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 .
DETAILED ACTION
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, 3, 4, 6 and 8-10 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification as originally filed does not support the fabrication of a “rigid mold while simultaneously filling said mold with a heat curable polymer”. No portion of the original specification discloses the mold as “rigid”. Additionally, the claim now requires the fabrication of the mold while simultaneously filling said mold. The original specification only required the fabrication of a portion of rigid mold while simultaneously filling. The specification is limited to filling while fabrication a portion of the mold, rather than the mold.
In claim 6, there is no support for the limitation reciting “filling of said rigid mold is performed using a heated polymer-delivery nozzle”. The specification only supports “heating said heat curable polymer” (original step (c)) with the heated polymer-delivery nozzle.
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.
Claims 1, 3, 4, 6 and 8-10 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites fabricating “a rigid mold while simultaneously filling said mold with a heat curable polymer”. It is not clear how simultaneous filling can occur when the mold is fabricated. Because the applicant has removed the previously required iterative steps (previously claimed step (d)), it’s unclear how simultaneously filling while manufacturing is performed.
Claim 3 recites “medical grade silicone”. The limitation is unclear because neither the claim nor the specification provide objective boundaries for determining what constitutes “medical grade”. For the purposes of this examination, any heat curable polymer that is capable of being used in any medical context meets the limitation.
Claim Rejections - 35 USC § 102
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 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4, 6 and 8-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okamoto (US 2015/0190964).
As to claim 1, Okamoto discloses a method of fabricating an object 10 comprising: (a) using additive manufacturing to fabricate a rigid (para 71-75) mold 12 (para 60-66) while simultaneously filling said mold with a heat curable polymer 11 (figs 1a-h, para 56, 81, para 136, 233-235); ; (b) heating said heat curable polymer (para 76) during and/or following (a) thereby fabricating the object (para 52-136, 233-235, figs 1a-g),
As to claim 4, Okamoto discloses the object is a medical implant (para 313)
As to claim 6, Okamoto discloses filling of said rigid mold is performed using a heated polymer-delivery nozzle (para 113-116, fig 3)
As to claim 8, Okamoto disclose said mold is manufactured from a dissolvable material (para 85-86)
As to claim 9, Okamoto disclose said dissolvable material can be High Impact Polystyrene (HIPS) or Polyvinyl Alcohol (PVA) or any other dissolvable element (para 85-86, 260)
As to claim 10, Okamoto discloses the methos wherein said additive manufacturing and filling are performed using side-by-side print nozzles (para 11-120, fig 3, both discharge unit same structure).
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.
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okamoto (US 2015/0190964).
Okamoto discloses the heat curable polymer is silicone (para 235)
Okamoto does not expressly disclose the heat curable polymer is capable of use in a medical device. However, Okamoto discloses the object can be a medical implant (para 313). As such, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, for the silicone heat curable polymer to be medical grade, wherein said heat curable polymer is still capable of medical use after curing and fabricating the object as such is required by the design incentives and market forces for success of the medical implant.
Response to Arguments
Applicant's arguments filed 7/20/26 have been fully considered but they are not persuasive. Applicant asserts Okamoto prints and cures the object and mold (referred to by applicant as the shell) at each step. P. 5 Remarks. Applicant then asserts that Okamoto does not meet the amended claims because said claims require formation of the rigid mold into which the curable polymer is cast and separately cured. Applicant further asserts the claims exclude co-curing and co-printing as disclosed by Okamoto. These arguments are not persuasive for several reasons. First, the arguments are not commensurate with the scope of claims. The claims do not require separately printing (i.e. not co-printing) and separately curing the mold and the polymer. Rather, the claims require fabricating the rigid mold “while simultaneously filling said mold with a heat curable polymer”. This is a co-printing because the fabricating and printing occur simultaneously.
Applicant asserts claim 1 clarifies “the printed mold is rigid, i.e., it is printed using a molten (at the nozzle) material (e.g., claim 9) that self-rigidifies at the printing bed and as such, the mold is not co-cured with the object as is the case with Okamoto.” These asserts are not commensurate with scope of claims. The claims do not recite any of the following: a molten material; self-rigidifying; a printing bed; and “not co-curing”. Applicant does not have support to claim “rigid”. Contrary to applicant’s assertion on p. 5, the claims do not recite “bubble evacuation”. Applicant then asserts the claimed invention requires that the ”mold is gradually printed and filled”. This argument is contrary to the previous arguments that the mold is separately fabricated then filled. Finally, applicant’s assertion that the “claimed invention enables the use of multiple materials or multiple densities of a single material” is not commensurate with the scope of the claims as the claims do not require such.
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 CHRISTOPHER T SCHATZ whose telephone number is (571)272-6038. The examiner can normally be reached Monday through Friday, 9-6.
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 Orlando can be reached at 571-270-5038. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER T SCHATZ/Primary Examiner, Art Unit 1746
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