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 .
Claims 16-31 are pending in this application and were examined on their merits.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/26/2025 has been entered.
Claim Interpretation
The preamble of Claim 16 has been construed as a recitation of the intended use
of the invention which does not result in a manipulative distinction from the prior art and
therefore is not given patentable weight.
If the body of the claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See the MPEP at 2111.02, Il.
Claim Objections/Rejections removed
The objections to Claims 19 and 24 have been withdrawn due to the Applicant’s amendments to the claims filed 08/26/2025.
Claim Rejections - 35 USC § 102
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 16, 17, 21, 22, 23, 25 and 30 are rejected under 35 U.S.C. § 102(a)(1)
and § 102(a)(2) as being anticipated by Laugharn et al. (WO 2005/056748 A1), cited in
the IDS, as evidenced by Helmenstine (2025), of record.
Laugharn et al. teaches a sample which may be any material, including body tissue (inherently derived from a living body), such as liver (Pg. 3, Lines 21-23);
placing a sample (Fig. 2A, #110) into a container (sample vessel, Fig. 2A, #220) which may be interfitted with a processing vessel (Fig. 2A, #205) which may have a buffer in it (a buffer being a solution containing either a weak acid and its salt or a weak base and its salt, which is resistant to changes in pH, see Helmenstine, Pg. 2, Lines 5- 6), which may be released into the sample vessel before fragmentation (Pg. 19, Lines 13-21);
a partition dividing the sample vessel into an upper and lower space (Fig. 2A, #227) the sample vessel having an opening part/communicating hole through the partition which protrudes toward the opening part/communicating hole at the apex of the partition (Fig. 2A, #222),
the partition having (therefore including/comprising a single) slanted/sloped portions (Fig. 2A, #227),
and wherein the movement of the sample/buffer is limited to the sample vessel with the single-sloped partition (which inherently would act as a guide for inducing tissue movement in the lower space of the container during pressing of the container) and pressing the sample vessel to impart pressure to the tissue/buffer (Fig. 2A), and reading on Claim 16.
With regard to Claim 17, Laugharn et al. teaches pressing the sample vessel to impart pressure to the tissue/buffer (Fig. 2A).
With regard to Claim 21, Laugharn et al. teaches the lower space (sample
vessel) is configured so that the protruding part protruding toward the opening is formed
by the partition (Fig. 2A, #227).
With regard to Claim 22, Laugharn et al. teaches the opening/communication
hole is at the apex of the partition (Fig. 2A, #222).
With regard to Claims 23 and 25, Laugharn et al. teaches the partition has
slanted portions the edges of which are in the shape of lines resembling an inverted V
which are not horizontal to the bottom of the vessel and converge toward the top (Fig.
2A, #227).
With regard to Claim 30, Laugharn et al. teaches a cylindrical container (sample vessel, Fig. 2A, #220) which would meet the limitation of being “bag shaped”.
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.
Claims 16, 17, 18, 20, 21, 22, 23, 25, 29 and 30 are rejected under 35 U.S.C. §
103 as being unpatentable over Laugharn et al. (WO 2005/056748 A1), cited in the IDS,
as evidenced by Helmenstine (2025), of record.
The teachings of Laugharn et al. were discussed above.
Laugharn et al. did not teach a method wherein the partition separates the upper space and the lower space in a volume ratio of 1 to 10:1, as required by Claim 29.
It would have been obvious to those of ordinary skill in the art before the instant invention to utilize a partition separating the upper space and the lower space in a volume ratio of 1 to 10:1 because while the Laugharn et al. reference is silent with regard to the volume ration of the partition separated upper and lower spaces of the container, the reference teaches container is separated by a partition into upper and lower spaces each having a volume determined by the placement of the partition. Thus, the volume ratio is a result-effective variable. The determination of the optimal or workable ranges of the volume ratio of the upper and lower container spaces by routine experimentation and optimization of result effective variables is not inventive. In this instance, the volume ratio of the upper and lower spaces will directly affect the volume in the lower space containing the solution and tissue.
Those of ordinary skill in the art before the effective filing date on the instant invention would have been motivated to make this modification in order to obtain a more or less concentrated tissue/solution homogenate. There would have been a reasonable expectation of success in making this modification because the reference already provides partitioned container with an upper and lower space of some volume and the determination of result effective variables by routine optimization and experimentation is within the purview of those of ordinary skill in the art.
Claims 16, 17, 18, 20, 21, 22, 23, 25, 29 and 30 are newly rejected under 35 U.S.C. § 103 as being unpatentable over Laugharn et al. (WO 2005/056748 A1), cited in the IDS, as evidenced by Helmenstine (2025), as applied to Claims 16, 17, 21, 22, 23, 25, 29 and 30 above, and further in view of Sharpe et al. (US 3,819,158), both of record.
The teachings of Laugharn et al. were discussed above.
The Examiner notes that Laugharn et al. teaches a mechanical impact providing device which includes at least one impact providing surface (Pg. 12, Lines 10-15).
Laugharn et al. did not teach pressing the sample vessel with one or more paddles of a paddle-type homogenizer, as required by Claim 18;
or generating flow of the solution within the container by sequentially pressing two or more sites of the container, as required by Claim 20.
Sharpe et al. teaches a device for the homogenizing single components which may be liquid, semi-liquid or solid materials and preparing a sample for bacteriological or chemical testing (Column 1, Lines 3-9);
the device comprising a container (bag) having a main body with an opening (Fig. 1, #9) and a partition (clamp) which separates an upper space (portion of bag above clamp) from a lower space (portion of bag below clamp) of the bag, thereby restricting the movement of the materials to the lower space of the container (Fig. 2, #8);
pressing the container to impart pressure to the sample within the container with the paddles of a paddle-type homogenizer (Fig. 2, #s 3-4) to provide a reciprocating movement out of phase against the surface of the bag and causing the sample to be subjected to shearing actions (Column 2, Lines 28-41).
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Laugharn et al. of processing a tissue sample with an impact providing device to use the paddle-type homogenizer of Sharpe et al. because Laugharn et al. is not limited to any particular type of impact providing device and Sharpe et al. provides a specific type of device suitable for providing impact to a tissue sample. Those of ordinary skill would have been motivated to make this modification in order to provide a suitable impact providing device to the tissue processing method of Laugharn.
There would have been a reasonable expectation of success in making this modification because Laugharn teaches a generic impact providing device for tissue processing and Sharpe teaches a particular impact providing device suitable for tissue processing.
Claims 16, 17, 19, 21, 22, 23, 25, 29 and 30 are rejected under 35 U.S.C. § 103 as being unpatentable over Laugharn et al. (WO 2005/056748 A1), cited in the IDS, as evidenced by Helmenstine (2025), as applied to Claims 16, 17, 21, 22, 23, 25, 29 and 30 above, and further in view of Li et al. (2013), both of record.
The teachings of Laugharn et al. were discussed above.
Laugharn et al. did not teach wherein CD56+ cells are isolated from the tissue derived from the living body, as required by Claim 19.
Li et al. teaches a method for isolating intrahepatic lymphocytes (IHL) from liver biopsies (Pg. 2, “Samples’) comprising homogenizing/dissociating hepatic tissue by cutting the tissue and shaking in an enzyme solution (Pg. 3, Lines 1-7) and staining for CD56 (Pg. 3, Column 1, Lines 18-28 and Fig. 1A).
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Laugharn et al. of processing a tissue sample derived from a living body such as liver, to isolating CD56+ lymphocytes from liver biopsies as taught by Li et al. because the tissue processing method of Laugharn et al. is not particularly limited to any particular liver sample and Li et al. provides a specific liver biopsy sample in need of processing/homogenization for desired cell isolation. Those of ordinary skill in the art would have been motivated to make this modification in order to homogenize liver biopsy tissue samples and isolate particular cells of interest therefrom. There would have been a reasonable expectation of success in making this modification because both of the references are drawn to the same field of endeavor, that is, tissue sample homogenization/processing methods.
Claim(s) 16, 17, 21, 22, 23, 24, 25, 26, 27, 28, 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Laugharn et al. (WO 2005/056748 A1), cited in the IDS, as evidenced by Helmenstine (2025), of record.
The teachings of Laugharn et al. were discussed above.
Laugharn et al. did not teach a single embodiment comprising the limitations of Claim 16 and those of Claims 27 and 28;
wherein the slopes of the shape that resembles the inverted V-shape converging at atop portion are asymmetrical, as now required by Claim 24;
or wherein the slopes of the shape that resembles the shape of two tilted lines converging at the top are asymmetrical, as now required by Claim 26.
With regard to Laugharn et al. the reference further teaches another embodiment wherein the sample is constrained in the lower sample vessel during pressing with a sealed part (stopper, Fig. 2A, #230) attaching to the sample vessel which isolates the sample from the external environment and optionally maintains the sample in a sterile environment (Pg. 15, Lines 13-16).
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Laugharn et al. of processing a tissue sample and comprising a processing vessel interfitted to the upper end of the sample vessel to use a stopper attached to the sample vessel to seal the sample vessel during pressing because the reference discloses both embodiments. Those of ordinary skill in the art would have been motivated to make this modification in order to maintain sterility of the sample during pressing. There would have been a reasonable
expectation of success in making this modification because the reference discloses both alternative embodiments for processing tissue samples.
It would have been further obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of processing a tissue sample of Laugharn et al. which utilizes a partition having slanted portions the edges of which are in the shape of lines resembling an inverted V which are not horizontal to the bottom of the vessel and converge toward the top to use asymmetrical slopes for the slanted portions converging toward the top because changing of the shape/aesthetic design changes (orientation or symmetry of parts) are prima facie obvious as the changes do not significantly result in a product/method distinct from the reference product/method. See the MPEP at 2144.04, I. and IV. Those of ordinary skill in the art would have been motivated to make this modification because the orientation of the slanted portions as perfectly symmetrical is not necessary to the restriction of the movement of the sample materials to the lower space of the container. There would have been a reasonable expectation of success in making this modification because the orientation/symmetry of the slanted regions is immaterial as long as it prevents the sample material from exiting the sample vessel and attaches to the processing vessel or stopper.
Claims 16, 17, 18, 20, 21, 22, 23, 25, 29, 30 and 31 are rejected under 35 U.S.C. § 103 as being unpatentable over Laugharn et al. (WO 2005/056748 A1), cited in the IDS, as evidenced by Helmenstine (2025), of record, as applied to Claims 16, 17, 18, 20, 21, 22, 23, 25, 29 and 30 above, and further in view of Sato et al. (JP2008062970A), cited in the IDS, machine translation.
The teachings of Laugharn et al. were discussed above.
Laugharn et al. did not teach a method wherein the container does not include more than one partition, the one partition being the single-sloped partition, as required by Claim 31.
Sato et al. teaches a container which may be a packaging bag for dispensing a content in a fixed amount and divided into an upper (quantitative determination chamber) and lower space (storage chamber) by a single sloped partition (Pg. 2, Claim 1 and Fig. 6b).
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Laugharn et al. of processing a tissue sample in a solution with a partitioned container to use the partitioned container of Sato et al. because this would provide the ability to quantitatively meter/aliquot samples of the processed tissue/solution mixture for further analysis or storage. Those of ordinary skill would have been motivated to make this modification in order to provide a processed tissue sample which can be aliquoted into desired amounts. There would have been a reasonable expectation of success in making this modification because both Laugharn and Sato are directed to methods utilizing sample containing internally partitioned containers.
Response to Arguments
Applicant’s arguments, see Remarks, filed 08/26/2025, with respect to the above withdrawn objections have been fully considered and are persuasive.
Applicant's arguments filed 08/26/2025 have been fully considered but they are not persuasive.
The Applicant argues that Laugharn does not teach or suggest the limitations of amended Claim 16, noting that the reference teaches a threaded fitting that acts as a barrier for structurally isolating the sample from an external environment rather than a single sloped partition as claimed (Remarks, Pg. 10, Lines 3-15).
This is not found to be persuasive for the following reasons, as discussed in the new rejections set forth above, Laugharn et al. teaches a sample which may be any material, including body tissue (inherently derived from a living body) (Pg. 3, Lines 21-23); placing a sample (Fig. 2A, #110) into a container (sample vessel, Fig. 2A, #220) which may be interfitted with a processing vessel (Fig. 2A, #205) which may have a buffer in it (a buffer being a solution containing either a weak acid and its salt or a weak base and its salt, which is resistant to changes in pH, see Helmenstine, Pg. 2, Lines 5- 6), which may be released into the sample vessel before fragmentation (Pg. 19, Lines 13-21);
a partition dividing the sample vessel into an upper and lower space (Fig. 2A, #227) the sample vessel having an opening part/communicating hole through the partition which protrudes toward the opening part/communicating hole at the apex of the partition (Fig. 2A, #222), the partition having (therefore including/comprising a single) slanted/sloped portions (Fig. 2A, #227), and wherein the movement of the sample/buffer is limited to the sample vessel with the single-sloped partition (which inherently would act as a guide for inducing tissue movement in the lower space of the container during pressing of the container) and pressing the sample vessel to impart pressure to the tissue/buffer (Fig. 2A).
The Applicant argues that the claims depending from Claim 16 as well as the newly added claims are allowable for the reasoning provided in the above argument (Remarks, Pg. 11, Lines 10-11 and 17-18 and Pg. 12, Lines 3-4 and 6-7).
This is not found to be persuasive for the reasoning provided above and in the new rejections.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/Examiner, Art Unit 1653 09/02/2025