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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks filed on November 11th, 2025. Claims 1-4, 6-9 and 11-21 are pending. Claims 11-20 are withdrawn from consideration. Claims 5 and 10 are canceled. Claim 21 is newly added.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 11th, 2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 and 6-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amendments to claim 1 to “the flow channel comprises an internal geometry that produces hydrodynamic forces during operation that provide…” is drawn to new matter in the claims.
Applicant’s disclosure does not provide support to such a recitation. Examiner notes that par.[0083] of Applicant’s pre-grant publication US 2021/0389246 speaks general discussion of inner core stream geometry, however, the inner core stream is drawn to a prospective fluid flow of a coaxial flow of fluid stream with such an inner core flow of sample that is sheathed by an outer sheath fluid, and this does not speak to particular flow channel inner geometry(ies) that afford such “produces hydrodynamic forces…” as recited herein.
Examiner further notes that par.[0060] speaks to the flow channel 2 includes an orienting nozzle tip which hydrodynamically biases sperm towards a uniform orientation as the sperm exit orifice 5, but such disclosure is not commensurate with the claimed flow channel comprising an internal geometry that produces hydrodynamic forces.
Further, the disclosure is absent any discussion to those “internal geometries” of the flow channel that afford such functionality.
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 1-4 and 6-9 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 metes and bounds of the sought analytical instrument are indefinitely defined as it is unclear what internal geometries of the flow channel constitute those that produce hydrodynamic forces as claimed.
Applicant’s disclosure is absent discussion to this, let alone to particularly define and set forth these “internal geometries” to the flow channel that afford such sought functionality.
Further, the metes and bounds of the claimed “analytical instrument for sperm” are indefinitely defined in its sought analysis. Herein, the claims provide “an analyzer that receives the signal from the at least one detector,” wherein such recitation does not amount to an analyzer (or analysis function) as the analyzer is merely receiving a signal. By this, the claims indefinitely provided for the set forth “analytical instrument for sperm.” Does Applicant intend to recite something on the order of –
an analyzer that receives the signal from the at least one detector and analyzes the signal to indicate presence or absence of sperm
Further, the recitations “the sample fluid” and “the sheath flow” lack proper antecedent basis in the claims wherein Examiner notes that the initial recitations thereto have been removed from the claim in the latest set.
Lastly, the recitation “the interrogation location” lacks antecedent basis in the claims, wherein Examiner notes that the initial recitation thereto has been removed from claim 1.
It appears that Applicant intends to provide such an interrogation location as it pertains to the positively claimed flow channel.
Claim 9 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 9 introduces a new element of a “deflection plates or an ablation laser…” to that of the analytical instrument of claim 1, however, the metes and bounds of the sought operative arrangement of the analytical instrument with this added element are indefinitely defined.
Herein, the claim does not provide a structural and/or functional relationship of the “deflection plates or ablation laser” within the confines of the constituent part(s) of the analytical instrument and its incorporation is indefinitely defined.
For example, are the deflection plates located between the laser and the flow channel? (This may also be written in a functional sense as by their optical constitution in relation to the laser beam).
Is the ablation laser a separate, and second laser to that of the initially claimed laser? Is the ablation laser structurally/functionally provided to produce a different, second beam in a constitution with the flow channel/interrogation zone?
How are these additional elements of 1) deflection plates, and 2) an ablation laser physically/optically related within the confines of the analytical instrument?
Additionally, the functionality of the ablation laser to damage sperm based on their classification is indefinitely provided as the claims lack any basis for classification(s) in the first place so as to inform this functionality. Does Applicant intend to provide light scatter sensor(s) in optical correspondence to the flow channel/interrogation zone and a controller assesses the light scatter values against a threshold(s) to inform actuation of the laser?
Clarification is required.
Claim 21 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.
As likewise discussed above with respect to claim 1, the metes and bounds of the claimed “analytical instrument for sperm” are indefinitely defined in its sought analysis. Herein, the claims provide “an analyzer that receives the signal from the at least one detector,” wherein such recitation does not amount to an analyzer (or analysis function) as the analyzer is merely receiving a signal. By this, the claims indefinitely provided for the set forth “analytical instrument for sperm.” Does Applicant intend to recite something on the order of –
an analyzer that receives the signal from the at least one detector and analyzes the signal to indicate presence or absence of sperm
Clarification is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-3, and 8, as best understood, is/are rejected under 35 U.S.C. 102a1 as being anticipated by Appleyard et al. (US 2015/0114093), hereafter Appleyard.
With regard to claim 1, Appleyard discloses an analytical instrument for sperm comprising a flow channel 164 through which a coaxial flow as claimed may flow (herein, Examiner notes that none of the sheath fluid, sample fluid, are drawn to positively recited elements of the instrument and are drawn to prospective workpieces and the recitation remains drawn to the positively claimed structure of a flow channel , wherein Appleyard discloses a commensurately arranged and structured flow channel in as much as recited herein that is fully capable of flowing such prospective coaxial flow as claimed; Further, the discussion to “while in operation” is drawn to a conditional process recitation that is not afforded patentable weight in a device and noting that the recitation itself is conditional). Furthermore to the above, Appleyard discloses a flow channel comprising “an internal geometry that produces hydrodynamic forces during operation that provide…” in which Appelyard discloses producing hydrodynamic forces to the channel (pars.[0157-0161], for example), and the claimed “internal geometry” as the physical aspect of the flow channel is commensurately found given that of the internal geometry of the flow channel 164 in Appleyard wherein it is noted that such “internal geometry” is indefinitely defined herein and is without particular bounds provided in the disclosure so as to preclude the internal geometry of the flow channel 164 providing this in as much as claimed herein . Further, as in cl. 1, Appleyard discloses a laser 147 that produces a laser beam (pars.[0007,0049,0141-0143,0188,0217,0238,0260], figs. 5&16, for example).
Additionally, Appleyard discloses beam shaping optics 181 that shape the laser beam to have a beam width and beam height at an interrogation location as claimed (Appleyard provides that the beam shaping optics 181 may be pair of lenses, and such as in a pair of cylindrical lenses (par.[0216,0217] and in which such constitution is equivalent to that of front and rear lenses provided by the “beam shaping optics that shape…such that between a center half and a center quarter…” as given above in the interpretation under 35 USC 112 6th/F (figs. 5&16, for example). Appleyard further discloses a beam path along which the laser beam traverses between the laser and the beam shaping optics (see fig. 5 and arrow projecting downward from the laser to the beam shaping optics 181).
Appleyard further discloses at least one detector 154 that generates a signal in response to electromagnetic radiation from the interrogation location, and an analyzer 156 that receives the signal from the at least one detector (pars.[0193,0194,0276-0278], figs. 5, 6A, for example).
With regard to claim 2, the recitation is drawn to an intended use recitation not afforded patentable weight wherein the core stream is predicated on prospective workpieces not positively recited herein. As the device of Appleyard commensurately provides the recited structures, arranged and capable of functioning as claimed, Appleyard is said to provide for such inner core stream minor axis comprising an inner core stream depth in as much as recited and required herein.
With regards to claim 3, Appleyard discloses a beam width of 15 microns to a beam height of 2.5 microns which is a ratio of 6:1 (pars.[0217,0349], for example).
With regard to claim 8, as amended, Appleyard provides an analytical instrument that is configured to generate a population of sperm having a skewed sex ratio of viable sperm in as much as claimed and required herein as Appleyard provides to commensurately disclose the arrangement of elements to the analytical instrument of claim 1/8 and is thus said to be fully capable of such “generating a population…” in as much as claimed and recited herein, and further noting that claim 8 does not add any further structural element(s) or structural detail to a prior-claimed element and is drawn to a characterization of the instrument as a whole that is found by Appleyard.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Appleyard in view of Durack et al. (US 2016/0326489), hereafter Durack.
Appleyard has been discussed above.
Appleyard does not specifically disclose beam shaping optics that shape the beam width to a range as in claim 4.
Durack discloses a system for sorting particles, wherein sperm are classified and sorted in which a focused beam spot is utilized with a beam width of about 80 microns is utilized (L1 is correlated to the width as claimed, as can be seen from fig. 6, and in which W1 is akin to the claimed height, and further noting that the claimed “width and height” are not particularly relatively oriented with respect to the beam/channel so as to be limited to a single viewpoint to the defined dimensions; par.[0810], fig, 6, for example).
It would have been obvious to one of ordinary skill in the art to modify Appleyard to utilize beam shaping optics to shape a beam width in a range of about 70 to about 90 microns such as taught by Durack in order to provide a suitable focused beam spot width for assessing sperm cells as likewise desired in Appleyard.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Appleyard in view of Feng et al. (US 2018/0188183), hereafter Feng.
Appleyard has been discussed above.
Appleyard does not specifically disclose that the beam path (and each additional beam path) has a length that is less than 18 inches as in claim 6.
Feng discloses a modular optical analysis system (abstract). Feng discloses light beams that enter beam shaping optics in which the position of the beam shaping lens may be controlled with tight tolerance near or in close proximity to the light sources to control beam divergence and optimize shaping of the light beams, such as by providing sufficient beam shape while still enabling the entire beam shape to pass through the objective without clipping any light (par.[0072], for example).
It would have been obvious to one of ordinary skill in the art to modify Appleyard to provide a beam path length between the laser and the beam shaping optics to be less than 18 inches such as suggested by Feng as given by teaching to provide the beam shaping optics near or in close proximity to the light source to control beam divergence and control beam shaping to remain to optimize shaping while still enabling the entire beam to pass without clipping and as would be ascertainable through routine experimentation to values less than 18 inches as reasonably afforded distances to try given disclosure to utilizing “near or close proximity” to the light source.
Claim(s) 9, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Appleyard in view of Sharpe et al. (US 2012/0287419), hereafter Sharpe.
Appleyard has been discussed above.
Appleyard does not specifically disclose that the analytical instrument further comprises deflection plates as in cl. 9.
Sharpe discloses a UV diode laser excitation flow cytometer system in which a discrimination system/analyzer 62 acts to permit electrostatic deflection plates are provided to deflect drops based on whether or not they contain the appropriate particle or cell (abstract; par.[0025], fig. 1, for example)
It would have been obvious to one of ordinary skill in the art to modify Appleyard to include a skewing element that generates a population of sperm as claimed, and in particular in the form of deflection plates in a droplet generating flow cytometer such as taught by Sharpe in order to provide the system with on-board means for discriminating cells for analysis/collection from those undesired, as is likewise appreciated by the analogous prior art of Appleyard in sperm discrimination (pars.[0007,0015,0058,0116], for example).
Allowable Subject Matter
Claims 7 and 21 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not teach or fairly suggest, as best understood herein, an analytical instrument for sperm comprising beam shaping optics that shape the laser beam to a beam height that is in a range of 15 microns to 19 microns as in cls. 7 and 21, which provides to reduce coincident of multiple sperm heads being within the shaped laser beam during the same measuring event.
Response to Arguments
Applicant's arguments filed November 11th, 2025 have been fully considered but they are not persuasive.
With regard to claim 9 rejected under 35 USC 112 b/2nd Applicant asserts that the amendment obviates the rejection.
Examiner assets that the claim remains rejected for likewise reasons and those further explained above in the body of the action.
In summation, claim 9 presents a additional component to that of the analytical instrument in that of deflection plates or an ablation laser without providing their physical/functional location within the confines of the claimed instrument so as to provide clear metes and bounds to the sought operative arrangement of such an instrument that includes one of these elements.
Examiner further asserts that claims 1-4, 6-10, and 21 are herein rejected under 35 USC 112 b/2nd for the reasons discussed above in the body of the action.
Further, as discussed above in the body of the action, claims 1-4 and 6-10 are rejected under 35 USC 112 a/1st.
With regards to claims 1-3 and 8 rejected under 35 USC 102a1 as being anticipated by Appleyard, Applicant traverses the rejection.
Applicant asserts that the claim has been amended to recite “the flow channel further comprises an internal geometry that produces hydrodynamic forces during operation that provide the inner core stream an elliptical shape…wherein the major axis comprises an inner core stream with between 24 and 40 microns” that is not disclosed in Appleyard.
Examiner asserts that Applicant’s arguments are not persuasive.
Examiner asserts that the coaxial flow and inner core stream are not positively claimed elements of the analytical instrument.
None of the sample fluid and sheath fluid (and which relate to the “inner core stream” and “outer core stream” recited herein) are drawn to positively recited elements of the instrument and are drawn to prospective workpieces as provided within a functional recitation of the flow channel.
The recitation remains drawn to the positively claimed structure of a flow channel with capability thereto flowing a coaxial flow as claimed.
The claims are drawn to a device wherein such asserted operational steps are not attributed patentable weight.
Appleyard discloses a commensurately arranged and structured flow channel 164 in as much as recited herein that is fully capable of flowing such prospective coaxial flow as claimed.
Further, the discussions to “while in operation” and “during operation” are drawn to a conditional process recitation that is not afforded patentable weight in a device and noting that the recitation itself is conditional.
Operation of the instrument is not afforded herein, and the claims are drawn to a statutory class of invention as in a device claim.
Furthermore to the above, Appleyard discloses a flow channel comprising “an internal geometry that produces hydrodynamic forces during operation that provide…” in which Appleyard discloses producing hydrodynamic forces to the channel (pars.[0157-0161], for example), and the claimed “internal geometry” as the physical aspect of the flow channel is commensurately found given that of the internal geometry of the flow channel 164 in Appleyard wherein it is noted that such “internal geometry” is indefinitely defined herein and is without particular bounds provided in the disclosure so as to preclude the internal geometry of the flow channel 164 providing this in as much as claimed herein.
Applicant further asserts that Appleyard does not teach or suggest beam shaping optics to shape the laser beam as claimed.
Applicant asserts that for these reasons “beam shaping optics are not generic placeholders,” and the limitations are entitled patentable weight.
Initially, Examiner asserts that Applicant’s assertion with respect to generic placeholders and the entitlement/non-entitlement of patentable weight is unfounded.
As it pertains to the prior claim interpretation under 35 USC 112 F/6th, this is merely a claim interpretation in which Applicant is afforded to utilize shorthand-type language to the claim without spelling out each and every possible structural element capable of accomplishing the appended functionality.
To this end, Examiner cited pars.[0065-0070]of Applicant’s pre-grant publication as providing the corresponding structure(s) thereto as afforded by Applicant’s own disclosure, and equivalents thereof to these structures as would be appreciated by one of ordinary skill in the art.
The recitation to the “beam shaping optics configure to shape…” has always received patentable weight, and a claim interpretation under 35 USC 112 F/6th with a designation of a generic placeholder does not preclude patentable weight being attributed as this is merely a claim interpretation that links back to the corresponding structure(s) as found in Applicant’s own disclosure.
In terms of the applied art of Appleyard and the recited “beam shaping optics configured to shape…such that between a center half and a center quarter…”, Examiner asserts that Appleyard commensurately discloses likewise structured and arranged beam shaping optics fully capable of (herein, “configured to”) provide such shaping.
As discussed above, Appleyard discloses beam shaping optics 181 that are a pair of lenses, and such as in a pair of cylindrical lenses (par.[0216,0217] and in which such constitution is equivalent to that of front and rear lenses provided by Applicant’s own disclosure to the structural constitution of the claimed “beaming shaping optics configured to shape…” as seen through pars.[0065-0070] of Applicant’s disclosure, and even further with respect to Applicant’s assertion that the structure of such beam shaping optics may be realized by numerous optical arrangement such as lenses or mirrors.
Examiner asserts that Applicant’s argument is not persuasive as Applicant has failed to structurally distinguish the claims from that of the prior art.
It is also noted that the configuration of the beam shaping optics is coincident and relies upon the prospective inner core stream that is not a positively claimed element of the instrument as discussed above. To this end, does Applicant intend to provide the functionality of the beam shaping optics with respect to particulars of the flow channel?
Otherwise, from Applicant’s comments and assertions, it appears Applicant intends a method claim with particular, procedural application of the flow cytometer system.
With regard to claim 4 rejected under 35 USC 103 as being obvious over Appleyard in view of Durack, Applicant traverses the rejection and asserts that Durack does not remedy the deficiencies of Appleyard as discussed with respect to claim 1.
Examiner asserts that as there are no such deficiencies with respect to Appleyard to the “internal geometry,” “inner core stream…” and “beam shaping optics configured to…”, claim 4 is maintained rejected for the reasons discussed above in the body of the action.
With regards to claims 5 and 6 rejected under 35 USC 103 as being unpatentable over Appleyard and Feng, and as in claims 8 and 9 rejected under 35 USC 103 as being unpatentable over Appleyard in view of Sharpe, Applicant traverses the rejections and asserts that Feng and Sharpe, respectively, do not remedy the deficiencies of Appleyard as previously discussed with respect to claim 1.
Examiner asserts that as there are no such deficiencies with respect to Appleyard to the “internal geometry,” “inner core stream…” and “beam shaping optics configured to…”, claims 5, 6, 8, and 9 are maintained rejected for the reasons discussed above in the body of the action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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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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/NEIL N TURK/Primary Examiner, Art Unit 1798