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 8 is objected to because of the following informalities:
---Claim 8 recites the following:
Claim 8. The connector of claim 6, wherein with the actuator in the second position, the plug is spaced apart from the first end opening of the lumen positioned at the end of the extension tip, and the second protrusion contacts and engages the split septum to force the split septum into an open position, such that the first valve member and the second valve member open the lumen to the external environment.
Notice that there is insufficient antecedent basis for the claim limitations of “the first end opening of the lumen” and “the end of the extension tip”. As such, the applicant should amend claim 8 to provide proper antecedent basis for these limitations by changing the definite article “the” in the above highlighted limitations to use the indefinite article “a” or “an” as appropriate.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 2-7, 10-15 and 17 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-7, 10-15 of prior U.S. Patent Feith US-12151078. This is a statutory double patenting rejection.
Notice that dependent claims 2 and 17 of the application mirrors all the limitations of independent claims 1 and 15 of the patent, respectively. Similarly, claims 3-4 of the application mirrors all the limitations of claims 2-3 of the patent, respectively; claims 5-7 of the application mirrors all the limitations of claims 5-7 of the patent, respectively; claim 10 of the application mirrors all the limitations of claim 4 of the patent; and claims 11-15 of the application mirrors all the limitations of claims 10-14 of the patent, respectively.
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, 8-9, 16 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-9, 15-16, 18 and 20 of U.S. Patent Feith US-12151078.
Although the claims at issue are not identical, they are not patentably distinct from each other because the device of the claims of the patent either explicitly or implicitly anticipates all the limitations of the present application and/or any missing structure or detail would be obvious over the cited prior art. Notice that independent claims 1 and 16 of the application broadly mirrors those of independent claims 1 and 15 of the patent with the patent claiming in greater detail the actuator whereas the application only broadly claims the actuator (see claims 2 and 17 of the application which mirrors claims 1 and 15 of the patent and as such are being rejected under statutory double patenting rejections). Similarly, claims 8-9 of the application broadly mirrors the limitations found in claims 8-9 of the patent, respectively; claim 18 of the application broadly mirrors the limitations found in claim 16 of the patent; claim 19 of the application broadly mirrors the limitations found in claim 18 of the patent; and claim 20 of the application broadly mirrors the limitations found in claim 20 of the patent. Following the rationale in In re Goodman cited in the preceding paragraph, where the applicant has once been granted a patent containing a claim for the specific or narrower invention, the applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Note that since the claims of the application are anticipated by the claims of the patent and since anticipation is the epitome of obviousness, then the claims of the application are obvious over the claims of the patent.
Conclusion
The prior/relevant art made of record and considered pertinent to applicant's disclosure:
---References A (Medical connector systems): Call US-11504517, Faden US-11065433, Stjernbeg Bejhed US-10518078, Browne US-9345828 and Watanabe US-5259843.
---References B (Valved medical connectors/Needle Free Valves): Putter US-11491317, Chih US-10806666, Yang US-10478606, Fangrow US-9933094, Chen US-9855412, Stroup US-9849277, Pan US-8277424, Whitley US-7645274, Korogi US-7559530, Baldwin US-7396051, Doyle US-6964406, Leinsing US-6706022, Leinsing US-5676346, Challender US-5492147, Zeytoonian US-9138572, Fangrow US-8647310, Fangrow US-7803140, Doyle US-20050087715.
---References C (Breakaway medical couplings): Mansour US-11708924, Ueda US-11491084, Kakinoki US-11207514, Jones US-10864362, Jones US-10655768, Dennis US-9861805, Fangrow US-7998134, Erskine US-5820614 and Memelshtein WO-2019171371.
---Reference D (Double Patenting): Feith US-12151078.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID COLON-MORALES, whose telephone number 571-270-1741 and fax number is 571-270-2741. If the applicant has authorized internet communications via the filling of form PTO/SB/439, the examiner can be reached via email at david.colon-morales@uspto.gov , email communication is not permitted if the applicant has not filed an authorization for internet communication (see MPEP 502.03 for more details on internet communications). The examiner can normally be reached on Monday-Friday (7:30AM-3:30PM EST).
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/DAVID COLON-MORALES/Primary Examiner, Art Unit 3753