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
Applicant’s election without traverse of Species A (claims 21-23 and 28-30) in the reply filed on 03/10/2026 is acknowledged.
Claims 24-27 and 31-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/10/2026.
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 10/23/2023, has been considered by the examiner.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “coupling device” in claims 21 and 28.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21, 28, and 29, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yap et al. (USPN 6,817,990).
[Claim 21] Yap teaches a device (figure 4, item 401) for delivering fluid to a user (abstract), the device (figure 4, item 401) comprising:
a fluid reservoir (figure 4, item 406) for holding the fluid, the fluid reservoir (figure 4, item 406) defining an internal volume (figure 4) and a stopper (figure 4, item 407) positioned in the internal volume of the fluid reservoir (figure 4, item 406), wherein the stopper (figure 4, item 407) is formed with a cavity (“threaded cavity”) (column 7, lines 20-43);
a piston (figure 4, item 405) having a distal end received within the cavity of the stopper (figure 4, item 407) (figure 4);
an actuator (figure 4, item 403) coupled to the piston (figure 4, item 405) for driving the piston (figure 4, item 405) into the internal volume of the fluid reservoir (figure 4, item 406) (column 7, lines 53-57); and
a coupling device (figure 4, items 424/426) coupled to the stopper (figure 4, item 407) and the piston (figure 4, item 405) and configured to prevent axial separation of the stopper (figure 4, item 407) from the piston (figure 4, item 405) (column 7, lines 34-43).
[Claim 28] Yap teaches the limitations of claim 21, upon which claim 28 depends. In addition, Yap discloses the coupling device (figure 4, items 424/426) is configured to prevent the stopper (figure 4, item 407) from slipping or reducing, in an uncontrolled manner, a volume of the fluid in the fluid reservoir (figure 4, item 406) by preventing the axial separation of the stopper (figure 4, item 407) from the piston (figure 4, item 405) (column 7, lines 34-43; column 10, lines 58-67).
[Claim 29] Yap teaches a device (figure 4, item 401) for detecting whether a fluid delivery device stopper (figure 4, item 407) (the examiner notes the “fluid delivery device stopper” is not a positively recited claim structure) is correctly positioned, the device (figure 4, item 401) comprising:
a fluid reservoir (figure 4, item 406) for holding fluid, the fluid reservoir (figure 4, item 406) defining an internal volume (figure 4), wherein the fluid delivery device stopper (figure 4, item 407) is formed with a cavity (“threaded cavity”) (column 7, lines 20-43);
a piston (figure 4, item 405) having a distal end received within the cavity of the fluid delivery device stopper (figure 4, item 407) (figure 4); and
a sensor (“encoder”) configured to generate information indicative of whether there is axial separation of the fluid delivery device stopper (figure 4, item 407) from the piston (figure 4, item 405) (the examiner notes that the functional limitation of “information indicative of whether there is axial separation” does not require a measurement; as such, the “monitoring the number of motor rotations” is considered to be “information indicative” of axial separation) (column 8, lines 43-48).
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 22, 23, and 30, are rejected under 35 U.S.C. 103 as being unpatentable over Yap et al. (USPN 6,817,990), in view of Tong et al. (PGPub 2021/0196935).
[Claim 22] Yap teaches the limitations of claim 21, upon which claim 22 depends. Although disclosing the coupling device (figure 4, items 424/426) comprises a first component (figure 4, item 424) mounted to the stopper (figure 4, item 407) and a second component (figure 4, item 426) mounted to the piston (figure 4, item 405), which are configured to engage the piston (figure 4, item 405) in the cavity of the stopper (figure 4, item 407) at a desired position to prevent the axial separation of the stopper (figure 4, item 407) from the piston (figure 4, item 405) (column 7, lines 34-43; column 10, lines 58-67), Yap does not specifically disclose the coupling device is magnetic.
However, Tong teaches a fluid delivery device (figure 8, item 210) comprising a magnet coupling device (figure 8, item 292) for connection of two parts (paragraph 0054]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the coupling device taught by Yap, with the use of a magnetic coupling device, as taught by Tong, in order to provide increased functionality and versatility, by allowing for an alternative means of achieving the same result of coupling the piston and the stopper.
[Claim 23] Yap and Tong teach the limitations of claim 22, upon which claim 23 depends. Although teaching a sensor (“encoder”), coupled to at least one of the first component (figure 4, item 424) or the second component (figure 4, item 426), for determining whether the piston (figure 4, item 405) is engaged in the cavity of the stopper (figure 4, item 407) at a desired position (column 8, lines 43-48), Yap does not specifically disclose the sensor is configured to detect magnetic field strength.
However, Tong teaches a fluid delivery device (figure 8, item 210) comprising a sensor (figure 8, item 290) configured to detect magnetic field strength to generate information indicative of whether there is the axial separation of the fluid delivery device stopper from the piston (Tong teaches the use of a magnetoresistive switch, reed switch, or Hall sensor) (the examiner notes that the functional limitation of “information indicative of whether there is axial separation” does not require a measurement; as such, the detecting connection between two parts is considered to be “information indicative” of axial separation) (paragraph [0054]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the sensor taught by Yap, with the use of a magnetic sensitive sensor, as taught by Tong, in order to provide increased functionality and versatility, by allowing for an alternative, yet equivalent, means of monitoring the relative position of device components.
[Claim 30] Yap teaches the limitations of claim 29, upon which claim 30 depends. Although teaching a sensor (“encoder”) for generating information indicative of whether there is axial separation of the fluid delivery device stopper (figure 4, item 407) from the piston (figure 4, item 405) (column 8, lines 43-48), Yap does not specifically disclose the sensor is configured to detect magnetic field strength.
However, Tong teaches a fluid delivery device (figure 8, item 210) comprising a sensor (figure 8, item 290) configured to detect magnetic field strength to generate information indicative of whether there is the axial separation of the fluid delivery device stopper from the piston (Tong teaches the use of a magnetoresistive switch, reed switch, or Hall sensor) (again, the examiner notes that the functional limitation of “information indicative of whether there is axial separation” does not require a measurement; as such, the detecting connection between two parts is considered to be “information indicative” of axial separation) (paragraph [0054]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the sensor taught by Yap, with the use of a magnetic sensitive sensor, as taught by Tong, in order to provide increased functionality and versatility, by allowing for an alternative, yet equivalent, means of monitoring the relative position of device components.
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 21-23 and 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 10-12 of U.S. Patent No. 11,724,045. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the elements of the recited instant application claims are found in the recited patent claims. For example, all of the elements of claim 21 of the instant application can be found in claim 1 of the patent. The difference between claim 21 of the instant application and claim 1 of the patent lies in the fact that the patent claim includes more elements and is thus more specific. Thus, the invention of claim 1 of the patent is in effect a “species” of the "generic” invention of claim 21 of the instant application. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 21 of the instant application is anticipated by claim 1 of the patent, it is not patentably distinct from claim 1 of the patent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 03/27/2026
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