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 without traverse of Species 8, Fig. 12 in the reply filed on 08 September 2025 is acknowledged. Claim(s) 95-96 is/are withdrawn.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 89-94, 97-104 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 101-119 of copending Application No. 17/215,026 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claim 89, the reference patent claims (see Clm. 101, see also Claim 117) a method of implanting a medical device in a human patient, wherein the medical device comprises an artificial contacting surface for a joint and at least one inlet configured to receive a lubricating fluid from a reservoir (not explicitly claimed in Claim 101, but implicit to the step of “lubricating said artificial contacting surface” which necessarily requires the contacting surface to have a receiving region, i.e. an inlet, for receipt of the lubrication from the implanted reservoir, see also the “channel” recited in Claim 117),
said method comprising the steps of:
a. creating an opening reaching from outside of the human body into the joint,
b. providing said artificial contacting surface to said joint,
c. fixating the artificial contacting surface to the joint,
d. implanting said reservoir in the human body, and
e. lubricating said artificial contacting surface with use of a lubricating fluid contained in said reservoir.
Regarding Claim 90, see Clm. 103
Regarding Claim 91, see Clm. 104
Regarding Claim 92, see Clm. 105
Regarding Claim 93, see Clm. 106
Regarding Claim 94, see Clm. 107
Regarding Claim 97, see Clm. 110
Regarding Claim 99, see Clm. 111
Regarding Claim 100, see Clm. 112
Regarding Claim 101, see Clm. 114
Regarding Claim 102, see Clm. 115
Regarding Claim 103, see Clm. 116
Regarding Claim 104, the reference patent claims (see Clm. 117) a method of lubricating an implantable medical device, said medical device comprising an artificial contacting surface adapted to carry weight in a joint of a patient, said artificial contacting surface comprises at least one channel for transporting of a lubricating fluid, said method comprises the steps of:
a. implanting said medical device in a joint of the human patient,
b. implanting a conduit to be connected to said medical device
c. implanting an operation device for transporting a lubricating fluid inside said conduit
d. implanting a reservoir adapted to hold a lubricating fluid, and
e. at least postoperatively transporting, by said operation device, said lubricating fluid from said reservoir to said artificial contacting surface in said conduit and further through said channel in said artificial contacting surface, thereby applying said lubricating fluid to said artificial contacting surface.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented..
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.
Claim(s) 90-93 and 98-101 is/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.
Regarding Claim(s) 90-93 and 98-101, these claims include limitations which appear intended to further limit previous method steps recited in the preceding claims. However, each of these claims have an extraneous commas separating the previous method step which they appear intended to limit and the specific new limitations which further limit said step. The use of this comma appears grammatically incorrect and creates confusion as toward the dependencies of these clauses as to whether they’re intended to modify the immediately proceeding clause or intended to modify the general method as presented in the preamble.
For example, Claim 90 recites “The method according to claim 89, wherein the step of lubricating said artificial contacting surface with use of lubricating fluid contained in said reservoir, comprises implanting an operation device transporting said fluid from said reservoir to said artificial contacting surface” wherein the comma between “the step of lubricating…” and “comprises implanting” would suggest that these two clauses are independent of one another.
Or for example, Claim 99 recites “The method according to claim 89, wherein the step of providing said artificial contacting surface, comprises the step of providing said artificial contacting surface, from the abdominal side of the pelvic bone” which appears to have two extraneous commas.
For the sake of prosecution the claims will be interpreted without consideration of these commas. To the extent that ignoring these extraneous commas might change the way the claim is interpreted from how it was intended to be interpreted by Applicant these claims are held to be indefinite and require appropriate correction.
Claim Rejections - 35 USC § 102
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.
Claim(s) 89, 94, 102, 103, is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by U.S. Publication No. 2003/0060891 (“Shah”)
Regarding Claims 89, Shah discloses a method of implanting a medical device (10) in a human patient, wherein the medical device comprises an artificial contacting surface (12) adapted to carry weight in a joint of the patient and at least one inlet (26 – at 24; see Fig. 5) configured to receive a lubricating fluid (40) from a reservoir (26 – at 18), the method comprising the steps of:
Creating an opening from outside of the human body to the joint and providing the artificial contacting surface to the joint and fixating the artificial contacting surface to the joint (see Fig. 1) implanting the reservoir in the human body (see Fig. 1) and lubricating the artificial contacting surface with use of a lubricating fluid contained in the reservoir (Abstract; Fig. 5).
Regarding Claim 94, Shah discloses the step of implanting said reservoir in the human body comprises the step of implanting said reservoir at least partially inside of a bone of the patient (see Fig. 1).
Regarding Claim 102, Shah discloses the method further comprising the step of implanting an injection port (28, 30, 32) for filling of said reservoir.
Regarding Claim 103, Shah discloses the step of implanting said injection port comprises the step of implanting said injection port in connection with bone (see Fig. 1).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 90-92, 104 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Publication No. 2003/0060891 (“Shah”) as applied above, and further in view of U.S. Patent No. 5,350,379 (“Spievack”)
Regarding Claim 90-92, Shah discloses the invention substantially as claimed except that that the step of lubricating the artificial contacting surface with use of a lubricating fluid contained in said reservoir, comprises implanting an operation device transporting the fluid from the reservoir to the artificial contacting surface. Specifically, Shah recites the “the lubricant can be introduced through the one-way valve, through the catheter 30 and into the channel 26” (Par. 42) but fails to explicitly disclose what provides the motive force to actually introduce the lubricant. However, Spievack discloses a related orthopedic device configured to supply a fluid from an implantable reservoir (72) to the device using an operation device (re: a pump 32), the pump being powered by an energy source in the form of an implantable battery (86) in order to ensure an adequate supply of fluid is provided and maintained. It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the device of Shah with a battery powered, implantable pump, as disclosed by Spievack, in order to ensure that a sufficient volume of lubricant is provided for sustained use and ensure that the system maintains sufficient pressure to ensure delivery of the lubricant throughout the implant.
Regarding Claim 104, Shah discloses a method of lubricating an implantable medical device (Abstract), said medical device comprising an artificial contacting surface (inter alia 12) adapted to carry weight in a joint of a patient, said artificial contacting surface comprises at least one channel (34 and the interior passage leading thereto from catheter 30) for transporting of a lubricating fluid, said method comprises the steps of:
a. implanting said medical device in a joint of the human patient (see Fig. 1),
b. implanting a conduit (30) for to be connected to said medical device;
d. implanting a reservoir adapted to hold a lubricating fluid (see generally at 32); and
e. at least postoperatively transporting said lubricating fluid from said reservoir to said artificial contacting surface in said conduit and further through said channel in said artificial contacting surface, thereby applying said lubricating fluid to said artificial contacting surface (Abstract).
Shah discloses the invention substantially as claimed except that that the method includes implanting an operation device for transporting a lubricating fluid inside said conduit through the reservoir. Specifically, Shah recites the “the lubricant can be introduced through the one-way valve, through the catheter 30 and into the channel 26” (Par. 42) but fails to explicitly disclose what provides the motive force to actually introduce the lubricant. However, Spievack discloses a related orthopedic device configured to supply a fluid from an implantable reservoir (72) to the device using an operation device (re: a pump 32), the pump being powered by an energy source in the form of an implantable battery (86) in order to ensure an adequate supply of fluid is provided and maintained. It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the device of Shah with a battery powered, implantable pump, as disclosed by Spievack, in order to ensure that a sufficient volume of lubricant is provided for sustained use and ensure that the system maintains sufficient pressure to ensure delivery of the lubricant throughout the implant.
Claim(s) 93 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Publication No. 2003/0060891 (“Shah”) and U.S. Patent No. 5,350,379 (“Spievack”) as applied above, and further in view of U.S. Patent No. 4,457,752 (“Vadaz”).
Regarding Claim 93, Shah, as modified by Spievack, provides for the step of implanting an operation device (re: the pump, see Spivak) to transport a lubricating fluid from the reservoir to the artificial contacting surface. In the instant case Spievack fails to disclose that the operation device is “integrated” in said reservoir. Rather, Spievack discloses the reservoir (72) to be provided remotely from the pump (32). However, Vandaz discloses an implantable pump (Fig. 1) wherein an operation device (re: spring 30 and piston 22) are provided integrated in the reservoir (see Fig. 1) allowing the pump to be externally controlled to provide for an adjustable rate of fluid delivery to transport the fluid from the reservoir through the exit tubing (24). It would have been obvious for one having ordinary skill in the art at the time the invention was made to replace the battery powered pump of the invention of Shah (modified in view of Spievack) with a spring powered pump with the spring integrated in the reservoir, as disclosed by Vadaz, in order to allow for an integrated fluid handling and delivery system allowing the system to be miniaturized so as to be less obtrusive for the user.
Claim(s) 97 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Publication No. 2003/0060891 (“Shah”) as applied above, and further in view of U.S. Publication No. 2007/0088442 (“Cima”).
Regarding Claim 97, Shah discloses the invention substantially as claimed except that that the reservoir is implanted at least partially inside of a bone of the human body comprising the pelvic bone. Rather Shah discloses integrating the reservoir in the femoral head of the hip joint. However, Cima discloses that a hip joint prosthesis can be lubricated an artificial contacting surface via reservoirs provided integrated with the acetabular cup component (20) of the hip joint (Par. 74). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Shah to be integrated into an acetabular cup contacting surface of the hip prosthesis, as disclosed by Cima, in conjunction with or as a replacement to integration in the femoral head component in order to ensure that the acetabular cup is sufficiently lubricated.
Claim(s) 98 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Publication No. 2003/0060891 (“Shah”) as applied above, and further in view of U.S. Patent No. 3,866,248 (“Kummer”).
Regarding Claim 98, Shah discloses the invention substantially as claimed except that that method includes the step of creating an opening in the pelvic bone, from the abdominal side of the pelvic bone. However, Kummer discloses a related method of hip joint replacement which includes securing the implant within the acetabular cup of the pelvis by creating a plurality of openings in the pelvic bone, the openings being throughgoing such that they extent from the abdominal side of the pelvic bone into the acetabular cup (see Fig. 6), wherein these openings allow for emplacing a “restrictor” (22) which allows the bone cement to bond through the bone, but not freely escape into the abdominal cavity (see Fig. 6 - Abstract) thereby ensuring better adhesion between the implant and the bone. It would have been obvious for one having ordinary skill in the art at the time the invention was made to include modifying the method of Shah to utilize restrictors provided in holes extending from the abdominal wall into the acetabular cup, as disclosed by Kummer, in order to ensure proper boding of the implant with the acetabular cup while ensuring that cement does not leak uncontrolled into the abdominal cavity.
Claim(s) 100-101 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Publication No. 2003/0060891 (“Shah”) as applied above, and further in view of U.S. Publication No. 2007/0016163 (“Santini”)
Regarding Claim 100-101, Shah discloses the invention substantially as claimed except that reservoir is implanted “subcutaneously”. However, Santini discloses a related fluid delivery means (80) which is implantable in order to provide for prosthetic delivery of fluids to the hip joint, wherein the apparatus can be implanted in a “subcutaneous” pocket in the abdominal region (Par. 64). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide a fill reservoir (generally 32) of the device of Shah in a subcutaneous pocket formed in the abdominal region of the patient, as disclosed by Santini, in order to locate the reservoir at an easy to access and predictable location for refilling as needed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
11/03/2025