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.
Claim 6 is 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.
Claim 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.
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 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 1-4, 6-7, and 32-34 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hsu et al. (US 2023/0031283 from IDS).
Regarding claim 1 Hsu discloses an apparatus for passively isolating a population of motile sperm from a semen sample solution, the apparatus comprising:( See Hsu Abstract and Figs. 1-5 wherein a device isolates motile sperm from a semen sample) 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 Hsu Figs. 2-5 wherein a first vessel 3 receives a semen sample solution 100 and an SID, i.e. sorting unit 4 may receive a nutrient media 120. The SID has a frame 41 and a porous barrier, i.e. filter 44, 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 Hsu [0084] wherein pore diameter, i.e. passthrough dimension is from 8 to 20 microns.)
Regarding claim 2 Hsu 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 HSU [0084] wherein pore diameter, i.e. hole hydraulic diameter, is from 8 to 20 microns.)
Regarding claim 3 Hsu 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 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 HSU discloses all the claim limitations as set forth above as well as the device wherein the SID is substantially conical and adapted for limiting and stabilizing its insertion within the first vessel. (See HSU Figs. 1-5 wherein the SID 40 is substantially conical and has a rim which limits and stabilizes insertion into the first vessel.)
Regarding claim 6 HSU 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 HSU Figs. 1-5 wherein there is no pump, i.e. means for promoting fluid flow, between the reservoir and the chamber.)
Regarding claim 7 HSU discloses all the claim limitations as set forth above as well as the device wherein the apparatus comprises more than one SID disposed within the first vessel. (See HSU Figs. 7-9 wherein two SIDs, i.e. sorters 40, are disposed in the first vessel 3.)
Regarding claim 32 HSU discloses a sperm isolation device (SID) for passively isolating a population of motile sperm from a semen sample solution, the device comprising:a) a frame; and b) a porous barrier comprising a plurality of holes, each having a passthrough dimension in a range of from 6 microns to 30 microns. (See HSU Figs. 2-5 wherein an SID, i.e. sorting unit 4 may receive a nutrient media 120. The SID has a frame 41 and a porous barrier, i.e. filter 44, 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 HSU [0084] wherein pore diameter, i.e. passthrough dimension is from 8 to 20 microns.)
Regarding claim 33 HSU discloses all the claim limitations as set forth above as well as the device wherein:a) the frame and the porous barrier form a chamber having an opening at the upper end suitable for receiving a portion of a media; b) the SID has a lower portion suitable for insertion into a semen sample solution; and c) the chamber and the solution are fluidly connected through at least a portion of the holes in the in the porous barrier when: i) the sperm isolation device has received the portion of media; and ii) the SID is inserted into the solution. (See Hsu Figs. 2-5 wherein the SID has a frame 41 and a porous member44 forming a chamber with an open to top to receive media. The SID has 3a lower portion for insertion into semen sample solution 11. The chamber and solution are connected through pores in the barrier when inserted into said solution.)
Regarding claim 34 HSU 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 HSU Figs. 1-5 wherein the SID 40 is substantially conical and has a rim which limits and stabilizes the vertical position when inserted into a semen sample solution)
Claims 1, 5, 32 and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang (US 2020/0147615).
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.)
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.
Regarding claims 5 and 35 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 bas to the rim.)
Conclusion
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONATHAN M HURST/ Primary Examiner, Art Unit 1799
Prosecution Insights