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 .
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. Currently, no claim limitation is being interpreted as invoking 35 U.S.C. 112(f).
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 1-17 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 limitation “the locked position” in line 6. There is insufficient antecedent basis for this limitation in the claim. Line 4 of claim 1 recites “a locked configuration” and it appears that the locked position refers to the locked configuration, but consistent terminology must be used. Further, it appears that “an unlocked configuration” in line 7 should be “the unlocked configuration” referring back to “an unlocked configuration” as recited in line 4. Claims 2-17 are rejected based on their dependence from claim 1.
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 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,702,233 (the ‘233 patent) in view of US Patent Application Publication 2011/0186177 to Lanier, Jr. et al. (Lanier). Although the claims at issue are not identical, they are not patentably distinct from each other because all of the limitations of claims 1-17 are recited by the ‘233 patent except for the filling aid having a window which is aligned with the septum in the unlocked configuration and is not aligned with the septum in the locked configuration. However, Lanier teaches a filling method which includes a rotatable shutter assembly (184) having a window (190) which moves between a position blocking access to a septum (146) and a position unblocking the septum in which the window is aligned with the septum (see [0222] and Figs. 7A-7B). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a window in the filling aid of claim 1 of the ‘233 patent as taught by Lanier such that the septum is sealed off prior to unlocking access thereto to reduce the chance of contaminates reaching the septum. Claims 1 and 2 correspond to claim 1 of the ‘233 patent as modified by Lanier. Claims 3 and 4 correspond to claim 4 of the ‘233 patent. Claim 5 corresponds to claim 3 of the ‘233 patent. Claims 6 and 7 correspond to claim 5 of the ‘233 patent. Claim 8 corresponds to claim 6 of the ‘233 patent. Claims 9 and 10 correspond to claim 8 of the ‘233 patent. Claim 11 and 12 correspond to claim 10 of the ‘233 patent. Claim 13 and 14 correspond to claim 13 of the ’233 patent. Claims 15 and 16 correspond to claims 14 and 15 of the ‘233 patent, respectively. Claim 17 corresponds to claim 17 of the ‘233 patent.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12,179,949 (the ‘949 patent) in view of US Patent Application Publication 2011/0186177 to Lanier, Jr. et al. (Lanier). Although the claims at issue are not identical, they are not patentably distinct from each other because all of the limitations of claims 1-2 are recited by the ‘949 patent except for the filling aid having a window which is aligned with the septum in the unlocked configuration and is not aligned with the septum in the locked configuration. However, Lanier teaches a filling method which includes a rotatable shutter assembly (184) having a window (190) which moves between a position blocking access to a septum (146) and a position unblocking the septum in which the window is aligned with the septum (see [0222] and Figs. 7A-7B). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a window in the filling aid of claim 7 of the ‘949 patent as taught by Lanier such that the septum is sealed off prior to unlocking access thereto to reduce the chance of contaminates reaching the septum. Further, regarding claims 3 and 4, the ‘949 patent does not recite removing the disposable housing from the filling aid after priming or filling the disposable housing. However, the disposable housing is releasably attached to the filling aid and it would be obvious to one of ordinary skill in the art that to use the filling aid with a further disposable housing, the filled or primed disposable housing must be removed from the filling aid.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and claimed invention.
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/NICOLAS A ARNETT/Primary Examiner, Art Unit 3753 December 17, 2025