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 .
Responses to Arguments
Applicant’s arguments are NOT persuasive to overcome rejection of claims 11 and 15-16 as set forth in the most recent office action mailed 04/29/2026. Hence, the rejections of claims 11 and 15-16 are maintained.
On page 7 of remarks of 07/21/2026, applicant argues that modifying the angle of the inlet port modifies the operation of the device; namely, changing tissue sample transportation when compared to a horizontal inlet axis. Thus, the proposed modification of Flagle as asserted by the Office Action is not obvious and is not a mere rearrangement of parts. Examiner disagrees because the reference of Flagle does not positively state that the angle formed by having the inlet axis extending radially relative to the longitudinal axis and intersecting the longitudinal axis cannot be bent/changed from a right angle to an acute angle. The reference of Flagle also did not state that bending or changing the angle to an acute angle will destroy the operation of Flagle. Changing tissue sample transportation when compared to a horizontal inlet axis does not stop the reference of Flagle from capturing the tissue sample. Hence, modifying the angle of the inlet port does not modify the operation of the device i.e. capturing the tissue sample.
On page 7 of remarks of 07/21/2026, applicant argues that the inlet axis being disposed at an angle relative to a horizontal plane that is orthogonal to the longitudinal axis is a configuration that "reduces tissue sample movement as it passes through the entry port and facilitates the tissue sample exiting the entry port in an orientation that lays the tissue sample substantially flat in the tissue storage compartment for imaging." It is noted that the features upon which applicant relies (“reduces tissue sample movement as it passes through the entry port and facilitates the tissue sample exiting the entry port in an orientation that lays the tissue sample substantially flat in the tissue storage compartment for imaging”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
On page 7 of remarks of 07/21/2026, applicant argues that Flagle does not describe or suggest any need for the cover of the tissue holder assembly to be used to help orient the tissue sample for imaging. It is only the present application that describes using the structure of the cover of the tissue holder to help orient the tissue sample for imaging. Examiner disagrees. It is noted that the features upon which applicant relies (“using the structure of the cover of the tissue holder to help orient the tissue sample for imaging”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
On pages 7-8 of remarks of 07/21/2026, applicant argues that the Office Action finds that a motivation for the rearrangement of parts is that "when moving a tissue specimen into a holder or transport container, tilting the sample at an angle can help prevent it from sliding/spilling out and reduce pressure on delicate structures." This motivation is not gleaned from the prior art and Flagle does not describe at least tilting, sliding, or spilling the tissue sample nor that the tissue sample is delicate. See MPEP § 2142 "To reach a proper determination under 35 U.S.C. 103, the examiner must step backward in time and into the shoes worn by the hypothetical "person of ordinary skill in the art". That time is "before the effective filing date of the claimed invention" for 35 U.S.C. 103 or "at the time the invention was made" for pre-AIA 35 U.S.C. 103. In view of all factual information, the examiner must then make a determination whether the claimed invention "as a whole" would have been obvious at that time to a hypothetical person of ordinary skill in the art. Knowledge of applicant's disclosure must be put aside in reaching this determination, yet kept in mind in order to determine the "differences," conduct the search, and evaluate the "subject matter as a whole" of the invention. The tendency to resort to "hindsight" based upon applicant's disclosure is often difficult to avoid due to the very nature of the examination process. However, impermissible hindsight must be avoided and the legal conclusion must be reached on the basis of the facts gleaned from the prior art."
Examiner disagrees. In response to Applicant’s argument that the Examiner’s conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the Applicant’s disclosure, such a reconstruction is proper. In re McLaughlin, 443 F.2d 1392; 170 USPQ 209 (CCPA 1971).
Applicants may also argue that the combination of two or more references is "hindsight" because "express" motivation to combine the references is lacking. However, there is no requirement that an "express, written motivation to combine must appear in prior art references before a finding of obviousness." See Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1276, 69 USPQ2d 1686, 1690 (Fed. Cir. 2004).
“A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at 421, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418, 82 USPQ2d at 1396. See also In re Sovish, 769 F.2d 738, 743 (Fed. Cir. 1985) (skill is presumed on the part of one of ordinary skill in the art) and In re Bozek, 416 F.2d 1385, 1390 (CCPA 1969).
In this case, Flagle teaches a tissue holder assembly (fig.4A-4B and 5B) comprising: a base; a cover 291 configured to removably couple to the base and define an interior chamber (described fig.4A; fig.4B and described fig.5B); and a tissue holder 242 disposed within the interior chamber and rotatable around a longitudinal axis of the tissue holder assembly ([0089] and described fig.4A; fig.4B and described fig.5B), wherein the cover 291 comprises: an entry port 245 defining a fluid pathway through the cover 291 and into the interior chamber, the entry port 245 including an inlet defining an inlet axis, the inlet is shaped and sized to at least partially receive an inlet tube ([0059]: the inlet port 245 is coupled to a first portion of the vacuum line, which corresponds to “inlet tube”), the inlet axis extending radially relative to the longitudinal axis and intersecting the longitudinal axis at a right angle.
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While Flagle teaches the inlet axis extending radially relative to the longitudinal axis and intersecting the longitudinal axis at a right angle, it does not explicitly teach the inlet axis extending radially relative to the longitudinal axis and intersecting the longitudinal axis at an acute angle.
It would thus have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify angle of inlet channel 245 of Flagle to include the inlet axis extending radially relative to the longitudinal axis and intersecting the longitudinal axis at an acute angle, because when moving a tissue specimen into a holder or transport container, tilting the sample at an angle can help prevent it from sliding/spilling out and reduce pressure on delicate structures, since it has been held that rearranging parts of an invention i.e. angle of inlet channel 245 of Flagle involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Note that applicant did not address motivation pointed out on page 4 of the most recent office action. For example, Applicant did not explain/address that “when moving a tissue specimen into a holder or transport container, tilting the sample at an angle can help prevent it from sliding/spilling out and reduce pressure on delicate structures” is wrong or not functional.
Accordingly, the rejections of claims 11 and 15-16 are maintained.
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, 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.
Claims 11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Flagle – US 20130231585.
As to claim 1, Flagle teaches a tissue holder assembly (fig.4A-4B and 5B) comprising: a base; a cover 291 configured to removably couple to the base and define an interior chamber (described fig.4A; fig.4B and described fig.5B); and a tissue holder 242 disposed within the interior chamber and rotatable around a longitudinal axis of the tissue holder assembly ([0089] and described fig.4A; fig.4B and described fig.5B), wherein the cover 291 comprises: an entry port 245 defining a fluid pathway through the cover 291 and into the interior chamber, the entry port 245 including an inlet defining an inlet axis, the inlet is shaped and sized to at least partially receive an inlet tube ([0059]: the inlet port 245 is coupled to a first portion of the vacuum line, which corresponds to “inlet tube”), the inlet axis extending radially relative to the longitudinal axis and intersecting the longitudinal axis at a right angle.
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While Flagle teaches the inlet axis extending radially relative to the longitudinal axis and intersecting the longitudinal axis at a right angle, it does not explicitly teach the inlet axis extending radially relative to the longitudinal axis and intersecting the longitudinal axis at an acute angle.
It would thus have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify angle of inlet channel 245 of Flagle to include the inlet axis extending radially relative to the longitudinal axis and intersecting the longitudinal axis at an acute angle, because when moving a tissue specimen into a holder or transport container, tilting the sample at an angle can help prevent it from sliding/spilling out and reduce pressure on delicate structures, since it has been held that rearranging parts of an invention i.e. angle of inlet channel 245 of Flagle involves only routine skill in the art. In re Japikse, 86 USPQ 70.
As to claim 15, Flagle further teaches the tissue holder 242 includes a plurality of tissue storage compartments 243 (or “tissue accepting slots” 243), the entry port 245 disposed above one of the plurality of tissue storage compartments 243, and wherein the inlet axis is circumferentially offset relative to a radial centerline of the one of the plurality of tissue storage compartments 243 (see described fig.4A).
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Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Flagle – US 20130231585 and further in view of Sloan – US 20150231627.
As to claim 16, Flagle does not explicitly teach at least a portion of the base, the cover, or the tissue holder includes an anticoagulant surface coating.
Sloan teaches a concept of: inner surface of pathway and/or other surfaces along the fluid pathway such as but not limited to the sample inlet to the interior of a sample collection vessel may be coated with an anti-coagulant solution. The anti-coagulant solution helps prevent the sample, e.g., blood, from clotting when provided to the fluidic device ([0153]).
It would thus have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify Flagle with teachings of Sloan to include at least a portion of the base, the cover, or the tissue holder includes an anticoagulant surface coating, because it helps prevent sample, e.g., blood, from clotting when provided to fluidic device ([0153]).
Allowable Subject Matter
Claims 1-10 are allowable.
The following is an examiner’s statement of reasons for allowance:
As to claim 1, claim 1 includes a first cross-sectional area of the transition channel at the inlet is smaller than a second cross-sectional area of the transition channel at the outlet, when in combination with all other elements in claim 1 distinguish the present invention from the prior arts.
As to claims 2-10, claims 2-10 are also allowable because they are dependent on claim 1.
As to claim 17, claim 17 includes an outlet disposed above the tissue storage compartment, when in combination with all other elements in claim 17 distinguish the present invention from the prior arts.
As to claims 18-20, claims 18-20 are also allowable because they are dependent on claim 17.
Claims 12-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As to claim 12, claim includes the transition channel has a larger cross-sectional area proximate the outlet than proximate the inlet, when in combination with all other elements in claim 1 distinguish the present invention from the prior arts.
As to claims 13-14, claims 13-14 are also allowable because they are dependent on claim 12.
Conclusion
THIS ACTION IS MADE FINAL. 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 TRUONG D PHAN whose telephone number is (571)272-8883. The examiner can normally be reached Monday-Friday.
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, John Breene can be reached on 571-272-4107. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRUONG D PHAN/Examiner, Art Unit 2855
/JOHN FITZGERALD/Primary Examiner, Art Unit 2855
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