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 .
Response to Election/Restriction filed on December 2, 2025 is acknowledged.
Claims 1-14 are pending in this application.
Restriction
Applicant’s election without traverse of Group 1 (claims 1-10) and the election of species without traverse as follows
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in the reply filed on December 2, 2025 is acknowledged. Restriction requirement is deemed to be proper and is made FINAL in this office action. Claims 11-14 are hereby withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Claims 7 and 9 are withdrawn from further consideration as being drawn to nonelected species. Claims 1-6, 8 and 10 are examined on the merits in this office action.
Objections
5. The abstract is objected to for the following minor informality:
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
In the instant case, the abstract recites, “An anti-osteoclastic composition...in which the rate of bone resorption exceed the rate of bone formation” at lines 1-7 of the abstract. This first sentence appears to be an incomplete sentence. Applicant should correct these informalities. See MPEP 608.01(b).
6. The drawings are objected to because some of the drawings are missing the Y axis labels (see for example, FIG. 6A and FIG. 6B). 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.
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Rejections
U.S.C. 102
7. 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.
8. 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.
9. Claim(s) 1-6 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jay et al (WO 2016/123123, filed with IDS), as evidenced by Osteoporosis and Metabolic Bone Health Center (https://www.hss.edu/departments/medicine/endocrinology-metabolic-bone/osteoporosis-center, pp. 1-5, Accessed 2/26/2026).
10. Jay et al teach that PRG4 glycoprotein is also known as lubricin (see abstract) and proteoglycan 4 is PRG4 (see paragraph [0003]). Jay et al teach that “when the surface is in a human subject, the human suffers from a bone metabolic disorder and exposing the receptor to PRG4 reduces or inhibits osteoclast differentiation” (see paragraph [0024]). As evidenced by Metabolic Bone Health Center, “Metabolic bone disease refers to abnormalities in bones caused by a broad spectrum of disorders. Conditions that are often considered metabolic bone disorders include osteoporosis, osteomalacia, rickets, hypophosphatemia and Paget’s disease” (see p. 1). Since the elected species osteoporosis is a metabolic bone disease, Jay et al meets the limitation of instant claims 1 and 8. Jay et al teach that conditions of the joints or bones may be treated by systemic administration of PRG4 and reducing or inhibiting inflammatory responses in tissues of the eye, joints, cartilage and bone (see paragraph [0083]). Jay et al teach that “for administration, lubricin is preferably combined with a pharmaceutically acceptable carrier…pharmaceutically acceptable carriers include buffers…also include biomaterials such as matrices, hydrogel, polymers, tissue scaffolds…Lubricin for administration can be presented in a dosage unit form and can be prepared by any suitable method and should be formulated to be compatible with its intended route of administration” (see paragraph [0074]), meeting the limitation of instant claim 3. Jay et al teach that the PRG4 administered is a recombinant human PRG4 (see paragraph [0013]), meeting the limitation of instant claim 2. Jay et al teach that “The PRG4-containig compositions may be administered in any manner suitable to direct PRG4 to the location within a patient, including by direct injection or placement of a pre-formed PRG4 composition during an open surgery or during a laparoscopic or arthroscopic procedure” (see paragraph [0008]), meeting the limitation of instant claims 4-5.
Furthermore, with respect to “wherein the administration of the anti-osteoclastic composition inhibits or delays onset of a pathological condition of the bone (claim 6)” according to MPEP 2111.04: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. <”. In the instant case, it is not deemed that the “wherein” clause limits the claim to particular structural features.
Additionally, with respect to the limitation in the preamble of claims 1-6 and 8, “A method for reducing or inhibiting bone resorption comprising administering to a human or animal..”, please note that MPEP 2111.02 II states "a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention." In the instant case, the preamble does not affect the method steps. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation. Furthermore, the patient population is not defined by the claims. Therefore, anybody being administered a composition comprising proteoglycan 4 would have the same end result of “reducing or inhibiting bone resorption”.
Since the refence teaches ALL of the active method steps of instant claims, the reference anticipates instant claims 1-6 and 8.
11. Claim(s) 1-6 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jay et al (US 2018/0015141, filed with IDS), as evidenced by Osteoporosis and Metabolic Bone Health Center (https://www.hss.edu/departments/medicine/endocrinology-metabolic-bone/osteoporosis-center, pp. 1-5, Accessed 2/26/2026).
12. Jay et al teach that PRG4 glycoprotein is also known as lubricin (see abstract) and proteoglycan 4 is PRG4 (see paragraph [0003]). Jay et al teach that “when the surface is in a human subject, the human suffers from a bone metabolic disorder and exposing the receptor to PRG4 reduces or inhibits osteoclast differentiation” (see paragraph [0024]). As evidenced by Metabolic Bone Health Center, “Metabolic bone disease refers to abnormalities in bones caused by a broad spectrum of disorders. Conditions that are often considered metabolic bone disorders include osteoporosis, osteomalacia, rickets, hypophosphatemia and Paget’s disease” (see p. 1). Since the elected species osteoporosis is a metabolic bone disease, Jay et al meets the limitation of instant claims 1 and 8. Jay et al teach that conditions of the joints or bones may be treated by systemic administration of PRG4 and reducing or inhibiting inflammatory responses in tissues of the eye, joints, cartilage and bone (see paragraph [0083]). Jay et al teach that “for administration, lubricin is preferably combined with a pharmaceutically acceptable carrier…pharmaceutically acceptable carriers include buffers…also include biomaterials such as matrices, hydrogel, polymers, tissue scaffolds…Lubricin for administration can be presented in a dosage unit form and can be prepared by any suitable method and should be formulated to be compatible with its intended route of administration” (see paragraph [0074]), meeting the limitation of instant claim 3. Jay et al teach that the PRG4 administered is a recombinant human PRG4 (see paragraph [0013]), meeting the limitation of instant claim 2. Jay et al teach that “The PRG4-containig compositions may be administered in any manner suitable to direct PRG4 to the location within a patient, including by direct injection or placement of a pre-formed PRG4 composition during an open surgery or during a laparoscopic or arthroscopic procedure” (see paragraph [0008]), meeting the limitation of instant claims 4-5.
Furthermore, with respect to “wherein the administration of the anti-osteoclastic composition inhibits or delays onset of a pathological condition of the bone (claim 6)” according to MPEP 2111.04: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. <”. In the instant case, it is not deemed that the “wherein” clause limits the claim to particular structural features.
Additionally, with respect to the limitation in the preamble of claims 1-6 and 8, “A method for reducing or inhibiting bone resorption comprising administering to a human or animal..”, please note that MPEP 2111.02 II states "a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention." In the instant case, the preamble does not affect the method steps. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation. Furthermore, the patient population is not defined by the claims. Therefore, anybody being administered a composition comprising proteoglycan 4 would have the same end result of “reducing or inhibiting bone resorption”.
Since the refence teaches ALL of the active method steps of instant claims, the reference anticipates instant claims 1-6 and 8.
U.S.C. 103
13. 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.
14. 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.
15. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
16. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
17. Claim(s) 1-6, 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jay et al (WO 2016/123123, filed with IDS or US 2018/0015141, filed with IDS), as evidenced by Osteoporosis and Metabolic Bone Health Center (https://www.hss.edu/departments/medicine/endocrinology-metabolic-bone/osteoporosis-center, pp. 1-5, Accessed 2/26/2026) in view of Kwon et al (European Journal of Pharmacology, 2015, 768: 189-198).
The applied reference has a common Inventor (Schmidt) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
18. Jay et al teach that PRG4 glycoprotein is also known as lubricin (see abstract) and proteoglycan 4 is PRG4 (see paragraph [0003]). Jay et al teach that “when the surface is in a human subject, the human suffers from a bone metabolic disorder and exposing the receptor to PRG4 reduces or inhibits osteoclast differentiation” (see paragraph [0024]). As evidenced by Metabolic Bone Health Center, “Metabolic bone disease refers to abnormalities in bones caused by a broad spectrum of disorders. Conditions that are often considered metabolic bone disorders include osteoporosis, osteomalacia, rickets, hypophosphatemia and Paget’s disease” (see p. 1). Since the elected species osteoporosis is a metabolic bone disease, Jay et al meets the limitation of instant claims 1 and 8. Jay et al teach that conditions of the joints or bones may be treated by systemic administration of PRG4 and reducing or inhibiting inflammatory responses in tissues of the eye, joints, cartilage and bone (see paragraph [0083]). Jay et al teach that “for administration, lubricin is preferably combined with a pharmaceutically acceptable carrier…pharmaceutically acceptable carriers include buffers…also include biomaterials such as matrices, hydrogel, polymers, tissue scaffolds…Lubricin for administration can be presented in a dosage unit form and can be prepared by any suitable method and should be formulated to be compatible with its intended route of administration” (see paragraph [0074]), meeting the limitation of instant claim 3. Jay et al teach that the PRG4 administered is a recombinant human PRG4 (see paragraph [0013]), meeting the limitation of instant claim 2. Jay et al teach that “The PRG4-containig compositions may be administered in any manner suitable to direct PRG4 to the location within a patient, including by direct injection or placement of a pre-formed PRG4 composition during an open surgery or during a laparoscopic or arthroscopic procedure” (see paragraph [0008]), meeting the limitation of instant claims 4-5.
Furthermore, with respect to “wherein the administration of the anti-osteoclastic composition inhibits or delays onset of a pathological condition of the bone (claim 6)” according to MPEP 2111.04: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. <”. In the instant case, it is not deemed that the “wherein” clause limits the claim to particular structural features.
Additionally, with respect to the limitation in the preamble of claims 1-6 and 8, “A method for reducing or inhibiting bone resorption comprising administering to a human or animal..”, please note that MPEP 2111.02 II states "a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention." In the instant case, the preamble does not affect the method steps. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation. Furthermore, the patient population is not defined by the claims. Therefore, anybody being administered a composition comprising proteoglycan 4 would have the same end result of “reducing or inhibiting bone resorption”.
Since the refence teaches ALL of the active method steps of instant claims, the reference anticipates instant claims 1-6 and 8.
The difference between the reference and instant claim is that the reference does not teach additional second anti-osteoclastic composition.
19. However, Kwon et al teach additional compound, such as myristoleic acid that inhibits osteoclast formation and bone resorption (see for example, TITLE).
20. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Jay et al as evidenced by Osteoporosis and Metabolic Bone Health Center and Kwon et al, because both references teach inhibiting or reducing bone resorption and osteoclast formation. On of ordinary skill in the art would be motivated to combine with a reasonable expectation of success, because adding a compound known for having the same function would at least have an additive effect. The MPEP states that “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). But see In re Geiger, 815 F.2d 686, 2 USPQ2d 1276 (Fed. Cir. 1987) (“Based upon the prior art and the fact that each of the three components of the composition used in the claimed method is conventionally employed in the art for treating cooling water systems, the board held that it would have been prima facie obvious, within the meaning of 35 U.S.C. 103, to employ these components in combination for their known functions and to optimize the amount of each additive....Appellant argues... hindsight reconstruction or at best,... obvious to try’.... We agree with appellant.”).
Therefore, the combined art is prima facie obvious over instant claims 1-6, 8 and 10.
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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/JULIE HA/Primary Examiner, Art Unit 1654
2/26/2026