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 .
DETAILED ACTION
This paper is in response to papers filed 6/15/2026. Currently, claims 1-10 are currently pending, wherein claims 3, 6, and 7 are amended, and no claims are withdrawn are canceled. It is noted that claim 1 is an independent claim.
Therefore, claims 1-10 are under examination to which the following grounds of rejection are applicable.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to Chinese Patent Application No. 112110670, filed on March 22, 2023. The certified untranslated copy of Chinese Patent No. 112110670 was filed on 04/30/2024,
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non- English application.
Thus, the earliest possible priority for the instant application is March 22, 2023.
Response to Arguments
Maintained Objections/Rejections in Response to Applicants Arguments or Amendments
Claim Rejections - 35 USC § 112
Claims 3 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 3, it is indefinite in its recitation of the term “retina” in line 9 and lacks antecedent basis. Claim 1 recites that the biological tissue is from the eye, and claim 2 only recites “retinal tissue”.
Response to Arguments as they apply to the rejection of Claim 3 as being unpatentable over 35 U.S.C 112(b)
Beginning on page 1 of the remarks filed on June 15, 2026, Applicants essentially argue the following:
Applicant respectfully submits that the claims should be claims 3, 6 and 7 based on the detail comments of the rejections, and these rejections should be overcome by the amended claims 3, 6 and 7.
Applicant's arguments filed June 15, 2025 have been fully considered but they are not persuasive.
Regarding 1), although claim 3 has been amended to depend on the limitation of claim 2, there remains a lack of antecedent basis in regard to the term “the retina” as claim 2 only recites retinal tissue.
Claim Rejections - 35 USC § 103
Claim(s) 1-6, 8 and 10 remain rejected under 35 U.S.C. 103 as being unpatentable over Hirata et al. (Published: 2018. Trans Vis Sci Tech. 2018; 7(1):15. Cited in IDS filed 08/14/2024) and in further view of Dimenstein et al. (Published: 2016. Journal of Histotechnology, vol. 39, no. 3, 2 July 2016, pp. 76–80).
Regarding claim 1, Hirata describes a method for treating a specimen from a biological tissue, wherein the biological tissue is from an eye (page 4 col 1, "The ILM obtained during surgery for MH showed homogenous dense reticular membranous tissue in the observed sections"), wherein the specimen is immersed in a fixative solution (page 2 col 2, "Within 15 minutes after the ILM peeling, all specimens were immersion fixed in a mixture of 2.5% glutaraldehyde and 2% paraformaldehyde in 0.1 M cacodylate buffer (pH 7.4) for at least 2 hours and then stored for further preparation."), and embedding the specimen (Figure 1, Figure 1 caption :"lntraoperative findings and the embedded specimen. (A, B) After the application of brilliant blue G, ILM peeling with the ERM was performed as one sheet. (C) ILM was embedded as a whole mount in epoxy resin.)
However, Hirata fails to teach sandwiching the specimen into a carrier and placing a pad on the outside of the carrier.
Dimenstein discloses a method for a prostate needle biopsy utilizing the specimen sandwiched between filter paper (reading on a carrier), with pads placed on the outside of the paper (page 76, Abstract, “ If the cores were placed between the sponges and prevented from direct contact with the sponge by porous lens paper, such a ‘sandwich’ would be optimal for keeping the cores flat and would secure completeness of submission”).
It would have been obvious to incorporate Dimenstein’s steps of sandwiching the specimen into a carrier using filter paper, and placing the pad outside of the carrier before Hirata’s step of immersing the specimen in a fixative solution, to aid in treating a specimen from biological tissue, particularly because Dimenstein discloses that such combination would allow the cores to remain flat and keep them secure during downstream applications such as embedding. There would have been reasonable expectations of success in combining these teachings as one of ordinary skill in the art would recognize to combine known elements in the art to give predictable results.
Regarding claim 2, the combined teachings of Dimenstein and Hirata render obvious the claimed methodology. Moreover, Hirata teaches that the specimen is from retinal tissue (page 4, col 1, "The ILM obtained during surgery for MH showed homogenous dense reticular membranous tissue in the observed sections (Figs. 2A, 2B)").
Regarding claim 3, wherein the retina is claimed as a product by process of obtaining said retinal tissue by pars plan vitrectomy and/or macular surgery, it is noted that Hirata teaches that the retina was obtained through vitrectomy. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is noted that, if the prior art discloses identical chemical structure, the properties applicant discloses and/or claims are necessarily present, In re Spada, 911 F.2d 705, 709, 15 USPQ2d.
Regarding claim 4, the combined teachings of Dimenstein and Hirata render obvious the claimed methodology of claim 1. Moreover, Dimenstein teaches that the carrier comprises filter paper (Abstract, “ If the cores were placed between the sponges and prevented from direct contact with the sponge by porous lens paper, such a ‘sandwich’ would be optimal for keeping the cores flat and would secure completeness of submission”).
Regarding claim 5, the combined teachings of Dimenstein and Hirata render obvious the claimed methodology of claim 1. Moreover, Dimenstein teaches that the pad comprises a sponge pad (Abstract, “ If the cores were placed between the sponges and prevented from direct contact with the sponge by porous lens paper, such a ‘sandwich’ would be optimal for keeping the cores flat and would secure completeness of submission”).
Regarding claim 6, the combined teachings of Dimenstein and Hirata render obvious the claimed methodology of claim 1. Moreover, Hirata teaches that the fixative solution comprises ethanol (page 3 col 1, "After the staining, all specimens were dehydrated in an ethanol series, followed by infiltration of epoxy resin (Epon 812; TAAB Laboratories Equipment Ltd., Berkshire, UK) mixture, and polymerized for 72 hours at 60°C (Fig. IC).")
Regarding claim 8, the combined teachings of Dimenstein and Hirata render obvious the claimed methodology of claim 1. Moreover, Hirata teaches that after the embedding step, the specimen is sliced (page 3, col 1, "The surface of the embedded specimens was exposed using a diamond knife on an Ultracut E microtome (Leica, Wetzlar, Germany).").
Regarding claim 10, the combined teachings of Dimenstein and Hirata render obvious the claimed methodology. Moreover, Hirata teaches that the specimen is stained (page 2, col 2, "Subsequently, after the specimens were en bloc stained in a solution of 4% uranyl acetate solution overnight for contrast enhancement, they were washed with distilled water").
Response to Applicant Arguments as they apply to the rejection of claims 1-6, 8 and 10
under 35 USC § 103 in view of Hirata and Dimenstein
Beginning on page 1 of the remarks filed on June 15, 2026, Applicants essentially argue the following:
Hirata fails to disclose the method for treating a specimen from an eye as claimed in the claim 1 of the present application. Hirata is totally silent about the step of sandwiching the specimen into a carrier and the step of placing a pad on the outside of the carrier, not mention to the following steps of fixing and embedding the specimen with the carrier and the pad
Hirata merely teaches an eye specimen preparation method for the scanning electron microscope (SEM) examination. As stated in [0005] and [0006] of the specifications of the present application, Hirata applied the flat-mount preparation, which has limitations for the following pathological examination.
Dimenstein discloses a method for treatment of prostate needle biopsy. A person having ordinary skills in the art understands that the specimen from prostate tissue is totally distinct from that from eye tissue.
Applicant's arguments filed June 15, 2025 have been fully considered but they are not persuasive.
Regarding 1), with regard to Applicant’s argument that Hirata does not teach the entire claimed subject matter, the Examiner agrees. However, Hirata is not applied alone, but in combination with Dimenstein, and the claimed invention becomes obvious when the references are considered together as a whole rather than each alone. In the instant case, Hirata discloses a method preparing and mounting a specimen from internal limiting membrane, which is retinal tissue and satisfies the limitation of claim 1 that requires that the biological specimen is from the eye, es evidenced by Wikipedia (Internal limiting membrane. (2024). In Wikipedia.). As set forth above, the Examiner acknowledges that Hirata alone does not teach all the limitations of claim 1, however, Hirata is relied upon for the processing and preparation of ocular tissue (pp. 2, right col, para 3) immersing the specimen into a fixative solution, and embedding the specimen . Dimenstein satisfies the deficiencies of Hirata, by placing a tissue specimen (prostate) in between two porous lens papers with sponge pads outside the lens paper during tissue processing (pp. 78, right col, Figure 4). Moreover, Dimenstein teaches that this orientation of preparing the specimen would be “optimal for keeping cores flat and would secure completeness of submission” (pp. 78, Abstract). Therefore, the fact that Hirata does not independently disclose the carrier and pad does not overcome the combined teachings of Hirata and Dimenstein.
Regarding 2), Hirata expressly discloses that internal limiting membrane was embedded as a whole mount in epoxy resin, then divided into four quadrants for downstream analysis (pp. 3, Figure 1 caption, bottom of page). Therefore, Hirata does not disclose the preparation as flat-mount preparation discussed in the Specification of the instant application. Although Hirata ultimately uses the preparation method for scanning electron microscopy, the rejection is relied upon Hirata’s teachings of treatment of retinal tissue and mounting prior to such examination. Specifically, Hirata teaches that the specimens were fixed in a glutaraldehyde and paraformaldehyde solution, dehydrated, then embedded into epoxy resin (pp. 2 right col, para 3). It would have been obvious to incorporate Dimenstein’s steps of sandwiching the specimen into a carrier using filter paper, and placing the pad outside of the carrier before Hirata’s step of immersing the specimen in a fixative solution to aid in treating a specimen from biological tissue, particularly because Dimenstein discloses that such combination would allow the cores to remain flat and keep them secure during downstream applications such as embedding
Regarding 3), in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Dimenstein is not relied upon for the treat of prostate needle biopsy. Rather, Dimenstein is relied upon to satisfy the deficiencies of Hirata, wherein Hirata fails to teach sandwiching the specimen into a carrier with pads outside of the carrier. Dimenstein discloses a method of stabilizing the specimen in a carrier, by placing a tissue specimen (prostate) in between two porous lens papers with sponge pads outside the lens paper during tissue processing (pp. 78, right col, Figure 4). Moreover, Dimenstein teaches that this orientation of preparing the specimen would be “optimal for keeping cores flat and would secure completeness of submission” (pp. 78, Abstract). Therefore, a person with ordinary skill in the art would have been motivated to modify the method of treating a specimen. Moreover, in relation to applicants’ remarks at page 2 “ For example, 18 gauge needle is used for prostate biopsy and the obtained specimen generally has at least 2 cm oflength”, the claimed retinal biological tissues does not require any length. Hence the argument is not persuasive as they argue limitations that are not present in the claims.
***
Claim(s) 1 , 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hirata et al. (Published: 2018. Trans Vis Sci Tech. 2018; 7(1):15. Cited in IDS filed 08/14/2024) in view of Dimenstein et al. (Published: 2016. Journal of Histotechnology, vol. 39, no. 3, 2 July 2016, pp. 76–80) as applied to claim 1 above , and in further view of Sunny et al. (Published: 2021. Indian Journal of Pathology and Microbiology 64(1):p 102-106)
Regarding claim 1, the combined teachings of Dimenstein and Hirata render obvious the claimed methodology of claim 1 render obvious the claimed methodology, as iterated above in the 103 rejection the content of which is incorporated herein, in its entirety. Moreover, Hirata teaches that after dehydratation of the specimen in ethanol series, the specimen was infiltrated (embedded) with epoxy resin (page 3, col.1)
However, the combined teachings of Hirata and Dimenstein fail to teach the immersing step further comprising transferring the specimen with the carrier and the pad into an embedding tissue cassette, and immersing the embedding tissue cassette into a fixative solution.
Regarding claims 7 and 9, Sunny teaches a method for performing an optimal core needle biopsy, comprising an immersion step of transferring the specimen with the carrier and the pad into an embedding tissue cassette, and immersing the embedding tissue cassette into a fixative solution, wherein the fixative solution comprises of formalin (page 103, col 2 “Subsequently, the cassettes with tissue cores placed between the two foam pieces were sealed and dropped into containers containing 10% buffered neutral formalin for fixation overnight.”).
It would have been obvious to one of ordinary skill in the art to modify the order of the steps of fixation and embedding of a tissue taught by Hirata and Dimenstein with the steps of Sunny comprising embedding the tissue into an embedding tissue cassette and then immersing the embedding tissue cassette into a fixative solution as the order of steps are two alternatives for embedding and fixing specimens and be used for downstream applications. There would have been reasonable expectations of success in combining these teachings as one of ordinary skill in the art would recognize to combine known elements in the art to give predictable results.
Response to Applicant Arguments as they apply to the rejection of claims 1-6, 8 and 10
under 35 USC § 103 in view of Sunny
Beginning on page 1 of the remarks filed on June 15, 2026, Applicants essentially argue the following:
Sunny also discloses a method directed to the treatment of prostate needle biopsy specimens. Thus, Sunny cannot cure the deficiencies of the combination of Hirata and Dimenstein. Accordingly, claim 1 of the present application is patentable over Hirata in view of Dimenstein, and further in view of Sunny.
Applicant's arguments filed June 15, 2025 have been fully considered but they are not persuasive.
Regarding 1), in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Sunny is relied upon for the deficiency of the immersing step further comprising transferring the specimen with the carrier and the pad into an embedding tissue cassette and immersing the embedding tissue cassette into a fixative solution. Essentially, Sunny teaches a method for performing an optimal core needle biopsy, comprising an immersion step of transferring the specimen with the carrier and the pad into an embedding tissue cassette, and immersing the embedding tissue cassette into a fixative solution, wherein the fixative solution comprises of formalin (page 103, col 2, para 2). Furthermore, Sunny teaches that this modified procedure influenced histologic yield and improved intactness of the core (pp. 105, col 1, para 2). Moreover, Sunny reveals that this method is cost-effective and decreases the number of patients that would have to do repeat biopsies (pp. 105 col 2 para 2). Therefore, a person with ordinary skill in the art would have been motivated to modify the method of Hirata, to further comprise the limitation of claim 9 to present a cost-effective method of analyzing biopsies without having to extract for samples from patients.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Katriel B Kasayan whose telephone number is (571)272-1402. The examiner can normally be reached 10-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria G Leavitt can be reached at (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATRIEL BARCELLANO KASAYAN/ Examiner, Art Unit 1634
/MARIA G LEAVITT/ Supervisory Patent Examiner, Art Unit 1634
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