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 1, claims 1 - 6 in the reply filed on 09/08/2025 is acknowledged.
Claims 7 - 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Election was made without traverse in the reply filed on 09/08/2025.
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.
Specification
The disclosure is objected to because of the following informalities:
In the specification (as filed), at page 5, line 16, “oF100%” appears to be a typographical error.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “4” in Fig. 1. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 – 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 6 of copending Application No. 18/725,971 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they seek to encompass the same invention (i.e., a method for analysing a device for spraying a pharmaceutical fluid product comprising providing a spray head having a spray orifice, providing a receiving surface comprising a plurality of discrete contact zones (i.e., perforated plate), the contact zones being electrically conductive (i.e., charging of the perforated plate with an electrostatic charge), passing a flow of ionized gas through the orifice (i.e., compressed air), visualizing the impact zone and analysing the visualization of the impact zone in order to determine whether or not said impact zone complies with predetermined specifications).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Objections
Claim 1 is objected to because of the following informalities:
As to Claim 1, line 1 states “The method”. Examiner suggests to replace “The” with “A” such that it reads “A method”.
As to Claim 5, both lines 4 and 5 state “the spray heads”. Examiner suggests to replace “heads” with “head” to be consistent with limitations of independent claim 1 from which the instant claim depends on.
Appropriate correction is required.
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 1 – 6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to Claim 1, the instant claim recites the limitation “the impact zone” in line 10. There is insufficient antecedent basis for this limitation resulting in unclear scope of the claim.
As to Claim 1, the instant claim recites the limitation “said visualization” in line 12. There is insufficient antecedent basis for this limitation resulting in unclear scope of the claim.
As to Claim 4, the instant claim recites the limitation “said step for analysis” in line 2. There is insufficient antecedent basis for this limitation resulting in unclear scope of the claim.
As to Claim 4, the instant claim recites the limitation “the geometry” in line 2 and “the symmetry” in lines 2 - 3. There is insufficient antecedent basis for this limitation resulting in unclear scope of the claim.
As to Claim 4, the instant claim recites the limitation “said flow of compressed gas” in line 3. There is insufficient antecedent basis for this limitation resulting in unclear scope of the claim.
As to Claim 5, the instant claim recites the limitation “said flow of compressed gas” in line 3. There is insufficient antecedent basis for this limitation resulting in unclear scope of the claim.
As to Claim 5, the instant claim recites the limitation “said planar extent” in lines 4 and 5. There is insufficient antecedent basis for this limitation resulting in unclear scope of the claim.
As to Claim 6, the instant claim recites the limitation “means of man-machine interface” in last line. It is vague/unclear as to what structure the “man-machine interface” refers to. Examiner notes that the specification at page 3 only recites “visualizing said impact zone by means of a man-machine interface” without describing the structure or element it uses. Furthermore, pages 6 – 7 describing processing means 40 which is provided to “visualize the impact zone” (page 6 last paragraph). However, it is not clear if the processing means 40 is the man-machine interface (i.e., considered as user interface) or not.
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.
Claim(s) 1 - 5 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2019/0376106 A1 to Boisvilliers (hereinafter “Boisvilliers”) in view of U.S. Patent Application Publication No. 2019/0198307 A1 to Jones et al. (hereinafter “Jones”).
Regarding Claim 1, Boisvilliers teaches the method for analysing a device for spraying a pharmaceutical fluid product (see abstract see Fig. 3), characterized in that it comprises the following steps:
-providing a spray head (see spray head 1, Fig. 3, see, abstract and claim 1) for a device for spraying a pharmaceutical fluid product, said spray head comprising a spray orifice (see spray orifice 2, Fig. 3, see claim 1).
Even though Boisvilliers teaches providing a receiving surface as illustrated at Figs. 3 – 6 where the flow 5 is being analyzed for further analysis, Boisvilliers does not explicitly teach providing a receiving surface comprising a plurality of discrete contact zones separated by voids, said contact zones being electrically conductive, and passing a flow of ionised gas through said spray orifice of said spray head, said flow of ionised gas being charged with electrons,
Jones, in the field of ionization spot measurement and validation systems, teaches providing a receiving surface comprising a plurality of discrete contact zones separated by voids (see detector or sensor for instance at Figs. 4A – 6C which illustrates detectors such as 403, 503 and 603 which have receiving surface with discrete contact zones separated by space/voids, see paragraphs [0182]-[0183], [0196] – [0197] and [0208] – [0209]), said contact zones being electrically conductive (detector array 403, 503 or 603 which may comprise a conductive detector as described at paragraphs [0056], [0199], see also paragraphs [0069] – [0071] describing the detector comprising two or more spaced apart detectors), and passing a flow of ionised gas through said spray orifice of said spray head (see paragraphs [0163] – [0164] describing the various embodiments directed to an apparatus comprising an ion source 10 that emits a spray of charged droplets towards the receiving surface, see paragraph [0182] describing spray of charged droplets directed at a surface of a measurement region or detector array 403), said flow of ionised gas being charged with electrons (see paragraphs [0182] – [0183], [0191] – [0197] describing use of spray of charged droplets, hence reading on the invention as claimed).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the receiving surface and ionized gas of Jones into Boisvilliers in order to efficiently and accurately determine one or more parameters or properties including profile or geometry of the spray of charged droplets impacting a surface of a detector. The modification further improves overall quality and reliability of the system (see also paragraphs [0024] – [0028]).
Boisvilliers in view of Jones as modified above further teaches;
-sending said flow of ionised gas onto said receiving surface (see generator means 24 for causing a test fluid to pass through the spray head 1 of Boisvilliers and/or see ion source of Jones that emits a spray of charged droplets towards the receiving surface, see paragraph [0182] of Jones describing spray of charged droplets directed at a surface of a measurement region or detector array 403),
-visualising the impact zone for said flow of ionised gas on said receiving surface (see strioscopic setup 20 of Boisvilliers which aid in displaying the flow of the test fluid leaving the spray orifice 2 and/or see paragraphs [0181], [0203] of Jones which describe using a camera which detects the surface), and
-analysing said visualisation of said impact zone in order to determine whether or not said impact zone complies with predetermined specifications (see paragraphs [0044] – [0048] of Boisvilliers which describes analyzer means 30 for determining whether or not the test-fluid spray coming from said spray head complies with predetermined specification, see Figs. 4 – 6 showing images obtained with the method of the invention and in which it is possible to measure and/or to evaluate the cone angle of the spray, Figs. 7 – 8 further illustrate test-fluid that is classed as being compliant and non-compliant respectively and/or see for instance paragraphs [0189] – [0194] and Fig. 5 of Jones).
Regarding Claim 2, Boisvilliers in view of Jones as modified above teaches in which said flow of ionised gas is a flow of compressed air (see compressed air source at the generator means 24 of Fig. 1 of Boisvilliers).
Regarding Claim 3, Boisvilliers in view of Jones as modified above teaches in which said flow of ionised gas (F1) is a flow of ionised pulsed air (see paragraphs [0163] – [0164] of Jones describing the various embodiments directed to an apparatus comprising an ion source that emits a spray of charged droplets towards the receiving surface, hence reading on the invention as claimed).
Regarding Claim 4, Boisvilliers in view of Jones as modified above teaches in which said step for analysis comprises determining the geometry, in particular the symmetry, of the impact zone for said flow of compressed gas on said receiving surface (see paragraphs [0038], [0167], [0179] and claim 3 of Jones describing determining one or more parameters related to a geometry, symmetry of the spray of charged droplets).
Regarding Claim 5, Boisvilliers in view of Jones as modified above teaches in which said predetermined specifications comprise a predetermined planar extent of the impact zone for said flow of compressed gas on said receiving surface, in a manner such that the spray heads for which said planar extent is similar to said predetermined planar extent are classified as compliant, and the spray heads for which said planar extent is different from said predetermined planar extent are classified as non-compliant (see paragraphs [0016], [0047] and claim 4 of Boisvilliers and/or see Fig. 5 and paragraphs [0189] – [0195] of Jones, hence reading on the invention as claimed).
Allowable Subject Matter
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if the Double Patenting rejection and 112 rejections can be overcome and if rewritten in independent form including all of the limitations of the base claim and any intervening claims. However, an updated search will again be made upon applicant’s response.
Regarding Claim 6, none of the prior art of record appear to teach an operating cycle comprising connecting said receiving surface to ground in order to eliminate any electrical charges (see arrangement at Figs. 1, 2 illustrating base 14 which is preferably insulating and which may be connected to ground), and detecting each contact zone (see contact zone 12, Figs. 1, 2) which becomes charged with negative ions in contact with said flow of ionized gas flow in combination with remaining limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form accompanying this office action which includes the following relevant prior art:
Bettinelli (U.S. 2016/0216108 A1) teaches a device for controlling the distribution of fluid ejected from a fluid nebulizing dispenser comprising a discharging nozzle for a nebulized fluid, detecting means for detecting the temperature difference between at least part of the nebulized fluid ejected from the dispenser ant at least one contrast space being arranged so as to be at least partially incident to the nebulized fluid.
Marriott et al. (U.S. 2014/0033979 A1) teaches A system for monitoring the application of coating to a surface of a substrate, the coating being applied as a spray from a plurality of nozzles spaced apart along at least one dimension of the substrate, the system comprising: a coherent radiation source arranged to direct a beam of coherent radiation through said spray; an imaging device for obtaining an image of said beam as it propagates through said spray, and a computing device having a processor to receive an input from said imaging device and process said image in order to determine variations in a characteristic indicative of the presence of said spray.
Savkar et al. (U.S. 5,047,612) teaches apparatus and method for controlling powder deposition in a plasma spray process comprising a plasma plume and target or workpiece 16.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARRIT EYASSU whose telephone number is (571)270-1403. The examiner can normally be reached M - F: 9:00AM - 6:00PM.
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/MARRIT EYASSU/Primary Examiner, Art Unit 2855