DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant's election with traverse of group I in the reply filed on 12/29/2025 is acknowledged. The traversal is on the grounds that as amended groups I, II, and III are no longer patentably distinct. Examiner agrees. Groups I-III (claims 1-6) are examined below. The traversal is also on the grounds that the Examiner has not shown a serious burden would result if all of the claims are examined together. This is not found persuasive because as indicated on page 11 of the restriction requirement mailed 10/29/2025, a serious search burden exists since the inventions have acquired a separate status in the art in view of their different classification and require a different field of search (E.G. searching different classes/subclasses or electronic resources, or employing different search strategies or search queries); and/or prior art applicable to one group would not likely be applicable to another group. Although groups I-III are being examined together in view of the amendments made to claims 2 and 5, groups I-III are still patentable distinct from group IV, group V, and group VI for reasons indicated on page 3-10 of the restriction requirement mailed 10/29/2025. Additionally, a serious search burden still exists due to the reasons indicated on page 11 of the restriction requirement mailed 10/29/2025.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/29/2025.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 60/860,392 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 60/860,392 fails to provide support for claim 4, specifically that the current conducted through the coil of said tractive electromagnet can be increased causing the temperature of said coil to be increased to a level suitable for thermal angioplasty and ablation of atheromatous, infected, and malignant tissue.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/25/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Examiner notes the listed references on page 2, and page 5-page 11 of the specification for example have not been considered.
Specification
The abstract of the disclosure is objected to because:
Line 1-2 recites “the outer layer of tubular anatomical structures”. As the outer layer has not been previously introduced, Examiner suggests replacing “the outer layer” in line 1 with “an outer layer”.
Line 2-3 recites “the outer layer of within the parenchyma”. As the outer layer has not been previously introduced, Examiner suggests replacing “the outer layer” in line 2-3 with “an outer layer”.
Line 4 recites “the substate structure”. As the substate structure has not been previously introduced, Examiner suggests replacing “the substate structure” in line 4 with “a substate structure”.
Line 5 recites “the wall”. As the wall has not been previously introduced, Examiner suggests replacing “the wall” in line 5 with “a wall”.
Line 7 recites “the body surface”. As the body surface has not been previously introduced, Examiner suggests replacing “the body surface” in line 7 with “a body surface”.
Line 8 recites “the placement”. As the placement has not been previously introduced, Examiner suggests replacing “the placement” in line 8 with “a placement”.
Line 10 recites “the magnets”. As the magnets have not been previously introduced, Examiner suggests replacing “the magnets” in line 10 with “magnets”.
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).
The disclosure is objected to because of the following informalities:
Page 1 of the specification references application 15932172. Application 15932172 has been patented as U.S. patent no 11389171. Examiner suggests amending the specification to include that Application 15932172 has been patented as U.S. patent no 11389171.
Page 1 of the specification directly under “Field of invention” states “This divisional application”. Examiner notes the instant application is not a divisional application. Examiner suggests amending “This divisional application” to properly reflect that the instant application is a continuation in part. Examiner notes all other instances of reference to the instant application as a divisional application should be corrected.
Page 4, line 1 states “The copending application entitled Stay Insertion Tools” should be referenced either with an application number or a patent number. It is unclear which application page 4, line 1 refers to, as no application number or patent number is provided.
Page 4, line 26, page 12, line 12, page 12, line 23, page 14, line 10, page 15, line 24, page 16, line 21, page 19, line 11, page 26, line 12, and page 28, line 16 references Application 15932172. Application 15932172 has been patented as U.S. patent no 11389171. Examiner suggests amending the specification to reference Application 15932172 as U.S. patent no 11389171.
Page 14, line 10 states “This nonprovisional divisional application”. Examiner notes the instant application is not a divisional application. Examiner suggests amending “This nonprovisional divisional application” to properly reflect that the instant application is a continuation in part. Examiner notes all other instances of reference to the instant application as a divisional application should be corrected.
Page 16, line 3 recites “Figs 71 and 78 of the parent application” and page 16, line 5 recites “Fig. 79 of the parent application”. The instant application has several parent applications. It is unclear which parent application the specification is referring to.
Page 16, line 15-16 recites “Figs. 81 and 82 of the parent application” and page 16, line 17 recites “Figs 31 and 32 of the parent application”. The instant application has several parent applications. It is unclear which parent application the specification is referring to.
Page 16, line 22 states “This divisional application”. Examiner notes the instant application is not a divisional application. Examiner suggests amending “This nonprovisional divisional application” to properly reflect that the instant application is a continuation in part. Examiner notes all other instances of reference to the instant application as a divisional application should be corrected.
Page 16, line 25, Page 17, line 25, page 17, line 27, page 17, line 30, page 19, line 3, page 20, line 3, page 21, line 4, page 21, line 20, page 22, line 7-8, page 23, line 22, page 24, line 28, page 24, line 29-page 25, line 1, page 25, line 21, page 25, line 23, page 26, line 2, page 27, line 13, page 27, line 15, page 28, line 4, page 28, line 11, page 28, line 15, page 29, line 1, page 30, line 8-9, page 32, line 10, page 33, line 26, page 35, line 25, page 36, line 28, and page 37, line 1-2 states “the parent application”. The instant application has several parent applications. It is unclear which parent application the specification is referring to.
Appropriate correction is required.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
“An extension” in claims 1-6 lacks antecedent basis in the specification.
Drawings
Page 23, line 28 states “shown in Figs 35 thru 37”. Page 24, line 2 recites “shown in Fig. 31”. Page 24, line 8 recites “shown in Figs 31 thru 34”. Page 24, line 10 recites “In fig. 33”. Page 24, line 13-14 recites “Figs 31 and 33”. Page 24, line 15 recites “Figs 32 and 34”. Page 24, line 25 recites “Figs 34”. Page 25, line 9-10 recites “Figs 35 thru 37”. Page 25, line 25 recites “Fig 36”. Page 25, line 26 recites “Fig. 37”. Page 35, line 11 recites “Fig 85”. Page 35, line 12 recites “Fig 84”. The drawings do not include the referenced figures and it is not specified that the figures are of a different application. It is unclear which figures the disclosure is intending to reference. It is noted that page 16 does state “Figure numbers higher than 10 appear in the parent application”. Several parent applications however exist of the instant application and therefore it is unclear which application is being referenced.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Figures 1 and 8 contains handwritten text, which may affect clarity once reproduced. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
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: item 48, item 15, item 47, item 49, item 50, item 51, item 57, item 58, item 84, item 65, item 172, item 64, item 178, item 170, item 98, item 175, and item 160. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: item 150. Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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.
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: means for the delivery of intervention therapy and an aid to imaging in claim 1.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Objections
Claims 2-4 objected to because of the following informalities:
Line 1 of claims 2-4 recites “An extension”. As the extension is claimed as being the extension of claim 1, Examiner suggests replacing “An extension” in line 1 of claims 2-4 with “The extension” to more clearly refer to the extension of claim 1 which has already been introduced.
Claim 3 objected to because of the following informalities:
Line 2 recites “in claim 1 with”. Examiner suggests adding a comma after “claim 1” to put the claim in clearer grammatical form.
Claim 4 objected to because of the following informalities:
Line 2 recites “in claim 1 wherein”. Examiner suggests adding a comma after “claim 1” to put the claim in clearer grammatical form.
Claim 5 objected to because of the following informalities:
Line 3 recites “anatomical structure whereby”. Examiner suggests adding a comma between “anatomical structure” and “whereby” to put the claim in clearer grammatical form.
Line 4 recites “variable discharge pressure medical interventional airgun”. All other claims refer to the variable discharge pressure medical interventional airgun as the variable discharge-pressure medical interventional airgun. Examiner suggests replacing “variable discharge pressure” in line 4 of claim 5 with “variable discharge-pressure” to put the claim in clearer form.
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.
In regard to claim 1,
Line 1 recites “the barrel”. There is insufficient antecedent basis for the limitation in this claim. It is unclear which barrel is being referenced. Examiner suggests replacing “the barrel” in line 1 of claim 1 with “a barrel”.
Line 1-2 recites “An extension for the barrel of a variable discharge-pressure medical interventional airgun for use as a hand tool for the insertion into tissue”. It is unclear if the extension or the variable discharge-pressure medical interventional airgun is for use as a hand tool for the insertion into tissue. For examination purposes Examiner construes the extension to be for use as a hand tool for the insertion into tissue. Examiner suggests replacing “An extension for the barrel of a variable discharge-pressure medical interventional airgun for use as a hand tool for the insertion into tissue” with “An extension for a barrel of a variable discharge-pressure medical interventional airgun, the extension configured for use as a hand tool for an insertion into tissue”.
Line 2 recites “the insertion”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the insertion” in line 2 of claim 1 with “an insertion”.
Line 2 recites “the introduction”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the introduction” in line 2 of claim 1 with “an introduction”.
Line 3 recites “the lumen”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the lumen” in line 3 of claim 1 with “a lumen”.
Line 4 recites “the wall”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the wall” in line 4 of claim 1 with “a wall”.
Line 4-5 recites “as a means for the delivery of intervention therapy and an aid to imaging”. It is unclear what structure is the means for the delivery of intervention therapy and an aid to imaging. It is unclear if the extension and variable discharge-pressure medical interventional airgun both serve as the means for the delivery of intervention therapy and an aid to imaging. For examination purposes Examiner construes the extension and the variable discharge-pressure medical intervention airgun to function as a means for the delivery.
Line 5 recites “the delivery”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the delivery in line 5 of claim 1 with “a delivery”.
In regard to claim 2,
Line 1 recites “a variable discharge-pressure medical interventional airgun”. Claim 2 depends on claim 1. Claim 1 introduces a variable discharge-pressure medical interventional airgun. It is unclear if claim 2 is intending to introduce a second variable discharge-pressure medical interventional airgun or refer to the variable discharge-pressure medical interventional airgun of claim 1. For examination purposes Examiner construes the variable discharge-pressure medical interventional airgun of claim 1 and claim 2 to be the same. Examiner suggests replacing “a variable discharge-pressure medical interventional airgun” in line 1 of claim 2 with “the variable discharge-pressure medical interventional airgun”.
Line 2 recites “a hand tool”. Claim 2 depends on claim 1. Claim 1 introduces a hand tool. It is unclear if claim 2 is intending to introduce a second hand tool or refer to the hand tool of claim 1. For examination purposes Examiner construes the hand tool of claim 1 and claim 2 to be the same. Examiner suggests replacing “a hand tool” in line 2 of claim 2 with “the hand tool”.
Line 3 recites “the distal terminus”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the distal terminus” in line 3 of claim 2 with “a distal terminus”.
Line 3 recites “the distal terminus from which the spherules are discharged”. It is unclear due to the phrase “are discharged” if a method step is being claimed. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “the distal terminus from which the spherules are discharged” to be “a distal terminus from which the spherules are configured to be discharged”. Examiner suggests replacing “the distal terminus from which the spherules are discharged” in line 3 of claim 2 with “a distal terminus from which the spherules are configured to be discharged”.
Line 5 recites “proximal thereto”. It is unclear what structure “thereto” refers to. It is unclear if thereto refers to the distal terminus, the extension, the airgun or another structure. For examination purposes Examiner construes “proximal thereto” to be ““proximal to the distal terminus”. Examiner suggests clarifying which structure “thereto” refers to.
Line 5 recites “said electromagnet”. Line 4-5 recites “at least one tractive electromagnet”. It is unclear if “said electromagnet” refers to “said at least one tractive electromagnet” or to a specific electromagnet of the at least one tractive electromagnet. For examination purposes Examiner construes “said electromagnet” to be “said at least one tractive electromagnet”. Examiner suggests replacing “said electromagnet” in line 5 of claim 2 with “said at least one tractive electromagnet”.
Line 5-6 recites “so that energizing said electromagnet allows a misplaced spherule to be recovered”. It is unclear due to the term “allows” if a method step is being claimed. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “so that energizing said electromagnet allows a misplaced spherule to be recovered” to be “so that energizing said at least one tractive electromagnet is configured to allow a misplaced spherule to be recovered”. Examiner suggests replacing “so that energizing said electromagnet allows a misplaced spherule to be recovered” in line 5-6 of claim 2 with “so that energizing said at least one tractive electromagnet is configured to allow a misplaced spherule to be recovered”.
In regard to claim 3,
Line 1 recites “a variable discharge-pressure medical interventional airgun”. Claim 3 depends on claim 1. Claim 1 introduces a variable discharge-pressure medical interventional airgun. It is unclear if claim 3 is intending to introduce a second variable discharge-pressure medical interventional airgun or refer to the variable discharge-pressure medical interventional airgun of claim 1. For examination purposes Examiner construes the variable discharge-pressure medical interventional airgun of claim 1 and claim 3 to be the same. Examiner suggests replacing “a variable discharge-pressure medical interventional airgun” in line 1 of claim 3 with “the variable discharge-pressure medical interventional airgun”.
Line 2 recites “a hand tool”. Claim 3 depends on claim 1. Claim 1 introduces a hand tool. It is unclear if claim 3 is intending to introduce a second hand tool or refer to the hand tool of claim 1. For examination purposes Examiner construes the hand tool of claim 1 and claim 3 to be the same. Examiner suggests replacing “a hand tool” in line 2 of claim 3 with “the hand tool”.
Line 2 recites “claim 1, with an unobstructed passageway”. It is unclear what structure has the unobstructed passageway and if the extension further comprises the unobstructed passageway. For examination purposes Examiner construes “claim 1, with an unobstructed passageway” to be “claim 1, the extension further comprising an unobstructed passageway”. Examiner suggests replacing “claim 1, with an unobstructed passageway” in line 2 of claim 3 with “claim 1, the extension further comprising an unobstructed passageway”.
Line 3 recites “its longitudinal central axis”. It is unclear what structure “its” refers to. For examination purposes Examiner construes “its longitudinal central axis” to be “a longitudinal central axis of the extension”. Examiner suggests replacing “its longitudinal central axis” in line 3 of claim 3 with “a longitudinal central axis of the extension”.
Line 3 recites “to allow different miniature cabled devices”. It is unclear what the miniature cabled devices are allowed to do. The claim does not specify what the unobstructed passageway allows the different miniature cabled devices to do. For examination purposes Examiner construes the different miniature cabled devices to be allowed to be inserted in the unobstructed passageway.
Regarding line 3-6 of claim 3, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear whether scopes, lasers, intravascular ultrasound probes, a rod to deploy an embolic filter at the distal end of said extension, and a rod with a pressure sensor which the operator can view to test the force of expulsion needed to insert the spherule implant into that tissue are part of the claimed invention. For examination purposes Examiner construes the scopes, lasers, intravascular ultrasound probes, a rod to deploy an embolic filter at the distal end of said extension, and a rod with a pressure sensor which the operator can view to test the force of expulsion needed to insert the spherule implant into that tissue to not be a part of the invention or positively required by the claim. Examiner suggests deleting “such as scopes, lasers, intravascular ultrasound probes, a rod to deploy an embolic filter at the distal end of said extension, and a rod with a pressure sensor which the operator can view to test the force of expulsion needed to insert the spherule implant into that tissue”.
Line 4 recites “the distal end of said extension”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the distal end of said extension” in line 4 of claim 3 with “a distal end of said extension”.
Line 5 recites “the operator”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the operator” in line 5 of claim 3 with “an operator”.
Line 5-6 recites “the force of expulsion”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the force of expulsion” in line 5-6 of claim 3 with “a force of expulsion”.
Line 6 recites “the spherule implant”. Claim 3 depends on claim 1. Claim 1 recites “magnetically susceptible spherules”. It is unclear if the spherule implant of claim 3 refers is one of the magnetically susceptible spherules or is an additional implant to the magnetically susceptible spherules. For examination purposes Examiner construes “the spherule implant” to be “one of the magnetically susceptible spherules”. Examiner suggests replacing “the spherule implant” in line 6 of claim 3 with “one of the magnetically susceptible spherules”.
Line 6 recites “that tissue”. It is unclear which tissue “that tissue” refers to. Claim 3 depends on claim 1. Claim 1 introduces tissue. It is unclear if the tissue of claim 3 is the same as the tissue of claim 1. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “that tissue” in line 6 of claim 3 with “the tissue”.
Line 6-7 recites “each such longitudinally configured device”. There is insufficient antecedent basis for the limitation in this claim. It is unclear if “each such longitudinally configured device” is the same as the different miniature cabled devices or different. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “each such longitudinally configured device” in line 6-7 of claim 3 with “each of the different miniature cabled devices”.
Line 7-8 recites “each such longitudinally configured device insertable interchangeably during an interventional procedure thereby imparting considerable imaging and therapeutic capability”. It is unclear if a method step is being claimed due to the term “insertable”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “each such longitudinally configured device insertable interchangeably during an interventional procedure thereby imparting considerable imaging and therapeutic capability” to be “each of the different miniature cabled devices are configured to be insertable interchangeably during an interventional procedure thereby imparting considerable imaging and therapeutic capability”. Examiner suggests replacing “each such longitudinally configured device insertable interchangeably during an interventional procedure thereby imparting considerable imaging and therapeutic capability” in line 7-8 of claim 3 with “each of the different miniature cabled devices are configured to be insertable interchangeably during an interventional procedure thereby imparting considerable imaging and therapeutic capability”.
In regard to claim 4,
Line 1 recites “a variable discharge pressure operated airgun”. Claim 4 depends on claim 1. Claim 1 introduces a variable discharge-pressure medical interventional airgun. It is unclear if claim 4 is intending to introduce a second variable discharge-pressure airgun or refer to the variable discharge-pressure medical interventional airgun of claim 1. For examination purposes Examiner construes the airgun of claim 1 and claim 3 to be the same. Examiner suggests replacing “a variable discharge pressure operated airgun” in line 1 of claim 4 with “the variable discharge-pressure medical interventional airgun”.
Line 2 recites “the current”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the current” in line 2 of claim 4 with “a current”.
Line 2 recites “the coil”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the coil” in line 2 of claim 4 with “a coil”.
Line 2 recites “said tractive electromagnet”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “said tractive electromagnet” in line 2 of claim 4 with “a tractive electromagnet”.
Line 3 recites “the temperature”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the temperature” in line 3 of claim 4 with “a temperature”.
Line 2-4 recites “wherein the current conducted through the coil of said tractive electromagnet can be increased causing the temperature of said coil to be increased to a level suitable for thermal angioplasty and ablation of atheromatous, infected, and malignant tissue”. Claim 4 depends on claim 1. Claim 1 does not introduce a coil or a tractive electromagnet. It is unclear if claim 4 is positively requiring the coil and tractive electromagnet and if so, what structure the coil and tractive electromagnet are a part of. For examination purposes Examiner construes the coil and tractive electromagnet to not be positively required by the claim. If intended to be positively required, Examiner suggests positively introducing the coil and tractive electromagnet and then further defining the coil and tractive electromagnet.
In regard to claim 5,
Line 1-2 recites “a variable discharge-pressure medical interventional airgun. Claim 5 includes the limitations of claim 1. Claim 1 introduces a variable discharge-pressure medical interventional airgun. It is unclear if claim 5 is intending to introduce a second variable discharge-pressure medical interventional airgun or refer to the variable discharge-pressure medical interventional airgun of claim 1. For examination purposes Examiner construes the variable discharge-pressure medical interventional airgun of claim 1 and claim 5 to be the same. Examiner suggests replacing “a variable discharge-pressure medical interventional airgun” in line 1-2 of claim 5 with “the variable discharge-pressure medical interventional airgun”.
Line 2 recites “a hand tool”. Claim 5 includes the limitations of claim 1. Claim 1 introduces a hand tool. It is unclear if claim 5 is intending to introduce a second hand tool or refer to the hand tool of claim 1. For examination purposes Examiner construes the hand tool of claim 1 and claim 5 to be the same. Examiner suggests replacing “a hand tool” in line 2 of claim 5 with “the hand tool”.
Line 3 recites “a tubular anatomical structure”. Claim 5 includes the limitations of claim 1. Claim 1 introduces a tubular anatomical structure. It is unclear if the tubular anatomical structure of claim 5 is intended to refer to the tubular anatomical structure of claim 1 or if the tubular anatomical structure of claim 5 is intended to be a second tubular anatomical structure. For examination purposes Examiner construes the tubular anatomical structure of claim 1 and claim 5 to be the same. Examiner suggests replacing “a tubular anatomical structure” in line 3 of claim 5 with “the tubular anatomical structure”.
Line 4 recites “a variable discharge pressure medical interventional airgun. Claim 5 includes the limitations of claim 1. Claim 1 introduces a variable discharge-pressure medical interventional airgun and line 1-2 of claim 5 also introduces a variable discharge-pressure medical interventional airgun. It is unclear if claim 5, line 4 is intending to introduce a second variable discharge-pressure medical interventional airgun or refer to the variable discharge-pressure medical interventional airgun of claim 1 and claim 5, line 1-2. For examination purposes Examiner construes the variable discharge-pressure medical interventional airgun of claim 1 and claim 5 to be the same. Examiner suggests replacing “a variable discharge pressure medical interventional airgun” in line 4 of claim 5 with “the variable discharge-pressure medical interventional airgun”.
Line 3-5 recites “the extension for the barrel of a variable discharge pressure medical interventional airgun is used to implant”. It is unclear if a method step is being claimed due to the phrase “is used”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “the extension for the barrel of a variable discharge pressure medical interventional airgun is used to implant” to be “the extension for the barrel of the variable discharge-pressure medical interventional airgun is configured to be used to implant”. Examiner suggests replacing “the extension for the barrel of a variable discharge pressure medical interventional airgun is used to implant” in line 3-5 of claim 5 with “the extension for the barrel of the variable discharge-pressure medical interventional airgun is configured to be used to implant”.
Line 5 recites “ferromagnetic spherules”. Claim 5 includes the limitations of claim 1. Claim 1 recites “medicinal and magnetically susceptible spherules”. It is unclear if the ferromagnetic spherules are the same or in addition to the medicinal and magnetically susceptible spherules. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “ferromagnetic spherules” in line 5 of claim 5 with “the medicinal and magnetically susceptible spherules”.
Line 5 recites “the tissue lining the lumen of said tubular structure”. Claim 5 includes the limitations of claim 1. Claim 1 recites “for the insertion into tissue”. The tissue of claim 1 is not specified as tissue lining the lumen of said tubular structure. It appears antecedent basis has not been provided for the tissue lining the lumen of said tubular structure in claim 5. For examination purposes Examiner construes the tissue of claim 1 and 5 to be different. Examiner suggests replacing “the tissue lining the lumen of said tubular structure” in line 5 of claim 5 with “tissue lining the lumen of said tubular anatomical structure”.
Line 5-6 recites “said tubular structure”. Claim 5 includes the limitation of claim 1. Claim 1 introduces a tubular anatomical structure. It unclear if “said tubular structure” of claim 5 is the same or different than the tubular anatomical structure of claim 1. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “said tubular structure” in line 5-6 of claim 5 with “said tubular anatomical structure”.
Line 6 recites “said spherules”. Line 5 of claim 5 recites ferromagnetic spherules and claim 1, which claim 5 requires the limitations of, recites medicinal and magnetically susceptible spherules. It is unclear which spherules “said spherules” of claim 5 refers to. For examination purposes Examiner construes the spherules of claim 5 and claim 1 to be the same. Examiner suggests amending line 5 of claim 5 as suggested above.
Line 7 recites “the external surface of said tubular anatomical structure”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the external surface of said tubular anatomical structure” in line 7 of claim 5 with “an external surface of said tubular anatomical structure”.
In regard to claim 6,
Line 1 recites “the barrel”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the barrel” in line 1 of claim 6 with “a barrel”.
Line 1-2 recites “An extension for the barrel of a variable discharge-pressure medical interventional airgun used as a hand tool”. It is unclear if the extension or the variable discharge-pressure medical interventional airgun is used as a hand tool. For examination purposes Examiner construes the extension to be used as a hand tool. Examiner suggests replacing “An extension for the barrel of a variable discharge-pressure medical interventional airgun used as a hand tool” in line 1-2 of claim 6 with “An extension for a barrel of a variable discharge-pressure medical interventional airgun, the extension configured to be used as a hand tool”.
Line 2 recites “the insertion”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the insertion” in line 2 of claim 6 with “an insertion”.
Line 2-3 recites “used as a hand tool for the insertion into tissue of small therapeutic, magnetically susceptible, and radiopaque spherules”. It is unclear if a method step is being claimed due to the phrase “used as”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “used as a hand tool for the insertion into tissue of small therapeutic, magnetically susceptible, and radiopaque spherules” to be “configured to be used as a hand tool for an insertion into tissue of small therapeutic, magnetically susceptible, and radiopaque spherules”. Examiner suggests replacing “used as a hand tool for the insertion into tissue of small therapeutic, magnetically susceptible, and radiopaque spherules” in line 2-3 of claim 6 with “configured to be used as a hand tool for an insertion into tissue of small therapeutic, magnetically susceptible, and radiopaque spherules”.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-6 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Wallace (U.S. PG publication 20020087177).
In regard to claim 1,
Wallace discloses an extension (figure 1 and 2, item 110) for the barrel of a variable discharge-pressure medical interventional airgun (Examiner notes “for the barrel of a variable discharge-pressure medical interventional airgun” is a functional limitation. The barrel of a variable discharge-pressure medical interventional airgun is not positively required by the claim. The extension is fully capable of the recited functional use of being attached to a suitably sized variable discharge-pressure medical interventional airgun with a barrel due to its structure) for use as a hand tool for the insertion into tissue and the introduction into, passage through, and discharge within the lumen of a tubular anatomical structure of medicinal and magnetically susceptible spherules into the wall surrounding said tubular anatomical structure as a means for the delivery of interventional therapy and an aid to imaging (Examiner notes for use as a hand tool for the insertion into tissue and the introduction into, passage through, and discharge within the lumen of a tubular anatomical structure of medicinal and magnetically susceptible spherules into the wall surrounding said tubular anatomical structure as a means for the delivery of interventional therapy and an aid to imaging” is a functional limitation. The medicinal and magnetically susceptible spherules are not positively required by the claim. Due to the structure of the extension, it is fully capable of the recited functional use. Suitably sized medicinal and magnetically susceptible spherules are fully capable of use with the extension).
In regard to claim 2,
Wallace discloses an extension for the barrel of a variable discharge-pressure medical interventional airgun for use as a hand tool as defined in claim 1, further comprising a muzzle head (distal terminal end of item 110 shown in figure 2), that is the distal terminus from which the spherules are discharged (see 112 rejection above for claim interpretation. Examiner notes spherules are fully capable of being discharged from the muzzle head due to its structure. As noted above the spherules are not positively required by the claim), wherein at least one tractive electromagnet (figure 2, item 210) is mounted proximal thereto (see figure 2) so that energizing said electromagnet allows a misplaced spherule to be recovered (see 112 rejection above for claim interpretation. Examiner notes the structure of item 210 is fully capable of the recited function of allowing a misplaced spherule to be recovered as supported by paragraph [0031]). As noted above the spherules are not positively required by the claim).
In regard to claim 3,
Wallace discloses an extension for the barrel of a variable discharge-pressure medical interventional airgun for use as a hand tool as defined in claim 1 with an unobstructed passageway entirely through its longitudinal central axis (see figure 2 and see 112 rejection above for claim interpretation) to allow different miniature cabled devices such as scopes, lasers, intravascular ultrasound probes, a rod to deploy an embolic filter at the distal end of said extension, and a rod with a pressure sensor which the operator can view to test the force of expulsion needed to insert the spherule implant into that tissue (see 112 rejection above for claim interpretation; Examiner notes “different miniature cabled devices such as scopes, lasers, intravascular ultrasound probes, a rod to deploy an embolic filter at the distal end of said extension, and a rod with a pressure sensor which the operator can view to test the force of expulsion needed to insert the spherule implant into that tissue” are construed as not positively being required by the claim. Due to the structure of the extension, appropriately sized miniature cabled devices are fully capable of use with the extension), each such longitudinally configured device (see 112 rejection above for claim interpretation) insertable interchangeably during an interventional procedure thereby imparting considerable imaging and therapeutic capability (As noted above the different miniature cabled devices/ longitudinally configured devices are not positively required by the claim. Due to the structure of the unobstructed passageway, appropriately sized miniature cabled devices/ longitudinally configured devices are fully capable of being inserted interchangeably during an interventional procedure thereby imparting considerable imaging and therapeutic capability).
In regard to claim 4,
Wallace discloses an extension for the barrel of a variable discharge pressure operated airgun as set forth in claim 1 wherein the current conducted through the coil of said tractive electromagnet can be increased causing the temperature of said coil to be increased to a level suitable for thermal angioplasty and ablation of atheromatous, infected, and malignant tissue (see 112 rejection above for claim interpretation. The coil and said tractive electromagnet are not positively required by the claim. The current conducted through an appropriately sized coil of a tractive electromagnet used with the extension would be fully capable of being increased to cause the temperature of said coil to be increased to a level suitable for thermal angioplasty and ablation of atheromatous, infected, and malignant tissue. The claim does not require the coil or tractive electromagnet to be structures of the extension).
In regard to claim 5,
Wallace discloses an apparatus (see all of figure 1) comprising the extension (figure 1 and 2, item 110) for the barrel of a variable discharge-pressure medical interventional airgun for use as a hand tool as defined in claim 1 (see rejection of claim 1 above), wherein the apparatus is configured for stenting a tubular anatomical structure (Examiner notes “configured for stenting a tubular anatomical structure” is a functional limitation. The apparatus is fully capable of the recited use as an appropriately sized stent could be delivered through the apparatus) whereby the extension for the barrel of a variable discharge pressure medical interventional airgun is used to implant ferromagnetic spherules within the tissue lining the lumen of said tubular structure (see 112 rejection above for claim interpretation. Examiner notes “is used to implant ferromagnetic spherules within the tissue lining the lumen of said tubular structure” is a functional limitation. The extension is fully capable of the recited function due to its structure. Appropriately sized ferromagnetic spherules could be implanted using the extension), said spherules (Examiner notes the spherules are not positively required by the claim) susceptible to a magnetically generated tractive force in relation to magnetized material about the external surface of said tubular anatomical structure (Examiner notes spherules which are susceptible to a magnetically generated tractive force in relation to magnetized material about the external surface of said tubular anatomical structure are fully capable of use with the extension. The tubular anatomical structure and magnetized material are not further defined. The magnetized material is also not positively required by the claim).
In regard to claim 6,
Wallace discloses an extension (figure 1 and 2, item 110) for the barrel of a variable discharge-pressure medical interventional airgun (Examiner notes “for the barrel of a variable discharge-pressure medical interventional airgun” is a functional limitation. The barrel of a variable discharge-pressure medical interventional airgun is not positively required by the claim. The extension is fully capable of the recited functional use of being attached to a suitably sized variable discharge-pressure medical interventional airgun with a barrel due to its structure) used as a hand tool for the insertion into tissue of small therapeutic, magnetically susceptible, and radiopaque spherules (see 112 rejection above for claim interpretation. Small therapeutic, magnetically susceptible, and radiopaque spherules are not positively required by the claim. The extension is fully capable of the recited function of being used as a hand tool for the insertion into tissue of appropriately sized small therapeutic, magnetically susceptible, and radiopaque spherules due to its structure).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Ormsby (U.S. Patent no 6190382) discloses wherein the current conducted through the coil of said tractive electromagnet can be increased causing the temperature of said coil to be increased to a level suitable for thermal angioplasty and ablation of atheromatous, infected, and malignant tissue (see column 8, line 7-24).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783