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 .
Election/Restrictions
Claims 41 and 43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/18/26.
Applicant’s election without traverse of claims 42, 45-51 and 57-70 in the reply filed on 9/18/26 is acknowledged.
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 45-46, 50-51, 63-65 and 67-69 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.
Regarding claims 45 and 46, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 45 and 46 are duplicate claims.
Claim 50 recites the limitation "the dimensions," “the initial component,” and “the desired shape” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
The term “reduction” in claim 51 is a relative term which renders the claim indefinite. The term “reduction” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 63 recites the limitation "the component" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 64 recites the limitation "the component" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 65 recites the limitation "the body portion" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 67 recites the limitation to “to aid in detection” which indefinite because the term “aid” is not defined. How does one aid in detection?
The term “PVA” is not defined in claims 68 and 69.
Claim 68 recites the limitation “the PVA" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 69 contains the trademark/trade name Dacron. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a polyethylene terephthalate and, accordingly, the identification/description is indefinite.
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.
Claim(s) 42, 45-51 and 57-70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mannarino et al. (US 2018/0369454) in view of Lerner (US 2024/0075247).
Mannarino discloses an article, comprising: an elongated tube, wherein the elongated tube comprises a first material comprising a water-soluble polymer; the elongated tube comprising a first portion and a second portion, wherein one or more of the following holds: i) the first material has a Young's elastic modulus of greater than or equal to 500 MPa in a dehydrated state and a Young's elastic modulus of less than or equal to 300 MPa and greater than or equal to 5 MPa at an equilibrium water content state; ii) the first material is configured to swell in an amount greater than or equal to 5 w/w% and less than or equal to 50 w/w% from a dehydrated state to an equilibrium water content state in less than or equal to 60 minutes at 25 °C; iii) the first material is free of covalent crosslinks between the water-soluble polymer that forms the first material; and iv) the first material comprises pores that each have a diameter of 1 µm or less (paragraphs [0005-0012], [0015-0024], [0031-0037], [0145], [0151], [0241-0243], [0258], [0287-0290]).
Mannarino does not disclose wherein the first portion comprises a radius of curvature different than a radius of curvature of the second portion, in a relaxed state of the elongated tube.
Lerner discloses wherein the first portion comprises a radius of curvature different than a radius of curvature of the second portion, in a relaxed state of the elongated tube (paragraphs [0004], [0009], [0049] and Figs. 2 and 6) in a catheter for the purpose of providing reduced withdrawal resistance and improved blood flow.
Therefore it would have been obvious to one of ordinary skill in the art at the time applicant’s invention was made to have provided wherein the first portion comprises a radius of curvature different than a radius of curvature of the second portion, in a relaxed state of the elongated tube in Mannarino in order to provide reduced withdrawal resistance and improved blood flow as taught or suggested by Lerner.
Claims 47-49, in their entirety, recite method limitations which have been given little to no patentable weight since the method by which a product is made is not germane to the patentability of a product in a product claim (MPEP 2113).
The limitations recited in dependent claims 45-46, 50-51 and 57-70 are taught or suggested by Mannarino (paragraphs [0005-0012], [0015-0024], [0031-0037], [0145], [0151], [0241-0243], [0258], [0287-0290]).
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 42, 45-51 and 57-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 18/599,841 in view of Lerner (US 2024/0075247).
Claims 1-27 of copending Application No. 18/599,841 recite an article, comprising: an elongated tube, wherein the elongated tube comprises a first material comprising a water-soluble polymer; the elongated tube comprising a first portion and a second portion, wherein one or more of the following holds: i) the first material has a Young's elastic modulus of greater than or equal to 500 MPa in a dehydrated state and a Young's elastic modulus of less than or equal to 300 MPa and greater than or equal to 5 MPa at an equilibrium water content state; ii) the first material is configured to swell in an amount greater than or equal to 5 w/w% and less than or equal to 50 w/w% from a dehydrated state to an equilibrium water content state in less than or equal to 60 minutes at 25 °C; iii) the first material is free of covalent crosslinks between the water-soluble polymer that forms the first material; and iv) the first material comprises pores that each have a diameter of 1 µm or less.
Claims 1-27 of copending Application No. 18/599,841 does not disclose wherein the first portion comprises a radius of curvature different than a radius of curvature of the second portion, in a relaxed state of the elongated tube.
Lerner discloses wherein the first portion comprises a radius of curvature different than a radius of curvature of the second portion, in a relaxed state of the elongated tube (paragraphs [0004], [0009], [0049] and Figs. 2 and 6) in a catheter for the purpose of providing reduced withdrawal resistance and improved blood flow.
Therefore it would have been obvious to one of ordinary skill in the art at the time applicant’s invention was made to have provided wherein the first portion comprises a radius of curvature different than a radius of curvature of the second portion, in a relaxed state of the elongated tube in claims 1-27 of copending Application No. 18/599,841 in order to provide reduced withdrawal resistance and improved blood flow as taught or suggested by Lerner.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL C MIGGINS whose telephone number is (571)272-1494. The examiner can normally be reached Monday-Friday, 1-9 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Aaron Austin can be reached at 571-272-8935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL C MIGGINS/Primary Examiner, Art Unit 1782
MCM
October 8, 2026
