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 .
The information disclosure statement filed September 24, 2024 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
Foreign document #3 is not in English.
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.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract includes legal phraseology, such as “comprises”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claim 1 is directed to and explicitly recites a computer readable medium that is not defined as comprising any structural elements. A product (machine, apparatus) must have a physical or tangible form in order to fall within one of the statutory categories. MPEP 2106.03. The phrase "computer readable medium” covers "non-transitory tangible media" or "transitory propagating signals". Transitory propagating signals are not eligible under 101.
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. 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. It is presumed that the term “having” in line 1 is intended to be comprising. However, it is noted that no instructions are 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.
It is noted that a sample and fluid are not specified as being any specific material, substance, chemical, etc.
It is noted “a fluid flow” is not defined as being any flow of any specific fluid nor is such flow required to be present/occur within any specific structure.
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” and “optionally” provide 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.
It is noted that each of the dependent claims 3-9 and 12-18 begin with “A” which should be “The”.
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”.
As to claim 9, it is noted that any organism that is capable of being moved via any force (stimulus) can be considered as capable of exhibiting taxis.
It is noted that the phrases “one or more” such as in claim 12 and “one or both” in claim 15 only require one.
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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
As to claim 1, it is unclear what is required, meant by the phrase “the fluid flow has a sample introduction flow velocity set so that…” because it is unclear what is the nexus of “the fluid flow” and “a sample”. It is unclear if the unspecified fluid is intended to be the same as, include, or different from the sample because the claim does not clearly establish such. It is further unclear what is required to be done by who/what to “set” a sample introduction flow velocity because such is not clear in the claim. It is noted that the phrase “may be” is directed to a possibility rather than what is required. One can “set” a velocity in one’s mind. (See also claims 6, 10-11, and 14-15). 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.
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). Furthermore, there is no indication as to what is the structural relationship/connectivity of such respective zones to each other and the prior elements of the separating device, the fluid inlet (not defined in the claim as being any specific structure) and “fluid terminus” (not defined in the claim as being any specific(s); could be any end point/location of the broad, separating device) because the claim does not provide for such. Furthermore, there is no specific defined structure recited of the separating device recited in/on which the fluid or sample is introduced and required to flow within at the recited velocities.
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 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 3-5 and 16-18 each recite the respective broad recitations of “time is greater than or equal to 30 seconds”; “sample introduction flow velocity is greater than or equal to 100 micrometres per second”; and “operational flow velocity is greater than or equal to 20 micrometres per second”; “the another predetermined period of time is greater than or equal to 1 minute”; “the sample collection flow velocity is greater than or equal to 150 micrometres per second”; and “priming flow velocity is greater than or equal to 800 micrometres per second” , and each of the respective claims also subsequently recite further ranges which are narrower statements of each respective initial, broad range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The term “substantially” in claim 6 is a relative term which renders the claim indefinite. The term “substantially” 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. There is no recitation provided for in the claim as to values, variances from the exact value of the operational velocity (not numerically defined in the claim) are considered as “substantially at the operational flow velocity”.
Furthermore, it is unclear what is meant by “another predetermined period of time” because the claim does not clearly provide for a basis of what is meant “another” (other than what other period of time).
As to claim 10, see applicable rejections above.
As to claim 10, it is unclear where the preamble ends and the body of the claim begins. it is presumed that the term “having” in line 1 is intended to be “comprising”. However, 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 instructions because such instructions are not specified. Instead, the claim provides for what us intended to result from the instructions, what the instructions can provide for if/when (condition not required to ever occur) executed by a computer that is not an element of the invention. 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. Furthermore, it is unclear how a computer (not an element of invention) can provide for the recited results because a computer is not a mechanical device that can provide for all of the recited results. 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 elements of the sample separation device (fluid inlet, fluid terminus, sample introduction zone, sample collection zone, fluid delivery unit, and controller; none of which are defined by any specific structures in the claim).
As to claim 12, it is presumed that “each channel” refers to the “one or more channels”; however, it is unclear what is the structural nexus/connectivity of the one or more channels to the sample introduction zone and the sample collection zone (not structurally defined by any specific structures) because the claim does not provide for such.
As to claim 13, it is unclear what is the structural nexus/connectivity of the plurality of channels to the one or more channels, whether such are the same, inclusive of, or are different because the claim does not provide for such. It is noted that the last two paragraphs beginning with “optionally” do not provide for any further required structures. However, it is unclear what/which channel(s) is/are being referenced by “each channel”.
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 collection zone (both not structurally defined, see remarks above).
As to claim 13, it is unclear which/what collection zone is being reference by “the collection zone” because claim 11 also recites “a sample collection zone”.
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.
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.
As to claim 14, it is unclear what is the nexus of “an organism” to the previously recited “motile organisms in the sample” because the claim does not recite such.
As to claims 14-15, it is also unclear what/which channel is being refenced by the phrase “the channel” because claim 12 recites “one or more channels”.
As to claim 15, it is unclear what/which channel(s) and channel dimensions of what/which channel(s) are being referenced by the phrase “channel dimensions” because the claim does not provide for such. Furthermore, it is unclear what vortices (not structures, nor required to be present, generated, etc. ) of what is being referenced. However, it is noted that channel dimensions are not the only factor that determine if any vortices of anything are formed in any channels.
It is presumed that it is intended for some, unspecified channel to comprise an opening. However, such is not recited in the claim.
The term “proximal” in claim 15 is a relative term which renders the claim indefinite. The term “proximal” 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 “proximal” does not provide for any definitive structural relationship, connectivity, distance, etc. between structures. Any structures can be subjectively considered as “proximal” to each other. What may be considered as proximal to one person may not be considered as such to another and vice versa.
As to claim 15, it is unclear which/what organisms are being reference by “the organisms” because claim 12 recites an organism and claim 11 recites “motile organisms” and “other organisms” none of such are positively claimed as elements of the apparatus.
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, 9-13, 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 figure 1 B):
A system (10) for 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) 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;
a second inlet (70) 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 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;
delivering a sample comprising sperm to the second inlet of the system, wherein the flow speed of 10 µI/minute or greater prevents sperm delivered to the second inlet from entering the collection chamber;
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
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 10-11, 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 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, 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 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.
Getman; Anya L.; Flores-Saiffe Farias; Adolfo et al.; ALLAHRABBI; Narjes et al.; ABBASPOURRAD; Alireza et al.; Abbaspourrad; Alireza et al.; Li; Bor-Ran et al.; Tseng; Fan-Gang et al.; Asghar; Waseem; Tseng; Fan-Gang et al.; Appleyard; David et al.; Mueth; Daniel et al.; Demirci; Utkan et al.; Gale; Bruce K. et al.; SHAKED; Natan Tzvi et al.; YAMASHITA; Kenichi et al.; APPLEYARD; David et al.; Sharpe; Johnathan Charles et al.; Wooder; Nicholas James et al.; Demirci; Utkan et al.; Qiu; Tian et al.; TSENG; Fan-Gang et al.; Landers; James P. et al.; Landers; JamesP et al.; Mueth, Daniel et al.; and Takayama, Shuichi et al.disclose devices and methods directed to motile organisms.
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..
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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