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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 17th 2026 has been entered.
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.
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: “sliding element” (claim 1; interpreted as equivalents to Applicant’s member 370); “connection portion” (claim 2; interpreted as equivalents to Applicant’s member 735d); “sliding element connection portion” (claim 2; interpreted as equivalents to Applicant’s member 675); “one-touch fixing connection element” (claim 5; interpreted as equivalents to Applicant’s member 635).
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 § 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.
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 1-5, 7, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Conston et al. (US 2006/0149194).
Regarding claim 1, Conston et al. disclose a hollow shaft assembly (1; Figure 1) capable of use with an implantation device having a housing comprising: a hollow shaft (1) having a distal end and a proximal end and being configured to be mounted over the distal end of a fixed shaft (4; e.g. the shaft is fixed to member 5) and to be connected to a sliding element at its proximal end (a sliding element of some design could be connected to member 1 or 2; the sliding element being interpreted under 35 U.S.C. 112(f) as being a structure capable of sliding over a fixed shaft in order to guide movement of a hollow shaft connected thereto), the hollow shaft being configured to retain an implant within a portion thereof at its distal end (¶[0033], [0043]), the hollow shaft being configured to be retracted over the fixed shaft by movement of the sliding element from its first to second positions to release the implant from within distal end of the hollow shaft (a sliding element and housing of some design could be made to retract the hollow shaft over the fixed shaft as claimed); an implant positioned in the distal end of the hollow shaft (¶[0033], [0044]); and a fixing element (2; interpreted under 35 U.S.C. 112(f) as any structure capable of fixing a fixed shaft to a housing) to which the hollow shaft is connected, wherein the fixing element is configured for insertion into the housing over the fixed shaft and for engagement with a sliding element within the housing (a housing and sliding element could be designed to allow for the claimed insertion).
Conston et al. fail to disclose that the fixing element has a shape that permits its insertion into the housing in only a single rotational orientation relative to the housing. However, Conston et al. disclose that the fixing element can be a Luer fitting (¶[0022]).
Official notice is taken that it is known in the art to provide a Luer fitting with an asymmetric proximal end-shape that would only allow its insertion into a hole or housing in a single rotational orientation. Evidentiary support is given by Timm (US 2009/0149527; Figure 2; ¶[0030]). Further evidentiary support can be provided.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the Luer fitting of the fixing element of Conston et al. with a known asymmetrical proximal end-shape in order to take advantage of this known cross-sectional shape for Luer fittings. This modification would only allow the fixing element to be inserted into at least some appropriately designed housings in a single rotational orientation.
Regarding claim 2, the fixing element comprises a connection portion (any of the cylindrical portions of 2, distal to the proximal end, can be regarded as an indented fixing portion as claimed) configured to engage with a sliding element connection portion.
Regarding claim 3, the connection portion of the fixing element comprises an indent providing at least two engagement surfaces, and, the sliding element connection portion comprises at least two end portions configured to be pushed apart by the insertion of the fixing element, the at least two end portions being configured to provide engagement surfaces which engage with the engagement surfaces of the fixing element (any of the cylindrical portions of 2, distal to the proximal end, can be regarded as an indented fixing portion having engagement surfaces capable of mating with an appropriately designed sliding element as claimed).
Regarding claim 4, the fixing element comprises a body portion having a surface thereof configured to indicate a correct orientation for insertion of the fixing element into the housing (any surface of 2 can be regarded as the body portion and its relative alignment with a suitably constructed housing can be used to indicate a correct orientation for insertion as claimed).
Regarding claim 5, the fixing element comprises a one-touch fixing connection element (e.g. the proximal end flange can be connected within a suitably designed sliding element for one-touch insertion to serve as the connection element as claimed).
Regarding claim 7, the hollow shaft comprises a biocompatible metal material (¶[0025]).
Regarding claim 9, the distal end of the hollow shaft is configured to be flexible to match the curvature of ocular tissues of the eye where the implant is to be implanted (¶[0021]).
Regarding claim 10, the hollow shaft comprises at least one marker indicating an insertion depth for the posterior space with respect to an anterior chamber of the eye (¶[0023]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Conston et al. (US 2006/0149194) in view of Hickingbotham et al. (US 2013/0178822).
Regarding claim 6, Conton et al. fail to disclose that the hollow shaft comprises a substantially transparent material as claimed.
Hickingbotham et al. teath that a hollow shaft of an ophthalmic cannula can be transparent as claimed in order to allow visualization of an item therein in order to improve deployment position and orientation (¶[0034], [0095], [0234], 0267]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Hickingbotham et al. to have made the hollow shaft of Conston et al. from a transparent material as claimed in order to improve deployment position and orientation of the implant.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Conston et al. (US 2006/0149194) in view of Weiss (US 9,949,875).
Regarding claim 8, Conston et al. fail to disclose that the hollow shaft have a beveled tip. Conston et al. disclose that the hollow shaft may be used to create a tissue tract (¶[0030]).
Weiss teach that a hollow shaft for an ophthalmic cannula can have a beveled tip in order to pierce tissue (col. 5, lines 5-15; Figure 10B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Weiss to have provided the hollow shaft of Conston et al. with a beveled tip in order to allow it to pierce tissue to create a tissue tract.
Claims 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Conston et al. (US 2006/0149194) in view of Silvestrini (US 2012/0310137).
Regarding claim 11, Conston et al. disclose that the implant is an intraocular implant for providing a drainage pathway between the anterior chamber of the eye to a posterior part of the eye (Abstract, ¶[0033], [0032], [0043]) but fail to disclose that the implant comprises a biocompatible polymer scaffold that defines an array of interconnected pores having similar diameters wherein the implant has a substantially cylindrical shape with an elliptical cross-section.
Silvestrini discloses an intraocular implant (100, 500) for providing a drainage pathway between the anterior chamber of the eye to a posterior part of the eye (¶[0041]) comprising a biocompatible polymer scaffold that defines an array of interconnected pores (¶[0060]) having similar diameters (claim 5) wherein the implant has a substantially cylindrical shape with an elliptical cross-section (¶[0042]). The implant promotes tissue ingrowth, prevents scarring and prevents unwanted migration (¶[0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have adapted the implant of Silvestrini to serve as the implant of Conston et al. in order to promote tissue ingrowth, prevents scarring and prevent unwanted migration.
Regarding claim 12, Silvestrini discloses that the mean diameter of the pores is 20-60 μm but fails to specifically disclose that the mean diameter of the pores is in a range between 25 μm and 36 μm.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the implant such that the mean diameter of the pores is between 25 μm and 36 μm since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 13 and 14, Silvestrini discloses that the implant has a length between 3 mm and 9 mm (¶[0100]) but fails to disclose that it has a thickness between 0.3 mm and 1 mm and a width between 0.5 mm and 2 mm. However, Silvestrini discloses that the implant may be rectangular or oval (¶[0042]) and can have a cross-sectional area within 0.1 mm2 to 3.0 mm2 (¶[0100]; the cross-sectional areas produced by the dimensions claims 13 and 14 being within this range). It is well-known in the art that the size of biomedical implants is a result effective variable, where changing the dimensions results in an implant that fits patients with differing anatomies with the least amount of disruption or discomfort. 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 of Silvestrini (as applied to Conston et al.) by making the length 5mm and the width and thickness within the claimed range as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, Applicant has placed no criticality on these claimed values/ranges, simply stating that the implant “may” utilize the claimed ranges for the dimensions and that a “preferred embodiment” has the specific recited dimensions (Specification, ¶[0110]).
Regarding claim 15, a marker or markers are located in a proximity of a proximal end of the implant (¶[0072], [0116] of Silvestrini).
Response to Arguments
Applicant's arguments filed September 3rd 2025 have been fully considered but they are either moot in view of the modified grounds of rejection above or are not persuasive. Applicant has argued that the above terms should not be interpreted under 35 U.S.C. 112(f). The claimed “fixing element” has been structurally modified by claim 1 such that it is no longer interpreted under 35 U.S.C. 112(f). It is respectfully asserted that the enumerated properties listed by Applicant do not impose any structural limitations that would prevent the above interpretation for the remaining terms. It is noted that the “one-touch fixing connection element” of claim 5 does not depend from claims 2 or 3. The “connection portion” of claim 3 has not been interpreted under 35 U.S.C. 112(f).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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