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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/13/25 has been entered.
Response to Arguments
Applicant's arguments filed 08/13/25 have been fully considered but they are not persuasive.
On pages 8-10 regarding prior art rejections, Applicant argues amendments overcome the rejections of record.
The Examiner respectfully disagrees and refers to the rejection below regarding amended claims.
Priority
Claims 58-77 have priority to 06/10/21, the day of their filing, since the parent applications fail to have support for the invention being method which includes “removing the cover cranial implant member” from the base and “assessing” a functional surgical neurosurgical implant within the cavity “without removing the base member from the patient’s skull”.
The parent applications also fail to have support for the method of performing surgery including resecting a portion of a patient’s skull/cranium and positioning an cranial device therein.
The parent applications also fail to have support for the method comprising “observing brain pathology”, imaging the brain, ultrasonically imaging the brain, removing and replacing a portion of the functional neurosurgical implant, the method including replacing a battery of the functional neurosurgical implant, removing and replacing the functional neurosurgical implant, assembling a cover after accessing the functional neurosurgical implant.
Claim Objections
Claims 58, 67, 72 are objected to because of the following informalities:
Claim 58 is objected to for twice referring to “the patient’s skull” with improper antecedent basis.
The claim is further unclear for referring to “that portion” of the outer convex first surface when there is improper antecedent basis for this in the claims.
The claim also claims “positioning the cranial device within an intercranial space in a manner replacing a resected portion of a cranium” but it appears either a word/words are missing after “manner”.
Claim 67 is objected to for referring to “the outer convex first surface of the cranial device” with improper antecedent basis.
The claim is further unclear for referring to “that portion” of the outer convex first surface when there is improper antecedent basis for this in the claims.
The claim also claims “positioning a cranial device within an intercranial space in a manner replacing a resected portion of a cranium” but it appears either a word/words are missing after “manner”.
Claim 72 is objected to for referring to assembling “a cover cranium implant member”. It is unclear how, if at all this relates to the previously claimed “cover cranial implant member”, and whether this is an issue with both spelling and improper antecedent basis, or whether or not this is a distinct implant member.
Appropriate correction is required.
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 58-66 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 58 is rejected for having new matter for claiming the peripheral edge of the cover is shaped and dimensioned for engagement with the outer convex first surface of the base member “along an entirety of a periphery of the recess of the base member”. The specification does not mention anywhere how much of the peripheral edge of the cover is engaged with the outer convex first surface of the base along the base member’s recess.
Remaining claims are rejected for depending on a claim with new matter.
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 58-72, 74-77 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 pre-AIA the applicant regards as the invention.
Claim 58 is indefinite for referring to replacing a “resected portion of a cranium” when it is unclear how, if at all, this relates to the previously claimed resected portion of the patient’s skull that is referred to previously in the claims. It is unclear whether or not these are different items, or the same item being referred to twice and with improper antecedent basis.
The claim is further indefinite for claiming “accessing a functional neurosurgical implant disposed within the cavity” when it is unclear how, it at all, this relates to the previously claimed “functional neurosurgical implant housed within the recess”. The Examiner notes the previously presented claims were marked as being indefinite since “the base member forms a recess, and the cover cranial implant member, over the recess, defines a cavity. However, the figures/disclosure indicate that the cavity/recess are actually the same thing, making it unclear how they are claimed both separately.” The presently amended claims did not clarify this matter, and the Examiner is unclear where the implant is (the recess or cavity), whether there are two or more implants, one in each of the recess or cavity, or whether there is another explanation.
The claim is further indefinite for claiming that the base member forms a recess, and the cover cranial implant member, over the recess, defines a cavity. However, the figures/disclosure indicate that the cavity/recess are actually the same thing, making it unclear how they are claimed both separately.
Claim 67 is indefinite for referring to “a cranium” when it is unclear how, if at all, this relates to the “patient’s skull” that was previously described as being resected. It is unclear to the Examiner whether or not these are the same, different, or overlapping items.
Further, the claim later relates to “a resected portion of the patient’s skull” when the claims have previously referenced “a resected portion of a cranium”, as well as “resecting a portion of a patient’s skull”. It is unclear to the Examiner if/how all these resected portions relate to one another.
The claim is further indefinite for claiming the peripheral edge is shaped/dimensioned “for engagement with…the base member along the cover cranial implant member being removably secured…”. It appears an entire word/phrase or punctuation is missing to complete the thought of the claim.
The claim is further indefinite for claiming “the outer convex first surface of the cranial device comprises an outer convex first surface of the cranial device”. It is unclear how the outer convex first surface comprises the outer convex first surface (or whether the redundancy was intended for another reason).
Claim 68 is indefinite for claiming “accessing the functional neurosurgical implant disposed within the cavity” when it is unclear how, it at all, this relates to the previously claimed “functional neurosurgical implant housed within the recess”. The Examiner notes the previously presented claims were marked as being indefinite since “the base member forms a recess, and the cover cranial implant member, over the recess, defines a cavity. However, the figures/disclosure indicate that the cavity/recess are actually the same thing, making it unclear how they are claimed both separately.” The presently amended claims did not clarify this matter, and the Examiner is unclear where the implant is (the recess or cavity), whether there are two or more implants, one in each of the recess or cavity, or whether there is another explanation.
The claim is further indefinite for claiming that the base member forms a recess, and the cover cranial implant member, over the recess, defines a cavity. However, the figures/disclosure indicate that the cavity/recess are actually the same thing, making it unclear how they are claimed both separately.
Claim 74 is indefinite for referring to observing “a functional neurosurgical implant inside the cavity” when it is unclear whether or not this is simply referring to the previously recited implant with improper antecedent basis, or whether this is actually referring to a new functional neurosurgical implant, since this one appears to be positioned within the “cavity” when the previously recited implant is positioned with the recess. The Examiner again notes the ambiguity between the recess and cavity, and how clarification on this was requested in a previous office action (see 112 rejections to claims 58, 67, above).
Remaining claims are rejected for depending on an indefinite claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Special Definitions observed by the Examiner in Applicant’s Specification which are used in the claim language:
“functional neurosurgical implant”: “any therapeutic hardware or compositions including, but not limited to, medicines to treat any patient-specific illness, or electronic, mechanical, imaging modality and/or electro-mechanical device to remotely monitor (e.g., via Wi-Fi connectivity) or intervene any specific neurological illness, including imaging, monitoring, electrostimulation, radiation therapy, polarized light/laser neuronal modulation devices”.
Claims 58-72, 74-77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Applicant’s Admitted Prior Art (see specification filed 06/10/21, pages 2-5), hereinafter known as AAPA in view of Osorio et al. (US 7346391 B1) hereinafter known as Osorio, and further in view of Lin et al. (US 8840556 B2), hereinafter known as Lin.
Regarding claim 58, as is best understood, AAPA discloses a method comprising:
fabricating and assembling a cranial device (page 3 paragraphs 1-2: custom craniofacial implants, made via surgeons reshaping/resizing a custom implant made via CAD/CAM),
positioning the cranial device within an intracranial space in a manner replacing a resected portion of a cranium (page 3 paragraph 2: cranioplasty patients receive a modified custom implant to perfectly fit into the skull defect),
but is silent with regards to the implant including a base member with inner/outer surfaces and a thickness and a recess, the base member edge conforming to the patient’s skull, and the implant including a cover removably secured to the base, which also includes inner/outer surfaces and a thickness, so a peripheral edge of the implant’s cover being shaped and dimensioned to engage with the outer surface of the implant’s base along an entirety of a periphery of the recess such that the outer first surface of the implant comprises the outer convex first surface of the cover and the portion of the first surface of the base member not covered by the cover, and a functional neurosurgical implant housed within the recessed and covered by the cover member; and
removing the cover from the base and accessing a functional neurosurgical implant without removing the base from the skull.
However, regarding claim 58 Osorio teaches a device including:
a base member (Figures 3-4 item 43) with an outer surface (Figures 3-4 item 118 (see also Annotated Figure 5a)), an inner surface (Figures 3-4 item 106/108 (see also Annotated Figure 5a)), and a peripheral edge extending therebetween and defining a thickness (see Figures 3-5a which show the thickness of the base member 43 extending through the skull 47 (see also Annotated Figure 5a)),
wherein the base member includes a recess in the outer convex surface with side walls and a bottom (see Figures 3-5a which show the recess extending through the thickness of the skull 47 (see also Annotated Figure 5a));
a cover (Figures 3-4 item 68) disposed over the recess to define a cavity (see Figures 3-5a and Annotated Figure 5a),
wherein the cover is removably secured to the base (Column 15 lines 42-52) and includes an outer convex surface (Annotated Figure 5a), an inner surface (Annotated Figure 5a) and a peripheral edge shaped and dimensioned to engage with the outer surface of the base member (Annotated Figure 5a), and
a “functional neurosurgical implant” housed within the recess and covered by the cover (Figures 3-4, 6c item 66 or “D”; Column 12 lines 27-67 elements “D” or 66 can be sensors, communication links, storage, output mechanism, control mechanism, positioning mechanism, power source etc., which are understood to meet the limitation of Applicant’s “functional neurosurgical implant”; Column 12 lines 31-35 the elements 66/D can be located in either the base 43 or cover 68); and
removing the cover from the base (Column 15 lines 42-52); and
accessing the “functional neurosurgical implant” disposed within the cavity without removing the base from the skull (Column 15 lines 42-52).
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AAPA and Osorio are involved in the same field of endeavor, namely cranial implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of AAPA by utilizing an implant shaped as is taught by Osorio, since the person of ordinary skill would find it obvious to utilize any existing implant shape. The courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C). In this case, the use of an implant with a removeable cover would have improved the AAPA implant by allowing access to internal workings/elements of the implant.
Further, regarding the base member’s inner surface concave, Osorio teaches that the base member 43’s inner surface 106/108 is co-planarly aligned with the surrounding inner surface of the inner table of the subject’s skull 47 (Column 13 lines 7-10). As can be seen in Figures 2 and 9a-b, the inner surface of the skull is concave, which would lead a person of ordinary skill to understand that the inner surface 106/108 should be concave in order to match the skull’s natural shape.
Regarding the base member’s outer surface being convex, see at least Figure 3 item 118 which shows a convex outer surface. Alternatively, if not explicitly disclosed, the person of ordinary skill in the art would have understood the obviousness of having the outer surface 118 be convex based on the outward curve of the outer surface seen in Figure 3.
Regarding the cover’s inner surface being convex, the Examiner refers to Figure 4 which shows the cover 68 with outer and inner surfaces both curved to match the shape of the skull. Alternatively, if not explicitly disclosed, the person of ordinary skill in the art would have understood the obviousness of having the inner surface of the cover 68 be convex based on the curve of the inner surface seen in Figure 4.
Further, regarding the base member’s peripheral edge being shaped and dimensioned to conform to a resected portion of the patient’s skull, the AAPA Osorio Combination is understood to meet this limitation, since AAPA indicate that cranioplasty implants are custom-made using preoperative CT scans, CAD/CAM techniques, and thus perfectly fit into and shaped to match the skull defect (page 3 paragraph 2).
Further, regarding claim 58 Lin teaches a cranial device which includes a base (Figures 1 and 3 item 11) and cover (Figures 1 and 3 item 13) wherein a peripheral edge of the cover is shaped/dimensioned to engage with the outer surface of the base along an entire periphery of a recess in the base (Figure 3) such that an outer surface of the implant comprises the outer surface of the cover and a portion of the outer surface of the base not covered by the cover cranial implant member (Lin Figure 3; Alternatively, see Osorio Figure 11 where part of the base 178 engages the cover 68 so the two form an outer surface of the implant). AAPA and Lin are involved in the same field of endeavor, namely cranial implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the AAPA Osorio Combination so that the implant’s cover and base engage on a periphery of the recess as is taught by Lin since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the disclosed device would perform equally well shaped as disclosed by the AAPA Osorio Combination.
Regarding claim 59 the AAPA Osorio Lin Combination teaches the method of claim 58 substantially as is claimed,
wherein AAPA further discloses the device is a custom implant (page 3 paragraph 2).
Regarding claim 60 the AAPA Osorio Lin Combination teaches the method of claim 58 substantially as is claimed,
wherein Osorio further teaches the device is clear and lucent (Column 19 lines 5-7),
and wherein the method includes observing brain pathology through the device (Column 5 lines 42-44).
Regarding claims 61-62 the AAPA Osorio Lin Combination teaches the method of claim 58 substantially as is claimed,
wherein Osorio further teaches the device is clear and lucent (Column 19 lines 5-7), and
the method comprises ultrasonically imaging brain pathology through the implant (Column 5 lines 42-44).
Regarding claim 63 the AAPA Osorio Lin Combination teaches the method of claim 58 substantially as is claimed,
wherein Osorio further teaches removing and replacing a portion of the neurosurgical implant (Column 15 lines 46-49).
Regarding claim 64 the AAPA Osorio Lin Combination teaches the method of claim 63 substantially as is claimed,
wherein Osorio further teaches the portion is a battery (Column 15 lines 46-49).
Regarding claim 65 the AAPA Osorio Lin Combination teaches the method of claim 58 substantially as is claimed,
wherein Osorio further teaches removing and replacing the neurosurgical implant (Column 12 lines 27-67 elements “D” or 66 can be sensors, communication links, storage, output mechanism, control mechanism, positioning mechanism, power source etc., which are understood to meet the limitation of Applicant’s “functional neurosurgical implant”; Column 15 lines 46-49 a battery (e.g. power source) can be replaced. See also Column 5 lines 27-38, 55-64).
Regarding claim 66 the AAPA Osorio Lin Combination teaches the method of claim 58 substantially as is claimed,
wherein Osorio further teaches replacing the cover after accessing (Column 5 lines 38-42; Column 16 lines 1-5. After access, the cover is replaced. Alternatively, the person of ordinary skill in the art at the time the invention was filed would have understood that it is obvious to replace the cover when finished accessing the elements thereunder, in order to allow the implant to continue to function for the user.).
Regarding claim 67 AAPA discloses a method of performing surgery comprising:
resecting a portion of a patient’s skull (page 2 paragraph 3);
positioning the cranial device within an intracranial space in a manner replacing a resected portion of a cranium (page 3 paragraph 2: cranioplasty patients receive a modified custom implant to perfectly fit into the skull defect),
but is silent with regards to the device including a base member with inner/outer surfaces and a thickness and a recess, the base member edge conforming to the patient’s skull, the implant including a cover which also includes inner/outer surfaces and a thickness, a peripheral edge of the implant’s cover being shaped and dimensioned to engage with the outer surface of the implant’s base, the cover being removably secured to the base such that the outer first surface of the implant comprises the outer convex first surface of the cover and the portion of the first surface of the base member not covered by the cover, and a functional neurosurgical implant housed within the recess and covered by the cover.
However, regarding claim 67 Osorio teaches a method which includes positioning a cranial implant within an intercranial space in a manner replacing a resected portion of a cranium (Figures 1-2 item 41 shows the implant, item 47 shows the skull; Column 15 lines 42-52),
wherein the device comprises:
a base member (Figures 3-4 item 43) with an outer surface (Figures 3-4 item 118 (see also Annotated Figure 5a)), an inner surface (Figures 3-4 item 106/108 (see also Annotated Figure 5a)), and a peripheral edge extending therebetween and defining a thickness (see Figures 3-5a which show the thickness of the base member 43 extending through the skull 47 (see also Annotated Figure 5a)),
wherein the base member includes a recess in the outer convex surface with side walls and a bottom (see Figures 3-5a which show the recess extending through the thickness of the skull 47 (see also Annotated Figure 5a));
a cover (Figures 3-4 item 68) disposed over the recess to define a cavity (see Figures 3-5a and Annotated Figure 5a),
wherein the cover is removably secured to the base (Column 15 lines 42-52) and includes an outer convex surface (Annotated Figure 5a), an inner surface (Annotated Figure 5a) and a peripheral edge shaped and dimensioned to engage with the outer surface of the base member (Annotated Figure 5a), and
a “functional neurosurgical implant” housed within the recess and covered by the cover (Figures 3-4, 6c item 66 or “D”; Column 12 lines 27-67 elements “D” or 66 can be sensors, communication links, storage, output mechanism, control mechanism, positioning mechanism, power source etc., which are understood to meet the limitation of Applicant’s “functional neurosurgical implant”; Column 12 lines 31-35 the elements 66/D can be located in either the base 43 or cover 68).
AAPA and Osorio are involved in the same field of endeavor, namely cranial implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of AAPA by utilizing an implant shaped as is taught by Osorio, since the person of ordinary skill would find it obvious to utilize any existing implant shape. The courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C). In this case, the use of an implant with a removeable cover would have improved the AAPA implant by allowing access to internal workings/elements of the implant.
Further, regarding the base member’s inner surface concave, Osorio teaches that the base member 43’s inner surface 106/108 is co-planarly aligned with the surrounding inner surface of the inner table of the subject’s skull 47 (Column 13 lines 7-10). As can be seen in Figures 2 and 9a-b, the inner surface of the skull is concave, which would lead a person of ordinary skill to understand that the inner surface 106/108 should be concave in order to match the skull’s natural shape.
Regarding the base member’s outer surface being convex, see at least Figure 3 item 118 which shows a convex outer surface. Alternatively, if not explicitly disclosed, the person of ordinary skill in the art would have understood the obviousness of having the outer surface 118 be convex based on the outward curve of the outer surface seen in Figure 3.
Regarding the cover’s inner surface being convex, the Examiner refers to Figure 4 which shows the cover 68 with outer and inner surfaces both curved to match the shape of the skull. Alternatively, if not explicitly disclosed, the person of ordinary skill in the art would have understood the obviousness of having the inner surface of the cover 68 be convex based on the curve of the inner surface seen in Figure 4.
Further, regarding the base member’s peripheral edge being shaped and dimensioned to conform to a resected portion of the patient’s skull, the AAPA Osorio Combination is understood to meet this limitation, since AAPA indicate that cranioplasty implants are custom-made using preoperative CT scans, CAD/CAM techniques, and thus perfectly fit into and shaped to match the skull defect (page 3 paragraph 2).
Further, regarding claim 67 Lin teaches a cranial implant which includes a base (Figures 1 and 3 item 11) and cover (Figures 1 and 3 item 13) wherein a peripheral edge of the cover is shaped/dimensioned to engage with the outer surface of the base (Figure 3) such that an outer surface of the implant comprises the outer surface of the cover and a portion of the outer surface of the base not covered by the cover cranial implant member (Lin Figure 3; Alternatively, see Osorio Figure 11 where part of the base 178 engages the cover 68 so the two form an outer surface of the implant). AAPA and Lin are involved in the same field of endeavor, namely cranial implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the AAPA Osorio Combination so that the implant’s cover and base engage on a periphery of the recess as is taught by Lin since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the disclosed device would perform equally well shaped as disclosed by the AAPA Osorio Combination.
Regarding claim 68 see the rejection to claim 58 above.
Regarding claim 69 see the rejection to claim 63 above.
Regarding claim 70 see the rejection to claim 64 above.
Regarding claim 71 see the rejection to claim 65 above.
Regarding claim 72 see the rejection to claim 66 above.
Regarding claim 74 the AAPA Osorio Lin Combination teaches the method of claim 67 substantially as is claimed,
wherein Osorio further teaches the cover is clear (Column 19 lines 5-7),
and the method includes observing a functional neurosurgical implant inside the cavity through the cover (Column 5 lines 57-60).
Regarding claim 75 see the rejection to claim 60 above.
Regarding claim 76 see the rejection to claim 61 above.
Regarding claim 77 see the rejection to claim 62 above.
Conclusion
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 10/27/25