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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-7 and 32-35 in the reply filed on 1/15/2026 is acknowledged.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 44 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.
Regarding Claim 6 the limitation “means for promoting fluid flow” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Additionally such a recitation is so broad it not only excludes all active pumping devices but also prevents the device from existing in natural conditions, i.e. gravity promotes fluid flow, capillary forces in the porous mater promote fluid flow, as well as contradicts the use of the device which requires such a flow and as such the flow must be promoted by some means otherwise no flow between the device would occur and it would be rendered useless for the required purpose. Since the claim invokes 112(f) and does not provide any corresponding structure in the specification it is unclear what such a claim limitation is limited to and any device having walls or holes has structure “which promotes fluid flow” and thus one of ordinary skill cannot be appraised of the limits of the claim.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 44 recites the limitation "the reservoir". There is insufficient antecedent basis for this limitation in the claim.
Claim 44 recites the limitation "the ratio". There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-4, 6-7, 32, 34, and 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (US 2020/0147615) and further in view of Hsu et al. (US 2023/0031283 from IDS).
Claims 1-4, 6-7, 32, 34, and 43-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Regarding claims 1 and 32 Huang discloses an apparatus for passively isolating a population of motile sperm from a semen sample solution and a sperm isolation device the apparatus comprising a) a first vessel for receiving the semen sample solution, and b) a sperm isolation device (SID) for receiving a nutrient media, the device comprising a frame and a porous barrier, the porous barrier comprising a plurality of holes (See Huang Abstract, Fig. 1 and [0027]-[0028] and [0085] wherein the device may isolate cells, i.e. this includes sperm cells, wherein a first vessel 2 may receive a solution including semen and an SID, i.e. strainer 1, has an opening which may receive a nutrient media. The SID has a frame 3,4,5 and a porous barrier, i.e. filter 6, with a plurality of holes, i.e. pores.)wherein each hole has a passthrough dimension in a range of from 6 microns to 30 microns. (See Huang [0028] wherein pore diameter, i.e. passthrough dimension is from includes those of 20 microns.)
Huang discloses all the claim limitations as set forth above as well as the device wherein:a) the frame of the SID has a rim member attached to a solid base by at least two downwardly extending supports; and b) the porous barrier is positioned between each pair of adjacent supports and extends from the solid base to the rim member. (See Huang Fig. 1 wherein the SID has a rim 3 with a plurality of supports which extend to a solid base 5. A porous filter barrier 6 is positioned between each pair of adjacent support and extends from the base to the rim.)
In regards to limitations directed to intended use, i.e. isolating motile sperm, and materials worked on, i.e. semen sample and nutrient media, it is noted that the device of the cited prior art is fully capable of separating sperm and holding such materials and such limitations do not define structural elements which differentiate the claimed invention from the cited art. See MPEP 2114 and 2115.
Huang discloses all the claim limitations as set forth above as well as the device wherein the container includes an upper collection means and a reservoir at its lower end. (See Fig. 1 wherien the container has an upper collection portion and a lower conical reservoir end.) Huang also disclose that the container may take nearly any shape according to use (See Huang [0073]-[0074]) but does not specifically disclose the upper end having a conical shape.
Hsu et al. discloses a container for collecting sample liquids having a conical upper collection means and a reservoir at its lower end.(See Hsu Claims 36-38 wherein a sample collection vessel has an upper conical collection means 321’ and a liquid reservoir 31’ at its lower end.)
It would have been obvious to one of ordinary skill in the art at the time of filing to provide a sample holding container having a conical upper and and reservoir at its lower end as described by Hsu in the device of Huang because such a container fulfills the need for a specific container shape espoused by Huang and such a container allows the advantageous and efficient collecting and holding of sperm as would be desirable in the device of Haung.
Additionally it would have been obvious to one of ordinary skill in the art at the time of filing to provide a container with an upper conical shape and lower reservoir portion because such a modification would have required a mere change in shape in order to easily allow collection of a sperm sample and because the change in configuration of shape of a device is obvious absent persuasive evidence that the particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 2 Huang discloses all the claim limitations as set forth above as well as the device wherein each hole has a hydraulic diameter in the range of from 6 microns to 30 microns. (See (See Huang [0028] wherein pore diameter, i.e. hole hydraulic diameter, is 20 microns.)
Regarding claim 3 Huang discloses all the claim limitations as set forth above as well as the device wherein a) the first vessel has a reservoir suitable for receiving the semen sample solution; b) the SID has a chamber suitable for receiving the nutrient media; c) the SID fits within the first vessel such that the reservoir and the chamber are fluidly connected through at least a portion of the holes in the porous barrier when:i) the first vessel has received the semen sample solution; ii) the SID has received the nutrient media; and iii) the SID is engaged with the first vessel. (See See Huang Fig. 1 wherein the first vessel 2 has a reservoir to hold a sample and the SID 2 has a frame and chamber for hold a medium which is placed within the first vessel when the materials are within the reservoir and chamber such that the reservoir and chamber fluidly communicate through holes in the porous barrier. Also see HSU Figs. 1-5 wherein the first vessel 3 has a reservoir which receives semen sample 100 and the SID has a frame 41 and a porous member44 forming a chamber with an open to top to receive media. The SID has a lower portion for insertion into semen sample solution in the first vessel. The chamber and reservoir are connected through pores in the barrier when inserted into said solution.)
Regarding claim 4 Huang discloses all the claim limitations as set forth above as well as the device wherein the SID is adapted for limiting and stabilizing its insertion within the first vessel. (See Huang Figs. 1 wherein the SID 1 has a rim which limits and stabilizes insertion into the first vessel 2.)
Furthermore in regards to the SID being conical Huang specifically notes the shape of the SID may be modified according the analysis performed and the shape of the receiving container (See Huang [0066]-[0068]).
It is noted that such a modification would have required a mere change in shape of the SID which would have been obvious to one of ordinary skill in the art at the time of filing to optimize placement in receiving container and because the change in configuration of shape of a device is obvious absent persuasive evidence that the particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 6 Huang discloses all the claim limitations as set forth above as well as the device wherein the apparatus does not include any means for promoting fluid flow between the reservoir in the first vessel and the chamber in the SID. (See Huang Figs. 1 wherein there is no pump, i.e. means for promoting fluid flow, between the reservoir and the chamber.)
Regarding claim 7 Huang discloses all the claim limitations as set forth above but does not disclose more than one SID disposed within the first vessel.
HSU discloses stacking a plurality of SIDs within a first vessel to provide sperm with higher motility. (See HSU Figs. 7-9 wherein two SIDs, i.e. sorters 40, are disposed in the first vessel 3.)
It would have been obvious to one of ordinary skill in the art at the time of invention to stack a plurality of SIDs within a first vessel as described by HSU in the device of Huang because doing so allows one to obtain a sample having an increased and tailored level of motility and purity as would be desirable in the device of Huang.
Regarding claim 34 Huang discloses all the claim limitations as set forth above as well as the device wherein the frame of the SID is adapted for limiting and/or stabilizing the vertical position of the sperm isolation device when inserted into a semen sample solution. (See Huang Figs. 1 wherein the SID has a rim 3 and/or4 which limits and stabilizes the vertical position when inserted into a semen sample solution)
Regarding claim 43 Huang discloses all the claim limitations as set forth above as well as the device wherein the SID comprises materials of construction that will prevent or minimize damage to sperm cells, surfaces comprising one or more antioxidants to prevent or mitigate oxidative degradation of sperm cells, or a combination thereof. (See Huang [0028] wherein the SID is formed of materials which are biocompatible, i.e. they prevent and/or minimize damage to sperm cells.)
Regarding claim 44 Huang discloses all the claim limitations as set forth above as well as the device the SID comprises a chamber configured to hold a first volume of a first fluid; the reservoir has a second volume of a second fluid;(See Huang Fig. 1 wherein the SID includes a chamber holding a first volume of fluid and a reservoir holding a second volume of fluid.)
Huang does not disclose and the ratio of the second volume to the first volume is in the range of from 2:3 to 10:1.
It is noted that such a modification would have required a mere change in size of the various volumes which would have been obvious to one of ordinary skill in the art at the time of invention to optimize sample and fluid medium space and because A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device, Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Response to Arguments
Applicant's arguments filed 6/30/2026 have been fully considered but they are not persuasive.
Applicant argues that “The "means" language in claim 6 is not "modified by functional language" in the § 112(f) sense in that it is not defining a claimed element by what it does. It is excluding a category of structure entirely. As MPEP § 2173.01 expressly states: "Applicant may use functional language,Page 11 of 14
alternative expressions, negative limitations, or any style of expression or format of claim which makes clear the boundaries of the subject matter for which protection is sought." (emphasis added)
The argument is therefore grounded in both § 2173.05(i) (negative limitations are not inherently indefinite) and § 2181 (§ 112(f) is not triggered because prong (B) - the means being "modified by functional language" to define a positive claim element - is not satisfied by a pure exclusionary clause).
Applicant's specification states, "...when in operation, the porous barrier, the first fluid, and the second fluid remain motionless or substantially motionless with respect to an external force, and the only motion is at the cellular level..." (Applicant's Specification, [0062]).”
The examiner notes that claim 6 was not rejected because the negative limitations themselves render the claim indefinite but the fact that such limitations invoke 112(f) and do not satisfy the required conditions thereof.
In this case the claim limitation:
Uses the term “means for”
It is modified by the functional language “promoting fluid flow”
It does not include any structure at all and thus is not modified by any sufficient structure for performing the promoting fluid flow.
Thus the claim satisfies all conditions of the 3-prong analysis. The examiner notes such an analysis does not require any determination that the language is used in a positive or negative limitation and such a negative limitation is fully capable of invoking 112(f) as in the present case.
Additionally the examiner notes such a claim recitation is so broad it not only excludes all active pumping devices but also prevents the device from existing in natural conditions, i.e. gravity promotes fluid flow, capillary forces in the porous mater promote fluid flow, low fluid viscosity promotes fluid flow, etc. Furthermore in order to such a device to work as intended a flow must be promoted by some means, natural or otherwise, otherwise no flow between the device components would occur and it would be rendered useless for the required purpose. Since the claim invokes 112(f) and does not provide any corresponding structure in the specification it is unclear what such a claim limitation is limited to and what structure is intended to be not included in the device. The plain reading of such a broad limitation prevents any device having walls, holes, gravitation force, liquids of low viscosity, etc. “which promote fluid flow” and thus one of ordinary skill cannot be appraised of the limits of the claim as the mere existence of a device which accomplishes fluid flow must have some means to promote the said flow.
In regards to applicant’s arguments with respect to other claims it is noted that additional references and/or rational have been provided to make up for any argued deficiencies in the previously cited art and as such applicant’s arguments with respect to such features are moot.
Conclusion
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 JONATHAN M HURST whose telephone number is (571)270-7065. The examiner can normally be reached on M-F 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HURST/ Primary Examiner, Art Unit 1799
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