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 .
Response to Amendment
The examiner acknowledges the reply filed on 03/30/2026 in which claims 1, 2, 4, 7-11, 14, and 17, were amended. Currently, claims 1-17 are pending for examination in this application.
Response to Arguments
With regards to the Drawing Objections, Applicant’s representative asserts “the removeable cover of claims 4 and 16 and the collapsible sleeve of claim 16” are not necessary for the understanding of the subject matter to be patented. Applicant’s representative simply states that “one of skill in the art, when reviewing the Figures and the specification of the present application, would understand the features.” The examiner respectfully disagrees. The examiner notes that any interaction and/or connection of these structures to the needle cannula and piercing element could be implemented in a variety of forms and would be necessary for the understanding of the exact subject matter to be patented. Furthermore, even if applicant’s representative disagrees with the above assessment, the examiner directs attention to MPEP 608.02(d)(a) which states: “The drawing in a nonprovisional application must show every feature of the invention specified in the claims. However, conventional features disclosed in the description and claims, where their detailed illustration is not essential for a proper understanding of the invention, should be illustrated in the drawing in the form of a graphical drawing symbol or a labeled representation (e.g., a labeled rectangular box).” As such, applicant’s representative’s arguments relative to the standing Drawing Objections are not persuasive.
With regards to the claim interpretation of the “connecting member” in claim 2; “biasing element” in claim 8; “piercing element” in claim 13; and “connecting assembly” in claim 15, as interpreted under 35 U.S.C. 112(f), applicant’s representative asserts said interpretation does not apply as each term has “structural meaning.” The examiner respectfully disagrees. First, the examiner reiterates that the presumption that the claim limitations are not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitations recite function without reciting sufficient structure, material or acts to entirely perform the recited function. Applicant’s representative’s arguments to not address this rebuttal. Although stating each term has a “well-known structural meaning,” applicant’s representative’s arguments fail to indicate a position on the structural meaning of each term. Again, each term noted above and in the interpretation below has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitations use a generic placeholder (“member,” “element,” and “assembly”) 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 (“connecting,” “biasing,” and “piercing” are not structural modifiers). As such, applicant’s representative has failed to present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Applicant’s arguments, see pages 7-9, filed 03/30/2026, with respect to the rejection(s) of the amended independent claim(s) 1, 2, and 11, under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of an alternative interpretation of Anderson et al. (USPN 6,364,170).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “removable cover” (claims 4 and 16) and the “collapsible sleeve” (claim 16) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
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: “connecting member” in claim 2; “biasing element” in claim 8; “piercing element” in claim 13; and “connecting assembly” in claim 15.
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 1-3 and 5-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson et al. (USPN 6,364,170).
[Claims 1 and 10] Anderson teaches an adapter (figure 6, item 10) for delivering a metered dose of flowable media subcutaneously or intramuscularly (column 2, lines 28-52) comprising:
a spray pump device (figure 6, items 20/22/24) having a first end (figure 6, item 24) defining a luer tip (figure 6, item 60; column 6, lines 23-29) and a second end (figure 6, at item 34) configured for accessing a media reservoir (figure 6, item 26) to receive the metered dose of flowable media (see 112b interpretation above) (column 5, lines 11-18),
wherein the luer tip (figure 6, item 60) is configured to be secured to a needle cannula (figure 3, item 62) to deliver the metered dose of the flowable media received from the spray pump device (figure 6, items 20/22/24) (figure 3; column 6, lines 20-39),
wherein the first end (figure 6, item 24) and the second end (figure 6, at item 34) are axially aligned (figure 6).
[Claims 2 and 3] Anderson teaches a device (figure 6, item 10) for delivering a metered dose of flowable media (column 2, lines 28-52) comprising:
a media reservoir (figure 6, item 26) configured for holding the flowable media (column 5, lines 13-15);
an actuator (figure 6, items 24/66) having a first end (figure 6, item 52), a second end (figure 6, item 46), and a conduit (figure 6, item 50) extending between the first (figure 6, item 52) and second end (figure 6, item 46), said second end (figure 6, item 46) of said actuator (figure 6, items 24/66) configured for movement between a first position (uncompressed) and a second position (compressed) upon and application of an actuating force thereto (column 6, lines 31-39);
an inlet (connection between channel 48 and valve 42) provided at the second end (figure 6, item 46) of the actuator (figure 6, items 24/66), said inlet (connection between channel 48 and valve 42) configured for transferring the metered dose of the flowable media from the media reservoir (figure 6, item 26) into the conduit (figure 6, item 50) of the actuator (figure 6, items 24/66);
an opening (distal opening of channel 50) in the first end (figure 6, item 52) of the actuator (figure 6, items 24/66); and
a connecting member (figure 6, item 60), comprising a luer tip (column 6, lines 23-29), associated with the first end (figure 6, item 52) of the actuator (figure 6, items 24/66), said connecting member (figure 6, item 60) configured for cooperation with a needle cannula (figure 3, item 62) such that the needle cannula (figure 3, item 62) is in fluid communication with the opening (distal opening of channel 50) in the first end (figure 6, item 52) of the actuator (figure 6, items 24/66) to deliver the metered dose of the flowable media (figure 3; column 6, lines 20-39),
wherein the first end (figure 6, item 52) and the second end (figure 6, item 46) of the actuator (figure 6, items 24/66) are axially aligned (figure 6).
[Claim 5] Anderson teaches the limitations of claim 2, upon which claim 5 depends. In addition, Anderson discloses the media reservoir (figure 6, item 26) is a vial (figure 6, item 26; column 5, lines 13-15) and the second end (figure 6, item 46) of the actuator (figure 6, items 24/66) is configured for attachment (the examiner notes a direct, physical connection is not required) to the vial (figure 6, item 26) (figure 6).
[Claims 6 and 7] Anderson teaches the limitations of claim 5, upon which claims 6 and 7 depend. Anderson further discloses the vial (figure 6, item 26) includes a pierceable septum (“sealed end”; column 7, lines 21-24) and the second end (figure 6, item 46) of the actuator (figure 6, items 24/66) includes a piercing element (non-patient cannula) (figure 6, item 76) configured to pierce the septum (“sealed end”) of the vial (figure 6, item 26) associated therewith (the examiner interprets the piercing element as not necessarily being a part of the “second end” of the actuator, but merely “associated” with it), said piercing element (figure 6, item 76) including a fluid passageway (figure 6, item 28) for providing fluid communication between the actuator (figure 6, items 24/66) and vial (figure 6, item 26) (figure 6).
[Claim 8] Anderson teaches the limitations of claim 2, upon which claim 8 depends. Anderson also discloses the actuator (figure 6, items 24/66) includes a biasing element (figure 6, item 66) to return the actuator (figure 6, items 24/66) to the first position (uncompressed) after application of the actuating force thereto (column 6, lines 40-47).
[Claim 9] Anderson teaches the limitations of claim 2, upon which claim 9 depends. Additionally, Anderson discloses a valve (figure 6, item 42) configured for cooperation with the inlet (connection between channel 48 and valve 42) of the actuator (figure 6, items 24/66), wherein movement of the actuator (figure 6, items 24/66) to the second position (compressed) causes said valve (figure 6, item 42) to open to admit the metered dose of the flowable media into the conduit (figure 6, item 50) of the actuator (figure 6, items 24/66) (column 5, lines 64-67; column 6, lines 1-19).
[Claim 11] Anderson teaches a method of delivering a metered dose of flowable media (column 2, lines 28-52) comprising:
providing a media reservoir (figure 6, items 18/26) having a spray pump device (figure 6, items 20/22/24) associated therewith (figure 6), the spray pump device (figure 6, items 20/22/24) having an exit opening (distal opening of channel 50) and an end (figure 6, item 46) configured for accessing the media reservoir (figure 6, items 18/26), the spray pump device (figure 6, items 20/22/24) being configured for supplying the metered dose upon application of an actuation force thereto (column 6, lines 31-39);
securing a needle cannula (figure 3, item 62) to the exit opening (distal opening of channel 50) of the spray pump device (figure 6, items 20/22/24), wherein application of the actuation force to the spray pump device (figure 6, items 20/22/24) causes said metered dose of flowable media to exit through the needle cannula (figure 3, item 62) (column 6, lines 19-39),
wherein the exit opening (distal opening of channel 50) and the end (figure 6, item 46) configured for accessing the media reservoir (figure 6, items 15/26) are axially aligned (figure 6).
[Claim 12] Anderson teaches the limitations of claim 11, upon which claim 12 depends. Anderson further discloses providing a luer tip (figure 6, item 60) to the exit opening (distal opening of channel 50) of the spray pump device (figure 6, items 20/22/24) for securing the needle cannula (figure 3, item 62) thereto (figure 3; column 6, lines 23-29).
[Claims 13 and 14] Anderson teaches the limitations of claim 11, upon which claims 13 and 14 depend. Anderson also teaches the media reservoir (figure 6, items 18/26) comprises a vial (figure 6, item 26) having a pierceable septum (“sealed end”; column 7, lines 21-24) and the spray pump device (figure 6, items 20/22/24) includes a piercing element (non-patient cannula) (figure 6, item 76) configured for piercing the septum (“sealed end”) of the vial (figure 6, item 26) and wherein the method includes piercing the septum (“sealed end”) of the vial (figure 6, item 26) with the piercing element (figure 6, item 76) (figure 6; column 7, lines 21-24).
[Claim 15] Anderson teaches the limitations of claim 13, upon which claim 15 depends. In addition, Anderson teaches at least one of the vial (figure 6, item 26) and the spray pump device (figure 6, items 20/22/24) includes a connecting assembly (figure 6, item 70) to secure the vial (figure 6, item 26) and the spray pump device (figure 6, items 20/22/24) together (figure 6; column 7, lines 21-26).
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.
Claims 4, 16, and 17, are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (USPN 6,364,170), in view of Thomas (USPN 4,955,871).
[Claim 4] Anderson teaches the limitations of claim 2, upon which claim 4 depends. Although disclosing the needle cannula (figure 3, item 62) is preassembled (figure 3) (the examiner notes the term “preassembled” is not explicitly defined and does not require a connection between the two structures at any specific point in time) to the luer tip (figure 6, item 60), Anderson does not specifically disclose a removable cover for the needle cannula.
However, Thomas teaches a device (figure 1, item 10) for delivering a metered dose of a flowable media comprising a needle cannula (figure 1, item 12) in fluid communication with a media reservoir (figure 2, item 46), wherein the device further comprises a removable cover (figure 1, item 30) for the needle cannula (figure 1, item 12) (column 5, lines 14-33).
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 device taught by Anderson, to have utilized a removable cover for the needle cannula, as taught by Thomas, in order to provide increased functionality and safety, by allowing for a means by which sterility might be maintained, as well as providing for means to prevent accidental needle sticks (Thomas; column 5, lines 25-33).
[Claim 16] Anderson teaches the limitations of claim 13, upon which claim 16 depends. The embodiment relied upon in Anderson does not specifically disclose a removable cover for the needle cannula or a collapsible sleeve for the piercing element.
However, Thomas teaches a device (figure 1, item 10) for delivering a metered dose of a flowable media comprising a needle cannula (figure 1, item 12) in fluid communication with a media reservoir (figure 2, item 46), wherein the device further comprises a removable cover (figure 1, item 30) for the needle cannula (figure 1, item 12) (column 5, lines 14-33).
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 method taught by Anderson, to have utilized a removable cover for the needle cannula, as taught by Thomas, in order to provide increased functionality and safety, by allowing for a means by which sterility might be maintained, as well as providing for means to prevent accidental needle sticks (Thomas; column 5, lines 25-33).
Additionally, an alternative embodiment (figure 26) in Anderson discloses a collapsible (“sponge-like”) sleeve (figure 26, item 170) for the piercing element (figure 26, item 76) (column 8, lines 48-53).
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 method taught by Anderson and Thomas, to have utilized a collapsible sleeve for the piercing element, as taught by the alternative embodiment of Anderson, in order to provide increased functionality and safety, by providing for a means by which a user would be protected from accidental needle sticks in the event of a vial rupture.
[Claim 17] Anderson teaches the limitations of claim 13, upon which claim 17 depends. Although disclosing a functionally capable needle cannula, Anderson does not specifically disclose the method step of the metered dose of flowable media being applied subcutaneously or intramuscularly.
However, Thomas teaches a device (figure 1, item 10) for delivering a metered dose of a flowable media comprising a needle cannula (figure 1, item 12) in fluid communication with a media reservoir (figure 2, item 46), wherein a metered dose of flowable media is applied intramuscularly (column 4, lines 67-68; column 5, lines 1-2).
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 method taught by Anderson, to apply the metered dose of flowable media intramuscularly, as taught by Thomas, in order to provide increased functionality and versatility, by allowing for additional well-known treatment delivery routes.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 06/04/2026
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