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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: closed base 22. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The amendment filed 27 Sep 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the incorporation by reference of the international patent application PCT/EP2023/054806 and of the foreign patent application GB 2204727.8 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 27 Feb 2023, see MPEP 1893.03(b). Therefore the specification amendment of 27 Sep 2024 to include the incorporation by reference is new matter, per MPEP 608.01(p).
Applicant is required to cancel the new matter in the reply to this Office Action.
The disclosure is objected to because of the following informalities:
Pg. 13, Ln. 18 reads “flexible arms 34” which should read “flexible arms 3”
Appropriate correction is required.
Claim Objections
Claim(s) 14 is/are objected to because of the following informalities:
Claim 14, Ln. 1 recites “any preceding” which should be deleted
Appropriate correction is required.
Claim Interpretation - 35 USC § 112(f)
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: “an engagement element configured to selectively resist movement of the container towards the outlet of the housing” in claim 1.
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.
The corresponding structure for the “engagement element” is best understood from the specification as at least: engagement element 2 comprising one or more flexible arms 3 and extending from needle holder 42 (Figs. 1-3), engagement element 102 comprising one or more flexible arms 103 at an upper end of slide 150 (Figs. 4-5), engagement element 202 comprising one or more flexible arms 203 at an upper end of slide 250 (Figs. 6-7) or engagement element 302 comprising one or more projections 304 at an upper end of slide 350 (Figs. 8-9).
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4, 6-13 and 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davies et al. (U.S. Pub. 2007/0131717).
Regarding claim 1, Davies discloses a fluid delivery device (Figs. 4-5; ¶¶0242-0251) for discharging a fluid comprising: a) a housing (Fig. 4 #9; ¶0243) comprising a basal end (Fig. 4 bottom of #9) and a discharge end (Fig. 4 top of #9) having an outlet (Fig. 4 #15; ¶0249) for discharging the fluid; b) a container (Fig. 4 #30; ¶0243) defining a chamber for storage of the fluid, the container being slideably moveable relative to the housing from a storage configuration (Fig. 4) to a dispensing configuration (when Fig. 4 is moved like in Fig. 3; ¶0248); c) a trigger mechanism (Figs. 3-4 #22, 23; ¶¶0235-0236, 0248) configured to apply a force to the container to move the container towards the outlet of the housing (e.g. Fig. 3); and d) an engagement element (Figs. 4-5 #39; ¶¶0243-0245) configured to selectively resist movement of the container towards the outlet of the housing. Detent 39 is read as an equivalent structure to the flexible arm configuration of the disclosed engagement element. It is noted that the language “trigger mechanism” is not interpreted as invoking 35 U.S.C. 112(f) because the term “trigger” reasonably connotes an understood structure.
Regarding claim 2, Davies discloses the engagement element comprises one or more flexible arms (Figs. 4-5 #39; ¶¶0243-0245). The instant claim does not invoke 35 U.S.C. 112(f).
Regarding claim 4, Davies discloses the or each of the flexible arms is biased towards a centre of the container to thereby create frictional engagement with the container (Figs. 4-5; ¶¶0244-0245)
Regarding claim 6, Davies discloses the or each of the flexible arms is arranged between the container and the discharge end of the housing when the container is in the storage configuration (Fig. 4)
Regarding claim 7, Davies discloses the or each of the flexible arms extends from an extension of the housing (Fig. 4 – detent 39 is an extension of a piece connected to the housing 9).
Regarding claim 8, Davies discloses the engagement element comprises one or more protrusions (Figs. 4-5 #39; ¶¶0243-0245) configured to contact a surface of the container (Figs. 4-5) to thereby exert a force on the container to selectively resist movement of the container towards the outlet of the housing. The instant claim does not invoke 35 U.S.C. 112(f). The “protrusions” can be read as either all of detent 39 or only the bottom protruding tip of detent 39 (Fig. 5).
Regarding claim 9, Davies discloses the engagement element comprises one or more flexible arms (Figs. 4-5 all of #39; ¶¶0243-0245), and wherein each of the one or more flexible arms comprises one of the one or more protrusions (Figs. 4-5 bottom tip of #39).
Regarding claim 10, Davies discloses the or each of the one or more protrusions comprises one or more elongate ribs (Figs. 4-5 #39; ¶¶0243-0245) arranged around a circumference of the container (Fig. 4).
Regarding claim 11, Davies discloses the engagement element is configured to engage the container to thereby selectively resist movement of the container towards the outlet of the housing (Figs. 4-5; ¶¶0244-0245).
Regarding claim 12, Davies discloses the engagement element is configured to engage one or more of an outer face (Figs. 4-5)
Regarding claim 13, Davies discloses the container comprises
Regarding claim 15, Davies discloses in a first movement phase the trigger mechanism is configured to push the container towards the outlet of the housing to overcome the resistance of the engagement element before the container is moved to the dispensing configuration (Figs. 4-5; ¶¶0243-0245). The upward motion in Figs. 4-5 of Davies can be divided into infinite portions. The initial moment when the resistance of the engagement element is overcome may be read as the first movement phase and the immediately following additional upward movement may be read as a further movement phase.
Regarding claim 16, Davies discloses in a second movement phase the trigger mechanism is configured to push the container towards the outlet of the housing such that the container is moved to the dispensing configuration (e.g. the continued motion shown in Fig. 3 until a full upward position would be reached in Fig. 4).
Claim(s) 1-2, 4, 8, 10-16 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Warby et al. (U.S. Pub. 2012/0234861).
Regarding claim 1, Warby discloses a fluid delivery device (Fig. 1; ¶¶0059-0060) for discharging a fluid comprising: a) a housing (Fig. 1 #2, 3; ¶0059) comprising a basal end (Fig. 1 bottom of #3) and a discharge end (Fig. 1 top of #2) having an outlet (Fig. 1 #10; ¶0060) for discharging the fluid; b) a container (Fig. 5 #20; ¶0062) defining a chamber for storage of the fluid, the container being slideably moveable relative to the housing from a storage configuration (Fig. 5) to a dispensing configuration (¶0072 – when device is triggered); c) a trigger mechanism (Fig. 4 #5, 81, 82; ¶0072) configured to apply a force to the container to move the container towards the outlet of the housing (¶0072 – spring 5 applies force when allowed by motion of pads 81, 82); and d) an engagement element (Figs. 4-5 #80; ¶¶0068, 0070, 0072) configured to selectively resist movement of the container towards the outlet of the housing. Restraining arm 80 is read an equivalent structure to the flexible arm configuration of the disclosed engagement element. It is noted that the language “trigger mechanism” is not interpreted as invoking 35 U.S.C. 112(f) because the term “trigger” reasonably connotes an understood structure.
Regarding claim 2, Warby discloses the engagement element comprises one or more flexible arms (Figs. 4-5 #80; ¶¶0068, 0070, 0072). The instant claim does not invoke 35 U.S.C. 112(f).
Regarding claim 4, Warby discloses the or each of the flexible arms is biased towards a centre of the container to thereby create frictional engagement with the container (Figs. 4-5; ¶¶0068, 0070, 0072), wherein the or each of the flexible arms is optionally in frictional engagement with an outer face of the container (Figs. 4-5; ¶¶0068, 0070, 0072).
Regarding claim 8, Warby discloses the engagement element comprises one or more protrusions (Figs. 4-5 #80; ¶¶0068, 0070, 0072) configured to contact a surface of the container (Figs. 4-5) to thereby exert a force on the container to selectively resist movement of the container towards the outlet of the housing. The instant claim does not invoke 35 U.S.C. 112(f).
Regarding claim 10, Warby discloses the or each of the one or more protrusions comprises one or more elongate ribs (Figs. 4-5 #80) arranged around a circumference of the container (Fig. 4).
Regarding claim 11, Warby discloses the engagement element is configured to engage the container to thereby selectively resist movement of the container towards the outlet of the housing (Figs. 4-5; ¶¶0068, 0070, 0072).
Regarding claim 12, Warby discloses the engagement element is configured to engage one or more of an outer face (Figs. 4-5)
Regarding claim 13, Warby discloses the container comprises
Regarding claim 14, Warby discloses a container holder (Figs. 4-5 #80; ¶¶0068, 0070, 0072) configured to hold the container, wherein the engagement element is arranged on the container holder. It is noted that the claim does not require the container holder to be any more than the engagement element. Restraining arms 80 operate to hold container 20 in place (e.g. Fig. 5).
Regarding claim 15, Warby discloses in a first movement phase the trigger mechanism is configured to push the container towards the outlet of the housing to overcome the resistance of the engagement element before the container is moved to the dispensing configuration (Figs. 4-5; ¶¶0068, 0070, 0072). The coordinated operation of pads 81, 82 and spring 5 overcome the resistance of restraining arms 80 such that container 20 can be moved upward. The upward motion of container 20 can be divided into infinite portions. The initial moment when the resistance of the engagement element is overcome may be read as the first movement phase and the immediately following additional upward movement may be read as a further movement phase.
Regarding claim 16, Warby discloses in a second movement phase the trigger mechanism is configured to push the container towards the outlet of the housing such that the container is moved to the dispensing configuration (e.g. the continued upward motion of container 20 caused by spring 5 after flange 34 has been disengaged; ¶0072).
Regarding claim 18, Warby discloses the trigger mechanism comprises a slidable button (Fig. 4 #81 or #82; ¶0072 – slidable inward under finger pressure), the slidable button being configured to push the container towards the outlet of the housing (¶0072 – sliding of pads 81, 82 enables spring 5 to push container 20 upwards).
Allowable Subject Matter
Claim(s) 3, 5, 17 and 19-22 is/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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 3, neither Davies not Warby teaches or suggests the or each of the flexible arms is configured to be inserted into an open end of the container during movement of the container towards the outlet of the housing and is optionally biased outwards to thereby engage with an inner face and/or upper edge of the container. Davies has no consideration of a flexible arm, serving as the claimed engagement element, being inserted into an open end of the container during movement of the container towards the outlet of the housing. Similarly, Warby has no consideration of a flexible arm, serving as the claimed engagement element, being inserted into an open end of the container during movement of the container towards the outlet of the housing.
Other prior art of particular note related to claim 1 are Ritsche (U.S. Patent 6257454; Fig. 1 – lock 20 as an engagement element) and Stradella (U.S. Pub. 2008/0116223; Figs. 3-4 – blocking means 40 as an engagement element). Neither Ritsche nor Stradella teach or suggest a flexible arm configured to be inserted into an open end of the container during movement of the container.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 17, neither Davies not Warby teaches or suggests a biasing element, wherein: in the first movement phase the trigger mechanism is arranged in a cocked configuration in which the trigger mechanism is configured to prevent transfer of a biasing force of the biasing element to the container; the trigger mechanism is configured to move to a triggered configuration during the second movement phase; and in the triggered configuration, the trigger mechanism is configured to apply the biasing force to the container to thereby push the container towards the outlet of the housing. It is noted that the language “biasing element” is not interpreted as invoking 35 U.S.C. 112(f) because the terminology “biasing element” would be well recognized by one of ordinary skill in the art.
Davies has no consideration of any structure relatable to the claimed biasing element. Warby teaches upward motion of container 20 as caused in part by spring 5. However, spring 5 needs to be read as part of the triggering mechanism of claim 1. Thus, spring 5 cannot also be read as the biasing element of the instant claim as the biasing element is recited as a distinct structure from the triggering mechanism.
Other prior art of particular note related to claim 1 are Ritsche (U.S. Patent 6257454; Fig. 1 – lock 20 as an engagement element) and Stradella (U.S. Pub. 2008/0116223; Figs. 3-4 – blocking means 40 as an engagement element). Neither Ritsche nor Stradella teach or suggest a biasing element operable in the manner required by the instant claim.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 21, neither Davies not Warby teaches or suggests a piercer defining a delivery channel for delivering fluid towards the outlet of the housing; and a pierceable stopper arranged within the chamber, the pierceable stopper being configured to be pierced by the piercer so as to discharge the fluid from the chamber along the delivery channel and out of the outlet of the housing. The phrasing in the claim related to piercing would be understood by one of ordinary skill in the art to require a puncturing maneuver.
Davies has no consideration of any structure relatable to the claimed piercer. Warby similarly has no consideration of any structure relatable to the claimed piercer.
Other prior art of particular note related to claim 1 are Ritsche (U.S. Patent 6257454; Fig. 1 – lock 20 as an engagement element) and Stradella (U.S. Pub. 2008/0116223; Figs. 3-4 – blocking means 40 as an engagement element). Neither Ritsche nor Stradella teach or suggest a biasing element operable in the manner required by the instant claim. Ritsche is close to the requirements of the instant claim in the operation of piston 14 to be inserted through seal 30. However, seal 30 would not be accurately considered by one of ordinary skill in the art as a stopper within the chamber of the container.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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