DETAILED ACTION
This is the initial Office action for application 18/387,842 filed November 7, 2023. Claims 1-20, as originally filed, are currently pending.
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 . 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.
Claim Objections
Claim 17 is objected to because it contains a period (.) in the middle of line 4. Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). For examination purposes, claim 17 has been interpreted as ending after the first period in line 4, wherein the limitations at the end of line 4 through line 6 are being disregarded since they are also recited in claim 18.
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 10, 11, 17, and 18 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.
Claims 10, 11, 17, and 18 each recite the limitation “a controlling member”; however, since claims 1 and 14 each previously recite the limitation “at least one controlling member”, it is unclear if the controlling member of claims 10, 11, 17, and 18 is referring to the same previously recited at least one controlling member of claims 1 and 14 or an additional controlling member. For examination purposes, the limitation “a controlling member” as recited in claims 10, 11, 17, and 18 has been interpreted as “the at least one controlling member” in order to clearly refer to the same limitation previously recited in claims 1 and 14.
Claims 10, 11, 17, and 18 each recite the limitation “the rod member”; however, there is insufficient antecedent basis for this limitation in the claims. Although claim 2 previously recites “a firm elastomeric rod member” and claim 9 previously recites “a rod member”, claims 10, 11, 17, and 18 do not depend from either claims 2 or 9. For examination purposes, the limitation “the rod member” as recited in claims 10, 11, 17, and 18 has been interpreted as “the patella anchor” as previously recited in claims 1 and 14.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 8 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 8 recites the limitation “the inner facing side of the C-shaped rod member being pressed in contact with the lateral side edge of the patella” in lines 3-4; however, this limitation positively includes the patella to define the invention. For examination purposes, the above limitation of claim 8 has been interpreted as “the inner facing side of the C-shaped rod member is configured to be pressed in contact with the lateral side edge of the patella”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5, 7-10, and 14-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osti et al. (US 6,287,269).
Regarding claims 1 and 14, Osti discloses an apparatus (knee brace 1) and a method comprising:
a patella anchor (supporting element or support A) dimensioned and configured to trace and apply sideways pressure to a perimeter edge of a human patella in a direction traversing a central plane of patella that lies between the patella’s anterior and posterior sides, the pressure being applied via portions of tissue covering and proximate to the same perimeter edge (Figs. 1 & 3-6; column 2, lines 34-39; column 3, lines 54-64), and
at least one controlling member (traction belts or arms E + tubular structure) configured to apply at least one mitigating force vector to the patella anchor (A) which thereby causes or maintains the sideways pressure (Fig. 1; column 2, lines 40-51; column 3, lines 39-40 & 65-67; column 4, lines 1-5).
Regarding claims 2 and 8, Osti discloses that the patella anchor (A) comprises a firm elastomeric rod member, wherein the rod member is in a shape of a C and having an outward facing side forming an outer curved of the C shape and inner facing side form an inner curve of the C shape, wherein the inner facing side of the C-shaped rod member is configured to be pressed in contact with a lateral side edge of the patella when the patella anchor (A) applied the sideways pressure to the lateral side edge in order to create a mitigating force acting on the patella (Figs. 1 & 3-6; column 3, lines 54-64; column 4, lines 15-25).
Regarding claims 3 and 15, Osti discloses that the sideways pressure is in a medial, lateral, top, or bottom tracking direction (Figs. 4-5).
Regarding claims 5, 7, 10, 16, and 17, Osti discloses a carrying web (tubular structure) configured to carry the patella anchor (A), wherein the carrying web comprises a sleeve configured to snugly fit around the leg at portions of the leg above, below and around the knee, and wherein the sleeve comprises a push support configured to support the controlling member (E) configured to push the patella anchor (A) into the perimeter edge (Fig. 1; column 3, lines 39-40; column 4, lines 15-25).
Regarding claim 9, Osti discloses that the patella anchor (A) comprises a rod member formed in a shape in order to interface with and apply pressure to the patella’s perimeter edge (Figs. 1 & 3-6; column 3, lines 54-64; column 4, lines 15-25).
Claims 1, 3-5, 7, 11, 14-16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sigurdsson et al. (US 2016/0095734).
Regarding claims 1 and 14, Sigurdsson discloses an apparatus (patella device 10) and a method comprising:
a patella anchor (elongate boy 82 of support 80) dimensioned and configured to trace and apply sideways pressure to a perimeter edge of a human patella in a direction traversing a central plane of patella that lies between the patella’s anterior and posterior sides, the pressure being applied via portions of tissue covering and proximate to the same perimeter edge (Figs. 1 & 9; ¶ 0113-0114), and
at least one controlling member (sleeve 12 + straps 84, 86 of support 80) configured to apply at least one mitigating force vector to the patella anchor (82) which thereby causes or maintains the sideways pressure (Fig. 1; ¶ 0072 & 0113-0114).
Regarding claims 3 and 15, Sigurdsson discloses that the sideways pressure is in a medial, lateral, top, or bottom tracking direction (Fig. 1; ¶ 0114).
Regarding claim 4, Sigurdsson discloses that the patella anchor (82) includes a firm pad dimensioned and configured to apply posterior pressure to a central anterior portion of the patella, the posterior pressure being applied via portions of tissue covering the central anterior portion of the patella (Fig. 9; ¶ 0113-0114).
Regarding claims 5, 7, 11, 16, and 18, Sigurdsson discloses a carrying web (sleeve 12) configured to carry the patella anchor (82), wherein the carrying web (12) comprises a sleeve configured to snugly fit around the leg at portions of the leg above, below and around the knee, and wherein the sleeve comprises a pull support configured to support the controlling member (12+84/86) configured to pull the patella anchor (82) into the perimeter edge (Fig. 1; ¶ 0072-0073 & 0113-0114).
Claims 1, 3, 5, 6, and 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Milana-Panopoulos. (US 5,944,682).
Regarding claims 1 and 14, Milana-Panopoulos discloses an apparatus (knee brace 10) and a method comprising:
a patella anchor (patellar support 20) dimensioned and configured to trace and apply sideways pressure to a perimeter edge of a human patella in a direction traversing a central plane of patella that lies between the patella’s anterior and posterior sides, the pressure being applied via portions of tissue covering and proximate to the same perimeter edge (Figs. 1-5; column 3, lines 1-30), and
at least one controlling member (substrate 12) configured to apply at least one mitigating force vector to the patella anchor (20) which thereby causes or maintains the sideways pressure (Figs. 1-5; column 2, lines 43-50).
Regarding claims 3 and 15, Milana-Panopoulos discloses that the sideways pressure is in a medial, lateral, top, or bottom tracking direction (Fig. 5).
Regarding claims 5, 6, and 16, Milana-Panopoulos discloses a carrying web (housing 14) configured to carry the patella anchor (20), wherein the carrying web (14) is in the form of a C-shape (Figs. 1 & 3; column 2, lines 51-54; column 3, lines 1-10).
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.
Claims 12, 13, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Milana-Panopoulos as applied to claims 1 and 14 above, in view of Staudinger (US 5,711,312).
Milana-Panopoulos discloses the invention substantially as claimed, as described above, and further discloses that the at least one controlling member (12) comprises adhesive configured to be removably adhered to skin of the leg in order to apply to the patella a mitigating force vector in a direction causing the patella anchor to apply the sideways pressure, wherein the side edge of the patella is the lateral, medial top or bottom side edge of the patella (Fig. 5).
However, Milana-Panopoulos fails to teach that the at least one controlling member comprises two attachment straps each with the adhesive.
Staudinger discloses an apparatus and method comprising a patella anchor (unslit part 1) and at least one controlling member (strips 2, 3) configured to apply at least one mitigating force vector to the patella anchor (1), wherein the at least one controlling member (2, 3) comprises two attachments straps, each with adhesive and fixed to the patella anchor (1) at one end and configured to be removably adhered to skin of the leg at an end opposite the one end, and wherein the attachment straps are positioned and adhered in order to apply to the patella anchor (1) a mitigating force vector in a direction causing the patella anchor (1) to apply sideways pressure to the lateral, medial, top, or bottom side edge of the patella (Figs. 1-2; column 1, lines 5-7; column 2, lines 22-64).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the apparatus and method taught by Milana-Panopoulos such that the at least one controlling member comprises two attachment straps each with the adhesive as taught by Staudinger for the purpose of providing distal and/or proximal support as well as lateral or medial support for the patella to prevent unwanted lateral or medial movement of the patella.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to the applicant’s disclosure: Osti et al. (US 2021/0128337), Hahn et al. (US 10,869,776), Cropper (US 8,926,539), Huffa et al. (US 9,744,063), Sheuermann et al. (US 9,393,147), Forbes et al. (US 9,017,274), Kase (US D639,963), Arbesman et al. (US D616,554), Bauerfeind et al. (US 8,579,843), Arbesman et al. (US 2010/0016771), Scott (US 7,959,590), Dean et al. (US 2009/0131844), Scott (US 2008/0300524), Hunter et al. (US 7,625,350), Sindel et al. (US 7,819,830), Szlema et al. (US 6,149,616), Falk et al. (US 6,080,124), Fulkerson (US 5,873,848), Springs (US 5,865,776), Fareed (US 5,865,782), Palumbo (US 5,613,943), France et al. (US 5,277,697), Palumbo (US 4,296,744).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Keri J. Nelson whose telephone number is 571-270-3821. The examiner can normally be reached Monday - Friday, 9am - 4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael E. Bredefeld, can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KERI J NELSON/Primary Examiner, Art Unit 3786 5/29/2025