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 (IDS) submitted on 09/01/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure is being considered by the examiner. Note: CN 207519503 U was provided, but not listed on the IDS. The associated document and machine translation have been provided by the examiner and cited in the 892.
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 elastic buckle in claim 7 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 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 4-9 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 4 recites the limitation "the front-end sheet" in the second line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Furthermore, claim 4 recites the limitation “the second recess is located at a rear end of the first recess”. It is unclear how the position of the second recess is with respect to the first. Thus, if the second recess is located adjacent to the first recess, this will be viewed as satisfying this claim limitation.
Claim 5 recites the limitation "the front-end sheet" in the second line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation “the first annular boss being located at a rear end of the second annular boss”. It is unclear how the position of the first annular boss is with respect to the second annular boss. Thus, if the first annular boss is located along the same body as the second annular boss, this will be viewed as satisfying this claim limitation.
Claim 7 recites the limitation “an inner sleeve comprises an the elastic buckle engaged with the first annular boss and second annular boss”. It is unclear what structure entails an elastic buckle. Furthermore, the drawings provided fail to distinctly show the structure of the elastic buckle of the sleeve. Thus, a latching device will be viewed as satisfying this claim limitation.
Claim 8 recites the limitation "the elastic buckle " in the first line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the front-end sheet" in the second line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the elastic buckle " in the first line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the front-end sheet" in the second line of the claim. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Inui et al. (US 20190141986 A1) (already referenced in IDS) in view of Butler et al. (US 20110275153 A1) (already referenced in IDS).
Regarding claim 1, Inui et al. teaches a vessel (carrier) for cryopreservation (device 1, See annotated Figure 1A), specifically for use in the cryopreservation by vitrification of cells or embryos (biological tissue) (abstract), comprising:
a carrier rod body (main grip 10, connector 11, thin sheet part 12, tip part 13, and grip 17 - Figure 1A) (para. [0054])
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wherein a front end of the carrier rod body (thin sheet part 12) comprises a first recess (recess 15) for an embryo to be placed therein (“it is easier to insert a fertilized egg into a recess 15 when the thin sheet part 12 has the ability to bend to a near-horizontal state when dipping the recesses 15 on the vessel for cryopreservation by vitrification 1 into a shallow culture plate” - para. [0058]).
Inui et al. fails to teach the following limitation:
A sleeve sleeved on the carrier rod body
Butler et al. teaches a device (10) for cryogenically preserving biological matter, specifically for enclosing a volume of biological material within the device (para. [0019]). Butler et al. specifically teaches a sheath (element 60, interpreted as the sleeve) that can be slid to the proximal end portion 22 of the shuttle 20, which exposes trough 40 for convenient placement of the biological sample (para [0038]). Butler et al. teaches that placement of a biological sample M upon the trough 40 and properly aligning the sheath 60 with respect to the shuttle 20 is an easy and rapid process (para. [0038]).
It would have been obvious to one of ordinary skill in the art at the time of filing to use Butler et al.’s teaching of a sliding sleeve in Inui et al.’s vessel for cryopreservation because the sleeve exposes the trough or recess for convenient placement of the sample. This allows placement of the sample and aligning the sheath with respect to the shuttle to be easy and rapid. This method of improving Inui et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Butler et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Butler et al. and Inui et al. to obtain the invention specified in claim 1.
Regarding claim 2, modified Inui et al. teaches the carrier according to claim 1. Inui et al. also teaches wherein the angle between the wall and the bottom of the first recess is less than or equal to 90° (See annotated FIG. 3B below, which displays a cross-sectional view of the recess, which is less than or equal to 90°).
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Regarding claim 3, modified Inui et al. teaches the carrier according to claim 1. Inui et al. also teaches wherein the carrier rod body that comprises a front-end sheet (thin sheet part 12) and rear-end carrier rod (main grip 10 and grip 17), and the first recess is on the front-end sheet (recess 15, located on the thin sheet part 12). (See annotated FIG. 1A below, which displays thin sheet part 12 (front-end sheet) and main grip 10 & grip 17 (rear-end carrier rod).
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Regarding claim 4, modified Inui et al. teaches the carrier according to claim 1. Inui et al. also teaches a second recess is on the front-end sheet (See annotated FIG. 1A above, recesses 15), and the second recess is located adjacent to the first recess.
Regarding claim 5, modified Inui et al. teaches the carrier according to claim 4. Modified Inui et al. fails to teach that the second recess runs through an upper surface of the front-end sheet. Butler et al. teaches of a recess (trough 40) that extends through the upper surface of the shuttle 20 (para. [0020]), as the trough 40 is configured such that a sample completely fits within the void created within the trough 40 (para. [0022]). Butler et al. also teaches that “trough 40 is configured such that a nominal biological sample M placed thereon is not disturbed when the sheath 60 is initially slid over and removed from the shuttle 20.” (para. [0022).
It would have been obvious to one of ordinary skill in the art at the time of filing to use Butler et al.’s teaching of a recess that runs through an upper surface (trough 40) in Inui et al.’s vessel for cryopreservation because the trough would allow the biological sample to not be disturbed when the sheath (sleeve) is slid over and removed from the shuttle. This method of improving Inui et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Butler et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Butler et al. and Inui et al. to obtain the invention specified in claim 5.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Inui et al. (US 20190141986 A1) (already referenced in IDS), Butler et al. (US 20110275153 A1) (already referenced in IDS) as applied to claim 1, and in further view of Xue et al. (CN 109430245 A – Machine Translation provided) (already referenced in IDS).
Regarding claim 6, modified Inui et al. teaches the carrier according to claim 1. Modified Inui et al. fails to teach that the carrier rod body comprises of annular bosses. Xue et al. teaches of an annular boss (element 31) in their vitrification refrigeration carrier device (para. [0002] of MT). The annular boss (element 31) forms the connection between the support rod and the handle, and prevents the sleeve from slipping out of the support rod (para. [0024] of MT).
It would have been obvious to one of ordinary skill in the art at the time of filing to use Xue et al.’s teaching of an annular boss in Inui et al.’s vessel for cryopreservation because the annular boss would prevent the sleeve from slipping out of the support rod. Furthermore, it has been established that duplication of parts is unpatentable (See MPEP § 2144.04 VI). The addition of a second annular boss would amount to duplication of the annular boss element. This method of improving Inui et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Xue et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Inui et al. and Xue et al. to obtain the invention specified in claim 6.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Inui et al. (already referenced in IDS), Butler et al. (already referenced in IDS), Xue et al. (already referenced in IDS) as applied to claim 6, and in further view of Rao et al. (CN 207519503 U with attached Machine Translation) (Note: this document was provided but was not listed on the IDS – it has been listed on the 892).
Regarding claim 7, modified Inui et al. teaches the carrier according to claim 6. Modified Inui et al. fails to teach that the inner surface of the sleeve comprises an elastic buckle engaged with the first annular boss and second annular boss. Rao et al. teaches a latching device (interpreted as buckle device) arranged on the sleeve (element 13) for their vitrification cryopreservation carrier for human embryos and oocytes (para. [0002]). Rao et al. also teaches that the latching device includes a plurality of latching pins, which latch the sleeve (element 13) onto the rod body (element 11) (para. [0041]).
It would have been obvious to one of ordinary skill in the art at the time of filing to use Rao et al. teaching of a buckle built into the sleeve in modified Inui et al.’s device with annular bosses because the buckle would allow the sleeve to latch onto the rod body (including the annular bosses). This method of improving Inui et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Rao et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Rao et al. and Inui et al. to obtain the invention specified in claim 7.
Regarding claim 8, modified Inui et al. teaches the carrier according to claim 6. Modified Inui et al. fails to teach that when the first annular boss is engaged by the buckle, the front-end sheet of the carrier rod body is exposed outside the sleeve. Butler et al. teaches a proximal end or step (element 82, being interpreted as the first annular boss), as sheath (element 60, interpreted as the sleeve) can be positioned or moved towards proximal end portion (element 22) for convenient placement of a biological sample (para. [0038]). Figure 1A also displays the configuration where the sheath is disposed over the proximal end of the shuttle with the trough exposed (para. [0009]), which emulates the state where “the front-end sheet of the carrier rod body is exposed outside the sleeve.”
It would have been obvious to one of ordinary skill in the art at the time of filing to use Butler et al.’s teaching of a first annular boss and sleeve in modified Inui et al.’s device with a buckle because moving the sleeve to the first annular boss would allow for convenient placement of the biological sample. This method of improving Inui et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Butler et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Butler et al. and Inui et al. to obtain the invention specified in claim 8.
Regarding claim 9, modified Inui et al. teaches the carrier according to claim 6. Modified Inui et al. fails to teach that when the second annular boss is engaged by the buckle, the front-end sheet of the carrier rod body is covered by the sleeve. Butler et al. teaches a flared distal tip (element 24a – interpreted as a second annular boss) on the carrier rod body (shuttle 20) (para. [0039]). Butler et al. teaches that this distal end portion is configured such that the sheath 60 (interpreted as sleeve) is retained upon the shuttle (element 20) (para. [0039]). Figure 1 also displays the configuration where the sheath encloses the trough (para. [0008]) – which emulates the state where “the front-end sheet of the carrier rod body is covered by the sleeve”.
It would have been obvious to one of ordinary skill in the art at the time of filing to use Butler et al.’s teaching of a second annular boss and sleeve in modified Inui et al.’s device with a buckle because moving the sleeve to the second annular boss (flared distal tip) would place the sheath in a position that encloses the recess (trough) (FIG. 1), while the second annular boss (flared distal tip) allows the sheath (sleeve) to be retained upon the shuttle. This method of improving Inui et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Butler et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Butler et al. and Inui et al. to obtain the invention specified in claim 9.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIUS FRANCIS YOH whose telephone number is (571)272-3489. The examiner can normally be reached Monday-Friday: 7:30-5 PM.
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/JULIUS FRANCIS YOH/Examiner, Art Unit 1799 /William H. Beisner/Primary Examiner, Art Unit 1799