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 .
Claim Objections
Claims 1, 9, 15, 18, 22-23, 25, 28 and 32 are objected to because of the following informalities:
Claim 1, lines 2-3 recites “the tip portion” and should recite “a tip portion”.
Claim 1, lines 4-5 recites “the site of the injection” and should recite “a site of injection”.
Claim 9, line 2 recites “its tip portion” and should recite “the tip portion”.
Claim 15, line 2 recites “the rear end of the sleeve” and should recite “a rear end of the sleeve”.
Claim 15, line 5 recites “the rear end of the needle holder” and should recite “a rear end of a needle holder”.
Claim 15, line 5 recites “the other end” and should recite “an other end of the inner tube”.
Claim 15, line 6 recites “the other end of the inner tube” and should recite “an other end of the inner tube”.
Claim 15, line 6 recites “the rear end of the needle” and should recite “a rear end of the needle”.
Claim 18, line 2 recites “the rear end of the sleeve” and should recite “a rear end of the sleeve”.
Claim 18, line 8 recites “the axial axis” and should recite “an axial axis”.
Claim 22, line 2 recites “the chamber” and should recite “a chamber”.
Claim 23, lines 1-2 recites “an ocular injection assembly” and should recite “the ocular injection assembly”.
Claim 25, line 2 recites “the end of the pushrod” and should recite “an end of the pushrod”.
Claim 28, line 2 recites “the pushing stroke” and should recite “a pushing stroke”.
Claim 32, line 5 recites “the distal end of the needle” and should recite “a distal end of the needle”.
Appropriate correction is required.
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 needle seat and the needle holder recited in claim 15 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: the needle seat and the needle holder recited in claim 15.
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 15, 28, 31-32 and 35 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.
Claim 15 recites “a needle seat” in line 2 and “the needle holder” in line 5. There is no mention of these elements in the specification and it is unclear if these are two separate elements or if they refer to the same element. Clarification is required. For purposes of examination these recitations are assumed to be different elements.
Claim 28 recites “a second stop”. There is no first stop recited in this claim or an of its antecedent claims. It is therefore unclear if this limitation requires two stops as indicated by the term “second” or if “second” is used as an adjective and this requires only one stop. Clarification is required. For purposes of examination this limitation is assumed to require only one stop
Claim 31, line 3 recites “ocular tissue at the injection site”. It is unclear if this refers to the ocular tissues at the site of injection recited in base claim 1 or an additional element. Clarification is required. For purposes of examination this limitation is assumed to refer to the ocular tissue at the injection site recited in base claim 1.
Claim 32, line 6 recites “the target ocular tissue at the injection site”. It is unclear if this refers to the ocular tissues at the site of injection recited in base claim 1 or the ocular tissue at the injection site in base claim 31. Clarification is required. For purposes of examination this limitation is assumed to be an additional element.
Claim 35 recites “the eye surface” in line 2 and “the eye tissue” in lines 3 and 5. It is unclear if this refers to the ocular tissues recited in base claim 1 or the ocular tissue in base claim 31. Clarification is required. For purposes of examination these limitations are assumed to refer to the ocular tissue at the injection site recited in base claim 1.
Claims dependent thereon inherit the deficiencies of the respective base claim.
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 1-2, 6, 9-11, 22-24, 28, 31-32 and 35 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Paques et al. (US 2010/0010452).
Regarding claim 1, Paques discloses an ocular injection assembly (Figure 3) comprising a sleeve (121) and a needle (133), wherein the needle can be set within the sleeve (Figure 3), a clamping port (112) is provided at the end of the sleeve (Figure 3), and the tip portion of the needle (Figure 3, lower part of needle 133) can pass through the clamping port (Figure 3), and wherein when the ocular injection assembly is used, the clamping port is contacted with and pressed against ocular tissues (paragraph 51 describes plate 110 and associated clamping port 112 in contact with eye tissue) at the site of the injection to cause the ocular tissues at the site of the injection to protrude into the sleeve (Intended use, when the annular plate 110 as shown in figure 2 is pressed against the eye, a portion of the ocular tissue will bulge through port 112).
Regarding claim 2, Paques discloses the invention as claimed and described above. Paques further discloses wherein the clamping port has an annular end surface (Figure 2 show the end surface of the clamping port 112, which makes contact with the eye, is annular).
Regarding claim 6, Paques discloses the invention as claimed and described above. Paques further discloses wherein the end of the sleeve is a constricted section (Figure 3, lower section near numeral 133) and the clamping port is located at the end of the constricted section (Figure 3); the constricted section has a cross-sectional size that is progressively larger in a direction away from the clamping port (Figure 3 shows this).
Regarding claim 9, Paques discloses the invention as claimed and described above. Paques further discloses wherein the needle, when mated with the sleeve, extends with its tip portion outside the clamping port for 500- 2000 micrometers (paragraph 70 describes the needle extending its tip portion 3mm into the eye, i.e. 300 micrometers outside the clamping port, so during this operation the needle extends its tip to 500 micrometers and 2000 micrometers outside of the clamping port).
Regarding claim 10, Paques discloses the invention as claimed and described above. Paques further discloses wherein the sleeve is provided with a canal (Figure 3 shows the sleeve 121 has an interior canal in which the needle 133 sits) and the needle is movably attached within the canal (Figure 3 shows the needle 133 is attached within the canal via the structures at the top of the figure and moves longitudinally through the canal in use).
Regarding claim 11, Paques discloses the invention as claimed and described above. Paques further discloses wherein a needle holder (Figure 3, 123 and 137) is attached to the needle at an end opposite to the tip portion (Figure 3 shows the needle is attached to the needle holder at the upper end of the needle, opposite the tip portion near the ocular tissue), and the sleeve and the needle holder are provided with an adjusting assembly (131) for adjusting the length of the tip portion outside the clamping port (paragraph 60 describes the adjusting assembly 131 adjusting the movement of the needle support 134 and thus the tip of the needle).
Regarding claim 22, Paques discloses the invention as claimed and described above. Paques further discloses wherein the chamber within the sleeve (Figure 3, space within sleeve 121) forms a hermetically sealed chamber when the clamping port is closed (paragraph 83 describes a removable cap that is positioned over 212, which is the clamping port 112 in figure 3, and seals the chamber).
Regarding claim 23, Paques discloses the invention as claimed and described above. Paques further discloses an ocular injection device (Figure 3, 130 and 132) comprising a syringe (130), and an ocular injection assembly as claimed in claim 1 (see rejection of claim 1 above) being mountable on the syringe (Figure 3).
Regarding claim 24, Paques discloses the invention as claimed and described above. Paques further discloses wherein the syringe comprises a medication container (131) and a pushrod (132), the pushrod being capable of sliding within the medication container (paragraph 58), the medication container being used for storing a medicinal solution (paragraph 58 describes a therapeutic medium and paragraph 147 describes the therapeutic medium as treating and/or preventing disorders of the eye, i.e. a medicinal solution), and the medication container being cooperatively connected to the needle (Figure 3).
Regarding claim 28, Paques discloses the invention as claimed and described above. Paques further discloses further comprising a second stop (See 112 above. The stop is the lip provided in the upper portion of 131 right above the numeral 136) provided between the pushrod and the medication container to limit the pushing stroke of the pushrod (Figure 3 shows the stop works to physically stop the pushrod 132 from proceeding all the way into medication container 131).
Regarding claim 31, Paques discloses the invention as claimed and described above. Paques further discloses comprising using the ocular injection device to contact and press the clamping port of the sleeve against ocular tissue at the injection site (See 112 above. Figure 3 shows the clamping port 112 is pressed against the ocular tissue 111 at the injection site, i.e. right below the tip of needle 133) to cause the ocular tissue at the injection site to bulge into the sleeve (when pressure is applied to the assembly as described in paragraph 67, the assembly will necessarily cause the ocular tissue to bulge into the sleeve).
Regarding claim 32, Paques discloses the invention as claimed and described above. Paques further discloses wherein when or after a bulge of the ocular tissue at the injection site into the sleeve is formed by contacting and pressing the clamping port of the sleeve on the ocular tissue at the injection site (Step 2 as shown in figure 5), the tip portion of the needle punctures the ocular tissue at the injection site to reach the distal end of the needle to the target ocular tissue at the injection site (See 112 above. Paragraph 69 describes inserting the tip portion of the needle until it reaches the vitreous body of the eye, i.e. the target ocular tissue, in step 3 shown in figure 6).
Regarding claim 35, Paques discloses the invention as claimed and described above. Paques further discloses wherein one side of the clamping port is first brought into contact with the eye surface to become a pivot part (Figure 4 shows that the left side of the apparatus makes contact with the ocular tissue first, and thus the left side of the clamping port 112 with respect to figure 4 comes in contact with the ocular tissue and acts as a pivot part), then the clamping port is pivoted around the pivot part so that the needle pierces the eye tissue at the injection site (Figure 6 shows the clamping port is fully pivoted so that the needle 133 pierces the ocular tissue), and the clamping port is further pivoted so that the other side of the clamping port is brought into contact with the eye surface and the eye tissue forms a bulge into the sleeve (Figure 5 shows the right side of the apparatus, and thus the right side of the clamping port 112 is pivoted to make contact with the ocular tissue, and thus forms the bulge when pressure is applied to deploy the needle).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Paques et al. (US 2010/0010452) in view of Iwase et al. (US 2011/0166520).
Regarding claim 3, Paques discloses all the essential features of the invention as claimed and described above except wherein the clamping port has a minimum inner diameter of 1 mm-3 mm.
Iwase teaches wherein the clamping port has a minimum inner diameter of 1 mm-3 mm (paragraph 65 describes the adjustment unit diameter, i.e. clamping port diameter, is 3mm).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Paques’s invention to include wherein the clamping port has a minimum inner diameter of 1 mm-3 mm in order to prevent forming a blister when administering medication as suggested and taught by Iwase in paragraph 65.
Regarding claim 8, Paques discloses all the essential features of the invention as claimed and described above except wherein the needle tip portion has a blade length less than or equal to 550 micrometers.
Iwase teaches wherein the needle tip portion has a blade length less than or equal to 550 micrometers (paragraph 33 describes the blade length as .5mm, i.e. 500 micrometers).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Paques’s invention to include wherein the needle tip portion has a blade length less than or equal to 550 micrometers in order to use a standard injection needle as suggested and taught in Iwase paragraph 33.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Paques et al. (US 2010/0010452) in view of Eaton et al. (US 2014/0221970).
Regarding claim 7, Paques discloses all the essential features of the invention as claimed and described above except wherein the side wall of the sleeve is provided with a visible window of transparent material, or the sleeve is a transparent material member.
Eaton teaches wherein the side wall of the sleeve is provided with a visible window of transparent material, or the sleeve is a transparent material member (paragraph 9 describes the sleeve as clear or transparent).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Paques’s invention to include wherein the side wall of the sleeve is provided with a visible window of transparent material, or the sleeve is a transparent material member in order to allow visualization of the needle as suggested and taught by Eaton in paragraph 9.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Paques et al. (US 2010/0010452) in view of Cabiri et al. (US 2022/0047813).
Regarding claim 15, Paques discloses all the essential features of the invention as claimed and described above except wherein a needle seat is connected to the rear end of the sleeve; the needle seat is provided with an adjustment assembly comprising a telescopic rod assembly and a drive mechanism;
the telescoping rod assembly comprises an outer tube and an inner tube, one end of the outer tube is connected to the rear end of the needle holder and the other end is sheathed on the inner tube, and the other end of the inner tube is connected to the rear end of the needle; and the outer tube, the inner tube, and the needle are sequentially connected, or, the rear end of the needle passes sequentially through the inner and the outer tubes and outside the outer tube; and
the drive mechanism is connected to the inner tube to drive the inner tube axially relative to the outer tube, and the inner tube is capable of moving the needle.
Cabiri teaches wherein a needle seat (Figure 7J, 758) is connected to the rear end of the sleeve (646); the needle seat is provided with an adjustment assembly (767, 650 and 744) comprising a telescopic rod assembly (767 and 650) and a drive mechanism (Figure 7J, 744);
the telescoping rod assembly comprises an outer tube (767) and an inner tube (650), one end of the outer tube is connected to the rear end of the needle holder (Figure 7J shows the lower end of the outer tube 767 is connected to the rear end of the needle holder 647) and the other end is sheathed on the inner tube (Figure 7J), and the other end of the inner tube is connected to the rear end of the needle (Figure 7J shows the lower end of the inner tube 650 is connected to the rear end 648 of needle 660); and the outer tube, the inner tube, and the needle are sequentially connected, or, the rear end of the needle passes sequentially through the inner and the outer tubes and outside the outer tube (Figure 7J); and
the drive mechanism is connected to the inner tube to drive the inner tube axially relative to the outer tube, and the inner tube is capable of moving the needle (Figure 7J shows the drive mechanism moves the inner tube axially along 677 with respect to the outer tube and moves needle 660).
“When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person having ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product of innovation, but of ordinary skill and common sense.” KSR at 1397.
There had been a recognized problem or need in the art including a design need or market pressure to solve a problem. In this case, extending or retracting a needle can be accomplished by rotating couplings, telescoping transmission or a direct linear movement of a plunger as described by Cabiri in paragraph 286. One having ordinary skill in the art could have pursued the known potential options (rotating couplings, telescoping transmission or a direct linear movement) with a reasonable expectation of success.
Therefore wherein a needle seat is connected to the rear end of the sleeve; the needle seat is provided with an adjustment assembly comprising a telescopic rod assembly and a drive mechanism;
the telescoping rod assembly comprises an outer tube and an inner tube, one end of the outer tube is connected to the rear end of the needle holder and the other end is sheathed on the inner tube, and the other end of the inner tube is connected to the rear end of the needle; and the outer tube, the inner tube, and the needle are sequentially connected, or, the rear end of the needle passes sequentially through the inner and the outer tubes and outside the outer tube; and
the drive mechanism is connected to the inner tube to drive the inner tube axially relative to the outer tube, and the inner tube is capable of moving the needle would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product of innovation, but of ordinary skill and common sense”.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Paques et al. (US 2010/0010452) in view of Yamamoto et al. (US 2018/0250224).
Regarding claim 18, Paques discloses all the essential features of the invention as claimed and described above except wherein a needle seat is connected to the rear end of the sleeve, and a release assembly comprising a resilient member and a first stop member is provided between the sleeve and the needle seat; the sleeve is connected to the needle seat via the resilient member;
one end of the first stop member is detachably connected to the sleeve and/or the other end of the first stop member is detachably connected to the needle seat;
when the first stop member is connected to the sleeve and the needle seat, the resilient member is in a tensile state, capable of providing tension along the axial axis.
Yamamoto teaches wherein a needle seat (Figure 9, 6) is connected to the rear end (right end of 10 in figures 9 and 10) of the sleeve (Figure 10, 10), and a release assembly (Annotated figure 9) comprising a resilient member (9) and a first stop member (Annotated figure 9) is provided between the sleeve and the needle seat (Annotated figure 9); the sleeve is connected to the needle seat via the resilient member (Annotated figure 9);
one end of the first stop member (left end in figure 9) is detachably connected to the sleeve (Figure 9) and/or the other end of the first stop member (right end in figure 9) is detachably connected to the needle seat (Figure 9);
when the first stop member is connected to the sleeve and the needle seat, the resilient member is in a tensile state, capable of providing tension along the axial axis (Intended use, paragraph 73).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Paques’s invention to include wherein a needle seat is connected to the rear end of the sleeve, and a release assembly comprising a resilient member and a first stop member is provided between the sleeve and the needle seat; the sleeve is connected to the needle seat via the resilient member;
one end of the first stop member is detachably connected to the sleeve and/or the other end of the first stop member is detachably connected to the needle seat;
when the first stop member is connected to the sleeve and the needle seat, the resilient member is in a tensile state, capable of providing tension along the axial axis in order to maintain pressure of the tissue and apparatus as suggested and taught in paragraph 74.
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Claims 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Paques et al. (US 2010/0010452) in view of Van Damme et al. (US 2015/0073344).
Regarding claim 25, Paques discloses all the essential features of the invention as claimed and described above except wherein a thrust assembly is provided between the end of the pushrod and the medication container to apply a constant thrust at the pushrod.
Van Damme teaches wherein a thrust assembly (Figure 40, 8) is provided between the end of the pushrod (Far left portion of pushrod 6) and the medication container (reservoir 3) to apply a constant thrust at the pushrod (Intended use, paragraph 190 describes a constant force).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Paques’s invention to include wherein a thrust assembly is provided between the end of the pushrod and the medication container to apply a constant thrust at the pushrod in order to provide a system that is maximally comfortable for both the subject and the operator as suggested and taught by Van Damme in paragraph 190.
Regarding claim 27, Paques in view of Van Damme teach the invention as claimed and described above. Van Damme further discloses wherein the thrust assembly produces a constant thrust with a threshold value of no more than 6N (paragraph 190 describes a threshold of 4N).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Katheryn Malatek whose telephone number is (571)272-5689. The examiner can normally be reached Monday - Thursday, 9 am - 6 pm.
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/KATHERYN A MALATEK/ Primary Examiner, Art Unit 3741
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