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 under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, in claims 18-19, “gripping surface wings” 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: “engagement structure” in claim 1. The disclosure refers to the “engagement structure” as frustoconical or non-frustoconical barbs structures ([0043]).
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.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 of this instant application are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12 of U.S. Patent No. 11,602,759. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Application Claims
US Patent No. 11,602,759
1. A removable applicator configured to be secured to a syringe for directing materials to be dispensed from the syringe, the applicator comprising: a hub comprising a lower surface and an upper surface, wherein the upper surface includes an aperture, and the lower surface includes a neck comprising at least one engagement structure configured to be inserted into a syringe nozzle to frictionally engage an interior wall of the syringe nozzle, wherein a frictional engagement of the at least one engagement structure and the interior wall forms a fluid-tight seal; and an applicator tip extending distally from the hub's upper surface in axial alignment with the hub's aperture, and wherein the hub and the applicator tip cooperate to define a fluid passage therethrough, the fluid passage being configured to minimize fluid volume.
1. An applicator configured to be secured to a syringe for directing materials to be dispensed from the syringe, the applicator comprising: a hub defining a fluid passage therethrough, wherein the hub comprises a lower surface and an upper surface, the upper surface includes an aperture that communicates with the fluid passage, the fluid passage containing at least two three successively different concentric passage sections of differing diameters, and including at least one proximal barb thereon, the barb configured to frictionally engage an interior of a syringe nozzle, the hub further comprising a neck extending outwardly from the lower surface of the hub and configured to be inserted into the syringe nozzle, wherein the fluid passage narrowing axially from a fluid inlet section of the neck to the aperture, and wherein the at least one barb is disposed on the neck; and an applicator tip extending distally from the aperture of the hub.
12. (Original) The applicator of claim 1 wherein the fluid passage tapers inwardly from an inlet end to an outlet end.
It is clear that all the elements of claim 1 of this instant application are to be found in claims 1 and 12 of the patent. The difference between claims of the application and the patent lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus the invention of claims of the patent is in effect a “species” of the “generic” invention of claims of the 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 claims of the application is anticipated by claims of the patent as cited in the above, the claims of the application are not patentably distinct from claims of the patent.
Following the rationale of in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 13 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 3, 13 and 17 recite the limitation "the neck feature". There is insufficient antecedent basis for this limitation in the claims.
Claim 3 recite "at least one engagement structure", it is unclear if the limitation is referring to the “at least one engagement structure” cited in claim 1.
Claim Rejections - 35 USC § 102
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, 7 and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jensen (US 2007/0225658).
Regarding claim 1, Jensen discloses a removable applicator configured to be secured to a syringe for directing materials to be dispensed from the syringe (fig.1-21), the applicator comprising: a hub (24) comprising a lower surface and an upper surface (see fig.2-3), wherein the upper surface includes an aperture (26 in 24), and the lower surface includes a neck comprising at least one engagement structure configured to be inserted into a syringe nozzle to frictionally engage an interior wall of the syringe nozzle (24 in 23 and [0038]), wherein a frictional engagement of the at least one engagement structure and the interior wall forms a fluid-tight seal ([0038]); and an applicator tip (26) extending distally from the hub's upper surface in axial alignment with the hub's aperture (see fig.2-3), and wherein the hub and the applicator tip cooperate to define a fluid passage therethrough, the fluid passage being configured to minimize fluid volume (see fig.9, aperture from 24 to 46 is reduced).
Regarding claim 2, Jensen discloses the neck extends in axial alignment outwardly from the hub lower surface opposite the applicator tip (see fig.2-5).
Regarding claim 3, Jensen discloses the neck feature and at least one engagement structure are the same ([0038]).
Regarding claim 7, Jensen discloses a shape of the fluid passage is selected from straight, tapered, and stepped so that the fluid passage minimizes the fluid volume (see from 24 to 46 in fig.9).
Regarding claim 12, Jensen discloses engagement with the syringe is from the frictional engagement between the at least one engagement structure and the syringe nozzle interior wall ([0038], via “barbed”).
Regarding claim 13, Jensen discloses engagement with the syringe is from the frictional engagement between the neck feature and the syringe nozzle interior wall ([0038], via “barbed”).
Regarding claim 14, Jensen discloses a body with luer lock threads configured to engage with a syringe's luer-equipped apron (see fig.19-21).
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 4 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 2007/0225658) in view of Fischer (US 2004/0138642).
Regarding claim 4, Jensen is silent in disclosing the at least one engagement structure exhibits a non-frustoconical shape. However, Fischer teaches the commonality of having a hub with at least one engagement structure exhibiting a non-frustoconical shape (see area 18, of 10 in fig.1-2). It would have been obvious to one having ordinary skill in the art before the effective filling date of the application to modify the engagement feature of Jensen to a non-frustoconical shape as taught by Fischer, in order to offer a sturdy locking mechanism.
Regarding claim 18, Jensen is silent in disclosing the hub further comprises gripping surface wings that facilitate mating of the tip with the syringe. However, Fischer teaches the commonality of having a hub with gripping surface wings that facilitate mating of the tip with the syringe (via 20, see fig.1). It would have been obvious to one having ordinary skill in the art before the effective filling date of the application to add to the surface of the hub of Jensen a wing as taught by Fischer, in order to assemble and disassemble parts conveniently.
Claims 5-6 is rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 2007/0225658)
Jensen is silent in disclosing the at least one engagement structure has a diameter between 1.5mm - 4.0mm; and the at least one engagement structure has a length between 0.1mm - 10mm. Instead, Jensen in fig.2 teaches the frustoconical-shape being inserted into the interior wall of (22) at a proper length; and Jensen also teaches the device is a hand held dental syringe ([0008]). At the time the invention was made, it would have been obvious to a person of ordinary skill in the art to have the at least one engagement structure with a diameter between 1.5mm - 4.0mm; and the at least one engagement structure with a length between 0.1mm - 10mm, since Applicant has neither placed criticality on such insertion length nor has disclosed that such length provides an advantage, is used for a particular purpose, or solves a stated problem other than causing a proper connection between the hub and the syringe nozzle, in which Jensen provides such an end result. Further, one of ordinary skill in the art, would have expected Jensen’s frustoconical-shape length, and applicant’s invention, to perform equally well with either the length taught by Jensen or the claimed invention because both length would perform the same function of providing a tight seal and fluid spillage prevention between the hub and syringe. Therefore, it would have been obvious to modify Jensen to obtain the invention as specified in claims 5-6 because such a modification would have been considered an obvious alteration to the device of Jensen which fails to be patentably distinguished.
Claim 8 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 2007/0225658) in view of Lum (US 2011/0028909).
Jensen is silent in disclosing the hub is injection molded from one or more of the following materials: polyethylene, polypropylene, nylon, polyamide, acrylonitrile butadiene styrene, polylactic acid, polystyrene, and polytetrafluoroethylene; the applicator tip extends distally from the hub and comprises a metal cannula, a polyimide cannula, or a combination of a metal and polyiide cannula; and the hub and applicator tip comprise a single injection molded polymeric material. However, Lum teaches the common features of a syringe hub being injection molded from one or more of the following materials: polyethylene, polypropylene, nylon, polyamide, acrylonitrile butadiene styrene, polylactic acid, polystyrene, and polytetrafluoroethylene; the applicator tip extends distally from the hub and comprises a metal cannula, a polyimide cannula, or a combination of a metal and polyiide cannula; and the hub and applicator tip comprise a single injection molded polymeric material ([0051]). It would have been obvious to one having ordinary skill in the art before the effective filling date of the application to modify the material of the tip and the hub of Jensen to a polymeric injection mold as taught by Lum, in order to minimize the costs and plastic productions with high precision.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 2007/0225658) in view of Discko (US 5,324,273).
Jensen is silent in disclosing the applicator tip extends distally from the hub and has a diameter between 16 gauge and 33 gauge. However, Discko teaches the commonality of having a dispensing tip with diameter between 16 gauge and 33 gauge (col 2, ll.43-49). It would have been obvious to one having ordinary skill in the art before the effective filling date of the application to modify the tip of the tube of Jensen to a size as taught by Discko, in order to provide proper support for the applicator tip.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 2007/0225658) in view of Shidham (US 2005/0101879).
Jensen is silent in disclosing the applicator to interface with 6% luer taper syringes. Instead, Shidham teaches a friction fit of tip (22) into hub area (78 of 24; [0047]) in a predetermined length (see fig.3). At the time the invention was made, it would have been obvious to a person of ordinary skill in the art to have a 6% interface between applicator and luer, since Applicant has neither placed criticality on such interface nor has disclosed that such interface provides an advantage, is used for a particular purpose, or solves a stated problem other than causing a proper connection between the hub and the syringe nozzle, in which Shidham provides such an end result. Further, one of ordinary skill in the art, would have expected Jensen’s interface, and applicant’s invention, to perform equally well with either the length taught by Jensen or the claimed 6% interface because both length would perform the same function of providing a tight seal and fluid spillage prevention between the tip and syringe. Therefore, it would have been obvious to modify the syringe of Jensen and Shidham in combination to obtain the invention as specified in claim 15 because such a modification would have been considered an obvious alteration to the device of Jensen and Shidham in combination which fails to be patentably distinguished.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 2007/0225658) in view of Tezel (US 2010/0152679).
Jensen discloses the frictional engagement arises solely from a frictional engagement force between the at least one engagement structure and the syringe nozzle interior wall; and the frictional engagement arises solely from a frictional engagement force between the neck feature and the syringe nozzle interior ([0038]).
Jensen is silent to disclose a friction force being in the amount of at least 5N. However, Tezel teaches use of at least 5N force in syringe devices is well-known feature ([0037]). It would have been obvious to one having ordinary skill in the art before the effective filling date of the application to import the teaching of Tezel with regard to the amount of the engagement force into the device of Jensen in order to operate the device safely.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 2007/0225658) as applied to claim 1 above, and further in view of Fischer (US 2004/0138642) and of Lum (US 2011/0028909).
Jensen discloses the hub further comprises a body with luer lock threads configured to engage with a syringe's luer-equipped apron (see fig.19-21).
Jensen is silent in disclosing the hub further comprises gripping surface wings that facilitate mating of the tip with the syringe, and wherein the applicator comprises a single injection molded polymeric material. However, Fischer teaches the commonality of having a hub with gripping surface wings that facilitate mating of the tip with the syringe (via 20, see fig.1). It would have been obvious to one having ordinary skill in the art before the effective filling date of the application to add to the surface of the hub of Jensen a wing as taught by Fischer, in order to assemble and disassemble parts conveniently. Further, Lum teaches the common features of an applicator made of a single injection molded polymeric material ([0051]). It would have been obvious to one having ordinary skill in the art before the effective filling date of the application to modify the material of the applicator of Jensen to a polymeric injection mold as taught by Lum, in order to minimize the costs and producing plastic products with high precision.
State of the Prior Arts
Regarding claim 1, the prior arts to Klein (EP 2688606 B1), Lee (KR 20100106751 A), Fischer (US 2007/0262178), HO (US 2010/0261138), Miles (US 2015/0034114), Hall (US 2,792,976), Sneider (US 4,274,555), Riitano (US 6,079,979), Broyles (US 6,095,813) as cited in PTO-892, either individually or in combination are disclosing/teaching significant pertinent structures or features to the applicant’s claimed invention with regard to a removable applicator to be secured to a syringe for directing materials to be dispensed from the syringe, the applicator having a hub with a lower surface and an upper surface, the upper surface includes an aperture, and the lower surface includes a neck with at least one engagement structure to be inserted into a syringe nozzle to frictionally engage an interior wall of the syringe nozzle, a frictional engagement of the at least one engagement structure and the interior wall forms a fluid-tight seal; and an applicator tip extending distally from the hub's upper surface in axial alignment with the hub's aperture, and the hub and the applicator tip cooperate to define a fluid passage therethrough, and the fluid passage to minimize fluid volume. It appears that claim 1 does not provide any inventive concept over the cited prior arts.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bob Zadeh whose telephone number is (571)270-5201. The examiner can normally be reached Monday-Friday 8am-4pm E.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Paul Durand can be reached at (571) 272-4459. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BOB ZADEH/Primary Examiner, Art Unit 3754
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