during manufacture and reduce the degree of degradation of the formed product (Cohn: para. [0006]-[0010]).
With regards to claim 16, Coward discloses its formulation as including 20% by weight filler and 80% by weight polydimethyl siloxane (PDMS), which corresponds to a weight ratio of 4:1 (i.e., given 80:20, (80/20):(20/20) = 4:1) (Coward: para. [0078]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Coward as applied to claim 1 above.
With regards to claim 17, Coward discloses a prosthesis as applied to claim 1 above (see above discussion). Coward notes that the amount of filler ranges from about 10 to about 30 wt%, and further, the composition includes up to about 5 wt% thixotropic agent and up to 12.5 wt % crosslinking agent, which leads to a corresponding amount of curable polymer (i.e., curable material, note that the crosslinking agent need not be the curable material of the claims due to the “comprising” language of the claim) of about 52.5 wt % to about 90 wt% (i.e., 100 – 30 – 5 – 12.5 = 52.5; 100 – 10 = 90) (Coward: para. [0033]-[0035]). This range overlaps the claimed range of from 55 to 70 wt%, thereby establishing a prima facie case of obviousness. See MPEP 2144.05.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Coward as applied to claim 1 above, and in further view of Angeli (WO2017096263A1).
With regards to claim 18, Coward discloses a prosthesis as applied to claim 1 above (see above discussion). However, Coward does not appear to disclose whether the curable polymer used to form its prosthesis is mono-functional or multi-functional, nor does Coward disclose specific molecular weight ranges of mono-functional or multi-functional material.
Angeli is directed to a crosslinkable polymer for 3D printing of soft articles having complex shapes which correspond to geometries of tissues or other biological structures, the crosslinkable polymer having one or more dormant functional groups (i.e., functional groups) (Angeli: page 5, lines 14-20; page 28, lines 25-30). Angeli teaches improving the stability of its printed article via adjusting the crosslinking density of the polymer, which is controlled by the number of functional groups within the polymer (Angeli: page 1, lines 9-14; page 15, lines 5-20). According to Angeli, the Young’s modulus of its polymer may be directly set by varying such crosslinking density (Angeli: page 15, lines 5-20). It is submitted that Coward would appreciate the ability to control Young’s modulus, as Coward advocates for controlling the mechanical properties of its printed prosthesis depending on its design requirements (See above discussion). Angeli further teaches that its polymer may be in the form of PDMS (i.e., which is the same as the curable polymer of Coward) (Angeli: page 12, lines 29-31). Coward and Angeli are analogous art in that they are related to the same field of endeavor of 3D printed PDMS articles for soft prostheses. A person of ordinary skill in the art would have found it obvious to have adjusted the degree of functionality (i.e., to select either mono-functional PDMS, multi-functional PDMS, or both), and to have optimized the relative amounts of mono-functional PDMS and/or multi-functional PDMS, in order to achieve mechanical properties consistent with the formation of a 3D printed prosthesis (Angeli: page 1, lines 9-14; page 15, lines 5-20).
With regards to claim 19, Angeli teaches selection the selection of mono-functional and/or multi-functional PDMS having a glass transition temperature of below 250⁰C in order to facilitate printing and the formation of a stable product (Angeli: page 15, line 21 through to page 16, line 4). This range overlaps the claimed range of less than -10⁰C, thereby establishing a prima facie case of obviousness. See MPEP 2144.05.
With regards to claim 20, Angeli teaches selection the selection of mono-functional and/or multi-functional PDMS having a glass transition temperature of below 250⁰C in order to facilitate printing and the formation of a stable product (Angeli: page 15, line 21 through to page 16, line 4). This range overlaps the claimed range of less than -10⁰C, thereby establishing a prima facie case of obviousness. See MPEP 2144.05.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. US12,528,244B2. Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap in scope.
Claim 1 of the ‘244 patent includes each of the limitations of claims 1, 4-5, and 13 of the present application. The only differences are the recitation of a Tear Resistance of from about 150 N/m to about 500 N/m, a formulation comprising photocurable materials, and that the voxels of an additional material which is a hardened from of an elastomeric curable formulation are characterized by a Tear Resistance of at least 4,000 N/m. However, col. 33, lines 12-24 of the ‘244 patent defines the claimed curable material as a photopolymerizable (i.e., photocurable) material, specifically. In addition, claims 6-20 of the present application describe compositions for the voxels of material and voxels of additional material which are substantially identical to those of the claimed invention. A composition and its properties have been held to be inseparable, per MPEP 2112. Therefore, the composition according to the claims of the present application is expected to possess the claimed tear resistances. Furthermore, that claim 1 of the ‘244 patent recites tear resistances, but the later claims further describe narrower, specific compositions achieving the claimed tear resistances, then as best understood, the later claims of the ‘244 patent describe a specific composition capable of the claimed tear resistances (and said later claims are the same as the claims of the present application).
Claims 2-3 of the ‘244 patent are identical to claims 2-3 of the present application.
Claims 4-18 of the ‘244 patent are identical to claims 6-20 of the present application, respectively.
Examiner’s Note
Claims 4-12 include subject matter which is distinguishable over the prior art of record. Presuming the issues of Double Patenting are overcome, claims 4-12 would subsequently be found allowable.
The following is a statement of reasons for the indication of subject matter distinguishing over the prior art of record:
The closest prior art of record are Coward et al and Bernal (US2016/0372011A1).
As also noted in parent Application No. 18/087,851 (i.e., corresponding to U.S. Patent No. US12,528,244B2), Coward fails to disclose a 3D printed anatomical prosthesis comprising voxels of material which are a hardened form of an elastic curable formulation. Bernal is directed to a synthetic eye module formed by 3D printing a mixture of an elastic and a rigid material. However, Bernal fails to provide adequate reason for the incorporation of a hardened form of an elastic curable formulation, and in particular, reason to combine with voxels of a material having the claimed hardness values.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ETHAN WEYDEMEYER whose telephone number is (571)270-1907. The examiner can normally be reached Monday - Friday 8:30 - 5:00.
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, Maria V. Ewald can be reached on (571) 272-8519. 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.
/ETHAN WEYDEMEYER/
Examiner, Art Unit 1783
Prosecution Insights