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 .
Response to Arguments
Applicant's arguments filed July 20, 2026 have been fully considered but they are not persuasive.
The claims have not been amended to overcome all 112 rejections. See rejections herein.
As to the 102 rejection applicant states:
Claim 1 requires "controlling the fluid delivery unit to set the fluid flow velocity from the sample introduction flow velocity to an operational flow velocity lower than the sample introduction flow velocity by gradually reducing the fluid flow velocity from the sample introduction flow velocity to the operational flow velocity over a first predetermined period". This limitation is neither taught, nor suggested, by Asghar.
Asghar discloses "lowering the flow speed to a speed of about 0.5 pl/minute to about 8 pl/minute for a suitable period of time such that motile sperm travel against the fluid flow and enter the collection chamber." (Asghar at [0029], claim 9). However, there is no discussion of how the flow speed is lowered, or over the amount of time the flow speed is lowered. The claims, on the other hand, recite that it is "gradually" lowered.
The examiner disagrees. Applicant’s claim does not specify what is required to constitute what is considered as “gradually reducing the fluid flow velocity”. The phrase is broad. The claim does not specify how the velocity is gradually reduced.
As to Asghar, one of ordinary skill would understand according to the laws and principles of physics and fluid mechanics that inherently during lowering the flow speed of a fluid previously flowing in a channel at a first speed to a lower speed involves the fluid being decelerated (gradually reduced) from the higher, first speed for some time period until the second, lower speed is reached.
Applicant’s specification nor claims do not provide for any special, specific definition of the term “gradual”. Although applicant provides for a definition from Mirriam-Webester.com, if applicant intends for the claims to limited such a definition, then such should be provided for in the specification and/or claims.
As to applicant remarks directed to unexpected results, it is noted that unexpected results are not applicable to 102 rejections. Furthermore, it is noted that such remarks are not presented in any declaration.
The claims are rejected as given herein.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements or steps listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
As to the apparatus claims 10-15, it is noted that the claims mention fluid flow, a sample, motile organisms, flow velocity, computer, and fluidic jets. However, none of such are positively claimed as structural elements of the invention. All of such are considered as materials/articles intended to be, can be worked upon, and used with the apparats.
As to claim 10, it is noted that the claim is directed to an apparatus, a computer readable medium, that is not defined by any structural elements in the claim. Instead, the claim attempts define the computer readable medium relative to the intended use and intended results of the possible usage with an unclaimed computer that is not a structural element of the computer readable medium. However, it is noted that instructions are not structures and such instructions are not specified in the claim. Along with the prior articles/materials specified above, the fluid delivery unit (and structural elements of such) and sample separating device (and structural elements of such) are also not structural elements of the computer readable medium.
As to claim 1, there is no indication as to who/what is required to perform each of the “controlling” steps and further recited acts. Such steps can be performed mentally and/or manually. Furthermore, it is noted that while the claim refers to “a sample separating device”, such device is positively claimed as comprising any structure that is capable of “separating” any “sample”.
It is noted that a sample and fluid are not specified as being any specific material, substance, chemical, etc.
It is noted that a delivery unit, fluid inlet, fluid terminus, sample introduction zone, and sample collection zone are not structurally defined as being any specific structures.
It is noted that the term “or” provides for alternative options, not requirements.
It is noted that any amount, value, or period of time can be considered as “predetermined” relative to any future event or future time. There is no requirement in any of the claims for anyone nor anything to determine any amount of time relative to, before any event nor future moment in time.
As to claim 7, it is noted that there is nothing precluding the “sample introduction velocity” and “the sample collection velocity” from being the same values because both are only required to higher than “the operational flow velocity”.
It is noted that the phrases “one of” such as in claims 3-5 and “one or both” in claim 13 only require one.
It is noted that the phrase “operable to…” in claim 11 does not provide for any further structure of the controller. The phrase is directed to what the controller can do relative to the sampling device and further unclaimed materials that are not elements of the apparatus.
Claim Rejections - 35 USC § 112
Claims 1 and 3-18 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.
As to claim 1, it is unclear what is structurally required to be considered as “a sample introduction zone” and “sample collection zone” (and central sample collection zone) because such are not structurally defined in the claim by any specific structure(s), dimensions, structural boundaries , etc. so as to structurally distinguish the “zones” from each other nor any further structure of the separating device (so as to determine where such zones begin and end).
It is noted that claims 10-11 employ the same or similar language as claim 1 above. Therefore, applicant should see applicable rejections of claim 1 above.
Claims 3-8 and 12-18 are rejected via dependency upon a rejected claim.
As to claim 10, see applicable rejections above.
As to claim 10, it is unclear what is structurally required to define the medium because the claim does not provide for such. Instructions are not structure. It is unclear what are the instructions because such instructions are not specified in the claim. Instead, the claim provides for what is intended to result from the instructions, what the instructions can provide for if/when (condition not required to ever occur) executed by a computer relative to an unclaimed sample separating device that are not an element of the computer readable medium. There is no requirement for the medium, unspecified instructions to ever be used with any computer nor any other further articles and materials that are not structural elements of the medium. The computer, fluid delivery unit, separating device, fluid, sample, etc. are not structural elements of the invention, a computer readable medium.
As to claim 11, see above applicable remarks and rejections. Furthermore, it is noted that there is no definitive structural connectivity, relative location provided for between each of the controller and fluid delivery unit, and prior positively claimed structural elements of the sample separating device.
In claim 11, in the paragraph beginning with “control a delivery unit”, it is unclear what is the nexus of such delivery unit to the prior recited “a delivery unit”. If it is intended for such to be the same, then the claim should read as “control the deliver unit”.
Claims 12-15 are rejected via dependency upon a rejected claim.
As to claim 13, it is presumed that “each second channel” is intended to refer to “each of the plurality of second channels”. Therefore, the claim should clearly recite such.
Furthermore, it is unclear if it is intended for the apparatus or some other prior positively claimed element of the apparatus to comprise “a central sample collection zone” and what is structurally required to define such zone because the clam does not provide for such.
Furthermore, in the last paragraph, it is noted that the phrase “extends around” is vague, ambiguous, and does not provide for any definitive structural connectivity/relationship between the sample introduction zone and the sample collection zone (both not structurally defined, see remarks above).
It is unclear what is further structurally required by claims 14-15 because the claims are directed to process steps related to the sample flow velocity and the operational flow velocity that are not structural elements of the apparatus. There is no requirement for the apparatus to ever be used to perform any steps. The condition recited in the “when” clauses are never required to occur. Employing the phrase “configured to” prior to recitations of intended use and/or process steps does not provide for any further structure of the apparatus.
Furthermore, in claim 14, it is noted that fluidic jets are not positively claimed as elements of the apparatus nor structurally defined in the claim and no fluidic jets are ever required to be formed anywhere.
Claim 15 recites the limitation "each second channel". There is insufficient antecedent basis for this limitation in the claim. The term implies that there is prior mention of a plurality of second channels. However, claim 11 recites “a second channel”.
As to claim 15, it is unclear what/which channel(s) and channel dimensions (length, width, height, radius, diameter, etc.) of are being referenced by the phrase “channel dimensions” because the claim does not provide for such. However, it is noted that channel dimensions are not the only factor that determine if any vortices of anything are formed in any channels. There is no requirement of any vortices to ever be induced in any unclaimed fluid that is not a structural element of the invention. The claim is directed to intended/possible use and process of use relative to the unclaimed fluid and unclaimed motile organisms that are not elements of the apparatus.
The term “adjacent” in claim 15 is a relative term which renders the claim indefinite. The term “adjacent” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “adjacent” does not provide for any definitive structural relationship, connectivity, distance, etc. between structures. Any structures can be subjectively considered as “adjacent” to each other. What may be considered as adjacent to one person may not be considered as such to another and vice versa.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-6, 9, 11-13, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Asghar, Waseem WO 2020/041303.
Asghar discloses (claim 1 and figures 1A-2 and corresponding descriptions):
A system (10) for (separating sperm) sorting sperm comprising:
a flexible housing (20) operably connected to a substrate (30) having a first end and a second end; a micro fluidic system supported by the flexible housing;
a first inlet (60) (fluid inlet) positioned proximate to the first end and providing access to the microfluidic system to deliver fluid to the microfluidic system, wherein the first inlet is generally cylindrical and about 0.5mm to about 1 .5mm in diameter and about 1 .5mm to about 3mm in height; As shown in the figures a first channel 105 is connected to the fluid inlet 60 and a fluid terminus define at a second end of the substrate at an end of a channel.
a second inlet (70) (sample introduction zone) disposed distal to the first end and providing access to the micro fluidic system to deliver sperm to the micro fluidic system, wherein the second inlet is generally cylindrical and about 3mm to about 20mm in diameter and about 1 .5mm to about 3mm in height;
an outlet (80) comprising a collection chamber (sample collection zone connected fluid path by a second channel connected to the first channel; See for examples Figures 1A-2) providing access to the micro fluidic system to collect sorted sperm from the microfluidic system, the outlet disposed between the first inlet (60) and the second inlet (70), the outlet having dimensions of about 5mm- 11 mm x 2.5 mm elliptical and about 1.5mm to about 3mm in height;
a waste chamber (90) providing access to the microfluidic system for collecting waste fluid from the microfluidic system, the waste chamber disposed proximate to the second end; and a flow channel (100) extending from the first inlet to the waste chamber that provides a flow path for sperm to travel from the second inlet to the collection chamber against a fluid flow from the first inlet to the waste chamber, wherein the first inlet, the second inlet, the outlet, and the waste chamber are fluidly connected to the flow channel and the flow channel is about 1 mm to about 50 mm in length, about 1 mm to about 20mm in width, and about 25µm to about 250µm in height,
wherein the microfluidic system is configured such that fluid flows between the first inlet and the outlet (110), and between the outlet and the second inlet (110), at a speed higher than fluid flows along all other points of the flow channel.
Asghar discloses a method for sorting sperm for separating motile sperm from non-motile sperm (see claim 9 and paragraph 0006), which comprises:
providing the above system for sorting sperm;
delivering a suitable amount of fluid to the first inlet of the system such that the microfluidic system is substantially filled with fluid;
continuing to deliver fluid and increasing the fluid's flow rate to 10 µI/minute or greater, wherein the fluid flows from the first inlet to the waste chamber resulting in a flow path, and wherein fluid flows between the first inlet and the outlet, and between the outlet and the second inlet, at a speed higher than fluid flows along all other points of the flow channel; (controlling a delivery unit, pump (paragraphs 0010, 27, 29, 63) to set a flow velocity of a fluid in the sample separation device identified above);
delivering a sample comprising sperm to the second inlet of the system, wherein the flow speed of 10 µI/minute or greater prevents sperm (motile organism) delivered to the second inlet from entering the collection chamber; (introducing a sperm sample to the sample introduction zone);
lowering the flow speed to a speed of about 0.5 µI/minute to about 8 µI/minute for a suitable period of time such that motile sperm travel against the fluid flow and enter the collection chamber; and (gradually reducing the flow of fluid from the sample introduction velocity to an operational velocity over a period of time, the fluid is decelerated from the higher flow velocity to the second lower operational velocity); and
harvesting motile sperm that have entered the collection chamber.
As to claims 4-5, while the linear velocity is not explicitly indicated, the indicated volumetric speed in combination with the indicated dimension of the flow channel 100 can be calculated to fall within the range of the linear velocity indicated in claims 4 and 5. E.g. when selecting values within the mid-ranges indicated, such as a width of 4 mm and a height of 100 µm, the cross-sectional area of the channel is 4 mm x 0.1 mm = 0.4 mm2. A flow rate of 10 µI/minute or greater, as indicated for the sample introduction velocity, then corresponds to 10 mm3/ (0,4mm2 • 60 s) = 0.42 mm/s = 420 µm/s or greater. This value falls well within the range indicated in claim 4. Analogous calculations can be made for the values of the operational flow velocity, i.e. the range 0.5 - 8 µI/min indicated in claim 9 of Asghar corresponds to 21-333 µm/s.
As to claims 11, Asghar discloses the system (10) for sorting sperm disclosed (see claim 1, figure 1 and the explanations here above) comprises all the features of present claim 11. As to the "controller" to control fluid delivery, D1 discloses to use a syringe pump (see paragraph 0027). A syringe pump (controller) is typically used to controllably pump at a constant rate which can be manually input or which can optionally be programmed (via a computer readable medium) in advance to follow a scheme. Whichever mode is selected, the syringe pump as such is viewed as a "controller" to set the fluid velocity.
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.
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) 7-8, 10, 14-15, and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asghar, Waseem WO 2020/041303 as applied above.
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
As to claims 7 and 17, while no sample collection flow velocity is indicated in Asghar, it would have been obvious to and within the common sense, knowledge and skill of one of ordinary skill in the art before the effective filing date of the invention to optionally harvest the sample by selecting a higher velocity in order to flush the sample out of the sample collection zone.
As to claims 8 and 18, while no specific device priming flow velocity is indicated in Asghar, it would have been obvious to and within the common sense, knowledge and skill of one of ordinary skill in the art before the effective filing date of the invention to select a high velocity, e.g. in the view of quickly achieving priming and removing air etc.
As to claim 10, Asghar does not disclose a non-transitory computer readable medium having comprising instructions recorded thereon which, when executed by a computer, cause the computer control structures to perform the method steps of claim 1.
However, Asghar does state election of an appropriate software program is within the ordinary skill of the art. (paragraph 0027).
It would have been obvious to and within the common sense, knowledge and sill of one of ordinary skill in the art to provide program a computer including a computer readable medium and/or provide for a computer readable medium that includes instructions for controlling the apparatus of Asghar to perform the method to provide for automated performance of the method to reduce/minimize the involvement of a user because such does not require any special skills beyond that of one of ordinary skill in the art and it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art.
As to claim 14-15, it is noted that the claims are directed to process steps that do not provide for further positively claimed structural elements. No fluidic jets and vortices (not structure) of any fluid are positively claimed as elements of the invention. However, it would have been obvious to and within the common sense, knowledge and skill of one of ordinary skill in the art before the effective filing date of the invention to employ fluidic jets and provide for the production of vortices to provide for manipulation and transportation fluids within the apparatus.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other 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, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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