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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/26/25 has been entered.
Claims 1-11, 13-20 remain pending, of which claims 2-4 were previously withdrawn.
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 liquid leaking hole is a through hole 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.
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: buffer liquid conveying device in claims 16-17.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5-11, 13-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The amendment to claim 1, recites “the liquid leaking hole is a through hole” which is not found in the present Specification as filed nor drawings. Despite Applicant’s statement on pg. 6 of the remarks that the amendments have support based on paragraphs [0041], [0048] and Fig 2, the term “through hole” is not found in either paragraph, nor is there any liquid leaking hole in the auxiliary baffle depicted in Figure 2. Further it is noted that paragraph [0041] discloses a liquid leaking hole on the blocking plate 2, not a liquid leaking hole on the auxiliary baffle as currently claimed.
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.
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.
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.
Claim(s) 1, 5-8, 16-18, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over NEUSIDL (US 20100274257) in view of NIGAM (US 2002/0029981)(newly cited).
Regarding claim 1, NEUSIDL discloses a tissue inserter (transfer device) comprising an instrument 10 (transfer device body), the instrument has a hollow rigid tube like a barrel or handle 12 containing an irrigation tube 53 (picking up plate) with a tissue holder or transfer chamber 14 at the distal end of the irrigation tube (carrying plate); wherein the tube 12 is fixedly connected to a first edge portion of the tissue holder 14, such that it is configured to drive the tissue holder to move, the tissue holder being configured to retrieve tissue (pick up) and carry it to a recipient (Fig 1, 13 0042, 0065) but does not explicitly disclose the device further comprises an auxiliary baffle configured to assist transfer of the object, the baffle provided with a liquid leaking hole.
However, NIGAM discloses an implant storage tool (transfer device) (0015) comprising an implant applicator tool 19 (transfer device body) comprising an implant applicator member 45 (carrying plate), with a handle (picking up plate) and a retaining member 16 (auxiliary baffle) configured to assist transfer of the object to be transplanted to the member 45 and prevent it from falling off (0040), the retaining member 16 (auxiliary baffle) has a plurality of fluid communication openings 18 (liquid leaking holes) that are through holes, including one located on the upper tab (end of baffle close to plate is provided with liquid leaking hole) (Fig 2, 4, 13, 0044, 0051).
It would have been obvious to one of ordinary skill in the art to modify the device of NEUSIDL to further include the retaining member (auxiliary baffle) as disclosed by NIGAM because the retaining member (auxiliary baffle) forms an implant enclosure which is operable to retain the implant while immersed in a storage fluid and also is detachable, providing a user with ready access to the implant (0040).
Regarding claim 5, NEUSIDL discloses the irrigation tube (picking up plate) and the tissue holder can be integrated (formed into an integral structure) (0062).
Regarding claim 6, NEUSIDL does not explicitly disclose the carrying plate is provided with at least one liquid leaking hole. However, NIGAM discloses the applicator member 45 (carrying plate) surface 42 has a plurality of openings 22 that allow for drawing off the fluid on the surface through to the underside of the openings (at least one liquid leaking hole configured to allow the liquid on the plate to leak) (0041, 0054, Fig 3, 12). It would have been obvious to one of ordinary skill in the art to modify the platform of NEUSIDL to the openings of NIGAM because it allows the surgeon to properly align the implant on the surface (0054) and rest the implant firmly against the applicator tool surface (0011).
Regarding claim 7-8, NEUSIDL discloses the instrument (transfer device body) further comprises tissue holder flaps 22 (at least one blocking plate) with an end of the flaps fixedly connected to a second edge portion of the tissue holder 14, the second edge portion does not overlap the first edge portion and the flaps will block the tissue to be transplanted from sliding out of the holder (Fig 5a, 0043).
Regarding claim 16, 17, buffer liquid conveying device is interpreted under 35 USC 112f as stated above to be a buffer bottle or box (spec. 0053). NEUSIDL discloses the instrument has irrigation channels 40 or tube 53 (fixed to picking up plate) connected to an irrigation supply (buffer liquid conveying device) at one end (0049) and a forward end (proximal carrying plate) with a hemispherical closure 53a (liquid outlet) (0057) that provide fluids to the platform 14, if the tissue sticks or resists unfolding (configured to output a buffer liquid such that the object moves under driving of the buffer liquid) (0044, Fig 7-8).
Regarding claim 18, 20, NEUSIDL discloses the instrument and its components (transfer device and carrying plate) can be made from many materials including steel (non-transparent material, stainless steel) or polymers (0065).
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over NEUSIDL (US 20100274257) in view of newly cited NIGAM (US 2002/0029981) as applied above, and further in view of ZONGBIAO (CN203182762), paragraphs cited from the attached translation document.
Regarding claim 9-11, NEUSIDL discloses the tissue holder flaps 22 (at least one blocking plate) as stated above, but does not explicitly disclose the flaps have at least one liquid leaking hole.
However, ZONGBIAO discloses a spatula (transfer device) comprising a handle (picking up plate) integrally connected to one edge of a shovel body (carrying plate), the shovel body has sidewall (blocking plate) connected to a second edge portion of the body, the sidewall having circular filter bores therein (liquid leaking holes) that allow a fluid to drain (Fig 1, 0006, 0015). It would have been obvious to one of ordinary skill in the art to modify the platform of NEUSIDL to include the sidewalls having filter bores as taught by ZONBIAO because they would allow draining of excess fluid in the sample by tilting the device backward, and therefore retaining the sample, instead of through the open leading edge of the platform which could cause the sample to inadvertently slide out.
Claim(s) 13-15, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over NEUSIDL (US 20100274257) in view of newly cited NIGAM (US 2002/0029981) as applied above, and further in view of FURNESS (US 2881500).
Regarding claims 13-15, NEUSIDL discloses the instrument (transfer device body) further comprises tissue holder flaps 22 (at least one blocking plate) with an end of the flaps fixedly connected to a second edge portion of the tissue holder 14, (Fig 5a, 0043), but does not explicitly disclose an auxiliary baffle matched with the shape of a third edge portion, or the details of the third edge portion as claimed. However, FURNESS discloses a clamp for holding a cornea (transfer device) with a supporting end 2 (carrying plate) and securing end 3 (auxiliary baffle) that is configured to assist transfer of the cornea on the supporting end (carrying plate), the securing end shape matches the shape of a third edge portion of the supporting end, the securing end has an aperture that allows it to be placed over the supporting end’s curved portion (blocking plate) without fully overlapping it, and when combined constitute the entire edge of the supporting end (Fig 1-3). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the instrument of NEUSIDL to have the auxiliary baffle as taught by FURNESS because it provides an inexpensive instrument to hold the desired tissue firmly (Col. 1, lines 37-47).
Regarding claim 19, NEUSIDL discloses the platform 14 has a blunted spade like shape with a convex leading edge that has a radius of curvature (0045, Fig 8) but does not explicitly disclose the surface of the platform (carrying plate) is a circular surface.
However, FURNESS discloses a clamp for holding a cornea (transfer device) with a supporting end (carrying plate) having a circular shape (Fig 1, 2). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the shape of the platform of NEUSIDL to be circular as taught by FURNESS in order to match the shape of the tissue it supports. Additionally, shape of the claimed carrying plate surface is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration was significant (MPEP 2144.04).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 5-11, 13-20 have been considered but are moot because the new ground of rejection (over NIGAM) does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument (directed to MAEDA).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. NIGAM (US 2013/0123916) is cited as it discloses a transfer device body and auxiliary baffle with liquid leaking hole which is a through hole, as relates to applicant’s invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIELLE B HENKEL/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799