Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Claims 1-8 are currently pending and the claims as originally filed on 12/04/2023 are acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claims 4, 5 and 8 are not disclosed in the specification which lacks sufficient antecedent basis.
Objection
Claim 5 is objected to a minor informality.
Claim 5 recites “a continuous cumulated laminated flow” in line 2 , but which would be better to write “the continuous cumulated laminated flow”.
Appropriate correction is requested
Claim Rejections - 35 USC § 112
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 1-8 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 “the die” in line 4 and “the cross-section” in line 4, but which lacks sufficient antecedent basis.
Each of claims 2 and 6 recites “said one or more of the annular rings” in line 2 of claim 2 and line 1 of claim 6, but which lacks sufficient antecedent basis because base claim 1 does not recite “one or more annular rings”, and but rather recites “annular rings” in line 6 of claim 1 which embraces only two layers.
Claim 7 recites “the two or more of the annular rings” in line 1, but which lacks sufficient antecedent basis because base claim 1 does not recite “one or more annular rings”, and but rather recites “annular rings” in line 6 of claim 1.
The remaining claims are also rejected due to the rejection of base claim 1.
Appropriate correction is requested.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of patent no. 9381712B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both methods require combining at least two flow streams, subjecting the combined flow streams to repeated division and overlapping to form a continuous cumulated laminated flow within the die, extruding the said flow to produce an extracted multilayered polymer solid having annular rings with a micro or nanometer radial thickness (instant claim 1 and claim 1 of patent ‘712).
The difference between both claims is that the instant claims require medical device is implantable device having annular rings while the patent ‘712 recites tubular shape device. However, medical device type/shape varies depending on the intended uses and it is a matter of choice or design which a person of ordinary skill in the art would have found obvious absent evidence to the contrary. See MPEP 2144.05 IV. B
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘712.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of patent no. 10,195,114B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both methods require combining at least two flow streams, subjecting the combined flow streams to repeated division and overlapping to form a continuous cumulated laminated flow within the die, extruding the said flow to produce an extracted multilayered polymer solid having annular rings with a micro or nanometer radial thickness, and processing it into an implantable medical device (instant claim 1 and patent ‘114 claim 1), and both claims (instant claims 3-5 vs. patent claims 2-4) are the same.
The difference between both claims is that the instant claims require medical device is implantable device while the patent ‘114 recites medical device is pill. However, whether to further determine if medical device is pill varies depending on the intended uses and indeed it is a matter of choice or design.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘114.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of patent no. 10,695,267B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both methods require combining at least two flow streams, subjecting the combined flow streams to repeated division and overlapping to form a continuous cumulated laminated flow within the die, extruding the said flow to produce an extracted multilayered polymer solid having annular rings with a micro or nanometer radial thickness, and processing it into an implantable medical device (instant claim 1 and patent ‘114 claim 1), and both claims (instant claims 2-7 vs. patent claims 4-7 and 11) are the same.
The difference between both claims is that the instant claims require medical device is implantable device while the patent ‘267 recites medical device is tubular and stent. However, instant claim 1 embraces such medical device type/shape that varies depending on the intended uses and it is a matter of choice or design which a person of ordinary skill in the art would have found obvious absent evidence to the contrary. See MPEP 2144.05 IV. B. In this regard, the instant disclosure has medical device including stents.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘267.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of patent no. 11,850,212B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both methods require combining at least two flow streams, subjecting the combined flow streams to repeated division and overlapping to form a continuous cumulated laminated flow within the die, extruding the said flow to produce an extracted multilayered polymer solid having annular rings with a micro or nanometer radial thickness, and processing it into an implantable medical device (instant claim 1 and patent ‘114 claim 1), and both claims (instant claims 2-7 vs. patent claims 2-6 and 11) are the same.
The difference between both claims is that the patent ‘212 further recites laminations has micro or nanometer thickness. However, since the claimed extruded multilayered polymer solid having a cross-section of annular rings from the laminations has a micro or nanometer radial thickness, such micro or nanometer-size of laminations would be implicit.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘212.
Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US2010/0215879A1 (Dooley et al.)
Dooley discloses multilayer structures having annular profiles and method of making the same; the method comprises feeding the multilayer flow stream of thermoplastic resinous materials to annular die; splitting the multilayer flow stream into at least two flow streams; combining the multiple sub-streams in a stacking fashion and compressing, thereby forming a multilayer flow stream, and the multiple stacked sub-streams are fused to each other in an adjacent and a generally parallel relationship with one another in the multilayer flow stream which continuous cumulated laminate flow to produce an extruded multilayered solid via annular die, and within the multilayer flow stream, the multiple sub-streams exhibit uniformity, continuity, and thickness specifically calculated to provide a desired configuration having desired properties, and the layer multiplication process may yield multilayer flow streams that contain many layers, such as several hundred layers ([0051] and claim 1 of prior art), and the multilayer structures is called as “microlayer” structure ([0052]), and the multilayer structure has annular film structure having a thickness of at least about 7 micrometers ([0089]); and the structures have improved barrier properties when the polymer has unique crystalline morphology ([0021], [0031] and [0126]); the multilayer flow streams is typically provided from a multilayer coextrusion process step ([0045]-[0047]); and the method further comprises providing a multilayer flow stream formed by dividing a multilayer flow stream containing the thermoplastic resinous materials into first, second, and optionally other sub-streams through an extruder (i.e., by extrusion) ([0046] and [0051]). However, Dooley does not teach processing polymer solid into a medical implantable device.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613