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 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:
“elastic unit” in claim 3 which, for examination purposes, has been interpreted as a spring or any structural equivalent thereof based on the specification (see paragraph [35]).
“fixing unit” in claim 5 which, for examination purposes, has been interpreted as an end cap or any structural equivalent thereof based on the specification (see paragraph [28] and fixing unit 350 in Fig.6).
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 6 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 6 recites “a pedestal…is seated on a surface of the eye,” thereby requiring the surface of the eye, which is a naturally occurring part of the body, to be a part of the claimed invention.
The Examiner recommends amending claim 6 so that it reads “a pedestal…configured to be [[is]] seated on a surface of the eye” to overcome this rejection.
Claim Rejections - 35 USC § 102
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 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 and 4-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryu et al. (US 2025/0186083 A1).
Regarding claim 1, Ryu discloses an aqueous humor outflow device insertion apparatus for inserting an aqueous humor outflow device for glaucoma treatment into an eye (see [0051], [0052] and Fig. 1), the apparatus comprising: a cylindrical housing (100, 200); an injection needle (10) which accommodates the aqueous humor outflow device (300, see Fig. 3A) therein and protrudes or retracts in a longitudinal direction of the housing through a sliding hole formed on a top of the housing to move between a first position and a second position (needle 10 moves between extended and retracted positions along a longitudinal direction of the housing in response to movement of the handle 30, see Fig. 5A-5C and [0059]); and a support (20) having a lower end fixed to the housing and an upper end inserted into the injection needle (guide pin 20 is fixed to the housing via support rod 50 and feed adjustment unit 70, see Fig. 7A and [0080]), wherein the support supports a lower portion of the aqueous humor outflow device accommodated in the injection needle (guide pin 20 supports a lower end of the implant 300, see Fig. 7B and [0078]), upon the injection needle protruding through the sliding hole to be placed in the first position (the implant 300 is supported by guide pin 20 when the needle is in the extended position of Fig. 7B), and the aqueous humor outflow device is exposed to an outside by movement of the injection needle and support of the support, upon the injection needle retracting through the sliding hole to move from the first position to the second position (the implant 300 is exposed to an outside of the device when the needle is retracted, see Fig. 9B).
Regarding claim 2, Ryu further discloses a slot (110, see Fig. 1) formed on a lateral side of the housing extends along the longitudinal direction, and a lever (30) connected to the injection needle and protruding outward through the slot moves together with the injection needle along the slot (handle 30 is connected to needle 10 and controls longitudinal movement of the needle, see [0059]).
Regarding claim 4, Ryu further discloses a buffer disposed between a lower end of the housing and a lever inside the housing prevents the injection needle from rapidly moving from the first position to the second position (the groove 111 is considered a buffer positioned between a lower end of the housing and the lever formed by handle 30 since it prevents unwanted longitudinal movement of the needle from the extended first position to the retracted second position, see [0090], [0091] and Fig. 5B).
Regarding claim 5, Ryu further discloses a fixing unit coupled to the lower end of the support is coupled to a lower end of the housing (feed adjustment unit 70 is considered a fixing unit which has been interpreted as an end cap under 35 U.S.C. 112f since feed adjustment unit 70 is an end cap coupled to a lower ended of the housing, see Fig. 2A and [0083]).
Regarding claim 6, Ryu further discloses a pedestal (121, see Fig. 11B) protruding from a lateral side of the housing is seated on a surface of the eye and prevents the housing from shaking upon the insertion of the injection needle (stopper 121 is configured to be seated on the surface of the eye and would provide stability to the device once seated on the eye to prevent shaking, see [0107]).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ryu, as applied to claim 2 above, and further in view of Singh (US 2017/0216092).
Regarding claim 3, Ryu discloses the apparatus of claim 2, wherein a locking portion (111, see Fig. 5B) is formed in the slot to prevent movement of the lever upon the injection needle being located in the first position (groove 111 prevents movement of the lever formed by handle 30 and thereby prevents movement of needle 10 from the extended first position to the retracted second position, see [0090] and [0091]).
Ryu fails to teach an elastic unit disposed between an upper end of the housing and the lever inside the housing provides an elastic force to move the injection needle from the first position to the second position.
Singh, in the same field of art, teaches a related device (100, see Fig. 1) a housing (102), a needle (outer sleeve 106 includes a penetrative tip 110, see [0031]) movable between a first position to second position (outer sleeve 106 can move between an extended first position and a retracted second position via movement of control member 114, see [0033]), a lever (114), and an elastic unit (there is a spring around outer sleeve 106, see Fig. 2) disposed between an upper end of the housing and the lever inside the housing provides an elastic force to move the needle from the first position to the second position (the spring biases the needle to the proximal, retracted position, see [0033]).
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 apparatus of Ryu to further include an elastic unit, as taught by Singh, since doing so would prevent unwanted deployment of the needle.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
All of the documents cited in the attached PTO-892 teaches related devices for inserting an implant into an eye.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
