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 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: “sliding element” (claim 1); “fixing element” (claims 1, 2 and 5); “connection portion” (claim 2); “sliding element connection portion” (claim 2); “one-touch fixing connection element” (claim 5).
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 § 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 1-15 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 1 recites the limitation "its first and second positions" in line 6. There is insufficient antecedent basis for this limitation in the claim.
In claim 1, it is unclear whether the “a sliding element” in line 11 is the same structure as the “a sliding element” recited in line 3 or not.
In claim 15 it is unclear what “a proximal end” is a proximal end of.
Claims 2-14 are rejected due to their dependence from 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 1-5, 7, 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 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 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) 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).
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]).
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hickingbotham et al. (US 2013/0178822).
Regarding claim 1, Hickingbotham et al. disclose a hollow shaft assembly (6/8; Figure 4) for use with an implantation device having a housing (4) 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 (1) and to be connected to a sliding element (11) at its proximal end, the hollow shaft being configured to retain an implant (103) within a portion thereof at its distal end Figure 12), 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 (¶[0239]); an implant (103) positioned in the distal end of the hollow shaft); and a fixing element (12) 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 (e.g. if 24 is removed).
Regarding claim 2, the fixing element comprises a connection portion configured to engage with a sliding element connection portion (13).
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 (the fixing element is asymmetrically shaped and can therefore indicate a correct orientation as claimed).
Regarding claim 5, the fixing element comprises a one-touch fixing connection element (a single touch can be part of the procedure of connecting the fixing connection element - screw hole).
Regarding claim 6, the hollow shaft comprises a substantially transparent plastics material, the substantially transparent plastics material comprising one of: a thermosetting plastics material and a thermoplastics material (¶[0034],[0095],[0234],[0267]).
Regarding claim 7, the hollow shaft comprises a biocompatible metal material (¶[0097]).
Regarding claim 8, the hollow shaft comprises a beveled tip (tip 91, Figure 19b, forms a bevel or angle with the remainer of the shaft).
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 (¶[0070], [0072]).
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 (member 33, Figure 6, can be regarded as a marking as claimed).
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 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).
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.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
If there are any inquiries that are not being addressed by first contacting the Examiner or the Supervisor, you may send an email inquiry to TC3700_Workgroup_D_Inquiries@uspto.gov.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THOMAS MCEVOY/Primary Examiner, Art Unit 3771