DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 14-18, in the reply filed on June 4, 2026 is acknowledged.
Claim Objections
Claim 14 is objected to because of the following informalities: “a reservoir” should be “the reservoir” in line 2. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: “slidable connected” should be “slidably connected” in line 4. Appropriate correction is required.
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.
Claim 18 is 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 18 recites the limitation "the filling needle cradle" in line 1. There is insufficient antecedent basis for this limitation in the claim. Further, claim 15 includes “a filling needle cradle” and it is unclear whether claim 18 should depend from claim 15 and not claim 14.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 14-15 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Lanigan et al. (US 2010/0198182).
Regarding claim 14, Lanigan discloses a system for filling a reservoir (see Fig. 181) comprising: a disposable housing assembly 804 comprising a reservoir 904 (see Figs. 48-49C, 181); a fill adapter 2714, 2718, 2702, 2704, 2736, 2738, 2742 for releasably engaging the disposable housing assembly (see Fig. 181), the fill adapter comprising a pump chamber plunger 2704; and a filling aid 2732 configured to releasably engage the fill adapter (see par. 451), wherein the pump chamber plunger actuates a pump chamber in the disposable housing assembly when the disposable housing assembly and the fill adapter are engaged (see par. 419, 440, 441, pump chamber containing reservoir).
Regarding claim 15, Lanigan discloses wherein the filling aid comprising: a needle housing portion 2734, including 2733a and 2733b, comprising at least one tab having a starting position and a filling position (see Figs. 181, tabs at bottom of 2733a and 2733b, allowing for starting position when handling needle housing portion to filling position in Fig. 182 when needle housing portion is attached to the fill adapter); and a filling needle cradle 2732a comprising a filling needle 2720, 2724, the filling needle cradle slidably connected to the needle housing portion (see Fig. 181, par. 455) and having a starting position and a filling position (see Fig. 181 and Fig. 182), wherein when the at least one tab on the needle housing moves from a starting position to a filling position, the filling needle cradle slides from a starting position to a filling position (see Figs. 181 and 182, as needle cradle is part of housing, when housing slides into place over adapter, needle cradle will do so as it is part of housing).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lanigan.
Regarding claim 16, Lanigan further discloses the fill adapter comprising: a housing 2714, 2738, 2742 (see Figs. 181 and 199A) having a cavity portion configured to attach to the disposable housing assembly (see Figs. 181 and 199A, cavity in which disposable housing assembly 804 is placed); a filling aid base 2736 connected to the housing configured to receive the filling aid (see Figs. 181-183 and 199B); and a button assembly actuator 2702 attached to the housing, the button assembly actuator comprising one or more button assemblies (see par. 441) but does not disclose the actuator springingly attached to the housing.
Lanigan discloses a different embodiment (see Fig. 198) having a button assembly actuator 2802 that includes button 2812 and spring 2814 and is springingly attached to the housing to help limit amount of force transferred to reservoir (see par. 468). It would have been obvious to a person before the time of invention to have the button assembly actuator be springingly attached as disclosed by Lanigan to help limit the force transferred to the reservoir.
Claims 17 and 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ranalletta et al. (US 2007/0215235).
Regarding claim 17, Lanigan discloses the system further comprising a filling vial 2716, the filling vial configured to connect to the filling aid (see Figs. 181-183) but does not disclose a filling syringe.
Ranalletta discloses a receptacle holding medicament can be in the form of vials, ampoules, syringes, bottles (see par. 33, 90, 185). Therefore, it would have been obvious to a person having ordinary skill in the art to have the filling vial be a filling syringe, as Ranalletta discloses such well known substitution and this would predictably result in a receptacle in the form of a syringe that could be connected with the system and used for filling.
Regarding claim 18, Lanigan discloses a filling needle cradle 2732a further comprising a connector for a filling vial 2716 (see Fig. 181-184, “connector” being broad and any part of the cradle that connects with the vial).
Ranalletta discloses a receptacle holding medicament can be in the form of vials, ampoules, syringes, bottles (see par. 33, 90, 185). Therefore, it would have been obvious to a person having ordinary skill in the art to have the filling vial be a filling syringe, as Ranalletta discloses such well known substitution and this would predictably result in a receptacle in the form of a syringe that could be connected with the system and used for filling.
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 14-15 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-3 of prior U.S. Patent No. 10,926,030, hereinafter ‘030. This is a statutory double patenting rejection.
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.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. ‘030.
Regarding claim 18, although the claims at issue are not identical, they are not patentably distinct from each other because claim 4 discloses all limitations required by claim 18.
Claims 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-11 of U.S. Patent No. 9,456,955, hereinafter ‘955.
Although the claims at issue are not identical, they are not patentably distinct from each other because the corresponding claims of the current application are disclosed by the corresponding claims of ‘955 as identified below:
Current claims
14
15
16
17
18
‘955 claims
8
9
8
10
11
Claims 14-15 and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 5-6 of U.S. Patent No. 12,128,006, hereinafter ‘006.
Although the claims at issue are not identical, they are not patentably distinct from each other because the corresponding claims of the current application are disclosed by the corresponding claims of ‘006 as identified below:
Current claims
14
15
17
18
‘006 claims
3
5
6
6
Claims 14-15 and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-4 and 6 of U.S. Patent No. 11,723,841, hereinafter ‘841.
Although the claims at issue are not identical, they are not patentably distinct from each other because the corresponding claims of the current application are disclosed by the corresponding claims of ‘841 as identified below:
Current claims
14
15
17
18
‘841 claims
3
4
6
6
Claims 14 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 10,105,286, hereinafter ‘286.
Although the claims at issue are not identical, they are not patentably distinct from each other because the corresponding claims of the current application are disclosed by the corresponding claims of ‘286 as identified below:
Current claims
14
17
‘286 claims
13
13
Claims 14 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11,701,300, hereinafter ‘300.
Although the claims at issue are not identical, they are not patentably distinct from each other because the corresponding claims of the current application are disclosed by the corresponding claims of ‘300 as identified below:
Current claims
14
17
‘300 claims
4
4
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11,524,151, hereinafter ‘151.
Although the claims at issue are not identical, they are not patentably distinct from each other because the corresponding claims of the current application are disclosed by the corresponding claims of ‘151 as identified below:
Current claims
14
‘300 claims
3
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA E EISENBERG can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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