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 .
Election/Restrictions and Claim Status
Applicant’s amendments and arguments filed 11/21/25 are acknowledged. Any objection or rejection from the 5/21/25 office action that is not addressed below is withdrawn based on the amendments.
Previously, Group 2 and the species of PDGF and collagen were elected.
Claims 13-14 and 16-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/31/25.
Claims 5, 15 and 23-24 have been canceled.
Claims 1-4 and 6-12 are being examined.
Priority
The priority information is found in the filing receipt of 1/22/25.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/21/25 has been considered by the examiner.
Claim Rejections - 35 USC § 112
Claims were previously rejected under 112. Since the claims have been amended the rejection is updated to correspond to the instant claims. The part of the rejection based on the use of the term ‘polypeptides’ is a new rejection necessitated by amendment.
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 1-4 and 6-12 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.
Claim 1 has been amended to recited that ‘the matrix molecule is’ and further recite ‘polypeptides’ as an option. Claim 1 specifically uses the plural term ‘polypeptides’ while other members of the group are not pluralized. It is unclear if the term ‘polypeptides’ requires at least 2 separate and distinct polypeptides or if the use of the plural term is intended to encompass multiple copies of a single polypeptide. As such, there is more than one reasonable interpretation of the claim. None of dependent claims 2, 4, 6-8 and 10-12 clarify the claim scope.
Claim 1 recites ‘matrix molecule’ and claim 1 specifically recites ‘or a derivative thereof’. The specification does not provide a definition of ‘matrix molecule’ and merely states that ‘A matrix molecule can be an extracellular molecule found in the extracellular matrix’ (page 5 5th paragraph). The use of the word ‘can’ is not specifically limiting. The required features of a ‘matrix molecule’ are not clear. For example, it is unclear if the origin of the molecule or some type of structural feature would allow it to be classified as a ‘matrix molecule’. Since claim 1 recites ‘derivatives’ it would seem that derivatives are within the scope of the claim. Further, the specification refers to collagens and variants thereof (page 5 last paragraph) so claim 9 is interpreted in such fashion. If derivatives (and variants) are within the scope of the claim, it is not clear what type of derivative or what degree of derivatization would allow the molecule to be considered a ‘matrix molecule’. None of the dependent claims clarify the claim scope.
Claim 8 refers to storage at a certain condition. As amended, the storage temperature is unclear. It is unclear if the first number is minus 80 or 80 (positive 80). The problem is that the claim includes strikethrough and it is unclear if a minus sign is intended after the strikethrough. CFR 1.121(c)(2) recognizes that double brackets can be used if the strike-through cannot be easily perceived.
Although unclear, the claims have been given the broadest reasonable interpretation consistent with the specification.
Response to Arguments - 112
Applicant's arguments filed 11/21/25 have been fully considered but they are not persuasive with respect to the rejections set forth above.
Although applicants argue that claim 1 has been amended, the amended claim is addressed above.
Although applicants argue that the term derivative is known, the issue in the instant case is that the term is used in reference to a matrix molecule. It is not clear what type of derivative or what degree of derivatization would allow the molecule to be considered a ‘matrix molecule’. Collagen can be over 1000 amino acids long and thus has many positions which can be substituted. It is not clear what type of derivatization (for example, substitution, addition, deletion or insertion) can be performed to result in a version that is still a matrix molecule. Stated another way, the phrase ‘matrix molecule’ might be interpreted to imply some type of functional requirement. However, it is unclear how to determine what is classified as a ‘matrix molecule’.
Claim Rejections - 35 USC § 102
Claims were previously rejected based on the references cited below. Since the claims have been amended, the rejections are updated to correspond to the instant claims.
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 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.
Claim(s) 1-4 and 6-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 101954122 (Wang et al. 01-2011; ‘Wang’).
Wang is not in the English language. A copy of the translated document (Translation of CN 101954122 (Wang et al. 01-2011), 6 pages; ‘Wangtranslation’) is provided.
Wangtranslation teach that a collagen solution was prepared that contained 20 mg/ml collagen and 15 ng/ml platelet-derived growth factor (section 0032). Wangtranslation teach that the composition was freeze-dried (section 0033). Wangtranslation teach the inclusion of bone morphogenetic protein (sections 0013, 0016 and 0032).
In another example, Wangtranslation teach that a collagen solution was prepared that contained 10 mg/ml collagen and platelet-derived growth factor (section 0026). The original Wang document shows that the amount of platelet-derived growth factor is 10 ng/ml (section 0026). Wangtranslation teach that the composition was freeze-dried (section 0027). Wangtranslation teach the inclusion of bone morphogenetic protein (sections 0013, 0016 and 0026).
In relation to the matrix molecule and collagen and amounts of claims 1, 3-4 and 9, Wangtranslation teach that a collagen solution was prepared that contained 20 mg/ml collagen (section 0032). Wangtranslation teach that a collagen solution was prepared that contained 10 mg/ml collagen (section 0026).
In relation to the growth factor of claims 1, 6 and 11, Wangtranslation teach that a collagen solution was prepared that contained 15 ng/ml platelet-derived growth factor (section 0032). Wangtranslation teach that a collagen solution was prepared that contained platelet-derived growth factor (section 0026). The original Wang document shows that the amount of platelet-derived growth factor is 10 ng/ml (section 0026).
In relation to the ratios of claims 1 and 7, Wangtranslation teach that a collagen solution was prepared that contained 20 mg/ml collagen and 15 ng/ml platelet-derived growth factor (section 0032). 15ng/ml is 0.000015 mg/ml (1000000ng/mg) so the ratio is 0.00000075:1.
In relation to drying of claims 1-2, Wangtranslation teach that the composition was freeze-dried (sections 0027 and 0033). Further, Wangtranslation teach that the freeze-drying results in a blocky repairing material (section 0014). Wangtranslation teach that the picture (figure 1) shows the bone repairing material with size of 1x1x0.5 cm (section 0021) and the original Wang document shows the image (page 7). The instant specification does not define powder to require any specific shape or size of particles. Since Wangtranslation teach that the freeze-drying results in a blocky repairing material (section 0014) and the picture shows the bone repairing material with size of 1x1x0.5 cm (section 0021), such particles are interpreted as meeting the claim limitation.
In relation to the storage of claim 8, Wangtranslation teach storage at -80 degrees centigrade (sections 0027 and 0033) which is interpreted as meeting the claim limitation as recited in claim 8.
In relation to the functionality recited in claim 10, the prior art teach the elected components as claimed so they would function as claimed. Wangtranslation refer to the material as stable and self-stable (abstract and section 0016).
In relation to claim 12, Wangtranslation teach the inclusion of bone morphogenetic protein (sections 0013, 0016 and 0032) which is a tissue repair material. Wangtranslation teach the inclusion of bone morphogenetic protein (sections 0013, 0016 and 0026) which is a tissue repair material.
Claim(s) 1, 3-4 and 8-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. (US 5,399,361; ‘Song’).
Song teach that a collagen solution containing PDGF was prepared (column 5 lines 34-45). Song teach that 2g of collagen was prepared in 50 ml of water (column 5 lines 34-45) which results in 40 mg/ml collagen. Song teach that to 16 ml of the solution 4 ml was added which contained 2 mg/ml PDGF (column 5 lines 34-45) which results in 32 mg/ml collagen. Song teach that the solution was dried (column 5 lines 34-45).
In relation to the matrix molecule and collagen of claims 1, 3-4 and 9, Song teach that 2g of collagen was prepared in 50 ml of water (column 5 lines 34-45) which results in 40 mg/ml collagen. Song teach that to 16 ml of the solution 4 ml was added which contained 2 mg/ml PDGF (column 5 lines 34-45) which results in 32 mg/ml collagen.
In relation to the growth factor of claims 1 and 11, Song teach that to 16 ml of the solution 4 ml was added which contained 2 mg/ml PDGF (column 5 lines 34-45).
In relation to the ratios of claim 1, Song teach that 2g of collagen was prepared in 50 ml of water (column 5 lines 34-45) which results in 40 mg/ml collagen. Song teach that to 16 ml of the solution 4 ml was added with contained 2 mg/ml PDGF (column 5 lines 34-45) which results in 32 mg/ml collagen. Song teach that to 16 ml of the solution 4 ml was added which contained 2 mg/ml PDGF (column 5 lines 34-45). So the ratio is 2:32 or .0625:1.
In relation to drying of claim 1, Song teach that the solution was dried (column 5 lines 34-45). Instant claim 1 recites ‘performing a drying process to the solution, thereby obtaining..’. Since Song teach drying, the resultant product is interpreted as being obtained. The instant specification does not define powder to require any specific shape or size of particles.
In relation to the storage of claim 8, Song teach 30-50C (column 5 lines 34-45) which is interpreted as meeting the claimed limitation.
In relation to the functionality recited in claim 10, the prior art teach the elected components as claimed so they would function as claimed.
Response to Arguments - 103
Applicant's arguments filed 11/21/25 have been fully considered but they are not persuasive with respect to the rejections set forth above.
Although applicants argue that claim 1 has been amended, the amended claim is addressed above.
Although applicants argue that Wang teach a blocky or other shape, the instant specification does not define powder to require any specific shape or size of particles. Since Wangtranslation teach that the freeze-drying results in a blocky repairing material (section 0014) and the picture (figure 1) shows the bone repairing material with size of 1x1x0.5 cm (section 0021), such particles are interpreted as meeting the claim limitation.
Although applicants argue that Wang refers to a net structure, instant claim 1 expressly recites ‘preserving’ and ‘matrix molecule’. The presence of a net structure is consistent with the ability to preserve and to act as a matrix molecule. Thus, such citations support the rejection.
Although applicants argue that claim 1 is very different from the composition of Wang, it is not clear how it is specifically different. The term ‘powder’ is broad with respect to the size and shape of particles.
Although applicants argue about utilizing a powder composition, the active steps of claim 1 are providing and drying. As such, no utilizing step is required. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Although applicants argue that Song does not teach a step of drying to obtain a powder composition, Song teach that the solution was dried (column 5 lines 34-45). Instant claim 1 recites ‘performing a drying process to the solution, thereby obtaining..’. Since Song teach drying, the resultant product is interpreted as being obtained. The instant specification does not define powder to require any specific shape or size of particles.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658