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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS(s)) submitted on 9/19/24 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner, but where the documents in the IDS(s) will be considered in the same manner as other documents in Office search files while conducting a search of the prior art in a proper field of search.
Status of the Claims
Claims 1-11 are pending in the application.
Claim Objections
Claim 5, line 1, is objected to, where “the fluid flow restriction” should be “the fluid flow restriction means”. Appropriate correction is suggested.
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.
Claim 11 is 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 pre-AIA the applicant regards as the invention.
Claim 11 is considered indefinite for the use of the term “it” in line 1, where it is unclear what element “it” is, and where the term ophthalmic implant cannot be the element “it”, as the recited fluid flow restriction means is already one of the elements of the ophthalmic implant, also making the claim indefinite. Appropriate correction is required, replacing the term “it” with the element(s) of the ophthalmic implant recited that are “configured to be autoclaved or sterilized with the fluid flow restriction means element of claim 1.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4, 18, and 10-11 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for: failing to further limit the subject matter of the claim upon which it depends; OR for failing to include all the limitations of the claim upon which it depends. Another requirement is that the dependent claim must specify a further limitation(s) of the subject matter claimed. The test as to whether a claim is a proper dependent claim is that it shall include every limitation of the claim from which it depends (35 U.S.C. 112(d)), or in other words that it shall not conceivably be infringed by anything which would not also infringe the base claim. MPEP 608.01(n)(II)-(III).
Claims 4, 8, and 10-11 fail to include all of the limitations of the claims from which they depend. In claim 4, line 1, the term “The knot as in claim 3”, fails to include all of the limitations of claim 3; In claim 8, line 1, the term “The band as in claim 7”, fails to include all of the limitations of claim 7; and In claim 10, the term “The cable tie as in claim 9”, fails to include all of the limitations of claim 9. Appropriate correction is required, e.g., each of claims 4, 8, and 10, line 1, should recite “The ophthalmic implant as in claim [INSERT CLAIM]”.
Claim 11 fails to further limit the claim from which it depends, where dependent device claims must further limit the structure or function of at least one element of the claim(s) from which it depends. Appropriated correction is required, e.g., deleting claim 11 or amending claim 11 to recite a further structure or function that further limits claim 1, from which claim 11 depends (where method of making (sterilize or autoclave device) is not considered for patentability and thus fail to further limit the claim from which it depends).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
The claim limitation “fluid flow restriction means” (Claim 1, line 17) has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “means” or “means for” coupled with functional language “fluid flow restriction”, without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 11 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f), or pre-AIA 35 U.S.C. 112, sixth paragraph, limitation: the “fluid flow restriction means” (Claim 1, line 17) can be: a knot, cable tie, or clamp (Spec:[0090],ll.4; [0094],ll.1-3, original claims 3-4,7-8,9-10) or another tube (Spec:[0097],ll.1-2), where fluid flow restriction means occludes the drainage tube (Spec:[0077],ll.1-2; claim 2). If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq., including MPEP 2181, and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for ‘establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103 and potential 35 U.S.C. 102(a)(2) prior art under 35 U.S.C. 103. Claims 1-4 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Baerveldt (US 5476445 A) in view of Molteno (US 2007/0249984 A1).
As to claim 1, Baerveldt teaches an ophthalmic implant 10 (Fig.2-7; Col.5,ll.26-Col.13,ll.37, incorporated herein) for treating or alleviating the symptoms of glaucoma (Abstract), the implant 10 comprising:
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a. a plate 38 (plate/seton 38 Fig.2-7,6a-b; Col.5,ll.30) shaped to fit a portion of the surface of an eye when implanted (Col.5,ll.34-36), an inner ridge 66/69 (Figs. 6a, 6 & 7; Col.8,ll.8-10) located on [the] a a region (Fig.6) encompassed by the inner ridge 66/69 defines a primary drainage region 82 into which (through tube 41) fluid flow from an anterior chamber or posterior chamber of the eye is drawable in use (Fig.6,6a; Col.9,ll.3);
b. a secondary drainage region 40 outside the inner ridge 66/69 (Fig.6a) into which fluid from the primary drainage region 82 is receivable in use (Fig.6,6a; Col.8,ll.12-14;Col.7,ll.32-44); c. a hole 72 in the inner ridge 66/69 (Fig.7, Col.8,ll.14-20) having a size enabling a drainage tube 41 for draining the fluid from the interior chamber or the posterior chamber of the eye to the primary drainage region 82 (Col.9,ll.3) to be connected to the hole 72 so that fluid is transferable through the tube 41 and into the primary drainage region 82 (Fig.7; Col.9,ll.3-6), the secondary drainage region 40 is defined (as inside edges of 40 Fig.6a) by the inner ridge 66/69 and either the edge of the plate 38 or an outer ridge (as curved outer edge adjacent 70 of plate 38 Fig.6a) located on the
d. wherein the drainage tube 41 comprises a fluid flow restriction means 63/67 (Fig.2;Col.6,ll.54-57).
Baerveldt does not teach that the inner ridge is located on the upper convex surface of the plate (the inner ridge is located on the lower concave surface of the plate).
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However, in the same field, Molteno teaches an ophthalmic implant for treating or alleviating the symptoms of glaucoma (Abstract, Figs. 1-4; [0069]-[0079]), the implant 1 comprising:
a. a plate 3 shaped to fit a portion of the surface of an eye when implanted [0070], an inner ridge 5 located on the upper convex surface of the plate (Fig.1,4; [0071]), where a region encompassed by the inner ridge 5 defines a primary drainage region 6 into which fluid flow from an anterior chamber or posterior chamber of the eye is drawable in use (Fig.1,4; [0072]); b. a secondary drainage region 3 outside the inner ridge 5 into which fluid from the primary drainage region 6 is receivable in use (Fig.1,4; [0071]);
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c. a hole 15 in the inner ridge 5 having a size enabling a drainage tube 7 for draining the fluid from the anterior chamber or posterior chamber of the eye to the primary drainage region 6 to be connected to the hole 15 so that fluid is transferable through the tube 7 and into the primary drainage region 6 (Fig.1,4; [0074], [0077]), the secondary drainage region 3 is defined by the inner ridge 5 and either the edge of the plate (Fig. 1) or an outer ridge 16 located on the upper convex surface of the plate Fig.4,1;
wherein the height of the inner ridge 5 relative to the surface of the plate 3 is greater than the height of the outer ridge 16 relative to the surface of the plate (Fig.3,4; [0077],ll.7-9); in order to provide a greater fluid dispersion area within a single plate and tube device, a lower profile for easier implantation, and improved contact between the inner ridge and the overlying Tenon's tissue ([0078],ll.3-6). It would have been obvious to one of skill before the effective filing date to modify the plate of Baerveldt with inner ridge location on the upper convex surface of the plate according to Molteno, and one of skill would have been motivated to do so, in order to provide a greater fluid dispersion area within a single plate and tube device, a lower profile for easier implantation, and improved contact between the inner ridge and the overlying Tenon's tissue.
As to claim 2-3 and 9, Baerveldt teaches wherein the fluid flow restriction means occludes the drainage tube and wherein the fluid flow restriction on the drainage tube is comprised of a knot or tie (63/67; as fluid restriction of drainage tube with a suture teaches a knot or tie as provided with a suture, as required to restrict fluid flow; Fig.2; Col.6,ll.53).
As to claims 4 and 10, Baerveldt teaches wherein the knot or tie is made of a degradable suture (63; where suture as knot or tie is degradable as bioabsorbed or dissolvable Fig.2; Col.6,ll.63-65).
As to claim 11, Baerveldt does not specifically teach wherein [the device] (see 112 rejections of claim 11 above) is autoclaved or sterilized with the fluid flow restriction means attached (however, where method of making is not considered for patentability of device, AND/OR alternatively, where medical implant devices would necessarily, and required to, be autoclaved or sterilized prior to use).
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Baerveldt and Molteno in view of Chew (US 2017/0020730 A1).
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As to claims 5-8, Baerveldt and/or Molteno fail to specifically teach wherein the fluid flow restriction [means] on the drainage tube is comprised of a degradable band or clip.
However, Chew, in the same field, teaches an ophthalmic implant for treating or alleviating the symptoms of glaucoma (ocular drainage device for treating glaucoma, Abstract, [0001]; Fig.1A; [0058]-[0079]); comprising a plate 4 and [claims 5-8] a fluid flow restriction means as a cuff/band 18 surrounding drain tube 6 for restricting fluid flow along a drainage tube 6 Fig.1A [0066]; wherein: [claims 5-8] the fluid flow restriction on the drainage tube is comprised of a degradable band or clip (biodegradable cuff 18 positioned along a section of the length of the tube 6, covering the outer surface circumference defined by a section of the tube as biodegradable cuff 18 (thus forming a band or clip around the tube 6 ) [0066],ll.8-12; that restricts or controls fluid flow out the eye, order to prevent hypotomy prior to the formation of fibrous tissue over the plate 4 and prevent post-operative raised IOP at a later phase [0075]). It would have been obvious to modify the ophthalmic implant of Baerveldt and/or Molteno to provide the biodegradable band/cuff of Chew, and one of skill would have been motivated to do so, in order to prevent hypotomy prior to the formation of fibrous tissue over the plate 4 and prevent post-operative raised IOP at a later phase, and where it would also have been obvious to provide the cuff as a biodegradable clip as an obvious design choice within the skill of the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art, including, e.g.: Frankfort (WO 2013/155252 A1) (e.g., Fig.1,4; [0011]); and Pinchuk (US 2013/0184631 A1) (e.g., [0014]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to: GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri., 11 am to 6 pm Eastern Time. The direct fax number is (571) 270-4689.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA EISENBERG, can be reached on 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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.
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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