Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Election/Restrictions
Applicant timely traversed the restriction requirement in the reply filed on 06/30/2026 with the election of Claims 1-6 and 8-10 and Figs. 11-12C, 10I, 10L, 26A-D, 39A-D, 38 and 65. Therefore, claims 7 and 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Thus, claims 1-6 and 8-10 are presently pending in this application.
Applicants’ election with traverse is acknowledged. The traversal is on the grounds that the species and subspecies would not be a serious burden on the Examiner. This is not found persuasive because each of the listed species and subspecies are mutually exclusive embodiments with mutually exclusive characteristics that are not obvious variants of each other. If the applicants believe that these are in fact similar and should not be considered mutually exclusive species, the applicant is required to state that these embodiments do not have mutually exclusive characteristics and a single prior art disclosing one would disclose the other since they are obvious variants of each other.
The requirement is still deemed proper and is therefore made FINAL.
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 “the grippable housing comprises a window along a length of the grippable housing, and the window defines a side port that is configured to receive the implant into the delivery conduit of the needle” 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: specification should be amended to include the “the grippable housing comprises a window along a length of the grippable housing, and the window defines a side port that is configured to receive the implant into the delivery conduit of the needle.” limitation in claim 1.
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 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.
In claim 1, “a first control mechanism” and “a second control mechanism” are being interpreted under 112 (f). Applicant is encouraged to amend claims to recite sufficient structure, material, or acts to entirely perform the recited function because currently the claims can be interpreted to mean the pusher member 508 and the trigger 502/504 (par. 0175 of the PGPub of the present invention).
Claim Rejections - 35 USC § 103
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.
Claims 1-6 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (2013/0245534) in view of Shemi (2011/0275891).
Regarding claim 1, Miller discloses an implant 5 delivery system (Fig. 7 and par. 0053), comprising: a grippable housing (housing shown in Fig. 7); a needle 35 extending from the grippable housing (Fig. 7), wherein the needle is hollow and defines a delivery conduit that extends from a proximal end of the needle to a distal end of the needle (par. 0053 disclose a hollow needle and Fig. 8-9 discloses the hollow needle 35 having a conduit that extends from its beveled tip at the distal end), wherein the distal end of the needle is a piercing end that is configured to pierce a nasal tissue (par. 0055 discloses the needle pierces through the skin which is fully capable of being nasal tissue); a first control mechanism that is configured to advance an implant 5 from a proximal position at which the implant is loaded into the needle to a distal position in the needle (par. 0056 and Fig. 12 discloses pusher 45 pushes or advances the implant 5 within the needle conduit); and a second control mechanism that is configured to retract the needle away from the implant at the distal position and toward the grippable housing to deliver the implant to an implant location in the nasal tissue (par. 0057 and Figs. 12-13 disclose the needle 35 is retracted away from the implant 5 in a proximal direction which is towards the housing in order to deliver the implant). Miller is silent regarding a nasal implant and wherein the grippable housing comprises a window along a length of the grippable housing, and the window defines a side port that is configured to receive the implant into the delivery conduit of the needle. However, Shemi teaches a similar implant delivery system (Fig. 11B) comprising a nasal implant (par. 0035 discloses a nasal treatment element) and wherein a grippable housing 22 comprises a window 120 along a length of the grippable housing, and the window defines a side port that is configured to receive the implant into the delivery conduit of the needle (par. 0272; Fig. 11B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant delivery system in Miller to include nasal implant and wherein the grippable housing comprises a window along a length of the grippable housing, and the window defines a side port that is configured to receive the implant into the delivery conduit of the needle, as taught and suggested by Shemi, for facilitating ease of inserting the implant within the needle conduit and to treat a nasal target site (par. 0029 and par. 0272).
Regarding claim 2, Miller discloses wherein the needle is configured to at least partially retract into the grippable housing (par. 0057 discloses the needle is retracted proximally which is towards the grippable housing).
Regarding claim 3, further comprising an implant pusher member 45 that is disposed in the delivery conduit of the needle 35 (Fig. 11), wherein the implant pusher member is configured such that moving the first control mechanism in a distal direction relative to the grippable housing moves the implant pusher member against a proximal end of the implant (as shown in Fig. 11, the pusher 45 moves distally towards the implant 5 to push the implant by contacting its proximal end) and pushes the implant near the distal end of the needle (par. 0057 and Fig. 11).
Regarding claim 4, Miller discloses wherein the implant pusher member 45 is further configured to maintain the implant at the implant location in the nasal tissue while the second control mechanism retracts the needle away from the implant (Figs. 11-12 and par. 0057).
Regarding claim 5, Miller discloses wherein a proximal end of the implant pusher member is positioned within the grippable housing (Figs 7 and 9 disclose the housing and the pusher member is located within the housing).
Regarding claims 6 and 8-9, Miller discloses the claimed invention of claim 1; except for wherein the second control mechanism comprises a trigger member on the grippable housing; a user-controlled safety element that is configured to unlock the second control mechanism to retract the needle toward the grippable housing and the user- controlled safety element is a button on the grippable housing. However, Shemi teaches a similar implant delivery system 52 (Fig. 11A) comprising a second control mechanism comprises a trigger member on the grippable housing (trigger arms located on housing 22 adjacent window 120); a user-controlled safety element that is configured to unlock the second control mechanism to retract the needle toward the grippable housing and the user-controlled safety element is a button on the grippable housing (shaft lock 28 controls the length of the distal end of needle 112 and is a button on the housing 22; Fig. 11A and par. 0276). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant delivery system in Miller to include the second control mechanism comprises a trigger member on the grippable housing; a user-controlled safety element that is configured to unlock the second control mechanism to retract the needle toward the grippable housing and the user- controlled safety element is a button on the grippable housing, as taught and suggested by Shemi, for providing a controlled retraction of the needle and to limit needle penetration.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (2013/0245534) in view of Shemi (2011/0275891) further in view of Dineen et al. (2008/0066769) “Dineen”.
Miller in view of Shemi disclose the claimed invention of claim 1; except for the implant comprises: a first end; a second end; and an elongate body portion extending-between the first end and the second end, wherein the first end comprises a resiliently deformable portion including a plurality of tines, wherein the resiliently deformable portion configured to have a contracted first shape and an expanded second shape expanded, wherein the contracted first shape comprises a non-circular cross-section configured to correspond to a cross-sectional shape of the delivery conduit, and wherein, in the expanded second shape, respective ends of the tines of the resiliently deformable portion protrude outwardly from the cross-section of the elongated body portion so as to anchor the implant to nasal tissue when the implant is in place in the nasal tissue.
However, Dineen teaches a similar nasal implant 5100 (Figs. 7A-7B) comprising a first end; a second end; and an elongate body portion extending-between the first end and the second end (as shown in Figs. 7A-7B), wherein the first end comprises a resiliently deformable portion including a plurality of tines (par. 0069 discloses resiliently deformable prongs), wherein the resiliently deformable portion configured to have a contracted first shape (Fig. 7A) and an expanded second shape expanded (Fig. 7B), wherein the contracted first shape comprises a non-circular cross-section (Fig. 7A discloses a profile of the implant 5100 having a non-circular shape) configured to correspond to a cross-sectional shape of the delivery conduit (the implant 5100 is fully capable of performing this intended use), and wherein, in the expanded second shape, respective ends of the tines of the resiliently deformable portion protrude outwardly from the cross-section of the elongated body portion so as to anchor the implant to nasal tissue when the implant is in place in the nasal tissue (par. 0069 and Fig. 7B disclose the prongs protruding outwardly and fully capable of performing this intended use in the nasal tissue).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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