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 .
Status of Claims
Claims 1-45 are pending in the present application and are examined on the merits.
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: drive mechanism in claims 1, and 28 (the term “mechanism” being a generic placeholder and “drive” being the function) and the sliding seal element in claims 1-3, 5-6, 19, 31, and 35 (the term “element” being a generic placeholder and “sliding” and “seal” both being the function).
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.
In the instant case, the drive mechanism is interpreted as a motor-driven cam, as described in ¶ 6 of Applicant’s specification, as well as all known equivalents.
Additionally, the sliding seal element is interpreted as o-rings, quad-rings, or other toroidal seals, as described in ¶s 92, 94, and 105 of Applicant’s specification, as well as all known equivalents.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,161,585. Although the claims at issue are not identical, they are not patentably distinct from each other because although claim 1 recites a lower end region, this appears to be a portion of the manifold of U.S. Patent No. 12,161,585, and thus would be met by the same limitations. The instant application also recites additional limitations not found in U.S. Patent No. 12,161,585, but these limitations are largely functional.
Further, claim 1 of the instant application recites specifically “delivering the therapeutic agent as a horizontal stream of microdroplets to a corneal surface of an eye” in the preamble, the lower end region being “moveably engaged with the drive spool forming a variable volume, the sliding seal element being “sized and shaped to form a seal within the inner bore”, and the inner bore “breaks the seal between the sliding seal element and the inner bore allowing the variable volume space to be in fluid communication with the internal volume of the fluid container for receiving the dose of the plurality of doses within the fluid container”.
These limitations are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, device of U.S. Patent No. 12,161,585 has all the structure of the instant device as claimed. As such, it would appear capable of meeting the additional functional limitations of the instant application. Further, many of these additional functional limitations are found in the dependent claims of U.S. Patent No. 12,161,585, particularly in dependent claims 2 and 47.
In addition, claim 1 (and thus claim 12) recites a reservoir manifold, the inner bore having first and second inner diameters, the inner bore being separated from the internal volume, and that the fluid cartridge is disposable. The claims of the present application are more generic than the patented claims and are therefore anticipated. The patented claims present the species, while the claims of the current application present a genus. In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993).
Further, the additional limitations of the reservoir manifold, inner bore diameters, inner bore being separated, and the fluid cartridge being disposable are found in respectively in dependent claims 7, 4, 8, and 43 of the instant Application.
Additionally, all the limitations of the instant claims below are found in the corresponding claims of U.S. Patent No. 12,161,585.
Double Patenting
Corresponding Claims
Instant Application
Claim 1
Claim 4
Claim 7
Claim 8
Claim 9
Claim 12
U.S. Patent No. 12,161,585
Claims 1, 2
Claim 1
Claim 1
Claim 1
Claim 10
Claim 11
Double Patenting
Corresponding Claims
Instant Application
Claim 13
Claim 14
Claim 15
Claim 16
Claim 17
Claim 24
U.S. Patent No. 12,161,585
Claims 3
Claim 3
Claim 7
Claim 8
Claim 9
Claim 5
Double Patenting
Corresponding Claims
Instant Application
Claim 25
Claim 28
Claim 43
Claim 44
Claim 45
U.S. Patent No. 12,161,585
Claims 6
Claim 14
Claim 1
Claim 20
Claim 21
Allowable Subject Matter
Claims 2-3, 5-6, 10-11, 18-23, 26-27, and 29-42 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Additionally claim 1 recites allowable subject matter if the above double patenting rejection were to be overcome.
Reasons for Allowable Subject Matter
The following is an examiner’s statement of reasons for indicating allowable subject matter:
The closest prior art drawn to Wilkerson et al. (US 2017/0136484 A1), fails to show or make obvious the claimed combination of elements, particularly the limitations as set for in claims 1, 22, and 42, which recites features not taught or suggested by the prior art.
With respect to independent claim 1, Wilkerson does disclose a device for delivering a volume of fluid using a reservoir, but does not explicitly disclose an active pump comprising a drive spool slidingly positioned within an inner bore and comprising a sliding seal element; and a floating spool movably coupled to the drive spool and slidingly positioned within the inner bore and comprising a second sliding seal element.
Batista et al. (US 2023/0239968 A1) does teach using driving and floating spools. However, Batista uses said spools to advance forward, and gradually push fluid out fluid from the reservoir. Batista does not disclose the spools having a sliding seal element that is sized and shaped to form a seal with the inner bore and wherein driving the floating spool so the sliding seal element is located within the inlet region of the inner bore breaks the sea, between the sliding seal element and the inner bore allowing the variable volume space to be in fluid communication with the internal volume.
While prior art references such as Oyama et al. (US 8,696,072 B2) and Foster (US 5,103,866) disclose similar mechanisms described as “poppet valves”, such references differ in the field of endeavor.
More applicable prior art, such as Ciavarella et al. (US 2014/0261799 A1) do teach the use of poppet valves in the art of dispensers, but only recites such limitations at a high degree of generality.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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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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/ALESSANDRO R DEL PRIORE/ Examiner, Art Unit 3781
/GUY K TOWNSEND/ Primary Examiner, Art Unit 3781
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