DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s preliminary amendment filed 11/19/2024, is acknowledged. Claims 1-15 are cancelled. Claims 16-33 are new and pending.
Claim Rejections - 35 USC § 112
Claims 24, 26-27, 29-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for surface alteration utilizing a solution of a nano-roughing agent, the specification does not reasonably provide enablement for surface alteration by other means such with the use of laser. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Chen et al., Bioengineering Conference, 2009 IEEE 35th Annual Northeast, IEEE, Piscataway NJ, April 3, 2009, pp. 1-2.
Regarding claims 16 and 24, Cheng et al. teaches the formation of nano surfaces on polyvinyl chloride endotracheal tubes using bacterial lipase solutions (current claims 18, 28 and 30). Cheng et al. teaches that "[t]his nano scale etching is thought to be able to reduce bacterial adhesion, preventing infection". See "Conclusion" at page 2. The etching was in the form of uniform lines. See page 2. This would imply valleys or slopes.
Regarding claims 19, 22-23 and 31-32, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claims 20-21 and 32-33, Cheng et al. teaches that "[t]his nano scale etching is thought to be able to reduce bacterial adhesion, preventing infection". See "Conclusion" at page 2. If the bacterial adhesion is reduced, it would be implied that proliferation and colonization of bacterial cells would be inhibited. Moreover, granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in or obviousness from the prior art. Here, Cheng et al. already teaches inhibiting adherence of bacterial cells. Thus, the composition of Cheng et al. would naturally inhibit proliferation or colonization of bacterial cells . See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (“when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated.”)
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 16-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 10,493,793. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims describe an obvious variety of the subject matter claimed in the '793 patent. For instance, both sets of claims are directed to an anti-bacterial substrate comprising a substrate and a polymer substrate having a nanoscale surface geometry sufficient to inhibit adherence of bacterial cells to the polymer substrate surface.
Claims 24-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,138,952. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims describe an obvious variety of the subject matter claimed in the '952 patent. For instance, both sets of claims are directed to an anti-bacterial substrate comprising a substrate and a polymer substrate having a nanoscale surface geometry sufficient to inhibit adherence of bacterial cells to the polymer substrate surface.
Claims 24, 26-28 and 30-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11,560,014. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims describe an obvious variety of the subject matter claimed in the 014 patent. For instance, both sets of claims are directed to an anti-bacterial substrate comprising a substrate and a polymer substrate having a nanoscale surface geometry sufficient to inhibit adherence of bacterial cells to the polymer substrate surface.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT S CABRAL/Primary Examiner, Art Unit 1614
